Journal articles on the topic 'CLTI'
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Khattri, Ram B., Kyoungrae Kim, Trace Thome, Zachary R. Salyers, Kerri A. O’Malley, Scott A. Berceli, Salvatore T. Scali, and Terence E. Ryan. "Unique Metabolomic Profile of Skeletal Muscle in Chronic Limb Threatening Ischemia." Journal of Clinical Medicine 10, no. 3 (February 2, 2021): 548. http://dx.doi.org/10.3390/jcm10030548.
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Chronic limb threatening ischemia (CLTI) is the most severe manifestation of peripheral atherosclerosis. Patients with CLTI have poor muscle quality and function and are at high risk for limb amputation and death. The objective of this study was to interrogate the metabolome of limb muscle from CLTI patients. To accomplish this, a prospective cohort of CLTI patients undergoing either a surgical intervention (CLTI Pre-surgery) or limb amputation (CLTI Amputation), as well as non-peripheral arterial disease (non-PAD) controls were enrolled. Gastrocnemius muscle biopsy specimens were obtained and processed for nuclear magnetic resonance (NMR)-based metabolomics analyses using solution state NMR on extracted aqueous and organic phases and 1H high-resolution magic angle spinning (HR-MAS) on intact muscle specimens. CLTI Amputation specimens displayed classical features of ischemic/hypoxic metabolism including accumulation of succinate, fumarate, lactate, alanine, and a significant decrease in the pyruvate/lactate ratio. CLTI Amputation muscle also featured aberrant amino acid metabolism marked by elevated branched chain amino acids. Finally, both Pre-surgery and Amputation CLTI muscles exhibited pronounced accumulation of lipids, suggesting the presence of myosteatosis, including cholesterol, triglycerides, and saturated fatty acids. Taken together, these metabolite differences add to a growing body of literature that have characterized profound metabolic disturbance’s in the failing ischemic limb of CLTI patients.
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Frese, Jan Paul, Larissa Schawe, Jan Carstens, Karlis Milbergs, Fiona Speichinger, Alexandra Gratl, Andreas Greiner, and Ben Raude. "A Modified Run-Off Resistance Score from Cross-Sectional Imaging Discriminates Chronic Critical Limb Ischemia from Intermittent Claudication in Peripheral Arterial Disease." Diagnostics 12, no. 12 (December 14, 2022): 3155. http://dx.doi.org/10.3390/diagnostics12123155.
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Atherosclerotic peripheral arterial disease (PAD) leads to intermittent claudication (IC) and may progress into chronic limb-threatening ischemia (CLTI). Scoring systems to determine the atherosclerotic burden of a diseased extremity have been developed. This study aimed to evaluate a modification of the run-off resistance (mROR) score for its usability in cross-sectional imaging. The mROR was determined from preoperative imaging of patients undergoing revascularization for PAD. A total of 20 patients with IC and 20 patients with CLTI were consecutively included. A subgroup analysis for diabetic patients was conducted. The mROR was evaluated for its correlation with disease severity and clinical covariates. Patients with CLTI were older; cardiovascular risk factors, diabetes, and ASA 4 were more frequent. The mROR scores were higher in CLTI than in IC. In diabetic patients, no difference was detected between CLTI and IC. In CLTI, non-diabetic patients had a higher mROR. The mROR score is positively correlated with the severity of PAD and can discriminate CLTI from IC. In diabetic patients with CLTI, the mROR is lower than in non-diabetic patients. The mROR score can be determined from cross-sectional imaging angiographies. It may be useful for clinicians helping with vascular case planning, as well as for scientific purposes.
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De Stefano, Frank, Luis H. Paz Rios, Brian Fiani, Jawed Fareed, and Alfonso Tafur. "National Trends for Peripheral Artery Disease and End Stage Renal Disease From the National Inpatient Sample Database." Clinical and Applied Thrombosis/Hemostasis 27 (January 1, 2021): 107602962110256. http://dx.doi.org/10.1177/10760296211025625.
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Peripheral artery disease (PAD), and subsequent chronic limb-threatening ischemia (CLTI), are frequently encountered among patients with end-stage renal disease (ESRD). Their coexistence is less favorable in comparison to patients with ESRD alone. We sought to investigate trends, comorbidities, determinants for cost, and prognostic outcomes in patients with concomitant ESRD and PAD. A retrospective analysis was performed using data from the National Inpatient Sample database from the years 2005-2014. ICD-9 codes were used to identify patients with diagnoses of PAD, CLTI, and ESRD. Pearson’s Chi-square, T-test, ANOVA, and multivariate binary logistic regression were used in this analysis. 7,214,843 patients with ESRD were identified. Of these, 123,499 patients were diagnosed with PAD and 102,447 with CLTI. Compared to ESRD alone, mortality rates increased with PAD and CLTI (5.7% vs. 13.9% vs. 15.9%, P < 0.001). Length of stay in days (7.3 vs. 10.2 vs. 11.1, P < 0.001) and in-hospital costs (59,872 vs. 85,866 vs. 89,016, P < 0.001) were higher with PAD and CLTI, respectively. CLTI demonstrated the highest independent predictor of mortality [OR = 6.93 (6.43-7.46), P < 0.001]. A decreasing trend in the rate of PAD (2005: 1.9% vs. 2014: 1.4%, P < 0.001) and CLTI (2005: 1.6% vs. 2014: 1.1%, P < 0.001) was noted. The presence of coexisting PAD, and furthermore CLTI, in patients with ESRD significantly raised in-hospital mortality, cost, and length of stay. A negative trend in rates of PAD and CLTI were observed. Proactive identification of this high-risk population may lead to accurate diagnosis and tailored therapeutic strategies.
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Syed, Muzammil H., Abdelrahman Zamzam, Jason Valencia, Hamzah Khan, Shubha Jain, Krishna K. Singh, Rawand Abdin, and Mohammad Qadura. "MicroRNA Profile of Patients with Chronic Limb-Threatening Ischemia." Diagnostics 10, no. 4 (April 17, 2020): 230. http://dx.doi.org/10.3390/diagnostics10040230.
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Chronic limb-threatening ischemia (CLTI) results in devastating complications such as lower-limb amputations. In this study, a genome-wide plasma microRNAs (miRNA) sequencing was performed to identify miRNA(s) associated with CLTI. Blood samples were collected from early stage CLTI patients (ABI < 0.9) and non-PAD controls (ABI ≥ 0.9) for 3 experiments: discovery phase (n = 23), confirmatory phase (n = 52) and validation phase (n = 20). In the discovery phase, next generation sequencing (NGS) was used to identify miRNA circulating in the plasma CLTI (n = 13) patients, compared to non-PAD controls (n = 10). Two down-regulated miRNAs (miRNA-6843-3p and miRNA-6766-5p) and three upregulated miRNAs (miRNA-1827, miRNA-320 and miRNA-98-3p) were identified (≥2-fold change). In the confirmatory phase, these 5 deregulated miRNAs were further investigated in non-PAD (n = 21) and CTLI (n = 31) patients using qRT-PCR. Only miRNA-1827 was found to be significantly upregulated (≥3-fold, p-value < 0. 001) in the CLTI group. Lastly, to minimize the influence of confounding factors, miRNA-1827 plasma levels were validated in a third cohort of CLTI patients (n = 10) matched to non-PAD controls (n = 10). Our analysis demonstrated that miRNA-1827 expression was increased in the CLTI cohort (≥2-folds, p-value < 0.001). In summary, circulating miRNA-1827 is significantly elevated in patients with CLTI.
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Hurst, Joanne E., Peta Ellen Tehan, Keith Hussey, and James Woodburn. "Association of peripheral artery disease and chronic limb-threatening ischemia with socioeconomic deprivation in people with diabetes: A population data-linkage and geospatial analysis." Vascular Medicine 26, no. 2 (January 25, 2021): 147–54. http://dx.doi.org/10.1177/1358863x20981132.
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The association between the prevalence and geographical distribution of peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI) in patients with diabetes in the context of socioeconomic deprivation is not well understood. We undertook a retrospective cohort study of 76,307 people with diabetes admitted as a hospital inpatient in a large Scottish health administrative area. Utilising linked health records, we identified diagnoses of PAD and/or CLTI and their distribution using small area cartography techniques according to multiple deprivation maps. Spatial autocorrelation techniques were applied to examine PAD and CLTI patterning. Association between crude inpatient prevalence-adjusted outcome rates and exposure to social deprivation were determined. We found crude prevalence-adjusted rates of 8.05% for PAD and 1.10% for CLTI with a five- to sevenfold difference from the least to most deprived regions. Statistically significant hot spots were found for PAD ( p < 0.001) and CLTI ( p < 0.001) in the most deprived areas, and cold spots for PAD ( p < 0.001) but not CLTI ( p = 0.72) in the least deprived areas. Major health disparities in PAD/CLTI diagnoses in people with diabetes is driven by socioeconomic deprivation.
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Kim, Tanner I., Carlos Mena, and Bauer E. Sumpio. "The Role of Lower Extremity Amputation in Chronic Limb-Threatening Ischemia." International Journal of Angiology 29, no. 03 (May 14, 2020): 149–55. http://dx.doi.org/10.1055/s-0040-1710075.
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AbstractChronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease associated with high rates of limb loss. The primary goal of treatment in CLTI is limb salvage via revascularization. Multidisciplinary teams provide improved care for those with CLTI and lead to improved limb salvage rates. Not all patients are candidates for revascularization, and a subset will require major amputation. This article highlights the role of amputations in the management of CLTI, and describes the patients who should be offered primary amputation.
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Van Den Hoven, Pim, Lauren N. Goncalves, Paulus H. A. Quax, Catharina S. P. Van Rijswijk, Jan Van Schaik, Abbey Schepers, Alexander L. Vahrmeijer, Jaap F. Hamming, and Joost R. Van Der Vorst. "Perfusion Patterns in Patients with Chronic Limb-Threatening Ischemia versus Control Patients Using Near-Infrared Fluorescence Imaging with Indocyanine Green." Biomedicines 9, no. 10 (October 9, 2021): 1417. http://dx.doi.org/10.3390/biomedicines9101417.
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In assessing the severity of lower extremity arterial disease (LEAD), physicians rely on clinical judgements supported by conventional measurements of macrovascular blood flow. However, current diagnostic techniques provide no information about regional tissue perfusion and are of limited value in patients with chronic limb-threatening ischemia (CLTI). Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used extensively in perfusion studies and is a possible modality for tissue perfusion measurement in patients with CLTI. In this prospective cohort study, ICG NIR fluorescence imaging was performed in patients with CLTI and control patients using the Quest Spectrum Platform® (Middenmeer, The Netherlands). The time–intensity curves were analyzed using the Quest Research Framework. Fourteen parameters were extracted. Successful ICG NIR fluorescence imaging was performed in 19 patients with CLTI and in 16 control patients. The time to maximum intensity (seconds) was lower for CLTI patients (90.5 vs. 143.3, p = 0.002). For the inflow parameters, the maximum slope, the normalized maximum slope and the ingress rate were all significantly higher in the CLTI group. The inflow parameters observed in patients with CLTI were superior to the control group. Possible explanations for the increased inflow include damage to the regulatory mechanisms of the microcirculation, arterial stiffness, and transcapillary leakage.
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Woronowicz-Kmiec, Sandra, Thomas Betz, Ingolf Töpel, Stefan Bröckner, Markus Steinbauer, and Christian Uhl. "Short and long-term outcome after common femoral artery hybrid procedure in patients with intermittent claudication and chronic limb threatening ischemia." Vasa 50, no. 5 (September 2021): 363–71. http://dx.doi.org/10.1024/0301-1526/a000954.
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Summary: Background: This study aimed to evaluate the differences between the outcomes of patients with intermittent claudication (IC) and chronic limb threatening ischemia (CLTI) who underwent a hybrid procedure comprising common femoral artery endarterectomy and endovascular therapy. Patients and methods: This was a retrospective single-center study of all patients with peripheral arterial occlusive disease (PAD) who underwent the hybrid procedure between March 2007 and August 2018. The primary endpoint was primary patency after 7 years. The secondary endpoints were primary-assisted patency, secondary patency, limb salvage, and survival. Results: During the follow-up period, 427 limbs in 409 patients were treated. A total of 267 and 160 patients presented with clinical signs of IC and CLTI, respectively. The 30-day mortality was 1.4% (IC: 0% vs. CLTI: 3.8%, p=0.001). The overall 30-day major amputation rate was 1.6% (IC: 0% vs. CLTI: 4.4, p=0.001). The rates of primary and secondary patency after 7 years were 63% and 94%, respectively, in the IC group and 57% and 88%, respectively, in the CLTI group; the difference was not significant. Limb salvage (94% vs. 82%, p=0.000) and survival (58% vs. 29%, p=0.000) were significantly higher in the IC group. In a multivariate analysis, CLTI was the only risk factor for major amputation. CLTI and single vessel run-off were risk factors for death. Statin therapy was a protective factor. Conclusions: The hybrid procedure provides excellent results as a treatment option for multilevel lesions in patients with PAD. However, patients with CLTI had a shorter long-term survival and lower limb salvage rate.
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Hart, Odette, Nicole Xue, Brittany Davis-Havill, Mark Pottier, Minesh Prakash, Sascha-Akito Reimann, Jasmin King, William Xu, and Manar Khashram. "The Incidence of Chronic Limb-Threatening Ischemia in the Midland Region of New Zealand over a 12-Year Period." Journal of Clinical Medicine 11, no. 12 (June 9, 2022): 3303. http://dx.doi.org/10.3390/jcm11123303.
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The epidemiology of severe PAD, as characterized by short-distance intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI), remains undefined in New Zealand (NZ). This was a retrospective observational cohort study of the Midland region in NZ, including all lower limb PAD-related surgical and percutaneous interventions between the 1st of January 2010 and the 31st of December 2021. Overall, 2541 patients were included. The mean annual incidence of short-distance IC was 15.8 per 100,000, and of CLTI was 36.2 per 100,000 population. The annual incidence of both conditions was greater in men. Women presented 3 years older with PAD (p < 0.001). Patients with short-distance IC had lower ipsilateral major limb amputation at 30 days compared to CLTI (IC 2, 0.3% vs. CLTI 298, 16.7%, p < 0.001). The 30-day mortality was greater in elderly patients (<65 years 2.7% vs. ≥65 years 4.4%, p = 0.049), but did not differ depending on sex (females 36, 3.7% vs. males 64, 4.1%, p = 0.787). Elderly age was associated with a worse survival for both short-distance IC and CLTI. There was a worse survival for females with CLTI. In conclusion, PAD imposes a significant burden in NZ, and further research is required in order to reduce this disparity.
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Kim, Tanner I., and Peter A. Schneider. "New Innovations and Devices in the Management of Chronic Limb-Threatening Ischemia." Journal of Endovascular Therapy 27, no. 4 (May 18, 2020): 524–39. http://dx.doi.org/10.1177/1526602820921555.
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As the number of patients afflicted by chronic limb-threatening ischemia (CLTI) continues to grow, new solutions are necessary to provide effective, durable treatment options that will lead to improved outcomes. The diagnosis of CLTI remains mostly clinical, and endovascular revascularization remains mostly balloon-based. Multiple innovative techniques and technologies are in development or in early usage that may provide new solutions. This review categorizes areas of advancement, highlights recent developments in the management of CLTI and looks forward to novel devices that are currently under investigation.
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Lakomek, Antonia, Jeanette Köppe, Henrike Barenbrock, Kristina Volkery, Jannik Feld, Lena Makowski, Christiane Engelbertz, Holger Reinecke, Nasser M. Malyar, and Eva Freisinger. "Outcome in octogenarian patients with lower extremity artery disease after endovascular revascularisation: a retrospective single-centre cohort study using in-patient data." BMJ Open 12, no. 8 (August 2022): e057630. http://dx.doi.org/10.1136/bmjopen-2021-057630.
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ObjectivesTo investigate the clinical benefit of endovascular revascularisation (EVR) in octogenarian (aged ≥80 years) patients with lower extremity artery disease (LEAD).DesignRetrospective single-centre study.SettingUniversity hospital with a specialised centre for vascular medicine.Participants681 LEAD patients undergoing EVR between 2010 and 2016 were stratified by age.Main outcome measureTechnical success, complications and mortality.ResultsThe cohort comprised 172 (25.3%) octogenarian and 509 (74.7%) non-octogenarian patients. Despite higher LEAD stages and complexity of EVR in octogenarians, primary technical success rate (79% octogenarians vs 86% non-octogenarians, p=0.006) and 1-year survival (87% vs 96%, p<0.001) were overall on high levels. Especially for the octogenarians, 1-year survival depends on the presence of chronic limb-threatening ischaemia (CLTI) (octogenarians: non-CLTI 98%; CLTI 79% p<0.001 vs non-octogenarians: non-CLTI 99%; CLTI 91%, p<0.001). In octogenarians, female sex (HR 0.45; 95% CI (0.24 to 0.86); p=0.015), the intake of statins (HR 0.34; 95% CI 0.19 to 0.65; p=0.001) and platelet aggregation inhibitors (HR 0.10; 95% CI 0.02 to 0.45; p=0.003) were independently associated with improved survival after EVR.ConclusionEVR can be performed safely and with sustained clinical benefit also in octogenarian patients with LEAD. After-care including medical adherence is of particular importance to improve long-term survival.
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Mine, Kaori, Makoto Sugihara, Takafumi Fujita, Yuta Kato, Koki Gondo, Tadaaki Arimura, Yosuke Takamiya, Yuhei Shiga, Takashi Kuwano, and Shin-ichiro Miura. "Impact of Controlling a Nutritional Status Score on Wound Healing in Patients with Chronic Limb-Threatening Ischemia after Endovascular Treatment." Nutrients 13, no. 11 (October 22, 2021): 3710. http://dx.doi.org/10.3390/nu13113710.
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Background: Chronic limb-threatening ischemia (CLTI) is the most advanced stage of peripheral artery disease. Therefore, a multidisciplinary approach is necessary to avoid major amputation in CLTI patients. Malnutrition worsens the condition of CLTI patients, and therefore, it may be important to evaluate the nutritional status in patients with CLTI. This study was designed to evaluate the baseline patient characteristics and the influence of the controlling nutritional status (CONUT) score on the clinical results. Method and Results: A retrospective, single-center, non-randomized study was conducted to evaluate the associations of death, major amputation, and wound healing rate at 12 months with the CONUT score on admission. Consecutive CLTI patients (mean age 73.2 ± 10.4 years; 84 males) who underwent endovascular therapy (EVT) for infra-popliteal lesions at Fukuoka University Hospital from January 2014 to May 2019 were enrolled and divided into two groups (higher and lower CONUT score groups). The higher CONUT group showed a higher percentage of dialysis (66.7% vs. 33.9%, p < 0.001) and a higher clinical frailty scale (5.9 ± 1.4 vs. 4.9 ± 1.9, p = 0.005) than the lower CONUT group. Rates of amputation-free survival were 89.5% and 69.8% in the lower and higher CONUT groups, respectively. In addition, rates of wound healing at 12 months were 98.0% and 78.3% in the lower and higher CONUT groups, respectively. Multivariate regression analysis demonstrated that a higher CONUT score was an independent predictor for delayed wound healing (OR: 11.2; 95% CI: 1.29–97.5; p = 0.028). Conclusion: An assessment of the nutritional status using the CONUT score could be useful for predicting wound healing, and earlier nutritional intervention may improve the outcome of CLTI patients. Early examination and treatment, along with raising awareness of the issue, may be important for improving the prognosis.
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Garbaisz, Dávid, Péter Osztrogonácz, András Mihály Boros, László Hidi, Péter Sótonyi, and Zoltán Szeberin. "Comparison of arterial and venous allograft bypass in chronic limb-threatening ischemia." PLOS ONE 17, no. 10 (October 27, 2022): e0275628. http://dx.doi.org/10.1371/journal.pone.0275628.
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Introduction Femoro-popliteal bypass with autologous vascular graft is a key revascularization method in chronic limb-threatening ischemia (CLTI). However, the lack of suitable autologous conduit may occur in 15–45% of the patients, necessitating the implantation of prosthetic or allogen grafts. Only little data is available on the outcome of allograft use in CLTI. Aims Our objective were to evaluate the long term results of infrainguinal allograft bypass surgery in patients with chronic limb-threatening ischemia (CLTI) and compare the results of arterial and venous allografts. Methods Single center, retrospective study analysing the outcomes of infrainguinal allograft bypass surgery in patients with CLTI between January 2007 and December 2017. Results During a 11-year period, 134 infrainguinal allograft bypasses were performed for CLTI [91 males (67.9%)]. Great saphenous vein (GSV) was implanted in 100 cases, superficial femoral artery (SFA) was implanted in 34 cases. Early postoperative complications appeared in 16.4% of cases and perioperative mortality (<30 days) was 1.4%. Primary patency at one, three and five years was 59%, 44% and 41%, respectively, while secondary patency was 60%, 45% and 41%, respectively. Primary patency of the SFA allografts was significantly higher than GSV allografts (1 year: SFA: 84% vs. GSV: 51% p = 0,001; 3 years: SFA: 76% vs. GSV: 32% p = 0,001; 5 years: SFA: 71% vs. GSV: 30% p = 0.001). Both primary and secondary patency of SFA allograft implanted in below-knee position were significantly higher than GSV bypasses (p = 0.0006; p = 0.0005, respectively). Limb salvage at one, three and five years following surgery was 74%, 64% and 62%, respectively. Long-term survival was 53% at 5 years. Conclusion Allograft implantation is a suitable method for limb salvage in CLTI. The patency of arterial allograft is better than venous allograft patency, especially in below-knee position during infrainguinal allograft bypass surgery.
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Azab, Sandi M., Abdelrahman Zamzam, Muzammil H. Syed, Rawand Abdin, Mohammad Qadura, and Philip Britz-McKibbin. "Serum Metabolic Signatures of Chronic Limb-Threatening Ischemia in Patients with Peripheral Artery Disease." Journal of Clinical Medicine 9, no. 6 (June 16, 2020): 1877. http://dx.doi.org/10.3390/jcm9061877.
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Peripheral artery disease (PAD) is characterized by the atherosclerotic narrowing of lower limb vessels, leading to ischemic muscle pain in older persons. Some patients experience progression to advanced chronic limb-threatening ischemia (CLTI) with poor long-term survivorship. Herein, we performed serum metabolomics to reveal the mechanisms of PAD pathophysiology that may improve its diagnosis and prognosis to CLTI complementary to the ankle–brachial index (ABI) and clinical presentations. Non-targeted metabolite profiling of serum was performed by multisegment injection–capillary electrophoresis–mass spectrometry (MSI–CE–MS) from age and sex-matched, non-diabetic, PAD participants who were recruited and clinically stratified based on the Rutherford classification into CLTI (n = 18) and intermittent claudication (IC, n = 20). Compared to the non-PAD controls (n = 20), PAD patients had lower serum concentrations of creatine, histidine, lysine, oxoproline, monomethylarginine, as well as higher circulating phenylacetylglutamine (p < 0.05). Importantly, CLTI cases exhibited higher serum concentrations of carnitine, creatinine, cystine and trimethylamine-N-oxide along with lower circulating fatty acids relative to well matched IC patients. Most serum metabolites associated with PAD progression were also correlated with ABI (r = ±0.24−0.59, p < 0.05), whereas the ratio of stearic acid to carnitine, and arginine to propionylcarnitine differentiated CLTI from IC with good accuracy (AUC = 0.87, p = 4.0 × 10−5). This work provides new biochemical insights into PAD progression for the early detection and surveillance of high-risk patients who may require peripheral vascular intervention to prevent amputation and premature death.
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Stella, Jacqueline, Christiane Engelbertz, Katrin Gebauer, Juan Hassu, Matthias Meyborg, Eva Freisinger, and Nasser M. Malyar. "Outcome of patients with chronic limb-threatening ischemia with and without revascularization." Vasa 49, no. 2 (March 1, 2020): 121–27. http://dx.doi.org/10.1024/0301-1526/a000831.
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Summary: Background: Patients with chronic critical limb-threatening ischemia (CLTI) are at high risk of amputation and death. Despite the general recommendation for revascularization in CTLI in the guidelines, the underlying evidence for such a recommendation is limited. The aim of our study was to assess the outcome of patients with CLTI depending on the use of revascularization in a retrospective real-world cohort. Patients and methods: Administrative data of the largest German Health insurance (BARMER GEK) were provided for all patients that were hospitalized for the treatment of CLTI Rutherford category (RF) 5 and 6 between 2009 and 2011. Patients were followed-up until December 31st, 2012 for limb amputation and death in relation to whether patients did (Rx +) or did not have (Rx −) revascularization during index-hospitalization. Results: We identified 15,314 patients with CLTI at RF5 (n = 6,908 (45.1%)) and RF6 (n = 8,406 (54.9%)), thereof 7,651 (50.0%) underwent revascularization (Rx +) and 7,663 (50.0%) were treated conservatively (Rx −). During follow-up (mean 647 days; 95% CI 640–654 days) limb amputation (46.5% Rx− vs. 40.6% Rx+, P < 0.001) and overall mortality (48.2% Rx− vs. 42.6% Rx+, P < 0.001) were significantly lower in the subgroup Rx+. Conclusions: In a real-world setting, only half of CLTI were revascularized during the in-hospital treatment. Though, revascularization was associated with significantly better observed short- and long-term outcome. These data do not allow causal conclusion due to lack of data on the underlying reason for applied or withheld revascularization and therefore may involve a relevant selection bias.
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Dinh, Krystal, Miguel Lemos Gomes, Shannon D. Thomas, Sharath C. V. Paravastu, Andrew Holden, Peter A. Schneider, and Ramon L. Varcoe. "Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Journal of Endovascular Therapy 27, no. 2 (February 18, 2020): 175–85. http://dx.doi.org/10.1177/1526602820904783.
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Purpose: To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10–429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: The mean follow-up was 25.6 months (range 6–60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). Conclusion: There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.
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Katelnitsky, I. I., V. V. Darvin, and A. A. Zorkin. "Comprehensive treatment of patients with chronic limb-threatening ischaemia: are we using all the possibilities of anticoagulant therapy?" Russian Medical Inquiry 4, no. 7 (2020): 445–51. http://dx.doi.org/10.32364/2587-6821-2020-4-7-445-451.
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Background: medical correction of the hemostatic system is one of the most important directions for complex treatment of obliterating diseases of lower limbs arteries (ODLLA), including cases of chronic limb-threatening ischaemia (CLTI).Aim: to evaluate the efficacy and safety of the sulodexide use in patients with ODLLA when conducting a comprehensive treatment of CLTI.Patients and Methods: 520 patients underwent two-center prospective study, 318 of whom (211 — with signs of ODLLA, 107 — without signs of CLTI) underwent revascularization interventions, whereas, 202 patients with CLTI received multicomponent complex conservative treatment. In addition to standard treatment, 30 patients who underwent surgery interventions and the group of 50 patients receiving conservative treatment received sulodexide orally in 2 capsules bis in day (1000 LE/day). The severity of the pain syndrome, the distance of pain-free walking, some laboratory indicators of hemostatic system, as well as the presence of adverse events and complications were evaluated before and after treatment. Results: in operated patients with both CLTI and without it, regardless of the sulodexide use, there was a significant decrease in the severity of pain syndrome and an increase in the distance of pain-free walking. Sulodexide use was accompanied by reduced fibrinogen, D-dimer, soluble fibrin monomer complexes (SFMC) and plasminogen activator inhibitor (PAI-1) in the subgroup of patients with CLTI, and indicators of fibrinogen and PAI-1 in the subgroup of patients without CLTI (p<0.05). In non-operated patients with CLTI, sulodexide use was accompanied by a decrease in pain syndrome and indicators of fibrinogen, D-dimer, SFMC, and PAI-1 (p<0.05). However, it was less significant after performed revascularization. There were no adverse events or complications associated with the sulodexide use.Conclusions: improvement of clinical and laboratory parameters was mainly determined by the efficacy of performed limb revascularization. In the complex treatment of patients with ODLLA, the sulodexide use was safe and effective, which was manifested by a decrease in the pain severity, an increase in the distance of pain-free walking and normalization of some coagulogram indicators.KEYWORDS: chronic limb-threatening ischaemia, critical limb ischemia, obliterating diseases of lower limb arteries, complex treatment, sulodexide.FOR CITATION: Katelnitsky I.I., Darvin V.V., Zorkin A.A. Comprehensive treatment of patients with chronic limb-threatening ischaemia: are we using all the possibilities of anticoagulant therapy? Russian Medical Inquiry. 2020;4(7):445–451. DOI: 10.32364/2587-6821-2020-4-7-445-451.
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Meecham, Lewis, Mathew A. Popplewell, Gareth R. Bate, Smitaa Patel, and Andrew W. Bradbury. "A Comparison of Contemporary Clinical Outcomes Following Femoro-Popliteal Plain Balloon Angioplasty and Bypass Surgery for Chronic Limb Threatening Ischemia." Vascular and Endovascular Surgery 55, no. 6 (April 22, 2021): 544–50. http://dx.doi.org/10.1177/15385744211004656.
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Introduction: Despite the BASIL-1 trial concluding that bypass surgery (BS) was superior to plain balloon angioplasty (PBA) in terms of longer-term amputation free (AFS) and overall survival (OS), CLTI patients are increasingly offered an endovascular-first revascularization strategy. This study investigates whether the results of BASIL-1 are still relevant to current practice by comparing femoro-popliteal (FP) BS with PBA in a series of CLTI patients treated in our unit 10 years after BASIL-1 (1999-2004). Methods: We retrospectively analyzed prospectively gathered hospital data pertaining to 279 patients undergoing primary FP BS or PBA for CLTI in the period 2009 to 2014. We report baseline characteristics, 30-day morbidity and mortality, major adverse cardiovascular events (MACE) and long-term AFS, limb salvage (LS), OS, major adverse limb events (MALE), and freedom from re-intervention (FFR). Results: 234 (84%) and 45 (16%) patients underwent PBA and BS respectively. PBA patients were significantly older (77 vs 71 years, P = 0.001) and more likely to be female (45% vs 28%, P = 0.026). Bollinger and GLASS anatomic scores were significantly more severe in the BS group. Technical success was better for BS (100% vs 87%, P = 0.007). Index hospital stay was shorter for PBA (9.1 vs 15.6 days, P = 0.035) but there was no difference in hospital days or admissions over the next 12 months. AFS (HR 1.00), LS (HR 1.44), OS (HR 0.81), MALE (HR 1.25) and FFR (HR = 1.00) were not significantly different between PBA and BS. Conclusion: Important clinical outcomes following FP BS and PBA for CLTI have not changed significantly in our unit in the 10 years following the BASIL-1 trial. BASIL-1 therefore remains relevant to our current practice and should inform our approach to the management of CLTI going forward.
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Biscetti, Federico, Elisabetta Nardella, Maria Margherita Rando, Andrea Leonardo Cecchini, Antonio Gasbarrini, Massimo Massetti, and Andrea Flex. "Outcomes of Lower Extremity Endovascular Revascularization: Potential Predictors and Prevention Strategies." International Journal of Molecular Sciences 22, no. 4 (February 18, 2021): 2002. http://dx.doi.org/10.3390/ijms22042002.
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Peripheral artery disease (PAD) is a manifestation of atherosclerosis, which may affect arteries of the lower extremities. The most dangerous PAD complication is chronic limb-threatening ischemia (CLTI). Without revascularization, CLTI often causes limb loss. However, neither open surgical revascularization nor endovascular treatment (EVT) ensure long-term success and freedom from restenosis and revascularization failure. In recent years, EVT has gained growing acceptance among all vascular specialties, becoming the primary approach of revascularization in patients with CLTI. In clinical practice, different clinical outcomes after EVT in patients with similar comorbidities undergoing the same procedure (in terms of revascularization technique and localization of the disease) cause unsolved issues that need to be addressed. Nowadays, risk management of revascularization failure is one of the major challenges in the vascular field. The aim of this literature review is to identify potential predictors for lower extremity endovascular revascularization outcomes and possible prevention strategies.
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Caicedo, Diego, Pablo Devesa, Víctor M. Arce, Julia Requena, and Jesús Devesa. "Chronic limb-threatening ischemia could benefit from growth hormone therapy for wound healing and limb salvage." Therapeutic Advances in Cardiovascular Disease 12, no. 2 (December 22, 2017): 53–72. http://dx.doi.org/10.1177/1753944717745494.
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Revascularization for chronic limb-threatening ischemia (CLTI) is necessary to alleviate symptoms and wound healing. When it fails or is not possible, there are few alternatives to avoid limb amputation in these patients. Although experimental studies with stem cells and growth factors have shown promise, clinical trials have demonstrated inconsistent results because CLTI patients generally need arteriogenesis rather than angiogenesis. Moreover, in addition to the perfusion of the limb, there is the need to improve the neuropathic response for wound healing, especially in diabetic patients. Growth hormone (GH) is a pleiotropic hormone capable of boosting the aforementioned processes and adds special benefits for the redox balance. This hormone has the potential to mitigate symptoms in ischemic patients with no other options and improves the cardiovascular complications associated with the disease. Here, we discuss the pros and cons of using GH in such patients, focus on its effects on peripheral arteries, and analyze the possible benefits of treating CLTI with this hormone.
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Hashimoto, Takuya, Satoshi Yamamoto, Masaru Kimura, Masaya Sano, Osamu Sato, and Juno Deguchi. "Long-Term Outcomes following Common Femoral Endarterectomy." Journal of Clinical Medicine 11, no. 22 (November 21, 2022): 6873. http://dx.doi.org/10.3390/jcm11226873.
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Thromboendarterectomy of the common femoral artery (CFA) for occlusive disease is a crucial procedure in vascular surgery. As an outcome reference for emerging endovascular procedures and new devices, we need more robust evidence of the outcome of this gold standard technique. The purpose of this study was to report 10-year results after femoral endarterectomy (FEA). A retrospective review of medical records at our institution identified eighty consecutive patients (91 limbs) who underwent FEA for CFA lesions. Indications for FEA included 50 limbs (55%) for intermittent claudication (IC) and 39 limbs (43%) with chronic limb-threatening ischemia (CLTI). Two limbs (2%) underwent FEA to prevent hemodynamic steal during extra-anatomical bypass. Adjunctive procedures included endovascular therapy in 32%. CFAs were closed with patch angioplasty in 44%. With a mean follow-up period of 39 months, the survival rates at 3 and 8 years were 85% and 77%, respectively. Limb salvage rates were 92% and 87%. Primary patencies were 98% and 84%. Freedom from target lesion revascularization was 95% at 3 years and 91% at 8 years. Our findings support the durability of FEA, with comparable long-term procedural results in CLTI patients as well as IC patients. Since the FEA is a gate maneuver for hybrid revascularization in CLTI patients, our findings support a strategy combining open and endovascular approaches. Femoral endarterectomy remains a durable solution for common femoral occlusive disease in IC and CLTI in the era of endovascular therapy.
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Hata, Yosuke, Osamu Iida, Nobuhiro Ito, Yoshimitsu Soga, Masashi Fukunaga, Daizo Kawasaki, Masahiko Fujihara, Amane Kozuki, Mitsuyoshi Takahara, and Toshiaki Mano. "Roles of Angioplasty With Drug-Coated Balloon for Chronic Ischemia in Wound Healing." Journal of Endovascular Therapy 28, no. 5 (June 21, 2021): 778–87. http://dx.doi.org/10.1177/15266028211025023.
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Purpose: Clinical trials have demonstrated sustained benefits of drug-coated balloon (DCB) angioplasty compared with noncoated balloon angioplasty in symptomatic peripheral artery disease (PAD) presenting with femoropopliteal (FP) artery disease. However, there is still controversy whether particulate embolization caused by crystalline paclitaxel, the so-called “downstream effect,” is adversely associated with clinical outcomes after use of FP DCB among chronic limb-threatening ischemia (CLTI) patients. The current RADISH (Roles of Angioplasty with Drug-coated balloon for chronic ISchemia in wound Healing) study investigated wound healing following DCB therapy vs non-DCB therapy for real-world CLTI patients presenting with FP lesions. Materials and Methods: This multicenter, retrospective study analyzed 927 patients with CLTI (mean age, 76±10 years; male, 57.8%; diabetes mellitus, 64.5%; dialysis, 50.7%) presenting with FP lesions and treated endovascularly via DCB (138 patients) vs non-DCB therapy (789 patients) between April 2014 and March 2019. The primary outcome measure was 1-year wound healing, while the secondary outcome measure was 1-year primary patency. Clinically-driven target lesion revascularization (CD-TLR), limb salvage and overall survival were also analyzed by using propensity score matching analysis. Results: The propensity score matching extracted 111 pairs (as many patients in the DCB group and 629 patients in the non-DCB group). The 1-year cumulative incidence of wound healing (95% CI) was 74.4% (62.6% to 82.5%) in the DCB group and 71.9% (60.4% to 80.1%) in the non-DCB group, with no significant intergroup difference (p=0.93). The DCB group had a higher rate of primary patency (p=0.002) and freedom from CD-TLR (p=0.010) than the non-DCB group, whereas there was no significant intergroup difference in limb salvage (p=0.21) or overall survival (p=0.93). Conclusion: The current analysis of data from the RADISH study demonstrated that DCB therapy did not lead to delayed wound healing and reduced restenosis rate in CLTI patients presenting FP lesions. From this results, DCB therapy would be a reasonable treatment option for CLTI patients.
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Krishnan, Prakash, Arthur Tarricone, Allen Gee, Serdar Farhan, Haroon Kamran, Vishal Kapur, Karthik Gujja, Annapoorna Kini, and Samin Sharma. "Analysis of Interwoven Nitinol Stenting for the Treatment of Critical Limb Ischemia: Outcomes From an Average 3-Year Follow-up Period." Angiology 73, no. 5 (October 7, 2021): 407–12. http://dx.doi.org/10.1177/00033197211043406.
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We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.
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Ceja Rodriguez, Maria, John R. Mark, Melissa Gosdin, and Misty D. Humphries. "Perceptions of patients with wounds due to chronic limb-threatening ischemia." Vascular Medicine 26, no. 2 (February 19, 2021): 200–206. http://dx.doi.org/10.1177/1358863x20987896.
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Patients with chronic limb-threatening ischemia (CLTI) face numerous barriers to caring for lower extremity wounds. We explored the perceptions of CLTI patients to their wound/management and sought to determine attitudes towards their vascular provider as well as willingness for management through telemedicine. Patients admitted to hospital for treatment of Rutherford Grade 5 and 6 CLTI were asked complete a wound evaluation survey and took part in a semi-structured interview. Semi-structured interviews were recorded, transcribed, and analyzed using an inductive coding strategy. Codes were grouped for thematic analysis and aggregated into assertions. Eleven patients with a mean age of 60 years (35–79 years) were interviewed. All patients had peripheral artery disease (PAD) and eight patients had diabetes as well. Three overarching themes were identified. First, patients appear to have limited coping mechanisms and are overwhelmed by the care of their wounds. Second, in this cohort of patients, many had become passive observers of their care as demonstrated by a limited understanding of their disease processes and detachment from wound management. The third theme was how strong the desire to do everything to prevent limb loss was, but patients acknowledged this is hard to translate into real life with limited resources. Patients with CLTI have concerns that vascular providers must recognize and address to build strong patient–provider relationships and increase activation for management of their wounds and other medical conditions. Patients who have access to technology and with guidance may be able to understand getting care through remote medicine.
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krisnasari, Imelda, Novi Kurnianingsih, Mohammad Saifur Rohman, and Budi Satrijo. "Limb Preservation with Balloon Angioplasty in Critical Limb Threatening Ischemia: A Case Report." Heart Science Journal 2, no. 2 (April 1, 2021): 25–30. http://dx.doi.org/10.21776/ub.hsj.2021.002.02.6.
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Introduction: Chronic limb-threatening ischemia (CLTI) is a syndrome that represents the end-stage of peripheral artery disease (PAD) that increased the risk of major amputation and cardiovascular events. The initial treatment for CLTI may significantly impact the risk of major amputation or death. Objective: This case report aims to describe limb preservation with balloon angioplasty in a Critical Limb Ischemia patient. Case Presentation: A hypertensive 72-years old female complained of left leg pain followed by a wound on her left toe four months ago. Her toe was amputated, but the wound persists. On physical examination, the pulsation was diminished in her left foot. Duplex ultrasound showed monophasic spectral doppler from left popliteal artery to distal left anterior tibial artery (ATA) and distal posterior tibial artery (PTA). CT-Angiography showed short total occlusion (2cm) at the distal left Superficial Femoral artery (SFA), multiple stenoses with maximal 90% stenosis at the left ATA, and chronic total occlusion at the proximal-mid left posterior tibial artery (PTA). She was diagnosed with CLTI left inferior extremity Fontaine IV Rutherford 5. The angiography result was similar to the CT-angiography result. The patient was successfully treated with plain balloon angioplasty from distal left SFA to distal left ATA and drug-coated balloon angioplasty from the distal left SFA to the popliteal artery. Her wound was also consulted to the surgical department. Conclusion: Appropriate revascularization is fundamental to limb preservation. We successfully perform endovas- cular strategy with TIMI flow 3 from left SFA to distal left ATA and distal PTA in our patient, but we still need further holistic CLTI management.
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Dhillon, Ashwat S., Jorge Caro, Han Tun, David G. Armstrong, Vincent Rowe, David M. Shavelle, and Leonardo C. Clavijo. "Therapeutic Window of Clopidogrel and Ticagrelor in Patients With Critical Limb-Threatening Ischemia." Journal of Cardiovascular Pharmacology and Therapeutics 25, no. 2 (September 24, 2019): 158–63. http://dx.doi.org/10.1177/1074248419877411.
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Background: Critical limb-threatening ischemia (CLTI) is associated with an increased risk of major adverse limb events and mortality. High on-treatment platelet reactivity (HPR) is associated with an increased risk of ischemic events, while low on-treatment platelet reactivity (LPR) is associated with an increased risk of bleeding. This study investigates the frequency with which patients with CLTI on clopidogrel or ticagrelor achieve a “therapeutic window” (TW) of platelet inhibition. Methods: Data from the “Switch To Ticagrelor in Critical Limb Ischemia Anti-Platelet Study” were assessed retrospectively to determine the incidence of TW of on-treatment platelet reactivity in 50 consecutive patients with CLTI (mean age: 65.2 ± 10.5 years, 54% male). The data included 4 measurements of patients’ platelet reactivity using the VerifyNow P2Y12 Assay: baseline and steady state platelet reactivity on clopidogrel 75 mg daily and on ticagrelor 90 mg twice daily. Results: At baseline, 46% of patients on clopidogrel were within TW of on-treatment platelet reactivity compared to 10% of patients on ticagrelor ( P < .0001). At steady state, 42% of patients on clopidogrel were within the TW compared to 10% of patients on ticagrelor ( P < .0001). Patients on ticagrelor exhibited higher rates of LPR compared to those on clopidogrel at baseline as well as at steady state (baseline 88% vs 18%, steady state 88% vs 28%; P < .0001). Conclusion: Although ticagrelor has been proposed as an alternative for patients with HPR on clopidogrel, the current study observes an excess of platelet inhibition with ticagrelor in most patients with CLTI at a dose of 90 mg twice daily.
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Kum, Steven, Jetty Ipema, Derek Ho Chun-yin, Darryl M. Lim, Yih Kai Tan, Ramon L. Varcoe, Constantijn E. V. B. Hazenberg, and Çağdaş Ünlü. "Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry." Journal of Endovascular Therapy 27, no. 4 (May 29, 2020): 616–22. http://dx.doi.org/10.1177/1526602820922524.
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Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR ( Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.
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Leonard, Chelsea, George Sayre, Sienna Williams, Alison Henderson, Daniel Norvell, Aaron P. Turner, and Joseph Czerniecki. "Understanding the experience of veterans who require lower limb amputation in the veterans health administration." PLOS ONE 17, no. 3 (March 18, 2022): e0265620. http://dx.doi.org/10.1371/journal.pone.0265620.
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Purpose There is limited qualitative research on the experience of patients undergoing lower limb amputation due to chronic limb threatening ischemia (CLTI) and their participation in amputation-level decisions. This study was performed to understand patient lived experiences related to amputation and patient involvement in shared decision making. Materials and methods Phenomenological interviews were conducted with Veterans 6–12 months post transtibial or transmetatarsal amputation due to CLTI. Interviews were read and summarized by two analysts who discussed the contents of each interview and relationships between interviews to identify emergent, cross-cutting elements of patient experience. Results Twelve patients were interviewed between March and August 2019. Three cross cutting elements of patient lived experience and participation in shared decision making were identified: 1) Lacking a sense of decision making; 2) Actively working towards recovery as response to a perceived loss of independence; and 3) Experiencing amputation as a Veteran. Conclusions Patients did not report a high level of involvement in shared decision making about their amputation or amputation level. Understanding patient experiences and priorities is crucial to supporting shared decision making for Veterans with amputation due to CLTI.
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Miyata, T., S. Mii, H. Kumamaru, A. Takahashi, H. Miyata, K. Shigematsu, N. Azuma, et al. "Risk prediction model for early outcomes of revascularization for chronic limb-threatening ischaemia." British Journal of Surgery 108, no. 8 (March 6, 2021): 941–50. http://dx.doi.org/10.1093/bjs/znab036.
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Abstract Background Quantifying the risks and benefits of revascularization for chronic limb-threatening ischaemia (CLTI) is important. The aim of this study was to create a risk prediction model for treatment outcomes 30 days after revascularization in patients with CLTI. Methods Consecutive patients with CLTI who had undergone revascularization between 2013 and 2016 were collected from the JAPAN Critical Limb Ischemia Database (JCLIMB). The cohort was divided into a development and a validation cohort. In the development cohort, multivariable risk models were constructed to predict major amputation and/or death and major adverse limb events using least absolute shrinkage and selection operator logistic regression. This developed model was applied to the validation cohort and its performance was evaluated using c-statistic and calibration plots. Results Some 2906 patients were included in the analysis. The major amputation and/or mortality rate within 30 days of arterial reconstruction was 5.0 per cent (144 of 2906), and strong predictors were abnormal white blood cell count, emergency procedure, congestive heart failure, body temperature of 38°C or above, and hemodialysis. Conversely, moderate, low or no risk in the Geriatric Nutritional Risk Index (GNRI) and ambulatory status were associated with improved results. The c-statistic value was 0.82 with high prediction accuracy. The rate of major adverse limb events was 6.4 per cent (185 of 2906), and strong predictors were abnormal white blood cell count and body temperature of 38°C or above. Moderate, low or no risk in the GNRI, and age greater than 84 years were associated with improved results. The c-statistic value was 0.79, with high prediction accuracy. Conclusion This risk prediction model can help in deciding on the treatment strategy in patients with CLTI and serve as an index for evaluating the quality of each medical facility.
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Schmidt, Andrej, Michiel A. Schreve, Eline Huizing, Costantino Del Giudice, Daniela Branzan, Çağdaş Ünlü, Ramon L. Varcoe, Roberto Ferraresi, and Steven Kum. "Midterm Outcomes of Percutaneous Deep Venous Arterialization With a Dedicated System for Patients With No-Option Chronic Limb-Threatening Ischemia: The ALPS Multicenter Study." Journal of Endovascular Therapy 27, no. 4 (May 18, 2020): 658–65. http://dx.doi.org/10.1177/1526602820922179.
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Purpose: To evaluate the midterm results of patients suffering from no-option chronic limb-threatening ischemia (CLTI) treated with a dedicated system for percutaneous deep venous arterialization (pDVA). Materials and Methods: Thirty-two consecutive CLTI patients (mean age 67±14 years; 20 men) treated with pDVA using the Limflow device at 4 centers between 11 July 2014 and 11 June 2018 were retrospectively analyzed. Of all patients, 21 (66%) had diabetes, 8 (25%) were on immunosuppression, 4 (16%) had dialysis-dependent renal failure, 9 (28%) had Rutherford category 6 ischemia, and 25 (78%) were deemed at high risk of amputation. The primary outcome was amputation-free survival (AFS) at 6 months. Secondary outcomes were wound healing, limb salvage, and survival at 6, 12, and 24 months. Results: Technical success was achieved in 31 patients (96.9%). The median follow-up was 34 months (range 16–63). At 6, 12, and 24 months, estimates were 83.9%, 71.0%, and 67.2% for AFS, 86.8%, 79.8% and 79.8% for limb salvage, and 36.6%, 68.2%, and 72.7% for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range 0.5–15). The DVA circuit occluded during follow-up in 21 patients; the median time to occlusion was 2.6 months. Reintervention for occlusion was performed in 17 patients: 16 because of unhealed wounds and 1 for a newly developed ulcer. Conclusion: This study represents the largest population of patients with no-option CLTI treated with pDVA using the LimFlow device with midterm results. In this complex group of patients, pDVA using the LimFlow device has been shown to be feasible, with a high technical success rate and AFS at 6 up to 24 months coupled with wound healing. In selected patients with no-option CLTI, pDVA could be a recommended treatment to prevent amputation and heal wounds.
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Muntholib, Muntholib, Suhadi Ibnu, Sri Rahayu, Fauziatul Fajaroh, Sentot Kusairi, and Bambang Kuswandi. "Chemical Literacy: Performance of First Year Chemistry Students on Chemical Kinetics." Indonesian Journal of Chemistry 20, no. 2 (March 2, 2020): 468. http://dx.doi.org/10.22146/ijc.43651.
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This study aims to (1) develop and validate a multiple choice chemical literacy test instrument (MC-CLTI) on chemical kinetics and (2) conduct a small survey on chemical literacy of first year chemistry students. The development of the instrument involved expert consultation and judgment, validation and two times pilot studies. The first pilot study involved 119 first year chemistry students while the second pilot study involved 197 second year chemistry students. The final form of MC-CLTI consists of 30 valid and reliable items (Cronbach's Alpha coefficient = 0.744). The survey showed that the average score of respondents' chemical literacy was 63.24. This score is in the range of the average scores reported by several previous studies.
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Geskin, Gennady, Michael D. Mulock, Nicole L. Tomko, Anna D’Asta, and Sandeep Gopalakrishnan. "Effects of Lower Limb Revascularization on the Microcirculation of the Foot: A Retrospective Cohort Study." Diagnostics 12, no. 6 (May 26, 2022): 1320. http://dx.doi.org/10.3390/diagnostics12061320.
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Background: Current assessment standards in chronic limb-threatening ischemia (CLTI) focus on macrovascular function while neglecting the microcirculation. Multispectral near-infrared spectroscopy (NIRS) provides hemodynamic characteristics of the microcirculation (i.e., capillaries) and may be a powerful tool for monitoring CLTI and preventing extremity loss. The aims of this study were to (1) investigate the effects of lower limb revascularization on the microcirculation and (2) determine if macrovascular and microvascular assessments correlate. Methods: An observational, retrospective cohort study of 38 endovascular interventions in 30 CLTI subjects was analyzed pre- and post-intervention for arterial Doppler acceleration times (AcT; macrovascular) and NIRS metrics (microvascular). Pre-intervention ankle-brachial index (ABI) was also analyzed. Results: AcT significantly decreased (p = 0.009) while oxyhemoglobin (HbO) significantly increased (p < 0.04) after endovascular intervention, indicating treatment efficacy. However, macrovascular measurements (ABI, AcT) and NIRS metrics of oxygenation and perfusion did not correlate (p > 0.06, r2 < 0.15, n = 23) indicating that macro- and microvascular assessment are not congruent. Conclusion: These findings suggest that macrovascular and microvascular assessments can determine interventional efficacy in their corresponding vasculature. Their lack of correlation, however, suggests the need for simultaneous assessment as independent use may cause diagnostic information to be missed.
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Guetl, Raggam, Muster, Gressenberger, Vujic, Avian, Hafner, Wehrschuetz, Brodmann, and Gary. "The White Blood Cell Count to Mean Platelet Volume Ratio for the Prediction of Chronic Limb-Threatening Ischemia in Lower Extremity Artery Disease." Journal of Clinical Medicine 8, no. 10 (October 2, 2019): 1593. http://dx.doi.org/10.3390/jcm8101593.
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: Background: The white blood cell count to mean platelet volume ratio (WMR) is increasingly gaining importance as a promising prognostic marker in atherosclerotic disease, but data on lower extremity artery disease (LEAD) are not yet available. The principle aim of this study was to assess the association of the WMR with the occurrence of CLTI (chronic limb-threatening ischemia) as the most advanced stage of disease. Methods: This study was performed as a retrospective analysis on 2121 patients with a diagnosis of LEAD. Patients were admitted to the hospital for the reason of LEAD and received conservative or endovascular treatment. Blood sampling, in order to obtain the required values for this analysis, was implemented at admission. Statistical analysis was conducted by univariate regression in a first step and, in case of significance, by multivariate regression additionally. Results: Multivariate regression revealed an increased WMR (p < 0.001, OR (95%CI) 2.258 (1.460–3.492)), but also advanced age (p < 0.001, OR (95%CI) 1.050 (1.040–1.061)), increased CRP (p < 0.001, OR (95%CI) 1.010 (1.007–1.014)), and diabetes (p < 0.001, OR (95%CI) 2.386 (1.933–2.946)) as independent predictors for CLTI. Conclusions: The WMR presents an easily obtainable and cost-effective parameter to identify LEAD patients at high risk for CLTI.
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de Donato, Gianmarco, Filippo Benedetto, Francesco Stilo, Roberto Chiesa, Domenico Palombo, Edoardo Pasqui, Claudia Panzano, et al. "Evaluation of Clinical Outcomes After Revascularization in Patients With Chronic Limb-Threatening Ischemia: Results From a Prospective National Cohort Study (RIVALUTANDO)." Angiology 72, no. 5 (January 7, 2021): 480–89. http://dx.doi.org/10.1177/0003319720980619.
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We evaluated the outcomes of revascularization in patients with chronic limb-threatening ischemia (CLTI) treated in real-world settings. This is a prospective multicenter cohort study with 12-month follow-up enrolling patients (n = 287) with CLTI undergoing open, endovascular, or hybrid lower extremity revascularization. The primary end point was amputation-free survival (AFS) at 12 months. Cox proportional analysis was used to determine independent predictors of amputation and restenosis. At 30 days, major adverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%, respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and the primary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis, smoking (hazard ratio [HR] = 2.2, P = 0.04), renal failure (HR = 2.3, P = 0.03), Rutherford class (≥5) (HR = 3.2, P = 0.01), and below-the-knee disease (HR = 2.0, P = 0.05) were significant predictors of amputation; iloprost infusion (>10 vials) (HR = 0.64, P = 0.05) was a significant protective factor. Cilostazol administration (HR = 0.77, P = 0.05) was a significant protective factor for restenosis. Results from this prospective multicenter registry offer a consistent overview of clinical outcomes of CLTI patients at 1 year when adequately revascularized. Medical treatment, including statins, cilostazol and iloprost, were associated with improved 1-year freedom from restenosis and amputation.
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Giannopoulos, Stefanos, Sheila Ghanian, Sahil A. Parikh, Eric A. Secemsky, Peter A. Schneider, and Ehrin J. Armstrong. "Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis." Journal of Endovascular Therapy 27, no. 4 (June 7, 2020): 647–57. http://dx.doi.org/10.1177/1526602820931559.
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Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.
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Giannopoulos, Stefanos, Eric A. Secemsky, Jihad A. Mustapha, George Adams, Robert E. Beasley, George Pliagas, and Ehrin J. Armstrong. "Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia." Journal of Endovascular Therapy 27, no. 5 (July 3, 2020): 714–25. http://dx.doi.org/10.1177/1526602820935611.
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Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study ( ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.
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Pecoraro, Felice, David Pakeliani, Salvatore Bruno, Ettore Dinoto, Francesca Ferlito, Domenico Mirabella, Mario Lachat, Bianca Cudia, and Guido Bajardi. "Simultaneous Hybrid Treatment of Multilevel Peripheral Arterial Disease in Patients with Chronic Limb-Threatening Ischemia." Journal of Clinical Medicine 10, no. 13 (June 28, 2021): 2865. http://dx.doi.org/10.3390/jcm10132865.
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Background: Hybrid treatments (HT) aim to reduce conventional open surgery invasiveness and address multilevel peripheral arterial disease (PAD). Herein, the simultaneous HT treatment in patients with chronic limb-threatening ischemia (CLTI) is reported. Methods: Retrospective analysis, for the period from May 2012 to April 2018, of patients presenting multilevel PAD with CLTI addressed with simultaneous HT. The outcomes of these interventions were measured the following metrics: early technical successes (within 30 days following treatment) and late technical successes (30 days or more following treatment) and included mortality, morbidity symptoms recurrence, and amputation. Survival and patencies were estimated. The median follow-up was 43.77 months. Results: In the 45 included patients, the HT consisted of femoral bifurcation patch angioplasty followed by an endovascular treatment in 38 patients (84.4%) and endovascular treatment followed by a surgical bypass in 7 patients (15.6%). Technical success was 100% without perioperative mortality. Eight (17.8%) patients presented early complications without major amputations. During the follow-up, seven (15.6%) deaths occurred and six patients (13.3%) experienced symptoms recurrence, with five of those patients requiring major amputation. An estimated survival time of 5 years, primary patency, and secondary patency was 84.4%, 79.2%, and 83.3% respectively. Conclusions: Hybrid treatments are effective in addressing patients presenting with multilevel PAD and CLTI. The common femoral artery involvement influences strategy selection. Larger studies with longer-term outcomes are required to validate the hybrid approach, indications, and results.
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Didenko, Sergii N., Andrii V. Ratushniuk, Oleksandr V. Liksunov, Oleksandr M. Orlych, Yurii M. Hupalo, and Dmytro A. Makivchuk. "FINE-NEEDLE ANGIOGRAPHY IN CHRONIC LIMB-THREATENING ISCHEMIA DIABETIC PATIENTS." Wiadomości Lekarskie 75, no. 11 (2022): 2581–84. http://dx.doi.org/10.36740/wlek202211104.
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The aim: The features and efficiency of performing fine-needle angiography for Chronic Limb-Threatening Ischemia (CLTI) in Diabetic Patients diagnosis. Materials and methods: From 2015-2020, a total of 180 angiography procedures were performed in below-the-knee (BTK) arterial disease diabetic patients with CLTI (Rutherford category 4 to 6). Relative contraindications such as severe heart failure, myocardial infarction (MI), arterial hypertension, impaired renal function, allergy to contrast media and intolerance to antiplatelet therapy we carefully evaluated and compared with the major amputation risks. Patients were selected with adequate inflow to the common and popliteal arterys, as defined by presence of normal ipsilateral femoral and popliteal pulse, biphasic or triphasic Doppler waveform. Ultrasound controlled fine-needle angiography, by retrograde puncture of the superficial femoral artery (SFA) was performed with an 18G-70mm angiographic needle in 96 patients (1st group). Antegrade angiography using femoral sheath in 84 patients (2nd group). Results: We have obtained adequate visualization BTK vessels by administering “Omnipak 300” 70% solution 9 mL with a power injector at a 3 mL/sec rate through the needle. Through the sidearm of the femoral sheath a total of contrast 15 mL, administered at 5 mL/sec rate. Fine-needle angiography 2.16 times reduces the injected contrast amount in patients. The hemorrhagic events frequency in the 1st group was significantly lower. Conclusions: Fine-needle angiography is recommended for CLTI Diabetic Patients diagnosis.
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Holyachenko, Oleksandr A., Anatolii M. Kravchenko, Andrii O. Golyachenko, Vitaliy G. Gurianov, and Ivan V. Karol. "FEMOROPOPLITEAL ANGIOPLASTY VS OPEN SURGERY FOR CHRONIC LIMB-THREATENING ISCHEMIA." Wiadomości Lekarskie 75, no. 11 (2022): 2585–88. http://dx.doi.org/10.36740/wlek202211105.
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The aim: To compare the results of femoro-popliteal PTA vs open surgery in chronic limb-threatening ischemia (CLTI) and analyze clinical efficacy long-term results. Materials and methods: Between 2018 – 2019, 145 patients with CLTI who underwent femoro-popliteal arterial segment steno-occlusive lesions (SOL) unilateral revascu¬larization. Open surgery were performed for – 48 (33, 1℅), percutaneous transluminal angioplasty (PTA) for – 73 (50.3%), and were treated with hybrid surgical interventions for – 24 (16.6%). Results: During the analysis, no statistically significant difference was found among the three groups patients indicators. According to the diabetes patients indicator, the differences among the groups are statistically significant (p<0.001), diabetes was present in only 16.7% of open surgical intervention group patients, 45.8% of PTA group patients, 54.8% of the hybrid surgery group patients. In the overall comparison 2-year limb preservation after open surgery 93.8%, after PTA 91.7%, and after hybrid surgery 91.6%; amputations: open surgery – 6.2% PTA- 8.2 %, hybrid surgery -8.3%; exemption from surgical re-intervention: open surgery - 68.7%, PTA- 58.9%, hybrid surgery – 75%. There were no differences in limb preservation and amputation between open surgery, hybrid intervention, and PTA. A difference was found only in reintervention tactic among the open surgery and PTA groups as opposed to the hybrid surgery. Сonclusions: Limb salvage and CLTI patients survival after open surgery and PTA who were not performed major amputation in 2 years term after revascularization were comparable regardless of treatment method.
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Giri, S., B. Rajgopalan, S. Dwivedi, DK Shrivastaba, S. Singh, and I. Kaur. "Lipoprotein (a) and Comprehensive Lipid Tetrad Index in Young Patients of Coronary Artery Disease." Nepalese Heart Journal 3, no. 3 (December 30, 2004): 8–9. http://dx.doi.org/10.3126/njh.v3i3.26056.
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To compare the clinico-biochemical profile of young patients (< 40 years) having coronary artery disease (CAD) with age-sex matched controls with a special reference to lipoprotein (a) [Lp(a)] and comprehensive lipid tetrad index (CLTI).
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Montelione, Nunzio, Vincenzo Catanese, Teresa Gabellini, Francesco Alberto Codispoti, Antonio Nenna, Francesco Spinelli, and Francesco Stilo. "Duplex and Angiographic-Assisted Evaluation of Outcomes of Endovascular Embolization after Surgical Deep Vein Arterialization for the Treatment No-Option Critical Limb Ischemia Patients." Diagnostics 12, no. 12 (November 29, 2022): 2986. http://dx.doi.org/10.3390/diagnostics12122986.
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Objective: To report early and mid-term outcomes of the arterialization of the deep venous system in no-option critical limb-threatening ischemia (CLTI) using duplex ultrasound and angiographic evaluation to improve limb perfusion. Methods: A single-center prospective study of patients with no-option CLTI treated with hybrid surgical arterialization of the deep venous circulation and staged endovascular embolization of the venous collateral. Embolization was performed using a controlled-release spiral, within two weeks after bypass surgery. Patients were assessed for clinical status, wound healing, median transcutaneous partial pressure of O2 (TcPO2), and post-operative duplex ultrasound evaluating peak systolic velocity (PSV), end diastolic velocity (EDV), and resistance index (RI) to assess foot perfusion and bypass features. Primary endpoint analysis was primary technical success, limb salvage, patency rates, and clinical improvement. Secondary endpoints were 30-day and long-term mortality, major cardiovascular events (MACE), including myocardial infarction or stroke, and serious adverse events (SAE). Results: Five patients with no-option CLTI were treated at our center using the hybrid deep vein arterialization technique. Clinical stage was grade 3 in one patient and grade 4 in the remaining four. Mean age was 65.8 years (range 49–76 years), and two patients were affected by Buerger’s disease. Primary technical success was achieved in all patients, and all the bypasses were patent at the angiographic examination. At 30-day and at average follow-up of 9.8 months (range 2–24 months), mortality, major cardiovascular events (MACE), and serious adverse events (SAE) were not reported, with a primary patency and limb salvage rates of 100%. Three patients required minor amputation. Clinical improvement was demonstrated in all patients with granulation, resolution of rest pain, or both. Median TcPO2 values rose from 10 mm Hg (range 4–25) before the procedure to 35 (range 31–57) after surgery, and to 59 mm Hg (range 50–76) after the staged endovascular procedure. Conclusions: In our initial experience, the arterialization of the deep venous circulation, with subsequent selective embolization of the venous escape routes from the foot, seems a feasible and effective solution for limb salvage in patients with no-option CLTI and those in the advanced wound, ischemia, and foot infection (WIfI) clinical stage.
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Jiang, Xiaoyan, Yi Yuan, Yu Ma, Miao Zhong, Chenzhen Du, Johnson Boey, David G. Armstrong, Wuquan Deng, and Xiaodong Duan. "Pain Management in People with Diabetes-Related Chronic Limb-Threatening Ischemia." Journal of Diabetes Research 2021 (May 8, 2021): 1–11. http://dx.doi.org/10.1155/2021/6699292.
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Management of neuropathic pain in people with diabetes has been widely investigated. However, little attention was paid to address ischemic-related pain in patients with diabetes mellitus who suffered from chronic limb-threatening ischemia (CLTI), the end stage of lower extremity arterial disease (LEAD). Pain management has a tremendous influence on patients’ quality of life and prognosis. Poor management of this type of pain owing to the lack of full understanding undermines patients’ physical and mental quality of life, which often results in a grim prognosis, such as depression, myocardial infarction, lower limb amputation, and even mortality. In the present article, we review the current strategy in the pain management of diabetes-related CLTI. The endovascular therapy, pharmacological therapies, and other optional methods could be selected following comprehensive assessments to mitigate ischemic-related pain, in line with our current clinical practice. It is very important for clinicians and patients to strengthen the understanding and build intervention strategy in ischemic pain management and possible adverse consequence.
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Aarabi, Ghazal, Michael Raedel, Thea Kreutzburg, Sandra Hischke, Eike Sebastian Debus, Ursula Marschall, Udo Seedorf, and Christian-Alexander Behrendt. "Periodontal treatment and peripheral arterial disease severity – a retrospective analysis of health insurance claims data." Vasa 49, no. 2 (March 1, 2020): 128–32. http://dx.doi.org/10.1024/0301-1526/a000846.
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Summary: Background: Although epidemiological data suggest an association between periodontitis (PD) and peripheral arterial disease (PAD), it is currently unclear whether treatment of PD influences the severity of PAD. Patients and methods: Whether periodontal treatment is associated with PAD disease severity was examined by analysing health insurance claims data of patients insured by the German health insurance fund, BARMER, between January 1, 2012 and December 31, 2016. The presence of PAD was determined in individuals using International Classification of Diseases (ICD) 10th revision codes for intermittent claudication (IC) or chronic limb threatening ischaemia (CLTI). Treatment of PD was assessed by adequate ambulatory coding for non-surgical and surgical treatment of PD. Multivariate logistic regression analysis was performed to evaluate the association between PAD stages and periodontal treatment, adjusted for diabetes, age and sex. Results: The study cohort included 70,944 hospitalized patients with a diagnosis of symptomatic PAD (54.99 % women, 49.05 % IC). Among these patients, 3,567 (5.03 %) had received prior treatment for PD by supra- or sub-gingival debridement. PAD patients who had received periodontal treatment showed a lower proportion of CLTI (28.76 % among treated vs. 52.12 % among non-treated). Using multivariable regression methods, exhibiting a CLTI (vs. IC) was associated with not being treated for PD (Odds Ratio 1.97, 95 %–CI 1.83–2.13) after adjustment for age, gender, and diabetes. Conclusions: In this large-scale retrospective analysis of health insurance claims data comprising hospitalized symptomatic PAD patients, treatment of PD was associated with PAD disease severity independent of age, gender and diabetes. A potential benefit of periodontal treatment in relation to PAD will have to be determined in further prospective studies.
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Weissler, E. Hope, Yongfei Wang, Jordan M. Gales, Dmitriy N. Feldman, Shipra Arya, Eric A. Secemsky, Herbert D. Aronow, et al. "Cardiovascular and Limb Events Following Endovascular Revascularization Among Patients ≥65 Years Old: An American College of Cardiology PVI Registry Analysis." Journal of the American Heart Association 11, no. 12 (June 21, 2022). http://dx.doi.org/10.1161/jaha.121.024279.
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Background We aimed to characterize the occurrence of major adverse cardiovascular and limb events (MACE and MALE) among patients with peripheral artery disease (PAD) undergoing peripheral vascular intervention (PVI), as well as associated factors in patients with chronic limb threatening ischemia (CLTI). Methods and Results Patients undergoing PVI in the American College of Cardiology’s (ACC) National Cardiovascular Data Registry’s PVI Registry who could be linked to Centers for Medicare and Medicaid Services data were included. The primary outcomes were MACE, MALE, and readmission within 1 month and 1 year following index CLTI‐PVI or non‐CLTI‐PVI. Cox proportional hazards regression was used to identify factors associated with the development of the primary outcomes among patients undergoing CLTI‐PVI. There were 1758 (49.7%) patients undergoing CLTI‐PVI and 1779 (50.3%) undergoing non‐CLTI‐PVI. By 1 year, MACE occurred in 29.5% of patients with CLTI (n=519), and MALE occurred in 34.0% of patients with CLTI (n=598). By 1 year, MACE occurred in 8.2% of patients with non‐CLTI (n=146), and MALE occurred in 26.1% of patients with non‐CLTI (n=465). Predictors of MACE at 1 year in CLTI‐PVI included end‐stage renal disease on hemodialysis, congestive heart failure, prior CABG, and severe lung disease. Predictors of MALE at 1 year in CLTI‐PVI included treatment of a prior bypass graft, profunda femoral artery treatment, end‐stage renal disease on hemodialysis, and treatment of a previously treated lesion. Conclusions Patients ≥65 years old undergoing PVI experience high rates of MACE and MALE. A range of modifiable and non‐modifiable patient factors, procedural characteristics, and medications are associated with the occurrence of MACE and MALE following CLTI‐PVI.
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Kawarada, Osami, Kan Zen, Koji Hozawa, Hideaki Obara, Kentaro Matsubara, Yoshito Yamamoto, Tatsuki Doijiri, et al. "Characteristics, Antithrombotic Patterns, and Prognostic Outcomes in Claudication and Critical Limb-Threatening Ischemia Undergoing Endovascular Therapy." Journal of Endovascular Therapy, November 23, 2022, 152660282211348. http://dx.doi.org/10.1177/15266028221134886.
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Purpose: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study aimed to clarify differences in clinical features and prognostic outcomes between IC and CLTI, and prognostic factors in patients undergoing endovascular therapy (EVT). Materials and Methods: A total of 692 patients with 808 limbs were enrolled from 20 institutions in Japan. The primary measurements were the 3-year rates of major adverse cardiovascular event (MACE) and reintervention. Results: Among patients, 79.0% had IC and 21.0% had CLTI. Patients with CLTI were more frequently women and more likely to have impaired functional status, undernutrition, comorbidities, hypercoagulation, hyperinflammation, distal artery disease, short single antiplatelet and long anticoagulation therapies, and late cilostazol than patients with IC. Aortoiliac and femoropopliteal diseases were dominant in patients with IC and infrapopliteal disease was dominant in patients with CLTI. Patients with CLTI underwent less frequently aortoiliac intervention and more frequently infrapopliteal intervention than patients with IC. Longitudinal change of ankle-brachial index (ABI) exhibited different patterns between IC and CLTI (pinteraction=0.002), but ABI improved after EVT both in IC and in CLTI (p<0.001), which was sustained over time. Dorsal and plantar skin perfusion pressure in CLTI showed a similar improvement pattern (pinteraction=0.181). Distribution of Rutherford category improved both in IC and in CLTI (each p<0.001). Three-year MACE rates were 20.4% and 42.3% and 3-year reintervention rates were 22.1% and 46.8% for patients with IC and CLTI, respectively (log-rank p<0.001). Elevated D-dimer (p=0.001), age (p=0.043), impaired functional status (p=0.018), and end-stage renal disease (p=0.019) were independently associated with MACE. After considering competing risks of death and major amputation for reintervention, elevated erythrocyte sedimentation rate (p=0.003) and infrainguinal intervention (p=0.002) were independently associated with reintervention. Patients with CLTI merely showed borderline significance for MACE (adjusted hazard ratio 1.700, 95% confidence interval 0.950–3.042, p=0.074) and reintervention (adjusted hazard ratio 1.976, 95% confidence interval 0.999–3.909, p=0.05). Conclusions: The CLTI is characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared with IC. Also, CLTI has approximately twice MACE and reintervention rates than IC, and the underlying inflammatory coagulation disorder per se is associated with these outcomes. Clinical Impact The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study, JPASSION study found that CLTI was characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared to IC. Also, CLTI had approximately twice major adverse cardiovascular event (MACE) and reintervention rates than IC. Intriguingly, the underlying inflammatory coagulation disorder per se was independently associated with MACE and reintervention. Further studies to clarify the role of anticoagulation and anti-inflammatory therapies will contribute to the development of post-interventional therapeutics in the context of peripheral artery disease.
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Shah, Samir K., Dan Neal, Scott A. Berceli, Mark Segal, Michol A. Cooper, Thomas S. Huber, Gilbert R. Upchurch, and Salvatore T. Scali. "National Treatment Patterns and Outcomes for Hospitalized Patients with Chronic Limb-Threatening Ischemia and End-Stage Kidney Disease." Vascular and Endovascular Surgery, December 21, 2022, 153857442211468. http://dx.doi.org/10.1177/15385744221146868.
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Background Chronic limb-threatening ischemia (CLTI) can be associated with dismal outcomes but there are limited real-world data to further define the impact of end-stage kidney disease (ESKD) on outcomes nationally in this subset of patients. We sought to characterize national patterns of inpatient treatment of CLTI and compare outcomes in patients without ESKD. Methods The National Inpatient Sample was queried from 2015-2018 for all hospital admissions including treatment for CLTI. Mixed-effects linear and logistic regression models were used to estimate the effect of ESKD on outcomes and treatment choice. Results We identified 11 652 hospital admissions with CLTI alone and 2705 with CLTI + ESKD. Hospital admissions with CLTI + ESKD patients included patients who were younger (66 vs 69 years, P < .0001), less likely to be white (39% vs 63%, P < .0001), and more likely to reside in lower income large metropolitan areas. Admissions for CLTI + ESKD patients had a lower likelihood of open arterial reconstruction (OR .40, P < .0001) and a higher likelihood of endovascular revascularization or major limb amputation (OR 1.70, P < .0001). Admissions for CLTI + ESKD also had a 4.5- and 1.5-fold higher odds of in-hospital death and complications. These findings were associated with a longer LOS ( P < .0001), increased probability of discharge to rehabilitation facility (50% vs 41%, P < .0001), and greater hospital charges (median, $107 K vs $85 K, P < .0001). Conclusions Compared to hospital admissions for patients without ESKD, admissions for patients with CLTI + ESKD demonstrated distinctive demographic characteristics, a lower likelihood of open revascularization and a higher likelihood of endovascular revascularization and major limb amputation. Chronic limb-threatening ischemia + ESKD hospital admissions showed worse overall outcomes and greater resource utilization compared to CLTI admissions without ESKD.
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Beck, KJ, and DPJ Howard. "Distal venous arterialisation for ‘no-option’ chronic limb-threatening ischaemia." Journal of Vascular Societies Great Britain and Ireland 1 (2022). http://dx.doi.org/10.54522/jvsgbi.2022.016.
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Chronic limb-threatening ischaemia (CLTI), defined as significant peripheral arterial disease causing ischaemic rest pain and/or tissue loss, is associated with a high amputation and mortality rate. Avoiding amputation in CLTI is crucial and restoration of blood flow is usually achieved using endovascular or open surgical revascularisation. However, significant occlusion of the distal limb vasculature may result in ‘no option’ CLTI, where there are no available target vessels for angioplasty or bypass. An emerging procedure to treat patients with ‘no option’ CLTI is distal venous arterialisation (DVA). This involves using the distal venous system as a conduit for arterial blood to revascularise the lower limb. This report describes a patient presenting with ‘no option’ CLTI who underwent limb-saving treatment with DVA. The case highlights how worsening clinical outcomes may occur despite technical success of DVA. It also emphasises complications of the procedure. Finally, the evidence base surrounding DVA for CLTI is examined.
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Kim, Young, Charles S. Decarlo, Karthik Thangappan, Nikolaos Zacharias, Abhisekh Mohapatra, and Anahita Dua. "Distal Bypass Versus Infrageniculate Endovascular Intervention for Chronic Limb-Threatening Ischemia." Vascular and Endovascular Surgery, March 31, 2022, 153857442210863. http://dx.doi.org/10.1177/15385744221086347.
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Chronic limb-threatening ischemia (CLTI) carries a high risk of amputation and warrants urgent intervention. CLTI involving the infrageniculate vessels, in particular, carries a considerably higher risk of major limb amputation. Open surgical bypass is the historical gold standard for the treatment of tibial arterial disease; however, endovascular therapy provides an attractive alternative in this high-risk patient population. In this article, we review the existing literature regarding distal bypass and infrageniculate endovascular intervention in patients with CLTI.
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Huang, Ivan, Tatsuya Nakama, Shigeo Ichihashi, and Uei Pua. "Technical Aspects of Percutaneous Deep Venous Arterialization Using Off-the-Shelf Devices." Journal of Endovascular Therapy, September 28, 2022, 152660282211278. http://dx.doi.org/10.1177/15266028221127850.
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Purpose: Chronic limb-threatening ischemia (CLTI) represents the clinical end stage of lower extremity peripheral arterial disease (PAD). Although conventional open and endovascular revascularization options are available, some CLTI patients do not respond to these treatments, generally due to small vessel occlusive disease, with only limited or no clinical improvement achieved. This article aims to provide insights related to pertinent venous anatomy of the leg and below the ankle and a technical review of percutaneous deep venous arterialization (pDVA) creation using commonly-available devices. Technique: For patients with “no-option” CLTI, the risk of major amputation and mortality remains high. Although arterial revascularization remains the optimal treatment of CLTI, some patients with severely-diseased or gracile distal arteries have poor outcome. Deep venous arterialization (DVA), in a subset of patients with tibial anatomy amenable to DVA creation, represents the last-ditch attempt before these patients are deemed to have “no-hope” at limb salvage, and major amputation becomes necessary. Refinement in technique and advancement in device development have been shown to allow pDVA to be created with respectable outcomes for the “no-option” CLTI patient population. Conclusion: The pDVA has garnered increasing interest among endovascular specialists to further understand the anatomical and technical key points of this procedure, and it may yet prove to be a useful addition in the armamentarium in our battle against CLTI. Clinical Impact Percutaneous deep venous arterialisation provides another option in the treatment of challenging “no-option” CLTI patients, and off-the-shelf devices will allow this procedure to be performed in centers where dedicated devices are not available.
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Anantha Narayanan, Mahesh, Rajkumar P. Doshi, Krunalkumar Patel, Azfar B. Sheikh, Fiorella Llanos-Chea, Jinnette D. Abbott, Raul J. Guzman, et al. "Abstract 16190: Trends in Admissions and Outcomes in Patients With Chronic Limb-threatening Ischemia-a National Inpatient Sample Analysis." Circulation 142, Suppl_3 (November 17, 2020). http://dx.doi.org/10.1161/circ.142.suppl_3.16190.
Full textAbstract:
Introduction: Chronic limb threatening ischemia (CLTI) morbidity and mortality rates have historically been higher, however recent trends have not been reported. In patients admitted with CLTI, we aimed to examine trends in in-hospital mortality, major amputations, length of stay, and cost of admissions overall, and stratified by type of revascularization procedures. Hypothesis: We hypothesized there would be an increase in CLTI-related admissions, with outcomes only marginally improving. Methods: Using 2011-2017 National Inpatient Sample data, we identified CLTI-related admissions based on ICD-9 and 10-CM codes. We stratified outcomes based on endovascular or open surgical interventions. We also performed multivariable regression analyses based on age, sex, race, hospital size, type and location. Results: We identified 2,643,087 CLI-related admissions between 2011 and 2017. CLI admissions increased from 0.9% to 1.4% P trend <0.0001 as well as overall PAD admissions (4.5% to 8.9%, P trend <0.0001). In-hospital mortality for the entire CLTI cohort decreased from 3.3% to 2.7%, P trend <0.0001 and major amputations decreased from 10.9% to 7%, P trend <0.0001. A decline was also noted for length of stay from 5.7 (3.1-10.1) to 5.4 (3.0-9.2) (P trend <0.0001), whereas admission costs increased from 11,791 (6,676 - 21,712) to 12,597 (7,248 - 22,748) (P trend <0.0001). The volume of endovascular interventions increased (P<0.0001) against a decline in surgical interventions (P<0.0001). Black race, female sex and age ≥60 years were associated with higher in-hospital mortality. Conclusions: A relatively small decrease in absolute numbers for mortality and major amputations were observed against a backdrop of increasing CLTI admission volumes over recent years. As patients with CLTI receive more endovascular interventions than surgical interventions over time, mortality rates and length of stay have generally improved.