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1
Ludman, Peter F. "UK TAVI registry." Heart 105, Suppl 2 (March 2019): s2—s5. http://dx.doi.org/10.1136/heartjnl-2018-313510.
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The UK Transcatheter Aortic Valve Implantation (TAVI) registry has collected data about every TAVI procedure performed in the UK. The latest data are from 2016 when 3250 procedures (49.5 pmp) were performed. There has been no change in the mean age of patients but there has been a shift to lower risk with fall in mean Logistic Euroscore since 2012. The switch from general anaesthetic to conscious sedation has been rapid, and propensity-adjusted analysis has not shown a difference in outcomes. In-hospital mortality has fallen to 1.8% in 2016, and relative survival analysis has shown outcome the same as the matched general population to 3 years. The UK TAVI registry has provided valuable benchmarks, and a risk adjustment model that includes frailty measures has been successfully developed and is available online.
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Masiero, Giulia, and Giuseppe Musumeci. "Transcatheter aortic valve implantation in Italy: an uneven growth." European Heart Journal Supplements 22, Supplement_E (March 29, 2020): E96—E100. http://dx.doi.org/10.1093/eurheartj/suaa070.
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Abstract Transcatheter aortic valve implantation (TAVI) is the treatment of choice in patients with severe symptomatic aortic stenosis who are not suitable for surgery. The procedure has become the preferred strategy in patients at intermediate/high surgical risk with favourable clinical and anatomical characteristics. The collected scientific evidences, as well as the technologic innovations shaping the newer devices, allowed for a progressive reduction of the procedure-related complications as a well as a simplification of the procedure itself, promoting the gradual expansion of the indication for TAVI with the consequent increase in the estimated number of procedures performed each year. There are significant geographic and socio-economic disparities in the use of TAVI around the world and in Italy as well, reflecting an application of the procedure directly related to the economic prosperity of the Health System of the Country examined. The Italian situation, similar to the worldwide reality, reveals an uneven application of the procedure, signalling a disparity in the socio-economic and organizational capabilities of each single region. Standardization of patient selection for treatment, and of the clinical pathway for TAVI are crucial for an homogeneous integration of this new technology in the current Health Care System.
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Tagliari, Ana Paula, Rodrigo Petersen Saadi, Eduardo Ferreira Medronha, and Eduardo Keller Saadi. "The Use of BASILICA Technique to Prevent Coronary Obstruction in a TAVI-TAVI Procedure." Journal of Clinical Medicine 10, no. 23 (November 26, 2021): 5534. http://dx.doi.org/10.3390/jcm10235534.
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Transcatheter aortic valve implantation (TAVI) to manage structural bioprosthetic valve deterioration has been successful in mitigating the risk of a redo cardiac surgery. However, TAVI-in-TAVI is a complex intervention, potentially associated with feared complications such as coronary artery obstruction. Coronary obstruction risk is especially high when the previously implanted prosthesis had supra-annular leaflets and/or the distance between the prosthesis and the coronary ostia is short. The BASILICA technique (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) was developed to prevent coronary obstruction during native or valve-in-valve interventions but has now also been considered for TAVI-in-TAVI interventions. Despite its utility, the technique requires a not so widely available toolbox. Herein, we discuss the TAVI-in-TAVI BASILICA technique and how to perform it using more widely available tools, which could spread its use.
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Sündermann, Simon H., Michael Gessat, Willibald Maier, Jörg Kempfert, Thomas Frauenfelder, Thi D. L. Nguyen, Francesco Maisano, and Volkmar Falk. "Simulated Prosthesis Overlay for Patient-Specific Planning of Transcatheter Aortic Valve Implantation Procedures." Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery 10, no. 5 (September 2015): 314–22. http://dx.doi.org/10.1097/imi.0000000000000198.
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Objective We tested the hypothesis that simulated three-dimensional prosthesis overlay procedure planning may support valve selection in transcatheter aortic valve implantation (TAVI) procedures. Methods Preoperative multidimensional computed tomography (MDCT) data sets from 81 consecutive TAVI patients were included in the study. A planning tool was developed, which semiautomatically creates a three-dimensional model of the aortic root from these data. Three-dimensional templates of the commonly used TAVI implants are spatially registered with the patient data and presented as graphic overlay. Fourteen physicians used the tool to perform retrospective planning of TAVI procedures. Results of prosthesis sizing were compared with the prosthesis size used in the actually performed procedure, and the patients were accordingly divided into three groups: those with equal size (concordance with retrospective planning), oversizing (retrospective planning of a smaller prosthesis), and undersizing (retrospective planning of a larger prosthesis). Results In the oversizing group, 85% of the patients had new pacemaker implantation. In the undersizing group, in 66%, at least mild paravalvular leakage was observed (greater than grade 1 in one third of the cases). In 46% of the patients in the equal-size group, neither of these complications was observed. Conclusions Three-dimensional prosthesis overlay in MDCT-derived patient data for patient-specific planning of TAVI procedures is feasible. It may improve valve selection compared with two-dimensional MDCT planning and thus yield better outcomes.
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Poels, Thomas T., Elien B. Engels, Suzanne Kats, Leo Veenstra, Vincent van Ommen, Kevin Vernooy, Jos G. Maessen, and Frits W. Prinzen. "Occurrence and Persistency of Conduction Disturbances during Transcatheter Aortic Valve Implantation." Medicina 57, no. 7 (July 7, 2021): 695. http://dx.doi.org/10.3390/medicina57070695.
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Background and Objectives: Conduction disturbances such as left bundle branch block (LBBB) and complete atrio-ventricular block (cAVB) are relatively frequent complications following trans-catheter aortic valve implantation (TAVI). We investigated the dynamics of these conduction blocks to further understand luxating factors and predictors for their persistency. Materials and Methods: We prospectively included 157 consecutive patients who underwent a TAVI procedure. Electrocardiograms (ECGs) were obtained at specific time points during the TAVI procedure and at follow-up until at least six months post-procedure. Results: Of the 106 patients with a narrow QRS complex (nQRS) before TAVI, ~70% developed LBBB; 28 (26.4%) being classified as super-transient (ST-LBBB), 20 (18.9%) as transient (T-LBBB) and 24 (22.6%) as persistent (P-LBBB). Risk of LBBB was higher for self-expandable (SE) than for balloon-expandable (BE) prostheses and increased with larger implant depth. During the TAVI procedure conduction disturbances showed a dynamic behavior, as illustrated by alternating kinds of blocks in 18 cases. Most LBBBs developed during balloon aortic valvuloplasty (BAV) and at positioning and deployment of the TAVI prosthesis. The incidence of LBBB was not significantly different between patients who did and did not undergo BAV prior to TAVI implantation (65.3% and 74.2%, respectively (p = 0.494)). Progression to cAVB was most frequent for patients with preexisting conduction abnormalities (5/34) patients) and in patients showing ST-LBBB (6/28). Conclusions: During the TAVI procedure, conduction disturbances showed a dynamic behavior with alternating types of block in 18 cases. After a dynamic period of often alternating types of block, most BBBs are reversible while one third persist. Patients with ST-LBBB are most prone to progressing into cAVB. The observation that the incidence of developing LBBB after TAVI is similar with and without BAV suggests that a subgroup of patients has a substrate to develop LBBB regardless of the procedure.
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Angellotti, Domenico, Rachele Manzo, Domenico Simone Castiello, Maddalena Immobile Molaro, Andrea Mariani, Cristina Iapicca, Dalila Nappa, et al. "Echocardiographic Evaluation after Transcatheter Aortic Valve Implantation: A Comprehensive Review." Life 13, no. 5 (April 24, 2023): 1079. http://dx.doi.org/10.3390/life13051079.
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Transcatheter aortic valve implantation (TAVI) is an increasingly popular treatment option for patients with severe aortic stenosis. Recent advancements in technology and imaging tools have significantly contributed to the success of TAVI procedures. Echocardiography plays a pivotal role in the evaluation of TAVI patients, both before and after the procedure. This review aims to provide an overview of the most recent technical advancements in echocardiography and their use in the follow-up of TAVI patients. In particular, the focus will be on the examination of the influence of TAVI on left and right ventricular function, which is frequently accompanied by other structural and functional alterations. Echocardiography has proven to be key also in detecting valve deterioration during extended follow-up. This review will provide valuable insights into the technical advancements in echocardiography and their role in the follow-up of TAVI patients.
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Yemets, G. I., O. V. Telehuzova, G. B. Mankovsky, A. V. Maksymenko, Ye Yu Marushko, A. A. Dovhaliuk, A. A. Sokol, and I. M. Yemets. "Features of echocardiographic assessment on transcatheter aortic valve implantation multiple stages." Ukrainian Journal of Cardiology 28, no. 1 (March 22, 2021): 43–51. http://dx.doi.org/10.31928/1608-635x-2021.1.4351.
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The aim – to systematize information on key features of echocardiographic evaluation of transcatheter aortic valve implantation (TAVI) procedure stages and their effectiveness in cardiac surgery, in patients with severe aortic valve stenosis.Materials and methods. We initiated a single-center clinical study to evaluate the XPand device and initial analysis of the primary results was performed. Patients met the inclusion criteria underwent a full range of examinations and TAVI procedures using the XPand device. The key parameters for echocardiographic examination in TAVI, which influence the formation of further procedure strategy, have been determined for the cardiac surgeon.Results and discussion. Based on the determined echocardiographic parameters, we obtained the primary outcomes of TAVI XPand in patients (n=7), the result of implantation was good. Minimal paravalvular insufficiency absence was found in 71.5 % of patients and minimal insufficiency in 14,5 %. In one patient to moderate insufficiency was observed. There was a statistically significant improvement in the ejection fraction (p<0.05) and a decrease in the mean gradient at the aortic valve (p<0.01).Conclusions. Echocardiographic parameters at all TAVI stages in patients over 75 years allow to control the implementation of the procedure and to improve the immediate post procedural outcome. The first experience of using the novel device for transcatheter implantation of the XPand aortic valve prosthesis confirms its effectiveness and safety in elderly patients with severe aortic stenosis.
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Intorcia, Alfredo, Vittorio Ambrosini, Michele Capasso, Riccardo Granata, Fabio Magliulo, Giannignazio Luigi Carbone, Stefano Capobianco, et al. "Management of Transcatheter Aortic Valve Implantation and Complex Aorta Anatomy: The Importance of Pre-Procedural Planning." International Journal of Environmental Research and Public Health 19, no. 8 (April 14, 2022): 4763. http://dx.doi.org/10.3390/ijerph19084763.
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Aortic stenosis is the most common primary valve lesion requiring surgery or, especially for older patients, transcatheter intervention (TAVI). We showcase a successful transfemoral TAVI procedure in a very high-risk patient and an extremely tortuous S-shaped descending aorta, characterized by heavy calcifications and multiple strong resistance points. We demonstrated that transfemoral TAVI using the “buddy stiff guidewire” technique could be a feasible, simple, quick, and easy procedure able to straighten an extremely abdominal aorta tortuosity. With all techniques available and careful pre-procedural planning, and thanks to the flexibility of new generation TAVI delivery systems, it is possible to safely perform the procedure even in the most challenging patients.
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Bohmann, Katja, Christof Burgdorf, Tobias Zeus, Michael Joner, Héctor Alvarez, Kira Lisanne Berning, Maren Schikowski, et al. "The COORDINATE Pilot Study: Impact of a Transcatheter Aortic Valve Coordinator Program on Hospital and Patient Outcomes." Journal of Clinical Medicine 11, no. 5 (February 23, 2022): 1205. http://dx.doi.org/10.3390/jcm11051205.
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The transcatheter aortic valve implantation (TAVI) treatment pathway is complex, leading to procedure-related delays. Dedicated TAVI coordinators can improve pathway efficiency. COORDINATE was a pilot observational prospective registry at three German centers that enrolled consecutive elective patients with severe aortic stenosis undergoing TAVI to investigate the impact a TAVI coordinator program. Pathway parameters and clinical outcomes were assessed before (control group) and after TAVI coordinator program implementation (intervention phase). The number of repeated diagnostics remained unchanged after implementation. Patients with separate hospitalizations for screening and TAVI had long delays, which increased after implementation (65 days pre- vs. 103 days post-implementation); hospitalizations combining these were more efficient. The mean time between TAVI and hospital discharge remained constant. Nurse (p = 0.001) and medical technician (p = 0.008) working hours decreased. Patient satisfaction increased, and more consistent/intensive contact between patients and staff was reported. TAVI coordinators provided more post-TAVI support, including discharge management. No adverse effects on post-procedure or 30-day outcomes were seen. This pilot suggests that TAVI coordinator programs may improve aspects of the TAVI pathway, including post-TAVI care and patient satisfaction, without compromising safety. These findings will be further investigated in the BENCHMARK registry.
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Petrov, I., Z. Stankov, P. Polomski, and D. Boychev. "Eight-year single-center experience with transcatheter aortic valve implantation (TAVI)." Interventional Cardiology Forum 2 (December 22, 2022): 52–63. http://dx.doi.org/10.3897/icf.2.e98590.
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The first TAVI implantation was performed in 2002 by Cribier and colleagues. From then, we have seen significant progress in technology, with the appearance of new generations – lower-profile, longer-lasting and more stable during positioning TAVI prostheses. The present publication presents single-center results and experience with TAVI procedures over an eight-year period. During the period 2013 – November 2022 a total of 354 TAVI procedures were performed in Acibadem City Clinical Cardiovascular Center. Two operating strategies are used – standard and minimalist approach. From the first procedure in 2013 until mid-2018 the standard approach (surgical vascular access, general anesthesia, direct valve implantation where possible) was mostly used. Then, the minimalist approach (percutaneous access, no intubation anesthesia, mandatory valve predilation and use of rapid pacing) was introduced as a standard approach in the center.
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Wheen, Peter, Richard Armstrong, Andrew Maree, and Stephen O'Connor. "Late ventricular standstill following an elective TAVI." BMJ Case Reports 12, no. 12 (December 2019): e232477. http://dx.doi.org/10.1136/bcr-2019-232477.
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Transcatheter aortic valve implantations (TAVIs) may be complicated by a need for permanent pacemaker implantation post procedure, usually due to local trauma or compression on the conduction system. There are some features that might help predict that a patient is high risk for developing conduction disease following TAVI, for example, underlying right bundle branch block or use of certain types of TAVI. It might also become apparent during the procedure, or before temporary wire removal post procedure. Higher risk patients may undergo rhythm monitoring for longer periods post TAVI. We present a case where a patient required an unexpected emergency pacemaker following a TAVI, despite low risk clinical features, a low risk baseline ECG, and the use of a low risk TAVI valve. In addition, this very significant conduction disease only became apparent over 72 hours following implantation, despite normal resting ECGs and telemetry up to that point.
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Papamanoli, Aikaterini, Brandon Muncan, Puja Parikh, Hal A. Skopicki, and Andreas Kalogeropoulos. "55. Infective Endocarditis After Surgical or Transcatheter Aortic Valve Replacement." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S38—S39. http://dx.doi.org/10.1093/ofid/ofab466.055.
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Abstract Background Infective endocarditis (IE) can complicate both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) with significant morbidity and mortality despite differing pathogenesis. In the presence of limited data from direct comparison studies and recent expansion of TAVI to younger and lower- risk patients, we compared the incidence and timing of IE in TAVI versus SAVR. Methods Using data from the TriNetX electronic health records network, we identified (1) a cohort of patients who underwent TAVI between January 2016 and December 2020 (CPT procedure code 1021150) and (2) a propensity score-matched cohort of patients who underwent SAVR (CPT procedure codes 1035167 or 1029693, without any associated transcatheter procedure). We examined the incidence of IE (captured with ICD-10 codes I33, I38, or I39) over a 5-year follow up period and matched the cohorts for demographic data and clinically relevant background history. We used Kaplan-Meier estimates and Cox proportional hazards models to compare incidence between matched cohorts. Results We identified 6,302 patients with TAVI and 6,302 matched patients with SAVR. The baseline characteristics of the cohorts were well balanced, Table 1. All standardized mean differences were < 0.05, indicating adequate matching between cohorts. The Kaplan-Meier mortality at 5 years was 38.0% in the TAVI vs. 22.0% in the SAVR cohort (log-rank P < 0.001). There were 290 cases with IE in the TAVI and 604 cases in the SAVR cohort. The corresponding 5-year event rates were 10.0% vs. 16.9% (log-rank P < 0.001), respectively, Figure 1. The risk ratio of TAVI vs. SAVR related IE over the entire 5-year period was 0.48 (95%CI 0.42 — 0.55; P < 0.001). However, the relative risk for IE was non-proportional between groups over the 5-year period, with an early pronounced incidence among SAVR relative to TAVI patients and gradual convergence of the hazard rates over time, Figure 2. Figure 1. Cumulative 5-Year Incidence (Kaplan-Meier Estimates) of Infective Endocarditis Among Matched Transcatheter Aortic Valve Implantation (TAVI) vs. Surgical Aortic Valve Replacement (SAVR) Recipients Figure 2. Risk of Infective Endocarditis in SAVR vs. TAVI Recipients Over Time Conclusion In this comparative study, the risk for IE was lower among TAVI vs. SAVR recipients, primarily due to the higher risk of IE during the early post-SAVR period. With increasing uptake of TAVI procedures, a better understanding of the temporal occurrence and pathophysiology of IE and application of effective treatment strategies in these patients is required. Disclosures All Authors: No reported disclosures
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Paparoni, F., F. De Remigis, G. Tomassoni, A. Marrangoni, G. Marrone, G. Fragassi, A. Lezzi, and D. Fabiani. "C49 NO CONTRAST TAVI." European Heart Journal Supplements 25, Supplement_D (May 2023): D21. http://dx.doi.org/10.1093/eurheartjsupp/suad111.048.
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Abstract Background Chronic renal failure is a common comorbidity in patients undergoing TAVI. Large amounts of contrast media are generally needed to safely perform TAVI with potential deleterious effects on renal function and long term life quality. Objectives Every step of the procedure can be safely replaced by no contrast techniques: ultrasound guided vascular puncture and final check, alignement of 3 guides in Valsalva sinuses to check coplanarity or cusp overlap, coupling of hemodynamics and transthoracic echocardiography to check the results and need of postdilatation, measure of gradient across the arterial puncture to rule out iatrogenic stenosis. Matherials and Methods 3 patients with severe renal failure (GFR < 30 ml/min/ 1.73 m2) and 1 patient with moderate renal failure and previous double renal transplantation underwent TAVI with protocol without contrast in our center in the last year. All cases were performed with local anesthesia and conscious sedation. 3 cases were performed with balloon expandable bioprosthesis and 1 with self expandable bioprosthesis. Results We were able to perform TAVI procedure without contrast in all 4 patients in which the technique was attempted without complications. Hemodynamics was excellent in all cases with no residual gradient or significant leaks. No vascular complication occured. Procedural time was generally 20% longer than average procedure but X rays dose exposure was reduced because less cine acquisitions were needed. Conclusions TAVI with no use of contrast media is feasible and safe by extensive use of vascular ultrasound, hemodynamics, transthoracic echocardiography and multiple guides to depict coronary sinuses and assure correct prothesis implantation.
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Calderón-Parra, Jorge, Juan E. de Villarreal-Soto, Juan Francisco Oteo-Domínguez, María Mateos-Seirul, Elsa Ríos-Rosado, Laura Dorado, Beatriz Vera-Puente, Carlos Arellano-Serrano, Antonio Ramos-Martínez, and Alberto Forteza-Gil. "Risk of Infective Endocarditis Associated with Transcatheter Aortic Valve Implantation versus Surgical Aortic Valve Replacement: A Propensity Score-Based Analysis." Journal of Clinical Medicine 12, no. 2 (January 11, 2023): 586. http://dx.doi.org/10.3390/jcm12020586.
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Background: Infective endocarditis (IE) is a feared complication after surgical aortic valve replacement (SAVR)/transcatheter aortic valve implantation (TAVI). It is not certain which procedure carries a higher risk. Our aim was to assess the risk of IE after SAVR/TAVI. Methods: We conducted an observational study of a prospective cohort, including patients with TAVI/SAVR, from March 2015 to December 2020. IE was defined according to the modified Duke’s criteria. IE occurring during the first 12 months of the procedure was considered early IE, and an episode occurring after 12 months was considered late IE. The propensity score was designed to include variables previously associated with TAVI/SAVR and IE. An inverse probability of treatment weight was generated. Results: In total, 355 SAVR and 278 TAVI were included. Median follow-up, 38 vs. 41 months, p = 0.550. IE occurred in 5 SAVR (1.41%, 95% CI 0.2–2.6) vs. 13 TAVI (4.65%, 95% CI 2.2–7.2), p = 0.016. TAVI patients had more frequent early IE (3.2% vs. 0.3%, p = 0.006). In the PS analyses, IE risk did not differ: OR 0.65, 95% CI 0.32–1.32. Factors associated with TAVI IE included younger age (74y vs. 83y, p = 0.030), complicated diabetes mellitus (38.5% vs. 6.8%, p = 0.002), COPD (46.2% vs. 16.3%, p = 0.015), advanced heart failure (100% vs. 52.9%, p < 0.001), and peripheral arteriopathy (61.5% vs. 26.7%, p = 0.011). Conclusions: Early IE was higher with TAVI, but in the PS analyses, the risk attributable to each procedure was similar. Studies are needed to identify and optimize the risk factors of IE prior to TAVI.
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Petrov, I., Z. Stankov, P. Polomski, J. Stoykova, A. Cherneva, D. Boychev, and M. Bonev. "Safety and efficiency of the minimalistic and precise approachfor transcatheter aortic valve implantation (TAVI) comparedto the standard one." Bulgarian Cardiology 28, no. 2 (June 20, 2022): 79–89. http://dx.doi.org/10.3897/bgcardio.28.e82274.
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Since the first procedure in humans in 2002, transcatheter aortic valve implantation (TAVI) has evolved from innovative procedure of the future to treatment of choice in high-risk patients with potential to become a routine procedure in the near future. Thanks to the excellent safety profile, the emerging evidence from clinical trials, TAVI has raised its class of recommendation in the guidelines. The constantly upraising frequency of TAVI and the experience gained have led to the need of procedure improvement and standardization. Between 2013 and 2021 208 patients underwent TAVI in our cardiovascular center. The standard approach was used for 141 of them and the minimalistic and precise approach for the rest 67 patients. The main focus of this manuscript is improvement of the procedure results, quality of life and comfort of the patients, while providing a better pharmacoeconomic profile.The minimalistic and precise protocol of implantation and the vascular device closure are thoroughly described. The safety and the efficiency of the minimalistic and precise approach compared to the standard one, which is considered the ”gold standard” are proven. At the same time the minimalistic approach is described as superior to the standard one in using the radial artery as second vascular approach to reduce vascular complications and bleeding. Other advantage of the minimalistic approach is the implantation of the transcatheter aortic valve in position 0/1 while using rapid pacing, to reduce the frequency of pacemaker implantation, reduction of paravalvular leak and reduction of hospital stay. TAVI has proved to be an alternative to surgical aortic valve replacement in high risk patients and in the past years also in intermediate and low risk patients. In order TAVI to become a PCI-like procedure it must be simplified. That is exactly why the minimalistic and precise approach for TAVI is needed and it is the future of the procedure.
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Szlapka, Michal, Eriberto Michel, Mark J. Ricciardi, and S. Christopher Malaisrie. "Valve-in-valve-prosthesis embolization and aortic dissection: single procedure, double complication." European Journal of Cardio-Thoracic Surgery 56, no. 1 (December 14, 2018): 204–5. http://dx.doi.org/10.1093/ejcts/ezy424.
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Abstract Transcatheter aortic valve implantation (TAVI) is a recognized treatment method for high-risk patients with aortic stenosis. TAVI is also recommended for structural valve degeneration of a biological valve prosthesis. TAVI-specific complications, such as prosthesis embolization and aortic dissection, are uncommon but potential concerns. A 73-year-old woman presented with structural valve degeneration 14 years after aortic root replacement with a bioprosthetic valved conduit. The patient underwent TAVI valve-in-valve under monitored anaesthesia care. Intraoperatively, the self-expandable prosthesis was difficult to deploy within the valved conduit and ultimately migrated distally. During the technically difficult passage of the prosthesis delivery system through the tortuous aorta, the patient started reporting symptoms suggestive of aortic dissection. An emergency computed tomography scan confirmed type B dissection. Thoracic endovascular aortic repair followed by deployment of a balloon-expandable prosthesis below the self-expandable implant was performed. Careful prosthesis selection in valve-in-valve patients after aortic root replacement is crucial for procedural success.
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Oettinger, Vera, Klaus Kaier, Timo Heidt, Markus Hortmann, Dennis Wolf, Andreas Zirlik, Manfred Zehender, Christoph Bode, Constantin von zur Mühlen, and Peter Stachon. "Outcomes of transcatheter aortic valve implantations in high-volume or low-volume centres in Germany." Heart 106, no. 20 (February 18, 2020): 1604–8. http://dx.doi.org/10.1136/heartjnl-2019-316058.
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ObjectiveTranscatheter aortic valve implantation (TAVI) is the most common aortic valve replacement in Germany. Since 2015, to ensure high-quality procedures, hospitals in Germany and other countries that meet the minimum requirement of 50 interventions per centre are being certified to perform TAVI. This study analyses the impact of these requirements on case number and in-hospital outcomes.MethodsAll isolated TAVI procedures and in-hospital outcomes between 2008 and 2016 were identified by International Classification of Diseases (ICD) and the German Operation and Procedure Classification codes.Results73 467 isolated transfemoral and transapical TAVI procedures were performed in Germany between 2008 and 2016. During this period, the number of TAVI procedures per year rose steeply, whereas the overall rates of hospital mortality and complications declined. In 2008, the majority of procedures were performed in hospitals with fewer than 50 cases per year (54.63%). Until 2014, the share of patients treated in low-volume centres constantly decreased to 5.35%. After the revision of recommendations, it further declined to 1.99%. In the 2 years after the introduction of the minimum requirements on case numbers, patients were at decreased risk for in-hospital mortality when treated in a high-volume centre (risk-adjusted OR 0.62, p=0.012). The risk for other in-hospital outcomes (stroke, permanent pacemaker implantation and bleeding events) did not differ after risk adjustment (p=0.346, p=0.142 and p=0.633).ConclusionA minimum volume of 50 procedures per centre and year appears suitable to allow for sufficient routine and thus better in-hospital outcomes, while ensuring nationwide coverage of TAVI procedures.
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Klyshnikov, K. Yu, V. I. Ganyukov, A. V. Batranin, D. V. Nushtaev, and E. A. Ovcharenko. "Simulation of Transcatheter Aortic Valve Implantation Procedure." Mathematical Biology and Bioinformatics 14, no. 1 (May 20, 2019): 204–19. http://dx.doi.org/10.17537/2019.14.204.
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The study is devoted to numerical modeling of transcatheter aortic valve implantation (TAVI) from the position of prognostic value in comparison with clinical data. The finite element method implemented in the Abaqus/CAE software and the reconstruction of three-dimensional models based on the computer microtomography of the CoreValve bioprosthesis of a size of 29 mm and the patient-specific data of functional studies (multispiral tomography) were used in the work. The study included three variations in the modeling of the aortic valve prosthesis procedure, which determine the level of detalization of the numerical experiment. All stages of the TAVI process were reproduced: the crimp of the prosthesis, the movement of the delivery system, the interaction of the guide - guidewire with the elements of the “prosthesis-root” of the aorta system, implantation itself. In silico experiment demonstrated significant quantitative and qualitative agreement with the data of intraoperative fluorography and computed tomography after the TAVI procedure. It is shown that the inclusion of additional elements – the guidewire and catheter of the delivery system into the “aortic root” has a positive effect on the convergence of the data with the clinical results. The analysis of the stress-strain state of the elements interacting in the experiment demonstrated a significant contribution to the analyzed parameters of the prosthetic motion stage along the guidewire as part of the delivery system catheter. Nevertheless, a comparison with the results of the clinical evaluation of the TAVI procedure revealed a number of differences in the response of the model of the bioprosthesis at the later stages of modeling, which requires further researches of a level of detalization. The approach is extremely promising both for practitioners and for research work of prosthetic designers, it can be applied in further R&D tasks.
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Van Mieghem, Nicolas, Apostolos Tzikas, Rutger-Jan Nuis, Carl Schultz, Peter de Jaegere, Patrick Serruys, Johan Bosmans, and Rüdiger Lange. "How should I treat a staggering TAVI procedure?" EuroIntervention 6, no. 3 (August 2010): 418–23. http://dx.doi.org/10.4244/eijv6i3a69.
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Kennon, Simon, and Zhan Lim. "Transcatheter Aortic Valve Implantation Without General Anaesthetic." Interventional Cardiology Review 9, no. 2 (2011): 130. http://dx.doi.org/10.15420/icr.2011.9.2.130.
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Transcatheter aortic valve implantation (TAVI) procedures are increasingly being performed under local anaesthetic, generally with sedation. Operators hope this will reduce mortality, morbidity and length of hospital stay. A general anaesthetic (GA), however, although involving intrinsic risk, permits transoesophageal echocardiogram (TOE) imaging throughout a procedure as well as eliminating patient anxiety, pain and movement. This article reviews the published literature, all single-centre experiences, comparing TAVI procedures performed with and without a GA. Procedures performed without GA are generally shorter with reduced length of stay compared with those performed under GA. There is no evidence of any difference in outcomes.
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Watanabe, Yusuke, and Ken Kozuma. "Transcatheter Aortic Valve Implantation for Patients with Smaller Anatomy." Interventional Cardiology Review 10, no. 3 (2015): 155. http://dx.doi.org/10.15420/icr.2015.10.03.155.
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Transcatheter aortic valve implantation (TAVI) has reached relative maturity for the treatment of severe, symptomatic aortic stenosis (AS). TAVI for patients with smaller anatomy is a challenging procedure due to specific anatomical difficulty and complications including annulus rupture and vascular complications. Prevention of these complications, and the introduction of a newer-generation and lowerprofile TAVI system, will encourage the prevalence of TAVI for patients with smaller anatomy.
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Supannika Kawvised, Supannika, Napat Ritlumlert, Phornpailin Pairodsantikul, Wannasa Piantham, Numfon Tweeatsani, Wongsakorn Luangphiphat, Komen Sen-ngam, et al. "Patient radiation dose from fluoroscopic-guided transcatheter cardiac aortic valve implantation procedure: A single-center study in Thailand." Journal of Associated Medical Sciences 56, no. 1 (January 3, 2023): 166–74. http://dx.doi.org/10.12982/jams.2023.020.
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Background: The trend in the use of fluoroscopic-guided transcatheter aortic valve implantation (TAVI) is increasing because the procedure is less invasive than surgical procedure. However, high radiation doses have been reported with the procedure. Moreover, the amount of radiation received by patients undergoing TAVI has never before been registered in Thailand. Objectives: This study aimed to investigate the radiation dose and the effects of sex and body mass index (BMI) on the radiation dose received by patients undergoing TAVI at Chulabhorn Hospital. Materials and methods: Data were collected on the radiation dose received by patients undergoing the TAVI procedure during the first 26 months after the operation at the Cardiology Center, Chulabhorn Hospital. We recorded patient demographic data including age, sex, and BMI and the following measures of radiation dose from the procedure: the number of exposure images, air kerma-area product (PKA), cumulative air kerma at the patient entrance reference point (Ka,r), and total fluoroscopy time. Results: In total, 68 patients (35 male and 33 female) underwent TAVI, with median exposure images, PKA, Ka,r, and total fluoroscopy time of 1,067 images, 166.14 Gy/cm2, 1,171.50 mGy, and 31.90 minutes, respectively. The patient’s sex did not affect total fluoroscopy time or the radiation dose received. Patients with BMI ≥30.0 kg/m2 had the highest median values of PKA, Ka,r, and total fluoroscopy time. Moreover, patients with BMI ≥18.5-24.9 kg/m2 received higher doses of radiation than patients with BMI ≥25.0-29.9 kg/m2; the result corresponded with longer total fluoroscopy time in the lower BMI category. Conclusion: The amount of radiation that patients received during TAVI was appropriate for diagnosis and treatment. However, to ensure patient safety, operators should consider reducing the duration of radiation during the procedure. Data from this study are a starting point for the recording of radiation doses received by patients undergoing TAVI and can be used as a future dose reference.
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Kawvised, Supannika, Napat Ritlumlert, Phornpailin Pairodsantikul, Wannasa Piantham, Numfon Tweeatsani, Wongsakorn Luangphiphat, Komen Sen-ngam, et al. "Patient radiation dose from fluoroscopic-guided transcatheter cardiac aortic valve implantation procedure: A single-center study in Thailand." Journal of Associated Medical Sciences 56, no. 1 (January 4, 2023): 167–75. http://dx.doi.org/10.12982/jams.2023.032.
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Background: The trend in the use of fluoroscopic-guided transcatheter aortic valve implantation (TAVI) is increasing because the procedure is less invasive than surgical procedure. However, high radiation doses have been reported with the procedure. Moreover, the amount of radiation received by patients undergoing TAVI has never before been registered in Thailand. Objectives: This study aimed to investigate the radiation dose and the effects of sex and body mass index (BMI) on the radiation dose received by patients undergoing TAVI at Chulabhorn Hospital. Materials and methods: Data were collected on the radiation dose received by patients undergoing the TAVI procedure during the first 26 months after the operation at the Cardiology Center, Chulabhorn Hospital. We recorded patient demographic data including age, sex, and BMI and the following measures of radiation dose from the procedure: the number of exposure images, air kerma-area product (PKA), cumulative air kerma at the patient entrance reference point (Ka,r), and total fluoroscopy time. Results: In total, 68 patients (35 male and 33 female) underwent TAVI, with median exposure images, PKA, Ka,r, and total fluoroscopy time of 1,067 images, 166.14 Gy/cm2, 1,171.50 mGy, and 31.90 minutes, respectively. The patient’s sex did not affect total fluoroscopy time or the radiation dose received. Patients with BMI ≥30.0 kg/m2 had the highest median values of PKA, Ka,r, and total fluoroscopy time. Moreover, patients with BMI ≥18.5-24.9 kg/m2 received higher doses of radiation than patients with BMI ≥25.0-29.9 kg/m2; the result corresponded with longer total fluoroscopy time in the lower BMI category. Conclusion: The amount of radiation that patients received during TAVI was appropriate for diagnosis and treatment. However, to ensure patient safety, operators should consider reducing the duration of radiation during the procedure. Data from this study are a starting point for the recording of radiation doses received by patients undergoing TAVI and can be used as a future dose reference.
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Avelar, Fernando Genovez, Isabel Emmerick, and Joana Alves. "Spatial analysis and factors associated with transcatheter aortic valve implantation in Portugal: a retrospective analysis from 2015 to 2017." BMJ Open 13, no. 2 (February 2023): e070715. http://dx.doi.org/10.1136/bmjopen-2022-070715.
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ObjectivesTo identify the factors associated with transcatheter aortic valve implantation (TAVI) use of TAVI in inpatients with aortic stenosis (AS) in Portugal and its geographical distribution.MethodsA quantitative, observational and retrospective study using the Portuguese National Health Service inpatient discharge database from 2015 to 2017. Surgical aortic valve replacement (SAVR) and TAVI procedures were selected using the International Classification of Diseases. First, we mapped the yearly age-standardised rate for each procedure using QGIS. Then, we performed χ2tests, independent t-tests and logistic regressions to study the factors associated with TAVI use.ResultsFrom 2015 to 2017, 8398 hospitalisations were selected, 88.5% SAVR and 11.5% TAVI. From 2015 to 2017, SAVR use increased in the Northern region and decreased in the Lisbon region, while the opposite was observed for TAVI. TAVI was performed among the most complex (p<0.001) and older patients (the mean (SD) age for SAVR was 70 (±11) years old and 81 (±7) years old for TAVI, p<0.001). The results for the logistic regressions showed that, more recent hospitalisations, being older, living in the Lisbon region and having a higher Charlson Comorbidity Index was associated with an increased likelihood of undergoing TAVI (p<0.001).ConclusionsTAVI increased over the years. TAVI is more often performed in more severe patients as an alternative to SAVR with similar discharge outcomes. These results suggest the existence of geographic disparities in the availability and access to healthcare services and technologies.
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Matta, Anthony G., Thibault Lhermusier, Francisco Campelo Parada, Frederic Bouisset, Ronan Canitrot, Vanessa Nader, Stéphanie Blanco, Meyer Elbaz, Jerome Roncalli, and Didier Carrié. "Impact of Coronary Artery Disease and Percutaneous Coronary Intervention on Transcatheter Aortic Valve Implantation." Journal of Interventional Cardiology 2021 (March 24, 2021): 1–7. http://dx.doi.org/10.1155/2021/6672400.
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Introduction. The prevalence of coronary artery disease (CAD) detected in preoperative work-up for transcatheter aortic valve implantation (TAVI) is high. Instead, the management of a concomitant CAD remains unclear. We evaluate the impact of CAD and percutaneous coronary intervention (PCI) on TAVI procedures. Materials and Methods. A retrospective study was conducted on 1336 consecutive patients who underwent TAVI in Toulouse University Hospital, Rangueil, France. The studied population was divided into 2 groups: CAD-TAVI group and No CAD-TAVI group. Then, the CAD-TAVI group was segregated into 2 subgroups: PCI-TAVI group and No PCI-TAVI group. In-hospital adverse clinical outcomes were assessed in each group. Results. Pre-TAVI work-up revealed significant CAD in 36% of 1030 patients eligible for inclusion in the study. The overall prevalence of in-hospital death, stroke, major or life-threatening bleeding, minor bleeding, major vascular complications, minor vascular complications, pacemaker implantation, and acute kidney injury was 2.7%, 2.4%, 2.8%, 3.6%, 3.9%, 7.5%, 12.5%, and 2.7%, respectively. Among the studied population, 55% were admitted to the cardiac care unit. No significant statistical difference was observed between groups. Discussion. CAD-TAVI population was not more likely to develop in-hospital adverse clinical outcomes post-TAVI procedure compared to others. Also, no significant difference regarding in-hospital death was observed. In parallel, performing PCI prior to TAVI did not increase the risk of in-hospital death and complications. The difference in terms of the distribution of antithrombotic regimen may explain the higher prevalence of bleeding events in the PCI-TAVI group. Conclusion. This study provides direct clinical relevance useful in daily practice. No negative impact has been attributed to the presence of a concomitant CAD and/or preoperative PCI on the TAVI hospitalization period.
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Hui, Dawn S., David M. Shavelle, Mark J. Cunningham, Ray V. Matthews, and Vaughn A. Starnes. "Contemporary Use of Balloon Aortic Valvuloplasty in the Era of Transcatheter Aortic Valve Implantation." Texas Heart Institute Journal 41, no. 5 (October 1, 2014): 469–76. http://dx.doi.org/10.14503/thij-13-3757.
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The development of transcatheter aortic valve implantation (TAVI) has increased the use of balloon aortic valvuloplasty (BAV) in treating aortic stenosis. We evaluated our use of BAV in an academic tertiary referral center with a developing TAVI program. We reviewed 69 consecutive stand-alone BAV procedures that were performed in 62 patients (mean age, 77 ± 10 yr; 62% men; baseline mean New York Heart Association functional class, 3 ± 1) from January 2009 through December 2012. Enrollment for the CoreValve® clinical trial began in January 2011. We divided the study cohort into 2 distinct periods, defined as pre-TAVI (2009–2010) and TAVI (2011–2012). We reviewed clinical, hemodynamic, and follow-up data, calculating each BAV procedure as a separate case. Stand-alone BAV use increased 145% from the pre-TAVI period to the TAVI period. The mean aortic gradient reduction was 13 ± 10 mmHg. Patients were successfully bridged as intended to cardiac or noncardiac surgery in 100% of instances and to TAVI in 60%. Five patients stabilized with BAV subsequently underwent surgical aortic valve replacement with no operative deaths. The overall in-hospital mortality rate (17.4%) was highest in emergent patients (61%). The implementation of a TAVI program was associated with a significant change in BAV volumes and indications. Balloon aortic valvuloplasty can successfully bridge patients to surgery or TAVI, although least successfully in patients nearer death. As TAVI expands to more centers and higher-risk patient groups, BAV might become integral to collaborative treatment decisions by surgeons and interventional cardiologists.
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Jagielak, Dariusz, Radoslaw Targonski, and Dariusz Ciecwierz. "First-in-Human Use of the Next-generation ProtEmbo Cerebral Embolic Protection System During Transcatheter Aortic Valve-in-valve Implantation." Interventional Cardiology Review 16, Supplement 1 (February 2, 2021): 1–4. http://dx.doi.org/10.15420/icr.2021.s1.
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Cerebral embolic protection (CEP) devices aim to reduce the risk of periprocedural cerebrovascular events during transcatheter aortic valve implantation (TAVI). Here, the authors describe the first-in-human experience with the ProtEmbo Cerebral Protection System (Protembis), a next-generation CEP device, during TAVI. This case is part of a larger European trial evaluating the safety and performance of this device. After deployment of the ProtEmbo in the aortic arch, a first transcatheter heart valve was implanted. Despite postdilatation, moderate to severe aortic regurgitation persisted. The operating team decided to perform a valve-in-valve procedure using a second transcatheter heart valve. The ProtEmbo demonstrated good coverage of all three head vessels and no interaction with TAVI catheters in the aortic arch throughout the entire procedure. No adverse events were observed during hospitalisation or follow-up, and there was a significant reduction in aortic regurgitation at follow-up echocardiography. Despite a challenging overall procedure with presumably high embolic burden, diffusion-weighted MRI at follow-up showed a low number (n=3) and volume (156 mm3) of new hyperintense lesions. The first-in-human use of the ProtEmbo was safe and feasible, despite a challenging TAVI valve-in-valve procedure.
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Matta, Anthony, Ronan Canitrot, Vanessa Nader, Frederic Bouisset, Thibault Lhermusier, Francisco Campelo-Parada, Etienne Grunenwald, et al. "Prevalence of Posttranscatheter Aortic Valve Implantation Vascular Complications in Real Life." Journal of Interventional Cardiology 2021 (October 12, 2021): 1–7. http://dx.doi.org/10.1155/2021/5563486.
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Background. Vascular complications (VCs) are commonly observed after transfemoral transcatheter aortic valve implantation (TAVI) procedures. Closure devices for the access site were developed to reduce their incidence. We aim to evaluate the prevalence, predictors, and outcomes of the occurrence of post-TAVI VCs. Materials and Methods. A retrospective study was conducted on 1336 consecutive patients who underwent TAVI at the University Hospital of Toulouse, France, between January 2016 and March 2020. All included procedures were performed through the common femoral artery, and ProGlide® was the used closure device. The studied population was divided into two groups depending on the occurrence of VCs defined according to Valve Academic Research Consortium-2 criteria. Results. The mean age of the studied population was 84.4 ± 6.9, and 48% were male. 90% of TAVI interventions were performed through the right femoral artery. The prevalence of VCs was 18.8%, and 3.7% were major. Prolonged procedure duration was an independent predictor of VCs. Using the right access site and smaller introducer size (14 Fr) were preventive factors. No significant difference in mortality rate was detected between the two groups. Conclusion. This study showed a low prevalence for post-TAVI VCs, especially for the major type. An increase in bleeding events and prolonged cardiac care unit stay were the common adverse outcomes.
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Sudarsky, Doron, Yarden Drutin, Fabio Kusniec, Liza Grosman-Rimon, Ala Lubovich, Wadia Kinany, Evgeni Hazanov, Michael Gelbstein, Edo Y. Birati, and Ibrahim Marai. "Acute Kidney Injury Following Transcatheter Aortic Valve Implantation: Association with Contrast Media Dosage and Contrast Media Based Risk Predication Models." Journal of Clinical Medicine 11, no. 5 (February 23, 2022): 1181. http://dx.doi.org/10.3390/jcm11051181.
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The effect of contrast media (CM), delivered prior to- and during transcatheter aortic valve implantation (TAVI), on kidney function, following the procedure, is debatable. Consequently, the performance of CM-based, acute kidney injury (AKI) risk prediction models is also questionable. We retrospectively studied 210 patients that underwent TAVI. We recorded the dose of CM used prior and during TAVI, calculated the results of different AKI risk assessment models containing a CM module, and tested their association with AKI after the procedure. AKI was diagnosed in 38 patients (18.1%). The baseline estimated glomerular filtration rate (eGFR) was lower in the AKI+ group compared to AKI− group (51 ± 19.3 versus 64.5 ± 19 mL/min/1.73 mr2, respectively). While the dose of CM delivered prior to TAVI, during TAVI or the cumulative amount of both did not differ between the groups, the results of all tested risk models were higher in AKI+ patients. However, by multivariable analysis, only eGFR had a consistent independent association with AKI. We suggest that the dose of CM delivered prior or during TAVI is not associated with AKI and that the predictive power of CM based AKI risk models is, in all probability, limited to eGFR alone.
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Lunardi, Mattia, Michele Pighi, Gabriele Venturi, Paolo Alberto Del Sole, Gabriele Pesarini, Andrea Mainardi, Roberto Scarsini, Valeria Ferrero, Leonardo Gottin, and Flavio Ribichini. "Short-and-Long-Term Outcomes after Coronary Rotational Atherectomy in Patients Treated with Trans-Catheter Aortic Valve Implantation." Journal of Clinical Medicine 10, no. 1 (December 31, 2020): 112. http://dx.doi.org/10.3390/jcm10010112.
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Background. Coronary artery disease (CAD) is a common finding among patients undergoing trans-catheter aortic valve implantation (TAVI), who often present severely calcified coronary lesions. Evidence is scarce about the use of rotational atherectomy (RA) in this setting, in particular regarding long-term outcome. Methods. RA was performed on severely calcified coronary lesions concomitant with TAVI in a consecutive series of patients treated between 2010 and 2020. Immediate and long-term clinical outcomes are reported. Results. A concomitant CAD (coronary stenosis visually > 50%) was observed in 402/845 (47.6%) consecutive patients undergoing TAVI at the University Hospital of Verona. Angioplasty was performed in 104 patients (12.3%). Among these, 19 patients (18.3%, 20 coronary arteries), were treated with RA after TAVI: 10 after implantation of a balloon-expandable trans-catheter valve and 9 after a self-expandable valve. All procedures were successful. Hypotension occurred in 3 patients (15.8%), with rapid recovery after the procedure; CI-AKI (contrast-induced acute kidney injury) in 3 patients (15.8%), of which two recovered within discharge. At a median follow-up of 21.5 months (Q1–3: 6–36) event free survival was 83.3%. Only one patient suffered a target vessel failure >2 years after RA. Neither stroke nor peri-procedural infarctions were detected. Conclusions. RA concomitant with TAVI was feasible and safe in patients treated with implantation of either self-expandable, or balloon-expandable trans-catheter aortic valves. Long-term clinical events related to the coronary procedure were extremely infrequent and the survival rate at median follow-up of 21.5 months was 83.3%.
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Kadowaki, Hiroshi, Kazuyuki Yahagi, Yu Horiuchi, and Kengo Tanabe. "Malignant Findings in Candidates for Transcatheter Aortic Valve Implantation." Heart Surgery Forum 23, no. 2 (April 23, 2020): E250—E254. http://dx.doi.org/10.1532/hsf.2699.
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Background: In candidates for transcatheter aortic valve implantation (TAVI), preoperative computed tomography (CT) may detect clinically relevant non-cardiac findings. In particular, when malignant findings are detected, patients may be less likely to undergo the procedure. Additionally, they might require further examinations, which may prolong their time to treatment. We investigated how malignant findings affect candidacy for TAVI.
Methods: In this single-center retrospective study, 98 patients with severe aortic stenosis who had undergone preoperative CT between September 2013 and October 2016 were evaluated for malignant findings.
Results: Seven patients (7.1%) had malignant findings. 74 of 91 patients who did not have malignant findings underwent TAVI, SAVR, or balloon aortic valvuloplasty (81.3%). All patients who had malignant findings underwent TAVI or SAVR, and they underwent the procedure sooner after CT than the rest of the patients (mean time to TAVI or SAVR: 24.6 ± 16.8 versus 48.5 ± 45.4 days; P = .003). All 5 patients who had malignant findings without metastatic cancer and who underwent TAVI were still alive during the follow-up period (the mean duration of the follow-up period was 22.3 ± 8.8 months). However, 1 patient who had a malignant finding with metastatic cancer died 7 months after CT.
Conclusion: Our outcomes indicated that the mean duration before TAVI or SAVR was reduced when malignant findings were detected by CT; and TAVI may be a safe and effective treatment for patients with aortic stenosis and a malignant tumor.
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Kaier, Klaus, Vera Oettinger, Holger Reinecke, Claudia Schmoor, Lutz Frankenstein, Werner Vach, Philip Hehn, et al. "Volume–outcome relationship in transcatheter aortic valve implantations in Germany 2008–2014: a secondary data analysis of electronic health records." BMJ Open 8, no. 7 (July 2018): e020204. http://dx.doi.org/10.1136/bmjopen-2017-020204.
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ObjectivesWe examine the volume–outcome relationship in isolated transcatheter aortic valve implantations (TAVI). Our interest was whether the volume–outcome relationship for TAVI exists on the centre level, whether it occurs equally for different outcomes and how it develops over time.DesignSecondary data analysis of electronic health records. The comprehensive German Federal Bureau of Statistics Diagnosis Related Groups database was queried for data on all isolated TAVI procedures performed in Germany between 2008 and 2014. Logistic and linear regression analyses were carried out. Risk adjustment was applied using a predefined set of patient characteristics to account for differences in the risk factor composition of the patient populations between centres and over time. Centres performing TAVI were stratified into groups performing <50, 50–99 and ≥100 procedures per year.SettingGermany 2008–2014.ParticipantsAll patients undergoing isolated TAVI in the observation period.InterventionsNone.Primary and secondary outcome measuresIn-hospital mortality, bleeding, stroke, probability of ventilation >48 hours, length of hospital stay and reimbursement.ResultsBetween 2008 and 2014, a total of 43 996 TAVI procedures were performed in 113 different centres in Germany with a total of 2532 cases of in-hospital mortality. Risk-adjusted in-hospital mortality decreases over the years and is lower the higher the annual procedure volume at the centre is. The magnitude of the latter effect declines over the observation period. Our results indicate a ceiling effect in the volume–outcome relationship: the volume–outcome relationship is eminent in circumstances of relatively unfavourable outcomes. Alongside improving outcomes, however, the volume–outcome relationship decreases. Also, a volume–outcome relationship seems to be absent in circumstances of constantly low event rates.ConclusionsThe hypothesised volume–outcome relationship for TAVI exists but diminishes and may disappear over time. This should be taken into account when considering mandatory minimum thresholds.
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Furbatto, F., G. Carpinella, D. D‘Andrea, R. Moscato, F. Serino, and C. Mauro. "P300 AORN A. CARDARELLI NAPOLI/ FEDERICO II UNIVERSITY INTERHOSPITAL PROTOCOL: TAVI IN A COMPLEX SCENARIO." European Heart Journal Supplements 25, Supplement_D (May 2023): D158. http://dx.doi.org/10.1093/eurheartjsupp/suad111.374.
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Abstract Rational: In order to provide the best treatment for patients affected by severe aortic stenosis at intermediate–high surgical risk, since more than 3 years an interhospital protocol beetween the Cardiology, UTIC and Cath–lab department of AORN A. Cardarelli of Naples, a center without cardiac surgery, and the cath–lab of the department of Cardiovascular Emergencies, Clinical Medicine and Ageing Medicine of AOU Federico II, is active. The agreement provides the carrying out of a TAVI procedures for patients hospitalized at the A. Cardarelli, by transfering them with a resuscitation ambulance to the Federico II cath–lab, and subsequent return to the department of origin after the execution of the interventional procedure. Case report: 85 year old lady with hypertension, moderate–severe chronic respiratory failure and atrial fibrillation treated with NOAC, is admitted in the emergency room for acute pulmonary edema and contextual diagnosis of severe aortic stenosis is made. After clinical stabilization, the TAVI program is started: both an angio–CT scan and a coronary angiography are carried out, with the detection of a critical calcified stenosis involving left main branch and proximal LAD and a chronic occlusion of Cx branch. Multidisciplinary evaluation and collegial evaluation with the colleagues from the Federico II University are carried out, and indication is given to TAVI with contextual PTCA of LM and LAD critical stenosis. A joint procedure of PTCA with 2 DES and TAVI with Evolute R 29 valve is then carried out in a single session at the Federico II University of Naples and after post–procedural observation, the patient is transferred back to the UTIC of A. Cardarelli for hospitalization. During the hospital stay, no procedural complications are reported and the patient is discharged 4 days after in good clinical conditions; a triple therapy with NOAC and DAPT is started, continuing it for 1 month with subsequent suspension of ASA and carrying on therapy with NOAC + Clopidogrel. At 1 and 6 months clinical follow–up, the patient is stable and well compensated, without significant clinical complications and with NYHA class 2. Conclusions The results of these years–experience, highlight the feasibility and safety of this strategy, making it possible to plan and carry out TAVI procedures even in centers that do not have onsite cardiac surgery, considering the growing indications for TAVI and the subsequent increase of patients who need this procedure
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Kinthala, Sudhakar, Poovendran Saththasivam, Abistanand Ankam, and Sudhakar Sattur. "Embolization of aortic valve leaflet during valve-in-valve transcatheter aortic valve implantation: a case report." European Heart Journal - Case Reports 4, no. 1 (February 1, 2020): 1–5. http://dx.doi.org/10.1093/ehjcr/ytaa010.
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Abstract Background Aortic stenosis (AS) is one of the most common valvular disorders worldwide. An increasing number of transcatheter aortic valve implantation (TAVI) procedures are being performed yearly for managing AS. This, along with the occurrence of common complications, makes timely diagnosis essential to manage rare complications and improve patient outcomes. Case summary We present a case of a 77-year-old Caucasian male with severe AS with a dysfunctional bioprosthetic valve following previous surgical valve replacement. During valve-in-valve TAVI, we noted bioprosthetic valve leaflet avulsion and embolization causing a major vascular occlusion that resulted in vascular insufficiency of the left lower extremity. This condition was managed successfully via immediate diagnosis using transoesophageal echocardiogram, angiogram, and vascular surgical intervention for retrieving the embolized valve to re-establish circulation. Discussion To our knowledge, this is the first case of aortic valve leaflet embolization during TAVI resulting in significant vascular insufficiency. Vascular complications are common during TAVI. However, not all vascular complications are the same. Our case highlights an embolic vascular complication from an avulsed prosthetic material during a challenging valve-in-valve TAVI procedure.
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Folliguet, Thierry A., Emmanuel Teiger, Sylvain Beurtheret, Thomas Modine, Thierry Lefevre, Eric Van Belle, Martine Gilard, et al. "Carotid versus femoral access for transcatheter aortic valve implantation: a propensity score inverse probability weighting study." European Journal of Cardio-Thoracic Surgery 56, no. 6 (July 31, 2019): 1140–46. http://dx.doi.org/10.1093/ejcts/ezz216.
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Abstract OBJECTIVES The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI. METHODS Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment. RESULTS Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62–1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7–1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01–2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87–13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04–2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76–2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90–2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01–2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96–1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32–0.43; P < 0.001). CONCLUSIONS TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.
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Trani, Carlo, Cristina Aurigemma, Enrico Romagnoli, and Francesco Burzotta. "Percu-Ax aortic valve implantation with a double arm approach: a case report." European Heart Journal - Case Reports 4, no. 5 (October 1, 2020): 1–5. http://dx.doi.org/10.1093/ehjcr/ytaa225.
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Abstract Background Transaxillary route for structural and coronary percutaneous interventions represents a valid alternative access in patients with obstructive peripheral disease. Nevertheless, its widespread use is limited by a less manageable haemostasis procedure. Case summary In this case, we describe a minimalistic high-risk transcatheter aortic valve implantation (TAVI) procedure (TAVI Score 6.42%) conducted with a double arm approach (radial and axillary accesses) in an 88-year-old patient with severe aortic stenosis and multiple co-morbidities preventing both surgical (Society of Thoracic Surgeons mortality 7.9%) and percutaneous transfemoral approach (extensive peripheral artery disease). We also described the successful management of a complicated transaxillary haemostasis with this technique. Discussion In our cases, a minimalist double-arm approach was successfully used for TAVI procedure as an alternative to transfemoral approach assuring effective and safe management of vascular access haemostasis.
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Barbe, Thomas, Thomas Levesque, Eric Durand, Christophe Tron, Najime Bouhzam, Nicolas Bettinger, Thibaut Hemery, et al. "TAVI, the road to a minimalist “stent-like” procedure." Archives of Cardiovascular Diseases Supplements 14, no. 2 (June 2022): 201. http://dx.doi.org/10.1016/j.acvdsp.2022.04.100.
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Lüscher, Thomas F. "TAVI: from an experimental procedure to standard of care." European Heart Journal 39, no. 28 (July 21, 2018): 2605–8. http://dx.doi.org/10.1093/eurheartj/ehy465.
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Gać, Paweł, Aleksandra Grochulska, and Rafał Poręba. "Incidental Vascular Findings in Computed Tomography Performed in the Qualification for the TAVI Procedure." Diagnostics 12, no. 11 (November 13, 2022): 2773. http://dx.doi.org/10.3390/diagnostics12112773.
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Transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR) is now a very widespread treatment method for symptomatic and severe aortic stenosis as an alternative for patients at intermediate or high risk of surgery or contraindications to surgery. The key role of imaging examinations before TAVI is to assess the morphology of the aortic valve, the routes of surgical access, and non-cardiac and extravascular structures. The objective of this article is to present and discuss the importance of selected accidental vascular findings in computed tomography examinations of the heart and large vessels performed in the TAVI qualification procedure: persistent left superior vena cava (SVC) with absent right SVC, right aortic arch, ectopic right coronary artery ostium, and left superior pulmonary vein draining into left brachiocephalic vein.
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Dapás, Juan Ignacio, Cynthia Rivero, Pablo Burgos, and Andrea Vila. "Pseudomonas aeruginosa Infective Endocarditis Following Transcatheter Aortic Valve Implantation: A Note of Caution." Open Cardiovascular Medicine Journal 10, no. 1 (February 19, 2016): 28–34. http://dx.doi.org/10.2174/1874192401610010028.
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Transcatheter aortic valve implantation (TAVI) is an alternative treatment for severe aortic valve stenosis (AS) in patients with prohibitive risk for surgical aortic valve replacement (SAVR). Prosthetic valve endocarditis (PVE) is a rare complication of this relatively novel procedure and current guidelines do not include specific recommendations for its treatment. We report a case of PVE due to Pseudomonas aeruginosa after TAVI that required SAVR, with successful outcome. PVE usually occurs during the first year after TAVI and entails a high mortality risk because patients eligible for this min-imally invasive procedure are fragile (i.e. advanced age and/or severe comorbidities). Additionally, clinical presentation may be atypical or subtle and transesophageal echocardiogram (TEE) may not be conclusive, which delays diagnosis and treatment worsening the prognosis. This case highlights that open SAVR might be ultimately indicated as part of treatment for TAVI-PVE despite a high-risk surgery score.
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Alam, Maqsood, Ghazala Irfan, Ali Ammar, Parveen Akhtar, Kanwal Fatima Aamir, and Tahir Saghir. "INCIDENCE AND PREDICTORS OF PERMANENT PACEMAKER IMPLANTATION AFTER TRANS AORTIC VALVE IMPLANTATION (TAVI) – A SINGLE CENTER EXPERIENCE." Pakistan Heart Journal 55, no. 4 (December 31, 2022): 364–69. http://dx.doi.org/10.47144/phj.v55i4.2389.
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Objectives: The objective of the study is to evaluate the incidence and predictors of permanent pacemaker (PPM) implantation in patients undergoing transaortic valve implantation (TAVI). Methodology: This study was conducted at the “National Institute of Cardiovascular Diseases (NICVD) Karachi, Pakistan”. All the consecutive patients who underwent TAVI between July 2015 and February 2020 were included in the study. Patient data were extracted from Hospital TAVI Registry. We included patients with severe symptomatic aortic stenosis (AS) with moderate to high surgical risk as per “society of thoracic surgeon score (STS)” and “EURO II score”, underwent TAVI. Patients were stratified into two groups based on the implantation of PPM, demographic characteristics, clinical characteristics, co-morbid conditions, valve pathology, and procedural characteristics were compared between both groups. Results: Among 100 patients included only 22 patients (22%) underwent PPM implantation. The indication for implantation of PPM for all patients was complete heart block. Clinical characteristics which shows statistical significance for PPM implantation are preprocedural left ventricular dysfunction (p=0.015), right bundle branch block (RBBB) p<0.001, and left anterior hemiblock (p<0.001) noted on ECG and post-deployment valve area post-procedure (p<0.001). Multivariate analysis showed that pre-procedure RBBB and large post-deployment valve area are independent predictors for PPM implantation in Post TAVI patients. Conclusion: The incidence of PPM implantation in patients who underwent TAVI at NICVD is 22%. Preprocedural left ventricular dysfunction, RBBB, and post-procedure large post-deployment valve area were noted to be significant predictors for PPM implantation.
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Vairo, Alessandro, Lorenzo Zaccaro, Andrea Ballatore, Lorenzo Airale, Fabrizio D’Ascenzo, Gianluca Alunni, Federico Conrotto, et al. "Acute Modification of Hemodynamic Forces in Patients with Severe Aortic Stenosis after Transcatheter Aortic Valve Implantation." Journal of Clinical Medicine 12, no. 3 (February 3, 2023): 1218. http://dx.doi.org/10.3390/jcm12031218.
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Transcatheter aortic valve implantation (TAVI) is the established first-line treatment for patient with severe aortic stenosis not suitable for surgery. Echocardiographic evaluation of hemodynamic forces (HDFs) is a growing field, holding the potential to early predict improvement in LV function. A prospective observational study was conducted. Transthoracic echocardiography was performed before and after TAVI. HDFs were analyzed along with traditional left ventricular (LV) function parameters. Twenty-five consecutive patients undergoing TAVI were enrolled: mean age 83 ± 5 years, 74.5% male, mean LV Ejection Fraction (LVEF) at baseline 57 ± 8%. Post-TAVI echocardiographic evaluation was performed 2.4 ± 1.06 days after the procedure. HDF amplitude parameters improved significantly after the procedure: LV Longitudinal Forces (LF) apex-base [mean difference (MD) 1.79%; 95% CI 1.07–2.5; p-value < 0.001]; LV systolic LF apex-base (MD 2.6%; 95% CI 1.57–3.7; p-value < 0.001); LV impulse (LVim) apex-base (MD 2.9%; 95% CI 1.48–4.3; p-value < 0.001). Similarly, HDFs orientation parameters improved: LVLF angle (MD 1.5°; 95% CI 0.07–2.9; p-value = 0.041); LVim angle (MD 2.16°; 95% CI 0.76–3.56; p-value = 0.004). Conversely, global longitudinal strain and LVEF did not show any significant difference before and after the procedure. Echocardiographic analysis of HDFs could help differentiate patients with LV function recovery after TAVI from patients with persistent hemodynamic dysfunction.
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Maurovich-Horvat, Pál, Milán Vecsey-Nagy, Judit Simon, Bálint Szilveszter, Júlia Karády, Ádám Jermendy, and Béla Merkely. "Role of Multidetector Computed Tomography in Transcatheter Aortic Valve Implantation – from Pre-procedural Planning to Detection of Post-procedural Complications." Journal Of Cardiovascular Emergencies 4, no. 4 (December 1, 2018): 178–86. http://dx.doi.org/10.2478/jce-2018-0022.
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Abstract Transcatheter aortic valve implantation (TAVI) is an effective treatment option for patients suffering from symptomatic, severe aortic valve stenosis. Previously, only patients with prohibitive or high surgical risk were TAVI candidates; however, current guidelines already recommend TAVI as a treatment alternative for patients with intermediate surgical risk. Multidetector computed tomography (MDCT) has gained great importance in the periprocedural assessment of patients who undergo TAVI. Due to the three-dimensional image visualization, MDCT allows the evaluation of anatomical structures in a more comprehensive manner compared to echocardiography, the traditional tool used in TAVI patient work-up. By providing accurate measurements of the aortic root, MDCT helps to avoid potential patient-prosthesis mismatch throughout transcatheter valve sizing. Moreover, MDCT is also a feasible tool for access route evaluation and to determine the optimal projection angles for the TAVI procedure. Although the routine MDCT follow-up of patients is currently not recommended in clinical practice, if performed, it could provide invaluable information about valve integrity and asymptomatic leaflet thrombosis. Post-procedural MDCT can provide details about the position of the prosthesis and complications such as leaflet-thrombosis, aortic regurgitation, coronary occlusion, and other vascular complications that can represent major cardiac emergencies. The aim of the current review is to overview the role of MDCT in the pre- and post-procedural assessment of TAVI patients. In the first part, the article presents the role of pre-TAVI imaging in the complex anatomical assessment of the aortic valve and the selection of the most appropriate device. The second part of the review describes the role of MDCT in patients who underwent TAVI to assess potential complications, some of them leading to a major cardiovascular emergency.
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Petrini, F., I. Paduvakis, A. Cerillo, and P. Stefano. "P28 CONVERSION TO OPEN SURGERY FOR COMPLICATED TAVI: STILL FUTILE?" European Heart Journal Supplements 25, Supplement_D (May 2023): D49. http://dx.doi.org/10.1093/eurheartjsupp/suad111.114.
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Abstract Background and aim Mechanical complications of TAVI may be catastrophic, and conversion to open surgery in this context has been associated with an extremely poor prognosis, with a mortality close to 50%. We report our recent experience on 9 patients requiring cardiac surgery during TAVI. Patients and methods: 9 patients undergoing various transcatheter procedures at a high volume centre required cardiac surgery for valve misplacement (2), valve embolization (2), annular rupture (3), acute coronary occlusion (1) and aortic dissection (1). Four patients were initially treated by a hybrid team including a cardiac surgeon performing transcatheter procedures (3 TAVI in NAVR and one transseptal Mitral VIV), while five were performed by an interventional cardiology team (all TAVI). Results The complications and the surgical procedures performed are reported in the table. Four patients underwent immediate conversion in the hybrid room, 3 underwent delayed conversion and two were managed conservatively. Eight patients survived and were discharged from the hospital. The only patient dying was a TAVI patient having aortic valve embolization. A second transcatheter valve was deployed too ventricular. The patient had cardiac arrest needing CRP and the surgical team was called to start ECMO assistance several minutes after the initial complication. Comment: Our small series suggests that prompt conversion to open surgery, especially if performed immediately by surgeons that were initially involved in the transcatheter procedure, might offer excellent results. We believe that hybrid teams may offer a significant benefit, especially in low–risk patients and during complex or off–label procedures.
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Baumbusch, Jennifer, Sandra B. Lauck, Leslie Achtem, Tamar O’Shea, Sarah Wu, and Davina Banner. "Understanding experiences of undergoing transcatheter aortic valve implantation: one-year follow-up." European Journal of Cardiovascular Nursing 17, no. 3 (October 31, 2017): 280–88. http://dx.doi.org/10.1177/1474515117738991.
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Background: Transcatheter aortic valve implantation (TAVI) is the treatment of choice for frail, older adults with severe symptomatic aortic stenosis. Although research about long-term clinical outcomes is emerging, there is limited evidence from the perspectives of patients and family caregivers on their perceived benefits and challenges after TAVI. Aims: The aim of this study was to describe older adults and family caregivers’ perspectives on undergoing TAVI at one year post-procedure. Methods: Qualitative description was the method of inquiry. A purposive sample of 31 patients and 15 family caregivers was recruited from a TAVI programme in western Canada. Semi-structured interviews were conducted with participants one year after TAVI. Data were analysed thematically. Results: All participants were satisfied with the decision to undergo TAVI. There were three central themes. First, recovery was experienced in the context of aging and comorbidities, which was shaped by patients’ limited options for care and post-procedure symptom burden. Second, reconciling expectations with reality meant that, for some patients, symptom burden remained prevalent and was also influenced by others’ expectations. Third, recommendations for recovery related to having information needs met, keeping informed of evolving care processes, and addressing individualised needs for support. Conclusions: The perspectives of participants provide a valuable contribution to the literature about undergoing TAVI. Clinicians need to be attentive to patients’ expectations of benefit and temper these with consideration of the individual’s broader health situation to provide treatment decision support. Patients and family caregivers also need adequate teaching and support to facilitate safe transition home given the shift towards early discharge after TAVI.
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Russo, Eleonora, Domenico R. Potenza, Michela Casella, Raimondo Massaro, Giulio Russo, Maurizio Braccio, Antonio Dello Russo, and Mauro Cassese. "Rate and Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation: Current Status." Current Cardiology Reviews 15, no. 3 (May 6, 2019): 205–18. http://dx.doi.org/10.2174/1573403x15666181205105821.
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Transcather aortic valve implantation (TAVI) has become a safe and indispensable treatment option for patients with severe symptomatic aortic stenosis who are at high surgical risk. Recently, outcomes after TAVI have improved significantly and TAVI has emerged as a qualified alternative to surgical aortic valve replacement in the treatment of intermediate risk patients and greater adoption of this procedure is to be expected in a wider patients population, including younger patients and low surgical risk patients. However since the aortic valve has close spatial proximity to the conduction system, conduction anomalies are frequently observed in TAVI. In this article, we aim to review the key aspects of pathophysiology, current incidence, predictors and clinical association of conduction anomalies following TAVI.
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Kaliamoorthy, Ilankumaran, Akila Rajakumar, Joye Varghese, Susan George, and Mohamed Rela. "Living Donor Liver Transplantation Following Transcatheter Aortic Valve Implantation for Aortic Valvular Disease." Seminars in Cardiothoracic and Vascular Anesthesia 24, no. 3 (November 27, 2019): 273–78. http://dx.doi.org/10.1177/1089253219887162.
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Over the last few decades, outcomes with living donor liver transplantation (LDLT) have improved significantly. This has resulted in patients who were denied liver transplantation previously, due to various comorbidities and high risk, now being considered for LDLT. This includes patients with severe valvular heart disease such as aortic stenosis. These patients require aortic valve replacement to help cope with significant perioperative hemodynamic changes. High-risk cardiac procedures like aortic valve replacement are associated with serious perioperative morbidity and mortality in patients with end-stage liver disease. Since the advent of transcatheter aortic valve implantation (TAVI) in 2002, there have been a few case reports of its successful use prior to deceased donor liver transplantation, but there is no literature on this procedure before LDLT. In this article, we report our experience with 2 patients, the first patient with infective endocarditis-induced acute aortic regurgitation and the second patient with bicuspid aortic stenosis who underwent uneventful TAVI followed by successful LDLT. In conclusion, with the increasing expertise and experience in this procedure, an increasing number of potential recipients, previously considered as high-risk transplant candidates, can now be offered liver transplantation by performing pretransplant TAVI.
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Nakashima, Makoto, and Yusuke Watanabe. "Transcatheter Aortic Valve Implantation in Small Anatomy: Patient Selection and Technical Challenges." Interventional Cardiology Review 13, no. 2 (2018): 1. http://dx.doi.org/10.15420/icr.2017:28:1.
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Transcatheter aortic valve implantation (TAVI) has become a standard treatment for severe aortic stenosis. Although this technique has reached relative maturity, further optimisation of patient selection and device implantation is essential to improve prognosis. Smaller body size is a predictor of a challenging TAVI procedure due to specific anatomical difficulty and adverse events including annulus rupture, acute coronary obstruction and vascular complications. A newer generation, lower profile TAVI system is useful for patients with smaller anatomy. Moreover, TAVI is superior to surgical aortic valve replacement in patients with a narrowing annulus because this treatement has a low incidence of prosthesis�patient mismatch.
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Kuntjoro, Ivandito, Edgar Tay, Jimmy Hon, James Yip, William Kong, Kian Keong Poh Poh, Tiong Cheng Yeo, et al. "Cost-Effectiveness of Transcatheter Aortic Valve Implantation in Intermediate and Low Risk Severe Aortic Stenosis Patients in Singapore." Annals of the Academy of Medicine, Singapore 49, no. 7 (July 31, 2020): 423–33. http://dx.doi.org/10.47102/annals-acadmedsg.2019198.
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Introduction: Singapore has the world’s second most efficient healthcare system while costing less than 5% GDP. It remains unclear whether transcatheter aortic valve implantation (TAVI) is cost-effective for treating intermediate-low risk severe aortic stenosis (AS) patients in a highly efficient healthcare system. Materials and Methods: A two-phase economic model combining decision tree and Markov model was developed to assess the costs, effectiveness, and the incremental cost-effectiveness ratio (ICER) of transfemoral (TF) TAVI versus surgical aortic valve replacement (SAVR) in intermediate-low risk patients over an 8-year time horizon. Mortality and complications rates were based on PARTNER 2 trial cohort A and Singapore life table. Costs were mainly retrieved from Singapore National University Health System database. Health utility data were obtained from Singapore population based on the EuroQol-5D (EQ-5D). A variety of sensitivity analyses were conducted. Results: In base case scenario, the incremental effectiveness of TF-TAVI versus SAVR was 0.19 QALYs. The ICER of TF-TAVI was S$33,833/QALY. When time horizon was reduced to 5 years, the ICER was S$60,825/QALY; when event rates from the propensity analysis was used, the ICER was S$21,732/QALY and S$44,598/QALY over 8-year and 5-year time horizons, respectively. At a willingness to pay threshold of S$73,167/QALY, TF-TAVI had a 98.19% probability of being cost-effective after 100,000 simulations. The model was the most sensitive to the costs of TF-TAVI procedure. Conclusion: TF-TAVI is a highly cost-effective option compared to SAVR for intermediate-low risk severe AS patients from a Singapore healthcare system perspective. Increased procedure experience, reduction in device cost, and technology advance may have further increased the cost-effectiveness of TF-TAVI per scenario analysis. Keywords: Surgical aortic valve replacement, Quality of life, Transfemoral TAVI, Reimbursement
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Schoechlin, Simon, Fares Jalil, Thomas Blum, Philipp Ruile, Manuel Hein, Thomas G. Nührenberg, Thomas Arentz, and Franz-Josef Neumann. "Need for pacemaker implantation in patients with normal QRS duration immediately after transcatheter aortic valve implantation." EP Europace 21, no. 12 (October 3, 2019): 1851–56. http://dx.doi.org/10.1093/europace/euz261.
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Abstract Aims We sought to assess the need for permanent pacemaker implantation (PPI) in patients with QRS <120 ms in electrocardiogram (ECG) after transcatheter aortic valve implantation (TAVI). Methods and results We retrospectively analysed 1139 consecutive patients who underwent transfemoral TAVI between 2008 and 2016, receiving different valve types. All patients were surveyed by continuous ECG monitoring for 48 h, 12-lead ECGs starting immediately after procedure, as well as 24-h Holter recording the day before discharge. Indication for PPI was at the discretion of the attending physician. Among 760 patients with QRS <120 ms prior to the TAVI procedure, 400 patients showed QRS <120 ms immediately after procedure, whereas 360 patients had QRS ≥120 ms. In the group with QRS <120 ms, PPI was performed in 34 patients [8.5%; 95% confidence interval (CI) 5.6–11.2%] during the first week. Eight of the PPIs in the group with QRS <120 ms (2%; CI 0.8–3.5%) fulfilled Class I indications for PPI after TAVI, whereas 26 PPIs had different indications [left bundle branch block, sick sinus, low-grade atrioventricular (AV) block]. Complete AV block developed in three patients of the group of QRS <120 ms (0.75%; CI 0.0–1.7%), which in all cases occurred after the 48 h-surveillance period. During 1-year follow-up, 11 PPIs were performed (2.8%; CI 1.2–4.5%), thereof three PPI for Class I indications including one complete AV block. Conclusion In patients with QRS duration <120 ms immediately after TAVI, the risk for complete AV block was low during the first week after TAVI and 1-year follow-up.