Journal articles: 'Prophylactic ICD-implantation'

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Pedersen, Susanne Bendesgaard, Dóra Körmendiné Farkas, Søren Pihlkjær Hjortshøj, Hans Erik Bøtker, Jens Brock Johansen, Berit Thornvig Philbert, Jens Haarbo, Reimar Wernich Thomsen, and Jens Cosedis Nielsen. "Significant regional variation in use of implantable cardioverter-defibrillators in Denmark." European Heart Journal - Quality of Care and Clinical Outcomes 5, no. 4 (February 20, 2019): 352–60. http://dx.doi.org/10.1093/ehjqcco/qcz008.

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Abstract Aims Implantable cardioverter-defibrillator (ICD) treatment prevents sudden cardiac death in high-risk patients. This study examined geographical variation in ICD implantation rates in Denmark and potential causes of variation. Methods and results We obtained numbers of ICD implantations in the 5 Danish regions and 98 municipalities during 2007–13 from the Danish Pacemaker and ICD Registry. Standardized implantation rates (SIRs) were computed as ICD implantations per 1 000 000 person-years, and age- and gender-standardized to the Danish population. We examined associations of the municipal SIR with mean age and Charlson Comorbidity Index score of ICD recipients, percentage of implantations with primary prophylactic indication, and distance from patient residency to ICD implanting centre. Based on 7192 ICD implantations, the nationwide SIR was 186 [95% confidence interval (CI) 182–190], ranging from 170 (95% CI 158–183) in the North Denmark Region to 206 (95% CI 195–218) in the Region of Zealand. Municipalities with higher patient comorbidity scores, higher percentages of implantations with primary prophylactic indication, and shorter distances to ICD implanting centres, had higher SIRs [differences between SIRs of municipalities in highest and lowest quartiles 22 (95% CI 10–34), 45 (95% CI 33–58), and 35 (95% CI 24–47), respectively]. Regional differences in SIRs decreased over time and had become insignificant during 2011–13. Conclusion Implantable cardioverter-defibrillator implantation rates in Denmark varied significantly between regions but variation decreased during 2007–13. Geographical variation was associated with differences in patient comorbidity score, variation in use of primary prophylactic ICD treatment, and distance to ICD implanting centre.

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Sacher, Frédéric, Vincent Probst, Dominique Babuty, Frederique Mizon-Gerard, Philippe Maury, Jacques Mansourati, Philippe Mabo, et al. "Multicenter study of prophylactic ICD implantation in Brugada syndrome." Heart Rhythm 2, no. 5 (May 2005): S40. http://dx.doi.org/10.1016/j.hrthm.2005.02.133.

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Boas, Rune, Nikolay Sappler, Lukas von Stülpnagel, Mathias Klemm, Ulrik Dixen, Jens Jakob Thune, Steen Pehrson, et al. "Periodic Repolarization Dynamics Identifies ICD Responders in Nonischemic Cardiomyopathy: A DANISH Substudy." Circulation 145, no. 10 (March 8, 2022): 754–64. http://dx.doi.org/10.1161/circulationaha.121.056464.

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Background: Identification of patients with nonischemic cardiomyopathy who may benefit from prophylactic implantation of a cardioverter-defibrillator. We hypothesized that periodic repolarization dynamics (PRD), a marker of repolarization instability associated with sympathetic activity, could be used to identify patients who will benefit from prophylactic implantable cardioverter defibrillator (ICD) implantation. Methods: We performed a post hoc analysis of DANISH (Danish ICD Study in Patients With Dilated Cardiomyopathy), in which patients with nonischemic cardiomyopathy, left ventricular ejection fraction (LVEF) ≤35%, and elevated NT-proBNP (N-terminal probrain natriuretic peptides) were randomized to ICD implantation or control group. Patients were included in the PRD substudy if they had a 24-hour Holter monitor recording at baseline with technically acceptable ECG signals during the night hours (00:00–06:00). PRD was assessed using wavelet analysis according to previously validated methods. The primary end point was all-cause mortality. Cox regression models were adjusted for age, sex, NT-proBNP, estimated glomerular filtration rate, LVEF, atrial fibrillation, ventricular pacing, diabetes, cardiac resynchronization therapy, and mean heart rate. We proposed PRD ≥10 deg 2 as an exploratory cut-off value for ICD implantation. Results: A total of 748 of the 1116 patients in DANISH qualified for the PRD substudy. During a mean follow-up period of 5.1±2.0 years, 82 of 385 patients died in the ICD group and 85 of 363 patients died in the control group ( P =0.40). In Cox regression analysis, PRD was independently associated with mortality (hazard ratio [HR], 1.28 [95% CI, 1.09–1.50] per SD increase; P =0.003). PRD was significantly associated with mortality in the control group (HR, 1.51 [95% CI, 1.25–1.81]; P <0.001) but not in the ICD group (HR, 1.04 [95% CI, 0.83–1.54]; P =0.71). There was a significant interaction between PRD and the effect of ICD implantation on mortality ( P =0.008), with patients with higher PRD having greater benefit in terms of mortality reduction. ICD implantation was associated with an absolute mortality reduction of 17.5% in the 280 patients with PRD ≥10 deg 2 (HR, 0.54 [95% CI, 0.34–0.84]; P =0.006; number needed to treat=6), but not in the 468 patients with PRD <10 deg 2 (HR, 1.17 [95% CI, 0.77–1.78]; P =0.46; P for interaction=0.01). Conclusions: Increased PRD identified patients with nonischemic cardiomyopathy in whom prophylactic ICD implantation led to significant mortality reduction.

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Zabel, Markus, Rik Willems, Andrzej Lubinski, Axel Bauer, Josep Brugada, David Conen, Panagiota Flevari, et al. "Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: results of the EU-CERT-ICD controlled multicentre cohort study." European Heart Journal 41, no. 36 (May 6, 2020): 3437–47. http://dx.doi.org/10.1093/eurheartj/ehaa226.

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Abstract Aims The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy. Methods and results We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537–0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class <III, and chronic obstructive pulmonary disease. Adjusted mortality associated with ICD vs. control was 27% lower (HR 0.731, 95% CI 0.569–0.938, P = 0.0140). Subgroup analyses indicated no ICD benefit in diabetics (adjusted HR = 0.945, P = 0.7797, P for interaction = 0.0887) or those aged ≥75 years (adjusted HR 1.063, P = 0.8206, P for interaction = 0.0902). Conclusion In contemporary ICM/DCM patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a 27% lower mortality after adjustment. There appear to be patients with less survival advantage, such as older patients or diabetics.

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PAISEY, J. "P-494 The prevalence of criteria for prophylactic ICD implantation." Europace 4 (December 2003): B183. http://dx.doi.org/10.1016/s1099-5129(03)92242-2.

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Paisey, J. R., Y. Yue, K. Elkins, T. Betts, P. R. Roberts, and J. M. Morgan. "P-494 The prevalence of criteria for prophylactic ICD implantation." EP Europace 4, Supplement_2 (December 1, 2003): B183. http://dx.doi.org/10.1016/eupace/4.supplement_2.b183.

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Sacher, F., J. Mansourati, D. Babuty, V. Probst, M. Salvador, S. Garrigue, P. Sanders, M. Haissaguerre, J. Clementy, and H. Le Marec. "434 Multicenter study of prophylactic ICD implantation in Brugada syndrome." EP Europace 7, Supplement_1 (2005): 96–97. http://dx.doi.org/10.1016/eupace/7.supplement_1.96-b.

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Mallavarapu, Vamshi, Bhargavi Degapudi, Monica Williams, Glenn Frazier, Arshneel Kochar, Alaa Shalaby, Francis E. Marchlinski, et al. "Outcomes in veteran patients with ischemic cardiomyopathy undergoing prophylactic ICD implantation." Heart Rhythm 2, no. 5 (May 2005): S282—S283. http://dx.doi.org/10.1016/j.hrthm.2005.02.889.

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Zabel, Markus, Christian Sticherling, Rik Willems, Andrzej Lubinski, Axel Bauer, Leonard Bergau, Frieder Braunschweig, et al. "Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation." ESC Heart Failure 6, no. 1 (October 9, 2018): 182–93. http://dx.doi.org/10.1002/ehf2.12367.

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Luermans, J. G. L. M., M. Mafi Rad, and K. Vernooy. "A call for re-evaluation of the guidelines for prophylactic ICD implantation." Netherlands Heart Journal 22, no. 10 (August 29, 2014): 429–30. http://dx.doi.org/10.1007/s12471-014-0591-3.

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Zakine, Cyril, Rodrigue Garcia, Kumar Narayanan, Estelle Gandjbakhch, Vincent Algalarrondo, Nicolas Lellouche, Marie-Cécile Perier, et al. "Prophylactic implantable cardioverter-defibrillator in the very elderly." EP Europace 21, no. 7 (March 19, 2019): 1063–69. http://dx.doi.org/10.1093/europace/euz041.

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Aims Current guidelines do not propose any age cut-off for the primary prevention implantable cardioverter-defibrillator (ICD). However, the risk/benefit balance in the very elderly population has not been well studied. Methods and results In a multicentre French study assessing patients implanted with an ICD for primary prevention, outcomes among patients aged ≥80 years were compared with <80 years old controls matched for sex and underlying heart disease (ischaemic and dilated cardiomyopathy). A total of 300 ICD recipients were enrolled in this specific analysis, including 150 patients ≥80 years (mean age 81.9 ± 2.0 years; 86.7% males) and 150 controls (mean age 61.8 ± 10.8 years). Among older patients, 92 (75.6%) had no more than one associated comorbidity. Most subjects in the elderly group got an ICD as part of a cardiac resynchronization therapy procedure (74% vs. 46%, P < 0.0001). After a mean follow-up of 3.0 ± 2 years, 53 patients (35%) in the elderly group died, including 38.2% from non cardiovascular causes of death. Similar proportion of patients received ≥1 appropriate therapy (19.4% vs. 21.6%; P = 0.65) in the elderly group and controls, respectively. There was a trend towards more early perioperative events (P = 0.10) in the elderly, with no significant increase in late complications (P = 0.73). Conclusion Primary prevention ICD recipients ≥80 years in the real world had relatively low associated comorbidity. Rates of appropriate therapies and device-related complications were similar, compared with younger subjects. Nevertheless, the inherent limitations in interpreting observational data on this particular competing risk situation call for randomized controlled trials to provide definitive answers. Meanwhile, a careful multidisciplinary evaluation is needed to guide patient selection for ICD implantation in the elderly population.

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Dimitriadis, Zisis, Frank van Buuren, Nikola Bogunovic, Dieter Horstkotte, and Lothar Faber. "Marked Regression of Left Ventricular Hypertrophy after Outflow Desobliteration in HOCM." Case Reports in Medicine 2012 (2012): 1–2. http://dx.doi.org/10.1155/2012/546942.

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We present an HOCM patient in whom marked regression of left ventricular hypertrophy occurred within two years following outflow desobliteration by percutaneous septal ablation. Maximum wall thickness (initially documented by both echo and MRI) decreased from 34 mm to 22 mm (followup by echo only due to presence of the ICD), crossing the threshold value of 30 mm which was one of the risk markers that had triggered the primary prophylactic ICD implantation in this case prior to septal ablation.

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Timal, Rohit J., Veronique de Gucht, Joris I. Rotmans, Liselotte C. R. Hensen, Maurits S. Buiten, Mihaly K. de Bie, Hein Putter, Martin J. Schalij, Ton J. Rabelink, and J. Wouter Jukema. "The impact of transvenous cardioverter-defibrillator implantation on quality of life, depression and optimism in dialysis patients: report on the secondary outcome of QOL in the randomized controlled ICD2 trial." Quality of Life Research 30, no. 6 (February 19, 2021): 1605–17. http://dx.doi.org/10.1007/s11136-020-02744-7.

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Abstract Rationale The impact of prophylactic implantable cardioverter-defibrillator (ICD) implantation on the psychological well-being of patients on dialysis is unknown. Objective We aimed to identify the effect of primary ICD implantation on quality of life (QoL), mood and dispositional optimism in patients undergoing dialysis. Methods and results We performed a prespecified subanalysis of the randomized controlled ICD2 trial. In total, 177 patients on chronic dialysis, with an age of 55–81 years, and a left ventricular ejection fraction of ≥ 35%, were included in the per-protocol analysis. Eighty patients received an ICD for primary prevention, and 91 patients received standard care. The Short Form-36 (SF-36), Geriatric Depression Scale-15 (GDS-15), Revised Life Orientation Test (LOT-R) questionnaires were administered prior to ICD implantation (T0), and at 1-year follow-up (T1) to assess QoL, depression and optimism, respectively. The patients were predominantly male (76.0%), with a median age of 67 years. Hemodialysis was the predominant mode of dialysis (70.2%). The GDS-15 score difference (T1 − T0) was 0.5 (2.1) in the ICD group compared with 0.3 (2.2) in the control group (mean difference − 0.3; 95% CI − 1.1 to 0.6; P = 0.58). The LOT-R score difference was − 0.2 (4.1) in the ICD group compared with − 1.5 (4.0) in the control group (mean difference − 1.1 (0.8); 95% CI − 2.6 to 0.4; P = 0.17). The mean difference scores of all subscales of the SF-36 were not significantly different between randomization groups. Conclusions In our population of patients on dialysis, ICD implantation did not affect QoL, mood or dispositional optimism significantly during 1-year follow-up. Clinical Trial Registration Unique identifier: ISRCTN20479861. http://www.controlled-trials.com.

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Vamos, Mate, Laszlo Saghy, and Gabor Bencsik. "Implantation of a VDD implantable cardioverter-defibrillator lead via a persistent left superior vena cava." Herzschrittmachertherapie + Elektrophysiologie 33, no. 1 (January 6, 2022): 81–83. http://dx.doi.org/10.1007/s00399-021-00835-7.

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AbstractA persistent left superior vena cava (LSVC) represents a challenging congenital abnormality for transvenous cardiac device implantation. In the current case a secondary prophylactic VDD implantable cardioverter-defibrillator (ICD) implantation was planned in a 75-year-old woman presenting with ischemic cardiomyopathy and elevated stroke risk. Since no venous communication to the right side was identified intraoperatively, the lead was placed via the persistent LSVC. The far-field signal on the floating atrial dipole could be successfully blanked out, and appropriate device function with high and stable atrial sensing was demonstrated at follow-up.

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Argentiero, Adriana, Maria Cristina Carella, Donato Mandunzio, Giulia Greco, Saima Mushtaq, Andrea Baggiano, Fabio Fazzari, et al. "Cardiac Magnetic Resonance as Risk Stratification Tool in Non-Ischemic Dilated Cardiomyopathy Referred for Implantable Cardioverter Defibrillator Therapy—State of Art and Perspectives." Journal of Clinical Medicine 12, no. 24 (December 18, 2023): 7752. http://dx.doi.org/10.3390/jcm12247752.

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Non-ischemic dilated cardiomyopathy (DCM) is a disease characterized by left ventricular dilation and systolic dysfunction. Patients with DCM are at higher risk for ventricular arrhythmias and sudden cardiac death (SCD). According to current international guidelines, left ventricular ejection fraction (LVEF) ≤ 35% represents the main indication for prophylactic implantable cardioverter defibrillator (ICD) implantation in patients with DCM. However, LVEF lacks sensitivity and specificity as a risk marker for SCD. It has been seen that the majority of patients with DCM do not actually benefit from the ICD implantation and, on the contrary, that many patients at risk of SCD are not identified as they have preserved or mildly depressed LVEF. Therefore, the use of LVEF as unique decision parameter does not maximize the benefit of ICD therapy. Multiple risk factors used in combination could likely predict SCD risk better than any single risk parameter. Several predictors have been proposed including genetic variants, electric indexes, and volumetric parameters of LV. Cardiac magnetic resonance (CMR) can improve risk stratification thanks to tissue characterization sequences such as LGE sequence, parametric mapping, and feature tracking. This review evaluates the role of CMR as a risk stratification tool in DCM patients referred for ICD.

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Nodera, Minoru, Hitoshi Suzuki, Yoshiyuki Matsumoto, Masashi Kamioka, Takashi Kaneshiro, Akiomi Yoshihisa , Tetsuya Ohira, and Yasuchika Takeishi. "Association between Serum Uric Acid Level and Ventricular Tachyarrhythmia in Heart Failure Patients with Implantable Cardioverter-Defibrillator." Cardiology 140, no. 1 (2018): 47–51. http://dx.doi.org/10.1159/000488851.

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Objectives: The uric acid (UA) level is related to cardiac events and mortality, but little is known about the clinical significance of serum UA with regard to the ventricular tachyarrhythmia (VT) risk in patients with heart failure. Methods: The present study enrolled 56 patients with ischemic and nonischemic cardiomyopathy (37 males, mean age 64.7 ± 11.1 years) who received prophylactic implantable cardioverter-defibrillator (ICD) implantation. Based on a median serum UA value, study subjects were divided into two groups: serum UA < 6.1 mg/dL (group L, n = 29) and ≥6.1 mg/dL (group H, n = 27). Echo- and electrocardiograms (QRS duration and QTc intervals) were examined in each group. Results: During the follow-up period (30 ± 8 months), 22 (39%) patients had appropriate ICD therapies for sustained VT. There was no significant difference in the electro- and echocardiographic data between both groups. However, appropriate ICD therapies were significantly higher in group H than in group L (p = 0.02). In multivariate analysis, UA was an independent predictor of appropriate ICD therapies (hazard ratio 1.826, 95% confidence interval 1.248–2.671, p = 0.002). Conclusions: Serum UA levels might be a predictor of VT, providing new aspects regarding the decision to adapt ICD implantation in patients with heart failure.

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Wichterle, Dan. "Risk Stratification in Post-myocardial Infarction Patients." European Cardiology Review 6, no. 3 (2010): 22. http://dx.doi.org/10.15420/ecr.2010.6.3.22.

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Despite the implementation of modern therapy for acute myocardial infarction (AMI), the substrate for fatal ventricular tachycardia/fibrillation develops frequently. Primary prevention therapy by implantable cardioverter–defibrillator (ICD) to reduce the risk of sudden cardiac death is recommended in post-MI patients with significant left ventricular (LV) dysfunction. While the benefit of ICD therapy in chronic post-MI patients has been firmly established, the implantation of ICDs in the early post-MI period is not warranted. LV dysfunction has been a major determinant for entry into the primary preventative ICD trials. Currently, numerous risk stratifiers are under investigation in order to improve the efficacy of ICD therapy. More specific selection of patients at risk of preventable cardiac death, based on more than simply ejection fraction, is crucial for the future development of cost-effective prophylactic treatments aimed at closing the gap between scientific evidence and the limited resources of healthcare systems.

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SCHAER, B. "P-177 Is a prophylactic icd implantation in patients with DCM useful or not?" Europace 4 (December 2003): B108. http://dx.doi.org/10.1016/s1099-5129(03)91929-5.

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Schaer, B., M. Zellweger, T. Cron, and S. Osswald. "P-177 Is a prophylactic icd implantation in patients with DCM useful or not?" EP Europace 4, Supplement_2 (December 1, 2003): B108. http://dx.doi.org/10.1016/eupace/4.supplement_2.b108-b.

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Fischer-Rasokat, Ulrich, Matthias Renker, Christoph Liebetrau, Maren Weferling, Andreas Rolf, Andreas Hain, Johannes Sperzel, Yeong-Hoon Choi, Christian W. Hamm, and Won-Keun Kim. "Long-Term Survival in Patients with or without Implantable Cardioverter Defibrillator after Transcatheter Aortic Valve Implantation." Journal of Clinical Medicine 10, no. 13 (June 30, 2021): 2929. http://dx.doi.org/10.3390/jcm10132929.

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Patients with symptomatic aortic stenosis (AS) can have concomitant systolic heart failure (HF) that persists even after correction of afterload by transcatheter aortic valve implantation (TAVI). These patients qualify as potential candidates for prophylactic therapy with an implantable cardioverter defibrillator (ICD). We compared survival between patients with or without an ICD after successful TAVI. This retrospective study analyzed Kaplan-Meier survival data during a follow-up period of three years in two populations: (a) patients with a left ventricular ejection fraction (LVEF) ≤ 35% before TAVI (overall population); (b) patients with additionally documented LVEF ≤ 35% 3 months after TAVI (persistent LV dysfunction subpopulation). In the overall population, 53 patients with and 193 patients without an ICD had similar baseline characteristics and procedural success rates, and HF medication at discharge was comparable. Three-year mortality rates were 26.4% for patients with an ICD and 24.4% for patients without an ICD (p = 0.758). Cardiovascular death rates were similar between groups (p = 0.914), and deaths were most often attributed to worsening of HF. Survival rates in patients with persistent LV dysfunction with an ICD (n = 24) or without an ICD (n = 59) were similar between groups (p = 0.872), with cardiovascular deaths mostly qualified as worsening HF and none as sudden cardiac death. Patients of the overall study population with biventricular pacing devices showed only a tendency to have better outcomes (p = 0.298). ICD therapy in elderly patients with AS and LV dysfunction undergoing TAVI did not demonstrate a survival benefit during a 3-year follow-up period.

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Zabel, Markus, Simon Schlögl, Andrzej Lubinski, Jesper Hastrup Svendsen, Axel Bauer, Elena Arbelo, Sandro Brusich, et al. "Present criteria for prophylactic ICD implantation: Insights from the EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope) project." Journal of Electrocardiology 57 (November 2019): S34—S39. http://dx.doi.org/10.1016/j.jelectrocard.2019.09.001.

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Naegele, H., M. A. Castel, G. Groth, F. M. Wagner, and H. H. Reichenspurner. "Sudden death in patients evaluated for heart transplantation: HFSS detects possible candidates for prophylactic ICD implantation." Journal of Heart and Lung Transplantation 23, no. 2 (February 2004): S57. http://dx.doi.org/10.1016/j.healun.2003.11.046.

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Haanschoten, Danielle, and Arif Elvan. "The DAPA Trial in the Context of Previous Prophylactic ICD Landmark Trials." Arrhythmia & Electrophysiology Review 10, no. 3 (October 27, 2021): 154–58. http://dx.doi.org/10.15420/aer.2021.23.

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In patients with ischaemic cardiomyopathy and severely reduced left ventricular ejection fraction (LVEF), an arrhythmogenic milieu is created by a complex interplay between myocardial scarring (assessed by cardiac MRI) and multiple other factors (ventricular ectopy, ischaemia and autonomic imbalance), favouring the occurrence of arrhythmic sudden cardiac death (SCD). Currently, a dynamic and robust model of dichotomised SCD risk assessment after primary percutaneous coronary intervention (PCI) is lacking, underlining the urgent need for further refinement of the widely accepted and guidelines-based criteria (ischaemic cardiomyopathy, LVEF ≤35%) for primary prevention. This review addresses the potential additional value of the recently published Defibrillator After Primary Angioplasty (DAPA) trial results. The DAPA trial conveys important messages and provides novel perspectives regarding left ventricular function post-primary PCI as an (early) risk marker for SCD and the impact of prophylactic ICD implantation on survival in this cohort. In the context of other previous primary prevention trials, DAPA was the first trial including only ST-elevation MI patients all treated with acute PCI.

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Versteeg, Henneke, Ivy Timmermans, Jos Widdershoven, Geert-Jan Kimman, Sébastien Prevot, Thomas Rauwolf, Marcoen F. Scholten, et al. "Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial." EP Europace 21, no. 9 (June 5, 2019): 1360–68. http://dx.doi.org/10.1093/europace/euz140.

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AbstractAimsThe European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD).Methods and resultsThe sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3–6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients’ medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients’ health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed.ConclusionLarge clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586.

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Frydensberg, Vivi Skibdal, Jens Brock Johansen, Sören Möller, Sam Riahi, Sonja Wehberg, Jens Haarbo, Berit Thornvig Philbert, et al. "Anxiety and depression symptoms in Danish patients with an implantable cardioverter-defibrillator: prevalence and association with indication and sex up to 2 years of follow-up (data from the national DEFIB-WOMEN study)." EP Europace 22, no. 12 (October 27, 2020): 1830–40. http://dx.doi.org/10.1093/europace/euaa176.

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Abstract Aims To investigate (i) the prevalence of anxiety and depression and (ii) the association between indication for implantable cardioverter-defibrillator (ICD) implantation and sex in relation to anxiety and depression up to 24 months’ follow-up. Methods and results Patients with a first-time ICD, participating in the national, multi-centre, prospective DEFIB-WOMEN study (n = 1496; 18% women) completed the Hospital Anxiety and Depression Scale at baseline, 3, 6, 12, and 24 months. Data were analysed using linear mixed modelling for longitudinal data. Patients with a secondary prophylactic indication (SPI) had higher mean anxiety scores than patients with a primary prophylactic indication (PPI) at baseline, 3, and 12 months and higher mean depression scores at all-time points, except at 24 months. Women had higher mean anxiety scores as compared to men at all-time points; however, only higher mean depression scores at baseline. Overall, women with SPI had higher anxiety and depression symptom scores than men with SPI. Symptoms decreased over time in both women and men. From baseline to follow-up, the prevalence of anxiety (score ≥8) was highest in patients with SPI (13.3–20.2%) as compared to patients with PPI (range 10.0–14.7%). The prevalence of depression was stable over the follow-up period in both groups (range 8.5–11.1%). Conclusion Patients with a SPI reported higher anxiety and depression scores as compared to patients with PPI. Women reported higher anxiety scores than men, but only higher depression scores at baseline. Women with SPI reported the highest anxiety and depression scores overall.

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Oebel, SR, S. Hilbert, L. Ueberham, J. Kosiuk, S. Richter, M. Doering, A. Bollmann, et al. "P1747Risk stratification by CMR imaging for patients undergoing primary prophylactic ICD implantation - Differences between ischemic and non- ischemic etiology." EP Europace 19, suppl_3 (June 2017): iii382. http://dx.doi.org/10.1093/ehjci/eux161.057.

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Kleemann, T., M. Strauss, K. Kouraki, N. Werner, and R. Zahn. "P463Risk assessment for primary prophylactic ICD implantation in hypertrophic cardiomyopathy using the risk calculator: discrepancy between theory and clinical practice?" EP Europace 20, suppl_1 (March 1, 2018): i92—i93. http://dx.doi.org/10.1093/europace/euy015.272.

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Waezsada, Elias, Julie Hutter, Patrick Kahle, Joerg Yogarajah, Johannes Sperzel, Malte Kuniss, Thomas Neumann, Horst Esser, Christian Hamm, and Andreas Hain. "Guideline Directed Medical Therapy at Discharge and Further Uptitration Leading to Reduction in Indication for Prophylactic ICD Implantation during Protected Waiting Period." Journal of Clinical Medicine 11, no. 20 (October 18, 2022): 6122. http://dx.doi.org/10.3390/jcm11206122.

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Heart failure with reduced ejection fraction (LV-EF < 35%) is diagnosed in app. 11,000,000 patients worldwide. For the treatment of these patients, guideline directed medical therapy has proven to reduce mortality and rehospitalization regardless of the disease’s etiology. It is implemented to treat clinical symptoms by improving the left ventricular ejection fraction. Patients with a transient risk of ventricular tachycardia and sudden cardiac death can be protected by a defibrillator vest. The defibrillator vest is capable to detect and terminate ventricular arrhythmias during Guideline Directed Medical Therapy (GDMT). It is based on the recommendations of the European society of cardiology for 3 months. Afterwards, the WCD wear time could be prolonged, or, in case of persistent low ejection fraction (LV-EF ≤ 35%), an implantable cardioverter defibrillator (ICD) should be implanted, as shown in the WEARIT-II-registry. Our goal was to evaluate the effects of GDMT on LV-recovery and reduction of ICD implantations under protection with a defibrillator vest—depending on the uptitration of GDMT. Methods: 339 consecutive patients between August 2017 and September 2020 with newly diagnosed cardiomyopathy and an EF ≤ 35% were analyzed retrospectively by chart review. All patients were protected by a wearable cardioverter defibrillator (WCD). GDMT as recommended by the ESC started at discharge from hospital. The left ventricular ejection fraction (LV-EF) was determined by transthoracic echocardiography at week 4, 8 and at week 12 (in case of prolonged WCD wear time). Uptitration was performed after 4 and 8 weeks during patient visits. We focused on baseline medication as per GDMT and the dosage increase at week 4, 8 and 12. The aim was the uptitration to the maximum dosage tolerated by the patient. We also compared the LV-EF improvement in the group with and without uptitration of medication dosage. Results: The patient age was, on average, 63.2 years (SD ± 11.9 years). A total of 129 pts (38%) had ICM, 196 (58%) had NICM (incl 66 pts (19%) with DCM and 51 pts (15%) with Myocarditis, 79 pts (24%) with unknown origin) and 14 pts (4%) had other entities (e.g., Tachycardiomyopathy). In total, 21 pts (6%) had an LV-EF of less than 16%, 130 pts (38%) between 16–25% and 183 pts (54%) between 26–35%. GDMT started at discharge from the hospital included treatment with beta blocker for 327 pts (96.5%), ACE-inhibitors/Angiotensin/ARNI for 283 pts (83.5%) and Mineralcorticoid receptor antagonists (MRA) for 334 pts (88.4%). Uptitration was performed in all groups at a rate of 82.3%, 91.1% and 81.0% after 4 weeks and 64.7%, 50.3% and 66.3% after 8 weeks, respectively. After 4 weeks, 25 pts (7.4%) and, after 8 weeks, 171 pts (50.4%) had an EF increase of 5% or more (mean 14.2%). After 4 weeks, 81 patients had an LV-EF more than 35%. A total of 169 pts had a wear time of 12 weeks and an improvement of LVEF of more than 35%. Interestingly, in our study we did not find a significant difference in LV-EF improvement between the group with no uptitration and the group with uptitration. Conclusions: Guideline-directed medical therapy under protection with a WCD from ventricular arrhythmia can reduce the need for implantation of an ICD and can lead to an improvement of ejection fraction. Interestingly, the LV-EF improvement depends on the GDMT at discharge. Current guidelines recommend an initiation of all therapy columns of GDMT (sacubitril/valsartan, ACE-inhibitor/AT1-blocker, mineralcorticoidreceptorblocker, beta blocker) at once and further uptitration to the maximal dosage (ESC Guidelines 2021). A further uptitration of all drugs of GDMT should lead to improvement of LV-EF and consequently to a reduction in ICD implantations.

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Silka, Michael J., and Yaniv Bar-Cohen. "Should patients with congenital heart disease and a systemic ventricular ejection fraction less than 30% undergo prophylactic implantation of an ICD?" Circulation: Arrhythmia and Electrophysiology 1, no. 4 (October 2008): 298–306. http://dx.doi.org/10.1161/circep.108.801522.

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Triedman, John K. "Should patients with congenital heart disease and a systemic ventricular ejection fraction less than 30% undergo prophylactic implantation of an ICD?" Circulation: Arrhythmia and Electrophysiology 1, no. 4 (October 2008): 307–16. http://dx.doi.org/10.1161/circep.108.805903.

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von Stülpnagel, Lukas, Bernhard Wolf, and Axel Bauer. "Biosignal-guided personalized therapy." Current Directions in Biomedical Engineering 3, no. 2 (September 7, 2017): 179–81. http://dx.doi.org/10.1515/cdbme-2017-0037.

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AbstractSudden cardiac death (SCD) is the leading single cause of death in the industrialized world. Current guidelines recommend a prophylactic implantation of an implantable cardioverter-defibrillator (ICD) in patients with reduced left-ventricular ejection fraction (LVEF ≤ 35%). However, most deaths after myocardial infarction (MI) occur in patients with normal or moderately reduced LVEF (>35%). There is a large body of evidence that cardiac autonomic dysfunction after MI is linked to increased susceptibility to malignant arrhythmias. Deceleration capacity of heart rate (DC) and periodic repolarization dynamics (PRD) are novel ECG-based risk markers, which capture different facets of cardiac autonomic dysfunction. Both parameters are strong and independent predictors of mortality and SCD after MI. Previous studies indicated that combined assessment of DC and PRD allows identification of a new high-risk group among post-infarction patients that is not addressed by current guidelines, thus opening new perspectives for biosignal-guided personalized therapies.

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Oebel, SR, S. Hilbert, L. Ueberham, J. Kosiuk, S. Richter, M. Doering, A. Bollmann, et al. "P1746Risk stratification for patients undergoing primary prophylactic ICD implantation- the role of CMR imaging for predicting new onset ventricular arrhythmias and death." EP Europace 19, suppl_3 (June 2017): iii381—iii382. http://dx.doi.org/10.1093/ehjci/eux161.056.

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Faber, Lothar. "Percutaneous Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: From Experiment to Standard of Care." Advances in Medicine 2014 (2014): 1–14. http://dx.doi.org/10.1155/2014/464851.

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Hypertrophic cardiomyopathy (HCM) is one of the more common hereditary cardiac conditions. According to presence or absence of outflow obstruction at rest or with provocation, a more common (about 60–70%) obstructive type of the disease (HOCM) has to be distinguished from the less common (30–40%) nonobstructive phenotype (HNCM). Symptoms include exercise limitation due to dyspnea, angina pectoris, palpitations, or dizziness; occasionally syncope or sudden cardiac death occurs. Correct diagnosis and risk stratification with respect to prophylactic ICD implantation are essential in HCM patient management. Drug therapy in symptomatic patients can be characterized as treatment of heart failure with preserved ejection fraction (HFpEF) in HNCM, while symptoms and the obstructive gradient in HOCM can be addressed with beta-blockers, disopyramide, or verapamil. After a short overview on etiology, natural history, and diagnostics in hypertrophic cardiomyopathy, this paper reviews the current treatment options for HOCM with a special focus on percutaneous septal ablation. Literature data and the own series of about 600 cases are discussed, suggesting a largely comparable outcome with respect to procedural mortality, clinical efficacy, and long-term outcome.

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Forleo, Giovanni B., Francesco Solimene, Ennio C. Pisanò, Gabriele Zanotto, Valeria Calvi, Carlo Pignalberi, Giampiero Maglia, et al. "Long‐term outcomes after prophylactic ICD and CRT‐D implantation in nonischemic patients: Analysis from a nationwide database of daily remote‐monitoring transmissions." Journal of Cardiovascular Electrophysiology 30, no. 9 (June 18, 2019): 1626–35. http://dx.doi.org/10.1111/jce.14006.

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Santangeli, Pasquale, Luigi Di Biase, Eloisa Basile, Amin Al-Ahmad, and Andrea Natale. "Outcomes in Women Undergoing Electrophysiological Procedures." Arrhythmia & Electrophysiology Review 2, no. 1 (2013): 41. http://dx.doi.org/10.15420/aer.2013.2.1.41.

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The number of invasive electrophysiological procedures is steadily increasing in Western countries, as the age of the population increases and technologies advance. In recent years, gender-related differences in cardiac rhythm disorders have been increasingly appreciated, which can potentially have a great impact on the outcomes of invasive electrophysiological procedures. Among supraventricular arrhythmias, women have a higher incidence of atrioventricular nodal re-entrant tachycardia and a significantly lower incidence of atrioventricular re-entrant tachycardia compared with males, and present to ablation procedures later and after having failed more antiarrhythmic drugs. The results of catheter ablation of atrial fibrillation in women have been reported worse than in men. This finding is possibly due to a later referral of females to ablation procedures, who present older and with a higher incidence of long-standing persistent atrial fibrillation. With regard to cardiac device implantation procedures, a smaller survival benefit from prophylactic implantable cardioverter defibrillator (ICD) implantation has been shown in women, essentially due to gender-specific differences in the clinical course of patients with severe left ventricular dysfunction, with women dying predominantly from non-arrhythmic causes. On the other side, the clinical outcome of cardiac resynchronisation therapy seems to be more favourable in women, who experience a greater degree of reverse left ventricular remodelling and a striking decrease of heart failure events or mortality after biventricular pacing. This review will summarise the available evidence on gender-related differences in outcomes of invasive electrophysiological procedures.

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Briasoulis, Alexandros, Christos Kourek, Adamantia Papamichail, Konstantinos Loritis, Dimitrios Bampatsias, Evangelos Repasos, Andrew Xanthopoulos, Elias Tsougos, and Ioannis Paraskevaidis. "Arrhythmias in Patients with Cardiac Amyloidosis: A Comprehensive Review on Clinical Management and Devices." Journal of Cardiovascular Development and Disease 10, no. 8 (August 5, 2023): 337. http://dx.doi.org/10.3390/jcdd10080337.

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Cardiac amyloidosis (CA) is a rare but potentially life-threatening disease in which misfolded proteins accumulate in the cardiac wall tissue. Heart rhythm disorders in CA, including supraventricular arrhythmias, conduction system disturbances, or ventricular arrhythmias, play a major role in CA morbidity and mortality, and thus require supplementary management. Among them, AF is the most frequent arrhythmia during CA hospitalizations and is associated with significantly higher mortality, while ventricular arrhythmias are also common and are usually associated with poor prognosis. Early diagnosis of potential arrythmias could be performed through ECG, Holter monitoring, and/or electrophysiology study. Clinical management of these patients is quite significant, and it usually includes initiation of amiodarone and/or digoxin in patients with AF, potential electrical cardioversion, or ablation in specific patients with indication, as well as initiation of anticoagulants in all patients, independent of AF and CHADS-VASc score, for potential intracardiac thrombus. Moreover, identification of patients with conduction disorders that could benefit from prophylactic pacemaker implantation and/or CRT as well as identification of patients with life-threatening ventricular arrythmias that could benefit from ICD could both increase the survival rates of these patients and improve their quality of life.

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Klein, Helmut U., Michael Block, Heinz Voeller, Wolfram Kamke, Thomas Fetsch, Andreas Suciu, and Klaus Contzen. "Prophylactic ICD-implantation in real life 2 years after MADIT II unmasked by the prevention of sudden cardiac death II - registry: Only few patients receive ICDs." Heart Rhythm 2, no. 5 (May 2005): S243—S244. http://dx.doi.org/10.1016/j.hrthm.2005.02.762.

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Heidbuchel, Hein, Rik Willems, Luc Jordaens, Brian Olshansky, Francois Carre, Ignacio F. Lozano, Matthias Wilhelm, et al. "Intensive recreational athletes in the prospective multinational ICD Sports Safety Registry: Results from the European cohort." European Journal of Preventive Cardiology 26, no. 7 (February 27, 2019): 764–75. http://dx.doi.org/10.1177/2047487319834852.

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Background In the ICD Sports Safety Registry, death, arrhythmia- or shock-related physical injury did not occur in athletes who continue competitive sports after implantable cardioverter-defibrillator (ICD) implantation. However, data from non-competitive ICD recipients is lacking. This report describes arrhythmic events and lead performance in intensive recreational athletes with ICDs enrolled in the European recreational arm of the Registry, and compares their outcome with those of the competitive athletes in the Registry. Methods The Registry recruited 317 competitive athletes ≥ 18 years old, receiving an ICD for primary or secondary prevention (234 US; 83 non-US). In Europe, Israel and Australia only, an additional cohort of 80 ‘auto-competitive’ recreational athletes was also included, engaged in intense physical activity on a regular basis (≥2×/week and/or ≥ 2 h/week) with the explicit aim to improve their physical performance limits. Athletes were followed for a median of 44 and 49 months, respectively. ICD shock data and clinical outcomes were adjudicated by three electrophysiologists. Results Compared with competitive athletes, recreational athletes were older (median 44 vs. 37 years; p = 0.0004), more frequently men (79% vs. 68%; p = 0.06), with less idiopathic ventricular fibrillation or catecholaminergic polymorphic ventricular tachycardia (1.3% vs. 15.4%), less congenital heart disease (1.3% vs. 6.9%) and more arrhythmogenic right ventricular cardiomyopathy (23.8% vs. 13.6%) ( p < 0.001). They more often had a prophylactic ICD implant (51.4% vs. 26.9%; p < 0.0001) or were given a beta-blocker (95% vs. 65%; p < 0.0001). Left ventricular ejection fraction, ICD rate cut-off and time from implant were similar. Recreational athletes performed fewer hours of sports per week (median 4.5 vs. 6 h; p = 0.0004) and fewer participated in sports with burst-performances ( vs. endurance) as their main sports: 4% vs. 65% ( p < 0.0001). None of the athletes in either group died, required external resuscitation or was injured due to arrhythmia or shock. Freedom from definite or probable lead malfunction was similar (5-year 97% vs. 96%; 10-year 93% vs. 91%). Recreational athletes received fewer total shocks (13.8% vs. 26.5%, p = 0.01) due to fewer inappropriate shocks (2.5% vs. 12%; p = 0.01). The proportion receiving appropriate shocks was similar (12.5% vs. 15.5%, p = 0.51). Recreational athletes received fewer total (6.3% vs. 20.2%; p = 0.003), appropriate (3.8% vs. 11.4%; p = 0.06) and inappropriate (2.5% vs. 9.5%; p = 0.04) shocks during physical activity. Ventricular tachycardia/fibrillation storms during physical activity occurred in 0/80 recreational vs. 7/317 competitive athletes. Appropriate shocks during physical activity were related to underlying disease ( p = 0.004) and competitive versus recreational sports ( p = 0.004), but there was no relation with age, gender, type of indication, beta-blocker use or burst/endurance sports. The proportion of athletes who stopped sports due to shocks was similar (3.8% vs. 7.5%, p = 0.32). Conclusions Participants in recreational sports had less frequent appropriate and inappropriate shocks during physical activity than participants in competitive sports. Shocks did not cause death or injury. Recreational athletes with ICDs can engage in sports without severe adverse outcomes unless other reasons preclude continuation.

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Lewenhardt, Marie, Fabienne Kreimer, Assem Aweimer, Andreas Pflaumbaum, Andreas Mügge, and Michael Gotzmann. "Benefit of primary and secondary prophylactic implantable cardioverter defibrillator in elderly patients." Clinical Cardiology, November 14, 2023. http://dx.doi.org/10.1002/clc.24191.

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AbstractBackgroundThe benefit of implantable cardioverter‐defibrillator (ICD) in elderly patients has been questioned. In the present study, we aimed to analyse the outcome of patients of different age groups with ICD implantation.MethodsWe included all patients who received an ICD in our hospital from 2011 to 2020. Primary endpoints were (1) death from any cause and (2) appropriate ICD therapy (antitachycardia pacing/shock). A “benefit of ICD implantation” was defined as appropriate ICD therapy before death from any cause/or survival. “No benefit of ICD implantation” was defined as death from any cause without prior appropriate ICD therapy.ResultsA total of 422 patients received an ICD (primary prophylaxis n = 323, secondary prophylaxis n = 99). At the time of implantation, 35 patients (8%) were >80 years and 106 patients were >75 years (25%). During the study period of 4.2 ± 3 years, benefit of ICD occurred in 89 patients (21%) and no benefit in 84 patients (20%). In primary prevention, the proportion of patients who had a benefit from ICD implantation decreased with increasing age, and there were no patients who benefited from ICD therapy in the group of patients >80 years. In secondary prophylaxis, the proportion of patients with a benefit from ICD implantation ranged from 20% to 30% in all age groups.ConclusionOur study suggests that the indication of primary prophylactic ICD in elderly and very old patients should be critically assessed. On the other hand, no patient should be denied secondary prophylactic ICD implantation because of age.

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Sams, L. E., M. Klemm, M. Woerndl, L. Bachinger, L. E. Villegas Sierra, S. Massberg, and K. D. Rizas. "Periodic Repolarization Dynamics (PRD) identifies patients who profit from ICD implantation, A meta-analysis of the predictive value of PRD." European Heart Journal 44, Supplement_2 (November 2023). http://dx.doi.org/10.1093/eurheartj/ehad655.681.

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Abstract Background Periodic repolarization dynamics (PRD) is an electrocardiographic marker that quantifies sympathetic-activity associated instabilities of cardiac repolarization. PRD is a strong predictor of mortality in patients with ischemic (ICM) and non-ischemic cardiomyopathy (NICM) and has been proposed to identify patients who benefit from prophylactic ICD implantation. Purpose To conduct a systematic review and meta-analysis concerning the prognostic value of PRD for predicting all-cause mortality in relation to prophylactic ICD-implantation. Methods This meta-analysis follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. A total of 25 articles were screened and 7 randomized and non-randomized controlled trials identified. Finally, a total of 5 could be included in the analysis (Fig.1). Patients were stratified into patients with or without prophylactic ICD-implantation (Fig.2). The prognostic value of PRD for predicting all-cause mortality was extracted from published data as hazard ratio (HR) per 1 deg2 increase in PRD. We used inverse-variance-weighted average meta-analysis to calculate fixed and random effect models to estimate the overall predictive value of PRD in both groups. The interaction between PRD and prophylactic ICD-implantation for predicting mortality was calculated using meta-regression analysis. All analyses were performed using CRAN R v. 4.1.2 and the meta-package v 5.2.0. Results We included 4,338 patients in this meta-analysis, of whom 3,167 (73%) suffered from ICM and 1,171 (27%) from NICM. 1,906 (44%) patients were treated with an ICD. During an estimated mean follow-up time of 3.2 years, 604 (14%) patients died. Fig. 2 (left) shows patients without ICD treatment (N = 2,432, 56%). In these patients, a 1 deg2 increase in PRD was significantly associated with an overall 8% increase in mortality (fixed effect HR 1.08; 95% CI 1.06-1.10; p< 0.001, random effect HR 1.08; 95% CI 1.06-1.11; p < 0.001). Fig. 2 (right) displays the prognostic value of PRD in patients treated by ICD (N = 1,906). In these patients, a 1 deg2 increase in PRD was significantly associated with an overall 3% increase in mortality (fixed-effect HR 1.03; 95% CI 1.01-1.05; p< 0.001, random-effect HR 1.03; 95% CI 1.00-1.06; p < 0.001). An increase in PRD was not significantly associated with an increase in mortality in patients from the EU-CERT-ICD and DANISH trial. There was a significant interaction between PRD and prophylactic ICD-implantation for predicting all-cause mortality (p = 0.008). Conclusion In patients with ICM and NICM, PRD is a strong predictor of all-cause mortality in patients with and without prophylactic ICD. The significant interaction between PRD and prophylactic ICD-implantation most probably implies a reduction in the risk identified by PRD through ICD implantation. Consequently, PRD could prove a useful tool for identifying patients that might benefit from ICD treatment.Figure 1Figure 2

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Migliore, Federico, Nicolò Martini, Leonardo Calo', Annamaria Martino, Giulia Winnicki, Riccardo Vio, Chiara Condello, et al. "Predictors of late arrhythmic events after generator replacement in Brugada syndrome treated with prophylactic ICD." Frontiers in Cardiovascular Medicine 9 (July 22, 2022). http://dx.doi.org/10.3389/fcvm.2022.964694.

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IntroductionPredictors of late life-threatening arrhythmic events in Brugada syndrome (BrS) patients who received a prophylactic ICD implantation remain to be evaluated. The aim of the present long-term multicenter study was to assess the incidence and clinical-electrocardiographic predictors of late life-threatening arrhythmic events in BrS patients with a prophylactic implantable cardioverter defibrillator (ICD) and undergoing generator replacement (GR).MethodsThe study population included 105 patients (75% males; mean age 45 ± 14years) who received a prophylactic ICD and had no arrhythmic event up to first GR.ResultsThe median period from first ICD implantation to last follow-up was 155 (128–181) months and from first ICD Implantation to the GR was 84 (61–102) months. During a median follow-up of 57 (38–102) months after GR, 10 patients (9%) received successful appropriate ICD intervention (1.6%/year). ICD interventions included shock on ventricular fibrillation (n = 8 patients), shock on ventricular tachycardia (n = 1 patient), and antitachycardia pacing on ventricular tachycardia (n = 1 patient). At survival analysis, history of atrial fibrillation (log-rank test; P = 0.02), conduction disturbances (log-rank test; P < 0.01), S wave in lead I (log-rank test; P = 0.01) and first-degree atrioventricular block (log-rank test; P = 0.04) were significantly associated with the occurrence of late appropriate ICD intervention. At Cox-regression multivariate analysis, S-wave in lead I was the only independent predictor of late appropriate ICD intervention (HR: 9.17; 95%CI: 1.15–73.07; P = 0.03).ConclusionsThe present study indicates that BrS patient receiving a prophylactic ICD may experience late appropriate intervention after GR in a clinically relevant proportion of cases. S-wave in lead I at the time of first clinical evaluation was the only independent predictor of persistent risk of life-threatening arrhythmic events. These findings support the need for GR at the end of service regardless of previous appropriate intervention, mostly in BrS patients with conduction abnormalities.

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Kleemann, T., K. Kouraki, M. Strauss, O. Mohammad, A. Wenz, and R. Zahn. "Incidence of ventricular tachyarrhythmias and clinical outcomes in primary prophylactic ICD patients in relation to localization of myocardial infarction." Europace 25, Supplement_1 (May 24, 2023). http://dx.doi.org/10.1093/europace/euad122.308.

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Abstract Funding Acknowledgements Type of funding sources: None. Introduction According to current guidelines, primary prophylactic ICD implantation is indicated with a class IA recommendation in patients with severely reduced EF < 35% and ischaemic heart disease. However, it is unclear whether there are differences in patient outcomes related to the localization of myocardial infarction. Aim of the study was to compare the incidence of ventricular tachyarrhythmias and clinical outcomes in primary prophylactic ICD-patients with ischaemic heart disease in relation to the localization of myocardial infarction. Methods A total of 448 consecutive ICD patients from a prospective single-centre ICD-registry who underwent primary prophylactic ICD implantation due to ischaemic cardiomyopathy between 1996 and 2021 were analyzed. Patients with previous anterior wall myocardial infarction (AWMI, n = 293) were compared to those with posterior wall myocardial infarction (PWMI, n = 155). Patients with both AWMI and PWMI were excluded. The median follow-up time was 6 years in both groups. Results Patients with AMWI were younger, more often female, and less often received cardiac synchronization therapy (Table 1). Patients with previous PWMI more often had ICD therapy during follow-up (Figure 1) due to the higher incidence of ventricular tachycardias (Table 1). The all-cause mortality rate was similar between both groups. Conclusion Primary prophylactic ICD patients with previous PWMI have a 10% higher incidence of ventricular tachycardias after 6-year follow-up than ICD patients with previous AMWI. This might be explained by the proximity of the inferior infarction to the mitral isthmus and should be considered when ablating VTs in patients with PWMI.

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Kristen, Arnt V., Thomas J. Dengler, Ute Hegenbart, Stefan O. Schonland, Falk-Udo Sack, Frederick Voss, Rüdiger Becker, Hugo A. Katus, and Alexander Bauer. "Abstract 1657: Prophylactic Implantation Of Cardioverter Defibrillators In Patients With Severe Cardiac Amyloidosis." Circulation 116, suppl_16 (October 16, 2007). http://dx.doi.org/10.1161/circ.116.suppl_16.ii_347-c.

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Objectives: Benefit of prophylactic implantation of a cardioverter defibrillator (ICD) in patients with cardiac light-chain amyloidosis (CA) was assessed. Background: CA carries a high risk for sudden cardiac death (SCD). Methods: Implantation of ICD was performed in 19 patients with histologically proven CA because of a high risk for SCD. These 19 patients were compared to historical controls of CA without ICD. Survival was defined as absence of death or heart transplantation. Definition of high risk for SCD was based on heart failure (NYHA ≥II), a history of unexplained syncope, interventricular septal thickness ≥15mm (IVS), left ventricular ejection fraction ≤45% (LVEF), ventricular premature contractions Lown ≥IVa, serum level of troponin T ≥0.03 μg/l (TnT) and/or a N-terminal-proBNP level ≥3500 ng/l. Results: Patients had NYHA class ≥II (n=17; 89%), syncopes (n=9; 47%), IVS ≥15mm (n=17; 89%), LVEF ≤45% (n=5; 26%), Lown ≥IVa (n=15; 79%), TnT >0.03 μg/l (n=9; 47%), and NT-proBNP ≥3500 ng/l (n=12; 63%). There were no severe perioperative complications. During a median follow-up of 380 days 2 patients with sustained ventricular tachyarrhythmias were successfully treated by the ICD. There were 9 deaths from electromechanical dissociation (n=5), heart transplantation (n=2) or non-cardiac causes (n=2). Survival of ICD patients did not differ from matched controls. Non-survivors had higher NT-proBNP plasma levels (7576±1571 ng/l) than survivors (4036±737 ng/l, p<0.05). Conclusions: ICD implantation in high-risk patients with CA is feasible, but while selected patients may benefit from an ICD, routine prophylactic implantation is not recommended. More specific predictors of SCD need to be identified.

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Yang, P. S., Y. Kang, J. H. Sung, H. D. Park, and B. Joung. "Survival among ischemic and non-ischemic heart failure patients with primary implantable cardioverter defibrillator therapy in Korea: a nationwide cohort study." European Heart Journal 42, Supplement_1 (October 1, 2021). http://dx.doi.org/10.1093/eurheartj/ehab724.0698.

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Abstract Background Concerns still exist about the efficacy of prophylactic implantable electrocardiogram defibrillators (ICD) in patients with non-ischemic heart failure (HF). We evaluated the mortality and predictors of mortality in patients with prophylactic ICD implantation for ischemic and non-ischemic HF. Methods From 2008 to 2017, 1097 patients (667 non-ischemic; 430 ischemic) with prophylactic ICD implantation who were aged 19 years or older were identified from the Korean National Health Insurance Service database. We used propensity score overlap weighting to correct for differences between two groups. Results Compared with non-ischemic HF patients, ischemic HF patients were older (67.0±10.1 years vs. 61.8±14.2), more often male (71.4% vs. 63.7%), and had more comorbidities. During a median follow-up of 37.3 months (interquartile range (IQR), 14.2–53.8 months), all-cause death was higher in unweighted ischemic than non-ischemic HF patients (10.9 and 6.4 per 100 person-years, hazard ratio [HR] 1.74, 95% confidence interval [CI] 1.38–2.20, p<0.001). However, after weighting, annual all-cause mortality rate was similar in both groups (9.5 vs. 8.8 per 100 person-years) without difference in the risk of all-cause death (HR 1.08, 95% CI 0.68–1.71, p=0.755). Older age and chronic kidney disease were independent predictors of all-cause mortality in both groups. There was also no difference in cardiac and non-cardiac mortality between weighted non-ischemic and ischemic HF groups. Conclusions All-cause, cardiac and non-cardiac mortality were similar between non-ischemic and ischemic HF patients undergoing prophylactic ICD implantation. Our findings support the current guidelines recommendation for primary-prevention ICD in HFrEF patients with ischemic and non-ischemic HF. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Korean Healthcare Technology R&D project funded by the Ministry of Health and Welfare

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Kawahara, Yusei, Hisanori Kanazawa, Seiji Takashio, Yuichiro Tsuruta, Hitoshi Sumi, Takuya Kiyama, Shozo Kaneko, et al. "Clinical, electrocardiographic, and echocardiographic parameters associated with the development of pacing and implantable cardioverter-defibrillator indication in patients with transthyretin amyloid cardiomyopathy." Europace, April 26, 2023. http://dx.doi.org/10.1093/europace/euad105.

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Abstract Aims This study aimed to identify factors for attention leading to future pacing device implantation (PDI) and reveal the necessity of prophylactic PDI or implantable cardioverter-defibrillator (ICD) implantation in transthyretin amyloid cardiomyopathy (ATTR-CM) patients. Methods and results This retrospective single-center observational study included consecutive 114 wild-type ATTR-CM (ATTRwt-CM) and 50 hereditary ATTR-CM (ATTRv-CM) patients, neither implanted with a pacing device nor fulfilling indications for PDI at diagnosis. As a study outcome, patient backgrounds were compared with and without future PDI, and the incidence of PDI in each conduction disturbance was examined. Furthermore, appropriate ICD therapies were investigated in all 19 patients with ICD implantation. PR-interval ≥220 msec, interventricular septum (IVS) thickness ≥16.9 mm, and bifascicular block were significantly associated with future PDI in ATTRwt-CM patients, and brain natriuretic peptide ≥35.7 pg/mL, IVS thickness ≥11.3 mm, and bifascicular block in ATTRv-CM patients. The incidence of subsequent PDI in patients with bifascicular block at diagnosis was significantly higher than that of normal atrioventricular (AV) conduction in both ATTRwt-CM [hazard ratio (HR): 13.70, P = 0.019] and ATTRv-CM (HR: 12.94, P = 0.002), whereas that of patients with first-degree AV block was neither (ATTRwt-CM: HR: 2.14, P = 0.511, ATTRv-CM: HR: 1.57, P = 0.701). Regarding ICD, only 2 of 16 ATTRwt-CM and 1 of 3 ATTRv-CM patients received appropriate anti-tachycardia pacing or shock therapy, under the number of intervals to detect for ventricular tachycardia of 16–32. Conclusions According to our retrospective single-center observational study, prophylactic PDI did not require first-degree AV block in both ATTRwt-CM and ATTRv-CM patients, and prophylactic ICD implantation was also controversial in both ATTR-CM. Larger prospective, multi-center studies are necessary to confirm these results.

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"434 Multicenter study of prophylactic ICD implantation in Brugada syndrome." Europace 7 (June 2005): 96–97. http://dx.doi.org/10.1016/s1099-5129(05)80286-7.

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Alhakak, A., L. Ostergaard, J. H. Butt, M. Vinther, B. T. Philbert, P. K. Jacobsen, J. K. Petersen, et al. "Mortality after implantable cardioverter defibrillators in dialysis patients: a nationwide study." European Heart Journal 41, Supplement_2 (November 1, 2020). http://dx.doi.org/10.1093/ehjci/ehaa946.0791.

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Abstract Background Although randomized clinical trials have shown that implantable cardioverter defibrillators (ICDs) reduce mortality in selected patients, patients on dialysis are excluded from these trials. Thus, data on mortality risk after ICD implantation in these patients are sparse. Purpose To examine all-cause mortality in patients receiving an ICD according to dialysis status and to identify factors associated with all-cause mortality in patients on dialysis. Methods Using Danish nationwide registries from 2000–2017, all patients ≥18 years old undergoing first-time ICD implantation were included. Patients on dialysis were identified prior to ICD implantation and followed for up to five years. The cumulative incidence of all-cause mortality according to dialysis status was assessed. Factors associated with all-cause mortality after ICD implantation in dialysis patients were examined using multivariable Cox proportional hazard regression. Results A total of 14,681 ICD patients were identified, of which 218 (1.5%) were on dialysis prior to ICD implantation. Compared with ICD patients not on dialysis, those on dialysis were younger (median age 64 years [IQR: 58–70] vs. 66 years [IQR: 57–72], p=0.02), more likely to receive an ICD for secondary prophylaxis (69.7% vs 53.7%), and had more comorbidities including ischaemic heart disease (60.6% vs. 46.3%), diabetes (28.4% vs. 20.4%), and peripheral vascular disease (10.1% vs. 5.6%) (p for all <0.05). The median time to death among ICD patients on dialysis and not on dialysis were 1.3 years (IQR: 0.4–2.8 years] and 2.2 years [IQR: 1.0–3.5 years], respectively. One-year mortality among ICD patients on dialysis (13.0%) was significantly higher compared with ICD patients not on dialysis (4.7%), p<0.001 (Figure). Five-year mortality was significantly higher in ICD patients on dialysis than those not on dialysis (42.2% vs 23.6%), p<0.001 (Figure). Factors associated with increased risk of all-cause mortality among ICD patients on dialysis were age ≥65 years at time of implantation (reference: age <65 years) (HR 1.90 [95% CI: 1.13–3.19]), primary prophylactic ICD (HR 1.81 [95% CI 1.08–3.05]), and diabetes (HR 1.87 [95% CI 1.14–3.07]). Sex, ischaemic heart disease, heart failure, stroke, chronic obstructive pulmonary disease, and malignancy were not associated with the risk of mortality (p>0.05 for all). Cardiovascular causes of death were common both in patients with- and without dialysis, 69.6% and 60.0%, respectively. Conclusion Five-year mortality in ICD patients on dialysis was 42% and twice as high compared with ICD patients not on dialysis. Age ≥65 years, primary prophylactic indication, and diabetes were factors associated with increased mortality. Careful evaluation of the potential benefit from an ICD implantation in dialysis patients is important considering the overall high mortality rates. Funding Acknowledgement Type of funding source: None

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Gama, F., M. S. Carvalho, G. Rodrigues, F. M. Costa, D. Matos, J. Carmo, F. Mendes, et al. "Idiopathic HFrEF. Is there room left for defibrillators?" European Heart Journal 41, Supplement_2 (November 1, 2020). http://dx.doi.org/10.1093/ehjci/ehaa946.0727.

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Abstract Background and aim Prophylactic implantation of an implantable cardioverter-defibrillator (ICD) is class 1 recommendation for heart failure (HF) patients with reduced ejection fraction (HFrEF) even though its proven advantage is weaker among nonischemic aetiology. In fact, in an era where both optimal medical therapy (OMT) and cardiac resynchronization therapy (CRT) significantly reduce sudden cardiac death (SCD), it is questionable whether ICD still have additional value. The aim of this study was to assess the current benefit of ICDs in preventing sudden cardiac death through resuscitated cardiac arrest (RCA), appropriate therapy for sustained ventricular tachycardia (VT) or fibrillation (VF) in a contemporary population of idiopathic HFrEF patients. Methods Single-centre retrospective study of consecutive symptomatic (NYHA class II to IV) idiopathic HFrEF patients with an ICD (either alone or in association with CRT), and remote monitoring with the corresponding software (MerlinTM, LatitudeTM, CarelinkTM, MicroPortTM or BiotronikTM) to assure appropriate event supervising. Idiopathic aetiology was assumed after excluding other probable causes. Coronary angiogram was required to exclude ischemic aetiology. Only those with prophylactic ICD implantation were included. RCA was defined as collapse with clinical signs of cardiac arrest and VF or VT appropriately terminated by ICD. In order to be sustained, VT episode had to have last at least 30 seconds. Results From 781 remote monitoring controlled patients, a total of 187 consecutive symptomatic idiopathic HFrEF patients with an ICD (125 men, mean age 64±18 years) were enrolled. Patients were on optimal medical therapy (ACEi/ARB: n=168, 90%; BB: n=154, 82%; mineralocorticoid antagonists: n=91, 49%; CRT: n=130, 70%; see Table). After a median follow-up of 99 months (IQR 62.2), RCA occurred in 10.7% (n=20) and 36.9% (n=69) had appropriately terminated VT. Both left ventricular ejection fraction (LVEF) improvement and CRT implantation did not independently reduce the incidence of RCA and VT requiring ICD therapy (OR, 1.02; 95% CI, 0.99–1.05; P=0.146 and OR, 0.85; 95% CI, 0.34–2.13; P=0.728; respectively). All cause mortality was 20 (10.7%). Inappropriate therapy was given as shocks to 41 patients (21.9%) and as antitachycardia pacing (ATP) to 30 (16%), opposing with appropriately given therapy to 43 (23%) and 63 (33.7%) patients, respectively (see Figure), contributing to a net clinical benefit (NCB) of 18.8%, favouring ICD implantation. Conclusion In this contemporaneous real-world population of symptomatic idiopathic HFrEF patients, episodes of impending cardiac death were frequent. Prophylactic ICD implantation seems to have added further benefit reducing SCD on top of optimal medical therapy, LVEF improvement and coexisting CRT. Funding Acknowledgement Type of funding source: None

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Zheng, C., A. H. Christensen, C. Joens, N. Risum, H. S. Bosselmann, B. T. Philbert, R. Frosted, and H. Bundgaard. "Marked differences in ICD therapy frequencies between phenotypes." European Heart Journal 44, Supplement_2 (November 2023). http://dx.doi.org/10.1093/eurheartj/ehad655.685.

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Abstract Background Implantable cardioverter defibrillators (ICD) are implanted due to a broad range of cardiac conditions according to guidelines. Purpose The aim of this study was to compare the distribution of ICD therapies across different cardiac diseases. Methods In this descriptive study, we included patients from Eastern Denmark with an ICD implanted up until November 2021. Data was obtained from the national ICD registry and the diagnosis leading to implantation of the ICD was registered. ICD interrogations and number of episodes of appropriate ICD therapies (shock/anti-tachycardia pacing (ATP)) were obtained. End of follow-up was November 8, 2021 or date of death or heart transplantation. Cumulated numbers of therapies were calculated for each patient during the follow-up period (shock/ATP therapies per 1,000 patients per year). Results Data on 3,068 patients (median (IQR) age at implantation 65 years (56-72)) across 10 cardiac disorders was obtained (Figure). A total of 1,403 patients had the ICD implanted as primary prophylaxis and 1,554 as secondary prophylaxis and in 111 patients it was unclear. Mean follow-up time of 595 years per diagnostic subgroup (210-12,911 years). The median (IQR) shock/ATP rate per 1,000 patients per year was 1.47 (0.70-2.62). The numerically highest shock/ATP rate of 28.9 therapies per 1,000 patients per year was seen in patients with arrhythmogenic right ventricle cardiomyopathy and the lowest shock/ATP rate of 0.05 therapies per 1,000 patients per year was seen in patients with ischemic heart disease. In patients with ischemic heart disease, the shock/ATP rate per year was 0.06 in patients with an ICD implanted as primary prophylactic and 0.15 in patients with an ICD as secondary prophylactic. Conclusion The frequency of ICD shock/ATP therapy varies several-fold between cardiac disorders, with the highest rate in patient with arrhythmogenic right ventricle cardiomyopathy and the lowest rate in the major group of patients, i.e. patients with ischemic heart disease. These findings may indicate a need for adjustments of patient selection for ICD implantation.

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Pelli, Ari, M. Juhani Junttila, Tuomas V. Kenttä, Simon Schlögl, Markus Zabel, Marek Malik, Tobias Reichlin, et al. "Q waves are the strongest electrocardiographic variable associated with primary prophylactic implantable cardioverter-defibrillator benefit: a prospective multicentre study." EP Europace, November 29, 2021. http://dx.doi.org/10.1093/europace/euab260.

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Abstract Aim The association of standard 12-lead electrocardiogram (ECG) markers with benefits of the primary prophylactic implantable cardioverter-defibrillator (ICD) has not been determined in the contemporary era. We analysed traditional and novel ECG variables in a large prospective, controlled primary prophylactic ICD population to assess the predictive value of ECG in terms of ICD benefit. Methods and results Electrocardiograms from 1477 ICD patients and 700 control patients (EU-CERT-ICD; non-randomized, controlled, prospective multicentre study; ClinicalTrials.gov Identifier: NCT02064192), who met ICD implantation criteria but did not receive the device, were analysed. The primary outcome was all-cause mortality. In ICD patients, the co-primary outcome of first appropriate shock was used. Mean follow-up time was 2.4 ± 1.1 years to death and 2.3 ± 1.2 years to the first appropriate shock. Pathological Q waves were associated with decreased mortality in ICD patients [hazard ratio (HR) 0.54, 95% confidence interval (CI) 0.35–0.84; P < 0.01] and patients with pathological Q waves had significantly more benefit from ICD (HR 0.44, 95% CI 0.21–0.93; P = 0.03). QTc interval increase taken as a continuous variable was associated with both mortality and appropriate shock incidence, but commonly used cut-off values, were not statistically significantly associated with either of the outcomes. Conclusion Pathological Q waves were a strong ECG predictor of ICD benefit in primary prophylactic ICD patients. Excess mortality among Q wave patients seems to be due to arrhythmic death which can be prevented by ICD.

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