Predictors for early mortality and arrhythmic events in patients with cardiac resynchronization therapy with defibrillator: A two center cohort study

Background: Guidelines of heart failure therapy include cardiac resynchronization as standard ofcare in patients with severely depressed left ventricular function and wide QRS complex. It has beenshown that patients benefit regarding mortality and morbidity. However, early mortality precludes longtermbenefits from the device. The aim of the study was to identify predictors for early occurrence ofboth death and first-ever implantable cardioverter-defibrillator (ICD) therapy using a large combineddatabase of patients with cardiac resynchronization therapy with defibrillator (CRT-D).Methods: From two registries (tertiary care centers) 904 patients were identified, no single patient wasexcluded. Early death was defined as death occurring within the 3 years after implantation whereasearly ICD therapy as such occurring within the first year. 33 baseline parameters were compared usinguni- and multivariate analysis with the Cox model and binary logistic regression.Results: The population was predominantly male (77%), with mean age of 63 ± 11 years and primaryprevention indication in 80%. Mean follow-up was 55 ± 38 months. 256 (28%) patients hadICD therapies whereof the first-ever event occurred early in 52%. 270 (30%) patients died after 41 ±± 31 months, mostly from advancing heart failure (41%), 141 (52%) patients of them early. Independentpredictors for early ICD therapy were secondary prevention and renal failure. Independent predictors forearly mortality were a history of percutaneous coronary intervention and of peripheral vascular disease.Conclusions: Predictors for early mortality after CRT-D implantation were a history of percutaneouscoronary intervention and peripheral vascular disease, present in only a minority of patients, thus limitingtheir use in clinical practice

Shock and patient preimplantation type D personality are associated with poor health status in patients with implantable cardioverter-defibrillator

Background: Implantable cardioverter-defibrillator (ICD) shock is a critical event to patients associated with well-being after implantation, although other factors may play an equally important role. We compared the association of shock and the patient's preimplantation personality with health status, using a prospective study design. Methods and Results: Consecutively implanted ICD patients (n=383; 79% men) completed the Type D Scale at baseline and the Short-Form Health Survey 36 (SF-36) at baseline and 3, 6, and 12 months. Of all patients, 23.5% had a Type D personality and 13.8% received a shock during follow-up. Shocked patients reported significantly poorer health status, as did Type D patients. Health status patterns were poorest in patients with combined Type D personality and shock during follow-up. Shock during follow-up was a significant independent associate of poorer health status for 4 of 8 subscales of the SF-36 and the Mental Component Summary (all P<.05), with shocked patients scoring between 2.60 to 13.30 points lower than nonshocked patients. Type D personality was an independent associate of poor postimplantation health status for 6 of 8 of the SF-36 subscales and the Mental Component Summary, with Type D patients scoring between 2.12 to 8.02 points lower, adjusting for demographic and clinical characteristics. Conclusions: ICD shock and the patient's preimplantation personality disposition were equally important associates of health status 12 months after implantation. Identification of the patient's personality profile before ICD implantation may help identify subsets of patients who may need additional care, for example, with a psychosocial component

Йосиф Конрадович Пачоський: історіографія проблеми

Проаналізовано наукові, науково-популярні, публіцистичні, літературні джерела щодо біографії і наукової діяльності Й.К. Почоського, розділені на три періоди: перший — дореволюційний період вивчення життєвого шляху та наукової діяльності вченого (1882—1917), другий — радянський (1917—1989), третій — сучасний (1989 р.). Окрім вітчизняних, висвітлено праці дослідників із Польщі.Проанализированы научные, научно-популярные, публицистические, литературные источники по биографии и научной деятельности И.К.Пачоского, разделенные на три периода: первый — дореволюционный период изучения жизненного пути и научной деятельности ученого (1882—1917), второй советский (1917—1989), третий — современный (с 1989 г. ). Кроме отечественных, освещены работы исследователей из Польши.The paper contains analysis of scientific, popular-scientific, publicistic and literary sources on the scientific biography of I.K. Pachosky, divided in the three periods: first — pre-revolutionary (1882—1917), second — soviet (1917—1989), third — contemporary (1989 and on). Apart from national scientists, works of scientists from Poland also included

Prospective blinded evaluation of a novel sensing methodology designed to reduce inappropriate shocks by the subcutaneous implantable cardioverter-defibrillator

Background: Most inappropriate shocks from the subcutaneous implantable cardioverter-defibrillator (S-ICD) are caused by cardiac oversensing. A novel sensing methodology, SMART Pass (SP; Boston Scientific Corporation, Natick, MA), aims to reduce cardiac oversensing. Objective: The purpose of this study was to evaluate the effect of SP on shocks in ambulatory patients with S-ICD. Methods: Patients implanted in 2015–2016 and enrolled in a remote patient monitoring system were included and followed for 1 year. Shocks were adjudicated by 3 independent blinded reviewers as appropriate or inappropriate. Shock incidence was calculated for patients with SP programmed enabled or disabled at implantation, censoring patients when SP programming changed or at the last transmission. The SP setting (enabled vs disabled) was modeled as a time-dependent Cox regression variable. Results: The cohort consisted of 1984 patients, and a total of 880 shocks were adjudicated. At implantation, SP was enabled in 655 patients (33%) and disabled in 1329 patients (67%). SP reduced the risk for the first inappropriate shock by 50% (P <.001) and the risk for all inappropriate shocks by 68% (P <.001) in multivariate analysis adjusted for age and device programming. The incidence of inappropriate shocks was 4.3% in the SP enabled arm vs 9.7% in the SP disabled arm. The incidence of appropriate shocks was similar (5.2

Follow-up of CRT-D patients downgraded to CRT-P at the time of generator exchange

Background: Some patients with cardiac resynchronisation therapy (CRT) experience super-response (LVEF improvements to ≥50%). At generator exchange (GE), downgrading (DG) from CRT-defibrillator (CRT-D) to CRT-pacemaker (CRT-P) could be an option for these patients on primary prevention ICD indication and no required ICD therapies. Long-term data on arrhythmic events in super-responders is scarce. Methods: CRT-D patients with LVEF improvement to ≥50% at GE were identified in four large centres for retrospective analysis. Mortality, significant ventricular tachyarrhythmia and appropriate ICD-therapy were determined, and patient analysis was split into two groups (downgraded to CRT-P or not). Results: Sixty-six patients (53% male, 26% coronary artery disease) on primary prevention were followed for a median of 129 months [IQR: 101–155] after implantation. 27 (41%) patients were downgraded to CRT-P at GE after a median of 68 [IQR: 58–98] months (LVEF 54% ± 4%). The other 39 (59%) continued with CRT-D therapy (LVEF 52% ± 6%). No cardiac death or significant arrhythmia occurred in the CRT-P group (median follow-up (FU) 38 months [IQR: 29–53]). Three appropriate ICD-therapies occurred in the CRT-D group [median FU 70 months (IQR: 39–97)]. Annualized event-rates after DG/GE were 1.5%/year and 1.0%/year in the CRT-D group and the whole cohort, respectively. Conclusions: No significant tachyarrhythmia were detected in the patients downgraded to CRT-P during follow-up. However, three events were observed in the CRT-D group. Whilst downgrading CRT-D patients is an option, a small residual risk for arrhythmic events remains and decisions regarding downgrade should be made on a case-by-case basis.</p

Outcome of Insertable Cardiac Monitors in Symptomatic Patients with Brugada Syndrome at Low Risk of Sudden Cardiac Death

Introduction: There is limited data on the experience with insertable cardiac monitors (ICMs) in patients with Brugada syndrome. Objective: To evaluate the outcome of ICM in symptomatic patients with Brugada syndrome who are at suspected low risk of sudden cardiac death (SCD). Methods: We conducted a prospective single-center cohort study including all symptomatic patients with Brugada syndrome who received an ICM (Reveal LINQ) between July 2014 and October 2019. The main indication for monitoring was to exclude ventricular arrhythmias as the cause of symptoms and to establish a symptom-rhythm relationship. Results: A total of 20 patients (mean age, 39 ± 12 years; 55% male) received an ICM during the study period. Nine patients (45%) had a history of syncope (presumed nonarrhythmogenic), and 5 patients had a recent syncope (<6 months). During a median follow-up of 32 months (interquartile range, 11-36 months), 3 patients (15%) experienced an episode of nonsustained ventricular arrhythmia. No patient died suddenly or experienced a sustained ventricular arrhythmia, and no

Clinical experience with a novel subcutaneous implantable defibrillator system in a single center

Background: Implantable cardioverter-defibrillators (ICDs) reduce mortality in both primary and secondary prevention, but are associated with substantial short- and long-term morbidity. A totally subcutaneous ICD (S-ICD) system has been developed. We report the initial clinical experience of the first 31 patients implanted at our hospital. Methods: All patients had an ICD indication according to the ACC/AHA/ESC guidelines. The first 11 patients were part of the reported CE trial. The implantation was performed without fluoroscopy. The device was implanted subcutaneously in the anterior axillary line, with a parasternal lead tunneled from the xiphoid to the manubrial-sternal junction. Ventricular fibrillation (VF) was induced to assess detection accuracy and defibrillation efficacy using 65 J shocks. Results: Post-implant, 52 sustained episodes of VF were induced. Sensitivity was 100% and induced conversion efficacy was 100% (with standard polarity in 29 patients). Mean time to therapy was 13.9 ± 2.5 s (range 11-21.6 s). Late procedure-related complications were observed in 2 of the first 11 implantations (lead migration). During follow-up, spontaneous ventricular arrhythmias occurred in four patients, with accurate detection of all episodes. Inappropriate therapy was observed in five patients. Recurrences were prevented with reprogramming. Conclusions: The S-ICD system can be implanted without the use of fluoroscopy by using anatomical landmarks only. Episodes of VF were accurately detected using subcutaneous signals, and all induced and clinical episodes were successfully converted. The S-ICD system is a viable alternative to conventional ICD systems for selected patients

Ventricular tachycardia in ischemic cardiomyopathy; a combined endo-epicardial ablation as the first procedure versus a stepwise approach (EPILOGUE) - study protocol for a randomized controlled trial

Background: The role of epicardial substrate ablation of ventricular tachycardia (VT) as a first-line approach in patients with ischemic heart disease is not clearly defined. Epicardial ablation as a first-line option is standard for patients with nonischemic dilated cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy. Several nonrandomized studies, including studies on patients with ischemic heart disease, have shown that epicardial VT ablation improves outcome but this approach was often used after a failed endocardial approach. The aim of this study is to determine whether a combined endo-epicardial scar homogenization as a first-line approach will improve the outcome of VT ablation. Methods/Design: The EPILOGUE study is a multicenter, two-armed, nonblinded, randomized controlled trial. Patients with ischemic heart disease who are referred for VT ablation will be randomly assigned to combined endo-epicardial scar homogenization or endocardial scar homogenization only (control group). The primary outcome is recurrence of sustained VT during a 2-year follow-up. Secondary outcomes include procedural success and safety. Discussion: This study is the first randomized trial that evaluates the role of a combined endo-epicardial scar homogenization versus endocardial scar homogenization for the treatment of ischemic scar-related VT. Trial registration:NL4816807814v0

Telemonitoring for heart failure:a meta-analysis

AIMS: Telemonitoring modalities in heart failure (HF) have been proposed as being essential for future organization and transition of HF care, however, efficacy has not been proven. A comprehensive meta-analysis of studies on home telemonitoring systems (hTMS) in HF and the effect on clinical outcomes are provided. METHODS AND RESULTS: A systematic literature search was performed in four bibliographic databases, including randomized trials and observational studies that were published during January 1996-July 2022. A random-effects meta-analysis was carried out comparing hTMS with standard of care. All-cause mortality, first HF hospitalization, and total HF hospitalizations were evaluated as study endpoints. Sixty-five non-invasive hTMS studies and 27 invasive hTMS studies enrolled 36 549 HF patients, with a mean follow-up of 11.5 months. In patients using hTMS compared with standard of care, a significant 16% reduction in all-cause mortality was observed [pooled odds ratio (OR): 0.84, 95% confidence interval (CI): 0.77-0.93, I2: 24%], as well as a significant 19% reduction in first HF hospitalization (OR: 0.81, 95% CI 0.74-0.88, I2: 22%) and a 15% reduction in total HF hospitalizations (pooled incidence rate ratio: 0.85, 95% CI 0.76-0.96, I2: 70%). CONCLUSION: These results are an advocacy for the use of hTMS in HF patients to reduce all-cause mortality and HF-related hospitalizations. Still, the methods of hTMS remain diverse, so future research should strive to standardize modes of effective hTMS.</p

Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study

AIMS: To report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices. METHODS AND RESULTS: Kaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7-5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2-11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS. CONCLUSION: In this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization. KEY QUESTION: Is subcutaneous implantable cardioverter-defibrillator (S-ICD) shock efficacy maintained over time? KEY FINDING: Subcutaneous implantable cardioverter-defibrillator shock efficacy remains high for discrete and storm episodes. For discrete episodes first and final shock efficacy do not change over time or by rhythm type. TAKE-HOME MESSAGE: The EFFORTLESS study 5-year results provide the longest follow up of a large patient cohort implanted with the S-ICD. For 984 patients with a median follow-up of 5.1 years, the S-ICD maintains a high level of shock efficacy of 98%