Implantable Cardioverter-defibrillator Group Research Articles

Arrhythmic CArdiac DEath in MYotonic dystrophy type 1 patients (ACADEMY 1) study: the predictive role of programmed ventricular stimulation

Myotonic dystrophy type 1 (DM1) predisposes to the development of life-threatening arrhythmias and sudden cardiac death. Our study aimed to evaluate the prognostic value of programmed ventricular stimulation (PVS) in DM1 patients with conduction system disease. Arrhythmic CArdiac DEath in MYotonic dystrophy type 1 patients (ACADEMY 1) is a double-arm non-randomized interventional prospective study. Myotonic dystrophy type 1 patients with permanent cardiac pacing indication were eligible for the inclusion. The study population underwent to pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation according to the inducibility of ventricular tachyarrhythmias at PVS. Primary endpoint of the study was a composite of appropriate ICD therapy and cardiac arrhythmic death. The secondary study endpoint was all-cause mortality. Seventy-two adult-onset DM1 patients (51 ± 12 years; 39 male) were enrolled in the study. A ventricular tachyarrhythmia was induced in 25 patients (34.7%) at PVS (PVS+) who underwent dual chambers ICD implantation. The remaining 47 patients (65.3%) without inducible ventricular tachyarrhythmia (PVS-) were treated with dual-chamber PM. During an average observation period of 44.7 ± 10.2 months, nine patients (12.5%) met the primary endpoint, four in the ICD group (16%) and five (10.6%) in the PM group. Thirteen patients died (18.5%), 2 in the ICD group (8%) and 11 in PM group (23.4%). The Kaplan-Meier analysis did not show a significantly different risk of both primary and secondary endpoint event rates between the two groups. The inducibility of ventricular tachyarrhythmias has shown a limited value in the arrhythmic risk stratification among DM1 patients.

Predictors of shoulder limitations and disability in patients with cardiac implantable electronic devices: Importance of device size.

Generator-induced shoulder impairment is a common complication of cardiac implantable electronic device (CIED) implantation. Although implantable cardioverter-defibrillators (ICDs) have become smaller in size, they are still bigger than pacemakers (PMs). This study aimed to investigate the effects of single-chamber PM and ICD sizes on shoulder function. This retrospective study included 200 consecutive patients, of whom 123 had PMs and 77 had ICDs. The CIED implantation effects on shoulder function, pain, disability, and quality of life (QoL) were evaluated. The range of motion (ROM), Visual Analog Scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH), and Short Form-36 (SF-36) Health Survey (Physical and Mental Component Summary [PCS and MCS]) were used. The flexion and abduction range limitation rates were significantly higher in the ICD group than in the PM group (16.9%vs. 7.3%, p=.035 and 19.5%vs. 8.9%, p=.031, respectively). The two groups had similar VAS scores. The median QuickDASH score was significantly higher in the ICD group than in the PM group (8.2 [3.6-19.6] vs. 4.6 [2.6-17.9], p=.034). There were no significant differences in SF-36 components between the two groups. ICD implantation (OR: 1.642, 95% CI: 1.293-2.776; p=.001) and incision length (OR: 1.343, 95% CI: 1.194-2.064; p=.01) were independent predictors of shoulder ROM limitations. Reduced device sizes with advancing technology can decrease shoulder functional limitations and disability after implantation. Healthcare professionals should not neglect shoulder evaluations during the pre- and postimplantation periods.

Comparison of new implantation of cardiac implantable electronic device between tertiary and non-tertiary hospitals: a Korean nationwide study

This study compared the characteristics and mortality of new implantation of cardiac implantable electronic device (CIED) between tertiary and non-tertiary hospitals. From national health insurance claims data in Korea, 17,655 patients, who underwent first and new implantation of CIED between 2013 and 2017, were enrolled. Patients were categorized into the tertiary hospital group (n = 11,560) and non-tertiary hospital group (n = 6095). Clinical outcomes including in-hospital death and all-cause death were compared between the two groups using propensity-score matched analysis. Patients in non-tertiary hospitals were older and had more comorbidities than those in tertiary hospitals. The study population had a mean follow-up of 2.1 ± 1.2 years. In the propensity-score matched permanent pacemaker group (n = 5076 pairs), the incidence of in-hospital death (odds ratio [OR]: 0.76, 95% confidence interval [CI]: 0.43–1.32, p = 0.33) and all-cause death (hazard ratio [HR]: 0.92, 95% CI 0.81–1.05, p = 0.24) were not significantly different between tertiary and non-tertiary hospitals. These findings were consistently observed in the propensity-score matched implantable cardioverter-defibrillator group (n = 992 pairs, OR for in-hospital death: 1.76, 95% CI 0.51–6.02, p = 0.37; HR for all-cause death: 0.95, 95% CI 0.72–1.24, p = 0.70). In patients undergoing first and new implantation of CIED in Korea, mortality was not different between tertiary and non-tertiary hospitals.

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

RationaleThe impact of prophylactic implantable cardioverter-defibrillator (ICD) implantation on the psychological well-being of patients on dialysis is unknown.ObjectiveWe aimed to identify the effect of primary ICD implantation on quality of life (QoL), mood and dispositional optimism in patients undergoing dialysis.Methods and resultsWe 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.ConclusionsIn our population of patients on dialysis, ICD implantation did not affect QoL, mood or dispositional optimism significantly during 1-year follow-up.Clinical Trial RegistrationUnique identifier: ISRCTN20479861. http://www.controlled-trials.com.

Transvenous lead performance of implantable cardioverter-defibrillators and pacemakers.

After the reports of recalled leads, several technological improvements have been introduced and the durability of implantable cardioverter defibrillator (ICD) leads has improved. The incidence of lead failures is now less than in the previous studies. However, there are few reports that have shown the long-term durability of ICD leads as compared to pacemaker (PM) leads. This study analyzed the medium to long-term performance of transvenous ICD leads as compared to PM leads. We retrospectively studied 1227 cases from April 2007 to December 2017 who underwent an initial transvenous ICD or PM implantation. The number of lead failures and patient background characteristics were analyzed. During a median 3-3.5 years follow up period, 1 (0.3%) ICD lead and 18 (2.4%) PM leads failed. The incidence of lead failures was significantly higher in the PM group than ICD group (p=.019). Males were associated with a higher incidence of lead failures in the PM group. Since the era of recalled ICD leads, the durability of ICD leads has remarkably improved and the incidence of lead failures with non-recalled ICD leads has been less than that for PM leads.

Association between CRT(D)/ICD and renal insufficiency: A systematic review and meta-analysis.

Cardiac resynchronization therapy with or without a defibrillator (CRT(D)) and implantable cardioverter defibrillator (ICD) may reduce the risk of arrhythmia or heart failure-specific mortality and improves the prognosis of patients with chronic kidney disease (CKD) or dialysis. The aim of this study was to perform a meta-analysis investigating the relationship between CRT(D)/ICD and renal insufficiency. Cochrane Library, Web of Science, Embase, and Pubmed were systematically searched from inception to 29 October 2019. We included studies that report all-cause mortality of patients with renal insufficiency who received CRT(D)/ICD therapy. Twenty-six studies (n=119,263) were included, exploring the relationship between CRT(D)/ICD and renal insufficiency from two aspects: (1) Compared with ICD-only, CRT(D) was associated with lower risk of all-cause mortality in CKD patients (odds ratios (OR)=0.67; 95% confidence interval (CI), 0.60 to 0.75). For non-primary prevention (secondary prevention or both), the analysis revealed a lower risk of all-cause mortality in the ICD group than in the no-ICD group (OR=0.47; 95% CI, 0.40 to 0.55). (2) CKD increased all-cause mortality in comparison with control group (OR=2.12; 95% CI, 1.85 to 2.44), and so did dialysis (OR=2.53; 95% CI, 2.34 to 2.73). Furthermore, compared with CKD3 (eGFR: 30-59 ml/min/1.73 m2 ), CKD4/5 (eGFR <30ml/min/1.73m2 ) was observed to have a significantly higher risk of all-cause mortality (OR=2.70; 95% CI, 1.93 to 3.80). This review shows a clear association between CRT(D)/ICD and renal insufficiency in the aspect of all-cause mortality, and may provide a reference for the clinical application of CRT(D)/ICD.

Implantable Cardioverter Defibrillator Therapy in Patients with Acute Decompensated Heart Failure with Reduced Ejection Fraction: An Observation from the KCHF Registry

It remains unclear the clinical characteristics and prognosis of implantable cardioverter defibrillator (ICD) on prevention for sudden cardiac death (SCD) in Japanese patients with acute decompensated heart failure (ADHF) and reduced left ventricular ejection fraction (LVEF). We investigated the prevalence, clinical characteristics, and clinical outcomes in a contemporary large-scale Japanese ADHF registry. Among the consecutive 3785 patients hospitalized for ADHF and discharged alive in the Kyoto Congestive Heart Failure registry, we identified 1409 patients with reduced LVEF (ICD: N = 115, non-ICD: N = 1294). Patients in the ICD group were younger (69.3 ± 12.9/74.2 ± 13.6 years; p < 0.001), more likely to be men (84%/65%), and more often had a history of heart failure hospitalization (70%/36%; p = 0.001), cardiomyopathy as the underlying heart disease (51%/27%; p < 0.001), and previous serious ventricular arrhythmia (57%/3.8%; p < 0.001), and had lower LVEF (25.4±7.4%/29.5±6.9%; p < 0.001), and estimated glomerular filtration rate (43.0±19.7/47.8±23.4 mL/min/1.73m2; p = 0.04) than those in the non-ICD group. The cumulative 1-year incidence of the primary arrhythmic composite endpoint of SCD, arrhythmic death, or resuscitated cardiac arrest trended to be lower in the ICD group than in the non-ICD group (0.0% versus 3.4%, p = 0.053), and the lower adjusted risk of the ICD group relative to the non-ICD group was significant for the primary arrhythmic endpoint (HR 0.10, 95% CI, 0.01-0.53; p = 0.003). However, there were no differences in the cumulative incidences of all-cause death between the ICD and non-ICD groups (17.3% versus 17.5%, p = 0.68), and the adjusted risk of the ICD group relative to the non-ICD group remained insignificant for all-cause death (HR, 0.85; 95%CI, 0.52-1.36, p = 0.51). This study elucidated the real-world features of ADHF patients between those with ICD and those without. ICD use in patients with ADHF and reduced LVEF as compared with non-ICD use was associated with significant risk reduction for arrhythmic events, but not for mortality.

Long-Term Outcome of the Randomized DAPA Trial.

The randomized DAPA trial (Defibrillator After Primary Angioplasty) aimed to evaluate the survival benefit of prophylactic implantable cardioverter defibrillator (ICD) implantation in early selected high-risk patients after primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction. A randomized, multicenter, controlled trial compared ICD versus conventional medical therapy in high-risk patients with primary percutaneous coronary intervention, based on one of the following factors: left ventricular ejection fraction <30% within 4 days after ST-segment-elevation myocardial infarction, primary ventricular fibrillation, Killip class ≥2 or TIMI (Thrombolysis in Myocardial Infarction) flow <3 after percutaneous coronary intervention. ICD was implanted 30 to 60 days after MI. Primary end point was all-cause mortality at 3 years follow-up. The trial prematurely ended after inclusion of 266 patients (38% of the calculated sample size). Additional survival assessment was performed in February 2019 for the primary end point. A total of 266 patients, 78.2% males, with a mean age of 60.8±11.3 years, were enrolled. One hundred thirty-one patients were randomized to the ICD arm and 135 patients to the control arm. All-cause mortality was significant lower in the ICD group (5% versus 13%, hazard ratio, 0.37 [95% CI, 0.15-0.95]) after 3 years follow-up. Appropriate ICD therapy occurred in 9 patients at 3 years follow-up (5 within the first 8 months after implantation). After a median long-term follow-up of 9 years (interquartile range, 3-11), total mortality (18% versus 38%; hazard ratio, 0.58 [95% CI, 0.37-0.91]), and cardiac mortality (hazard ratio, 0.52 [95% CI, 0.28-0.99]) was significant lower in the ICD group. Noncardiac death was not significantly different between groups. Left ventricular ejection fraction increased ≥10% in 46.5% of the patients during follow-up, and the extent of improvement was similar in both study groups. In this prematurely terminated and thus underpowered randomized trial, early prophylactic ICD implantation demonstrated lower total and cardiac mortality in patients with high-risk ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention. Registration: URL: https://www.trialregister.nl; Unique identifier: Trial NL74 (NTR105).

Active Implantable cardioverter-defibrillators in Continuous-flow Left Ventricular Assist Device Recipients.

Implantable cardioverter-defibrillator (ICD) in patients with heart failure with reduced ejection fraction reduces mortality secondary to malignant arrhythmias. Whether end-stage heart failure (HF) with continuous-flow left ventricular assist device (cf-LVAD) derive similar benefits remains controversial. We performed a systematic literature review and meta-analysis of all published studies that examined the association between active ICDs and survival in advanced HF patients with cfLVAD. We searched PubMed, Medline, Embase, Ovid, and Cochrane for studies reporting the association between ICD and all-cause mortality in advanced HF patients with cfLVAD. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data. Ten studies (9 retrospective and one prospective) with a total of 7,091 patients met inclusion criteria. There was no difference in all-cause mortality (RR 0.84, 95% CI 0.65-1.10, p=0.20, I2 =62.40%), likelihood of survival to transplant (RR 1.07, 95% CI 0.98-1.17, p= 0.13, I2 =0%), RV failure (RR 0.74, 95% CI 0.44-1.25, p = 0.26, I2 =34%) between Active ICD and inactive/no ICD groups, respectively. Additionally, 27.5% received appropriate ICD shocks, while 9.5% received inappropriate ICD shocks. No significant difference was observed in terms of any complications between the two groups. All-cause mortality, the likelihood of survival to transplant, and worsening RV failure were not significantly different between active ICD and inactive/no ICD in cf-LVAD recipients. A substantial number of patients received appropriate ICD shocks suggesting a high-arrhythmia burden. The risks and benefits of ICDs must be carefully considered in patients with cf-LVAD.

The Effects of Cardiac Resynchronization Therapy on Cardiovascular and Non-cardiovascular Hospitalization: A Long-term Follow-up MADIT-CRT Sub-study

Introduction Little is known about the effects of cardiac resynchronization therapy (CRT-D) on hospitalizations during long-term follow up. We assessed the impact of CRT-D on CV and non-CV hospitalizations in patients randomized to implantable cardioverter-defibrillator (ICD) or CRT-D in the MADIT-CRT trial. Methods and Results MADIT-CRT randomized 1820 patients with mild heart failure (HF), low ejection fraction and a wide QRS to ICD or CRT-D. Hospitalization rates and lengths of hospital stay were compared. At an average of 5.6 years follow-up, there was a lower rate of all-cause hospitalizations in the CRT-D arm compared with the ICD group (72.6 events per 100 pt-years versus 82.6 events per 100 pt-years, p=0.020). This was driven by a reduction in CV-hospitalizations with CRT-D vs. ICD (28.8 events per 100 pt-years vs. 42.6 events per 100 pt-years, p Conclusions Among patients with NYHA class I/II heart failure, CRT-D therapy significantly reduces all-cause hospitalizations, HF, and CV hospitalizations with reductions in hospital length of stay. Any hospitalization was associated with an increased risk of death.

Prevention of Cardiac Implantable Electronic Device-Related Infection in Patients With Cancer: The Role of a Comprehensive Prophylactic Bundle Approach That Includes the Antimicrobial Mesh.

BackgroundOncological patients have several additional risk factors for developing a cardiac implantable electronic device (CIED)–related infection. Therefore, we evaluated the clinical impact of our comprehensive bundle approach that includes the novel minocycline and rifampin antimicrobial mesh (TYRX) for the prevention of CIED infections in patients living with cancer.MethodsWe retrospectively reviewed all consecutive patients who had a CIED placement at our institution during 2012–2017 who received preoperative vancomycin, intraoperative pocket irrigation with bacitracin and polymyxin B, plus TYRX antimicrobial mesh, followed by postoperative oral minocycline.ResultsA total of 154 patients had a CIED, with 97 permanent pacemakers (PPMs), 23 implantable cardioverter defibrillators (ICDs), and 34 cardiac resynchronization therapy (CRT) devices. An underlying solid cancer was present in 62% of patients, while 38% had a hematologic malignancy. Apart from a higher proportion of surgical interventions in the PPM group than in the ICD and CRT groups (P = .007), no other oncologic variables were statistically significantly different between groups. Despite an extensive median follow-up period (interquartile range) of 21.9 (6.7–33.8) months, 16 patients (10%) had a mechanical complication, while only 2 patients (1.3%) developed a CIED infection, requiring the device to be explanted.ConclusionsOur comprehensive prophylactic bundle approach using TYRX antimicrobial mesh in an oncologic population at high risk for infections was revealed upon extensive follow-up to be both safe and effective in maintaining the rate of CIED infection at 1.3%, well within published averages in the broader population of CIED recipients.

Subcutaneous or Transvenous Defibrillator Therapy

BackgroundThe subcutaneous implantable cardioverter–defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.MethodsWe conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.ResultsA total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan–Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P=0.01 for noninferiority; P=0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).ConclusionsIn patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.)

Long-Term Outcomes of Implantable Cardioverter-Defibrillator Therapy in the SCD-HeFT

BackgroundThe SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) randomized 2,521 patients with moderate heart failure (HF) to amiodarone, placebo drug, or implantable cardioverter-defibrillator (ICD) therapy. Original trial follow-up ended October 31, 2003. Over a median 45.5-month follow-up, amiodarone, compared with placebo, did not affect survival, whereas randomization to an ICD significantly decreased all-cause mortality by 23%. ObjectivesThis study sought to describe the extended treatment group survival of the SCD-HeFT cohort. MethodsMortality outcomes for the 1,855 patients alive at the end of the SCD-HeFT trial were collected between 2010 and 2011. These data were combined with the 666 deaths from the original study to compare long-term outcomes overall and for key pre-specified subgroups. ResultsMedian (25th to 75th percentiles) follow-up was 11.0 (10.0 to 12.2) years. On the basis of intention-to-treat analysis, the ICD group had overall survival benefit versus placebo drug (hazard ratio [HR]: 0.87; 95% confidence interval [CI]: 0.76 to 0.98; p = 0.028). When treatment benefit was examined as a function of time from randomization, attenuation of the ICD benefit was observed after 6 years (p value for the interaction = 0.0015). Subgroup analysis revealed long-term ICD benefit varied according to HF etiology and New York Heart Association (NYHA) functional class: ischemic HF HR: 0.81; 95% CI: 0.69 to 0.95; p = 0.009; nonischemic HF HR: 0.97; 95% CI: 0.79 to 1.20; p = 0.802; NYHA functional class II HR: 0.76; 95% CI: 0.65 to 0.90; p = 0.001; NYHA functional class III HR: 1.06; 95% CI: 0.86 to 1.31; p = 0.575. ConclusionsFollow-up of SCD-HeFT patients to 11 years demonstrated heterogenous treatment-related patterns of long-term survival with ICD benefit most evident at 11 years for ischemic HF patients and for those with NYHA functional class II symptoms at trial enrollment. (SCD-HeFT 10 Year Follow-up [SCD-HeFT10 Yr]; NCT01058837)

Trends of Acute Kidney Injury Requiring Dialysis Among Hospitalized Patients Undergoing Invasive Electrophysiology Procedures.

Electrophysiology (EP) procedures carry the risk of kidney injury due to contrast/hemodynamic fluctuations. We aim to evaluate the national epidemiology of acute kidney injury requiring dialysis (AKI-D) in patients undergoing EP procedures. Using the National Inpatient Sample, we included 2,747,605 adult hospitalizations undergoing invasive diagnostic EP procedures, ablation and implantable device placement from 2006 to 2014. We examined the temporal trend of AKI-D and outcomes associated with AKI-D. The rate of AKI-D increased significantly in both diagnostic/ablation group (8-21/10,000 hospitalizations from 2006 to 2014, P = 0.02) and implanted device group (19-44/10,000 hospitalizations from 2006 to 2014, P < 0.01), but it was explained by temporal changes in demographics and comorbidities. Cardiac resynchronization therapy and pacemaker placement had higher risk of AKI-D compared to implantable cardioverter-defibrillator placement (23 vs. 31 vs. 14/10,000 hospitalizations in cardiac resynchronization therapy, pacemaker placement, and implantable cardioverter-defibrillator group, respectively). Development of AKI-D was associated with significant increase in in-hospital mortality (adjusted odds ratio, 9.6 in diagnostic/ablation group, P < 0.01; adjusted odds ratio, 5.1 in device implantation group, P < 0.01) and with longer length of stay (22.5 vs. 4.5 days in diagnostic/ablation group, 21.1 vs. 5.7 days in implanted device group) and higher cost (282,775 vs. 94,076 USD in diagnostic/ablation group, 295,660 vs. 102,007 USD in implanted device group). The incidence of AKI-D after EP procedures increased over time but largely explained by the change of demographics and comorbidities. This increasing trend, however, was associated with significant increase in resource utilization and in-hospital mortality in these patients.

P1147Complications in young ICD patients - a retrospective analysis

Abstract Introduction In specific situations implantable cardioverter defibrillator (ICD) therapy is recommended for patients under the age of 40 years. Due to the active lifestyle of this patient population, complication rates in devices with conventional transvenous electrodes may be higher than for the remaining population. Methods The ICD-YOUNG study is a retrospective analysis of consecutive patients ≤ 40 years undergoing transvenous or subcutaneous ICD (s-ICD) implantation, device change or lead revision at our centre between July 2006 and December 2017. Rehospitalization for lead failure or device battery depletion was documented. Results Out of 586 patients undergoing ICD implantation, 35 patients (6.0%) were ≤ 40 years. Mean age was 30.0 ± 7.2 years, 48.6% were female, 37.1% received ICD therapy for primary prevention and 11.4% primarily received s-ICD. Median follow up was 7.3 (interquartile range, 1.8-12.0) years, with a lower follow up duration in s-ICD patients than conventional ICD patients (median, 2.9 vs. 9.0 years). Over the course of follow-up, 37.1% received successful anti-tachycardia therapy. 19.4% of patients in the conventional ICD group had right ventricular lead problems requiring intervention, while none of the s-ICD patients had to be revised. Time to first device change due to battery depletion and/or device upgrade was similar in young and remaining patients (median 5.4 vs 6.0 years, p = 0.23). Discussion Young patients requiring ICD have a high rate of lead problems. In most young patients, s-ICD therapy is an encouraging alternative to conventional ICD therapy with a lower lead failure rate.

Involving patients as key stakeholders in the design of cardiovascular implantable electronic device data dashboards: Implications for patient care.

BackgroundData from remote monitoring (RM) of cardiovascular implantable electronic devices (CIEDs) currently are not accessible to patients despite demand. The typical RM report contains multiple pages of data for trained technicians to read and interpret and requires a patient-centered approach to be curated to meet individual user needs.ObjectiveThe purpose of this study was to understand which RM data elements are important to patients and to gain design insights for displaying meaningful data in a digital dashboard.MethodsAdults with implantable cardioverter–defibrillators (ICDs) and pacemakers (PMs) participated in this 2-phase, user-centered design study. Phase 1 included a card-sorting activity to prioritize device data elements. Phase 2 included one-on-one design sessions to gather insights and feedback about a visual display (labels and icons).ResultsTwenty-nine adults (mean age 71.8 ± 11.6 years; 51.7% female; 89.7% white) participated. Priority data elements for both ICD and PM groups in phase 1 (n = 19) were related to cardiac episodes, device activity, and impedance values. Recommended replacement time for battery was high priority for the PM group but not the ICD group. Phase 2 (n = 10) revealed that patients would like descriptive, nontechnical terms to depict the data and icons that are intuitive and informative.ConclusionThis user-centered design study demonstrated that patients with ICDs and PMs were able to prioritize specific data from a comprehensive list of data elements that they had never seen before. This work contributes to the goal of sharing RM data with patients in a way that optimizes the RM feature of CIEDs for improving patient outcomes and clinical care.

Who leaves the hospital without a defibrillator after a sudden cardiac arrest?

Implantable Cardioverter Defibrillator (ICD) in sudden cardiac arrest (SCA) is indicated in non-reversible cardiac causes. A systematic description of SCA survivors discharged without an ICD has not been undertaken thus far. We aimed to describe the frequency, characteristics and etiologies of SCA survivors discharged without an ICD. In this prospective ongoing multicentre community-based study (6.7 million inhabitants), data from all SCA cases alive at hospital discharge, over a 5-year period, were analyzed with a specific focus on survivors. All medical records were reviewed by two cardiologists to identify underlying mechanisms and ascertain etiologies. Among the 18,622 out-of-hospital cardiac arrests from May 2011 to May 2016, 717 survivors at hospital discharge fulfilled definition for cardiac SCA. Among them, 247 patients (34.5%) received an ICD and 468 (65.4%) did not. Compared to the ICD group, the group without ICD were older (58.9 vs. 52.6 years, P < 0.001). Main etiologies were acute coronary syndrome (ACS) (397, 84.8%), chronic CAD (28, 6.0%), structural non-ischemic heart disease (31, 6.6%) and non-structural heart disease (12, 2.6%). Among survivors with ACS, 93.6% (397 out of 424) were discharged without an ICD and 18 of those were due to coronary spasm (representing 75% of coronary spasm related-SCAs survivors), including three refractory spasms despite pharmacological therapy. Factors independently associated with ICD non-implantation in ACS were the absence of personal CAD history (OR 2.86, CI95% 0.19–6.67, P = 0.014) and immediate angioplasty at admission (OR 2.77, CI95% 1.02–6.78, P = 0.033). Almost two third of SCA survivors were discharged without an ICD; while this was largely related to ACS and coronary stenting, some cases of chronic CAD as well as drug refractory coronary spasm in this population may represent lost opportunity, warranting further studies addressing this specific issue.

Survival Benefit of Implantable-Cardioverter Defibrillator Therapy in Ambulatory Patients With Left Ventricular Assist Device

BackgroundAnalysis of the prognostic effect of concomitant use of left ventricular assist devices (LVADs) and implantable -cardioverter defibrillators (ICDs) is lacking. The aim of this study is to define the survival effects of ICD therapy in ambulatory patients with LVAD. Methods and resultsPatients with continuous-flow (cf) LVAD in a single tertiary center from December 2010 to May 2016 were retrospectively analyzed. Over a 6-year period, 257 patients had cf-LVAD implantation, 227 of them survived to discharge after the first month of LVAD implantation and were included in the study. The median follow-up time was 14 months, and 104 (45.8%) patients had ICD. One hundred and thirty-two (58.1%) patients were still under LVAD support at the end of the study period. Forty (17.6%) patients had heart transplantation, and 55 (24.2%) died. There was no significant difference between groups with ICD and without ICD for baseline characteristics except for higher pulmonary pressures and amiodarone use in the ICD group. Survival analysis showed significant survival benefit of ICD therapy (P = .02). After multivariate analyses including age, sex, left ventricular ejection fraction, and β-blocker usage, the benefit of ICD continued (hazard ratio: 0.54; 95% confidence interval, 0.303-0.975; P = .041). ConclusionsVentricular arrhythmias (VAs) do not cause acute hemodynamic deterioration in patients with LVAD. However, VAs might be associated with poor prognosis. The present study showed that ICD therapy may improve survival among ambulatory patients with cf-LVAD–supported heart failure.

Prediction of mortality benefit based on periodic repolarisation dynamics in patients undergoing prophylactic implantation of a defibrillator: a prospective, controlled, multicentre cohort study

A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality. We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (≤35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality. Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2·7 years [IQR 2·0-3·3] in the ICD group and 1·2 years [0·8-2·7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0·57 [95% CI 0·41-0·79]; p=0·0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0·0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7·5 deg or higher (n=199; adjusted HR 0·25 [95% CI 0·13-0·47] for the ICD group vs the control group; p<0·0001) than in those with periodic repolarisation dynamics less than 7·5 deg (n=1166; adjusted HR 0·69 [95% CI 0·47-1·00]; p=0·0492; pinteraction=0·0056). The number needed to treat was 18·3 (95% CI 10·6-4895·3) in patients with periodic repolarisation dynamics less than 7·5 deg and 3·1 (2·6-4·8) in those with periodic repolarisation dynamics of 7·5 deg or higher. Periodic repolarisation dynamics predict mortality reductions associated with prophylactic implantation of ICDs in contemporarily treated patients with ischaemic or non-ischaemic cardiomyopathy. Periodic repolarisation dynamics could help to guide treatment decisions about prophylactic ICD implantation. The European Community's 7th Framework Programme.

When is an implantable cardioverter-defibrillator controversial?

When is an implantable cardioverter-defibrillator controversial?