Implantable Cardioverter-defibrillator Replacement Research Articles

Impact of taurolidine use during cardiac electronic implantable device implantation in heart failure patients

Abstract Background Cardiac Implantable Electronic Device (CIED) infections represent a critical health threat with potentially fatal consequences. The TauroPace™ is an innovative solution that contains taurolidine specifically formulated to eradicate environmental microbial contamination on the surface of CIEDs. To date, scarce data are available in literature about Taurolidine’s effect on preventing CIED infections. Aims To investigate the ability of the TauroPace™ to reduce major CIED infections through 12 months follow-up in fragile patients such as heart failure (HF) patients. Methods This prospective cohort study included patients with HF and an ejection fraction ≤ 35%, who were referred for de novo implantation, upgrading or battery replacement of Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy with defibrillator (CRT-D), to the EP labs of two tertiary care hospitals. Patients with previous CIED infections were excluded. During the procedures, the catheters were submerged in the TauroPace™ solution and the pocket was irrigated with taurolidine. Starting from the main risk factors for the development of CIED-related infections as identified in the literature (including individuals with heart failure, diabetes, chronic kidney disease, and those undergoing defibrillators implantation, especially upgrades or revisions procedure), we conducted a meta-analysis and meta-regression to evaluate the relationship between the treatment effect's magnitude and various predictors. To estimate the incidence of CIED infections in high-risk subgroups, we utilized the percentage of patients with diabetes, chronic renal failure, or those undergoing replacement, upgrade, or revision procedures, along with other risk factors for CIED infections, as continuous variables and we were able to modify our comparison parameters based on the real percentage of risk factors that we obtained. Results The study included 69 consecutive patients (53 male [76.8 %], 34 ischemic [49,3 %], median [IQR] age 68 [59-73] years, 19 diabetic [27.5 %] and 34 [49.2 %] with chronic renal failure), of whom 39 (56.5 %) received ICD and 30 (43.5 %) CRT-D, with 28 (40.6 %) replacement procedures, 2 (2.9 %) upgrades, and 39 (57%) de novo implantations. During the one-year follow-up period, 1 [1.45 (Standard Error, SE 0.014) %] patient undergoing a CRT replacement developed an infection. The available data from the literature estimate an incidence rate of 6% (SE 0.0106) when considering a selected patient population with a very high risk of infection similar to our population. This is significantly higher than our cohort (z-score -2.5447, p value = 0.011). Conclusions Taurolidine has yielded promising results, demonstrating a low incidence rate of infections within our cohort of high-risk patients, which is below that reported in the literature. Further data will be necessary to validate and confirm these initial findings.

Left bundle branch pacing lead for sensing ventricular arrhythmias in implantable cardioverter-defibrillator: A pilot study (LBBP-ICD study)

BackgroundLeft bundle branch pacing (LBBP) has been suggested as an alternative modality for biventricular pacing in cardiac resynchronization therapy (CRT)–eligible patients. As it provides stable R-wave sensing, LBBP has been recently used to provide sensing of ventricular arrhythmia in patients receiving implantable cardioverter-defibrillator (ICD) with CRT. ObjectiveThe aim of this study was to analyze the long-term safety and efficacy of the LBBP lead for appropriate detection of ventricular arrhythmia and delivery of antitachycardia pacing (ATP) in patients requiring defibrillator therapy with CRT. MethodsCRT-eligible patients who underwent successful LBBP-optimized ICD and LBBP-optimized CRT with defibrillator were enrolled. The LBBP lead was connected to the right ventricular-P/S port after capping the IS-1 connector plug of the DF-1–ICD lead. LBBP-optimized ICD or LBBP-optimized CRT with defibrillator was decided on the basis of correction of conduction system disease. Documented arrhythmic episodes and therapy delivered were analyzed. ResultsThirty patients were enrolled. The mean age was 59.7 ± 10.5 years. LBBP resulted in an increase in left ventricular ejection fraction from 29.9% ± 4.6% to 43.9% ± 11.2% (P < .0001). During a mean follow-up of 22.9 ± 12.5 months, 254 ventricular arrhythmic events were documented. Appropriate events (n = 225 [89%]) included nonsustained ventricular tachycardia (VT) (n = 212 episodes [94%]), VT (n = 8 [3.5%]), and ventricular fibrillation (n = 5 [2.5%]). ATP efficacy in terminating VT was 75%. Eleven percent of episodes (n = 29) were inappropriately detected because of T-wave oversensing. Inappropriate therapy (ATP) was delivered for 14 episodes (5.5%). Three patients (10%) had worsening of tricuspid regurgitation. ConclusionSensing from the LBBP lead for arrhythmia detection is safe as ∼90% of the episodes were detected appropriately. Future studies with a dedicated LBBP-defibrillator lead along with algorithms to avoid oversensing can help in combining defibrillation with conduction system pacing.

PO-01-049 KICKSTARTING PATIENT ENGAGEMENT: AN EVENT PLANNING BLUEPRINT FOR CELEBRATING THE ICD PATIENT

Approximately 33% of patients living with an implantable cardioverter defibrillator (ICD) experience significant psychological, social, and physical distress. Addressing these issues via regular support group sessions may improve patient knowledge, psychological well-being, and community support. To characterize the process for initiating a successful ICD support group for eligible patients at a large academic center. 1673 patients with an implantable cardioverter defibrillator were identified via an electronic medical record search from October 2017 to October 2022. An electronic survey was sent to the identified ICD patients inquiring about their interest in participating in regularly scheduled ICD support group sessions, logistical details, and desired topics of discussion. Based on these results, a virtual and in-person “Kickstarter” ICD support group event was created. A satisfaction survey was conducted following the event. 248/1673 (15%) patients responded to the electronic survey invitation. Of these patients, 71/248 (28.5%) were interested and 108/248 (43%) were unsure in participating in an ICD support group. The most desired program content was coping with an ICD and cardiac conditions (69%). 38% of respondents indicated that they experience psychological distress related to their ICD. 225/248 (93%) of respondents reported that they understood the indication and function of their ICD. Regarding the Kickstarter event, 20 patients attended in-person and 50 patients attended virtually. 31 patients completed the event satisfaction survey and 100% of patients reported that they would be interested in participating in regular support groups. Using electronic medical records to identify patients and sample patient interest in an ICD support group was effective in providing a successful kickstart of our ICD support group at a large academic institution. Results indicated that many patients may be unsure about participation and may need more specifics about the proposed support group before stating an intention. Nonetheless, patient centric information that emphasizes instilling reassurance, confidence, and action planning were particularly salient topics and allowed for a strong initial meeting attendance.

EP News: Clinical.

Friedman et al (N Engl J Med August 28, 2022; doi: 10.1056/NEJMoa2206485, PMID 36036522) conducted a prospective, nonrandomized, clinical study of an extravascular implantable cardioverter-defibrillator (ICD). The primary efficacy end point was successful defibrillation at implantation. The primary safety end point was freedom from major complications at 6 months. Among the 302 patients who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7%. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6%. No major intraprocedural complications were reported. At 6 months, 25 major complications were observed in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing was 50.8%. A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement. The authors conclude that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation.

Efficacy and Safety of an Extravascular Implantable Cardioverter–Defibrillator

BackgroundThe extravascular implantable cardioverter–defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known.MethodsWe conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%.ResultsA total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan–Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period.ConclusionsIn this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.)

FACTORS INFLUENCING PATIENT DECISION AID USE FOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR DECISIONS IN THREE CANADIAN ACADEMIC HOSPITALS

FACTORS INFLUENCING PATIENT DECISION AID USE FOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR DECISIONS IN THREE CANADIAN ACADEMIC HOSPITALS

Predictors of late arrhythmic events after generator replacement in Brugada syndrome treated with prophylactic ICD.

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.

Implantable cardioverter-defibrillators and the older patient: the Dutch clinical practice

Balance between benefit and burden of implantable cardioverter-defibrillator (ICD) therapy is more debatable in older patients, compared to younger patients. Of around 6000 yearly implanted ICDs in the Netherlands, 1:4 is received by patients ≥75 years. We aimed to evaluate the current clinical practice in the Netherlands for ICD implants and generator replacements, with a special focus on the older ICD patients. Cardiologists from all Dutch ICD implanting centres (n = 28) were interviewed. Questions aimed to evaluate outpatient care, pre-operative patient assessment, end-of-life-care counselling, evaluation of social and cognitive wellbeing, clinical evaluation of all patients prior to ICD replacement, and the consideration of the option to downgrade or not replace a device. Implanting cardiologists from all 28 implanting centres were approached for an interview. Response rate was 86%. Management appeared diverse. An age ≥80 years was consistently reported as incentive for more extensive patient evaluation. Patients were invited for counselling prior to device replacements in only the minority (46%) of hospitals. Downgrade or non-replacement was performed in rare cases. End-of-life care discussions were not standard procedure in 67% of the hospitals. Evaluation of social and cognitive wellbeing of patients was based solely on the general clinical impression of the physician in 83%, or not at all assessed in 8% of the centres. A structured framework for care and evaluation of cognitive and/or physical limitations is currently absent in most hospitals. At time of ICD (re-)evaluation, several factors may be considered before deciding on (continuation of) ICD therapy: patient preferences and comorbidity, the need for pacemaker therapy, primary vs. secondary prevention, procedural risks, and patient preferences.

Healthcare costs in implantable cardioverter-defibrillator recipients: A real-life cohort study on 19,408 patients from the French national healthcare database

BackgroundThe aim is to report healthcare costs in a nationwide cohort of patients with an implantable cardioverter defibrillator (ICD). MethodsThis real-life longitudinal retrospective cohort study was based on the French National Health Data System and enrolled all adult patients from the general health insurance scheme implanted with an ICD between 2008 and 2011, and followed them until 2018. ResultsOverall, 19,408 patients were included (mean age 63.8, SD 12.4 years, 81.6% males), with cardiac resynchronization therapy (CRTD), single-chamber, and dual-chamber ICD in 42.5%, 29.8%, 27.7% of patients, respectively. After a mean follow-up of 6.6 SD 3.3 years, 9514 patients (49.0%) died, and 8678 patients (44.7%) had their ICD replaced. The total healthcare cost (all diseases and injuries combined) was €15,893/patient-year, of which 32% were estimated to be ICD-related. These ICD-related costs were: the implantation hospital stay (representing 59% of the ICD-related costs), ICD replacement (22%), complications' management (11%), and follow-up (9%). Some health events (e.g., a complication during ICD replacement) were counted in two categories, hence the sum of the proportions is >100%. Being under 55 vs. above 75 years old, being treated for hypertension vs. not treated, and receiving a CRT-D vs. a single-chamber ICD each increased the mean total ICD-related cost per patient by approximately 20%; ICD replacement vs. no replacement increased it by 71%. ConclusionsAlmost two thirds of the total ICD patients' healthcare costs remained not ICD-related. Advancing the understanding of direct and indirect costs may help improving cost-effectiveness of patients' care pathway.

Electromagnetic interference from left ventricular assist device in patients with transvenous implantable cardioverter-defibrillator.

Many advanced heart failure patients have both a left ventricular assist device (LVAD) and an implantable cardioverter-defibrillator (ICD). This study examines incidence, clinical impact, and management of LVAD-related EMI. We performed a three-center retrospective analysis of transvenous ICD implanted patients with LVAD implanted between January 1, 2005 and December 31, 2020. The primary outcome was EMI after LVAD implantation, categorized as LVAD-related noise or telemetry interference. The rate of LVAD-related EMI among the 737 patients (mean age 58.6 ± 12.8 years) studied was 5.0%. Telemetry interference (1.5%) compromised ICD interrogation in all patients. This was resolved successfully with use of a metal shield, encased wand, radiofrequency tower, different ICD programmer or by increasing distance between ICD programmer and LVAD (n=6). ICD replacement was required to reestablish successful communication in three patients. LVAD-related noise (3.5%) led to oversensing (n=4), inappropriate mode switches (n=4), noise reversion (n=3), inhibition of pacing (n=2), inappropriate detection as atrial fibrillation (AF) (n=2) and inappropriate detection as ventricular tachycardia (VT) and/or ventricular fibrillation (VF) (n=2). This noise interference persisted (n=3), resolved spontaneously (n=16), resolved with programming change (n=6) or required lead revision (n=1). EMI from LVAD impacts ICD function, although, the incidence rate is low. Physicians implanting both, LVAD in patients with ICD (more common) or ICD in patients with LVAD, should be aware of possible interferences. Telemetry failure not resolved by metal shielding was overcome by ICD generator replacement to a different manufacturer. In most cases, LVAD-related noise resolves spontaneously.

Mortality after cardioverter-defibrillator replacement: Results of the DECODE survival score index

Device replacement is the ideal time to reassess health care goals regarding continuing implantable cardioverter-defibrillator (ICD) therapy. Only few data are available on the decision making at this time. The goals of this study were to identify factors associated with poor prognosis at the time of ICD replacement and to develop a prognostic index able to stratify those patients at risk of dying early. DEtect long-term COmplications after implantable cardioverter-DEfibrillator replacement (DECODE) was a prospective, single-arm, multicenter cohort study aimed at estimating long-term complications in a large population of patients who underwent ICD/cardiac resynchronization therapy - defibrillator replacement. Potential predictors of death were investigated, and all these factors were gathered into a survival score index (SUSCI). We included 983 consecutive patients (median age 71 years (63-78)); 750 (76%) were men, 537 (55%) had ischemic cardiomyopathy; 460 (47%) were implanted with cardiac resynchronization therapy - defibrillator. During a median follow-up period of 761 days (interquartile range 628-904 days), 114 patients (12%) died. In multivariate Cox regression analysis, New York Heart Association class III/IV, ischemic cardiomyopathy, body mass index < 26 kg/m2, insulin administration, age ≥ 75 years, history of atrial fibrillation, and hospitalization within 30 days before ICD replacement remained associated with death. The survival score index showed a good discriminatory power with a hazard ratio of 2.6 (95% confidence interval 2.2-3.1; P < .0001). The risk of death increased according to the severity of the risk profile ranging from 0% (low risk) to 47% (high risk). A simple score that includes a limited set of variables appears to be predictive of total mortality in an unselected real-world population undergoing ICD replacement. Evaluation of the patient's profile may assist in predicting vulnerability and should prompt individualized options, especially for high-risk patients.

Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.

Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences. The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD. A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice. A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively). It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

P181 Implantable cardioverter defibrillator and cardiac resynchronisation therapy use in New Zealand

Abstract Introduction The ANZACS-QI DEVICE registry is a national registry designed to collect data on all cardiac implantable electronic devices (CIED) implanted in New Zealand (NZ). This study aims to provide a contemporary analysis of the clinical characteristics and implant details of patients receiving implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT), including CRT-Pacemaker (CRT-P) and CRT-Defibrillator (CRT-D). Methods Complete datasets of ICD, CRT-D and CRT-P implants from the ANZACS-QI DEVICE registry from 1st January 2014 to 31st December 2017 were analysed. Results A total of 1579 ICD implants were identified. Of the 1152 (73.0%) new implants, 565 (49.0%) were for primary prevention and 587 (51.0%) were for secondary prevention. The baseline demographics of both groups were similar, with a median age of 62 and predominantly male (79.2-81.4%), with European (63.7-66.8%) and Maori (21.1-24.8%) being the most common ethnicities. The mean BMI was 29.6-30.2 kg/m², with most patients (75.2-80.7%) being in sinus rhythm at the time of ICD implant. Compared to the secondary prevention group, the primary prevention group had more patients with a history of heart failure (80.4% vs 39.7%), worse heart failure symptoms (NYHA Class II-III 77.1% vs 47.3%), poorer left ventricular ejection fraction (LVEF) (mean 25.1% vs 30.3%) and the aetiology was more likely to be non-ischaemic (57.5% vs 44.2%). The mean QRS duration was longer (129.9ms vs 113.4ms), with a higher incidence of left bundle branch block (31.9% vs 16.0%) and a correspondingly higher rate of CRT-D implants (27.4% vs 8.3%). In the 427 (27.0%) ICD replacements, over a mean duration of 6.27 years, 46.6% had delivered appropriate therapy (including 38.4% with appropriate ICD shocks) whilst 17.8% had delivered inappropriate therapy. Compared to primary prevention CRT-D (n = 155), patients receiving CRT-P (n = 175) were older (median age 74 vs 66) and more likely to be female (38.3% vs 19.4%). CRT-D patients had longer mean QRS duration (169.2ms vs 160.8ms) and poorer LVEF (mean 24.3% vs 28.7%). Conclusion This analysis provides contemporary data on ICD and CRT use in New Zealand. Primary prevention ICD patients were more likely to have a history of heart failure, worse heart failure symptoms, more prolonged QRS duration, left bundle branch block and poorer LV function compared to secondary prevention ICD. Compared to primary prevention CRT-D, patients receiving CRT-P were older and more likely to be female.

Implantable cardioverter defibrillator and cardiac resynchronization therapy use in New Zealand (ANZACS-QI 33).

BackgroundThe ANZACS‐QI Cardiac Implanted Device Registry (ANZACS‐QI DEVICE) collects nationwide data on cardiac implantable electronic devices in New Zealand (NZ). We used the registry to describe contemporary NZ use of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT).MethodsAll ICD and CRT Pacemaker implants recorded in ANZACS‐QI DEVICE between 1 January 2014 and 31 December 2017 were analyzed.ResultsOf 1579 ICD implants, 1152 (73.0%) were new implants, including 49.0% for primary prevention and 51.0% for secondary prevention. In both groups, median age was 62 years and patients were predominantly male (81.4% and 79.2%, respectively). Most patients receiving a primary prevention ICD had a history of clinical heart failure (80.4%), NYHA class II‐III symptoms (77.1%) and LVEF ≤35% (96.9%). In the secondary prevention ICD cohort, 88.4% were for sustained ventricular tachycardia or survived cardiac arrest from ventricular arrhythmia. Compared to primary prevention CRT Defibrillators (n = 155), those receiving CRT Pacemakers (n = 175) were older (median age 74 vs 66 years) and more likely to be female (38.3% vs 19.4%). Of the 427 (27.0%) ICD replacements (mean duration 6.3 years), 46.6% had received appropriate device therapy while 17.8% received inappropriate therapy. The ICD implant rate was 119 per million population with regional variation in implant rates, ratio of primary prevention ICD implants, and selection of CRT modality.ConclusionIn contemporary NZ practice three‐quarters of ICD implants were new implants, of which half were for primary prevention. The majority met current guideline indications. Patients receiving CRT pacemaker were older and more likely to be female.

Association between the Charlson comorbidity index and outcomes after implantable cardioverter defibrillator generator replacement.

Recipients of implantable cardioverter defibrillator (ICD) generator replacement with multiple medical comorbidities may be at higher risk of adverse outcomes that attenuate the benefit of ICD replacement. The aim of this investigation was to study the association between the Charlson comorbidity index (CCI) and outcomes after ICD generator replacement. All patients undergoing first ICD generator replacement at Mayo Clinic, Rochester and Beth Israel Deaconess Medical Center, Boston between 2001 and 2011 were identified. Outcomes included: (a) all-cause mortality, (b) appropriate ICD therapy, and (c) death prior to appropriate therapy. Multivariable Cox regression analysis was performed to assess association between CCI and outcomes. We identified 1421 patients with mean age of 69.6 ± 12.1 years, 81% male and median (range) CCI of 3 (0-18). During a mean follow-up of 3.9 ± 3 years, 52% of patients died, 30.6% experienced an appropriate therapy, and 23.6% died without experiencing an appropriate therapy. In multivariable analysis, higher CCI score was associated with increased all-cause mortality (Hazard ratio, HR 1.10 [1.06-1.13] per 1 point increase in CCI, P<.001), death without prior appropriate therapy (HR 1.11 [1.07-1.15], P<.0001), but not associated with appropriate therapy (HR 1.01 [0.97-1.05], P=.53). Patients with CCI ≥5 had an annual risk of death of 12.2% compared to 8.7% annual rate of appropriate therapy. CCI is predictive of mortality following ICD generator replacement. The benefit of ICD replacement in patients with CCI score ≥5 should be investigated in prospective studies.

Impact of defibrillation threshold testing on burden of heart failure hospitalizations

Background: Defibrillation threshold testing (DT) following implantable cardioverter defibrillator (ICD) implantation has not shown to improve mortality. However, the impact of DT on burden of heart failure (HF) hospitalisations has not been well defined.Methods: We studied retrospectively consecutive patients who underwent ICD implantation or generator change between 2008 and 2014. Primary outcome was burden of HF hospitalisations within 30 days following implantation. Secondary outcomes were mortality, stroke, and ICD shock within 30 days and one-year mortality.Results: Three hundred and eleven of 501 patients (62%) were in DT+ group versus 190 (38%) were in DT− group. The percentage of new implantations was higher in DT+ group than in DT− group (69% vs 39%, p < .001) but the distributions of NYHA function classes were similar between two groups. The burden of HF hospitalisations at 30-days was significantly higher in DT+ group than in DT− group (17.4% vs 4.7%, HR 0.842, 95% CI 0.774–0.915, p < .0001). No difference in mortality, stroke or ICD shocks was found between two groups at 30 days and mortality at 1 year.Conclusions: DT after new ICD or generator replacement was associated with increased HF hospitalisation rates at 30 days after ICD implant in a non-trial HF population. However, there was no association between DT and mortality, stroke and ICD shocks at 30 days or mortality at 1 year. The increased burden of HF hospitalisation in this observational study requires validation by randomised studies.

Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry.

The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population. Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 ± 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU. Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs. URL: http://clinicaltrials.gov/ Identifier: NCT02076789.

Risk factors and prognostic impact of left ventricular assist device–associated infections

Left ventricular assist device (LVAD)-associated infections may be life-threatening and impact patients' outcome. We aimed to identify the characteristics, risk factors, and prognosis of LVAD-associated infections. Patients included in the ASSIST-ICD study (19 centers) were enrolled. The main outcome was the occurrence of LVAD-associated infection (driveline infection, pocket infection, or pump/cannula infection) during follow-up. Of the 652 patients enrolled, 201 (30.1%) presented a total of 248 LVAD infections diagnosed 6.5 months after implantation, including 171 (26.2%), 51 (7.8%), and 26 (4.0%) percutaneous driveline infection, pocket infection, or pump/cannula infection, respectively. Patients with infections were aged 58.7 years, and most received HeartMate II (82.1%) or HeartWare (13.4%). Most patients (62%) had implantable cardioverter-defibrillators (ICDs) before LVAD, and 104 (16.0%) had ICD implantation, extraction, or replacement after the LVAD surgery. Main pathogens found among the 248 infections were Staphylococcus aureus (n = 113' 45.4%), Enterobacteriaceae (n = 61; 24.6%), Pseudomonas aeruginosa (n = 34; 13.7%), coagulase-negative staphylococci (n = 13; 5.2%), and Candida species (n = 13; 5.2%). In multivariable analysis, HeartMate II (subhazard ratio, 1.56; 95% CI, 1.03 to 2.36; P = .031) and ICD-related procedures post-LVAD (subhazard ratio, 1.43; 95% CI, 1.03-1.98; P = .031) were significantly associated with LVAD infections. Infections had no detrimental impact on survival. Left ventricular assist device-associated infections affect one-third of LVAD recipients, mostly related to skin pathogens and gram-negative bacilli, with increased risk with HeartMate II as compared with HeartWare, and in patients who required ICD-related procedures post-LVAD. This is a plea to better select patients needing ICD implantation/replacement after LVAD implantation.

Coronary vein defibrillator coil placement in patients with high defibrillation thresholds.

BackgroundElevated defibrillation threshold (DFT) occurs in 2%‐6% of patients undergoing implantable cardioverter defibrillator (ICD) implantation. Adding a defibrillation coil in the coronary sinus (CS) or its branches can result in substantial reductions in the mean DFT. However, data regarding acute success and long‐term stability remain lacking. We report our experience with this bailout strategy.MethodsPatients with elevated DFT at implantation (safety margin at implantation <10 J) and those with failed ICD shocks for ventricular arrhythmias (VA) referred for high DFT underwent placement of an additional defibrillation coil in the CS. DFT testing was performed at the completion of the implantation procedure. External potentially reversible factors were excluded. High‐output devices were systematically used.ResultsFour patients with high DFT at implantation and two with several failed shock attempts underwent placement of a defibrillation coil in the CS. Mean age was 41.8 (23‐78). They presented a mean LVEF of 21% (15‐30), QRS‐complex duration of 109.8 milliseconds (87‐168), body surface area of 1.96 m2 (1.45‐2.58), and a mean R wave of 16.3 mV (8‐27). Defibrillation coil implantation in the CS (final shocking configuration of right ventricle as anode and left ventricle (LV) plus can as cathode) was associated with successful DFT testing in all. Three patients had a concomitant LV lead for biventricular pacing. During a mean follow‐up of 54.67 months (10‐118), two patients experienced successful ICD shocks for VA (one of them also presented inappropriate shocks because of the fast conducting atrial fibrillation).ConclusionsPositioning of a defibrillation coil in the CS can result in a substantial reduction in mean DFT and associates with optimal long‐term stability.