Remarkably high and accelerating failure rate of a widely used implantable cardioverter-defibrillator lead:A large-scale manufacturer-independent multicenter study with long accurate follow-up

Background: A high annual failure rate of the Linox family defibrillator lead was reported in various small single-center studies. No independent multicenter long-term performance information exists for this lead. Objective: Our aim was to assess the longevity of the Linox family leads and to evaluate clinical variables and adverse events associated with failure. Methods: This 4-center study included adults &gt;18 years of age who received Linox family leads for the prevention of sudden cardiac death. From November 2006 to November 2016, a total of 3993 high-voltage leads of the Linox family were implanted and followed up on. Results: The absolute failure rate was 10.6% (dwell time to lead failure of 6.3 ± 3.4 years). Multivariate analysis confirmed younger age (for every 5 years younger than 65 years) (hazard ratio 1.09, 95% confidence interval 1.05–1.14, P &lt; .001) and subclavian access (hazard ratio 1.46, 95% confidence interval 1.18–1.81, P &lt; .001) as independent risk factors for lead failure. Patients frequently presented themselves with inappropriate shocks (20% in patients with lead failure) due to detection of nonphysiologic high-rate signals/noise. Conclusion: This is the largest physician-driven multicenter study on the very long-term performance of Linox family leads. Our data report a remarkably high failure rate of these leads. Our findings have significant implications for the management of patients. Monitoring by remote care should be available for all active Linox family leads.</p

Inappropriate Implantable Cardioverter-Defibrillator Shocks Incidence, Predictors, and Impact on Mortality

ObjectivesThe purpose of this study was to assess the incidence, predictors, and outcome of inappropriate shocks in implantable cardioverter-defibrillator (ICD) patients.BackgroundDespite the benefits of ICD therapy, inappropriate defibrillator shocks continue to be a significant drawback. The prognostic importance of inappropriate shocks outside the setting of a clinical trial remains unclear.MethodsFrom 1996 to 2006, all recipients of defibrillator devices equipped with intracardiac electrogram storage were included in the current analysis and clinically assessed at implantation. During follow-up, the occurrence of inappropriate ICD shocks and all-cause mortality was noted.ResultsA total of 1,544 ICD patients (79% male, age 61 ± 13 years) were included in the analysis. During the follow-up period of 41 ± 18 months, 13% experienced ≥1 inappropriate shocks. The cumulative incidence steadily increased to 18% at 5-year follow-up. Independent predictors of the occurrence of inappropriate shocks included a history of atrial fibrillation (hazard ratio [HR]: 2.0, p < 0.01) and age younger than 70 years (HR: 1.8, p = 0.01). Experiencing a single inappropriate shock resulted in an increased risk of all-cause mortality (HR: 1.6, p = 0.01). Mortality risk increased with every subsequent shock, up to an HR of 3.7 after 5 inappropriate shocks.ConclusionsIn a large cohort of ICD patients, inappropriate shocks were common. The most important finding is the association between inappropriate shocks and mortality, independent of interim appropriate shocks

Prognostic Importance of Atrial Fibrillation in Implantable Cardioverter-Defibrillator Patients

ObjectivesThis study aimed to assess the prevalence of different types of atrial fibrillation (AF) and their prognostic importance in implantable cardioverter-defibrillator (ICD) patients.BackgroundThe prevalence of AF has taken epidemic proportions in the population with cardiovascular disease. The prognostic importance of different types of AF in ICD patients remains unclear.MethodsData on 913 consecutive patients (79% men, mean age 62 ± 13 years) receiving an ICD at the Leiden University Medical Center were prospectively collected. Among other characteristics, the existence and type of AF (paroxysmal, persistent, or permanent) were assessed at implantation. During follow-up, the occurrence of appropriate or inappropriate device therapy as well as mortality was noted.ResultsAt implantation, 73% of patients had no history of AF, 9% had a history of paroxysmal AF, 7% had a history of persistent AF, and 11% had permanent AF. During 833 ± 394 days of follow-up, 117 (13%) patients died, 228 (25%) patients experienced appropriate device discharge, and 139 (15%) patients received inappropriate shocks. Patients with permanent AF exhibited more than double the risk of mortality, ventricular arrhythmias triggering device discharge, and inappropriate device therapy. Patients with paroxysmal or persistent AF did not show a significant increased risk of mortality or appropriate device therapy but demonstrated almost 3 times the risk of inappropriate device therapy.ConclusionsIn the population currently receiving ICD treatment outside the setting of clinical trials, a large portion has either a history of AF or permanent AF. Both types of AF have prognostic implications for mortality and appropriate as well as inappropriate device discharge

EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring

Aim: Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated. Methods and results: Atotal of 312 patients with VVI-or DDD-ICD implants from 17 centres in six EU countries were randomised to HMON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar-or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 +/- 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 +/- 1.67 vs. 5.53 +/- 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 +/- 1.50 vs. 0.62 +/- 1.25; P < 0.005), more non-office-based contacts (1.95+3.29 vs. 1.01 +/- 2.64; P < 0.001), more Internet sessions (11.02 +/- 15.28 vs. 0.06 +/- 0.31; P < 0.001) and more in-clinic discussions (1.84 +/- 4.20 vs. 1.28 +/- 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 +/- 1.18 vs. 0.85 +/- 1.43, P = 0.23) and shorter length-of-stay (6.31 +/- 15.5 vs. 8.26 +/- 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): (sic)204 169-238) vs. (sic)213 (182-243); range for difference ((sic)-36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of (sic)408 (327-489) vs. (sic)400 (345-455); range for difference ((sic)-104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different. Conclusion: For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation

Trends in adoption of extravascular cardiac implantable electronic devices:the Dutch cohort

Introduction: Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of pocket- and lead-related complications in particular. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on patient or centre characteristics related to the actual adoption of EVDs are lacking. Objective: To assess real-world nationwide trends in EVD adoption in the Netherlands. Methods: Using the Netherlands Heart Registration, all consecutive patients with a de novo S‑ICD or conventional single-chamber ICD implantation between 2012–2020, or de novo LP or conventional single-chamber pacemaker implantation between 2014–2020 were included. Trends in adoption are described for various patient and centre characteristics. Result: From 2012–2020, 2190 S‑ICDs and 10,683 conventional ICDs were implanted; from 2014–2020, 712 LPs and 11,103 conventional pacemakers were implanted. The general use has increased (S-ICDs 8 to 21%; LPs 1 to 8%), but this increase seems to have reached a plateau. S‑ICD recipients were younger than conventional ICD recipients (p &lt; 0.001) and more often female (p &lt; 0.001); LP recipients were younger than conventional pacemaker recipients (p &lt; 0.001) and more often male (p = 0.03). Both S‑ICDs and LPs were mainly implanted in high-volume centres with cardiothoracic surgery on-site, although over time S‑ICDs were increasingly implanted in centres without cardiothoracic surgery (p &lt; 0.001). Conclusion: This nationwide study demonstrated a relatively quick adoption of innovative EVDs with a plateau after approximately 4 years. S‑ICD use is especially high in younger patients. EVDs are mainly implanted in high-volume centres with cardiothoracic surgery back-up, but S‑ICD use is expanding beyond those centres.</p

Five-year safety and efficacy of leadless pacemakers in a Dutch cohort

BACKGROUND: Adequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing.OBJECTIVE: The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort.METHODS: In this retrospective cohort study, all consecutive patients with a first LP implantation from December 21, 2012, to December 13, 2016, in 6 Dutch high-volume centers were included. The primary safety endpoint was the rate of major procedure- or device-related complications (ie, requiring surgery) at 5-year follow-up. Analyses were performed with and without Nanostim battery advisory-related complications. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold ≤2.0 V at implantation and without ≥1.5-V increase at the last follow-up visit.RESULTS: A total of 179 patients were included (mean age 79 ± 9 years), 93 (52%) with a Nanostim and 86 (48%) with a Micra VR LP. Mean follow-up duration was 44 ± 26 months. Forty-one major complications occurred, of which 7 were not advisory related. The 5-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. No advisory-related major complications occurred a median 10 days (range 0-88 days) postimplantation. The pacing capture threshold was low in 163 of 167 patients (98%) and stable in 157 of 160 (98%).CONCLUSION: The long-term major complication rate without advisory-related complications was low with LPs. No complications occurred after the acute phase and no infections occurred, which may be a specific benefit of LPs. The performance was adequate with a stable pacing capture threshold.</p

Assessment of ICD eligibility in non-ischaemic cardiomyopathy patients:a position statement by the Task Force of the Dutch Society of Cardiology

International guidelines recommend implantation of an implantable cardioverter-defibrillator (ICD) in non-ischaemic cardiomyopathy (NICM) patients with a left ventricular ejection fraction (LVEF) below 35% despite optimal medical therapy and a life expectancy of more than 1 year with good functional status. We propose refinement of these recommendations in patients with NICM, with careful consideration of additional risk parameters for both arrhythmic and non-arrhythmic death. These additional parameters include late gadolinium enhancement on cardiac magnetic resonance imaging and genetic testing for high-risk genetic variants to further assess arrhythmic risk, and age, comorbidities and sex for assessment of non-arrhythmic mortality risk. Moreover, several risk modifiers should be taken into account, such as concomitant arrhythmias that may affect LVEF (atrial fibrillation, premature ventricular beats) and resynchronisation therapy. Even though currently no valid cut-off values have been established, the proposed approach provides a more careful consideration of risks that may result in withholding ICD implantation in patients with low arrhythmic risk and substantial non-arrhythmic mortality risk.</p