Aafke C. van der Heijden

The clinical course of patients with implantable cardioverter-defibrillators: Extended experience on clinical outcome, device replacements, and device-related complications

BACKGROUND Large randomized trials demonstrated the beneficial effect of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) treatments in selected patients. Data on long-term follow-up of patients outside the setting of clinical trials are scarce. OBJECTIVE The aim of this study was to evaluate the long-term outcome of ICD and CRT-D recipients. METHODS All patients who underwent ICD (n = 1729 [57%]) or CRT-D (n = 1326 [43%]) implantation at the Leiden University Medical Center since 1996 were evaluated. Follow-up visits were performed every 3-6 months, and events were registered. Cumulative incidence curves of device therapy and device-related complications were adjusted for the competing risk of all-cause mortality. RESULTS After a median follow-up of 5.1 years (25th-75th percentile 3.1-7.8 years), 842 patients (28%) died. The cumulative incidence of all-cause mortality was 49% (95% confidence interval [CI] 45%-54%) in ICD recipients after 12 years of follow-up and 55% (95% CI 52%-58%) in CRT-D recipients after 8 years of follow-up. A total of 1081 patients (35%) received appropriate defibrillator therapy. The cumulative incidence of appropriate therapy in ICD patients was 58% (95% CI 54%-62%) after 12 years of follow-up and 39% (95% CI 35%-43%) in CRT-D patients after 8 years of follow-up. Twelve-year cumulative incidences of adverse events were 20% (95% CI 18%-22%) for inappropriate shock, 6% (95% CI 5%-8%) for device-related infection, and 17% (95% CI 14%-21%) for lead failure. CONCLUSION After long-term follow-up of ICD (12 years) and CRT-D (8 years) recipients, 49% of ICD recipients and 55% of CRT-D recipients had died. Appropriate ICD therapy was received by the majority (58%) of ICD recipients and by almost 40% of CRT-D recipients.

How adequate are the current methods of lead extraction? A review of the efficiency and safety of transvenous lead extraction methods

Currently several extraction tools are available in order to allow safe and successful transvenous lead extraction (TLE) of pacemaker and ICD leads; however, no directives exist to guide physicians in their choice of extraction tools and approaches. To aim of the current review is to provide an overview of the success and complication rates of different extraction methods and tools available. A comprehensive search of all published literature was conducted in the databases of PubMed, Embase, Web of Science, and Central. Included papers were original articles describing a specific method of TLE and the corresponding success rates of at least 50 patients. Fifty-three studies were included; the majority (56%) utilized 2 (1-4) different venous extraction approaches (subclavian and femoral), the median number of extraction tools used was 3 (1-6). A stepwise approach was utilized in the majority of the studies, starting with simple traction which resulted in successful TLE in 7-85% of the leads. When applicable the procedure was continued with non-powered tools resulting in a successful extraction of 34-87% leads. Subsequently, powered tools were applied whereby success rates further increased to 74-100%. The final step in TLE was usually utilized by femoral snare leading to an overall TLE success rate of 96-100%. The median procedure-related mortality and major complication described were, respectively, 0% (0-3%) and 1% (0-7%) per patient. In conclusion, a stepwise extraction approach can result in a clinical successful TLE in up to 100% of the leads with a relatively low risk of procedure-related mortality and complications.

Gender-specific differences in clinical outcome of primary prevention implantable cardioverter defibrillator recipients

Objective To assess differences in clinical outcome of implantable cardioverter-defibrillator (ICD) treatment in men and women. Design Prospective cohort study. Setting University Medical Center. Patients 1946 primary prevention ICD recipients (1528 (79%) men and 418 (21%) women). Patients with congenital heart disease were excluded for this analysis. Main outcome measures All-cause mortality, ICD therapy (antitachycardia pacing and shock) and ICD shock. Results During a median follow-up of 3.3 years (25th–75th percentile 1.4–5.4), 387 (25%) men and 76 (18%) women died. The estimated 5-year cumulative incidence for all-cause mortality was 20% (95% CI 18% to 23%) for men and 14% (95% CI 9% to 19%) for women (log rank p<0.01). After adjustment for potential confounding covariates all-cause mortality was lower in women (HR 0.65; 95% CI 0.49 to 0.84; p<0.01). The 5-year cumulative incidence for appropriate therapy in men was 24% (95% CI 21% to 28%) as compared with 20% (95% CI 14% to 26%) in women (log rank p=0.07). After adjustment, a non-significant trend remained (HR 0.82; 95% CI 0.64 to 1.06; p=0.13). Conclusions In clinical practice, 21% of primary prevention ICD recipients are women. Women have lower mortality and tend to experience less appropriate ICD therapy as compared with their male peers.

Epicardial leads in adult cardiac resynchronization therapy recipients: a study on lead performance, durability, and safety.

BACKGROUND Transvenous left ventricular (LV) lead placement for cardiac resynchronization therapy-defibrillator (CRT-D) delivery is unsuccessful in 8% to 10% of cases. These patients might benefit from an epicardial lead. However, data on long-term epicardial lead performance are scarce. Furthermore, extracting an epicardial lead requires a rethoracotomy. OBJECTIVE The purpose of this study was to determine data on almost a decade of experience with epicardial leads and investigate the safety of partially leaving this lead in place after device infection. METHODS All adult patients receiving an epicardial lead (Medtronic CapSure Epi, model 4968) for CRT-D in the Leiden University Medical Center were included. Leads were implanted during a standalone procedure or in combination with other cardiothoracic procedures. Electrical lead parameters were assessed at implantation and every 6 months thereafter. In case of device infection the epicardial lead was cut off parasternal, just outside the thoracic cavity, leaving the distal part of the lead in place. RESULTS Two-hundred sixteen patients were included with a median follow-up of 3 years (25th-75th percentile 1.0-5.5). LV pacing threshold decreased within 6 months after implantation [1.1 V (95% confidence interval [CI] 0.9-1.2) vs 0.8 V (95% CI 0.7-0.9), P = .01] and stabilized thereafter. Mean LV electrogram was 15.2 ± 7.5 mV, and average lead impedance was 633.5 ± 174.0 Ω. Five-year cumulative incidence was 1.6% for lead failure and 9.6% for device infection. The retained epicardial lead caused skin erosion in 3 patients and fistula formation in 1. CONCLUSION This study demonstrates that epicardial LV leads have an excellent long-term performance. Partially retaining the lead after device infection was associated with a risk of reinfection with limited long-term clinical implications for the patient.

Application and comparison of the FADES, MADIT, and SHFM-D risk models for risk stratification of prophylactic implantable cardioverter-defibrillator treatment.

Aims Implantable cardioverter-defibrillator (ICD) treatment is beneficial in selected patients. However, it remains difficult to accurately predict which patients benefit most from ICD implantation. For this purpose, different risk models have been developed. The aim was to validate and compare the FADES, MADIT, and SHFM-D models. Methods and results All patients receiving a prophylactic ICD at the Leiden University Medical Center were evaluated. Individual model performance was evaluated by C-statistics. Model performances were compared using net reclassification improvement (NRI) and integrated differentiation improvement (IDI). The primary endpoint was non-benefit of ICD treatment, defined as mortality without prior ventricular arrhythmias requiring ICD intervention. A total of 1969 patients were included (age 63 ± 11 years; 79% male). During a median follow-up of 4.5 ± 3.9 years, 318 (16%) patients died without prior ICD intervention. All three risk models were predictive for event-free mortality (all: P < 0.001). The C-statistics were 0.66, 0.69, and 0.75, respectively, for FADES, MADIT, and SHFM-D (all: P < 0.001). Application of the SHFM-D resulted in an improved IDI of 4% and NRI of 26% compared with MADIT; IDI improved 11% with the use of SHFM-D instead of FADES (all: P < 0.001), but NRI remained unchanged (P = 0.71). Patients in the highest-risk category of the MADIT and SHFM-D models had 1.7 times higher risk to experience ICD non-benefit than receive appropriate ICD interventions [MADIT: mean difference (MD) 20% (95% CI: 7–33%), P = 0.001; SHFM-D: MD 16% (95% CI: 5–27%), P = 0.005]. Patients in the highest-risk category of FADES were as likely to experience ICD intervention as ICD non-benefit [MD 3% (95% CI: –8 to 14%), P = 0.60]. Conclusion The predictive and discriminatory value of SHFM-D to predict non-benefit of ICD treatment is superior to FADES and MADIT in patients receiving prophylactic ICD treatment.

Prognostic Impact of Implementation of QRS Characteristics in the Seattle Heart Failure Model in ICD and CRT-D Recipients.

The Seattle Heart Failure Model (SHFM) provides accurate estimates of survival in heart failure (HF) patients. The model is, however, not developed for HF patients with cardiac resynchronization therapy (CRT). The aim of this study was to assess the prognostic value of SHFM combined with QRS morphology and CRT‐related change in QRS duration in implantable cardioverter defibrillator (ICD) and CRT defibrillator (CRT‐D) recipients.

Patients With an ICD Remain at Risk for Painful Shocks in Last Moments of Life

Patients with an implantable cardioverter-defibrillator (ICD) are at risk of unnecessary painful shocks at the end of life when tachytherapy is still active. In 2010, the European Heart Rhythm Associations and the American Heart Rhythm Society published statements on ICD-therapy in patients nearing

Primary prevention implantable cardioverter-defibrillator implantation in elderly patients: is it justified to withhold treatment?

Implementation of primary prevention implantable cardioverter-defibrillator (ICD) treatment in the current clinical guidelines led to a significant increase in patients that may benefit from implantation of an ICD. Currently non-guideline-guided patient selection takes place by physicians whereby patients at higher age are more frequently excluded for ICD implantation. This editorial focuses on ICD treatment in the elderly and aims to clarify whether it is justified to withhold ICD treatment in these patients.