Long-Term Complications Related to Biventricular Defibrillator Implantation

Abstract

on behalf of the Cardiovascular Centers Participating in the ClinicalService ProjectBackground-Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome. Methods and Results-We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single-and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; Pϭ0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; Pϭ0.682). Conclusions-In current clinical practice device-related events are more frequent in CRT-D than in single-or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01007474.

Acute and mid-term outcomes of transvenous implant of a new left ventricular quadripolar lead versus bipolar leads for cardiac resynchronization therapy: Results from a single-center prospective database

“…Some patients do not respond to the therapy, and other potential problems include phrenic stimulation, the absence of an adequate capture threshold, lead dislocations (especially the left ventricular [LV]), and in general, a higher rate of events related to the device compared with patients who receive cardiac defibrillator (ICD) implants without CRT [1][2][3]. To overcome many of these difficulties, new technical advances had been developed in the last few years but despite these developments, the leads cannot be properly positioned in some patients [4], and non-percutaneous surgical implantation is used whenever possible.…”

Almanac 2013: cardiac arrhythmias and pacing

“…In a study of 3253 patients from 117 Italian centres who underwent de novo implantation of a CRT-D device, investigators found that device related events were more frequent in patients who received CRT-D devices compared with those who received ICDs only (single or dual chamber), although these events were not associated with a worse clinical outcome (123). In a multicentre, longitudinal cohort study of 104 049 patients receiving single and dual chamber ICDs, dual chamber device implantation was more common, but was associated with increased peri-procedural complications and inhospital mortality compared with single chamber ICDs (124).…”

Most Important Outcomes Research Papers on Device Therapies for Cardiomyopathies

“…71 Lastly, CRT is complex and implantation is associated with a greater risk of adverse events. 10 Furthermore, CRT device longevity is much less than an ICD meaning that patients may be exposed to long-term risk associated with device replacement. 72 The following summaries concern multiple topics pertinent to CRT therapy including evaluation of the cause of disparities in the uptake of CRT, 73 long-term untoward effects of CRT, 10 the benefit of CRT in patients with diabetic cardiomyopathy, 74 and the role of CRT in patients with HF and a narrow QRS (< 120ms).…”

“…8,9 Third, these devices are not without significant untoward effects; understanding and minimizing these adverse events, and in particular long-term events, is important particularly in the context of improving patient survival. 10 For example, patient longevity now often exceeds that of ICD's and 70% of patients are expected to require an ICD replacement in their lifetime exposing patients to risks from multiple surgical procedures. 11 Similarly, VADs are increasingly used as long-term destination therapy.…”