Considerations in Patients With Cardiac Implantable Electronic Devices at End of Life.

Since the introduction of implantable cardiac pacemakers in 1958 and implantable cardioverter-defibrillators in 1980, these devices have been proven to save and prolong lives. Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy are deemed life-sustaining therapies. Despite these life-saving technologies, all patients ultimately will reach the end of their lives from either their heart disease or development of a terminal illness. Clinicians may be faced with patient and family requests to withdraw these life-sustaining therapies. The purpose of this article is to educate clinicians about the legal and ethical principles that underlie withdrawal of life-sustaining therapies such as device deactivation and to highlight the importance of proactive communication with patients and families in these situations.

Transvenous implantable cardioverter-defibrillator lead reliability: implications for postmarket surveillance.

BACKGROUND: As implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers. METHODS AND RESULTS: We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow-up. CONCLUSIONS: Currently marketed implantable cardioverter-defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter-defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.

Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads.

BACKGROUND: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance. OBJECTIVE: To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers. METHODS: The study included adults who received St Jude Medical Riata or Riata ST leads. Data for Quattro Secure leads were obtained from an earlier study. RESULTS: From 2002 to 2010, 1081 patients received a Riata (n = 774) or Riata ST (n = 307) lead. Follow-up was longer for Riata than Riata ST leads (4.2 ± 2.4 years vs 3.3 ± 1.7 years; P<.0001). During the study, 67 leads failed (6.2%), including 62 of 774 Riata (8.0%) and 5 of 307 Riata ST (1.6%) leads. Forty-seven of 67 lead failures (70.1%) were caused by electrical malfunction, and 20 lead failures (29.9%) were due to externalized conductors (ECs) that were electrically intact. Of 110 leads examined fluoroscopically, ECs were found in 26 of 81 Riata (32%) and 1 of 29 Riata ST (3.4%) leads. Of 26 Riata leads with ECs, 7 (27%) were malfunctioning. Riata leads had lower overall and malfunction free survival compared to Quattro leads (P<.0001), while Riata ST lead survival was not different (P = .422). CONCLUSIONS: The survival of Riata (but not Riata ST) leads was lower than Quattro leads; however, Riata ST leads had significantly shorter follow-up than Riata leads. ECs were common in Riata leads, and more than a quarter of Riata leads that had ECs were malfunctioning. Our observations suggest that systematic fluoroscopic examination of patients with Riata leads is appropriate.

Implantable cardioverter defibrillator therapy.

Sudden cardiac death (SCD) is a major healthcare problem worldwide. The majority of SCD events occur in patients with clinically recognized heart disease and most episodes result from ventricular tachyarrhythmias. Implantable cardioverter defibrillator (ICD) therapy prevents SCD in specific patient populations. Significant progress in the design and technology has been made since the Food and Drug Administration first approved the ICD in 1985. First-generation ICDs were large, were implanted in the abdomen, required a thoracotomy for placing epicardial defibrillation patches, and were nonprogrammable. Contemporary ICDs have been substantially downsized, are implanted via a transvenous approach, and are multiprogrammable. Device implantation has been simplified to be similar to that of a permanent pacemaker. In addition to treating life-threatening ventricular arrhythmias, ICDs now treat bradyarrhythmias, atrial arrhythmias, and congestive heart failure. The purpose of this article is to describe the evidence supporting the use of ICD therapy and to explain the current devices used in clinical practice.

Cardiac resynchronization therapy for heart failure management.

Heart failure (HF) is responsible for an immense burden on our healthcare system. The prevalence of this disease continues to increase as a result of an aging population, successful treatment of acute coronary syndrome, and the use of new pharmacotherapies. Although pharmacotherapy with angiotensin converting enzyme inhibitors and beta-blockers shows improvement in morbidity and mortality, the overall prognosis of these patients remains poor. Cardiac transplant has limited applicability. Conduction disturbances are frequent in patients with advanced heart failure and may cause worsening systolic function and ventricular dyssynchrony. Biventricular pacing to achieve cardiac resynchronization is a recent and promising therapy for HF patients with an intraventricular conduction defect. Randomized clinical trials have substantiated that cardiac resynchronization therapy (CRT) through biventricular pacing offers significant benefit in morbidity and mortality in a select group of HF patients. Because of the high incidence of sudden cardiac death in patients with severe HF, the combination biventricular pacing with implantable cardioverter defibrillator therapy will provide additional benefit. This article provides an overview of CRT with the intent of describing ventricular dyssynchrony, the benefits of CRT, and the implications for advanced practice nurses.