ABSTRACT
QUESTION UNDER STUDY: Cardiac resynchronisation therapy (CRT) with defibrillator back-up (CRT-D) is widely used in selected patients with moderate/severe heart failure. Renal failure is common in these patients. Data on the impact of CRT on renal function are controversial and limited by short follow-up. The aim of this study was to describe changes in glomerular filtration rate (GFR) from baseline compared with 1 and 2 years after CRT implantation. METHODS: A total of 284 CRT-D patients with creatinine levels at baseline and after 1 year were identified in two prospective registries. In 149 patients, levels after 2 years were available. GFR in ml/min/1.73 m2 was estimated with the Modification Diet in Renal Disease equation and patients stratified into GFR stages 1 to 4. RESULTS: The population was predominantly male (75%), mean (± standard deviation) age was 61 ± 7 years and ejection fraction 24% ± 8 %. GFR was 63 ± 24 ml/min/1.73 m2 at implantation and 60 ± 24 ml/min/1.73 m2 after 1 year (p = 0.26). At the 2-year follow-up, GFR had decreased from 60 ± 21 to 56 ± 21 ml/min/1.73 m2 (p = 0.04). Mean GFR decreased in stages 1 and 2, remained stable in stage 3 and improved in stage 4 patients. After 2 years, GFR had decreased ≥10 ml/min/1.73 m2 in 42%, but improved in only 15% (p = 0.04). CONCLUSIONS: Overall, mean GFR in CRT-D patients decreases at 1 and 2 years after implantation, depending in part on the initial degree of renal function. However, the chance of further substantial deterioration (≥10 ml/min/1.73 m2) is considerable.
Subject(s)
Cardiac Resynchronization Therapy , Glomerular Filtration Rate , Heart Failure/therapy , Kidney/physiopathology , Registries , Renal Insufficiency, Chronic/physiopathology , Adolescent , Adult , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy Devices , Child , Defibrillators, Implantable , Disease Progression , Female , Follow-Up Studies , Heart Failure/complications , Humans , Male , Middle Aged , Prospective Studies , Renal Insufficiency, Chronic/complications , Young AdultABSTRACT
AIMS: In 2007, the Medtronic™ Sprint Fidelis(®) lead was withdrawn from the market due to elevated failure rates. Since then, several studies were published with failure rates between 1.3 and 3.75%/year. However, they included a very high percentage of active fixation leads. Data in a population with passive leads are missing. METHODS AND RESULTS: All 166 patients who received a Fidelis lead between December 2004 and October 2007 in two teaching hospitals were identified. We excluded nine patients with incomplete data and 18 with active fixation leads. The study population thus consists of 139 patients with passive leads. Pacing and high-voltage impedance values were systematically collected at implant and in intervals of 6 months. Follow-up was 49 ± 15 months. All leads were 6948 models. During a follow-up of 41 ± 15 months, nine leads (6.5%) failed. Annual failure rate was 1.9%/year (95% CI 0.4-4.2), cumulative 5-year survival 95.8%. There were no differences between leads used in resynchronization and non-resynchronization devices (8.9 and 5.3%, P value 0.47). CONCLUSION: In a population with only passive leads, the Fidelis lead exhibited an impaired long-term survival, but performance was better than in previous studies in which >90% of leads were active models.
Subject(s)
Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Electric Countershock/instrumentation , Prosthesis Failure , Aged , Chi-Square Distribution , Death, Sudden, Cardiac/etiology , Female , Hospitals, Teaching , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Switzerland , Time Factors , Treatment OutcomeABSTRACT
Remote monitoring is useful for management of implantable cardioverter defibrillator (ICD) patients regarding detection of arrhythmias and probable device or lead failure. We report the case of a patient who died suddenly while being on remote monitoring. The ICD was not retrieved postmortem. Even though clinical circumstances were suspicious of an arrhythmic death, this was excluded due to a distinctive manufacturer feature of the system.
