Aurelio Quesada

Left Ventricular Lead Position and Clinical Outcome in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT) Trial

Background— An important determinant of successful cardiac resynchronization therapy for heart failure is the position of the left ventricular (LV) pacing lead. The aim of this study was to analyze the impact of the LV lead position on outcome in patients randomized to cardiac resynchronization-defibrillation in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT) study. Methods and Results— The location of the LV lead was assessed by means of coronary venograms and chest x-rays recorded at the time of device implantation. The LV lead location was classified along the short axis into an anterior, lateral, or posterior position and along the long axis into a basal, midventricular, or apical region. The primary end point of MADIT-CRT was heart failure (HF) hospitalization or death, whichever came first. The LV lead position was assessed in 799 patients, (55% patients ≥65 years of age, 26% female, 10% LV ejection fraction ⩽25%, 55% ischemic cardiomyopathy, and 71% left bundle-branch block) with a follow-up of 29±11 months. The extent of cardiac resynchronization therapy benefit was similar for leads in the anterior, lateral, or posterior position (P=0.652). The apical lead location compared with leads located in the nonapical position (basal or midventricular region) was associated with a significantly increased risk for heart failure/death (hazard ratio=1.72; 95% confidence interval, 1.09 to 2.71; P=0.019) after adjustment for the clinical covariates. The apical lead position was also associated with an increased risk for death (hazard ratio=2.91; 95% confidence interval, 1.42 to 5.97; P=0.004). Conclusion— LV leads positioned in the apical region were associated with an unfavorable outcome, suggesting that this lead location should be avoided in cardiac resynchronization therapy. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT00180271.

Survival with Cardiac-Resynchronization Therapy in Mild Heart Failure

BACKGROUND The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) showed that early intervention with cardiac-resynchronization therapy with a defibrillator (CRT-D) in patients with an electrocardiographic pattern showing left bundle-branch block was associated with a significant reduction in heart-failure events over a median follow-up of 2.4 years, as compared with defibrillator therapy alone. METHODS We evaluated the effect of CRT-D on long-term survival in the MADIT-CRT population. Post-trial follow-up over a median period of 5.6 years was assessed among all 1691 surviving patients (phase 1) and subsequently among 854 patients who were enrolled in post-trial registries (phase 2). All reported analyses were performed on an intention-to-treat basis. RESULTS At 7 years of follow-up after initial enrollment, the cumulative rate of death from any cause among patients with left bundle-branch block was 18% among patients randomly assigned to CRT-D, as compared with 29% among those randomly assigned to defibrillator therapy alone (adjusted hazard ratio in the CRT-D group, 0.59; 95% confidence interval [CI], 0.43 to 0.80; P<0.001). The long-term survival benefit of CRT-D in patients with left bundle-branch block did not differ significantly according to sex, cause of cardiomyopathy, or QRS duration. In contrast, CRT-D was not associated with any clinical benefit and possibly with harm in patients without left bundle-branch block (adjusted hazard ratio for death from any cause, 1.57; 95% CI, 1.03 to 2.39; P=0.04; P<0.001 for interaction of treatment with QRS morphologic findings). CONCLUSIONS Our findings indicate that in patients with mild heart-failure symptoms, left ventricular dysfunction, and left bundle-branch block, early intervention with CRT-D was associated with a significant long-term survival benefit. (Funded by Boston Scientific; ClinicalTrials.gov numbers, NCT00180271, NCT01294449, and NCT02060110.).

Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial.

AIMS This randomized trial evaluated clinically significant adverse events (CSAEs), in patients implanted with dual-chamber (DC) vs. single-chamber (SC) implantable cardioverter defibrillator (ICD). DC-ICD had atrial tachyarrhythmia (AT) therapy capabilities. Strict programming recommendations were reinforced. METHODS AND RESULTS Patients with conventional SC-ICD indication were randomized to DC-ICD, SC-ICD, or a DC-ICD programmed as an SC-ICD (SC-simulated) and followed for 16 months. Patients in the DC and SC-simulated groups crossed over after 8 months. The primary endpoint was a composite of CSAE: all-cause mortality; invasive intervention; hospitalization (> 24 h) for cardiovascular causes; inappropriate shocks (two or more episodes); and sustained symptomatic AT lasting > 48 h. The outcome variable was a pre-specified score that corrected for clinical severity and follow-up duration. Three hundred and thirty-four patients were analysed (DC-ICD, n = 112; SC-ICD, n = 111; SC-simulated, n = 111). The mean left ventricular ejection fraction was 0.36 +/- 0.13, 69% were in functional class > or = II. CSAE occurred in 65 DC-ICD, 82 SC-ICD, and 84 SC-simulated patients. The outcome variable was 33% lower in the DC-ICD group (OR 0.31; 95% CI 0.14-0.67; P = 0.0028). Mortality was 4% in DC, 9% in SC, and 10% in SC-simulated. CONCLUSION In patients with a standard SC-ICD indication, DC-ICD was associated with less CSAE when compared with SC-ICD.

The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring

Background Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. Objective The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. Methods In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. Results The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25th-75th percentile, 1-4) days vs 29 (25th-75th percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). Conclusions RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. Trial Registration Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).

Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE‐CARE multicentre randomized controlled trial

The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT‐D) with advanced diagnostics.

Managed ventricular pacing compared with conventional dual-chamber pacing for elective replacement in chronically paced patients: results of the Prefer for Elective Replacement Managed Ventricular Pacing randomized study

BACKGROUND Several studies have shown that unnecessary right ventricular pacing has detrimental effects. OBJECTIVE To evaluate whether minimization of ventricular pacing as compared with standard dual-chamber pacing (DDD) improves clinical outcomes in patients referred for pacemaker or implantable cardioverter-defibrillator (ICD) replacement. METHODS In an international single-blind, multicenter, randomized controlled trial, we compared DDD with managed ventricular pacing (MVP), a pacing mode developed to minimize ventricular pacing by promoting intrinsic atrioventricular conduction. We included patients referred for device replacement with >40% ventricular pacing, no cardiac resynchronization therapy upgrade indication, no permanent atrial fibrillation (AF), and no permanent complete atrioventricular block. Follow-up was for 2 years. The primary end point was cardiovascular hospitalization. The intention-to-treat analysis was performed by using Kaplan-Meier method and the log-rank test. RESULTS We randomized 605 patients (556 referred for pacemaker and 49 referred for ICD replacement; mean age 75 ± 11 years; 365 [60%] men, at 7.7 ± 3.3 years from first device implantation) to MVP (n = 299) or DDD (n = 306). We found no significant differences in the primary end point cardiovascular hospitalization (MVP: 16.3% vs DDD: 14.5%; P = .72) and the secondary end point persistent AF (MVP: 15.4% vs DDD: 11.2%; P = .08), permanent AF (MVP: 4.1% vs DDD: 3.1%; P = .44), and composite of death and cardiovascular hospitalization (MVP: 23.9% vs DDD: 20.2%; P = .48). MVP reduced right ventricular pacing (median 5% vs 86%; Wilcoxon, P < .0001) as compared with DDD. CONCLUSIONS In patients referred for pacemaker and ICD replacement with clinically well-tolerated long-term exposure to >40% ventricular pacing in the ventricle, a strategy to minimize ventricular pacing is not superior to standard DDD in reducing incidence of cardiovascular hospitalizations.

The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: Rationale and design

BACKGROUND With the advent of remote monitoring, current models of implantable cardioverter defibrillators (ICDs) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload, atrial fibrillation and device integrity issues. Timely treatment of these events has the potential to improve patient outcome, but this has not as yet been proven. METHODS The MORE-CARE study is a multicenter randomized controlled trial evaluating the efficacy of advanced device diagnostics and remote monitoring in improving the outcome of patients with biventricular ICDs. Up to 1720 patients with a standard indication for a biventricular ICD will be randomized to standard in-office follow-up, or to a remote monitoring strategy using the CareLink network and involving automatic alerts for lung fluid overload, atrial fibrillation, and device integrity issues. The first phase aims at evaluating the delay between an alert event, and clinical action to the event. The second phase of the study will evaluate whether the remote monitoring strategy results in a significant reduction of a combined end point of total mortality or cardiovascular and device-related hospitalization. The duration of the study will be event-driven due to its sequential design. CONCLUSION MORE-CARE will evaluate the efficacy of remote monitoring for improving patient outcome in patients implanted with a biventricular ICD.

Recommendations of the European Cardiac Arrhythmia Society Committee on Device Failures and Complications

Recommendations of the European Cardiac Arrhythmia Society Committee on Device Failures and Complications MASSIMO SANTINI,* JOHANNES BRACHMANN,† RICCARDO CAPPATO,‡ WYN DAVIES,§ JERONIMO FARRE,‖ SAMUEL LEVY,¶ AURELIO QUESADA,# RENATO P. RICCI,** EDWARD ROWLAND,†† NEIL SULKE‡‡ From *San Filipo Neri Hospital, Rome, Italy, †Klinikum Coburg, Germany, ‡Policlinico S. Donato, Milan, Italy, §St. Mary Hospital, London, UK, ‖Fundacion Jimenez Diaz, Madrid, Spain, ¶Hopital Nord des Bourrellys, Marseille, France, #Hospital General University of Valencia, Spain, **San Filippo Neri Hospital, ††St. George Medical School, London, UK, ‡‡Eastbourne General Hospital, Sussex, UK

Dual defibrillator improves quality of life and decreases hospitalizations in patients with drug refractory atrial fibrillation.

AbstractAim of the study: to evaluate the impact of dual defibrillator implantation on quality of life and resource utilization in patients with drug refractory atrial fibrillation (AF) without prior ventricular arrhythmias. Methods: Forty patients (28 M, mean age 64 ± 10) received a dual defibrillator Medtronic 7250. AF was persistent in 60% and paroxysmal in 40%. Results: The follow-up lasted 15 ± 4 months (range 12–30). Eighty-five percent of patients had atrial tachyarrhythmia recurrences. Among 1366 treated episodes, overall success rate was 60.1% for antitachy pacing and 88.2% for atrial shock. Within one year after implant, arrhythmia related hospitalization number decreased from 1.5 ± 2.0 to 0.4 ± 0.8 (p < 0.01) and 77% of patients were free from hospitalization. As regard to quality of life, Symptom Checklist/Frequency and Severity Scale improved after implant for all items and SF-36 questionnaire showed significant improvements in physical activities because of health problems and social activities. The patients assigned to early delivery of atrial shock after AF onset, when compared with the patients who did not accept atrial shock, showed a significant reduction of AF burden, a higher reduction of hospitalization number and a greater improvement of quality of life. Conclusion: Dual defibrillator improved quality of life and decreased resource utilization in patients with drug refractory AF. Early delivering of atrial shock seems to be the most effective option.

Spanish Implantable Cardioverter-defibrillator Registry. Eleventh Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2014).

INTRODUCTION AND OBJECTIVES We present the results of the Spanish Implantable Cardioverter-defibrillator Registry for 2014, as compiled by the Electrophysiology and Arrhythmia Section of the Spanish Society of Cardiology. METHODS Data collection sheets were voluntarily completed by each implantation team and prospectively sent to the Spanish Society of Cardiology. RESULTS The number of reported implantations was 4911 (82% of the estimated total number of implantations). The implantation rate was 106 per million population while the estimated rate was 128. First implantations comprised 72.2%. Data were obtained from 162 hospitals (8 more than in 2013). Most implantations (82%) were performed in men. The mean patient age was 61.8±13.7 years. Most patients showed severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. The most frequent cardiac condition was ischemic heart disease, followed by dilated cardiomyopathy. Implantations for primary prevention indications comprised 58.5%. Electrophysiologists performed 85.6% of the implantations. CONCLUSIONS The 2014 Spanish Implantable Cardioverter-defibrillator Registry received information on 82% of the implantations performed in Spain. The number of implantations has increased from previous years and the percentage of implantations for primary prevention indications has increased from the previous year.