Antonio Curnis

Implantable Cardioverter-Defibrillator Therapy for Prevention of Sudden Death in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia

Background—Arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D) is a condition associated with the risk of sudden death (SD). Methods and Results—We conducted a multicenter study of the impact of the implantable cardioverter-defibrillator (ICD) for prevention of SD in 132 patients (93 males and 39 females, age 40±15 years) with ARVC/D. Implant indications were a history of cardiac arrest in 13 patients (10%), sustained ventricular tachycardia in 82 (62%), syncope in 21 (16%), and other in 16 (12%). During a mean follow-up of 39±25 months, 64 patients (48%) had appropriate ICD interventions, 21 (16%) had inappropriate interventions, and 19 (14%) had ICD-related complications. Fifty-three (83%) of the 64 patients with appropriate interventions received antiarrhythmic drug therapy at the time of first ICD discharge. Programmed ventricular stimulation was of limited value in identifying patients at risk of tachyarrhythmias during the follow-up (positive predictive value 49%, negative predictive value 54%). Four patients (3%) died, and 32 (24%) experienced ventricular fibrillation/flutter that in all likelihood would have been fatal in the absence of the device. At 36 months, the actual patient survival rate was 96% compared with the ventricular fibrillation/flutter-free survival rate of 72% (P <0.001). Patients who received implants because of ventricular tachycardia without hemodynamic compromise had a significantly lower incidence of ventricular fibrillation/flutter (log rank=0.01). History of cardiac arrest or ventricular tachycardia with hemodynamic compromise, younger age, and left ventricular involvement were independent predictors of ventricular fibrillation/flutter. Conclusions—In patients with ARVC/D, ICD therapy provided life-saving protection by effectively terminating life-threatening ventricular arrhythmias. Patients who were prone to ventricular fibrillation/flutter could be identified on the basis of clinical presentation, irrespective of programmed ventricular stimulation outcome.

Long-term survival in patients undergoing cardiac resynchronization therapy: the importance of performing atrio-ventricular junction ablation in patients with permanent atrial fibrillation

Aims To investigate the effects of cardiac resynchronization therapy (CRT) on survival in heart failure (HF) patients with permanent atrial fibrillation (AF) and the role of atrio-ventricular junction (AVJ) ablation in these patients. Methods and results Data from 1285 consecutive patients implanted with CRT devices are presented: 1042 patients were in sinus rhythm (SR) and 243 (19%) in AF. Rate control in AF was achieved by either ablating the AVJ in 118 patients (AVJ-abl) or prescribing negative chronotropic drugs (AF-Drugs). Compared with SR, patients with AF were significantly older, more likely to be non-ischaemic, with higher ejection fraction, shorter QRS duration, and less often received ICD back-up. During a median follow-up of 34 months, 170/1042 patients in SR and 39/243 in AF died (mortality: 8.4 and 8.9 per 100 person-year, respectively). Adjusted hazard ratios were similar for all-cause and cardiac mortality [0.9 (0.57–1.42), P = 0.64 and 1.00 (0.60–1.66) P = 0.99, respectively]. Among AF patients, only 11/118 AVJ-abl patients died vs. 28/125 AF-Drugs patients (mortality: 4.3 and 15.2 per 100 person-year, respectively, P < 0.001). Adjusted hazard ratios of AVJ-abl vs. AF-Drugs was 0.26 [95% confidence interval (CI) 0.09–0.73, P = 0.010] for all-cause mortality, 0.31 (95% CI 0.10–0.99, P = 0.048) for cardiac mortality, and 0.15 (95% CI 0.03–0.70, P = 0.016) for HF mortality. Conclusion Patients with HF and AF treated with CRT have similar mortality compared with patients in SR. In AF, AVJ ablation in addition to CRT significantly improves overall survival compared with CRT alone, primarily by reducing HF death.

Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure

AIMS We performed a randomized, double blind, crossover study of cardiac contractility modulation (CCM) signals in heart failure patients. METHODS AND RESULTS One hundred and sixty-four subjects with ejection fraction (EF) < 35% and NYHA Class II (24%) or III (76%) symptoms received a CCM pulse generator. Patients were randomly assigned to Group 1 (n = 80, CCM treatment 3 months, sham treatment second 3 months) or Group 2 (n = 84, sham treatment 3 months, CCM treatment second 3 months). The co-primary endpoints were changes in peak oxygen consumption (VO2,peak) and Minnesota Living with Heart Failure Questionnaire (MLWHFQ). Baseline EF (29.3 +/- 6.7% vs. 29.8 +/- 7.8%), VO2,peak (14.1 +/- 3.0 vs. 13.6 +/- 2.7 mL/kg/min), and MLWHFQ (38.9 +/- 27.4 vs. 36.5 +/- 27.1) were similar between the groups. VO2,peak increased similarly in both groups during the first 3 months (0.40 +/- 3.0 vs. 0.37 +/- 3.3 mL/kg/min, placebo effect). During the next 3 months, VO2,peak decreased in the group switched to sham (-0.86 +/- 3.06 mL/kg/min) and increased in patients switched to active treatment (0.16 +/- 2.50 mL/kg/min). MLWHFQ trended better with treatment (-12.06 +/- 15.33 vs. -9.70 +/- 16.71) during the first 3 months, increased during the second 3 months in the group switched to sham (+4.70 +/- 16.57), and decreased further in patients switched to active treatment (-0.70 +/- 15.13). A comparison of values at the end of active treatment periods vs. end of sham treatment periods indicates statistically significantly improved VO2,peak and MLWHFQ (P = 0.03 for each parameter). CONCLUSION In patients with heart failure and left ventricular dysfunction, CCM signals appear safe; exercise tolerance and quality of life (MLWHFQ) were significantly better while patients were receiving active treatment with CCM for a 3-month period.

Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry.

Aims The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management. Methods and results The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5–86.0%] and 97.4% (CI, 96.5–98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1–14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53–0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0–107.0) min × health personnel/100 patients. Conclusion Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.

Atrial fibrillation in heart failure patients: Prevalence in daily practice and effect on the severity of symptoms. Data from the ALPHA study registry

Estimates of the prevalence of atrial fibrillation (AF) in heart failure (HF) originate from patients enrolled in clinical trials.

A review of multisite pacing to achieve cardiac resynchronization therapy

Non-response to cardiac resynchronization therapy remains a significant problem in up to 30% of patients. Multisite stimulation has emerged as a way of potentially overcoming non-response. This may be achieved by the use of multiple leads placed within the coronary sinus and its tributaries (dual-vein pacing) or more recently by the use of multipolar (quadripolar) left ventricular pacing leads which can deliver pacing stimuli at multiple sites within the same vein. This review covers the role of multisite pacing including the interaction with the underlying pathophysiology, the current and planned studies, and the potential pitfalls of this technology.

Hybrid approach for the treatment of long-standing persistent atrial fibrillation: electrophysiological findings and clinical results †

OBJECTIVES The sequential, staged hybrid approach has recently emerged as a novel strategy for the treatment of long-standing persistent atrial fibrillation (AF); nevertheless, the potential modifications in terms of electrophysiological findings and their correlation with mid-term results have not been fully elucidated so far. METHODS Forty-five patients with long-standing persistent AF underwent a hybrid procedure combining surgical closed-chest posterior left atrium (LA) and pulmonary veins (PV) isolation (box lesion) first, followed by transcatheter evaluation at least 1 month afterwards. Electrophysiological findings and their correlation with rhythm outcomes were assessed at different time points, i.e. following the surgical ablation (T1), during (T2) and at the end (T3) of the transcatheter evaluation and at 28-month follow-up (T4). RESULTS At T1, exit and entrance blocks were achieved in 100 and 91.1% (41 of 45) of patients, respectively. At T2, the percentage of conduction block was unchanged, while at T3 also entrance block was achieved in all instances. In terms of electrophysiological findings (at T2), PV reconnection occurred in 6.7% (3 of 45) of patients, fractionated electrograms were targeted in 44.4% (20 of 45) while right atrium isthmus lesion was performed in 24.4% (11 of 45) of patients. Sinus rhythm was restored in 75.6% (34 of 45) at T1, at T2 (with AF induction) in 68.9% (31 of 45), at T3 in 93.3% (42 of 45) and at T4 in 88.9% (40 of 45) of patients, respectively. In those patients with a bidirectional block at T1, sinus rhythm restoration steadily improved from 78 (32 of 41) at T1 to 82.9 (34 of 41) at T2 and finally 92.6% (38 of 41) at T4. CONCLUSION Complete posterior LA and PV isolation with the box lesion in a staged hybrid approach is associated with incremental benefits in terms of sinus rhythm maintenance in patients with long-standing persistent AF.

Multicenter Experience with Transvenous Lead Extraction of Active Fixation Coronary Sinus Leads

Background/Objective: Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding extraction of chronically implanted active fixation CS leads are limited.

Long-Term Survival in Patients Treated with Cardiac Resynchronization Therapy: A 3-Year Follow-Up Study from the InSync/InSync ICD Italian Registry

Background: Studies reporting the long‐term survival of patients treated with cardiac resynchronization therapy (CRT) outside the realm of randomized controlled trials are still lacking. The aim of this study was to quantify the survival of patients treated with CRT in clinical practice and to investigate the long‐term effects of CRT on clinical status and echocardiographic parameters.

Cost-Utility Analysis of the EVOLVO Study on Remote Monitoring for Heart Failure Patients With Implantable Defibrillators: Randomized Controlled Trial

Background Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. Objective We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. Methods Two hundred patients implanted with a wireless transmission–enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. Results Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. Conclusions Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations. Trial Registration ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).