ABSTRACT
AIMS: Shock therapy delivery by implantable cardioverter-defibrillators (ICD) can be painful and may have negative psychological consequences. Reducing shock burden for patients with ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) may have beneficial consequences. This may be achieved by avoiding inappropriate shocks for supraventricular tachycardia (SVT) and by limiting appropriate shocks to only those that are necessary to convert ventricular arrhythmias. METHODS AND RESULTS: The programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock study (PROVIDE) is a prospective, randomized, multicentre study that will test the hypothesis that a combination of pre-selected ventricular tachyarrhythmia detection, anti-tachycardia pacing, and SVT discriminator parameters will prolong the time to first shock without increasing arrhythmic syncope in patients receiving ICDs for primary prevention. Patients receiving St Jude Medical ICDs and CRT-Ds for primary prevention will be randomized 1:1 to one of two arrhythmia detection and therapy approaches. The study will enroll and follow 1600 patients for at least 1 year or until 226 first shocks have been documented in the total study population. The primary endpoint of the study is the mean time to first shock and the safety endpoint is the rate of arrhythmic syncope. CONCLUSION: The PROVIDE trial is a randomized controlled study, designed to assess if a pre-selected combination of programming parameters can reduce shock burden among patients receiving ICDs/CRT-Ds for primary prevention.
Subject(s)
Cardiac Pacing, Artificial/methods , Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Primary Prevention , Tachycardia, Supraventricular/diagnosis , Electrocardiography , Humans , Incidence , Proportional Hazards Models , Prospective Studies , Syncope/epidemiology , Tachycardia, Supraventricular/physiopathology , Time FactorsABSTRACT
OBJECTIVES: the PROVE trial was designed to determine if antitachycardia pacing (ATP) is clinically beneficial for primary prevention in patients who have implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds). BACKGROUND: use of ICDs and CRT-Ds reduces mortality in patients with ventricular dysfunction and mild to moderate heart failure. However, in studies of the primary prevention population, shock-only ICDs are predominantly used, without ATP programming for less painful termination of ventricular tachycardia (VT). METHODS: we conducted a prospective, nonrandomized, multicenter study using market-released ICDs and CRT-Ds. Patients received devices programmed to deliver ATP for VT cycle lengths of 270-330 ms. Follow-up evaluation was performed at 3, 6, and 12 months. The incidence of VT and the rate of successful termination by ATP were analyzed. RESULTS: of 830 patients in the study population (men, 73%; mean age, 67.3 ± 12 years), 32% received single-chamber ICDs, 44% dual-chamber ICDs, and 24% CRT-Ds. ATP was attempted for 112 VT episodes in 71 patients, and 103 (92%) of the VT episodes were successfully terminated. Three VT episodes were accelerated by ATP and required termination by ICD shock; 6 episodes terminated spontaneously or by ICD shock. CONCLUSIONS: VT is common in patients without a history of this arrhythmia who have received ICDs or CRT-Ds for primary prevention indications. Programming ICDs for ATP therapy at the time of implantation could potentially terminate most VT episodes and reduce the number of painful shocks for these patients.
