Implantable cardioverter defibrillator shock reduction using new antitachycardia pacing therapies.
The main purpose of ICDs is to abort sudden death by delivering therapy at the moment of tachycardia. Shocks accomplish this goal but are painful. Alternatively antitachycardia pacing is painless and if deemed safe may be reasonable substitute. Multiple trials show a high efficacy rate by ATP (78-94%) for treating VTs below 200 bpm. ATP has had less efficacy for faster VTs (41-79%) and have higher probability of accelerating tachycardia (5-55%). The PainFREE trials address these issues. The first pilot study PainFREE Rx applied standardized VT detection and ATP regimen to 220 patients with 1100 spontaneous episodes of VT. ATP success for slow VT success was 92% and fast VT > 188 bpm raw success rate was 89%. None of these trials randomize shock versus ATP so comparative safety data was missing. Thus, the PainFREE Rx II trial was designed to make direct safety comparison between shock and ATP therapies for fast VT > 188 bpm. It included 634 patients with either ischemic or nonischemic cardiomyopathy followed for 1 year yielding 1760 episodes of slow VT, fast VT plus VF. The results of the PainFREE Rx II trial showed that a single regimen of ATP, burst pace 8 pulses at 88% VT cycle length could safely terminate 77% of fast VT and 90% of slow VT. Consequently, shocks were reduced by 70% compared to the shock group. Furthermore, ATP was proven safe because there was no increase in sudden death, syncope or even arrhythmia acceleration compared to shock. The quality of life of the ATP group was found to be superior to the shock group validating ATP's intent. Secondary yet important findings also included the fact that by programming the ICD to wait for 18 beats in PainFREE Rx II before treating an episode reduced markedly the number of episodes treated when compared to 12 beat detection as done in PainFREE Rx I. Since syncope occurred in only 1% of episodes, the authors suggested that a longer wait for ICD detection needs to be evaluated.
Wathen
Mark
M
Vanderbilt University, Nashville, TN, USA. mark.wathen@mcmail.vanderbilt.edu
D002986:Clinical Trials as Topic; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004554:Electric Countershock / Q000009:adverse effects* / Q000379:methods*; D006801:Humans; D010146:Pain / Q000209:etiology* / Q000517:prevention & control*; D013610:Tachycardia / Q000517:prevention & control*