Why the study?
Ventricular tachyarrhythmia reduces LVAD efficacy and worsens clinical outcomes and mortality, but whether prophylactic intra-operative ablation at LVAD implantation reduces recurrence remains unproven.
Does prophylactic intra-operative VTA ablation reduce recurrent VTA and adverse events in LVAD candidates with a history of VTA?
Does prophylactic intra-operative VTA ablation reduce recurrent VTA and adverse events in LVAD candidates with a history of VTA?
The PIVATAL trial is the first randomized trial designed to assess whether prophylactic intra-operative ablation during LVAD surgery reduces ventricular tachyarrhythmia recurrence.
Hypothesis-generating for prophylactic intra-operative VTA ablation at LVAD implantation; leaves open impact on recurrent VT or outcomes.
BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.
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Huang et al. (2023) studied this question.
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