Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial

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

Anticoagulation Bridging In Patients With Heartmate3 Left Ventricular Assist Device: A Regional Analysis Of The Momentum 3 Trial

Introduction: Advances in left ventricular assist device (LVAD) technologies have led to a significant improvement in pump hemocompatibility. Due to concerns of thromboembolic complications in older generation LVADs, bridging was commonly performed in patients with subtherapeutic INRs. The effects of this strategy on new generation devices are unclear. We analyzed management strategies of subtherapeutic INRs and their effect on outcomes in a subset of patients enrolled in MOMENTUM 3 trial (CAP and IDE). Methods: All patients enrolled in the MOMENTUM 3 trial (CAP and IDE) across 6 centers were screened for inclusion. Patients were included if they underwent implantation of an HMIII device and had a subtherapeutic INR following discharge from their admission for LVAD implant. All episodes of subtherapeutic INR underwent manual chart review to evaluate management strategies taken by clinicians. Strategies were divided into two groups, bridging (with parenteral or intravenous agents) or non-bridging (consisting of adjustments or no change in coumadin dosing). The primary outcome was a composite of death, rehospitalization, CVA, and bleeding events. Results: Of the 225 patients included in the analysis there were total of 235 subtherapeutic INR events. Fifty-six (23.8%) of these INR\u27s were treated with bridging (n= 30 with parenteral agents, n=26 with IV agents) and 179 patients that were not bridged (n=100 coumadin dose adjustment, n=79 no change in coumadin dose). There was no difference in the composite outcome of patients that were bridged compared to those that were not. Conclusion: Subtherapeutic INR is a common event in patients with HM3 LVAD. The management strategy of subtherapeutic INR varies. Management strategy had no effect on mortality, rehospitalization, CVA, or bleeding events

Anticoagulation bridging in patients with left ventricular assist device: A regional analysis of HeartMate 3 recipients

Advances in left ventricular assist device technologies have led to an improvement in pump hemocompatibility and outcomes. Because of concerns of thromboembolic complications in prior generations of left ventricular assist devices, bridging with parenteral anticoagulants was routinely. Management strategies of subtherapeutic INRs and their effects on the current generation of devices deserve review. We performed analysis of the MOMENTUM 3 trial including 6 centers in the mid-America region. Patients with subtherapeutic INRs (INR \u3c 2) occurring after the index admission underwent chart review to determine the management strategies taken by clinicians. Strategies were divided into two groups, bridging or nonbridging. Of the 225 patients included in the analysis, 130 (58%) patients had a total of 235 subtherapeutic international normalized ratio (INR) events. Most (n = 179, 76.2%) of these INRs were not bridged (n = 100 warfarin dose adjustment, n = 79 no change in warfarin dose). Among those INRs (n = 56, 23.8%) treated with bridging, approximately half (n = 30, 53.6%) were treated with subcutaneous agents and other half (n = 26, 46.4%) were treated with intravenous agents. There was no difference in individual outcomes or composite endpoints of death, rehospitalization, CVA, or bleeding events between the groups

Health-related quality of life in patients with a left ventricular assist device (QOLVAD) questionnaire : Initial psychometrics of a new instrument

Background Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. Objective We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. Methods In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. Results Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79–.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). Conclusion Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed

Health-Related Quality of Life in Patients With a Left Ventricular Assist Device (QOLVAD) Questionnaire

Background Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. Objective We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. Methods In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. Results Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79–.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). Conclusion Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed

Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.

Background: Heart failure (HF) is associated with both mortality and a significant decline in health status. Inter-atrial shunting is increasingly being investigated as a novel therapeutic option. Objectives: The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURETM Transcatheter Shunt System in patients with symptomatic HF. Methods: 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure (PCWP) \u3e15mmHg at rest or 25mmHg during exercise. Results: Between May 2018 and September 2022, 87 patients underwent attempted APTURETM shunt implantation. Mean age was 71 years, and 53% were male. At baseline mean LVEF was 59% with 90% of the patients being NYHA III. Device success was achieved in 78 (90%) of patients with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 (2.3%) patients at 30 days. At 6 months health status improved: 68% of participants achieved NYHA I-II status, with a 23-point improvement (p\u3c0.0001, 95% CI [17, 29]) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-watt exercise pulmonary capillary wedge pressure was -7mmHg lower (p\u3c0.0001, 95% CI [-11, -4]) without change in right atrial pressure or other right heart function indices. Conclusions: In this single-arm experience, the APTURETM Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in PCWP and clinically meaningful improvements in HF symptoms and quality of life indices. Keywords: HFpEF; HFrEF; atrial shunting; coronary sinus; heart failure; inter-atrial shunting; left atrial