CRT-700.1 Multi-Center Compassionate use Early Feasibility Evaluation of J-Valve Transcatheter Treatment for Severe Aortic Valve Regurgitation: Preliminary Results

Background: Although transcatheter aortic valve replacement (TAVR) is accepted therapy for treatment of symptomatic severe aortic valve stenosis (AS), current devices are associated with increased procedural complications and sub-optimal outcomes when used to treat of aortic valve regurgitation (AR). Severe AR is the indication for 20-30% of surgical aortic valve replacements and is associated with increased morbidity and mortality. J-valve is a short frame, self-expanding TAVR device. (Figure) specifically designed for treatment of severe AR. Anchor rings facilitate commissural alignment and secure attachment to non-calcified native valves. Methods: From Sept 2019 through Oct 2022, patients with symptomatic severe AR who were not surgical candidates or excluded from the ALIGN-AR trial were enrolled into a compassionate use early feasibility study at 5 North American centers. All patients signed informed consent for protocol approved by respective institutional review boards. Results: Data from 13/28 patients (mean age 80 yrs; 38.5% male) with symptomatic (92.3% NYHA class III/IV; mean LVEF 48% [range 23-64%]) severe (92% grade III/IV) AR, atrial fibrillation (53.8%), and pacemaker/ICD (15.4%), had J-valve TAVR (15.4% alternative access). There were no deaths to 30 days and post-procedural AR grade was none/trivial in all patients. In follow-up (mean 333 days) there are 0 cardiac deaths (total mortality 30.7%; 3 malignancies, 1 sepsis). Serial echocardiograms demonstrate AR grade none/mild in 89%, and 100% at 30 days and 1 year respectively). Conclusion: Despite high risk profile, preliminary analysis of this multi-center compassionate use study suggests that J-valve is safe with durable effectiveness for the treatment of symptomatic severe AR. Full data set on all patients will be presented

Ultrasound-Guided Continuous Bilateral Erector Spinae Plane Blocks Are Associated with Reduced Opioid Consumption and Length of Stay for Open Cardiac Surgery: A Retrospective Cohort Study

This study tested the hypothesis that continuous bilateral erector spinae plane blocks placed preoperatively would reduce opioid consumption and improve outcomes compared with standard practice in open cardiac surgery patients. Patients who received bilateral continuous erector spinae plane blocks for primary open coronary bypass, aortic valve, or ascending aortic surgery were compared to a historical control group. Patients in the block group received a 0.5% ropivacaine bolus preoperatively followed by a 0.2% ropivacaine infusion begun postoperatively. No other changes were made to the perioperative care protocol. The primary outcome was opioid consumption. Secondary outcomes were time to extubation and length of stay. Twenty-eight patients received continuous erector spinae plane blocks and fifty patients served as historic controls. Patients who received blocks consumed less opioids, expressed as oral morphine equivalents, both intraoperatively (34 ± 17 vs. 224 ± 125 mg) and during their hospitalization (224 ± 108 vs. 461 ± 185 mg). Patients who received blocks had shorter times to extubation (126 ± 87 vs. 257 ± 188 min) and lengths of stay in the intensive care unit (35 ± 17 vs. 58 ± 42 h) and hospital (5.6 ± 1.6 vs. 7.7 ± 4.6 days). Continuous erector spinae plane blocks placed prior to open cardiac surgical procedures reduced opioid consumption, time to extubation, and length of stay compared to a standard perioperative pathway