One-Year Results From the COMPASSION S3 Trial: Treatment of Patients With a Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit or Previously Implanted Pulmonic Valve With the SAPIEN 3 Transcatheter Heart Valve
Presenter
Vasilis C. Babaliaros, M.D., Emory University, Atlanta, GA
Vasilis C. Babaliaros, M.D., Emory University, Atlanta, GA, Dennis W. Kim, M.D., Ph.D., FSCAI, Children's Healthcare of Atlanta - Egleston, Atlanta, GA, Jamil A. Aboulhosn, M.D., FSCAI, Ahmanson/UCLA ACHD Center, Los Angeles, CA, Daniel S. Levi, M.D., FSCAI, David Geffen School of Medicine at UCLA, Pacific Palisades, CA, Gregory A. Fleming, M.D., FSCAI, Duke University Medical Center, Durham, NC, Michael Hainstock, M.D., The University of Virginia, Charlottesville, VA, Robert J. Sommer, M.D., NewYork-Presbyterian Columbia University Irving Medical Center, New York, NY, Alejandro J. Torres, M.D., FSCAI, NewYork-Presbyterian Morgan Stanley Children's Hospital, Larchmont, NY, Girish Shirali, M.D., Children's Mercy Hospital, Kansas City, CA, Jeremy Gorelick, PhD, Edwards Lifesciences, Irvine, CA and D. Scott Lim, M.D., The University of Virginia School of Medicine, Charlottesville, VA
Keywords: Structural Heart Disease (SHD) and TPVR/Pulmonary Valve
Background:
Significant pulmonary regurgitation (PR) and pulmonary stenosis are common in right ventricle to pulmonary artery conduits and bioprosthetic pulmonary valves after the surgical repair of congenital heart defects.
Methods:
This prospective, single-arm, multicenter trial evaluated the safety and effectiveness of SAPIEN 3 transcatheter heart valve (THV) in patients with a dysfunctional RVOT conduit or previously implanted valve in the pulmonic position and at least moderate-to-severe PR and/or a mean RVOT gradient ≥ 35 mmHg. The primary endpoint was a non-hierarchical composite of THV dysfunction at 1 year including: RVOT re-intervention, moderate or greater total PR, and mean RVOT gradient > 40 mmHg. A performance goal of less than 25% was pre-specified for the primary endpoint using a 95% exact binomial confidence interval (CI).
Results:
Enrollment of 58 patients occurred from July 2016 to June 2018. The mean age was 32 years. At 1 year, the primary endpoint composite was 4.3% (2/47). Components of the composite included 0 (0/56) RVOT re-intervention, 2.1% (1/47) moderate or greater PR (Figure 1), and 2.1% (1/48) mean RVOT gradient > 40 mmHg. At 30 days, there were no major CEC-adjudicated adverse events. At 1 year, no mortality, endocarditis, tricuspid injury, or valve malposition was reported.
Conclusions:
These results support the safety and effectiveness of the SAPIEN 3 THV in patients with dysfunctional RVOT conduits or previously implanted valves in the pulmonic position to 1 year. 