Impact Of Congenital Bicuspid Valve On Outcomes And Hemodynamic Performance Of A Stented Bovine Pericardial Aortic Valve
Louis Labrousse1, Michiel D. Vriesendorp2, Martin Misfeld3, Michael J. Reardon4, Thorsten C.W. Wahlers5, Robert J. Steffen6, Elizabeth Gearhart7, Joseph F. Sabik, III8, Robert J.M. Klautz2.
1Hopital Haut Lévèque, PESSAC, France, 2Leiden University Medical Center, Leiden, Netherlands, 3Heart Center Leipzig, Leipzig, Germany, 4Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA, 5Heart Center, University Hospital Cologne, Cologne, Germany, 6Abbott Northwestern Hospital, Minneapolis, MN, USA, 7Medtronic, Mounds View, MN, USA, 8University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
BACKGROUND: To compare baseline and procedural data and 2-year outcomes between patients with congenital bicuspid versus tricuspid valve disease undergoing surgical aortic valve replacement (SAVR). METHODS: This is a post hoc analysis of the PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial, a prospective, nonrandomized multicenter study of consecutive patients receiving a bovine pericardial aortic valve. Patients were stratified according to the presence of a congenital bicuspid or tricuspid valve. Mortality and valve-related safety events were assessed by Kaplan-Meier analysis. Mean aortic gradient and effective orifice area (EOA) were evaluated to assess hemodynamic performance. RESULTS: 1076 patients were analyzed; 328 patients had a bicuspid valve, and 748 had a tricuspid valve. Patients with a bicuspid valve were younger than those with a tricuspid valve (64.3±9.5 vs 72.9±7.2 y, respectively; P<0.01) and had a lower Society of Thoracic Surgeons (STS) risk of mortality (1.3±0.8% vs 2.3±1.4%; P<0.01). Baseline mean gradient was 44.4±18.2 mmHg (n=318) in the bicuspid group and 41.6±16.1 mmHg (n=728) in the tricuspid group (P=0.02); EOA was 0.91±0.61 cm2 (n=304) and 0.87±0.44 cm2 (n=674), respectively (P=0.36). Patients in the bicuspid group more frequently underwent surgery through a right thoracotomy (34/328 [10.4%]) than those in the tricuspid group (35/748 [4.7%]) (P<0.01). Concomitant coronary artery bypass grafting was less frequent in the bicuspid than the tricuspid group (60/328 [18.3%] vs 294/748 [39.3%]; P<0.01). Larger valves (25, 27 mm) were more common in the bicuspid group (P<0.01). The Kaplan-Meier all-cause mortality rate was higher in the tricuspid group at 2 years; Kaplan-Meier estimates for clinical safety events are shown in the Table. At 2 years, mean aortic gradient was 13.5±5.7 mmHg (n=237) in the bicuspid group and 13.1±4.6 mmHg (n=525) in the tricuspid group (P=0.35); EOA was 1.51±0.44 cm2 (n=226) and 1.46±0.35 cm2 (n=507), respectively (P=0.16). CONCLUSIONS: Patients with a congenital bicuspid aortic valve were younger and had lower STS mortality risk scores than patients with a tricuspid valve, and unadjusted mortality after SAVR was lower among patients in the bicuspid group. Hemodynamic performance at 2 years was similar between groups. Adjusted outcomes will be provided at the presentation.LEGEND: Kaplan-Meier Event Rates to 2 Years in Patients With a Congenital Bicuspid or Tricuspid Aortic Valve Who Underwent Valve Replacement With a Stented Bovine Pericardial Valve1Subjects may have >1 event. 2Log-rank test.
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