Abstract 19473: Safety and Efficacy of Second Generation Self Expanding Portico® Valve System for the Treatment of Failed Aortic Bioprosthesis: Results From an International Multicenter Valve-in-Valve Registry
Background: Portico valve is a second-generation self-expanding repositionable system with a nitinol stent frame and bovine pericardial leaflets, which is increasingly utilized for transcatheter aortic valve replacement (TAVR) . In this report, we describe the procedural and early clinical results from an international multicenter registry of Portico implantation in patients with degenerated aortic bioprosthesis (Portico ViV).
Methodology: Baseline data and outcomes were collected on standard case report forms and by the Valve-in-Valve International Data network from 14 centers across three continents. Procedural endpoints included implantation success and coronary obstruction. Clinical endpoints included death, myocardial infarction (MI), stroke, major bleeding at 30 days as defined by Valve Academic Research consortium II (VARCII).
Result: 45 patients undergoing Portico ViV were included in analysis. The mean age was 79± 7 years with STS (mortality) score of 7±4. These procedures had mainly utilized peripheral arterial access (93%), with transesophageal echocardiogram guidance (60%) for treatment of surgical valve label size ≤21, >21-<25, and ≥25mm in 36, 38 and 27% respectively. Four (9%) of the failed surgical bioprostheses were stentless. Successful implantation was achieved in 44 (98%) cases with no malposition events or clinically-evident coronary obstruction. Post implantation valve area was 1.3 ±0.4 cm2, mean gradient of 17.1 ± 7.7 mmHg and ≥ moderate aortic insufficiency was observed in 3 (7%). One death (2%) related to ischemic stroke occurred within 30 days. Major bleeding and vascular complication in 5 (11%) and 1 (2%) respectively. One patient required permanent pacemaker implantation (2%).
Conclusion: Results from this international multicenter registry show that Portico offers a safe and effective treatment of failed surgical bioprosthesis with an added advantage of device retrievability, resulting in low incidence of malpositioning and coronary obstruction. Additional studies and comparison with other transcatheter devices should further determine the hemodynamic and clinical performance of this device for selection of optimal treatment of high risk patients with failed surgical bioprostheses
Author Disclosures: S. Alnasser: None. D. Dvir: None. T. Walther: None. W. Kim: None. F. Bedogni: None. L. Testa: None. H. Amrane: None. A. Boven: None. H. Blomer: None. M. Pelletier: None. J. Rodes-Cabau: None. M. Del Trigo: None. N. van Mieghem,: None. P. de Jaegere: None. C. Frerker: None. G. Manoharan: None. M. Spence: None. S. Worthley: None. A. Asgar: None. R. Reda Ibrahim: None. C. Carmelo Sgroi: None. G. Gerlando Pilato: None. D. Stub: None. J. Webb: None. A. Cheema: None.
- © 2015 by American Heart Association, Inc.