Steven Tsui

and 9 more

Introduction The Carpentier-Edwards PERIMOUNT Magna Ease valve is a third-generation bioprosthesis for aortic valve replacement (AVR). This is a postapproval study reporting on its 8‑year outcomes. Methods Adults undergoing AVR with the Magna Ease valve between October 2007 and December 2012 were enrolled for this prospective, nonrandomized, single‑arm, multicenter study. Assessments occurred preoperatively, at hospital discharge, 6 months, 1 year, and annually thereafter up to 8 years. Outcomes included safety endpoints, hemodynamic performance, and New York Heart Association (NYHA) Functional Class. Results Of the 258 study patients, 67.5% were in NYHA Class I or II, and 32.5% were in NYHA Class III or IV at baseline. Concomitant procedures were performed in 44.2%. Total follow-up was 1,597.6 patient-years, median follow‑up was 7 years (interquartile range: 5.5–8.0 years). Eight years following AVR, functional class remained improved from baseline with 93.9% in NYHA Class I/II and 6.1% in NYHA Class III; thirty-eight deaths had occurred, eight of which were valve related; freedom from all‑cause mortality was 80.7% (95% confidence intervals 74.9, 86.4); freedom from valve-related mortality was 95.8% (92.8, 98.8); freedom from reintervention, explant, major bleeding events, and structural valve deterioration were 89.8% (85.1, 94.6), 94.8% (91.7, 97.9), 85.1% (80.0, 90.1), and 90.1% (84.7, 95.4), respectively; effective orifice area was 1.5±0.5 cm 2, mean gradient was 14.8±8.3 mmHg, and 88.6% of patients had no or trivial aortic regurgitation. Conclusions This study demonstrated satisfactory safety and sustained hemodynamic and functional improvements at 8 years following AVR with the Magna Ease valve.
Background Post-Cardiotomy ECMO (PC-ECMO) represents a unique subset of critically ill patients, with a paucity of data regarding long-term survival, and characteristics correlated with short and long-term outcomes. We present a retrospective cohort PC patients supported with ECMO at a single institution, with outcomes at 1 and 3-year follow-up. Methods Data was collected retrospectively for all patients requiring ECMO within 72 hours of index cardiac operation, excluding assist devices and heart transplantation. Operative data, frozen mediastinum status, cannulation site, postoperative hemorrhage, and timing of cannulation (immediate versus delayed) were all collected and examined. Primary outcomes were ability to wean from ECMO, hospital survival, and long-term survival. Results 33 patients required PC ECMO, representing a total of 179 days of ECMO support. Overall survival data were: ability to wean 61%, hospital survival 55%, one month survival 45%. The estimated 12 and 36 month survival for all PC ECMO patients was 40% and 33% respectively. Twelve and 36 month survival for all hospital survivors was 66% and 60% respectively. Operative times, type of operation performed, open chest status, reoperation for hemorrhage and cannulation location (central/peripheral) were all compared. There were no statistically significant relationships of these variables short or long-term survival. Conclusions Overall 12 month survival for PC-ECMO patients was 40%, and was 33% at 36 months. For hospital survivors, 1 year survival was 66%, and was 60% at 36 months. These data support PC-ECMO as a reasonable salvage strategy, with mid-term survival comparable to other surgically treated diseases.