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.

Megan Joffe

and 10 more

OBJECTIVES The objectives of this study were to understand the challenges faced by early adopters of MIS mitral surgery in the national health system in the United Kingdom. It was to (i) capture the significance of the scrutiny introduced by reporting surgeon specific results during the introduction of surgical innovation, (ii) understand how individual personality and behaviour helped these surgeons succeed despite, in many cases, little wider support, (iii) to help more surgeons adopt these patient-centred techniques. SETTING AND PARTICIPANTS The study is based on a qualitative exploration of the reported experiences of all ten early adopters of MIS cardiac surgery in the NHS between 2006-2016. Interviewees were recruited by invitation through their professional society (BISMICS). All interviewees consented to the process; ethical permission was not deemed necessary. RESULTS The experience of introducing surgical innovation into the NHS was unanimously noted to be difficult with few incentives and many systemic and institutional obstacles. Despite this there was a general belief in pushing forward with these patient centred procedures while accumulating the evidence to support it. CONCLUSIONS Individual determination, confidence, mental agility and self-reflection were seen as characteristics of those who were successful. All surgeons agreed that the reporting of surgeon specific results were not conducive to adoption of innovation in teams. Starting a new program as two surgeons appeared to help reduce perceived pressures. Surgical innovation and its early adoption are always likely to be difficult and needs to be recognised as such, within the NHS