International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches

Objective To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. Methods Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy ( n = 266) or ministernotomy ( n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. Results Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. Conclusions In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.

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“…Indications for sutureless AVR were driven by recommendations of the International Consensus on Sutureless valves. 19…”

Section: The Device Is Available In 4 Sizes (S-m-l-xl)mentioning

confidence: 99%

Minimally Invasive Aortic Valve Replacement with Sutureless Valves: Results From an International Prospective Registry

Glauber

Bacco

Cuenca

et al. 2019

Innovations�(Phila)

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“…93 At the same time, two additional groups of experts recently published two consensus papers on sutureless and rapid deployment valve in standard approach and in MI approaches. 17,94 The first series of recommendations concern sutureless AVR in comparison with stented AVR are found in Supplemental Table 8, http://links.lww.com/INNOV/A129. 17 The second series of recommendations concern MI sutureless AVR and are found in Supplemental Table 9, http://links.lww.com/ INNOV/A130.…”

Section: Guidelines and Recommendationsmentioning

confidence: 99%

“…17,94 The first series of recommendations concern sutureless AVR in comparison with stented AVR are found in Supplemental Table 8, http://links.lww.com/INNOV/A129. 17 The second series of recommendations concern MI sutureless AVR and are found in Supplemental Table 9, http://links.lww.com/ INNOV/A130. 94…”

Section: Guidelines and Recommendationsmentioning

confidence: 99%

The Perceval Sutureless Aortic Valve

Powell

Pelletier

Chu

et al. 2017

Innovations�(Phila)

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Surgical aortic valve replacement with a stented prosthesis has been the standard of care procedure for aortic stenosis. The Perceval (LivaNova, London, United Kingdom) is a sutureless aortic valve bioprosthesis currently implanted in more than 20,000 patients. The purpose of this article was to review the literature available after 9 years of clinical experience of the Perceval aortic valve. PubMED, Embase, and the Cochrane Library databases were searched. A meta-analysis of summary statistics from individual studies was conducted. A total of 333 studies were identified and 84 studies were included. Thirty-day mortality and 5-year survival ranged from 0% to 4.9% and 71.3% to 85.5%, respectively. Compared with stented prosthesis, pooled analysis demonstrated a statistically significant reduction in aortic cross-clamp and cardiopulmonary bypass times (minutes) with Perceval (38.6 vs 63.3 and 61.4 vs 84.9, P < 0.00001, respectively). Compared with transcatheter aortic valve implantation, pooled analysis demonstrated a statistically significant reduction with Perceval in paravalvular leakage (1.26% vs 14.31%) and early mortality (2.3% vs 6.9%). Favorable hemodynamics, acceptable valve durability, and ease of implantation in minimally invasive cases were reported as benefits. A trend toward increased rates of permanent pacemaker implantation and low postoperative platelet count were identified. Special use and off-label procedures described included bicuspid aortic valves, valve-in-valve for homo-graft and stentless prosthesis failure, concomitant valvular procedures, porcelain aorta, and endocarditis. The Perceval valve has shown safe clinical and hemodynamic outcomes. Outcomes support its continued usage and potential expansion.

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“…One of the concerns in minimally invasive surgery has been the longer CCT and CPB times, particularly when using a right anterior mini thoracotomy approach 28. Therefore, the use of SU-AVR may help reduce operative times and has been recommended by some authors 29. However, standardised techniques and high-volume practice can also reduce operative times 30…”

Section: Specific Indications For Sutureless Valvesmentioning

confidence: 99%

Sutureless aortic valve prostheses

Bilkhu

Borger

Briffa

et al. 2019

Heart

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Conventional surgical aortic valve replacement (AVR) is the ‘gold standard’ for treatment of severe or symptomatic aortic valve stenosis. The increasing age of patients and increasing comorbidities has led to the development of procedures to minimise operative time and reduce risks of surgery. One method of reducing operative times is the use of sutureless aortic valves (SU-AVR). We examine the current literature surrounding the use of SU-AVR. Alternatives to AVR are SU-AVR, sometimes referred to as rapid deployment valves, or transcatheter aortic valve implantation (TAVI). TAVI has been demonstrated to be superior over medical therapy in patients deemed inoperable and non-inferior in high and intermediate-risk patients compared with surgical AVR. However, the lack of excision of the calcified aortic valve and annulus raises concerns regarding long-term durability and possibly thromboembolic complications. TAVI patients have increased rates of paravalvular leaks, major vascular complications and pacemaker implantation when compared with conventional AVR. SU-AVR minimises the need for suturing, leading to reduced operative times, while enabling complete removal of the calcified valve. The increase in use of SU-AVR has been mostly driven by minimally invasive surgery. Other indications include patients with a small and/or calcified aortic root, as well as patients requiring AVR and concomitant surgery. SU-AVR is associated with decreased operative times and possibly improved haemodynamics when compared with conventional AVR. However, this has to be weighed against the increased risk of paravalvular leak and pacemaker implantation when deciding which prosthesis to use for AVR.

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International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches

Cited by 47 publications

References 60 publications

Minimally Invasive Aortic Valve Replacement with Sutureless Valves: Results From an International Prospective Registry

Minimally Invasive Aortic Valve Replacement with Sutureless Valves: Results From an International Prospective Registry

The Perceval Sutureless Aortic Valve

Sutureless aortic valve prostheses

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