Nearly 20 years have passed since the adoption of minimally invasive approaches gained traction in our country, approximately the same period we incorporated sutureless bioprosthesis implantation into our technical arsenal (including the now-discontinued ATS/Medtronic 3F). Upholding the principle imparted by our mentors—”neither be the first to adopt a technique nor the last to abandon it”—sufficient time has passed to solidify data on this type of prosthesis. Since its inception, the Perceval prosthesis has attracted equal support and criticism, suggesting that, as in many aspects of our field and life, virtue lies at the center.

Regardless, aortic valve replacement (AVR) remains a relevant technique with excellent outcomes for managing primary aortic valve disease, whether in the form of stenosis, regurgitation of degenerative or rheumatic origin, or various forms of dual lesions. According to the STS registry, AVR mortality has improved from 4.3% to 2.6%. Nonetheless, the patient profile undergoing surgery has evolved with the advent of TAVI, though enhanced surgical teams, perfusion techniques, and postoperative care have also played an essential role.

This study presents real-world results from the international SURE-AVR registry, encompassing 73 centers across 18 countries in Europe, Canada, the USA, and Australia, sponsored by Corcym S.r.l. (Vercelli, Italy). This registry compiles data for all the sponsor’s products for aortic valve disease treatment, with a focus on the Perceval prosthesis, a division recently acquired.

Between 2011 and 2021, 1,652 patients received AVR with the Perceval bioprosthesis in 55 centers worldwide. During this period, various stages in the prosthesis evolution were included, from anticalcification treatments to modifications in implant techniques. The patient population closely mirrors that of our region, with an average age of 75 years; 82.4% were symptomatic; and morbidities such as diabetes mellitus (31%), COPD (14%), renal insufficiency (11%), prior stroke (6.5%), or preoperative AF >20% contributed to an intermediate surgical risk level (EuroSCORE II 4.1±6.3%). Notably, 16.3% had undergone previous cardiac surgery. Early implant indications for the Perceval bioprosthesis deviated from initial recommendations for sutureless prostheses, including endocarditis (2.1%) and bicuspid aortic valve (8%). The only contraindications for implantation were aneurysmal dilation and/or aortic root dissection (the classic UST/annulus ratio >1.3 is no longer considered contraindicated) and known hypersensitivity to nickel alloys.

In 45.3% of cases, patients underwent minimally invasive approaches, with over one-third involving concomitant procedures. Of these, 26% were myocardial revascularization, while combined valve surgeries such as mitral valve (5.8%) or tricuspid valve (2.8%) procedures were less common. The Perceval prosthesis was successfully implanted on the first attempt in 98.5% of cases, with mean aortic clamp and extracorporeal circulation times of 61 minutes and 77 minutes, respectively; isolated valve procedures averaged 51 and 77.4 minutes, respectively. These times were consistent across minimally invasive and median sternotomy approaches. With a maximum follow-up of 8 years, reaching 5 years in 87.3% of patients, postoperative mortality was 0.3% in the immediate perioperative period, with cardiovascular mortality at 1.9%/patient-years and all-cause mortality at 4.5%/patient-years. Overall 5-year survival reached 78.8%.

An essential aspect of prosthesis performance is valve-related complications. Grade 2+ paravalvular leakage occurred in only 0.1%, and grade 2+ intraprosthetic leakage in 0.2%. No patient experienced both intraprosthetic and paravalvular leaks. Permanent pacemaker implantation was necessary in just 5.7% of cases. Prosthesis-related reintervention was required in 0.8%/patient-years, due to endocarditis (7 cases, 0.4%), structural valve deterioration (10 cases, 0.6%), and non-structural dysfunction (6 cases, 0.3%). Of the 16 cases of structural and non-structural deterioration, 12 were resolved through TAVI-in-Perceval procedures, with only 4 requiring open surgery. As typical for this prosthesis, gradients remained stable throughout follow-up, with excellent mean values of 13 mmHg and peak values of 24 mmHg, yielding a residual mean aortic valve area of 1.8 cm².

The authors conclude that the prospective real-world data from the SURE-AVR registry demonstrates that the Perceval bioprosthesis is a safe and effective surgical option for aortic valve disease, providing excellent clinical and hemodynamic outcomes over the mid-term follow-up.

COMMENTARY:

The SURE-AVR registry offers one of the largest published experiences with the Perceval bioprosthesis, featuring data from a wide range of centers, collected prospectively over a decade. Rather than a limitation, the introduced heterogeneity should be seen as democratizing this prosthesis type, accessible to any surgical team across different settings. While this is a sponsored registry, it stands out for its transparency and a proper declaration of conflict of interest, with independent clinical data. Several results warrant separate discussion due to their relevance.

First, the patient profile is of intermediate surgical risk, still minimally impacted by the TAVI phenomenon. Also notable is the use of the prosthesis in selected cases of infectious endocarditis (without annular destruction) and bicuspid valve disease (Sievers type 1 or 2). From a technical perspective, favorable mortality results align with technical aspects that show no marked superiority compared to standard practice in our region: limited minimally invasive approaches and conventional surgical times, even for isolated AVR. This likely reflects real-world data rather than selected-center results, offering an authentic perspective on international surgical practice without any sense of inferiority.

The evolving patient profile is also evident, with AVR frequently combined with other procedures, making isolated AVR in moderate-to-low risk patients under 75 increasingly rare. While over one-third were combined procedures, most involved myocardial revascularization (despite an initial perception that its suprannular profile was unsuitable for proximal anastomoses). Surprisingly, there was a low rate of combined valve procedures in the registry, one scenario where this prosthesis might offer technical advantages. Currently, the Perceval bioprosthesis is indicated for:

• Minimizing surgical times in AVR combined with other valve and/or revascularization procedures.
• Promoting minimally invasive approaches, whether in initial procedures or reoperations requiring limited dissection.
• Challenging small or hostile aortic roots, where it achieves superior hemodynamic results compared to sutured prostheses.

The low rate of combined valve surgeries may reflect the limited experience of some teams with the prosthesis in combined procedures.

Finally, the hemodynamic performance of the prosthesis is exceptional, with a higher rate of L and XL sizes (54%) than in typical practice. Paravalvular and intraprosthetic leak rates were minimal, with very low permanent pacemaker requirement rates, largely influenced by an updated implant technique applied to most registry cases. Structural deterioration rates are comparable to benchmarks like the Carpentier-Edwards Perimount, with 1.99% and 15% degeneration at 10 and 20 years, respectively. The registry lacks long-term data beyond 10–15 years when bioprostheses tend to experience structural failure. The initial version of Perceval accounted for most cases, with only 233 Perceval Plus implants, anticipated to improve durability due to its new anticalcification treatment and aldehyde-free storage medium (FREE). Structural dysfunction was resolved via valve-in-valve procedures, offering advantages over sutured prostheses:

• Nitinol’s superelastic stent allows for larger TAVI prosthesis implantation without high-risk ring fracture and avoids patient-prosthesis mismatch, enhancing hemodynamic outcomes.
• The stent extends the sinuses of Valsalva, distancing them from prosthetic leaflets and preventing their sequestering and coronary occlusion.

In conclusion, the SURE-AVR registry supports the Perceval bioprosthesis’s mid-term benefits, its accessible use, and its place as a viable alternative to sutured bioprostheses with unique design and implantation advantages. It is hoped that the Perceval Plus modifications will enhance durability, enabling it to compete effectively with sutured counterparts and TAVI.

REFERENCE:

Concistré G, Baghai M, Santarpino G, Royse A, Scherner M, Troise G, et al. Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry. Interdiscip Cardiovasc Thorac Surg. 2023 Jun 1;36(6). doi: 10.1093/icvts/ivad103.