There is an increasing body of evidence supporting percutaneous aortic valve implantation (TAVI) for treating aortic stenosis, including low-risk patients (as studied in PARTNER 3 and DEDICATE trials, previously analyzed on this platform). This evidence primarily stems from clinical trials comparing TAVI with surgical aortic valve replacement (SAVR) using conventional sutured prostheses, with limited studies contrasting TAVI with sutureless surgical valves. The Perceval® sutureless prosthesis (Corcym®), crafted from bovine pericardium on a self-expanding nitinol stent and introduced in 2007, has consistently demonstrated excellent clinical outcomes, safety, and adaptability, facilitating minimally invasive approaches and combined surgeries (results validated in meta-analyses and several studies reviewed on this platform). Among the few drawbacks identified was the high pacemaker implantation rate, initially linked to oversizing. However, this has been mitigated by the sizing adjustment strategy introduced in 2017, confirmed by a recent international multicenter registry (SuRD-IR) involving 19 centers (also reviewed on this platform). Another concern was limited long-term data on the prosthesis’s durability due to a lack of studies. This study aims to shed light on the long-term experience and outcomes of the sutureless Perceval® valve at UZ Leuven Hospital (Belgium) after 13 years of cumulative experience.
A retrospective analysis was conducted on postoperative and follow-up data of all patients treated with this sutureless prosthesis (isolated or combined surgery) between 2007 and 2019. A total of 784 patients were treated. The mean age was 78 years, with a EuroSCORE II of 4.2% (interquartile range, 2.6%-7.2%). SAVR accounted for 45% of cases; 30% involved concomitant coronary surgery, and the remaining 25% consisted of other types of intervention. Median ischemic times were 38 minutes for isolated SAVR, 70 minutes for coronary cases, and 89 minutes for multiple valve surgeries. Prosthesis implantation success was 99.1%, and in-hospital mortality was 3.3%. Postoperative stroke or transient ischemic attack (TIA) occurred in 1.9% of patients, and 1% required dialysis post-surgery. Median survival was 7.0 years, with a cumulative follow-up of 2797.8 patient-years. The freedom from reintervention at 1, 5, and 10 years was 99%, 97%, and 94%, respectively.
The authors conclude that these data represent the longest available follow-up for the Perceval sutureless prosthesis. Favorable early outcomes, with low rates of early mortality, stroke, and other major complications, were observed. The valve’s durability is promising, with low valve degeneration rates and a limited need for reintervention.
COMMENTARY:
The study discussed today was conducted in a center with extensive experience in the use of the Perceval® prosthesis. Similarly, the Complexo Hospitalario Universitario de A Coruña (CHUAC) has also accumulated significant experience with this prosthesis. From 2013 to January 2024, we performed SAVR with Perceval in 1,559 patients, marking the largest single-hospital series worldwide to date. While our results are pending publication in the coming months, we will use this platform to preview, share, and compare them with the findings of this study.
The ease of implanting this prosthesis, which requires only three guiding sutures and minimal manipulation of the aortic root, allows for reduced surgical and ischemic times. This results in several clinical benefits, such as low mortality rates despite high-risk profiles, a low incidence of adverse events like stroke, and a reduction in dialysis requirement, among others. Additionally, this type of prosthesis enables the use of minimally invasive techniques in isolated SAVR cases. In experienced hands, it can be an effective solution in complex cases such as reoperations, endocarditis, extended combined surgeries, or calcified aortic roots.
The overall 30-day mortality rate in this study was low (3.3%), slightly lower than predicted. Similarly, the overall mortality at CHUAC was 3.4%, with an isolated SAVR mortality rate of 1.8% achieved via ministernotomy.
In the study by Lamberigts et al., only 45% of cases were isolated SAVR (75.7% in our series), with 30% involving concomitant coronary surgery (15.9% in our case) and the remaining 25% representing other types of intervention (8.4% at CHUAC). Our experience illustrates the versatility of this prosthesis in diverse clinical contexts, as reflected in the 43 cases of endocarditis, 89 reoperations, and 86 concurrent mitral surgeries performed.
At Leuven Hospital, 47.9% of isolated SAVR cases with the Perceval® prosthesis were performed via minimally invasive surgery. This percentage significantly increased to 84% in the last two years. In contrast, the minimally invasive surgery rate for sutured prostheses generally reached only 20%. At our hospital, 73.7% of isolated SAVR cases with sutureless prostheses were performed via ministernotomy, underscoring and confirming the ease of performing minimally invasive surgery with these prostheses.
Additionally, it is worth highlighting the short ischemic (51 minutes) and cardiopulmonary bypass (CPB) (81 minutes) times achieved in this study, similar to other notable published registries. However, our surgical times were clearly superior, with isolated SAVR ischemic times of 31 minutes or 38 minutes for the overall series. Furthermore, we published years ago that this prosthesis democratizes the surgical technique, as no significant differences were observed among surgeons in terms of surgical times or clinical outcomes. This suggests that it is a reproducible technique that minimizes operator-dependent disparities.
The incidence of postoperative complications in this series was also low. The combined incidence of stroke and TIA was 1.9% (1.5% at our hospital), and the dialysis requirement rate was 1% (1.6% at our hospital). The relatively long hospital stay (2 days in the ICU, 11 on the ward) can be explained by peculiarities such as limited patient transfer to other hospitals for recovery completion in this elderly cohort. At CHUAC, our stay was significantly shorter, with 2.5 days in the ICU and 6.1 days on the ward, aligning more with expected outcomes for this patient type and procedure.
In terms of long-term outcomes, with a median follow-up of 7 years, a very low reintervention rate was observed. The 1-year survival of 91.5%, with a 1-year reoperation-free survival rate of 99.2%, is comparable to other studies using conventional prostheses. Five- and ten-year survival rates of 70.8% and 27.3%, respectively, align with those expected for a population with a mean implantation age of 78 years. However, among surviving patients at ten years, the incidence of serious prosthesis-related complications, such as structural valve deterioration (SVD) or endocarditis, was low (22.3%). The five-year survival rate of 78.8% in our A Coruña series slightly exceeds that of this study, possibly due to the lower mean patient age in our series (74 vs. 78 years).
The ten-year freedom from reintervention in this study was 94%. Most reinterventions were due to endocarditis, with only three cases of SVD. These results corroborate previous publications from our group, where, with an average echocardiographic follow-up of over three years, no severe SVD and a very low rate of moderate SVD were observed. It is important to note that in cases of severe SVD in a Perceval® prosthesis, TAVI valve-in-valve has emerged as a valid and safe alternative, as demonstrated in multiple publications. On the other hand, the Lamberigts et al. study found a low endocarditis incidence, with a 0.46% annual rate, similar to that of other studied prostheses.
The hemodynamic outcomes in the Leuven series were favorable, with mean and peak gradients of 11 mmHg and 20 mmHg, respectively, and an EOA of 1.5 cm² at the latest follow-up. These results are practically superimposable to those in our series. Paravalvular leak incidence was only 1.3%, comparable to results in our center.
Avoiding prosthesis oversizing is critical to prevent complications such as elevated gradients or an excessive need for pacemaker implantation, as demonstrated by our hospital over seven years ago and corroborated in the recent international multicenter registry (SuRD-IR). This has been confirmed again in a sub-study of this series, analyzing patients before and after 2017, when the sizing technique was modified to select a prosthesis smaller than initially recommended. The overall pacemaker implantation rate was 8.8%, surpassing the rate observed in our hospital (overall rate of 5.06%), compared to the 13.1% rate in 2014.
In summary, the results of this study, as well as those from our CHUAC series soon to be published, support the positive short-term and, more importantly, long-term outcomes of this sutureless prosthesis, as previously observed in earlier studies. Additionally, they confirm its versatility across various contexts, the reduction in surgical times, and the simplicity of use in minimally invasive surgeries without any penalty.
REFERENCE:
Lamberigts M, Szecel D, Rega F, Verbrugghe P, Dubois C, Meuris B. Sutureless aortic valves in isolated and combined procedures: Thirteen years of experience in 784 patients. J Thorac Cardiovasc Surg. 2024 May;167(5):1724-1732.e1. doi: 10.1016/j.jtcvs.2022.09.053.
