Perceval Sutureless Aortic Valve Implantation: Midterm Outcomes

Szecel, Delphine; Eurlings, Roxanne; Rega, Filip; Verbrugghe, Peter; Meuris, Bart

doi:10.1016/j.athoracsur.2020.06.064

Cited by 36 publications

(66 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Nguyen et al (13) emphasized that the most crucial point during surgery is to recreate three natural nadirs points positioned at 120 • with the aim of recreating a circular annulus. Four retrospective clinical studies (13,34,39,40) with a small population ranging between 11 and 88 patients evidenced a low mortality rate (0-4%) and PVL incidence (0-2.3%). However, there was a high incidence of PPI (0-20%), and stroke (0-8%) (Table 3).…”

Section: Bicuspid Aortic Valves and Percevalmentioning

confidence: 99%

Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis

Dokollari

Ramlawi

Torregrossa

et al. 2022

Front. Cardiovasc. Med.

View full text Add to dashboard Cite

Objective: To highlight the main target points covered by clinical studies on the Perceval sutureless valve for surgical aortic valve replacement (SAVR) and raise a point of discussion for further expansion of its use when compared with stented bioprostheses (SB) and transcatheter aortic valve replacement (TAVR).Methods: We reviewed clinical trials and retrospective studies published up to date and compared the outcomes in terms of mortality, myocardial infarction (MI) stroke, paravalvular leak (PVL), permanent pacemaker implantation (PPI), bleeding and long-term outcomes.Results: Clinical studies showed that 30-day mortality ranged from 0–4% for Perceval and 2.9–7% for TAVR. The incidence of PVL (Perceval 1.9–19.4 vs. TAVR 9–53.5%), PPI (Perceval 2–11.2 vs. TAVR 4.9–25.5%), stroke (Perceval 0 vs. TAVR 0–2.8%), MI (Perceval 0 vs. TAVR 0–3.5%), were all higher in the TAVR group. Compared to other SB, mortality ranged from 0–6.4% for Perceval and 0–5.9% for SB. The incidence of PVR (Perceval 1–19.4 vs. SB 0–1%), PPI (Perceval 2–10.7 vs. SB 1.8–8.5%), stroke (Perceval 0–3.7 vs. SB 1.8–7.3%) and MI (Perceval 0–7.8 vs. SB 0–4.3%) were comparable among the groups. In patients with a bicuspid aortic valve, mortality rate was (0–4%) and PVL incidence was (0–2.3%). However, there was a high incidence of PPI (0–20%), and stroke (0–8%). Long-term survival ranged between 96.7–98.6%.Conclusions: The Perceval bioprosthesis has proved to be a reliable prosthesis for surgical aortic valve replacement due to its implantation speed, the reduced cardiopulmonary bypass time, the reduced aortic cross-clamp time and the shorter intensive care unit and hospital length of stay.

show abstract

Section: Bicuspid Aortic Valves and Percevalmentioning

confidence: 99%

Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis

Dokollari

Ramlawi

Torregrossa

et al. 2022

Front. Cardiovasc. Med.

View full text Add to dashboard Cite

show abstract

“…Considering the growth of the aging population and increasing demand for minimally invasive surgery, the use of sutureless or rapid deployment valves is expected to increase in the future. In addition, many recent studies have reported good midand long-term clinical outcomes of sutureless and rapid deployment valves in terms of safety, efficacy, hemodynamic performance, and durability [4,5,25,26].…”

Section: Discussionmentioning

confidence: 99%

“…Although surgical aortic valve replacement (AVR) is the standard treatment for aortic valve disease, there have been some limitations in applying conventional AVR in all patients. Recently, transcatheter aortic valve implantation has been used for intermediate-and high-risk patients [1,2], and sutureless (or rapid deployment) AVR (SuAVR) has also gained attention as a new alternative option for highrisk patients [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

Changes in the Prosthesis Types Used for Aortic Valve Replacement after the Introduction of Sutureless and Rapid Deployment Valves in Korea: A Nationwide Population-Based Cohort Study

et al. 2021

View full text Add to dashboard Cite

Background: Sutureless and rapid deployment valves for aortic valve replacement (AVR) were introduced in Korea in December 2016. This study evaluated changing trends in the prosthetic valves used for AVR in Korea after the introduction of sutureless and rapid deployment valves. Methods: From December 2016 to December 2018, 4,899 patients underwent AVR in Korea. After applying the exclusion criteria, 4,872 patients were analyzed to determine changes in the type of prosthetic valve used for AVR. The study period was divided into 5 groups corresponding to 5-month intervals. Results: The total number of AVR cases was 194.88±28.78 per month during the study period. Mechanical valves were used in approximately 27% to 33% of cases, and the proportion of mechanical valve use showed a tendency to decrease, with marginal significance overall (p=0.078) and significant decreases in patients less than 60 years of age and in men (p=0.013 and p=0.023, respectively). The use of sutureless valves increased from 13.4% to 25.8% of cases (p<0.001), especially in elderly patients (>70 years) and those requiring concomitant surgery. In a comparison between sutureless and rapid deployment valves, the use of Perceval S valves (a type of sutureless valve), gradually increased (p<0.001). Conclusion:After the introduction of sutureless and rapid deployment valves in Korea, the rate of use of these new valves remarkably increased, especially in elderly patients and those requiring concomitant surgery. Further studies should investigate the clinical outcomes of these new prostheses.

show abstract

“…New prostheses have been developed to minimize the surgical risk in patients with multiple comorbidities and to reduce operating times. Sutureless prostheses have shown promising results in terms of mortality, morbidity, and hemodynamic performance (5)(6)(7). Several studies have demonstrated that sutureless valves decrease the cardiopulmonary bypass (CPB) and aortic crossclamping (ACC) times, facilitating minimally and conventional invasive cardiac surgery (5)(6)(7)(8), but no randomized controlled trials have directly compared this technology with traditional stented valves (9).…”

Section: Introductionmentioning

confidence: 99%

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial

Fischlein

Caporali

Asch

et al. 2022

Front. Cardiovasc. Med.

Self Cite

View full text Add to dashboard Cite

ObjectiveSutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab.MethodsPerceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance.ResultsThe site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups.ConclusionAt 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

show abstract

Perceval Sutureless Aortic Valve Implantation: Midterm Outcomes

Cited by 36 publications

References 14 publications

Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis

Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis

Changes in the Prosthesis Types Used for Aortic Valve Replacement after the Introduction of Sutureless and Rapid Deployment Valves in Korea: A Nationwide Population-Based Cohort Study

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial

Contact Info

Product

Resources

About