Perceval Less Invasive Aortic Replacement Register: multicentric Spanish experience with the Perceval S bioprosthesis in moderate–high-risk aortic surgery

García, Elisabet; Rosell, Maria Luisa Camara; Estévez-Cid, Francisco; Sanchez, Eladio; Barrera, Remedios Rios; Sbraga, Fabrizio; Puente, Julio G.; Diez, Elena Rosello; Caballero, Gregorio Pablo Cuerpo; Munguira, Juan Bustamante; Copa, Guillermo Reyes; Pajuelo, Marian Tena; Fiz, Santiago Serrano; Miñano, J.; Martín, Iván García; Castillo, José; López, Sergio Cánovas; Pinto, Ángel González; Baliarda, Xavier Ruyra

doi:10.1093/icvts/ivx384

Cited by 9 publications

(5 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The two most important factors to decrease the incidence of PVL in SV are adequate sizing of the device and complete decalcification of the aortic annulus. 32,36,51 In contrast, the zero incidence of PVL in the ARE group is consistent with other global studies. 30…”

Section: Discussionsupporting

confidence: 91%

Sutureless valves versus aortic root enlargement for aortic valve replacement in small aortic annulus: A systematic review and pooled analysis

Agarwal

Arnav

Ranjan

et al. 2023

Asian Cardiovasc Thorac Ann

View full text Add to dashboard Cite

Background Very few studies provide direct comparisons between aortic root enlargement and sutureless valve implantation in patients with a small aortic annulus who underwent aortic valve replacement. This study aims to provide comparative outcomes between the two in such a subset of patients, through a systematic review and pool analysis. Methods The PubMed, Scopus and Embase databases were searched using the appropriate terms. The data from original articles mentioning aortic root enlargement and sutureless valves in a single or comparative study with another group of patients with a small aortic annulus were pooled and analyzed using descriptive statistics. Results Both cardiopulmonary bypass (68.4 vs. 125.03 min, p < 0.001) and aortic cross-clamp times were significantly shorter in the sutureless valve group, along with a concomitantly higher number of minimally invasive surgeries. The incidence of permanent pacemaker implantation (9.76% vs. 3.16%, p < 0.00001), patient prosthesis mis-match and paravalvular leak was significantly higher in the sutureless valve group. In comparison, the incidence of re-exploration for bleeding was higher in the aortic root enlargement group (5.27% vs. 3.16%, p < 0.02). The two groups had no differences in the duration of hospital stays or mortality. Conclusions Sutureless valves demonstrated a comparable hemodynamic outcome with aortic root enlargement in patients with a small aortic annulus. In addition to this, it greatly facilitated minimally invasive surgery. However, the high incidence of pacemaker implantation is still a concern for the widespread recommendation of sutureless valves, especially in young patients with a small aortic annulus.

show abstract

Section: Discussionsupporting

confidence: 91%

Sutureless valves versus aortic root enlargement for aortic valve replacement in small aortic annulus: A systematic review and pooled analysis

Agarwal

Arnav

Ranjan

et al. 2023

Asian Cardiovasc Thorac Ann

View full text Add to dashboard Cite

show abstract

“…[5][6][7] The lesser invasiveness and the reduced surgical trauma of minimally invasive aortic valve replacement (MI-AVR) could lead to optimal outcomes even in increased-risk-profile patients. [8][9][10] MI-AVR became popular in the 1990s and has gradually been recognized as a less traumatic approach when compared with median sternotomy. 11 Currently, the upper ministernotomy (MS) and the right anterior minithoracotomy (RAT) are the most common approaches for MI-AVR.…”

Section: Introductionmentioning

confidence: 99%

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

Glauber

Bacco

Cuenca

et al. 2019

Innovations�(Phila)

View full text Add to dashboard Cite

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.

show abstract

“…After thorough literature review, the experts rated evidencebased recommendations but no guidelines could be established (40). Different studies have been performed on sutureless aortic valves (SU-SAVR) or rapid deployment of aortic valves (R-SAVR) (41)(42)(43)(44)(45). In terms of clinical and hemodynamic behaviour, both valves seem very comparable and appropriate for the majority of procedures.…”

Section: Current Clinical Perspectivementioning

confidence: 99%

History, development and clinical perspectives of sutureless and rapid deployment surgical aortic valve replacement

Carrel

Heinisch

2020

Ann Cardiothorac Surg

View full text Add to dashboard Cite

Degenerative aortic stenosis is the most frequent valvular heart disease in industrialized countries. Conservative treatment may beneficially influence symptoms but is never successful. Surgical aortic valve replacement (SAVR) was the only recognized treatment option to provide substantially prolonged survival until 2008. Operative mortality of isolated SAVR has been reported as low as 0.5% to 1% in experienced institutions, while long-term survival is close to that observed in a control healthy population of similar age. A multitude of studies have demonstrated the beneficial effects of SAVR with regard to improvement in quality of life and physical performance in the majority of symptomatic patients. In the last decade, transcatheter aortic valve implantation (TAVI) has emerged as an equal treatment modality, first in patients with high surgical risk and more recently in patients with intermediate and low surgical risk. Paravalvular regurgitation and the higher rate of pacemaker implantation remain points of consideration. Additionally, the long-term durability of TAVI devices and occurrence of stroke late after TAVI require additional analyses. Sutureless (SU-SAVR) and rapid deployment valve (R-SAVR) were designed to simplify and accelerate a conventional or less invasive surgical procedure while allowing complete excision of the calcified native valve. From 3 different implants tested more than 10 to 15 years ago, only two are available on the market today: the Perceval ® valve from Liva Nova and the Intuity ® sutureless prosthesis from Edwards Lifesciences. There has been extensive experience with these two devices in previous years and the results obtained are comparable to those observed following the use of conventional implants. The sutureless devices may be of particular interest for more complex and combined surgical procedures. This review summarizes the sutureless (SU-SAVR) and rapid deployment valve technologies and presents a clinical outlook for the patient population managed with these devices.

show abstract

Perceval Less Invasive Aortic Replacement Register: multicentric Spanish experience with the Perceval S bioprosthesis in moderate–high-risk aortic surgery

Abstract: This is a prospective multicentric study on the largest cohort of patients with sutureless valves conducted in Spain to date. It is a reproducible procedure that has enabled surgery on patients with a moderate-high risk with low morbidity and mortality, providing good haemodynamic results.

Cited by 9 publications

References 28 publications

Sutureless valves versus aortic root enlargement for aortic valve replacement in small aortic annulus: A systematic review and pooled analysis

Sutureless valves versus aortic root enlargement for aortic valve replacement in small aortic annulus: A systematic review and pooled analysis

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

History, development and clinical perspectives of sutureless and rapid deployment surgical aortic valve replacement

Contact Info

Product

Resources

About