Effect of sutureless implantation of the Perceval S aortic valve bioprosthesis on intraoperative and early postoperative outcomes

Flameng, Willem; Herregods, Marie‐Christine; Hermans, Hadewich; Mieren, Gerry Van der; Vercalsteren, Monique; Poortmans, Gert; Hemelrijck, J. Van; Meuris, Bart

doi:10.1016/j.jtcvs.2011.02.021

Cited by 153 publications

(138 citation statements)

References 11 publications

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“…There were no randomized controlled trials. The mean follow-up time was 6 to 8 months for 3 studies (15,18,19), 10 to 16 months for 5 studies (10,11,13,21,22), and 18 to 24 months for 3 studies (12,20,23), as seen in Table 1.…”

Section: Quality Of Evidencementioning

confidence: 98%

“…All 14 studies were observational, which included 7 prospective (11,14,16,(19)(20)(21)(22) and 7 retrospective studies (10,12,13,15,17,18,23). There were no randomized controlled trials.…”

Section: Quality Of Evidencementioning

confidence: 99%

“…All studies originated from specialised tertiary referral centers. Eleven centers reported results in greater than 100 patients (range, 120-314) (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23). Seven studies presented multi-center data (12,13,(15)(16)(17)19,23).…”

Section: Quality Of Evidencementioning

confidence: 99%

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Early results of the Sorin® Perceval S sutureless valve: systematic review and meta-analysis

Sian

Selvakumar

et al. 2017

J. Thorac. Dis.

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Background: Minimally invasive aortic valve replacement (MAVR) has demonstrated a benefit with respect to increased patient satisfaction due to minimised pain and earlier recovery. Sutureless valves may benefit MAVR and conventional aortic valve replacement (AVR) by reducing operative times and blood transfusion requirements. The Perceval valve (Sorin, Salluggia, Italy) is a self-expanding prosthesis made from bovine pericardium mounted in a nitinol stent, designed to simplify the implantation of an aortic valve. This metaanalysis evaluates the clinical, haemodynamic, and survival outcomes of the Perceval sutureless valve.Methods: An electronic search of 4 databases was performed from January 2000 to December 2016.Primary outcomes included mortality and stroke. Secondary outcomes included minimally invasive access, paravalvular leak, overall long-term survival, postoperative echocardiographic findings, and functional class improvement.Results: After the application of inclusion and exclusion criteria, 14 of 66 relevant articles were selected for assessment. Of these 14 studies, a total number of 2,505 patients were included. The current evidence on the Perceval valve for aortic valve disease is limited to observational studies only. Minimally invasive surgery was performed in 976 patients, of which 336 were via the right anterior thoracotomy approach. The Perceval M and L sutureless valves were the most frequently used, 782 and 770 respectively. The incidence of major adverse events included 30-day mortality (0 to 4.9%), cerebrovascular accident (0 to 3%), permanent pacemaker insertion (0 to 17%), moderate to severe paravalvular leak (0 to 8.6%), and re-operation (0 to 4.8%). Post-operative mean aortic valve gradient ranged from 9 to 15.9 mmHg and post-operative New York Heart Association (NYHA) Class I or II ranged from 82% to 96%. The 1-year survival ranged from 86% to 100%; and 5-year survival was 71.3% to 85.5% in two studies. Conclusions:The Perceval valve is associated with excellent post-operative results in MAVR and in conventional AVR. Larger randomised controlled studies are required to evaluate the long-term efficacy of the prosthesis.

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Section: Quality Of Evidencementioning

confidence: 98%

“…All 14 studies were observational, which included 7 prospective (11,14,16,(19)(20)(21)(22) and 7 retrospective studies (10,12,13,15,17,18,23). There were no randomized controlled trials.…”

Section: Quality Of Evidencementioning

confidence: 99%

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Early results of the Sorin® Perceval S sutureless valve: systematic review and meta-analysis

Sian

Selvakumar

et al. 2017

J. Thorac. Dis.

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“…Although the sutureless Perceval aortic valve bioprosthesis (Sorin Group, Saluggia, Italy) has been introduced only recently, several reports have shown promising results in terms of mortality, morbidity and haemodynamic performance [9][10][11][12]. However, the impact of sutureless bioprostheses on LV mass is unknown.…”

Section: Introductionmentioning

confidence: 99%

Left ventricular mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis: Preliminary results

Santarpino¹,

Pfeiffer²,

Concistrè³

et al. 2013

Thorac cardiovasc Surg

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OBJECTIVES: Left ventricular (LV) hypertrophy in aortic stenosis (AS) is considered a compensatory response helping maintain systolic function, but constitutes a risk factor for cardiac morbidity and mortality. The aim of this study was to assess the degree of LV mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis (Sorin Group, Saluggia, Italy). METHODS:Between March 2010 and July 2012, 78 patients with symptomatic AS underwent isolated aortic valve replacement (AVR) with the Perceval bioprosthesis. Mean age was 77.1 ± 5.3 years, 46 patients were female (59%) and mean logistic EuroSCORE was 11 ± 7.5%. Echocardiography was performed preoperatively, at discharge, and at follow-up (mean 13.5 ± 7.3 months). LV mass was calculated using the Devereux formula and indexed to body surface area. RESULTS:There was 1 in-hospital non-cardiac death and 3 late deaths. LV mass index decreased from 148.4 ± 46 g/m 2 at baseline to 119.7 ± 38.5 g/m 2 at follow-up (P = 0.002). No significant changes were observed in LV hypertrophy and/or relative wall thickness >0.42 as well as in LV ejection fraction. Mean aortic gradient decreased from 49.5 ± 15.8 mmHg at baseline to 11.6 ± 5.1 mmHg at discharge and 8.3 ± 4.4 mmHg at follow-up (P < 0.001), resulting in significant clinical improvement. No moderate or severe paravalvular leakage was observed at discharge and at follow-up. CONCLUSIONS:In AS patients, isolated AVR with the Perceval sutureless bioprosthesis is associated with significant LV mass regression at 1-year follow-up. However, longer-term follow-up is necessary to confirm these findings.

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“…[20] Perceval S kullanılarak dikiş-siz biyoprotez AKR yapılan hastalarda erken dönem kalıcı kalp pili ihtiyacı oranı yaklaşık %9 olarak bildirilmiştir. [21] Transkateter aort kapak implantasyonu hastalarında bu oran %26'lar civarındadır. [22] Bizim çalışmamızda ise ameliyat sonrası AV tam blok gelişen iki hasta vardı.…”

Section: Discussionunclassified

Early- and mid-term results of sutureless aortic valve replacement in high-risk patients: our single-center experience

Göde¹

2016

Turk Gogus Kalp Dama

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ÖZAmaç: Bu çalışmada kalsifik ileri aort darlığı olan yüksek riskli hastalarda dikişsiz biyoprotez aort kapak replasmanının erken ve orta dönem sonuçları sunuldu. Ça lış ma pla nı: Temmuz 2014 -Temmuz 2015 tarihleri arasında üç tipten biri (3F Enable, Perceval S ve Edwards) kullanılarak dikişsiz biyoprotez aort kapak replasmanı yapılan 27 hasta (9 erkek, 18 kadın; ort. yaş 72.96±6.15 yıl; dağılım 62-85 yıl) çalışmaya alındı. Hastaların demografik verileri ve taburculuk sırasında, üçüncü ve altıncı ayda ekokardiyografi sonuçları karşılaştırıldı. Bul gu lar: Onbir hastaya aort kapak replasmanı ile birlikte koroner arter baypas greftleme yapıldı. Ortalama total perfüzyon zamanı ve aortik kros klemp zamanı sırasıyla, 84.2±33.8 dakika ve 45.2±19.2 dakika idi. Hastaların takip ekokardiyografilerinde iyi hemodinamik performans ve düşük aortik gradiyent saptandı. Üçüncü ay ve sonrasındaki ekokardiyografilerde septum kalınlığı, taburculuk ekokardiyografisine kıyasla, anlamlı olarak azaldı (p=0.008). Hastaların biri protez kapak migrasyonu, biri de ileri paravalvüler kaçak gelişmesi nedeni ile tekrar ameliyat edildi. İki hasta ise kalp dışı nedenlerden dolayı 37. ve 81. günlerde kaybedildi. So nuç: İşlem sonrası erken dönemde migrasyon ve paravalvüler kaçak gibi kapağa bağlı komplikasyonlar görülebilmekle birlikte, dikişssiz aort kapak replasmanının total perfüzyon zamanını ve aortik kross klemp zamanını azaltması en büyük avantajlarındandır.Anah tar söz cük ler: Aort kapak replasmanı; mortalite; dikişsiz aort kapak. ABSTRACTBackground:In this study, we present early-and mid-term results of sutureless bioprosthetic aortic valve replacement in high-risk patients with severe calcific aortic stenosis. Methods: Between July 2014 and July 2015, 27 patients (9 males, 18 females; mean age 72.96±6.15 years; range 62 to 85 years) who underwent sutureless bioprosthetic aortic valve replacement using one of three types (3F Enable, Perceval S, and Edwards) were included in the study. Demographic data of the patients and echocardiographic findings at discharge, three and six months were compared. Results:Eleven patients underwent aortic valve replacement in conjunction with coronary artery bypass grafting. The mean total perfusion time and aortic cross-clamp time were 84.2±33.8 min and 45.2±19.2 min, respectively. Good hemodynamic performance and low aortic gradient were detected on follow-up echocardiographies of the patients. The septal thickness was lower at three months and thereafter on echocardiography, than the discharge echocardiography (p=0.008). Two patients were reoperated due to prosthetic valve migration and advanced paravalvular leak. Two patients died due to non-cardiac causes in the 37 th and 81 st postoperative days.

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Effect of sutureless implantation of the Perceval S aortic valve bioprosthesis on intraoperative and early postoperative outcomes

Cited by 153 publications

References 11 publications

Early results of the Sorin® Perceval S sutureless valve: systematic review and meta-analysis

Early results of the Sorin® Perceval S sutureless valve: systematic review and meta-analysis

Left ventricular mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis: Preliminary results

Early- and mid-term results of sutureless aortic valve replacement in high-risk patients: our single-center experience

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