Early and Mid-Term Results of Rapid Deployment Valves: The Intuity Italian Registry (INTU-ITA)

D’Onofrio, Augusto; Tessari, Chiara; Filippini, Claudia; Bagozzi, Lorenzo; Diena, Marco; Alamanni, Francesco; Massetti, Massimo; Livi, Ugolino; Eusanio, Marco Di; Mignosa, Carmelo; Russo, Claudio; Rinaldi, Mauro; Bartolomeo, Roberto Di; Salvador, Loris; Antona, Carlo; Maselli, Daniele; Paulis, Ruggero De; Luzi, Giampaolo; Alfieri, Ottavio; Filippo, Carlo Maria De; Portoghese, Michele; Musumeci, Francesco; Bortolotti, Uberto; Gerosa, Gino

doi:10.1016/j.athoracsur.2018.07.002

Cited by 26 publications

(35 citation statements)

References 21 publications

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“…These incidences of PPM implantation are nevertheless lower than those found after a procedure by TAVR, which is estimated between 12% and 36% [ 7 , 8 ]. The underlying mechanism of these conductive disorders is probably related to direct trauma of the conduction pathways during the pneumatic expansion of the bioprosthesis with or without secondary inflammation [ 20 , 22 , 23 , 25 , 26 ]. In our study, the valve size was not associated with the pacemaker implantation, but conduction disturbances were most often observed immediately, arguing for a mechanical stress.…”

Section: Discussionmentioning

confidence: 99%

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Pacemaker implantation after aortic valve replacement: rapid-deployment Intuity® compared to conventional bioprostheses

Herry

Laghlam

Touboul

et al. 2020

European Journal of Cardio-Thoracic Surgery

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OBJECTIVES The aim of this study was to compare the incidence of permanent pacemaker (PPM) implantation after aortic valve replacement by rapid-deployment bioprosthesis (RDB) and standard valve (Standard). METHODS All patients undergoing aortic valve replacement between 2015 and 2018, in 1 centre, were included. A multivariate analysis on the whole cohort and then a propensity score matching were used to compare the 2 groups. The primary end point was PPM implantation. RESULTS We studied 924 patients (256 RDBs and 668 Standards). Overall, 67 PPM were implanted, 37 (14.5%) in the RDB group and 26 (3.9%) in the Standard group (P < 0.0001, univariate analysis). The multivariate analysis in the unmatched population found 4 independent factors associated with PPM implantation: right bundle branch block with odds ratios (ORs 3.7, 95% CI 2.9–6.7; P < 0.0001), RDB (OR 3.6, 95% CI 2.0–6.2; P < 0.0001), age (OR 1.1, 95% CI 1.0–1.1; P < 0.006) and endocarditis (OR 3.4, 95% CI 1.0–11.0; P < 0.04). In the propensity score-matched RDB group (203 patients per group), 25 patients required PPM implantation versus 3 in the Standard group (12.3% vs 1.5%, P < 0.0001). RDBs also had more postoperative left bundle branch block and new onset of atrial fibrillation (30.2% vs 5.1%, P < 0.0001 and 34.0% vs 24.1%, P = 0.029). RDBs had lower operating times (in min): aortic cross-clamping = 62 (44–76.5) vs 72 (57.5–91.5) and cardiopulmonary bypass = 81 (63–98.5) vs 91 (75–112), P < 0.0001. There was no significant difference in other outcomes. CONCLUSIONS RDBs were associated with reduced operating times, increased risk of atrial fibrillation and PPM implantation as compared with standard aortic valves.

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Section: Discussionmentioning

confidence: 99%

“…The aim of our study was to compare the incidence of conductive disorders and PPM implantation after AVR with RDB and standard bioprostheses [ 22 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

Pacemaker implantation after aortic valve replacement: rapid-deployment Intuity® compared to conventional bioprostheses

Herry

Laghlam

Touboul

et al. 2020

European Journal of Cardio-Thoracic Surgery

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“…Rapid deployment valves, such as the Intuity Valve (Edwards Lifesciences Corporation) has allowed easier replacement through a simplified procedure and shorter cardioplegic arrest and CPB times . The technique we developed by rolling the aortic leaflets (Figure B and C) and adding an extra pledgeted horizontal mattress suture at the noncoronary sinus toward the left‐non commissure, ensures proper sitting and avoidance of leakage between the nadir of the noncoronary sinus and the left‐noncommissure.…”

Section: Discussionmentioning

confidence: 99%

“…A potential concern about sutureless/rapid deployment valves is the development of paravalvular leakage. The incidence varies between 1% and 7%, is associated with detrimental sequelae for the patient, and patients with a larger annulus and aortic insufficiency (AI) are at increased risk . We, herein, report a surgical technique that we developed to decrease or eliminate paravalvular leakage in patients with AI.…”

Section: Introductionmentioning

confidence: 99%

Preservation of aortic leaflets during rapid deployment valve implantation in patients with aortic insufficiency

et al. 2019

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“…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

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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.

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Early and Mid-Term Results of Rapid Deployment Valves: The Intuity Italian Registry (INTU-ITA)

Abstract: Aortic RDBs provide good early and mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.

Cited by 26 publications

References 21 publications

Pacemaker implantation after aortic valve replacement: rapid-deployment Intuity® compared to conventional bioprostheses

Pacemaker implantation after aortic valve replacement: rapid-deployment Intuity® compared to conventional bioprostheses

Preservation of aortic leaflets during rapid deployment valve implantation in patients with aortic insufficiency

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

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