Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve

Wendt, Daniel; Al–Rashid, Fadi; Kahlert, Philipp; Eißmann, Mareike; El-Chilali, Karim; Jánosi, Rolf Alexander; Pasa, Susanne; Tsagakis, Konstantinos; Liakopoulos, Oliver J.; Erbel, Raimund; Jakob, Heinz; Thielmann, Matthias

doi:10.1016/j.athoracsur.2015.03.079

Cited by 27 publications

(18 citation statements)

References 18 publications

(24 reference statements)

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“…Since postoperative complications contribute to prolongation of both ICU and hospital stay, the experts identified reduced ventilation times,19,25 reduced blood transfusion rates, and lower incidence of atrial fibrillation and pleura effusions,25 as possible reasons for improved overall outcome. Transcatheter aortic valve implantation patients showed paravalvular leakages more frequently than sutureless and rapid deployment valves8; recent studies, however, suggest a decrease of transvalvular regurgitation58 and paravalvular leakages59 with modified design. Multivariate analysis showed sutureless aortic valve replacement to have a not statistically significant protective effect against aortic regurgitation, pacemaker implantation, and renal replacement therapy as compared with transapical TAVI 60.…”

Section: Discussionmentioning

confidence: 99%

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches

Glauber

Moten

Quaini

et al. 2016

Innovations�(Phila)

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Objective To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement. Methods A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach. Results No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed to-mographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs. Conclusions Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.

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Section: Discussionmentioning

confidence: 99%

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches

Glauber

Moten

Quaini

et al. 2016

Innovations�(Phila)

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“…These results have been observed in other contemporary studies. 19,20 However, the association between the grade of PVR and the degree of AVC across the several iterations of the same valve prosthesis has not been investigated so far. In the present study, we demonstrated that the grade of significant PVR is independently associated with the degree of AVC according to Agatston calcium scoring (log-transformed Agatston score, odds ratio 3.478, 95% CI 1.424 to 8.498, p ¼ 0.006).…”

Section: Discussionmentioning

confidence: 98%

Impact of Different Iterations of Devices and Degree of Aortic Valve Calcium on Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation

Kong

Rosendael

Kley

et al. 2016

The American Journal of Cardiology

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The iterations of the SAPIEN prosthesis might impact the incidence and grade of paravalvular regurgitation (PVR). The aim of this study was to assess the impact of iterations of balloon-expandable valves (SAPIEN, SAPIEN XT, and SAPIEN 3) and degree of aortic valve calcification (AVC) on the severity of PVR after transcatheter aortic valve implantation (TAVI). Comprehensive echocardiographic examinations and multidetector computed tomography (MDCT) were performed in 272 patients (127 men, 81 ± 7 years old, logistic EuroScore of 21 ± 13%) who underwent TAVI with 23- and 26-mm balloon-expandable valves. The degree of AVC was assessed with MDCT. PVR grade was assessed with echocardiography. The cover index was calculated as (prosthesis area - MDCT annulus area)/prosthesis area. SAPIEN, SAPIEN XT, and SAPIEN 3 prostheses were implanted in 103 patients (38%), 105 patients (38.5%), and 64 patients (23.5%), respectively. Significant PVR (≥moderate) occurred in 14%, 10%, and 0% of patients receiving the SAPIEN, SAPIEN XT, and SAPIEN 3, respectively (p = 0.010). Across the groups, the aortic annulus size, degree of calcification, and cover index were comparable. Larger burden of AVC was independently associated with significant PVR (odds ratio 3.48, p = 0.006) after adjusting for age, body surface area, gender, aortic annulus area, cover index, and prosthesis iteration. SAPIEN 3 was associated with lower frequency of significant PVR (odds ratio 0.31, p = 0.002). In conclusion, the incidence of significant PVR significantly decreased over time with improvement in valve design. SAPIEN 3 was associated with less significant PVR after TAVI independently of the AVC burden.

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“…There were no mild-moderate or above PVL for the Lotus, whereas the Sapien had 5% mild-moderate PVL. It should be noted that the majority of Sapien cases were performed with Sapien XT, and the newer Sapien-3 has been designed to reduce the frequency of PVL [14, 15]. These figures can still be benchmarked against the incidence of moderate or above PVL in larger studies, where the Lotus valve system had a 1% frequency, the Sapien 3 had a 3,3% frequency, and the Sapien XT had a 13% frequency [7, 14] of moderate to severe PVL.…”

Section: Discussionmentioning

confidence: 99%

The safety of introducing a new generation TAVR device: one departments experience from introducing a second generation repositionable TAVR

Bjursten

Nozohoor

Johansson

et al. 2017

BMC Cardiovasc Disord

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BackgroundIn the evolving field of transcatheter aortic valve replacements a new generation of valves have been introduced to clinical practice. With the complexity of the TAVR procedure and the unique aspects of each TAVR device, there is a perceived risk that changing or adding a new valve in a department could lead to a worse outcome for patients, especially during the learning phase. The objective was to study the safety aspect of introducing a second generation repositionable transcatheter valve (Boston Scientific Lotus valve besides Edwards Sapien valve) in a department.MethodsIn a retrospective study, 53 patients receiving the Lotus system, and 47 patients receiving the Sapien system over a period of three years were compared for short-term outcome according to VARC-2 definitions and 1-year survival.ResultsOutcome in terms VARC-2 criteria for early safety and clinical efficacy, stroke rate, and survival at 30 days and at 1 year were similar. The Lotus valve had less paravalvular leakage, where 90% had none or trace aortic insufficiency as compared to only 48% for the Sapien system.ConclusionsIntroduction of a new generation valve can be done with early device success and safety, and without jeopardizing the outcome for patients up to one year. We found no adverse effects by changing valve type and observed improved outcome in terms of lower PVL-rates. Both existing and new centers starting a TAVR program can benefit from the use of a new generation device.

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Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve

Cited by 27 publications

References 18 publications

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches

Impact of Different Iterations of Devices and Degree of Aortic Valve Calcium on Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation

The safety of introducing a new generation TAVR device: one departments experience from introducing a second generation repositionable TAVR

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