Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial

Lanz, Jonas; Kim, Won-Keun; Walther, Thomas; Burgdorf, Christof; Möllmann, Helge; Linke, Axel; Redwood, Simon; Thilo, Christian; Hilker, Michael; Joner, Michael; Thiele, Holger; Conzelmann, Lars O.; Conradi, Lenard; Kerber, Sebastian; Schymik, Gerhard; Prendergast, Bernard; Hüsser, Oliver; Stortecky, Stefan; Heg, Dik; Jüni, Peter; Windecker, Stephan; Pilgrim, Thomas

doi:10.1016/s0140-6736(19)32220-2

Cited by 204 publications

(187 citation statements)

References 23 publications

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“…Of those, 52 were further excluded because they were not pertinent to the design of the meta-analysis or did not meet the explicit inclusion criteria. One RCT [14] and five observational studies [15][16][17][18][19] enrolling the total of 2818 patients were eventually included in the analysis. Potential sources of the studies' bias were analyzed with the use of components recommended by the Cochrane Collaboration and ROBINS-I tool, and the results are enclosed as Table A2.…”

Section: Study Selection and Biasmentioning

confidence: 99%

“…Most commonly, biases arose from participants selection for the study by designated heart teams and subjective distribution of the participants within the study arms. All but one study [14] lacked a core lab assessment of PVL and central adjudication of clinical events.…”

Section: Study Selection and Biasmentioning

confidence: 99%

“…To minimize these shortcomings, technological innovations were developed in next-generation valves including the following: balloon-expandable SAPIEN 3 (Edwards Lifesciences, Irvine, CA, USA) and self-expandable ACURATE neo (Boston Scientific Corporation, Marlborough, MA, USA). Since direct comparisons of these two devices are few and one recent randomized controlled trial (RCT) [14] did not demonstrate non-inferiority of the ACURATE neo device as compared to SAPIEN 3 as opposed to previous observational studies [15][16][17][18][19][20][21] that, however, pointed to comparable or superior results with ACURATE, the debate is ongoing.…”

Section: Introductionmentioning

confidence: 99%

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Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Gozdek

Zieliński

Pasierski

et al. 2020

JCM

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Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with earlier-generation devices. Current meta-analysis compared outcomes of TAVR with next-generation devices: ACURATE neo and SAPIEN 3. In random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. One randomized controlled trial and five observational studies including 2818 patients (ACURATE neo n = 1256 vs. SAPIEN 3 n = 1562) met inclusion criteria. ACURATE neo was associated with a 3.7-fold increase of moderate-to-severe PVL (RR (risk ratio): 3.70 (2.04–6.70); P < 0.0001), which was indirectly related to higher observed 30-day mortality with ACURATE valve (RR: 1.77 (1.03–3.04); P = 0.04). Major vascular complications, acute kidney injury, periprocedural myocardial infarction, stroke and serious bleeding events were similar between devices. ACURATE neo demonstrated lower transvalvular pressure gradients both at discharge (P < 0.00001) and at 30 days (P < 0.00001), along with lower risk of patient–prosthesis mismatch (RR: 0.29 (0.10–0.87); P = 0.03) and pacemaker implantation (RR: 0.64 (0.50–0.81); P = 0.0002), but no differences were observed regarding composite endpoints early safety and device success. In conclusion, ACURATE neo, as compared with SAPIEN 3, was associated with higher rates of moderate-to-severe PVL, which were indirectly linked with increased observed 30-day all-cause mortality.

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Section: Study Selection and Biasmentioning

confidence: 99%

Section: Study Selection and Biasmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Gozdek

Zieliński

Pasierski

et al. 2020

JCM

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“…Der Kardiologe 2 · 2020 75 unterschiedlicher TAVI-Prothesentypen vorgestellt [8]. Hierbei wurde die selbstexpandierbare ACURATE neo (Boston Scientific, Marlborough, MA, USA) mit der Ballon-expandierbaren SAPIEN 3 (Edwards Lifesciences, Irvine, CA, USA) verglichen [8]…”

Section: Aortic Valve Stenosis · Catheter-based Interventions · Mitraunclassified

Herzklappenerkrankungen 2019

Frerker

Möllmann

2020

Kardiologe

Self Cite

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Die häufigsten Herzklappenerkrankungen sind heutzutage die Aortenklappenstenose sowie die Mitral-und Trikuspidalklappeninsuffizienz. Das Vorliegen einer dieser unbehandelten Klappenerkrankungen ist meist mit einer deutlich eingeschränkten Lebensqualität und erhöhten Sterblichkeit der Patienten assoziiert. Die Einführung katheterbasierter Therapieformen in den letzten Jahren hat die Behandlung dieser Herzklappenerkrankungen maßgeblich verändert. In der vorliegenden Arbeit sollen relevante Studien zu diesem Thema aus dem Jahr 2019 vorgestellt werden. Aortenklappenstenose Indikationsstellung und ErgebnisrealitätDie Therapie der Aortenklappenstenose (AS) erfuhr in den letzten Jahren mit Etablierung der Transkatheteraortenklappenimplantation (TAVI) eine dramatische Weiterentwicklung. Die erste TAVI-Prozedur erfolgte im Jahr 2002 bei einem inoperablen Patienten mit hochgradiger AS im kardiogenen Schock [6]. In der Folge führten die Ergebnisse randomisierter Studien dazu, dass die TAVI erstmals in der europäischen Leitlinie für Herzklappenerkrankungen im Jahr 2012 als Therapie für inoperable und Hochrisikopatienten empfohlen wurde. Nachdem die TAVI bei den inoperablen und Hochrisikopatienten gute Ergebnisse gegenüber der konservativen bzw. dem konventionell chirurgischen Aortenklappenersatz (AKE) zeigte, folgten Studien bei Patienten mit intermediärem Risiko. Hierbei zeigte sich, dass die TAVI dem chirurgischen AKE hin-sichtlich Sterblichkeit und Schlaganfall mindestens gleichwertig, teilweise sogar überlegen ist, wenn sie über einen transfemoralen Zugang durchgeführt wird. Aufgrund dieser guten Ergebnisse erfolgte in der aktuellen Leitlinie aus dem Jahr 2017 und dem deutschen Kommentar der Leitlinie eine Indikationsausweitung der TAVI auf sämtliche Patienten mit hochgradiger AS mit Ausnahme des Niedrigrisikokollektives [2, 3]. Für diese Patientengruppe brachte nun das letzte Jahr 2019 die noch offenen Antworten. Die Evolut Low Risk-Studie randomisierte 1468 Patienten mit einem niedrigen operativen Risiko (STS [Society of Thoracic Surgeons] Score <3 % Sterblichkeit) zur transfemoralen TAVI oder einem konventionellen AKE [13]. Das mittlere Patientenalter betrug 74 Jahre. Es zeigte sich, dass die TAVI dem chirurgischen AKE hinsichtlich des primären Studienendpunktes (Tod oder schwerer Schlaganfall) nach 2 Jahren nicht unterlegen ist (TAVI vs. AKE: 5,3 % vs. 6,7 %) [13]. » Es zeigte sich eine signifikant niedrigere In-Hospital-Sterblichkeit nach TAVI gegenüber dem AKE Die PARTNER 3-Studie zeigte ebenso bei einem Niedrigrisikopatientenkollektiv (STS Score <4 %) mit 1000 Patienten und einem mittleren Lebensalter von 73 Jahren, dass die transfemorale TAVI dem AKE nicht unterlegen ist [9]. Hierbei war die TAVI hinsichtlich des primären Studienendpunktes (Tod, Schlaganfall oder Rehospitalisierung) nach 12 Mona-ten sogar überlegen (TAVI vs. AKE: 8,5 % vs. 15,1 %; p = 0,001 für Überlegenheit) [9]. Zusätzlich zu den beiden großen randomisierten Studien gibt es eine Arbeit aus dem Deutschen Aortenklappenregister zu diesem Thema. Be...

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“…However, the proof of potential advantages of different TAVI devices lies in robust comparative randomized trials and it is a credit of the investigators and the company to have done one of the first such studies to compare the promising “kid” ‐ the ACURATE neo to the well‐established “champ” ‐ the balloon expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) looking at a composite endpoint of safety and efficacy at 30‐days in a noninferiority trial, the SCOPE‐1 which was presented at the TCT in San Francisco in September 2019 with simultaneous publication . Seven hundred and thirty nine patients (mean age 82.8 years) at increased surgical risk were randomized.…”

mentioning

confidence: 99%

A novel self‐expanding transcatheter heart valve: Shaping the story beyond accuracy

Seth

Kumar

2019

Cathet Cardio Intervent

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Key Points As transcatheter aortic valve implantation expands to low risk patients, the key to prolonged survival would be large effective orifice area with extremely low rates of paravalvular leak and permanent pacemaker implantation. New transcatheter valve technologies look promising to enable this, ACURATE neo is one such device. The results of ongoing trials with ACURATE neo and ACURATE neo2 are keenly awaited.

show abstract

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial

Cited by 204 publications

References 23 publications

Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Herzklappenerkrankungen 2019

A novel self‐expanding transcatheter heart valve: Shaping the story beyond accuracy

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