Performance of the Evolut‐R 34 mm versus Sapien‐3 29 mm in Transcatheter aortic valve replacement patients with larger annuli: Early outcome results of Evolut‐R 34 mm as compared with Sapien‐3 29 mm in patients with Annuli ≥26 mm

Eitan, Amnon; Witt, Julian; Stripling, Jan; Haselbach, Timo; Rieß, Friedrich-Christian; Schöfer, Joachim

doi:10.1002/ccd.27588

Cited by 29 publications

(20 citation statements)

References 15 publications

(21 reference statements)

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“…Another study (16) examined gender-based differences in outcomes, in a cohort of Evolut R and Sapien 3 TAVI patients without any comparison between the 2 valves. A total of 5 studies (8,17–20) met the inclusion criteria and were included in the systematic review and meta-analysis. No randomized controlled trials were available for inclusion.…”

Section: Resultsmentioning

confidence: 99%

“…Four (8,18–20) were retrospective cohort studies, while one was a prospective study (17). The prospective study (17) compared outcomes between Evolut R and Sapien 3 valves in patients with large annuli (≥26 mm). None of the remaining studies used any exclusion criteria based on any patient characteristic.…”

Section: Resultsmentioning

confidence: 99%

“…The procedural details of the included studies are presented in Table II. Two studies (17,18) utilized transfemoral access in all patients, while in the remaining studies, the transfemoral route was used in >89% of the study participants. One study (17) compared the 34 mm Evolut R valve with 29 mm Sapien 3 valve.…”

Section: Resultsmentioning

confidence: 99%

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Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

He¹,

Lang

2019

Exp Ther Med

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The aim of this study was to systematically search literature and conduct a meta-analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66–1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83–3.54; P=0.14; I2=0%). Both mean [random; mean difference (MD) = −3.96; 95% CI, −4.61 to −3.31; P<0.00001, I2=0%] and peak (random; MD = −6.85; 95% CI, −8.22 to −5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30-day mortality (OR, 1.32; 95% CI, 0.45–3.87; P=0.62; I2=0%) or 30-day stroke outcomes (OR, 0.76; 95% CI, 0.32–1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short-term complications. The differences between the 2 devices for post-operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi-center randomized controlled trial to provide stronger evidence on this subject.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

He¹,

Lang

2019

Exp Ther Med

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“…Small series from local registries have been recently published showing comparable success and complication rates for the novel 34 mm Evolut R valve compared to the smaller Evolut R prostheses . A small recent non‐randomized study compared the new Evolut R 34 mm device with the balloon expandable Sapien‐3 29 mm for patients with aortic annuli bigger than 26 mm showing comparable periprocedural complication rates . However, to date, there are no data comparing the novel self‐expandable device with its 31 mm predecessor.…”

Section: Introductionmentioning

confidence: 99%

Real‐world comparison of the new 34 mm self‐expandable transcatheter aortic prosthesis Evolut R to its 31 mm core valve predecessor

Kalogeras

Kabir

Mittal

et al. 2018

Cathet Cardio Intervent

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Objectives The aim of the present study was to compare the incidence of periprocedural complications and short‐term outcomes between the second‐generation recapturable 34 mm Evolut‐R and its first‐generation 31 mm predecessor. Background Although already in extensive clinical use in real world patients, the periprocedural complications and clinical outcomes of the new 34 mm device have not been investigated yet. Methods Consecutive patients who had undergone transcatheter aortic valve implantation in two centers with either a 31 mm CoreValve or a 34 mm Evolut‐R device were retrospectively studied. Periprocedural complications of malpositioning, valve‐in‐valve implantation, conversion to full sternotomy or percutaneous coronary intervention and vascular complications were compared between the two groups. Short‐term outcomes at discharge were compared using Valve Academic Research Consortium (VARC‐2) criteria. Results The study group included 106 patients (35 Evolut‐R 34 mm; 71 CoreValve 31 mm). Significantly lower rates of valve‐in‐valve implantation were demonstrated for the 34 mm group compared to the first‐generation device (0% vs. 11.9%, respectively, P = 0.036). All other periprocedural complications were similar between groups. At discharge, the rates of new pacemaker implantation (5.7% vs. 26.8%, P = 0.037) and bleeding complications (2.9% vs. 19.6%, P = 0.025) were statistically significantly lower among the 34 mm group. With regards to VARC‐2 defined combined endpoints, rates of early safety were significantly improved among the 34 mm group compared to 31 mm group (0% vs. 27.9%, respectively, P = 0.004). Conclusions The recently introduced 34 mm Evolut‐R seems to demonstrate an improved safety profile, as evidenced by the reduced bleeding rates, lower rates of valve‐in‐valve implantation and lower PPM rates compared to its 31 mm predecessor.

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“…The need for postprocedural PPI was significantly enhanced in HA using a 34 mm device size. A higher incidence of PPI was already described in the large new‐generation TAVR device 18 and is also frequently experienced in dependency from calcification burden and implantation depth 19 . However, the large system failed to be a dependent or independent predictor for PPI, whereas a valve size of 26 mm was highly preventive for PPI need.…”

Section: Discussionmentioning

confidence: 90%

Novel insights on outcome in horizontal aorta with self‐expandable new‐generation transcatheter aortic valve replacement devices

Veulemans

Maier

Bosbach

et al. 2020

Cathet Cardio Intervent

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Background: The impact of a horizontal aorta (HA) on adverse events (AE) following in transcatheter aortic valve replacement (TAVR) is dealt controversially. Using newgeneration self-expandable devices, we aimed to reevaluate an appropriate threshold of the aortic root angulation (ARA) in terms of HA and its impact on outcome. Methods: The 466 consecutive patients, who underwent transfemoral TAVR with self-expandable new-generation devices, were analyzed. Patients were classified into cases with HA (ARA ≥ 51 ; n = 225; 48%) and without HA (ARA <51 ; n = 241; 52%). Primary endpoints were device success and 30-day mortality. Secondary endpoints were specific AE according to VARC-2 definitions.

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Performance of the Evolut‐R 34 mm versus Sapien‐3 29 mm in Transcatheter aortic valve replacement patients with larger annuli: Early outcome results of Evolut‐R 34 mm as compared with Sapien‐3 29 mm in patients with Annuli ≥26 mm

Abstract: As compared to Sapien-3 29 mm the Evolut-R 34 mm is a real alternative for TAVR in patients with a large annulus with a comparable peri-procedural complication rate, better hemodynamic results but a trend for higher pacemaker rate.

Cited by 29 publications

References 15 publications

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

Real‐world comparison of the new 34 mm self‐expandable transcatheter aortic prosthesis Evolut R to its 31 mm core valve predecessor

Novel insights on outcome in horizontal aorta with self‐expandable new‐generation transcatheter aortic valve replacement devices

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