Comparison of the self-expanding Evolut-PRO transcatheter aortic valve to its predecessor Evolut-R in the real world multicenter ATLAS registry

Kalogeras, Konstantinos; Ruparelia, Neil; Kabir, Tito; Jabbour, Richard J.; Naganuma, Toru; Vavuranakis, Manolis; Nakamura, Sunao; Wang, Brian; Sen, Sayan; Hadjiloizou, Nearchos; Malik, Iqbal; Mikhail, Ghada; Dalby, Miles; Panoulas, Vasileios F.

doi:10.1016/j.ijcard.2020.02.070

Cited by 29 publications

(21 citation statements)

References 29 publications

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“…Notably, the incidence of mild PVL was also very low and similar (16% vs. 15% in EVR and EVP group, respectively). In this sense, several recent studies have not observed differences in the rate of PVL between EVR and EVP (12,21). These findings are comparable to those obtained in our study and corroborate data obtained in the real world.…”

Section: Previous Studiessupporting

confidence: 93%

“…Another important point is related to the need of new PPI. Some studies show lower PPI rates with EVP compared with EVR (5,12). In contrast, our study and others find no difference in this respect (21,22).…”

Section: Previous Studiescontrasting

confidence: 83%

“…The EVP has been recently introduced in the market and, therefore, information on its mid-term results is critical to better understand the clinical value of this novel device. Only one previous paper has reported the 1-year clinical follow up, with similar survival between both protheses (12). However, our study not only ratifies this finding, but also examines information on events other than mortality, including in MACE and composite endpoint, during mid-term followup.…”

Section: Previous Studiessupporting

confidence: 82%

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Transcatheter aortic valve replacement using the new Evolut-Pro system: a prospective comparison with the Evolut-R device

Alvarado¹,

Rivero²,

Diego³

et al. 2021

J Thorac Dis

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Background: Evolut Pro (EVP) is a novel self-expandable aortic valve. This prosthesis consists of an external porcine pericardial wrap designed to reduce paravalvular leak (PVL), maintaining the benefits of its predecessor, the Evolut R (EVR). The aim was to compare the functional and clinical results in the short and medium term of the new EVP with the EVR system.Methods: Consecutive patients receiving either the EVR (n=50) or the EVP (n=33) from June 2015 to October 2018 were compared. Baseline characteristics, cardiovascular imaging, procedural outcomes, short and mid-term follow-up outcomes were prospectively collected and assessed.Results: Residual mild PVL was common and comparable in the two groups (EVR 79% vs. EVP 70%; P=0.4). In the EVR group, the presence of PVL was directly related to prosthesis size, but this correlation was not observed in the EVP group. Conduction abnormalities were more prevalent with the EVP, but these did not translate into a higher need of permanent pacemaker implantation. Vascular and bleeding complications were infrequent in both groups. At mid-term clinical follow-up (median survival time: EVR 11±0.3 months, EVP 12±0.2 months), the 1-year rate of adverse events was similar (EVR: 24%, EVP: 33%; P=0.3).Conclusions: Both protheses are effective for the treatment of severe aortic stenosis with excellent results at mid-term clinical follow up. The EVP remains associated with a significant rate of residual mild PVL that appears to be similar to that observed with EVR.

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Section: Previous Studiessupporting

confidence: 93%

Section: Previous Studiescontrasting

confidence: 83%

Section: Previous Studiessupporting

confidence: 82%

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Transcatheter aortic valve replacement using the new Evolut-Pro system: a prospective comparison with the Evolut-R device

Alvarado¹,

Rivero²,

Diego³

et al. 2021

J Thorac Dis

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“…The device was successfully implanted in all patients with a very low rate of severe complications, including major vascular complications, major bleeding, stroke and more than moderate PVL. As for new onset PPMI after TAVI, we noted a similar incidence compared with that in recent multicenter studies using newer-generation self-expanding devices [ 19 – 21 ]. Sammour et al recently found that deploying the balloon-expandable SAPIEN 3 valve in RAO and CAU views could better achieve higher implantation than in conventional co-planar views, which results in significant reduction in post-TAVI PPMI [ 1 ].…”

Section: Discussionsupporting

confidence: 80%

A CT-based technique to predict optimal projection for self-expanding TAVI in patients with different aortic valve anatomies

Wang

Chen

Xiong

et al. 2021

BMC Cardiovasc Disord

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Background Optimal projection is essential for valve deployment during transcatheter aortic valve implantation (TAVI). The purpose of this study was to propose an approach to predict optimal projection in TAVI candidates with different aortic valve anatomies. Methods 331 patients undergoing self-expanding TAVI were included and the so-called non-coronary cusp (NCC)-parallel technique was utilized, which generated the predicted projection by connecting NCC commissures on the transverse plane on the pre-procedural computed tomography images. Results 37.8% of the study cohort were bicuspid aortic valve (BAV) patients. Around 80% of both NCC-parallel views and final views were in the right anterior oblique (RAO) and caudal (CAU) quadrant. There was less than 5° change required from the NCC-parallel view to the final implanted view in 79% of tricuspid aortic valve (TAV) patients but only in 27% (13/48) of type 0 BAV patients with coronary arteries originated from the different cusps. After excluding the above mentioned BAV patients, 62.3% (48/77) of BAV patients needed less than 5° change to achieve optimal projection and only in 8 patients, the angular change was larger than 10° in either left/right anterior oblique or cranial/caudal direction. Conclusions The NCC-parallel technique provides reliable prediction for optimal projection in self-expanding TAVI in all TAV and most BAV patients, with a vast majority of views in the RAO and CAU quadrant.

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“…More recently, several contemporary studies with the SAPIEN 3 and SAPIEN 3 Ultra valves have demonstrated new PPM rates as low as 4.4% to 6.5%, grossly comparable to the surgical risk [ 81 ]. Recent studies have also shown a reduction in the rate of new PPM with the self-expanding Evolut R and PRO valves (Medtronic, Minneapolis, MN, USA) to 10–20% or less [ 82 , 83 ].…”

Section: Optimal Valve Positioning To Reduce Pace-maker Implantationmentioning

confidence: 99%

Advancements in Transcatheter Aortic Valve Implantation: A Focused Update

et al. 2021

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Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65–75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).

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Comparison of the self-expanding Evolut-PRO transcatheter aortic valve to its predecessor Evolut-R in the real world multicenter ATLAS registry

Cited by 29 publications

References 29 publications

Transcatheter aortic valve replacement using the new Evolut-Pro system: a prospective comparison with the Evolut-R device

Transcatheter aortic valve replacement using the new Evolut-Pro system: a prospective comparison with the Evolut-R device

A CT-based technique to predict optimal projection for self-expanding TAVI in patients with different aortic valve anatomies

Advancements in Transcatheter Aortic Valve Implantation: A Focused Update

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