This research received no specific grant from any funding agency in the public, commercial, or nonprofit sectors. Symptomatic severe aortic stenosis (AS) when left untreated carries a dismal prognosis [1].

Genereux P, Head SJ, Hahn R, et al.

Iung B, Laouenan C, Himbert D, et al. Although the studies demonstrated positive results, these first-generation TAVR devices were far from perfect. No differences regarding clinical parameters, such as major bleeding events (Evolut R vs. Evolut Evolut Pro’s new design was tested by the investigators of the Evolut PRO clinical study. A simple risk tool (the OBSERVANT score) for prediction of 30-day mortality after transcatheter aortic valve replacement.

Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial.

J Am Coll Cardiol. This article is based on previously conducted studies and does not involve any new studies of human or animal subjects performed by any of the authors.

Whether this still holds true with the latest-generation Evolut PRO remains unknown at present. All statistical analyses were performed with SPSS 23. Many of our patients had pre-existing RBBB or LBBB placing them at a higher risk (16.6% PRO and 19.6% R groups). Although the first successful surgical aortic valve replacement (SAVR) dates back to the 1960s, advanced age and co-morbid conditions remained a significant limiting factor in performing SAVR for elderly patients with symptomatic severe AS [2]. Cardiol Ther 6, 183–192 (2017). Despite the additional pericardial skirt and larger sheath size of Evolut PRO, outcomes were comparable between the two Evolut systems, supporting adoption of the newest generation valve in the management of severe aortic stenosis as well as continued use of the Evolut R in patients with smaller vasculature warranting a lower profile device. Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy. 2012;366:1705–15. Choice of balloon-expandable versus self-expanding transcatheter aortic valve impacts hemodynamics differently according to aortic annular size. JAMA. N Engl J Med. N Engl J Med. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate risk patients with aortic stenosis. Am J Cardiol. The interaction of the prosthetic valve at the level of membranous septum has the potential to create conduction system disturbances.

Three patients experienced life-threatening or major bleeding in the PRO group while 2 patients experienced a major bleed in the R group. Leon MB, Smith CR, Mack MJ, et al.

All patients included in the study had valve implantation via iliofemoral access. 2015;66:1327–34. Comparative matched outcome of Evolut-R vs CoreValve transcatheter aortic valve implantation. Despite improved survival and superior hemodynamics compared to surgical aortic valve replacement (SAVR), [2–4] randomized, controlled trials demonstrated that patients undergoing TAVR consistently have higher rates of PVL as compared to SAVR, [4, 5] resulting in higher risk of adverse events and mortality [6, 7].

Similarly, the rates of permanent pacemaker implantation for SAPIEN 3 and Evolut PRO were 13.3% and 10.0%, respectively, during the 30-day follow-up period in the aforementioned trials [49, 53]. Kapadia SR, Kodali S, Makkar R, et al.

In the Evolut PRO group versus R group, respectively, 3 patients (5%) versus 2 patients (3.5%) received a 23 mm valve, 28 patients (46.7%) versus 18 (27.3%) received a 26 mm valve, and 29 patients (48.3%) versus 19 (33.9%) received a 29 mm valve. 2011;364:2187–98. 2011;366:1686–95. This latest technology is currently available in 23, 26, and 29 mm sizes. The Evolut PRO has an external pericardial wrap designed to reduce prosthetic valve regurgitation. In a matched comparison of the Evolut R and Evolut PRO devices in high-risk patients, Hellhammer et al 11 reported comparable clinical outcomes for the two devices.

Multidetected computer tomography was used for anatomic assessments in all patients for aortic sizing as well as peripheral vascular suitability.

The mean age for TAVI and SAVR patients in the propensity-score matched population was 79.1 years and STS-PROM was 4.0 ± 1.5% for TAVI and 3.9% ± 1.3% for SAVR. Eggebrecht H, Schmererund A, Voigtlander T, et al. 2017;10:268–75. This study was conducted retrospectively, and the decision of the type of valve used for treatment was not affected by this study. Treatment of symptomatic severe aortic stenosis with a novel resheathable supra-annular self-expanding transcatheter aortic valve system. Early Real-World Experience with CoreValve Evolut PRO and R Systems for Transcatheter Aortic Valve Replacement, Department of Cardiology, North Shore University Hospital, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, USA, Department of Internal Medicine, North Shore University Hospital, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, USA, Department of Cardiovascular and Thoracic Surgery, North Shore University Hospital, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, USA, Correct positioning of single valve in proper anatomical location, Intended performance of prosthetic heart valve, Mean gradient <20 mm Hg or peak velocity <3 m/s, Absence of moderate or severe prosthetic regurgitation, A. Vahanian, O. Alfieri, F. Andreotti et al., “Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS),”, D. H. Adams, J. J. Popma, M. J. Reardon et al., “Transcatheter aortic-valve replacement with a self-expanding prosthesis,”, J. J. Popma, D. H. Adams, M. J. Reardon et al., “Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery,”, M. J. Reardon, N. M. Van Mieghem, J. J. Popma et al., “Surgical or transcatheter aortic-valve replacement in intermediate-risk patients,”, C. R. Smith, M. B. Leon, M. J. Mack et al., “Transcatheter versus surgical aortic-valve replacement in high-risk patients,”, S. Kodali, P. Pibarot, P. S. Douglas et al., “Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes,”, G. Athappan, E. Patvardhan, E. M. Tuzcu et al., “Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature,”, S. H. Ewe, A. C. Ng, J. D. Schuijf et al., “Location and severity of aortic valve calcium and implications for aortic regurgitation after transcatheter aortic valve implantation,”, L. Azzalini, B. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. Coronary obstruction following transcatheter aortic valve implantation: a systematic review. We noticed decreasing rates of PVL over the time course, suggesting operator comfort with repositioning and lower valve implantation likely, played a role. Circulation. 2015;8:1084–91.

On the basis of this data, TAVR is now approved for use in intermediate surgical risk patients in the USA. Schulz E, Jabs A, Gori T, et al. IJC Heart Vasc. Incidence and treatment of procedural cardiovascular complications associated with trans-arterial and trans-apical interventional aortic valve implantation in 412 consecutive patients. However, this analysis is valuable in comparison to the randomized trial by Medtronic as it is reflective of a real-world clinical practice in which valve choice decisions are made by a Heart Team and based on patient’s baseline characteristics. Several studies are underway to evaluate various antiplatelet and anticoagulation regimens to determine the optimal pharmacological regimen post TAVR. Survival in elderly patients with severe aortic stenosis is dramatically improved by aortic valve replacement: results from a cohort of 277 patients aged > or = 80 years. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards Sapien valve in the PARTNER trial: characterizing patients and impact on outcomes. There were no mortalities, and the VARC-2 safety endpoint at 30 days was comparable. This delivery system also allowed for 1:1 torque response to allow more accurate positioning of the valve.

Pre-TAVR balloon aortic valvuloplasty was performed in 11 (18.3%) patients in the PRO versus 14 (25%) patients in the R group (). However, this difference was not apparent in patients with a medium or large annulus as their hemodynamics were comparable between these two valve platforms. 2010;5:673–9. Researchers showed that self-expandable valve implantation yielded superior hemodynamics as compared to balloon-expandable valves in patients with a small aortic annulus. The corresponding author will consider request for general access to these data after publication of this article; however, approval will be at the discretion of the Northwell Health Institutional Review Board. Initial data on 30-day outcomes with this new-generation device was published by Manoharan and colleagues who reported overall device success rate of 78.6% per the VARC-2 (Valve Academic Research Consortium-2) and low rates of moderate (3.4%) and severe (0%) PVL, major vascular complications (8.3%), and permanent pacemaker implantation (11.7%) [40].

The rate of all-cause mortality or disabling stroke at 30-days significantly favored TAVI (0.5% vs 5.1%; p = 0.006). 2013;112:850–60. Article  *All studies used valve size 26 mm and 29 mm, and the results were not stratified per valve size, Mean transaortic valve gradient pre and post TAVR [12, 42, 49]. These limitations have led to iterative technological advancements in transcatheter heart valve (THV) design, with efforts to create lower profile, repositionable devices with optimal radial force and annular sealing. https://doi.org/10.1007/s40119-017-0100-z, DOI: https://doi.org/10.1007/s40119-017-0100-z, Over 10 million scientific documents at your fingertips, Not logged in Tchetche D, Dumonteil N, Sauguet A, et al.

2017;30:72–8.

2017;70:252–289. The current commercially available valves are broadly grouped into balloon expandable and self-expandable valves. J Am Coll Cardiol. Aortic valve replacement with a caged ball valve. Comparison of different invasive hemodynamic measurements as a prediction tool for mortality after transcatheter aortic valve replacement in men: a retrospective observational study. 2017;389:2383–2392.

Similar findings were shown by several large European registries [20,21,22]. This second-generation device was tailored in such a manner as to reduce the overall height of the prosthesis while preserving the height of the pericardial skirt and extending it to allow a more secure seal against PVL. Legend: New electrocardiogram findings of left bundle branch block (LBBB) and new permanent percutaneous pacemaker (PPM) requirement in the patients implanted with CoreValve Evolut PRO and CoreValve Evolut R. There is no significant difference between the two groups. 2014;113:1851–8.



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