scholarly journals Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement

Author(s):  
Fernando L. M. Bernardi ◽  
Josep Rodés‐Cabau ◽  
Gabriela Tirado‐Conte ◽  
Ignacio J. Amat Santos ◽  
Claudia Plachtzik ◽  
...  

Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self‐expanding valves. Methods and Results This study included a real‐world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1‐year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P <0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P =0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P =0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P =0.003) and increased 1‐year mortality (hazard ratio, 2.06; P =0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success ( P <0.001) and a trend toward increased mortality ( P =0.05). Conclusions Repositioning a self‐expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1‐year mortality, regardless of the type of valve implanted.

2021 ◽  
Vol 77 (18) ◽  
pp. 1129
Author(s):  
Giorgio Medranda ◽  
Cheng Zhang ◽  
Brian Case ◽  
Charan Yerasi ◽  
Brian Forrestal ◽  
...  

2021 ◽  
Vol 14 (11) ◽  
pp. 1209-1215
Author(s):  
Giorgio A. Medranda ◽  
Anees Musallam ◽  
Cheng Zhang ◽  
Hank Rappaport ◽  
Paige E. Gallino ◽  
...  

2020 ◽  
Vol 109 (10) ◽  
pp. 1261-1270 ◽  
Author(s):  
Victor Mauri ◽  
Maria I. Körber ◽  
Elmar Kuhn ◽  
Tobias Schmidt ◽  
Christian Frerker ◽  
...  

Abstract Objective The objective of this study was to assess imaging predictors of mitral regurgitation (MR) improvement and to evaluate the impact of MR regression on long-term outcome in patients undergoing transcatheter aortic valve replacement (TAVR). Background Concomitant MR is a frequent finding in patients with severe aortic stenosis but usually left untreated at the time of TAVR. Methods Mitral regurgitation was graded by transthoracic echocardiography before and after TAVR in 677 consecutive patients with severe aortic stenosis. 2-year mortality was related to the degree of baseline and discharge MR. Morphological echo analysis was performed to determine predictors of MR improvement. Results 15.2% of patients presented with baseline MR ≥ 3 +, which was associated with a significantly decreased 2-year survival (57.7% vs. 74.4%, P < 0.001). MR improved in 50% of patients following TAVR, with 44% regressing to MR ≤ 2 +. MR improvement to ≤ 2 + was associated with significantly better survival compared to patients with persistent MR ≥ 3 +. Baseline parameters including non-severe baseline MR, the extent of mitral annular calcification and large annular dimension (≥ 32 mm) predicted the likelihood of an improvement to MR ≤ 2 +. A score based on these parameters selected groups with differing probability of MR ≤ 2 + post TAVR ranging from 10.5 to 94.4% (AUC 0.816; P < 0.001), and was predictive for 2-year mortality. Conclusion Unresolved severe MR is a critical determinant of long term mortality following TAVR. Persistence of severe MR following TAVR can be predicted using selected parameters derived from TTE-imaging. These data call for close follow up and additional mitral valve treatment in this subgroup. Graphic abstract Factors associated with MR persistence or regression after TAVR


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
I Michalowska ◽  
L Kalinczuk ◽  
M Dabrowski ◽  
Z Chmielak ◽  
K Zielinski ◽  
...  

Abstract Introduction Severe annular and valve cusps calcification is frequent among patients treated with transcatheter aortic valve replacement (TAVR). Severe annular calcification increases the risk of paravalvular leak (PVL) and was associated with worse outcomes. Whether it is accompanied by an independent effect of calcifications localized on cusps and whether the impact of cusps/annular calcification depends on supra vs intra-annular valve design is unknown. Purpose To assess the impact of cusps/annular calcifications on occurrence of moderate PVL after successful TAVR with devices of either intra- or supra-annular design. Methods 282 consecutive patients (80.3±7.6 yrs, 63% female) with baseline 384-slice CT scan were successfully treated with TAVR between Jul 2012 and Oct 2017, either with intra-annular or supra-annular devices. Severe annular calcification (clear protrusion) and severe cusps calcification (Rosenhek 4 score) were identified using a Syngo Via. Results 138 (48.9%) patients were treated with intra-annular and 144 (51.15) with supra-annular devices. Whereas severe annular calcification was similar (23.9% vs 20.1%), there was more severe cusps calcification among intra-annular valves (52.9% vs 41.7%, p=0.073). Intra-annular devices were used less frequently among bicuspid aortic valves, were also of smaller diameter, less frequently deployed after pre-dilation, and less frequently post-dilated. Post-procedure mean aortic gradient tended to be higher among intra-annular devices. Moderate PVL was less frequent among intra- vs supra-annular valves (14.5% vs 34.0%, p&lt;0.001). However, PVL occurrence was higher (30.3%) among those (33/138, 23.9%) treated with an intra-annular valve who had severe annular calcification vs 9.5% in pts treated with an intra-annular TAVR who did not have severe annular calcification (p=0.008) unlike in patients treated with a supra-annular valve who had a high frequency of PVL with or without severe annular calcium (37.9% vs 33.0%). After excluding patients with severe annular calcium (n=62, 22%), moderate PVL was similar between those with vs without severe cusp calcification whether treated with intra- or supra-annular valves (11.8% vs 7.4% and 29.3% vs 35.1%, respectively). Combined VARC-2 safety endpoints plus 2-yr mortality occurrence were lower for intra- vs supra-annular devices (30.4% vs 43.8%, p=0.026). Conclusions Moderate PVL after intra-annular TAVR device deployment occurs in 30% of patients with protruding annular calcification. Severe cusps calcification unaccompanied by annular calcium was not associated with PVL occurrence. Higher frequency of moderate PVL (34%) seen after supra-annular valve deployment appears to be related to other parameters rather than presence of severe annular or cusps calcification. Funding Acknowledgement Type of funding source: None


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