Resheathing of self-expanding bioprosthesis: Impact on procedural results, clinical outcome and prosthetic valve durability after transcatheter aortic valve implantation

Kefer, Joëlle; Maes, Frédéric; Renkin, Jean; Kautbally, Shakeel; Meester, Christophe de; Delacour, Marine; Pouleur, Anne‐Catherine

doi:10.1016/j.ijcha.2019.100462

Cited by 9 publications

(29 citation statements)

References 27 publications

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“…Although prior studies in the TAVR field have shown resheathing rates of ≈30%, similar to our research, there has been a considerable variation among them according to valve type, ranging from 21% to 41%. 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 Of note, MR, defined as the need for ≥2 partial or total recapture of the device, was required in 28% of all resheathing cases (≈10% overall), somewhat lower than the 38% reported by a recent smaller study. 13 More important, in our research, MR was more frequent with a Portico versus Evolut R/Pro device, and by multivariable analysis, the use of a Portico THV increased ≈3‐fold the chances for MR.…”

Section: Discussionmentioning

confidence: 65%

“… 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 Of note, MR, defined as the need for ≥2 partial or total recapture of the device, was required in 28% of all resheathing cases (≈10% overall), somewhat lower than the 38% reported by a recent smaller study. 13 More important, in our research, MR was more frequent with a Portico versus Evolut R/Pro device, and by multivariable analysis, the use of a Portico THV increased ≈3‐fold the chances for MR. This has also been consistent with the literature, as shown in the recent Portico‐I trial, where 41% of the cases needed at least 1 resheathing.…”

Section: Discussionmentioning

confidence: 65%

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

Bernardi

Rodés‐Cabau

Tirado‐Conte

et al. 2021

JAHA

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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.

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Section: Discussionmentioning

confidence: 65%

Section: Discussionmentioning

confidence: 65%

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

Bernardi

Rodés‐Cabau

Tirado‐Conte

et al. 2021

JAHA

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“…Incidence at 1 year and 5 years or more from included studies were pooled in meta-analyses, respectively. Except one article, the others reported the incidence of SVD at 3.2 years [ 19 ]. Two studies were rated as moderate risk of bias through QUIPS risk assessment [ 14 , 17 ], and the overall quality of evidence was rated down to moderate due to inconsistency (Supplementary Tables 2 and 3 ) [ 14 , 17 ].…”

Section: Resultsmentioning

confidence: 99%

Incidence and Predictors of Structural Valve Deterioration after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Long

Liu

2020

Journal of Interventional Cardiology

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Background. Transcatheter aortic valve replacement (TAVR), widely used as an alternative therapy in patients with severe aortic stenosis, is expected to be offered to low-risk patents with a longer life expectancy. The durability of transcatheter aortic valve is becoming of increasing importance. Method. PubMed, Embase, and Cochrane CENTRAL from the inception to March 2020 were systematically screened for studies reporting on structural valve deterioration (SVD) in TAVR patients. Incidence of SVD was diagnosed according to the latest European consensus as the primary end point. Predictors of SVD evaluated at multivariable analysis and cumulative incidence function (CIF) of SVD were the secondary end point. Result. Twelve studies encompassing 10031 patients evaluating the incidence of SVD were included, with a follow-up between 1 and 8 years. The pooled incidence of SVD was 4.93% (95% CI, 2.75%–7.70%, I2 = 96%) at 1 year and 8.97% (95% CI, 6.89%–11.29%, I2 = 86%) in the long term (≥5 years). Subgroup analysis was performed to identify the valve type that may result in partial heterogeneity. SVD was more frequent in patents with a valve diameter of <26 mm (HR: 3.57, 1.47–8.69), oral anticoagulants (OAC), exposure at discharge (OR: 0.48, 0.38–0.61), or by a disease of renal dysfunction (OR 1.42, 1.03–1.96). Conclusion. SVD represents infrequent events after TAVR in the long term (>5 years), occurring more commonly in renal dysfunction patients, with small valve diameter and without OAC exposure. There may be an underestimation of the incidence if we assume death as a competing risk.

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“…Another benefit of the self‐expanding valves is their ability to be resheathed and repositioned prior to final deployment. A concern with resheathing a bioprosthetic valve is the possibility of dislodging calcifications resulting in embolization during the procedure or damage to the prosthetic leaflets during crimping 55,67 . Kefer et al investigated the clinical outcomes of resheathing the Nitinol self‐expanding CoreValve Evolut or Portico valves against the balloon‐expanding Sapien valves and noted no significant differences in stroke or valve durability in the 20 months following the procedure 67 .…”

Section: Cardiovascular Applications For Shape Memory Materialsmentioning

confidence: 99%

“…A concern with resheathing a bioprosthetic valve is the possibility of dislodging calcifications resulting in embolization during the procedure or damage to the prosthetic leaflets during crimping 55,67 . Kefer et al investigated the clinical outcomes of resheathing the Nitinol self‐expanding CoreValve Evolut or Portico valves against the balloon‐expanding Sapien valves and noted no significant differences in stroke or valve durability in the 20 months following the procedure 67 . However, the study had a relatively small sample size undergoing resheathing, and thus, larger studies with long‐term outcomes should be conducted.…”

Section: Cardiovascular Applications For Shape Memory Materialsmentioning

confidence: 99%

Smart materials in cardiovascular implants: Shape memory alloys and shape memory polymers

2020

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Smart materials have intrinsic properties that change in a controlled fashion in response to external stimuli. Currently, the only smart materials with a significant clinical impact in cardiovascular implant design are shape memory alloys, particularly Nitinol. Recent prodigious progress in material science has resulted in the development of sophisticated shape memory polymers. In this article, we have reviewed the literature and outline the characteristics, advantages, and disadvantages of shape memory alloys and shape memory polymers which are relevant to clinical cardiovascular applications, and describe the potential of these smart materials for applications in coronary stents and transcatheter valves.

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Resheathing of self-expanding bioprosthesis: Impact on procedural results, clinical outcome and prosthetic valve durability after transcatheter aortic valve implantation

Cited by 9 publications

References 27 publications

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

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

Incidence and Predictors of Structural Valve Deterioration after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Smart materials in cardiovascular implants: Shape memory alloys and shape memory polymers

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