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

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.

Nonstandard Abbreviations and Acronyms

Clinical Perspective

What Is New?

• Multiple resheathing is required in up to 10% of cases, with independent predictors being associated with the type of valve implanted (more with Portico) and with the presence of moderate/severe aortic regurgitation at baseline.

• Multiple resheathing, but not single resheathing, was associated with worse device success, determined by a higher need for a second valve, more device embolization, and increased 1‐year mortality, regardless of the type of valve implanted.

What Are the Clinical Implications?

• Multiple resheathing may not necessarily be the direct cause of the worse outcomes, but a marker of more complicated anatomical features for an optimal device implantation.

• It may be reasonable for the operators to consider changing the strategy/approach or type/size of the valve before final release in cases where multiple resheathing is needed.

Since the beginning of the transcatheter aortic valve replacement (TAVR) era, there has been a continuous evolution of the transcatheter heart valves (THVs) that led to significant improvement in clinical outcomes.¹, ², ³, ⁴, ⁵, ⁶ Early generation of TAVR devices had been associated with increased risk of complications and device failure, such as moderate or severe paravalvular leak, high incidence of conduction disturbances requiring new permanent pacemaker implantation, and need for a second THV.⁷, ⁸, ⁹ The newer‐generation devices have been designed to overcome these limitations.

Among the different self‐expanding THVs, both the Evolut R/Pro (Medtronic, Minneapolis, MN) and the Portico (Abbott, Chicago, IL) valves use a delivery system with a mechanism that allows for resheathing and recapturing of the THV before complete deployment, in case repositioning is required. This novel feature allows the operators to have 2 or even multiple attempts to position th

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