Initial Experience and Bench Validation of the CLEVE Prosthetic Leaflet Modification Procedure During Aortic and Mitral Valve-in-Valve Procedures

Abstract

Background: Some patients with failing surgical aortic or mitral valves are anatomically unsuitable for typical valve-in-valve procedures due to threatened coronary artery or left ventricular outflow tract obstruction, respectively.

Objectives: The authors assessed the clinical and benchtop efficacy of the novel CLEVE (CLEveland Valve Electrosurgery) leaflet modification technique in patients with the previous concerns.

Methods: Eight patients with degenerated aortic valve replacement (AVR) and 6 patients with mitral valve replacement (MVR) at high risk for obstruction of left main coronary artery (AVR) or left ventricular outflow tract (MVR) were treated. The threatening prosthetic leaflet was punctured using electrosurgical techniques and dilated progressively, followed by deployment of a balloon-expandable valve into the modified leaflet. Benchtop analyses were performed using the same techniques to assess the response of the surgical leaflet ex vivo.

Results: Successful leaflet clearance was achieved in all without evidence of ostial coronary artery obstruction (AVR) or left ventricular outflow tract obstruction (MVR). One patient experienced left main trunk obstruction due to suspected embolization of material that was treated percutaneously (patient expired due to further complications). No other complications at 30 days. On the benchtop, the procedure demonstrated complete clearance of the threatening leaflet, with detachment from one of the surgical posts in the AVR model and splitting across the leaflet edge in the MVR model.

Conclusions: Patients with a degenerated surgical valve who are unsuitable for a valve-in-valve replacement due to anatomic concerns regarding displacement of the index prosthetic leaflet can be successfully treated after using the CLEVE method of leaflet modification. Further studies of the procedure should be considered.

Keywords: TAVR; coronary obstruction; leaflet modification; left ventricular outflow tract obstruction; transcatheter aortic valve replacement; transcatheter mitral valve replacement; valve-in-valve replacement.