Severe aortic regurgitation (AR) may account for 20% to 30% of all surgical aortic valve replacements (SAVR) and is often associated with aortic stenosis (AS).
Transcatheter treatment of these patients is limited due to anatomical factors such as root and annular dilation, large annular dimensions, and less calcification in the valve leaflets to serve as an anchor for currently available prostheses.
Research with second-generation valves designed for AS treatment has shown a high rate of complications and suboptimal outcomes. To date, there are no transcatheter valves approved for use in patients with AR.
The objective of this multicenter observational registry was to describe the experience of compassionate use of a dedicated transcatheter device called J-Valve in the United States. J-Valve is a low-profile, self-expandable Nitinol valve made of bovine pericardium.
This study analyzed data from 27 patients with severe AR treated with J-Valve between 2018 and 2022. Mean patient age was 81 years old, and most patients were men. Furthermore, 81% of the patients had a high surgical risk (mean STS score: 4.3; range: 2.6-5.3). Most patients had advanced symptoms of heart failure (NYHA class III or IV in 96% of all cases). Regarding valve characteristics, the most common etiology was degenerative (78%), and the most frequent morphology was tricuspid (89%). The average ejection fraction was 54%. As for the procedures, most of them were elective (96%), performed under general anesthesia (85%), and via transfemoral access (75%).
Procedural success, defined as J-Valve implantation without the need for crossover to surgery or a second device, was 81% (22 out of 27 cases). In terms of in-hospital clinical outcomes, there was one death due to multiorgan failure and sepsis following device embolization, one case of stroke in a patient with transcarotid access, and five vascular complications related to access. At 30 days, no deaths, stroke events, or additional hospitalizations were reported. Thirteen percent of the patients required a permanent pacemaker, and most of them (88%) were classified as NYHA class I or II. In an echocardiographic analysis, 52% of patients presented absence of residual AR, with no presence of moderate or severe AR.
Conclusion
Compassionate use of J-Valve for the treatment of native AR in the United States showed positive results. There was an increase in procedural success, a reduction in the complications rate, a marked decrease in heart failure symptoms, and an improvement in hemodynamic parameters. Percutaneous treatment of this valve disease is advancing fast, and the development of new devices will hopefully allow this therapy to expand its scope in the near future.
Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.
Original Title: Transcatheter Treatment of Native Aortic Valve Regurgitation The North American Experience With a Novel Device.
Reference: Santiago Garcia, MD et al J Am Coll Cardiol Intv 2023.
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