Focus on Aortic Regurgitation and Transcatheter Aortic Valve ReplacementNew Research Paper: StructuralTranscatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device
Central Illustration
Section snippets
Study design and patients
The compassionate-use study is an investigator-initiated, multicenter, North American observational registry designed to capture the early clinical experience with J-Valve for the treatment of patients with symptomatic, severe, pure AR from May 2018 to October 2022. A total of 5 sites were included in the present analysis: 1) The Christ Hospital (Cincinnati, Ohio); 2) St. Paul’s Hospital (Vancouver, British Columbia, Canada); 3) Houston Methodist (Houston, Texas); 4) Henry Ford Hospital
Results
The baseline characteristics of the study cohort are presented in Table 1. A total of 27 patients with native valve AR were treated with J-Valve during the study period. Consistent with the compassionate-use intent of the protocol, the study cohort was composed of elderly patients (median age 81 years; range: 72-85 years) at either high (81%) or extreme or prohibitive (8%) surgical risk (median Society of Thoracic Surgeons score 4.3; range: 2.6-5.3). Most patients exhibited advanced heart
Discussion
This 5-year (2018-2022) compassionate-use experience with a dedicated THV designed to treat severe native AR in patients at high or prohibitive surgical risk provides several important observations (Central Illustration). First, overall procedural success was 81%, with all complications requiring surgery or urgent placement of a second valve occurring during the first 2 years of the experience with the first generation of the device. Root-cause analyses of these cases led to modifications in
Conclusions
The early North American compassionate-use experience with the J-Valve for the treatment of patients with native AR is characterized by increasingly higher procedural success, few complications, marked reductions in heart failure symptoms, and improvements in valve hemodynamic status. Transcatheter treatment of patients with AR is rapidly evolving, and device enhancements will likely result in expansion of this therapy in the near future.
Funding Support and Author Disclosures
This study was supported by a JC Medical grant to the data coordinating center at the Lindner Center for Research and Education. Dr Garcia has received institutional grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; serves as a proctor and steering committee member for Edwards Lifesciences; and serves on advisory boards for Boston Scientific and Medtronic. Dr Kereiakes is a consultant for JC Medical and JenaValve; and is a member of the ALIGN-AR trial
References (14)
- et al.
2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
J Am Coll Cardiol
(2021) - et al.
Long-term outcomes in patients with aortic regurgitation and preserved left ventricular ejection fraction
J Am Coll Cardiol
(2016) - et al.
Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients
Ann Thorac Surg
(2015) - et al.
Transcatheter aortic valve replacement in pure native aortic valve regurgitation
J Am Coll Cardiol
(2017) - et al.
30-Day outcomes of transfemoral transcatheter aortic valve replacement for aortic regurgitation with a novel self-expanding prosthesis
J Am Coll Cardiol
(2021) - et al.
A new transcatheter aortic valve replacement system for predominant aortic regurgitation implantation of the J-Valve and early outcome
J Am Coll Cardiol Intv
(2015) - et al.
Valvular heart disease: aortic regurgitation
Circulation
(2005)
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