Study design and rationale of the heterotopic implantation of the Edwards-Sapien XT transcatheter valve in the inferior VEna cava for the treatment of severe tricuspid regurgitation (HOVER) trial.
BACKGROUND
Tricuspid regurgitation (TR) is an under treated disease. Although surgery for TR remains an effective therapy, many patients are considered to be at a high risk or otherwise inoperable. Caval valve implant (CAVI) offers an alternative to surgery in these patients. Trials assessing the safety and efficacy of caval valve implant are lacking.


METHODS
The Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna cava for the treatment of severe Tricuspid Regurgitation (HOVER) trial is an FDA approved, physician initiated, prospective, non-blinded (open label), non-randomized safety and feasibility study to determine the safety and efficacy of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe TR in patients who are at high risk or inoperable. Patients with severe TR in the absence of severe pulmonary hypertension will be recruited. They will be evaluated by a multi-disciplinary team who will agree by consensus that the patients' symptoms are from TR. They will undergo imaging to assess the size of the inferior vena cava (IVC) to determine feasibility of the procedure. If patients meet the inclusion criteria and are free from exclusion criteria, after informed consent they will be eligible for enrollment in the study. A total of 30 patients will be enrolled. The primary objective of the study will be to demonstrate procedural success at 30-days and patient success at 1-year.


CONCLUSIONS
Caval valve implant may present an alternative for patients who are at high risk or inoperable for tricuspid valve surgery (TVS) for TR. © 2016 Wiley Periodicals, Inc.
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Brian P
BP
O'Neill
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Grayson
G
Wheatley
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Riyaz
R
Bashir
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Daniel
D
Edmundowicz
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Brian
B
O'Murchu
Henry Ford Health System, Detroit, Michigan.
William W
WW
O'Neill
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Pravin
P
Patil
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Andrew
A
Chen
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Paul
P
Forfia
Temple Heart and Vascular Institute, Philadelphia, Pennsylvania.
Howard A
HA
Cohen
D002405:Catheterization, Central Venous / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D002985:Clinical Protocols; D005240:Feasibility Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D006439:Hemodynamics; D006801:Humans; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014261:Tricuspid Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D014262:Tricuspid Valve Insufficiency / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D014682:Vena Cava, Inferior / Q000000981:diagnostic imaging / Q000503:physiopathology
Transcatheter Aortic Valve; Tricuspid Regurgitation; heterotopic; inoperable; percutaneous