Transcatheter aortic valve replacement for treatment of aortic stenosis has now become an accepted alternative to surgical valve replacement for some patients. In addition, transcatheter mitral valve ...repair is also routinely used in high surgical risk patients with mitral regurgitation. Other transcatheter procedures are in rapid development. The current review attempts to summarize the procedures and echocardiographic imaging used for transcatheter valve replacement or valve repair.
Anatomy and Physiology of the Tricuspid Valve Dahou, Abdellaziz; Levin, Dmitry; Reisman, Mark ...
JACC. Cardiovascular imaging,
March 2019, 2019-03-00, 20190301, Letnik:
12, Številka:
3
Journal Article
Recenzirano
Odprti dostop
An appreciation of the complex and variable anatomy of the tricuspid valve is essential to unraveling the pathophysiology of tricuspid regurgitation. A greater appreciation of normal and abnormal ...anatomy is important as new methods of treating the tricuspid regurgitation are developed. This review of tricuspid valve and right heart anatomy is followed by a discussion of the possible pathophysiology of secondary (functional) tricuspid regurgitation.
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Tricuspid regurgitation is a prevalent disease associated with high morbidity and mortality, with few treatment options. The aim of the TRILUMINATE trial is to evaluate the safety and effectiveness ...of TriClip, a minimally invasive transcatheter tricuspid valve repair system, for reducing tricuspid regurgitation.
The TRILUMINATE trial is a prospective, multicentre, single-arm study in 21 sites in Europe and the USA. Patients with moderate or greater triscuspid regurgitation, New York Heart Association class II or higher, and who were adequately treated per applicable standards were eligible for enrolment. Patients were excluded if they had systolic pulmonary artery pressure of more than 60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. Tricuspid regurgitation was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was a reduction in tricuspid regurgitation severity by at least one grade at 30 days post procedure, with a performance goal of 35%, analysed in all patients who had an attempted tricuspid valve repair procedure upon femoral vein puncture. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups. The trial has completed enrolment and follow-up is ongoing; it is registered with ClinicalTrials.gov, number NCT03227757.
Between Aug 1, 2017, and Nov 29, 2018, 85 patients (mean age 77·8 years SD 7·9; 56 66% women) were enrolled and underwent successful TriClip implantation. Tricuspid regurgitation severity was reduced by at least one grade at 30 days in 71 (86%) of 83 patients who had available echocardiogram data and imaging. The one-sided lower 97·5% confidence limit was 76%, which was greater than the prespecified performance goal of 35% (p<0·0001). One patient withdrew before 6-month follow-up without having had a major adverse event and was excluded from analysis of the primary safety endpoint. At 6 months, five (6%) of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (p<0·0001). Single leaflet attachment occurred in five (7%) of 72 patients. No periprocedural deaths, conversions to surgery, device embolisations, or strokes occurred. At 6 months, all-cause mortality had occurred in four (5%) of 84 patients.
The TriClip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post procedure.
Abbott.
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