Transcatheter Repair for Patients with Tricuspid Regurgitation.

BACKGROUND: Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease. METHODS: We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed. RESULTS: A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days. CONCLUSIONS: Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.).

Peak mechanical loads induced in the in vitro edge-to-edge repair of posterior leaflet flail.

BACKGROUND: Percutaneous edge-to-edge mitral valve (MV) repair is a potential therapeutic option for patients presenting with mitral regurgitation, who may not be suitable for surgery. We characterized the edge-to-edge repair forces in a posterior leaflet flail MV model to identify potential modes of mechanical failure. METHODS: Porcine MVs were evaluated in two different sizes (Physio II 32 and 40) in a left-side heart simulator under physiologic hemodynamic conditions. Edge-to-edge repair was simulated by suturing miniature force transducers near the free edge of the anterior and posterior leaflets, on the ventricular side, resulting in a double orifice MV. Posterior leaflet flail was created by selective chordal cutting. RESULTS: Chordal cutting resulted in posterior leaflet flail and mitral regurgitation; all valves coapted normally before chordal cutting. Peak systolic control forces (size 32, 0.098 ± 0.058 N; size 40, 0.236 ± 0.149 N) were not significantly different from systolic flail forces (size 32, 0.136 ± 0.107 N; size 40, 0.220 ± 0.128 N) for either MV size. No correlation was observed between force magnitude and flail height or width. Peak systolic force was greater (p = 0.08) for the larger MVs (size 40 compared with size 32). Finally, peak diastolic force was significantly smaller (p = 0.04) than peak systolic force regardless of valve size. CONCLUSIONS: For the first time, forces imparted on an edge-to-edge MV repair were quantified for a posterior leaflet flail model. Force magnitude was not significantly altered with flail compared with control; it was greatest during peak systole and increased with valve size.

Altered right ventricular papillary muscle position and orientation in patients with a dilated left ventricle.

OBJECTIVE: To investigate the impact of left ventricular dilatation on right ventricular papillary muscle displacement. METHODS: Thirteen patients underwent high-resolution cardiac magnetic resonance imaging at Emory University Hospital: Seven patients with congestive heart failure and a dilated left ventricle composed the dilated left ventricular group, and 6 normal subjects were used as a control. A total of 120 cardiac magnetic resonance imaging slices were acquired in a short-axis view at end diastole for each subject. Cardiac magnetic resonance imaging slices were used to identify the papillary muscle tip position in 3-dimensional coordinates for the septal, posterior, and anterior papillary muscles. The centroid of the papillary muscle coordinates was used as the reference point for comparison between subjects. The relative orientation between the right ventricular papillary muscles was evaluated and compared between the dilated left ventricular group and normal subjects. RESULTS: Dilatation of the left ventricle resulted in a significant (P = .05) displacement of the septal right ventricular papillary muscle toward the centroid: normal group, 0.0285 ± 0.036 mm/mm versus dilated left ventricular group, 0.1437 ± 0.026 mm/mm. More specifically, the septal papillary muscle significantly (P = .03) moved away from the septal wall (normal group: 0.61 ± 0.09 mm/mm, dilated left ventricular group: 0.379 ± 0.037 mm/mm). Specific locations of all 3 right ventricular papillary muscles were reported for normal subjects and patients with a dilated left ventricle. CONCLUSIONS: Patients with a dilated left ventricle have significantly increased displacement of the septal right ventricular papillary muscle away from the septum when compared with normal controls. This demonstrates pathophysiologic contribution of the left ventricle to specific papillary muscle alterations within the right ventricle.