Author + information
- Received April 16, 2020
- Revision received May 18, 2020
- Accepted May 26, 2020
- Published online September 21, 2020.
- David Planer, MD,
- Ronen Beeri, MD and
- Haim D. Danenberg, MD∗ ()
- ↵∗Address for correspondence:
Dr. Haim D. Danenberg, Department of Cardiology, Hadassah Hebrew University Medical Center, P.O. Box 12000, Jerusalem 91120, Israel.
Objectives This study sought to report short-term results of safety, performance, and efficacy of the Mistral device first-in-human study in patients suffering from severe functional tricuspid insufficiency.
Background Patients who suffer from severe tricuspid regurgitation (TR) and who are at high surgical risk have no standard care therapy. Therefore, minimally invasive and safer methods are sought. The Mistral device is an investigational spiral-shaped device intended for percutaneous transcatheter repair. The Mistral device approximates the tricuspid leaflets by grasping together the chordae tendineae of the tricuspid valve.
Methods Seven patients (4 women; mean age 73.14 ± 7.4 years) with severe (n = 5) and massive (n = 2) symptomatic TR and high surgical risk underwent Mistral tricuspid repair under transesophageal echocardiography guidance.
Results Mistral was successfully implanted in all cases with a single device deployed in 6 patients, with 2 devices deployed in 1 patient. No procedural or 30-day adverse events occurred. TR was reduced by at least 1 grade in all patients. Effective regurgitant orifice area was reduced from median 0.52 cm2 (interquartile range [IQR]: 0.40 to 0.60 cm2) at baseline to 0.15 cm2 (IQR: 0.14 to 0.21 cm2) at 30 days post-procedure (p < 0.01), vena contracta width was reduced from 0.95 cm (IQR: 0.81 to 1.16 cm) to 0.62 cm (IQR: 0.52 to 0.67 cm) (p < 0.05), and regurgitant volume decreased from 49.4 ml/beat (IQR: 45.2 to 57.7 ml/beat) to 19.7 ml/beat (IQR: 12.4 to 23.9 ml/beat) (p < 0.01). Right ventricular fractional area change improved from 27.0% (IQR: 21.3% to 33.5%) at baseline to 38.5% (IQR: 29.0% to 47.1%) at 30-day follow-up (p < 0.05). Significant improvements in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, and 6-min walk test were observed at 30 days.
Conclusions Tricuspid valve repair with the Mistral device appears safe and leads to 30-day reduction of tricuspid insufficiency and improvement of right ventricular function and exercise capacity.
Drs. Planer and Danenberg have served as consultants to Mitralix Ltd. Dr. Beeri has reported that he has no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received April 16, 2020.
- Revision received May 18, 2020.
- Accepted May 26, 2020.
- 2020 American College of Cardiology Foundation
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