Transcatheter Pledget-Assisted Suture Tricuspid Annuloplasty (PASTA): First-in-Human Report

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Conference Proceeding

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JACC Cardiovasc Interv


Background: Tricuspid regurgitation (TR) is a malignant disease with high surgical mortality. Pledget-Assisted Suture Tricuspid Annuloplasty (PASTA) is a percutaneous annular repair to create a double orifice tricuspid valve using marketed equipment. Methods: An 83-year-old man with torrential defibrillator-lead induced tricuspid regurgitation and recurrent hospital admissions with right-sided heart failure was deemed by the heart team to have no good options and was offered PASTA on a compassionate basis. The Institutional Review Board approved this retrospective communication. X-ray fluoroscopy, intracardiac echocardiography, and transesophageal echocardiography guided the procedure. Catheters directed paired coronary guidewires to septal and lateral targets on the tricuspid annulus. Guidewires were electrified to traverse the annular targets and exchanged for sutures using a crimped half-hitch knot. The sutures were buttressed with pledgets on the annulus, and drawn together and knotted. Results: Baseline annular area was 1817 mm2 (Figure 1A), and vena contracta width 22.9 mm (Figure 1C) (severe > 7 mm). After PASTA, a double orifice tricuspid valve was formed at the annular level (Figure 1B). Annular area reduced to 782 mm2, and vena contracta width < 1 mm (Figure 1D). The right coronary artery remained intact. Unfortunately, the annulus dehisced over the following 2 days with recurrent severe TR. The patient was discharged home and was alive at 6-month follow-up but with persistent symptoms. Conclusion: This first-in-human report is proof of principal that an annular double orifice valve can eliminate torrential TR. However, the results were short-lived due to annular dehiscence in this enormously dilated annulus. PASTA may be feasible in humans who have a smaller and less friable tricuspid annuli, treated at an earlier stage in the disease. [Figure presented]





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