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Transcatheter pledget‐assisted suture tricuspid annuloplasty (PASTA) to create a double‐orifice valve
Author(s) -
Khan Jaffar M.,
Rogers Toby,
Schenke William H.,
Greenbaum Adam B.,
Babaliaros Vasilis C.,
Paone Gaetano,
Ramasawmy Rajiv,
Chen Marcus Y.,
Herzka Daniel A.,
Lederman Robert J.
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27531
Subject(s) - medicine , tricuspid valve , regurgitation (circulation) , body orifice , fibrous joint , percutaneous , surgery , cardiology , anatomy
Objectives Pledget‐assisted suture tricuspid valve annuloplasty (PASTA) is a novel technique using marketed equipment to deliver percutaneous trans‐annular sutures to create a double‐orifice tricuspid valve. Background Tricuspid regurgitation is a malignant disease with high surgical mortality and no commercially available transcatheter solution in the US. Methods Two iterations of PASTA were tested using trans‐apical or trans‐jugular access in swine. Catheters directed paired coronary guidewires to septal and lateral targets on the tricuspid annulus under fluoroscopic and echocardiographic guidance. Guidewires were electrified to traverse the annular targets and exchanged for pledgeted sutures. The sutures were drawn together and knotted, apposing septal and lateral targets, creating a double orifice tricuspid valve. Results Twenty‐two pigs underwent PASTA. Annular and chamber dimensions were reduced (annular area, 10.1 ± 0.8 cm 2 to 3.8 ± 1.5 cm 2 (naïve) and 13.1 ± 1.5 cm 2 to 6.2 ± 1.0 cm 2 (diseased); septal‐lateral diameter, 3.9 ± 0.3 mm to 1.4 ± 0.6 mm (naïve) and 4.4 ± 0.4 mm to 1.7 ± 1.0 mm (diseased); and right ventricular end‐diastolic volume, 94 ± 13 ml to 85 ± 14 ml (naïve) and 157 ± 25 ml to 143 ± 20 ml (diseased)). MRI derived tricuspid regurgitation fraction fell from 32 ± 12% to 4 ± 5%. Results were sustained at 30 days. Pledget pull‐through force was five‐fold higher (40.6 ± 11.7N vs 8.0 ± 2.6N, P < .01) using this strategy compared to single puncture techniques used to anchor current investigational devices. Serious complications were related to apical access. Conclusions PASTA reduces annular dimensions and tricuspid regurgitation in pigs. It may be cautiously applied to selected patients with severe tricuspid regurgitation and no options. This is the first transcatheter procedure, to our knowledge, to deliver standard pledgeted sutures to repair cardiac pathology.