Author + information
- Jaffar Khan1,
- Toby Rogers2,
- William Schenke3,
- Adam Greenbaum4,
- Vasilis Babaliaros5,
- Gaetano Paone4,
- Rajiv Ramasawmy1,
- Marcus Chen6,
- Daniel Herzka1 and
- Robert Lederman7
- 1NHLBI, Bethesda, Maryland, United States
- 2NIH, Bethesda, Maryland, United States
- 3NIH, New York, New York, United States
- 4Henry Ford Hospital, Detroit, Michigan, United States
- 5Emory University School of Medicine, Atlanta, Georgia, United States
- 6National Institutes of Health, Bethesda, Maryland, United States
- 7National Institutes of Health, Bethesda, Maryland, United States
Tricuspid regurgitation is a malignant disease with high surgical mortality and no commercially available transcatheter solution in the US. We propose a percutaneous pledget-assisted suture tricuspid valve annuloplasty (PASTA) using marketed equipment.
X-ray fluoroscopy and intracardiac echocardiography guided in vivo procedures in swine with and without iatrogenic tricuspid regurgitation caused by chronic pressure and volume overload. Trans-apical (n=16) or trans-jugular (n=6) 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 pledgeted sutures using a crimped half-hitch knot. The sutures were drawn together and knotted, reducing annular dimensions.
Twenty-two pigs underwent attempted PASTA. Sutures were accurately placed at the intended site in 20 of 22 cases. Annular and chamber dimensions were reduced (annular area, 10.1±0.8cm2 to 3.8±1.5cm2 (naïve) and 13.1±1.5 cm2 to 6.2±1.0 cm2 (diseased); septal-lateral diameter, 3.9±0.3mm to 1.4±0.6mm (naïve) and 4.4±0.4mm to 1.7±1.0mm (diseased); and right ventricular end-diastolic volume, 94±13ml to 85±14ml (naïve) and 157±25ml to 143±20ml (diseased)). MRI derived tricuspid regurgitation fraction fell from 32±12% to 4±5%. Results were sustained at 30 days. Pledget pull-through force was 40.6±11.7N in non-survival explants and 41.1±11.5N in 30-day survival explant. This was significantly higher than for a single ex vivo needle directed puncture (8.0±2.6N, p<0.01). Serious complications were related to apical access.
PASTA reduces annular dimensions and tricuspid regurgitation in pigs. Percutaneous suture annuloplasty using commercially available medical equipment was enabled by several novelties: 1) implanting suture pledgets spanning across two holes, widely applied in surgery; 2) exchanging guidewire for permanent suture using a low profile knot; and 3) employing a muscular septal 'bite' to establish a pledgeted septal anchor. This is the first transcatheter procedure, to our knowledge, to deliver standard pledgeted sutures to repair cardiac pathology. It may be cautiously applied to selected patients with severe tricuspid regurgitation and no options.
STRUCTURAL: Valvular Disease: Other