Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve

Jaffar M. Khan, Toby Rogers, William H. Schenke, Adam B. Greenbaum, Vasilis C. Babaliaros, Gaetano Paone, Rajiv Ramasawmy, Marcus Y. Chen, Daniel Herzka, Robert J. Lederman

Research output: Contribution to journalArticle

Abstract

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 cm2 to 3.8±1.5 cm2 (naïve) and 13.1±1.5 cm2 to 6.2±1.0 cm2 (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.

Original languageEnglish (US)
JournalCatheterization and Cardiovascular Interventions
DOIs
StateAccepted/In press - Jan 1 2018
Externally publishedYes

Fingerprint

Sutures
Tricuspid Valve Insufficiency
Tricuspid Valve
Swine
Equipment and Supplies
Punctures
Stroke Volume
Neck
Catheters
Pathology
Mortality

Keywords

  • Structural heart disease
  • Transcatheter electrosurgery
  • Tricuspid annuloplasty
  • Tricuspid valve regurgitation

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Khan, J. M., Rogers, T., Schenke, W. H., Greenbaum, A. B., Babaliaros, V. C., Paone, G., ... Lederman, R. J. (Accepted/In press). Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve. Catheterization and Cardiovascular Interventions. https://doi.org/10.1002/ccd.27531

Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve. / Khan, Jaffar M.; Rogers, Toby; Schenke, William H.; Greenbaum, Adam B.; Babaliaros, Vasilis C.; Paone, Gaetano; Ramasawmy, Rajiv; Chen, Marcus Y.; Herzka, Daniel; Lederman, Robert J.

In: Catheterization and Cardiovascular Interventions, 01.01.2018.

Research output: Contribution to journalArticle

Khan, Jaffar M. ; Rogers, Toby ; Schenke, William H. ; Greenbaum, Adam B. ; Babaliaros, Vasilis C. ; Paone, Gaetano ; Ramasawmy, Rajiv ; Chen, Marcus Y. ; Herzka, Daniel ; Lederman, Robert J. / Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve. In: Catheterization and Cardiovascular Interventions. 2018.
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abstract = "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 cm2 to 3.8±1.5 cm2 (na{\"i}ve) and 13.1±1.5 cm2 to 6.2±1.0 cm2 (diseased); septal-lateral diameter, 3.9±0.3 mm to 1.4±0.6 mm (na{\"i}ve) 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 (na{\"i}ve) 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.",
keywords = "Structural heart disease, Transcatheter electrosurgery, Tricuspid annuloplasty, Tricuspid valve regurgitation",
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AU - Khan, Jaffar M.

AU - Rogers, Toby

AU - Schenke, William H.

AU - Greenbaum, Adam B.

AU - Babaliaros, Vasilis C.

AU - Paone, Gaetano

AU - Ramasawmy, Rajiv

AU - Chen, Marcus Y.

AU - Herzka, Daniel

AU - Lederman, Robert J.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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 cm2 to 3.8±1.5 cm2 (naïve) and 13.1±1.5 cm2 to 6.2±1.0 cm2 (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.

AB - 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 cm2 to 3.8±1.5 cm2 (naïve) and 13.1±1.5 cm2 to 6.2±1.0 cm2 (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.

KW - Structural heart disease

KW - Transcatheter electrosurgery

KW - Tricuspid annuloplasty

KW - Tricuspid valve regurgitation

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