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Six-month angiographic follow-up of the PAS-Port II clinical trial.
- Source :
-
The Annals of thoracic surgery [Ann Thorac Surg] 2006 Jan; Vol. 81 (1), pp. 90-6. - Publication Year :
- 2006
-
Abstract
- Background: The PAS-Port device (Cardica, Redwood City, CA) allows the rapid deployment of a clampless proximal anastomosis between a vein graft and the aorta.<br />Methods: Fifty-four patients awaiting elective coronary artery bypass graft surgery were enrolled. Outcome variables were intraoperative device performance, early and 6- month angiographic graft patency, and 12-month clinical follow-up.<br />Results: Sixty-three PAS-Port devices were deployed in 54 patients. Two deployments were unsuccessful. There were no reoperations for bleeding. Two patients died of causes unrelated to the device. Patency evaluation at discharge was performed by angiogram on 49 implants and computed tomography in 2 implants (86% follow-up). At discharge, all evaluated grafts were patent (100%) and rated Fitzgibbon A. At 6-month follow-up, there was no additional mortality; 47 implants (88% follow-up) were evaluated by angiography (Fitzgibbon O [n = 1], Fitzgibbon B [n = 1], and Fitzgibbon A [n = 45]) and 5 by computed tomography. All grafts but 1 were patent (98.1%). At 12 months, 2 additional patients died of causes unrelated to the PAS-Port implant. Forty-six of 50 alive patients (95.8%) were followed up without any reports of device-related major adverse cardiac events.<br />Conclusions: Discharge (100%) and 6-month patency (98%) are excellent; patency and 12 months' clinical follow-up compares favorably with data from historical hand-sewn controls. The PAS-Port system safely allows the clampless creation of a proximal anastomosis.
- Subjects :
- Aged
Anastomosis, Surgical instrumentation
Anticoagulants classification
Anticoagulants therapeutic use
Aorta surgery
Controlled Clinical Trials as Topic statistics & numerical data
Elective Surgical Procedures
Equipment Design
Female
Follow-Up Studies
Graft Occlusion, Vascular diagnostic imaging
Graft Occlusion, Vascular epidemiology
Humans
Male
Middle Aged
Multicenter Studies as Topic statistics & numerical data
Postoperative Complications diagnostic imaging
Postoperative Complications epidemiology
Postoperative Complications prevention & control
Prospective Studies
Thrombosis prevention & control
Tomography, X-Ray Computed
Treatment Outcome
Vascular Patency
Coronary Angiography
Coronary Artery Bypass instrumentation
Subjects
Details
- Language :
- English
- ISSN :
- 1552-6259
- Volume :
- 81
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The Annals of thoracic surgery
- Publication Type :
- Academic Journal
- Accession number :
- 16368343
- Full Text :
- https://doi.org/10.1016/j.athoracsur.2005.06.035