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Robotically-Assisted, Completely Endoscopic Transmyocardial Revascularization using an Optical Fiber-Based Laser Delivery System is Safe and Efficacious
Louis A. Brunsting, III1, Averel B. Snyder2, Eric E. Espinal3, Sudhir P. Srivastava4.
1University of Alabama at Birmingham, Birmingham, AL, USA, 2St. Joseph's Hospital, Atlanta, GA, USA, 3Akron City Hospital, Akron, OH, USA, 4The International Centre for Robotic Surgery, New Delhi, India.

OBJECTIVE: Sole therapy transmyocardial revascularization (TMR) is effective treatment for refractory angina in patients who are not candidates for further direct coronary revascularization options, yielding improved survival over maximal medical therapy. The need for either sternotomy or thoracotomy incisions has limited application of TMR. The purpose of this study was to assess the procedural success and safety of an endoscopic, optical fiber-based, laser delivery system (LDS), developed to perform sole therapy TMR in a totally endoscopic, robotically-assisted operation.
METHODS: Forty-two patients were enrolled in a multi-center, prospective, single-arm clinical trial conducted at 4 U.S. centers between 2005 and 2007. TMR was performed completely endoscopically with robotic assistance, introducing the Ho:YAG LDS via a 5mm port. Completion of the operation endoscopically defined procedural success. Clinical data and adverse events were recorded before, during, and at least 30 days following the procedure.
RESULTS: All patients had CCS angina Class IV at baseline. Average EF was 49% (R:28-71), mean age 59.1 yr (R:36-80), 71% (30/42) were male, previous CABG surgery 86% (36/42), and prior coronary stenting in 76% (32/42). Procedural success was accomplished in 93% (39/42), with 3 conversions to thoracotomy: excessive adhesions (2) and obese body habitus (1). For the procedural successes, average number of TMR channels was 32 (R:16-50), mean operative time was 106 min (R:48-250 min), and mean length of stay postoperatively was 3.8 days (R:2-11). There was no operative or 30-day mortality. No patient required re-exploration for bleeding or transfusion. At 30 days, freedom from major adverse cardiac events was 95% (2 patients had transient congestive heart failure). At median six-month follow-up (single center data, n=12), mean CCS angina score was 1.3+0.05 (p<0.001 vs. baseline).
CONCLUSIONS: Robotically-assisted TMR can safely be performed using an endoscopic, optical fiber-based LDS, with high procedural success, avoidance of adverse clinical events, and successful angina relief.


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