Scientific Publications by FDA Staff
Ann Thorac Surg 2012 Nov;94(5):1500-8
Long-Term Outcomes After Transmyocardial Revascularization.
Tavris DR, Brennan JM, Sedrakyan A, Zhao Y, O'Brien SM, Peterson ED, Gross TP, Horvath KA, Marinac-Dabic D
BACKGROUND: Two independent reports documented substantially higher operative mortality associated with transmyocardial revascularization (TMR) when used in isolation than that reported in the premarket clinical trials. To clarify the state of the art, this article assesses temporal trends in the use of TMR, short-term and long-term outcomes, and outcomes stratified by procedure type (TMR only and TMR + coronary artery bypass graft [CABG]) and by the 2 specific TMR devices. METHODS: The study population included all patients undergoing TMR in isolation or in combination with CABG at 435 cardiothoracic hospitals in the United States participating in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) from January 2000 through November 2006 (n = 15,386). Analysis of long-term outcomes was accomplished through linkage to Medicare claims data. Short-term and long-term (7 years) adverse outcomes were assessed and compared between the 2 TMR device types. RESULTS: The use of TMR in conjunction with CABG surgery is increasing. This study showed modest differences in short-term morbidity and mortality between the 2 devices. In combination with CABG, after risk adjustment, patients treated with the holmium:YAG laser (experienced a higher rate of operative mortality (3.5% vs 2.5%; adjusted hazard ratio 1.39, 95% confidence level 1.03 to 1.87) but no difference in the composite short-term rate of major morbidity or mortality, compared with the Heart Laser CO2 transmyocardial revascularization system (PLC Medical Systems, Inc, Milford, MA). However, there were no clinically meaningful differences in long-term results. CONCLUSIONS: Modest differences in short-term morbidity and mortality between the 2 devices suggest the usefulness of further research.
|Category: Journal Article|
|PubMed ID: #22835557||DOI: 10.1016/j.athoracsur.2012.05.068|
|Includes FDA Authors from Scientific Area(s): Medical Devices|
|Entry Created: 2012-07-28||Entry Last Modified: 2013-01-08|