title: Long-term outcomes after transmyocardial revascularization.
abstract: 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.
authors: US Food and Drug Administration, Center for Devices and Radiological Health, Division of Epidemiology, Silver Spring, MD 20993, USA. dale.tavris@fda.hhs.gov
authors: Dale R
authors: DR
authors: Tavris
authors: James Matthew
authors: JM
authors: Brennan
authors: Art
authors: A
authors: Sedrakyan
authors: Yue
authors: Y
authors: Zhao
authors: Sean M
authors: SM
authors: O'Brien
authors: Eric D
authors: ED
authors: Peterson
authors: Thomas P
authors: TP
authors: Gross
authors: Danica
authors: D
authors: Marinac-Dabic
authors: Keith A
authors: KA
authors: Horvath
mesh_terms: D000368:Aged; D001026:Coronary Artery Bypass; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods*; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D016896:Treatment Outcome