CLINICAL RESEARCH
From controlled trials to clinical practice
monitoring transmyocardial revascularization use and outcomes
Eric D. Peterson, MD, MPH, FACC*,*,
Padma Kaul, PhD* ,
Ronald G. Kaczmarek, MD ,
Bradley G. Hammill, BA, MS*,
Paul W. Armstrong, MD, FACC ,
Charles R. Bridges, MD, ScD, FACC ,
T. Bruce Ferguson, Jr, MD|| Society of Thoracic Surgeons
* Duke Clinical Research Institute, Durham, North Carolina, USA
University of Alberta, Edmonton, Canada
Food and Drug Administration, Rockville, Maryland, USA
University of Pennsylvania, Philadelphia, Pennsylvania, USA
|| Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA
* Reprint requests and correspondence: Dr. Eric D. Peterson, Duke University Medical Center, Box 3236, Durham, North Carolina 27710, USA. peter016{at}mc.duke.edu
OBJECTIVES: We sought to examine trends in the use and outcomes of transmyocardial revascularization (TMR) in community practice. We also identified important risk factors for TMR and compared outcomes of TMR combined with coronary artery bypass graft surgery (TMR + CABG) versus bypass alone in patients receiving incomplete revascularization.
BACKGROUND: Although it is approved for use as a stand-alone procedure, there are limited data on the outcomes of (TMR + CABG).
METHODS: We identified 3,717 patients receiving TMR at 173 U.S. hospitals participating in the Society of Thoracic Surgeons (STS) National Cardiac Database. Baseline characteristics and outcomes in these patients were compared with those from six published randomized TMR trials. Multivariable logistic regression was used to identify clinical risk factors for mortality with TMR. Risk-adjusted mortality was also compared for TMR + CABG relative to CABG only in patients not amenable to complete traditional revascularization.
RESULTS: Between January 1998 and December 2001, the number of STS hospitals performing TMR and total procedural counts increased markedly, driven predominately by more TMR + CABG cases. Overall mortality rates for TMR-alone and TMR + CABG were 6.4% and 4.2%, respectively. Operative risks were significantly higher in those patients with recent myocardial infarction, unstable angina, and depressed ventricular function. Among patients receiving incomplete revascularization, TMR + CABG was not associated with decreased mortality risk compared with CABG alone, adjusted odds ratio 1.11 (95% confidence interval 0.74 to 1.67).
CONCLUSIONS: The use of TMR, and in particular, TMR + CABG, is expanding in community practice. Although procedural risks are high, there is room for optimization through improved patient selection and timing of the procedure. Further studies of TMR + CABG are needed given its growing use and unclear benefits.
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Abbreviations and Acronyms
| | CABG | = coronary artery bypass graft surgery | | CI | = confidence interval | | DCRI | = Duke Clinical Research Institute | | FDA | = Food and Drug Administration | | MI | = myocardial infarction | | OR | = odds ratio | | RCT | = randomized clinical trial | | STS | = Society of Thoracic Surgeons | | TMR | = transmyocardial revascularization |
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