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Keith B. Allen
Robert D. Dowling
William W. Angell
Deepak M. Gangahar
Tommy L. Fudge
Wayne Richenbacher
Samuel L. Selinger
Michael R. Petracek
Douglas Murphy
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Ann Thorac Surg 2004;77:1228-1234
© 2004 The Society of Thoracic Surgeons

Original article: cardiovascular

Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial

Keith B. Allen, MDa*, Robert D. Dowling, MDb, William W. Angell, MDc, Deepak M. Gangahar, MDd, Tommy L. Fudge, MDe, Wayne Richenbacher, MDf, Samuel L. Selinger, MDg, Michael R. Petracek, MDh, Douglas Murphy, MDi

a Department of Cardiothoracic Surgery, Indiana Heart Institute, Indianapolis, Indiana, USA
b Department of Cardiothoracic Surgery, University of Louisville, Jewish Heart and Lung Institute, Louisville, Kentucky, USA
c Department of Cardiothoracic Surgery, Tampa General Hospital, Tampa, Florida, USA
d Department of Cardiothoracic Surgery, Nebraska Heart Hospital, Nebraska Heart Institute, Lincoln, Nebraska, USA
e Department of Cardiothoracic Surgery, Cardiovascular Institute of South-Surgery, Houma, Louisiana, USA
f Department of Cardiothoracic Surgery, University of Iowa Hospital, Iowa City, Iowa, USA
g Department of Cardiothoracic Surgery, Sacred Heart Hospital, Spokane, Washington, USA
h Department of Cardiothoracic Surgery, St. Thomas Heart Institute, Nashville, Tennessee, USA
i St. Joseph's Hospital, Atlanta, Georgia, USA

Accepted for publication January 22, 2004.

* Address reprint requests to Dr Allen, 10590 N Meridian St, Indianapolis, IN 46260, USA
e-mail: kallen2340{at}aol.com

BACKGROUND: In prospective randomized trials at 1 year, transmyocardial revascularization (TMR) provided superior relief of angina, decreased rehospitalizations, and improved exercise times. We evaluated 5-year mortality and angina class in "no-option" patients with diffuse coronary artery disease randomized to TMR or continued medical management.

METHODS: Two hundred twelve patients with refractory class IV angina who were not candidates for conventional therapy were randomized to receive holmium:yttrium-aluminum-garnet TMR (n = 100) or continued medical management (n = 112) at nine centers. Follow-up included all-cause mortality along with angina class assessment by blinded evaluators. Mean follow-up was 5.7 ± 0.8 years.

RESULTS: Mean angina scores for TMR patients were 4.0 ± 0.0 at baseline, 1.5 ± 1.4 at 1 year, and 1.2 ± 1.1 at a mean of 5 years (p < 0.001). After an average of 5 years, a significantly greater proportion of TMR than medical management patients experienced two or more class improvement in angina (88% versus 44%; p < 0.001). Kaplan-Meier intention-to-treat survival at 5 years was 65% versus 52% (TMR versus medical management; p = 0.05). Cumulative hazard curves demonstrated a significantly reduced risk of late death for TMR patients; average annual mortality beyond 1 year was 8% versus 13% (TMR versus medical management; p = 0.03).

CONCLUSIONS: Five-year follow-up of prospectively randomized, no-option class IV angina patients demonstrated significantly increased Kaplan-Meier survival in patients randomized to TMR. The significant angina relief observed 12 months after sole therapy TMR was sustained long term and continued to be superior to that observed for patients maintained on continued medical management alone.




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