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Ann Thorac Surg 2005;79:2200
© 2005 The Society of Thoracic Surgeons
Starr-Wood Cardiac Group, Providence St. Vincent Hospital, 9155 SW Barnes Rd, Portland, OR 97225
(E-mail: tfurnary{at}starrwood.com).
I read with keen interest the article by Allen and colleagues [1], who retrospectively evaluated the 5-year results from a previous prospective study of 275 "no option" coronary artery disease patients initially enrolled in the randomized holmium:yttrium-aluminum-garnet (Ho:YAG) transmyocardial laser revascularization (TMR) versus medical management trial. The current analysis is significantly incomplete. Thirty percent of the original cohort (63 of 275 patients) was excluded from any follow-up whatsoever; and angina follow-up is only 30% (84 of 275) or 40% (84 of 212). Although the word "prospective" is repeated throughout the article after inclusion in the title, this study is anything but; if it were, angina class would have been followed-up on at least an annual basis with a > 30% follow-up.
"Significant angina relief after sole therapy [Ho:YAG] TMR... was sustained long term." In reality, a majority (54%; 26 of 48) of the Ho:YAG TMR followed patients did not receive true "sole therapy" because they required additional procedures to achieve "sustained angina relief." Allen and colleagues [1] write that only 22% of Ho:YAG TMR patients underwent a postenrollment intervention. Using what denominator? Was additional procedure follow-up complete in all 100 patients, including those who died?
Why were 3 patients in the Ho:YAG TMR group transplanted? Was it for ongoing angina or for heart failure? In either case, the transplant rate following Ho:YAG TMR is alarmingly high at either 3% (3 of 100) or 6% (3 of 48) again, depending on the denominator used.
These patients, and those who had additional CABG, PCI and TMR, were kept in the Ho:YAG TMR group because this study was presented as an "intent-to-treat" study in which the initial randomization assignment is considered the only variable under study. This type of "study design" lends itself well to medical drug trails, but is not appropriate to use as an evaluation tool for a surgical therapy. It has the ability to disguise the true results of a surgical therapy, because those results can be altered by subsequent procedures.
Even the medical management (MM) patients were not "maintained on medical management alone" as stated. Thirty-three of the MM patients, outside of the crossover group, went on to have TMR. If 92% (33 of 36) of the MM patients went on to have Ho:YAG TMR, this study becomes a trial of immediate versus delayed Ho:YAG TMR.
What we as readers really want to know is what is the average angina class at 5 years of patients who received Ho:YAG TMR and nothing else, regardless of the group into which they were originally enrolled? This question should be answered by excluding all patients who have received any other interventional therapy since undergoing TMR. It should include the 22 sole therapy patients from the TMR group, 33 patients from the MM group, and any of the crossover patients who had no additional therapies. This is the true surgical effectiveness question, which we as practitioners respectfully request an honest and straightforward answer.
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