Background The construction of subendocardial channels to perfuseischemic areas of the myocardium has been investigated sincethe 1950s. We assessed the safety and efficacy of transmyocardialrevascularization with a carbon dioxide laser in patients withrefractory angina and left ventricular free-wall ischemia thatwas not amenable to direct coronary revascularization.
Methods In a prospective, controlled, multicenter trial, werandomly assigned 91 patients to undergo transmyocardial revascularizationand 101 patients to receive continued medical treatment. Theseverity of angina (according to the Canadian CardiovascularSociety [CCS] classification), quality of life, and cardiacperfusion (as assessed by thallium-201 scanning) were evaluatedat base line and 3, 6, and 12 months after randomization.
Results At 12 months, angina had improved by at least two CCSclasses in 72 percent of the patients assigned to transmyocardialrevascularization, as compared with 13 percent of the patientsassigned to medical treatment who continued medical treatment(P<0.001). Patients in the transmyocardial-revascularizationgroup also had a significantly improved quality of life as comparedwith the medical-treatment group. Myocardial perfusion improvedby 20 percent in the transmyocardial-revascularization groupand worsened by 27 percent in the medical-treatment group (P=0.002).In the first year of follow-up, 2 percent of patients assignedto undergo transmyocardial revascularization were hospitalizedbecause of unstable angina, as compared with 69 percent of patientsassigned to medical treatment (P<0.001). The perioperativemortality rate associated with transmyocardial revascularizationwas 3 percent. The rate of survival at 12 months was 85 percentin the transmyocardial-revascularization group and 79 percentin the medical-treatment group (P=0.50).
Conclusions In patients with angina refractory to medical treatmentand coronary artery disease that precluded coronary-artery bypasssurgery or percutaneous transluminal coronary angioplasty, transmyocardialrevascularization improved cardiac perfusion and clinical statusover a 12-month period.
In the 1950s, Goldman and associates1 and Massimo and Boffi2proposed that natural or artificial conduits could be implantedin the subendocardium to direct left ventricular blood throughthe coronary sinusoids and into ischemic areas of the myocardium.In 1968, after extensive experiments in animals, Sen and colleagues3described transmyocardial revascularization through transmuralchannels created with a 16-gauge intravenous cannula. In 1981,Mirhoseini and Cayton4 used a laser to create transmyocardialchannels in animals; five years later, Okada and colleagues5did the same in humans. Investigators have continued to testtransmyocardial revascularization in both animals6,7,8,9 andhumans.10
In a nonrandomized, longitudinal trial undertaken to establishthe safety, efficacy, and value of transmyocardial revascularizationperformed with a laser in 201 patients at eight U.S. centers,angina was relieved and cardiac perfusion improved in 75 percentof the patients over a 12-month period.10 We conducted a prospective,randomized, multicenter trial to examine further the safetyand efficacy of transmyocardial revascularization in patientswith refractory angina and documented left ventricular free-wallischemia that was not amenable to direct coronary revascularizationand to compare this treatment with maximal medical therapy.
Methods
Study Design
Between July 1995 and September 1997, 12 U.S. centers participatedin this prospective, randomized, controlled study. Written informedconsent was obtained from each patient before enrollment. Bymeans of randomization at a central institution, patients wereassigned, in a 1:1 ratio, to undergo transmyocardial revascularizationwith a carbon dioxide laser (the Heart Laser System, PLC MedicalSystems, Franklin, Mass.) or to receive continued medical treatment.Patients were selected by the attending cardiologist, interventionalcardiologist, or surgeon after a review of clinical symptoms,recent angiograms, and perfusion scans.
To be enrolled in the trial, patients were required to meetthe following criteria: Canadian Cardiovascular Society (CCS)class III or IV angina that was refractory to medical treatment,reversible ischemia of the left ventricular free wall, and coronarydisease that was not amenable to coronary-artery bypass graftingor percutaneous transluminal coronary angioplasty. Patientswhose coronary disease was severe and diffuse or who did nothave a target vessel or conduit suitable for grafting were consideredto have disease not amenable to the latter two procedures. Patientswere excluded if the left ventricular ejection fraction wasless than 20 percent or if they had a concurrent major illness.
Crossover from medical treatment to transmyocardial revascularizationwas allowed if a patient had unstable angina that necessitatedintravenous antianginal therapy for 48 hours or more in an intensivecare unit. After crossover, patients were followed for an additional12 months, regardless of how long they had been in the groupassigned to medical treatment. These patients were consideredpart of the medical-treatment group until crossover, after whichthey were followed separately.
Clinical Evaluation
The patients' clinical status was evaluated with respect toCCS angina class, use of cardioactive medications, and responseson quality-of-life questionnaires. Angina was classified atenrollment and at 3, 6, and 12 months according to CCS guidelines.To eliminate potential bias, angina was also classified in ablinded manner by an independent evaluator. Success at follow-upwas defined as an angina class at least two classes below thatat base line.
To study fully the effects of transmyocardial revascularizationin comparison with medical treatment, both intention-to-treatand "on-treatment" analyses of angina were conducted. The intention-to-treatanalysis, which included patients who remained in the medical-treatmentgroup as well as patients who were crossed over to transmyocardialrevascularization as part of the medical-treatment group, provideda conservative estimate of the effect of transmyocardial revascularization,preventing overly optimistic conclusions. The on-treatment analysis,which did not include patients who were crossed over to transmyocardialrevascularization, was considered the best way to evaluate theresults from a clinical perspective. Thus, patients assignedto transmyocardial revascularization were compared first withall the patients assigned to medical treatment and then separatelywith those assigned to medical treatment and not crossed over.
Quality of life was assessed in all patients at enrollment andat 3, 6, and 12 months during follow-up. At these times, eachpatient completed two questionnaires: the 36-item Medical OutcomesStudy Short-Form General Health Survey (SF-36)11 and the SeattleAngina Questionnaire.12
Single-Photon-Emission Computed Tomography
The extent and reversibility of myocardial ischemia at restand during exercise were assessed in each patient at enrollmentand at 3, 6, and 12 months. Patients underwent thallium-201single-photon-emission computed tomography (SPECT) with pharmacologicstress testing (with dipyridamole at a dose of 0.56 mg per kilogramof body weight, to a maximum of 6 mg) and four-hour redistribution–reinjectionimaging. All the images were processed according to a standardprotocol by a single technician at Cedars–Sinai MedicalCenter. Every image was then analyzed by an experienced nuclearcardiologist who was unaware of the patient's identity, treatmentassignment, and scan date.
Each image was divided into three cross sections (apical, midventricular,and basal) parallel to the atrioventricular groove. Each ofthese cross sections was then divided into eight segments, whichwere individually analyzed to assess perfusion status. Eachsegment was examined for the presence of normal tissue, a fixeddefect (scar), a reversible defect (ischemic or hibernatingmyocardium), or both fixed and reversible defects. The sum ofthe number of segments in each perfusion category is expressedas a percentage of all 24 segments and used to characterizethe perfusion of the left side of the heart. Perfusion resultsat 3, 6, and 12 months were compared with the scores at baseline for each patient.
Transmyocardial Revascularization
The technique of transmyocardial revascularization has beendescribed in detail elsewhere.10 Transmural channels approximately1 mm in diameter were created with a single pulse of the carbondioxide laser (peak power, 850 W) through the left ventricle.Approximately one channel was created per square centimeterof myocardial surface. Transmural penetration by the laser wasconfirmed by transesophageal echocardiography.
Statistical Analysis
Analyses were performed with a two-sided standard t-test, pairedt-test, or analysis of variance for normally distributed continuousvariables; with a two-sided Wilcoxon signed-rank test, the Wilcoxonrank-sum test, or the Kruskal–Wallis test for variablesnot normally distributed; with a two-sided chi-square test orFisher's exact test for discrete variables; and with the Kaplan–Meiertest or a log-rank test for survival free of cardiac events.P values of less than 0.05 were considered to indicate statisticalsignificance.
To determine whether specific outcomes, such as treatment successor mortality, could be predicted on the basis of the patient'scharacteristics at base line, multivariate logistic-regressionanalyses were conducted with stepwise regression (SAS software,version 6.12, SAS, Cary, N.C.).
Results
Characteristics of the Study Population
Ninety-one patients were randomly assigned to undergo transmyocardialrevascularization, and 101 patients were assigned to receivemedical therapy (Figure 1). The groups were balanced at baseline with respect to sex, age, cardiac status, medical history,and cardiac risk factors (Table 1). Approximately 60 percentof the patients in each group were considered to be at highrisk for a poor outcome as determined by the established scoringsystem of the Cleveland Clinic for surgical revascularization.13All the patients in both groups had severe coronary diseasewith lesions in all three major vessels.
Figure 1. Overview of the Outcomes of Patients Assigned to Undergo Transmyocardial Revascularization (TMR), Those Assigned to Receive Medical Treatment Alone, and Those Crossed over from Medical Treatment to TMR.
Numbers in parentheses are numbers of patients. "Procedure" refers to any additional revascularization procedure, including percutaneous transluminal coronary angioplasty or coronary-artery bypass grafting.
Table 1. Characteristics of the Patients at Randomization.
Results of Transmyocardial Revascularization
During surgery, a mean (±SD) of 36±13 channelswere created, 30±8 of which were confirmed by transesophagealechocardiography to be transmural. Epicardial sutures were neededfor hemostasis in 1 percent of the patients. There were no intraoperativedeaths. The median stay in the intensive care unit for the patientswho underwent transmyocardial revascularization was two days,for a median hospital stay of seven days.
Clinical Status
Two patients assigned to transmyocardial revascularization andfour assigned to medical treatment were lost to follow-up. Twoof the four patients in the medical-treatment group had beencrossed over to transmyocardial revascularization; thus, thesix patients were evenly distributed among the three groupsanalyzed (Figure 1) and their exclusion did not modify the results,regardless of the outcome.
Angina Class
With success at follow-up defined as a reduction of at leasttwo angina classes as compared with base line, transmyocardialrevascularization was significantly more successful in bothanalyses (Figure 2). At three months, 67 percent of the patientsassigned to transmyocardial revascularization, 20 percent ofthose assigned to medical treatment (including those crossedover), and 6 percent of those assigned to medical treatmentand not crossed over had a clinically successful result (P<0.001for the comparison between the transmyocardial-revascularizationgroup and each medical-treatment group) (Figure 2). At 6 months,the success rates were 67 percent, 27 percent, and 6 percent,respectively, and at 12 months, the success rates were 72 percent,43 percent, and 13 percent, respectively (P<0.001 for bothsets of comparisons).
Figure 2. Relief of Angina According to Treatment Group.
Results are shown for both intention-to-treat and on-treatment analyses. The intention-to-treat analysis included all patients assigned to the medical-treatment group, including those crossed over to transmyocardial revascularization (TMR). Relief was defined as an improvement in angina by at least two Canadian Cardiovascular Society classes from base line. The T bars indicate standard deviations. Asterisks indicate P<0.001 for the comparison with the transmyocardial-revascularization group.
A blinded, independent assessment of angina was conducted inaddition to the on-site evaluations. For 80 percent of the patients,the result of the independent assessment was within one CCSclass of the result of the on-site assessment, indicating consistencyin the evaluations. When the on-site and independent evaluationswere compared, no significant differences were found (P=0.20).
Cardioactive Medications
Changes in the use of cardioactive medications (nitrates, beta-blockers,and calcium-channel blockers) from base line to follow-up wereanalyzed for their potential influence on outcomes with respectto angina. The clinical success of transmyocardial revascularizationwas not due to changes in medication; the use of medicationsdecreased or remained unchanged in 83 percent of the patientsin whom transmyocardial revascularization was successful. Conversely,the use of medications increased or remained unchanged in 86percent of the patients assigned to medical treatment.
Quality of Life
According to the responses on the SF-36 questionnaire, patientsin the transmyocardial-revascularization group had a greaterimprovement in their quality of life (38 percent improvement)than patients in the medical-treatment group (6 percent improvement)as compared with base line at three months (P<0.001). Thisdifference was also significant at 6 and 12 months (P=0.01 andP<0.001, respectively). For each of 15 components of theSeattle Angina Questionnaire, transmyocardial revascularizationwas associated with a significantly better result than medicaltreatment.
Spect Scans
The rates of compliance with the protocol and the proportionof scans that were usable during follow-up were similar in thetwo groups (81 percent and 72 percent, respectively, in thetransmyocardial-revascularization group and 79 percent and 69percent, respectively, in the medical-treatment group). Themean number of segments with reversible perfusion defects atenrollment was 7.1±3.7 per patient in the transmyocardial-revascularizationgroup and 6.8±3.3 in the medical-treatment group (P=0.60).At enrollment, the mean number of segments that were judgedto have fixed defects was 9.0±3.6 in the transmyocardial-revascularizationgroup and 9.0±3.3 in the medical-treatment group (P=0.96).
Medications were not stopped before the performance of SPECTimaging. Use of medications was balanced between the groupsat each time point. Figure 3 shows the percent change in left-sidedmyocardial perfusion at 3, 6, and 12 months. In the group assignedto transmyocardial revascularization, reversible ischemia decreasedby an average of 1.5 segments per patient at 3 months, 0.8 segmentat 6 months, and 1.4 segments at 12 months. In contrast, inthe group assigned to medical treatment, reversible ischemiaincreased by an average of 0.8, 0.8, and 1.3 segments, respectively(P=0.001 for the comparison between groups at 3 months, P=0.02for the comparison at 6 months, and P=0.002 for the comparisonat 12 months). However, there were no statistically significantdifferences between the groups at any of these time points inthe number of fixed defects per patient.
Figure 3. Change in Left-Sided Myocardial Perfusion during Follow-up, According to Treatment Assignment.
The percent change in myocardial perfusion differed significantly between the groups at each time point (P=0.001 at 3 months, P=0.02 at 6 months, and P=0.002 at 12 months). The percentage change in myocardial perfusion is calculated as the number of defects at base line minus the number of defects at follow-up, divided by the number of defects at base line. Numbers shown represent results from patients with usable data. TMR denotes transmyocardial revascularization.
Morbidity
During the first 30 days after transmyocardial revascularization,6 patients (7 percent) had acute myocardial infarction, 10 (11percent) had congestive heart failure, 7 (8 percent) had ventriculartachycardia or ventricular fibrillation, and 1 (1 percent) hadunstable angina. Sixty-two patients had no complications, 18had one, 7 had two, 1 had three, 1 had four, and 2 had five.The only complication resulting specifically from the surgicalprocedure was an accidental laser-induced injury of the mitralapparatus, which was repaired, in one patient.
During the 12-month follow-up period, the rate of hospital admissiondue to unstable angina was 2 percent among patients assignedto transmyocardial revascularization and 69 percent among patientsassigned to medical treatment (P<0.001). Rates of admissionto the intensive care unit during the 12-month period were 0.02admission per patient in the transmyocardial-revascularizationgroup and 1.37 admissions per patient in the medical-treatmentgroup. There was no significant difference in the rate of freedomfrom acute myocardial infarction between patients assigned totransmyocardial revascularization (87 percent) and those assignedto medical treatment who did not cross over (80 percent, P=0.24),but the rate of freedom from unstable angina was significantlyhigher after transmyocardial revascularization (84 percent,as compared with 25 percent after medical treatment only; P<0.001).The proportion of patients who did not die and who were freeof acute myocardial infarction, unstable angina, and class IVangina was also significantly higher in the transmyocardial-revascularizationgroup (66 percent, as compared with 11 percent in the medical-treatmentgroup; P<0.001). Event-free survival is shown in Figure 4.
Figure 4. Event-free Survival According to Treatment Group.
Cardiac events were defined as acute myocardial infarction, unstable angina, or class IV angina. TMR denotes transmyocardial revascularization.
Mortality
There were no intraoperative deaths among the patients assignedto transmyocardial revascularization; the 12-month survivalrate was 85 percent. In comparison, the 12-month survival ratewas 79 percent among the 41 medically treated patients who werenot crossed over to transmyocardial revascularization (P=0.50).Of the patients assigned to transmyocardial revascularization,3 (3 percent) died perioperatively, and 10 (11 percent) diedfrom cardiac causes during follow-up (Table 2).
Table 2. Causes of Death According to Treatment Group.
The sole predictor of perioperative mortality was the occurrenceof unstable angina. The time between an occurrence of unstableangina and surgery was significantly related to the risk ofperioperative death (P<0.001): the risk increased by a factorof 22.9 when the time between angina and surgery decreased toless than 2 weeks (1 to 7 days: 8 of 30 patients died [27 percent;95 percent confidence interval, 11 to 43 percent]; 8 to 14 days:3 of 19 died [16 percent; 95 percent confidence interval, 0to 32 percent]; 15 days: 1 of 102 died [1 percent; 95 percentconfidence interval, 0 to 3 percent]) (P<0.001). A low leftventricular ejection fraction was a significant predictor ofoverall mortality in the transmyocardial-revascularization group(P=0.02). The incidence of acute myocardial infarction duringthe study was significantly associated with overall mortalityin both groups (transmyocardial revascularization, P= 0.05;medical treatment, P=0.03). The treatment-group assignment wasnot predictive of mortality, confirming the similarity of overallmortality in the two groups.
Crossover Group
Of the 101 patients assigned to medical treatment 60 (59 percent)were crossed over to transmyocardial revascularization a meanof 107±89 days after randomization. Because of theirunstable angina, these patients were considered to be at highrisk for a poor outcome (Cleveland Clinic risk score, 9.3±3.6,as compared with a score of 5.8±2.9 at enrollment forall patients assigned to medical treatment, where a score of5 indicates a high risk; P=0.02). During the first 30 days aftersurgery, 3 of the 60 patients (5 percent) had acute myocardialinfarction, 2 (3 percent) had unstable angina, 3 (5 percent)had arrhythmias, and 3 (5 percent) had congestive heart failure.One patient sustained laser-induced damage to the mitral apparatusduring surgery. Twenty-three of the patients who were crossedover underwent the 12-month follow-up assessment of angina;16 of these 23 patients (70 percent) had CCS class I or II angina,3 (13 percent) had class III, and 4 (17 percent) had class IV.
Discussion
Before this study was conducted, the potential benefits of transmyocardialrevascularization performed with a carbon dioxide laser hadbeen observed in most of the 2500 patients who had undergonethis treatment. A nonrandomized study of these patients showedsignificant improvement in symptoms and perfusion after thelaser treatment.10 Whether this improvement would have occurredwithout transmyocardial revascularization was unknown. Thisquestion prompted the current randomized investigation.
In this study, the proportion of patients who had relief fromangina was greater in the group assigned to undergo transmyocardialrevascularization (72 percent) than in the patients in the groupassigned to receive maximal medical therapy who did not crossover to transmyocardial revascularization (13 percent). Thissignificant decrease in the patients' CCS class was confirmedby a blinded, independent assessment and with use of the SeattleAngina Questionnaire. Moreover, patients who were assigned tomedical treatment had a rate of hospital admission for unstableangina of 69 percent, as compared with only 2 percent in thetransmyocardial-revascularization group. Among patients whounderwent transmyocardial revascularization, relief of acuteand chronic angina resulted in an improved quality of life,as measured by the SF-36 questionnaire, and reduced use of antianginalmedications.
In addition, myocardial perfusion improved after transmyocardialrevascularization and worsened with medical treatment alone.The price of the benefits of transmyocardial revascularizationwas a 3 percent rate of perioperative mortality. If the procedurewas deferred for two weeks, this rate decreased to 1 percent,making the mortality associated with transmyocardial revascularizationless than that associated with coronary-artery bypass grafting.14Overall survival at 12 months was similar in the two groups(transmyocardial revascularization, 85 percent; medical treatment,79 percent; P=0.50).
This study did not directly address the mechanisms underlyingthe benefits of transmyocardial revascularization; however,several inferences can be made. There may be a short-lived placeboeffect. In a nonrandomized trial, long-term follow-up of patientswho underwent transmyocardial revascularization showed no changein the improvement in symptoms after 3 years (average CCS class,3.8±0.4 at base line, 1.4±1.2 at 12 months, and1.5±1.2 at 36 months).15 The conversion of ischemic myocardi-umto infarcted myocardium may also improve anginal symptoms. Inour study, however, the extent of fixed defects in perfusionover the 12-month period was similar in the two groups, andthere was no significant increase in fixed defects after transmyocardialrevascularization as compared with medical treatment. Denervationis another possible mechanism of the benefit. If this were theexplanation, however, one would expect to see an increase inmyocardial infarction, sudden death, and heart failure withtransmyocardial revascularization — none of which increasedin the patients assigned to this treatment.
Improved perfusion and relief of symptoms after transmyocardialrevascularization could result from patent channels createdby the laser or from laser-induced angiogenesis. Isolated anatomicalevidence of patent channels has been reported.16,17 In addition,real-time, high-resolution contrast echocardiography has shownpatent laser channels perfusing a 1.5-cm3 section of myocardiumwith each systole.18 In our study, perfusion improved over aperiod of 12 months, indicating that the laser may increaseperfusion by stimulating angiogenesis.
Although we assume that transmyocardial revascularization directlyenhances myocardial perfusion, providing relief of angina, wecannot establish a direct correlation. Changes in clinical symptomsand changes on perfusion scans reflect two related but distinctphenomena, and in our study the degree of symptomatic improvementwas not necessarily matched by the degree of improvement inthe results on scanning. Symptoms and perfusion improved inmost of the patients assigned to transmyocardial revascularizationbut not in those assigned to medical treatment who did not crossover to transmyocardial revascularization.
The option for crossover from the medical-treatment group tothe transmyocardial-revascularization group was the greatestlimitation of this study. Crossover was allowed as an incentivefor patients assigned to maximal medical therapy to remain inthe study if medical therapy failed. The attrition rate in thisgroup was considerable because the condition of these patientsdid not improve substantially and because, by definition, theyhad unstable angina that required intravenous medication. Despitethe limitation inherent in the crossover design, the patientsassigned to transmyocardial revascularization showed improvementat three and six months as compared with their base-line valuesand as compared with values in their medically treated counterparts.In addition, although lifestyle changes can be limiting factorsin clinical trials, there were no significant differences inlifestyle or medication use that might have influenced the outcomes.
In a recent report on a randomized study at a single center,19Schofield et al. concluded that transmyocardial revascularizationshould not be recommended because it did not significantly increaseexercise capacity or 12-minute walking distance at 12 months.However, the patients who underwent transmyocardial revascularizationdid have significantly decreased angina (as indicated by theCCS class), increased functional capacity, less need for antianginalmedications, and fewer hospital admissions as compared withmedically treated patients. With respect to exercise capacityand walking times, comparisons were made between the groupsat each follow-up period, not between base line and follow-upwithin each group. The authors reported similar decreases inreversible defects in the two groups. However, they did notconsider the effect of changes in fixed defects.
With regard to fixed defects, there was no significant changefrom base line to 12 months in the transmyocardial-revascularizationgroup.19 The medically treated group, however, had a significantincrease in fixed defects from base line (38 segments [8 percent])to 12 months (68 segments [17 percent]); in other words, reversibledefects decreased when fixed defects increased, as ischemicareas became scarred. In addition, follow-up data on perfusionwere pooled, and comparisons were again made between the groupsrather than between base line and follow-up.
In general, the study by Schofield et al.19 is not closely comparablewith our multicenter trial. Patients in our trial were muchsicker (70 to 80 percent had CCS class IV angina at base line,as compared with 27 percent in the study by Schofield et al.19),and we did not exclude patients with unstable angina, whereasSchofield et al. did. If patients with unstable angina are excluded,the perioperative mortality rate in our study falls to 1 percent,which is less than the 5 percent reported in the other series.19
In summary, we conducted this multicenter, randomized, controlledtrial to determine the effect of transmyocardial revascularizationwith a carbon dioxide laser on symptoms and cardiac perfusionin patients with end-stage coronary disease. We found that transmyocardialrevascularization significantly alleviated angina and improvedcardiac perfusion in patients with severe angina that was refractoryto conventional medical therapy or revascularization procedures.
We are indebted to Philip T. Lavin, Ph.D. (Boston Biostatistics,Boston), for statistical assistance and to Marianne Mallia (TexasHeart Institute, Houston) for editorial assistance in the preparationof the manuscript.
* Other members of the Transmyocardial Carbon Dioxide Laser RevascularizationStudy Group are listed in the Appendix.
Source Information
From the Department of Cardiovascular Surgery and Research, Texas Heart Institute, Houston (O.H.F.); the Department of Cardiovascular Surgery, Rush–Presbyterian–St. Luke's Medical Center, Chicago (R.J.M.); and the Division of Cardiothoracic Surgery, Northwestern University Medical School, Chicago (K.A.H.).
Address reprint requests to Dr. Frazier at the Texas Heart Institute, P.O. Box 20345, Houston, TX 77225-0345.
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Appendix
Other members of the Transmyocardial Carbon Dioxide Laser RevascularizationStudy Group were A.M. Lansing (Audubon Regional Medical Center,Louisville, Ky.), L.H. Cohn and S.F. Aranki (Brigham and Women'sHospital, Boston), G. Fontana (Cedars–Sinai Medical Center,Los Angeles), B.W. Lytle (Cleveland Clinic, Cleveland), C. Smith(Columbia–Presbyterian Medical Center, New York), K.P.Landolfo and J.E. Lowe (Duke University Hospital, Durham, N.C.),J.R. Crew (Seton Medical Center, San Francisco), M.R. Mirhoseini(St. Luke's Medical Center, Milwaukee), D.A. Cooley and K.A.Kadipasaoglu (Texas Heart Institute, Houston), B.P. Griffithand B. Hattler (University of Pittsburgh Presbyterian Hospital,Pittsburgh), and S.W. Boyce (Washington Hospital, Washington,D.C.).
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(2008). Transmyocardial revascularization to enhance myocardial vasculogenesis and hemodynamic function.. J. Thorac. Cardiovasc. Surg.
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Horvath, K. A., Zhou, Y.
(2008). Transmyocardial Laser Revascularization and Extravascular Angiogenetic Techniques to Increase Myocardial Blood Flow. Card Surg Adult
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Tasse, J., Arora, R.
(2007). Transmyocardial Revascularization: Peril and Potential. J CARDIOVASC PHARMACOL THER
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Lapenna, E., Rapati, D., Cardano, P., De Bonis, M., Lullo, F., Zangrillo, A., Alfieri, O.
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(2006). Reproducibility of Measurements of Regional Myocardial Blood Flow in a Model of Coronary Artery Disease: Comparison of H215O and 13NH3 PET Techniques. JNM
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15 days: 1 of 102 died [1 percent; 95 percent confidence interval, 0 to 3 percent]) (P<0.001). A low left ventricular ejection fraction was a significant predictor of overall mortality in the transmyocardial-revascularization group (P=0.02). The incidence of acute myocardial infarction during the study was significantly associated with overall mortality in both groups (transmyocardial revascularization, P= 0.05; medical treatment, P=0.03). The treatment-group assignment was not predictive of mortality, confirming the similarity of overall mortality in the two groups. 
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