Interactive Cardiovascular and Thoracic Surgery 3:586-592(2004)
© 2004 European Association of Cardio-Thoracic Surgery
Best evidence topic - Cardiac general |
Is transmyocardial revascularisation of benefit to people with ‘no option’ angina?
Aliu Sanni and
Joel Dunning*
Department of Cardiothoracic Surgery, Freeman Hospital, Freeman Road, Newcastle NE7 7DN, UK
* Corresponding author. Tel./fax: +44-780-154-8122. (E-mail: joeldunning{at}doctors.org.uk).
Received June 22, 2004;
accepted June 28, 2004
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Abstract
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A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether the use of transmyocardial revascularisation is of benefit in patients with severe angina but ungraftable areas of myocardium. Altogether 345 papers were found using the reported search, of which 11 represented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results, and study weaknesses were tabulated. We conclude that in selected stable patients with ‘no option’ CCS grade III–IV angina, TMR can significantly reduce the grade of angina at the cost of a perioperative mortality of around 5%.
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1. Introduction
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A best evidence topic was constructed according to a structured protocol. This protocol is fully described in the ICVTS [1].
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2. Clinical scenario
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You are seeing a 67-year-old diabetic with CCS grade IV angina. A perfusion scan demonstrated clear areas of reversible ischaemia. Unfortunately you have carefully reviewed the angiogram with a colleague and although there is a significant disease in all three regions, the disease is diffuse and there are no graftable vessels. You cannot offer this patient a coronary arterial bypass graft which disappoints the patient greatly, as he has no quality of life currently. A colleague has recently been to America and came back reporting that the use of TMR was widespread. Your colleague has, therefore, recently acquired a Holmium:YAG laser. You wonder whether to offer this option to your patient, but you resolve to look up the reported benefit and the mortality risk first so the patient can be adequately informed.
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3. Three-part question
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In [patients with ‘no option’ angina] is the use of [transmyocardial revascularisation] of any benefit in terms of [angina relief or survival]?
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4. Search strategy
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Medline 1966–June 2004 using the OVID interface [Transmyocardial.mp OR TMR.mp OR TMLR.mp OR DMR.mp OR exp laser surgery/] AND [angina.mp OR exp angina pectoris, variant/ OR exp angina pectoris/ OR exp angina unstable/] LIMIT to human studies.
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5. Search outcome
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A total of 345 abstracts as found from Medline of which 11 were relevant. These are summarised in Table 1.
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6. Results
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Bridges et al. in 2004 [2] issued a guideline for the Society of Thoracic Surgeons for TMR, stating that there was general agreement that any patient with CCS grade III or IV angina with maximal medical therapy, not amenable to revascularisation, should undergo TMR as long as the ejection fraction was more than 30%. This was a very pro-TMR document with 2 members of the guideline committee being major advocates and active researchers in TMR. They reviewed 5 RCTs and the USA retrospective cohort, however, they did not consider the negative results from Burns et al. from the European Registry.
Burns et al. in 1999 [3] reported the results of an international registry which was set up in 1994 to collect data on this emerging procedure. They reported 932 procedures from 15 centres and found an overall 10% mortality, 30% complication rate, and only 34% of patients had an improvement of CCS class of more than 2 classes at 12 months.
Of the randomised controlled trials, the Atlantic Trial [4] was conducted in 16 US centres in 1999. By a left lateral thoracotomy or medical management alone, 182 patients were randomised to TMR. These patients all had not only demonstrable reversible ischaemic regions, but also at least one area of protected myocardium (mostly from previous revascularisation) and an ejection fraction of over 30%. Five patients died in the TMR group, and only 1 within 30 days of the procedure. Nine died within 1 year in the medical management group. Independent assessors were used to measure angina at 2 years. CCS score was II or lower in 48% of patients but only 14% in the medical management alone group. It is interesting to note that the non-independent assessors (i.e. the surgeons) graded 32% of TMR patients as having a lower angina score than the independent assessors but only 11% higher. This systematic bias disappeared for the medical management group. This is an important finding when reading the other studies as this shows a clear problem with assessment of patients post-operatively by non-independent, operating surgeons. The Atlantic trial was a well-conducted study that showed good results with a low mortality for TMR.
Allen et al. in 2004 [5] published their 5-year follow-up of their trial of TMR versus medical therapy in 212 class IV angina patients. They found that the mean angina score at 5 years was 1.2 in the TMR group, and that 88% of patients had a 2 class or more improvement in angina compared to 44% in the medically managed group. Allen also demonstrated a survival benefit, with a 65% 5-year survival in the TMR group versus a 52% survival in medically managed patients. However, only 99 of the original 275 patients were followed up to 5 years, and 40% of medically managed patients ended up having a surgical procedure, including TMR for 26% of the patients. Although there were many confounders in this study, their results are still impressive for TMR. Of note, this study extended the findings from the original study published in the New England Journal of Medicine in 1999 [6], reporting the 1-year findings.
The most significant negative randomised controlled trial came from Papworth in 1999 [7]. They studied 188 patients randomised to TMR via a small antero-lateral thoracotomy or medical management alone. The primary outcome measure was the maximum exercise time and they found no improvement in this or the maximum walking distance. They found that only 25% of patients had an improvement of CCS angina score of more than 2 classes, and together with the 5% mortality they concluded that TMR cannot be advocated and should not be performed outside the context of a trial. This was a well-conducted trial published in the Lancet but the angina scores were not independently assessed, and other authors have criticised the fact that only 27% of patients in this study had grade IV angina.
Aaberge et al. [8] reported the 5-year follow-up findings of 100 patients randomised to TMR or conservative treatment in a Norwegian PRCT. They had a 4% operative mortality, but found that 24% had at least a 2-point improvement in CCS angina score at 5 years compared to a 3% improvement in conservatively managed patients. They also found that the rate of heart failure treatment had increased in the TMR group and there was no effect on ejection fraction or mortality.
Frazier [9] performed a multicentre PRCT in 192 patients from 12 US centres. They found that with only a 3% perioperative mortality, angina improved by 2 or more grades in 72% of patients at 1 year compared to only 13% of patients in the medical management group. They also found some benefits in perfusion defects but no changes in survival. It should be noted that this study was complicated by the fact that 60 of the 101 medically managed patients had ‘failed treatment’ and underwent TMR.
Hattler et al. [10] reported the findings of a multicentre cohort study comparing TMR for chronic angina with TMR for unstable angina in patients who were taken from the CCU after 7 days of iv nitrates and 3 failed attempts to wean this therapy. They found that in the 76 patients who had unstable angina, there was a 16% perioperative mortality compared to 5% in the chronic angina group, and only a 25% improvement of more than 2 CCS grades, although angina was not assessed independently. They reported that TMR was still a possible option in these otherwise ‘no option’ patients, although this mortality rate does seem very high and there was no control group to determine what the conservative management outcome would have been.
Peterson et al. in 2003 [11] reported the results of the Society of Thoracic Surgeons database, and compared this with the published RCTs on this topic. Interestingly they found that TMR is being increasingly performed in the USA and 36% of US centres now perform TMR, although this is mostly in combination with CABG. They found that the operative mortality of TMR alone in the STS database was 6.4% compared to the reported mortality of only 3.5% in the RCTs. They also reported that mortality was significantly higher in patients with unstable angina, depressed ventricular function and patients with a recent MI.
The Society of Thoracic surgeons in the USA recommend TMR in selected ‘no option’ patients. This recommendation is supported by all but one of the RCTs that addressed this subject, where significant improvements in angina were consistently found, with a pre-operative mortality risk of around 5%.
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7. Clinical bottom line
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In selected stable patients with ‘no option’ CCS grade III–IV angina TMR can significantly reduce the grade of angina at the cost of a perioperative mortality of around 5%.
doi:10.1016/j.icvts.2004.06.012
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Abstract
1. Introduction