ABSTRACT: Percutaneous myocardial laser (PML) reduces symptoms in patients with intractable angina. PML leads to a certain loss of viable myocardium, we therefore assessed if troponin or cardiac markers release may explain the clinical effect, and furthermore assessed the markers release during percutaneous sham procedures.
Eighty-two patients with chronic refractory angina were randomized to either percutaneous myocardial laser or a true sham procedure. Cardiac markers were assessed before the procedure, and (1/2), 2, 4, 6, and 10-12 h postprocedure.
Troponin I increased to median peak levels (range) of 4 (0.6-43) microg/L in the laser group vs. 1.5 (0.1-5.9) microg/L, p=0.001, and creatine kinase MB to 14 (6-357) microg/L vs. 11 (3-40) microg/L, p<0.05, within and between-group comparison, the rise of CK-MB occurred significantly earlier in the sham group, 3.8 vs. 2.5 h. A time-dependent between-group difference was only detected for troponin. 88% of sham and 100% of laser patients had marker levels above reference limits. There was no correlation between the number of laser/sham created channels, biomarker levels postprocedure, and changes in left ventricular ejection fraction or angina improvement during 12 months of follow-up.
The release of cardiac markers is not related to relief of angina after myocardial laser. The use of intracardiac catheters induces a considerable marker release, which is not caused by acute ischemia.
International Journal of Cardiology 10/2005; 104(2):144-51. · 7.08 Impact Factor
ABSTRACT: This prospective, double-blind, randomized, sham-controlled trial was designed to control for patient and investigator bias in assessing symptomatic improvement after percutaneous myocardial laser revascularization (PMLR) therapy. Eighty-two patients with stable angina pectoris (class III or IV) not amenable to conventional revascularization and with evidence of reversible ischemia, ejection fraction >/=25%, and myocardial wall thickness >/=8 mm were randomized to either PMLR with optimal medical therapy (n = 40) or to a sham procedure with optimal medical therapy (n = 42). With the exception of 1 laser technician, all patients, investigators, and assessors were blinded to treatment through the 12-month follow-up. The primary end point was restricted to Canadian Cardiovascular Society angina class improvement to limit the number of patients exposed to a sham procedure. Secondary assessments included medication usage, quality of life, exercise testing, ejection fraction, and hospitalizations. The incidence of serious adverse events, as determined by cardiac event-free survival at 12 months, was similar between groups. At 12 months, Canadian Cardiovascular Society angina scores improved by >/=2 classes in significantly more PMLR-treated patients than sham control patients (35% vs 14%, p = 0.04). Angina-specific quality-of-life measures were significantly higher in the PMLR group at each follow-up (p <0.05). Exercise and medication usage was similar between groups at 12 months. We conclude that PMLR therapy is reasonably safe and effective as symptomatic improvement in patients refractory to medical therapy, and that the clinical benefit is not attributable to placebo effect or investigator bias.
The American Journal of Cardiology 05/2004; 93(9):1086-91. · 3.37 Impact Factor
ABSTRACT: The aims of this study were to evaluate the effect of transmyocardial laser treatment on quality of life and to assess the correlation between preoperative expectations and clinical improvement after one year.
13 patients (median age 56 years) with disabling angina pectoris were subjected to transmyocardial holmium: YAG laser. Quality of life was assessed preoperatively and at three and 12 months by Hospital Anxiety and Depression Scale (HAD), Physical Symptom Distress Index (PSDI) and Life Satisfaction Index (LSI). Expectations were evaluated by Leedham's scale.
A significant improvement in Canadian Cardiovascular Society Score (CCS) from 3.4 +/- 0.5 (mean +/- SD) preoperatively to 1.6 +/- 1.0 and 1.7 +/- 0.8 three and 12 months after treatment was observed (p < 0.01). Quality of life (PSDI and LSI) improved. No significant changes in ejection fraction or exercise performance were found. Preoperative expectations were generally high, but did not correlate significantly with improvements in CCS or quality of life.
Although no changes in objective parameters were found, the lack of significant correlations between preoperative expectation and subjective clinical improvement indicate that the improvement of angina pectoris only partly can be explained by placebo effects.
Tidsskrift for Den norske legeforening 09/2002; 122(21):2102-4.