Maisch B, Funck R, Schönian U, Moosdorf R
Zentrum für Innere Medizin-Schwerpunkt Kardiologie, Marburg.
Z Kardiol. 1996;85 Suppl 6:269-79.
In symptomatic endstage coronary artery disease after full medical therapy (antianginal drugs, betablockers and ACE-inhibitors) further therapeutical options both for the interventional cardiologist with little hope for improvement by PTCA, stent, rotablation and atherectomy and for the cardiac surgeon with bypass surgery and endarterectomy are not available by definition due to the diffuse arteriosclerotic vessel morphology. In those patients one can therefore consider transmyocardial laser therapy (TMR) as the ultimate treatment option. It then is primarily a palliative measure to reduce the patient's symptoms. Improving perfusion and prognosis remains the most important goals, however. TMR can be utilized as the only revascularizing treatment measure or in combination with CABG or PTCA. According to data from international registries, few controlled and several non controlled studies and our own registry in Marburg with now 101 patients improvement of angina and/or dyspnoea can be expected in more than 60% of patients with end stage coronary artery disease (CAD). The patient cohort comprises symptomatic individuals after CABG or multiple PTCAs or with diffuse CAD in diabetes mellitus or with most severe hypercholesterinemia. We consider these above mentioned criteria as the only validated criteria to enter patients with endstage CAD in our controlled study. Hypothetical options for treatment by TMR such as vasculopathies after heart transplantation, cardiomyopathies under the notion of a possible but not proven microangiopathy are not accepted in our institution at present. Before TMR all patients are assessed for their angina class according to the Canadian Cardiac Society (CCS I-IV)) and their exercise capacity according to the New York Heart Association classification (NYHA I-IV) and reassessed regularly after 3, 6 and 12 months. Thallium/Te MIBI scans at rest- and whenever possible at exercise as well as stress echocardiography are carried in the patients to assess symptomatic improvement, alterations in myocardial perfusion and functional efficacy by TMR. By intermediate analysis the 101 patients of our registry more than 60% of the patients had improved their angina class by at least one classe, some patients have improved perfusion as assessed by scintigraphy, which makes at present a trend but not yet a significant difference, whereas central hemodynamics and ejection fraction remained virtually unchanged in most patients reassessed after TMR. In our analysis mortality of the 101 TMR patients was assessed and plotted on Kaplan Meier survival curves. Mortality at 6 months was 11%. When compared to a historical group of patients with identical CCS and comparable NYHA classes, who were worked up in the manner of a case control study, the TMR mortality was marginally but not yet significantly lower than one would expect from these control patients with terminal CAD treated purely by medication: Their 6 months mortality was 14%. Remarkably but not unexpectedly patients with comparable CCS classes, who could still be treated by PTCA and/or CABG had a significantly lower 6 months mortality than TMR patients or patients on antianginal drugs only. The pathophysiological mechanisms for the symptomatic improvement by laser therapy are not yet fully understood. The 1 mm transmyocardial channels created by the CO2 laser have been postulated to permit perfusion from the ventricular cavity and to seek connection to capillaries and vessels present in the malperfused myocardium thus improving the perfusion by newly created connections and sinusoids from the ventricular cavity. Although there is clear evidence for the presence of open channels acutely and within a few days after TMR therapy little evidence in man is as yet available on the question whether the channels remain open in the long run and, if so, whether they can actually improve perfusion to a substantial degree...
在经过充分药物治疗(抗心绞痛药物、β受体阻滞剂和血管紧张素转换酶抑制剂)后出现症状的终末期冠状动脉疾病中,对于经皮冠状动脉腔内血管成形术(PTCA)、支架置入术、旋切术和斑块旋切术改善希望渺茫的介入心脏病学家,以及对于进行搭桥手术和动脉内膜切除术的心脏外科医生而言,由于弥漫性动脉硬化血管形态的原因,从定义上来说没有进一步的治疗选择。因此,对于这些患者,可以考虑经心肌激光血运重建术(TMR)作为最终的治疗选择。那么,它主要是一种减轻患者症状的姑息性措施。然而,改善灌注和预后仍然是最重要的目标。TMR可以作为唯一的血运重建治疗措施使用,也可以与冠状动脉旁路移植术(CABG)或PTCA联合使用。根据国际注册机构的数据、少数对照研究和几项非对照研究以及我们在马尔堡拥有101例患者的注册机构的数据,预计在超过60%的终末期冠状动脉疾病(CAD)患者中,心绞痛和/或呼吸困难会得到改善。患者队列包括冠状动脉旁路移植术后或多次PTCA术后有症状的个体,或患有糖尿病弥漫性CAD或最严重高胆固醇血症的个体。在我们的对照研究中,我们将上述标准视为纳入终末期CAD患者的唯一经过验证的标准。目前,我们机构不接受TMR治疗的假设性选择,如心脏移植后的血管病变、在可能但未经证实存在微血管病变概念下的心肌病。在进行TMR之前,根据加拿大心血管学会(CCS I-IV)对所有患者的心绞痛分级进行评估,并根据纽约心脏协会分级(NYHA I-IV)对其运动能力进行评估,并在3、6和12个月后定期重新评估。对患者进行静息状态下以及尽可能在运动状态下的铊/锝甲氧基异丁基异腈(Te MIBI)扫描以及负荷超声心动图检查,以评估症状改善情况、心肌灌注变化以及TMR的功能疗效。通过中期分析,我们注册机构的101例患者中,超过60%的患者心绞痛分级至少提高了一级,一些患者经闪烁扫描评估灌注有所改善,目前这只是一种趋势但尚未有显著差异,而在TMR后重新评估的大多数患者中,中心血流动力学和射血分数几乎保持不变。在我们的分析中,对101例TMR患者的死亡率进行了评估,并绘制在Kaplan Meier生存曲线上。6个月时的死亡率为11%。与一组具有相同CCS且NYHA分级相当(按照病例对照研究方式进行评估)的历史患者组相比,TMR死亡率略低于但尚未显著低于这些仅接受药物治疗的终末期CAD对照患者预期的死亡率:他们6个月时的死亡率为14%。值得注意但并不意外的是,具有相当CCS分级且仍可接受PTCA和/或CABG治疗的患者6个月死亡率明显低于TMR患者或仅服用抗心绞痛药物的患者。激光治疗症状改善的病理生理机制尚未完全了解。二氧化碳激光形成的1毫米经心肌通道被假定可使心室腔进行灌注,并寻找与灌注不良心肌中存在的毛细血管和血管相连,从而通过新形成的心室腔连接和血窦改善灌注。尽管有明确证据表明在TMR治疗后急性期及几天内存在开放通道,但关于这些通道在长期内是否保持开放以及如果保持开放是否能实际在很大程度上改善灌注,在人体中尚未有足够证据……