Percutaneous laser revascularistion for refractory angina pectoris (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Percutaneous laser revascularistion for refractory angina pectoris
| Patients with refractory angina pectoris have chest pain (because of insufficient oxygen delivery to their heart muscle) that cannot be controlled by optimal medical or surgical management. Percutaneous laser revascularisation involves insertion of a catheter into major vessels of the groin, which is advanced to the heart, to drill holes on the heart muscle using a laser beam. The aim is to enable blood flow from the heart chambers into the heart muscle, to relieve myocardial ischaemia and reduce chest pain |
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The National Institute for Health and Clinical Excellence (NICE) is examining interventional procedure overview of percutaneous laser revascularistion for refractory angina pectoris and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about percutaneous laser revascularistion for refractory angina pectoris. This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
Note that this document is not NICE's formal guidance on this procedure. The recommendations are provisional and may change after consultation. The process that NICE will follow after the consultation period ends is as follows.
For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual). NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate. Closing date for comments: 24 February 2009 Target date for publication of guidance: May 2009 |
| 1 | Provisional recommendations |
| 1.1 | Current evidence on percutaneous laser revascularisation (PLR) for refractory angina pectoris shows no efficacy and suggests that the procedure may pose unacceptable safety risks. Therefore, this procedure should not be used. |
| 2 | The procedure |
| 2.1 | Indications and current treatments |
| 2.1.1 | Angina pectoris is chest discomfort, often described as pressure or pain, typically occurring on exertion. It is caused by inadequate delivery of oxygen to the heart muscle, usually because of coronary artery disease. Refractory angina is a severe form of angina that cannot be controlled by normal medical or surgical treatment. |
| 2.1.2 | The treatment and management of angina depends on patient characteristics and coronary angiography findings. Treatments include anti-anginal medication and interventions to improve blood flow (coronary angioplasty, stenting or coronary artery bypass surgery). For patients with refractory angina, these treatments have either failed or are not clinically suitable, so other treatment options include transcutaneous nerve and spinal cord stimulation. |
| 2.2 | Outline of the procedure |
| 2.2.1 | Percutaneous laser revascularisation for refractory angina pectoris is undertaken under local anaesthesia and under fluoroscopic control. A special catheter is inserted through the major vessels of the groin, and advanced to the heart. Echocardiography or a myocardial perfusion scan is used to identify the section of the myocardium needing revascularisation. A laser device is then used to create a number of channels in the myocardium. |
| 2.2.2 | A number of different devices can be used for this procedure. |
| A systematic review of the published evidence on the efficacy and safety of transmyocardial and percutaneous laser revascularisation for refractory angina pectoris was commissioned by NICE. Sections 2.3 and 2.4 describe efficacy and safety outcomes from the systematic review that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the systematic review, available at www.nice.org.uk/IP390review. |
| 2.3 | Efficacy |
| 2.3.1 | A meta-analysis of six randomised controlled trials (RCTs) involving 1040 patients reported no difference in mortality at 12-month follow-up between PLR-treated patients and medically-managed patients (three RCTs), spinal cord stimulation (one RCT), or sham therapy (two RCTs) (pooled odds ratio [OR] 0.74; 95% confidence interval [CI] 0.32 to 1.7). |
| 2.3.2 | An RCT of 298 patients reported no difference in mean myocardial perfusion test score (using single photon emission computed tomography [SPECT] imaging; scoring system not described) between patients treated with high-dose PLR (defined as 20–25 laser pulses), low-dose PLR (defined as 10–15 laser pulses) or sham therapy (17.7 points, 19.3 points, and 17.3 points, respectively at 6 month follow-up [p = 0.35]). |
| 2.3.3 | An RCT of 221 patients comparing PLR with medical management reported no difference in mean left ventricular ejection fraction between PLR-treated patients (median 51%) and medically-managed patients (median 50%) at 3‑month follow-up (level of significance not stated). An RCT of 82 patients reported no difference in mean left ventricular ejection fraction between patients treated with PLR (64%) and sham therapy (63%) at 12-month follow-up (level of significance not stated). |
| 2.3.4 | A meta-analysis of three RCTs including 587 patients reported no difference in post-procedural exercise tolerance using the Bruce Protocol Stress Test (a treadmill test) between PLR-treated patients and medically-managed patients (one RCT), spinal cord stimulation (one RCT), or sham therapy (one RCT) at 6-month follow-up (40.3 seconds; 95% CI 14.7 to 95.3), with a reported improvement at 12 months (17.7 seconds; 95% CI 4.4 to 31.0). When only studies with adequate blinding of patients to allocated treatment were included in the meta-analysis, exercise tolerance differences at either 6 or 12 months were not significant. |
| 2.3.5 | Three RCTs measured Canadian Cardiac Society Angina score (CCSA) change. In the RCTs of 298 and 141 patients there was no difference in the proportion of patients whose angina scores improved by 2 or more classes at 6-month follow-up (p = 0.33). In one RCT of 82 patients, the proportion of patients with an improved angina score of 2 or more classes compared with baseline in the PLR group was not significantly different to patients treated with sham therapy at 12-month follow-up (35% [14/40]; 14% [6/42] respectively) (p = 0.04). |
| 2.3.6 | Specialist Advisers considered key efficacy outcomes to include reduction of angina, which may or not be associated with objective measures, including improvement of perfusion scans, angina status, and exercise capacity. |
| 2.4 | Safety |
| 2.4.1 | Meta-analysis of five RCTs including 819 patients reported no difference in mortality (up to 30-days follow-up) between PLR-treated patients and medically-managed patients (three RCTs), spinal cord stimulation (one RCT), or sham therapy (two RCTs) (OR 1.4; 95% CI 0.4 to 4.9). |
| 2.4.2 | In six RCTs including 938 patients, the overall (pooled) rate of myocardial infarction was higher in PLR-treated patients (7% [34/515]) than in the control groups (4% [17/423]). One RCT of 221 patients reported a higher rate of left bundle branch block following PLR (5% [5/110]) compared with medical management (1% [1/111]; level of significance and follow-up not stated). |
| 2.4.3 | RCTs of 298 and 221 patients reported left ventricular perforation rates of 1% (2/196) and 3% (3/110) respectively in PLR-treated patients (none in patients treated with either spinal cord stimulation or a sham procedure; events occurred during < 30‑day follow-up and within 24 hours, respectively; level of significance not stated for either study). In a case series of 25 patients the rate of myocardial perforation was 4% (1/25). A case series of 30 patients treated with PLR reported that 3% (1/30) of patients suffered pericardial tamponade during the procedure. |
| 2.4.4 | Among four RCTs, cerebrovascular accident or transient ischaemic attack occurred more frequently in patients treated with PLR (4% [10/285]) than in patients in the control arms of the studies (2% [5/287]; level of significance and follow-up not stated). |
| 2.4.5 | The Specialist Advisers stated that adverse events reported in the literature include myocardial infarction, arrhythmias and puncture site complications. The Specialist Advisers considered theoretical adverse events to include death, perforation of the cardiac muscle, damage to coronary arteries or other important structures, stroke and pericardial effusion. |
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
December, 2008
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This page was last updated: 30 March 2010