SCS in angina pectoris STOCKHOLM 100829 Mats Borjesson, FESC MD, PhD, assoc prof Goteborg, Sweden Paincenter, Dept of Medicine Sahlgrenska University Hospital/Östra, Göteborg, Sweden
Refractory Angina Pectoris Definition Severe stable angina pectoris (CCS 3-4) Coronary artery disease (recently performed angiography) Not accessible to further conventional pharmacological treatment or for further revascularization procedures (CABG/PCI) Current myocardial ischemia should be confirmed if possible Clinical diagnosis CCS; Canadian Cardiovascular Society classification of angina functional class CABG; Coronary Artery Bypass Grafting, PCI; Percutaneous Coronary Intervention Report from the ESC Joint Study Group on the Treatment of Refractory Angina. Mannheimer et al. Eur Heart J 2002;23(5):355-70
Report from the ESC Joint Study Group on the treatment of refractory angina Therapeutic alternative 1 Neuromodulation techniques Mannheimer et al. Eur Heart J 2002:23;355-370
SCS for angina pectoris IMPLANTATION TECHNIQUE Electrode tip T1-T2 Lead entry T6-T7 The paraesthesia to cover the area of the patients anginal pain
SCS for angina pectoris OVERVIEW Safety and acute effects of TENS/SCS Long-term follow-up studies Clinical experience Cost-effectiveness?
SCS for angina pectoris SAFETY Myocardial infarction and unstable angina give rise to symptoms during neuromodulation according to studies and clinical experience According to long-term follow-up studies, there are no adverse effects of SCS on mortality and morbidity * Holter monitoring in daily-life show no increase in arrhythmias Andersen, Br Heart J, 1994; Börjesson, Cor Art Dis, 1997; Ekre Eur Heart J, 2002; Mannheimer Circulation, 1998, dejongste Br Heart J 1994
Workload MECHANISMS OF ACTION? Angina Ischemia No angina No ischemia Control SCS Rest Stress to angina Rest Comparable max load Stress to angina Decrease in myocardial ischemia decrease in myocardial oxygen consumption Mannheimer et al. Circulation, 1985; Mannheimer et al. BMJ, 1993
Spinal Cord Stimulation Effects on heart rate, ST-depression and myocardial lactate extraction Parameter Control P1 P2 Heart rate (bpm) 128 ± 13 128 ± 14 149 ± 15 Depression ST-segment (mm) -1.8 ± 0.9-1.0 ± 0.6-1.8 ± 1.0 Myoc lact extr (%) - 8 ± 33 8 ± 21-3 ± 21 P <0.001 P2 vs C <0.001 P2 vs P1 0.01 C vs P1 0.04 P2 vs P1 0.003 P1 vs C 0.01 P2 vs P1 (Mannheimer et al BMJ 1993. 307: 477-480)
Spinal Cord Stimulation Effect on coronary sinus blood flow and myocardial oxygen consumption Parameter Control P1 P2 p CSBF (ml/min) 136 65 124 63 145 55 0.01 P1 vs C 0.003 P2 vs P1 MVO 2 (ml/min) 19 11 16 9 19 9 0.02 P1 vs C 0.002 P2 vs P1 (Mannheimer et al Brit Med J 1993. 307: 477-480)
Workload SCS for angina pectoris MECHANISM OF ACTION? Angina Ischemia No angina No ischemia Control SCS Mechanism of decreased oxygen consumption Release of beta-endorphin A general decrease in sympathetic activity Eliasson et al. Cardiology, 1998 Norrsell et al. Eur Heart J, 1997;
SCS for angina pectoris REDISTRIBUTION OF CORONARY BLOOD FLOW? Hautvast et al. Am J Cardiology, 1996 PET, pharmacological stress, redistribution Jessurun et al. Am J Cardiology, 1998 Intracoronary doppler during PCI, TENS
SCS for angina pectoris Vascular effects of TENS in healthy subjects and patients with refractory angina Increase in forearm bloodflow and lowering of vascular resistance in healthy subjects but not in refractory angina patients. Due to impaired endothelial function? Hallen K et al accepteded for publication 2010
TENS/SCS for angina pectoris ACUTE EFFECTS At rest Minor or no changes in myocardial metabolism. During stress at comparable stress level Disappearence in myocardial ischemia as a result of a decrease in myocardial oxygen consumption. At maximal stress level Myocardial ischemia gives rise to anginal pain A release of beta-endorphin and/or a general decrease in sympathetic activity may contribute to these effects
Efficacy- systematic reviews
NEUROSTIMLATION IN ANGINA PECTORIS- LONG TERM STUDIES 20 studies Consistent results confirmig efficacy on ischemia, symptoms and safety Flaws: Design Number of patients- few Follow-up period- short
Spinal Cord Stimulation Comparison to CABG The ESBY trial Patients n = 104 (males 83; age 69 9) angina class III-IV, accepted for CABG No expected prognostic benefit from CABG. Indication: symptom relief. Random assignment: CABG n = 51; SCS n = 53 Follow up: 6 months and 5 years (Mannheimer et al Circulation 1998; 97:1157-63)
SCS for angina pectoris THE ESBY TRIAL - 6 MONTHS FOLLOW-UP 18 16 14 12 10 8 6 4 2 0 Anginal attacks/ week Pre Symptom relief Post 16 14 12 10 8 6 4 2 0 Pre SAN/ week Post CABG SCS (Mannheimer et al Circulation 1998; 97:1157-63)
SCS for angina pectoris THE ESBY TRIAL - 6 MONTHS FOLLOW-UP Mortality and total morbidity Parameter CABG SCS p Mortality 7 1 0.02 Non-fatal morbidity 7 7 NS Total morbidity 14 8 NS (0.08) (Mannheimer et al Circulation 1998; 97:1157-63)
SCS for angina pectoris THE ESBY TRIAL - 6 MONTHS FOLLOW-UP Cerebrovascular and cardiac morbidity Parameter CABG SCS p Cardiac events 9 8 NS Cerebrovascular events 11 4 <0.05 Mannheimer et al Circulation, 1998
SCS for angina pectoris THE ESBY TRIAL - 6 MONTHS FOLLOW-UP Quality of Life Generic (NHP) and disease specific (AP- QLQ) questionnaires Improvement in both groups after 6 months Ekre et al. Eur Heart J, 2002
SCS for angina pectoris THE ESBY TRIAL LONG-TERM FOLLOW-UP Quality of life Lasting improvement of quality of life in both groups up to > 4 years Morbidity SCS had less hospitalization days due to coronary heart disease than CABG during 2 years follow-up Ekre et al. Eur Heart J, 2002; Andréll et al. Cardiology, 2003
Cumulative Survival Spinal Cord Stimulation The ESBY trial long term follow up Survival 5 years 1,8 CABG SCS,6,4,2 0 0 500 1000 1500 2000 (Mannheimer et al Data on file)
Efficacy of SCS: summary Symptom relief Quality of life Functional status
Meta-analysis
SCS for angina pectoris CLINICAL EXPERIENCE Indications for SCS in angina pectoris Refractory angina severe angina in patients with increased peroperative risk and only symptomatic benefits from CABG. Syndrome X
SCS for angina pectoris STIMULATION PATTERN *Prophylactic stimulation 2 hours x 4/day = Low intensity stimulation *At onset of attack = High intensity stimulation (30-60 seconds) Patient controlled treatment
SCS for angina pectoris CLINICAL EXPERIENCE Patient selection The chest pain must be secondary to current myocardial ischemia Chest pain of other origin poor effect of SCS with SCS restriction
SCS for angina pectoris WORLDWIDE EXPERIENCE Estimate ~ 3 000 patients worldwide ~ 800 patients in Gothenburg > 80% success rate Lasting symptom relief Improvement in physical activity and quality of life Reduction in hospital admissions No adverse effects on morbidity and mortality
SCS for angina pectoris CONCLUSION SCS is a suitable therapy for symptom relief in patients with refractory and severe angina pectoris SCS is a safe treatment with a documented anti-ischemic effect (in systemic reviews) SCS does not deprive the patient of a warning More data needed regarding cost-effectiveness
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