Immediate and long-term clinical outcome after spinal cord stimulation for refractory stable angina pectoris

The treatment of patients with angina pectoris refractory to medical therapy and unsuitable for revascularization procedures has yet not been well standardized. Previous retrospective studies and small prospective studies have suggested beneficial effects of spinal cord stimulation (SCS) in these patients. We created a Prospective Italian Registry of SCS to evaluate the short- and long-term clinical outcome of patients who underwent SCS device implantation because of severe refractory angina pectoris. Overall, 104 patients were enrolled in the registry (70 men, aged 68 +/- 17 years), most of whom (83%) had severe coronary artery disease. Average follow-up was 13.2 +/- 8 months. Overall, 17 patients (16%) died, 8 (8%) due to cardiac death. Among clinical variables, only age was found to be significantly associated both with total mortality (p = 0.04) and cardiac mortality (p = 0.02) on Cox regression analysis. A significant improvement of anginal symptoms (> or =50% reduction of weekly anginal episodes, compared with baseline) occurred in 73% of patients, and Canadian Cardiovascular Society angina class improved by > or =1 class in 80% and by > or =2 classes in 42% of patients, with a relevant reduction in the rate of hospital admission and days spent in the hospital because of angina (p <0.0001 for both). No life-threatening or clinically serious complications were observed. The most frequent side effect consisted of superficial infections, either at the site of puncture of electrode insertion or of the abdominal pocket, which occurred in 6 patients. In conclusion, our prospective data point out that SCS can be performed safely and is associated with a sustained improvement of anginal symptoms in a relevant number of patients with refractory stable angina pectoris.     

An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial.

AIMS: Refractory angina pectoris leads to significant morbidity. Treatment options include percutaneous myocardial laser revascularization (PMR) and spinal cord stimulation (SCS). This study was designed to compare these two treatments. METHODS AND RESULTS: Subjects with Canadian Cardiovascular Society (CCS) class 3/4 angina and reversible perfusion defects were randomized to SCS (34) or PMR (34). The primary outcome was to compare exercise treadmill time on a modified Bruce protocol over 12 months. Thirty subjects in both groups completed 12-month follow-up. The mean total exercise time was 6.38 +/- 3.45 min in the SCS group and 7.41+/-3.68 min in the PMR group at baseline and 7.08 +/- 0.67 min in the SCS group and 7.12 +/-0.71 min in the PMR group at 12 months (95% confidence limits for the difference between the groups -1.02 to + 2.2 min, P = 0.466). There were no differences in angina-free exercise capacity, CCS class, and quality of life between treatments. SCS patients had more adverse events in the first 12 months, mainly angina or SCS system related (P = 0.001). CONCLUSION: There was little evidence of a difference in effectiveness between SCS and PMR in patients with refractory angina.     

Spinal cord stimulation significantly decreases the need for acute hospital admission for chest pain in patients with refractory angina pectoris

OBJECTIVE: To assess the impact of spinal cord stimulation (SCS) on the need for acute admissions for chest pain in patients with refractory angina pectoris. DESIGN: Retrospective analysis of case records. PATIENTS: 19 consecutive patients implanted for SCS between 1987 and 1997. All had three vessel coronary disease, and all were in New York Heart Association functional group III/IV. METHODS: Admission rates were calculated for three separate periods: (1) from initial presentation up until last revascularisation; (2) from last revascularisation until SCS implantation; (3) from SCS implantation until the study date. Post-revascularisation rates were then compared with post-SCS rates, without including admissions before revascularisation, as this would bias against revascularisation procedures. RESULTS: Annual admission rate after revascularisation was 0.97/patient/year, compared with 0.27 after SCS (p = 0.02). Mean time in hospital/patient/year after revascularisation was 8.3 days v 2.5 days after SCS (p = 0.04). No unexplained new ECG changes were observed during follow up and patients presented with unstable angina and acute myocardial infarction in the usual way. CONCLUSIONS: SCS is effective in preventing hospital admissions in patients with refractory angina, without masking serious ischaemic symptoms or leading to silent infarction.     

Spinal cord stimulation for long-term treatment of severe angina pectoris: what does the evidence say?

Patients who continue to suffer from severe and disabling angina pectoris, despite optimum treatment in terms of conventional pharmacological therapy and/or revascularization procedures, have been termed as having refractory angina pectoris. The future group of patients with refractory angina pectoris will be different from today's patients and represent a 'moving target' as risk factors, efficacy of treatment and indications continue to change. Spinal cord stimulation (SCS) is today considered as first-line treatment of refractory angina pectoris, by the European Society of Cardiology, with an anti-ischemic effect. There is strong evidence for SCS giving symptomatic benefits (decrease in anginal attacks), improved quality of life and improvement of functional status. In addition, SCS seems to be cost effective with a 'break-even' after approximately 15-16 months.     

Effects of spinal cord stimulation on myocardial ischaemia during daily life in patients with severe coronary artery disease. A prospective ambulatory electrocardiographic study.

BACKGROUND--Spinal cord stimulation (SCS) may be a useful additional therapy for pain in patients with therapeutically refractory angina pectoris. But doubts remain about whether it also relieves ischaemia. METHODS--Indices of ischaemia were studied with and without SCS in 10 patients with otherwise intractable angina and evidence of myocardial ischaemia on 48 h ambulatory electrocardiographic (ECG) recording. Primary end points assessed by 48 h ECG recordings were total ischaemic burden, number of ischaemic episodes, and duration of ischaemic episodes. In addition, symptoms were assessed by a diary of glyceryl trinitrate intake and angina attacks. RESULTS--During SCS the total ischaemic burden of the entire group was significantly reduced from a median of 27.9 (1.9-278.2) before SCS to 0 (0-70.2) mm x min with SCS (p < 0.03). In six out of the 10 patients there was no myocardial ischaemia during 48 h ambulatory ECG monitoring with SCS. The number of ischaemic episodes was reduced from a median of 3 (1-15) before SCS to 0 (0-9) with SCS (p < 0.04). The duration of ischaemic episodes decreased from a median of 20.6 (1.7-155.4) min before SCS to 0 (0-48.3) min with SCS (p < 0.03). This was accompanied by a significant improvement in symptoms with a reduction in daily glyceryl trinitrate intake from a median of 3.0 (0-10) before SCS to 0.3 (0-10) tablets per 48 h (p < 0.02) and a decrease in the frequency of anginal attacks from a median of 5.5 (2-14) before SCS to 1.0 (0-10) per 48 h with SCS (p < 0.03). CONCLUSIONS--SCS not only reduced symptoms but also myocardial ischaemia. Therefore, SCS appears to be both a safe and an effective therapy for patients with refractory angina.     

Treatment of refractory angina pectoris

Refractory angina pectoris is defined as Canadian Cardiovascular Society class III or IV angina, where there is marked limitation of ordinary physical activity or inability to perform ordinary physical activity without discomfort, with an objective evidence of myocardial ischemia and persistence of symptoms despite optimal medical therapy, life style modification treatments, and revascularization therapies. The patients with refractory angina pectoris may have diffuse coronary artery disease, multiple distal coronary stenoses, and or small coronary arteries. In addition, a substantial portion of these patients cannot achieve complete revascularization and continue to experience residual anginal symptoms that may impair quality of their life and increase morbidity. This represents an end-stage coronary artery disease characterized by a severe myocardial insufficiency usually with impaired left ventricular function. As the life expectancy is increasing, patients with angina pectoris refractory to conventional antianginal therapeutics are a challenging problem. We review the nonconventional therapies to treat the refractory angina pectoris, including pharmacotherapy, therapeutic angiogenesis, transcutaneus electrical nerve and spinal cord stimulation, enhanced external counterpulsation, surgical transmyocardial laser revascularization, percutaneous transmyocardial laser revascularization, percutaneous in situ coronary venous arterializations, and percutaneous in situ coronary artery bypass. These therapies are not supported by a large body of data and have only a complementary role; therefore, the aggressive traditional and proven treatment of angina pectoris should be continued along with these therapies, used on an individual basis.     

Effect of spinal cord stimulation on spontaneous and stress-induced angina and 'ischemia-like' ST-segment depression in patients with cardiac syndrome X.

AIMS: A significant number of patients with cardiac syndrome X (CSX) present frequent episodes of severe chest pain, refractory to maximal multi-drug therapy. A few, small, uncontrolled data suggested that spinal cord stimulation (SCS) may have favourable clinical benefits in these patients. METHODS AND RESULTS: We studied 10 CSX patients who were being treated by SCS for refractory angina pectoris for 17+/-16 months (median 8). Patients were randomized to either continue or withdraw SCS for a period of 3 weeks and were then crossed over to the other condition for a further 3-week period. During each 3-week period patients kept a detailed diary of angina episodes occurring in the last 2 weeks of each phase. Furthermore, at the end of each 3-week period, angina status was also assessed by Seattle Angina Questionnaire (SAQ), a 0-100 visual analogue scale (VAS), and patients underwent 24-h Holter monitoring (HM) and echocardiographic dobutamine stress test (DST). Compared with the withdrawal phase, SCS reduced the number (P=0.01), duration (P=0.022), and severity (P=0.011) of angina episodes, and nitrate consumption (P=0.042). SAQ scores (P< or =0.013 for all) and VAS (P<0.001) were also improved, the number of episodes of ST-segment depression on HM was decreased (P=0.014), and time to angina (P=0.045) and to 1 mm ST-segment depression (P=0.04) during DST were both prolonged by SCS. CONCLUSIONS: Our data point out that SCS may be an effective form of treatment in patients with CSX suffering from frequent angina episodes significantly impairing quality of life (QOL) and refractory to maximally tolerated drug therapy.     

Usefulness and safety of percutaneous myocardial laser revascularization for refractory angina pectoris

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.     

Cost-effectiveness of spinal cord stimulation versus coronary artery bypass grafting in patients with severe angina pectoris--long-term results from the ESBY study

The present study is a 2-year follow-up of the 104 patients participating in the ESBY study (Electrical Stimulation versus Coronary Artery Bypass Surgery in Severe Angina Pectoris), a randomised prospective study including patients with increased surgical risk and no prognostic benefit from revascularisation. Hospital care costs, morbidity and causes of death after spinal cord stimulation (SCS) and coronary artery bypass grafting (CABG) were assessed, as well as the complication rate of SCS treatment. SCS proved to be a less expensive symptomatic treatment modality of angina pectoris than CABG (p < 0.01). The SCS group had fewer hospitalisation days related to the primary intervention (p < 0.0001) and fewer hospitalisation days due to cardiac events (p < 0.05). The groups did not differ with regard to causes of death. There were no serious complications related to the SCS treatment.     

External counterpulsation therapy improves endothelial function in patients with refractory angina pectoris

OBJECTIVES: The goal of this study was to investigate the influence of short-term external counterpulsation (ECP) therapy on flow-mediated dilation (FMD) in patients with coronary artery disease (CAD). BACKGROUND: In patients with CAD, the vascular endothelium is usually impaired and modification or reversal of endothelial dysfunction may significantly enhance treatment. Although ECP therapy reduces angina and improves exercise tolerance in patients with CAD, its short-term effects on FMD in patients with refractory angina pectoris have not yet been described. METHODS: We prospectively assessed endothelial function in 20 consecutive CAD patients (15 males), mean age 68 +/- 11 years, with refractory angina pectoris (Canadian Cardiovascular Society [CCS] angina class III to IV), unsuitable for coronary revascularization, before and after ECP, and compared them with 20 age- and gender-matched controls. Endothelium-dependent brachial artery FMD and endothelium-independent nitroglycerin (NTG)-mediated vasodilation were assessed before and after ECP therapy, using high-resolution ultrasound. RESULTS: External counterpulsation therapy resulted in significant improvement in post-intervention FMD (8.2 +/- 2.1%, p = 0.01), compared with controls (3.1 +/- 2.2%, p = 0.78). There was no significant effect of treatment on NTG-induced vasodilation between ECP and controls (10.7 +/- 2.8% vs. 10.2 +/- 2.4%, p = 0.85). External counterpulsation significantly improved anginal symptoms assessed by reduction in mean sublingual daily nitrate consumption, compared with controls (4.2 +/- 2.7 nitrate tablets vs. 0.4 +/- 0.5 nitrate tablets, p <0.001 and 4.5 +/- 2.3 nitrate tablets vs. 4.4 +/- 2.6 nitrate tablets, p = 0.87, respectively) and in mean CCS angina class compared with controls (3.5 +/- 0.5 vs. 1.9 +/- 0.3, p <0.0001 and 3.3 +/- 0.6 vs. 3.5 +/- 0.5, p = 0.89, respectively). CONCLUSIONS: External counterpulsation significantly improved vascular endothelial function in CAD patients with refractory angina pectoris, thereby suggesting that improved anginal symptoms may be the result of such a mechanism.     

Usefulness of intramyocardial injection of autologous bone marrow-derived mononuclear cells in patients with severe angina pectoris and stress-induced myocardial ischemia

Bone marrow cell transplantation has been proposed as a novel therapeutic option for patients with coronary artery disease. This study investigated whether autologous bone marrow-derived mononuclear cell injection into the ischemic myocardium of patients with severe angina pectoris could safely reduce anginal symptoms, improve myocardial perfusion, and increase left ventricular (LV) function. In a total of 20 patients (63 +/- 10 years old; 16 men) with angina pectoris, myocardial segments with stress-induced ischemia as assessed by gated single-photon emission computed tomography were injected with 30 to 100 million mononuclear cells. Anginal symptoms, Canadian Cardiovascular Society class, and quality of life were assessed at 3 and 6 months of follow-up. At baseline and 3 months of follow-up, an exercise test, gated single-photon emission computed tomography, and magnetic resonance imaging were performed to assess exercise capacity, myocardial perfusion, and LV function. Intramyocardial injection of autologous bone marrow-derived mononuclear cells was safe. The Canadian Cardiovascular Society class improved from 3.5 +/- 0.5 at baseline to 2.4 +/- 0.6 after 3 months (p <0.01) and 2.4 +/- 0.6 after 6 months (p <0.01). The quality-of-life score improved from 52 +/- 10% to 71 +/- 10% at 3 months (p <0.01) to 73 +/- 15% at 6 months (p <0.01). The exercise capacity increased from 79 +/- 31% to 84 +/- 29% (p <0.05). Magnetic resonance imaging revealed an increased LV ejection fraction from 51 +/- 11% to 54 +/- 10% (p <0.01) and a reduced LV end-systolic volume from 97 +/- 50 to 88 +/- 42 ml (p <0.01). The wall motion score index improved from 0.36 +/- 0.32 to 0.24 +/- 0.28 (p <0.01). The number of segments with stress-induced ischemia decreased from 5.1 +/- 3.2 to 2.3 +/- 2.6 (p<0.01). In conclusion, autologous bone marrow-derived mononuclear cell injection in patients with ischemia is safe, reduces anginal symptoms, improves myocardial perfusion, and increases LV function.     

Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina: A Single-Center Experience

Objectives

The aim of this study was to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina.

Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris: a prospective, open-label, multicenter, safety feasibility first-in-man study.

OBJECTIVES: This study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures. BACKGROUND: Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization. METHODS: Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation. RESULTS: All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p < 0.0001). Stress-induced ST-segment depression was reduced in 6 of 9 patients and was eliminated in 2 of these 6 (p = 0.047). The extent and severity of myocardial ischemia by dobutamine echocardiography and by thallium single-photon emission computed tomography was reduced (p = 0.004 [n = 13] and p = 0.042 [n = 10], respectively). CONCLUSIONS: Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.     

Spinal cord stimulation for the treatment of angina pectoris

Opinion statement Spinal cord stimulation (SCS) has been demonstrated to cause clinical improvement in patients with refractory angina pectoris in the number of anginal episodes, in nitroglycerin consumption, in maximal exercise time, in exercise time until angina, in the number of episodes of myocardial ischemia, in the duration of episodes of myocardial ischemia, and in ischemic ST-segment depression at a comparable workload. Double-blind, randomized, placebo-controlled studies have not been performed with SCS. The clinical improvement from SCS occurred despite no improvement in measured regional myocardial blood flow during exercise or in myocardial oxygen consumption as assessed by the heart rate times systolic pressure product at maximal exercise. The mechanisms of clinical improvement by SCS are unclear. SCS must be considered experimental at this time, and it remains a potential therapeutic option for the treatment of refractory angina pectoris in patients unable to have coronary revascularization or at very high risk for coronary revascularization.     

Ranolazine for the treatment of refractory angina in a veterans population

BackgroundPivotal ranolazine trials did not require optimization of conventional medical therapy including coronary revascularization and antianginal drug therapy prior to ranolazine use. This case series describes the use of ranolazine for the treatment of chronic stable angina refractory to maximal medical treatment in a veterans population.ResultsA total of 18 patients with a median age of 66 years were identified. All patients had prior percutaneous coronary intervention and/or coronary artery bypass graft surgery; 83% had three-vessel coronary artery disease, with left main disease present in 39% of patients. Prior to initiating ranolazine, antianginal use consisted of beta blockers (94%), long-acting nitrates (83%) and calcium channel blockers (61%). Median blood pressure (116.2/61.8 mmHg) and pulse (65 beats per min) were controlled. Median preranolazine angina episodes and sublingual nitroglycerin (SLNTG) doses per week were 14 and 10, respectively, with a Canadian Cardiovascular Society (CCS) angina grade of III–IV in 67% of patients. After initiation of ranolazine, median angina episodes per week and SLNTG doses used per week decreased to 0.7 and 0, respectively, with CCS grade of III–IV declining to 17%. Of the 18 subjects enrolled, 44% had complete resolution of angina episodes.ConclusionThe addition of ranolazine to maximally tolerated conventional antianginal drug therapy post coronary revascularization was associated with decreases in angina episodes and SLNTG utilization and improvement in CCS angina grades. Ranolazine may provide an effective treatment option for revascularized patients with refractory angina.     

Temporary cessation of spinal cord stimulation in angina pectoris-effects on symptoms and evaluation of long-term effect determinants

BACKGROUND: Spinal cord stimulation (SCS) has been used since 1985 for patients with refractory angina pectoris. Spinal cord stimulation has anti-ischaemic effects and reduces angina effectively. After long-term treatment, temporary cessation of stimulation may occur due to SCS battery depletion or electrode fracture. The aim of the present study was to assess anginal symptoms and functional status during SCS dysfunction and after its restitution. DESIGN: A prospective follow-up study of angina patients treated with SCS, where temporary SCS dysfunction had occurred. METHODS: Thirty-two patients treated with SCS for angina pectoris over 65 months, on average (range 14-181 months), were included. Complete stimulator dysfunction had occurred due to battery depletion (n=25) or electrode fracture (n=7). The number of anginal attacks and the amount of short-acting nitrates consumed were assessed during dysfunction and after restitution of SCS function. The Seattle Angina Questionnaire (SAQ) was used to assess functional status. RESULTS: The anginal frequency increased during dysfunction (18.9 per week) and decreased after restitution of SCS function (7.6 episodes per week; p<0.001). The consumption of short-acting nitrates decreased as well (21.7 versus 7.1 tablets per week; p<0.01). The functional status according to the SAQ also improved with regard to anginal stability, anginal frequency, and disease perception. No evidence of tolerance development to SCS was found. CONCLUSION: This study indicates that SCS relieves angina effectively also after long-term treatment, without development of tolerance. The findings suggest that mechanisms other than placebo and spontaneous variation of symptoms are responsible for the improvement in angina during SCS.     

Two-year outcomes in patients with mild refractory angina treated with enhanced external counterpulsation

BACKGROUND: In the International Enhanced External Counterpulsation Patient Registry (IEPR), approximately 85% of the patients treated are in Canadian Cardiovascular Society (CCS) class III-IV with no option for further invasive coronary revascularization procedures. HYPOTHESIS: This study sought to determine whether it is clinically important to establish whether the observed durable reduction in disabling severe angina with enhanced external counterpulsation (EECP) treatment can be extended to those with less severe CCS class II angina, who also have no option for further revascularization. METHODS: This study evaluated the immediate response, durability and clinical events over a 2-year period after EECP treatment in 112 patients with Canadian Cardiovascular Society (CCS) class II angina versus 1346 patients with class III-IV angina using data from the International EECP Patient Registry (IEPR). RESULTS: Treatment with EECP significantly (by at least one CCS class) reduced angina frequency, nitroglycerin use, and improved quality of life in both groups. At 2-year follow-up, 74% of class II and 70% of class III-IV patients remained free of major adverse cardiovascular events (MACE) and continued to demonstrate a durable CCS class improvement over baseline. CONCLUSION: The robust effectiveness of EECP as a noninvasive device, together with its relatively low start-up and recurrent costs, makes it an attractive consideration for treating patients with milder refractory angina in addition to the patient with severely disabling angina treated in current practice.     

Effect of spinal cord stimulation on regional myocardial perfusion assessed by positron emission tomography.

Spinal cord stimulation (SCS) can relieve symptoms in patients with severe angina pectoris refractory to conventional medical or surgical therapy. This symptomatic improvement may result from decreased myocardial ischemia. To test this hypothesis, positron emission tomography (PET) and potassium-38 as a flow tracer were used in 8 patients for the quantitative evaluation of regional myocardial perfusion at rest and after exercise, before and during SCS. Potassium uptake was evaluated as myocardial clearance (flow times net extraction) in ml/min/100 g. Tomographic segments were categorized as nonaffected and affected on the basis of the absence or presence of arterial stenosis on coronary angiography and on the basis of thallium scintigraphic data. In nonaffected segments, before SCS, regional myocardial clearance significantly increased from rest (28 +/- 4) to exercise (47 +/- 13 clearance units; p less than 0.004). A similar increase occurred after SCS. In affected segments, before SCS, regional myocardial clearance barely increased (p = 0.065) from rest (26 +/- 6) to exercise (33 less than or equal to 12). In comparison, after SCS, the resting regional myocardial clearance was slightly elevated (29 +/- 8) reflecting an increased double product, but did not increase (p = 0.192) with exercise (34 +/- 12). However, the magnitude and duration of ST-segment depression decreased during treatment with SCS. Anginal pain occurred in all patients during control exercise, but was attenuated in all but one with SCS. These results indicate that SCS improves exercise-induced angina and electrocardiographic signs of ischemia but this influence does not appear to be mediated by changes in regional myocardial perfusion.     

One-year follow-up of transcoronary sinus administration of autologous bone marrow in patients with chronic refractory angina

PURPOSE: Based on our preclinic studies with autologous unfractionated bone marrow (AUBM) via coronary sinus with transitory occlusion, a clinic study in patients with chronic refractory angina was designed. The objectives were to evaluate tolerance of the procedure, safety, and feasibility with 1 year follow-up. METHODS AND MATERIALS: Clinical study with inclusion and exclusion criteria defined by an Independent Clinical Committee was carried out. Fifteen patients underwent transcoronary sinus administration with a 15-min occlusion of freshly aspirated and filtered AUBM (60-120 ml). Feasibility was evaluated with Seattle Angina Questionnaire (SAQ), Canadian Cardiovascular Society (CCS) angina classification, perfusion dipyridamole, and coronary angiography. RESULTS: There were no changes in the tolerance parameters. There were no deaths or myocardial infarction during the follow-up. Three patients were readmitted into the hospital. During the follow-up, one patient was diagnosed with cancer of the lung. Improvement of 30% in the quality of life was evaluated by SAQ. The CCS angina classification showed that the mean angina class was 3.0+/-0.53 at baseline, which improved to 1.6+/-0.63 at 1 year (P<.001). Perfusion imaging (core lab) showed improvement in 12 of 15 patients, with a mean improvement of 40.9% at rest (22 vs. 13) (P<.01) and 45.3% at stress (26.5 vs. 14.5) (P<.05). Coronary angiography showed more collateral vessels in 10 of 15 patients. CONCLUSIONS: We can conclude that AUBM via coronary sinus is feasible in patients with chronic refractory angina after 1 year follow-up, and it appears to be safe.     

Coronary balloon angioplasty for elderly patients with severe angina

From February 1983 to December 1986, 65 angioplasty procedures were attempted in 51 patients aged 65 or more. All had angina refractory to medical treatment and 89% of procedures were performed in patients in Canadian Cardiovascular Society angina class III or IV. Sixty eight per cent of patients had multivessel disease. Angioplasty was attempted on a single vessel in 52 instances (80%) and on multiple vessels in 13 (20%). The initial success rate was 75% for stenosis and 44% for occlusion. No attempt was made to treat all visible lesions in every case. At least one major complication occurred in 6.2% of the procedures: Q wave infarction in 4.6%, emergency surgery in 4.6%, and death in 4.6%. After a median follow up of four months (range 1-31) 37% of the patients in whom the procedure was initially successful were asymptomatic and 76% were improved by at least one Canadian Cardiovascular Society angina class. Angiographic restenosis occurred in 28% of treated lesions and 39% of patients had at least one recurrent stenosis. Among the patients with an initially successful procedure, 11% needed surgical revascularisation during the follow up period compared with 50% of those with a failed angioplasty. Balloon coronary angioplasty can be an effective form of treatment for the relief of severe angina in elderly patients.