Cost-effectiveness analysis of intravascular ultrasound guided percutaneous coronary intervention versus conventional percutaneous coronary intervention.

OBJECTIVE: Investigation of the cost-effectiveness of intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI) compared to PCI guided by coronary angiography (CAG). METHODS: One hundred and eight men referred for PCI, were randomized to IVUS or CAG guided PCI. After 6 months, the patients were subjected to a study related clinical and invasive follow-up investigation by CAG, IVUS and intracoronary Doppler flow measurements. Incremental costs of IVUS guided procedures and costs of re-interventions were estimated using the Activity Based Costing (ABC) method. RESULTS: Patients randomized to IVUS guided PCI experienced an improved clinical outcome, with lower angina levels than patients in the CAG guided group. The initial cost of performing IVUS guidance was increased due to extra procedure time, IVUS catheters and slightly more balloons and stents, but fewer patients in the IVUS guided group needed re-intervention. Overall, these savings outweighed the initial cost increase. CONCLUSION: Our data suggest that when performing IVUS guided PCI, costs as well as benefits increase. The increased benefits measured as cost savings resulting from less restenosis outweigh the cost increase from performing the IVUS guided PCI as opposed to CAG guided PCI.

[DANAMI. A Danish study of invasive versus conservative treatment of patients with post-infarction ischemia who had received thrombolytic therapy]. / DANAMI. En dansk undersøgelse af invasiv versus medicinsk behandling af trombolysebehandlede patienter med postinfarkt iskaemi.

INTRODUCTION: To compare an invasive strategy employing percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass grafting (CABG) with a medical strategy in patients who had received thrombolytic treatment for first acute myocardial infarction (AMI), and with signs of inducible ischaemia. METHODS: In a prospective study 1008 patients were randomized, 503 to invasive treatment, of whom 266 (52.9%) had PTCA, and 147 (29.2%) CABG, 505 to conservative treatment, of whom eight (1.6%) were revascularized within two months. RESULTS: After a median follow-up of 2.4 years the mortality in the invasive group was 3.6% vs. 4.4% (p = 0.45) in the conservative group, re-infarction incidence was 5.6% vs. 10.5% (p = 0.0038) and percentage of admissions with unstable angina was 17.9% vs. 29.5% (p < 0.00001). DISCUSSION: We conclude that post-infarct patients with inducible ischaemia should be referred to coronary angiography and revascularised accordingly.

Emergency coronary artery bypass surgery after failed percutaneous transluminal coronary angioplasty.

Coronary complications caused by percutaneous transluminal coronary angioplasty (PTCA) may necessitate emergency coronary artery bypass grafting (CABG). In 1994-1998, 132 patients (1.5% of the patients registered in the Danish PTCA registry) underwent CABG within 24 h because of angioplasty complications. We reviewed the files of 86 patients who had emergency operations within 6 h and found that 35% suffered from 1-vessel disease. Fifty-eight percent were taken directly to the operating room from the cardiovascular laboratory, and 13% were given preoperative cardiovascular resuscitation. The vessels most frequently injured were the right coronary artery and the left anterior descending branch (LAD). The patients received a mean of 2.4 coronary bypasses each. Forty-three percent of the patients with lesions of the left main coronary artery and/or the LAD received a vein graft to the LAD. A perioperative Q-wave myocardial infarction developed in 51% of the patients. The in-hospital mortality rate was 12%. These results are inferior to those obtained after elective surgery. Local cardiothoracic backup is vital when PTCA is performed in an unselected patient group.

Danish multicenter randomized study of invasive versus conservative treatment in patients with inducible ischemia after thrombolysis in acute myocardial infarction (DANAMI). DANish trial in Acute Myocardial Infarction.

BACKGROUND: The aim of the DANish trial in Acute Myocardial Infarction (DANAMI) study was to compare an invasive strategy of percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) with a conservative strategy in patients with inducible myocardial ischemia who received thrombolytic treatment for a first acute myocardial infarction (AMI). METHODS AND RESULTS: Of the 503 patients randomized to an invasive strategy, PTCA was performed in 266 (52.9%) and CABG in 147 (29.2%) from 2 to 10 weeks after the AMI. Of the 505 patients in the conservative treatment group, only 8 (1.6%) had been revascularized 2 months after the AMI. The patients were followed up from 1 to 4.5 years. The primary end points were mortality, reinfarction, and admission with unstable angina. At 2.4 years' follow-up (median), mortality was 3.6% in the invasive treatment group and 4.4% in the conservative treatment group (not significant). Invasive treatment was associated with a lower incidence of AMI (5.6% versus 10.5%; P=.0038) and a lower incidence of admission for unstable angina (17.9% versus 29.5%; P<.00001). The percentages of patients with a primary end point were 15.4% and 29.5% at 1 year, 23.5% and 36.6% at 2 years, and 31.7% versus 44.0% at 4 years (P=<.00001) in the invasive and conservative treatment groups, respectively. At 12 months, stable angina pectoris was present in 21% of patients in the invasive treatment group and 43% in the conservative treatment group. CONCLUSIONS: Invasive treatment in post-AMI patients with inducible ischemia results in a reduction in the incidence of reinfarction, fewer admissions due to unstable angina, and lower prevalence of stable angina. We conclude that patients with inducible ischemia before discharge who have received treatment with thrombolytic drugs for their first AMI should be referred to coronary arteriography and revascularized accordingly.

Randomized double-blind Scandinavian trial of angiopeptin versus placebo for the prevention of clinical events and restenosis after coronary balloon angioplasty.

Angiopeptin, a somatostatin analogue, inhibits intimal hyperplasia after percutaneous transluminal coronary artery balloon angioplasty (PTCA) in several animal models. This pilot study sought to determine the effect of subcutaneous infusion of angiopeptin on clinical events and restenosis in patients undergoing successful PTCA. One hundred twelve patients were randomized to receive continuous subcutaneous angiopeptin (750 micrograms/day) or placebo infusion from the day before PTCA and for the following 4 days in a double-blind study. An additional subcutaneous injection of 375 micrograms of angiopeptin or saline was given immediately before PTCA. Eighty patients had a successful PTCA, and 75 of these patients with 94 lesions underwent angiography 6 +/- 2 months after PTCA. All 112 patients underwent a 12-month clinical follow-up examination. Age, sex, smoking, diabetes, hypertension, hyperlipidemia, and morphologic features of stenosis were similar in both groups. The hierarchical 12-month event rate (death, myocardial infarction, coronary artery bypass grafting, and repeated PTCA) was reduced from 34% to 25% (p = 0.30) by angiopeptin by intention-to-treat analysis. Restenosis (> or = 50% diameter stenosis) was significantly reduced in lesions treated with angiopeptin (12% vs 40%; p = 0.003). Late lumen loss also was significantly reduced after angiopeptin treatment (0.12 +/- 0.46 mm vs 0.52 +/- 0.64 mm; p = 0.003). In conclusion, continuous subcutaneous angiopeptin infusion for 5 days tended to decrease clinical events and restenosis after PTCA.

[Recanalization of occluded coronary arteries with percutaneous transluminal coronary angioplasty]. / Rekanalisering af okkluderede koronararterier ved hjaelp af perkutan transluminal koronarangioplastik.

Percutaneous transluminal coronary angioplasty (PTCA) was attempted in 56 totally occluded coronary arteries. The occlusions were estimated to be between two weeks to six months old, less than 4 cm long and accessible to PTCA. Primary technical success was achieved in 40 cases (71%) with best results if the time from AMI to PTCA was less than six months. Twenty-six patients were without recurrence in the follow-up period which was longer than six months. In the follow-up period eight patients had re-PTCA performed and six had coronary artery bypass grafting (CABG). There were significantly more patients in the group of failed PTCA who had CABG than in the group of successful PTCA. At clinical follow-up examination 23 patients (41%) were free of symptoms and seven (13%) had less pain than before PTCA. One patient died in heart failure (mortality 1.8%) within 24 hours after failed PTCA. PTCA of totally chronically occluded coronary arteries is a method with acceptable good primary success, especially if the occlusion is not too old. There is a good symptomatic effect if the PTCA is successful. The procedure reduces the need for CABG and is associated with few complications in stable angina pectoris. PTCA is cheaper and less traumatic for the patients and with much shorter recovery period compared to CABG. PTCA is considered indicated in total chronic occlusions in selected cases.

Short- and long-term survival after aortic balloon valvuloplasty for calcified aortic stenosis in 137 elderly patients.

UNLABELLED: Percutaneous transluminal balloon aortic valvuloplasty was performed in 137 patients with symptomatic severe calcified aortic stenosis (50 men and 87 women, mean age 77 years) between December 1986 and September 1990. The purpose of the study was to evaluate short- and long-term survival after balloon aortic valvuloplasty, mean follow-up was 19 months. At the time of balloon aortic valvuloplasty congestive heart failure (NYHA III-IV) was present in 89%, angina pectoris in 47%, and syncope in 31% of the patients. Aortic balloon dilatation produced significant decreases in peak pressure gradient from 91 +/- 34 mmHg to 40 +/- 26 mmHg (p < 0.001). The procedure related mortality was 8% (11 pts) and the 30-days mortality 17% (23 pts). Severe complications occurred in 25% of the patients during the procedure and within the first 24 hours. Immediate clinical improvement was noted in 68% of the patients surviving the treatment. The overall survival rate was at one, two, three and four years follow-up 63%, 40%, 28%, and 21%, respectively. These survival rates were all statistically different from the survival rates in an age- and sex-matched background population (p < 0.001). A multivariate Cox analysis revealed that only female sex and angina before treatment seemed to improve survival. CONCLUSION: The long-term outcome after aortic balloon valvuloplasty for severe aortic stenosis is so poor that we recommend aortic valve replacement as the initial treatment in these patients, if at all possible.

Reproducibility of the acute rejection diagnosis in human cardiac allografts. The Stanford Classification and the International Grading System.

Transplantation has become an accepted treatment of many cardiac end-stage diseases. Acute cellular rejection accounts for 15% to 20% of all graft failures. The first grading system of acute cellular rejection, the Stanford Classification, was introduced in 1979, and since then many other grading systems have evolved. Most recently, the International Grading System was introduced in The Journal of Heart and Lung Transplantation. In this study the interobserver reproducibility of both the Stanford Classification and the International Grading System is evaluated using Kappa statistics. Three observers evaluated 168 endomyocardial biopsy specimens according to the Stanford Classification and 100 endomyocardial biopsy specimens according to the International Grading System. The evaluation was carried out blindly. Kappa values of 54.1% and 51.5%, respectively, were obtained, both significantly above zero but not optimal. In addition to the interobserver reproducibility analysis of the two grading systems, the International Grading System is discussed. In the original description of the grading system terms such as focal, multifocal, and aggressive infiltrates and myocyte damage and myocyte necrosis are used. These terms create some difficulties in understanding or interpreting the various grades. The main problem is to distinguish between grade 1A and grade 3A. Despite the difficulties, the grading system is easy to use, but a revision is needed.

Epidural morphine for outpatients with severe anginal pain.

Seven patients who had chronic coronary artery disease and had undergone coronary artery bypass surgery still suffered from anginal attacks several times daily despite optimal medical treatment. An epidural system of analgesia was implanted subcutaneously and treatment with epidural morphine started. The morphine was administered by the patients themselves or members of their family. During a median observation time of four months (range three to 11) all patients were free of pain while receiving this treatment.

The effect of coronary artery bypass surgery on ventricular arrhythmias.

The effect of coronary artery bypass surgery (CAB) on ventricular arrhythmias (VA) was studied in a prospective investigation involving 32 patients (mean age 54 years) who underwent CAB because of severe stable angina pectoris. Prior to CAB as well as 12 months later each patient was subjected to the following investigational programme: resting ECG, exercise ECG, 24-h ECG, selective coronary arteriography, ventriculography and cardiac catheterization. Exercise ECG showed VA in only three patients. The prevalence of VA during 24-h ECG was 56 and 66% on the two occasions (NS), while complicated VA (multiform, repetitive, R on T) was seen in 18 and 28%, respectively (NS). The persistence (number of 6-h periods showing VA) was 33 and 47% with regard to any VA (P less than 0.05), while complicated VA occurred in 13 and 15% of the 6-h periods (NS). Except for an increase in dp/dtmax/P at the postoperative measurement (P less than 0.05), no significant change in the performance of the left ventricle was seen after CAB though the graft patency was 77%. It is concluded that in patients with 'medically intractable' stable angina pectoris, CAB does not effect the occurrence of VA to any great extent--probably because left ventricular function is unchanged one year after as compared with that prior to CAB.