[Transluminal coronary angioplasty. Arguments for prognostic indication].
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Publications and source records attributed to C Kadel.
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In chronic coronary occlusions the chance of successful reopening by angioplasty can be judged from the age of the occlusion. Often, however, time since occlusion cannot be accurately assessed. Therefore we determined whether the chance of reopening can be predicted from angiographic morphology. In cineangiograms from 60 consecutive patients with chronic coronary occlusions morphological details in at least two projections were evaluated in relation to the rate of success and the estimated age of occlusion. Morphological features associated with a higher rate of success (type A) were a clearcut proximal stump, absence of side branches at the site of occlusion, absence of bridging collaterals, and only slight filling of the distal part of the vessel. Features associated with a low success rate (type B) were absence of proximal stump, side branches at the site of occlusion, bridging collaterals, and rapid high-contrast filling of the distal part of the vessel. 48/60 (80%) of occlusions could be classified as type A or type B. The success rate was 17/21 (81%) in type A versus 5/27 (18.5%) in type B (P < 0.0002). The estimated age of type B occlusions was higher than that of type A medians 8 and 4 months (P < 0.002). Thus in chronic coronary occlusions the likelihood of successful reopening can be judged in many patients from morphological features.
OBJECTIVE: To assess the indications for coronary angiography and percutaneous transluminal coronary angioplasty (PTCA) according to the criteria of the RAND Corporation's expert panel ratings; to compare the results with those already published in the literature; and to examine the method with respect to its appropriateness as a measure of quality control. PATIENTS AND METHODS: The parameters necessary for rating according to the RAND Corporation's published criteria were prospectively obtained in 116 consecutive patients (89 men, 27 women; mean age 59.4 +/- 10.7 years) undergoing coronary angiography and 138 patients (112 men, 26 women; mean age 61.5 +/- 9.4 years) undergoing PTCA. RESULTS: For coronary angiography the >>inappropriate rate << was 22.4%, for >> uncertain indications << 15.5%, >> appropriate indications << 24.1%, and for >> necessary indications << 37.9%. 38.6% of coronary angiographies, performed in the course of angiographic control after PTCA, were >> inappropriate <<, but only 12.5% of other coronary angiographies (P < 0.01). In 48.6% of >> appropriate << or >> necessary << procedures invasive treatment followed, compared with 19.2% of those rated >> inappropriate << (P < 0.05). In 10.1% of patients the indications for PTCA were judged >> inappropriate <<, in 32.6% as >> uncertain <<, in 13.0% as >> appropriate << and 44.2% as >> necessary <<. There was no correlation between ratings and the acute results of PTCA. These findings pertaining to indications for coronary angiography and PTCA correspond to those reported in the literature. CONCLUSIONS: As the RAND criteria take inadequate account of individual peculiarities, they are not suitable for individual clinical decisions. But they are useful as screening method in a quality control project, because procedures for which indications have not been adequately proven are singled out by an unfavourable rating and can thus be thoroughly analysed in the individual case.
UNLABELLED: Rating the indications for invasive cardiac procedures often is regarded as one key method for quality assessment in cardiology. The aim of this study was to evaluate the validity of the method proposed by the RAND Corporation and the University of California, Los Angeles, appropriateness and necessity rating. Two hypotheses were tested: 1. The acute and long-term benefit of PTCA is less clearly in cases rated "uncertain" than in cases rated "appropriate" or "necessary", and 2. in cases rated "necessary", successful PTCA improves the patients long-term prognosis, since RAND's definition of "necessary" implies that a successful PTCA will avert major harm from this patient. PATIENTS: Five hundred and one consecutive patients dilated between 1981 and 1984 were included. BASELINE DATA: Age 52.5 +/- 8.2 years, male gender 87.0%, Canadian Heart Classification (CHC) class I or II 40.5%, positive and extremely positive stress test 54.4% and 33.3%, single vessel disease 72.5%. The long-term follow-up was determined by questionnaire 91 +/- 21 months after PTCA, and a complete 5-year follow-up was available in 95.4% of all patients. RESULTS: According to RAND's 1991 published criteria, 1.0% of all indications were rated "inappropriate", 21.4% "uncertain", 27.1% "appropriate", and 50.5% "necessary". Before PTCA, patients rated "uncertain" were less symptomatic and had a higher exercise capacity than patients rated "necessary" (CHC I or II: 85.0% vs. 8.7%, p < 0.001; 693 +/- 214 vs. 520 +/- 251 watts*min, p < 0.001). Following PTCA, "uncertain" patients reported less often a lasting symptomatic improvement or freedom of symptoms than "necessary" patients (63.9% vs. 76.3%, p = n.s.), and they experienced no relevant improvement in exercise capacity (10 +/- 263 vs. 139 +/- 308 watts*min, p < 0.05). The acute success rate was significantly lower for patients who underwent PTCA for indications rated "revascularization necessary" or "CABG necessary", p < 0.03. This resulted in a high rate of CABG within the first year for patients with these rating (29.0% and 36.1%, compared to 15.0% to 20.6% in cases rated "uncertain", "appropriate", or "PTCA necessary", p < 0.02). Only in patients with the rating "PTCA necessary" (n = 184), a significant difference in long-term survival was observed between successful and unsuccessful uncomplicated cases (5-year-survival-probability 97.8 +/- 1.3% vs. 85.5 +/- 6.0%, p < 0.001). In contrast, "uncertain" cases (n = 107) had a 5-year-survival-probability of 94.8 +/- 2.5% following successful and 94.4 +/- 5.4% following unsuccessful PTCA. CONCLUSION: These results are in agreement with both hypotheses and therefore support the validity of RAND's 1991 appropriateness and necessity criteria for PTCA in a historic series of patients. Thus, even if these particular ratings may be outdated today, the technique of appropriateness and necessity rating is expected to be a useful and valid tool for quality assessment in PTCA.
A 29-year-old otherwise symptom-free patient had undergone a partial thyroidectomy 5 years ago followed by an episode of ventricular tachycardia and (after lidocaine injection) ventricular fibrillation requiring external defibrillation. No cause for the arrhythmias had been found at that time. Two subsequent syncopes led to her hospitalization. An asystole occurred while she was being monitored, and during the resuscitation there were several periods of ventricular fibrillation, which responded to external defibrillation. Subsequently several episodes of self-limiting ventricular tachycardia were recorded. A long QT syndrome with torsade-de-pointes tachycardia was diagnosed on the basis of typical ECG changes (QT interval 545 ms). Extensive diagnostic tests failed to find a cause. To prevent further tachycardias she was given propranolol, 40 mg three times daily, and an automatic defibrillator was implanted as a precaution. But no defibrillator discharge has so far been required (more than 10 months).
In patients with coarctation of the aorta arterial hypertension frequently persists when surgical repair is performed after age 20 years. There are little data on the long-term effect of angioplasty and the question remains to be determined whether hypertension is sufficiently treated by this procedure. Twenty-nine consecutive patients (9 females and 20 males) 14 to 54 years old (median, 25) underwent angioplasty for native coarctation of the aorta. Twenty-five patients (86%) had pre-existing systolic arterial hypertension (> 140 mm Hg). The mean peak systolic pressure gradient decreased from 62 +/- 18 to 21 +/- 13 mm Hg immediately after angioplasty. At hospital discharge 13 patients still had hypertension. After a mean follow-up interval of 4.0 years (range, 0.3-9.5) the residual peak pressure gradient was 14 +/- 13 mm Hg. Blood pressure was normal without antihypertensive therapy in 23 patients (79%). In the six hypertensive patients the pressure gradients were 7, 13, 30, 30, 35, and 60 mm Hg. One patient died 8 months after angioplasty and another underwent surgery for aortic aneurysm. Although this was an uncontrolled study the data suggest that normalization of blood pressure may occur more frequently after angioplasty than after surgery in adolescents and adults with native coarctation.
The application of formal methods of quality assessment in medicine is a relatively new activity. Interventional cardiology is expected to be one of the fields of clinical medicine adopting formal schemes of quality assessment at a relatively early phase because of its invasive nature, the associated risks, the rapid growth of this treatment and the correspondingly increasing total cost. We therefore aim to compile the requirements for the development of quality assessment schemes in angioplasty and coronary angiography. The rather disparate nature of methodologies applied in previous and present quality initiatives is reviewed, grouping the numerous methods of organizing quality initiatives found in the literature into a few generic schemes. This new classification of methods is provided as a prerequisite for the discussion of general problems inherent in current quality initiatives in the medical field and for the selection of approaches to quality development best suited for the environment of the catheterization laboratory. Here we identify the concrete steps of goal definition, quality indicator selection, definition of standards and thresholds for these indicators and the selection of a quality management scheme for monitoring the aspects of quality previously defined. Because of the limitations of each of the original methodologies of quality assessment, we propose a synthesis of the most important approaches as the basis for new quality initiatives in interventional cardiology.
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Between January 1979 and October 1991, percutaneous transluminal angioplasty of stenosed or occluded coronary bypass grafts was attempted 180 times in 146 patients (180 lesions in 157 bypass grafts); 6/157 grafts were internal mammary grafts. The procedure was successful in 129/157 grafts (82%) and in 151/180 lesions (84%). Failures occurred almost exclusively in recanalization attempts. Cardiac complications occurred in 4/146 patients (2.7%). Three patients developed an acute myocardial infarction, another patient died after acute occlusion of a native vessel dilated during the same procedure. In successful attempts the severity of stenosis was reduced from 87 +/- 10% to 33 +/- 15%. 113/129 successfully dilated grafts had at least one (mean 2.7) control angiogram. 54/113 (48%) showed recurrence after a mean follow up of 6 months. An additional 15 grafts showed late restenosis in a second control angiogram (mean follow-up 23 months). The total restenosis rate was 61%. Restenoses were dilated again one to six times (mean 1.9) with comparable success and recurrence rate. Two patients died during the sixth angioplasty. Finally, 32/129 (25%) grafts were occluded or presumably occluded, and 97/129 (75%) were angiographically confirmed open without restenosis. Thus, angioplasty of bypass grafts is an alternative to a repeat revascularization surgery. The acute results are comparable to the results of angioplasty in native coronary arteries. The restenosis rate is high. One has to be aware of late restenosis. Restenosis can be dilated repeatedly with a comparable success rate and with no significant increase in restenosis rate.
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We hypothetized that conservative treatment might be justified in asymptomatic adults with a small persistent ductus arteriosus. The data of 100 patients (age, 18-72 years) who later underwent non-operative closure were retrospectively analyzed. Left- and right-heart catheterization as well as angiographic measurement of PDA-size had been performed in all patients. Thirty-five patients were asymptomatic and 65 patients had cardiac symptoms. Six patients had a history of endocarditis. There were no significant differences with respect to Qp/Qs ratio (1.69 +/- 0.45 vs. 1.57 +/- 0.32) and ductus-diameter (4.7 +/- 1.4 mm vs. 4.8 +/- 1.3 mm) between symptomatic and asymptomatic patients. In the six patients with endocarditis the diameter was 4.5-7.0 mm. Symptomatic patients had higher mean pulmonary artery pressures (22.1 +/- 9.7 mm Hg vs. 18.5 +/- 5.1 mm Hg; p < 0.05) and were older (48.4 +/- 14.3 years vs. 30.9 +/- 11.2 years; p < 0.001) than asymptomatic patients. Neither from the size of the ductus nor from the Qp/Qs ratio could the development of cardiac symptoms or the risk of endocarditis be predicted individually. From these data it might be concluded that closure should be performed even in asymptomatic adults with small ductus and insignificant left-to-right shunt.
The unprotected left main stenosis still represents one of the contraindications of PTCA; recently developed concepts using percutaneous bypass techniques have not changed this fact so far. However, following bypass grafting the procedure can be done with low risk and may improve prognosis in case of later bypass occlusion. This study should clarify whether a higher rate of bypass occlusion is caused by postsurgical left main PTCA. From October 1981 to January 1991 a left main stenosis was dilated in 41 patients, 2 weeks to 12 years (mean 3.5 years) after bypass grafting. To date, 17/65 venous bypass grafts were already occluded, and 72.4% of the patients suffered from typical angina. In 34/41 patients (82.9%) PTCA was successful, severe complications (death, emergency surgery or myocardial infarction) did not occur and clinical improvement was achieved in 80% of symptomatic patients. Four months later, 26/34 patients (76.5%) had angiographic follow-up. Fifteen restenoses were found and a second PTCA was performed in 9/15. None of the venous bypass grafts, open at the time of the first PTCA, was occluded at follow-up. In one case PTCA of the left main stenosis turned out to be life-saving 7 years later because an occlusion of RCA- and LCX-bypasses occurred and the LAD graft showed a subtotal thrombosis. It is concluded that PTCA of left main stenosis after bypass grafting is a safe procedure and does not lead to a higher rate of venous bypass occlusions. A prognostic indication seems to be justified.
Recently published studies prove a favourable long term prognosis after coronary angioplasty, especially in patients with single vessel disease. PTCA success, progression of atherosclerosis, cardiac risk factors, extent of coronary artery disease and left ventricular function are determinants of the long term outcome. A lasting PTCA success can be assumed in patients without evidence of restenosis 6 months after PTCA. These observations are helpful criteria in the assessment of insurance risks.
Reopening of chronically occluded coronary arteries by angioplasty, initially considered a low risk procedure, may carry similar risks at PTCA of coronary stenoses. We report 3 cases with ventricular fibrillation or sudden death 2-4 days after reopening of 1- to 5-month-old coronary occlusions.
One hundred patients undergoing routine diagnostic or interventional catheterization were randomly assigned to receive either percutaneously applied collagen (group A; n = 50) or conventional pressure dressing (group B; n = 50) for sealing of the femoral artery. Clinical variables were comparable in both groups. The heparin dose was 100 IU/kg in 30 patients and 200 IU/kg in 20 patients of either group. The average compression time was 4.3 min in group A and 42.3 min in group B (p < .001). Bleeding was not observed in group A but was observed in 6/50 patients in group B. The time to ambulation was 6.4 hr (range, 4-12 hr) in group A and 21.6 hr (range, 10-48 hr) in group B (p < .001). Hematomas with a diameter of > 6 cm developed in 4/50 patients in group A and in 11/50 patients in group B (p < .05). Blood-transfusions or surgical interventions were not required and there was no loss of ankle pulses in either group. In conclusion, percutaneously applied collagen reduced compression time and duration of bedrest after diagnostic catheterization and PTCA. Despite earlier ambulation, the incidence of bleeding was lower with collagen than with conventional pressure dressing.
Seven hundred ninety-eight patients with symptomatic single-vessel disease who underwent percutaneous transluminal coronary angioplasty (PTCA) between 1977 and 1985 were reevaluated by questionnaire 78 +/- 23 months after dilatation. Indication for PTCA was stenosis of > or = 70%, anginal symptoms, and objective signs of myocardial ischemia. The immediate success rate was 81.2%, and severe complications occurred in 7.1%, which included two fatal complications (0.3%). Repeat angiograms were performed in 582 of 648 patients who underwent successful dilatation and showed restenosis in 143 cases (24.6%). Within 1 year after the first dilatation, 586 patients had been successfully revascularized by PTCA (i.e., there was no evidence of restenosis or redilatation was successful), and 113 patients had undergone bypass surgery. The remaining 99 patients were treated medically if PTCA was unsuccessful or if restenosis (> or = 70%) that was not amenable to redilatation was present. The 8-year overall survival probability was 91.7%, and cardiac survival was 95.5%. The 8-year event-free survival probability was 52.7% for all patients: 62.5% in patients who had successful PTCA and 14.5% in patients who had unsuccessful PTCA (p = 0.0000). The cardiac survival probabilities of patients with lasting PTCA success at 1 year and of surgically treated patients were significantly better than those of patients who did not have successful revascularization (at 8 years 97.2% and 98.1% vs 88.9%; p < 0.04). Late events (> or = 1 year) occurred more often in patients who did not have successful revascularization compared with patients who had successful PTCA (at 8 years 57.9% were event-free vs 74.4%; p < 0.0001); even fewer late events were observed in surgically treated patients (at 8 years 88.2% were event-free; p < 0.004). Cox's proportional hazards regression analysis revealed left ventricular ejection fraction and revascularization status at 1 year as determinants of overall, cardiac, infarct-free, and event-free survival probabilities. At the time of reevaluation significantly more patients in the successful PTCA subgroup were still free of symptoms or had experienced improvement than patients in the bypass or medical subgroups (86.8% vs 68.9% and 59.5%, respectively; p < 0.0001), and more patients in the successful PTCA subgroup were still working (75.4% vs 53.3% and 56.9%, respectively; p < 0.001). We concluded that patients with single-vessel disease who have undergone successful dilatation have an excellent long-term prognosis with regard to survival, cardiac symptoms, and vocational status.(ABSTRACT TRUNCATED AT 400 WORDS)
In chronic coronary occlusions the rate of successful reopening seems to be improved with the help of new techniques; the chance of success can be judged by the age of occlusion. Frequently this age cannot be fixed exactly. The purpose of the study was therefore to find out, whether the chance of reopening can be judged by morphology. 60 patients in whom the occlusions could not be passed with a conventional wire were treated with the ROTACS system. Cine angios were reviewed carefully, morphological details in at least two projections were evaluated in graphic representations and correlated with the acute success rate and the estimated age of occlusion. Morphological parameters associated with a higher rate of success (type A) were: 1) a clearcut proximal stump with 2) no sidebranches at the site of occlusion, 3) no bridging collaterals and 4) only a slight filling of the distal vessel. Parameters with a low success rate (type B) were: 1) no proximal stump, 2) sidebranches at the site of occlusion, 3) bridging collaterals and 4) a very good distal filling. 48/60 (80%) of occlusions could be classified in type A or type B. The success rate was 17/21 (81%) (type A) versus 5/27 (18.5%) (type B) (p < 0.0002). The estimated age of type B occlusions was significantly higher than in type A: median 8 versus median 4 months (p < 0.002). It is concluded that the rate of success in reopening chronic coronary occlusions can be judged in the majority of patients using morphological parameters.