Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: a randomized trial.

UNLABELLED: 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 minutes in group A and 42.3 minutes in group B (p < 0.001). Bleeding was not observed in group A but was observed in 6/50 patients in group B. The time to ambulation was 6.4 hours (range: 4-12 hours) in group A and 21.6 hours (range: 10-48 hours) in group B (p < 0.001). Hematomas with a diameter of > 6 cm developed in 4/50 patients in group A and in 11/50 patients in group B (p < 0.05). Blood transfusion or surgical interventions were not required and there was no loss of ankle pulses in either group. 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.

Chronic coronary occlusions: age, morphology and chance of reopening.

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.

[Long-term results of coronary angioplasty]. / Langzeitergebnisse der Koronarangioplastie.

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.

[Evaluation of indications for PTCA]. / Die Bewertung von Indikationen zur PTCA.

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.

[Persistent ductus arteriosus--is closure indicated also in asymptomatic adults with small ductus and minor shunt?]. / Persistierender Ductus arteriosus--ist auch bei asymptomatischen Erwachsenen mit kleinem Ductus und geringem Shunt ein Verschluss indiziert?

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.

Requirements for quality assessment in coronary angiograph and angioplasty.

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.

[Quality assurance in invasive cardiology. A prospective study for the evaluation of indications for coronary angiography and coronary dilatation using the "Rand Corporation" method]. / Qualitätssicherung in der invasiven Kardiologie. Eine prospektive Untersuchung zur Bewertung von Indikationen zur Koronarangiographie und zur Koronardilatation nach der Methode der "RAND Corporation".

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.

Recognition of restenosis: can patients be defined in whom the exercise-ECG result makes angiographic restudy unnecessary?

The value of exercise ECG in predicting the occurrence of restenosis after successful transluminal coronary angioplasty (PTCA) was investigated in 398 patients with exercise tests of comparable workload before, immediately after and within 6 months after PTCA. In patients with normalized exercise ECG (n = 166) restenosis was observed in 16.3% and indication for repeat PTCA was present in 6.6%. RePTCA was recommended in only 3.2% of patients if the exercise test was still normal at restudy and if the patients were free of anginal symptoms. In patients with a renewed ST-segment depression (n = 77) the rate of restenosis was 67.5% and the indication for rePTCA was present in 52%. In patients without changes in the exercise tests before and after PTCA and at restudy (n = 155) restenosis was seen in 25.8% and rePTCA was recommended in 14.2%. It is concluded that from the clinical point of view, in patients with improved exercise ECG at restudy, especially if they are free of angina, there is no need for a re-angiogram because indications for rePTCA are very rare.

Results of repeat angiography up to eight years following percutaneous transluminal angioplasty.

Percutaneous transluminal coronary angioplasty (PTCA) has become a widely accepted procedure that provides acute and medium-term relief of anginal symptoms and myocardial ischaemia. The acute success rate has risen from about 50% in the early days to approximately 90% in recent years. Serial repeat angiograms obtained in different patient groups have shown a 20% incidence of angiographically defined restenosis in patients who had been successfully treated initially. Despite the restenosis, many of these patients were symptomatically improved since the lesions shown at follow-up angiography were often less severe than those that had existed prior to original PTCA. These figures suggest that a success rate of 80% at 1 year should now be a realistic expectation, especially when patients with repeat PTCA are included. None of the 87 patients re-angiographed between 2 and 8 years after successful PTCA developed restenosis after the first year of treatment. However, new stenoses of 50% or more were found in other vessel segments, in both symptomatic and asymptomatic patients, at a rate of about 7% per year.

[Long-term results after coronary dilatation]. / Langzeitergebnisse nach Koronardilatation.

The angiographic long-term success of percutaneous transluminal coronary angioplasty (PTCA) is 80% for all patients with attempted PTCA, and 90% for all patients with acutely successful intervention. This long-term success rate results from todays acute success rate of more than 90%, even though an increasing number of more and more complex stenoses have been dilated during recent years, from a rate of restenosis of 20-30% and a success-rate exceeding 90% in patients who undergo redilatation due to a restenosis. The long-term clinical course of successfully dilated patients is considerably influenced by the progression of the underlying coronary heart disease, with a development of new hemodynamically significant stenoses in some 5% of the patients per year. A large percentage of these patients undergo successful redilatation so that aortocoronary bypass surgery can again be avoided in the majority of these cases. In a minority--mostly patients with multivessel disease - aortocoronary bypass surgery can at least be postponed. Successful PTCA results in a long-term improvement of cardiac symptoms and vocational status, perhaps even in a reduction of the incidence of myocardial infarction of cardiac death. Results on latter, derived from retrospective studies, have to be confirmed by prospective trials.

Long-term effects of balloon coarctation angioplasty on arterial blood pressure in adolescent and adult patients.

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.

[Implantable defibrillator in the long QT syndrome]. / Implantierbarer Defibrillator bei QT-Syndrom.

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).

Long-term follow-up after percutaneous transluminal coronary angioplasty in patients with single-vessel disease.

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)

A word of caution: reopening chronic coronary occlusions.

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.

[Long-term clinical follow-up after coronary dilatation]. / Langfristiger klinischer Verlauf nach Koronardilatation.

To determine the long-term clinical course after percutaneous transluminal coronary angioplasty (PTCA), 841 patients, 615 with successful PTCA and 226 without, were restudied by questionnaire 2-9 years after the intervention. After successful PTCA a lasting symptomatic improvement was seen in 78% of patients vs 55% of patients without successful PTCA (p less than 0.0001). The probability of myocardial infarction 8 years after successful PTCA was 6% vs 24% after unsuccessful PTCA (p less than 0.0005). The 8-year survival probability (non-cardiac deaths excluded) was 95.7% in patients with demonstrable PTCA success, and 92.0% in patients without (p less than 0.05). Similar significant differences in favor of patients with successful PTCA were seen in the long-term prognosis of patients with single-vessel disease (n = 580). It is concluded that a long-term improvement of the cardiac prognosis by successful PTCA is probable.

Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: a randomized trial.

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.

[Long-term therapy following myocardial infarct with isosorbide dinitrate in a low and high dose]. / Langzeittherapie nach Herzinfarkt mit Isosorbiddinitrat in niedriger und hoher Dosis.

The favorable response to nitrates in the case of coronary heart diseases is based on both reduction in left ventricular pre- and afterload and improvement in coronary flow. These effects were studied in the setting of a long-term ISDN therapy with reference to the prognosis of patients after myocardial infarction. Following acute treatment in the respective hospitals, 608 patients with myocardial infarctions were allocated to two double-blind treatment groups with different ISDN dosage levels (group 1 = 5 x 2.5 mg i.d.; group 2 = 5 x 40 mg i.d.) and followed up over a period of 2 years. No differences were found with regard to the end points sudden cardiac death, reinfraction, and indication for revascularization. There was, however, a more frequent additional administration of calciumantagonists to patients of the low-dose group (p less than 0.05), a more frequent drop-out due to the lack of beneficial therapeutic results, and a more exceptional drop-out due to side effects in patients treated with low doses of ISDN (n.s.). The absence of any significant difference with regard to the end points might be attributed to; 1) a loss of potency of high-dose ISDN and simultaneous ineffectiveness of low-dose ISDN; 2) an efficacy of low doses; 3) an absence of actual influence on the target parameters, and 4) an inadequate follow-up time period.

[Chronic therapy of congestive cardiomyopathy: effects of prenalterol and digoxin]. / Chronische Therapie der kongestiven Kardiomyopathie: Wirkungen von Prenalterol und Digoxin.

UNLABELLED: Prenalterol (P), a partial adrenergic agonist with functional beta 1-specificity, has been shown to have inotropic effects when given orally and thus represents a potential substitute or adjunct to conventional digitalis therapy (D) in the long-term management of congestive cardiomyopathy (COCM). A direct comparison between both drugs has not been reported. In a blind controlled trial, 15 patients with COCM (NYHA II-III) with sinus rhythm and a left ventricular ejection fraction (LV-EF) of 34.5 +/- 2.6% received consecutively D (0.25-0.5 mg/d), placebo (PLAC), P (slow releases = SR) (80 mg/d SR) and both drugs combined in respective doses. After 4 weeks of therapy with each drug, effects were assessed by gated blood pool scintigraphy at rest (R) and during graded bicycle exercise (EX), systolic time intervals (STI), Holter monitoring and a clinical score. Plasma levels of both drugs and of catecholamines and lactate were also determined. Compared to PLAC, LV-EF was not significantly altered by D at R (34.5 +/- 2.6 vs. 31.9 +/- 2.3%, p = ns), but a shortening of the QS2-interval could be demonstrated (533 +/- 7 vs. 550 +/- 6 msec, p less than 0.05). In contrast, during EX an improvement of LV-EF was observed (34.5 +/- 3 vs. 31.3 +/- 2.8%, p less than 0.05). P alone showed no significant alterations in LV-EF and STI, along with a lack of symptomatic improvement. The addition of D (D + P) resulted in improved left ventricular performance both at R (LV-EF 37.9 +/- 3.3 vs. 31.9 +/- 2.3%, p less than 0.01, QS2 530 +/- 8 vs. 550 +/- 6 msec, p less than 0.01) and during EX (LV-EF 35.3 +/- 2.5 vs. 31.1 +/- 2.8%). Values between D and D + P were not significantly different. No drug or combination improved maximal working capacity. CONCLUSIONS: Beneficial effects of chronic treatment with D could be demonstrated in patients with COCM, particularly during EX. Further studies are needed to determine why the acute effects of P are not fully sustained during long-term therapy.