Franz Leisch

Pro-CAS: A Prospective Registry of Carotid Angioplasty and Stenting

Background and Purpose— The German Societies of Angiology and Radiology have instituted a prospective registry of carotid angioplasty and stenting (CAS) to limit uncontrolled use of CAS and to collect data about technique and results of CAS outside clinical trials. Methods— A total of 38 centers register their patients prospectively before CAS is performed. At discharge, technical details, periprocedural medication, and the clinical course are reported on a standardized form. Results— During the first 48 months, 3853 planned interventions were recorded, and CAS was actually attempted on 3267 patients of whom 1827 (56%) were symptomatic and 1433 (44%) were asymptomatic. In 3127 (98%) cases, stents were used, of which 2784 (89%) were of the self-expanding type. Other technical aspects such as the use of guiding catheters and protection devices varied widely among the centers. Periprocedural medication rather uniformly included aspirin and clopidogrel before and after CAS and high-dose heparin and atropin during CAS. CAS was successful in 3207 (98%) cases. There was a 0.6% (n=18) mortality rate, a 1.2% (n=38) major stroke rate, and a 1.3% (n=41) minor stroke rate. The combined stroke and death rate was 2.8% (n=90). Conclusions— These prospective multicenter data are likely to give a realistic picture of the possibilities and limitations of CAS in the general community. They suggest that CAS may be performed with similar results in the general community as they have been reported by highly specialized centers and in clinical studies.

Predictors of Death and Stroke After Carotid Angioplasty and Stenting A Subgroup Analysis of the Pro-CAS Data

Background and Purpose— Little is known about the significance of patient characteristics, clinical indications, and technical details on the risk of carotid angioplasty and stenting (CAS). The purpose of this study was to test these parameters as to their predictive value for the peri-interventional risk of CAS. Methods— Pro-CAS is a prospective, multicenter registry of CAS. Logistic regression analysis of possible predictive factors was performed on 5341 interventions that had been entered by 25 clinical centers between July 1999 and June 2005. Results— The combined in-hospital mortality and stroke rate was 3.6%. The following were found to be significant predictors of peri-interventional stroke and death: center experience (≤50 versus 51 to 150 versus ≥151 interventions), age, prior symptoms, primary intervention as compared with intervention for restenosis, angioplasty without stent, predilatation, and heparin dosage >5000 IU. No statistically significant result was found for year of intervention, patient volume, gender, interval between symptoms and CAS, ocular versus neurological symptoms, side of CAS, degree of stenosis of the target lesion, presence of contralateral high-degree stenosis or occlusion, method of gaining access to the carotids, stent type, and use of a protection system. Conclusions— Our findings underline the need for dedicated training and strict credentialing rules for CAS. In addition, they might help to identify subgroups of patients at differential risk for CAS and carotid endarterectomy and yield a basis for correcting risks due to differences in case mix in reports about CAS.

Long-term outcomes in patients with atrioventricular block undergoing septal ventricular lead implantation compared with standard apical pacing

AIMS Left ventricular function may be altered by right ventricular apical pacing. The aims of the study were to compare the long-term course of different parameters of left ventricular dysfunction in patients undergoing implantation of a dual-chamber pacemaker with the ventricular lead in a septal position vs. in a standard apical position. METHODS We randomized 98 patients with atrioventricular block (AV-block) undergoing pacemaker implantation to positioning the ventricular lead in the high or mid septum (n = 53) or in the apex (n = 45) of the right ventricle. N-terminal pro-brain natriuetic peptide (BNP) levels, left ventricular ejection fraction (LVEF), and exercise capacity were analysed 3 days, 3 months, and 18 months after the implantation. The primary endpoints were the changes of these parameters from baseline to 18 months. RESULTS Changes of BNP levels, LVEF, and exercise capacity from baseline to 18 months were statistically not different between septal and apical stimulation. The clinical occurrence or deterioration of overt heart failure was similar in both treatment arms. CONCLUSION With regard to different parameters of congestive heart failure, a septal stimulation site is not superior to conventional apical pacing in unselected patients undergoing pacemaker implantation for AV-block.

Carotid sinus reactions during carotid artery stenting: Predictors, incidence, and influence on clinical outcome

Carotid sinus reactions (CSR), defined as asystole ≥ 3 sec and hypotension (systolic blood pressure ≤ 90 mm Hg), are frequent events during carotid artery stenting (CAS). Factors predisposing a patient to CSR as well as the impact of CSR on periprocedural complications have not yet been investigated in a prospective manner. The relationship between various clinical, morphologic, and procedural variables and the occurrence of CSR was examined among 105 consecutive patients undergoing successful CAS. After predilatation with a compliant balloon, tubular‐slotted stents were used in all patients. No CSR occurred in 63 (60%) patients, whereas CSR developed in 42 (40%) patients. The most common type of CSR was asystole in combination with short‐term hypotension without clinical symptoms. The most important predictor of CSR was bifurcation location of carotid stenosis (bifurcation > ostial > isolated internal carotid artery; P < 0.001). The other independent predictors were presence of contralateral stenosis (P < 0.02), length of stenosis (P < 0.03), and balloon‐to‐artery ratio (P < 0.02). Occurrence of CSR was unrelated to periprocedural cerebral or cardiovascular complications (7.1% vs. 9.5%; NS). We conclude that CSR occurs frequently (40%) during CAS. Bifurcation location of stenosis is the most important predictor of CSR. CSR does not increase the risk of periprocedural complications. Cathet Cardiovasc Intervent 2003;58:516–523.

Risk Score for Peri-Interventional Complications of Carotid Artery Stenting

Background and Purpose— Routinely available independent risk factors for the peri-interventional outcome of patients undergoing elective carotid artery stenting (CAS) are lacking. The rationale of the study was to create a risk score identifying high-risk patients. Methods— We prospectively enrolled 606 consecutive patients assigned to CAS at a secondary care hospital. Various biochemical, clinical, and lesion-related risk factors were prospectively defined. The primary end point reflecting periprocedural complications encompassed minor and major stroke, nonfatal myocardial infarction and all-cause mortality within 30 days. Results— Three percent of patients (n=18) experienced a nonfatal minor (n=13) or major (n=5) stroke. 1.3% of patients (n=8) died from fatal stroke (n=4) or other causes (n=4). No myocardial infarction was observed within 30 days after stenting. Multivariable analysis revealed diabetes mellitus with inadequate glycemic control (HbA1c >7%), age ≥80 years, ulceration of the carotid artery stenosis, and a contralateral stenosis ≥50% as independent risk factors. A risk score formed with these variables showed a superior predictive value (C-statistic=0.73) compared with single risk factors. The presence of 2 or more of these risk factors identified patients with a risk of 11% for a periprocedural complication compared with 2% in patients with a score of 0 or 1. Conclusions— In patients undergoing elective CAS, a risk score based on routinely accessible variables was able to identify patients at high-risk for atherothrombotic events and all-cause death within 30 days after the intervention.

Clinical efficacy of intravenous amiodarone in the short term treatment of recurrent sustained ventricular tachycardia and ventricular fibrillation.

The clinical efficacy of intravenous amiodarone in terminating sustained ventricular tachycardia and in preventing recurrences of ventricular tachycardia and ventricular fibrillation was evaluated in 26 patients. All of them presented with organic heart disease accompanied by depressed left ventricular function. Intravenous amiodarone terminated spontaneous ventricular tachycardia in eight of 19 patients. Fifteen of the 26 patients had had at least one episode of ventricular tachycardia or ventricular fibrillation each day in the period immediately before the intravenous administration of amiodarone. Amiodarone controlled ventricular tachycardia or ventricular fibrillation in nine of these 15 patients; in three further cases it was successful when supplemented by additional administration of a previously ineffective antiarrhythmic drug and ventricular pacing. Two patients died despite these measures. In one, the amiodarone infusion had to be stopped because of an arrhythmogenic effect. Sustained deterioration of haemodynamic function or of pre-existing intraventricular conduction disturbances was never seen. Intravenous amiodarone was effective in terminating sustained ventricular tachycardia and in preventing frequent episodes of ventricular arrhythmia that were refractory to other antiarrhythmic drugs.

Coronary angiography in patients undergoing carotid artery stenting shows a high incidence of significant coronary artery disease

Objective: To assess the incidence, morphology, and associated clinical symptoms of coronary artery disease in patients undergoing elective carotid artery stenting. Methods: In a prospective observational study at a tertiary care centre (university teaching hospital) 444 consecutive patients underwent elective stenting of the carotid artery. Twenty four patients had to be ruled out because of urgent carotid intervention for severe neurological symptoms, lack of compliance, complications from vascular puncture, or renal failure. In 390 patients, the coronary angiography was performed together with carotid artery stenting in a single session; the remaining 30 patients have had a recent coronary angiography. Results: One, two, and three vessel disease and left main stenoses were found in 70 (17%), 64 (15%), 93 (22%), and 31 (7%) patients, respectively. Sixty six (16%) patients had a history of coronary artery disease but no current significant stenosis. Only 39% of the patients with significant stenoses (n  =  258) had clinical cardiac symptoms. Conclusions: For patients undergoing elective stenting of the carotid, routine coronary angiography reliably discloses morphologically significant coronary artery disease and enables consecutive treatment in 61% and 29%. This safe measure is useful because a majority of patients with a significant stenosis are asymptomatic.

Acute Results of Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation Using a Single Mesh Catheter

Introduction: Catheter‐based pulmonary vein isolation (PVI) is an established therapy to treat patients with paroxysmal atrial fibrillation. We evaluated the efficacy of a simplified interventional procedure for PVI by using a single mesh catheter for mapping as well as ablation and with guidance of fluoroscopic imaging only.

Influence of a variant angina on the results of percutaneous transluminal coronary angioplasty.

Nineteen (86%) of 22 patients with variant angina and important coronary stenoses (greater than 60%) had successful percutaneous transluminal coronary angioplasty. The acute complications in two patients were not caused by coronary spasms but by dissection with disturbance of perfusion. One of these two patients required a coronary bypass graft; the other was treated conservatively. Myocardial infarction developed in both patients. Despite long term administration of nifedipine (30-80 mg daily), restenoses occurred within six months (on average after 10 weeks) in nine patients with symptoms and one without. In four patients the restenoses exceeded the degree of stenosis before angioplasty. Five patients were revascularised by surgical means. Vessels in three out of four patients were later successfully dilated. After a mean period of observation of 24 months (6-51 months) 18 of the 19 patients are symptom free and do not require medication. The results confirm that angioplasty is an effective method of treating patients with variant angina and important coronary stenoses. The problem of the high frequency of restenosis, however, remains unresolved.

The HQ time in congestive cardiomyopathies

Abstract 1. 1. In 41 per cent of patients with COCM there was a bundle branch block. All but one of these 18 patients showed a prolonged HQ time, indicating that the whole conduction system in these cases is involved and that there is just a predominance of one side. 2. 2. Fifty-nine per cent had a normal QRS complex and 50 per cent of these patients showed a prolonged HQ time. It must be assumed that in these cases the whole conduction system is diffusely involved to the same degree. This results in a pure HQ prolongation and not in bundle branch block. 3. 3. Patients with ICM showed significantly less often an HQ prolongation, indicating that the conduction system in these cases is not diffusely involved. 4. 4. The significant negative correlation between HQ time and EF indicates that the progression of the myocardial disease is concomitant with the progression of the conduction disturbances, which can be either diffuse in both branches, leading to a pure HQ prolongation, or be predominant in one of the bundles, leading to a bundle branch block with an HQ prolongation. 5. 5. There are no significant differences of the end-diastolic volumes within the group of COCM and between patients with COCM and ICM. Thus, ventricular enlargement, and myocardial dilatation, respectively, are not the cause of HQ prolongation.