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Aims: Several studies demonstrated an inverse relationship between cardioverter-defibrillator implantation volume and complication rates, suggesting better outcomes for higher volume centres. However, the association of institutional procedural volume with patient outcomes for permanent pacemaker (PPM) implantation remains less known, especially in decentralized implantation systems., Methods and Results: We performed retrospective examination of data on patients undergoing PPM from the German obligatory quality assurance programme (2007-12) to evaluate the relationship of hospital PPM volume (categorized into quintiles of their mean annual volume) with risk-adjusted in-hospital surgical complications (composite of pneumothorax, haemothorax, pericardial effusion, or pocket haematoma, all requiring intervention, or device infection) and pacemaker lead dislocation. Overall 430 416 PPM implantations were documented in 1226 hospitals. Systems included dual (72.8%) and single (25.8%) chamber PPM and cardiac resynchronization therapy (CRT) devices (1.1%). Complications included surgical (0.92%), and ventricular (0.99%), and atrial (1.22%) lead dislocation. Despite an increase in relatively complex procedures (dual chamber, CRT), there was a significant decrease in the procedural and fluoroscopy times and complications from lowest to highest implantation volume quintiles (P for trend <0.0001). The greatest difference was observed between the lowest (1-50 implantations/year-reference group) and the second-lowest (51-90 implantations/year) quintile: surgical complications [odds ratio (OR) 0.69; confidence interval (CI) 0.60-0.78], atrial lead dislocations (OR 0.69; CI 0.59-0.80), and ventricular lead dislocations (OR 0.73; CI 0.63-0.84)., Conclusions: Hospital annual PPM volume was directly related to indication-based implantation of relatively more complex PPM and yet inversely with procedural times and rates of early surgical complications and lead dislocations. Thus, our data suggest better performance and lower complications with increasing procedural volume., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Objectives: We sought to analyze outcomes of patients with degenerated surgically implanted bioprosthetic heart valves undergoing valve-in-valve (viv) transcatheter aortic valve implantation (TAVI)., Background: Redo cardiac surgery for degenerated bioprosthetic heart valves is associated with increased risks, particular in elderly patients with comorbidities. For these patients, TAVI may be an attractive, less invasive treatment option., Methods: Data from 47 patients age 64 to 97 years (logistic euroSCORE: 35.0 ± 18.5%) undergoing transfemoral (n = 25) or transapical (n = 22) viv-TAVI for failed bioprosthetic aortic valves 113 ± 65 months after initial surgery at 9 clinical sites in Germany and Switzerland were analyzed., Results: Valve-in-valve TAVI was technically successful in all patients, with 2 patients requiring bailout implantation of a second TAVI prosthesis for severe regurgitation during the procedure. There was 1 procedural death as the result of low-output failure. Valvular function after viv-TAVI was excellent with respect to valve competence, but increased transvalvular gradients ≥20 mm Hg were noted in 44% of patients. Vascular access complications occurred in 6 (13%) patients, and 5 (11%) patients required new pacemaker implantation after viv-TAVI. Renal failure requiring dialysis occurred in 4 (9%) patients. Mortality at 30 days was 17% (1 procedural and 7 post-procedural deaths), with 3 of 8 fatalities the result of non-valve-related septic complications., Conclusions: Valve-in-valve TAVI can be performed with high technical success rates, acceptable post-procedural valvular function, and excellent functional improvement. However, in these predominantly elderly high-risk patients with multiple comorbidities, viv-TAVI was associated with 17% mortality, often because of septic complications arising in the post-operative phase., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Data on the safety of carotid artery stenting (CAS) in a large number of unselected patients with contralateral occlusion and significant ipsilateral stenosis are less known. Accordingly, we evaluated 3,137 patients undergoing CAS who were enrolled in a German Registry from 2000 to 2008 and compared the clinical features and in-hospital outcomes of those with and without contralateral carotid occlusion. Contralateral carotid occlusion was present in 191 patients (6.1%) undergoing CAS. Despite the similar age of the patients with and without contralateral carotid occlusion, those with contralateral occlusion had a greater prevalence of co-morbidities, complex carotid stenosis, and greater number of focal neurologic lesions on the contralateral side. The incidence of in-hospital events, including death (1.0% vs 0.5%), ipsilateral major stroke (1.1% vs 1.1%), death or major ipsilateral stroke (1.6% vs 1.4%), ipsilateral transient ischemic attack (2.7% vs 2.5%), myocardial infarction (0.0% vs 0.1%), and reintervention (0.5% vs 1.1%), was low and was not significantly different between those with and without contralateral occlusion (p >0.05 for all comparisons). Among patients with carotid occlusion, major ipsilateral stroke (2.2%), death (2.2%), and a combination of these 2 events (3.3%) were observed exclusively in symptomatic patients with no event in asymptomatic patients. In conclusion, our data from a large number of patients undergoing CAS in a recent contemporary community-based practice attests to the low risk of periprocedural events among patients with contralateral carotid occlusion supporting CAS as an attractive option for the treatment of these patients.

Repeat carotid endarterectomy (CEA) for recurrent stenosis remains a challenging treatment option associated with high morbidity and mortality. Carotid artery stenting (CAS) is an attractive alternative management option for these patients. However, data about the effectiveness and safety of CAS in a large number of unselected patients are less known. We evaluated 3,070 patients who underwent CAS enrolled in a German registry from 1996 to 2006 at 31 sites. We compared clinical and angiographic features and in-hospital outcomes of patients with and without previous CEA who underwent CAS. Of 3,070 patients in the registry, 223 (7.3%) underwent CAS for restenosis after previous CEA. Median age was similar in patients with and without previous CEA (70 years, interquartile range 64 to 76 vs 71 years, interquartile range 65 to 76). Ipsilateral neurologic symptoms occurred in approximately 1/2 the patients in both groups. Other co-morbid conditions and angiographic or procedural factors did not differ between the 2 groups. In-hospital events including death (0% vs 0.4%), ipsilateral major stroke (1.4% vs 1.5%), death or major ipsilateral stroke (1.4% vs 1.7%), ipsilateral transient ischemic attack (1.9% vs 2.8%), myocardial infarction (0.4% vs 0.1%), and reintervention (0.7% vs 0.4%) were all low and not significantly different between those with and without previous CEA (p >0.05 for all comparisons). In conclusion, our data for a large number of patients who underwent CAS in a recent contemporary community-based practice attests to the low risk of periprocedural events in patients with recurrent stenosis after previous CEA. This low risk along with the less invasive nature of the procedure should make CAS an attractive and perhaps preferred option for the treatment of these patients.

We assessed the incidence, correlates, and outcomes of acute renal failure (ARF) after thoracic aortic stent-graft placement. Postprocedural ARF is an inherent complication of catheter-based interventional procedures that use intra-arterial contrast agents and has adverse effects on short- and long-term outcomes. However, few data exist on the incidence, predictors, and outcomes of ARF after thoracic aortic stent-graft placement. We analyzed data of 97 patients (64.4 +/- 11.6 years of age; 73% men) who underwent thoracic aortic stent-graft placement from July 1999 to October 2005. Postprocedural ARF was defined as an increase > or = 25% and/or > or = 0.5 mg/dl in preprocedural serum creatinine at 48 hours after the procedure. Baseline estimated glomerular filtration rate was 65 +/- 24 ml/min/1.73 m2. Chronic kidney disease (glomerular filtration rate < or = 60 ml/min/1.73 m2) at baseline was present in 45% of patients. During the stent-graft procedure, patients received 307 +/- 188 ml of nonionic contrast medium. Postprocedural ARF occurred in 33 patients (34%), and 3 required dialysis. Multivariable analysis identified American Society of Anesthesiologists class > 3 (odds ratio 5.53, 95% confidence interval 1.71 to 17.85, p = 0.004) and duration of the stent-graft procedure (odds ratio 1.01, 95% confidence interval 1.001 to 1.014, p = 0.022) as independent predictors of postprocedural ARF. Compared with patients without ARF, those with ARF had markedly higher 30-day (18.2 +/- 6.7% vs 1.6 +/- 1.6%, p = 0.0022) and 1-year (35.2 +/- 8.6% vs 10.1 +/- 3.9%, p = 0.001) mortality. In conclusion, postprocedural ARF is a frequent complication of thoracic aortic stent-graft placement and has a significant adverse effect on 30-day and 1-year survival. Baseline factors identified in our study as associated with increased risk of ARF may facilitate a comprehensive informed consent process by way of patient education. In addition, identification of an at-risk subset may allow modification of reversible periprocedural factors that may help decrease postprocedural ARF.