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Background: Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group., Aim: This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke., Methods: LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events., Results: A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan-Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS)., Conclusions: Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients., Gov Identifier: NCT02230748., (© 2024. The Author(s).)

Objectives: Chronic kidney disease (CKD) is associated with an increased complication rate after cardiac interventions. Although CKD has a high prevalence among atrial fibrillation patients, the impact of CKD on periprocedural complications and the outcome after an interventional left atrial appendage closure (LAAC) is unclear. The present study, therefore, aimed to investigate whether CKD influences the procedure's effectiveness and safety., Methods: LAARGE is a prospective, non-randomised registry. LAAC was conducted with different standard commercial devices, and the follow-up period was one year. CKD was defined by an eGFR < 60 mL/min/1.73 m 2 , and subgroups were further analysed (i.e. eGFR < 15, 15-29, and 30-59 mL/min/1.73 m 2 , respectively)., Results: Two hundred ninety-nine of 623 patients (48.0%) revealed a CKD. The prevalence of cardiovascular comorbidity, CHA 2 DS 2 -VASc score (4.9 vs. 4.2), and HAS-BLED score (4.3 vs. 3.5) was significantly higher in CKD patients (each p < 0.001). Implantation success was similarly high across all GFR groups (97.9%). Periprocedural MACCE (0.7 vs. 0.3%), and other major complications (4.7 vs. 3.7%) were comparably infrequent. Survival free of stroke was significantly lower among CKD patients within 1 year (82.0 vs. 93.0%; p < 0.001; consistent after adjustment for confounding factors), without significant accentuation in advanced CKD (i.e. eGFR < 30 mL/min/1.73 m 2 ; p > 0.05  vs. eGFR 30-59 mL/min/1.73 m 2 ). Non-fatal strokes were absolutely infrequent during follow-up (0 vs. 1.1%). Severe non-fatal bleedings were observed only among CKD patients (1.4 vs. 0%; p = 0.021)., Conclusions: Despite an increased cardiovascular risk profile of CKD patients, device implantation was safe, and LAAC was associated with effective stroke prevention across all CKD stages.

Aims: Several left atrial appendage (LAA) closure systems are available. Due to differences in device design, the results of specific occluders derived from trials cannot simply be generalised to all devices. The present analysis sought to assess two contemporary LAA closure devices in clinical practice., Methods and Results: The work represents a non-randomised sub-analysis of the prospective, multicentre, Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) registry. The WATCHMAN (group 1) and the AMPLATZER Cardiac Plug (ACP) or Amulet occluder (group 2) were assessed. A total of 641 patients at 38 centres were enrolled. Of these, 278 (43%) and 340 (53%) patients received the WATCHMAN and ACP/Amulet occluder, respectively. High technical success was achieved with a slight difference between the groups (96% in group 1 vs 99% in group 2; p=0.007). Procedural safety did not differ (98% in group 1 vs 97% in group 2; p=0.55). The Kaplan-Meier estimated one-year composite of death or stroke was 12.0% and 12.9%, respectively (p=0.79)., Conclusions: Both the WATCHMAN and the ACP/Amulet occluder provide excellent procedural results with comparable implantation success and no differences with respect to procedural safety and long-term effectiveness.

Left atrial appendage closure (LAAC) is an alternative to oral anticoagulation therapy in patients with non-valvular atrial fibrillation for the prevention of embolic stroke and systemic embolism. Although elderly patients (>75 years) have both higher ischemic and bleeding risk as compared with younger patients, they benefit from optimal anticoagulation. The subanalysis aimed to assess the indications, the safety, efficacy, and 1-year outcomes of interventional LAAC in elderly patients (≥ 75 years) compared with younger (< 75 years) patients in clinical practice. We analyzed data from the prospective Left-Atrium-Appendage Occluder Registry Germany. A total of 638 patients were included in the registry, 402 (63%) were aged ≥ 75 years. Compared with younger subjects, patients aged ≥75 were more likely to have higher CHA2DS2-VASC and HAS-BLED scores. Procedural success rate was high und similar in both groups (97.6%). Periprocedural adverse events were not statistically significant in groups (11.9% in <75 years vs 12.9% in ≥75 years; p = 0.80). At 1 year follow-up, all-cause mortality was higher in patients aged ≥75 compared withwith younger group (13.0% vs 7.8 %,p = 0.04), mainly due to non-cardiovascular causes (10.6% vs 6.0%). No significant differences in major bleeding, stroke, systemic embolism were observed. In conclusion, LAAC is feasible and safe in patients with AF at high stroke risk and with contraindications for OAC and should be considered as candidates for LAA closure. Elderly patients often present these characteristics and could benefit from this novel therapy., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relations that could have appeared to influence the work reported in this study., (Copyright © 2020. Published by Elsevier Inc.)

Objectives: To summarize the outcomes of acute ischemic stroke (AIS) intervention by interventional cardiologists (IC) working on a stroke team., Background: There is a geographic maldistribution of dedicated neuro-interventionalists (NI) to treat large vessel occlusion (LVO) AIS., Methods: Results of 166 consecutive patients who received endovascular therapy (EVT) for AIS due to LVO by IC at three centers between 2009 and 2019 are reported. A modified Rankin score (mRs) of ≤ 2 at 90 days after EVT was used as the primary measurement of a good neurological outcome. Univariate logistic regression was used to evaluate predictors of the mRS > 2 and mortality. Those variables with significance of p < .2 from the univariate analysis were included in a multivariate analysis., Results: All-cause mortality at 30 days was 22%. A favorable clinical outcome, mRS ≤ 2 at 90 days, was 49%. After multivariate analysis and controlling for confounders, a higher baseline NIHSS was predictive of 30-day mortality (OR 1.20 [95% CI 1.09-1.32] p < .001) and unfavorable clinical outcome (mRS > 2) at 90 days (OR 1.16 [95% CI 1.07-1.25] p < .001)., Conclusion: Outcomes for carotid stent capable IC performing EVT for AIS are comparable to those achieved by NI physicians in major randomized clinical trials. Our data supports conducting a clinical trial of carotid stent capable IC working on multidisciplinary stroke teams to perform EVT for AIS due to LVO in communities and hospitals without timely access (<60 min by ground transport) to dedicated NI., (© 2020 Wiley Periodicals LLC.)

Background: Interventional left atrial appendage closure (LAAC) effectively prevents thromboembolic events in atrial fibrillation patients. Impaired left ventricular ejection fraction (LVEF) increases not only the thromboembolic risk but also the complication rates of cardiac interventions. The LAAC procedure's benefit in patients with an impaired LVEF, therefore, has yet to be investigated., Methods: LAARGE is a prospective, non-randomized registry depicting the clinical reality of LAAC in Germany. Procedure was conducted with different standard commercial devices, and follow-up period was one year. In the sense of an as-treated analysis, patients with started procedure and documented LVEF were selected from the whole database., Results: 619 patients from 37 centers were categorized into one of three groups: LVEF > 55% (56%), 36-55% (36%), and ≤ 35% (8%). Prevalence of cardiovascular comorbidity increased with LVEF reduction (p < 0.001 for trend). CHA 2 DS 2 -VASc score was 4.3, 4.8, and 5.1 (p < 0.001), and HAS-BLED score was 3.7, 4.1, and 4.2 (p < 0.001). Implantation success was consistently high (97.9%), rates of intra-hospital MACCE (0.5%), and other major complications (4.2%) were low (each p = NS). Kaplan-Meier estimation showed a decrease in survival free of stroke with LVEF reduction during one-year follow-up (89.3 vs. 87.0 vs. 79.8%; p = 0.067), a trend which was no longer evident after adjustment for relevant confounding factors. Rates of non-fatal strokes (0.4 vs. 1.1 vs. 0%) and severe bleedings (0.7 vs. 0.0 vs. 3.1%) were consistently low across all groups (each p = NS)., Conclusions: LVEF reduction neither influenced the procedural success nor the effectiveness and safety of stroke prevention by LAAC., Trial Registration: ClinicalTrials.gov Identifier: NCT02230748.

Objectives: To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry., Background: The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse., Methods: In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year., Results: Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02)., Conclusions: TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating., (© 2019 Wiley Periodicals, Inc.)

Background: Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease., Aims: The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy., Methods and Results: From August 2010 until July 2013, 799 patients (age 75.3 ± 8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m 2 (underweight), BMI 20.0 to <25.0 kg/m 2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m 2 (overweight) and BMI ≥30 kg/m 2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011)., Conclusions: Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population., Methods and Results: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates., Conclusion: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to evaluate the technical and clinical success of acute stroke interventions performed in our interventional cardiology center., Background: Dedicated interventional stroke centers remain limited. Interventional cardiologists have established networks of catheterization laboratories and the necessary infrastructure to provide around the clock interventional therapy. These networks may also provide the currently lacking universal rapid access to prompt stroke intervention., Methods: Between July 2012 and July 2018, 70 consecutive patients underwent acute stroke intervention for large-vessel occlusions. Seventeen patients (24%) had tandem or multiple vessel occlusions. The majority (n = 63, 90%) were admitted via our local stroke unit, and 7 (10%) patients were transferred from other regional referral centers., Results: In 43 (61%) patients, systemic fibrinolytic therapy was started after baseline imaging. Mean time between symptom onset and arrival to the cath lab was 138 min; mean door-to-vascular access time was 64 min; mean time between cath lab activation and its operational readiness was 13 min. In all cases, access to supra-aortic vessels was achieved. Mean time between femoral arterial puncture and lesion crossing was 26 min. Stent implantation for extracranial stenosis or dissection was performed in 14 (20%) cases. Thrombectomy of intracranial occlusions was done with a stent retriever (n = 64, 91%) or an aspiration system (n = 14, 20%). In 20 (28%) cases, a combination of techniques was used. Recanalization was technically successful (Thrombolysis In Cerebral Infarction flow grade 2b or 3) in 65 (93%) patients. The 30-day mortality was 18% (n = 13). Favorable clinical outcome, defined as a modified Rankin Scale score of 0 to 2, was achieved in 61% at 3-month follow-up., Conclusions: Acute stroke interventions can be performed safely and with high technical and clinical success by experienced interventional cardiologists., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: This study evaluated the safety and performance of the Paladin System, a novel angioplasty balloon with an integrated embolic protection filter designed to increase embolic protection during post-dilation., Background: The risk of major adverse events during carotid artery stenting (CAS) is equivalent to carotid endarterectomy. However, the risk of minor stroke remains higher with CAS. Much of this risk occurs during post-stent dilation., Methods: A total of 106 patients were enrolled in 5 centers in Germany. The study's primary endpoint was all-cause death, myocardial infarction, and stroke at 30 days post-procedure. Pre- and post-procedural diffusion-weighted magnetic resonance imaging evaluated new ischemic lesions in 30 subjects. Filter histomorphometric analysis was performed in 23 patients. Retrospective analyses compared outcome rates to historical controls., Results: Device and procedural success rates were 100%. The combined major adverse event rate (death, myocardial infarction, and stroke) at discharge and at 30 days was 0% and 1.0%, respectively. The single adverse event was a stroke, which occurred at day 12 and was believed unrelated to the device or procedure. New ischemic lesions were found in 11 (36.7%) patients in the diffusion-weighted magnetic resonance imaging subset. New ipsilateral lesions were seen in 9 (30.0%) patients. Mean lesion volume per patient was 0.010 cm 3 . Debris was present in all filters, and approximately 90% of captured particles were <100 μm., Conclusions: Use of the Paladin System for post-stent dilation during CAS appears safe, and it may effectively decrease the number of embolic particles reaching the brain, which may help reduce the risk of procedure-related stroke. (A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection; NCT02501148)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: MitraClip therapy is increasingly used in patients deemed inoperable to treat severe mitral regurgitation (MR), but long-tern data is scarce., Aims: The multicentre, industry-independent German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises the largest prospectively enrolled cohort of patients treated by MitraClip therapy. The current analysis is focusing on long-term mortality rates, cardiac rehospitalization and reintervention., Methods and Results: Long-term follow-up (median time 1037 days) in the TRAMI registry was available for 722 patients treated at 20 German centres. Improvements in New York Heart Association (NYHA) functional class (I/II long-term: 65% vs. 1-year follow-up: 63.3%) and self-rated health-status (EuroQuol visual analogue scale [EQ VAS] long-term: 60 [50-70] vs. 1-year follow-up: 60 [50; 70]) were pertained over time. Estimated mortality rates by Kaplan-Meier method were 19.7% for 1-year, 31.9% for 2-year and 53.1% for 4-year follow-up without differences found for MR aetiology. Multivariable Cox-regression analysis identified previous aortic valve implantation (hazard ratio [HR] = 2.21; p < 0.0001), NYHA class IV (HR = 1.78; p < 0.001), prior cardiac decompensation (HR = 1.63; p < 0.001), creatinine > 1.5 mg/dl (HR = 1.63; p < 0.0001) and left ventricular ejection fraction < 30% (HR = 1.60; p < 0.001) as most predictive for long-term mortality., Conclusions: Long-term outcome in the TRAMI registry confirmed lasting clinical improvements and low intervention rates. Long-term mortality was strongly influenced by cardiac and non-cardiac co-morbidities and was found comparable for both MR aetiologies., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Aims: The aim of this study was to compare the efficacy and safety of the Occlutech Figulla Flex II Occluder (OFFII) with the Amplatzer Septal Occluder (ASO) in patients > 8kg undergoing transcatheter ASD closure., Methods and Results: Randomized, controlled, multi-center prospective clinical trial with randomization 2:1 in favor of the OFFII. Primary efficacy endpoint was the rate of successful device placement and defect closure without major complications at hospital discharge. All data were assessed through a core laboratory. Interim analysis was performed when 70% of the patients were treated to evaluate for noninferiority. From a total of 176 randomized subjects, interim analysis was performed on the first 158 patients (65.2% female) (107 OFFII/51 ASO) undergoing device closure at a median weight of 42 kg (range 13-125 kg). Seventy-six percent (120 patients) completed 6-month follow-up. Successful device placement (first attempt) was achieved in 99.1% of the OFF group vs 90.2% of the ASO group (P < 0.05). Early efficacy success was achieved in 94.4% of the OFFII group vs 90.2% of the ASO group (P < 0.001). The incidence of major complications was 5.6% for the OFFII group compared to 9.8% for the ASO., Conclusions: The OFFII device was not inferior to the ASO with less complications and greater efficacy than the ASO., (© 2018 Wiley Periodicals, Inc.)

Aims: We sought to evaluate the impact of pulmonary hypertension on outcomes following MitraClip therapy., Methods and Results: The 643 patients in the TRAnscatheter Mitral valve Interventions (TRAMI) registry were divided into three groups according to echocardiographically graded systolic pulmonary artery pressure (sPAP) (Group 1: patients with sPAP of ≤36 mmHg; Group 2: patients with sPAP of 37-50 mmHg; Group 3: patients with sPAP of >50 mmHg) and followed for 1 year. Recent cardiac decompensation, aortic valve disease and tricuspid valve insufficiency were observed more frequently in patients with higher sPAP. Furthermore, logEuroSCORE, Society of Thoracic Surgeons score and age were higher with rising sPAP values. No differences were observed in mitral regurgitation (MR) severity, co-morbidities or clinical findings (New York Heart Association class, 6-min walking distance). Reduction to MR of grade 1 or lower was achieved more often in patients with lower sPAP levels (P = 0.01). In Groups 2 and 3, sPAP was reduced significantly. Major adverse cardiac or cardiovascular events (MACCEs) occurring in hospital (death, myocardial infarction, stroke; <4% in each group), as well as 30-day rates of MACCEs (6.1% in Group 1, 11.9% in Group 2, 12.4% in Group 3) and rehospitalization (18.9% in Group 1, 24.8% in Group 2, 24.8% in Group 3) did not differ significantly. At 1 year, differences in rates of mortality and MACCEs (20.3% in Group 1, 33.1% in Group 2, 34.7% in Group 3; P < 0.01) were significant. Both Groups 2 [hazard ratio (HR) 1.81, P = 0.0122] and 3 (HR 1.85, P = 0.0092) were independently predictive of death. Rehospitalization rates did not differ during follow-up., Conclusions: Despite higher mortality in patients with elevated sPAP, these data suggest the safety, feasibility and benefit of MitraClip therapy even in advanced stages of disease. An early approach might prevent the progress of pulmonary hypertension and improve outcomes., (© 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.)

Background: This is the first clinical report on experience in the use of the Gore embolic filter in carotid interventions. It was designed as a guidewire and embolic protection system in carotid, peripheral, and coronary interventions. The ability to capture debris is driven by the frame of the filter, which is designed to improve vessel wall apposition and allows a short landing zone., Methods: We report the results of the first 20 consecutive patients undergoing carotid artery stenting using the Gore embolic filter in our institution. We analyzed technical success as well as the occurrence of transient ischemic attack (TIA), stroke, or death periprocedurally and through 30 days of follow-up. Mean patient age was 72 years and 12 patients (60%) were male. Seven patients were symptomatic and 4 patients suffered recurrent neurological events., Results: Technical success was achieved in all procedures. In 1 patient, the retrieval catheter was caught between the proximal struts of the stent and required further retrieval maneuvers. Within 30 days of follow-up, 1 patient had a TIA. No stroke, death, or myocardial infarction occurred., Conclusion: This initial experience suggests that the Gore embolic filter device can be used safely for distal embolic protection during carotid stenting procedures with high technical success.

Background: There are few long term studies to show the safety and efficacy of iliac artery aneurysm exclusion, especially in regards to the straight iliac branched device. The objective of our study was to add our data with a mean follow-up of 32 months to the existing data available., Methods: Patients undergoing iliac bifurcation procedure either as standalone or in combination with abdominal aortic aneurysm exclusion at two vascular centers had data prospectively gathered between 2004 and 2014. Collected data was analyzed for baseline characteristics, procedural events, and clinical follow-up; variables included endoleaks, reinterventions, and internal iliac artery (IIA) closure., Results: A total of 45 iliac vessels in 41 patients (36 male) with a mean age of 70.4 years were treated with the iliac branched device. Procedural success was achieved in 85% (35/41) of patients and 87% (39/45) vessels with no intraoperative death. Of the six technical failures, three occurred due to failure to place the straight iliac branched device or stent properly. Two occurred because of endoleaks at the end of the procedure, and one occurred because the IIA side-branch occluded and could not be reopened. The mean patient follow-up was 32.0 ± 27.3 months (range, 0-109 months). During this time period, the IIA patency rate on an intention-to-treat basis was 81%, and the freedom from endoleak rate on an intention-to-treat basis was 76% per patient. The freedom from reintervention per patient was 75%. No patient reported symptoms of pelvic ischemia and permanent buttock claudication., Conclusions: In this study with mean follow-up of 32 months, treatment with iliac bifurcated devices is a safe and durable option in a carefully selected population of patients with iliac artery bifurcation aneurysms., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Patent foramen ovale (PFO) is associated with cryptogenic strokes and transient ischemic attacks (TIAs). This study examined the initial experience with a new PFO occluder, the Nit-Occlud® PFO Occlusion Device., Methods: Sixty-three patients with history of cryptogenic stroke or TIA and PFO underwent percutaneous closure of the defect with the Nit-Occlud® PFO Occlusion Device. The primary endpoint was successful implantation without recurrent event, device malfunction, embolization, or the need for a replacement device over 6 ± 2 weeks. All patients underwent transesophageal echocardiography (TEE) at 6-weeks, and 42 patients had repeat TEE at 6-months. Clinical follow-up at 18.7 ± 7.4 months was also performed., Results: The device was successfully implanted in 62 (98.4%) patients with no relevant procedural complications. At 6-week follow-up, 60 (95.2%) patients met the primary endpoint. A residual shunt at rest and with Valsalva was noted in 8 (12.7%) and 31 (49.2%) patients respectively at 6-week TEE. At 6-months, 1 of 42 (2.4%) and 9 of 42 (21.4%) patients had a residual shunt at rest and with Valsava, respectively. At 18 months, 5/63 patients had recurrent events (3 TIAs, 2 strokes). No device-related complications occurred. One patient developed atrial fibrillation., Conclusion: In patients with cryptogenic stroke or TIA and a PFO, the Nit-Occlud® PFO Occlusion Device appears to be both a safe and effective means to occlude the PFO. It is associated with high procedural success and favorable rates of complete closure., (© 2015 Wiley Periodicals, Inc.)

Transcatheter aortic valve implantation (TAVI) is rapidly evolving in Germany. Especially severe reduced left ventricular ejection fraction (LVEF) is known as a prominent risk factor for adverse outcome in open heart surgery. Thus, the data of the prospective multicenter German Transcatheter Aortic Valve Interventions Registry were analyzed for outcomes in patients with severe depressed LVEF. Data of 1,432 patients were consecutively collected after transcatheter aortic valve implantation. Patients were divided into 2 groups (A: LVEF ≤30%, n = 169, age 79.9 ± 6.7 years, logES 34.2 ± 17.8%; B: LVEF >30%, n = 1,263, age 82.0 ± 6.1 years, logES 18.9 ± 12.0%), and procedural success rates, New York Heart Association classification, and quality of life were compared at 30 days and 1 year, respectively. Technical success was achieved in 95.9% (A) and 97.6% (B). Survival and the New York Heart Association classification at 30 days demonstrated an excellent outcome in both groups. There was a significant improvement according to the self-assessment in health condition (0 to 100 scale) with a much larger gain in group A (28 vs 19 patients, p <0.0001). Nevertheless, low cardiac output syndrome (12.3% vs 5.9%, p <0.01) and resuscitation (10.4% vs 5.6%, p <0.05) were more frequently seen in group A, contributing to a higher mortality at 30 days (14.3% vs 7.2%) and 1 year (33.7% vs 18.1%, p <0.001). In conclusion, this real-world registry demonstrated a comparably high success rate for patients with severe reduced LVEF and an early improvement in functional status as demonstrated by substantial benefit, despite a doubled postprocedural mortality., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Aims: This analysis from the German Mitral Valve Registry investigates the impact of the learning curve with the MitraClip(®) technique on procedural success and complications., Methods and Results: Consecutive patients treated since 2009 in centers that performed more than 50 transcatheter mitral repairs were included. Results of the first half of the patients were compared to those of the second. Altogether 496 patients from 10 centers were included. Patients treated later had less common severe heart failure symptoms (patients with NYHA IV: 22.1 vs. 14.5 %, p < 0.05). The EuroSCORE I (22.0 vs. 23.0 %, p = ns) and Society of Thoracic Surgeons (STS) score (7.5 vs. 9.5 %, p = ns) did not differ between both groups. Procedural success was 95.6 % (238/249) in the first cases and 94.7 % (232/245, p = ns) subsequently. Also procedural time (104.3 vs. 119 min, p = ns) and complications did not decrease over time., Conclusion: A learning curve using the MitraClip(®) device does not appear to significantly affect acute MR reduction, hospital and 30-day mortality. Most likely, the proctor system leads to already high initial procedure success and relatively short procedure time.

Objective: To evaluate in-hospital and short-term outcomes of percutaneous mitral valve repair according to patients' logistic EuroSCORE (logEuroSCORE) in a multicenter registry, Background: The logEuroSCORE is an established tool to predict the risk of mortality during cardiac surgery. In high-risk patients percutaneous mitral valve repair with the MitraClip system represents a less-invasive alternative, Methods: Data from 1002 patients, who underwent percutaneous mitral valve repair with the MitraClip system, were analyzed in the German Transcatheter Mitral Valve Interventions (TRAMI) Registry. A logEuroSCORE (mortality risk in %) ≥ 20 was considered high risk, Results: Of all patients, 557 (55.6%) had a logEuroSCORE ≥ 20. Implantation of the MitraClip was successful in 95.5 % (942/986) patients. Moderate residual mitral valve regurgitation was more often detected in patients with a logEuroSCORE ≥ 20 (23.8% vs. 17.1%, respectively, P < 0.05). In patients with a logEuroSCORE ≥ 20 the procedural complication rate was 8.9% (vs. 6.4, n.s.) and the in-hospital MACCE rate 4.9% (vs. 1.4% P < 0.01). The in-hospital mortality rate in patients with a logEuroSCORE ≥ 20 and logEuroSCORE < 20 was 4.3 and 1.1%, respectively (P ≤ 0.01) CONCLUSION: Percutaneous mitral valve repair with the MitraClip system is feasible in patients with a logEuroSCORE ≥ 20 with similar procedural results compared to patients with lower predicted risk. Although mortality was four times higher than in patients with logEuroSCORE < 20, mortality in high risk patients was lower than predicted. In those with a logEuroSCORE ≥ 20, moderate residual mitral valve regurgitation was more frequent., (© 2014 Wiley Periodicals, Inc.)

Objectives: The aim of this analysis is to examine the influence of gender differences on the outcome after transcatheter aortic valve implantation (TAVI) from a multicenter real-world registry in Germany (TAVI registry)., Background: The impact of gender differences on the clinical outcome after TAVI was examined in small studies with conflicting results., Methods: Consecutive patients (n = 1,432) undergoing TAVI in the period between January 2009 and June 2010 in Germany were evaluated. Differences in all-cause mortality were examined with Kaplan-Meier estimates and proportional hazards models., Results: Women comprised 57.8 % of the cohort. The Edwards Sapien valve (18.5 %) and CoreValve (81.5 %) were used through the transfemoral (87.7 %), subclavian (3.0 %), transapical (8.6 %), or transaortic approach (0.7 %). At baseline, women had higher aortic gradients and were older. Men had more comorbidities: prior myocardial infarction, prior revascularization, prior coronary artery bypass surgery, peripheral arterial vascular disease and chronic obstructive pulmonary disease. Women had more periprocedural vascular complications in comparison to men (25.2 vs. 17.2 %, p < 0.001). There was no significant difference in mortality at 30-day follow-up (7.6 % for women vs. 8.6 % for men, p = 0.55). The adjusted HR for 1-year all-cause mortality favored women, HR 0.75 (95 % CI 0.57-0.98, p = 0.0346) with a mortality rate of 17.3 vs. 23.6 % for men., Conclusions: Female gender is associated with better 1-year survival after TAVI. These results suggest that TAVI could be the best treatment modality for elderly women with symptomatic severe aortic stenosis.

Objective: Residual aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) has been associated with increased mortality. Nevertheless, a considerable proportion of these patients survives and appears to tolerate AR. Identification of patients at higher risk of death may assist in tailoring therapy, but predictors of mortality in this subset of patients is largely unknown., Methods: A total of 1432 patients were included in the German TAVI registry. One-year follow-up data were available for 1318 patients (92%). Of the latter, 201 patients (15.2%) had more-than-mild AR as evaluated by angiography and represent the population of the current analysis. Among these patients, baseline demographic, clinical, echocardiographic and angiographic characteristics were compared among survivors and non-survivors to identify factors associated with mortality at 1 year., Results: Mean age was 81.2±6.6 years and men represented 55%. The mean logistic EuroSCORE was 22±15%. Overall, 92% of patients received the Medtronic CoreValve and 8% received the Edwards Sapien valve. At 1 year, 61 patients (31%) with more-than-mild post-TAVI AR had died. Compared with patients who survived, patients who died had more commonly coronary artery disease, peripheral arterial disease and chronic renal impairment. Patients who died had a lower baseline LVEF (44±18% vs 52±16%, p=0.002), higher prevalence of more-than-mild (≥2+) mitral regurgitation (44% vs 27%, p=0.001), and a higher systolic pulmonary artery pressure (51±18 mm Hg vs 44±19 mm Hg, p=0.002), but the severity of aortic stenosis was similar, and the prevalence and severity of pre-TAVI AR was comparable (any AR in 88% vs 83%, respectively, p=0.29). Using Cox regression analysis, only baseline mitral regurgitation ≥2+ (HR 1.77, 95% CI 1.05 to 2.99, p=0.03) and systolic pulmonary artery pressure (HR 1.15, 95% CI 1.01 to 1.33, p=0.04) were independently associated with 1-year mortality, while female gender was protective (HR 0.54, 95% CI 0.30 to 0.96, p=0.03)., Conclusions: We identified preprocedural characteristics associated with 1-year mortality in patients with more-than-mild AR after TAVI. More-than-mild baseline mitral regurgitation, higher systolic pulmonary artery pressure and male gender were independently associated with worse outcome., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objectives: To determine the procedural safety, safety, and efficacy of left atrial appendage (LAA) occlusion in octogenarians., Background: Elderly patients with atrial fibrillation (AF) often do not receive appropriate anticoagulation. LAA occlusion is an option for patients with AF and contraindications to anticoagulation. Not much is known about the procedural safety and clinical efficacy of LAA occlusion in the very elderly., Methods: A retrospective review of LAA cases at our institution between 2002 and 2013 in patients 80 years of age or older was performed. Demographic, echocardiographic, procedural, and clinical follow-up data were collected., Results: Seventy-five cases were attempted in patients 80 years of age or older (average age 83.4 ± 2.8 years, 53.3% males). Hypertension, coronary artery disease, and heart failure were present in 96, 41.3, and 36%, respectively. Mean CHADS2 and CHA2DS-VASc scores were 3.3 and 5.2. Devices used included the WATCHMAN, ACP, PLAATO, Lariat, and Coherex devices, which were attempted in 34.7, 36, 17.3, 5.3, and 5.3%, respectively. Overall procedural success, safety endpoint, and 1-year device efficacy was 90.1, 3.9, and 97.4%, respectively., Conclusion: LAA closure is a safe and efficacious method of stroke prevention in the very elderly with AF., (Copyright © 2013 Wiley Periodicals, Inc.)

Patients with bicuspid aortic valves (BAVs) are considered a relative contraindication to transcatheter aortic valve implantation (TAVI). One of the main reasons is the presumed risk for residual aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV. Within the large German TAVI Registry, we sought to evaluate TAVI in older high-risk patients with BAV. From January 2009 to June 2010, a total of 1,424 patients with severe aortic stenosis undergoing TAVI were prospectively enrolled into the German TAVI Registry. For the present analysis, patients with valve-in-valve procedures were excluded and those with BAV (n = 38, 3%) were compared with those with tricuspid aortic valve (TAV; n = 1357, 97%). Patient characteristics did not markedly differ and procedural success was very high in both groups. There was a higher rate of relevant AR (≥II) after TAVI among patients with BAV (25 vs 15%, p = 0.05), whereas pacemakers were more often implanted in patients with TAV (17% vs 35%, p = 0.02). Thirty-day mortality rate was similar in both cohorts (11% vs 11%). In a Cox proportional regression analysis, BAV was not associated with higher 1-year mortality rate (hazard ratio 0.64, 95% confidence interval 0.29 to 1.41). In selected patients with BAV, TAVI can be performed with a satisfactory clinical result. Although the risk for relevant AR seems to be greater among patients with BAV, 30-day and 1-year mortality rates were not elevated compared with patients with TAV., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: With pilonidal sinus disease (PSD) incidence increasing, lifestyle issues have been suspected to be responsible to worsen the results of PSD surgery at the same time. The influence of smoking and body mass index (BMI) on long-term recurrence rate in primary PSD surgery has not been investigated yet., Methods: A total of 534 patients (German military cohort) were analyzed, comparing the wound healing rates of non-smoker with smoker, as well as recurrence rates in either groups. Simultaneously, the impact of BMI on wound healing and recurrence was studied. Recurrence rate was determined by Kaplan-Meier calculation following up to 20 years after primary PSD surgery., Results: Using primary open surgery, smokers' and non-smokers' recurrence rates did not differ statistically (p = 0.83; log rank). Comparable rates occurred following the primary midline closure technique (p = 0.14; log rank). A BMI of 25 and higher was not associated with adverse wound healing neither in the primary midline closure (p = 0.14) nor in the primary open treatment group (p = 0.3); nevertheless, a trend may be seen that a BMI of 25 and above could assist a favorable wound healing rate., Conclusions: The lifestyle parameter smoking and body weight statistically do not complicate wound healing or long-term recurrence rates for the first 20 years following primary PSD surgery in this study. As the BMI of 25 and above may have a beneficial influence on wound healing in primary open and primary midline closure, this observation has to be investigated for the today's surgical procedures of elective first choice-asymmetrical and flap procedures.

Objectives: To determine the incidence of symptomatic recurrent embolic events after patent foramen ovale (PFO) closure and potential causes for these events., Background: It is well-known that cerebral or other embolic events may occur after PFO closure., Methods: This is a retrospective analysis of consecutive patients who underwent PFO closure for secondary prevention of embolic events at a single institution., Results: 1,930 patients (mean age of 50 ± 13.3 years) underwent transcatheter PFO closure. Complete closure occurred in 92%. The annual recurrence rate of embolic events before PFO closure was 22.4% (785 events in 3,497 patient-years). During follow-up (mean 39 months), 63 recurrent events were documented: 25 strokes, 36 transient ischemic attacks (TIAs), and 2 peripheral embolic events. The overall annual recurrence rate after the procedure was 1% per year (63 events in 6,211 patient-years). The majority of events occurred in patients without residual shunts (54/63). There was no significant association between the presence of a residual shunt and recurrent events [hazard ratio (HR) 1.7; 95% confidence interval (CI) 0.8-3.6, P = 0.16]. The most common cause for recurrent events was atherosclerosis. Nine out of 63 events were considered likely or possible paradoxical embolism due to residual shunt [stroke (2), TIA (5), and peripheral embolism (2)]. After PFO closure, the annual rate of events potentially related to paradoxical embolism was 0.14% (9 events in 6,211 patient-years)., Conclusion: The incidence of symptomatic embolic events after PFO closure is low. Most recurrent events are related to coexistent conditions associated with thromboembolic risk rather than residual shunts., (Copyright © 2012 Wiley Periodicals, Inc.)

Objectives: To determine predictors of permanent pacemaker (PPM) implantation up to 30 days after transcatheter aortic valve implantation (TAVI) in a prospective multicenter registry., Background: Conduction disorders requiring PPM implantation are one of the most common complications seen after TAVI. Knowledge about possible predictors may help to decrease the rate of PPM implantations., Methods: In total, 1347 consecutive patients who underwent TAVI in 22 centers were prospectively enrolled in the German transcatheter aortic valve interventions registry. Both Medtronic CoreValve™ and Edwards Sapien™ valves were implanted. Patients with preprocedurally implanted PPM or implantable cardioverter defibrillator were excluded from the analysis (n = 199). Regression analysis of baseline and procedure characteristics of the remaining 1,147 patients was performed., Results: Procedural success was achieved in 97.4% of the cases. The rate for PPM after TAVI was 33.7%. The absence of prior valve surgery, the use of Medtronic CoreValve™ prosthesis and the presence of a porcelain aorta were identified as independent predictors for PPM after TAVI. Mortality at 30 days did not differ between patients with or without PPM necessity (6.0% vs. 8.1%, respectively; HR 0.72; CI (0.45-1.16); P = 0.17)., Conclusions: PPM is a common postprocedure requirement after TAVI. The absence of prior valve surgery, the implantation of Medtronic CoreValve™ prosthesis, and the presence of a porcelain aorta were independently associated with PPM after TAVI., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: Transcatheter aortic valve implantation (TAVI) was developed as a promising new therapy for inoperable and surgical high-risk patients as an alternative to traditional aortic valve replacement. After a successful procedure, prognosis may mainly be determined by comorbidities. However, no appropriate risk score to predict long-term outcome following TAVI is currently available. The aim of this study was to identify predictors of adverse short- and long-term outcomes., Methods: This is a two-centre registry study including a total of 426 TAVI procedures (274 transfemoral [TF] and 152 transapical [TA]) performed at the University Hospital and CardioVascular Center of Frankfurt (Germany) between 2005 and 2011., Results: Observed 30-day mortality was 4.8% among TF and 12.6% among TA patients (hazard ratio [HR] TF vs TA was 0.38; 95% confidence interval [CI] 0.19-0.77). Patients with a higher Society of Thoracic Surgeons (STS) score experienced a 6% elevation in the 30-day mortality per point (HR 1.06; 95% CI 1.03-1.10), whereas the predictive value of the logistic EuroSCORE (HR 1.03; 95% CI 1.01-1.05) and EuroSCORE 2 (HR 1.04; 95% CI 1.01-1.07) was slightly lower. Most interestingly, older age (>80 years) and the access type were predictors of 30-day mortality. However, the only independent predictor of long-term mortality in a 30-day landmark analysis was the STS score (HR 1.05; 95% CI 1.02-1.09)., Conclusions: The STS score outperforms the logistic EuroSCORE in predicting adverse outcomes following TAVI. The transapical approach is associated with higher perioperative mortality, but does not exert any influence on long-term prognosis beyond the periprocedural phase.

Aims: The influence of age on baseline demographics and outcomes of patients selected for MitraClip has not been previously investigated., Methods and Results: Baseline demographics and acute outcomes in 1,064 patients from the German TRAMI registry were stratified by age (525 patients ≥76 years and 539 patients <76 years). In elderly patients, logistic EuroSCORE was higher (25[15-40]% vs. 18[10-31]%, p<0.0001) and the proportion of women was greater (47.2% vs. 29.3%, p<0.0001). Elderly patients were more likely to have preserved left ventricular ejection fraction >50% (40.1% vs. 21.8%, p<0.0001) and degenerative mitral regurgitation (DMR, 35.3% vs. 25.6%, p<0.01). Age was the most frequent reason for non-surgical treatment in the elderly (69.4% vs. 36.1%, p<0.0001). The intrahospital MACCE (death, myocardial infarction, stroke) was low in both groups (3.5% vs. 3.4%, p=0.93) and the proportion of non-severe mitral regurgitation at discharge was similar (95.8% vs. 96.4%, p=0.73). A logistic regression model did not reveal any significant impact of age on acute efficacy and safety of MitraClip therapy. In both groups, the majority of patients were discharged home (81.8% vs. 86.2%, p=0.06)., Conclusions: Elderly and younger patients have similar benefits from MitraClip therapy. Age was the most frequent cause for denying surgery in elderly patients.

Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis., Patients and Methods: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex., Results: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months., Conclusions: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.

The presence of severe atherosclerosis of the ascending aorta, and its extreme form the "porcelain" aorta, is associated with a worse clinical outcome in patients undergoing surgical aortic valve replacement. Percutaneous transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis can overcome this problem: 1,374 TAVI procedures were performed at 27 hospitals in 147 patients (10.7%) with and 1,227 (89.3%) without a porcelain aorta. The mean reported prevalence of a porcelain aorta at the hospitals was 7.8% ± 14.8% (range 0% to 70%). Diabetes mellitus (46.3% vs 33.2%, p = 0.00018), chronic obstructive pulmonary disease (43.5% vs 22.2%, p <0.0001), and peripheral arterial obstructive disease (34.7% vs 20.0%, p <0.0001) were more prevalent in patients with a porcelain aorta. In patients with a porcelain aorta, coronary ischemia occurred more often (2.0% vs 0.1%, p <0.0001), with a tendency toward a greater stroke rate (5.5% vs 2.8%, p = 0.08), greater in-hospital death rate (10.9% vs 8.1%, p = 0.24), and greater death or stroke rate (14.4% vs 10.2%, p = 0.12). On multivariate analysis, the presence of a porcelain aorta was not associated with in-hospital death (odds ratio 1.36, 95% confidence interval 0.72 to 2.55, p = 0.3441) nor in-hospital death or stroke (odds ratio 1.50, 95% confidence interval 0.81 to 2.47, p = 0.2207). In conclusion, in this real-world TAVI registry, a "porcelain" aorta was diagnosed in almost every tenth patient. Although differences were found in its frequency among the participating hospitals, the presence of a porcelain aorta was not associated with in-hospital death or stroke., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis., Background: Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated., Methods: We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator., Results: Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions., Conclusions: Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly., (Copyright © 2012 Wiley Periodicals, Inc.)

Objective: To examine the prevalence and impact of concomitant coronary artery disease (CAD) on short-term outcome after transcatheter aortic valve implantation (TAVI)., Background: The prevalence of CAD in patients undergoing surgical aortic valve replacement is estimated at 30-50 % and its presence increases procedural risk. The prevalence and impact of CAD on outcome after TAVI are not well defined., Methods: We analyzed 1,382 patients enrolled in the German TAVI registry; the majority (81 %) received the Medtronic CoreValve. The presence of coronary lesions with ≥50 % stenosis on pre-TAVI angiography defined the existence of concomitant CAD., Results: 859 patients (62.2 %) had concomitant CAD, of which 534 (62.3 %) had multi-vessel and 83 (9.7 %) left main disease. Patients with CAD were younger (81.5 ± 6.1 vs. 82.1 ± 6.3 years, p < 0.05), more commonly males (49.4 vs. 30.0 %, p < 0.0001) and diabetics (36.9 vs. 31.2 %, p < 0.05), and had a worse Canadian Cardiovascular Society angina class at baseline compared to patients with no CAD. During TAVI patients with CAD more often required additional coronary intervention and had longer procedures, but procedural success rates were similar (97.1 vs. 97.7 %). Crude in-hospital mortality was higher in patients with CAD (10.0 vs. 5.5 %, OR 1.90, 95 % CI 1.23-2.93), but this was not significant after adjustment for confounders (adjusted OR 1.41, 95 % CI 0.85-2.33). Both groups had significant improvement in 30-day symptoms and quality of life., Conclusion: The prevalence of CAD in contemporary TAVI patients is high. Its presence characterizes a high-risk population and is associated with increased crude short-term mortality, largely explained by co-morbidities, but does not limit functional improvement after TAVI.

Aims: A substantial percentage of patients with mitral regurgitation (MR) in need of mitral valve repair are currently considered not suitable for conventional surgery. In Germany, the largest cohort of patients studied to date has been treated using a percutaneous, catheter-based approach. We report the acute outcomes of patients enrolled in the investigator-initiated German transcatheter mitral valve interventions (TRAMI) registry., Methods and Results: Between January 2009 and August 2011, 486 patients [median age 75 (interquartile range 70-80) years; 200 women (41%)] were enrolled in the registry (309 retrospectively and 177 prospectively), with 481 patients (99%) having undergone percutaneous edge-to-edge therapy for MR using the MitraClip. At baseline, 93% of patients were in New York Heart Association (NYHA) functional class III or IV and 71% of patients had a left ventricular ejection fraction (LVEF) ≤50%. Two-thirds of patients presented with functional MR. Procedural success was achieved in 94% of patients, with grade III present in 93% of patients at baseline yet only 6% post-intervention. Retrospective patients were followed for a median of 183 days, prospective patients for a median of 44 days. The periprocedural complication rate was low, with only minor bleedings as the most significant event. In-hospital and post-discharge mortality was 2.5% and 12.5%, respectively., Conclusions: Data from the German TRAMI registry suggest that MitraClip therapy is a viable treatment option in daily clinical routine for high surgical risk patients with significant MR.

Background: A significant proportion of patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant peripheral arterial disease (PAD), which plays a crucial role in the preinterventional selection process of determining an optimal vascular access site. The aim of our study was to determine the impact of PAD on clinical outcome after TAVI in a real-world setting., Methods: A total of 1,315 patients (mean logistic European System for Cardiac Operative Risk Evaluation 20.6% ± 13.7%) underwent TAVI in 27 centers and were included in the prospective German TAVI Registry., Results: Of the 1,315 patients with TAVI, 330 (25.1%) had PAD. These patients had a higher logistic European System for Cardiac Operative Risk Evaluation score (27.7% ± 16.0% vs 18.3% ± 12.0%, P < .0001), mainly attributed to more frequent and severe comorbidities. Compared with patients without PAD, patients with PAD had a higher rate of vascular complications (28.5% vs 20.7%, P < .01), dialysis-dependent renal failure (11.2% vs 5.4%, P < .001), myocardial infarction (1.2% vs 0.3%, P < .05), and, subsequently, 30-day mortality (12.7% vs 6.9%, P < .001). Choosing a surgical approach, for example, transapical access, did not reduce the periprocedural risk associated with PAD; in-hospital mortality was 15.7% for surgical and 10.5% for percutaneous patients with TAVI having PAD (P < .001). In a multivariate regression analysis, PAD was an independent predictor of 30-day mortality (hazard ratio 1.8, 95% CI 1.2-2.7, P = .004) after TAVI., Conclusions: In this real-world TAVI Registry, PAD was an independent predictor of mortality in patients with percutaneous and surgical TAVI, including vascular complications. Assessment of PAD should play a crucial role in the preinterventional selection process, regardless of the access strategy., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Objectives: The purpose of this study was to evaluate the efficacy and outcome of transcatheter aortic valve implantation (TAVI) in patients with low-flow, low-gradient aortic stenosis (LG-AS)., Background: Patients with LG-AS have a poor prognosis with medical treatment and a high risk for surgical aortic valve replacement., Methods: Between January 2009 and June 2010, a total of 1,302 patients underwent TAVI for severe AS and were prospectively included in the multicenter German TAVI registry., Results: LG-AS was present in 149 patients (11.4%; mean age: 80.2 ± 6.3 years). In this subgroup, the EuroSCORE was significantly higher (26.8 ± 16.6 vs. 20.0 ± 13.3; p < 0.0001) compared with patients with high-gradient AS (HG-AS). The procedural success rate (LG-AS: 95.3% vs. HG-AS: 97.5%; p = 0.13) and the rate of TAVI-associated complications were comparable in both groups (new pacemaker: 27.0% vs. 28.1%; p = 0.76; cerebrovascular events: 3.4% vs. 3.1%, p = 0.83). However, post-operative low-output syndrome occurred more frequently in the LG-AS-group (LG-AS: 14.9% vs. HG-AS: 5.7%, p < 0.0001), and mortality at 30 days and 1 year was significantly higher in this subgroup (LG-AS: 12.8% and 36.9% vs. HG-AS: 7.4% and 18.1%; p < 0.001 and p < 0.0001, respectively). Post-operative New York Heart Association functional class improved, and self-assessed quality of life increased significantly, demonstrating a substantial benefit in the LG-AS group at 30 days and 1 year after TAVI., Conclusions: In high-risk patients with LG-AS, TAVI is associated with a significantly higher mortality at 30 days and at 1 year. However, long-term survivors benefit from TAVI with functional improvement and a significantly increased quality of life. Therefore, in view of the poor prognosis with medical treatment, TAVI should be considered an option in high-risk patients with LG-AS., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: This study evaluates the correlation between closed, semi-closed and open-cell stent design and the association between stent type and clinical outcome as well as magnetic resonance imaging (MRI) findings., Design: A total of 194 patients who underwent unprotected carotid artery stenting (CAS) as well as diffusion-weighted magnetic resonance imaging (DW-MRI) before and after intervention were retrospectively reviewed., Materials and Methods: Three stent designs were studied: closed cell, semi-closed cell and open cell. Spearman's Rho test was performed between the stent free cell area and the number and area of ischaemic lesions found after intervention. Adverse events were evaluated., Results: There was no significant difference in clinical outcome between the three stent groups (Zilver, Cook Europe, Denmark; Smart, Codman, MA; and Wallstent, Stryker, MN, USA). A significant correlation was found between the stent free cell area and the number and area of new ischaemic lesions on DW-MRI (P = 0.023). There were significantly fewer new lesions with an open-cell design (Zilver; 12.76 mm(2) free cell area) than with a closed-cell design (Wallstent; 1.08 mm(2) free cell area)., Conclusions: Open-cell stent was related to a lower number and area of silent cerebral ischaemic lesions after unprotected CAS. However, clinical outcome, measured by incidence of adverse events and clinical neurologic assessment, was not significantly different between patients with different stent designs., (Copyright © 2011. Published by Elsevier Ltd.)

Aims: Treatment of elderly symptomatic patients with severe aortic stenosis and co-morbidities is challenging. Transcatheter aortic valve interventions [balloon valvuloplasty and transcatheter aortic valve implantation (TAVI)] are evolving as alternative treatment options to surgical valve replacement. We report the first results of the prospective multi-centre German Transcatheter Aortic Valve Interventions-Registry., Methods and Results: Between January 2009 and December 2009, a total of 697 patients (81.4 ± 6.3 years, 44.2% males, and logistic EuroScore 20.5 ± 13.2%) underwent TAVI. Pre-operative aortic valve area was 0.6 ± 0.2 cm² with a mean transvalvular gradient of 48.7 ± 17.2 mmHg. Transcatheter aortic valve implantation was performed percutaneously in the majority of patients [666 (95.6%)]. Only 31 (4.4%) procedures were done surgically: 26 (3.7%) transapically and 5 (0.7%) transaortically. The Medtronic CoreValve™ prosthesis was used in 84.4%, whereas the Sapien Edwards™ prosthesis was used in the remaining cases. Technical success was achieved in 98.4% with a post-operative mean transaortic pressure gradient of 5.4 ± 6.2 mmHg. Any residual aortic regurgitation was observed in 72.4% of patients, with a significant aortic insufficiency (≥Grade III) in only 16 patients (2.3%). Complications included pericardial tamponade in 1.8% and stroke in 2.8% of patients. Permanent pacemaker implantation after TAVI became necessary in 39.3% of patients. In-hospital death rate was 8.2%, and the 30-day death rate 12.4%., Conclusion: In this real-world registry of high-risk patients with aortic stenosis, TAVI had a high success rate and was associated with moderate in-hospital complications. However, careful patient selection and continued hospital selection seem crucial to maintain these results.

From 1 January 2007, requirements concerning animal welfare were introduced with effect to cross-compliance. Farmers receiving single payment as well as agri-environmental payments (payments of second pillar) shall respect the statutory management requirements of the following 3 directives in the area of animal welfare: Council Directive 91/629/EEC laying down minimum standards for the protection of calves; Council Directive 91/630/EEC laying down minimum standards for the protection of pigs; Council Directive 98/58/EC concerning the protection of animals kept for farming purposes. The competent authority shall carry out annual systematic inspections on at least 1% of all farmers submitting payments on the basis of a risk analysis and partly at random. In case of non-compliance with the conditions due to specific rules, there will be a reduction or cancellation of the payments to be granted in the calendar year in which non-compliance occurs. Cross-compliance controls should take place on the basis of documented procedures so as to ensure that these controls are carried out uniformly and are of a consistently high quality. For this purpose, a working group composed of representatives from the Federal Ministry of Food, Agriculture and Consumer Protection and from the Lander developed uniform control reports in order to monitor compliance and a guidance booklet for control execution of animal welfare requirements. In the control report (Level 1), the outcomes of inspections of all systematic testable animal welfare requirements are summarized in 6 items. Furthermore, the non-systematically testable requirements are integrated in the control report as a independent item. The guidance booklet (Level 2) with a matrix of validation serves as a specification for on-the-spot checks. Where appropriate, on-the-spot checks provided for cross-compliance and any other checks in animal welfare rules as well as requirements to animal identification and registration shall be carried out at the same time in Baden-Württemberg (integrated control system). Farmers subjected to on-the-spot checks shall be selected on the basis of a centralized common risk analysis and partly at random. This is the best way of safeguarding that the control rate will not be much higher than the established 1% with a minimum administrative burden and costs for farmers and competent control authorities. Integrated check lists for on-the-spot checks were established which take into account systematic cross compliance inspections to improve compliance with 3 existing standards in the area of animal welfare and official controls as proved in Council Directives concerning animal welfare and Regulation (EC) No 882/2004. All staff of the competent authorities performing controls received, for their area of competence, appropriate training enabling them to make their duties competently and to carry out controls in a consistent manner. Integrated systematic controls are very time-consuming and a burden for farmers and the competent authorities. For the beginning of this year, we will expect a discharge by Decision (EC) 2006/778. A controlling system was installed to ensure that cross compliance rules are applied consistently, for example by making subsequent controls by controlling institutions.

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.