Transfemoral aortic valve implantation: procedural hospital volume and mortality in Germany.

AIMS: Studies assessing transfemoral transcatheter aortic valve implantation (TF-TAVI) showed lower rates of in-hospital mortality at high-volume hospitals and minimum caseloads were recommended to assure quality standards. METHODS AND RESULTS: All patients in the German mandatory quality assurance registry with elective or urgent TF-TAVI procedures in 2018 and 2019 at 81 and 82 hospitals, respectively, were analysed. Observed in-hospital mortality was adjusted to expected mortality by the German AKL-KATH score (O/E) as well as by the EuroScore II (O/E2). Hospital volume and O/E were correlated by regression analyses and volume quartiles. 18 763 patients (age: 81.1 ± 1.0 years, mean EuroSCORE II: 6.9 ± 1.8%) and 22 137 patients (mean age: 80.7 ± 3.5 years, mean EuroSCORE II: 6.5 ± 1.6%) were analysed in 2018 and 2019, respectively. The average observed in-hospital mortality was 2.57 ± 1.83% and 2.36 ± 1.60%, respectively. Unadjusted in-hospital mortality was significantly inversely related to hospital volume by linear regression in both years. After risk adjustment, the association between hospital volume and O/E was statistically significant in 2019 (R2 = 0.049; P = 0.046), but not in 2018 (R2 = 0.027; P = 0.14). The variance of O/E explained by the number of cases in 2019 was low (4.9%). Differences in O/E outcome between the first and the fourth quartile were not statistically significant in both years (1.10 ± 1.02 vs. 0.82 ± 0.46; P = 0.26 in 2018; 1.16 0 .97 vs. 0.74 ± 0.39; P = 0.084 in 2019). Any chosen volume cut-off could not precisely differentiate between hospitals with not acceptable quality (>95th percentile O/E of all hospitals) and those with acceptable (O/E ≤95th percentile) or above-average (O/E < 1) quality. For example, in 2019 a cut-off value of 150 would only exclude one of two hospitals with not acceptable quality, while 20 hospitals with acceptable or above-average quality (25% of all hospitals) would be excluded. CONCLUSION: The association between hospital volume and in-hospital mortality in patients undergoing elective TF-TAVI in Germany in 2018 and 2019 was weak and not consistent throughout various analytical approaches, indicating no clinical relevance of hospital volume for the outcome. However, these data were derived from a healthcare system with restricted access to hospitals to perform TAVI and overall high TAVI volumes. Instead of the unprecise surrogate hospital volume, the quality of hospitals performing TF-TAVI should be directly assessed by real achieved risk-adjusted mortality.

The role of trigger factors in the occurrence of appropriate ICD shocks and their clinical and prognostic implications.

BACKGROUND: The role of triggers in the occurrence of appropriate implantable cardioverter-defibrillator (ICD) shocks due to ventricular tachyarrhythmias is not well known. The aim of the study was to assess the prevalence of trigger factors in appropriate ICD shocks and to analyze their prognostic impact on clinical outcome. METHODS: A total of 710 consecutive patients of a prospective single-center ICD-registry who received a first appropriate ICD shock between 2000 and 9/2021 were analyzed. RESULTS: In 35% of ICD patients with first ICD shock, at least one of the following triggers was found: Ischemia (22%), Compliance (9%), Decompensation (38%), Stress (12%), Technical (5%), Electrolyte/endocrinological disorder (22%) and Medication side effects (4%). The trigger factors can be summarized under the acronym ICD-STEMi. The prospective application of the ICD-STEMi scheme increased the rate of identified triggers from 32% to 56% (p < .001). Patients with triggered first ICD shock had an increased 5-year mortality rate (50% vs. 38%, p < .001). Patients with triggers did not show different mortality outcomes or recurrent ICD shocks whether they received arrhythmia therapy or not. CONCLUSIONS: The evaluation of trigger factors after the occurrence of ICD shocks is mandatory and can be systematically evaluated using the acronym ICD-STEMi. Systematic evaluation of triggers using the ICD-STEMi scheme can identify triggers in about half of ICD patients with first appropriate ICD shock. Patients with triggered ICD shock have a 12% higher 5-year mortality rate.

[Prehospital resuscitation : Current status, results and strategies for improvement in Germany]. / Prähospitale Reanimationen : Aktueller Stand, Ergebnisse und Verbesserungsansätze in Deutschland.

Out-of-hospital cardiac arrest (OHCA) is one of the most frequent causes of death in Europe and is associated with a dismal prognosis. The annual incidence in Germany is approximately 100-120 per 100,000 inhabitants (ca. 80,000-100,000 cases). With the use of cardiopulmonary resuscitation (CPR) about 40% of patients have a return of spontaneous circulation (ROSC); however, after OHCA only 15% of patients survive for 30 days and less than 10% survive with no or only minor neurological deficits. Data from the German Resuscitation Register demonstrate that there was no change in the results over the last 15 years, despite all medical innovations, higher rates of coronary interventions, higher use of mechanical support systems and improvement in intensive care treatment. A high proportion of patients with OHCA have a cardiac or coronary cause. As shown by the data from the German Cardiac Arrest Register (G-CAR) an early coronary angiography is often carried out after CPR in Germany; however, in randomized clinical studies an immediate coronary angiography in patients with non-ST segment elevation in the electrocardiogram (ECG) was not associated with an improvement in the prognosis. In large randomized studies the use of mechanical CPR systems and the implantation of mechanical circulatory support devices after OHCA also did not lead to a reduction in mortality. The most important impact factor for the success of CPR is the time interval between collapse and start of CPR, if possible also by bystander resuscitation. Therefore, the focus of efforts for improving CPR should be on increasing the rate of patients with early CPR. Experiences from Denmark and The Netherlands indicate that this can be successful by education and training of the general population, telephone resuscitation and apps for alerting lay persons.

Healthcare provision of transcatheter aortic valve implantation in Germany.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) for aortic stenosis in older patients is the standard of care with a well-established supply density in Germany. In the near future, healthcare reform is planned that may affect TAVI capacities. Therefore, it is important to know how political regulations may interfere with access to services and what the need for TAVI will be in the future, based on demographic trends. METHODS: The number of TAVI procedures (DRG F98A +F98) and the in-hospital main diagnoses of aortic stenosis (ICD I35) in 2021 were analyzed at the level of county or federal state based on anonymized data from hospital reports, according to § 21 of the German hospital reimbursement law. The number of TAVI and aortic stenosis cases was projected for 2035 based on data from the German Federal Statistical Office on demographic developments. With quality assurance data from hospitals in 2019 and a route planner, the travel time to the next hospital performing TAVI (OPS 5­35a.0) was calculated, and the consequence of a politically suggested minimum volume cut-off was analyzed. RESULTS: In 2021, a total of 26,506 TAVI procedures were reported with a mean number of TAVI per 100,000 inhabitants of 32 (range between federal states from 25 to 42). Among the 66,045 diagnoses of aortic stenosis, there was a variation per 100,000 inhabitants from 64 to 108 (mean 79) between federal states. Compared to 2021, an additional 8748 (+13%) diagnoses of aortic stenosis and an increase of 4673 (+18%) TAVI procedures is to be expected in 2035. In 2019, 57% of German citizens could reach a TAVI hospital within 30 min and 91% within 60 min of driving time by car (mean time to hospital 31 min). Applying a minimum number of 150 TAVI/hospital per year would increase the driving time to hospital from 33 to 52 min in Saxony-Anhalt and instantly remove six out of eight hospitals from service in Hesse. CONCLUSION: Regulation of TAVI services by minimum volume numbers would arbitrarily interfere with access to services, in contradiction to the medical service assurance tasks of federal state governments. These issues should be considered in the upcoming healthcare system reform.

Management of the COVID-19 pandemic in Rhineland-Palatinate hospitals of all levels of care : Results of the COVID-19 Registry RLP.

The COVID-19 pandemic placed a significant burden on the German healthcare system. Based on the experience of severe disease progression of the SARS-CoV­2 infection from neighboring European countries in the early 2020s, with ICU overload and high mortality rates, efforts were made in Germany to increase the capacity of available ICU beds. Subsequently, all documentation and reporting focused on the ICU capacities for COVID-19 patients. It was hypothesized that mainly a few large hospitals provided care for the majority of COVID-19 patients. The COVID-19 Registry RLP of Rhineland-Palatinate documented SARS-CoV­2 inpatients from daily mandatory queries of all hospitals throughout the pandemic from April 2020 to March 2023, distinguishing between patients in ICUs and normal wards. In its 18th Corona Ordinance, the state government required all hospitals to participate in the care of SARS-CoV­2 inpatients. We investigated the participation of hospitals at different levels of care in Rhineland-Palatinate in the management of the COVID-19 pandemic. Nine pandemic waves were documented during the pandemic and exemplary data on the respective pandemic peaks were evaluated. A distinction was made between the burden on hospitals at different levels of care: primary care hospitals, standard care hospitals, specialty hospitals, and maximal care hospitals. Analysis of the data showed that all hospital types participated equally in the care of SARS-CoV-2 patients. The requirement of the Ministry of Health of Rhineland-Palatinate to provide at least 20% of the available capacity was met by all levels of care and there were no disparities between hospitals of different levels of care in the management of the pandemic.Hospitals at all levels of care participated equally in the care of SARS-CoV­2 inpatients and thus contributed significantly to the management of the pandemic in Rhineland-Palatinate.

Current status of antithrombotic therapy and in-hospital outcomes in patients with atrial fibrillation undergoing percutaneous coronary intervention in Germany.

BACKGROUND: Little is known about current patterns of antithrombotic therapy in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) in clinical practice in Germany. METHODS: The RIVA-PCI is a prospective, non-interventional, multicenter study with follow-up until hospital discharge including consecutive patients with AF undergoing PCI. RESULTS: Between January 2018 and March 2020, 1636 patients (elective in 52.6%, non-ST elevation acute coronary syndrome [NSTE-ACS] in 39.3%, ST-elevation myocardial infarction in 8.2%) from 51 German hospitals were enrolled in the study. After PCI a dual antithrombotic therapy (DAT) consisting of OAC and a P2Y12 inhibitor was given to 66.0%, triple antithrombotic therapy (TAT) to 26.0%, dual antiplatelet therapy to 5.5%, and a mono-therapy to 2.5% of the patients. Non-vitamin K antagonist oral anticoagulants (NOACs) were given to 82.4% and vitamin K antagonists to 11.5% of the patients. In-hospital events included death in 12 cases (0.7%), myocardial infarction, stent thrombosis, and ischemic stroke in four (0.2%) patients each, while 2.8% of patients had bleeding complications. The recommended durations for DAT or TAT at discharge were 1 month (1.5%), 3 months (2.1%), 6 months (43.1%), and 12 months (45.6%), with a 6-month course of DAT (47.7%) most often recommended after elective PCI and a 12-month course of DAT (40.1%) after ACS. CONCLUSION: The preferred therapy after PCI in patients with AF is DAT with a NOAC and clopidogrel. In-hospital ischemic and bleeding events were rare. The recommended durations for combination therapy vary considerably.

Quality of life of patients with coronary heart disease treated with the bioresorbable vascular scaffold (ABSORB™): 2-year results from the GABI-R-registry.

BACKGROUND: Numerous studies have reported clinical endpoints following coronary revascularization using bioresorbable vascular scaffolds (BVS), while information about the impact on health-related quality of life is sparse. In this analysis of the German-Austrian ABSORB RegIstRy, the 2 year results concerning quality of life development in a large cohort of patients treated with BVS were reported. METHODS: Data were collected at baseline as well as 30 days, 6 and 24 months after coronary revascularization using BVS. The EQ-5D score, EQ visual analogue scale (VAS) and Seattle Angina Questionnaire (SAQ) were determined for each time point. Patients were categorized according to the indication for coronary revascularization [acute coronary syndrome (ACS), stable angina pectoris (SAP), silent myocardial ischemia (SMI), or other]. Binary logistic regression analysis was performed to determine factors that predict above-average scores two years after implantation. RESULTS: Data from 1317 patients in 88 centres were included. Reasons for revascularization were: ACS (n = 643), SAP (n = 443), SMI (n = 52), and other (n = 179). Mean EQ-5D was significantly increased after six months, while a value comparable to baseline was found two years after implantation. EQ VAS and four of five dimensions of SAQ were significantly improved over baseline at all follow-up surveys. Particularly strong improvements were seen in SAQ scores angina frequency and quality of life. Binary regressions showed different statistically significant predictors in the respective models. CONCLUSIONS: Following coronary revascularization with BVS strong decrease in self-reported angina frequency and increase of self-reported quality of life were observed with continuous improvements over two years of follow-up. Trial registration ClinicalTrials.gov Identifier: NCT02066623.

Everolimus eluting bioresorbable vascular scaffolds in patients with acute coronary syndromes: Two-year results from the German-Austrian ABSORB registry.

OBJECTIVES: To identify potential differences in 2-year outcome between patients who underwent coronary revascularization using bioresorbable vascular scafffolds (BVS) in stable coronary artery disease (CAD) and acute coronary syndromes (ACS). BACKGROUND: Data from randomized trials suggest a significantly higher event rate following coronary revascularization using everolimus-eluting BVS as compared to new generation drug eluting stents. Whether particular patient subgroups are at increased risk for scaffold thrombosis and target lesion failure (TLF) has not clearly been demonstrated. METHODS: German-Austrian ABSORB RegIstRy is a prospective all-comer multi-center observational study of consecutive patients who were considered for coronary revascularization with BVS. We compared 1499 patients with stable CAD to 1594 patients with ACS. Endpoints were major adverse cardiac events (MACE), TLF, and scaffold thrombosis. RESULTS: While single vessel disease was more prevalent in ACS (46% vs. 37%, p < 0.0001), lesion complexity (B2/C stenosis 37% vs. 36%, bifurcation 2.4% vs. 3.4%, p < 0.05), number of implanted scaffolds/patient (1.34 vs. 1.43), scaffold length (18 vs. 18 mm) or the rate of high pressure postdilatation (68% vs. 70%) did not differ between ACS and stable CAD. Two-year MACE rates were 11.6% in ACS and 11.4% in stable CAD, TLF occurred in 7.0% versus 7.4% and target vessel revascularization in 8.8 versus 10.2% (n.s. for all). Definite scaffold thrombosis rates were not significantly different (ACS 1.9% vs. stable CAD 2.1%). CONCLUSION: Real-world 2-year event rates after coronary revascularization with BVS are not significantly different between individuals with ACS as compared to stable CAD.

Predictors of scaffold failure and impact of optimized scaffold implantation technique on outcome: Results from the German-Austrian ABSORB RegIstRy.

AIMS: We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure. METHODS AND RESULTS: A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT. CONCLUSION: Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve.

Contralateral Stenosis and Echolucent Plaque Morphology are Associated with Elevated Stroke Risk in Patients Treated with Asymptomatic Carotid Artery Stenosis within a Controlled Clinical Trial (SPACE-2).

BACKGROUND: Asymptomatic carotid artery stenosis (ACS) has a low risk of stroke. To achieve an advantage over noninterventional best medical treatment (BMT), carotid endarterectomy (CEA) or carotid artery stenting (CAS) must be performed with the lowest possible risk of stroke. Therefore, an analysis of risk-elevating factors is essential. Grade of ipsilateral and contralateral stenosis as well as plaque morphology are known risk factors in ACS. METHODS: The randomized, controlled, multicenter SPACE-2 trial had to be stopped prematurely after recruiting 513 patients. 203 patients were randomized to CEA, 197 to CAS, and 113 to BMT. Within one year, risk factors such as grade of stenosis and plaque morphology were analyzed. RESULTS: Grade of contralateral stenosis (GCS) was higher in patients with any stroke (50%ECST vs. 20%ECST; p=0.012). Echolucent plaque morphology was associated with any stroke on the day of intervention (OR 5.23; p=0.041). In the periprocedural period, any stroke was correlated with GCS in the CEA group (70%ECST vs. 20%ECST; p=0.026) and with echolucent plaque morphology in the CAS group (6% vs. 1%; p=0.048). In multivariate analysis, occlusion of the contralateral carotid artery (CCO) was associated with risk of any stroke (OR 7.00; p=0.006), without heterogeneity between CEA and CAS. CONCLUSION: In patients with asymptomatic carotid artery stenosis, GCS, CCO, as well as echolucent plaque morphology were associated with a higher risk of cerebrovascular events. The risk of stroke in the periprocedural period was increased by GCS in CEA and by echolucent plaque in CAS. Due to small sample size, results must be interpreted carefully.

Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry.

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.

Transcatheter Mitral Valve Implantation (TMVI) Using Edwards SAPIEN 3 Prostheses in Patients at Very High or Prohibitive Surgical Risk: A Single-Center Experience.

BACKGROUND: Mitral valve surgery in patients with failing bioprosthesis, annuloplasty rings, or in patients with advanced mitral annular calcification (MAC) is associated with high morbidity and mortality rates. Percutaneous antegrade transseptal transcatheter mitral valve implantation (TMVI) has recently successfully been performed in those patients at high or prohibitive surgical risk, but data on patients treated by TMVI are sparse. This study sought to evaluate short- and midterm outcomes of patients treated by TMVI at our site in clinical practice. METHODS AND RESULTS: From October 2016 to February 2018, seven patients (six women and one man) at high or prohibitive surgical risk underwent TMVI at our site. Three procedures were performed as TMVI in failed mitral valve bioprostheses (TMVI-VIV, "valve-in-valve"), one procedure was performed as TMVI in a failed mitral annuloplasty ring (TMVI-R), and three procedures were performed as TMVI in advanced native mitral annular calcification (TMVI-MAC). Mean age of the population treated was 77 ± 8.1 years, and mean log EuroScore I was 39 ± 0.12%. In all patients, an Edwards SAPIEN 3 transcatheter heart valve was implanted under 3D-TOE and fluoroscopic guidance using a transvenous/transseptal access. Indication for TMVI was the presence of advanced heart failure symptoms in all patients (NYHA class III/IV). The predominant dysfunction of the mitral valve treated was severe regurgitation in 72% (n = 5) and severe stenosis in 29% (n = 2) of all patients. TMVI was technically successful in all procedures. Clinical success with functional improvement of at least one NYHA class after procedure compared with before procedure was also achieved in all patients. Median NYHA class improved significantly from 4 before procedure to 2 after TMVI (p=0.008). Mitral valve regurgitation was reduced to trace or mild in all but one patient, who showed moderate MR after TMVI-MAC. No patient-prosthesis mismatch or LVOT obstruction occurred after TMVI. Two patients underwent interventional ASD closure during the in-hospital course due to a large and persisting atrial septal defect after transseptal access. One patient underwent pacemaker implantation due to complete AV-block after TMVI. One patient died in hospital 12 days after the procedure due to severe hospital-acquired pneumonia and sepsis. In-hospital mortality rate was 14% (1/7) in this high-risk population. After hospital discharge, no death occurred and clinical improvement-according to NYHA functional class-remained stable during one-year follow-up. CONCLUSION: In this small single-center series, TMVI appears promising for patients at high or prohibitive surgical risk with either failing mitral bioprostheses/annuloplasty rings or native mitral valve dysfunction in combination with advanced MAC. Gaining experience in TMVI and new valves will further improve safety and efficacy of this new treatment option.

Patients at Intermediate Surgical Risk Undergoing Isolated Interventional or Surgical Aortic Valve Implantation for Severe Symptomatic Aortic Valve Stenosis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%-8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

Long-term performance and lead failure analysis of the Durata defibrillation lead compared to its previous model, the recalled Riata defibrillation lead.

INTRODUCTION: Data on long-term durability of St Jude Medical Durata defibrillation leads compared to its previous model, the St Jude Medical Riata leads in clinical practice are missing. Aim of the study was to analyze the long-term performance of the Durata defibrillation leads compared to the Riata leads in clinical practice. METHODS AND RESULTS: A total of 1407 consecutive patients of a prospective single-centre implantable cardioverter defibrillator (ICD)-registry were analyzed who underwent ICD implantation with a Durata (n = 913) or Riata (n = 494) ICD lead between 2002 and 2017. Most of the leads were implanted via a subclavian vein access. The estimated lead defect rates after 5 and 10 years were not different between the Durata (11% and 36%) and Riata leads (13% and 38%). Among Durata leads single coil and DF-4 connector ICD leads had a lower incidence of lead failure. Major causes of lead failure were compression of the lead in the clavicular region, generator to lead friction and distal fatigue fracture whereas lead defect due to externalization was a rare cause of lead defect in Riata leads (3%). CONCLUSION: Among ICD leads implanted via the subclavian vein access the lead defect rate of Durata leads after 10 years is similar to that of Riata leads. Single coil and DF-4 ICD leads are associated with a lower lead failure rate. Mechanical stress represents a major cause of lead failure mechanism whereas externalization might only play a minor role in clinical practice.

Gender based differences in drug eluting stent implantation - data from the German ALKK registry suggest underuse of DES in elderly women.

BACKGROUND: Observational studies suggest there are gender based differences in the treatment of coronary artery disease, with women receiving evidence based therapy less frequently than suggested by current guidelines. The aim of our study was to evaluate gender based differences in the use of DES. METHODS: We analysed prospectively collected data from 100704 stent implantations in the PCI registry of the ALKK between 2005 and 2009. RESULTS: The usage of DES increased from 16.0 to 43.9%. Although women had smaller vessel sizes, they received DES less often compared to men (28.2 vs. 31.3%), with an adjusted odds ratio of 0.93 (95% confidence interval 0.89-0.97) at the age of 75, and an adjusted odds ratio of 0.89 (95% confidence interval 0.84-0.94) at the age of 80. CONCLUSION: Despite having smaller vessels than men, women were treated less often with DES. These findings apply to women above the age of 75 years. These findings support previous reports, that elderly women with coronary artery disease are treated differently to men.

Incidence and Clinical Impact of Stroke Complicating Transcatheter Aortic Valve Implantation: Results From the German TAVI Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has emerged as a safe and effective treatment for patients with severe, symptomatic aortic valve stenosis at high surgical risk over the last years. However, besides its minimal invasive character, TAVI still is an invasive procedure usually performed in a population, carrying a substantial risk for vascular complications, like stroke. Stroke is known to be a rare but serious complication of transvascular interventions in clinical practice, which is associated with high morbidity and mortality rates. Despite broad clinical research in many fields of TAVI over the last years, only sparse data still exist on the incidence and clinical risk factors of stroke complicating TAVI in clinical practice today. METHODS: We analyzed data of 1.413 TAVIs, which were enrolled at 30 sites into the prospective and multicenter German TAVI Registry from January 2009 until June 2010. RESULTS: The overall incidence of cerebrovascular events complicating TAVI was 3.2% (n = 45/1.413) in a real-world population today. 40% of all cerebrovascular events were classified as transient ischemic attacks (TIA) with symptoms lasting < 24 hr (18/45) and 60% were classified as stroke with symptoms persisting > 24 hr (27/45). All strokes complicating TAVI of 50% were classified as major strokes leading to notable disability in patients, who survive this complication (Modified Ranking Scale 3-6). In-hospital mortality rate in patients with stroke/TIA was 28.9%, compared to 6.9% in patients without stroke/TIA and 1-year mortality rate 46.7% versus 18.6%, respectively. In multivariate analysis, prior stroke and renal impairment were found as the only independent predictors for stroke complicating TAVI. CONCLUSIONS: Stroke complicating TAVI is a serious complication with a clinically relevant incidence even in daily practice leading to a fivefold increase in 30-day-mortality rate, as well as a significant increase in morbidity and disability in patients, who survive this devastating complication. Further research is needed to identify risk factors and ways to reduce stroke after TAVI. © 2016 Wiley Periodicals, Inc.

Use and outcome of radial versus femoral approach for primary PCI in patients with acute ST elevation myocardial infarction without cardiogenic shock: results from the ALKK PCI registry.

OBJECTIVES: This study sought to compare the use and outcome of radial versus femoral access in patients treated with primary percutaneous coronary intervention (PCI) for acute ST elevation myocardial infarction (STEMI) in clinical practice. BACKGROUND: The radial approach for PCI in patients with STEMI has been suggested to have a lower rate of complications and bleeding and to improve prognosis compared with the femoral approach. However, there still is a large regional and national variation in its use. METHODS: Between 2008 and 2012 a total of 17,865 patients with STEMI without cardiogenic shock undergoing primary PCI were prospectively enrolled in the observational German PCI registry of the Arbeitsgemeinschaft leitende kardiologische Krankenhausärzte (ALKK). Transfemoral (TF) access was used in 15,270 (85.5%), transradial (TR) access in 2,530 (14.2%), and other access in 65 (0.3%) patients. In this analysis, 10,264 patients from 20 centers that had performed at least 5 TR-PCI for STEMI were included. This study compared TR-PCI (n = 2,454 23.9%) with TF-PCI (n = 7,810, 76.1%). RESULTS: Procedural success was high in both cohorts. Hospital mortality (1.8 vs. 5.1%, P < 0.001) and vascular access complications (0.3 vs. 1.8%, P < 0.001%) were lower in the TR group. In the multivariate analysis radial access was associated with an improved in-hospital survival rate (OR 0.47, 95% CI 0.35-0.65). CONCLUSIONS: The radial approach for PCI can be performed with excellent procedural success in selected STEMI patients and is associated with a lower rate of vascular access complications and hospital mortality.

Clinical course and prognostic relevance of antitachycardia pacing-terminated ventricular tachyarrhythmias in implantable cardioverter-defibrillator patients.

AIMS: In patients with an implantable cardioverter-defibrillator (ICD), ICD shocks due to ventricular tachycardia (VT) or ventricular fibrillation (VF) have been associated with an increased mortality. It is not known whether patients with antitachycardia pacing (ATP)-terminated VT/VF episodes have a similar worse outcome. The aim of this study was to evaluate the clinical course and prognostic impact of ATP-terminated episodes on mortality in ICD patients. METHODS AND RESULTS: A total of 1398 consecutive patients of the prospective single-centre ICD-registry Ludwigshafen who underwent an ICD implantation between 1992 and 2008 for primary or secondary prevention of sudden cardiac death were analysed. Patients treated with ATP were compared with patients with appropriate ICD shocks or patients without any appropriate ATP or ICD shock. During the median follow-up time of 6 years, 749 (54%) patients experienced 17 827 episodes of VT or VF which were terminated by ATP in 74% and by shock in 26% of patients. In approximately half (n = 321/749) of those patients with VT/VF, the first episode was terminated by ATP. In a multivariate analysis adjusted for different baseline confounding parameters, the occurrence of first ATP therapy was associated with a higher mortality rate [hazard ratio (HR) 2.60, 95% confidence interval (CI) 2.02-3.35]. When excluding all patients with appropriate ICD shocks first ATP therapy remained associated with a worse prognosis (HR 1.92, 95% CI 1.38-2.67). CONCLUSIONS: In ICD patients, about three-fourths of ventricular arrhythmias are terminated by ATP. The occurrence of ATP-terminated episode is associated with an increased mortality rate.