Venoarterial extracorporeal membrane oxygenation in patients with infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used in patients with cardiogenic shock despite the lack of evidence from adequately powered randomised clinical trials. Three trials reported so far were underpowered to detect a survival benefit; we therefore conducted an individual patient-based meta-analysis to assess the effect of VA-ECMO on 30-day death rate. METHODS: Randomised clinical trials comparing early routine use of VA-ECMO versus optimal medical therapy alone in patients presenting with infarct-related cardiogenic shock were identified by searching MEDLINE, Cochrane Central Register of Controlled Trials, Embase, and trial registries until June 12, 2023. Trials were included if at least all-cause death rate 30 days after in-hospital randomisation was reported and trial investigators agreed to collaborate (ie, providing individual patient data). Odds ratios (ORs) as primary outcome measure were pooled using logistic regression models. This study is registered with PROSPERO (CRD42023431258). FINDINGS: Four trials (n=567 patients; 284 VA-ECMO, 283 control) were identified and included. Overall, there was no significant reduction of 30-day death rate with the early use of VA-ECMO (OR 0·93; 95% CI 0·66-1·29). Complication rates were higher with VA-ECMO for major bleeding (OR 2·44; 95% CI 1·55-3·84) and peripheral ischaemic vascular complications (OR 3·53; 95% CI 1·70-7·34). Prespecified subgroup analyses were consistent and did not show any benefit for VA-ECMO (pinteraction ≥0·079). INTERPRETATION: VA-ECMO did not reduce 30-day death rate compared with medical therapy alone in patients with infarct-related cardiogenic shock, and an increase in major bleeding and vascular complications was observed. A careful review of the indication for VA-ECMO in this setting is warranted. FUNDING: Foundation Institut für Herzinfarktforschung.

Cardiac, possible cardiac, and likely non-cardiac origin of chest pain : A hitherto underestimated parameter in German chest pain units.

BACKGROUND: Current guidelines emphasize the diagnostic value of non-cardiac or possibly cardiac chest pain. The goal of this analysis was to determine whether German chest pain units (CPUs) adequately address conditions with "atypical" chest pain in existing diagnostic structures. METHOD: A total of 11,734 patients from the German CPU registry were included. The analyses included mode of admission, critical time intervals, diagnostic steps, and differential diagnoses. RESULTS: Patients with unspecified chest pain were younger, more often female, were less likely to have classic cardiovascular risk factors and tended to present more often as self-referrals. Patients with acute coronary syndrome (ACS) mostly had prehospital medical contact. Overall, there was no difference between these two groups regarding the time from the onset of first symptoms to arrival at the CPU. In the CPU, the usual basic diagnostic measures were performed irrespective of ACS as the primary working diagnosis. In the non-ACS group, further ischemia-specific diagnostics were rarely performed. Extra-cardiac differential diagnoses were not specified. CONCLUSION: The establishment of broader awareness programs and opening CPUs for low-threshold evaluation of self-referring patients should be discussed. Regarding the rigid focus on the clarification of cardiac causes of chest pain, a stronger interdisciplinary approach should be promoted.

Electrophysiology lab efficiency comparison between cryoballoon and point-by-point radiofrequency ablation: a German sub-analysis of the FREEZE Cohort study.

BACKGROUND: Pulmonary vein isolation (PVI) is recommended to treat paroxysmal and persistent atrial fibrillation (AF). This analysis aimed to assess the hospital efficiency of single-shot cryoballoon ablation (CBA) and point-by-point radiofrequency ablation (RFA). METHODS: The discrete event simulation used PVI procedure times from the FREEZE Cohort study to establish the electrophysiology (EP) lab occupancy time. 1000 EP lab days were simulated according to an illustrative German hospital, including 3 PVI cases per day using CBA at one site and RFA at the other. RESULTS: The analysis included 1560 CBA patients and 1344 RFA patients from the FREEZE Cohort. Some baseline patients' characteristics were different between groups (age, AF type, and some concomitant diseases), without being statistically associated to ablation procedure time. Mean procedure time was 122.2 ± 39.4 min for CBA and 160.3 ± 53.5 min for RFA (p < 0.0001). RFA was associated with a more than five-fold increase of cumulative overtime compared to CBA over the simulated period (1285 h with RFA and 253 h with CBA). 70.7% of RFA lab days included overtime versus 25.7% for CBA. CBA was associated with more days with an additional hour at the end of the EP lab shift compared to RFA (47.8% vs 11.5% days with one hour left, respectively). CONCLUSION: CBA is faster and more predictable than point-by-point RFA, and enables improvements in EP lab efficiency, including: fewer cumulative overtime hours, more days where overtime is avoided and more days with remaining time for the staff or for any EP lab usage. Clinical trial registration NCT01360008 (first registration 25/05/2011).

Selection and outcome of implantable cardioverter-defibrillator patients with and without cardiac resynchronization therapy: Comparison of 4384 patients from the German Device Registry to randomized controlled trials.

BACKGROUND: Registry data add important information to randomized controlled trials (RCT) on real-life aspects of implantable cardioverter-defibrillator (ICD) patients with and without cardiac resynchronization therapy (CRT-D). This analysis of the prospectively conducted German Device Registry aims at comparing mortality rates, comorbidities, complication rates to results from RCT. METHODS: The German Device registry (DEVICE) prospectively collected data on ICD and CRT-D first implantations from 50 German centres. Demographic data, details on cardiac disease, electrocardiogram (ECG), medication, and data about procedure, complications, and hospital stay were stored in electronic case report forms. One year after device implantation patients were contacted for follow-up. RESULTS: DEVICE included n = 4384 first ICD/CRT-D implantations (29.3% CRT-D devices). We found a strong adherence to guidelines with over 90% of patients being on ß-blocker and ACE-inhibitor medication and adequate QRS width in the majority of CRT-D patients. Patients receiving a CRT-D were older (67.6 ± 11.0 years vs. 63.9 ± 13.4 years, p < .001) and had lower ejection fractions (mean 25% vs. 30%, p < .001) compared to ICD patients. Dilated cardiomyopathy was the predominant underlying heart disease in CRT-D (53.3%), coronary artery disease in ICD patients (64.7%). Compared to RCT our DEVICE patients had more comorbidities (17.9% chronic kidney disease [CKD]) and higher 1-year mortality rates (10.7% ICD group, 12.3% CRT group). In multivariate analysis, CKD patients had an almost 2-fold higher risk of 1-year mortality. CONCLUSION: Despite relevant limitations of registry data, DEVICE highlights important differences between RCT and real-world registry data and the impact of comorbidities on mortality of ICD and CRT-D recipients.

Adverse events and stroke prevention by interventional left atrial appendage occlusion in patients with low CHA2 DS2 -VASc score-results from the multicenter German LAARGE registry.

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) is routinely performed in patients with nonvalvular atrial fibrillation and contraindications to standard anticoagulation. AIMS: We investigated its role in patients at low stroke risk, and compared the effectiveness and safety in patients with low versus high risk. METHODS: LAARGE is a prospective registry depicting the clinical reality of LAAO. LAAO was conducted with different standard commercial devices, and follow-up period was 1 year. Patients with started procedure and documented CHA2 DS2 -VASc score were selected from the whole database. RESULTS: A total of 638 patients from 38 centers were divided into CHA2 DS2 -VASc score ≤2, i.e., low-risk group (10.2%), and >2, i.e., high-risk group (89.8%). The latter had a pronounced cardiovascular risk profile and preceding strokes (0% vs. 23.9%; p < 0.001). Implantation success was consistently high (97.6%), frequencies of intrahospital major adverse cardiac and cerebrovascular events (0% vs. 0.5%) and other major complications (4.6% vs. 4.0%) were low (each p = not significant [NS]). Numerous moderate complications were also observed in the low-risk patients (12.3% vs. 9.4%; p = NS). Frequencies of nonfatal strokes (0% vs. 0.7%) and severe bleedings (0% vs. 0.7%) were low (each p = NS). In a specific analysis, patients at very high risk of stroke (i.e., CHA2 DS2 -VASc score >4) did not have increased rates of complications or nonfatal strokes in the first year after the procedure. CONCLUSIONS: Low-risk patients had no nonfatal strokes and major bleedings within 1 year after hospital discharge but had unexpectedly high rates of moderate procedural complications. The indication in these patients should be strictly defined based on an individual benefit-risk assessment.

Unexpected high level of severe events even in low-risk profile chest pain unit patients.

AIMS: Early heart attack awareness programs are thought to increase efficacy of chest pain units (CPU) by providing live-saving information to the community. We hypothesized that self-referral might be a feasible alternative to activation of emergency medical services (EMS) in selected chest pain patients with a specific low-risk profile. METHODS AND RESULTS: In this observational registry-based study, data from 4743 CPU patients were analyzed for differences between those with or without severe or fatal prehospital or in-unit events (out-of-hospital cardiac arrest and/or in-unit death, resuscitation or ventricular tachycardia). In order to identify a low-risk subset in which early self-referral might be recommended to reduce prehospital critical time intervals, the Global Registry of Acute Coronary Events (GRACE) score for in-hospital mortality and a specific low-risk CPU score developed from the data by multivariate regression analysis were applied and corresponding event rates were calculated. Male gender, cardiac symptoms other than chest pain, first onset of symptoms and a history of myocardial infarction, heart failure or cardioverter defibrillator implantation increased propensity for critical events. Event rates within the low-risk subsets varied from 0.5-2.8%. Those patients with preinfarction angina experienced fewer events. CONCLUSIONS: When educating patients and the general population about angina pectoris symptoms and early admission, activation of EMS remains recommended. Even in patients without any CPU-specific risk factor, self-referral bears the risk of severe or fatal pre- or in-unit events of 0.6%. However, admission should not be delayed, and self-referral might be feasible in patients with previous symptoms of preinfarction angina.

Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Gender-related outcomes in the German LAARGE Registry.

INTRODUCTION: Gender-based differences in atrial fibrillation have been identified, but limited data exist for patients undergoing left atrial appendage occluder (LAAO) implantation. This study reports gender-related periprocedural and 1-year outcomes of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). METHODS: LAARGE enrolled 641 patients who were scheduled for LAAO implantation from July 2014 to January 2016 in 38 hospitals in Germany. The data collected included demographics, clinical characteristics, details of implantation, and outcome. Efficacy and safety at 1-year follow-up were assessed by the occurrence of thrombembolic and bleeding events, as well as mortality. RESULTS: Of 638 patients undergoing LAAO implantation 38.9% were female and 61.1% male. Females were older (76.4 ± 8.2 [females] vs. 75.6 ± 7.7 [males], p = .042) and had a higher stroke risk (CHA2 DS2 -VASc score: 4.9 ± 1.5 vs. 4.3 ± 1.5, p < .001). In contrast, males suffered more often from coronary artery (33.1% vs. 53.8%, p < .001) and vascular disease (18.5% vs. 31.0%, p < .001). Technical success was high and similar for both genders (98.4% vs. 97.2%, p = .33). Severe periprocedural complications (6.9% vs. 3.1%, p = .032) occurred more often in females. At 1-year follow-up the rates of all-cause stroke (0.5% vs. 1.3%, p = .65) and severe bleeding (0.0% and 1.0%, p = .29) were low and comparable between the genders. Also, one-year all-cause mortality (9.2% vs. 13.1%, p = .14) did not differ significantly. CONCLUSION: LAARGE documented in this elderly patient population undergoing LAAO implantation a higher rate of severe periprocedural complications in females. At 1-year follow-up similar efficacy and safety outcomes were observed for both genders.

The impact of basic atrial rhythm during catheter ablation of atrial fibrillation on clinical outcomes: Lessons from the German Ablation Registry.

BACKGROUND: The impact of basic atrial rhythm (sinus rhythm [SR] vs. atrial fibrillation [AF]) during AF ablation on efficacy and safety is unknown. METHODS: About 3375 patients from the German Ablation Registry undergoing first-time AF ablation were divided according to the type of AF and the basic atrial rhythm during the ablation procedure: paroxysmal AF (PAF) and SR [group Ia], PAF and AF [group Ib]), persistent AF and SR (IIa), and persistent AF and AF (IIb). RESULTS: Patients in SR (n = 2312 [67%]) underwent cryoballoon ablation more often (Ia vs. Ib p = .002 and IIa vs. IIb p = .010, whereas in patients in AF (n = 1063 [33%]) radiofrequency (RF)-based ablation (Ia vs. Ib p = .006 and IIa vs. IIb p = .014) including left and/or right atrial substrate modification was more frequently performed. Depending on the basic rhythm there was no difference regarding arrhythmia recurrence during long-term follow-up. For patients suffering from persistent AF acute procedure-related complications were more often documented when ablated in AF (9.1% vs. 4.6%, p = .012). which was mainly driven by the higher occurrence of pericardial effusion/tamponade. For patients suffering from persistent AF, favorable results were found regarding 366-day Kaplan-Meier estimates of the incidence of MACCE (death, myocardial infarction, and stroke; p = .011) and the composite endpoint of death, myocardial infarction, stroke, and major bleeding (p = .006), when ablated in SR. CONCLUSION: Basic atrial rhythm at the time of AF ablation did not affect long-term rhythm outcome. For patients suffering from persistent AF a more favorable acute and long-term safety profile was observed when ablated in SR.

Management of Pulmonary Embolism: Results from the German Chest Pain Unit Registry.

INTRODUCTION: Since 2008, specialized chest pain units (CPUs) were implemented across Germany ensuring structured diagnostics in acute chest pain. This study aims to analyze the management of pulmonary embolism (PE) patients in such certified CPUs. METHODS: Data were retrieved from 13,902 patients enrolled in the German CPU registry and analyzed for the diagnosis of PE including patient characteristics, critical time intervals, diagnostic workup, treatment, and prognosis. PE patients were compared to the overall CPU patient cohort. Only patients with a complete 3-month follow-up were included. RESULTS: Overall, 1.1% of all CPU patients were diagnosed with PE. Chest pain and dyspnea were the leading symptoms. Patients with PE were older, presented with higher heart rates, and more frequently exhibited signs of heart failure, despite a normal left ventricular function. PE patients showed significantly longer time delays between symptom onset and the first medical contact, while PE patients with chest pain presented earlier than PE patients with dyspnea only. Whereas more PE patients had to be transferred to the intensive care unit, in-CPU mortality and event rates over 3 months were low. DISCUSSION/CONCLUSION: This study suggests a certain risk for underdiagnosis and consecutive potential undertreatment of PE patients in German Cardiac Society (GCS)-certified CPUs, which is thought to result from an anticipated focus on patients with acute coronary syndrome (ACS). Public awareness for PE beyond chest pain should be improved. Certified CPUs should be urged to implement strategic pathways for a better simultaneous diagnostic workup of differential diagnosis beyond ACS.

German chest pain unit registry: data review after the first decade of certification.

In 2008, the German Cardiac Society (GCS) introduced a certification program for specialized chest pain units (CPUs). In order to benchmark the performance of the certified CPUs, a nationwide German CPU registry was established. Since then, data for more than 34,000 patients have been included. The concept of certified CPUs in Germany has been widely accepted and its success is underlined by its recent inclusion in national and international guidelines. As of December 2019, 286 CPUs have been successfully certified or recertified by the GCS. This review focuses on the data retrieved from the CPU registry during the first decade of certification. As demonstrated by 16 manuscripts stemming from the registry, certified German CPUs demonstrate high quality of care in acute coronary syndrome and beyond. It is also noted that the German CPU registry allowed for further analysis of the gap in guideline adherence. With the current update of the CPU certification criteria, central data collection as a best-practice criterion will be abandoned, and after some productive years the registry has temporarily been stopped.

Quality benchmarks for chest pain units and stroke units in Germany.

BACKGROUND: Chest pain units (CPUs) and stroke units (SUs) provide specialized multidisciplinary in-hospital management for acute chest pain and ischemic stroke. We analyzed exemplary equivalent quality benchmarks in both concepts. MATERIAL AND METHODS: Data from the German CPU registry (2012-2015; 45 certified CPUs, 5881 patients) were compared with data from the SU registry of Rhineland-Palatinate (2011-2015; 29 SUs; 40,380 patients). Parameters comprised demographics, symptoms, diagnosis, medication, critical time intervals, therapeutics, and in-unit outcome. RESULTS: Non-ST-segment elevation myocardial infarction (47.4%) and ischemic stroke (63.0%) were the most frequent entities. An electrocardiogram was performed on average within 7 min in CPUs, cranial imaging within 49 min in SUs. The mean time interval from admission until coronary intervention or lysis was 42 min or 57 min, respectively. Rates of antiplatelet therapy (90.1% vs. 96.0%), brain imaging, and coronary angiography were high (99.3% vs. 81.1%) and the mortality was low (0.8% for CPUs vs. 3.6% for SUs). The length of stay was shorter in CPUs (1.5 days vs. 4.4 days). CONCLUSION: As reimbursement for emergency medicine in Germany was recently rearranged, quality benchmarking has gained incremental importance. Mandatory joint quality measurement in both concepts ensuring gap analysis and process improvement is encouraged.

[Comparison between chest pain units and stroke units : Essential components of the vascular emergency care system: comparison of structure, certification process, quality benchmarking and reimbursement]. / Vergleich von Chest Pain Units und Stroke Units : Elementare Bausteine der vaskulären Akutversorgung: Vergleich von Struktur, Zertifizierung, Qualitätserfassung und Vergütung.

BACKGROUND: Chest pain units (CPU) and stroke units (SU) have both become established as essential components of clinical emergency care. For both instances dedicated certification processes are installed. Up to summer 2020, 290 CPUs and 335 SUs have been successfully certified. OBJECTIVE: The aim of this review is to compare the structures and the current certification situation of CPUs and SUs. Also, the younger CPU certification process is compared to the long established SU certification standard. MATERIAL UND METHODS: The comparison includes the historical background, the certification process, quality benchmarking, possible additive structures, the current status of certification in Germany, the transfer of the concept to the European level as well as reimbursement issues. RESULTS: Both certification concepts show clear analogies. Evidence for SUs is supported by a positive Cochrane analysis and for CPUs there are many studies from the German CPU registry. The main differences include a uniform CPU system versus a multistep SU system of certification. Furthermore, SU have obligatory elements of quality documentation but only facultative quality indicator assessment for CPUs. From an economic viewpoint operation and procedural key (OPS) numbers guarantee a better reflection of the use of resources in the complex treatment of stroke, which could not yet be established for CPUs. CONCLUSION: The well-established CPU concept could additionally benefit from a superordinate quality control. Adequate quality benchmarking appears to be fundamental for gap analyses and for the establishment of a separate remuneration structure. In this respect the German Society for Cardiology as the certifying institution is required to establish an appropriate mechanism within the framework of regular updates of criteria.

Gender Differences in Patients Admitted to a Certified German Chest Pain Unit: Results from the German Chest Pain Unit Registry.

INTRODUCTION: Gender-specific atypical clinical presentation in acute coronary syndrome and sex-specific outcomes in cardiovascular disease in women are well known. The aim of this study is to analyze possible differences between men and women presenting to certified German chest pain units (CPUs). METHODS: Data from 13,900 patients derived from the German CPU registry were analyzed for gender differences in patient characteristics, cardiovascular disease manifestation, critical time intervals, treatment and prognosis. RESULTS: A total of 37.8% of patients were female. Typical chest pain occurred more frequently in men, while atypical symptoms occurred more frequently in women. Female gender was associated with longer pre- and in-hospital time delays. Women were more often diagnosed with a nonischemic origin of pain. In a 3-month follow-up, there was no gender-specific difference in combined major adverse coronary and cerebrovascular events. DISCUSSION/CONCLUSION: This study points out gender-specific differences in prehospital time intervals and a significantly higher percentage of atypical symptoms in suspected myocardial ischemia as well as more noncoronary diagnoses in women. Symptom awareness and a broader diagnostic workup in women are essential.

Can we rely on Danish? Real-world data on patients with nonischemic cardiomyopathy from the German Device Registry.

According to current guidelines prophylactic implantable cardioverter-defibrillator (ICD) therapy is recommended in patients with significantly impaired left ventricular systolic function. However, the recently published DANISH trial did not find a significantly lower long-term rate of death from any cause compared with usual clinical care in patients with non-ischemic cardiomyopathy. We investigated whether registry data from a multi-center 'real-life' registry on patients with non-ischemic cardiomyopathy are similar to this trial. The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5451 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focused on patients with non-ischemic cardiomyopathy and a left ventricular ejection fraction ≤35% who received a prophylactic ICD. Out of 779 patients with symptomatic heart failure and nonischemic cardiomyopathy, 33.1% received a single chamber ICD (VVI), while 11.0% were implanted with a dual-chamber ICD (DDD), and 55.8% received a defibrillator system for cardiac resynchronization therapy. Median follow-up was 16.1 months. 90.7% were alive at follow-up, 9.3% had died during this period. Overall mortality after one year was 5.4%. Overall mortality one year after implantation was significantly increased in patients 68 years and older(7.9%) as compared to younger patients (59-68 years: 2.5%; < 59 years: 3.8%; p < 0.015). Data from the present registry support the recently published results of the DANISH trial. In particular the influence of an increased age as proven in the DANISH trial might also play a role in the present collective. This limits the potential beneficial effect of ICD therapy in particular in the elderly population.

Long-term symptom improvement and patient satisfaction following catheter ablation of supraventricular tachycardia: insights from the German ablation registry.

AIMS: To analyse outcomes of supraventricular tachycardia (SVT) ablations performed within a prospective German Ablation Quality Registry. METHODS AND RESULTS: Data from 12 566 patients who underwent catheter ablation of SVT between January 2007 and January 2010 to treat atrial fibrillation (AFIB, 37.2% of procedures), atrial flutter (AFL, 29.9%), atrioventricular nodal re-entrant tachycardia (AVNRT, 23.2%), atrioventricular re-entrant tachycardia (6.3%), and focal atrial tachycardia (AT, 3.4%) were prospectively collected. Patients were followed for at least 1 year. The periprocedural success rate was 96.3%, ranging from 84.3% (focal AT) to 98.9% (AVNRT). Kaplan-Meier mortality estimate at 1 year was 1.4% overall, and as high as 2.6% in the AFL group and 2.8% in the focal AT group. Recurrence of ablated or another symptomatic SVT was observed in 3783 (32.6%) of patients, ranging from 17.2% (AVNRT) to 45.6% (AFIB). Repeat ablation was performed in 12.0% of patients. After 1 year, 74.1% of survivors perceived ablation therapy as successful, 15.7% as partly successful, and 9.6% as unsuccessful. Even in those patients with arrhythmia recurrence, 76.0% perceived ablation as successful or partly successful and 89.6% would still undergo repeat ablation in the same institution. CONCLUSION: Ablation therapy for SVT is a safe procedure bringing symptomatic improvement and satisfaction to three quarters of patients after 1 year. Even in patients with arrhythmia recurrence, a high satisfaction level and adherence to the ablating institution could be documented. Strikingly high mortality and stroke rates in follow-up were observed in AFL patients, who apparently need consistent long-term anticoagulation and more medical attention.

Complication Rates of Catheter Ablation of Atrial Fibrillation in Patients Aged ≥75 Years versus <75 Years-Results from the German Ablation Registry.

INTRODUCTION: Despite a rising demand for catheter ablation (CA) of atrial fibrillation (AF) in an elderly population, complication and success rates are not fully elucidated. We sought to compare complication rates of CA of AF in patients ≥75 versus <75 years of age. METHODS AND RESULTS: Patients with symptomatic, drug-refractory AF were prospectively enrolled from January 2007 to 2010 in this multicenter study. A total of 4,449 patients, group 1 ≥75 years and group 2 <75 years (n = 227, age 77.3 ± 2.2 vs. 59.7 ± 9.8 years, 52.0% vs. n = 4,222, 68.9% male, CHA2 DS2 -VASc-Score 3.7 ± 1.0 vs. 1.7 ± 1.2; P < 0.001, respectively), with paroxysmal AF (59.9% in group 1 vs. 63.3% in group 2, P = 0.30), and persistent AF (34.8% in group 1 vs. 29.4% in group 2, P = 0.082) underwent CA of AF. A centralized follow-up was obtained in 4,347 patients by the Institute for Myocardial Infarction Research (IHF, Ludwigshafen). There was a significant difference between periprocedural stroke rates in the elderly versus the younger cohort (1.3% vs. 0.1%, P < 0.01). In-hospital severe nonfatal complications did not differ significantly between the groups (4.4% vs. 2.7%, P = 0.14). Other procedure-related, in-hospital complications were not significantly different. After a mean follow-up of 472 ± 99 days (group 1) and 477 ± 94 days (group 2), no differences were found in complication rates. CONCLUSION: CA of AF in patients ≥75 years is associated with higher in-hospital stroke rates. In a 1-year follow-up, complication rates do not differ between the groups.

Long-term outcomes after event-free cardioverter defibrillator implantation: comparison between patients discharged within 24 h and routinely hospitalized patients in the German DEVICE registry.

AIMS: To analyse the long-term safety of implantable cardioverter defibrillators (ICDs) in patients discharged within 24 h or after 2- 5-day hospitalization, respectively, after complication-free implantation, in circumstances of actual care. METHODS AND RESULTS: Patients in the multicentre, nationwide German DEVICE registry were contacted 12-15 months after their first ICD implantation or device replacement. Data were collected on complications, potential arrhythmic events, syncope, resuscitation, ablation procedures, cardiac events, hospitalizations, heart failure status, change of medication, and quality of life. Of 2356 patients from 43 centres, 527 patients were discharged within 24 h and 1829 were hospitalized routinely for >24 h after complication-free implantations. The disease profiles and rates of co-morbidities were similar at baseline for both cohorts. During between 384 and 543 days of follow-up, there were no significant differences between the groups in terms of complications, hospitalizations, or quality of life. One-year rates of death were 4.5% in patients discharged early compared with 7.2% in hospitalized patients (hazard ratio 0.65; 95% confidence interval 0.42-1.02; P = 0.052). Rates of major adverse cardiovascular events or defibrillator events were not higher in patients discharged after 24 h. In both groups, a high rate of patients declared that they would opt for the procedure again in the same situation. CONCLUSION: Data from a large-scale registry reflecting current day-to-day practice in Germany suggest that most patients can be discharged safely within 24 h of successful ICD implantation if there are no procedure-related events. Follow-up data up to 1.5 years after implantation did not raise long-term safety concerns.

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.