[Understanding complex processes better-A case study on increasing patient safety and efficiency in a central operating room]. / Komplexe Prozesse besser verstehen ­ eine alltagsbezogene Fallstudie zur Erhöhung der Patientensicherheit und Effektivität in einem Zentral-OP.

BACKGROUND: Various professional groups are involved in the daily work of the central operating room with the aim of providing the best possible treatment for each individual using modern medical technology (sociotechnical system) in a cost-effective manner. Ensuring perioperative patient safety is of particular importance. At the same time, the efficient use of the central operating room is essential for the economic success of a hospital. Preoperative preparation is a complex process with many substeps that are often difficult to manage. Historically, the focus has been on retrospective learning from errors and incidents. More recent approaches take a systemic view. A central idea is to consider the mostly positive course of treatment and the adjustments to daily work that are currently required by the people involved (Safety-II). By taking greater account of how the many components of the system interact, processes can be better understood and specific measures derived. This strengthens the system's ability to adapt to changes and disturbances, thus ensuring that goals are achieved. The functional resonance analysis method (FRAM) is an internationally recognized method for modelling work as done compared to work as imagined. This paper presents the application of FRAM to preoperative preparation in a major regional hospital. OBJECTIVE: Is FRAM suitable for improving process understanding in preoperative preparation? MATERIAL AND METHODS: An interdisciplinary project team identified relevant functions of preoperative preparation through document analysis and walkthroughs. Based on this, more than 30 guided interviews were conducted with functionaries. The results were presented graphically and specific information, such as safety-related statements or reasons for the variability of functions, were also presented textually. In the next phase, statements were evaluated and compared with the target model and the job descriptions. RESULTS: The FRAM revealed the process as a complex network of relationships. During the modelling process, a varying degree of centrality and variability of certain functions became apparent. From the observations, the project team selected those with high relevance for patient safety and for the efficiency of the overall process in order to prioritize starting points for deriving measures to increase resilience. These starting points relate either to single functions, such as surgical site marking or to multiple functions that are variable in their execution, such as delays due to nonsynchronized duty times. CONCLUSION: The FRAM conducted provides valuable new insights into the functioning of complex sociotechnical systems that go far beyond classical linear methods. The awareness of operational processes gained and the resulting dynamic view of interactions within the system enable specific measures to be derived that promote resilient behavior and reduce critical variability, thus contributing to increased patient safety and efficiency.

LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry.

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.

Is spontaneous echo contrast associated with device-related thrombus or embolic events after left atrial appendage occlusion? - Insights from the multicenter German LAARGE registry.

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for prophylaxis of thromboembolic events (TEs) in nonvalvular atrial fibrillation patients, predominantly in those with high bleeding risk and contraindications for long-term OAC. Although spontaneous echo contrast (SEC) is a well-known risk factor for atrial thrombus formation, little is known about whether this means an increased risk of device-related thrombus (DRT) or TEs following LAAO. METHODS: This substudy of the prospective, multicenter German LAARGE registry assessed two groups according to absence (SEC -) or presence of SEC (SEC +) in preprocedural cardiac imaging. Clinical and echocardiographic parameters were registered up to 1 year after LAAO. RESULTS: Five hundred eighty-eight patients (SEC - 85.5 vs. SEC + 14.5%) were included. More SEC + patients were implanted for OAC non-compliance (11.8 vs. 4.6%, p = 0.008) and a higher proportion received only antiplatelet therapy without OAC at hospital discharge (96.5 vs. 86.0%, p = 0.007). The SEC + patients had larger LA diameters (50 (47; 54) vs. 47 (43; 51) mm, p < 0.001), wider LAA ostia (21 (19; 23) vs. 20 (17; 22) mm at 45°, p = 0.011), and lower left ventricular ejection fraction (50 (45; 60) vs. 60 (50; 60) %, p < 0.001) on admission. Procedural success was very high in both groups (98.1%, p = 1.00). Periprocedural major adverse cardiac and cerebrovascular events and other major complications were rare in both groups (3.8 vs. 4.7%, p = 0.76). At follow-up, DRT was only detected in the SEC - group (3.8 vs. 0%, p = 1.00). The rates of TEs (SEC - 1.2 vs. SEC + 0%, p = 1.00) after hospital discharge and 1-year mortality (SEC - 12.0 vs. SEC + 11.8%, p = 0.96) were not significantly different between the two groups. CONCLUSIONS: Presence of SEC at baseline was not associated with an increased rate of DRT or TEs at 1-year follow-up after LAAO in LAARGE.

Left atrial area index provides the best prediction of atrial fibrillation in ischemic stroke patients: results from the LAETITIA observational study.

Background and aims: Left atrial (LA) enlargement has been repeatedly shown to be associated with the diagnosis of atrial fibrillation (AF). In clinical practice, several parameters are available to determine LA enlargement: LA diameter index (LADI), LA area index (LAAI), or LA volume index (LAVI). We investigated the predictive power of these individual LA parameters for AF in patients with acute ischemic stroke or transient ischemic attack (TIA). Methods: LAETITIA is a retrospective observational study that reflects the clinical reality of acute stroke care in Germany. Consecutive patient cases with acute ischemic cerebrovascular event (CVE) in 2019 and 2020 were identified from the Mannheim stroke database. Predictive power of each LA parameter was determined by the area under the curve (AUC) of receiver operating characteristic curves. A cutoff value was determined. A multiple logistic regression analysis was performed to confirm the strongest LA parameter as an independent predictor of AF in patients with acute ischemic CVE. Results: A total of 1,910 patient cases were included. In all, 82.0% of patients had suffered a stroke and 18.0% had a TIA. Patients presented with a distinct cardiovascular risk profile (reflected by a CHA2DS2-VASc score ≥2 prior to hospital admission in 85.3% of patients) and were moderately affected on admission [median NIHSS score 3 (1; 8)]. In total, 19.5% of patients had pre-existing AF, and 8.0% were newly diagnosed with AF. LAAI had the greatest AUC of 0.748, LADI of 0.706, and LAVI of 0.719 (each p < 0.001 vs. diagonal line; AUC-LAAI vs. AUC-LADI p = 0.030, AUC-LAAI vs. AUC-LAVI p = 0.004). LAAI, increasing NIHSS score on admission, and systolic heart failure were identified as independent predictors of AF in patients with acute ischemic CVE. To achieve a clinically relevant specificity of 70%, a cutoff value of ≥10.3 cm2/m2 was determined for LAAI (sensitivity of 69.8%). Conclusion: LAAI revealed the best prediction of AF in patients with acute ischemic CVE and was confirmed as an independent risk factor. An LAAI cutoff value of 10.3 cm2/m2 could serve as an inclusion criterion for intensified AF screening in patients with embolic stroke of undetermined source in subsequent studies.

[Safety­II: a systemic approach for an effective clinical risk management]. / Safety­II: ein systemischer Ansatz für ein effektives klinisches Risikomanagement.

The healthcare system is an example of a complex sociotechnical system where the goal is the best possible individual treatment together with the cost-effective use of modern technology. Working in anesthesia requires medical knowledge as well as manual skills and the use of specialized technical equipment in an interdisciplinary and interprofessional setting. The susceptibility to errors and adverse events, especially in the care of critically ill patients, is high.In order to avoid unintentional hospital-induced patient harm, the healthcare system has recently taken the path of prescribing the best possible care for a large number of patients with the help of evidence-based guidelines and specific algorithms or instructions for action. Patient safety is defined accordingly as a state in which adverse events occur as rarely as possible (Safety­I).Following this approach clinical risk management is defined as the purposeful planning, coordination, execution and control of all measures that serve to avoid unintended hospital-induced patient harm or to limit its effects. For this purpose, the focus has recently been placed on instruments such as Critical Incident Reporting Systems (CIRS) or Morbidity and Mortality Conferences (M&MC); however, it is increasingly recognized that adverse events in complex sociotechnical systems such as the healthcare system arise situationally from the interaction of numerous components of the system. The effectiveness of CIRS and M&MC is limited because they do not comprehensively take situational effects into account. Thus, only selective changes are possible which, however, do not imply a sustainable improvement of the system. Newer approaches to strengthening safety in complex sociotechnical systems understand positive as well as negative events as being equally caused by the variable adaptation of behavior to daily practice. They therefore focus on the majority of positive courses of treatment and the necessary adaptations of the health professionals involved in daily practice (Safety­II). In this way, the adaptability of the system under unexpected conditions should be increased (Resilience Engineering). Taking this systemic approach into account, the Functional Resonance Analysis Method (FRAM) offers a variety of possibilities for the prospective analysis of a complex sociotechnical system or for retrospective incident analysis through modelling of actual everyday actions (work as done). Through interviews with the health professionals involved, document analyses and work inspections, processes and their functions as well as the associated variability are assessed and graphically presented. The FRAM models the collected information of the process as complexes of interconnected functions represented by hexagonal symbols. Each corner of the hexagon represents a given aspect, which together form the properties of the function (input, output, precondition, resource, time, control). Through this visualization and evaluation of the interview results, the actual everyday actions (work as done) can be compared with the predefined ones (work as imagined). The evaluation of the variability found in this way enables the strengths and weaknesses of processes to be uncovered. As a result, specific measures can be derived to strengthen the system. Increased consideration of the Safety­II approach within clinical risk management can be a valuable addition to existing clinical risk management methods.

Septal myocardial scar burden predicts the response to cardiac contractility modulation in patients with heart failure.

We hypothesized that myocardial septal scarring, assessed by cardiac magnetic resonance (CMR) using late gadolinium enhancement (LGE), at the site of cardiac contractility modulation (CCM) lead placement may predict treatment response. Eligible heart failure (HF) patients underwent LGE CMR imaging before CCM device implantation. The response to CCM therapy at follow-up was determined by a change in NYHA class and echocardiographic left ventricular ejection fraction (LVEF) assessment. Patients were classified as responders, if they showed an improvement in either NYHA class or improvement of LVEF by ≥ 5%. 58 patients were included. 67% of patients were classified as responders according to improved NYHA; 55% according to LVEF improvement. 74% of patients were responders if either NYHA class or LVEF improvement was observed. 90% of responders (according to NYHA class) showed septal LGE < 25% at septal position of the leads, while 44% of non-responders showed septal LGE > 25% (p < 0.01). In patients treated with CCM, an improvement of NYHA class was observed when leads were placed at myocardial segments with a CMR- LGE burden less than 25%.

Should HFrEF patients with NYHA class II expect benefit from CCM therapy? Results from the MAINTAINED observational study.

BACKGROUND: Cardiac contractility modulation (CCM) is an FDA-approved device therapy for patients with refractory systolic heart failure and normal QRS width. Randomized trials demonstrated benefits of CCM primarily for patients with severe heart failure (> NYHA class II). PURPOSE: To better understand individualized indication in clinical practice, we compared the effect of CCM in patients with baseline NYHA class II vs. NYHA class III or ambulatory IV over the 5-year period in our large clinical registry (MAINTAINED Observational Study). METHODS: Changes in NYHA class, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), NT-proBNP level, and KDIGO chronic kidney disease stage were compared as functional parameters. In addition, mortality within 3 years was compared with the prediction of the Meta-Analysis Global Group in Chronic heart failure risk score. RESULTS: A total of 172 patients were included in the analyses (10% with NYHA class II). Only patients with NYHA class III/IV showed a significant improvement in NYHA class over 5 years of CCM (II: 0.1 ± 0.6; p = 0.96 vs. III/IV: - 0.6 ± 0.6; p < 0.0001). In both groups, LVEF improved significantly (II: 4.7 ± 8.3; p = 0.0072 vs. III/IV: 7.0 ± 10.7%; p < 0.0001), while TAPSE improved significantly only in NYHA class III/IV patients (II: 2.2 ± 1.6; p = 0.20 vs. III/IV: 1.8 ± 5.2 mm; p = 0.0397). LVEF improvement was comparable in both groups over 5 years of CCM (p = 0.83). NYHA class II patients had significantly lower NT-proBNP levels at baseline (858 [175/6887] vs. 2632 [17/28830] ng/L; p = 0.0044), which was offset under therapy (399 [323/1497] vs. 901 [13/18155] ng/L; p = 0.61). Actual 3-year mortality was 17 and 26% vs. a predicted mortality of 31 and 42%, respectively (p = 0.0038 for NYHA class III/IV patients). CONCLUSIONS: NYHA class III/IV patients experienced more direct and extensive functional improvements with CCM and a survival benefit compared with the predicted risk. However, our data suggest that NYHA class II patients may also benefit from the sustained positive effects of LVEF improvement.

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.

Impact of baseline left ventricular ejection fraction on long-term outcomes in cardiac contractility modulation therapy.

BACKGROUND: Cardiac contractility modulation (CCM), being reserved for patients with symptomatic chronic heart failure (HF) and narrow QRS complex under guideline directed medical therapy, can recover initially reduced left ventricular ejection fraction (LVEF); however, the influence of pre-implantation LVEF on long-term outcomes is not fully understood. This study aimed to compare the effects of lower and higher preimplantation LVEF on long-term outcomes in CCM-therapy. METHODS: One-hundred seventy-two patients from our single-centre registry were retrospectively included (2002-2019). Follow-up data were collected up to 5 years after implantation. Patients were divided into Group 1 (baseline LVEF≤ 30%) and Group 2 (≥ 31%). Both groups were compared based on differences in survival, echocardiographic- and clinical parameters including LVEF, tricuspid annular plane systolic excursion (TAPSE), NYHA class or Minnesota living with heart failure questionnaire-score (MLWHFQ). RESULTS: 11% of the patients did have a LVEF ≥31%. Mean LVEF ± SD for both groups were 21.98 ± 5.4 versus 35.2 ± 3.7%, respectively. MLWHFQ (47 ± 21.2 vs. 42±21.4) and mean peak oxygen consumption (VO2, 13.6 ± 4.1 vs. 12.7 ± 2.8 ml/kg/min) were comparable between both groups. LVEF-grouping did not influence survival. Lower baseline LVEF resulted in significantly better recovery of echocardiographic parameters such as LVEF and TAPSE. Irrespective from baseline LVEF, both groups showed nearly comparable improvements for clinical parameters like NYHA-class and MLWHFQ. CONCLUSION: Long-term biventricular systolic recovery potential in CCM-therapy might be better for preimplantation LVEF values ≤30%, whereas clinical parameters such as NYHA-class can improve irrespective from baseline LVEF.

Treatment standards for direct oral anticoagulants in patients with acute ischemic stroke and non-valvular atrial fibrillation: A survey among German stroke units.

BACKGROUND: Acute ischemic stroke (AIS) in patients with non-valvular atrial fibrillation (AF) despite oral anticoagulation (OAC) is a complex and insufficiently investigated setting. Potential strategies range from maintaining the current OAC to changing the substance class. We have queried the specific treatment standards on German stroke units (SUs). METHODS: By means of a standardized online questionnaire via SurveyMonkey™ (San Mateo, CA, USA), all clinical heads of German SUs were asked about their treatment standards in the following clinical situations: first AIS of an OAC-naïve AF patient, AF patient with AIS despite administration of a vitamin K antagonist (VKA), AF patient with AIS despite administration of direct OAC (DOAC). In addition, the performance of specific coagulation tests in AF patients with AIS despite OAC was queried. RESULTS: 160 (48%) clinical heads of German SU responded. Data from pivotal trials (84%), own experience with substances (71%), and side-effect profiles (66%) determine the initial DOAC prescription. In case of an AIS despite OAC, 83 and 18% would switch from VKA to DOAC under certain conditions and always, respectively. Half of respondents would switch from DOAC to VKA under certain conditions, while the other half would decline. 96% would switch to an alternative DOAC. The vast majority of those who made preconditions considered concomitant diseases (92, 90, and 81%, respectively). Few would consider infarct pattern (<35%). 61% perform initial coagulation tests (only one-third substance-specific assessments); however, the majority do not use these to make further decisions. CONCLUSIONS: In the setting of an OAC-naïve AF patient with AIS, established pivotal data are most respected. In the unclear setting of an AIS despite OAC, most respondents consider concomitant diseases and give preference to switching to a (different) DOAC.

Cardiac Contractility Modulation in Patients with Ischemic versus Non-ischemic Cardiomyopathy: Results from the MAINTAINED Observational Study.

BACKGROUND: Cardiac contractility modulation (CCM) is an FDA-approved device-based therapy for patients with systolic heart failure and normal QRS width who are symptomatic despite optimal drug therapy. The purpose of this study was to compare the long-term therapeutic effects of CCM therapy in patients with ischemic (ICM) versus non-ischemic cardiomyopathy (NICM). METHODS: Changes in NYHA class, KDIGO CKD stage, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), and NT-proBNP levels were compared as functional parameters. Moreover, observed mortality rates at 1 and 3 years were compared to those predicted by the MAGGIC heart failure risk score, and observed mortality rates were compared between groups for the entire follow-up period. RESULTS: One hundred and seventy-four consecutive patients with chronic heart failure and CCM device implantation between 2002 and 2019 were included in this retrospective analysis. LVEF was significantly higher in NICM patients after 3 years of CCM therapy (35 ± 9 vs. 30 ± 9%; p = 0.0211), and after 5 years, also TAPSE of NICM patients was significantly higher (21 ± 5 vs. 18 ± 5%; p = 0.0437). There were no differences in other effectiveness parameters. Over the entire follow-up period, 35% of all patients died (p = 0.81); only in ICM patients, mortality was lower than predicted at 3 years (35 vs. 43%, p = 0.0395). CONCLUSIONS: Regarding improvement of biventricular systolic function, patients with NICM appear to benefit particularly from CCM therapy.

[Acute ischemic stroke and elevated troponin: Diagnostic work-up and therapeutic consequences]. / Akuter ischämischer Schlaganfall und Troponinerhöhung: Diagnostische Abklärung und therapeutische Konsequenzen.

Elevated troponin values are frequently detected in patients with acute ischemic stroke, requiring adequate diagnostic work-up due to the high cardiac mortality after stroke. Since dual platelet inhibition can cause secondary intracerebral hemorrhage careful consideration of invasive coronary intervention is mandatory. Based on three case reports, this review article presents a diagnostic algorithm taking into account latest findings from the literature.

Coronary Artery Disease in Patients Presenting With Acute Ischemic Stroke or Transient Ischemic Attack and Elevated Troponin Levels.

Background: There is little information concerning the invasive coronary angiography (ICA) findings of patients with acute ischemic stroke (AIS) or transient ischemic attack (TIA) with elevated troponin levels and suspected myocardial infarction (MI). This study analyzed patient characteristics associated with ICA outcomes. Methods: A total of 8,322 patients with AIS or TIA, treated between March 2010 and May 2020, were retrospectively screened for elevated serum troponin I at hospital admission. Patients in whom ICA was performed, due to suspected type 1 MI based on symptoms, echocardiography, and ECG, were categorized according to ICA results (non-obstructive coronary artery disease (CAD): ≥1 stenosis ≥50% but no stenosis ≥80%; obstructive CAD: any stenosis ≥80% or hemodynamically relevant stenosis assessed by FFR/iwFR). Results: Elevated troponin levels were detected in 2,205 (22.5%) patients, of whom 123 (5.6%) underwent ICA (mean age 71 ± 12 years; 67% male). CAD was present in 98 (80%) patients, of whom 51 (41%) were diagnosed with obstructive CAD. Thus, ICA findings of obstructive CAD accounted for 2.3% of patients with troponin elevation and 0.6% of all stroke patients. The clinical hallmarks of myocardial ischemia, including angina pectoris (31 vs. 15%, p < 0.05) and regional wall motion abnormalities (49 vs. 32%, p = 0.07), and increased cardiovascular risk indicated obstructive CAD. While there was no association between lesion site or stroke severity and ICA findings, causal large-artery atherosclerosis was significantly more common in patients with obstructive coronary disease (p < 0.05). Conclusion: The rate of obstructive CAD in patients with stroke or TIA and elevated troponin levels with suspected concomitant type I MI is low. The cumulation of several cardiovascular risk factors and clinical signs of MI were predictive. AIS patients with large-artery atherosclerosis and elevated troponin may represent an especially vulnerable subgroup of stroke patients with risk for obstructive CAD.

Left atrial appendage closure in patients with chronic kidney disease: results from the German multicentre LAARGE registry.

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 m2, and subgroups were further analysed (i.e. eGFR < 15, 15-29, and 30-59 mL/min/1.73 m2, respectively). RESULTS: Two hundred ninety-nine of 623 patients (48.0%) revealed a CKD. The prevalence of cardiovascular comorbidity, CHA2DS2-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 m2; p > 0.05 vs. eGFR 30-59 mL/min/1.73 m2). 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.

Comparison of transvenous vs subcutaneous defibrillator therapy in patients with cardiac arrhythmia syndromes and genetic cardiomyopathies.

BACKGROUND: Inherited arrhythmia syndromes and genetic cardiomyopathies attribute in a significant proportion to sudden cardiac death. Implantable cardioverter defibrillators (ICDs) are the cornerstone in the prevention of sudden death in high-risk patients. However, ICD therapy is also associated with high rates of inappropriate shocks and/or device-related complications especially in young patients. OBJECTIVE: To determine the outcome of high-risk patients with inherited arrhythmia syndromes and genetic cardiomyopathies comparing two defibrillator technologies. METHOD: Between 2010 and 2018, 183 consecutive patients from two large German tertiary care centers were enrolled in the study. The majority of patients (83%) had either cardiac channelopathies or idiopathic ventricular fibrillation without cardiac structural abnormalities, while the remaining 17% had a genetic cardiomyopathy (HCM/ARVC). Eighty-six patients (47%) received a transvenous ICD (TV-ICD), while a subcutaneous ICD (S-ICD) was implanted in another 97 patients (53%). RESULTS: During a mean follow-up of 4.3 years, 30 patients had an appropriate ICD therapy (annual rate 3.8%). Fifteen patients experienced an inappropriate shock (annual rate 1.9%). Lead failure occurred in 17 (9%) patients and was less frequent in the S-ICD group (OR 0.48, 95%CI 0.38-0.62). Adverse defibrillator events, defined as a composite of inappropriate shocks and lead failure requiring surgical revision were significantly lower in the S-ICD group as compared to the TV-ICD group (OR 0.55, 95%CI 0.41-0.72). There was a non-significant trend towards lower appropriate shocks in the S-ICD group, that in combination with all-cause shocks yielded in a significantly higher freedom of any shock in the S-ICD group (RR 39%, p = 0.003). No deaths occurred during follow-up. CONCLUSION: The present data favor the use of the subcutaneous ICD for patients with inherited arrhythmia syndromes and genetic cardiomyopathies who do not need anti-bradycardia pacing.

[Delayed Takotsubo syndrome - A critical perioperative incident]. / Das verspätete Tako-Tsubo-Syndrom ­ Ein kritischer perioperativer Zwischenfall.

INTRODUCTION: The term Takotsubo syndrome (TTS) describes a transient ventricular dysfunction. Symptoms and complication rate are similar to those of a myocardial infarction. MEDICAL HISTORY: An 81-year-old female patient was admitted for thrombendarterectomy of the left femoral artery. Prior to a recent biological aortic valve replacement, coronary heart disease had been ruled out. ANESTHETIC INDUCTION AND CLINICAL FINDINGS: After induction of anesthesia, relevant arterial hypotension and sinus bradycardia occurred. After catecholamine administration, transient ST segment elevations were observed, which postoperatively developed a myocardial infarction-like dynamic. Echocardiography and values of cardiac enzymes initially revealed no abnormalities. THERAPY, COURSE AND DIAGNOSIS: After a symptom-free interval the patient developed severe cardiac decompensation on the third postoperative day. At this point, the clinical picture of TTS was visible. Stabilisation of the clinical condition was achieved with levosimendan therapy. CONCLUSION: Dynamic ECG changes in the perioperative situation always require differentiated diagnosis and possibly longer monitoring. TTS is a relevant differential diagnosis because it is subject to severe complications.

Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry.

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). CHA2DS2-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.

Comparison of peri and post-procedural complications in patients undergoing revascularisation of coronary artery multivessel disease by coronary artery bypass grafting or protected percutaneous coronary intervention with the Impella 2.5 device.

BACKGROUND: While coronary artery bypass grafting remains the standard treatment of complex multivessel coronary artery disease, the advent of peripheral ventricular assist devices has enhanced the safety of percutaneous coronary intervention. We therefore evaluated the safety in terms of inhospital outcome comparing protected high-risk percutaneous coronary intervention with the Impella 2.5 device and coronary artery bypass grafting in patients with complex multivessel coronary artery disease. METHODS: This retrospective study included patients with complex multivessel coronary artery disease (SYNTAX score >22) undergoing either coronary artery bypass grafting before the implementation of a protected percutaneous coronary intervention programme with a peripheral ventricular assist device or protected percutaneous coronary intervention with the Impella 2.5 device following the start of the programme. The primary endpoint consisted of inhospital major adverse cardiac and cerebrovascular events. The combined secondary endpoint included peri and post-procedural adverse events. RESULTS: A total of 54 patients (mean age 70.1±9.9 years, 92.6% men) were enrolled in the study with a mean SYNTAX score of 34.5±9.8. Twenty-six (48.1%) patients underwent protected percutaneous coronary intervention while 28 (51.9%) patients received coronary artery bypass grafting. The major adverse cardiac and cerebrovascular event rate was numerically higher in the coronary artery bypass grafting group (17.9 vs. 7.7%; P=0.43) but was not statistically significant. The combined secondary endpoint was not different between the groups; however, patients undergoing coronary artery bypass grafting experienced significantly more peri-procedural adverse events (28.6 vs. 3.8%; P<0.05). CONCLUSION: Patients with complex multivessel coronary artery disease undergoing protected percutaneous coronary intervention with the Impella 2.5 device experience similar intrahospital major adverse cardiac and cerebrovascular event rates when compared to coronary artery bypass grafting. Protected percutaneous coronary intervention represents a safe alternative to coronary artery bypass grafting in terms of inhospital adverse events.

Real-world experience comparing two common left atrial appendage closure devices.

BACKGROUND: The interventional left atrial appendage closure (LAAC) is a guideline-conform alternative to oral anticoagulation (OAC) in non-valvular atrial fibrillation patients with OAC ineligibility. It was aimed to directly compare two contemporary devices in a real-world patient population. METHODS: LAAC was conducted in two centres between 2010 and 2014 as well as between 2014 and 2017, respectively, in a standard fashion based on the specific manufacturer's recommendations. Baseline characteristics, procedural data and event rates during intra-hospital and 6 months follow-up were registered in a retrospective approach, and analysed in device-related groups. RESULTS: A total of 189 patients presented for LAAC device implantation. Baseline characteristics were mostly evenly distributed. In 148 patients, a Watchman™ device (Boston Scientific, Natick, MA, USA) was successfully implanted, an Amplatzer™ Amulet™ (St. Jude Medical, St. Paul, MN, USA) in 34 patients (96.1 and 97.1%, respectively; p = 1.00). Major access site bleedings were more frequent in the Amplatzer™ Amulet™ group (8.9 versus 1.4%; p = 0.046). No intra-hospital thromboembolic event was present. During 6 months follow-up, peri-device leaks > 5 mm and thromboembolic events were uncommon (each p = n.s.). CONCLUSIONS: While procedural success was equally high with both contemporary devices, complications during follow-up were rare, and evenly distributed.