Myocardial injury after orbital atherectomy and its association with coronary lesion length.

BACKGROUND: Limited data are available regarding myocardial injury and its risk factors in percutaneous coronary interventions (PCI) of severe calcified lesions using orbital atherectomy (OA). METHODS: Patients who underwent OA at our institution were retrospectively enrolled into the present registry. High-sensitive Troponin I (hsTroponin I), EKG and echocardiography were used to assess myocardial injury after the procedure. RESULTS: A total of 27 patients between who underwent OA between January 2022 and June 2023 were included. Myocardial injury (elevation of hsTroponin I above the 99th percentile upper reference limit) occurred in all patients. Median hsTroponin I on the first day after the procedure was 1093 (557-4037) ng/l with a minimum of 86 ng/l and a maximum of 25,756 ng/l. Myocardial infarction occurred in two patients (7 %), who had severe coronary dissection after OA. Lesions were longer (47 [38-52] mm vs. 20 [14-47] mm; p = 0.009) in patients with hsTroponin I levels above the median compared to those with levels below. Furthermore, a moderate correlation between hsTroponin I and lesion length was detected (r = 0.54; p = 0.004). CONCLUSIONS: In the present study myocardial injury occurred in all patients after OA without loss of viable myocardium in the majority of patients. Lesions length was found to be a significant factor associated with markedly increased hsTroponin I after the OA procedure.

Embolization of percutaneous left atrial appendage closure devices: timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

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.

Coronary Angiography After Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation: One-Year Outcomes of a Randomized Clinical Trial.

Importance: Myocardial infarction is a frequent cause of out-of-hospital cardiac arrest (OHCA). The long-term effect of early coronary angiography on patients with OHCA with possible coronary trigger but no ST-segment elevation remains unclear. Objective: To compare the clinical outcomes of early unselective angiography with the clinical outcomes of a delayed or selective approach for successfully resuscitated patients with OHCA of presumed cardiac origin without ST-segment elevation at 1-year follow-up. Design, Setting, and Participants: The TOMAHAWK trial was a multicenter, international (Germany and Denmark), investigator-initiated, open-label, randomized clinical trial enrolling 554 patients between November 23, 2016, to September 20, 2019. Patients with stable return of spontaneous circulation after OHCA of presumed cardiac origin but without ST-segment elevation on the postresuscitation electrocardiogram were eligible for inclusion. A total of 554 patients were randomized to either immediate coronary angiography after hospital admission or an initial intensive care assessment with delayed or selective angiography after a minimum of 24 hours. All 554 patients were included in survival analyses during the follow-up period of 1 year. Secondary clinical outcomes were assessed only for participants alive at 1 year to account for the competing risk of death. Interventions: Early vs delayed or selective coronary angiography and revascularization if indicated. Main Outcomes and Measures: Evaluations in this secondary analysis included all-cause mortality after 1 year, as well as severe neurologic deficit, myocardial infarction, and rehospitalization for congestive heart failure in survivors at 1 year. Results: A total of 281 patients were randomized to the immediate angiography group and 273 to the delayed or selective group, with a median age of 70 years (IQR, 60-78 years). A total of 369 of 530 patients (69.6%) were male, and 268 of 483 patients (55.5%) had a shockable arrest rhythm. At 1 year, all-cause mortality was 60.8% (161 of 265) in the immediate angiography group and 54.3% (144 of 265) in the delayed or selective angiography group without significant difference between the treatment strategies, trending toward an increase in mortality with immediate angiography (hazard ratio, 1.25; 95% CI, 0.99-1.57; P = .05). For patients surviving until 1 year, the rates of severe neurologic deficit, myocardial infarction, and rehospitalization for congestive heart failure were similar between the groups. Conclusions and Relevance: This study found that a strategy of immediate coronary angiography does not provide clinical benefit compared with a delayed or selective invasive approach for patients 1 year after resuscitated OHCA of presumed coronary cause and without ST-segment elevation. Trial Registration: ClinicalTrials.gov Identifier: NCT02750462.

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.

Diagnostic Accuracy of High-Sensitive Troponin for the Identification of Myocardial Infarction in Patients Presenting with Acute Heart Failure.

BACKGROUND: The differentiation of myocardial infarction (MI) in the setting of acute heart failure (AHF) can be challenging because the majority of patients presenting with AHF show elevations of high-sensitive troponin (hs-Tn). Fast identification of MI is crucial to perform timely coronary angiography and to improve clinical outcome. OBJECTIVES: The aim of the present study was to assess the diagnostic accuracy of different levels of hs-Tn for the identification of type 1 MI in patients with AHF. METHODS: This was a retrospective single-center analysis of admitted AHF patients with documentation of high-sensitive troponin T (hs-TnT). RESULTS: A total of 649 patients were enrolled into the present study. Of them, 18% had type 1 MI, 7% had type 2 MI, 69% had myocardial injury, and 6% had no myocardial injury. The area under the curve of hs-TnT for the prediction of type 1 MI was 0.70. Sensitivity and specificity of the hs-TnT 99th percentile upper reference limit (URL) for type 1 MI was 100% and 8%, respectively. The Youden index derived cut-off of hs-TnT was 50 ng/L, showing a sensitivity and specificity for type 1 MI of 63% and 68%, respectively. No significant difference regarding 30-day mortality was found depending on the presence of type 1 MI (odds ratio 1.86; 95% confidence interval 0.91-3.81). CONCLUSIONS: Hs-TnT-based identification of type 1 MI in patients with AHF requires higher cut-offs compared with the 99th percentile URL used in overall acute coronary syndrome populations. However, the adjusted cut-off provided only moderate sensitivity and specificity.

Prognostic impact of high-sensitive troponin on 30-day mortality in patients with acute heart failure and different classes of left ventricular ejection fraction.

High-sensitive troponin T (hs-TnT) is increasingly used for prognostication in patients with acute heart failure (AHF). However, uncertainty exists whether hs-TnT shows comparable prognostic performance in patients with heart failure and different classes of left ventricular ejection fraction (LV-EF). The aim of the present study was to assess the prognostic value of hs-TnT for the prediction of 30-day mortality depending on the presence of HF with preserved ejection fraction (HFpEF), HF with mid-range LV-EF (HFmrEF) and HF with reduced LV-EF (HFrEF) in patients with acutely decompensated HF. Patients admitted to our institution due to AHF were retrospectively included. Clinical information was gathered from electronic and paper-based patient charts. Patients with myocardial infarction were excluded. A total of 847 patients were enrolled into the present study. A significant association was found between HF groups and hs-TnT (regression coefficient -0.018 for HFpEF vs. HFmrEF/HFrEF; p = 0.02). The area under the curve (AUC) of hs-TnT for the prediction of 30-mortality was significantly lower in patients with HFpEF (AUC 0.61) than those with HFmrEF (AUC 0.80; p = 0.01) and HFrEF (AUC 0.73; p = 0.04). Hs-TnT was not independently associated with 30-day outcome in the HFpEF group (OR 1.48 [95%-CI 0.89-2.46]; p = 0.13) in contrast to the HFmrEF group (OR 4.53 [95%-CI 1.85-11.1]; p < 0.001) and HFrEF group (OR 2.58 [95%-CI 1.57-4.23]; p < 0.001). Prognostic accuracy of hs-TnT in patients hospitalized for AHF regarding 30-day mortality is significantly lower in patients with HFpEF compared to those with HFmrEF and HFrEF.

Impact of atrial fibrillation pattern on outcomes after left atrial appendage closure: lessons from the prospective LAARGE registry.

BACKGROUND: Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death. METHODS: Comparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE). RESULTS: A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02-2.72, p = 0.041). CONCLUSION: Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality.

Anticoagulation versus antiplatelet therapy after percutaneous left atrial appendage closure-subanalysis from the multicenter LAARGE registry.

PURPOSE: Data regarding post-procedural antithrombotic therapy following percutaneous left atrial appendage (LAA) in real-world populations using various occluder systems is limited. In the present analysis, anticoagulation (AC) was compared against antiplatelet therapy (APT) using data from the real-world multi-center LAARGE study. METHODS: Patients following LAA closure enrolled in the LAARGE study were assigned to two groups depending on initial post-implantation antithrombotic regime consisting of either AC or APT. Selection of antithrombotic medication was at the discretion of the treating center and/or physician. RESULTS: From July 2014 until January 2016, a total of 627 patients at 38 centers were included. A total of 75 patients (12%) received AC and 552 patients (88%) received APT, respectively. No significant differences were found between the groups regarding the composite of death, stroke and systemic embolism 1 year after LAA closure (Kaplan-Meier estimated rate 9.4% for AC vs. 12.8% for APT; p log rank = 0.45). With respect to bleeding events also, no differences were observed 1 year after the procedure (major bleeding 4.0% vs. 2.0%, p = 0.23; moderate bleeding 4.0% vs. 4.9%, p = 1.00; any bleeding 8.0% vs. 6.9%, p = 0.73). CONCLUSIONS: Postprocedural antithrombotic treatment with AC and APT showed comparable results regarding the composite of death, stroke, and systemic embolism as well as regarding bleeding complications after LAA closure in a real-world all-comers population.

Impact of HAS-BLED Score on outcome after percutaneous left atrial appendage closure: insights from the German Left Atrial Appendage Occluder Registry LAARGE.

AIM: Percutaneous left atrial appendage (LAA) closure has been established as alternative stroke prophylaxis in patients with non-valvular atrial fibrillation (AF) and high bleeding risk. However, little is known regarding the outcome after LAA closure depending on the HAS-BLED score. METHODS: A sub-analysis of the prospective, multicenter, Left-Atrium-Appendage Occluder Register-GErmany (LAARGE) registry was performed assessing three different groups with respect to the HAS-BLED score (0-2 [group 1] vs. 3-4 [group 2] vs. 5-7 [group 3]). RESULTS: A total of 633 patients at 38 centers were enrolled. Of them, 9% (n = 59) were in group 1, 63% (n = 400) in group 2 and 28% (n = 174) in group 3. The Kaplan-Meier estimated 1-year composite of death, stroke and systemic embolism was 3.4% in group 1 vs. 10.4% in group 2 vs. 20.1% in group 3, respectively (p log-rank < 0.001). The difference was driven by death since stroke and systemic embolism did not show a significant difference between the groups. The rate of major bleeding at 1 year was 0% vs. 0% vs. 2.4%, respectively (p = 0.016). CONCLUSION: The present data show that patients had similarly low rates of ischemic complications 1 year after LAA closure irrespective of the baseline bleeding risk. Higher HAS-BLED scores were associated with increased mortality due to higher age and more severe comorbidity of these patients.

Accuracy of high-sensitive troponin depending on renal function for clinical outcome prediction in patients with acute heart failure.

High-sensitive troponin T (hs-TnT) is increasingly used for clinical outcome prediction in patients with acute heart failure (AHF). However, there is an ongoing debate regarding the potential impact of renal function on the prognostic accuracy of hs-TnT in this setting. The aim of the present study was to assess the prognostic value of hs-TnT within 6 h of admission for the prediction of 30-day mortality depending on renal function in patients with AHF. Patients admitted to our institution due to AHF were retrospectively included. Clinical information was gathered from electronic and paper-based patient charts. Patients with myocardial infarction were excluded. A total of 971 patients were enrolled in the present study. A negative correlation between estimated glomerular filtration rate (eGFR) and hsTnT was identified (Pearson r = - 0.16; p < 0.001) and eGFR was the only variable to be independently associated with hsTnT. The area under the curve (AUC) of hs-TnT for the prediction of 30-mortality was significantly higher in patients with an eGFR ≥ 45 ml/min (AUC 0.74) compared to those with an eGFR < 45 ml/min (AUC 0.63; p = 0.049). Sensitivity and specificity of the Youden Index derived optimal cut-off for hs-TnT was higher in patients with an eGFR ≥ 45 ml/min (40 ng/l: sensitivity 73%, specificity 71%) compared to patients with an eGFR < 45 ml/min (55 ng/l: sensitivity 63%, specificity 62%). Prognostic accuracy of hs-TnT in patients hospitalized for AHF regarding 30-day mortality is significantly lower in patients with reduced renal function.

Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation.

BACKGROUND: Myocardial infarction is a frequent cause of out-of-hospital cardiac arrest. However, the benefits of early coronary angiography and revascularization in resuscitated patients without electrocardiographic evidence of ST-segment elevation are unclear. METHODS: In this multicenter trial, we randomly assigned 554 patients with successfully resuscitated out-of-hospital cardiac arrest of possible coronary origin to undergo either immediate coronary angiography (immediate-angiography group) or initial intensive care assessment with delayed or selective angiography (delayed-angiography group). All the patients had no evidence of ST-segment elevation on postresuscitation electrocardiography. The primary end point was death from any cause at 30 days. Secondary end points included a composite of death from any cause or severe neurologic deficit at 30 days. RESULTS: A total of 530 of 554 patients (95.7%) were included in the primary analysis. At 30 days, 143 of 265 patients (54.0%) in the immediate-angiography group and 122 of 265 patients (46.0%) in the delayed-angiography group had died (hazard ratio, 1.28; 95% confidence interval [CI], 1.00 to 1.63; P = 0.06). The composite of death or severe neurologic deficit occurred more frequently in the immediate-angiography group (in 164 of 255 patients [64.3%]) than in the delayed-angiography group (in 138 of 248 patients [55.6%]), for a relative risk of 1.16 (95% CI, 1.00 to 1.34). Values for peak troponin release and for the incidence of moderate or severe bleeding, stroke, and renal-replacement therapy were similar in the two groups. CONCLUSIONS: Among patients with resuscitated out-of-hospital cardiac arrest without ST-segment elevation, a strategy of performing immediate angiography provided no benefit over a delayed or selective strategy with respect to the 30-day risk of death from any cause. (Funded by the German Center for Cardiovascular Research; TOMAHAWK ClinicalTrials.gov number, NCT02750462.).

Changes of Right Ventricular Function After Transcatheter Aortic Valve Replacement and Association With Outcomes.

BACKGROUND: Baseline right ventricular (RV) dysfunction represents a predictor for poor outcome in patients undergoing transcatheter aortic valve replacement (TAVR). However, RV function may improve after TAVR, which could have important implications on outcomes. The aim of the present study was to assess changes in RV function after TAVR and its prognostic value regarding clinical outcome. METHODS AND RESULTS: Patients undergoing TAVR at our institution were consecutively enrolled and categorized into 4 groups according to changes in RV function during echocardiographic follow-up at 6 months. A total of 188 patients were included. Of those showing normal function at baseline, 87% (130/149) had preserved RV function at follow-up (group 1), whereas 13% (19/149) developed new RV dysfunction (group 2). Of those with RV dysfunction at baseline (39 patients), RV function normalized in 46% (18/39) (group 3) and remained impaired in 54% (21/39) (group 4). The Kaplan-Meier estimated survival at 3 years was highest in patients in group 1 (83%), intermediate in group 2 (65%) and 3 (69%), whereas group 4 had the worst survival (37%; P < .001). Furthermore, new or persistent RV dysfunction was identified to be independently associated with mortality during follow-up (hazard ratio 2.55; interquartile range 1.03-6.47, P = .004). CONCLUSIONS: Patients with preserved RV function have a high 3-year survival. Normalization of RV function showed improved survival compared with patients with persistent RV dysfunction, who had a dismal prognosis despite TAVR.

Impact of sinus rhythm versus atrial fibrillation on left ventricular remodeling after transcatheter aortic valve replacement.

AIMS: Atrial fibrillation (AF) is associated with increased mortality after transcatheter aortic valve replacement (TAVR). Cerebrovascular complications and bleeding events associated with anticoagulation therapy are discussed to be possible causes for this increased mortality. The present study sought to assess whether AF is associated with impaired left ventricular (LV) reverse remodeling representing another possible mechanism for poor outcome. METHODS: All patients who underwent TAVR in our institution and had 1-year echocardiography follow-up were included. LV mass index (LVMI) at baseline and follow-up as well as LVMI change at 1 year were assessed with respect to the presence of AF (either at baseline or during hospitalization after TAVR) and sinus rhythm (SR). RESULTS: A total of 213 patients (n = 95 in AF; n = 118 in SR) were enrolled in the present study. Patients with AF had higher LVMI at 1 year compared to those with SR (173 ± 61 g/m2 vs. 154 ± 55 g/m2; p = 0.02) and they showed lower relative LVMI change at 1 year (- 2 ± 28% vs. - 9 ± 29%; p = 0.04). In linear regression analysis, AF was independently associated with relative LVMI change (regression coefficient ß 0.076 [95% CI 0.001-0.150]; p = 0.04). With respect to clinical outcome depending on AF and LVMI regression, the Kaplan-Meier estimated event-free of death or cardiac rehospitalization at 3 years was lowest among patients with AF and no LVMI regression. CONCLUSIONS: The present study identified a significant association of AF with changes in LVMI after TAVR, which was also shown to be associated with clinical outcome.

Dose-Dependent Effect of Renin-Angiotensin System Blockade Following Transcatheter Aortic Valve Replacement.

BACKGROUND: There is growing body of evidence from retrospective studies that renin-angiotensin system (RAS) blockade is associated with improved outcome after transcatheter aortic valve replacement (TAVR). However, it remains unknown whether the effect of RAS blockade is dose dependent. The current study sought to assess the dose-dependent effect of RAS blockade on survival and left-ventricular (LV) remodelling after TAVR. METHODS: Patients who were enrolled into our observational TAVR study at our institution were retrospectively assessed according to different doses of RAS blockade: group 1 (no RAS blockade), group 2 (25% of maximum daily dose), group 3 (50% of maximum daily dose), and group 4 (full daily dose). RESULTS: A total of 323 patients between January 2015 and September 2019 were included. Patients with higher doses of RAS blockade showed a trend toward higher overall survival at 3-year follow-up (56% with no RAS blockade vs 66% with the 25% dose vs 79% with the 50% dose vs 78% with the full dose; P = 0.063). After adjustment for baseline characteristics, the difference in survival was significant (P = 0.042). Besides New York Heart Association class and left-ventricular ejection fraction (LVEF), RAS blockade dose was identified as independent predictor for all-cause mortality (hazard ratio [HR] 0.72; 95% confidence interval [CI], 0.54-0.97; P = 0.03). With respect to LV remodelling, a significantly larger reduction of LV mass index was observed during the follow-up with higher doses of RAS blockade. CONCLUSIONS: The current study showed that the impact of RAS blockade treatment on clinical outcome and LV remodelling after TAVR is dose dependent.

Deep sedation versus general anaesthesia for transcatheter mitral valve repair: an individual patient data meta-analysis of observational studies.

AIMS: The aim of this meta-analysis was to compare general anaesthesia (GA) and deep sedation (DS) with regard to safety and length of intensive care unit (ICU) stay in patients undergoing percutaneous edge-to-edge mitral valve repair (PMVR). METHODS AND RESULTS: Four studies comparing GA and DS in patients undergoing PMVR were included in an individual patient data meta-analysis. Data were pooled after multiple imputation. The composite safety endpoint of all-cause death, stroke, pneumonia, or major to life-threatening bleeding occurred in 87 of 626 (13.9%) patients with no difference between patients treated with DS as compared to GA (56 and 31 events in 420 and 206 patients, respectively). In this regard, the odds ratio (OR) was 1.27 (95% confidence interval [CI]: 0.78 to 2.09; p=0.338) and 1.26 (95% CI: 0.49 to 3.22; p=0.496) following the one-stage and two-stage approach, respectively. Length of ICU stay was longer after GA as compared to DS (ratio of days 3.08, 95% CI: 2.18 to 4.36, p<0.001, and 2.88, 95% CI: 1.45 to 5.73, p=0.016, following the one-stage and two-stage approach, respectively). CONCLUSIONS: Both DS and GA might offer a similar safety profile. However, ICU stay seems to be shorter after DS.

Forced Centralized Allocation of Patients to Temporarily 'Closed' Emergency Departments.

BACKGROUND: Because insufficient data are available, the overall number of patients treated in German emergency departments can only be estimated. It is evident, however, that case numbers have been rising steadily in recent years, and that a lack of capacity is now leading with increasing freuqency to forced centralized allocation of patients by the emergency medical services (EMS) to emergency departments that are, officially, temporarily "closed". METHODS: Trends in patient allocation of this type in greater Munich, Germany, over the years 2013-2019 were analyzed for the first time on the basis of data from 904 997 cases treated by the emergency rescue services. RESULTS: From 2014 to 2019, the number of forced centralized patient allocations rose approximately by a factor of nine, from 70 to 634 per 100 000 persons per year. In the same period, the overall number of cases treated by the emergency rescue services rose by 14.5%. Peak values for forced centralized allocations were reached in the first quarter of each calendar year (2015: 1579, 2017: 2435, 2018: 3161, 2019: 3990). Of all medical specialties, internal medicine was the most heavily affected (more than 59% of the total). Especially in the years 2017-2019, the free availability of internal medicine declined in hospitals participating in the common greater Munich reporting system. CONCLUSION: The reasons for the sharp rise in forced centralized allocations are unclear. This observed trend seems likely to persist over the coming years, in view of the current staff shortage, the aging population, and diminishing hospital capacities. The relevant decision-makers must collaborate to create emergency plans that will prevent care bottlenecks so that patients will not be endangered.

[eHealth-smart devices revolutionizing cardiology]. / eHealth ­ Smart Devices revolutionieren die Kardiologie.

BACKGROUND: The use of smart devices such as smartphones and smartwatches in cardiology continues to significantly increase. The widespread use is also promoted by patients and the industry. OBJECTIVES: The goal is to assess different opportunities of smart devices in cardiology. MATERIALS AND METHODS: A selected review of the literature was carried out. Scientific and clinical studies regarding possible applications of these devices were evaluated. RESULTS: The use of smartphones in Germany is among the highest worldwide. This allows very broad use of this technology in general and in the medical field. There are various potential applications ranging from a reference source over clinical decision support to biosignal sensing. Particularly, the combination of biosignal collection and interpretation by artificial intelligence could lead to a significant improvement of our diagnostic methods and precisely predict the course of various cardiovascular diseases. CONCLUSIONS: Smart devices are already increasingly used in daily clinical practice. Due to the numerous technical opportunities, the use of these devices will further spread and, most probably, will transform cardiology.

Impact of timing of intraaortic balloon counterpulsation on mortality in cardiogenic shock - a subanalysis of the IABP-SHOCK II trial.

BACKGROUND: Conflicting results exist on whether initiation of intraaortic balloon pumping (IABP) before percutaneous coronary intervention (PCI) has an impact on outcome in this setting. Our aim was to assess the outcome of patients undergoing IABP insertion before versus after primary PCI in acute myocardial infarction complicated by cardiogenic shock. METHODS: The IABP-SHOCK II-trial randomized 600 patients with acute myocardial infarction and cardiogenic shock to IABP-support versus control. We analysed the outcome of patients randomized to the intervention group regarding timing of IABP implantation before or after PCI. RESULTS: Of 600 patients included in the IABP-SHOCK II trial, 301 were randomized to IABP-support. We analysed the 275 (91%) patients of this group undergoing primary PCI as revascularization strategy surviving the initial procedure. IABP insertion was performed before PCI in 33 (12%) and after PCI in 242 (88%) patients. There were no differences in baseline arterial lactate (p = 0.70), Simplified Acute Physiology Score-II-score (p = 0.60) and other relevant baseline characteristics. No differences were observed for short- and long-term mortality (pre vs. post 30-day mortality: 36% vs. 37%, odds ratio 0.99, 95% confidence interval (CI) 0.47-2.12, p = 0.99; one-year mortality: 56% vs. 48%, hazard ratio 1.08, 95% CI 0.65-1.80, p = 0.76; six-year-mortality: 64% vs. 65%, hazard ratio 1.00, 95% CI 0.63-1.60, p = 0.99). In multivariable Cox regression analysis timing of IABP-implantation was no predictor for long-term outcome (hazard ratio 1.08, 95% CI 0.66-1.78, p = 0.75). CONCLUSIONS: Timing of IABP-implantation pre or post primary PCI had no impact on outcome in patients with acute myocardial infarction complicated by cardiogenic shock.

Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN.

AIMS: Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. METHODS AND RESULTS: A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2 years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy. CONCLUSIONS: Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.