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.).

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.

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.

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.

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.

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.

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.

Immediate unselected coronary angiography versus delayed triage in survivors of out-of-hospital cardiac arrest without ST-segment elevation: Design and rationale of the TOMAHAWK trial.

Patients experiencing out-of-hospital cardiac arrest (OHCA) without ST-segment elevation are a heterogenic group with a variety of underlying causes. Up to one-third of patients display a significant coronary lesion compatible with myocardial infarction as OHCA trigger. There are no randomized data on patient selection and timing of invasive coronary angiography after admission. METHODS AND RESULTS: The TOMAHAWK trial randomly assigns 558 patients with return of spontaneous circulation after OHCA with no obvious extracardiac origin of cardiac arrest and no ST-segment elevation/left bundle-branch block on postresuscitation electrocardiogram to either immediate coronary angiography or initial intensive care assessment with delayed/selective angiography in a 1:1 ratio. The primary end point is 30-day all-cause mortality. Secondary analyses will be performed with respect to initial rhythm, electrocardiographic patterns, myocardial infarction as underlying cause, neurological outcome, as well as clinical and laboratory markers. Clinical follow-up will be performed at 6 and 12 months. Safety end points include bleeding and stroke. CONCLUSION: The TOMAHAWK trial will address the unresolved issue of timing and general indication of angiography after OHCA without ST-segment elevation.

Impact of transcatheter mitral valve repair on ventricular arrhythmias.

AIMS: Patients with heart failure and severe mitral regurgitation (MR) have a poor prognosis and carry an increased risk for ventricular arrhythmias. The present study evaluates the impact of transcatheter mitral valve repair using the MitraClip on the potential reduction of ventricular arrhythmias. METHODS AND RESULTS: Patients undergoing MitraClip implantation were prospectively enrolled into the present study and received 24 h Holter ECG assessment prior to and 6 months after the procedure. In addition, left ventricular dimensions and function were assessed at baseline and follow-up. A total of 50 patients with mainly functional MR (82%) were included. Non-sustained or sustained ventricular tachycardia (nsVT and/or sVT) occurred in 32% of patients and was reduced to 14% at follow-up (P = 0.01). Also, premature ventricular complex (PVC) burden ≥5% decreased from 16% to 4% (P = 0.04). Patients with persistent (n = 6) or new (n = 1) nsVT and/or sVT at follow-up showed a significant decrease in left ventricular ejection fraction from 38% (interquartile range 26-45%) to 33% (interquartile range 22-44%; P = 0.03). CONCLUSIONS: In this prospective study, transcatheter mitral valve repair using MitraClip was associated with a reduced prevalence of ventricular arrhythmias. The subset of patients with persistent or new ventricular arrhythmias after MitraClip implantation showed progression of left ventricular dysfunction.

Carotid artery stenting in clinical practice depending on patient age.

BACKGROUND: The age-dependent outcome of carotid artery stenting (CAS) outside of randomized controlled trials is largely unknown. Therefore, we assessed acute and long-term results of CAS in a single-center real-world registry. METHODS: All symptomatic and asymptomatic patients who consecutively underwent CAS were enrolled into the present analysis. The population was divided into three groups dependent on patients' age (<65, 65-74, and ≥75 years). RESULTS: Between 1999 and 2015, a total of 878 patients (24%, <65 years; 40%, 65-74 years; and 36%, ≥75 years) underwent CAS. The rate of the primary endpoint (30-day composite of death, stroke, and myocardial infarction [MACCE] plus long-term ipsilateral stroke) was higher in patients aged ≥75 years compared to the middle-age group (hazard ratio [HR] 2.30, confidence interval [CI] 1.22-4.36; P = 0.001). Similarly, the rate of the stroke endpoint (30-day any stroke plus long-term ipsilateral stroke) was higher in patients aged ≥75 years compared to patients aged 65-74 years (HR 2.03, CI 1.01-4.10; P = 0.04). There was no significant age-dependent difference of the primary endpoint and stroke endpoint in the subset of asymptomatic patients. Furthermore, age had no influence on the risk of stroke beyond the periprocedural period. CONCLUSIONS: Patients aged ≥75 years had poorer outcomes after CAS compared to younger patients. Importantly, age did not influence the outcome in asymptomatic patients and the risk for stroke beyond the periprocedural period.

A first in human evaluation of a novel contrast media saving device.

OBJECTIVES: This study evaluated the usability and contrast volume savings of the novel DyeVert™ System. BACKGROUND: During coronary diagnostic and interventional procedures, a substantial portion of injected contrast does not contribute to vessel imaging due to reflux into the ascending aorta. Contrast volume is the primary physician modifiable risk factor for prevention of contrast-induced acute kidney injury CI-AKI which is a frequent complication in patients undergoing coronary angiographic procedures and is related to increases in morbidity, mortality, and healthcare costs. METHODS: In this pilot trial, 44 patients undergoing coronary diagnostic and/or percutaneous coronary intervention (PCI) procedures were enrolled in two centers. All procedures were conducted using a manual manifold injection setup and the DyeVert System, which facilitates the diversion of excess contrast volume prior to injection into the patient. Direct measurements of both the amount of contrast that was attempted to be injected and the actual volume injected into the patient were taken. RESULTS: The difference between the two amounts indicated the volume saved. Procedure types included 34 diagnostic studies and 10 PCI. The mean percent volume saved by the DyeVert System was 47%, with a corresponding P value of <0.0001 achieving the pre-specified level of greater than 15% of contrast media being saved. Mean volume savings were similar for both diagnostic (47 ± 9%) and PCI (50 ± 9%) procedures. Image quality was good in 43/44 (98%) patients. CONCLUSIONS: The DyeVert System substantially decreases contrast delivered to patients during diagnostic or interventional coronary procedures while maintaining adequate image quality. © 2017 Wiley Periodicals, Inc.

Transient left atrial dysfunction is a feature of Takotsubo syndrome.

BACKGROUND: Takotsubo syndrome (TTS) is characterized by a transient left and/or right ventricular dysfunction as a consequence of a distinctive pattern of regional wall motion abnormalities. However, a systematic evaluation of the left atrial (LA) function in patients with TTS is lacking. The aim of the present study was therefore to comprehensively assess LA performance indexes and function in patients with TTS. METHODS: We compared LA function assessed by volumetric indexes derived from fractional volume changes in cardiovascular magnetic resonance (CMR) between 125 TTS patients and 125 patients with anterior ST-segment elevation myocardial infarction (STEMI). Furthermore, recovery of LA performance was evaluated in a subgroup of 20 TTS patients with follow-up CMR data. RESULTS: Patients with TTS demonstrated a significantly lower total LA emptying fraction (EF) [44% (interquartile range (IQR) 34-53%) versus 51% (IQR 42-56%); p < 0.01], passive LA-EF [21% (IQR 14-30%) versus 24% (IQR 20-29%); p = 0.03] and active LA-EF [29% (IQR 20-38%) versus 35% (28-42%); p < 0.01] compared to patients with anterior STEMI. Among the 20 TTS patients with serial CMR data, the total LA-EF significantly improved from 42% (IQR 29-48%) at the acute stage to 51% (IQR 46-59%) at follow-up (p < 0.01). Similarly, active LA-EF (p < 0.01) and passive LA-EF (p = 0.02) improved significantly as well. CONCLUSION: Compared to anterior STEMI, TTS patients demonstrated a significantly decreased LA function during the acute/subacute phase of the disease. However, impairment of LA performance seems to be transient in TTS with recovery during follow-up.

Left atrial appendage closure: First in man with the 4th generation WATCHMAN device.

OBJECTIVES: To evaluate the feasibility and safety of the fourth generation WATCHMAN device. BACKGROUND: The WATCHMAN left atrial appendage (LAA) closure device has been shown to be non-inferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with non-valvular atrial fibrillation. A new (fourth) generation of the WATCHMAN device was designed to facilitate easier delivery and improve safety. METHODS: We conducted a prospective, non-randomized study of LAA closure with use of the 4(th) generation WATCHMAN device in 36 patients with non-valvular atrial fibrillation. Follow-up was performed at 45 days, 6 months and 12 months following implantation. RESULTS: The mean age of the population was 73 ± 6 years and 67% were male. The mean CHADS2 and CHA2 DS2-VASc Score were 2.5 and 4.5, respectively. The device was implanted successfully in 34/36 (94%). No serious hospital complications related to the device or procedure occurred. During 12 month follow-up, three ischemic strokes (8%), one hemorrhagic stroke (3%), one TIA (3%) and three deaths (9%) occurred. Device-associated thrombus formation was detected in one patient (3%) during six-month follow-up and was treated successfully with low molecular weight heparin. CONCLUSIONS: LAA closure with the 4(th) generation WATCHMAN device is feasible and safe. New technical features may contribute to a better performance of the occluder, particularly regarding the risk of pericardial effusions.

Learning Curve Assessment for Percutaneous Left Atrial Appendage Closure With the WATCHMAN Occluder.

OBJECTIVES: We sought to evaluate the effect of increasing experience with left atrial appendage (LAA) closure on short-term outcome. BACKGROUND: Data regarding the impact of the learning curve of LAA closure-particularly regarding technical aspects of the procedure-are lacking. METHODS: The present analysis represents first data from a single-center all-comer registry. The population was divided into 3 groups according to treatment time (group 1: patients 1-30; group 2: patients 31-60; group 3: patients 61-90). RESULTS: The mean age of the population was 77 years. Median CHA2 DS2 VASC Score and HAS-BLED were 5 (IQR 3-5) and 3 (IQR 3-4), respectively. Implantation success was 90% with a slight but not statistically significant increase during the course of the registry. Procedure time (75 [62-108] vs. 50 [43-66] vs. 47 [41-61] minutes; P < 0.0001), fluoroscopy time (20 [15-30] vs. 11 [8-19] vs. 11 [9-18] minutes; P = 0.002), and contrast volume (105 [70-170] vs. 60 [50-75] vs. 50 [50-73] ml; P < 0.0001) were reduced across the 3 groups. In-hospital complications decreased significantly (20 vs. 7% vs. 0%; P = 0.021). The compression grade of the occluder was chosen higher with increasing learning curve (15 [11-25] vs. 25 [17-29] vs. 21 [14-26] %; P = 0.05). CONCLUSIONS: With increasing operator experience the performance and safety of percutaneous LAA closure improved continuously.

Predictors for prolonged hospital stay after transcatheter mitral valve repair with the MitraClip.

OBJECTIVE: The aim is to find predictors for a prolonged LOHS after MitraClip implantation. BACKGROUND: Due to its less invasive nature, average length of hospital stay (LOHS) after the MitraClip procedure is shorter compared to mitral valve surgery. However, some patients have a prolonged LOHS. METHODS: Records of consecutive patients who underwent MitraClip procedure were reviewed. A total of 41 consecutive patients with MitraClip implantation (76 ± 9 years, 59% men) were included. Median hospital stay was 7 days. Hospitalization lasting longer than 7 days was considered prolonged. RESULTS: Procedural success was achieved in 88% of the cases. In-hospital death occurred in 4 of 41 patients (10%). Patients with a prolonged hospital stay (46%) had a higher EuroSCORE I (22.7% [IQR 10.3-28.3] vs. 6.7% [IQR 3.5-18.3], P = 0.017), a higher STS mortality score (6.1%[(IQR 3.7-7.5] vs. 2.6% [IQR 1.4-4.8]; P = 0.043) and a higher STS long-length-of-stay score (18.9% [IQR 11.3-22.5] vs. 9.6% [IQR 6.2-16.1]; P = 0.039) as well as a lower estimated glomerular filtration rate (eGFR) (41 ml/min/1.73 m(2) [IQR 19-52] vs. 56 ml/min/1.73 m(2) [IQR 49-62]; P = 0.008) than those whose did not. In the multivariate model, lower eGFR was identified as predictor for a prolonged hospitalization. CONCLUSION: Lower pre-procedure eGFR is independently associated with a longer hospitalization.

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.

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.

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.

Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry.

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

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

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