Publications by authors named "Johannes Brachmann"

227 Publications

Differences in management of telemedicine alerts on weekdays and public holidays: Results from the OptiLink heart failure trial.

J Telemed Telecare 2021 Sep 15:1357633X211039398. Epub 2021 Sep 15.

Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital, 163331Saarland University, Germany.

Background: In the OptiLink heart failure study, timely and appropriate reactions to telemedicine alerts improved clinical outcomes in heart failure patients. This analysis investigates the relation between the weekday of alert transmission and the subsequent patient contact.

Methods: In patients enrolled in the intervention arm of the OptiLink heart failure study ( = 505, age 66.1 ± 10.1, 77.2% male, left-ventricular ejection fraction 26.7% ± 6.1%), fluid index threshold crossing alerts were analysed according to the weekday of the transmission. Transmissions on Mondays-Thursdays were categorized as TD1, Fridays-Sundays as well as public holidays as TD2.

Results: Of 1365 transmitted alerts, 867 (63.5%) were categorized as TD1 and 498 (36.5%) as TD2. Same day telephone contacts were more frequent in TD1 (46.2%) than in TD2 (18.3%;  < 0.001). Accordingly, the median time to contact was significantly longer in TD2 compared with TD1 (2(1-3) vs 0(0-1) days;  < 0.001). Rates of no telephone contact were no different between the groups (12.1% vs 12.4%;  = 0.866). Although signs of worsening heart failure were prevalent in 32.4% in TD1 versus 32.1% in TD2 ( = 0.996), initiation of a pharmacological intervention occurred more likely in TD1 compared with TD2 (27.9% vs 22.9%;  = 0.041). No differences existed concerning hospitalization for heart failure within 30 days after alert transmission (3.9% vs 3.4%;  = 0.636).

Conclusion: Alert transmissions during weekends and public holidays were less likely associated with timely patient contacts and initiation of pharmacological interventions than during the week. Telemedical centres providing 24/7 remote monitoring service and specific education programmes for physicians might help to optimize patient care.
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http://dx.doi.org/10.1177/1357633X211039398DOI Listing
September 2021

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

Clin Res Cardiol 2021 Aug 28. Epub 2021 Aug 28.

CardioVascular Center Frankfurt, Seckbacher Landstr. 65, 60389, Frankfurt, Germany.

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.
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http://dx.doi.org/10.1007/s00392-021-01911-1DOI Listing
August 2021

Inactivation of Native K Channels.

J Membr Biol 2021 Aug 12. Epub 2021 Aug 12.

Department of Cardiology, Medical University Hospital Heidelberg, 69120, Heidelberg, Germany.

We have experimented with isolated cardiomyocytes of mollusks Helix. During the whole-cell patch-clamp recordings of K currents a considerable decrease in amplitude was observed upon repeated voltage steps at 0.96 Hz. For these experiments, ventricular cells were depolarized to identical + 20 mV from a holding potential of - 50 mV. The observed spontaneous inhibition of outward currents persisted in the presence of 4-aminopyridine, tetraethylammonium chloride or E-4031, the selective class III antiarrhythmic agent that blocks HERG channels. Similar tendency was retained when components of currents sensitive to either 4-AP or TEA were mathematically subtracted. Waveforms of currents sensitive to 1 and 10 micromolar concentration of E-4031 were distinct comprising prevailingly those activated during up to 200 ms pulses. The outward current activated by a voltage ramp at 60 mV x s rate revealed an inward rectification around + 20 mV. This feature closely resembles those of the mammalian cardiac delayed rectifier I.
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http://dx.doi.org/10.1007/s00232-021-00195-wDOI Listing
August 2021

Rotablation of Heavily Calcified Left Main Stenosis and Aortic Valve Valvuloplasty Under ECMO Cardiopulmonary Support.

JACC Case Rep 2020 Dec 25;2(15):2448-2454. Epub 2020 Nov 25.

Department of Cardiology and Intensive Care Medicine, Medical Clinic II, Coburg Clinic, Coburg, Germany.

High-risk coronary intervention involving the left main coronary artery represents an indication for mechanical circulatory support in hemodynamically unstable patients. Extracorporeal membrane oxygenation permits adequate hemodynamic stabilization and myocardial recovery from life-threatening pulmonary and cardiac failure. Our case report demonstrates the importance of choosing the correct method of hemodynamic support in different case scenarios. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.10.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8304597PMC
December 2020

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

J Cardiovasc Electrophysiol 2021 Jul 27. Epub 2021 Jul 27.

Department of Cardiology, Klinikum Coburg, Coburg, Germany.

Introduction: Gender-based differences in atrial fibrillation have been identified, but limited data exist for patients undergoing left atrial appendage occluder (LAAO) implantation. This study reports gender-related periprocedural and 1-year outcomes of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE).

Methods: LAARGE enrolled 641 patients who were scheduled for LAAO implantation from July 2014 to January 2016 in 38 hospitals in Germany. The data collected included demographics, clinical characteristics, details of implantation, and outcome. Efficacy and safety at 1-year follow-up were assessed by the occurrence of thrombembolic and bleeding events, as well as mortality.

Results: Of 638 patients undergoing LAAO implantation 38.9% were female and 61.1% male. Females were older (76.4 ± 8.2 [females] vs. 75.6 ± 7.7 [males], p = .042) and had a higher stroke risk (CHA DS -VASc score: 4.9 ± 1.5 vs. 4.3 ± 1.5, p < .001). In contrast, males suffered more often from coronary artery (33.1% vs. 53.8%, p < .001) and vascular disease (18.5% vs. 31.0%, p < .001). Technical success was high and similar for both genders (98.4% vs. 97.2%, p = .33). Severe periprocedural complications (6.9% vs. 3.1%, p = .032) occurred more often in females. At 1-year follow-up the rates of all-cause stroke (0.5% vs. 1.3%, p = .65) and severe bleeding (0.0% and 1.0%, p = .29) were low and comparable between the genders. Also, one-year all-cause mortality (9.2% vs. 13.1%, p = .14) did not differ significantly.

Conclusion: LAARGE documented in this elderly patient population undergoing LAAO implantation a higher rate of severe periprocedural complications in females. At 1-year follow-up similar efficacy and safety outcomes were observed for both genders.
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http://dx.doi.org/10.1111/jce.15189DOI Listing
July 2021

Reexamination of the Embolic Stroke of Undetermined Source Concept.

Stroke 2021 Aug 1;52(8):2715-2722. Epub 2021 Jul 1.

Lankenau Hospital and Medical Research Center, Wynnewood, PA (P.K.).

Occult atrial fibrillation (AF) is a leading cause of stroke of unclear cause. The optimal approach to secondary stroke prevention for these patients remains elusive. The term embolic stroke of undetermined source (ESUS) was coined to describe ischemic strokes in which the radiographic features demonstrate territorial infarcts resembling those seen in patients with confirmed sources of embolism but without a clear source of embolism detected. It was assumed that patients with ESUS had a high rate of occult AF and would benefit from treatment with direct oral anticoagulants, which are at least as effective as vitamin K antagonists for secondary stroke prevention in patients with AF, but with a much lower risk of intracerebral hemorrhage. Two recent large randomized trials failed to show superiority of direct oral anticoagulants over aspirin in ESUS patients. These findings prompt a reexamination of the ESUS concept, with the goal of improving specificity for detecting patients with a cardioembolic cause. Based on the negative trial results, there is renewed interest in the role of long-term cardiac monitoring for AF in patients who fit the current ESUS definition, as well as the clinical implication of detecting AF. Ongoing trials are exploring these questions. Current ESUS definitions do not accurately detect the patients who should be prescribed direct oral anticoagulants, potentially because occult AF is less common than expected in these patients and/or anticoagulants may be less beneficial in patients with ESUS but no AF than they are for patients with stroke with established AF. More specific criteria to identify patients who may be at higher risk for occult AF and reduce their risk of subsequent stroke have been developed and are being tested in ongoing clinical trials.
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http://dx.doi.org/10.1161/STROKEAHA.121.035208DOI Listing
August 2021

Catheter ablation of supraventricular tachycardia in patients with and without structural heart disease: insights from the German ablation registry.

Clin Res Cardiol 2021 Jun 9. Epub 2021 Jun 9.

Department of Electrophysiology, University Heart Center Lübeck, Medical Clinic II, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, 23538, Lübeck, Germany.

Aim: To compare patient characteristics, safety and efficacy of catheter ablation of supraventricular tachycardia (SVT) in patients with and without structural heart disease (SHD) enrolled in the German ablation registry.

Methods And Results: From January 2007 until January 2010, a total of 12,536 patients (37.2% with known SHD) were enrolled and followed for at least one year. Patients with SHD more often underwent ablation for atrial flutter (45.8% vs. 20.9%, p < 0.001), whereas patients without SHD more often underwent ablation for atrioventricular nodal reentrant tachycardia (30.2% vs. 11.8%, p < 0.001) or atrioventricular reentrant tachycardia (9.1% vs. 1.6%, p < 0.001). Atrial fibrillation catheter ablation procedures were performed in a similar proportion of patients with and without SHD (38.1% vs. 36.9%, p = 0.21). Overall, periprocedural success rate was high in both groups. Death, myocardial infarction or stroke occurred in 0.2% and 0.1% of patients with and without SHD (p = 0.066). Major non-fatal complications prior to discharge were rare and did not differ significantly between patients with and without SHD (0.5% vs. 0.4%, p = 0.34). Kaplan-Meier mortality estimate at 1 year demonstrated a significant mortality increase in patients with SHD (2.6% versus 0.7%; p < 0.001).

Conclusion: Patients with and without SHD undergoing SVT ablation exhibit similar success rates and low major complication rates, despite disadvantageous baseline characteristics in SHD patients. These data highlight the safety and efficacy of SVT ablation in patients with and without SHD. Nevertheless Kaplan-Meier mortality estimates at 1 year demonstrate a significant mortality increase in patients with SHD, highlighting the importance of treating the underlying condition and reliable anticoagulation if indicated.
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http://dx.doi.org/10.1007/s00392-021-01878-zDOI Listing
June 2021

Cardiac glycosides are not associated with increased mortality or hospitalization rates in ICD and CRT-ICD patients after adjustment for baseline-characteristics at one-year follow-up: Results from the German DEVICE registry.

Int J Cardiol 2021 09 1;338:109-114. Epub 2021 Jun 1.

Clinic for Cardiology II - Electrophysiology, University Hospital Münster, Münster, Germany.

Aims: Despite lacking supporting randomized trials, cardiac glycosides (CGs) are widely used in heart failure and/or atrial fibrillation. Moreover, several pro- and retrospective studies and registry-data have recently raised serious concerns in terms of efficacy and safety of CGs in this field. We have therefore examined the association between CGs and clinical outcome of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization (CRT-ICD) patients of the large German DEVICE registry.

Methods And Results: Between 2007 and 2014, 3782 ICD and 1529 CRT-ICD patients were enrolled in the German DEVICE registry. Those two groups were analyzed independently according to medication with or without CGs. After adjustment for patient characteristics, CGs were not significantly associated with increased one-year mortality (HR 1.27, 95%-CI 0.91-1.76, p = 0.162), major adverse cardiac and cerebrovascular events (OR 1.36, 95%-CI 0.98-1.89, p = 0.063), ICD-shocks (OR 1.29, 95%-CI 0.95-1.74, p = 0.104) or the need for rehospitalization in ICD patients at one-year-follow-up. Similar findings were obtained in CRT-ICD patients. Regarding possible determinants for glycoside treatment, atrial fibrillation at enrollment was found to be most strongly associated with the prescription of glycosides in ICD (adjusted OR 3.25, 95%-CI 2.63-4.02) and CRT-ICD patients (adjusted OR 3.17, 95%-CI 2.39-4.19).

Conclusion: Overall harmful effects of CGs in ICD- and CRT-ICD patients could not be confirmed in DEVICE. Further large and randomized-controlled trials that investigate dose-dependent effects of CGs in addition to contemporary therapy of heart failure and atrial fibrillation are needed.
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http://dx.doi.org/10.1016/j.ijcard.2021.05.047DOI Listing
September 2021

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

Clin Res Cardiol 2021 May 27. Epub 2021 May 27.

Department of Cardiology, University Heart and Vascular Center Hamburg-Eppendorf, Martinistraße 52, 20251, Hamburg, Germany.

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 CHADS-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 CHADS-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.
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http://dx.doi.org/10.1007/s00392-021-01874-3DOI Listing
May 2021

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

J Cardiovasc Electrophysiol 2021 07 18;32(7):1833-1841. Epub 2021 May 18.

Department of Cardiology, Universitäres Herz-und Gefäßzentrum Hamburg-Eppendorf, Hamburg, Germany.

Background: The impact of basic atrial rhythm (sinus rhythm [SR] vs. atrial fibrillation [AF]) during AF ablation on efficacy and safety is unknown.

Methods: About 3375 patients from the German Ablation Registry undergoing first-time AF ablation were divided according to the type of AF and the basic atrial rhythm during the ablation procedure: paroxysmal AF (PAF) and SR [group Ia], PAF and AF [group Ib]), persistent AF and SR (IIa), and persistent AF and AF (IIb).

Results: Patients in SR (n = 2312 [67%]) underwent cryoballoon ablation more often (Ia vs. Ib p = .002 and IIa vs. IIb p = .010, whereas in patients in AF (n = 1063 [33%]) radiofrequency (RF)-based ablation (Ia vs. Ib p = .006 and IIa vs. IIb p = .014) including left and/or right atrial substrate modification was more frequently performed. Depending on the basic rhythm there was no difference regarding arrhythmia recurrence during long-term follow-up. For patients suffering from persistent AF acute procedure-related complications were more often documented when ablated in AF (9.1% vs. 4.6%, p = .012). which was mainly driven by the higher occurrence of pericardial effusion/tamponade. For patients suffering from persistent AF, favorable results were found regarding 366-day Kaplan-Meier estimates of the incidence of MACCE (death, myocardial infarction, and stroke; p = .011) and the composite endpoint of death, myocardial infarction, stroke, and major bleeding (p = .006), when ablated in SR.

Conclusion: Basic atrial rhythm at the time of AF ablation did not affect long-term rhythm outcome. For patients suffering from persistent AF a more favorable acute and long-term safety profile was observed when ablated in SR.
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http://dx.doi.org/10.1111/jce.15072DOI Listing
July 2021

Sudden Cardiac Death-A New Insight Into Potentially Fatal Genetic Markers.

Front Med (Lausanne) 2021 22;8:647412. Epub 2021 Mar 22.

Medical School, University of Split, Split, Croatia.

Sudden cardiac death (SCD) is an unexpected and dramatic event. It draws special attention especially in young, seemingly healthy athletes. Our scientific paper is based on the death of a young, 23-year-old professional footballer, who died on the football field after a two-year history of cardiac symptoms. In this study we analyzed clinical, ECG and laboratory data, as well as results of genetic testing analysis in family members. To elucidate potential genetic etiology of SCD in this family, our analysis included 294 genes related to various cardiac conditions.
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http://dx.doi.org/10.3389/fmed.2021.647412DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8019733PMC
March 2021

Atrial Fibrillation Burden and Clinical Outcomes in Heart Failure: The CASTLE-AF Trial.

JACC Clin Electrophysiol 2021 05 24;7(5):594-603. Epub 2021 Feb 24.

Cardiac Electrophysiology, Tulane University School of Medicine, New Orleans, Louisiana, USA. Electronic address:

Objectives: This subanalysis of the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial aimed to address the association between atrial fibrillation (AF) recurrence, AF burden, and hard clinical outcomes in heart failure (HF) patients with AF.

Background: The CASTLE-AF trial demonstrated the benefit of CA compared to pharmacological treatment in decreasing mortality and CV hospitalizations in patients with AF and HFrEF. However, the impact of AF recurrence and AF burden after ablation on long-term treatment benefit remains unknown.

Methods: The CASTLE-AF protocol randomized 363 patients with coexisting HF and AF in a multicenter prospective controlled fashion to catheter ablation (n = 179) versus pharmacological therapy (n = 184). Two hundred eighty patients were included in this subanalysis (as-treated), 128 of them underwent ablation and 152 received pharmacological treatment. All patients had implanted dual chamber or biventricular implantable defibrillators with activated home monitoring capabilities. The individual AF burden was calculated as the percentage of the atrial arrhythmia time per day.

Results: AF burden at baseline was not predictive of the primary endpoint (p = 0.473) or all-cause mortality (p = 0.446). AF recurrence (defined as any episode >30 s) did not show any relationship with the primary endpoints of mortality and occurrence of HF, irrespective of the treatment arm. An AF burden below 50% after 6 months of catheter ablation, was associated with a significant decrease in primary composite outcome (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.15 to 0.71; p = 0.014) and all-cause mortality (HR: 0.23; 95% CI: 0.07 to 0.71; p = 0.031). The risk of the primary endpoint or mortality was directly related to a low (<50%) or high (≥50%) AF burden at 6 months post-ablation.

Conclusions: AF burden at 6 months was predictive of hard clinical outcomes in HF patients with AF. The first recurrent atrial tachyarrhythmia episode >30 s after ablation was not associated with improvement in mortality and hospitalization for HF. (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF [CASTLE-AF]; NCT00643188).
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http://dx.doi.org/10.1016/j.jacep.2020.11.021DOI Listing
May 2021

Efficacy of LGE-MRI-guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation: The DECAAF II trial: Study design.

J Cardiovasc Electrophysiol 2021 04 2;32(4):916-924. Epub 2021 Mar 2.

Department of Cardiology, University of Washington Medical Center, Seattle, Washington, USA.

Introduction: Success rates of catheter ablation in persistent atrial fibrillation (AF) remain suboptimal. A better and more targeted ablation strategy is urgently needed to optimize outcomes of AF treatment. We sought to assess the safety and efficacy of targeting atrial fibrosis during ablation of persistent AF patients in improving procedural outcomes.

Methods: The DECAAF II trial (ClinicalTrials. gov identifier number NCT02529319) is a prospective, randomized, multicenter trial of patients with persistent AF. Patients with persistent AF undergoing a first-time ablation procedure were randomized in a 1:1 fashion to receive conventional pulmonary vein isolation (PVI) ablation (Group 1) or PVI + fibrosis-guided ablation (Group 2). Left atrial fibrosis and ablation induced scarring were defined by late gadolinium enhancement magnetic resonance imaging at baseline and at 3-12 months postablation, respectively. The primary endpoint is the recurrence of atrial arrhythmia postablation, including atrial fibrillation, atrial flutter, or atrial tachycardia after the 90-day postablation blanking period. Patients were followed for a period of 12-18 months with a smartphone ECG Device (ECG Check Device, Cardiac Designs Inc.). With an anticipated enrollment of 900 patients, this study has an 80% power to detect a 26% reduction in the hazard ratio of the primary endpoint.

Results And Conclusion: The DECAAF II trial is the first prospective, randomized, multicenter trial of patients with persistent AF using imaging defined atrial fibrosis as a treatment target. The trial will help define an optimal approach to catheter ablation of persistent AF, further our understanding of influencers of ablation lesion formation, and refine selection criteria for ablation based on atrial myopathy burden.
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http://dx.doi.org/10.1111/jce.14957DOI Listing
April 2021

Effects of Environmental Factors on Severity and Mortality of COVID-19.

Front Med (Lausanne) 2020 20;7:607786. Epub 2021 Jan 20.

Central Clinical Hospital of Ministry of the Interior and Administration, Warsaw, Poland.

Most respiratory viruses show pronounced seasonality, but for SARS-CoV-2, this still needs to be documented. We examined the disease progression of COVID-19 in 6,914 patients admitted to hospitals in Europe and China. In addition, we evaluated progress of disease symptoms in 37,187 individuals reporting symptoms into the COVID Symptom Study application. Meta-analysis of the mortality risk in seven European hospitals estimated odds ratios per 1-day increase in the admission date to be 0.981 (0.973-0.988, < 0.001) and per increase in ambient temperature of 1°C to be 0.854 (0.773-0.944, = 0.007). Statistically significant decreases of comparable magnitude in median hospital stay, probability of transfer to the intensive care unit, and need for mechanical ventilation were also observed in most, but not all hospitals. The analysis of individually reported symptoms of 37,187 individuals in the UK also showed the decrease in symptom duration and disease severity with time. Severity of COVID-19 in Europe decreased significantly between March and May and the seasonality of COVID-19 is the most likely explanation.
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http://dx.doi.org/10.3389/fmed.2020.607786DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855590PMC
January 2021

Impact of conscious sedation and general anesthesia on periprocedural outcomes in Watchman left atrial appendage closure.

Cardiol J 2021 13;28(4):519-527. Epub 2021 Jan 13.

Department of Cardiology, REGIOMED Klinikum Lichtenfels, Lichtenfels, Germany.

Background: Transcatheter left atrial appendage closure (LAAC) is performed either in conscious sedation (CS) or general anesthesia (GA), and limited data exist regarding clinical outcomes for the two approaches. The aim of the study was to analyze the effect of CS versus GA on acute outcomes in a large patient cohort undergoing LAAC with a Watchman occluder.

Methods: A cohort of 521 consecutive patients underwent LAAC with Watchman occluders at two centers (REGIOMED hospitals, Germany) between 2012 and 2018. One site performed 303 consecutive LAAC procedures in GA, and the other site performed 218 consecutive procedures in CS. The safety endpoint was a composite of major periprocedural complications and postoperative pneumonia. The efficacy endpoint was defined as device success.

Results: After a 1:1 propensity score matching, 196 (CS) vs. 115 (GA) patients could be compared. In 5 (2.6%) cases CS was converted to GA. The primary safety endpoint (3.5% [CS] vs. 7.0% [GA], p = 0.18) and its components (major periprocedural complications: 2.5% vs. 3.5%, p = 0.73; postoperative pneumonia: 2.6% vs. 4.3%, p = 0.51) did not differ between the groups. Also, device success was comparable (96.9% vs. 93.9%, p = 0.24).

Conclusions: In patients undergoing LAAC with the Watchman device, conscious sedation and general anesthesia showed comparable device success rates and safety outcomes. The type of anesthesia for LAAC may therefore be tailored to patient comorbidities, operator experience, and hospital logistics.
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http://dx.doi.org/10.5603/CJ.a2020.0184DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8277000PMC
September 2021

Remote Monitoring With Appropriate Reaction to Alerts Was Associated With Improved Outcomes in Chronic Heart Failure: Results From the OptiLink HF Study.

Circ Arrhythm Electrophysiol 2021 01 10;14(1):e008693. Epub 2020 Dec 10.

Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital, Saarland University, Homburg/Saar (J.W., V.P., F.M., M.B., C.U.).

Background: Impedance-based remote monitoring (RM) failed to reduce clinical events in the OptiLink heart failure (HF) trial. However, rates of alert-driven interventions triggered by intrathoracic fluid index threshold crossings (FTC) were low indicating physicians' inappropriate reactions to alerts.

Methods: We separated appropriate from inappropriate contacts to FTC transmissions in the OptiLink HF trial (Optimization of Heart Failure Management Using OptiVol™ Fluid Status Monitoring and CareLink™). Appropriate contacts had to meet the following criteria: (1) initial telephone contact within 2 working days after FTC transmission, (2) follow-up contacts according to study protocol, and (3) medical intervention initiated after FTC due to cardiac decompensation. We compared time to cardiovascular death or HF hospitalization between RM patients contacted appropriately or inappropriately and patients with usual care.

Results: In the RM group, at least one FTC alert was transmitted in 356 patients (70.5%; n=505). Of note, only 55.5% (n=758) of all transmitted FTCs (n=1365) were followed by an appropriate contact. While 113 patients (31.7%; n=356) have been contacted appropriately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an appropriate contact. Compared with usual care, RM with appropriate contacts to FTC alerts independently reduced the risk of the primary end point (hazard ratio, 0.61 [95% CI, 0.39-0.95]; =0.027).

Conclusions: RM appropriate reactions to FTC alerts are associated with significantly improved clinical outcomes in patients with advanced HF and implantable cardioverter-defibrillators.
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http://dx.doi.org/10.1161/CIRCEP.120.008693DOI Listing
January 2021

Safety and patient-reported outcomes in index ablation versus repeat ablation in atrial fibrillation: insights from the German Ablation Registry.

Clin Res Cardiol 2021 Jun 28;110(6):841-850. Epub 2020 Oct 28.

Department of Cardiology, University Heart and Vascular Center Hamburg-Eppendorf, Martinistraße 52, 20251, Hamburg, Germany.

Background: Pulmonary vein isolation is an established strategy for catheter ablation of atrial fibrillation (AF). However, in a significant number of patients, a repeat procedure is mandatory due to arrhythmia recurrence. In this study, we report safety data and procedural details of patients undergoing index ablation versus repeat ablation in a registry-based real-life setting.

Methods: Patients from the German Ablation Registry, a prospective, multicentre registry of patients undergoing ablation between January 2007 and January 2010 were included.

Results: A total of 4155 patients were enrolled in the study. Group I (index ablation) consisted of 3377/4155 (82.1%) and group II (repeat ablation) of 738/4155 (17.9%). Patients in group I had a significantly higher ratio of paroxysmal AF (69.3% vs 61.9%, p < 0.001) and significantly less persistent AF (30.7% vs 38.1%, p < 0.001). The repeat group showed significantly lower mean RF application duration (2580 s. vs 1960, p < 0.001), less fluoroscopy time (29 min. vs. 27 min., p < 0.001), less mean dose area product (DAP) (3744 cGy × cm vs 3325 cGy × cm, p = 0.001), and shorter study duration (181.2 min. vs 163.6 min., p < 0.001). No statistical difference between the groups was found in terms of mortality (0.3% vs 0.1%, p = 0.39), MACE (0.4% vs 0.3%, p = 0.58), MACCE (0.8% vs 0.6%, p = 0.47), composite safety endpoint (1.5% vs 1.4%, p = 0.76), and arrhythmia recurrence (43.8% vs 41.9%, p = 0.37) during 1-year follow-up. Both groups reported to have improved or no symptoms (80.4% vs 77.8%, p = 0.13).

Conclusion: Repeat catheter ablation is safe and provides a symptomatic relief comparable to index ablation. Repeat procedures are significantly shorter and use less fluoroscopy.
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http://dx.doi.org/10.1007/s00392-020-01763-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166687PMC
June 2021

Comparison in Patients < 75 Years of Age - Versus - Those > 75 Years on One-year-Events With Atrial Fibrillation and Left Atrial Appendage Occluder (From the Prospective Multicenter German LAARGE Registry).

Am J Cardiol 2020 12 15;136:81-86. Epub 2020 Sep 15.

Klinikum Ludwigshafen, Ludwigshafen, Germany; Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.. Electronic address:

Left atrial appendage closure (LAAC) is an alternative to oral anticoagulation therapy in patients with non-valvular atrial fibrillation for the prevention of embolic stroke and systemic embolism. Although elderly patients (>75 years) have both higher ischemic and bleeding risk as compared with younger patients, they benefit from optimal anticoagulation. The subanalysis aimed to assess the indications, the safety, efficacy, and 1-year outcomes of interventional LAAC in elderly patients (≥ 75 years) compared with younger (< 75 years) patients in clinical practice. We analyzed data from the prospective Left-Atrium-Appendage Occluder Registry Germany. A total of 638 patients were included in the registry, 402 (63%) were aged ≥ 75 years. Compared with younger subjects, patients aged ≥75 were more likely to have higher CHA2DS2-VASC and HAS-BLED scores. Procedural success rate was high und similar in both groups (97.6%). Periprocedural adverse events were not statistically significant in groups (11.9% in <75 years vs 12.9% in ≥75 years; p = 0.80). At 1 year follow-up, all-cause mortality was higher in patients aged ≥75 compared withwith younger group (13.0% vs 7.8 %,p = 0.04), mainly due to non-cardiovascular causes (10.6% vs 6.0%). No significant differences in major bleeding, stroke, systemic embolism were observed. In conclusion, LAAC is feasible and safe in patients with AF at high stroke risk and with contraindications for OAC and should be considered as candidates for LAA closure. Elderly patients often present these characteristics and could benefit from this novel therapy.
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http://dx.doi.org/10.1016/j.amjcard.2020.09.017DOI Listing
December 2020

Impact of Left Ventricular Function and Heart Failure Symptoms on Outcomes Post Ablation of Atrial Fibrillation in Heart Failure: CASTLE-AF Trial.

Circ Arrhythm Electrophysiol 2020 10 9;13(10):e008461. Epub 2020 Sep 9.

Department of Cardiology, Tulane University School of Medicine, New Orleans, LA (Y.Z., L.D., N.F.M.).

Background: Recent data demonstrate promising effects on left ventricular dysfunction and left ventricular ejection fraction (LVEF) improvement following ablation for atrial fibrillation (AF) in patients with heart failure. We sought to study the relationship between LVEF, New York Heart Association class on presentation, and the end points of mortality and heart failure admissions in the CASTLE-AF study (Catheter Ablation for Atrial Fibrillation With Heart Failure) population. Furthermore, predictors for LVEF improvement were examined.

Methods: The CASTLE-AF patients with coexisting heart failure and AF (n=363) were randomized in a multicenter prospective controlled fashion to ablation (n=179) versus pharmacological therapy (n=184). Left ventricular function and New York Heart Association class were assessed at baseline (after randomization) and at each follow-up visit.

Results: In the ablation arm, a significantly higher number of patients experienced an improvement in their LVEF to >35% at the end of the study (odds ratio, 2.17; <0.001). Compared with the pharmacological therapy arm, both ablation patient groups with severe (<20%) or moderate/severe (≥20% and <35%) baseline LVEF had a significantly lower number of composite end points (hazard ratio [HR], 0.60; =0.006), all-cause mortality (HR, 0.54; =0.019), and cardiovascular hospitalizations (HR, 0.66; =0.017). In the ablation group, New York Heart Association I/II patients at the time of treatment had the strongest improvement in clinical outcomes (primary end point: HR, 0.43; <0.001; mortality: HR, 0.30; =0.001).

Conclusions: Compared with pharmacological treatment, AF ablation was associated with a significant improvement in LVEF, independent from the severity of left ventricular dysfunction. AF ablation should be performed at early stages of the patient's heart failure symptoms.
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http://dx.doi.org/10.1161/CIRCEP.120.008461DOI Listing
October 2020

Outcomes of ablation in Wolff-Parkinson-White-syndrome: Data from the German Ablation Registry.

Int J Cardiol 2021 01 2;323:106-112. Epub 2020 Sep 2.

Department of Medicine I, University Hospital, LMU Munich, Germany; German Centre for Cardiovascular Research (DZHK); Partner Site: Munich Heart Alliance, Munich, Germany. Electronic address:

Aims: Catheter ablation is recommended for symptomatic WPW-syndrome. Commonly perceived low recurrence rates were challenged recently. We sought to identify patient strata at increased risk.

Method: Of 12,566 patients enrolled at 52 German Ablation Registry sites from 2007 to 2010, 789 were treated for WPW-syndrome. Patients were included for symptomatic palpitations and tachycardia documentation. Follow-up duration was one year. Overall complications were defined as serious, access-related, and ablation-related. We adjudicated WPW-recurrence for re-ablation during follow-up. Risk strata included: admission for repeat ablation at registry entry; accessory pathway localization; antiarrhythmic medical treatment before the ablation.

Results: WPW-syndrome patients were 42.8 ± 16.2 years on average; 39.9% were women. A majority of 95.9% was symptomatic; in 84.4%, a tachycardia was documented. Seventy-six (9.6%) patients presented for repeat procedures. Accessory pathways were located in the left atrium (71.4%), right atrium (21.1%), septum (4.4%), or coronary sinus diverticula (2.1%). Prior antiarrhythmic medication was used in 43.7% of patients. No serious events occurred. The overall complication rate was 2.5% (ablation related 1.2%, access-related 1.3%). Major determinants for complications were presentation for re-ablation as registry index procedure (6.9% vs 2.2%; p = 0.016) and septal pathway location (left 2.0% vs septal 9.1%, p = 0.014). The overall re-ablation rate was 9.7%. Usage of prior antiarrhythmic medication was associated with higher recurrence rates (12.2% vs. 7.6%; p = 0.035).

Conclusions: Patients at higher complication risk may be identified by repeat procedure and septal pathway location. Prior antiarrhythmic medication was associated with higher recurrence rates. Our findings may help improving peri-procedural patient management and information.
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http://dx.doi.org/10.1016/j.ijcard.2020.08.102DOI Listing
January 2021

Pharmacological rhythm versus rate control in patients with atrial fibrillation and heart failure: the CASTLE-AF trial.

J Interv Card Electrophysiol 2021 Sep 4;61(3):609-615. Epub 2020 Sep 4.

Tulane Research Innovation for Arrhythmia Discoveries (TRIAD), Heart and Vascular Institute, Tulane University School of Medicine, 1430 Tulane Avenue, Box 8548, New Orleans, LA, 70112, USA.

Background: The value of antiarrhythmics to maintain normal sinus rhythm in patients with atrial fibrillation (AF) and heart failure (HF) is still being debated. We aimed to determine whether rhythm control using antiarrhythmic drugs (AADs) is more effective than rate control in improving outcomes in this population.

Method: In this sub-analysis of the CASTLE-AF study, we included patients that were treated pharmacologically either to maintain sinus rhythm or to achieve rate control. The primary endpoint was defined as a composite of death from any cause or worsening of HF that led to an unplanned overnight hospitalization.

Result: Among 210 patients (mean age of 64.1 ± 10.8 years, 83.3% male) treated pharmacologically, 60 patients were in the rhythm control group and 150 were in the rate control group. Patients in the rhythm control group were less likely to be assigned a beta-blocker (53 (88.3%) vs 141 (97.9%), P = 0.004) and digitalis (8 (13.3%) vs 53 (36.8%), P < 0.001). Over a median follow-up of 3.76 (95% confidence interval (CI), 3.23, 4.48) years, the primary composite endpoint of all-cause mortality and HF admissions occurred in 23 patients (38.3%) in the rhythm control arm vs 67 (44.7%) in the rate control arm (hazard ratio, 0.99; 95% CI, 0.62 to 1.60; P = 0.976).

Conclusion: In CASTLE-AF among AF patients with HF, rhythm control with AADs did not significantly reduce the primary composite endpoint of all-cause mortality and HF hospitalization when compared with a pharmacological rate control strategy.
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http://dx.doi.org/10.1007/s10840-020-00856-1DOI Listing
September 2021

Survival and quality of life after early discharge in low-risk pulmonary embolism.

Eur Respir J 2021 02 4;57(2). Epub 2021 Feb 4.

Emergency Dept, Clinico San Carlos Hospital, IdISSC, Madrid, Spain.

Introduction: Early discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes.

Methods: The multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE) single-arm management trial investigated early discharge followed by ambulatory treatment with rivaroxaban. The study was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned population. The present analysis includes the entire trial population (576 patients). In addition to 3-month recurrence (primary outcome) and 1-year overall mortality, we analysed self-reported disease-specific (Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire) and generic (five-level five-dimension EuroQoL (EQ-5D-5L) scale) quality of life as well as treatment satisfaction (Anti-Clot Treatment Scale (ACTS)) after pulmonary embolism.

Results: The primary efficacy outcome occurred in three (0.5%, one-sided upper 95% CI 1.3%) patients. The 1-year mortality was 2.4%. The mean±sd PEmb-QoL decreased from 28.9±20.6% at 3 weeks to 19.9±15.4% at 3 months, a mean change (improvement) of -9.1% (p<0.0001). Improvement was consistent across all PEmb-QoL dimensions. The EQ-5D-5L was 0.89±0.12 at 3 weeks after enrolment and improved to 0.91±0.12 at 3 months (p<0.0001). Female sex and cardiopulmonary disease were associated with poorer disease-specific and generic quality of life; older age was associated with faster worsening of generic quality of life. The ACTS burden score improved from 40.5±6.6 points at 3 weeks to 42.5±5.9 points at 3 months (p<0.0001).

Conclusions: Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk pulmonary embolism. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.
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http://dx.doi.org/10.1183/13993003.02368-2020DOI Listing
February 2021

[ECG monitoring: The future has begun!]

Herzschrittmacherther Elektrophysiol 2020 Sep;31(3):239-240

II. Med. Klinik Kardiologie, Angiologie, Pneumologie, REGIOMED-KLINIKEN GmbH, Ketschendorfer Str. 33, 96450, Coburg, Deutschland.

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http://dx.doi.org/10.1007/s00399-020-00712-9DOI Listing
September 2020

Evaluation of Myocardial Gene Expression Profiling for Superior Diagnosis of Idiopathic Giant-Cell Myocarditis and Clinical Feasibility in a Large Cohort of Patients with Acute Cardiac Decompensation.

J Clin Med 2020 Aug 19;9(9). Epub 2020 Aug 19.

Institute of Cardiac Diagnostics and Therapy, IKDT GmbH, 12203 Berlin, Germany.

Aims: The diagnostic approach to idiopathic giant-cell myocarditis (IGCM) is based on identifying various patterns of inflammatory cell infiltration and multinucleated giant cells (GCs) in histologic sections taken from endomyocardial biopsies (EMBs). The sampling error for detecting focally located GCs by histopathology is high, however. The aim of this study was to demonstrate the feasibility of gene profiling as a new diagnostic method in clinical practice, namely in a large cohort of patients suffering from acute cardiac decompensation. : In this retrospective multicenter study, EMBs taken from = 427 patients with clinically acute cardiac decompensation and suspected acute myocarditis were screened (mean age: 47.03 ± 15.69 years). In each patient, the EMBs were analyzed on the basis of histology, immunohistology, molecular virology, and gene-expression profiling. Out of the total of = 427 patient samples examined, GCs could be detected in 26 cases (6.1%) by histology. An established myocardial gene profile consisting of 27 genes was revealed; this was narrowed down to a specified profile of five genes () which serve to identify histologically proven IGCM with high specificity in 25 of the 26 patients (96.2%). Once this newly established profiling approach was applied to the remaining patient samples, an additional = 31 patients (7.3%) could be identified as having IGCM without any histologic proof of myocardial GCs. In a subgroup analysis, patients diagnosed with IGCM using this gene profiling respond in a similar fashion to immunosuppressive therapy as patients diagnosed with IGCM by conventional histology alone. : Myocardial gene-expression profiling is a promising new method in clinical practice, one which can predict IGCM even in the absence of any direct histologic proof of GCs in EMB sections. Gene profiling is of great clinical relevance in terms of a) overcoming the sampling error associated with purely histologic examinations and b) monitoring the effectiveness of therapy.
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http://dx.doi.org/10.3390/jcm9092689DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7563288PMC
August 2020

[Clinical differential indication : Wearables vs implantables].

Herzschrittmacherther Elektrophysiol 2020 Sep 11;31(3):288-291. Epub 2020 Aug 11.

Klinikum Coburg, Coburg, Deutschland.

In order to document arrhythmias, indicated due to symptoms or for prognostic purposes, both invasive and noninvasive possibilities for ECG monitoring are available. The choice of the device for monitoring depends mainly on the frequency of arrhythmias. If they occur less than once a month, long-term monitoring becomes necessary which either continuously monitors the rhythm by an implantable device (implantables) or by wearable systems (wearables) which usually register the ECG discontinuously. Because wearables, e.g. smartphones, are basically ubiquitously available, they may be used for ECG monitoring. This paper comments on the use of implantables and wearables for the detection of atrial fibrillation and the documentation of symptomatic arrhythmias in syncope or palpitations.
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http://dx.doi.org/10.1007/s00399-020-00714-7DOI Listing
September 2020

Propensity-matched comparison of antiplatelet versus anticoagulant after left atrial appendage closure with the Watchman.

Pacing Clin Electrophysiol 2020 11 9;43(11):1242-1251. Epub 2020 Sep 9.

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, PR China.

Background: Optimal antithrombotic therapy following left atrial appendage closure (LAAC) with the Watchman occluder remains uncertain. This study retrospectively compared clinical outcomes of a 3-month dual antiplatelet therapy (DAPT group) and a protocol of anticoagulation plus aspirin for 45 days followed by DAPT for 6 months (ACT group) after LAAC with the Watchman device.

Methods: Of two Watchman registries (Coburg and Lichtenfels hospitals, Germany), 220 and 304 consecutive patients with successful LAAC were included. Patients in Coburg hospital received DAPT while they received ACT in Lichtenfels. After a 1:1 propensity score matching, 174 (DAPT) versus 174 (ACT) patients were compared by use of the primary efficacy endpoint of thromboembolic events and cardiovascular/unexplained death, the primary safety endpoint of nonprocedural related major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards.

Results: The mean age 77.5 ± 7.2 (DAPT) versus 77.3 ± 7.1 (ACT) years, CHA DS -VASc score 4.6 ± 1.5 versus 4.7 ± 1.6, and HAS-BLED score 3.3 ± 0.8 versus 3.3 ± 0.8 were similar. After 12 months, the clinical efficacy (13/174, 7.4% [DAPT] vs 11/174, 6.3% [ACT]; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.38-1.86; P = .66) and safety (6/174, 3.4% vs 8/174, 4.5%; HR, 0.86; 95% CI, 0.29-2.56; P = .79) as well as the combined hazard endpoint (18/174, 10.3% vs 18/174, 10.3%; HR,1.01; 95% CI, 0.53-1.95; P = .97) were comparable.

Conclusions: This study suggests comparable efficacy and safety of 3-month DAPT versus 6 weeks ACT plus aspirin following LAAC with the Watchman.
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http://dx.doi.org/10.1111/pace.14032DOI Listing
November 2020

Ablation of Atrial Fibrillation in Patients with Hypertension-An Analysis from the German Ablation Registry.

J Clin Med 2020 Jul 27;9(8). Epub 2020 Jul 27.

Department of Cardiology, Medical University Hospital, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany.

Background: Hypertension (HTN) constitutes a risk factor for the development of atrial fibrillation (AF), as well as for thromboembolic and bleeding events. We analysed the outcome after catheter ablation of AF in HTN in a cohort from the prospective multicenter German Ablation Registry.

Methods: Between 03/2008 and 01/2010, 626 patients undergoing AF-ablation were analysed. Patients diagnosed with HTN ( = 386) were compared with patients without HTN ( = 240) with respect to baseline, procedural and long-term outcome parameters.

Results: Patients with HTN were older and more often presented with persistent forms of AF and cardiac comorbidities. Major and moderate in-hospital complications were low. At long-term follow-up, major cardiovascular events were rare in both groups. Rates of AF-recurrence, freedom from antiarrhythmic medication and repeat ablation were not statistically different between groups. Most patients reported improvement of symptoms and satisfaction with the treatment. However, patients with HTN more frequently complained of dyspnea of New York Heart Association (NYHA) class ≥ II and angina. They were more often rehospitalized, particularly when persistent AF had been diagnosed.

Conclusion: Catheter ablation of AF is associated with low complication rates and favorable arrhythmia-related results in patients with HTN. Residual clinical symptoms may be due to cardiac comorbidities and require additional attention in this important subgroup of AF-patients.
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http://dx.doi.org/10.3390/jcm9082402DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7463680PMC
July 2020

Pulmonary artery pressure-guided therapy in ambulatory patients with symptomatic heart failure: the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF).

Eur J Heart Fail 2020 10 9;22(10):1891-1901. Epub 2020 Aug 9.

Internal Medicine III Cardiology, Angiology, Intensive Care, Saarland University Medical Centre, Homburg, Germany.

Aims: Heart failure (HF) leads to repeat hospitalisations and reduces the duration and quality of life. Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS™ HF system was shown to be safe and reduce HF hospitalisation (HFH) rates in New York Heart Association (NYHA) class III patients. However, these findings have not been replicated in health systems outside the United States. Therefore, the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) evaluated the safety, feasibility, and performance of this device in Germany, The Netherlands, and Ireland.

Methods And Results: A total of 234 NYHA class III patients (68 ± 11 years, 22% female, ≥1 HFH in the preceding year) from 31 centres were implanted with a CardioMEMS sensor and underwent PAP-guided HF management. One-year rates of freedom from device- or system-related complications and from sensor failure (co-primary outcomes) were 98.3% [95% confidence interval (CI) 95.8-100.0] and 99.6% (95% CI 97.6-100.0), respectively. Survival rate was 86.2%. For the 12 months post- vs. pre-implant, HFHs decreased by 62% (0.60 vs. 1.55 events/patient-year; hazard ratio 0.38, 95% CI 0.31-0.48; P < 0.0001). After 12 months, mean PAP decreased by 5.1 ± 7.4 mmHg, Kansas City Cardiomyopathy Questionnaire (KCCQ) overall/clinical summary scores increased from 47.0 ± 24.0/51.2 ± 24.8 to 60.5 ± 24.3/62.4 ± 24.1 (P < 0.0001), and the 9-item Patient Health Questionnaire sum score improved from 8.7 ± 5.9 to 6.3 ± 5.1 (P < 0.0001).

Conclusion: Haemodynamic-guided HF management proved feasible and safe in the health systems of Germany, The Netherlands, and Ireland. Physician-directed treatment modifications based on remotely obtained PAP values were associated with fewer HFH, sustainable PAP decreases, marked KCCQ improvements, and remission of depressive symptoms.
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http://dx.doi.org/10.1002/ejhf.1943DOI Listing
October 2020

Efficacy and complications of cavo-tricuspid isthmus-dependent atrial flutter ablation in patients with and without structural heart disease: results from the German Ablation Registry.

J Interv Card Electrophysiol 2021 Jun 27;61(1):55-62. Epub 2020 May 27.

Department of Cardiology II, Electrophysiology, University Hospital Muenster, Albert-Schweitzer Campus 1, D-48159, Münster, Germany.

Background: The impact of structural heart disease (SHD) on safety and efficacy of catheter ablation of cavo-tricuspid isthmus-dependent atrial flutter (AFLU) is unclear. In addition, recent data suggest a higher complication rate of AFLU ablation compared to the more complex atrial fibrillation (AF) ablation procedure.

Methods And Results: Within our prospective multicenter registry, 3526 consecutive patients underwent AFLU ablation at 49 German electrophysiological centers from 2007 to 2010. For the present analysis, the patients were divided into a group with SHD (n = 2164 [61.4%]; median age 69 years; 78.5% male) and a group without SHD (n = 1362 [38.6%]; 65 years; 70.3% male). In our study, SHD mainly encompasses coronary artery disease (52.6%), left ventricular ejection fraction ≤ 50% (47.6%), and hypertensive heart disease (28.0%). The primary ablation success (97%) and the incidence of major (0.2%) or moderate (1.2%) complications did not differ significantly between the two groups (P = 1.0 and 0.87, respectively). Vascular access site complications (0.6%), AV block III° (0.2%), and bleeding (≥ BARC II: 0.2%) were most common. After a median 562 days of follow-up, we observed a 2.92-fold higher one-year mortality (P < 0.0001) in patients with SHD. Patients' satisfaction with the ablation therapy (72.0% satisfied) was close to the overall subjective tachyarrhythmia-free rate (70.7%).

Conclusions: The present analysis demonstrates that ablation of cavo-tricuspid isthmus dependent AFLU in patients with SHD has a comparable, excellent risk-benefit profile in our large "real-world" registry. Mortality rates expectedly are higher in patients with SHD and AFLU compared to patients without SHD. CLINICALTRIALS.GOV: NCT01197638, http://clinicaltrials.gov/ct2/show/NCT01197638.
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http://dx.doi.org/10.1007/s10840-020-00769-zDOI Listing
June 2021

WATCHMAN versus ACP or Amulet devices for left atrial appendage occlusion: a sub-analysis of the multicentre LAARGE registry.

EuroIntervention 2020 Dec 4;16(11):e942-e949. Epub 2020 Dec 4.

CardioVascular Center CVC, Frankfurt, Germany.

Aims: Several left atrial appendage (LAA) closure systems are available. Due to differences in device design, the results of specific occluders derived from trials cannot simply be generalised to all devices. The present analysis sought to assess two contemporary LAA closure devices in clinical practice.

Methods And Results: The work represents a non-randomised sub-analysis of the prospective, multicentre, Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) registry. The WATCHMAN (group 1) and the AMPLATZER Cardiac Plug (ACP) or Amulet occluder (group 2) were assessed. A total of 641 patients at 38 centres were enrolled. Of these, 278 (43%) and 340 (53%) patients received the WATCHMAN and ACP/Amulet occluder, respectively. High technical success was achieved with a slight difference between the groups (96% in group 1 vs 99% in group 2; p=0.007). Procedural safety did not differ (98% in group 1 vs 97% in group 2; p=0.55). The Kaplan-Meier estimated one-year composite of death or stroke was 12.0% and 12.9%, respectively (p=0.79).

Conclusions: Both the WATCHMAN and the ACP/Amulet occluder provide excellent procedural results with comparable implantation success and no differences with respect to procedural safety and long-term effectiveness.
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http://dx.doi.org/10.4244/EIJ-D-19-01027DOI Listing
December 2020
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