Publications by authors named "Christoph Stellbrink"

106 Publications

Safety and efficacy of alcohol septal ablation in adolescents and young adults with hypertrophic obstructive cardiomyopathy.

Clin Res Cardiol 2021 Nov 24. Epub 2021 Nov 24.

Department of Cardiology and Intensive Care Medicine, Klinikum Bielefeld gemGmbH, University Hospital OWL, Teutoburger Straße 50, 33604, Bielefeld, Germany.

Introduction: Data regarding alcohol septal ablation (ASA) in young patients with hypertrophic obstructive cardiomyopathy (HOCM) are scarce. The purpose of our study is to evaluate the safety and efficacy of ASA in patients ≤ 25 years.

Methods And Results: All ASAs between 2002 and 2020 at our institution were assigned to a group of patients 14-25 years of age (group 1) and a reference group > 25 years (group 2). 1,264 procedures were analysed in group 2 (58.6 ± 13.5 years) and 41 procedures in group 1 (20.9 ± 3.3 years). The baseline interventricular septal diameter (IVSD) was higher in group 1 (26.0 ± 6.5 mm vs. 21.3 ± 4.4 mm; p < 0.0001). There was no difference in baseline left ventricular outflow tract gradient (LVOTG) (group 1: 54.4 ± 24.4 mmHg; group 2: 52.4 ± 36.6 mmHg; p = n.s.). A previous cardiac device was more often observed in group 1 (31.7% vs. 9.0%; p < 0.0001). Symptoms were improved after 6 months (group 1: mean NYHA class 2.5 at baseline and 1.3 at FU; p < 0.0001; group 2: mean NYHA class 2.7 at baseline and 1.4 at FU; p <0 .0001). IVSD (group 1: 20.3 ± 8.2 mm; group 2: 16.8 ± 5.7 mm; p < 0.0001 for each group compared to baseline) and LVOTG improved during FU (group 1: 25.5 ± 20.0 mmHg; group 2: 22.1 ± 21.7 mmHg; p < 0.0001 for each group). Intrahospital mortality was 0.0% in patients 14-25 years and 0.9% in the reference group. Persistent AV-block was observed in 12.2% of the group 1 and 15.9% of the group 2 patients (p = n.s.).

Conclusion: ASA is safe and effective in HOCM patients 14-25 years of age in experienced centres.
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http://dx.doi.org/10.1007/s00392-021-01960-6DOI Listing
November 2021

Acute and chronic effects of endocardial radiofrequency ablation of septal hypertrophy in HOCM.

J Cardiovasc Electrophysiol 2021 10 16;32(10):2617-2624. Epub 2021 Aug 16.

Department of Cardiology and Intensive Care Medicine, University Hospital Campus Klinikum Bielefeld, Bielefeld, Germany.

Introduction: Endocardial radiofrequency ablation of septal hypertrophy (ERASH) is an alternative to alcohol septal ablation (ASA) or surgical myectomy for hypertrophic obstructive cardiomyopathy (HOCM). Several studies have confirmed that septal radiofrequency ablation leads to a significant reduction in the left ventricular outflow tract gradient.

Objectives: We aimed to report the outcomes of 41 patients who underwent ERASH with a focus on severe complications.

Methods: Since 2004, 41 patients with HOCM (age: 58.2 ± 13 years) underwent ERASH at our institution. ERASH was performed, since ASA was ineffective (26 patients) or not possible (15 patients).

Results: The left ventricular outflow tract and the right ventricular septum were ablated in 26 and 15 patients, respectively. ERASH resulted in a significant reduction in acute gradient during the session and the results persisted during the 6-month follow-up (67% gradient reduction at rest and 73% after provocation, p = .0002). Pacemaker dependency after ERASH was 29% and pericardial tamponade occurred in two patients. In four patients, ERASH induced a paradoxical increase in obstruction (PIO), beginning suddenly at 30 min after the procedure and leading to lethal shock in one patient. PIO was not observed after ERASH from the right ventricular aspect.

Conclusion: Morbidity and mortality after ERASH were higher than those after ASA. PIO, a life-threatening complication, was observed in 9% of the patients. Our data indicate that ERASH might be considered in patients who are not candidates for surgical myectomy or ASA.
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http://dx.doi.org/10.1111/jce.15203DOI Listing
October 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

Comprehensive multicomponent cardiac rehabilitation in cardiac implantable electronic devices recipients: a consensus document from the European Association of Preventive Cardiology (EAPC; Secondary prevention and rehabilitation section) and European Heart Rhythm Association (EHRA).

Eur J Prev Cardiol 2021 Jan 26. Epub 2021 Jan 26.

Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium.

Cardiac rehabilitation (CR) is a multidisciplinary intervention including patient assessment and medical actions to promote stabilization, management of cardiovascular risk factors, vocational support, psychosocial management, physical activity counselling, and prescription of exercise training. Millions of people with cardiac implantable electronic devices live in Europe and their numbers are progressively increasing, therefore, large subsets of patients admitted in CR facilities have a cardiac implantable electronic device. Patients who are cardiac implantable electronic devices recipients are considered eligible for a CR programme. This is not only related to the underlying heart disease but also to specific issues, such as psychological adaptation to living with an implanted device and, in implantable cardioverter-defibrillator patients, the risk of arrhythmia, syncope, and sudden cardiac death. Therefore, these patients should receive special attention, as their needs may differ from other patients participating in CR. As evidence from studies of CR in patients with cardiac implantable electronic devices is sparse, detailed clinical practice guidelines are lacking. Here, we aim to provide practical recommendations for CR in cardiac implantable electronic devices recipients in order to increase CR implementation, efficacy, and safety in this subset of patients.
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http://dx.doi.org/10.1093/eurjpc/zwaa121DOI Listing
January 2021

Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes.

Nat Sci Sleep 2021 29;13:515-526. Epub 2021 Apr 29.

The Ohio State University, Columbus, OH, USA.

Background: The remedē System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) and improves sleep architecture and daytime sleepiness. Subsequently, the remedē System was approved by FDA in 2017. As a condition of approval, the Post Approval Study (PAS) collected clinical evidence regarding long-term safety and effectiveness in adults with moderate to severe CSA through five years post implant.

Methods: Patients remaining in the Pivotal Trial at the time of FDA approval were invited to enroll in the PAS and consented to undergo sleep studies (scored by a central laboratory), complete the Epworth Sleepiness Scale (ESS) questionnaire to assess daytime sleepiness, and safety assessment. All subjects (treatment and former control group) receiving active therapy were pooled; data from both trials were combined for analysis.

Results: Fifty-three of the original 151 Pivotal Trial patients consented to participate in the PAS and 52 completed the 5-year visit. Following TPNS therapy, the apnea-hypopnea index (AHI), central-apnea index (CAI), arousal index, oxygen desaturation index, and sleep architecture showed sustained improvements. Comparing 5 years to baseline, AHI and CAI decreased significantly (AHI baseline median 46 events/hour vs 17 at 5 years; CAI baseline median 23 events/hour vs 1 at 5 years), though residual hypopneas were present. In parallel, the arousal index, oxygen desaturation index and sleep architecture improved. The ESS improved by a statistically significant median reduction of 3 points at 5 years. Serious adverse events related to implant procedure, device or delivered therapy were reported by 14% of patients which include 16 (9%) patients who underwent a pulse generator reposition or lead revision (primarily in the first year). None of the events caused long-term harm. No unanticipated adverse device effects or related deaths occurred through 5 years.

Conclusion: Long-term TPNS safely improves CSA, sleep architecture and daytime sleepiness through 5 years post implant.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01816776.
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http://dx.doi.org/10.2147/NSS.S300713DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8092633PMC
April 2021

Hemodynamic monitoring by intracardiac impedance measured by cardiac resynchronization defibrillators: Evaluation in a controlled clinical setting (BIO.Detect HF II study).

Indian Pacing Electrophysiol J 2021 Jul-Aug;21(4):209-218. Epub 2021 Apr 15.

Heart Center and Clinical Institute, Aalborg University Hospital, Aalborg, Denmark.

Background: In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), intracardiac impedance measured by dedicated CRT-D software may be used to monitor hemodynamic changes. We investigated the relationship of hemodynamic parameters assessed by intracardiac impedance and by echocardiography in a controlled clinical setting.

Methods: The study enrolled 68 patients (mean age, 66 ± 9 years; 74% males) at 12 investigational sites. The patients had an indication for CRT-D implantation, New York Heart Association class II/III symptoms, left ventricular ejection fraction 15%-35%, and a QRS duration ≥150 ms. Two months after a CRT-D implantation, hemodynamic changes were provoked by overdrive pacing. Intracardiac impedance was recorded at rest and at four pacing rates ranging from 10 to 40 beats/min above the resting rate. In parallel, echocardiography measurements were performed. We hypothesized that a mean intra-individual correlation coefficient (r) between stroke impedance (difference between end-systolic and end-diastolic intracardiac impedance) measured by CRT-D and the aortic velocity time integral (i.e., stroke volume) determined by echocardiography would be significantly larger than 0.65.

Results: The hypothesis was evaluated in 40 patients with complete data sets. The r was 0.797, with a lower confidence interval bound of 0.709. The study hypothesis was met (p = 0.007). A stepwise reduction of stroke impedance and stroke volume was observed with increasing heart rate.

Conclusions: Intracardiac impedance measured by implanted CRT-Ds correlated well with the aortic velocity time integral (stroke volume) determined by echocardiography. The impedance measurements bear potential and are readily available technically, not requiring implantation of additional material beyond standard CRT-D system.
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http://dx.doi.org/10.1016/j.ipej.2021.04.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8263311PMC
April 2021

Alcohol-induced right bundle branch block is associated with a benign outcome in HOCM after alcohol septum ablation (ASA).

Clin Res Cardiol 2021 Mar 26. Epub 2021 Mar 26.

Department of Cardiology and Intensive Care Medicine, Klinikum Bielefeld gemGmbH, Teutoburger Straße 50, 33604, Bielefeld, Germany.

Introduction: Alcohol septum ablation (ASA) is a treatment option for hypertrophic obstructive cardiomyopathy (HOCM). We examined the impact of ASA-induced bundle branch block (BBB) on clinical and hemodynamic features.

Methods And Results: We retrospectively analysed 98 HOCM patients with regard to ASA-induced BBB. Clinical examination was performed at baseline, early after ASA and at chronic follow-up (FU). ASA reduced left ventricular outflow tract gradient (LVOTG) during chronic FU (69.2 ± 41.6 pre vs. 31.8 ± 30.3 mmHg post ASA; p < 0.05) and interventricular septal diameter (21.7 ± 3.4 pre vs. 18.7 ± 5.0 mm post ASA; p < 0.05). ASA-induced early right BBB (RBBB) until discharge was observed in 44.9% and chronic RBBB at FU in 32.7%. Left BBB (LBBB) occurred in 13.3% early after ASA and in only 4.1% at chronic FU. Chronic RBBB was associated with more pronounced exercise-induced LVOTG reduction (102.1 ± 55.2 with vs. 73.6 ± 60.0 mmHg without; p < 0.05). 6-min-walk-test (6-MWT) and NYHA class were not affected by RBBB. LBBB had no influence on LVOTG, 6-MWT and symptoms. More ethanol was injected in patients with early RBBB (1.1 ± 0.4 vs. 0.8 ± 0.3 ml without; p < 0.05), who also showed higher mean CK release (827 ± 341 vs. 583 ± 279 U/l without; p < 0.05). Pacemaker implantation during FU was necessary in 11.5% of patients with early RBBB, 3.1% with chronic RBBB, 7.7% with early LBBB and 0% with chronic LBBB (p = n.s. for BBB vs. no BBB).

Conclusion: ASA-induced RBBB is associated with a higher volume of infused ethanol and higher maximum CK release. RBBB does not adversely affect the clinical outcome or need for pacemaker implantation but was associated with higher exercise-induced LVOTG reduction during chronic FU.
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http://dx.doi.org/10.1007/s00392-021-01847-6DOI Listing
March 2021

Comprehensive multicomponent cardiac rehabilitation in cardiac implantable electronic devices recipients: a consensus document from the European Association of Preventive Cardiology (EAPC; Secondary prevention and rehabilitation section) and European Heart Rhythm Association (EHRA).

Europace 2021 09;23(9):1336-1337o

Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium.

Cardiac rehabilitation (CR) is a multidisciplinary intervention including patient assessment and medical actions to promote stabilization, management of cardiovascular risk factors, vocational support, psychosocial management, physical activity counselling, and prescription of exercise training. Millions of people with cardiac implantable electronic devices live in Europe and their numbers are progressively increasing, therefore, large subsets of patients admitted in CR facilities have a cardiac implantable electronic device. Patients who are cardiac implantable electronic devices recipients are considered eligible for a CR programme. This is not only related to the underlying heart disease but also to specific issues, such as psychological adaptation to living with an implanted device and, in implantable cardioverter-defibrillator patients, the risk of arrhythmia, syncope, and sudden cardiac death. Therefore, these patients should receive special attention, as their needs may differ from other patients participating in CR. As evidence from studies of CR in patients with cardiac implantable electronic devices is sparse, detailed clinical practice guidelines are lacking. Here, we aim to provide practical recommendations for CR in cardiac implantable electronic devices recipients in order to increase CR implementation, efficacy, and safety in this subset of patients.
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http://dx.doi.org/10.1093/europace/euaa427DOI Listing
September 2021

Distribution and impact of age in patients with implantable cardioverter-defibrillators regarding early complications and 1-year clinical outcome: results from the German Device Registry.

J Interv Card Electrophysiol 2021 Oct 22;62(1):83-93. Epub 2020 Sep 22.

Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University of Duisburg- Essen, Essen, Germany.

Background: Patients receiving implantable-cardioverter-defibrillators (ICD) in clinical practice are often older or younger than in clinical trials. Whether older patients benefit from ICD-therapy in a similar way as younger patients is under debate. The objective of this study was to provide real-world data regarding outcomes with respect to age in a large cohort in the German Device Registry.

Methods: Within the registry data from 50 German centers were collected between January 2007 and February 2014.

Results: Our analysis included 3239 ICD patients representing a group of young (28%; group I: < 58 years), intermediate aged (50%; group II: 58-74 years), and elderly patients (22%; group III: 75-92 years). Intergroup comparison of all groups was performed followed by individual comparison vs. group II serving as age-reference group. Procedure-related complications did not differ between all groups. Analysis of the primary endpoint, 1-year all-cause mortality, revealed an increased mortality in the elderly and a decreased mortality in the young cohort vs. the reference group II (group I 2.1%, group II 6.2%, group III 13.2%; p < 0.001). While all-cause rehospitalizations did not differ, we observed a difference in reported device revisions showing more device revisions required in younger patients (group I 8.9%, group II 6.8%, group III 4.0%; p = 0.001).

Conclusions: One-year mortality was doubled in elderly ICD patients probably due to non-cardiac causes. These results further underpin the need for re-evaluating the primary prevention ICD indication in octo- and nonagenarians. Young patients show lower mortality rates but seem to bear higher risk of device-related complications, which highlights the need for improved measures to reduce device-related complications in the young.
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http://dx.doi.org/10.1007/s10840-020-00876-xDOI Listing
October 2021

Transvenous phrenic nerve stimulation for central sleep apnea is safe and effective in patients with concomitant cardiac devices.

Heart Rhythm 2020 12 30;17(12):2029-2036. Epub 2020 Jun 30.

The Ohio State University Wexner Medical Center, Columbus, Ohio.

Background: Central sleep apnea is common in heart failure patients. Transvenous phrenic nerve stimulation (TPNS) requires placing a lead to stimulate the phrenic nerve and activate the diaphragm. Data are lacking concerning the safety and efficacy of TPNS in patients with concomitant cardiovascular implantable electronic devices (CIEDs).

Objective: To report the safety and efficacy of TPNS in patients with concomitant CIEDs.

Methods: In the remedē System Pivotal Trial, 151 patients underwent TPNS device implant. This analysis compared patients with concomitant CIEDs to those without with respect to safety, implant metrics, and efficacy of TPNS. Safety was assessed using incidence of adverse events and device-device interactions. A detailed interaction protocol was followed. Implant metrics included overall TPNS implantation success. Efficacy endpoints included changes in the apnea-hypopnea index (AHI) and quality of life.

Results: Of 151 patients, 64 (42%) had a concomitant CIED. There were no significant differences between the groups with respect to safety. There were 4 CIED oversensing events in 3 patients leading to 1 inappropriate defibrillator shock and delivery of antitachycardia pacing. There was no difference in efficacy between the CIED and non-CIED subgroups receiving TPNS, with both having similar percentages of patients who achieved ≥50% reduction in AHI and quality-of-life improvement.

Conclusion: Concomitant CIED and TPNS therapy is safe. The presence of a concomitant CIED did not seem to impact implant metrics, implantation success, and TPNS efficacy. A detailed interaction protocol should be followed to minimize the incidence of device-device interaction.
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http://dx.doi.org/10.1016/j.hrthm.2020.06.023DOI Listing
December 2020

Cannabis-induced recurrent myocardial infarction in a 21-year-old man: a case report.

Eur Heart J Case Rep 2020 Jun 17;4(3):1-5. Epub 2020 Apr 17.

Department of Cardiology and Intensive Care Medicine, Klinikum Bielefeld GmbH, Teutoburger Straße 50, Bielefeld D-33604, Germany.

Background: Acute coronary syndrome (ACS) is rarely caused by coronary artery disease in young patients unless cardiovascular risk factors are present. Although non-atherosclerotic causes of ACS are rare, they need to be considered in young patients.

Case Summary: We report on a 21-year-old patient referred to our institution with ACS. Electrocardiogram showed ST-segment elevation and coronary angiography revealed thrombotic occlusion of the left anterior descending artery. Reperfusion was achieved by thrombus aspiration, glycoprotein IIb/IIIa inhibitors (GPI), and drug-eluting stent (DES). The patient had no cardiovascular risk factors but reported cannabis consumption before symptom onset. Although he was put on dual antiplatelet therapy and strictly advised to avoid consumption, he continued to abuse cannabis and suffered three further ACS events within 18 months: the first 8 months later caused by thrombotic occlusion of a diagonal branch treated by GPI and DES, the second after 17 months due to thrombotic re-occlusion of the diagonal branch, and the third after 18 months by thrombotic occlusion of the circumflex artery, both events treated by GPI alone (all while still using cannabis). Since then, he stopped cannabis consumption and has been symptom-free for 8 months.

Discussion: This case highlights that cannabis-induced ACS must be considered as a cause of myocardial infarction in young adults. In contrast to ACS in the elderly population, this unusual ACS cause requires specific treatment. The risk of ACS relapse may substantial if cannabis abuse is continued. This potential hazard needs to be taken into consideration when legalization of cannabis is discussed.
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http://dx.doi.org/10.1093/ehjcr/ytaa063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7319859PMC
June 2020

Adherence to ESC cardiac resynchronization therapy guidelines: findings from the ESC CRT Survey II.

Europace 2020 06;22(6):932-938

Cardiology Division, Stavanger University Hospital, Postboks 8100, 4068 Stavanger, Norway.

Aims: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in patients with heart failure (HF) and electrical dyssynchrony. The European Society of Cardiology (ESC) Guidelines provide evidence-based recommendations indicating optimal patient selection for CRT implantation in both the 2013 European Heart Rhythm Association (EHRA) and the 2016 Heart Failure Association (HFA) Guidelines. We assessed the adherence to guidelines and identified factors associated with guideline adherence.

Methods And Results: In 2016, the HFA and EHRA conducted the CRT Survey II in 42 ESC countries. The data collected were sufficient to evaluate adherence to guidelines in 8021 patients. Of these, 67% had a Class I guideline indication for CRT implantation, which was significantly correlated with female gender (1.70, P < 0.0001), age <75 years (1.55, P < 0.0001), non-ischaemic HF aetiology (1.22, P < 0.0001), and elective admission (1.87, P < 0.0001). A further 26% of implants had a Class IIa indication, 5% IIb and only 2% a contraindication to CRT-a Class III indication. Patients implanted under Level IIa indications were much more likely to have more comorbidities than patients implanted under Level I indications. However, there were large variations in guideline adherence between ESC countries.

Conclusion: Implanters in ESC member states demonstrate a high degree of adherence to ESC guidelines with 98% of implants having a documented Class I, IIa or IIb indication. Cardiac resynchronization therapy implantation without a Class I indication was more likely in men, patients age ≥75 years, with HF of ischaemic origin and in patients admitted to hospital acutely.
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http://dx.doi.org/10.1093/europace/euaa067DOI Listing
June 2020

Impact of diabetes on clinical outcome of patients with heart failure undergoing ICD and CRT procedures: results from the German Device Registry.

ESC Heart Fail 2020 06 18;7(3):984-995. Epub 2020 Feb 18.

Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, Essen, Germany.

Aims: Diabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation.

Methods And Results: Within the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post-procedural clinical outcome, including a composite clinical endpoint of all-cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow-up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non-DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non-DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non-DM patients. Unadjusted and adjusted analyses revealed similar all-over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan-Meier survival analysis showed higher all-cause mortality after 1 year (9.0% vs 6.3%; log-rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non-DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89-1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68-2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9-5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42-1.28)].

Conclusions: The overall risk of periprocedural complications and short-term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT-D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT-D implantation.
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http://dx.doi.org/10.1002/ehf2.12613DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7261544PMC
June 2020

Single chamber implantable cardioverter defibrillator compared to dual chamber implantable cardioverter defibrillator: less is more! Data from the German Device Registry.

Clin Res Cardiol 2020 Jul 10;109(7):911-917. Epub 2019 Dec 10.

Klinikum Lüdenscheid, Luedenscheid, Germany.

Background: In patients with high risk for sudden cardiac death the implantation of a defibrillator is an established treatment. However the benefits and risks for patients in accordance to the number of the leads are not clear. Even in the current guidelines a recommendation to this question is missing. We analyzed advantage and disadvantages of single-chamber implantable cardioverter defibrillators (VVI-ICD) versus dual-chamber implantable cardioverter defibrillators (DDD-ICD) in the prospective German Device Registry.

Methods: The data of 2240 patients who underwent ICD implantation in 45 German Centers between January 2007 and March 2011 were included in a prospective device registry (VVI: n = 1629, male = 1358, EF = 34% ± 13%; DDD: n = 611, male = 491, EF = 35% ± 14%).

Results: The in-hospital complications were significantly higher in the DDD-ICD group with higher revision/device complication rates (3.0% vs. 1.2%; p = 0.003) but also higher mortality rate (1.0% vs. 0.1%; p < 0.001). Regarding the adjusted data at 1-year follow-up DDD-ICD caused more device revisions, but no difference in rehospitalization and mortality.

Conclusion: It is still unclear whether DDD-ICD may be beneficial for patients with preserved sinus and atrioventricular nodal function. Our data show that the decision of the operator to choose a DDD-ICD in these patients must be taken very carefully. By choosing a DDD-ICD the patient is exposed to a significantly higher periprocedural complication rate and higher in-hospital mortality. In absence of relevant bradycardias implantation of a DDD-ICD is not justified.
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http://dx.doi.org/10.1007/s00392-019-01584-xDOI Listing
July 2020

Comparison of current German and European practice in cardiac resynchronization therapy: lessons from the ESC/EHRA/HFA CRT Survey II.

Clin Res Cardiol 2020 Jul 6;109(7):832-844. Epub 2019 Dec 6.

Department of Cardiology and Intensive Care Medicine, Teutoburger Straße 50, 33604, Bielefeld, Germany.

Introduction: The European CRT Survey II was introduced to offer insights into CRT implantation practice in Europe. We compared the national data from the participating German centres with that of the other European countries with regard to differences in patient selection, implant results, and initial properties.

Methods And Results: 11,088 patients were enrolled in 288 centres from 42 countries between 2015 and 2017. Of these, 675 (6.1%) were included in 17 centres in Germany. Patients from Germany were older, had more comorbidities and more symptoms of heart failure (HF) than patients from other European countries. There were no differences with regard to HF aetiology and guideline-directed medical treatment was overall well implemented. There was a high use of CRT in patients with atrial fibrillation, even higher in German patients. CRT was most often applied due to HF with wide QRS complex (class I recommendation) but with relatively higher frequency in Germany due to HF with primary indication for an implantable cardioverter-defibrillator (class IIb) or a pacemaker with expected pacing dependency (class I). The overall implant success rate was high with some differences in the implant procedure. The use of remote monitoring was lower in Germany.

Conclusion: This analysis from the European CRT Survey II overall shows good guideline adherence, high implantation success and a low rate of complications in daily practice. There are some regional differences in baseline characteristics, CRT indication, and procedural aspects. The use of remote monitoring in Germany lags behind other European countries.
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http://dx.doi.org/10.1007/s00392-019-01574-zDOI Listing
July 2020

Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea.

Sleep 2019 10;42(11)

Advocate Heart Institute, Naperville, IL.

Study Objective: To evaluate long-term efficacy and safety of phrenic nerve stimulation (PNS) in patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy.

Methods: Patients in the remedē System Pivotal Trial were observed every 3 months after implant until US Food and Drug Administration approval. At the time of approval and study closure, all patients completed 24 months of follow-up; 33 patients had not reached the 36-month visit. Sleep metrics (polysomnography) and echocardiographic parameters are reported at baseline, 12, 18, and 24 months, in addition to available 36-month sleep results from polygraphy. Safety was assessed through 36 months; however, analysis focused through 24 months and available 36-month results are provided.

Results: Patients were assessed at 24 (n = 109) and 36 (n = 60) months. Baseline characteristics included mean age 64 years, 91% male, and mean apnea-hypopnea index 47 events per hour. Sleep metrics (apnea-hypopnea index (AHI), central apnea index, arousal index, oxygen desaturation index, rapid eye movement sleep) remained improved through 24 and 36 months with continuous use of PNS therapy. At least 60% of patients in the treatment group achieved at least 50% reduction in AHI through 24 months. Serious adverse events (SAEs) related to the remedē System implant procedure, device, or therapy through 24 months were reported by 10% of patients, no unanticipated adverse device effects or deaths, and all events resolved. No additional related SAEs were reported between 24 and 36 months.

Conclusion: These data suggest beneficial effects of long-term PNS in patients with CSA appear to sustain through 36 months with no new safety concerns.

Trial Registration: NCT01816776.
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http://dx.doi.org/10.1093/sleep/zsz158DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802564PMC
October 2019

Sex-Related Procedural Aspects and Complications in CRT Survey II: A Multicenter European Experience in 11,088 Patients.

JACC Clin Electrophysiol 2019 09 31;5(9):1048-1058. Epub 2019 Jul 31.

Department of Cardiology, Stavanger University Hospital, Stavanger, Norway; Institute of Internal Medicine, University of Bergen, Bergen, Norway.

Objectives: This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted.

Background: Sex-related differences in procedural aspects and complications in patients undergoing cardiac resynchronization therapy (CRT) implantation has not been explored in a real-life population.

Methods: A post-hoc analysis of procedural data and complications in different sexes and factors associated with events was performed from data collected in the European Society of Cardiology CRT Survey II.

Results: Of all patients (n = 11,088) included, 24.3% were women. The mean age (70 years of age) of male and female recipients was similar. Female patients more frequently had an idiopathic cardiomyopathy (67.4% vs. 44.1%) and fewer comorbidities, including atrial fibrillation (34.8% vs. 42.8%), diabetes (29.1% vs. 32.1%), chronic obstructive lung disease (10.3% vs. 12.6%), and renal failure (28.7% vs. 31.9%), compared with men. More women compared with men had a pacemaker (56.6% vs. 46.3%) and much less often an implantable cardioverter-defibrillator (CRT-D) (19.0% vs. 34.7%) implant. Periprocedural event rate was the highest in women with CRT with defibrillator (7.1% vs. 4.8% in men), followed by women with a CRT with pacing (5.5% vs. 4.4% in men). The higher periprocedural event rate in CRT-D women was attributable primarily to the occurrence of pneumothorax (1.4%), coronary sinus dissection (2.1%), and pericardial tamponade (0.3%). The rate of in-hospital major adverse events (6.0%) and complications necessitating reoperation (4.0%) was not different among sex and device type.

Conclusions: Women are more likely to experience adverse procedure-related events during CRT implantation. Thus, preventive strategies should be employed to minimize complication rate.
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http://dx.doi.org/10.1016/j.jacep.2019.06.003DOI Listing
September 2019

Implantable cardioverter defibrillators in patients with electrical heart disease and hypertrophic cardiomyopathy: data from the German device registry.

Clin Res Cardiol 2020 Apr 31;109(4):508-512. Epub 2019 Jul 31.

Clinic for Cardiology II-Electrophysiology, University of Münster, Albert-Schweitzer Campus 1, 48149, Münster, Germany.

Background: Implantable cardioverter- defibrillator (ICD) therapy is established for the prevention of sudden cardiac death (SCD) in different entities. However, data from large patient cohorts with electrical heart disease are rare. Therefore, we investigated these patients as well as patients with hypertrophic cardiomyopathy by analyzing registry data from a multi-center 'real-life' registry.

Methods: The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5450 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focussed on patients with electrical heart disease or HCM who received an ICD for primary or secondary prevention.

Results: 174 patients with HCM and 112 patients with electrical heart disease (long-QT syndrome, Brugada syndrome and arrhythmogenic right ventricular cardiomyopathy) were compared with 5164 other ICD patients. Median follow-up was 17.0 months. Patients in the control group were significantly older. Of note, overall mortality after 1 year was 1.8% in HCM patients, 6.6% in patients with electrical heart disease and 7.3% in the control group. Patients in the control group presented significantly more severe comorbidities. In contrast to HCM patients and the control group where primary prevention was the major indication for ICD implantation, 77.5% of patients with electrical heart disease received an ICD for secondary prevention. The number of surgical revisions was higher in patients with electrical heart disease.

Conclusion: Data from the present registry display a surprisingly high mortality in patients with electrical heart disease equivalent to the control group. A high proportion of patients who received an ICD for secondary prevention may be regarded as a major determinant for these results, while severe comorbidities such as diabetes, hypertension, and renal failure are major determinants for mortality in the control cohort.
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http://dx.doi.org/10.1007/s00392-019-01532-9DOI Listing
April 2020

Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation.

Europace 2019 Sep;21(9):1313-1324

Stiftung Institut fuer Herzinfarktforschung, Ludwigshafen, Germany.

Aims: To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF).

Methods And Results: Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations.

Conclusions: The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF.

Trial Registration: ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.
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http://dx.doi.org/10.1093/europace/euz155DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6735953PMC
September 2019

Cardiac resynchronization therapy pacemaker or cardiac resynchronization therapy defibrillator: what determines the choice?-findings from the ESC CRT Survey II.

Europace 2019 Jun;21(6):918-927

Cardiology Division, Stavanger University Hospital, Stavanger, Norway.

Aims: The decision to implant a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) may be challenging. There are no clear guideline recommendations as no randomized study of cardiac resynchronization therapy (CRT) has been designed to compare the effects of CRT-P with those of CRT-D on patients' outcomes. In the CRT Survey II, we studied patient and implantation centre characteristics associated with the choice of CRT-P vs. CRT-D.

Methods And Results: Clinical practice data from 10 692 patients undergoing CRT implantation of whom 7467 (70%) patients received a CRT-D and 3225 (30%) received a CRT-P across 42 ESC countries were collected and analysed between October 2015 and January 2017. Factors favouring the selection of CRT-P implantation included age >75 years, female gender, non-ischaemic heart failure (HF) aetiology, New York Heart Association functional Class III/IV symptoms, left ventricular ejection fraction >25%, atrial fibrillation, atrioventricular (AV) block II/III, and implantation in a university hospital.

Conclusion: In a large cohort from the CRT Survey II, we found that patients allocated to receive CRT-P exhibited particular phenotypes with more symptomatic HF, more frequent comorbidities, advanced age, female gender, non-ischaemic HF aetiology, atrial fibrillation, and evidence of AV block. There were substantial differences in the proportion of patients allocated to receive CRT-P vs. CRT-D between countries.
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http://dx.doi.org/10.1093/europace/euz002DOI Listing
June 2019

Change in indication for cardiac resynchronization therapy?

Eur J Cardiothorac Surg 2019 06;55(Suppl 1):i11-i16

Klinik für Kardiologie und Internistische Intensivmedizin, Klinikum Bielefeld, Bielefeld, Germany.

Cardiac resynchronization therapy (CRT) has rapidly evolved as a standard therapy for heart failure (HF) patients with ventricular conduction delay. Although in early trials, only patients with sinus rhythm and advanced stages of HF have been candidates for CRT, more recent data have expanded the indications to patients with mild-to-moderate HF and atrial fibrillation and patients in need of antibradycardia pacing with reduced left ventricular function. On the other hand, it is now well recognized that patients with a wide QRS (>150 ms) and left bundle branch block morphology benefit most from CRT, whereas in patients with a more narrow QRS complex (<130 ms) CRT may actually be harmful despite the evidence of ventricular dyssynchrony by echocardiography. There is no prospective randomized study showing mortality benefit from a combined CRT defibrillating device over a CRT pacer alone. This is especially important because recent data indicate that older patients with non-ischaemic cardiomyopathy may not benefit from the implantable cardioverter-defibrillator as much as previously thought. Thus, the decision for a CRT pacer versus CRT defibrillating should be tailored to the therapeutic goal (improvement in prognosis versus symptomatic relief), patient age, underlying cardiac disease and comorbidities. This article gives an overview over the current indications for CRT according to published literature and the European guidelines for pacing and HF.
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http://dx.doi.org/10.1093/ejcts/ezy488DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6526095PMC
June 2019

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial.

Clin Res Cardiol 2019 Oct 14;108(10):1117-1127. Epub 2019 Mar 14.

Department of Electrophysiology, University of Leipzig, Heart Center, Leipzig, Germany.

Aims: In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups.

Methods: Patients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 274) or CRT-D (n = 390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition.

Results: The prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P = 0.014), as was mortality (7.4% vs. 4.1%; P = 0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR = 0.55 (P = 0.058), HR = 0.39 (P = 0.17)] and CRT-D [OR = 0.68 (P = 0.10), HR = 0.35 (P = 0.018)] subgroups (insignificant interaction, P = 0.58-0.91).

Conclusion: Daily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.
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http://dx.doi.org/10.1007/s00392-019-01447-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6753058PMC
October 2019

How to implant a phrenic nerve stimulator for treatment of central sleep apnea?

J Cardiovasc Electrophysiol 2019 05 18;30(5):792-799. Epub 2019 Mar 18.

4th Military Hospital, Wroclaw, Poland.

Background: Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA.

Objective: To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remedē System, Respicardia, Inc).

Methods: The remedē System is placed in the pectoral region, typically on the right side. A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). A sensing lead is placed into the azygous vein to detect respiration.

Results: In the remedē System Pivotal trial, 147 of 151 (97%) patients were successfully implanted with the system. Sixty-two percent of stimulation leads were placed in the PPV and 35% in the RBC. Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant-related serious adverse events through 6 months.

Conclusion: In patients with CSA, transvenous phrenic nerve stimulation is an effective and safe therapy with an implant procedure similar to that of cardiac implantable electronic devices.
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http://dx.doi.org/10.1111/jce.13898DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850096PMC
May 2019

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

Heart Vessels 2019 Jul 3;34(7):1196-1202. Epub 2019 Jan 3.

Division of Electrophysiology, Department of Cardiovascular Medicine, University of Münster, Münster, Germany.

According to current guidelines prophylactic implantable cardioverter-defibrillator (ICD) therapy is recommended in patients with significantly impaired left ventricular systolic function. However, the recently published DANISH trial did not find a significantly lower long-term rate of death from any cause compared with usual clinical care in patients with non-ischemic cardiomyopathy. We investigated whether registry data from a multi-center 'real-life' registry on patients with non-ischemic cardiomyopathy are similar to this trial. The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5451 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focused on patients with non-ischemic cardiomyopathy and a left ventricular ejection fraction ≤35% who received a prophylactic ICD. Out of 779 patients with symptomatic heart failure and nonischemic cardiomyopathy, 33.1% received a single chamber ICD (VVI), while 11.0% were implanted with a dual-chamber ICD (DDD), and 55.8% received a defibrillator system for cardiac resynchronization therapy. Median follow-up was 16.1 months. 90.7% were alive at follow-up, 9.3% had died during this period. Overall mortality after one year was 5.4%. Overall mortality one year after implantation was significantly increased in patients 68 years and older(7.9%) as compared to younger patients (59-68 years: 2.5%; < 59 years: 3.8%; p < 0.015). Data from the present registry support the recently published results of the DANISH trial. In particular the influence of an increased age as proven in the DANISH trial might also play a role in the present collective. This limits the potential beneficial effect of ICD therapy in particular in the elderly population.
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http://dx.doi.org/10.1007/s00380-018-01337-2DOI Listing
July 2019

[New developments in cardiac implantable electronic devices].

Herzschrittmacherther Elektrophysiol 2018 Dec;29(4):325-326

Abteilung für Kardiologie/Elektrophysiologie, Kerckhoff-Klinik GmbH, Benekestr. 2-8, 61231, Bad Nauheim, Deutschland.

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http://dx.doi.org/10.1007/s00399-018-0596-5DOI Listing
December 2018

[Troubleshooting in Patients with Implanted Pacemaker and ICD].

Dtsch Med Wochenschr 2018 11 30;143(22):1608-1616. Epub 2018 Oct 30.

Because of the growing number of implanted cardiac pacemakers and defibrillators and the ever-increasing complexity of these devices a fundamental knowledge of device malfunctions is of utmost importance even for the non-cardiology physician. Apart from hardware problems such as device infection, lead fracture or dislocation, basic knowledge of the pacemaker sensing and pacing algorithms is also necessary in order to judge the stimulation behavior in different clinical settings. With this respect, there are specific problems for antibradycardia and resynchronizing pacemakers as well as implantable defibrillators. This article gives an overview of the most common problems with cardiac pacemakers and defibrillators as well as the differential diagnostic and therapeutic management for the physician without specific training in arrhythmology.
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http://dx.doi.org/10.1055/a-0560-3180DOI Listing
November 2018

[Transvenous neurostimulation in central sleep apnea associated with heart failure].

Herzschrittmacherther Elektrophysiol 2018 Dec 10;29(4):377-382. Epub 2018 Oct 10.

Klinik für Kardiologie und Internistische Intensivmedizin, Städtische Kliniken Bielefeld, Lehrkrankenhaus der Westfälischen Wilhelms-Universität Münster, Teutoburger Straße 50, 33604, Bielefeld, Deutschland.

Sleep-related breathing disorders can be classified as either obstructive (OSA) or central sleep apnea (CSA). Whereas there is substantial knowledge about the pathophysiology and sound recommendations for the diagnosis and treatment of OSA, the origin of CSA is still incompletely understood, patient identification is difficult and the necessity for specific treatment is under debate. CSA often accompanies heart failure and is associated with an adverse prognosis. Optimized heart failure treatment reduces CSA and is thus the cornerstone of CSA treatment. In contrast to OSA, noninvasive ventilation does not lead to prognostic improvement in CSA and ASV ventilation may even lead to an increase in mortality. Transvenous neurostimuation of the phrenic nerve is currently under clinical investigation as a new therapeutic modality for CSA. Early results demonstrate positive effects on sleep parameters and quality of life without any evidence for a negative impact on mortality. However, these results await confirmation in larger studies before this new approach can be advocated for routine clinical use.
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http://dx.doi.org/10.1007/s00399-018-0591-xDOI Listing
December 2018

Phrenic nerve stimulation to treat patients with central sleep apnoea and heart failure.

Eur J Heart Fail 2018 12 10;20(12):1746-1754. Epub 2018 Oct 10.

The Ohio State University, Columbus, OH, USA.

Aims: The presence of central sleep apnoea (CSA) is associated with poor prognosis in patients with heart failure (HF). The aim of this analysis was to evaluate if using phrenic nerve stimulation to treat CSA in patients with CSA and HF was associated with changes in HF-specific metrics.

Methods And Results: All patients randomized in the remedē System Pivotal Trial and identified at baseline with HF were included (n = 96). Effectiveness data from treatment and former control groups were pooled based on months since therapy activation. Changes from baseline to 6 and 12 months in sleep metrics, Epworth Sleepiness Scale, patient global assessment health-related quality of life, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and echocardiographic parameters are reported. HF hospitalization, cardiovascular death, and the composite of HF hospitalization or cardiovascular death within 6 months are reported by the original randomized group assignment for safety assessment. Sleep metrics and quality of life improved from baseline to 6 and 12 months. At 12 months, MLHFQ scores changed by -6.8 ± 20.0 (P = 0.005). The 6-month rate of HF hospitalization was 4.7% in treatment patients (standard error = 3.3) and 17.0% in control patients (standard error = 5.5) (P = 0.065). Reported adverse events were as expected for a transvenous implantable system.

Conclusions: Phrenic nerve stimulation reduces CSA severity in patients with HF. In parallel, this CSA treatment was associated with benefits on HF quality of life.
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http://dx.doi.org/10.1002/ejhf.1312DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6607512PMC
December 2018

Heart on a string: a novel approach to managing difficult access to the left pericardiacophrenic vein for phrenic nerve stimulation.

Herzschrittmacherther Elektrophysiol 2018 Sep;29(3):322-324

Klinik für Kardiologie und internistische Intensivmedizin, Klinikum Bielefeld Mitte, Teutoburger Straße 50, 33604, Bielefeld, Germany.

This case highlights the difficulties in pacing lead implantation for transvenous phrenic nerve stimulation to treat central sleep apnea in heart failure. Cannulation of the left pericardiacophrenic vein (PPV) initially failed due to vessel tortuosity. On the basis of sound knowledge of collateral vessels, the inferior phrenic vein (IPV), which drains into the inferior vena cava, was intubated using a guide catheter. A guidewire could be retrogradely advanced via the IPV to the left PPV and brachiocephalic vein. The wire was captured via a snare catheter, such that the heart was held "on a string", thereby providing adequate support for lead placement.
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http://dx.doi.org/10.1007/s00399-018-0587-6DOI Listing
September 2018
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