Publications by authors named "Frieder Braunschweig"

111 Publications

EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS).

Europace 2021 Jul;23(7):983-1008

Department of Cardiology, Hospital Santa Marta, Rua Santa Marta, 1167-024 Lisbon, Portugal.

With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.
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http://dx.doi.org/10.1093/europace/euaa367DOI Listing
July 2021

Response to: Kumar N, Ahmed M. Letter to the editor in response to Komen et al. 2021.

Eur Heart J Cardiovasc Pharmacother 2021 May;7(3):e31

Clinical Pharmacology Unit, Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.

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http://dx.doi.org/10.1093/ehjcvp/pvab028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141297PMC
May 2021

Internet-Delivered Exposure-Based Therapy for Symptom Preoccupation in Atrial Fibrillation: Uncontrolled Pilot Trial.

JMIR Cardio 2021 Mar 2;5(1):e24524. Epub 2021 Mar 2.

Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the adult population. AF is associated with a poor quality of life (QoL) and, in many patients, current medical treatments are inadequate in alleviating AF symptoms (eg, palpitations). Patients often present with symptom preoccupation in terms of symptom fear, avoidance, and control behaviors. Internet-delivered cognitive behavior therapy is effective for treating other somatic disorders but has never been evaluated in patients with AF.

Objective: The aim of this study is to evaluate the efficacy and feasibility of AF-specific internet-delivered cognitive behavior therapy.

Methods: We conducted an uncontrolled pilot study in which 19 patients with symptomatic paroxysmal AF underwent internet-delivered cognitive behavior therapy. Participants completed self-assessments at pretreatment, posttreatment, and at a 6-month follow-up along with handheld electrocardiogram measurements with symptom registration. The treatment lasted 10 weeks and included exposure to physical sensations, reduction in avoidance behavior, and behavioral activation.

Results: We observed large within-group improvements in the primary outcome, AF-specific QoL (Cohen d=0.80; P<.001), and in symptom preoccupation (Cohen d=1.24; P<.001) at posttreatment; the results were maintained at the 6-month follow-up. Treatment satisfaction and adherence rates were also high. We observed an increased AF burden, measured by electrocardiogram, at the 6-month follow-up, but a significant decrease was observed in the overestimation of AF symptoms at posttreatment and 6-month follow-up. Exploratory mediation analysis showed that a reduction in symptom preoccupation mediated the effects of internet-delivered cognitive behavior therapy on AF-specific QoL.

Conclusions: This study presents preliminary evidence for the potential efficacy and feasibility of a novel approach in treating patients with symptomatic AF with internet-delivered cognitive behavior therapy.

Trial Registration: ClinicalTrials.gov NCT02694276; https://clinicaltrials.gov/ct2/show/NCT02694276.
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http://dx.doi.org/10.2196/24524DOI Listing
March 2021

Recommendations for participation in leisure-time physical activity and competitive sports in patients with arrhythmias and potentially arrhythmogenic conditions: Part 1: Supraventricular arrhythmias. A position statement of the Section of Sports Cardiology and Exercise from the European Association of Preventive Cardiology (EAPC) and the European Heart Rhythm Association (EHRA), both associations of the European Society of Cardiology.

Eur J Prev Cardiol 2020 Jun 29. Epub 2020 Jun 29.

Italian National Olympic Committee, Institute of Sport Medicine and Science, Italy.

Symptoms attributable to arrhythmias are frequently encountered in clinical practice. Cardiologists and sport physicians are required to identify high-risk individuals harbouring such conditions and provide appropriate advice regarding participation in regular exercise programmes and competitive sport. The three aspects that need to be considered are: (a) the risk of life-threatening arrhythmias by participating in sports; (b) control of symptoms due to arrhythmias that are not life-threatening but may hamper performance and/or reduce the quality of life; and (c) the impact of sports on the natural progression of the underlying arrhythmogenic condition. In many cases, there is no unequivocal answer to each aspect and therefore an open discussion with the athlete is necessary, in order to reach a balanced decision. In 2006 the Sports Cardiology and Exercise Section of the European Association of Preventive Cardiology published recommendations for participation in leisure-time physical activity and competitive sport in individuals with arrhythmias and potentially arrhythmogenic conditions. More than a decade on, these recommendations are partly obsolete given the evolving knowledge of the diagnosis, management and treatment of these conditions. The present document presents a combined effort by the Sports Cardiology and Exercise Section of the European Association of Preventive Cardiology and the European Heart Rhythm Association to offer a comprehensive overview of the most updated recommendations for practising cardiologists and sport physicians managing athletes with supraventricular arrhythmias, and provides pragmatic advice for safe participation in recreational physical activities, as well as competitive sport at amateur and professional level. A companion text on recommendations in athletes with ventricular arrhythmias, inherited arrhythmogenic conditions, pacemakers and implantable defibrillators is published as Part 2 in Europace.
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http://dx.doi.org/10.1177/2047487320925635DOI Listing
June 2020

Stimulating the Resolution of Inflammation Through Omega-3 Polyunsaturated Fatty Acids in COVID-19: Rationale for the Trial.

Front Physiol 2020 11;11:624657. Epub 2021 Jan 11.

Translational Cardiology, Karolinska Institutet, Stockholm, Sweden.

Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). SARS-CoV-2 triggers an immune response with local inflammation in the lung, which may extend to a systemic hyperinflammatory reaction. Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications. In addition to the release of cytokines, referred to as cytokine release syndrome or "cytokine storm," increased pro-inflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an "eicosanoid storm," which contributes to the uncontrolled systemic inflammation. Specialized pro-resolving mediators, which are derived from omega-3 PUFA, limit inflammatory reactions by an active process called resolution of inflammation. Here, the rationale for omega-3 PUFA supplementation in COVID-19 patients is presented along with a brief overview of the study protocol for the trial "Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A single-blind, randomized, placebo-controlled feasibility study" (COVID-Omega-F). EudraCT: 2020-002293-28; clinicaltrials.gov: NCT04647604.
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http://dx.doi.org/10.3389/fphys.2020.624657DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7830247PMC
January 2021

Focal atrial tachycardia-the localization differences between men and women: A study of 487 consecutive patients.

Anatol J Cardiol 2020 Dec;24(6):405-409

Department of Cardiology, Karolinska Institutet, Karolinska University Hospital; Stockholm-Sweden.

Objective: The preferential sites for focal atrial tachycardia (FAT) are mainly in the right atrium in both sexes. However, a limited number of studies have indicated that sex differences in the localization of FAT. This study investigated possible sex differences in the distribution of FAT in a large cohort of patients referred for ablation.

Methods: From 2004 to 2019, 487 patients (298 women) were referred to our institution for ablation of FAT. A standard electrophysiological study was conducted, and isoproterenol or atropine was given when needed. Conventional catheter mapping, electroanatomic contact mapping, and noncontact mapping were used to assess the origin of ectopic atrial tachycardia.

Results: Overall, 451 foci were successfully ablated in 436 patients (90%). Although the foci located along the crista terminalis were more common in women than in men (42% vs. 29%; p=0.023), the opposite were found in the foci located along the tricuspid annulus (5% vs. 11%; p=0.032) and the right atrial appendage (RAA) (1% vs. 3%; p=0.032). Other locations were similarly distributed in men and women. In addition, the presence of persistent FAT was more frequent in men than in women (22% vs. 5%; p<0.001). Finally, the difference in the induction pattern of FAT was also remarkable between sexes.

Conclusion: The distribution of FAT in women and men is different. In addition, persistent FAT seems more often in men than in women. The different distribution, persistency, and induction pattern of FAT should be considered in the successful management of this type of tachycardia.
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http://dx.doi.org/10.14744/AnatolJCardiol.2020.93024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791299PMC
December 2020

Sinus heart rate post pulmonary vein ablation and long-term risk of recurrences.

Clin Res Cardiol 2021 Jun 12;110(6):851-860. Epub 2020 Nov 12.

Department of Cardiology, Karolinska University Hospital, S1:02, 17176, Solna, Stockholm, Sweden.

Purpose: Cather ablation is known to influence the autonomic nervous system. This study sought to investigate the association of sinus heart rate pre-/post-ablation and recurrences in patients with atrial fibrillation undergoing pulmonary vein isolation (PVI).

Methods: Between January 2012 and December 2017, data of 482 patients undergoing their first PVI were included. Sinus heart rate was recorded before (PRE), directly post-ablation (POST) and 3 months post-ablation (3 M). All patients were screened for atrial tachyarrhythmia recurrences during the one-year follow-up.

Results: In the total study cohort, the mean resting sinus heart rate at PRE [mean 57.9 bpm (95% CI 57.1-58.7 bpm)] increased by over 10 bpm to POST [mean 69.4 bpm (95% CI 68.5-70.3 bpm); p < 0.001] followed by a slight decrease at 3 M [mean 67.3 bpm (95% CI 66.4-68.2 bpm)] but still remaining higher compared to PRE (p < 0.001). This pattern was observed in patients with and without recurrences at POST and 3 M (both p < 0.001 compared to PRE). However, at 3 M the mean sinus heart rate was significantly lower in patients with compared to patients without recurrences (p = 0.031). In this regard, patients with a heart rate change < 11 bpm (PRE to 3 M) or, as an alternative parameter, patients with a heart rate < 60 bpm at 3 M had a significantly higher risk of recurrences compared to the remaining patients (Hazard ratio (HR) 1.82 (95% CI 1.32-2.49), p < 0.001 and HR 1.64 (95% CI 1.20-2.25), p = 0.002, respectively).

Conclusion: Our study confirms the impact of PVI on cardiac autonomic function with a significant sinus heart rate increase post-ablation. Patients with a sinus heart rate change < 11 bpm (PRE to 3 M) are at higher risk for recurrences during one-year post-PVI.
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http://dx.doi.org/10.1007/s00392-020-01765-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166690PMC
June 2021

Impact of Coronavirus Disease 2019 (COVID-19) Outbreak on Acute Admissions at the Emergency and Cardiology Departments Across Europe.

Am J Med 2021 04 30;134(4):482-489. Epub 2020 Sep 30.

Department of Cardiology, Aarhus University Hospital, Denmark.

Purpose: We evaluated whether the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) pandemic was associated with changes in the pattern of acute cardiovascular admissions across European centers.

Methods: We set-up a multicenter, multinational, pan-European observational registry in 15 centers from 12 countries. All consecutive acute admissions to emergency departments and cardiology departments throughout a 1-month period during the COVID-19 outbreak were compared with an equivalent 1-month period in 2019. The acute admissions to cardiology departments were classified into 5 major categories: acute coronary syndrome, acute heart failure, arrhythmia, pulmonary embolism, and other.

Results: Data from 54,331 patients were collected and analyzed. Nine centers provided data on acute admissions to emergency departments comprising 50,384 patients: 20,226 in 2020 compared with 30,158 in 2019 (incidence rate ratio [IRR] with 95% confidence interval [95%CI]: 0.66 [0.58-0.76]). The risk of death at the emergency departments was higher in 2020 compared to 2019 (odds ratio [OR] with 95% CI: 4.1 [3.0-5.8], P < 0.0001). All 15 centers provided data on acute cardiology departments admissions: 3007 patients in 2020 and 4452 in 2019; IRR (95% CI): 0.68 (0.64-0.71). In 2020, there were fewer admissions with IRR (95% CI): acute coronary syndrome: 0.68 (0.63-0.73); acute heart failure: 0.65 (0.58-0.74); arrhythmia: 0.66 (0.60-0.72); and other: 0.68(0.62-0.76). We found a relatively higher percentage of pulmonary embolism admissions in 2020: odds ratio (95% CI): 1.5 (1.1-2.1), P = 0.02. Among patients with acute coronary syndrome, there were fewer admissions with unstable angina: 0.79 (0.66-0.94); non-ST segment elevation myocardial infarction: 0.56 (0.50-0.64); and ST-segment elevation myocardial infarction: 0.78 (0.68-0.89).

Conclusion: In the European centers during the COVID-19 outbreak, there were fewer acute cardiovascular admissions. Also, fewer patients were admitted to the emergency departments with 4 times higher death risk at the emergency departments.
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http://dx.doi.org/10.1016/j.amjmed.2020.08.043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526639PMC
April 2021

Long-term outcome of patients with invasive electrophysiology procedure-related cardiac tamponade.

Europace 2020 10;22(10):1547-1557

Department of Cardiology, Karolinska University Hospital, S-17176 Stockholm, Sweden.

Aims: Iatrogenic cardiac tamponades are a rare but dreaded complication of invasive electrophysiology procedures (EPs). Their long-term impact on clinical outcomes is unknown. This study analysed the risk of death or serious cardiovascular events in patients suffering from EP-related cardiac tamponade requiring pericardiocentesis during long-term follow-up.

Methods And Results: Out of 19 997 invasive EPs at the Karolinska University Hospital between January 1998 and September 2018, all patients with EP-related periprocedural cardiac tamponade were identified (n = 60) and matched (1:3 ratio) to a control group (n = 180). After a follow-up of 5 years, the composite primary endpoint - death from any cause, acute myocardial infarction, transitory ischaemic attack (TIA)/stroke, and hospitalization for heart failure - occurred in significantly more patients in the tamponade than in the control group [12 patients (20.0%) vs. 19 patients (10.6%); hazard ratio (HR) 2.53 (95% confidence interval, CI 1.15-5.58); P = 0.021]. This was mainly driven by a higher incidence of TIA/stroke in the tamponade than in the control group [HR 3.75 (95% CI 1.01-13.97); P = 0.049]. Death from any cause, acute myocardial infarction, and hospitalization for heart failure did not show a significant difference between the groups. Hospitalization for pericarditis occurred in significantly more patients in the tamponade than in the control group [HR 36.0 (95% CI 4.68-276.86); P = 0.001].

Conclusion: Patients with EP-related cardiac tamponade are at higher risk for cerebrovascular events during the first 2 weeks and hospitalization for pericarditis during the first months after index procedure. Despite the increased risk for early complications tamponade patients have a good long-term prognosis without increased risk for mortality or other serious cardiovascular events.
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http://dx.doi.org/10.1093/europace/euaa155DOI Listing
October 2020

Lower socioeconomic status predicts higher mortality and morbidity in patients with heart failure.

Heart 2021 Feb 7;107(3):229-236. Epub 2020 Aug 7.

Department of Medicine, Karolinska Institute, Stockholm, Sweden

Objective: It is not fully understood whether and how socioeconomic status (SES) has a prognostic impact in patients with heart failure (HF). We assessed SES and its association with patient characteristics and outcomes in a contemporary and well-characterised HF cohort.

Methods: Socioeconomic risk factors (SERF) were defined in the Swedish HF Registry based on income (low vs high according to the annual median value), education level (no degree/compulsory school vs university/secondary school) and living arrangement (living alone vs cohabitating).

Results: Of 44 631 patients, 21% had no, 33% one, 30% two and 16% three SERF. Patient characteristics strongly and independently associated with lower SES were female sex and no specialist referral. Additional independent associations were older age, more severe HF, heavier comorbidity burden, use of diuretics and less use of HF devices. Lower SES was associated with higher risk of HF hospitalisation/mortality, and overall cardiovascular and non-cardiovascular events. These associations persisted after extensive adjustment for patient characteristics, treatments and care. The magnitude of the association increased linearly with the increasing number of coexistent SERF: HR (95% CI) 1.09 (1.05 to 1.13) for one, 1.16 (1.12 to 1.20) for two and 1.22 (1.18 to 1.28) for three SERF (p<0.01).

Conclusions: In a contemporary and well-characterised HF cohort and after comprehensive adjustment for confounders, lower SES was linked with multiple factors such as less use of HF devices and age, but most strongly with female sex and lack of specialist referral; and associated with greater risk of morbidity/mortality.
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http://dx.doi.org/10.1136/heartjnl-2020-317216DOI Listing
February 2021

Recommendations for participation in leisure-time physical activity and competitive sports in patients with arrhythmias and potentially arrhythmogenic conditions: Part 1: Supraventricular arrhythmias. A position statement of the Section of Sports Cardiology and Exercise from the European Association of Preventive Cardiology (EAPC) and the European Heart Rhythm Association (EHRA), both associations of the European Society of Cardiology.

Eur J Prev Cardiol 2020 Jun 29:2047487320925635. Epub 2020 Jun 29.

Italian National Olympic Committee, Institute of Sport Medicine and Science, Italy.

Symptoms attributable to arrhythmias are frequently encountered in clinical practice. Cardiologists and sport physicians are required to identify high-risk individuals harbouring such conditions and provide appropriate advice regarding participation in regular exercise programmes and competitive sport. The three aspects that need to be considered are: (a) the risk of life-threatening arrhythmias by participating in sports; (b) control of symptoms due to arrhythmias that are not life-threatening but may hamper performance and/or reduce the quality of life; and (c) the impact of sports on the natural progression of the underlying arrhythmogenic condition. In many cases, there is no unequivocal answer to each aspect and therefore an open discussion with the athlete is necessary, in order to reach a balanced decision. In 2006 the Sports Cardiology and Exercise Section of the European Association of Preventive Cardiology published recommendations for participation in leisure-time physical activity and competitive sport in individuals with arrhythmias and potentially arrhythmogenic conditions. More than a decade on, these recommendations are partly obsolete given the evolving knowledge of the diagnosis, management and treatment of these conditions. The present document presents a combined effort by the Sports Cardiology and Exercise Section of the European Association of Preventive Cardiology and the European Heart Rhythm Association to offer a comprehensive overview of the most updated recommendations for practising cardiologists and sport physicians managing athletes with supraventricular arrhythmias, and provides pragmatic advice for safe participation in recreational physical activities, as well as competitive sport at amateur and professional level. A companion text on recommendations in athletes with ventricular arrhythmias, inherited arrhythmogenic conditions, pacemakers and implantable defibrillators is published as Part 2 in Europace.
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http://dx.doi.org/10.1177/2047487320925635DOI Listing
June 2020

Early recurrences of atrial tachyarrhythmias post pulmonary vein isolation.

J Cardiovasc Electrophysiol 2020 03 31;31(3):674-681. Epub 2020 Jan 31.

Heart and Vascular Division, Karolinska University Hospital, Stockholm, Sweden.

Aims: To investigate the significance of early recurrence (ER) of atrial tachyarrhythmias after pulmonary vein isolation (PVI) on the development of late recurrence (LR) and to redefine the blanking period during which an ER is considered nonspecific.

Methods: Data of 713 patients undergoing their first PVI for paroxysmal or persistent atrial fibrillation between January 2012 and December 2017 were included. All patients were followed-up for 12 months according to clinical and outpatient routine and were screened for any atrial tachyarrhythmia lasting >30 seconds occurring during the first 3 months postablation (ER) and after the 3 months blanking period (LR).

Results: Patients with ER compared to those without ER had significantly more LR (74.5% vs 16.5% vs, P < .001). The occurrence of ER during the first, second and third months showed increasing LR rates of 35.2%, 67.9%, and 94.8%, respectively (P < .001). Receiver operator characteristic analysis revealed a blanking period of 46 days with the highest sensitivity (68.1%) and specificity (96.5%). Later timing and longer time span of ER were independent predictors for LR in multivariable analysis.

Conclusion: ER is a strong predictor for LR. Our study advocates a shortening of the post-PVI blanking period followed by a "gray zone" up to 3 months where individualized therapeutic decisions based on additional risk factors should be considered. We suggest that the ER time span might serve as such a predictor identifying patients at the highest risk for LR.
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http://dx.doi.org/10.1111/jce.14368DOI Listing
March 2020

Association of preceding antithrombotic therapy in atrial fibrillation patients with ischaemic stroke, intracranial haemorrhage, or gastrointestinal bleed and mortality.

Eur Heart J Cardiovasc Pharmacother 2021 Jan;7(1):3-10

Department of Medicine Solna, Clinical Epidemiology Unit/Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.

Aims: To analyse 90-day mortality in atrial fibrillation (AF) patients after a stroke or a severe bleed and assess associations with the type of antithrombotic treatment at the event.

Methods And Results: From the Stockholm Healthcare database, we selected 6017 patients with a known history of AF who were diagnosed with ischaemic stroke, 3006 with intracranial haemorrhage, and 4291 with a severe gastrointestinal bleed (GIB). The 90-day mortality rates were 25.1% after ischaemic stroke, 31.6% after intracranial haemorrhage, and 16.2% after severe GIB. We used Cox regression and propensity score-matched analyses to test the association between antithrombotic treatment at the event and 90-day mortality. After intracranial haemorrhage, there was a significantly higher mortality rate in warfarin compared to non-vitamin K oral anticoagulant (NOAC)-treated patients [adjusted hazard ratio (aHR) 1.36, 95% confidence interval (CI) 1.04-1.78]. After an ischaemic stroke and a severe GIB, patients receiving antiplatelets or no antithrombotic treatment had significantly higher mortality rates compared to patients on NOACs, but there was no difference comparing warfarin to NOACs (aHR 0.84, CI 0.63-1.12 after ischaemic stroke, aHR 0.91, CI 0.66-1.25 after severe GIB). Propensity score-matched analysis yielded similar results.

Conclusion: Mortality rates were high in AF patients suffering from an ischaemic stroke, an intracranial haemorrhage, or a severe GIB. NOAC treatment was associated with a lower 90-day mortality after intracranial haemorrhage than warfarin.
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http://dx.doi.org/10.1093/ehjcvp/pvz063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811399PMC
January 2021

Appropriate Shocks and Mortality in Patients With Versus Without Diabetes With Prophylactic Implantable Cardioverter Defibrillators.

Diabetes Care 2020 01 23;43(1):196-200. Epub 2019 Oct 23.

Research Unit of Internal Medicine, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.

Objective: Diabetes increases the risk of all-cause mortality and sudden cardiac death (SCD). The exact mechanisms leading to sudden death in diabetes are not well known. We compared the incidence of appropriate shocks and mortality in patients with versus without diabetes with a prophylactic implantable cardioverter defibrillator (ICD) included in the retrospective EU-CERT-ICD registry.

Research Design And Methods And Results: A total of 3,535 patients from 12 European EU-CERT-ICD centers with a mean age of 63.7 ± 11.2 years (82% males) at the time of ICD implantation were included in the analysis. A total of 995 patients (28%) had a history of diabetes. All patients had an ICD implanted for primary SCD prevention. End points were appropriate shock and all-cause mortality. Mean follow-up time was 3.2 ± 2.3 years. Diabetes was associated with a lower risk of appropriate shocks (adjusted hazard ratio [HR] 0.77 [95% CI 0.62-0.96], = 0.02). However, patients with diabetes had significantly higher mortality (adjusted HR 1.30 [95% CI 1.11-1.53], = 0.001).

Conclusions: All-cause mortality is higher in patients with diabetes than in patients without diabetes with primary prophylactic ICDs. Subsequently, patients with diabetes have a lower incidence of appropriate ICD shocks, indicating that the excess mortality might not be caused primarily by ventricular tachyarrhythmias. These findings suggest a limitation of the potential of prophylactic ICD therapy to improve survival in patients with diabetes with impaired left ventricular function.
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http://dx.doi.org/10.2337/dc19-1014DOI Listing
January 2020

Association Between Use of Primary-Prevention Implantable Cardioverter-Defibrillators and Mortality in Patients With Heart Failure: A Prospective Propensity Score-Matched Analysis From the Swedish Heart Failure Registry.

Circulation 2019 11 3;140(19):1530-1539. Epub 2019 Sep 3.

Division of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden (B.S., A.U., L.B., M.S., D.S., C.L., F.B., G.S.).

Background: Most randomized trials on implantable cardioverter-defibrillator (ICD) use for primary prevention of sudden cardiac death in heart failure with reduced ejection fraction enrolled patients >20 years ago. We investigated the association between ICD use and all-cause mortality in a contemporary heart failure with reduced ejection fraction cohort and examined relevant subgroups.

Methods: Patients from the Swedish Heart Failure Registry fulfilling the European Society of Cardiology criteria for primary-prevention ICD were included. The association between ICD use and 1-year and 5-year all-cause and cardiovascular (CV) mortality was assessed by Cox regression models in a 1:1 propensity score-matched cohort and in prespecified subgroups.

Results: Of 16 702 eligible patients, only 1599 (10%) had an ICD. After matching, 1305 ICD recipients were compared with 1305 nonrecipients. ICD use was associated with a reduction in all-cause mortality risk within 1 year (hazard ratio, 0.73 [95% CI, 0.60-0.90]) and 5 years (hazard ratio, 0.88 [95% CI, 0.78-0.99]). Results were consistent in all subgroups including patients with versus without ischemic heart disease, men versus women, those aged <75 versus ≥75 years, those with earlier versus later enrollment in the Swedish heart failure registry, and patients with versus without cardiac resynchronization therapy.

Conclusions: In a contemporary heart failure with reduced ejection fraction population, ICD for primary prevention was underused, although it was associated with reduced short- and long-term all-cause mortality. This association was consistent across all the investigated subgroups. These results call for better implementation of ICD therapy.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.043012DOI Listing
November 2019

Remote monitoring of implantable cardioverter-defibrillators and resynchronization devices to improve patient outcomes: dead end or way ahead?

Europace 2019 Jun;21(6):846-855

Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.

Remote monitoring (RM) has become a new standard of care in the follow-up of patients with implantable pacemakers and defibrillators. While it has been consistently shown that RM enables earlier detection of clinically actionable events compared with traditional in-patient evaluation, this advantage did not translate into improved patient outcomes in clinical trials of RM except one study using daily multiparameter telemonitoring in heart failure (HF) patients. Therefore, this review, focusing on RM studies of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators in patients with HF, discusses possible explanations for the differences in trial outcomes. Patient selection may play an important role as more severe HF and concomitant atrial fibrillation have been associated with improved outcomes by RM. Furthermore, the technical set-up of RM may have an important impact as a higher level of connectivity with more frequent data transmission can be linked to better outcomes. Finally, there is growing evidence as to the need of effective algorithms ensuring a fast and well-structured clinical response to the events detected by RM. These factors re-emphasize the potential of remote management of device patients with HF and call for continued clinical research and technical development in the field.
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http://dx.doi.org/10.1093/europace/euz011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6545502PMC
June 2019

EHRA White Paper: knowledge gaps in arrhythmia management-status 2019.

Europace 2019 07;21(7):993-994

Antwerp University and Antwerp University Hospital, Antwerp, Belgium.

Clinicians accept that there are many unknowns when we make diagnostic and therapeutic decisions. Acceptance of uncertainty is essential for the pursuit of the profession: bedside decisions must often be made on the basis of incomplete evidence. Over the years, physicians sometimes even do not realize anymore which the fundamental gaps in our knowledge are. As clinical scientists, however, we have to halt and consider what we do not know yet, and how we can move forward addressing those unknowns. The European Heart Rhythm Association (EHRA) believes that scanning the field of arrhythmia / cardiac electrophysiology to identify knowledge gaps which are not yet the subject of organized research, should be undertaken on a regular basis. Such a review (White Paper) should concentrate on research which is feasible, realistic, and clinically relevant, and should not deal with futuristic aspirations. It fits with the EHRA mission that these White Papers should be shared on a global basis in order to foster collaborative and needed research which will ultimately lead to better care for our patients. The present EHRA White Paper summarizes knowledge gaps in the management of atrial fibrillation, ventricular tachycardia/sudden death and heart failure.
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http://dx.doi.org/10.1093/europace/euz055DOI Listing
July 2019

[Improved stroke prevention in atrial fibrillation: the Stockholm experience of the introduction of NOACs].

Lakartidningen 2018 10 26;115. Epub 2018 Oct 26.

Karolinska Insitutet - Department of Medicine Solna Stockholm, Sweden Karolinska Insitutet - Department of Medicine Solna Stockholm, Sweden.

The introduction of NOACs has put a focus on stroke prevention in atrial fibrillation (AF). The number of patients in Stockholm diagnosed with non-valvular AF increased from 41 008 in 2011 to 51 266 in 2017 and their treatment has been markedly improved. Between 2011 and 2017 total oral anticoagulant treatment increased from 51.6% (warfarin) to 77.3% (31% warfarin, 46.3% NOACs) and aspirin decreased from 31.6% to 7.2%. Treatment was especially improved among patients with CHA2DS2-VASc scores ≥2 and elderly high risk patients. We found an excellent persistence with OAC treatment (88% at 1 year and 83% at 2 years). A comparative effectiveness study showed that NOACs were at least as effective and safe as warfarin even among patients ≥80 years or with previous serious bleeds. After a gradual introduction of NOACs with many educational activities apixaban is now the first-line choice for stroke prevention in AF in Stockholm. Swedish guideline goals are fulfilled and outcomes are improved.
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October 2018

Improved Stroke Prevention in Atrial Fibrillation After the Introduction of Non-Vitamin K Antagonist Oral Anticoagulants.

Stroke 2018 09;49(9):2122-2128

From the Clinical Pharmacology Unit, Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden (T.F., B.W., M.v.E., P.H.).

Background and Purpose- The purpose of this study was to investigate the impact of improved antithrombotic treatment in atrial fibrillation after the introduction of non-vitamin K antagonist oral anticoagulants on the incidence of stroke and bleeding in a real-life total population, including both primary and secondary care. Methods- All resident and alive patients with a recorded diagnosis for atrial fibrillation during the preceding 5 years in the Stockholm County Healthcare database (Vårdanalysdatabasen) were followed for clinical outcomes during 2012 (n=41 008) and 2017 (n=49 510). Results- Pharmacy claims for oral anticoagulants increased from 51.6% to 73.8% (78.7% among those with CHADS-VASc ≥2). Non-vitamin K antagonist oral anticoagulant claims increased from 0.4% to 34.4%. Ischemic stroke incidence rates decreased from 2.01 per 100 person-years in 2012 to 1.17 in 2017 (incidence rate ratio, 0.58; 95% CI, 0.52-0.65). The largest increases in oral anticoagulants use and decreases in ischemic strokes were seen in patients aged ≥80 years who had the highest risk of stroke and bleeding. The incidence rates for major bleeding (2.59) remained unchanged (incidence rate ratio, 1.00; 95% CI, 0.92-1.09) even in those with a high bleeding risk. Poisson regression showed that 10% of the absolute ischemic stroke reduction was associated with increased oral anticoagulants treatment, whereas 27% was related to a generally decreased risk for all stroke. Conclusions- Increased oral anticoagulants use contributed to a marked reduction of ischemic strokes without increasing bleeding rates between 2012 and 2017. The largest stroke reduction was seen in elderly patients with the highest risks for stroke and bleeding. These findings strongly support the adoption of current guideline recommendations for stroke prevention in atrial fibrillation in both primary and secondary care.
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http://dx.doi.org/10.1161/STROKEAHA.118.021990DOI Listing
September 2018

Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation.

ESC Heart Fail 2019 02 9;6(1):182-193. Epub 2018 Oct 9.

Department of Cardiology, Magdalena Klinika, Krapinske Toplice, Croatia.

Aims: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value.

Methods And Results: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years.

Conclusions: The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.
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http://dx.doi.org/10.1002/ehf2.12367DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351896PMC
February 2019

Cardiomyopathy and Left Bundle Branch Block: A Farewell to Drugs?

J Am Coll Cardiol 2018 01;71(3):318-320

Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden; Karolinska Institutet, Stockholm, Sweden.

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http://dx.doi.org/10.1016/j.jacc.2017.11.039DOI Listing
January 2018

Exposure-Based Therapy for Symptom Preoccupation in Atrial Fibrillation: An Uncontrolled Pilot Study.

Behav Ther 2017 11 8;48(6):808-819. Epub 2017 Jun 8.

Karolinska Institutet.

Atrial fibrillation (AF) is the most common cardiac arrhythmia. Patients often experience a range of symptoms resulting in a markedly reduced quality of life, and commonly show symptom preoccupation in terms of avoidance and control behaviors. Cognitive behavior therapy (CBT) has been shown to improve symptom burden and quality of life in other somatic disorders, but has never been evaluated in patients with AF. The purpose of this study was to evaluate the potential efficacy and feasibility of an AF-specific CBT protocol in an uncontrolled pilot study. The study included 19 patients with symptomatic paroxysmal (intermittent) atrial fibrillation who were assessed pre- and posttreatment and at 6-month follow-up. The CBT lasted 10 weeks and included exposure to physical sensations similar to AF symptoms, exposure to avoided situations or activities, and behavioral activation. We observed large within-group improvements on the primary outcome AF-specific quality of life measurement AFEQT posttreatment (Cohen's d = 1.54; p < . 001) and at 6-month follow-up (d = 1.15; p < . 001). We also observed improvements in self-reported frequency and severity of AF symptoms. All participants completed the treatment and treatment satisfaction was high. This study demonstrates the potential efficacy and feasibility of a novel CBT approach to reduce symptoms and increase quality of life in AF patients.
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http://dx.doi.org/10.1016/j.beth.2017.06.001DOI Listing
November 2017

Sex differences in outcomes of primary prevention implantable cardioverter-defibrillator therapy: combined registry data from eleven European countries.

Europace 2018 06;20(6):963-970

University Medical Center Utrecht, Heidelberglaan 100, Utrecht 3584 CX, The Netherlands.

Aims: Therapy with an implantable cardioverter defibrillator (ICD) is established for the prevention of sudden cardiac death (SCD) in high risk patients. We aimed to determine the effectiveness of primary prevention ICD therapy by analysing registry data from 14 centres in 11 European countries compiled between 2002 and 2014, with emphasis on outcomes in women who have been underrepresented in all trials.

Methods And Results: Retrospective data of 14 local registries of primary prevention ICD implantations between 2002 and 2014 were compiled in a central database. Predefined primary outcome measures were overall mortality and first appropriate and first inappropriate shocks. A multivariable model enforcing a common hazard ratio for sex category across the centres, but allowing for centre-specific baseline hazards and centre specific effects of other covariates, was adjusted for age, the presence of ischaemic cardiomyopathy or a CRT-D, and left ventricular ejection fraction ≤25%. Of the 5033 patients, 957 (19%) were women. During a median follow-up of 33 months (IQR 16-55 months) 129 women (13%) and 807 men (20%) died (HR 0.65; 95% CI: [0.53, 0.79], P-value < 0.0001). An appropriate ICD shock occurred in 66 women (8%) and 514 men (14%; HR 0.61; 95% CI: 0.47-0.79; P = 0.0002).

Conclusion: Our retrospective analysis of 14 local registries in 11 European countries demonstrates that fewer women than men undergo ICD implantation for primary prevention. After multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.
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http://dx.doi.org/10.1093/europace/eux176DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5982785PMC
June 2018

Safety of fluoroscopy-guided transseptal approach for ablation of left-sided arrhythmias.

Europace 2017 Dec;19(12):2023-2026

Department of Cardiology, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.

Aims: The transseptal approach is used for left atrial access during the ablation of atrial fibrillation (AF) and other left-sided arrhythmia substrates. Transseptal puncture (TP) is commonly performed with fluoroscopic guidance, contrast injection, and pressure monitoring. In many centres, additional techniques [intracardiac echocardiography (ICE), transoesophageal echocardiography (TEE), radiofrequency needle] are used to facilitate TP but its use adds costs. In this retrospective study, we studied the safety and complication rate when TP was routinely done with fluoroscopic guidance, contrast injection, and pressure monitoring using ICE or TEE only in selected cases.

Methods And Results: This study analysed 4690 consecutive TP performed between 2000 and 2015: 3408 (72.6%) were ablation of AF, left-sided atrial flutter, or left-sided atrial tachycardia (non-AP group); 1153 (24.6%) were ablation of left-sided accessory pathway, AP group; and 129 (2.8%) were ablation of ventricular tachycardia. Transseptal puncture was done under fluoroscopy, pressure monitoring, and commonly using contrast media injection. In 27 procedures, ICE or TEE was used to guide the TP. We found 34 tamponades (Tx) that required pericardial drainage of which 28 (0.59%) could possibly be TP related and six could not. The total complication rate for all Tx was 0.72%. A higher rate of tamponades was observed in the AF (non-AP) group than in the AP group (0.88 vs. 0.17%, P < 0.02). The highest rate of tamponades was registered during the operators 51-100 cases, 1.3%, and decreased to 0.4% in cases 101-200, P = 0.04.

Conclusion: TP can safely be done under fluoroscopy and pressure monitoring without routine use of additional techniques. With experience, operators should be able to further decrease complication rate.
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http://dx.doi.org/10.1093/europace/euw432DOI Listing
December 2017

Heart rate and dyssynchrony in patients with cardiac resynchronization therapy: a pilot study.

Scand Cardiovasc J 2017 Jun 23;51(3):143-152. Epub 2017 Mar 23.

b Department of Cardiology , Karolinska University Hospital , Stockholm , Sweden.

Objectives: The objective of this pilot study was to describe the impact of paced heart rate on left ventricular (LV) mechanical dyssynchrony in synchronous compared to dyssynchronous pacing modes in patients with heart failure.

Methods: Echocardiography was performed in 14 cardiac resynchronization therapy (CRT) patients at paced heart rates of 70 and 90 bpm in synchronous- (CRT), and dyssynchronous (atrial pacing + wide QRS activation) pacing modes. LV dyssynchrony was quantified using the 12-segment standard deviation model (Ts-SD) derived from Tissue Doppler Imaging. In addition, cardiac cycle intervals were assessed using cardiac state diagrams and stroke volume (SV) and filling pressure were estimated.

Results: Ts-SD decreased significantly with CRT at 90 bpm (25 ± 12 ms) compared to 70 bpm (35 ± 15 ms, p = .01), but remained unchanged with atrial pacing at different paced heart rates (p = .96). The paced heart rate dependent reduction in Ts-SD was consistent when Ts-SD was indexed to average Ts and systolic time interval. Cardiac state diagram derived analysis of cardiac cycle intervals demonstrated a significant reduction of the pre-ejection interval and an increase in diastole with CRT compared to atrial pacing. SV was maintained at the higher paced heart rate with CRT pacing but decreased with atrial pacing.

Discussion: Due to the small sample size in this pilot study general and firm conclusions are difficult to render. However, the data suggest that pacing at higher heart rates acutely reduces remaining LV dyssynchrony during CRT, but not during atrial pacing with dyssynchronous ventricular activation. These results need confirmation in a larger patient cohort.
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http://dx.doi.org/10.1080/14017431.2017.1308007DOI Listing
June 2017

Effects of Spinal Cord Stimulation on Cardiac Sympathetic Nerve Activity in Patients with Heart Failure.

Pacing Clin Electrophysiol 2017 May 23;40(5):504-513. Epub 2017 Mar 23.

Department of Medicine, Solna, Karolinska Institutet, and Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.

Background: Spinal cord stimulation (SCS) reduces sympathetic activity in animal models of heart failure with reduced ejection fraction (HF) but limited data exist of SCS in patients with HF. The aim of the present study was to test the primary hypothesis that SCS reduces cardiac sympathetic nerve activity in HF patients. Secondary hypotheses were that SCS improves left ventricular function and dimension, exercise capacity, and clinical variables relevant to HF.

Methods: HF patients with a SCS device previously participating in the DEFEAT-HF trial were included in this crossover study with 6-week intervention periods (SCS-ON and SCS-OFF). SCS (50 Hz, 210-μs pulse duration, aiming at T2-T4 segments) was delivered for 12 hours daily. Indices of myocardial sympathetic neuronal function (heart-to-mediastinum ratio, HMR) and activity (washout rate, WR) were assessed using I-metaiodobenzylguanidine (MIBG) scintigraphy. Echocardiography, exercise testing, and clinical data collection were also performed.

Results: We included 13 patients (65.3 ± 8.0 years, nine males) and MIBG scintigraphy data were available in 10. HMR was not different comparing SCS-ON (1.37 ± 0.16) and SCS-OFF (1.41 ± 0.21, P = 0.46). WR was also unchanged comparing SCS-ON (41.5 ± 5.3) and SCS-OFF (39.1 ± 5.8, P = 0.30). Similarly, average New York Heart Association class (2.4 ± 0.5 vs 2.3 ± 0.6, P = 0.34), quality of life score (24 ± 16 vs 24 ± 16, P = 0.94), and left ventricular dimension and function as well as exercise capacity were all unchanged comparing SCS-ON and SCS-OFF.

Conclusion: In patients with HF, SCS (12 hours daily, targeting the T2-T4 segments of the spinal cord) does not appear to influence cardiac sympathetic neuronal activity or function as assessed by MIBG scintigraphy.
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http://dx.doi.org/10.1111/pace.13050DOI Listing
May 2017

Association between demographic, organizational, clinical, and socio-economic characteristics and underutilization of cardiac resynchronization therapy: results from the Swedish Heart Failure Registry.

Eur J Heart Fail 2017 10 7;19(10):1270-1279. Epub 2017 Feb 7.

Karolinska Institutet, Department of Medicine, Stockholm, Sweden.

Aims: Cardiac resynchronization therapy (CRT) improves outcomes in heart failure (HF) but may be underutilized. The reasons are unknown.

Methods And Results: We linked the Swedish Heart Failure Registry to national registries with ICD-10 (International Classification of Diseases-10th Revision) co-morbidity diagnoses and demographic and socio-economic data. In patients with EF ≤39% and NYHA II-IV, we assessed prevalence of CRT indication and CRT use. In those with CRT indication, we assessed the association between 37 potential baseline covariates and CRT non-use using multivariable generalized estimating equation (GEE) models. Of 12 807 patients (mean age 71 ± 12 years, 28% female), 841 (7%) had CRT, 3094 (24%) had an indication for but non-use of CRT, and 8872 (69%) had no indication. Important variables independently associated with CRT non-use were: HF duration <6 months [risk ratio (RR) 1.21, 95% confidence interval (CI) 1.17-1.24]; non-cardiology planned follow-up (RR 1.14, 95% CI 1.09-1.18); age >75 years (RR 1.13, 95% CI 1.09-1.18); non-cardiology care at baseline (RR 1.10, 95% CI 1.07-1.14); small-town non-university centre (RR 1.08, 95% CI 1.05-1.12); female sex (RR 1.07 95% CI 1.03-1.10) (all P < 0.05); as was absence of AF, living alone; psychiatric diagnosis; smoking; and non-use of HF drugs. Education, income, cancer, or HF characteristics were not independently associated with CRT non-use.

Conclusion: In this population-wide HF registry, CRT was underutilized. Non-use was associated mostly with demographic and organizational, but not clinical or socio-economic factors. This calls for programmes to raise awareness of CRT indications and improve access and referrals to cardiology specialists.
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http://dx.doi.org/10.1002/ejhf.781DOI Listing
October 2017

Cardiac Resynchronization Therapy Follow-up: Role of Remote Monitoring.

Heart Fail Clin 2017 Jan;13(1):241-251

Department of Cardiology, Karolinska University Hospital, Karolinska Institutet, Stockholm S-17176, Sweden.

Cardiac resynchronization therapy (CRT) is increasingly used in heart failure treatment and management of these patients imposes significant challenges. Remote monitoring is becoming essential for CRT follow-up and allows close surveillance of device function and patient condition. It is helpful to reduce clinic visits, increase device longevity and provide early detection of device failure. Clinical effects include prevention of appropriate and inappropriate shocks and early detection of arrhythmias, such as atrial fibrillation. For modification of heart failure the addition of monitoring to CRT by means of device-based multiparameters may help to modify disease progression and improve survival.
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http://dx.doi.org/10.1016/j.hfc.2016.07.020DOI Listing
January 2017