Publications by authors named "Jacob M Larsen"

11 Publications

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Role of wearable rhythm recordings in clinical decision making-The wEHRAbles project.

Clin Cardiol 2020 Sep 22;43(9):1032-1039. Epub 2020 Jul 22.

Hannover Heart Rhythm Center, Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.

Background: Multiple wearable devices for rhythm analysis have been developed using either photoplethysmography (PPG) or handheld ECG.

Hypothesis: The aim of this survey was to assess impact of these technologies on physicians' clinical decision-making regarding initiation of diagnostic steps, drug therapy, and invasive strategies.

Methods: The online survey included 10 questions on types of devices, advantages, and disadvantages of wearable devices as well as case scenarios for patients with supraventricular arrhythmias and atrial fibrillation (AF).

Results: A total of 417 physicians (median age 37 [IQR 32-43] years) from 42 countries world-wide completed the survey. When presented a tracing of a regular tachycardia by a symptomatic patient, most participants would trigger further diagnostic steps (90% for single-lead ECG vs 83% for PPG, P < .001), while a single-lead ECG would be sufficient to perform an invasive EP study in approximately half of participants (51% vs 22% for PPG, P < .001). When presented with a single-lead ECG tracing suggesting AF, most participants (90%) would trigger further diagnostic steps. A symptomatic AF patient would trigger anticoagulation treatment to a higher extent as an asymptomatic patient (59% vs 21%, P < .001). PPG tracings would only rarely lead to therapeutic steps regardless of symptoms. Most participants would like scientific society recommendations on the use of wearable devices (62%).

Conclusions: Tracings from wearable rhythm devices suggestive of arrhythmias are most likely to trigger further diagnostic steps, and in the case of PPG recordings rarely therapeutic interventions. A majority of participants expect these devices to facilitate diagnostics and arrhythmia screening but fear data overload and expect scientific society recommendations on the use of wearables.
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http://dx.doi.org/10.1002/clc.23404DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462183PMC
September 2020

Impact of Left Common Pulmonary Veins in the Contact-Force vs. Cryoballoon Atrial Fibrillation Ablation (CIRCA-DOSE) Study.

J Cardiovasc Electrophysiol 2020 Jul 6. Epub 2020 Jul 6.

Heart Rhythm Services, Department of Medicine, University of British Columbia, Canada.

Background: Concerns remain regarding the effectiveness of PVI using the fixed diameter non-compliant cryoballoon in the presence of a left common pulmonary vein (LCPV). We sought to evaluate the effectiveness of PVI performed by contact-force guided radiofrequency (CF-RF) versus second-generation cryoballoon-based ablation in patients with LCPV.

Methods And Results: We enrolled 346 patients with paroxysmal AF and randomized them to CF-RF or cryoballoon ablation. PV anatomy was not assessed prior to enrolment, and there were no exclusions based on PV anatomy. All patients received an implantable cardiac monitor. LCPV was observed in 13.6% of patients (47/346). Left atrial time and fluoroscopy time did not differ between those with and without LCPV (P=0.58 and P=0.06, respectively). Freedom from any atrial tachyarrhythmia at one year was observed in 46.8% with LCPV and 54.5% without LCPV (P=0.06). In those with LCPV the freedom from any atrial tachyarrhythmia did not differ between those randomized to CF-RF or cryoballoon ablation (HR for recurrence 1.19, 95% CI 0.53-2.65, P=0.69). In those with LCPV the AF burden was reduced to a similar extent with CF-RF and cryoballoon ablation (99.7% vs. 99.5%, respectively; P=0.97).

Conclusions: In this randomized clinical trial, the presence of a LCPV was associated with a trend towards higher rates of arrhythmia recurrence following PVI. No significant difference in arrhythmia recurrence was observed between patients with LCPV randomized to cryoballoon ablation or contact-force guided RF ablation, suggesting that either ablation modality is suitable in this population. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE], NCT01913522) This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/jce.14652DOI Listing
July 2020

The Potential Impact of Intrathoracic Impedance on Defibrillation Threshold Testing in S-ICDs.

Can J Cardiol 2019 Nov 25;35(11):1604.e13-1604.e16. Epub 2019 Jul 25.

Heart Rhythm Services, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address:

A man with an ischemic cardiomyopathy and chronic obstructive pulmonary disease underwent subcutaneous implantable cardioverter-defibrillator (S-ICD) placement under general anesthesia. Following induction of ventricular fibrillation (VF), defibrillation testing (65J) failed, requiring external rescue. Repeat shock testing with reversed polarity (65J) failed. A third shock and external defibrillation failed (80J and 200J), followed by a second external defibrillation (200J), which did not immediately terminate VF, and a device shock 2 seconds later (80J, successful). Repeat shock testing (80J) under conscious sedation without mechanical ventilation was successful. We discuss this case of failed defibrillation testing during S-ICD placement, potentially due to lung hyperinflation, requiring double sequential defibrillation.
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http://dx.doi.org/10.1016/j.cjca.2019.07.624DOI Listing
November 2019

Mobile subcutaneous implantable cardioverter-defibrillator leads to oversensing and inappropriate shocks.

HeartRhythm Case Rep 2019 Jul 18;5(7):371-373. Epub 2019 Apr 18.

Heart Rhythm Services, Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, Canada.

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http://dx.doi.org/10.1016/j.hrcr.2019.04.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6630194PMC
July 2019

The Association of a classical left bundle Branch Block Contraction Pattern by vendor-independent strain echocardiography and outcome after cardiac resynchronization therapy.

Cardiovasc Ultrasound 2019 May 21;17(1):10. Epub 2019 May 21.

Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.

Background: The association of a Classical left bundle branch block (LBBB) contraction pattern and better outcome after cardiac resynchronization therapy (CRT) has only been studied using vendor-specific software for echocardiographic speckle-tracked longitudinal strain analysis. The purpose of this study was to assess whether a Classical LBBB contraction pattern on longitudinal strain analysis using vendor-independent software is associated with clinical outcome in CRT recipients with LBBB.

Methods: This was a retrospective cohort study including CRT recipients with LBBB, heart failure, and left ventricular (LV) ejection fraction ≤35%. Speckle-tracked echocardiographic longitudinal strain analysis was performed retrospectively on echocardiograms using vendor-independent software. The presence of a Classical LBBB contraction pattern was determined by consensus of two readers. The primary end point was a composite of time to death, heart transplantation or LV assist device implantation. Secondary outcome was ≥15% reduction in LV end-systolic volume. Intra- and inter-reader agreement of the longitudinal strain contraction pattern was assessed by calculating Cohen's κ.

Results: Of 283 included patients, 113 (40%) were women, mean age was 66 ± 11 years, and 136 (48%) had ischemic heart disease. A Classical LBBB contraction pattern was present in 196 (69%). The unadjusted hazard ratio for reaching the primary end point was 1.93 (95% confidence interval, 1.36-2.76, p < 0.001) when comparing patients without to patients with a Classical LBBB contraction pattern. Adjusted for ischemic heart disease and QRS duration < 150 milliseconds the hazard ratio was 1.65 (95% confidence interval, 1.12-2.43, p = 0.01). Of the 123 (43%) patients with a follow-up echocardiogram, 64 of 85 (75%) of patients with a Classical LBBB contraction pattern compared to 13 of 38 (34%) without, had ≥15% reduction in LV end-systolic volume (p < 0.001). Cohen's κ were 0.86 (95% confidence interval, 0.71-1.00) and 0.42 (95% confidence interval, 0.30-0.54) for intra- and inter-reader agreement, respectively.

Conclusion: Using vendor-independent strain software, a Classical LBBB contraction pattern is associated with better outcome in CRT recipients with LBBB, but inter-reader agreement for the classification of contraction pattern is only moderate.
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http://dx.doi.org/10.1186/s12947-019-0160-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6530090PMC
May 2019

Single-coil and dual-coil defibrillator leads and association with clinical outcomes in a complete Danish nationwide ICD cohort.

Heart Rhythm 2016 Mar 22;13(3):706-12. Epub 2015 Nov 22.

Department of Cardiology, Center for Cardiovascular Research, Aalborg University Hospital, Aalborg, Denmark.

Background: The best choice of defibrillator lead in patients with routine implantable cardioverter-defibrillator (ICD) is not settled. Traditionally, most physicians prefer dual-coil leads but the use of single-coil leads is increasing.

Objective: The purpose of this study was to compare clinical outcomes in patients with single- and dual-coil leads.

Methods: All 4769 Danish patients 18 years or older with first-time ICD implants from 2007 to 2011 were included from the Danish Pacemaker and ICD Register. Defibrillator leads were 38.9% single-coil leads and 61.1% dual-coil leads. The primary end point was all-cause mortality. Secondary end points were lowest successful energy at implant defibrillation testing, first shock failure in spontaneous arrhythmias, structural lead failure, and lead extraction outcomes.

Results: Single-coil leads were associated with lower all-cause mortality with an adjusted hazard ratio of 0.85 (95% confidence interval 0.73-0.99; P = .04). This finding was robust in a supplementary propensity score-matched analysis. However, dual-coil leads were used in patients with slightly higher preimplant morbidity, making residual confounding by indication the most likely explanation for the observed association between lead type and mortality. The lowest successful defibrillation energy was higher using single-coil leads (23.2 ± 4.3 J vs 22.1 ± 3.9 J; P < .001). No significant differences were observed for other secondary end points showing high shock efficacies and low rates of lead failures and extraction complications.

Conclusion: Shock efficacy is high for modern ICD systems. The choice between single-coil and dual-coil defibrillator leads is unlikely to have a clinically significant impact on patient outcomes in routine ICD implants.
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http://dx.doi.org/10.1016/j.hrthm.2015.11.034DOI Listing
March 2016

The patient perspective on the Riata defibrillator lead advisory: a Danish nationwide study.

Heart Rhythm 2014 Dec 16;11(12):2148-55. Epub 2014 Sep 16.

Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands; Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Department of Psychology, University of Southern Denmark, Odense, Denmark.

Background: The St Jude Medical Riata lead advisory was issued owing to insulation failures. The impact of this advisory on patients' well-being is unknown.

Objectives: The objectives of this study were to describe the acute impact of the Riata advisory on patients' well-being and psychological functioning and to examine changes over time.

Methods: Patients with active Riata leads completed standardized and validated patient-reported outcomes (PROs) in connection with a nationwide fluoroscopic screening with 12-month follow-up. They were matched (1:1) on age, sex, and implant indication with nonadvisory controls for baseline comparisons. Cohen's effect size d was used to determine the clinical relevance of the estimated adjusted mean differences (small, d = 0.20; moderate, d = 0.50; large, d ≥ 0.80).

Results: Of all Riata patients, 86% (256 of 299) completed baseline PROs and 70% (210 of 299) follow-up PROs. Riata patients reported poorer device acceptance (d = -0.28; P = .001) and increased device-related concerns (d = 0.29; P < .001) as compared with matched nonadvisory controls. There were no differences in symptoms of depression (d = 0.13; P = .13). Female sex was an independent predictor of a high advisory impact on general well-being as assessed with a purpose-designed question (odds ratio 2.24; P = .04). Device-related concerns decreased over time (d = -0.17; P = .002), but no changes were seen for other PROs.

Conclusion: The Riata advisory is associated with a persistent small reduction in device acceptance and a small increase in device-related concerns with minimal improvement over time. Female sex is a predictor of a high negative advisory impact on general well-being. A need for counseling may arise in vulnerable subsets of patients.
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http://dx.doi.org/10.1016/j.hrthm.2014.09.008DOI Listing
December 2014

Prospective nationwide fluoroscopic and electrical longitudinal follow-up of recalled Riata defibrillator leads in Denmark.

Heart Rhythm 2014 Dec 4;11(12):2141-7. Epub 2014 Jul 4.

Department of Cardiology and Center for Cardiovascular Research, Aalborg University Hospital, Aalborg, Denmark.

Background: Recalled St. Jude Medical Riata defibrillator leads are prone to insulation failures with externalized conductors (ECs). Longitudinal studies are needed to guide lead management.

Objective: The purpose of this study was to describe the dynamic nature of EC and the association with electrical abnormalities and lead extraction outcomes.

Methods: A nationwide cohort established in 2012 of 295 patients with recalled Riata leads with dwell time 5.1 ± 1.1 years, 34 ECs, and 19 electrical abnormalities were followed until death, lead discontinuation with fluoroscopy, or a new 2013 screening with fluoroscopy and device interrogation.

Results: Fluoroscopic follow-up of 239 patients with normal baseline fluoroscopy revealed incident overt EC in 8 leads and borderline EC in 2 leads after 1.1 ± 0.2 years, with an incidence rate of 3.7 per 100 person-years (95% confidence interval 2.0-6.9). Fluoroscopic follow-up in 27 patients with baseline EC showed an increase in EC length of 4 ± 1 mm (P <.001) after 1.1 ± 0.3 years. Electrical follow-up in 276 patients with normal baseline electrical function demonstrated 20 incident electrical abnormalities after 1.0 ± 0.3 years, with an incidence rate of 7.1 per 100 person-years (95% confidence interval 4.6-11.0). This rate was significantly higher in leads with baseline EC, with an adjusted incidence rate ratio of 4.4 (95% confidence interval 1.7-11.5, P = .002). In 15 extractions, all leads were removed, with 2 major complications.

Conclusion: The development of EC is a dynamic process despite long lead dwell time. ECs are associated with a higher risk of electrical abnormalities. Therefore, lead replacement should be considered, especially in patients with a long life expectancy.
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http://dx.doi.org/10.1016/j.hrthm.2014.07.003DOI Listing
December 2014

Paradoxical thromboembolic stroke during extraction of a recalled St Jude Medical Riata defibrillator lead with conductor externalization.

Europace 2014 Feb 9;16(2):240. Epub 2013 Aug 9.

Department of Cardiology and Center for Cardiovascular Research, Aalborg University Hospital, Hobrovej 18-22, 9000 Aalborg, Denmark.

Recalled St Jude Medical Riata leads have a high rate of insulation failures with potential thrombogenic externalized conductors. We report a paradoxical thromboembolic stroke through a persistent foramen ovale during extraction of a lead with externalization. We suggest mandatory transesophageal echocardiography prior to extraction to screen for lead-related thrombosis and routes of right-to-left shunting to reduce risk of thromboembolic complications.
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http://dx.doi.org/10.1093/europace/eut164DOI Listing
February 2014

Nationwide fluoroscopic screening of recalled Riata defibrillator leads in Denmark.

Heart Rhythm 2013 Jun 13;10(6):821-7. Epub 2013 Feb 13.

Department of Cardiology, Center for Cardiovascular Research, Aalborg University Hospital, Aalborg, Denmark.

Background: The natural history of insulation defects with inside-out conductor externalization in recalled St Jude Medical Riata defibrillator leads is not well understood.

Objectives: To determine the prevalence of externalization in a nationwide screening. Secondary aims were to examine time dependence and location of externalization, association with electrical failure, and fluoroscopic diagnostic performance.

Methods: All 299 patients with recalled Riata leads in Denmark were identified, and all except one underwent fluoroscopy and device interrogation. Externalizations were confirmed by multiple investigators.

Results: The prevalence of externalization was 32 of 298 (11%) at a mean dwell time of 5.1 years. The prevalence was 21 of 98 (21%) for 8-F leads and 11 of 200 (6%) for 7-F leads; however, 8-F leads had longer dwell times. The degree of externalization was correlated with dwell time (Spearman's ρ = .37; P = .03). Externalization more often included the lead segment below the tricuspid annulus in dual coil leads than in single coil leads (69% vs 16%; P = .004). No association was observed between externalization and electrical function. Fluoroscopic diagnostic performance was good with positive and negative predictive values of 88% and 99%, respectively.

Conclusions: The prevalence of externalization in a nationwide screening is at the same level as reported in previous studies with similar lead dwell times. The degree of externalization is time dependent, and location seems to differ between single and dual coil leads. Long-term lead performance and association with electrical failure need further clarification. Fluoroscopy has a good diagnostic performance in clinical practice.
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http://dx.doi.org/10.1016/j.hrthm.2013.02.010DOI Listing
June 2013

Reference intervals and age and gender dependency for arterial blood gases and electrolytes in adults.

Clin Chem Lab Med 2011 Sep 27;49(9):1495-500. Epub 2011 May 27.

Department of Clinical Biochemistry, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark.

Background: Although results from blood gas analyzers are frequently used in clinical work surprisingly few and small studies have examined reference intervals for arterial blood gases and acid-base status. We have established reference values based on a large group of healthy people with a wide age distribution.

Methods: A group of medical students (n=182) aged 20-32 years old and a group of health professionals aged 21-76 years were used in this study. Arterial samples were analyzed on the blood gas analyzer ABL from Radiometer(TM). Age and gender dependency was examined for all analytes and reference intervals were calculated non-parametrically.

Results: Females had significantly higher pH and lower PaCO(2) (partial pressure of carbon dioxide in an arterial sample), base excess (BE, standard, extra cellular fluid), plasma standard and actual HCO(3), when compared to males (p<0.01). However, the differences were minor and common reference intervals were therefore also determined, generally at the same level as previously published. The lactate values were similar among the genders but with a high upper limit of 2.5 mmol/L. The non-smoker group of females and males had similar PaO(2) values (partial pressure of oxygen in an arterial sample). However, an age dependent effect was found and PaO(2) decreased by 0.29 kPa per decade (confidence interval of slope -0.11 to -0.47 kPa). Electrolytes and anion gap results depicted smaller differences from previous published reference intervals for sodium (136-141 mmol/L) and anion gap (10-16 mmol/L, with potassium included or 6-12 mmol/L without potassium).

Conclusions: Reference intervals for analytes on modern blood gas analyzers were established on a large group of healthy people. Gender and age dependency is generally without clinical importance, except for a lower PaCO(2) in women and a decreasing PaO(2) with higher age.
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http://dx.doi.org/10.1515/CCLM.2011.603DOI Listing
September 2011