This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/ Heart Rhythm Society/ European Heart Rhythm Association/ Asia Pacific Heart Rhythm Society ...describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self‐management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored.
Atrioventricular (AV)-synchronous single-chamber leadless pacing using a mechanical atrial sensing algorithm produced high AV synchrony in clinical trials, but clinical practice experience with these ...devices has not yet been described.
To describe pacing outcomes and programming changes with AV-synchronous leadless pacemakers in clinical practice.
Consecutive patients without persistent atrial fibrillation who received an AV-synchronous leadless pacemaker and completed follow-up between February 2020 and April 2021 were included. We evaluated tracking index (atrial mechanical sense followed by ventricular pace AM-VP divided by total VP), total AV synchrony (sum of AM-ventricular sense AM-VS, AM-VP, and AV conduction mode switch), use of programming optimization, and improvement in AV synchrony after optimization.
Fifty patients met the inclusion criteria. Mean age was 69 ± 16.8 years, 24 (48%) were women, 24 (48%) had complete heart block, and 17 (34%) required ≥50% pacing. Mean tracking index was 41% ± 34%. Thirty-five patients (70%) received ≥1 programming change. In 36 patients with 2 follow-up visits, tracking improved by +9% ± 28% (P value for improvement = .09) and +18% ± 19% (P = .02) among 15 patients with complete heart block. Average total AV synchrony increased from 89% 67%, 99% to 93% 78%, 100% in all patients (P = .22), from 86% 52%, 98% to 97% 82%, 99% in those with complete heart block (P = .04), and from 73% 52%, 80% to 78% 70%, 85% in those with ≥50% pacing (P = .09).
In patients with AV-synchronous leadless pacemakers, programming changes are frequent and are associated with increased atrial tracking and increased AV synchrony in patients with complete heart block.
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Abstract
Background
The Micra transcatheter pacemaker has proven to be a safe and effective alternative to transvenous pacemakers (TVPs). However, the safety profile after Micra implantation in ...patients deemed poor candidates for TVPs is poorly understood.
Purpose
To evaluate the safety and all-cause mortality outcomes in Micra recipients stratified by whether or not they were precluded for therapy with TVP.
Methods
Micra patients from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were divided into groups based upon whether or not the implanting physician considered the patient to be precluded from receiving a transvenous pacing system. All-cause mortality was compared between the Micra patient groups and patients receiving a single-chamber transvenous pacing system (SC-TVP) since 2010 from the Medtronic product surveillance registry using univariate and multivariate Cox models.
Results
Among 2,819 patients who underwent a Micra implant attempt, the overall major complication rate through 24 months was 3.5%. In these patients, 548 were deemed precluded from TVP implantation. Prior device infection or bacteremia (38.9%), venous access issues (36.1%) and thrombosis (10.2%) were amongst the most common causes of preclusion for TVP implantation. These patients were younger (71.7 vs. 76.7 years), more frequently on hemodialysis (26.3% vs. 2.5%), and more often had a prior CIED implanted (38.4% vs. 4.4%) than non-precluded patients. Over an average follow-up of 13.5±11.1 months, all-cause mortality was significantly higher in precluded Micra patients compared with SC-TVP patients (HR: 2.16, 95% CI: 1.54–3.2, P<0.001) (Figure 1). However, there was no significant difference in all-cause mortality when comparing non-precluded Micra patients and SC-TVP patients (HR: 1.12, 95% CI: 0.86–1.44, P=0.401). Acute all-cause death (within 1 month) among Micra patients was 2.74% and 1.32% in the precluded and non-precluded TVP groups, respectively. The procedure-related death rate was 0.55% for the TVP precluded group and 0.13% for the not precluded group (P=0.092). The major complication rate through 24-months was similar between the two Micra groups (4.0% vs 3.4%, P=0.630).
All-cause mortality for Micra and SC-TVP
Conclusion
The overall safety profile of Micra remains is in line with previously reported data. All-cause mortality risk (both acute and long term) appears to be higher in patients who were precluded from receiving TVP.
Acknowledgement/Funding
Supported by Medtronic
Abstract
Funding Acknowledgements
Type of funding sources: None.
Background
Preprocedural transcatheter aortic valve intervention (TAVI) evaluation requires reliable aortic root measurements for ...correct valve sizing.
Purpose
To prospectively compare image-quality, reliability and graft sizing of a prototype self-navigated and a navigator-gated non-contrast three dimensional (3D) whole-heart magnetic-resonance-angiography (MRA) sequence with computed-tomography-angiography (CTA) for planning transcatheter-aortic-valve-intervention (TAVI).
Methods
Self- and navigator-gated 1.5T MRA were performed in 27 patients (aged 83 ± 5 years, 41% male) for aortic root sizing and coronary ostia height measurements; 15 (56%) patients underwent additional CTA. Subjective-image quality was graded on a 4-point Likert scale, objective MRA image-quality was assessed by signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR). Continuous MRA and CTA measurements were analyzed with regression and Bland-Altman analysis, valve sizing by kappa statistics.
Results
Median image-quality as rated by two observers was 1.5 interquartile range (IQR) 1-3 for self-navigated MRA and 1 IQR 1-2 for navigator-gated MRA (p = 0.059). SNR and CNR were comparable between MRA sequences (p = 0.471 and 0.445, respectively). Acquisition time was shorter for self-navigated MRA compared to navigator-gated MRA (5.5 ± 1 minutes vs, 6.5 ± 2 minutes, p = 0.029). Inter-observer correlation of aortic root measurements was high to very high for both self- and navigator-gated MRA (r = 0.75 to 0.94 and r = 0.85 to 0.96, respectively, all p < 0.0001). Theoretical prosthetic valve sizing of self-navigated MRA and CTA was equivalent (κ=1). However, in four patients (15%) one coronary ostium each (right coronary artery 3, left main artery 1) was not clearly definable on self-navigated MRA.
Conclusion
Self-navigated MRA enables aortic annulus TAVI measurements without significant difference to navigator-gated MRA at shortened acquisition time. Prosthesis sizing by self-navigated MRA measurements is equivalent to navigator-gated MRA and CTA-based choice.
Abstract Figure.
Abstract
Funding Acknowledgements
Type of funding sources: None.
Background
The natural history of thoracic aortic aneurysm (TAA) is one of progressive expansion. Asymptomatic patients who do not ...meet criteria for repair require conservative management including ongoing aneurysm surveillance, mostly carried out by contrast-enhanced computed tomography angiography (CTA).
Purpose
To prospectively compare image quality and reliability of a prototype non-contrast, self-navigated 3D whole-heart magnetic resonance angiography (MRA) with contrast-enhanced computed tomography angiography (CTA) for sizing of thoracic aortic aneurysm (TAA).
Methods
Self-navigated 3D whole-heart 1.5 T MRA was performed in 20 patients (aged 67 ± 8.6 years, 75% male) for sizing of TAA; a subgroup of 18 (90%) patients underwent additional contrast-enhanced CTA on the same day. Subjective image quality was scored according to a 4-point Likert scale and ratings between observers were compared by Cohen’s Kappa statistics. Continuous MRA and CTA measurements were analyzed with regression and Bland-Altman analysis.
Results
Overall subjective image quality as rated by two observers was 1 interquartile range (IQR) 1-2 for self-navigated MRA and 1.5 IQR 1-2 for CTA (p = 0.717). For MRA a perfect inter-observer agreement was found for presence of artefacts and subjective image sharpness (κ=1). Subjective signal inhomogeneity correlated highly with objectively quantified inhomogeneity of the blood pool signal (r = 0.78-0.824, all p <0.0001). Maximum diameters of TAA as measured by self-navigated MRA and CTA showed excellent correlation (r = 0.997, p < 0.0001) without significant inter-method bias (bias -0.0278, lower and upper limit of agreement -0.74 and 0.68, p = 0.749). Inter- and intraobserver correlation of aortic aneurysm as measured by MRA was excellent (r = 0.963 and 0.967, respectively) without significant bias (all p ≤ 0.05).
Conclusion
Self-navigated 3D whole-heart MRA enables reliable contrast- and radiation free aortic dilation surveillance without significant difference to standardized CTA while providing predictable acquisition time and by offering excellent image quality.
Abstract Figure.
In this study, the authors sought to perform a meta-analysis of controlled studies assessing the relationship between left atrial appendage (LAA) electrical isolation (EI) and recurrent atrial ...fibrillation (AF).
LAA triggers could play an important role in AF and can be treated with complete EI of the LAA via surgical or percutaneous approaches.
We conducted a meta-analysis of all controlled studies published as of November 21, 2016, assessing the relationship between left atrial appendage electrical isolation (LAAEI) and recurrent AF. The primary endpoint was atrial tachycardia (AT) or AF recurrence after the post-procedure blanking period. The association between LAAEI and AT/AF was estimated using random-effects modeling. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using the DerSimonian and Laird method.
We identified 7 studies including 1,037 patients; LAAEI was performed in 566 patients (55%). LAAEI was associated with a significantly lower rate of AT/AF recurrence in the primary analysis (OR: 0.38; 95% CI: 0.16 to 0.90; p = 0.02). The association between LAAEI and recurrent AT/AF was strongest in a sensitivity analysis restricted to studies of percutaneous LAAEI (OR: 0.22; 95% CI: 0.11 to 0.46; p < 0.001; 5 studies, n = 623). LAAEI was not associated with thromboembolism (OR: 0.50; 95% CI: 0.18 to 1.39; p = 0.18; 5 studies, n = 767), although these studies either incorporated LAA occlusion (3 studies, n = 552 patients) or follow-up echocardiography to assess LAA function (2 studies, n = 215 patients) to inform antithrombotic strategies.
LAAEI is associated with a significant reduction in recurrent AT/AF. Randomized trials are required to confirm the efficacy and long-term safety of LAAEI and to determine the optimal concomitant antithrombotic strategy.
Background
The prevalence of atrial fibrillation (AF) continues to increase; however, there are limited data describing the division of care among practitioners in the community and whether care ...differs depending on provider specialty.
Methods and Results
Using the Outcomes Registry for Better Informed Treatment of AF (ORBIT‐AF) Registry, we described patient characteristics and AF management strategies in ambulatory clinic practice settings, including electrophysiology (EP), general cardiology, and primary care. A total of 10 097 patients were included; of these, 1544 (15.3%) were cared for by an EP provider, 6584 (65.2%) by a cardiology provider, and 1969 (19.5%) by an internal medicine/primary care provider. Compared with those patients who were cared for by cardiologists or internal medicine/primary care providers, patients cared for by EP providers were younger (median age, 73 years interquartile range, IQR, 64, 80 years, Q1, Q3 versus 75 years IQR, 67, 82 years for cardiology and versus 76 years IQR, 68, 82 years for primary care). Compared with cardiology and internal medicine/primary care providers, EP providers used rhythm control (versus rate control) management more often (44.2% versus 29.7% and 28.8%, respectively, P<0.0001; adjusted odds ratio OR EP versus cardiology, 1.66 95% confidence interval, CI, 1.05 to 2.61; adjusted OR for internal medicine/primary care versus cardiology, 0.91 95% CI, 0.65 to 1.26). Use of oral anticoagulant therapy was high across all providers, although it was higher for cardiology and EP providers (overall, 76.1%; P=0.02 for difference between groups).
Conclusions
Our data demonstrate important differences between provider specialties, the demographics of the AF patient population treated, and treatment strategies—particularly for rhythm control and anticoagulation therapy.
Inhaled corticosteroids are the cornerstone of asthma management. Inhaled corticosteroid regimens differ slightly in various international guidelines on asthma management but are based on the ...principles of continuous treatment and titration to the lowest effective dose. Several recent studies, nevertheless, appear to demonstrate the potential value of preemptive or "pro re nata" regimens in infants and children. These studies were included in GINA 2015 for children 5 years of age and younger in whom discontinuous treatment is proposed as a second-line option. Should we change our practices after a critical reading of these studies?
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