Adherent skin barrier drape use is associated with a reduced risk of cardiac implantable device infection: Results from a prospective study of 14,225 procedures.

Background: Cardiac implantable electronic device (CIED) infection is a costly and highly morbid complication. Perioperative interventions, including the use of antibiotic pouches and intensified perioperative antibiotic regimens, have demonstrated marginal efficacy at reducing CIED infection. Additional research is needed to identify additional interventions to reduce infection risk. Objective: We sought to evaluate whether adherent skin barrier drape use is associated with a reduction in CIED infection. Methods: A prospective registry of all CIED implantation procedures was established at our institution in January 2007. The registry was established in collaboration with our hospital infection prevention team with a specific focus on prospectively identifying all potential CIED infections. All potential CIED infections were independently adjudicated by 2 physicians blinded to the use of an adherent skin barrier drape. Results: Over a 13-year period, 14,225 procedures were completed (mean age 72 ± 14 years; female 4,918 (35%); new implants 10,005 (70%); pulse generator changes 2585 (18%); upgrades 1635 (11%). Of those, 2469 procedures (17.4%) were performed using an adherent skin barrier drape. There were 103 adjudicated device infections (0.73%). The infection rate in patients in the barrier use groups was 8 of 2469 (0.32%) as compared with 95 of 11,756 (0.8%) in the nonuse group (P = .0084). In multivariable analysis, the use of an adherent skin barrier drape was independently associated with a reduction in infection (odds ratio 0.32; 95% confidence interval 0.154-0.665; P = .002). Conclusion: The use of an adherent skin barrier drape at the time of cardiac device surgery is associated with a lower risk of subsequent infection.

The use of smartwatch electrocardiogram beyond arrhythmia detection.

The adoption of wearables in medicine has expanded worldwide with a rapidly growing number of consumers and new features capable of real-time monitoring of health parameters such as the ability to record and transmit a single-lead electrocardiogram (ECG). Smartwatch ECGs are increasingly used but current smartwatches only screen for atrial fibrillation (AF). Most of the literature has focused on analyzing the smartwatch ECG accuracy for the detection of AF or other tachycardias. As with the conventional ECG, this tool may be used for many more purposes than only detection of AF. The objectives of this review are to describe the published literature regarding the accuracy and clinical value of recording a smartwatch ECG in other situations than diagnosis of tachycardia and discuss possible techniques to optimize the diagnostic yield.

Optimized workflow for pulmonary vein isolation using 90-W radiofrequency applications: a comparative study.

BACKGROUND: Ninety-watt applications are more sensitive to catheter instability and produce lesions that are shallower and smaller in diameter than 50-W applications. These characteristics were considered for the development of a combined (90-50 W) pulmonary vein isolation (PVI) strategy which was prospectively compared to a 50 W-only ablation index (AI)-guided PVI strategy. METHODS: One hundred fifty consecutive paroxysmal AF patients underwent PVI under general anesthesia using CARTO. In the first 75 patients, PVI was performed with a combined (90-50 W) strategy using the QDOT-MICRO catheter in a temperature-controlled mode. This strategy consisted of 90 W-4 s applications on the posterior LA wall (at sites of catheter stability and expectedly thin atrial tissue) with an interlesion distance (ILD) ≤ 4 mm and 50-W applications elsewhere (at sites of catheter instability or expectedly thick atrial tissue) with ILD < 6 mm. In the subsequent 75 patients, PVI was performed with a 50 W-only AI-guided strategy using the SmartTouch-SF catheter in a power-controlled mode. RESULTS: Both groups of patients had similar clinical characteristics and LA dimensions (123.1 ± 24.9 ml vs 119 ± 26.8 ml, P = 0.33). Total procedural times (61 [56-70] vs 65 [60-75] min, P = 0.12), first-pass PVI (82.6 vs 80%, P = 0.81), acute PV reconnection (0 vs 6.6%, P = 0.05), and 1-year SR maintenance (93.3 vs 90.6%, P = 0.57) rates were also similar in both groups of patients. There were no complications in the combined (90-50 W) group while only 2 groin hematomas were reported in the 50 W group. CONCLUSIONS: In paroxysmal AF patients, a combined (90-50 W) strategy for PVI did not improve safety, efficiency, or effectiveness compared to a 50 W-only AI-guided strategy.

Optimal interlesion distance for 90 and 50†watt radiofrequency applications with low ablation index values: experimental findings in a chronic ovine model.

AIMS: The optimal interlesion distance (ILD) for 90 and 50 W radiofrequency applications with low ablation index (AI) values in the atria has not been established. Excessive ILDs can predispose to interlesion gaps, whereas restrictive ILDs can predispose to procedural complications. The present study sought, therefore, to experimentally determine the optimal ILD for 90 W-4 s and 50 W applications with low AI values to optimize catheter ablation outcomes in humans. METHODS AND RESULTS: Posterior intercaval lines were created in eight adult sheep using CARTO and the QDOT-MICRO catheter in a temperature-controlled mode. In four animals, the lines were created with 50 W applications, a target AI value ≥350, and ILDs of 6, 5, 4, and 3 mm, respectively. In the other four animals, the lines were created with 90 W-4 s applications and ILDs of 6, 5, 4, and 3 mm, respectively. Activation maps were created immediately after ablation and at 21 days to assess linear block prior to gross and histological analyses. All eight lines appeared transmural and continuous on histology. However, for 50 W-only applications with an ILD of 3 mm resulted in durable linear electrical block, whereas for 90 W applications, only the lines with ILDs of 4 and 3 mm were blocked. No complications were detected during ablation procedures, but all power and ILD combinations except 50 W-6 mm resulted in asymptomatic shallow lung lesions. CONCLUSION: In the intercaval region in sheep, for 50 W applications with an AI value of ∼370, the optimal ILD is 3 mm, whereas for 90 W-4 s applications, the optimal ILD is 3-4 mm.

T-Wave Oversensing with Contemporary Implantable Cardioverter-Defibrillators.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) need to reliably detect ventricular tachycardia (VT) and ventricular fibrillation (VF) while avoiding T-wave oversensing (TWOS), which is associated with a risk of inappropriate therapies. The incidence of TWOS with endovascular ICDs appears to differ between manufacturers. OBJECTIVES: We aimed to evaluate the incidence and clinical consequences of TWOS with contemporary Medtronic and Boston Scientific ICDs. METHODS: Consecutive patients implanted with a recent Medtronic or Boston Scientific ICD and remotely monitored at three French centers were included. All transmitted EGMs labelled as VF, VT, non-sustained VT (NSVT), or ventricular oversensing (Medtronic) were screened for TWOS. RESULTS: Among 7589 transmitted episodes from 674 patients with a Boston Scientific ICD, we did not identify a single case of TWOS. Among 16,790 transmitted episodes from 1733 patients with a Medtronic ICD, we identified 60 patients (3.4%) with at least one episode of TWOS. In 46 patients, TWOS was intermittent (NSVT episodes). In the remaining 14 patients, TWOS resulted in 60 sustained episodes (completed counters). No inappropriate therapies were delivered in 12 of these patients because no therapies were programmed (in monitor zones, 11 episodes) or because therapies were inhibited by the morphology discriminator (Wavelet, 19 episodes) or by the anti-TWOS algorithm (26 episodes). Two patients received inappropriate therapies due to TWOS (0.1% of patients with Medtronic ICDs). CONCLUSION: On review of 24,379 transmitted episodes from 2407 patients with endovascular ICDs, we found no case of TWOS with Boston Scientific devices, whereas TWOS was not uncommon with Medtronic devices. However, the risk of inappropriate therapy with Medtronic ICDs was very low (0.1%) due to the often intermittent nature of this phenomenon, the morphology discriminator, and the anti-TWOS algorithm.

Remote management of worsening heart failure to avoid hospitalization in a real-world setting.

AIMS: From a patient and health system perspective, managing worsening heart failure (WHF) as an outpatient has become a priority. Remote management allows early detection of WHF, enabling timely intervention with the aim of preventing hospitalization. The objective of the study was to evaluate the feasibility and safety of remotely managing WHF events using a multiparametric platform. METHODS AND RESULTS: All patients enrolled in the heart failure remote management programme of the Bordeaux University Hospital Telemedicine Center between 1 January and 31 December 2021 were included in the study. Follow-up data were collected until 1 March 2022. Inclusion criteria were chronic heart failure (HF) with New York Heart Association ≥II symptoms and an elevated B-type natriuretic peptide (BNP > 100 pg/mL or N-terminal-pro-BNP > 1000 pg/mL). Patient assessments were performed remotely and included measurements of body weight, blood pressure, heart rate, symptoms, biochemical parameters, and data from cardiac implantable electronic devices when available. In total, 161 patients (71 ± 11 years old, 79% male) were followed for a mean of 291 ± 66 days with a mean adherence to the remote monitoring system of 80 ± 20%. Over this period, 52 (32.3%) patients had 105 WHF events, of which 66 (63%) were successfully managed remotely, the remaining requiring hospitalization. Freedom from WHF events and hospitalization at 300 days were 66% and 85%, respectively (P < 0.001 for the difference). Increased level of BNP was associated with an increased risk of WHF event [hazard ratio (HR) per unit increase in BNP: 1.001; 95% confidence interval (CI) 1-1.002; P = 0.001] and hospitalization (HR 1.002; 95% CI 1.002-1.003; P = 0.002). A decrease in the level of glomerular filtration rate was associated with an increased risk of hospitalization (HR per unit decrease in estimated glomerular filtration rate: 0.946; 95% CI 0.906-0.989; P = 0.014). WHF event recurrence and (re)hospitalization rates at 1-month were similar among patients managed remotely (18% and 12%, respectively) and those requiring hospitalization (21% and 10%, respectively). Iatrogenic complications occurred more often during hospitalization than remote management (26% vs. 3%, P < 0.001). CONCLUSIONS: Our study suggests that remote management of WHF events based on a multiparametric approach led by a telemedical centre is feasible and safe. Adopting such a strategy for patients with chronic HF could reduce HF-related hospitalizations with expected benefits for patients, care providers, and health care systems.

Diagnostic accuracy of point-of-care ultrasound with artificial intelligence-assisted assessment of left ventricular ejection fraction.

Focused cardiac ultrasound (FoCUS) is becoming standard practice in a wide spectrum of clinical settings. There is limited data evaluating the real-world use of FoCUS with artificial intelligence (AI). Our objective was to determine the accuracy of FoCUS AI-assisted left ventricular ejection fraction (LVEF) assessment and compare its accuracy between novice and experienced users. In this prospective, multicentre study, participants requiring a transthoracic echocardiogram (TTE) were recruited to have a FoCUS done by a novice or experienced user. The AI-assisted device calculated LVEF at the bedside, which was subsequently compared to TTE. 449 participants were enrolled with 424 studies included in the final analysis. The overall intraclass coefficient was 0.904, and 0.921 in the novice (n = 208) and 0.845 in the experienced (n = 216) cohorts. There was a significant bias of 0.73% towards TTE (p = 0.005) with a level of agreement of 11.2%. Categorical grading of LVEF severity had excellent agreement to TTE (weighted kappa = 0.83). The area under the curve (AUC) was 0.98 for identifying an abnormal LVEF (<50%) with a sensitivity of 92.8%, specificity of 92.3%, negative predictive value (NPV) of 0.97 and a positive predictive value (PPV) of 0.83. In identifying severe dysfunction (<30%) the AUC was 0.99 with a sensitivity of 78.1%, specificity of 98.0%, NPV of 0.98 and PPV of 0.76. Here we report that FoCUS AI-assisted LVEF assessments provide highly reproducible LVEF estimations in comparison to formal TTE. This finding was consistent among senior and novice echocardiographers suggesting applicability in a variety of clinical settings.

Dipyridamole and vascular healing following stent implantation.

Introduction: Patients undergoing coronary stent implantation incur a 2% annual rate of adverse events, largely driven by in-stent restenosis (ISR) due to neointimal (NI) tissue proliferation, a process in which smooth muscle cell (SMC) biology may play a central role. Dipyridamole (DP) is an approved therapeutic agent with data supporting improved vascular patency rates. Pre-clinical data supports that DP may enact its vasculoprotective effects via adenosine receptor-A2B (ADOR-A2B). We sought to evaluate the efficacy of DP to mitigate ISR in a pre-clinical rabbit stent model. Methods & Results: 24 New Zealand White Rabbits were divided into two cohorts-non-atherosclerosis and atherosclerosis (n = 12/cohort, 6 male and 6 female). Following stent implantation, rabbits were randomized 1:1 to control or oral dipyridamole therapy for 6 weeks followed by optical coherence tomography (OCT) and histology assessment of NI burden and stent strut healing. Compared to control, DP demonstrated a 16.6% relative reduction in NI volume (14.7 ± 0.8% vs. 12.5 ± 0.4%, p = 0.03) and a 36.2% relative increase in optimally healed stent struts (37.8 ± 2.8% vs. 54.6 ± 2.5%, p < 0.0001). Atherosclerosis demonstrated attenuated effect with no difference in NI burden (15.2 ± 1.0% vs. 16.9 ± 0.8%, p = 0.22) and only a 14.2% relative increase in strut healing (68.3 ± 4.1% vs. 78.7 ± 2.5%, p = 0.02). DP treated rabbits had a 44.6% (p = 0.045) relative reduction in NI SMC content. In vitro assessment of DP and coronary artery SMCs yielded dose-dependent reduction in SMC migration and proliferation. Selective small molecule antagonism of ADOR-A2B abrogated the effects of DP on SMC proliferation. DP modulated SMC phenotypic switching with ADOR-A2B siRNA knockdown supporting its role in the observed effects. Conclusion: Dipyridamole reduces NI proliferation and improves stent healing in a preclinical model of stent implantation with conventional antiplatelets. Atherosclerosis attenuates the observed effect. Clinical trials of DP as an adjunctive agent may be warranted to evaluate for clinical efficacy in stent outcomes.

Abnormal Atrial Potentials Recorded During Sinus Rhythm or Pacing Represent Substrates for Reentrant Atrial Tachycardia.

BACKGROUND: Abnormal atrial potentials (AAPs) recorded during sinus rhythm/atrial pacing may indicate areas of slow conduction capable of supporting reentrant atrial tachycardia (AT). Therefore, we sought to examine the relationship between AAPs and AT circuits. METHODS: One hundred twenty-three reentrant ATs in 104 patients were analyzed. AAPs, consisting of fragmented potentials and split potentials, were assessed using the Rhythmia LUMIPOINT algorithm. RESULTS: There was 93±13% overlap between areas with AAPs during sinus rhythm/atrial pacing and areas of slow conduction along the reentry circuit during AT. The cumulative area of AAPs was smaller in patients with localized-reentrant ATs compared with anatomic macro-reentrant ATs (20.0 [14.6-30.5] versus 28.9 [21.8-35.6] cm2; P=0.021). Patients with perimitral ATs had larger areas of AAPs on the lateral wall whereas patients with roof-dependent ATs had larger areas of AAPs on the roof and posterior wall (P≤0.018 for all comparisons). The patchy scar that was associated with localized-reentrant AT exhibited a larger area of AAPs at its periphery than the scar that did not participate in localized-reentrant AT (3.1 [2.4-4.5] versus 1.0 [0.7-1.6] cm2; P<0.001). CONCLUSIONS: AAPs recorded during sinus rhythm/atrial pacing are associated with areas of slow conduction during reentrant AT. The burden and distribution of AAPs may provide actionable insights into AT circuit features, including in cases in which ATs are difficult to map.

Electrophysiologic Determinants of Isoelectric Intervals on Surface Electrocardiograms During Atrial Tachycardia: Insights From High-Density Mapping.

BACKGROUND: Substrate abnormalities can alter atrial activation during atrial tachycardias (ATs) thereby influencing AT-wave morphology on the surface electrocardiogram. OBJECTIVES: This study sought to identify determinants of isoelectric intervals during ATs with complex atrial activation patterns. METHODS: High-density activation maps of 126 ATs were studied. To assess the impact of the activated atrial surface on the presence of isoelectric intervals, this study measured the minimum activated area throughout the AT cycle, defined as the smallest activated area within a 50-millisecond period, by using signal processing algorithms (LUMIPOINT). RESULTS: ATs with isoelectric intervals (P-wave ATs) included 23 macro-re-entrant ATs (40%), 26 localized-re-entrant ATs (46%), and 8 focal ATs (14%), whereas those without included 46 macro-re-entrant ATs (67%), 21 localized-re-entrant ATs (30%), and 2 focal ATs (3%). Multivariable regression identified smaller minimum activated area and larger very low voltage area as independent predictors of P-wave ATs (OR: 0.732; 95% CI: 0.644-0.831; P < 0.001; and OR: 1.042; 95% CI: 1.006-1.080; P = 0.023, respectively). The minimum activated area with the cutoff value of 10 cm2 provided the highest predictive accuracy for P-wave ATs with sensitivity, specificity, and positive and negative predictive values of 96%, 97%, 97%, and 95%, respectively. In re-entrant ATs, smaller minimum activated area was associated with lower minimum conduction velocity within the circuit and fewer areas of delayed conduction outside of the circuit (standardized ß: 0.524; 95% CI: 0.373-0.675; P < 0.001; and standardized ß: 0.353; 95% CI: 0.198-0.508; P < 0.001, respectively). CONCLUSIONS: Reduced atrial activation area and voltage were associated with isoelectric intervals during ATs.

Efficacy of Milrinone and Dobutamine in Cardiogenic Shock: An Updated Systematic Review and Meta-Analysis.

OBJECTIVES: Inotropic support is commonly used in patients with cardiogenic shock (CS). High-quality data guiding the use of dobutamine or milrinone among this patient population is limited. We compared the efficacy and safety of these two inotropes among patients with low cardiac output states (LCOS) or CS. DATA SOURCES: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched up to February 1, 2023, using key terms and index headings related to LCOS or CS and inotropes. DATA EXTRACTION: Two independent reviewers included studies that compared dobutamine to milrinone on all-cause in-hospital mortality, length of ICU stay, length of hospital stay, and significant arrhythmias in hospitalized patients. DATA SYNTHESIS: A total of eleven studies with 21,084 patients were included in the meta-analysis. Only two randomized controlled trials were identified. The primary outcome, all-cause mortality, favored milrinone in observational studies only (odds ratio [OR] 1.19 (95% CI, 1.02-1.39; p = 0.02). In-hospital length of stay (LOS) was reduced with dobutamine in observational studies only (mean difference -1.85 d; 95% CI -3.62 to -0.09; p = 0.04). There was no difference in the prevalence of significant arrhythmias or in ICU LOS. CONCLUSIONS: Only limited data exists supporting the use of one inotropic agent over another exists. Dobutamine may be associated with a shorter hospital LOS; however, there is also a potential for increased all-cause mortality. Larger randomized studies sufficiently powered to detect a difference in these outcomes are required to confirm these findings.

Incidence of Atrial Fibrillation as the Initial Manifestation of Cardiac Sarcoidosis: Insights From a Catheter Ablation Registry.

Background: Cardiac sarcoidosis (CS) is a rare form of arrhythmogenic cardiomyopathy; a delayed diagnosis can lead to significant consequences. Patients with clinically manifest CS often have minimal extracardiac involvement and thus frequently present initially to cardiology. Indeed, certain specific arrhythmic scenarios should trigger investigations for undiagnosed CS. Atrial fibrillation (AF) has been described as one of the presenting features of CS; however, the incidence of this presentation is not known. Methods: At our institution, cardiac computerized tomography is routinely performed prior to catheter ablation for AF. Noncardiac incidental findings are described by radiologists and are followed-up by interval investigations. We systematically reviewed noncardiac reports from 1574 consecutive patients in our prospective AF ablation registry. Specifically, we used text-scraping techniques to search on the following keywords: "adenopathy" and "sarcoidosis." Detailed chart review of identified cases was then performed to evaluate results of interval investigations and assess long-term outcomes. Results: Twenty of 1574 patients (1.3%) had noncardiac reports containing "adenopathy" and/or "sarcoidosis." After interval imaging and a follow-up period averaging 60 ± 35 months, only 2 patients of 1574 (0.13%) were diagnosed with CS. Four of 20 (20%) had a previous history of extracardiac sarcoidosis, and another 1 of 20 (5%) was subsequently diagnosed with extracardiac sarcoidosis. However, none of these 5 patients had evidence of cardiac involvement. Conclusions: CS is a rare finding among patients undergoing a first-time AF ablation. Our findings suggest that AF is an uncommon initial presentation of CS. Thus, investigations for CS in patients with AF are not warranted routinely, unless additional suggestive clinical features are present.

Contexte: La sarcoïdose cardiaque (SC) est une forme rare de cardiomyopathie arythmogène; un retard dans le diagnostic peut entraîner d'importantes conséquences. Les patients qui présentent une SC cliniquement manifeste ont souvent une atteinte extracardiaque minime, et consultent donc souvent d'abord en cardiologie. En effet, certains scénarios arythmiques précis devraient déclencher la recherche de signes d'une SC non diagnostiquée. La fibrillation auriculaire (FA) a été décrite comme un signe indicateur de SC; on ne connaît toutefois pas l'incidence de ce signe. Méthodologie: Dans notre établissement, la tomodensitométrie cardiaque est souvent réalisée avant une ablation par cathéter de la FA. Les découvertes non cardiaques fortuites sont décrites par les radiologues, puis font l'objet d'un suivi par des examens d'imagerie réalisés à intervalles déterminés. Nous avons systématiquement évalué les éléments non cardiaques signalés chez 1 574 patients consécutifs dans notre registre prospectif sur l'ablation de la FA. Nous avons utilisé des techniques de dépouillement du texte pour trouver les mots-clés suivants : « adenopathy ¼ (adénopathie) et « sarcoidosis ¼ (sarcoïdose). Un examen du dossier médical complet des cas retenus a été réalisé pour évaluer les résultats des examens de suivi et évaluer les résultats à long terme. Résultats: Parmi les 1 574 patients, 20 (1,3 %) présentaient des notes non cardiaques contenant les termes « adenopahy ¼ (adénopathie) ou « sarcoidosis ¼ (sarcoïdose). Après l'examen d'imagerie et une période de suivi d'une durée moyenne de 60 ±35 mois, seuls deux patients (0,13 %) ont reçu un diagnostic de SC. Quatre des 20 patients visés (20 %) présentaient des antécédents de sarcoïdose extracardiaque, et un patient sur 20 (5 %) a reçu un diagnostic de sarcoïdose extracardiaque à la suite de l'intervention. Toutefois, aucun de ces cinq patients ne montrait de signes d'atteinte cardiaque. Conclusions: La SC est une occurrence rare chez les patients qui subissent une première ablation de la FA. Nos constats indiquent que la FA est une présentation initiale peu commune de la SC. Aussi, la recherche de la SC chez les patients atteints de FA n'est pas justifiée dans une procédure de routine, à moins que d'autres caractéristiques cliniques pointant vers cette affection ne soient présentes.

Evaluation of a Rabbit Model of Vascular Stent Healing: Application of Optical Coherence Tomography.

Percutaneous coronary intervention (PCI) is a management strategy for symptomatic obstructive coronary artery disease (CAD). Despite advancements, in-stent restenosis (ISR) still imparts a 1-2% annual rate of repeat revascularization-a focus of ongoing translational research. Optical coherence tomography (OCT) provides high resolution virtual histology of stents. Our study evaluates the use of OCT for virtual histological assessment of stent healing in a rabbit aorta model, enabling complete assessment of intraluminal healing throughout the stent. ISR varies based on intra-stent location, stent length, and stent type in a rabbit model-important considerations for translational experimental design. Atherosclerosis leads to more prominent ISR proliferation independent of stent-related factors. The rabbit stent model mirrors clinical observations, while OCT-based virtual histology demonstrates utility for pre-clinical stent assessment. Pre-clinical models should incorporate clinical and stent factors as feasible to maximize translation to clinical practice.

A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT).

BACKGROUND: Arm restriction after cardiac implantable electronic device (CIED) placement is common practice despite minimal supporting evidence. Patients receive a range of restriction recommendations of variable durations with the goal of reducing complications such as wound dehiscence, infection, lead dislodgement, or hematoma formation. These movement limitations can lead to emotional stress and anxiety, complications such as frozen shoulder, and upper extremity venous thrombosis due to immobilization. There are no published clinical trials assessing the benefits and risks of arm restrictions post-CIED implant. OBJECTIVES: The randomized trial of lenient vs strict arm and activity instruction post-CIED surgery (LENIENT trial; NCT04915261) is a single center nonblinded randomized prospective study designed to evaluate lenient compared to restrictive post-CIED care instructions. We hypothesize that there will be no significant difference in complications between the arms. METHODS/DESIGN: All patients receiving a de novo CIED or those with upgrades and revisions requiring a new lead implant will be enrolled. Subjects are enrolled in a nonblinded randomized prospective trial with 6 randomly assigned 8-month periods, during which either a lenient or restrictive postoperative activity instructions will be given to all patients. Postoperative instructions are given at the time of discharge and further reinforced by recurrent interactive voice recognition (IVR) phone calls, text messages and emails. The requirement for individual consent has been waived. The primary end point is a composite of (1) lead dislodgement, (2) frozen shoulder, (3) upper extremity venous thrombosis, (4) clinically significant hematoma, and (5) infection occurring within 52 weeks of index surgery. The study is a noninferiority trial with a sample size of 1,250 per group. DISCUSSION: This is the first large randomized clinical trial designed to establish an evidence-based postoperative standard of care for patients undergoing CIED implantation. This will improve the quality of care provided to patients and help guide implanting physicians providing postoperative care instructions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04915261.

High-resolution mapping of reentrant atrial tachycardias: Relevance of low bipolar voltage.

BACKGROUND: Bipolar voltage is widely used to characterize the atrial substrate but has been poorly validated, particularly during clinical tachycardias. OBJECTIVE: The purpose of this study was to evaluate the diagnostic performance of voltage thresholds for identifying regions of slow conduction during reentrant atrial tachycardias (ATs). METHODS: Thirty bipolar voltage and activation maps created during reentrant ATs were analyzed to (1) examine the relationship between voltage amplitude and conduction velocity (CV), (2) measure the diagnostic ability of voltage thresholds to predict CV, and (3) identify determinants of AT circuit dimensions. Voltage amplitude was categorized as "normal" (>0.50 mV), "abnormal" (0.05-0.50 mV), or "scar" (<0.05 mV); slow conduction was defined as <30 cm/s. RESULTS: A total of 266,457 corresponding voltage and CV data points were included for analysis. Voltage and CV were moderately correlated (r = 0.407; P < .001). Bipolar voltage predicted regions of slow conduction with an area under the receiver operating characteristic curve of 0.733 (95% confidence interval 0.731-0.735). A threshold of 0.50 mV had 91% sensitivity and 35% specificity for identifying slow conduction, whereas 0.05 mV had 36% sensitivity and 87% specificity, with an optimal voltage threshold of 0.15 mV. Analyses restricted to the AT circuits identified weaker associations between voltage and CV and an optimal voltage threshold of 0.25 mV. CONCLUSION: Widely used bipolar voltage amplitude thresholds to define "abnormal" and "scar" tissue in the atria are, respectively, sensitive and specific for identifying regions of slow conduction during reentrant ATs. However, overall, the association of voltage with CV is modest. No clinical predictors of AT circuit dimensions were identified.

Implantation of a leadless pacemaker in young adults.

AIMS: Leadless pacing has emerged as an alternative to conventional transvenous pacemakers to mitigate the risks of pocket- and lead-related complications but its use remains controversial in young adults mostly because experience in this patient population is limited. We sought to examine the feasibility and safety of implanting leadless single chamber pacemakers in young adults. METHODS: This multicenter, retrospective, observational study sought to evaluate the safety, efficacy, and electrical performance of the Micra VR Transcatheter Pacemaker System (Medtronic) in patients between 18 and 40 years who underwent implantation of a leadless pacemaker for any indication at the university medical centers of Bordeaux, Clermont-Ferrand, Toulouse, and Tours (France), between 2015 and 2021. The primary safety endpoint was freedom from system-related or procedure-related major complications at 6 months. The primary efficacy endpoint was the combination of a low (≤2 V) and stable (increase within 1.5 V) pacing capture threshold at 6 months. RESULTS: Leadless pacemaker implantation was successful in all 35 patients. At 6 months, safety endpoint was met for 35 (100%) and efficacy endpoint for 34 (97%) patients. During a follow-up of 26 ± 15 months (range: 6-60 months), Safety endpoint remained 100% and efficacy endpoint was 94%. Leadless pacemaker retrieval was not required in any patient. Approximately one-third of patients (n = 13, 37%) had >40% ventricular pacing burdens at 1 year, including all 10 patients with a complete AV block but also 3 patients with normal AV conduction during implantation. One patient reported symptoms of pacemaker syndrome which was confirmed using Holter recording and successfully treated using reprogramming. CONCLUSION: In this observational study, leadless pacemakers demonstrated favorable short- and intermediate-term safety and effectiveness in young adults.

Arrhythmic Events and Mortality in Patients With Cardiogenic Shock on Inotropic Support: Results of the DOREMI Randomized Trial.

BACKGROUND: Inotropic support is widely used in the management of cardiogenic shock (CS). Existing data on the incidence and significance of arrhythmic events in patients with CS on inotropic support is at high risk of bias. METHODS: The Dobutamine Compared to Milrinone (DOREMI) trial randomized patients to receive dobutamine or milrinone in a double-blind fashion. Patients with and without arrhythmic events (defined as arrhythmias requiring intervention or sustained ventricular arrhythmias) were compared to identify factors associated with their occurrence, and to examine their association with in-hospital mortality and secondary outcomes. RESULTS: Ninety-two patients (47.9%) had arrhythmic events, occurring equally with dobutamine and milrinone (P = 0.563). The need for vasopressor support at initiation of the inotrope and a history of atrial fibrillation were positively associated with arrhythmic events, whereas predominant right ventricular dysfunction, previous myocardial infarction, and increasing left ventricular ejection fraction were negatively associated with them. Supraventricular arrhythmic events were not associated with mortality (relative risk [RR], 0.97; 95% confidence interval [CI], 0.68-1.40; P = 0.879) but were positively associated with resuscitated cardiac arrests and hospital length of stay. Ventricular arrhythmic events were positively associated with mortality (RR, 1.66; 95% CI, 1.13-2.43; P = 0.026) and resuscitated cardiac arrests. Arrhythmic events were most often treated with amiodarone (97%) and electrical cardioversion (27%), which were not associated with mortality. CONCLUSIONS: Clinically relevant arrhythmic events occur in approximately one-half of patients with CS treated with dobutamine or milrinone and are associated with adverse clinical outcomes. Five factors may help to identify patients most at risk of arrhythmic events.