A Modular Communicative Leadless Pacing-Defibrillator System.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS: The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).

Use of Artificial Intelligence in Improving Outcomes in Heart Disease: A Scientific Statement From the American Heart Association.

A major focus of academia, industry, and global governmental agencies is to develop and apply artificial intelligence and other advanced analytical tools to transform health care delivery. The American Heart Association supports the creation of tools and services that would further the science and practice of precision medicine by enabling more precise approaches to cardiovascular and stroke research, prevention, and care of individuals and populations. Nevertheless, several challenges exist, and few artificial intelligence tools have been shown to improve cardiovascular and stroke care sufficiently to be widely adopted. This scientific statement outlines the current state of the art on the use of artificial intelligence algorithms and data science in the diagnosis, classification, and treatment of cardiovascular disease. It also sets out to advance this mission, focusing on how digital tools and, in particular, artificial intelligence may provide clinical and mechanistic insights, address bias in clinical studies, and facilitate education and implementation science to improve cardiovascular and stroke outcomes. Last, a key objective of this scientific statement is to further the field by identifying best practices, gaps, and challenges for interested stakeholders.

Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator.

BACKGROUND: The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODS: We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. RESULTS: A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. CONCLUSIONS: In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).

An electrocardiogram-based AI algorithm for early detection of pulmonary hypertension.

BACKGROUND: Early diagnosis of pulmonary hypertension (PH) is critical for effective treatment and management. We aimed to develop and externally validate an artificial intelligence algorithm that could serve as a PH screening tool, based on analysis of a standard 12-lead ECG. METHODS: The PH Early Detection Algorithm (PH-EDA) is a convolutional neural network developed using retrospective ECG voltage-time data, with patients classified as "PH-likely" or "PH-unlikely" (controls) based on right heart catheterisation or echocardiography. In total, 39 823 PH-likely patients and 219 404 control patients from Mayo Clinic were randomly split into training (48%), validation (12%) and test (40%) sets. ECGs taken within 1 month of PH diagnosis (diagnostic dataset) were used to train the PH-EDA at Mayo Clinic. Performance was tested on diagnostic ECGs within the test sets from Mayo Clinic (n=16 175/87 998 PH-likely/controls) and Vanderbilt University Medical Center (VUMC; n=6045/24 256 PH-likely/controls). In addition, performance was tested on ECGs taken 6-18 months (pre-emptive dataset), and up to 5 years prior to a PH diagnosis at both sites. RESULTS: Performance testing yielded an area under the receiver operating characteristic curve (AUC) of 0.92 and 0.88 in the diagnostic test sets at Mayo Clinic and VUMC, respectively, and 0.86 and 0.81, respectively, in the pre-emptive test sets. The AUC remained a minimum of 0.79 at Mayo Clinic and 0.73 at VUMC up to 5 years before diagnosis. CONCLUSION: The PH-EDA can detect PH at diagnosis and 6-18 months prior, demonstrating the potential to accelerate diagnosis and management of this debilitating disease.

Realtime Diagnosis from Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation with Long Follow-Up (REGAL): Rationale and design of a pragmatic, decentralized, randomized controlled trial.

BACKGROUND: Atrial fibrillation (AF) is associated with increased risks of stroke and dementia. Early diagnosis and treatment could reduce the disease burden, but AF is often undiagnosed. An artificial intelligence (AI) algorithm has been shown to identify patients with previously unrecognized AF; however, monitoring these high-risk patients has been challenging. Consumer wearable devices could be an alternative to enable long-term follow-up. OBJECTIVES: To test whether Apple Watch, used as a long-term monitoring device, can enable early diagnosis of AF in patients who were identified as having high risk based on AI-ECG. DESIGN: The Realtime diagnosis from Electrocardiogram (ECG) Artificial Intelligence (AI)-Guided Screening for Atrial Fibrillation (AF) with Long Follow-up (REGAL) study is a pragmatic trial that will accrue up to 2,000 older adults with a high likelihood of unrecognized AF determined by AI-ECG to reach our target of 1,420 completed participants. Participants will be 1:1 randomized to intervention or control and will be followed up for 2 years. Patients in the intervention arm will receive or use their existing Apple Watch and iPhone and record a 30-second ECG using the watch routinely or if an abnormal heart rate notification is prompted. The primary outcome is newly diagnosed AF. Secondary outcomes include changes in cognitive function, stroke, major bleeding, and all-cause mortality. The trial will utilize a pragmatic, digitally-enabled, decentralized design to allow patients to consent and receive follow-up remotely without traveling to the study sites. SUMMARY: The REGAL trial will examine whether a consumer wearable device can serve as a long-term monitoring approach in older adults to detect AF and prevent cognitive function decline. If successful, the approach could have significant implications on how future clinical practice can leverage consumer devices for early diagnosis and disease prevention. CLINICALTRIALS: GOV: : NCT05923359.

First-in-man report of transsubclavian venous implantation of the Aveir leadless cardiac pacing system.

INTRODUCTION: Transsubclavian venous implantation of the Aveir leadless cardiac pacemaker (LCP) has not been previously reported. METHODS AND RESULTS: Three cases of transsubclavian implantation of the Aveir LCP are reported. Two cases were postbilateral orthotopic lung transplant, without appropriate femoral or jugular access due to recent ECMO cannulation and jugular central venous catheters. In one case, there was strong patient preference for same-day discharge. Stability testing confirmed adequate fixation and electrical testing confirmed stable parameters in all cases. All patients tolerated the procedure well without significant immediate complications. CONCLUSIONS: We demonstrate the feasibility of transsubclavian implantation of the Aveir LCP.

Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

INTRODUCTION: The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. METHODS: The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. RESULTS: From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). CONCLUSION: The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Dermatology's role in the fight against human trafficking: A report from the AAD Ad Hoc Task Force and call to action.

While the majority of American Academy of Dermatology members have some broad awareness of human trafficking, most are not aware of it in their communities or of the skin signs that could prompt identification of those being exploited, and have requested educational resources to assist patients affected by trafficking. The American Academy of Dermatology Ad Hoc Task Force on Dermatologic Resources for the Intervention and Prevention of Human Trafficking has been working to develop relevant resources, including an online toolkit on the American Academy of Dermatology website: https://www.aad.org/member/clinical-quality/clinical-care/human-trafficking.

Successful prediction of left bundle branch block-induced cardiomyopathy and treatment effect by artificial intelligence-enabled electrocardiogram.

BACKGROUND: Left bundle branch block (LBBB) induced cardiomyopathy is an increasingly recognized disease entity.  However, no clinical testing has been shown to be able to predict such an occurrence. CASE REPORT: A 70-year-old male with a prior history of LBBB with preserved ejection fraction (EF) and no other known cardiovascular conditions presented with presyncope, high-grade AV block, and heart failure with reduced EF (36%). His coronary angiogram was negative for any obstructive disease. No other known etiologies for cardiomyopathy were identified. Artificial intelligence-enabled ECGs performed 6 years prior to clinical presentation consistently predicted a high probability (up to 91%) of low EF. The patient successfully underwent left bundle branch area (LBBA) pacing with correction of the underlying LBBB. Subsequent AI ECGs showed a large drop in the probability of low EF immediately after LBBA pacing to 47% and then to 3% 2 months post procedure. His heart failure symptoms markedly improved and EF normalized to 54% at the same time. CONCLUSIONS: Artificial intelligence-enabled ECGS may help identify patients who are at risk of developing LBBB-induced cardiomyopathy and predict the response to LBBA pacing.

Split-face study to evaluate efficacy of global cryomodulation for reduction of pain and inflammation after nonablative fractional resurfacing.

OBJECTIVES: Cryomodulation, or the delivery of controlled cooling to downregulate inflammatory processes in the skin, has been proposed to mitigate acute side effects following various dermatologic treatments. A new controlled cooling device has been developed to deliver cryomodulation for a range of different indications. In this clinical study, we evaluate the device for the reduction of pain, erythema, and edema following nonablative fractional resurfacing (NAFR). METHODS: A single-blind, prospective, randomized, split-face study was conducted to assess the efficacy of the controlled dermal cooling device for the reduction of pain, edema, and erythema following nonablative fractional resurfacing with the dual 1550 nm erbium-doped fiber and 1927 nm thulium fiber laser. Subjects were randomized to receive a 10-min controlled cooling treatment to either the left or right side of the face immediately following full face NAFR. Pain ratings were recorded immediately postlaser treatment and immediately postcryomodulation treatment. At follow-up, subjects were surveyed for reduction of side effects and treatment satisfaction. Blinded review of photographs by two physicians was conducted to assess efficacy. RESULTS: The average pain score for subjects immediately post-NAFR was 5.15. Following cryomodulation, the average pain score on the treatment side was reduced by 69%, to an average of 1.6. The untreated side of the face was reduced by 19%, to an average of 4.2. Overall, 90% of subjects endorsed reduced discomfort. At follow-up, 70% of subjects reported a noticeable improvement in edema and 50% reported a noticeable improvement in erythema between the treatment and control sides. The average subject satisfaction score for the cryomodulation treatment was 4.2. All subjects (100%) indicated that they would elect to undergo the cryomodulation treatment again. Both blinded physician reviewers were successful in identifying the cryomodulation-treated side of the face in 70% of subjects' posttreatment photographs. CONCLUSIONS: The results of this split-face study support the efficacy of a global cryomodulation device for the reduction of pain, edema, and erythema following NAFR treatment. Cryomodulation was delivered in a simple 10 min procedure and yielded high patient satisfaction.

Histological analysis of laser-enabled tissue coring with a novel 2910 nm erbium-doped fluoride glass fiber laser.

OBJECTIVES: There remains an unmet need for a laser-enabled tissue coring device that can effectively improve face and neck skin laxity and rhytides. We investigate a novel 2910 nm erbium-doped fluoride glass fiber laser (2910 nm fiber laser) (UltraClear; Acclaro Medical) for laser-coring of submental tissue. METHODS: Five subjects, Glogau scale III-IV, were treated with a single pulse of the laser-coring mode of the 2910 nm fiber laser in the submentum. A 4 mm punch biopsy was immediately performed. Biopsy specimens were sectioned and stained with hematoxylin and eosin and placed on glass slides. All sections were reviewed, and sections containing the center of the transected core were analyzed for depth and diameter of the ablative microchannel and width of the surrounding zone of coagulation. RESULTS: A total of 15 intact micro-cores were analyzed. Histological analysis revealed an average ± standard deviation microchannel diameter of 242.5 ± 65.2 µm, an average ablative depth of 980 ± 318.8 µm, and an average zone of coagulation of 104 ± 32 µm. CONCLUSIONS: Laser-enabled tissue coring with a novel 2910 nm fiber laser can safely achieve a wider microchannel diameter with ablative depth extending to the mid and deep dermis, which has the potential for collagen contraction and tissue tightening. Laser-coring to this ablation diameter and depth and with the surrounding zone of coagulation was found to be safe without adverse effects of post-inflammatory erythema or scarring in our study.

Full-face and neck resurfacing with a novel ablative fractional 2910 nm erbium-doped fluoride glass fiber laser for advanced photoaging.

OBJECTIVES: Ablative fractional lasers have long been considered the gold standard for facial resurfacing for advanced photoaging. These lasers offer an improved safety profile compared to traditional ablative lasers but typically require more treatment sessions given their fractional approach. In this study, we evaluate a new novel 2910 nm erbium-doped fluoride glass fiber laser (2910 nm fiber laser) (UltraClear; Acclaro Medical) for full-face and neck resurfacing for the treatment of advanced photoaging. METHODS: Twenty-two healthy subjects aged 44-80 years presenting for advanced facial photoaging and rhytides were enrolled in the study. All subjects received three full-face and neck, multipass treatments utilizing the 2910 nm fiber laser spaced 6-8 weeks apart. Subjects were asked to rate the average level of pain during the treatment. At 90 days following subjects' third treatment subjects evaluated their improvement using a Global Aesthetic Improvement Scale (GAIS) and rated their satisfaction with the treatment. Evaluation of pretreatment and posttreatment photos was completed by two blinded physician reviewers. Reviewers were asked to identify the pretreatment and posttreatment photographs and to rate the degree of improvement utilizing a GAIS. RESULTS: Fifteen participants completed the study; six were exited from the study (withdrew or lost to follow-up). The average subject GAIS score for overall appearance was 3.8. The average subject satisfaction level at follow-up was 4.8. The average subject pain score was 4.9. One blinded physician reviewer correctly identified 100% of subjects' posttreatment photographs, while the second blinded reviewer correctly identified 93%. Blinded evaluation of digital photographs revealed an average GAIS score of 3.2. Posttreatment skin responses included pin-point hemorrhage, erythema, edema, and soft tissue crusting lasting 5-7 days. There were no instances of infection, scarring or hypopigmentation. There were two instances of temporary hyperpigmentation. CONCLUSIONS: Treatment with the novel 2910 nm fiber laser is safe and effective in treating advanced photoaging and rhytides. Three treatments produced moderate to marked improvement with high patient satisfaction and treatment was associated with less discomfort and downtime compared to conventional fractional ablative lasers.

The 730 nm picosecond titanium sapphire laser for treatment of café-au-lait macules in all skin types.

OBJECTIVES: Café-au-lait macules (CALM) are benign birthmarks presenting as uniformly pigmented, well demarcated, brown patches that can be distressing to patients, especially when located in cosmetically sensitive areas. As with all pigmentary lesions in skin of color patients, CALMs have been particularly challenging to treat. Here we present the first case series characterizing treatment parameters and clinical outcomes utilizing the 730-nm picosecond titanium sapphire laser for the treatment of CALMs. This device provides an additional safe and effective treatment option for these challenging cases. METHODS: We performed a retrospective review of patients treated at a single institution between April 2021 and December 2023. Clinical photographs were graded by 3 outside board-certified dermatologists using a 5-point visual analog scale. RESULTS: Fourteen patients (age range: 10 months-66 years, mean age: 27.4 years, Fitzpatrick skin types II-VI) were treated for CALM on the face (11) or body (3). On average, patients received 4.3 treatments, with treatment intervals ranging from 4 to 40 weeks. Treatment remains ongoing with the 730-nm picosecond laser for eight patients. Overall, patients were rated to have a mean improvement of 26%-50%. Two patients (FST III and VI) achieved 100% clearance after 4-5 treatment sessions. Our study included four patients whose CALM were of the smooth bordered "coast of California" subtype, three of whom had a mean improvement rating of only 1%-25%. The fourth patient had near complete resolution. Follow up for these patients has ranged from 6 weeks to 1.5 years. Of the patients treated, one patient experienced transient post-inflammatory hyperpigmentation and another transient post-inflammatory hypopigmentation, while a third patient experienced mild persistent guttate hypopigmentation. Three patients experienced partial recurrence indicating that maintenance treatments may be needed in some patients. CONCLUSION: The 730-nm picosecond titanium sapphire laser is a safe and efficacious treatment option, in the right morphologic setting, to improve the cosmetic appearance of CALMs in a wide range of ages and skin types. To our knowledge, this is the first reported treatment of CALMs with picosecond lasers in FST V and VI patients. Our study also supports prior studies which have found that CALM with smooth-bordered "coast of California" morphology have a poor response to laser therapy as compared to those with jagged or ill-defined bordered "coast of Maine" morphology.

Complications of Chemical Peels, Lasers, and Energy-Based Device Procedures Performed by Core Cosmetic Physicians: A Retrospective Analysis.

BACKGROUND: There has been a proliferation of physicians of different levels of experience and training offering nonsurgical cosmetic procedures. Rising demand, compounded by increasing utilization of new and existing technologies by numerous physician specialties, compels discussion of adequate standardized training and patient safety. METHODS: A retrospective chart review of patients who presented to our single site dermatology clinic for managment of complications following chemical peel, laser or energy-based device treatments performed by core cosmetic physicians between the years of 2013 and 2024 was conducted. Core cosmetic physicians included plastic surgery, facial surgery/otolaryngology, oculoplastic surgery, and dermatology. Charts were reviewed for documentation of the type of complication, procedure causing the complication, and physician credentials, and referral source. RESULTS: Twenty-five patients were identified as having complications from chemical peeling, laser treatment or energy-based devices. Devices implicated included CO2 laser (fractional or fully ablative), chemical peels, 1064 nm long-pulsed Nd:YAG laser, 1320 nm Nd:YAG laser, intense pulsed light, 595 nm pulsed dye laser, Q-switched Nd:YAG laser, radiofrequency with and without microneedling, and 1550 nm erbium-doped fiber laser. Complications included hypertrophic scarring, atrophic scarring, post-inflammatory erythema, post-inflammatory hyperpigmentation, and post-inflammatory hypopigmentation. CONCLUSIONS: Even in experienced hands, complications can arise. It is imperative that all physicians offering cosmetic treatments are equipped to recognize clinical endpoints, identify and manage complications, or make a timely referral to decrease the risk of a permanent and potentially devastating esthetic outcome for patients.

Efficacy of 785-nm Picosecond Titanium Sapphire Laser for Treatment of Brown Nevus of Ota Lesions in FST II-V: A Retrospective Analysis.

BACKGROUND: Nevus of Ota (NOTA) is a dermal melanocytosis acquired in early childhood or pregnancy. Given their color variability, NOTA often require a combination of wavelengths for successful treatment. Quality-switched lasers have consistently shown efficacy in targeting dermal pigment, while picosecond lasers (PSLs) are an emerging technology for pigmentary disorders. OBJECTIVE: To further elucidate its efficacy, the authors conducted a retrospective review of 17 patients with NOTA treated with a 785-nm PSL for brown NOTA lesions between 2021 and 2023. MATERIALS AND METHODS: The primary end point analyzed clinical improvement based on before and after photography reviewed by 3 board-certified dermatologists using a five-point visual analog scale. RESULTS: Seventeen patients of Fitzpatrick skin types (FSTs) II to V, ranging from ages 14 to 38 years, were included in this study. Patients were treated for an average of 3.2 sessions in 2 to 3-month intervals. Visual analog scale scores demonstrated a mean clearance of 51% to 75%. No pigmentary alterations were noted. CONCLUSION: Because NOTA is common in higher FSTs, the authors believe that the 785-nm PSL is an excellent treatment option for brown NOTA in these skin types. This study highlights the need for further investigation to determine optimal treatment parameters for the color-based laser treatment approach for NOTA.

Artificial intelligence-guided screening for atrial fibrillation using electrocardiogram during sinus rhythm: a prospective non-randomised interventional trial.

BACKGROUND: Previous atrial fibrillation screening trials have highlighted the need for more targeted approaches. We did a pragmatic study to evaluate the effectiveness of an artificial intelligence (AI) algorithm-guided targeted screening approach for identifying previously unrecognised atrial fibrillation. METHODS: For this non-randomised interventional trial, we prospectively recruited patients with stroke risk factors but with no known atrial fibrillation who had an electrocardiogram (ECG) done in routine practice. Participants wore a continuous ambulatory heart rhythm monitor for up to 30 days, with the data transmitted in near real time through a cellular connection. The AI algorithm was applied to the ECGs to divide patients into high-risk or low-risk groups. The primary outcome was newly diagnosed atrial fibrillation. In a secondary analysis, trial participants were propensity-score matched (1:1) to individuals from the eligible but unenrolled population who served as real-world controls. This study is registered with ClinicalTrials.gov, NCT04208971. FINDINGS: 1003 patients with a mean age of 74 years (SD 8·8) from 40 US states completed the study. Over a mean 22·3 days of continuous monitoring, atrial fibrillation was detected in six (1·6%) of 370 patients with low risk and 48 (7·6%) of 633 with high risk (odds ratio 4·98, 95% CI 2·11-11·75, p=0·0002). Compared with usual care, AI-guided screening was associated with increased detection of atrial fibrillation (high-risk group: 3·6% [95% CI 2·3-5·4] with usual care vs 10·6% [8·3-13·2] with AI-guided screening, p<0·0001; low-risk group: 0·9% vs 2·4%, p=0·12) over a median follow-up of 9·9 months (IQR 7·1-11·0). INTERPRETATION: An AI-guided targeted screening approach that leverages existing clinical data increased the yield for atrial fibrillation detection and could improve the effectiveness of atrial fibrillation screening. FUNDING: Mayo Clinic Robert D and Patricia E Kern Center for the Science of Health Care Delivery.

Physicians' perspectives on percutaneous left atrial appendage occlusion for patients with atrial fibrillation.

BACKGROUND: There has been an increasing uptake of transcatheter left atrial appendage occlusion (LAAO) for stroke reduction in atrial fibrillation. OBJECTIVES: To investigate the perceptions and approaches among a nationally representative sample of physicians. METHODS: Using the American Medical Association Physician Masterfile, we selected a random sample of 500 physicians from each of the specialties: general cardiologists, interventional cardiologists, electrophysiologists, and vascular neurologists. The participants received the survey by mail up to three times from November 9, 2021 to January 14, 2022. In addition to the questions about experiences, perceptions, and approaches, physicians were randomly assigned to 1 of the 4 versions of a patient vignette: white man, white woman, black man, and black woman, to investigate potential bias in decision-making. RESULTS: The top three reasons for considering LAAO were: a history of intracranial bleeding (94.3%), a history of major extracranial bleeding (91.8%), and gastrointestinal lesions (59.0%), whereas the top three reasons for withholding LAAO were: other indications for long-term oral anticoagulation (87.7%), a low bleeding risk (77.0%), and a low stroke risk (65.6%). For the reasons limiting recommendations for LAAO, 59.8% mentioned procedural risks, 42.6% mentioned "limiting efficacy data comparing LAAO to NOAC" and 32.8% mentioned "limited safety data comparing LAAO to NOAC." There was no difference in physicians' decision-making by patients' race, gender, or the concordance between patients' and physicians' race or gender. CONCLUSIONS: In the first U.S. national physician survey of LAAO, individual physicians' perspectives varied greatly, which provided information that will help customize future educational activities for different audiences. CONDENSED ABSTRACT: Although diverse practice patterns of LAAO have been documented, little is known about the reasoning or perceptions that drive these variations. Unlike prior surveys that were directed to Centers that performed LAAO, the current survey obtained insights from individual physicians, not only those who perform the procedures (interventional cardiologists and electrophysiologists) but also those who are closely involved in the decision-making and referral process (general cardiologists and vascular neurologists). The findings identify key evidence gaps and help prioritize future studies to establish a consistent and evidence-based best practice for AF stroke prevention.

Screening for peripartum cardiomyopathies using artificial intelligence in Nigeria (SPEC-AI Nigeria): Clinical trial rationale and design.

BACKGROUND: Artificial intelligence (AI), and more specifically deep learning, models have demonstrated the potential to augment physician diagnostic capabilities and improve cardiovascular health if incorporated into routine clinical practice. However, many of these tools are yet to be evaluated prospectively in the setting of a rigorous clinical trial-a critical step prior to implementing broadly in routine clinical practice. OBJECTIVES: To describe the rationale and design of a proposed clinical trial aimed at evaluating an AI-enabled electrocardiogram (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria. DESIGN: The protocol will enroll 1,000 pregnant and postpartum women who reside in Nigeria in a prospective randomized clinical trial. Nigeria has the highest reported incidence of peripartum cardiomyopathy worldwide. Women aged 18 and older, seen for routine obstetric care at 6 sites (2 Northern and 4 Southern) in Nigeria will be included. Participants will be randomized to the study intervention or control arm in a 1:1 fashion. This study aims to enroll participants representative of the general obstetric population at each site. The primary outcome is a new diagnosis of cardiomyopathy, defined as left ventricular ejection fraction (LVEF) < 50% during pregnancy or within 12 months postpartum. Secondary outcomes will include the detection of impaired left ventricular function (at different LVEF cut-offs), and exploratory outcomes will include the effectiveness of AI-ECG tools for cardiomyopathy detection, new diagnosis of cardiovascular disease, and the development of composite adverse maternal cardiovascular outcomes. SUMMARY: This clinical trial focuses on the emerging field of cardio-obstetrics and will serve as foundational data for the use of AI-ECG tools in an obstetric population in Nigeria. This study will gather essential data regarding the utility of the AI-ECG for cardiomyopathy detection in a predominantly Black population of women and pave the way for clinical implementation of these models in routine practice. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05438576.

New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation.

INTRODUCTION: A current limitation of single chamber implantable cardioverter defibrillators (ICDs) is the lack of an atrial lead to reliably detect atrial fibrillation (AF) episodes. A novel ventricular based atrial fibrillation (VBAF) detection algorithm was created for single chamber ICDs to assess R-R variability for detection of AF. METHODS: Patients implanted with Visia AF™ ICDs were prospectively enrolled in the Medtronic Product Surveillance Registry from December 15, 2015 to January 23, 2019 and followed with at least 30 days of monitoring with the algorithm. Time to device-detected daily burden of AF ≥ 6 min, ≥6 h, and ≥23 h were reported. Clinical actions after device-detected AF were recorded. RESULTS: A total of 291 patients were enrolled with a mean follow-up of 22.5 ± 7.9 months. Of these, 212 (73%) had no prior history of AF at device implant. However, 38% of these individuals had AF detected with the VBAF algorithm with daily burden of ≥6 min within two years of implant. In these 80 patients with newly detected AF by their ICD, 23 (29%) had a confirmed clinical diagnosis of AF by their provider. Of patients with a clinical diagnosis of AF, nine (39%) were newly placed on anticoagulation, including five of five (100%) patients having a burden >23 h. CONCLUSIONS: Continuous AF monitoring with the new VBAF algorithm permits early identification and actionable treatment for patients with undiagnosed AF that may improve patient outcomes.

Ventricular arrhythmias in patients with prior aortic valve intervention: Characteristics, ablation and outcomes.

INTRODUCTION: Data regarding ventricular tachycardia (VT) or premature ventricular complex (PVC) ablation in patients with aortic valve (AV) intervention (AVI) is limited. Catheter ablation (CA) can be challenging given perivalvular substrate in the setting of prosthetic valves. We sought to investigate the characteristics, safety, and outcomes of CA in patients with prior AVI and ventricular arrhythmias (VA). METHODS: We identified consecutive patients with prior AVI (replacement or repair) who underwent CA for VT or PVC between 2013 and 2018. We investigated the mechanism of arrhythmia, ablation approach, perioperative complications, and outcomes. RESULTS: We included 34 patients (88% men, mean age 64 ± 10.4 years, left ventricular (LV) ejection fraction 35.2 ± 15.0%) with prior AVI who underwent CA (22 VT; 12 PVC). LV access was obtained through trans-septal approach in all patients except one patient who had percutaneous transapical access. One patient had combined retrograde aortic and trans-septal approach. Scar-related reentry was the dominant mechanism of induced VTs. Two patients had bundle branch reentry VTs. In the VT group, substrate mapping demonstrated heterogeneous scar that involved the peri-AV area in 95%. Despite that, the site of successful ablation included the periaortic region only in 6 (27%) patients. In the PVC group, signal abnormalities consistent with scar in the periaortic area were noted in 4 (33%) patients. In 8 (67%) patients, the successful site of ablation was unrelated to the periaortic area. No procedure-related complications occurred. The survival and recurrence-free survival rate at 1 year tended to be lower in VT group than in PVC group (p = .06 and p = .05, respectively) with a 1-year recurrence-free survival rate of 52.8% and 91.7%, respectively. No arrhythmia-related death was documented on long-term follow-up. CONCLUSION: CA of VAs can be performed safely and effectively in patients with prior AVI.