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Objective The leadless cardiac pacemaker is typically implanted percutaneously and has been widely used for patients who have already undergone valve surgery. We sought to determine the feasibility and safety of implanting the leadless pacemaker under direct visualization during valve surgery. Methods We performed a retrospective analysis of consecutive adult patients (n = 15) who underwent implantation of a leadless pacemaker under direct visualization at the time of valve surgery. Indications for single-chamber pacing were sick sinus syndrome with pauses (53.3%), atrial fibrillation with slow ventricular rates (13.3%) or complete heart block (6.6%), and elevated risk for postoperative heart block (26.6%). Leadless pacemaker performance and pacing percentage were assessed. Results Patients' age was 67.5 ± 17 years, 6 patients (40%) were male, and 14 patients (93%) had atrial fibrillation. Isolated tricuspid valve replacement was performed in 5 patients (33.3%), and the remainder underwent multivalve surgery that included concomitant tricuspid valve repair/replacement. In 93% of the patients (n = 14), the immediate post–cardiopulmonary bypass pacing thresholds were normal (≤2.0 V at 0.24 ms) and normalized in the remaining patient by the next morning. The impedance/sensing values were normal and stable through follow-up (151 ± 119 days) in all patients. Reliable leadless pacemaker performance allowed for deferral of temporary epicardial wires in 11 patients (73%). There were no procedural complications or device malfunction. Conclusions Leadless cardiac pacemaker implantation during valve surgery is feasible and safe. This hybrid approach to pacing may simplify the perioperative management of patients undergoing valve surgery who have an indication for single-chamber pacing.

BACKGROUND Increasing interest in physiological pacing has been countered with challenges such as accurate lead deployment and increasing pacing thresholds with His-bundle pacing (HBP). More recently, left bundle branch area pacing (LBBAP) has emerged as an alternative approach to physiologic pacing. OBJECTIVE To compare procedural outcomes and pacing parameters at follow-up during initial adoption of HBP and LBBAP at a single center. METHODS Retrospective review, from September 2016 to January 2020, identified the first 50 patients each who underwent successful HBP or LBBAP. Pacing parameters were then assessed at first follow-up after implantation and after approximately one year, evaluating for acceptable pacing parameters defined as sensing R-wave amplitude >5 mV, threshold

Summary A library of well-characterized human induced pluripotent stem cell (hiPSC) lines from clinically healthy human subjects could serve as a useful resource of normal controls for in vitro human development, disease modeling, genotype-phenotype association studies, and drug response evaluation. We report generation and extensive characterization of a gender-balanced, racially/ethnically diverse library of hiPSC lines from 40 clinically healthy human individuals who range in age from 22 to 61 years. The hiPSCs match the karyotype and short tandem repeat identities of their parental fibroblasts, and have a transcription profile characteristic of pluripotent stem cells. We provide whole-genome sequencing data for one hiPSC clone from each individual, genomic ancestry determination, and analysis of mendelian disease genes and risks. We document similar transcriptomic profiles, single-cell RNA-sequencing-derived cell clusters, and physiology of cardiomyocytes differentiated from multiple independent hiPSC lines. This extensive characterization makes this hiPSC library a valuable resource for many studies on human biology., Highlights • A library of induced pluripotent stem cells from 40 healthy human subjects • Racially/ethnically diverse subjects of clinically well-characterized health • Whole-genome sequencing identifies variants of mild common phenotypes or incomplete penetrance • Similar physiology of cardiomyocytes from independent hiPSC clones and individuals, In this resource, Schaniel et al. report the generation and characterization of a gender-balanced, racially/ethnically diverse library of hiPSC lines from 40 clinically well-characterized healthy human individuals. The authors provide whole-genome sequencing data, ancestry determination, and analysis of mendelian disease genes and risks. Furthermore, similar physiology of cardiomyocytes differentiated from independent hiPSC clones derived from two individuals is documented.

Background The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. Methods and results The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). Conclusion This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

Early subcutaneous implantable cardioverter-defibrillator (S-ICD) studies included atypical cohorts of patients who were younger with fewer comorbidities. Recent S-ICD studies included patient populations with more comorbidities.The goals of this study were to determine the incidence and predictors of S-ICD-related infection over a 3-year follow-up period and to use these results to develop an infection risk score.The S-ICD Post Approval Study is a US prospective registry of 1637 patients. Baseline demographic characteristics and outcomes with 3-year postimplantation follow-up were compared between patients with and without device-related infection. A risk score was derived from multivariable proportional hazards analysis of 22 variables.Infection was observed in 55 patients (3.3%), with 69% of infections occurring within 90 days and a vast majority (92.7%) within 1 year of implantation. Late infections more likely involved device erosion; no infections occurred after year 2. The annual mortality rate postinfection was 0.6%/y. No lead extraction complications or bacteremia related to infection were observed. An infection risk score was created with diabetes, age, prior transvenous ICD implant, and ejection fraction as predictors. Patients with a risk score of ≥3 had an 8.8 hazard ratio (95% confidence interval 2.8-16.3) of infection compared with a 0 risk score.Infection rates in the S-ICD Post Approval Study were similar to other S-ICD populations and not associated with systemic blood-borne infections. Late infection (1 year) is uncommon and associated with system erosion. A high-risk infection cohort can be identified that may facilitate preventive measures.

BACKGROUND Same-day discharge (SDD) after atrial fibrillation (AF) ablation is increasingly being considered. This study examined the barriers and financial impact associated with SDD in a contemporary cohort of patients undergoing elective AF ablation. METHODS A single center retrospective review was conducted of the 249 first case-of-the-day outpatient AF ablations performed in 2019 to evaluate the proportion of patients that could have undergone SDD. Barriers to SDD were defined as any intervention that prevented SDD by 8 p.m. The financial impact of SDD was based on savings from avoidance of the overnight hospital stay and revenue related to management of chest pain facilitated by a vacant hospital bed. RESULTS SDD could have occurred in 157 patients (63%) without change in management and in up to 200 patients (80%) if avoidable barriers were addressed. Barriers to SDD included non-clinical logistical issues (43%), prolonged post-procedure recovery (42%) and minor procedural complications (15%). On multivariate analysis, factors associated with barriers to SDD included increasing age (P = .01), left ventricular ejection fraction ≤ 35% (P = .04), and severely dilated left atrium (P = .04). The financial gain from SDD would have ranged from $1,110,096 (assuming discharge of 63% of eligible patients) to $1,480,128 (assuming 80% discharge) over the course of a year. CONCLUSIONS Up to 80% of patients undergoing outpatient AF ablation were amenable to SDD if avoidable delays in care had been anticipated. Based on reduced hospital operating expenses and increased revenue from management of individuals with chest pain, this would translate to a financial savings of ∼$1.5 million.

Objectives This study sought to determine the impact of adjunctive renal sympathetic denervation to catheter ablation in patients with atrial fibrillation (AF) and history of hypertension. Background There are limited data regarding the impact of upstream adjunctive renal sympathetic denervation (RSDN) to pulmonary vein isolation (PVI) in patients with symptomatic atrial fibrillation (AF) and hypertension. Methods The data for this study were obtained from 2 prospective randomized pilot studies, the HFIB (Adjunctive Renal Denervation to Modify Hypertension and Sympathetic tone as Upstream Therapy in the Treatment of Atrial Fibrillation)-1 (n = 30) and HFIB (Adjunctive Renal Denervation to Modify Hypertension and Sympathetic tone as Upstream Therapy in the Treatment of Atrial Fibrillation)-2 (n = 50) studies, and we performed a meta-analysis including all published studies comparing RSDN+PVI versus PVI alone up to January 25, 2020, in patients with AF and hypertension. Results At 24 months, AF recurrence occurred in 53% and 38% in the PVI and PVI+RSDN groups (p = 0.43) in the HFIB-1 study, respectively, and 27% and 25% in the PVI and PVI+RSDN groups (p = 0.80) in the HFIB-2 study, respectively. When combined in a meta-analysis including 6 studies (n = 725), adjunctive RSDN significantly decreased the risk of AF recurrence (risk ratio [RR]: 0.68; 95% confidence interval [CI]: 0.55 to 0.83; p = 0.0002; I2 = 0%) when compared with PVI. Six renal artery complications occurred in the HFIB-1 study and none occurred in the HFIB-2 study with RSDN. However, in the meta-analysis, there were no significant differences in overall complications between both groups (RR: 1.43; 95% CI: 0.63 to 3.22; p = 0.40; I2 = 7%). When compared with baseline, RDSN significantly reduced the systolic blood pressure (–12.1 mm Hg; 95% CI: –20.9 to –3.3 mm Hg; p Conclusions The pilot HFIB-1 and HFIB-2 studies did not demonstrate a benefit with RSDN as an adjunctive upstream therapy during PVI. However, in the meta-analysis, adjunctive RSDN to PVI appears to be safe, and improves clinical outcomes in AF patients with a history of hypertension.

Infection remains a major complication of cardiac implantable electronic devices and can lead to significant morbidity and mortality. Implantable devices that avoid transvenous leads, such as the subcutaneous implantable cardioverter-defibrillator (S-ICD), can reduce the risk of serious infection-related complications, such as bloodstream infection and infective endocarditis. While the 2017 AHA/ACC/HRS guidelines include recommendations for S-ICD use for patients at high risk of infection, currently, there are no clinical trial data that address best practices for the prevention of S-ICD infections. Therefore, an expert panel was convened to develop a consensus on these topics.An expert process mapping methodology was used to achieve consensus on the appropriate steps to minimize or prevent S-ICD infections. Two face-to-face meetings of high-volume S-ICD implanters and an infectious diseases specialist, with expertise in cardiovascular implantable electronic device infections, were conducted to develop consensus on useful strategies pre-, peri-, and postimplant to reduce S-ICD infection risk.Expert panel consensus on recommended steps for patient preparation, S-ICD implantation, and postoperative management was developed to provide guidance in individual patient management.Achieving expert panel consensus by process mapping methodology for S-ICD infection prevention was attainable, and the results should be helpful to clinicians in adopting interventions to minimize risks of S-ICD infection.

Background Infection is a well‐recognized complication of cardiovascular implantable electronic device (CIED) implantation, including the more recently available subcutaneous implantable cardioverter‐defibrillator (S‐ICD). Although the AHA/ACC/HRS guidelines include recommendations for S‐ICD use, currently there are no clinical trial data that address the diagnosis and management of S‐ICD infections. Therefore, an expert panel was convened to develop consensus on these topics. Methods A process mapping methodology was used to achieve a primary goal – the development of consensus on the diagnosis and management of S‐ICD infections. Two face‐to‐face meetings of panel experts were conducted to recommend useful information to clinicians in individual patient management of S‐ICD infections. Results Panel consensus of a stepwise approach in the diagnosis and management was developed to provide guidance in individual patient management. Conclusion Achieving expert panel consensus by process mapping methodology in S‐ICD infection diagnosis and management was attainable, and the results should be helpful in individual patient management.

Breathometer was the first Shark Tank pitch where all five sharks invested in one deal. This case examines how Charles Yim created a product that tests blood alcohol levels that is connected to an iPhone or Android smartphone. The product was reported to be innovative in its design and functionality. In the early stages of the company, Yim was able to raise over 2 million dollars from Silicon Valley VC’s, Shark Tank, and Indiegogo. Ultimately, the product’s advertising claims were found to be dubious by the Federal Trade Commission, and they were ordered to provide refunds to all customers. The case examines the processes of value proposition development and investor due diligence. In addition, the case explores the issues related to board composition and the value that board members with extensive industry experience bring to the success of the company. Ultimately, the company underwent a major pivot, transforming its product into one that measures bad breath and oral health. The case and instructor materials provide the vehicle for class discussion and analysis of the early-stage venture success and failure and how industry experience is essential to long-term survivability.

ObjectivesTo evaluate an extended hybrid MR/PET imaging strategy in cardiac sarcoidosis (CS) employing qualitative and quantitative assessment of PET tracer uptake, and to evaluate its association with cardiac-related outcomes.BackgroundInvasive endomyocardial biopsy is the gold standard to diagnose CS, but it has poor sensitivity due to the patchy distribution of disease. Imaging with hybrid late gadolinium enhancement (LGE) MR and 18F-fluorodexyglucose (18F-FDG) PET allows simultaneous assessment of myocardial injury and disease activity and has shown promise for improved diagnosis of active CS based on the combined positive imaging outcome, MR(+)PET(+).Methods148 patients with suspected CS were enrolled for hybrid MR/PET imaging. Patients were classified based on presence/absence of LGE (MR+/MR-), presence/absence of 18F-FDG (PET+/PET-), and pattern of 18F-FDG uptake (focal/diffuse) into the following categories: MR(+)PET(+)FOCAL, MR(+)PET(+)DIFFUSE, MR(+)PET(-), MR(-)PET(+)FOCAL, MR(-)PET(+)DIFFUSE, MR(-)PET(-). Patients classified as MR(+)PET(+)FOCAL were designated as having active CS [aCS(+)], while all others were considered as having inactive or absent CS and designated aCS(-). Quantitative values of standard uptake value (SUVmax), target-to-background ratio (TBRmax), target-to-normal-myocardium ratio (TNMRmax) and T2 were measured. Occurrence of a cardiac-related clinical outcome was defined as any of the following during the 6-month period after imaging: cardiac arrest, ventricular arrhythmia, complete heart block, need for cardiac resynchronization/defibrillator/pacemaker/monitoring device (CRT-D, ICD/WCD, or ILR). MR/PET imaging results were compared to the presence of the composite clinical outcome.ResultsPatients designated aCS(+) had more than 4-fold increased odds of meeting the clinical endpoint compared to aCS(-) (unadjusted odds ratio 4.8; 95% CI 2.0-11.4; pConclusionsHybrid MR/PET imaging with an extended image-based classification of CS was statistically associated with clinical outcomes in CS. TNMRmax had high sensitivity and excellent specificity for quantifying the imaging-based classification of active CS.Condensed AbstractImaging with hybrid late gadolinium enhancement (LGE) MR and 18F-fluorodexyglucose (18F-FDG) PET allows simultaneous assessment of myocardial injury and disease activity and has shown promise for improved diagnosis of active cardiac sarcoidosis (CS). In this study, 148 patients with suspected CS were enrolled for hybrid MR/PET imaging. Patients were classified based on presence/absence of LGE (MR+/MR-), presence/absence of 18F-FDG (PET+/PET-), and pattern of 18F-FDG uptake (focal/diffuse). Patients classified as MR(+)PET(+)FOCAL were designated as having active CS and, compared to patients with any other imaging pattern, they had more than 4-fold increased odds of cardiac-related outcome at 6 months from imaging.

Transvenous implantable cardioverter-defibrillators (TV-ICD) infection is a serious complication that frequently requires complete device removal for attempted cure, which can be associated with patient morbidity and mortality. The objective of this study is to assess mortality risk associated with TV-ICD infection in a large Medicare population with de novo TV-ICD implants.A survival analysis was conducted using 100% fee-for-service Medicare facility-level claims data to identify patients who underwent de novo TV-ICD implantation between 7/2016 and 1/2018. TV-ICD infection within 2 years of implantation was identified using International Classification of Disease, 10th Edition and current procedural terminology codes. Baseline patient risk factors associated with mortality were identified using the Charlson Comorbidity Index categories. Infection was treated as a time-dependent variable in a multivariate Cox proportional hazards model to account for immortal time bias.Among 26,742 Medicare patients with de novo TV-ICD, 518 (1.9%) had a device-related infection. The overall number of decedents was 4721 (17.7%) over 2 years, with 4555 (17%) in the noninfection group and 166 (32%) in the infection group. After adjusting for baseline patient demographic characteristics and various comorbidities, the presence of TV-ICD infection was associated with an increase of 2.4 (95% CI: 2.08-2.85) times in the mortality hazard ratio.The rate of TV-ICD infection and associated mortality in a large, real-world Medicare population is noteworthy. The positive association between device-related infection and risk of mortality further highlights the need to reduce infections.

The Emirates Exploration Imager (EXI) on-board the Emirates Mars Mission (EMM) offers both regional and global imaging capabilities for studies of the Martian atmosphere. EXI is a framing camera with a field-of-view (FOV) that will easily capture the martian disk at the EMM science orbit periapsis. EXI provides 6 bandpasses nominally centered on 220, 260, 320, 437, 546, 635 nm using two telescopes (ultraviolet (UV) and visible(VIS)) with separate optics and detectors. Images of the full-disk are acquired with a resolution of 2–4 km per pixel, where the variation is driven by periapsis and apoapsis points of the orbit, respectively. By combining multiple observations within an orbit with planetary rotation, EXI is able to provide diurnal sampling over most of the planet on the scale of 10 days. As a result, the EXI dataset allows for the delineation of diurnal and seasonal timescales in the behavior of atmospheric constituents such as water ice clouds and ozone.This combination of temporal and spatial distinguishes EXI from somewhat similar imaging systems, including the Mars Color Imager (MARCI) onboard the Mars Reconnaissance Orbiter (MRO) (Malin et al. in Icarus 194(2):501–512, 2008) and the various cameras on-board the Hubble Space Telescope (HST; e.g., James et al. in J. Geophys. Res. 101(E8):18,883–18,890, 1996; Wolff et al. in J. Geophys. Res. 104(E4):9027–9042, 1999). The former, which has comparable spatial and spectral coverage, possesses a limited local time view (e.g., mid-afternoon). The latter, which provides full-disk imaging, has limited spatial resolution through most of the Martian year and is only able to provide (at most) a few observations per year given its role as a dedicated, queue-based astrophysical observatory. In addition to these unique attributes of the EXI observations, the similarities with other missions allows for the leveraging of both past and concurrent observations. For example, with MARCI, one can build on the ∼6 Mars years of daily global UV images as well as those taken concurrently with EXI.