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In a randomized trial involving patients with paroxysmal atrial fibrillation, pulsed field ablation was noninferior to thermal ablation with respect to freedom from a composite of procedural and arrhythmia events at 1 year.

Development of regenerative therapeutic strategies to reverse the progression of advanced heart failure is one of the most urgent clinical needs of this century. Insights gained from clinical trials of adult stem cells, together with fundamental scientific advances in cardiac stem cell and regenerative biology, are beginning to yield potential new targets and strategies for regenerative therapies. Of particular importance are new scientific discoveries related to intrinsic cardiac regeneration, renewal factors that can trigger regeneration, and tissue-engineering technology, which are beginning to change the way investigators view the scientific and clinical position of cardiovascular regenerative therapy.

Mitochondrial membrane potential (ΔΨm) arises from normal function of the electron transport chain. Maintenance of ΔΨm within a narrow range is essential for mitochondrial function. Methods for in vivo measurement of ΔΨm do not exist. We use 18F-labeled tetraphenylphosphonium (18F-TPP+) to measure and map the total membrane potential, ΔΨT, as the sum of ΔΨm and cellular (ΔΨc) electrical potentials. Eight pigs, five controls and three with a scar-like injury, were studied. Pigs were studied with a dynamic PET scanning protocol to measure 18F-TPP+ volume of distribution, VT. Fractional extracellular space (fECS) was measured in 3 pigs. We derived equations expressing ΔΨT as a function of VT and the volume-fractions of mitochondria and fECS. Seventeen segment polar maps and parametric images of ΔΨT were calculated in millivolts (mV). In controls, mean segmental ΔΨT = -129.4±1.4 mV (SEM). In pigs with segmental tissue injury, ΔΨT was clearly separated from control segments but variable, in the range -100 to 0 mV. The quality of ΔΨT maps was excellent, with low noise and good resolution. Measurements of ΔΨT in the left ventricle of pigs agree with previous in in-vitro measurements. We have analyzed the factors affecting the uptake of voltage sensing tracers and developed a minimally invasive method for mapping ΔΨT in left ventricular myocardium of pigs. ΔΨT is computed in absolute units, allowing for visual and statistical comparison of individual values with normative data. These studies demonstrate the first in vivo application of quantitative mapping of total tissue membrane potential, ΔΨT.

Contemporary cardiac and heart rate monitoring devices capture physiological signals using optical and electrode-based sensors. However, these devices generally lack the form factor and mechanical flexibility necessary for use in ambulatory and home environments. Here, we report an ultrathin (~1 mm average thickness) and highly flexible wearable cardiac sensor (WiSP) designed to be minimal in cost (disposable), light weight (1.2 g), water resistant, and capable of wireless energy harvesting. Theoretical analyses of system-level bending mechanics show the advantages of WiSP’s flexible electronics, soft encapsulation layers and bioadhesives, enabling intimate skin coupling. A clinical feasibility study conducted in atrial fibrillation patients demonstrates that the WiSP device effectively measures cardiac signals matching the Holter monitor, and is more comfortable. WiSP’s physical attributes and performance results demonstrate its utility for monitoring cardiac signals during daily activity, exertion and sleep, with implications for home-based care.Wearable electronics: digital fingers on the pulseA highly flexible, low-power wearable sensor that harvests energy and monitors cardiac signals has been developed by Lee et al. The team was led by Dr. Roozbeh Ghaffari and co-workers at MC10 Inc. and Northwestern University’s Center for Bio-Integrated Electronics at the Simpson & Querrey Institute, in collaboration with the Massachusetts General Hospital and Tsinghua University. The novel wearable sensors measure cardiac signals comparable in signal fidelity to those achievable with expensive monitoring systems used in hospitals. Wearable health-care solutions are fundamentally changing the way we monitor our well-being at all times of the day, no matter whether we are asleep at home or busy at work. The sensors reported here are lightweight, inexpensive to manufacture, robust to everyday use, and capable of wireless data transmission and energy harvesting to and from a smartphone. The approach proved successful for measuring episodic electrocardiograms (ECG) and continuous heart rate signals with significantly higher patient comfort scores compared to standard Holter monitors in an initial pilot study conducted at the Massachusetts General Hospital (MGH).

For patients with symptomatic atrial fibrillation (AF), physicians typically offer AF ablation for symptom relief; however, patients often anticipate/expect a life free from anticoagulation. This belief puts patients at increased risk of stroke due to the potential for asymptomatic AF postablation if anticoagulation is ceased contrary to clinical guidelines. Although the WATCHMAN device has been FDA-approved to decrease the risk of thromboembolism from the left atrial appendage (LAA) in patients with an appropriate rationale to avoid oral anticoagulation, it has not been well-studied following AF ablation. Additionally, there are limited data comparing the WATCHMAN device to direct oral anticoagulants. The OPTION study will investigate whether LAA closure with the WATCHMAN FLX device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for nonvalvular AF. OPTION is a multinational, multicenter, prospective randomized clinical trial. Patients with a CHA2DS2-VASc of ≥2 in men or ≥3 in women and who underwent a AF catheter ablation procedure between 90 and 180 days prior to randomization (sequential) or are planning to have catheter ablation within 10 days of randomization (concomitant) will be randomized in a 1:1 allocation of WATCHMAN FLX vs control. Control patients will start or continue market-approved oral anticoagulation for the duration of the trial. A total of 1600 patients were randomized from 130 global investigational sites. Follow-up for both device and control patients will occur at 3, 12, 24, and 36 months. The primary effectiveness noninferiority endpoint is stroke (ischemic or hemorrhagic), all-cause death, or systemic embolism at 36 months. The primary safety superiority endpoint is nonprocedural bleeding through 36 months (International Society on Thrombosis and Haemostasis [ISTH] major bleeding or clinically relevant nonmajor bleeding). The secondary noninferiority endpoint is ISTH major bleeding through 36 months (including procedural bleeding). This trial will assess the safety and efficacy of WATCHMAN FLX in a postablation contemporary clinical AF patient population at risk of stroke.

Catheter ablation and antiarrhythmic drugs (AADs) are the most common rhythm-control strategies for atrial fibrillation (AF). Data comparing the rate of stroke and cardiovascular events between the treatment strategies are limited. Therefore, this observational study uses claims data to compare rate of cardiovascular hospitalization and stroke for patients with AF treated with ablation or AADs. Patients in the MarketScan dataset with AF between January 2010 and December 2014 were categorized in the ablation group if an atrial catheter ablation was performed, or in the AAD group if a relevant AAD was prescribed for AF but no ablation was performed. One year of history was required, and the index event was selected as the most recent ablation or AAD prescription closest to January 1, 2013. A 2:1 propensity score match was performed for age, gender, co-morbidities, and total medical cost in the year before index event. Outcomes included thromboembolic event (ischemic stroke, transient ischemic attack, or systemic embolism) and all cardiovascular hospitalizations. Of the 164,639 patients in the AAD group, 29,456 were matched to the 14,728 ablation patients. There were no significant differences in age (64 ± 10 in both groups), gender (58% male), or CHA2DS2-VASc score (3.2 ± 1.3). Risk of hospitalization with primary diagnosis of thromboembolic event was 41% greater in the AADs group (p < 0.001), and cardiovascular hospitalizations were 13% more likely (p < 0.001). In conclusion, patients treated with catheter ablation of AF have lower risk of thromboembolic events and cardiovascular hospitalizations than a matched cohort of patients managed with AADs.

Atrial fibrillation (AFib) is the most common form of heart arrhythmia and a potent risk factor for stroke. Nonvitamin K antagonist oral anticoagulants (NOACs) are routinely prescribed to manage AFib stroke risk; however, nonadherence to treatment is a concern. Additional tools that support self-care and medication adherence may benefit patients with AFib. The aim of this study was to evaluate the perceived usability and usefulness of a mobile app designed to support self-care and treatment adherence for AFib patients who are prescribed NOACs. A mobile app to support AFib patients was previously developed based on early stage interview and usability test data from clinicians and patients. An exploratory pilot study consisting of naturalistic app use, surveys, and semistructured interviews was then conducted to examine patients' perceptions and everyday use of the app. A total of 12 individuals with an existing diagnosis of nonvalvular AFib completed the 4-week study. The average age of participants was 59 years. All participants somewhat or strongly agreed that the app was easy to use, and 92% (11/12) reported being satisfied or very satisfied with the app. Participant feedback identified changes that may improve app usability and usefulness for patients with AFib. Areas of usability improvement were organized by three themes: app navigation, clarity of app instructions and design intent, and software bugs. Perceptions of app usefulness were grouped by three key variables: core needs of the patient segment, patient workflow while managing AFib, and the app's ability to support the patient's evolving needs. The results of this study suggest that mobile tools that target self-care and treatment adherence may be helpful to AFib patients, particularly those who are newly diagnosed. Additionally, participant feedback provided insight into the varied needs and health experiences of AFib patients, which may improve the design and targeting of the intervention. Pilot studies that qualitatively examine patient perceptions of usability and usefulness are a valuable and often underutilized method for assessing the real-world acceptability of an intervention. Additional research evaluating the AFib Connect mobile app over a longer period, and including a larger, more diverse sample of AFib patients, will be helpful for understanding whether the app is perceived more broadly to be useful and effective in supporting patient self-care and medication adherence.

Percutaneous left atrial appendage (LAA) closure (LAAC) was developed as a nonpharmacologic alternative to oral anticoagulants (OACs) in patients with atrial fibrillation (AF) who are at an increased risk for stroke or systemic embolism. The Watchman device permanently seals off the LAA to prevent thrombi from escaping into the circulation. Previous randomized trials have established the safety and efficacy of LAAC compared to warfarin. However, direct OACs (DOACs) have become the preferred pharmacologic strategy for stroke prevention in patients with AF, and there is limited data comparing Watchman FLX to DOACs in a broad AF patient population. CHAMPION-AF is designed to prospectively determine whether LAAC with Watchman FLX is a reasonable first-line alternative to DOACs in patients with AF who are indicated for OAC therapy. A total of 3,000 patients with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women) were randomized to Watchman FLX or DOAC in a 1:1 allocation at 142 global clinical sites. Patients in the device arm were to be treated with DOAC and aspirin, DOAC alone, or DAPT for at least 3 months postimplant followed by aspirin or P2Y12 inhibitor for 1-year. Control patients were required to take an approved DOAC for the duration of the trial. Clinical follow-up visits are scheduled at 3- and 12-months, and then annually through 5 years; LAA imaging is required at 4 months in the device group. Two primary end points will be evaluated at 3 years: (1) composite of stroke (ischemic/hemorrhagic), cardiovascular death, and systemic embolism compared for noninferiority, and (2) nonprocedural bleeding (International Society on Thrombosis and Haemostasis [ISTH] major and clinically relevant nonmajor bleeding) tested for superiority in the device arm against DOACs. The third primary noninferiority end point is the composite of ischemic stroke and systemic embolism at 5 years. Secondary end points include 3- and 5-year rates of (1) ISTH-defined major bleeding and (2) the composite of cardiovascular death, all stroke, systemic embolism, and nonprocedural ISTH bleeding. This study will prospectively evaluate whether LAAC with the Watchman FLX device is a reasonable alternative to DOACs in patients with AF. NCT04394546

Left atrial appendage closure (LAAC) is an important strategy to reduce stroke risk in patients with non-valvular atrial fibrillation (AF) who are at high risk of bleeding on long-term anticoagulation. Real-world assessments of the safety of the Watchman LAAC device remain limited. The objective of this study was to determine the frequency and timing of adverse events associated with Watchman LAAC device implants performed after FDA approval. Adverse events associated with Watchman LAAC implants performed between March 2015 and March 2019 were identified through a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. During the study period, 3,652 unique adverse events were identified. An estimated 43,802 Watchman implants were performed in the United States during the study period. The overall adverse event rate was 7.3% and the mortality rate was 0.4%. Of the 159 unique types of adverse events identified, pericardial effusion was most common (1.4%). Most adverse events (73%) occurred intraoperatively (59%) or within 1 day of the procedure (15%). However, 19% of deaths, 24% of strokes and 27% of device embolizations occurred >1 month after implantation. The rates of most Watchman-related adverse events reported in the MAUDE database were comparable to those observed in clinical trials. A majority of adverse events occurred within 1 day of implant. In conclusion, while the absolute event rates were low, a significant proportion of device embolizations, strokes, and deaths occurred >1 month after Watchman implant.

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for surgical high-risk patients with severe aortic stenosis. The aim of this study was to determine the impact of atrial fibrillation (AF) on procedural outcomes. Data from 137 patients who underwent TAVR using Edwards SAPIEN valve were reviewed. The predictors of new-onset atrial fibrillation (NOAF) after the procedure were analyzed. In addition, the post-TAVR clinical outcomes and adverse events were compared according to the presence and absence of preprocedural and postprocedural AF. Previous AF was present in 49% of the patients who underwent TAVR. After the procedure, NOAF was detected in 21% of patients, and the cumulative incidence of post-TAVR AF was 60%. After TAVR, 50% of all the episodes of NOAF occurred in the initial 24 hours after the procedure. Transapical approach was observed to an important predictor of NOAF (adjusted odds ratio [OR] 5.05, 95% confidence interval [CI] 1.40 to 18.20, p = 0.013). The composite outcome of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after TAVR was significantly higher in patients with previous AF (33 of 67 vs 19 of 70, adjusted OR 2.60, 95% CI 1.22 to 5.54, p = 0.013) compared with patients who did not have previous AF. The presence of post-TAVR AF led to a prolongation in the duration of intensive care unit stay by an average of 70 hours (95% CI 25 to 114.7 hours, p = 0.002). Similarly, post-TAVR AF also led to the prolongation in the hospital stay by an average of 6.7 days (95% CI 4.69 to 8.73 days, p <0.0005). In conclusion, our study demonstrates that the presence of AF before TAVR is an important predictor of the composite end point of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after the procedure. AF after TAVR is more likely to be encountered with the transapical approach and is associated with a prolongation of intensive care unit and hospital stay.