Community Partnership to Co-Develop an Intervention to Promote Equitable Uptake of the COVID-19 Vaccine Among Pediatric Populations.

Objective: To describe the process of engaging community, caregiver, and youth partners in codeveloping an intervention to promote equitable uptake of the COVID-19 vaccine in non-Hispanic Black (Black) and Hispanic youth who experience higher rates of COVID-19 transmission, morbidity, and mortality but were less likely to receive the COVID-19 vaccine. Methods: A team of 11 Black and Hispanic community partners was assembled to codevelop intervention strategies with our interdisciplinary research team. We used a mixed-methods crowdsourcing approach with Black and Hispanic youth (n=15) and caregivers of Black and Hispanic youth (n=20) who had not yet been vaccinated against COVID-19, recruited from primary care clinics, to elicit perspectives on the acceptability of these intervention strategies. Results: We codeveloped five strategies: (1) community-tailored handouts and posters, (2) videos featuring local youth, (3) family-centered language to offer vaccines in the primary care clinic, (4) communication-skills training for primary care providers, and (5) use of community health workers to counsel families about the vaccine. The majority (56-96.9%) of youth and caregivers rated each of these strategies as acceptable, especially because they addressed common concerns and facilitated shared decision-making. Conclusions: Engaging community and family partners led to the co-development of culturally- and locally-tailored strategies to promote dialogue and shared decision-making about the COVID-19 vaccine. This process can be used to codevelop interventions to address other forms of public health disparities. Policy Implications: Intervention strategies that promote dialogues with trusted healthcare providers and support shared decision-making are acceptable strategies to promote COVID-19 vaccine uptake among youth from historically underserved communities. Stakeholder-engaged methods may also help in the development of interventions to address other forms of health disparities.

User-Centered Development of HEARTPrep, a Digital Health Psychosocial Intervention for Prenatally Diagnosed Congenital Heart Disease.

User-centered models for the development of digital health interventions are not consistently applied in healthcare settings. This study used a five-phase, user-centered approach to develop HEARTPrep©, a psychosocial intervention delivered via mobile app and telehealth to mothers expecting a baby with congenital heart disease (CHD) to promote maternal, family, and child well-being. Phases of intervention development were: (I) establishing partnerships; (II) creating content; (III) developing prototype and testable intervention; (IV) conducting think-aloud testing; and (V) completing beta testing. Partnerships with parents, clinicians, and design/technology experts were integral throughout the development of HEARTPrep©. Parents of children with CHD also served as participants in Phases II-V, contributing to the creation of content and providing feedback to inform the iterative refinement of HEARTPrep©. These five phases produced a refined digital health intervention with promising feasibility, usability, and acceptability results. This user-centered approach can be used to develop digital health interventions targeting various health outcomes.

Identification of cavotricuspid isthmus voltage patterns in typical atrial flutter ablation.

Background: Electroanatomical mapping is an essential tool in the ablation of typical AFL. Objectives: To identify the existence of voltage patterns in the CTI voltage maps and their relevance for typical AFL ablation. Methods: A voltage map of the CTI was made prior to ablation, identifying the areas of maximum voltage and their location along the CTI, allowing classification into patterns according to their distribution. A stepwise ablation approach targeting the areas of maximum voltage was conducted. The ablation characteristics were compared based on the pattern obtained. Results: Two voltage patterns were identified, with differences in ablation time to bidirectional CTI block. No complications occurred. Conclusions: Voltage mapping identifies patterns in the CTI with implications for typical AFL ablation.

Virtually Delivered Psychosocial Intervention for Prenatally Diagnosed Congenital Heart Disease: Feasibility and Acceptability of HEARTPrep.

Prenatal diagnosis of congenital heart disease (CHD) often leads to anxiety, depression, and traumatic stress in expectant mothers, with long-term implications for the child and family. However, psychosocial intervention is rarely incorporated into prenatal care. HEARTPrep is a virtually delivered psychosocial intervention aimed at reducing distress and social isolation and increasing parenting self-efficacy and hope for mothers expecting a baby with CHD to promote long-term child/family well-being. This study evaluated the feasibility and acceptability of HEARTPrep. Participants were mothers receiving cardiology care for a fetal CHD diagnosis. Partners could participate with the mother. HEARTPrep was delivered through a mobile app and telehealth. Feasibility was assessed through enrollment/retention rates. Acceptability was assessed through 20 Likert-scale and five open-ended questions. Of 39 recruited mothers, 35 (90%) enrolled. Half of partners (48%) also participated. Twenty-seven of 35 enrolled mothers (77%) completed HEARTPrep. On a scale from 0 (Not at All) to 4 (Very), mean item acceptability scores ranged from 3.5 to 3.9. Mothers reported HEARTPrep helped them feel less distressed (mean: 3.74), less alone (3.84), more prepared (3.89), and more hopeful (3.84). Opportunities to process emotions, develop coping skills, learn with their partner, navigate relationships, understand they are not alone, connect with peer support, access resources, and prepare for stressors were described as helpful. HEARTPrep is feasible and acceptable for mothers expecting a baby with CHD. Future research will evaluate its efficacy in preventing/reducing maternal mental health problems and improving postnatal clinical outcomes.

Impact of COVID-19 Campus Closure on Undergraduates.

Background: The COVID-19 pandemic resulted in an abrupt transition from in-person to online learning in Spring 2020. Objective: The purpose of this study was to identify the impact of the transition on undergraduates during the period following the campus closure. Method: 131 psychology undergraduate students completed an online survey of how the COVID-19 closure had impacted their academics, online learning environment, and traumatic stress symptoms (using the Posttraumatic Stress Disorder Checklist for the DSM-5). Results: Most participants reported increased academic difficulty compared to before closure. Approximately 30% reported elevated traumatic stress symptoms. Greater traumatic stress was associated with greater difficulty completing assignments, more limited access to the internet and quiet places to study, and greater sibling-care responsibilities. Conclusions: The acute transition to online instruction posed academic and emotional challenges to many students, especially those from environments with competing demands or less access to academic supports. Follow-up evaluation is needed to determine whether these difficulties have persisted in subsequent semesters of online instruction. Teaching Implication: Instructors should anticipate the emotional and academic needs of students who are relatively unfamiliar with online instruction and consider ways to minimize negative environmental impacts and increase access to mental health resources.

Repeat cryoablation as a redo procedure for atrial fibrillation ablation: Is it a good choice?

BACKGROUND: Ablation of atrial fibrillation (AF), both cryoablation ablation (CBA) and radiofrequency catheter ablation (RFCA), have demonstrated to be safe and effective. About 1 in 3 patients may face a redo due to recurrence and the best technique is unknown. The aim of this study is to assess the efficacy of CBA as a repeat procedure in patients with prior CBA or RFCA. METHODS: A nation-wide CBA registry (RECABA) was analyzed and patients were compared who had previously undergone CBA (Prior-CB) or RFCA (Prior-RF). The primary endpoint was AF recurrence at 12 months after a 3-month blanking period. A survival analysis was performed, univariate and multivariate Cox models were also built. RESULTS: Seventy-four patients were included. Thirty-three (44.6%) were in the Prior-CB group and 41 (55.4%) in the Prior-RF. There were more reconnected pulmonary veins in the Prior-RF than in Prior-CB group (40.4% vs.16.5%, p = 0.0001). The 12-month Kaplan-Meier estimate of freedom from AF recurrence after the blanking period was 61.0% (95% confidence interval [CI] 41.4-75.8%) in the Prior-CB, and 89.2% (95% CI 73.6-95.9%) in the Prior-RF group (p = 0.002). Multivariate Cox regression pointed Prior-CB as the sole independent predictor of AF recurrence, with an adjusted HR of 2.67 (95% CI 1.05-6.79). CONCLUSIONS: Repeat CBA shows higher rates of AF recurrences compared to CBA after a previous RFCA despite presenting less reconnected veins at the procedure. These data suggest that patients with AF recurrence after CBA may benefit from other ablation techniques after a recurrence. RECABA is registered at clinicaltrials.gov with the Unique Identifier NCT02785991.

Cardiac magnetic resonance outperforms echocardiography to predict subsequent implantable cardioverter defibrillator therapies in ST-segment elevation myocardial infarction patients.

Background: Implantable cardioverter defibrillators (ICD) are effective as a primary prevention measure of ventricular tachyarrhythmias in patients with ST-segment elevation myocardial infarction (STEMI) and depressed left ventricular ejection fraction (LVEF). The implications of using cardiac magnetic resonance (CMR) instead of echocardiography (Echo) to assess LVEF prior to the indication of ICD in this setting are unknown. Materials and methods: We evaluated 52 STEMI patients (56.6 ± 11 years, 88.5% male) treated with ICD in primary prevention who underwent echocardiography and CMR prior to ICD implantation. ICD implantation was indicated based on the presence of heart failure and depressed LVEF (≤ 35%) by echocardiography, CMR, or both. Prediction of ICD therapies (ICD-T) during follow-up by echocardiography and CMR before ICD implantation was assessed. Results: Compared to echocardiography, LVEF was lower by cardiac CMR (30.2 ± 9% vs. 37.4 ± 7.6%, p < 0.001). LVEF ≤ 35% was detected in 24 patients (46.2%) by Echo and in 42 (80.7%) by CMR. During a mean follow-up of 6.1 ± 4.2 years, 10 patients received appropriate ICD-T (3.16 ICD-T per 100 person-years): 5 direct shocks to treat very fast ventricular tachycardia or ventricular fibrillation, 3 effective antitachycardia pacing (ATP) for treatment of ventricular tachycardia, and 2 ineffective ATP followed by shock to treat ventricular tachycardia. Echo-LVEF ≤ 35% correctly predicted ICD-T in 4/10 (40%) patients and CMR-LVEF ≤ 35% in 10/10 (100%) patients. CMR-LVEF improved on Echo-LVEF for predicting ICD-T (area under the curve: 0.76 vs. 0.48, p = 0.04). Conclusion: In STEMI patients treated with ICD, assessment of LVEF by CMR outperforms Echo-LVEF to predict the subsequent use of appropriate ICD therapies.

Time to -30°C as a predictor of acute success during cryoablation in patients with atrial fibrillation.

BACKGROUND: Freezing rate of second-generation cryoballoon (CB) is a biophysical parameter that could assist pulmonary vein isolation. The aim of this study is to assess freezing rate (time to reach -30°C ([TT-30C]) as an early predictor of acute pulmonary vein isolation using the CB. METHODS: Biophysical data from CB freeze applications within a multicenter, nation-wide CB ablation registry were gathered. Successful application (SA), was defined as achieving durable intraprocedural vein isolation. And SA with time to isolation under 60 s (SA-TTI<60) as achieving durable vein isolation in under 60 s. Logistic regressions were performed and predictive models were built for the data set. RESULTS: 12,488 CB applications from 1,733 atrial fibrillation (AF) ablation procedures were included within 27 centers from a Spanish CB AF ablation registry. SA was achieved in 6,349 of 9,178 (69.2%) total freeze applications, and SA-TTI<60 was obtained in 2,673 of 4,784 (55.9%) freezes where electrogram monitoring was present. TT-30C was shorter in the SA group (33.4 ± 9.2 vs 39.3 ± 12.1 s; p < 0.001) and SA-TTI<60 group (31.8 ± 7.6 vs. 38.5 ± 11.5 s; p < 0.001). Also, a 10 s increase in TT-30C was associated with a 41% reduction in the odds for an SA (odds ratio [OR] 0.59; 95% confidence interval [CI] 0.56-0.63) and a 57% reduction in the odds for achieving SA-TTI<60 (OR 0.43; 95% CI 0.39-0.49), when corrected for electrogram visualization, vein position, and application order. CONCLUSIONS: Time to reach -30°C is an early predictor of the quality of a CB application and can be used to guide the ablation procedure even in the absence of electrogram monitoring.

Acceptability and Feasibility of eSCCIP: Results From a Pilot Study of the Electronic Surviving Cancer Competently Intervention Program.

BACKGROUND: Providing high-quality psychosocial care to parents and other primary caregivers of children with cancer (henceforth referred to as caregivers) is important, given the numerous challenges associated with a pediatric cancer diagnosis and the increased risk for negative psychosocial sequelae among caregivers. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is a psychosocial eHealth intervention for caregivers, developed using an iterative, user-centered process. METHOD: eSCCIP was tested in a single-arm pilot trial at Nemours Children's Hospital, Delaware (NCT05333601). The primary outcomes were intervention acceptability and feasibility, assessed via enrollment and retention targets, and item-level acceptability ratings. Enrollment and retention targets of 45% were set based on previous work, and an item-level acceptability threshold of 80% was set. A secondary exploratory analysis was conducted examining acute distress, anxiety, symptoms of post-traumatic stress, and family functioning. RESULTS: 44 caregivers enrolled in the study and 31 completed. The intervention was rated favorably by completers, with over 80% of the sample selecting "mostly true" or "very true" for all items of the eSCCIP Evaluation Questionnaire, which was used to assess acceptability and feasibility. Enrollment and retention rates were 54% and 70%, respectively. Exploratory psychosocial outcomes showed statistically significant decreases from pre-intervention to post-intervention for overall symptoms of post-traumatic stress disorder (PTSD), cluster D symptoms of PTSD (negative mood and cognitions), and anxiety. Small-moderate effect sizes were observed for all psychosocial outcomes of interest. CONCLUSIONS: eSCCIP is an acceptable and feasible intervention for caregivers. Results are promising regarding reductions in symptoms of post-traumatic stress and anxiety.

Cryoballoon Ablation for Persistent and Paroxysmal Atrial Fibrillation: Procedural Differences and Results from the Spanish Registry (RECABA).

Introduction: Cryoballoon ablation (CBA) has become a standard treatment for paroxysmal atrial fibrillation (PaAF) but limited data is available for outcomes in patients with persistent atrial fibrillation (PeAF). Methods: We analyzed the first 944 patients included in the Spanish Prospective Multi-center Observation Post-market Registry to compare characteristics and outcomes of patients undergoing CBA for PeAF versus PaAF. Results: A total of 944 patients (57.8 ± 10.4 years; 70.1% male) with AF (27.9% persistent) were prospectively included from 25 centers. PeAF patients were more likely to have structural heart disease (67.7 vs. 11.4%; p < 0.001) and left atrium dilation (72.6 vs. 43.3%; p < 0.001). CBA of PeAF was less likely to be performed under general anesthesia (10.7 vs. 22.2%; p < 0.001), with an arterial line (32.2 vs. 44.6%; p < 0.001) and assisted transeptal puncture (11.9 vs. 17.9%; p = 0.025). During an application, PeAF patients had a longer time to −30 °C (35.91 ± 14.20 vs. 34.93 ± 12.87 s; p = 0.021) and a colder balloon nadir temperature during vein isolation (−35.04 ± 9.58 vs. −33.61 ± 10.32 °C; p = 0.004), but received fewer bonus freeze applications (30.7 vs. 41.1%; p < 0.001). There were no differences in acute pulmonary vein isolation and procedure-related complications. Overall, 76.7% of patients were free from AF recurrences at 15-month follow-up (78.9% in PaAF vs. 70.9% in PeAF; p = 0.09). Conclusions: Patients with PeAF have a more diseased substrate, and CBA procedures performed in such patients were more simplified, although longer/colder freeze applications were often applied. The acute efficacy/safety profile of CBA was similar between PaAF and PeAF patients, but long-term results were better in PaAF patients.

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study.

Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.ClinicalTrials.gov number: NCT02785991.

Transient narrowing of a wide QRS tachycardia. What is the mechanism?

Electrocardiogram showing a regular wide QRS tachycardia with left branch block (LBBB) like in morphology at 200 beats per minute (bpm). During electrophysiology study, it suddenly gets narrow and faster. What is the mechanism of the switch from a broad complex to a narrow complex tachycardia?

Author Correction: A computationally designed chimeric antigen receptor provides a small-molecule safety switch for T-cell therapy.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

A computationally designed chimeric antigen receptor provides a small-molecule safety switch for T-cell therapy.

Approaches to increase the activity of chimeric antigen receptor (CAR)-T cells against solid tumors may also increase the risk of toxicity and other side effects. To improve the safety of CAR-T-cell therapy, we computationally designed a chemically disruptable heterodimer (CDH) based on the binding of two human proteins. The CDH self-assembles, can be disrupted by a small-molecule drug and has a high-affinity protein interface with minimal amino acid deviation from wild-type human proteins. We incorporated the CDH into a synthetic heterodimeric CAR, called STOP-CAR, that has an antigen-recognition chain and a CD3ζ- and CD28-containing endodomain signaling chain. We tested STOP-CAR-T cells specific for two antigens in vitro and in vivo and found similar antitumor activity compared to second-generation (2G) CAR-T cells. Timed administration of the small-molecule drug dynamically inactivated the activity of STOP-CAR-T cells. Our work highlights the potential for structure-based design to add controllable elements to synthetic cellular therapies.

Diagnosis-to-ablation time in atrial fibrillation: A modifiable factor relevant to clinical outcome.

INTRODUCTION: Recurrences after atrial fibrillation (AF) ablation are still common. Among the reported clinical and imaging predictors of recurrences, diagnosis-to-ablation time (DAT) has been defined as a predictor of ablation outcome in single-center studies. We aimed to validate DAT in a multicenter real-life cohort. METHODS: This was a multicenter study including consecutive patients undergoing first paroxysmal and persistent AF ablation with radiofrequency or cryoballoon catheters during 2013. Cox proportional hazard regression models were performed to identify predictors of recurrence. RESULTS: In total, 309 patients were included across nine centers (71% men, 57 ± 10 years old, 46% with hypertension, and 66% with CHA2 DS2 -VASc ≤ 1). Most patients had paroxysmal AF (67%) and underwent radiofrequency ablation (68%) with a median DAT of 51 (43) months. Patients with DAT ≤ 1 year (16.6%) were less likely to have repeat procedures (4% vs 18%; P = .017). The adjusted proportional hazards Cox model identified hypertension (P = .005), heart failure (P = .011), nonparoxysmal AF (P = .038), DAT > 1 year (P = .007), and LA diameter (P = .026) as independent predictors for AF recurrence. DAT > 1 year was the only modifiable factor independently associated with recurrence (HR 4.2 [95% CI, 1.5-11.9]) CONCLUSION: Diagnosis-to-ablation time is a modifiable factor independently associated with recurrent arrhythmia and repeat ablation after first AF ablation. An early intervention strategy during the first year from AF diagnosis might improve outcomes.

Differences in scar lesion formation between radiofrequency and cryoballoon in atrial fibrillation ablation: a comparison study using ultra-high-density mapping.

AIMS: Atrial fibrillation (AF) recurrence after pulmonary vein isolation (PVI) is usually associated to conduction gaps in pulmonary veins (PVs). Our objective was to characterize gaps in patients with recurrences after a first radiofrequency (RF) or cryoballoon (CB) PVI procedure, using a high-density mapping (HDM) system. METHODS AND RESULTS: Fifty patients with AF recurrence after a first PVI procedure (pre-RF 25 patients; pre-CB 25 patients) were included at two centres. Activation map (AM) and voltage map (VM) of the left atrium and PVs were built using the HDM Rhythmia® system. Superior PVs were reconnected more frequently in both groups. Right PVs were reconnected more frequently in pre-RF patients. Pre-RF patients had more reconnected veins than pre-CB patients (mean ± standard deviation: 3.00 ± 0.96 vs. 1.88 ± 1.13; P < 0.001) and more gaps (4.84 ± 2.06 vs. 2.16 ± 1.49; P < 0.001). Gaps in the VM were wider in pre-CB patients (16.5 ± 9.5 mm vs. 12.1 ± 4.8 mm; P = 0.006). There was a gap in 179 of the 800 PV segments analysed (22%); 52% were identified in both AM and VM maps; 39% only in the AM and 8% only in the VM. The highest sensitivity and specificity for gap detection was obtained with VM in pre-CB patients and with AM in pre-RF patients. CONCLUSION: In conclusion, HDM seems to be a useful and precise tool to detect conduction gaps after a first PVI procedure. The anatomical pattern and location of gaps depends on the technique used previously, usually being multiple, smaller, and better detected by AM after RF, and fewer, wider, and better detected by VM after CB.

Left atrial geometry and outcome of atrial fibrillation ablation: results from the multicentre LAGO-AF study.

Aims: Left atrial (LA) remodelling is a key determinant of atrial fibrillation (AF) ablation outcome. Optimal methods to assess this process are scarce. LA sphericity is a shape-based parameter shown to be independently associated to procedural success. In a multicentre study, we aimed to test the feasibility of assessing LA sphericity and evaluate its capability to predict procedural outcomes. Methods and results: This study included consecutive patients undergoing first AF ablation during 2013. A 3D model of the LA chamber, excluding pulmonary veins and LA appendage, was used to quantify LA volume (LAV) and LA sphericity (≥82.1% was considered spherical LA). In total, 243 patients were included across 9 centres (71% men, aged 56 ± 10 years, 44% with hypertension and 76% CHA2DS2-VASc ≤ 1). Most patients had paroxysmal AF (66%) and underwent radiofrequency ablation (60%). Mean LA diameter (LAD), LAV, and LA sphericity were 42 ± 6 mm, 100 ± 33 mL, and 82.6 ± 3.5%, respectively. Adjusted Cox models identified paroxysmal AF [hazard ratio (HR 0.54, P = 0.032)] and LA sphericity (HR 1.87, P = 0.035) as independent predictors for AF recurrence. A combined clinical-imaging score [Left Atrial Geometry and Outcome (LAGO)] including five items (AF phenotype, structural heart disease, CHA2DS2-VASc ≤ 1, LAD, and LA sphericity) classified patients at low (≤2 points) and high risk (≥3 points) of procedural failure (35% vs. 82% recurrence at 3-year follow-up, respectively; HR 3.10, P < 0.001). Conclusion: In this multicentre, real-life cohort, LA sphericity and AF phenotype were the strongest predictors of AF ablation outcome after adjustment for covariates. The LAGO score was easy to implement, identified high risk of procedural failure, and could help select optimal candidates. Clinical Trial Registration Information: NCT02373982 (http://clinicaltrials.gov/ct2/show/NCT02373982).

Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial.

BACKGROUND: The optimal dosage of cryotherapy during cryoballoon ablation of pulmonary veins is still unclear. This trial tested the noninferiority of a novel, individualized, cryotherapy-dosing strategy for each vein. METHODS AND RESULTS: This prospective, randomized, multicenter, noninferiority study included 140 patients with paroxysmal atrial fibrillation, which was refractory to antiarrhythmic drugs. Patients were randomly assigned to a conventional strategy of 180-second cryoballoon applications per vein with a bonus freeze (control group, n=70) or to a shorter-time application protocol, with 1 application that lasted the time required for electric block time to effect plus 60- and a 120-second freeze bonus (study group, n=70). Patients were followed with a long-term monitoring system of 30 days. At 1-year follow-up, no difference was observed in terms of free atrial fibrillation-recurrence rates: 79.4% in control versus 78.3% in study group (Δ=1.15%; 90% confidence interval, -10.33% to 12.63%; P=0.869). Time to effect was detected in 72.1% of veins. The control and study groups had similar mean number of applications per patient (9.6±2 versus 9.9±2.4; P=0.76). Compared with controls, the study group had a significantly shorter cryotherapy time (28.3±7 versus 19.4±4.3 minutes; P<0.001), left atrium time (104±25 versus 92±23 minutes; P<0.01), and total procedure time (135±35 versus 119±31 minutes; P<0.01). No differences were observed in complications or acute reconnections. CONCLUSIONS: The new time-to-effect-based cryotherapy dosage protocol led to shorter cryotherapy and procedure times, with equal safety, and similar acute and 1-year follow-up results, compared with the conventional approach. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT02789358.

Endo-epicardial versus only-endocardial ablation as a first line strategy for the treatment of ventricular tachycardia in patients with ischemic heart disease.

BACKGROUND: Epicardial ablation has shown improvement in clinical outcomes of patients with ischemic heart disease (IHD) after ventricular tachycardia (VT) ablation. However, usually epicardial access is only performed when endocardial ablation has failed. Our aim was to compare the efficacy of endocardial+epicardial ablation versus only endocardial ablation in the first procedure in patients with IHD. METHODS AND RESULTS: Fifty-three patients with IHD, referred for a first VT ablation to our institution, from 2012 to 2014, were included. They were divided in 2 groups according to enrollment time: from May 2013, we started to systematically perform endo-epicardial access (Epi-Group) as first-line approach in consecutive patients with IHD (n=15). Patients who underwent only an endocardial VT ablation in their first procedure (Endo-Group) included patients with previous cardiac surgery and the historical (before May 2013; n=35). All late-potentials in the scar zone were eliminated, and if VT was tolerated, critical isthmuses were also approached. The end point was the noninducibility of any VT. During a median follow-up of 15±10 months, the combined end point (hospital or emergency admission because of a ventricular tachycardia or reablation) occurred in 14 patients of the Endo-group and in one patient in the Epi-group (event-free survival curves by Grey-test, P=0.03). Ventricular arrhythmia recurrences occurred in 16 and in 3 patients in the Endo and Epi-Group, respectively (Grey-test, P=0.2). CONCLUSIONS: A combined endocardial-epicardial ablation approach for initial VT ablation was associated with fewer readmissions for VT and repeat ablations. Further studies are warranted.