Aims Early rhythm control therapy in atrial fibrillation (AF) results in higher freedom from atrial arrhythmia (AA) recurrence and improved cardiovascular outcomes. The optimal timing of cryoballoon ablation (CBA) is unknown. Methods and results We evaluated AA recurrence and procedure-related complications of early vs. late CBA (<= 12 vs. >12 months from diagnosis) in patients enrolled in the prospective Cryo Global Registry (121 centres in 37 countries, NCT02752737). A total of 3447 subjects were followed through 12 months and 1220 through 24 months. In summary, 1573 patients (46%) had early ablation at a median (IQR) of 0.3 (0.1-0.6) years from AF diagnosis (age 62 +/- 12 years., 35.8% female, 71.4% paroxysmal), and 1874 (54%) had late ablation at a median of 3.4 (1.9-6.7) years after diagnosis (age 61 +/- 11 years, 36.2% female, 75.0% paroxysmal). Early ablation patients were less hypertensive (53.5% vs. 57.9%, P = 0.01) and less symptomatic (1.5 +/- 1.1 vs. 1.8 +/- 1.1 symptoms/patient, P < 0.01) and had smaller left atrial diameters (41 +/- 7 mm vs. 42 +/- 7 mm, P < 0.01). Freedom from AA recurrence was 81.5% (95% CI: 78.7-83.9%) in the early vs. 71.7% (95% CI: 68.9-74.3%) in the late ablation group at 24 months (P < 0.01). The risk of cardioversion was 41% lower in the early ablation group [HRAdj: 0.59 (0.42-0.83), P < 0.01]. Serious procedure-related adverse events occurred in 2.4 and 3.5% of patients in the early and late ablation groups (P = 0.045), respectively. Conclusion CBA within 12 months from AF diagnosis resulted in higher freedom from AA recurrence and is associated with fewer safety events in a real-world evaluation.

BACKGROUND:Most single-shot pulsed-field ablation (PFA) catheters require extensive repositioning for pulmonary vein isolation (PVI), posing a challenge for obtaining contiguous, durable lesions. OBJECTIVE:To determine 1-year outcomes of a single-shot, all-in-one mapping and ablation PFA catheter for treating paroxysmal atrial fibrillation (PAF). METHODS:After PVI with the large-lattice catheter with expandable tip (Sphere-360), follow-up included Holter monitoring at 180 and 365 days and scheduled/symptomatic trans-telephonic monitoring (TTM) or modeled insertable loop recorder (ILR) data. Efficacy outcomes were acute PVI and 12-month freedom from atrial arrhythmias (AA), after 90-day blanking. Optional invasive remapping at 75 days facilitated waveform refinement from PULSE1, PULSE2, to the optimized PULSE3. RESULTS:At 3 centers, 100 PAF patients underwent PFA with PULSE1 (n = 30), PULSE2 (n = 20), or PULSE3 (n = 50). Procedure, left atrial dwell, and fluoroscopy times were 57.9 ± 20.6, 22.2 ± 11.8 and 6.8 ± 5.7 minutes, respectively. All 395 targeted PVs were acutely isolated, with a transpired PVI time of 11.5 ± 6.0 minutes, using 4.0 ± 1.3 lesions/PV. There were no primary safety events (serious device-related events within 7 days post-PFA). PVI durability with PULSE3 (n = 40) was 98% (per-vein) and 93% (per-patient). One-year freedom from AA recurrence was 82.0% (95% CI:73.0%-88.3%) overall, and 88.0% (95%CI, 75.2%-94.4%) for PULSE3 patients. Of the ILR sub-cohort (n = 15 PULSE3 patients), 3 patients (20%) had recurrences, with an AA burden reduction from 26% (baseline) to 1.6% (post-ablation). CONCLUSION:The large lattice PFA catheter was efficient, safe, and effective in treating PAF. The observed high PVI durability translated to clinical effectiveness, even in continuously monitored patients.

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): The registry was sponsored Medtronic, Inc., Minneapolis, MN. Background Atrial fibrillation (AF), the most common cardiac arrhythmia, burdening patients with a myriad of symptoms. Three recent randomized trials demonstrated that cryoballoon ablation (CBA) is superior to antiarrhythmic drugs (AADs) as a first-line treatment for the prevention of arrhythmia reoccurrence in patients with paroxysmal AF. However, the global outcome of CBA performed according to local standard of care as a first-line therapy for AF is not reported. Purpose To compare safety, efficacy, and quality of life outcomes in patients treated with CBA for first-line management of AF against patients treated with CBA following failed AAD therapy. Methods The Cryo AF Global Registry, an ongoing, prospective, multicenter registry, of AF patients undergoing index CBA performed according to local standards at 58 centers in 26 countries worldwide. In this analysis, subjects undergoing first-line cryoablation were compared to patients who were refractory to AAD therapy and/or taking AADs at baseline. Safety was assessed utilizing a composite of serious procedure-related complications. To evaluate efficacy, time-to-first atrial fibrillation, -flutter and/or -tachycardia (AF/AFL/AT) recurrence post a 90-day blanking period was compared between groups using Kaplan-Meier estimates. Quality of life was evaluated using the EQ-5D-3L questionnaire at baseline and at 12 months following CBA. Log-rank, two-sample t-test, and exact binomial tests were utilized to test difference between groups. Results Of 1,394 total patients, 433 (31.1%) were drug naïve prior to CBA. Patients in the AAD therapy cohort failed a mean of 1.2 ± 0.5 AADs before CBA. Freedom from AF/AFL/AT recurrence at 12 months was 87.8% in first-line patients compared to 81.6% in AAD-refractory patients (p<0.01). Serious adverse event rates were not statistically different (p=0.32) between first-line (2.3%) and AAD-refractory (3.4%) patients. First-line CBA resulted in a larger mean decline in symptoms upon follow-up, with 81% of patients reported to be symptom-free at 12 months. Further, first-line patients were prescribed AADs at a lower rate at discharge (18.6% vs.62.8%) and at 12-months (9.7% vs.29.9%) in comparison to patients in the AAD cohort. However, cryoablation did result in AAD prescriptions being reduced by approximately 50% in both cohorts from discharge to 12-months. As determined by the EQ-5D-3L score, quality of life improved for patients in both groups, with no significant difference between first-line and AAD-refractory patients (p=0.29). Conclusion This real-world global evaluation supports CBA as a safe and efficacious first-line treatment that improves the quality of life for patients with symptomatic AF.

Historically, catheter ablation, including cryoballoon ablation (CBA), has been evaluated in a smaller proportion of female study patients with atrial fibrillation (AF) compared to male participants. The resulting consequences of this differential representation are largely unexplored.

Background: Cryoablation is superior to antiarrhythmic drugs (AAD) for the prevention of arrhythmia recurrence in drug naïve (first-line) patients with paroxysmal atrial fibrillation (AF). The adoption and outcomes of first-line cryoablation in a real-world setting are unknown. Purpose: To describe global usage, safety, efficacy, and healthcare utilization outcomes in patients treated with cryoablation for first-line management of AF. Methods: Cryo Global Registry (NCT02752737) is an ongoing, prospective, multicenter registry. AF patients with an index cryoballoon ablation performed according to local standards of care at 58 centers in 26 global countries were included. Subjects undergoing first-line cryoablation were compared to patients with prior failed AAD usage and/or taking AADs at baseline. Serious procedure-related complication rates, 12-month freedom from a ≥30sec AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence after a 90-day blanking period, and healthcare utilization were compared. Results: Of 1,394 total patients, 433 (31.1%) were treated with first-line cryoablation. The proportion of first-line enrollments varied widely by world region and country. AAD-refractory patients failed a mean of 1.2 ± 0.5 AADs prior to cryoablation. Freedom from AF/AFL/AT after cryoablation in first-line and AAD-refractory was 90.0% (95% CI: 86.4-92.7%) vs 84.4% (95% CI: 81.5-86.8%) in paroxysmal AF and 72.9% (95% CI: 58.6-83.0%) vs 70.2% (95% CI: 62.9-76.4%) in persistent AF (overall p=0.02), respectively. Serious adverse event rates were not statistically different between first-line and AAD-refractory patients (2.3% vs 3.4%; p=0.32), with highest rates being groin-site complications (0.7% vs 0.5%), respectively. Freedom from repeat ablations in first-line vs AAD-refractory was 95.5% (95% CI: 92.7 - 97.2%) vs 93.1% (95% CI: 91.0 - 94.7%) in paroxysmal AF and 84.7% (95% CI: 71.8 - 92.1%) vs 88.2% (95% CI: 82.5 - 92.2%) in persistent AF (overall p=0.35), respectively. Conclusion: The current data support cryoablation as an early intervention strategy for treatment of patients with AF.

Abstract A chronic disease management model of care (Empower Health) was launched in rural and urban areas of Ghana and Kenya in 2018. The goal was to improve disease awareness, reduce the burden of disease, and improve the clinical effectiveness and efficiency of managing hypertension. Leveraging the model, clinicians provide patients with tailored management plans. Patients accessed regular blood pressure checks at home, at the clinic, or at community‐partner locations where they received real‐time feedback. On the mobile application, clinicians viewed patient data, provided direct patient feedback, and wrote electronic prescriptions accessible through participating pharmacies. To date, 1266 patients had been enrolled in the “real‐world” implementation cohort and followed for an average of 351 ± 133 days across 5 facilities. Average baseline systolic blood pressure (SBP) was 145 ± 21 mmHg in the overall cohort and 159 ± 16 mmHg in the subgroup with uncontrolled hypertension (n = 743) as defined by baseline SBP ≥ 140 mmHg. SBP decreased significantly through 12 months in both the overall cohort (−9.4 mmHg, p < .001) and in the uncontrolled subgroup (−17.6 mmHg, p < .001). The proportion patients with controlled pressure increased from 46% at baseline to 77% at 12 months (p < .001). In summary, a new chronic disease management model of care improved and sustained blood pressure control to 12 months, especially in those with elevated blood pressure at enrollment.

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic, Inc. OnBehalf Cryo AF Global Registry Investigators Background Heart failure (HF) concomitant to atrial fibrillation (AF) can exacerbate the risk of hospitalization, morbidity, mortality, and impairment in quality of life posed by each condition alone. While the reciprocal relationship between HF and AF challenges effective treatment for these patients, catheter ablation for treatment of AF is reasonable for select patients with AF and HF according to guidelines. Purpose: Assess real-world usage and healthcare utilization outcomes of cryoablation for patients with AF and HF. Methods: The Cryo AF Global Registry (NCT02752737) is an ongoing, prospective, multicenter registry. Patients with AF were enrolled and treated with cryoballoon ablation (Arctic Front Advance, Medtronic) according to clinical practice at 56 sites in 26 countries world-wide. Subjects with NYHA class I-III at baseline comprised the HF cohort and were compared to patients without HF (No-HF). Freedom from atrial arrhythmia recurrence ≥30 sec, adverse events associated with the AF ablation procedure, repeat ablations, AAD usage, and cardiovascular rehospitalization over a 12-month follow-up were compared between cohorts. Results: A total of 1,303 patients (318 HF, 985 No-HF) were included. The HF cohort included patients with NYHA Class I (56.3%) and II/III (43.7%) with either preserved (81.6%) or mid/reduced (18.4%) left ventricular ejection fraction. HF patients were more often female (45.6% vs 33.6%) with persistent AF (25.8% vs 14.3%), larger left atrial diameter (4.4 ± 0.9 vs 4.0 ± 0.7 cm), and higher rates of hypertension (67.9% vs 49.1%) and prior myocardial infarction (3.8% vs 1.7%; all, P < 0.05). The rate of serious procedure-related complications was 5.3% in HF and 3.0% in No-HF (P = 0.08). Freedom from atrial arrhythmia recurrence at 12-months was not different between HF and No-HF patients with either paroxysmal (84.2% (95% CI:78.6-88.4) vs 86.8% (95% CI: 84.2 – 89.0)) or persistent AF (69.6% (95% CI: 58.1 – 78.5) vs 71.8% (95% CI: 63.2-78.7)), respectively (p = 0.32, HF vs No-HF). AF-related symptoms and antiarrhythmic drug use were significantly reduced after cryoablation in the HF and No-HF cohorts (P < 0.05). Freedom from repeat ablation at 12-months was similar between HF and No-HF patients. Of patients who had a cardiovascular rehospitalization after cryoablation, 78% presented with a supraventricular tachyarrhythmia. Persistent AF and HF at baseline both increased the risk of cardiovascular rehospitalization after cryoballoon ablation (P < 0.05). Conclusion: Cryoablation is used to treat patients with AF and concomitant HF in real-world practice and is similarly safe and effective at 12-months in patients with and without HF.

Abstract Background Recent trials demonstrated the safety and efficacy of cryoballoon ablation prior to antiarrhythmic drug (AAD) usage in patients with paroxysmal atrial fibrillation (AF); however, global utilization and outcomes of first-line cryoablation in real-world AF patient management are unknown. Purpose To evaluate baseline characteristics and outcomes in patients selected for first-line cryoablation for treatment of AF. Methods The Cryo Global Registry (NCT02752737) is an ongoing, prospective, multicenter registry. In this analysis, AF patients with an index cryoballoon ablation performed according to local standards of care at 58 centers in 26 global countries were included. Subjects with no prior failed antiarrhythmic drug (AAD) usage and not taking an AAD at baseline were considered first-line and compared to drug-refractory patients who had failed an AAD prior to enrollment in the study and/or were taking an AAD at baseline. Baseline characteristics, serious procedure-related complication rates, and 12-month freedom from a ≥30sec AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence after a 90-day blanking period were compared between the groups. Results In total, 31% of the 1,394 patients (433 first-line, 961 drug-refractory) received a first-line cryoablation. The proportion of first-line enrollments by world region (3.7%-53.5%) and countries within region (i.e. EU: 0–59%) varied widely. Drug-refractory patients failed a mean of 1.2±0.5 AADs prior to cryoablation. First-line and drug-refractory patients were similar in age (60±13 vs 61±11), sex (35.1% vs 36.8% female), and CHA2DS2-VASC (2.0±1.6 vs 2.1±1.6). First-line was more often paroxysmal AF (87.3% vs 80.2%), with lower BMI (27±5 vs 28±5), diagnosed with AF fewer years (2.1±3.9 vs 3.7±5.0), and had smaller left atrial diameters (39±7 vs 42±8 mm; all p<0.05). Hypertension and history of congestive heart failure were less common in first-line (p<0.05), but similar rates of prior myocardial infarction, stroke, coronary artery disease, diabetes, and sleep apnea were reported. Procedure, left atrial dwell, and cryoapplication times were similar between cohorts (all p>0.05). Serious adverse event rates were not statistically different between first-line and drug-refractory patients (2.3% vs 3.4%, respectively; p=0.32). Freedom from AF/AFL/AT after cryoablation in first-line vs drug-refractory PAF was 90.0% (95% CI: 86.4–92.7%) and 84.4% (95% CI: 81.5–86.8%) and in first-line vs drug-refractory persistent AF was 72.9% (95% CI: 58.6–83.0%) vs 70.2% (95% CI: 62.9–76.4%), respectively. First-line ablation resulted in higher rates of freedom from arrhythmia recurrence (p=0.02). Conclusion First-line cryoablation in a real-world setting resulted in improved efficacy without increasing the risk of a safety event. These data support cryoablation as an early intervention strategy for treatment of AF. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic, Inc.

The risk of hospitalization and symptoms that reduce quality of life are exacerbated in patients with heart failure (HF) concomitant to atrial fibrillation (AF). Guidelines indicate that catheter ablation for the treatment of AF is reasonable in select patients with AF and HF.

Introduction: Atrial ablation for the treatment of atrial fibrillation has traditionally been performed in the hospital setting. Recently, the Centers for Medicare and Medicaid Services (CMS) announced the Hospitals Without Walls program, allowing ambulatory surgery centers (ASCs) to conduct procedures such as atrial ablations. As a result, the first cases of ablations in an ASC have recently been completed. This study aimed to compare patient length of stay (LOS) and between the ASC setting to a traditional hospital setting. Hypothesis: LOS in the ASC setting is shorter than in the traditional hospital. Methods: Data from all patients treated with cryoballoon pulmonary vein isolation (PVI) in a single ASC were analyzed. A random sample of patients treated by the same provider during the same timeframe in the hospital setting were then acquired and compared. Procedural approaches were similar, with transeptal puncture performed under intracardiac echo, contrast venography and pressure waveform analysis performed prior to ablation to ensure good venous seal. No 3D mapping was used at either site. Intraprocedural emergency protocols were established prior to ablations. Results: A total of 13 patients received treatment in the ASC, with a mean age of 71 ± 8 years, 38% female, 9 patients had paroxysmal atrial fibrillation and 4 persistent atrial fibrillation. The mean number of cryoablation applications per pulmonary vein was 1.4 ± 0.7 with average application duration of 187 ± 37 seconds. The mean procedural duration was 52 ± 10 minutes and mean time in the ASC was 5.4 ± 1.5 hours. No acute adverse events occurred; however, one patient later presented with a sore throat and a groin hematoma without active bleeding or pseudoaneurysm. A total of 13 patients were analyzed in the hospital setting. Mean time in the hospital was longer than in the ASC (13.0 ± 13.0 hours, p<0.01). This is inclusive of 2 patients staying overnight. The mean hospital length of stay was also longer than in the ASC for the 11 patients with same day discharge (8.2 ± 6.6 hours, p<0.01). Conclusions: Cryoballoon PVI performed in an ASC setting resulted in a shorter overall length of stay than in the traditional hospital setting, with no acute complications occurring.

OBJECTIVES STOP AF PAS (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study) is the first prospective, multicenter, 3-year study in North America to assess long-term safety and effectiveness of the cryoballoon for treatment of patients with drug-refractory symptomatic pAF. BACKGROUND The STOP AF PAS was required by the U.S. Food and Drug Administration at the time of approval of the first-generation cryoballoon for the treatment of paroxysmal atrial fibrillation (pAF). The second-generation cryoballoon (CB2) was commercially released shortly after this trial was initiated. METHODS The study was nonrandomized. Enrollment was completed with 344 eligible patients undergoing pulmonary vein isolation (PVI) using the CB2. Procedure-related safety and freedom from AF and symptomatic atrial flutter/atrial tachycardia through 3 years were determined. Documented atrial arrhythmias >= 30 s were considered treatment failures. RESULTS Acute PVI was achieved in 99.3% (1,341 of 1,350) of veins. Mean follow-up was 34 +/- 7 months. The rate of major complications was 5.8%, including a 3.2% rate of phrenic nerve injury, which resolved in all but 1 patient by 36 months. At 36 months, 11.7% of patients were prescribed antiarrhythmic agents, inclusive of "pill-in-the-pocket" administration. Freedom from AF was 81.6% at 12 months, 73.8% at 24 months, and 68.1% at 36 months. Freedom from AF and symptomatic atrial flutter/atrial tachycardia was 79.0% at 12 months, 70.8% at 24 months, and 64.1% at 36 months. Freedom from a repeat ablation procedure was 80.9% at 36 months. CONCLUSIONS PVI using the CB2 was an effective treatment for patients with pAF, with freedom from all atrial arrhythmias of 64% at 36 months. (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study [STOP AF PAS]; NCT01456949) (C) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

Isaac Kofi Owusu1, Fred Adomako-Boateng2, Fred Kueffer3, Molly Guy3, Chemuttaai Lang’at3, Daniel B Grossman4, Teri Whitman3, Keith Holloman3, Douglas A Hettrick3* and Opare-Sem O1 1Department of Medicine, School of Medical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana 2Regional Health Directorate, Ghana Health Service, Kumasi, Ghana 3Medtronic, Inc, Minneapolis, MN, USA 4Mayo Clinic, Rochester, MN, USA

Left ventricular (LV) remodeling after myocardial infarction (MI) is a strong predictor of heart failure and mortality. The predictors of long-term remodeling after MI have been incompletely studied. We therefore examined the correlates of LV remodeling in patients with large ST-segment elevation myocardial infarction and a patent infarct artery after percutaneous 2coronary intervention (PCI) from the randomized Post-Myocardial Infarction Remodeling Prevention Therapy trial. Peri-infarct pacing had a neutral effect on long-term remodeling in patients with large first MI. The present analysis includes 109 patients in whom an open artery was restored after PCI, and in whom LV end-diastolic volume (LVEDV) at baseline and 18 months was assessed by transthoracic echocardiography. Multivariable models were fit to identify the independent predictors of LVEDV at baseline and 18 months. By multivariable analysis, male sex (p = 0.004) and anterior MI location (p = 0.03) were independently associated with baseline LVEDV. The following variables were independent predictors of increased LVEDV at 18 months: younger age (p = 0.01), male sex (p = 0.03), peak creatine phosphokinase (p = 0.03), shorter time from MI to baseline transthoracic echocardiography (p = 0.04), baseline LVEDV (p < 0.0001), and lack of statin use (p = 0.03). In conclusion, patients with large MI and an open infarct artery after PCI, anterior MI location, and male sex were associated with greater baseline LVEDV, but MI location was not associated with 18-month LVEDV. In contrast, younger age, peak creatine phosphokinase, male sex, baseline LVEDV, and lack of statin use were associated with long-term LV remodeling.

Objective: A novel locally appropriate hypertension management model of care was developed and tested in the Republic of Ghana to address specific socioeconomic and community-related barriers to blood pressure (BP) control. Design and Methods: Patients with a history of hypertension were enrolled and each agreed to visit a participating nearby community pharmacy at least once per week for 6 months for a BP check, symptom review, and medication monitoring. Weekly pharmacy visit data were manually logged into a mobile application by the pharmacy staff. Guideline based logic in the application provided immediate feedback to the patient and transmitted data to the primary physician. Electronic prescriptions, from the primary physician, were accessible to participating pharmacies. Clinic blood pressure from the prior 6 months was also retrieved from patient records. Results: Compliance with weekly BP assessments in the 150 enrolled patients (57± 8 years; 73% Female) was 61% and 2705 total pharmacy BP assessments were conducted. Improvement in overall health awareness was reported in 82% of the patients and 95% indicated a desire to continue using the model of care in the future. During the 6-month voluntary program period, the number of scheduled office visits decreased by 60% compared to standard monthly visits. Despite fewer in clinic visits, average systolic BP decreased significantly from the 6-month pre-trial period baseline (137.4±14.0 to 129.8± 16.3 mmHg, p<0.01). The proportion of patients with blood pressure below target (140 mmHg) for least 75% of all readings increased from 41% in the 6 months prior to enrollment to 62% during the study follow up period (p<0.01). This improvement was associated with potential cardiovascular risk reduction of 5-21% based on previous randomized trials. The proportion of patients with > 75% controlled BP also improved in the subset of patients with BP below target at enrollment from 52% to 76% (p<0.01), implying potential risk benefits even in “well controlled” patients. Conclusions: The care model applied in this hypertensive West African resulted in fewer clinic visits and high patient and clinician satisfaction as well decreased systolic blood pressure and increased proportion of time with controlled blood pressure.

INTRODUCTION:Radiofrequency (RF) ablation is effective for slow pathway ablation, but carries a risk of inadvertent AV block requiring permanent pacing. By comparison, cryoablation with a 4-mm distal electrode catheter has not been reported to cause permanent AV block but has been shown to be less effective than RF ablation. We sought to define the safety and efficacy of a 6-mm distal electrode cryoablation catheter for slow pathway ablation in patients with atrioventricular nodal reentry tachycardia (AVNRT). METHODS AND RESULTS:Twenty-six U.S. and eight Canadian centers participated in the study. Patients with supraventricular tachycardia (SVT) thought likely to be AVNRT were enrolled. If AVNRT was inducible and confirmed to be the clinical SVT, then the slow pathway was targeted with a cryoablation catheter using a standardized protocol of best practices. Acute success was defined as inducibility of no more than one echo beat after cryoablation. Primary efficacy was defined as acute success and the absence of documented recurrent AVNRT over 6 months of follow-up. Primary safety was a composite of serious procedure-related adverse events and/or device-related complications. Note that 397 subjects met enrollment criteria after the EP study and received cryoablation. Mean ablation procedure duration (including a waiting period) was 89 ± 40 minutes, and mean fluoroscopy time was 4.8 ± 5.9 minutes. Isoproterenol was administered before cryoablation in 53% and after the last lesion in 85% of cases. Acute procedural success was realized in 95% (378 of 397) of subjects. No subject received a permanent pacemaker due to AV block. The slow pathway could not be ablated in 19 subjects, including: 12 due to inefficacy, 2 due to transient AV block, and 5 due to both inefficacy and transient AV block. RF ablation was used in the same procedure in 11 of 19 failed subjects, and was ineffective in 3 subjects. Among the group with acute success, 10 subjects (2.7%) had documented recurrent AVNRT over the 6-month follow-up period, and all occurred within 3 months of the index cryoablation. Serious procedure-related adverse events occurred in 4 subjects (1.0%), including one each: tamponade, pulmonary embolism, femoral vein hemorrhage, and diagnostic EP catheter knotting. None of these serious adverse events were related to use of the cryoablation catheter. Overall, 93% of subjects had successful slow pathway ablation at 6 months with the study cryoablation catheter. CONCLUSIONS:Cryoablation for AVNRT using a focal 6-mm catheter was safe and effective. It resulted in a low risk of recurrence over 6 months of follow-up with no incidence of AV block requiring permanent pacing.

Background: Logistic and socioeconomic barriers limit effective blood pressure (BP) control in many parts of Sub-Saharan Africa, including the Republic of Ghana. We tested a novel hypertension management model of care designed for resource-limited settings. Methods and Results: The “Akoma Pa” model was developed using human-centered design methodology involving patients, physicians, and nurses. The model consisted of a mobile tablet, BP machine and a novel software application in a unique platform to allow for longitudinal patient management. Patients were provided with a tailored hypertension management plan based on their enrollment comorbidities and risk factors. A cohort of 150 hypertensive patients (57±8 years; 73% female) accessed regular blood pressure assessments at a local pharmacy and received real-time automated feedback based on their individualized plan. On the mobile application, clinicians were able to view patient data, provide patients with feedback via SMS on their condition, and write electronic prescriptions which could be accessed by participating pharmacies. Average baseline BP was 135±18/84±10 mmHg in the overall cohort and 153±13/90±11 mmHg in the subgroup with uncontrolled hypertension (n=58). After 6 months of voluntary weekly monitoring, systolic blood pressure decreased significantly (p<0.01) in the overall cohort (-4.7±18.7 mmHg) and in the uncontrolled subgroup (-15.2±17.6mmHg). Systolic blood pressure remained constant in the sub group with controlled pressure at baseline. The proportion of the population with uncontrolled hypertension decreased from 39% to 27% (p=0.01). Patient compliance with weekly BP assessments was 61% and 2,855 BP assessments were conducted. During 33 of the 2,855 BP assessments (1% of pharmacy visits), the software application directly referred patients to a health facility (33 visits in 25 patients). Improvement in overall health awareness was reported in 82% of the participants and 95% of participants indicated a desire to continue using this model in the future. Conclusions: Compliance and satisfaction with this multifaceted hypertension care model were high and led to significant and sustained decreases in blood pressure in this West African hypertensive population.

Background Spinal cord stimulation (SCS) reduces sympathetic activity in animal models of heart failure with reduced ejection fraction (HF) but limited data exist of SCS in patients with HF. The aim of the present study was to test the primary hypothesis that SCS reduces cardiac sympathetic nerve activity in HF patients. Secondary hypotheses were that SCS improves left ventricular function and dimension, exercise capacity, and clinical variables relevant to HF. Methods HF patients with a SCS device previously participating in the DEFEAT‐HF trial were included in this crossover study with 6‐week intervention periods (SCS‐ON and SCS‐OFF). SCS (50 Hz, 210‐μs pulse duration, aiming at T2–T4 segments) was delivered for 12 hours daily. Indices of myocardial sympathetic neuronal function (heart‐to‐mediastinum ratio, HMR) and activity (washout rate, WR) were assessed using 123 I‐metaiodobenzylguanidine (MIBG) scintigraphy. Echocardiography, exercise testing, and clinical data collection were also performed. Results We included 13 patients (65.3 ± 8.0 years, nine males) and MIBG scintigraphy data were available in 10. HMR was not different comparing SCS‐ON (1.37 ± 0.16) and SCS‐OFF (1.41 ± 0.21, P = 0.46). WR was also unchanged comparing SCS‐ON (41.5 ± 5.3) and SCS‐OFF (39.1 ± 5.8, P = 0.30). Similarly, average New York Heart Association class (2.4 ± 0.5 vs 2.3 ± 0.6, P = 0.34), quality of life score (24 ± 16 vs 24 ± 16, P = 0.94), and left ventricular dimension and function as well as exercise capacity were all unchanged comparing SCS‐ON and SCS‐OFF. Conclusion In patients with HF, SCS (12 hours daily, targeting the T2–T4 segments of the spinal cord) does not appear to influence cardiac sympathetic neuronal activity or function as assessed by MIBG scintigraphy.

BACKGROUND:Outcomes of cryoballoon ablation for paroxysmal atrial fibrillation (PAF) have been reported in the Western countries but not in Japan. The CRYO-Japan PMS study was a single-arm, observational, multicenter, prospective study of the 2nd-generation cryoballoon Arctic Front Advance(TM). We evaluated device- and procedure-related complications and clinical outcomes at 6 months. METHODS AND RESULTS:The 616 patients (male, 72%; mean age, 63±11 years) were enrolled from 33 Japanese hospitals. Of all patients, 610 had PAF, and procedural data were analyzed in 607. A subset of 328 patients was followed for 6 months for the primary efficacy analysis. AF recurrence outside the 3-month blanking period or repeat ablation was considered treatment failure. Pulmonary vein isolation was achieved in 606/607 patients (99.8%); 1 patient (0.3%) had a repeat ablation during the blanking period. Freedom from AF at 6 months was 88.4% (95% CI: 84.1-91.6%). Device- and/or procedure-related adverse events included phrenic nerve injury unresolved at hospital discharge in 9/616 patients (1.5%), which resolved within 6 months in 7, pericardial effusion in 5/616 (0.8%), and tamponade in 4/616 (0.6%). One non-device-related death from pneumonia was reported 6 days post-procedure. CONCLUSIONS:Cryoballoon ablation is safe and effective for Japanese PAF patients, with 88.4% AF freedom at 6 months post-ablation. (Circ J 2016; 80: 1744-1749).