Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry.

BACKGROUND: Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized. METHODS: Patients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up. RESULTS: A total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection. CONCLUSIONS: Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02752737.

Impact of first-line cryoablation for atrial fibrillation on healthcare utilization, arrhythmia disease burden and efficacy outcomes: real-world evidence from the Cryo Global Registry.

BACKGROUND: Cryoballoon ablation (CBA) is an effective first-line treatment for symptomatic atrial fibrillation (AF), as recently demonstrated by three randomized trials. This sub-analysis of the Cryo Global Registry aims to examine current clinical practices of first-line CBA. METHODS: AF patients treated with first-line CBA were compared to CBA in antiarrhythmic drug (AAD)-refractory patients at 12 months. Efficacy was examined using time-to-first atrial arrhythmia recurrence following a 90-day blanking period. Healthcare utilization was evaluated by repeat ablations and hospitalizations. Disease burden was examined by assessing quality of life (QOL) and patients' reporting of symptoms. RESULTS: Of 1394 patients, 433 (31.1%) were treated with first-line CBA, which was more frequent in high-volume centers. Serious procedure-related adverse event rates were similar. Efficacy at 12 months was higher in the first-line group (87.8 vs. 81.6%, HRunadj 0.64 (95% CI 0.47-0.88); p < 0.01) regardless of the centers' CBA experience; when controlling for baseline characteristics, the difference was not significant (HRadj 0.87 (95% CI 0.56-1.37); p = 0.55). No difference was observed in repeat ablations and hospitalizations between cohorts. First-line patients experienced a larger mean reduction in symptoms and were prescribed AADs at a lower rate at 12-month follow-up (9.7 vs. 29.9%). QOL improved in both cohorts from baseline to 12 months with no significant difference between groups (p = 0.29). CONCLUSIONS: In this global real-world experience, first-line CBA in patients with symptomatic AF is effective, with a larger symptom reduction compared with CBA after AAD failure and without a difference in healthcare utilization at mid-term follow-up. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02752737.

Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Patients With Concomitant Heart Failure and Either Reduced or Preserved Left Ventricular Ejection Fraction: Results From the Cryo AF Global Registry.

Background Heart failure (HF) and atrial fibrillation (AF) often coexist; yet, outcomes of ablation in patients with AF and concomitant HF are limited. This analysis assessed outcomes of cryoablation in patients with AF and HF. Methods and Results The Cryo AF Global Registry is a prospective, multicenter registry of patients with AF who were treated with cryoballoon ablation according to routine practice at 56 sites in 26 countries. Patients with baseline New York Heart Association class I to III (HF cohort) were compared with patients without HF. Freedom from atrial arrhythmia recurrence ≥30 seconds, safety, and health care utilization over 12-month follow-up were analyzed. A total of 1303 patients (318 HF) were included. Patients with HF commonly had preserved left ventricular ejection fraction (81.6%), were more often women (45.6% versus 33.6%) with persistent AF (25.8% versus 14.3%), and had a larger left atrial diameter (4.4±0.9 versus 4.0±0.7 cm). Serious procedure-related complications occurred in 4.1% of patients with HF and 2.6% of patients without HF (P=0.188). Freedom from atrial arrhythmia recurrence was not different between cohorts with either paroxysmal AF (84.2% [95% CI, 78.6-88.4] versus 86.8% [95% CI, 84.2-89.0]) or persistent AF (69.6% [95% CI, 58.1-78.5] versus 71.8% [95% CI, 63.2-78.7]) (P=0.319). After ablation, a reduction in AF-related symptoms and antiarrhythmic drug use was observed in both cohorts (HF and no-HF), and freedom from repeat ablation was not different between cohorts. Persistent AF and HF predicted a post-ablation cardiovascular rehospitalization (P=0.032 and P=0.001, respectively). Conclusions Cryoablation to treat patients with AF is similarly effective at 12 months in patients with and without HF. Registration URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02752737.

Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real-world global setting: Results from the Cryo AF Global Registry.

BACKGROUND: Cryoballoon ablation is a commonly used approach to treat patients with atrial fibrillation (AF). OBJECTIVES: Report on the safety and efficacy of cryoballoon ablation for the treatment of AF in the largest global cohort of cryoablated patients prospectively studied within a single registry. METHODS: The Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) or persistent AF (PsAF) were treated with the cryoballoon catheter according to routine practices at 93 sites across 36 countries. Primary efficacy endpoints included freedom from AF and freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) ≥30 seconds. The primary safety endpoint was serious device- or procedure-related adverse events over 12 month follow-up. RESULTS: During this evaluation window, 2922 subjects completed an index cryoballoon procedure, and 1440 completed 12 month follow-up. The cohort was 61 ± 12 years of age, 36.3% female, and 78.7% PAF. Serious device- and procedure-related adverse event rates were 1.5% and 3.4%, respectively. Freedom from AF/AFL/AT after the 90 day blanking period was 86.4% (95% CI: 84.3%-88.3%) in patients with PAF and 70.9% (95% CI: 64.6%-76.4%) in patients with PsAF. Freedom from AF/AFL/AT in first-line PAF and PsAF was 90.0% (95% CI: 86.4%-92.7%) and 72.9% (95% CI: 58.6%-83.0%) at 12 months, respectively. CONCLUSIONS: The Cryo Global AF Registry is the largest evaluation to demonstrate cryoablation is an efficient, safe, and effective treatment for patients with AF worldwide. Cryoablation was commonly used to treat patients prior to an AAD failure and may facilitate earlier therapy for patients on the AF disease continuum.

Disordered Eating Attitudes Among University Students in Kuwait: The Role of Gender and Obesity.

BACKGROUND: This study aimed to highlight the proportion of disordered eating attitudes among university students in Kuwait by gender and obesity. METHODS: A sample of 530 Kuwaiti university students was selected from four universities in Kuwait (203 men and 327 women). The eating attitudes test-26 was used to determine disordered eating attitudes. RESULTS: The prevalence of disordered eating attitudes was 31.8% and 33.6% among men and women respectively. Obese students of both genders had doubled the risk of disordered eating attitudes compared to nonobese students (odds ratio 1.99 and 1.98, respectively). CONCLUSIONS: About one third of university students in Kuwait had disordered eating attitudes. There is an urgent need to prevent and treat disordered eating attitudes in university students in Kuwait.

The Gulf Implantable Cardioverter-defibrillator Registry: Rationale, Methodology, and Implementation.

BACKGROUND: The implantable cardioverter-defibrillator (ICD) is effective in the prevention of sudden cardiac death in high-risk patients. Little is known about ICD use in the Arabian Gulf. We designed a study to describe the characteristics and outcomes of patients receiving ICDs in the Arab Gulf region. METHODS: Gulf ICD is a prospective, multi-center, multinational, and observational study. All adult patients 18 years or older, receiving a de novo ICD implant and willing to sign a consent form will be eligible. Data on baseline characteristics, ICD indication, procedure and programing, in-hospital, and 1-year outcomes will be collected. Target enrollment is 1500 patients, which will provide adequate precision across a wide range of expected event rates. RESULTS: Fifteen centers in six countries are enrolling patients (Saudi Arabia, United Arab Emirates, Kuwait, Oman, Bahrain, and Qatar). Two-thirds of the centers have dedicated electrophysiology laboratories, and in almost all centers ICDs are implanted exclusively by electrophysiologists. Nearly three-quarters of the centers reported annual ICD implant volumes of ≤150 devices, and pulse generator replacements constitute <30% of implants in the majority of centers. Enrollment started in December 2013, and accrual rate increased as more centers entered the study reaching an average of 98 patients per month. CONCLUSIONS: Gulf ICD is the first prospective, observational, multi-center, and multinational study of the characteristics and, the outcomes of patients receiving ICDs in the Arab Gulf region. The study will provide valuable insights into the utilization of and outcomes related to ICD therapy in the Gulf region.

Perceived barriers to weight maintenance among university students in Kuwait: the role of gender and obesity.

OBJECTIVE: To investigate the barriers to weight maintenance among university students in Kuwait by gender and obesity. METHODS: A sample of 530 students was selected at convenience from four universities in Kuwait (2 public and 2 private). The age of students ranged from 19 to 26 years. A self-reported pretested questionnaire was used to obtain the barriers, which were divided into barriers to healthy eating and barriers to physical activity. Weight and height were based on self-reporting, and the students were grouped into non-obese and obese according to the WHO classification. The response options to barriers were: very important, somewhat important and not important. RESULTS: The main barriers to healthy eating for both genders were: "Do not have skills to plan, shop for, prepare or cook healthy foods" and "Not having time to prepare or eat healthy food". In general, there were no significant differences between men and women in barriers to healthy eating. There were highly significant differences between men and women regarding barriers to physical activity (P values ranged from <0.001 to <0.016). "Not having time to be physically active" and "The climate is not suitable for practising exercise" were the main barriers reported. Obese men were more likely to face barriers to healthy eating than non-obese men. There were no significant differences between obese and non-obese women regarding barriers to healthy eating and physical activity. CONCLUSION: The findings of this study can be utilized in intervention activities to promote a healthy lifestyle and to combat obesity in Kuwait, and maybe in other Arab countries.

Successful implantation of cardiac defibrillators without induction of ventricular fibrillation using upper limit of vulnerability testing.

INTRODUCTION: Conventionally, the implantable cardioverter-defibrillator (ICD) is tested at implantation by measurement of defibrillation threshold (DFT), which involves repeated induction of ventricular fibrillation (VF). We report our data on successful ICD implantation without VF induction using a modified upper limit of vulnerability (ULV) testing method, compared to standard DFT testing. METHODS: Fourteen patients underwent ICD implantation using a modified ULV testing method by delivering a 15 J shock during the vulnerable period on the peak of the T wave, and if VF was not induced 15 J shocks were repeated at -20 and -40 msec before the peak of T wave. Failure to induce VF, indicating a ULV <15 joules (J), suggested a DFT < or =20 J based on previous studies demonstrating a close correlation (+/-5 J) between ULV and DFT. If VF was induced, a 20 J rescue shock was delivered. ICD therapy was then programmed on the basis of ULV testing. All patients underwent pre-discharge DFT testing to confirm adequate DFT. RESULTS: Using a modified ULV testing method, ICD implantation was completed without induction of VF in 8 patients and only a single episode of VF in 6 patients. The mean number of VF episodes (0.42 +/- 0.5) induced with ULV testing was significantly lower (p <.001) than the number induced during DFT testing (3.9 +/- 0.8). Pre-discharge DFT testing did not alter ICD programming in any patient. During follow-up of 14.85 +/- 12.31 months, three patients had seven episodes of VT/VF, six of whom were converted with the programmed first-shock strength, while one required a second high-energy shock to convert. This patient had a pre-discharge DFT of 10 joules. CONCLUSIONS: Successful ICD implantation can be safely performed with no or fewer episodes of VF induction using a modified ULV testing method.