Outcome after percutaneous closure of a patent foramen ovale using the intrasept device: a multi-centre study

OBJECTIVES: This multi-centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept device. BACKGROUND: PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo-embolism. Currently, different devices are used for PFO closure. METHODS: Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo-embolism. Peri-procedural and mid-term complications were reported. RESULTS: Four-hundred thirty patients (mean age 50.7 +/- 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow-up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri-procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid-term follow-up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04). CONCLUSION: This multi-centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo-embolic events.status: publishe

Minimally invasive atrial fibrillation ablation and left anterior descending bypass grafting

Abstract Funding Acknowledgements Type of funding sources: None. Background Minimally invasive direct coronary artery bypass (MIDCAB) with robotic left internal mammary artery (LIMA) harvesting for a critical left anterior descending (LAD) stenosis and thoracoscopic ablation for atrial fibrillation (AF) may represent safe and effective alternatives to more invasive surgical approaches via sternotomy. Purpose To evaluate the feasibility, safety and efficacy of a MIDCAB procedure with concomitant thoracoscopic AF ablation. Methods We prospectively analysed all patients who underwent a minimally invasive, off-pump, MIDCAB through a left mini-thoracotomy with concomitant left-sided thoracoscopic AF ablation using a bipolar radio frequent clamp between 2017 and 2021. Results Twenty-three patients were included (age 69±8 years, BMI 29±4kg/m2, paroxysmal AF 61%, LAVI 42±11 ml/m2). All patients received an off-pump LIMA-LAD anastomosis. Ablation of the left (n=23) and right (n=22) pulmonary veins and box (n=21) was succeeded by epicardial validation of exit- and entrance block (n=22). No procedural complications were observed and complications during hospital admission and after discharge were: bleeding of the LIMA-LAD anastomosis n=1; myocardial infarction requiring percutaneous intervention of the LIMA-LAD n=1, respiratory insufficiency due to pleural effusion or atelectasis n=3, hospital readmission due to pleural- and pericardial effusion n=2. Duration of hospital stay was 6±2 days. After 12 months, 16/20 (80%) patients were in sinus rhythm when allowing anti-arrhythmic drugs and 18/20 (90%) patients were free from myocardial infarction. Conclusion Robot-assisted MIDCAB surgery for LIMA-LAD grafting concomitant with left-sided thoracoscopic AF ablation is a feasible, safe and efficacious minimally invasive treatment strategy for patients with a critical LAD stenosis and AF suitable for minimally invasive surgery. </jats:sec

Adherence to mobile health for intermittent rhythm monitoring to detect recurrences after emergency department visit for recent-onset atrial fibrillation: a subanalysis of the RACE 7 ACWAS trial

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Netherlands Organization for Health Research and Development–Health Care Efficiency Research Program Introduction In the Rate Control versus Electrical Cardioversion Trial 7–Acute Cardioversion versus Wait and See (RACE 7 ACWAS) trial an early cardioversion approach was compared to a delayed cardioversion approach for patients with recent-onset symptomatic atrial fibrillation (AF), followed by a four-week monitoring period using mobile health (mHealth). Purpose To evaluate the adherence and motivation to a four-week mHealth prescription to daily intermittent rhythm monitoring for recurrences after emergency department visit in patients with recent-onset AF. In addition, we studied predictors of mHealth adherence and motivation and evaluated whether recurrences during this four-week period influenced adherence and motivation patterns. Methods After the index visit, patients were asked to use an electrocardiographic-based telemetric device to record one minute heart rate and rhythm recordings three times daily and in case of symptoms during a period of four weeks. For patients who collected recordings for more than four weeks, data was censored at four weeks. Adherence and patient motivation based on the number of monitoring days and full monitoring days were evaluated. A p-value of &amp;lt;0.05 was considered statistically significant. Results 335 patients (58% men; median age 67±11 years) used the telemetric device and were included in the current analysis. The median overall adherence of all patients was 83.3% (IQR 29.9%). The median number of monitoring days was 27 (5), whereas the median number of full monitoring days was 16 (14). Age and the index episode being a recurrent paroxysm of AF rather than a first presentation were identified as independent predictors of adherence (odds ratio (OR) 1.037 (95%CI 1.015-1.060), p=0.001 and OR 1.863 (95%CI 1.190-2.916), p=0.007, respectively). Age (OR 1.031 (95%CI 1.009-1.053), p=0.005) and the use of antiarrhythmic drugs (OR 1.800 (95%CI 1.047-3.093), p=0.033) were identified as independent predictors of motivation. Patients with recurrences had significantly higher median adherence (87.7% vs 81.5%, p=0.028) and more full monitoring days (18 (14) days vs 15 (13) days, p=0.024), and were more likely to perform additional recordings (78.8% vs 49.2%, p=&amp;lt;0.001) compared to patients without recurrences. Conclusion Patients with recent-onset AF showed good adherence and motivation to a four-week mHealth prescription to monitor for AF recurrences after an emergency department visit for recent-onset AF. Adherence and motivation were high during the entire monitoring period, indicating that intermittent rhythm monitoring using mHealth is feasible for 1 month. Whether comparable mHealth adherence and motivation can be achieved in real world clinical scenarios outside a randomized study, warrants further observational studies. </jats:sec