Microtransesophageal Echocardiographic Guidance during Percutaneous Interatrial Septal Closure without General Anaesthesia.

OBJECTIVE: To study the safety and efficacy of microtransesophageal echocardiography (micro-TEE) and TEE during percutaneous atrial septal defect (ASD) and patent foramen ovale (PFO) closure. BACKGROUND: TEE has proven to be safe during ASD and PFO closure under general anaesthesia. Micro-TEE makes it possible to perform these procedures under local anaesthesia. We are the first to describe the safety and efficacy of micro-TEE for percutaneous closure. METHODS: All consecutive patients who underwent ASD and PFO closure between 2013 and 2018 were included. The periprocedural complications were registered. Residual shunts were diagnosed using transthoracic contrast echocardiography (TTCE). All data were compared between the use of TEE or micro-TEE within the ASD and PFO groups separately. RESULTS: In total, 82 patients underwent ASD closure, 46 patients (49.1 ± 15.0 years) with TEE and 36 patients (47.8 ± 12.1 years) using micro-TEE guidance. Median device diameter was, respectively, 26 mm (range 10-40 mm) and 27 mm (range 10-35 mm). PFO closure was performed in 120 patients, 55 patients (48.6 ± 9.2 years, median device diameter 25 mm, range 23-35 mm) with TEE and 65 patients (mean age 51.0 ± 11.8 years, median device diameter 27 mm, range 23-35 mm) using micro-TEE. There were no major periprocedural complications, especially no device embolizations within all groups. Six months after closure, there was no significant difference in left-to-right shunt after ASD closure and no significant difference in right-to-left shunt after PFO closure using TEE or micro-TEE. CONCLUSION: Micro-TEE guidance without general anaesthesia during percutaneous ASD and PFO closure is as safe as TEE, without a significant difference in the residual shunt rate after closure.

Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient-years of follow up.

OBJECTIVE: To evaluate the safety and efficacy of the Occlutech patent foramen ovale (PFO) device at long-term follow-up (FU). BACKGROUND: The Occlutech device has been proven safe and effective six-months after percutaneous PFO closure. We describe the safety and efficacy after more than 1,300 patient-years of FU. METHODS: All consecutive patients who underwent PFO closure between October 2008 and December 2015 were included. All complications were registered. Residual right-to-left shunt (RLS) was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe. RESULTS: In total, 250 patients (mean age 53.5 ± 10.7 years, 46.8% female) underwent percutaneous PFO closure using the Occlutech device. Mean FU was 5.9 ± 1.8 years, a total of 1,345 patient-years. Transient ischemic attack (TIA) or stroke was the main indication for closure (89.6%). Implantation was successful in 100%, no major complications occurred. Minor complications were inguinal hematoma in 16 patients (6.4%), pericardial effusion without the need for intervention in one patient (0.4%) and a supraventricular tachycardia in one patient (0.4%). A moderate or large shunt at one-year follow up was present in 5.9%. A cerebrovascular vascular event occurred in 2.0% at 1-year FU (four TIA, one stroke) and in 7.4% at long-term FU (nine TIA, eight stroke). The total cerebrovascular event rate (TIA and CVA) was 0.02% per patient-year of FU, with a stroke rate of 0.01%. CONCLUSION: The Occlutech device appears to be safe at long-term FU with a very low annual cerebrovascular event rate and a low moderate to large shunt rate at 1-year FU.