One year outcome and analysis of peri-device leak of left atrial appendage occlusion devices.

BACKGROUND: The prevalence of peri-device leak (PDL) of left atrial appendage occlusion (LAAO) devices has been previously reported. However, there have been only few data that compared different existing devices. The aim of this study was to assess the incidence of PDL with both devices WATCHMAN®, Boston Scientific and AMPLATZER Amulet®, Abbott Laboratories and to evaluate the clinical outcome at 12 months. METHODS: Consecutive patients who underwent LAAO between January 2018 and 2020 were randomly assigned to either WATCHMAN or AMPLATZER Amulet implantation based on a systematic 2-week alternation between both devices. LAA measurements were assessed using cardiac computed tomography angiography (CCTA) prior to and transesophageal echocardiography (TEE) during the procedure. At 8 weeks post-LAAO, patients underwent TEE and/or CCTA to identify the presence of PDL and/or device-related complications. Patients were then followed for 12 months to identify major adverse cardiovascular/embolic events. RESULTS: The cohort consisted of 51 patients (25 WATCHMAN, 26 AMPLATZER Amulet; mean age 76 ± 7 years; male gender 76%). Both groups were identically matched for demographics, comorbidities, and indication for LAAO. There were 19 patients who had PDL (13 WATCHMAN vs. 6 AMPLATZER Amulet, P-value = 0.033). Of them, 8 (15%) patients had significant PDL (7 WATCHMAN vs. 1 AMPLATZER Amulet, P-value = 0.018). On CCTA, the landing zone maximal diameter of the AMPLATZER Amulet device had the strongest correlation with the final deployed device size (Spearman's rho 0.92, P-value < 0.0001). In the multivariate analysis, male gender and device type were independent predictors of any PDL (P-values 0.016 and 0.031, respectively). On a mean follow-up of 12 months, the total number of events was more prevalent in the WATCHMAN group (P-value 0.008), but the incidence of cardio-embolic events reached borderline significance (16% vs. 0%, P-value = 0.051). CONCLUSIONS: Among patients who underwent LAAO, almost 15% had significant PDL with the majority belonging to the WATCHMAN group. Still, larger studies are warranted to evaluate its effectiveness in stroke prevention.

Case report: iatrogenic left ventricular outflow tract to right atrium fistula after trans-femoral transcatheter aortic valve implantation associated with asymmetric septal hypertrophy.

BACKGROUND: The transcatheter aortic valve implantation (TAVI) is becoming a leading treatment option for symptomatic aortic stenosis for patients in all surgical risk categories. Recognition and management of potential complications are essential to ensure patient life and comfort. We present here a case report of a left ventricular outflow tract (LVOT) to right atrium (RA) fistula which is an extremely rare complication after TAVI. CASE SUMMARY: An 85-year-old man with symptomatic severe aortic stenosis and non-obstructive asymmetric septal hypertrophy (ASH) underwent a transfemoral TAVI. Soon after the procedure, he developed chest pain and atrial fibrillation with rapid ventricular response. A transthoracic echocardiography followed by a transoesophageal echocardiography showed a small pseudo-aneurysm with a fistulous tract between the LVOT and the RA. This was confirmed by a contrast computed tomography scan of the heart. The patient remained asymptomatic throughout the rest of hospitalization. He was treated with diuretics and discharged home. One month follow-up showed increase in the width, jet size, and gradient of the fistula but the patient remained asymptomatic. The decision by Heart team was to closely monitor him for symptoms since the fistula is difficult to access percutaneously. DISCUSSION: We report a unique case of an LVOT to RA fistula in the setting of ASH that occurred post-TAVI. Alcohol septal ablation was proposed pre-TAVI for patients having septal thickening >15 mm and dynamic obstruction. Treatment options for iatrogenic fistula vary from symptomatic treatment to percutaneous or surgical closure.