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Background: Transcatheter aortic valve implantation (TAVI) is a very effective treatment option for patients with severe aortic stenosis who are either not suitable candidates or at high risk for surgical aortic valve replacement (AVR). Patients undergoing TAVI are often very elderly and their clinical status is burdened with multiple comorbidities, therefore evaluation of quality of life (QoL) might be challenging. We sought to provide an overview of available data on QoL changes after TAVI and critical insights on the instruments used to detect these changes., Methods: This analysis focuses on studies that evaluated QoL after TAVI with standardized questionnaires. Out of 706 items identified through literature search, 23 studies were included in the final review: 2 randomized controlled trials (one comparing QoL pre- vs post-TAVI, one TAVI vs AVR vs medical therapy) and 21 observational studies (19 studies comparing QoL pre- and post-TAVI and 2 studies TAVI vs AVR). The instruments used in all studies were not specific for TAVI patients., Results: Most studies reported a significant improvement in QoL after TAVI, greater for physical aspects compared with psychological components, which persisted at mid and long-term follow-up. A short-term benefit was found for transfemoral TAVI patients as compared with transapical TAVI and AVR; however, these differences tended to disappear over time., Conclusions: The study highlights an improvement in QoL after TAVI that persists over time. As different instruments resulted to be more sensitive to detect different aspects, multidimensional assessments - capable of combining disease-specific and disease-non-specific measures - should foster clinical research in order to have a more complete picture of QoL of TAVI patients.

Rationale: The impact of transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR) on cognitive status and quality of life in high-risk patients has been incompletely investigated., Methods: We conducted a prospective, multicenter study including all patients treated with TAVI and high-risk patients undergoing AVR (age ≥80 years or logistic EuroSCORE ≥15%) at participating centers. Multidimensional geriatric evaluation including Mini Mental State Examination (MMSE), EuroQol 5D (EQ5D) and Minnesota Living With Heart Failure Questionnaire (MLHFQ) were performed at baseline and at 3- and 12-month follow-up., Results: A total of 518 patients (151 AVR and 367 TAVI) were enrolled in 10 Italian institutions. Patients receiving AVR were older (82.7 ± 2.4 years), with a lower logistic EuroSCORE (12.5 ± 7.1%) as compared with TAVI patients (81.5 ± 6.2 years and 19.6 ± 14.0%, respectively, p=0.001 and p<0.001). Overall, 35.5% of patients showed some degree of cognitive impairment at baseline, with no differences between groups. No significant changes in the cognitive status were observed between baseline and follow-up and between groups at any time point. TAVI patients had a lower quality of life at baseline as compared with AVR patients. Generic and heart failure-related quality of life improved significantly after either procedure., Conclusions: In high-risk patients, both TAVI and AVR are associated with a significant improvement of quality of life up to 1 year without a detrimental effect on cognitive function.

Objectives: To evaluate the short- and mid-term clinical and echocardiographic outcome of HELEX Septal Occluder (HSO) implantation in patients with patent foramen ovale (PFO) and atrial septal aneurysm (ASA)., Background: Percutaneous closure of PFO and ASA with HSO device has not been systematically studied., Methods: We studied 90 patients with PFO and ASA with documented paradoxical embolic events. The procedural and clinical results of 30 consecutive patients treated with HSO were compared with those obtained in 30 consecutive patients treated with the Amplatzer PFO (APO) and with those of a further 30 consecutive patients treated with the Amplatzer Cribriform (AMF). Primary endpoint was the persistence of moderate to severe residual right-to-left shunting (rRLS) at 6-month follow-up. The incidence of death or recurrent embolic events (REE) at 1-year follow-up were also investigated., Results: The procedure was successfully completed in all patients. There was one HSO device embolization. Immediate moderate RLS was significantly higher in the HSO group compared to APO and AMF groups (20% vs 3% vs 0%, respectively; P=.008). The incidence of moderate rRLS decreased but was still significant at 6-month follow-up (17% in the HSO group vs 3% in the APO group; P=.02). At 1-year follow-up, moderate rRLS persisted only in the HSO group (7%). No deaths or REE were observed during hospitalization or at 1-year follow-up., Conclusion: HSO device seems to be a second-line device as compared to Amplatzer occluders for the treatment of PFO and ASA.

Objective: We sought to evaluate the short- and longterm outcomes of Amplatzer Multi-Fenestrated Septal Occluder Cribriform (AMF) device use in the percutaneous closure of patent foramen ovale (PFO) associated with atrial septal aneurysm (ASA)., Background: Since patients with PFO, associated with ASA, are at higher risk of embolic events (EE), the AMF device might offer advantages in this subgroup of patients., Methods: Overall, 38 consecutive patients, with both PFO and ASA, underwent percutaneous closure of the defect with the AMF device, and the results were compared to those in 38 patients with PFO and ASA treated with the Amplatzer PFO device (APO). Death due to embolism, stroke or transient ischemic attack (TIA) were considered recurrent EE. Pre- and post-intervention shunting and 6-month residual shunting were evaluated echocardiographically with intravenous contrast injection., Results: The procedure was successfully completed in all patients in both groups. No procedure-related complications were observed during hospitalization. Immediate closure was achieved in all patients in the AMF group, whereas 3 patients in the APO group showed a small residual shunt. Residual shunting was observed at 6 months in 2 patients in the APO group. No recurrence of EE was recorded in the AMF group. Recurrent TIA was observed in 3 patients in the APO group; 2/3 patients had a small residual shunt following the procedure and at 6-month follow up., Conclusion: The AMF device might offer advantages in terms of rate of EE recurrence or residual shunt compared to the APO device in PFO patients associated with ASA.