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Background: Transcatheter aortic valve implantation (TAVI) is a rapidly evolving strategy for therapy of aortic stenosis. We describe the effect of the learning curve from the first 270 high-risk patients in Vancouver, Canada., Methods: Patients underwent TAVI by transfemoral (63%) or transapical (37%) routes using balloon expandable valves. The experience was divided into the first half (FH, patients 1-135) and second half (SH, patients 136-270)., Results: The mean age was 83.2 ± 8 years (FH 83 ± 12 vs. SH 81 ± 7 years, P = 0.12). The mean Society of Thoracic Surgeons Score (STS) was 9.5% ± 5.2%- FH 10.5 vs. SH 8.5% (P = 0.01). The overall procedural success rate in the FH was 92.6%, improving to 97.8% in the SH (P = 0.05). The transfemoral procedural success improved-FH 89.3% to SH 98.8% (P = 0.01). The transapical procedural success remained high-FH 98.0% to SH 96.1% (P = 0.53). The overall 30-day mortality was 9.6%, improving from FH 13.3% to SH 5.9% (P = 0.04). In the transfemoral cases, 30-day mortality decreased by 56% [10.7-4.7%, P = 0.14], and similarly in transapical cases [17.6-7.8%, P = 0.14]. In-hospital stroke occurred in 3.3% (FH 3.7% vs. SH 2.9%, P = 0.74). The overall need for a new permanent pacemaker was 5.9% (FH 5.9% vs. SH 5.9%, P = 1). The overall major vascular injury rate was 6.7% (FH 8.1% vs. SH 5.2%, P = 0.33). The overall incidence of coronary vessel occlusion was 1.1% (FH 1.5 % vs. SH 0.7%, P = 0.56). Device embolization or failure to cross the valve was rare and largely seen in the FH only. Procedural experience (>135 procedures) was an independent predictor of 30-day survival (HR: 6.7, 95% CI: 1.2-18.1, P = 0.03)., Conclusion: TAVI outcomes improve with experience and device development. While overall complication rates are low, scope remains to further reduce procedural adverse events., (Copyright © 2011 Wiley Periodicals, Inc.)

Objectives: This study assesses if there exists a high-risk period for cerebrovascular events (CeV) after transcatheter aortic valve implantation (TAVI)., Background: Even though acute strokes after TAVI have been described, it is uncertain if stroke rates continue to remain high in the early months after TAVI. Furthermore, the optimal dose and duration of thromboprophylaxis is unclear., Methods: Patients who underwent TAVI were evaluated at baseline, at discharge, at 1 and 6 months, and yearly. Risk factors for CeV events, procedural details, and antithrombotic therapy were recorded. Outcomes assessed were CeV events and death. The timing of such events, predictors, and impact on survival were analyzed., Results: A total of 253 patients were assessed. Median age was 85 years. The median Society of Thoracic Surgeons score was 8.1% (interquartile range [IQR]: 5.5% to 12.0%). Risk factors included smoking (47%), hypertension (70%), dyslipidemia (66%), and diabetes mellitus (25%). Twenty-three percent had known cerebrovascular disease and 39% had atrial fibrillation. Median follow-up was 455 days (IQR: 160 to 912 days) at which time 23 patients experienced a CeV event. The incidence was highest in the first 24 h but remained high for 2 months. In-hospital mortality rate after a CeV event was 21%. A prior history of CeV disease was an independent predictor of an event (hazard ratio: 4.23, 95% CI: 1.60 to 11.11, p = 0.004)., Conclusions: The incidence of CeV events is highest within 24 h of TAVI, but this risk may remain elevated for up to 2 months. A prior history of cerebrovascular disease is an independent predictor. This may have implications for patient selection and antithrombotic strategies., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aims to assess the mid- to long-term follow-up of patients after valve embolization at the time of transcatheter aortic valve implantation (TAVI)., Background: Transcatheter heart valve (THV) embolization is a rare but serious complication during TAVI. Although various techniques have been developed to manage acute complications and reduce periprocedural morbidity/mortality, long-term clinical and hemodynamic consequences after these events are unknown., Methods: Patients who developed THV embolization after TAVI were prospectively assessed. Clinical and echocardiographic characteristics were recorded at baseline and after successful TAVI/surgical aortic valve replacement. The THV migration and strut fractures/degeneration were assessed by computed tomography., Results: A total of 7 patients had THV embolization, all of which occurred immediately after valve deployment. The embolized THV was repositioned in the aortic arch proximal to the left subclavian artery (n = 2), immediately distal to the left subclavian artery (n = 2), and in the abdominal aorta (n = 3). A second THV was implanted successfully at the same sitting in 4 patients and at the time of a second procedure in 2 patients. Elective conventional aortic valve replacement was performed in 1 patient. Median follow-up was 1,085 days. One patient died during follow-up from an unrelated cause. The remaining 6 survivors were in New York Heart Association functional class I or II at final follow-up. Mid-term computed tomography follow-up (n = 4,591 to 1,548 days) showed that the leaflets of the embolized THV remain open in all phases of the cardiac cycle. There was also no strut fracture or migration of these valves., Conclusions: Clinical outcomes remain good when THV embolization is managed effectively. There are no apparent hemodynamic consequences of a second valve placed in the series. These embolized valves remain in a stable position with no evidence of strut fractures at mid-term follow-up., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We describe initial human experience with a novel cerebral embolic protection device., Background: Cerebral emboli are the major cause of procedural stroke during percutaneous aortic valve interventions., Methods: With right radial artery access, the embolic protection device is advanced into the aortic arch. Once deployed a porous membrane shields the brachiocephalic trunk and the left carotid artery deflecting emboli away from the cerebral circulation. Embolic material is not contained or removed by the device. The device was used in 4 patients (mean age 90 years) with severe aortic stenosis undergoing aortic balloon valvuloplasty (n = 1) or transcatheter aortic valve implantation (n = 3)., Results: Correct placement of the embolic protection device was achieved without difficulty in all patients. Continuous brachiocephalic and aortic pressure monitoring documented equal pressures without evidence of obstruction to cerebral perfusion. Additional procedural time due to the use of the device was 13 min (interquartile range: 12 to 16 min). There were no procedural complications. Pre-discharge cerebral magnetic resonance imaging found no new defects in any of 3 patients undergoing transcatheter aortic valve implantation and a new 5-mm acute cortical infarct in 1 asymptomatic patient after balloon valvuloplasty alone. No patient developed new neurological symptoms or clinical findings of stroke., Conclusions: Embolic protection during transcatheter aortic valve intervention seems feasible and might have the potential to reduce the risk of cerebral embolism and stroke., (Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)