Safety and Efficacy of Left Atrial Appendage Closure with the Amplatzer Cardiac Plug in Very High Stroke and Bleeding Risk Patients with Non-Valvular Atrial Fibrillation.

INTRODUCTION: Limited data exist on the outcomes after left atrial appendage closure (LAAC) with the Amplatzer™ Cardiac Plug (ACP; St. Jude Medical, Minneapolis, MN, USA) in patients with atrial fibrillation (AF) with very high stroke and bleeding risks, the subset expected to benefit most from this procedure. The objective of this study was to report clinical outcomes after LAAC with the ACP device in a very high stroke and bleeding risk cohort of patients with non-valvular AF and contraindications to oral anticoagulation (OAC). METHODS: LAAC using the ACP device was performed in 96 patients with AF who had median CHA2DS2-VASc and HAS-BLED scores of 5 and 3, respectively. Post-procedure, patients received dual antiplatelet therapy for 6 months. A transesophageal echocardiography (TEE) was scheduled at 6 months. RESULTS: Procedural success was 100%. Procedural-related complications occurred in 7.3% (pericardial effusion, 4.2%; thromboembolic events, 2.1%; device embolization, 1.0%). Additional thromboembolic events occurred in three patients during follow-up (92.7% follow-up). After 93.4 patient-years of follow-up, the annual rates of thromboembolic and major bleeding events were 3.2% and 1.1%, respectively. In those with TEE follow-up (70%), complete LAAC with no leaks was observed. Thrombus formation on the device was noted on TEE in two patients. CONCLUSION: LAAC using the ACP device was associated with an acceptable low rate of embolic and bleeding events after a median follow-up of 9 months in a cohort of patients with AF who were amongst the highest stroke and bleeding risks reported so far in LAAC trials.

Transcatheter aortic valve implantation in patients with severely reduced left ventricular systolic function: a single-center experience.

AIMS: Current guidelines consider severe systolic left ventricular dysfunction [ejection fraction (EF) ≤20 %; left ventricular dysfunction (LVD)] a contraindication for transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the efficacy and safety of TAVI in this extreme risk subset of patients. METHODS AND RESULTS: The study population (253 patients) was divided into two groups; the LVD group [21 patients with left ventricular ejection fraction (LVEF) ≤20 %] and the control group (232 patients with LVEF >20 %). TAVI was generally performed transfemorally under analgosedation without mechanical circulatory support. Clinical and hemodynamic variables, as well as procedural and follow-up outcomes, were compared, and all events were defined according to the Valve Academic Research Consortium criteria for event definition. Mean EF in the LVD group was 18.3 ± 2.9 % compared to 50.9 ± 11.3 % in the control group. Patients in the LVD group were younger, more commonly males, had higher logistic EuroSCORE and lower mean aortic pressure gradients. Immediate procedural mortality was low and similar in both groups (0 vs. 2.2 % in the LVD and control group, respectively, p = 0.49). At 30 days, post-procedural vascular and bleeding complications as well as strokes were similar, but all-cause mortality was higher in the LVD group (14.3 vs. 3.4 %, p = 0.05). In the survivors of the LVD group, New York Heart Association functional class and LVEF significantly improved at 30 days and 6 months. Survival at 1 and 2 years was 70.2 vs. 86.0 % and 56.1 vs. 78.3 % in the LVD and control group, respectively (log-rank p = 0.03). CONCLUSIONS: TAVI without mechanical circulatory support appears feasible, safe and effective in patients with severe aortic stenosis and severe LVD, but short- and long-term mortality remain high. TAVI should be considered a viable treatment option in this subset of extremely compromised patients.

Comparison of outcomes in patients having isolated transcatheter aortic valve implantation versus combined with preprocedural percutaneous coronary intervention.

Coronary artery disease negatively affects the outcome of patients undergoing surgical aortic valve replacement and practice guidelines recommend revascularization at time of surgery. In patients undergoing transcatheter aortic valve implantation (TAVI), the impact of preprocedural percutaneous coronary intervention (PCI) on TAVI outcome has not been examined. We aimed in the present study to assess the feasibility and safety of performing PCI before TAVI and to evaluate procedural, 30-day, and 6-month clinical outcomes. We retrospectively analyzed 125 patients who underwent successful TAVI at a single institution and divided them into an isolated TAVI and a PCI + TAVI group. During the study period, a strategy of preprocedural PCI of all significant (>50%) lesions in major epicardial vessels was adopted. Study end points were adjudicated in accordance with the Valve Academic Research Consortium consensus on event definition. All patients were treated with the Medtronic CoreValve prosthesis (n = 55 with PCI + TAVI and n = 70 with isolated TAVI). Thirty-day mortality was 2% versus 6% for patients treated with PCI + TAVI versus isolated TAVI, respectively (p = 0.27). Neither periprocedural nor spontaneous myocardial infarction occurred in either group. Rates of 30-day stroke, major bleeding, major vascular complications, and the Valve Academic Research Consortium-defined combined safety end point (11% vs 13%, p = 0.74) did not differ between the 2 groups. Patients' symptoms significantly improved in the first month after TAVI, and extent of improvement did not differ between groups. Adverse events at 6 months were comparable. In conclusion, PCI before TAVI appears feasible and safe. Based on these early results revascularization should become an important consideration in patients with coronary artery disease undergoing TAVI.

Haemodynamic evaluation of aortic regurgitation after transcatheter aortic valve implantation using cardiovascular magnetic resonance.

AIMS: Echocardiography may underestimate the degree of paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve bioprosthesis due to inherent limitations of ultrasound imaging in the evaluation of implanted cardiac prostheses. We aimed to evaluate the accuracy and feasibility of cardiovascular magnetic resonance (CMR) in quantifying regurgitant volume (RV) and regurgitant fraction (RF) in patients treated with this bioprosthesis for severe calcific aortic stenosis, and to compare the results with echocardiography and aortography. METHODS AND RESULTS: This study included 16 patients with a mean age of 78.7 years (eight women, eight men) who underwent successful TAVI using Medtronic CoreValve bioprosthesis. AR was evaluated by CMR, echocardiography, and aortography. Angiography was performed immediately after valve implantation. CMR and echocardiography were performed four weeks after valve implantation. There was a highly significant correlation between the CMR-derived and the angiographically-estimated degree of AR (r=0.86, p<0.001). On the other hand, there was only a limited correlation between CMR and echocardiography (r=0.374, p=0.15) as well as angiography and echocardiography (r=0.319, p=0.23) regarding the degree of AR. The weighted kappa for agreement between echocardiography and angiography was 0.14, for agreement between echocardiography and CMR 0.20, and for agreement between angiography and CMR 0.72. Echocardiography underestimated AR by one degree compared to CMR in five patients and 2 degrees in two patients; in six of these, the degree of AR obtained by CMR was similar to angiography. CONCLUSIONS: In patients undergoing TAVI, comparisons between purely quantitative measurements of AR by CMR and qualitative assessment by angiography showed better correlations than those with echocardiography. This suggests that echocardiography may underestimate the degree of AR and CMR in these circumstances has a great potential in reliably measuring the severity of AR in a quantitative manner.

Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis.

OBJECTIVES: The purpose of this study was to determine the predictors of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI). BACKGROUND: TAVI has been associated with a high rate of paravalvular regurgitation, usually mild. Nevertheless, moderate to severe regurgitations still occur and may have negative clinical consequences. METHODS: Fifty patients with severe aortic stenosis were recruited and underwent successful TAVI with the Medtronic CoreValve bioprosthesis through the transfemoral route. The end point of this study is the early occurrence of significant AR, defined as the occurrence of grade II or more AR by post-procedural aortography. RESULTS: The study population's mean age was 80.5 ± 7.9 years, with a mean aortic valve area of 0.64 ± 0.17 cm². Post-procedural AR was absent in 3 patients and was grade I in 27 patients, grade II in 13 patients, and grade III in 7 patients. Using univariate analysis, the chance of significant AR increased with increasing angle of left ventricular outflow tract to ascending aorta (∠LVOT-AO) (odds ratio: 1.24, p < 0.001). For the depth of the device in relation to the noncoronary cusp, there was a minimum chance of AR corresponding to depth = 9.5 mm (odds ratio: 1.1, p = 0.01). Using multivariate analysis, we found a greater chance of significant AR with a greater angle (odds ratio: 1.24, p = 0.001), and that the chance of significant AR is a minimum when depth of the device in relation to the noncoronary cusp is ∼10 mm (odds ratio: 1.1, p = 0.024). A predictive model was generated, and if 2 ×∠LVOT-AO + (depth to noncoronary cusp - 10)² ≥ 50, the likelihood of occurrence of significant AR could be predicted with a sensitivity of 85% and a specificity of 87%. CONCLUSIONS: The occurrence of significant AR after TAVI can be predicted by anatomic and procedural variables. A model such as that presented can be used to select suitable patients for this procedure and guide operators during implantation of the device.