Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Multiobjective patient-specific estimation of a coronary circulation model for triple vessel disease.

Computational models can help understand the hemodynamics of the coronary circulation, which is of the upmost importance to help clinicians before, during and after a coronary artery bypass graft surgery. In this paper, we propose a multiobjective optimization method for parameter estimation of a computational model representing the coronary circulation on patients with a triple vessel disease. This estimation was not based on any assumption regarding the development of the collateral circulation, like in previous works. Indeed, the collateral development of a given patient is estimated through the model parameters. Parameter estimation was performed using clinical data from three patients, obtained before and during an off-pump coronary artery bypass graft surgery (CABG). Results showed a better performance when comparing the simulation with clinical data, since the total error estimation for three patients was reduced by 40 ± 22%. Moreover, the proposed method provides new insight regarding the heterogeneous configuration of the alternative collateral vessels.

Complicated acute type B aortic dissection: midterm results of emergency endovascular stent-grafting.

OBJECTIVE: This study assessed midterm results of emergency endovascular stent-grafting for patients with life-threatening complications of acute type B aortic dissection. METHODS: Between November 1996 and June 2004, 16 patients with complicated acute type B aortic dissections (mean age 57 years, range 16-88 years) underwent endovascular stent-grafting within 48 hours of presentation. Complications included contained rupture, hemothorax, refractory chest pain, and severe visceral or lower limb ischemia. Stent-graft types included custom-made first-generation endografts and second-generation commercial stent-grafts (Gore Excluder or TAG; W. L. Gore & Associates, Inc, Flagstaff, Ariz.). Follow-up was 100% complete, averaged 36 +/- 36 months, and included postprocedural surveillance computed tomographic scans. RESULTS: Early mortality was 25% +/- 11% (70% confidence limit), with no late deaths. No new neurologic complications occurred. According to the latest scan, 4 patients (25%) had complete thrombosis of the false lumen; the lumen was partially thrombosed in 6 patients (38%). Distal aortic diameter was increased in only 1 patient. Actuarial survival at 1 and 5 years was 73% +/- 11%; freedom from treatment failure (including aortic rupture, device fault, reintervention, aortic death, or sudden, unexplained late death) was 67% +/- 14% at 5 years. CONCLUSION: With follow-up to 9 years, endovascular stent-grafting for patients with complicated acute type B aortic dissection conferred benefit. Consideration of emergency stent-grafting may improve the dismal outlook for these patients; future refinements in stent-graft design and technology and earlier diagnosis and intervention should be associated with improved results.