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.

EuroSCORE is a good global predictor of long-term outcomes in high-risk but not in low-risk patients after unprotected left main angioplasty.

BACKGROUND: Percutaneous coronary intervention is increasingly emerging as a valuable alternative to surgery for the treatment of patients with unprotected left main coronary artery (ULMCA) disease. In this study, we aimed to assess the ability of the EuroSCORE risk stratification model to predict long-term major adverse cardiac events after unprotected left main angioplasty according to the individual level of risk. METHODS: Two hundred forty-six consecutive patients who underwent ULMCA in a single high volume center over a 5-year period were included. Major adverse cardiac events were defined as a combined end point of cardiac death, nonfatal myocardial infarction, or target lesion revascularization. RESULTS: Areas under the receiver-operating characteristic curve of EuroSCORE in the entire cohort were 0.687 (P = 0.005; 95% CI: 0.575-0.846) and 0.589 (P = 0.038; 95% CI: 0.511-0.673) respectively for cardiac death and major adverse cardiac events (MACE). One hundred twenty-four patients had a EuroSCORE value > 6 and constituted the high surgical risk (HSR) group. Actuarial 4-year survivals free from cardiac death and free from MACE were significantly lower in this group respectively at 84% versus 93% (log rank P = 0.02) and 50% versus 74% (log rank P = 0.004). EuroSCORE was the only independent predictor of long-term cardiac mortality by the Cox analysis (HR = 3.95, P = 0.027, 95% CI: 1.16-13.39). It had a good discriminatory power for predicting both cardiac death and MACE with AUC respectively at was 0.705 (P = 0.01, 95% CI: 0.55-0.86) and 0.65 (P = 0.013, 95% CI: 0.54-0.78) in the HSR cohort but not in the lower risk (EuroSCORE ≤ 6) cohort. CONCLUSION: EuroSCORE is a good predictor not only of cardiac death but also of MACE after ULMCA angioplasty; however, the discriminatory ability of EuroSCORE appears to be limited to patients with high surgical risk as defined by EuroSCORE values > 6.

Everolimus-eluting stent for the treatment of bare metal in-stent restenosis: clinical and angiographic outcomes at nine-month follow-up of XERES (Xience Evaluation in bare metal stent REStenosis) trial.

AIMS: Restenosis is a frequent complication of coronary stent implantation, especially bare metal stent (BMS) implantation. The everolimus-eluting stent (EES) has previously been shown to be efficacious in the treatment of de novo lesions. We performed this study to evaluate clinical, angiographic and IVUS results after EES implantation for the treatment of BMS ISR. XERES was a prospective, multicentre, nationwide study, enrolling 97 consecutive patients with in-stent restenosis (ISR) after BMS implantation across 20 centres in France. Suitable lesions had a reference vessel diameter between 2.5 mm and 4 mm, a length ≤22 mm and a diameter stenosis between 50 and 100%. The primary endpoint was angiographic in-stent late loss (LL) as determined by quantitative coronary angiography (QCA) at nine-month follow-up. QCA was required to be performed in each included patient and IVUS was performed in a subgroup of 27 patients. At nine-month follow-up, the in-stent late loss was 0.35±0.63 mm. The rate of in-stent binary restenosis was 12.22%, including two complete occlusions. The average volume of neointimal hyperplasia was 15.6±9.9 mm3. The in-stent percent volume obstruction was 8.5±5.2%. The in-segment percent area and diameter obstruction were 32±17% and 27±11%, respectively. Two initial malappositions were persistent and two other patients had late acquired stent malapposition. The cumulative incidence of major adverse cardiac events (MACE) was 10.1%. EES for the treatment of bare metal in-stent restenosis seemed safe and efficacious.

Percutaneous management of lower limb ischemia after the use of vascular closure devices.

BACKGROUND: Lower extremity ischemia after the use of vascular closure devices (VCDs) after transfemoral percutaneous coronary and peripheral interventions is an infrequent though relevant clinical entity. We aimed to assess immediate and midterm outcomes of a systematic endovascular approach for the treatment of VCD-related lower limb ischemia. METHODS: Between 2006 and 2008, all the patients who developed lower limb ischemia after the use of a VCD in a high volume French institution were systematically managed percutaneously and constituted the study population. Clinical characteristics, immediate, and midterm outcomes are reported. RESULTS: Of 2944 consecutive patients undergoing VCD placement after femoral access, 18 (3 men and 15 women) had VCD-related lower limb ischemia and were all managed percutaneously. Median age was 66.5 years. Devices were Angio-Seal (St Jude Medical) in 12 cases, StarClose (Abbott Vascular Devices) in 3 cases, and Perclose (Abbott Vascular Devices) in 3 cases. Limb ischemia occurred with a median delay of 2 days after device placement. Index procedures were coronary interventions in 14 cases and peripheral in 4 cases. The occlusion site was successfully crossed in all cases. Twelve patients were treated with balloon angioplasty and 6 with stent implantation. Angiographic success was obtained in all cases. After a median 32-month follow-up, only 2 patients initially treated using percutaneous transluminal angioplasty needed reintervention consisting of a balloon angioplasty in 1 case and stent implantation in the second case. At final follow-up, all the patients were asymptomatic. CONCLUSIONS: Endovascular treatment for VCD-related limb ischemia is a feasible and effective approach resulting in excellent immediate and midterm outcomes.

Unprotected left main angioplasty in nonagenarians: clinical characteristics, procedural features and outcome: a case series study.

UNLABELLED: Limited information is available on clinical characteristics and outcomes in very old patients with unprotected left main coronary artery disease (ULMCA) undergoing percutaneous coronary intervention (PCI). METHODS: From January 2004 and December 2008, 248 patients with ULMCA stenosis underwent coronary revascularization with stent implantation. Among those, 6 were older than 90 years at the time of the procedure and were included in this study. RESULTS: There were 5 males and 1 female; mean age was 91.5 years (range 91-93). All the patients presented with acute coronary syndromes. All of them had multivessel disease with a distal left main stenosis in 4 patients. All were deemed inoperable, with a mean EuroSCORE of 12.66 (range 10-20) and a predicted mortality at 34% (range15.8-86.6%). 5 patients received bare-metal stents and 1 patient a paclitaxel-eluting stent. Rotational atherectomy was required in 2 patients. Provisional side branch T-stenting with final kissing balloons was the technique used in all bifurcation lesions. Angiographic success was obtained in all patients. There were no in-hospital deaths or complications. After a 29.8-month (range 8-59) mean follow up period, a myocardial infarction caused by late stent thrombosis occurred in 1 patient and ischemia-driven target vessel revisualization was required in another; however, all patients were alive. CONCLUSION: In the very elderly patients at excessively high risk for surgery, PCI for ULMCA disease is a suitable alternative with excellent short-term results and acceptable long-term outcomes.