Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial).

BACKGROUND: Prolonged dual-antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention can be challenging. We assessed the clinical safety of bare-metal stent (BMS) implantation followed by drug-coated balloon (DCB) treatment in HBR patients for whom drug-eluting stent implantation could be problematic in maintaining low ischemic event rate without increasing hemorrhagic events. METHODS: The study included patients with at least 1 de novo lesion who were either under long-term anticoagulant treatment or required semi-urgent non-coronary intervention. The strategy consisted of PRO-Kinetic Energy BMS stent (Biotronik AG) implantation followed by Pantera Lux DCB (Biotronik AG) and patients were followed for up to 12 months in 37 French centers. RESULTS: Between October 2013 and April 2015, a total of 432 patients with 623 de novo lesions who were either under long-term anticoagulant treatment (n = 300) or required semi-urgent non-cardiac surgery (n = 132) were treated by BMS plus DCB. Mean patient age was 74.1 ± 9.1 years, 76.4% were men, and 38% were diabetic. The composite primary endpoint rate (defined as target-lesion failure at 12 months) was 5.6% (95% confidence interval, 3.3-7.9). Median duration for DAPT treatment was 33 days. Hemorrhagic events, as defined by the Bleeding Academic Research Consortium, occurred in 31 patients (7.2%) and definite stent thrombosis occurred in 5 patients (1.3%). CONCLUSIONS: The combination of BMS plus DCB intervention is safe even with a short duration of DAPT. This strategy might be an alternative to DES implantation in HBR patients if future randomized trials support this approach.

EFFICACY OF AN ADDITIONAL MOBILE LEADED SHIELD ON OPERATOR RADIATION DURING PERCUTANEOUS CORONARY ANGIOGRAPHY.

Operator radiation protection during percutaneous coronary angiography (CA) is a growing concern in the catheterisation laboratory (cath lab). The purpose of this study was to evaluate the efficacy of an additional mobile leaded shield on operator radiation exposure during diagnostic CA. The study involved two operators from the same cath lab and patients scheduled for diagnostic coronary catheterisation over a period of 2 months. Procedures were performed with standard radiation equipment during the first month. An additional mobile lead shield was added during the second month. Radiation exposure was measured by three dosimeters positioned on the operator's left hand, on their chest under the lead apron and on lead glasses. The intra-operator results were compared. Ninety-nine per cent of the procedures were carried out by radial access. For Operators 1 and 2, the mobile shield, respectively, decreased the radiation dose to the eyes by 43 and 33 % and to the hands by 61 and 83 %. Thorax dose was less than the minimum measurable dose (<0.01 mSv) for each operator. There was no significant difference in total procedure duration, fluoroscopy time or contrast dose required between the two groups of patients. Improved operator radiation protection is an important issue in the face of increased occupational doses. Mobile leaded shield, combined with standard preventive measures, seems to be an effective additional option to reduce the radiation exposure during diagnostic CA.

Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. OBJECTIVES: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. METHODS: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. RESULTS: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased. CONCLUSIONS: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).

Direct coronary stenting without balloon predilation of lesions requiring long stents: immediate and 6-month results of a multicenter prospective registry.

To assess the outcomes of direct coronary stenting (DS) using long stents and examine predictive factors of DS failure, this prospective multicenter registry included 128 consecutive patients who underwent the implantation of stents >or= 18 mm in length without balloon predilation for de novo coronary artery stenoses. Mean lesion and stent lengths were 20.7 +/- 5.4 and 21.4 +/- 3.8 mm, respectively. Rates of DS success, lesion success, and primary success were 82%, 99%, and 97.7%, respectively. At 6 months, rates of MACE and TVR were 12.5% and 6.3%, respectively. In multivariate analysis, factors predictive of DS failure vs. DS success were presence of calcifications (78% vs. 45%; P = 0.004) and reference vessel diameter (2.77 +/- 0.4 vs. 3.13 +/- 0.42 mm; P = 0.0002). DS of complex lesions with stents >or= 18 mm in length was performed safely and with a high success rate. This strategy was less successful in the treatment of small vessels and in presence of calcifications.