Background: No randomized study powered to compare balloon-expandable (BE) with self-expanding (SE) transcatheter heart valve (THV) on individual endpoints after transcatheter aortic valve replacement (TAVR) has been conducted to date. Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry included 12,141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for native aortic stenosis (AS). Long-term mortality status was available in all patients (median 20 months, IQR:14-30). 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 co-primary outcome was the occurrence of paravalvular regurgitation (PVR)≥moderate and/or in-hospital mortality. The 2 nd co-primary outcome was 2-year all-cause mortality. Results: In matched-propensity analyses, the incidence of the 1st co-primary outcome was higher with SE-THV (19.8%) compared with BE-THV(11.9%; RR=1.68; 95%CI:1.46-1.91; p<0.0001). Each component of the outcome was also higher in SE-THV patients: PVR≥moderate (15.5% vs. 8.3%; RR=1.90; 95% CI:1.63-2.22; p<0.0001) and in-hospital mortality (5.6% vs 4.2%, RR=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 was 29.8%) and in 801 patients treated with BE-THV (2-year mortality 26.6%; HR=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. Conclusions: The present study suggests that use of SE-THV was associated with a higher risk of PVR and higher in-hospital and 2-year mortality as compared with BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare head-to-head the latest generation of SE and BE-THV.

Background Ultrasound ( US ) guidance provides the unique opportunity to control the puncture zone of the artery during transfemoral transcatheter aortic valve replacement and may decrease major vascular complications ( VC ) and life‐threatening or major bleeding complications. This study aimed to evaluate the clinical impact of US guidance using a propensity score–matched comparison. Methods and Results US guidance was implemented as the default approach for all transfemoral transcatheter aortic valve replacement cases in our institution in June 2013. We defined 3 groups of consecutive patients according to the method of puncture (fluoroscopic/ US guidance) and the use of a transcatheter heart valve. Patients in the US ‐guided second‐generation group (Sapien XT [Edwards Lifesciences, Irvine, CA], Corevalve [Medtronic, Dublin, Ireland]) were successfully 1:1 matched with patients in the fluoroscope‐guided second‐generation group (n=95) with propensity score matching. In a second analysis we described the consecutive patients of the US ‐guided third‐generation group (Evolut‐R [Medtronic], Sapien 3 [Edwards Lifesciences], n=308). All vascular and bleeding complications were reduced in the US ‐guided second‐generation group compared with the fluoroscope‐guided second‐generation group: VC (16.8% versus 6.3%; P =0.023); life‐threatening or major bleeding (22.1% versus 6%; P =0.004); and VC related to vascular access (12.6% versus 4.2%; P =0.052). In the US ‐guided third‐generation group the rates of major VC and life‐threatening or major bleeding were 3.2% (95% CI , 1.6% to 5.9%) and 3.6% (95% CI , 1.8% to 6.3%). In the overall population (n=546), life‐threatening or major bleeding was associated with a 1.7‐fold increased mortality risk ( P =0.02). Conclusions We demonstrated that US guidance effectively reduced VC and bleeding complications for transfemoral transcatheter aortic valve replacement and should be considered the standard puncture method. Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 02628509.

A total of 39 patients with bilateral post-thyroidectomy vocal cord paralysis in adduction underwent CO 2 laser subtotal arytenoidectomies with removal of the posterior third of the false and true vocal cords. Total airway resistance (R tot ) evaluated before and 4-10 months after surgery showed marked preoperative impairment before and significant improvement after surgery (P < 0.05). In five patients revision surgery was performed due to a progressive impairment of respiratory function. A variable degree of voice breathiness was observed after surgery; the maximum phonation time mean values were lower than normal and peak sound pressure levels 63 ± 5 dB. In three cases aspiration was present in the first postoperative days, but swallowing dysfunctions disappeared within 1 week. Subtotal arytenoidectomy with removal of the posterior third of the true and false vocal folds was found to be a satisfactory surgical treatment for bilateral vocal cord paralysis in adduction. However, further research is still needed to define the surgical procedure able to balance respiratory, phonatory and sphincteric functions optimally.

During summer 2014, three hypersaline brines were discovered in two frozen lakes of Boulder Clay (Northern Victoria Valley, Antarctica). Ongoing research seeks to gain novel insights on the microbial ecology of such environments, in order to further the understanding of life adaptation to extreme conditions. To this aim, the abundance of prokaryotic cells (including cell morphologies and size for biomass conversion), the amount of viable cells (in terms of membrane-intact cells and respiring cells), the viral count, the physiological profiles at community level and the main microbial enzymatic activities were described. The brines differed each other in terms of prokaryotic cells' abundance, size, and viability as well as viral abundance. Cell morphotypes and metabolic responses also varied among the brine samples. Underground interconnections were likely to occur, with the microbial community becoming more abundant and structured to better exploit the limited resource availability. Overall, complex interactions among multiple environmental factors, including marine water origin, depth horizon, isolation time of the brines, and climatic variations, reflected on the microbial community distribution patterns and highlighted the need to preserve these niches of extreme life.

Victoria Land permafrost harbours a potentially large pool of cold-affected microorganisms whose metabolic potential still remains underestimated. Three cores (BC-1, BC-2 and BC-3) drilled at different depths in Boulder Clay (Northern Victoria Land) and one sample (DY) collected from a core in the Dry Valleys (Upper Victoria Valley) were analysed to assess the prokaryotic abundance, viability, physiological profiles and potential metabolic rates. The cores drilled at Boulder Clay were a template of different ecological conditions (different temperature regime, ice content, exchanges with atmosphere and with liquid water) in the same small basin while the Dry Valleys site was very similar to BC-2 conditions but with a complete different geological history and ground ice type. Image analysis was adopted to determine cell abundance, size and shape as well as to quantify the potential viable and respiring cells by live/dead and 5-cyano-2,3-ditolyl-tetrazolium chloride staining, respectively. Subpopulation recognition by apparent nucleic acid contents was obtained by flow cytometry. Moreover, the physiological profiles at community level by Biolog-Ecoplate™ as well as the ectoenzymatic potential rates on proteinaceous (leucine-aminopeptidase) and glucidic (ß-glucosidase) organic matter and on organic phosphates (alkaline-phosphatase) by fluorogenic substrates were tested. The adopted methodological approach gave useful information regarding viability and metabolic performances of microbial community in permafrost. The occurrence of a multifaceted prokaryotic community in the Victoria Land permafrost and a large number of potentially viable and respiring cells (in the order of 10-10) were recognised. Subpopulations with a different apparent DNA content within the different samples were observed. The physiological profiles stressed various potential metabolic pathways among the samples and intense utilisation rates of polymeric carbon compounds and carbohydrates, mainly in deep samples. The measured enzymatic activity rates suggested the potential capability of the microbial community to decompose proteins and polysaccharides. The microbial community seems to be appropriate to contribute to biogeochemical cycling in this extreme environment.

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Background A reduction of admission for MI has been reported in most countries affected by COVID-19. No clear explanation has been provided. Methods To report the incidence of myocardial infarction (MI) admission during COVID-19 pandemic and in particular during national lockdown in two unequally affected French provinces (10-million inhabitants) with a different media strategy, and to describe the magnitude of MI incidence changes relative to the incidence of COVID-19-related deaths. A longitudinal study to collect all MIs from January 1 until May 17, 2020 (study period) and from the identical time period in 2019 (control period) was conducted in all centers with PCI-facilities in northern “Hauts-de-France” province and western “Pays-de-la-Loire” Province. The incidence of COVID-19 fatalities was also collected. Findings In “Hauts-de-France”, during lockdown (March 18–May 10), 1500 COVID-19-related deaths were observed. A 23% decrease in MI-IR (IRR=0.77;95%CI:0.71–0.84, p <0.001) was observed for a loss of 272 MIs (95%CI:−363,−181), representing 18% of COVID-19-related deaths. In “Pays-de-la-Loire”, 382 COVID-19-related deaths were observed. A 19% decrease in MI-IR (IRR=0.81; 95%CI=0.73–0.90, p <0.001) was observed for a loss of 138 MIs (95%CI:−210,−66), representing 36% of COVID-19-related deaths. While in “Hauts-de-France” the MI decline started before lockdown and recovered 3 weeks before its end, in “Pays-de-la-Loire”, it started after lockdown and recovered only by its end. In-hospital mortality of MI patients was increased during lockdown in both provinces (5.0% vs 3.4%, p =0.02). Interpretation It highlights one of the potential collateral damages of COVID-19 outbreak on cardiovascular health with a dramatic reduction of MI incidence. It advocates for a careful and weighted communication strategy in pandemic crises. Funding The study was conducted without external funding.

IMPORTANCE Approximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned. OBJECTIVE To evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018. MAIN OUTCOMES AND MEASURES Death from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year. RESULTS Among 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P = .13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P = .001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P = .37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P = .04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P = .87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status. CONCLUSIONS AND RELEVANCE Routine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.