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).
Background— To assess the prevalence, determinants, and prognosis value of right ventricular (RV) ejection fraction (EF) impairment in organic mitral regurgitation. Methods and Results— Two hundred eight patients (62±12 years, 138 males) with chronic organic mitral regurgitation referred to surgery underwent an echocardiography and biventricular radionuclide angiography with regional function assessment. Mean RV EF was 40.4±10.2%, ranging from 10% to 65%. RV EF was severely impaired (≤35%) in 63 patients (30%), and biventricular impairment (left ventricular EF<60% and RV EF≤35%) was found in 34 patients (16%). Pathophysiologic correlates of RV EF were left ventricular septal function (β=0.42, P <0.0001), left ventricular end-diastolic diameter index (β=−0.22, P =0.002), and pulmonary artery systolic pressure (β=−0.14, P =0.047). Mitral effective regurgitant orifice size (n=84) influenced RV EF (β=−0.28, P =0.012). In 68 patients examined after surgery, RV EF increased strongly (27.5±4.3–37.9±7.3, P <0.0001) in patients with depressed RV EF, whereas it did not change in others ( P =0.91). RV EF ≤35% impaired 10-year cardiovascular survival (71.6±8.4% versus 89.8±3.7%, P =0.037). Biventricular impairment dramatically reduced 10-year cardiovascular survival (51.9±15.3% versus 90.3±3.2%, P <0.0001; hazard ratio, 5.2; P <0.0001) even after adjustment for known predictors (hazard ratio, 4.6; P =0.004). Biventricular impairment reduced also 10-year overall survival (34.8±13.0% versus 72.6±4.5%, P =0.003; hazard ratio, 2.5; P =0.005) even after adjustment for known predictors ( P =0.048). Conclusions— In patients with organic mitral regurgitation referred to surgery, RV function impairment is frequent (30%) and depends weakly on pulmonary artery systolic pressure but mainly on left ventricular remodeling and septal function. RV function is a predictor of postoperative cardiovascular survival, whereas biventricular impairment is a powerful predictor of both cardiovascular and overall survival.
et al.. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years Methods and results. AimsThe MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone.At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm 2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause *Corresponding author. Hôpital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.
We demonstrated that the VWF defect reflects the balance between degradation induced by the shear stress and the endothelial release of new VWF triggered by the pulsatility. This modulation of VWF levels could explain the relationship between pulsatility and bleeding observed in CF-MCS recipients. Preservation of pulsatility may be a new target to improve clinical outcomes of patients.
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.
In organic MR, mitral deceleration time, mitral E/E' and left atrial volume correlate with PASP. Pulmonary artery systolic pressure > or = 50 mmHg is an independent predictor of overall and cardiovascular mortality after surgery in organic MR.
Characteristic cardiac valve abnormalities and left ventricular hypertrophy are present in untreated patients with mucopolysaccharidosis type VI (MPS VI). Cardiac ultrasound was performed to investigate these findings in subjects during long-term enzyme replacement therapy (ERT) with recombinant human arylsulfatase B (rhASB, rhN-acetylgalactosamine 4-sulfatase, galsulfase, Naglazyme®). Studies were conducted in 54 subjects before ERT was begun and at specific intervals for up to 96 weeks of weekly infusions of rhASB at 1 mg/kg during phase 1/2, phase 2, and phase 3 trials of rhASB. At baseline, mitral and aortic valve obstruction was present and was significantly greater in those ≥12 years of age. Mild mitral and trace aortic regurgitation were present, the former being significantly greater in those <12 years. Left ventricular hypertrophy, with averaged z-scores ranging from 1.6–1.9 SD greater than normal, was present for ages both <12 and ≥12 years. After 96 weeks of ERT, ventricular septal hypertrophy regressed in those <12 years. For those ≥12 years, septal hypertrophy was unchanged, and aortic regurgitation increased statistically but not physiologically. Obstructive gradients across mitral and aortic valves remained unchanged. The results suggest that long-term ERT is effective in reducing intraventricular septal hypertrophy and preventing progression of cardiac valve abnormalities when administered to those <12 years of age.
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.
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