No abstract

Background: In nonrandomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), fewer symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and midrange or preserved ejection fraction (EF ≥40%). We conducted the first randomized sham-controlled trial to evaluate the IASD in HF with EF ≥40%. Methods: REDUCE LAP-HF I (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association class III or ambulatory class IV HF, EF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg. Participants were randomized (1:1) to the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness end point was exercise PCWP at 1 month. The primary safety end point was major adverse cardiac, cerebrovascular, and renal events at 1 month. PCWP during exercise was compared between treatment groups using a mixed-effects repeated measures model analysis of covariance that included data from all available stages of exercise. Results: A total of 94 patients were enrolled, of whom 44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years, and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared with sham control ( P =0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mm Hg in the treatment group versus 0.5±5.0 mm Hg in the control group ( P =0.14). There were no peri-procedural or 1-month major adverse cardiac, cerebrovascular, and renal events in the IASD group and 1 event (worsening renal function) in the control group ( P =1.0). Conclusions: In patients with HF and EF ≥40%, IASD treatment reduces PCWP during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT02600234.

ClinicalTrials.gov identifier: NCT02600234.

No abstract

(1) Comparable PGs were found among the TAVs in different models; (2) pinwheeling indices were found to be different between both TAVs; (3) turbulence patterns among both TAVs translated according to RSS were different. Rigid aortic models yield more conservative estimates of turbulence; (4) both TAVs exhibit peak maximal RSS that exceeds platelet activation 100 Pa threshold limit.

First, supraannular axial deployment is associated with lower PGs irrespective of commissural alignment. Second, subannular deployment is associated with more favorable sinus hemodynamics and less LF. Further in vivo studies are needed to substantiate these observations and facilitate optimal prosthesis positioning during ViV procedures.

Sinus flow dynamics are highly sensitive to aortic root characteristics and transcatheter aortic valve aortic root interaction. Differences in sinus-flow washout and stasis regions between representative patient models may be reflected in different risks of leaflet thrombosis or valve degeneration.

Arterial load is comprised of resistive and various pulsatile components, but their relative contributions to left ventricular (LV) remodeling in the general population are unknown. We studied 4,145 participants enrolled in the Multi-Ethnic Study of Atherosclerosis, who underwent cardiac magnetic resonance imaging and radial arterial tonometry. We computed systemic vascular resistance (SVR=mean arterial pressure/cardiac output), and indices of pulsatile load including total arterial compliance (TAC, approximated as stroke volume/central pulse pressure), forward wave amplitude (Pf), and reflected wave amplitude (Pb). TAC and SVR were adjusted for body surface area to allow for appropriate gender comparisons. We performed allometric adjustment of LV mass for body size and gender, and computed standardized regression coefficients (β) for each measure of arterial load. In multivariable regression models that adjusted for multiple confounders, SVR (β=0.08;P<0.001), TAC (β=0.44;P<0.001), Pb (β=0.73;P<0.001), and Pf (β=-0.23;P=0.001) were significant independent predictors of LV mass. Conversely, TAC (β=-0.43;P<0.001), SVR (β=0.22;P<0.001), and Pf (β=-0.18;P=0.004) were independently associated with the LV wall/LV cavity volume ratio. Women demonstrated greater pulsatile load than men, as evidenced by a lower indexed TAC (0.89 versus 1.04 mL/mmHg/m2, P<0.0001), while men demonstrated a higher indexed SVR (34.0 versus 32.8 Wood Units*m2, P<0.0001). In conclusion, various components of arterial load differentially associate with LV hypertrophy and concentric remodeling. Women demonstrated greater pulsatile load than men. For both LV mass and the LV wall/LV cavity volume ratio, the loading sequence (i.e. early load versus late load) is an important determinant of LV response to arterial load.