To assess the feasibility and accuracy of determining bioprosthetic aortic valve area from two-dimensional and Doppler echocardiographic measurements, three partially overlapping groups were selected from 55 patients with such bioprosthetic valves and adequate Doppler studies. These were Group 1, 37 patients with recent aortic valve replacement surgery and no clinical or echocardiographic evidence of valve dysfunction; Group 2, 12 patients with prosthetic valve stenosis documented by cardiac catheterization; and Group 3, 22 patients with both Doppler and catheterization studies in whom noninvasive and invasive determinations of aortic valve area could be directly compared. Left ventricular outflow tract diameter was measured from two-dimensional still frame images. Flow velocity proximal to the aortic valve, transvalvular velocity and acceleration time were determined from pulsed and continuous wave Doppler spectra. Aortic valve gradient was calculated with the modified Bernoulli equation and valve area by the continuity equation. In the 37 patients with a normally functioning valve, the calculated mean gradient ranged from 5 to 25 mm Hg (average 13.6 +/- 5.2) and valve area from 1.0 to 2.3 cm2 (mean 1.6 +/- 0.31). Linear regression analysis of prosthetic aortic valve area determined by Doppler imaging and cardiac catheterization demonstrated a high correlation (r = 0.93) between the two techniques. Comparison of the patients with and without prosthetic valve stenosis revealed statistically significant differences in mean gradient (42.8 +/- 12.3 versus 13.6 +/- 5.2 mm Hg; p = 0.0001), acceleration time (116 +/- 15 versus 80 +/- 13 ms; p = 0.0001) and valve area by the continuity equation (0.80 +/- 0.16 versus 1.6 +/- 0.31 cm2; p = 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)
IMPORTANCE Sodium glucose cotransporter 2 inhibitors reduce morbidity and mortality in patients with heart failure and reduced ejection fraction (HFrEF). Clinicians may find estimates of the projected long-term benefits of sodium glucose cotransporter 2 inhibitors a helpful addition to clinical trial results when communicating the benefits of this class of drug to patients. OBJECTIVE To estimate the projected long-term treatment effects of dapagliflozin in patients with HFrEF over the duration of a patient's lifetime.DESIGN, SETTING, AND PARTICIPANTS Exploratory analysis was performed of Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF), a phase 3 randomized, placebo-controlled clinical trial conducted at 410 sites in 20 countries. Patients with an ejection fraction less than or equal to 40% in New York Heart Association functional classification II to IV and elevated plasma levels of N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019. Mean (SD) duration of follow-up was 17.6 (5.2) months.INTERVENTIONS Dapagliflozin, 10 mg, once daily vs placebo in addition to standard therapy. MAIN OUTCOMES AND MEASURESThe primary composite outcome was time to first hospitalization for heart failure, urgent heart failure visit requiring intravenous therapy, or cardiovascular death. The trial results were extrapolated to estimate the projected long-term treatment effects of dapagliflozin over the duration of a patient's lifetime for the primary outcome and the secondary outcome of death from any cause.RESULTS A total of 4744 patients (1109 women [23.4%]; 3635 men [76.6%]) were randomized in DAPA-HF, with a mean (SD) age of 66.3 (10.9) years. The extrapolated mean event-free survival for an individual aged 65 years from a primary composite end point event was 6.2 years for placebo and 8.3 years for dapagliflozin, representing an event-free survival time gain of 2.1 years (95% CI, 0.8-3.3 years; P = .002). When considering death from any cause, mean extrapolated life expectancy for an individual aged 65 years was 9.1 years for placebo and 10.8 years for dapagliflozin, with a gain in survival of 1.7 years (95% CI, 0.1-3.3; P = .03) with dapagliflozin. Similar results were seen when extrapolated across the age range studied. In analyses of subgroups of patients in DAPA-HF, consistent benefits were seen with dapagliflozin on both event-free and overall survival. CONCLUSIONS AND RELEVANCEThese findings indicate that dapagliflozin provides clinically meaningful gains in extrapolated event-free and overall survival. These findings may be helpful in communicating the benefits of this treatment to patients with HFrEF.TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03036124
Objective: To determine whether the benefits of dapagliflozin in patients with heart failure and reduced ejection fraction (HFrEF) and type 2 diabetes in DAPA-HF varied by background glucose-lowering therapy (GLT). Research design and methods: We examined the effect of study treatment by the use or not of GLT, and by GLT classes and combinations. The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring intravenous therapy) or cardiovascular death. Results: In the 2139 type 2 diabetes patients, the effect of dapagliflozin on the primary outcome was consistent by GLT use/no use (hazard ratio 0.72 [95%CI 0.58-0.88] versus 0.86 [0.60-1.23]; P-interaction=0.39) and across GLT classes. Conclusions: In DAPA-HF, dapagliflozin improved outcomes irrespective of use/no use of GLT or by GLT type used in patients with type 2 diabetes and HFrEF.
This report is a description, based on four cases, of a variation from previously described approaches for accomplishing the "kissing balloon" technique for complex PTCA. We describe a case in which a single guiding catheter is utilized in combination with two over-the-wire monorail type balloon catheters allowing use of standard length (175 cm) guidewires. Various combinations of balloon diameters are described. We believe this approach has significant advantages over other techniques, principally in its rapid and easy usage.
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