Key result
Moderate-to-severe valvular heart disease is linked to ~36% higher mortality in the general population.
- RR 1.36
- 95% CI 1.15-1.62
- P=0.0005
- n=28,412
Why the study?
Valvular heart diseases are not usually regarded as a major public-health problem, and their prevalence and effect on overall survival in the general population needed assessment.
Is transcatheter mitral valve deployment within a partial annuloplasty band technically feasible in a preclinical porcine model?
Study Design
Type
Observational (n=28,412)
Structured PICO
Is transcatheter mitral valve deployment within a partial annuloplasty band technically feasible in a preclinical porcine model?
P
Population
28,412 adults comprising randomly selected individuals from the general population and a community cohort assessed via echocardiography to determine the prevalence and mortality impact of moderate or severe valvular heart disease.
E
Exposure
Transcatheter mitral valve replacement using a 23 mm Edwards SAPIEN 3 Ultra balloon-expandable valve, deployed within the partial annuloplasty band via a surgically constructed left atrial conduit under cardiopulmonary bypass.
O
Outcome
Technical success, defined according to the Mitral Valve Academic Research Consortium (MVARC) framework as successful access, delivery, and deployment of the valve within the band in the intended position with retrieval of the delivery system, and freedom from procedural death or emergency surgery or reintervention.surrogate
Main Result
Relative Risk: 1.36
p-value: p=0.0005
Limitations
- Single, acute, non-survival experiment cannot establish reproducibility, safety, durability, or generalizability.
- Preparation is model-specific, utilizing partial cardiopulmonary bypass, a surgically constructed dilated left atrium, a hypoplastic aorta, and an experimentally oversized band.
- Regurgitation was created by band oversizing with normal leaflets, differing from clinical failed repair which often involves tethered, fibrotic, or calcified leaflets.
- Observations apply specifically to the flexible band used and should not be generalized to semi-rigid and rigid designs.
- Quantitative endpoints (e.g., transmitral gradient, effective orifice area, left ventricular and left atrial pressures) were not acquired.
Ask about this paper
Answers are grounded in this paper and cite their sources.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Valvular heart disease (VHD) is common in the aging population but remains underestimated and undertreated, as contemporary, prospective, and comprehensive screening studies of the older, general U.S. population are lacking. Nkomo et al 1 conducted a retrospective meta-analysis of pooled population-based studies (ie, subjects with a diagnosis of VHD) and estimated the national prevalence of moderate-to-severe VHD to be 2.5%.”
Implication
This proof-of-concept preclinical study demonstrates acute technical feasibility of deploying a transcatheter heart valve within a partial mitral annuloplasty band, suggesting that a partial band may provide adequate anchoring for valve-in-band interventions.
Abstract
BACKGROUND: Valvular heart diseases are not usually regarded as a major public-health problem. Our aim was to assess their prevalence and effect on overall survival in the general population. METHODS: We pooled population-based studies to obtain data for 11 911 randomly selected adults from the general population who had been assessed prospectively with echocardiography. We also analysed data from a community study of 16 501 adults who had been assessed by clinically indicated echocardiography. FINDINGS: In the general population group, moderate or severe valve disease was identified in 615 adults. There was no difference in the frequency of such diseases between men and women (p=0.90). Prevalence increased with age, from 0.7% (95% CI 0.5-1.0) in 18-44 year olds to 13.3% (11.7-15.0) in the 75 years and older group (p<0.0001). The national prevalence of valve disease, corrected for age and sex distribution from the US 2000 population, is 2.5% (2.2-2.7). In the community group, valve disease was diagnosed in 1505 (1.8% adjusted) adults and frequency increased considerably with age, from 0.3% (0.2-0.3) of the 18-44 year olds to 11.7% (11.0-12.5) of those aged 75 years and older, but was diagnosed less often in women than in men (odds ratio 0.90, 0.81-1.01; p=0.07). The adjusted mortality risk ratio associated with valve disease was 1.36 (1.15-1.62; p=0.0005) in the population and 1.75 (1.61-1.90; p<0.0001) in the community. INTERPRETATION: Moderate or severe valvular diseases are notably common in this population and increase with age. In the community, women are less often diagnosed than are men, which could indicate an important imbalance in view of the associated lower survival. Valve diseases thus represent an important public-health problem.
Discussion
No takes yet. Share an insight, caveat, or question.
Cite This Study
Nkomo et al. (2006) conducted an observational in General population and community adults (assessment of valvular heart disease) (n=28,412). Moderate or severe valvular heart disease vs. Absence of moderate or severe valvular heart disease was evaluated on Overall survival (mortality risk) (RR 1.36, 95% CI 1.15-1.62, p=0.0005).