Evidence map›Paper›PMID 33399006›Full record

Trial reportJournal of the American Heart Association2021

Persistent Pulmonary Hypertension in Corrected Valvular Heart Disease: Hemodynamic Insights and Long-Term Survival.

Javier Bermejo, Ana González-Mansilla, Teresa Mombiela, Ana I Fernández, Pablo Martínez-Legazpi, Raquel Yotti, Rocío García-Orta, Pedro L Sánchez-Fernández, Mario Castaño, Javier Segovia-Cubero and 19 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00862043 (Sildenafil for Improving Outcomes After Valvular Correction), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00862043 phase4completednot on this map

Sildenafil for Improving Outcomes After Valvular Correction

TypeinterventionalSponsorHospital General Universitario Gregorio MarañonRan2009 to 2016Enrolled200ConditionsPulmonary Hypertension, Valvular Heart DiseaseArmsSildenafil Citrate, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 36 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors at 12 institutions in 1 country.

Javier BermejoHospital General Universitario Gregorio MarañónInstituto de Investigación Sanitaria Gregorio MarañónFacultad de Medicina, Universidad Complutense de Madrid, and CIBERCV Madrid Spain.
Ana González-MansillaHospital General Universitario Gregorio MarañónInstituto de Investigación Sanitaria Gregorio MarañónFacultad de Medicina, Universidad Complutense de Madrid, and CIBERCV Madrid Spain.
Teresa MombielaHospital General Universitario Gregorio MarañónInstituto de Investigación Sanitaria Gregorio MarañónFacultad de Medicina, Universidad Complutense de Madrid, and CIBERCV Madrid Spain.
Ana I FernándezHospital General Universitario Gregorio MarañónInstituto de Investigación Sanitaria Gregorio MarañónFacultad de Medicina, Universidad Complutense de Madrid, and CIBERCV Madrid Spain.
Pablo Martínez-LegazpiHospital General Universitario Gregorio MarañónInstituto de Investigación Sanitaria Gregorio MarañónFacultad de Medicina, Universidad Complutense de Madrid, and CIBERCV Madrid Spain.
Raquel YottiInstituto de Salud Carlos III Madrid Spain.
Rocío García-OrtaHospital Virgen de las Nieves Granada Spain.
Pedro L Sánchez-FernándezHospital Clínico Universitario de Salamanca, and CIBERCV Salamanca Salamanca Spain.
Mario CastañoHospital Universitario de León León Spain.
Javier Segovia-CuberoHospital Puerta de Hierro Majadahonda and CIBERCV Majadahonda Spain.
Pilar Escribano-SubiasHospital 12 de Octubre and CIBERCV Madrid Spain.
J Alberto San RománHospital Clínico de Valladolid and CIBERCV Valladolid Spain.
Xavier BorrásHospital Santa Creu i San Pau and CIBERCV Barcelona Spain.
Angel Alonso-GómezHospital Universitario de Araba-Txagorritxu Vitoria Spain.
Javier BotasHospital Universitario Fundación Alcorcón Alcorcón Spain.
María G Crespo-LeiroComplejo Hospitalario Universitario de A Coruña and CIBERCV A Coruña Spain.
Sonia VelascoHospital de Galdakao-Usansolo Usansolo Spain.
Antoni Bayés-GenísHospital Universitari Germans Trias i Pujol and CIBERCV Badalona Spain.
Amador LópezHospital Universitario Reina Sofía Córdoba Spain.
Roberto Muñoz-AguileraHospital Infanta Leonor Madrid Spain.
Manuel Jiménez-NavarroHospital Virgen de la Victoria and CIBERCV Málaga Spain.
José R González-JuanateyHospital Clínico de Santiago de Compostela and CIBERCV Santiago de Compostela Spain.
Arturo EvangelistaHospital Universitario de la Vall d'Hebron and CIBERCV Barcelona Spain.
Jaime ElízagaHospital General Universitario Gregorio MarañónInstituto de Investigación Sanitaria Gregorio MarañónFacultad de Medicina, Universidad Complutense de Madrid, and CIBERCV Madrid Spain.
Javier Martín-MoreirasHospital Clínico Universitario de Salamanca, and CIBERCV Salamanca Salamanca Spain.
José M González-SantosHospital Clínico Universitario de Salamanca, and CIBERCV Salamanca Salamanca Spain.
Eduardo Moreno-EscobarHospital Universitario San Cecilio Granada Spain.
Francisco Fernández-AvilésHospital General Universitario Gregorio MarañónInstituto de Investigación Sanitaria Gregorio MarañónFacultad de Medicina, Universidad Complutense de Madrid, and CIBERCV Madrid Spain.
SIOVAC (“Sildenafil for Improving Outcomes after VAlvular Correction”) Investigators
Centro de Investigación en Red en Enfermedades Cardiovasculares · ESUniversidad Complutense de Madrid · ESCentro de Investigación Biomédica en Red · ESHospital de Galdakao · ESHospital de León · ESHospital Txagorritxu · ESHospital Universitario Fundación Alcorcón · ESHospital Universitario Infanta Leonor · ESHospital Universitario Reina Sofía · ESHospital Universitario Virgen de las Nieves · ESInstituto de Investigación Biosanitaria de Granada · ESInstituto de Salud Carlos III · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background The determinants and consequences of pulmonary hypertension after successfully corrected valvular heart disease remain poorly understood. We aim to clarify the hemodynamic bases and risk factors for mortality in patients with this condition. Methods and Results We analyzed long-term follow-up data of 222 patients with pulmonary hypertension and valvular heart disease successfully corrected at least 1 year before enrollment who had undergone comprehensive hemodynamic and imaging characterization as per the SIOVAC (Sildenafil for Improving Outcomes After Valvular Correction) clinical trial. Median (interquartile range) mean pulmonary pressure was 37 mm Hg (32-44 mm Hg) and pulmonary artery wedge pressure was 23 mm Hg (18-26 mm Hg). Most patients were classified either as having combined precapillary and postcapillary or isolated postcapillary pulmonary hypertension. After a median follow-up of 4.5 years, 91 deaths accounted for 4.21 higher-than-expected mortality in the age-matched population. Risk factors for mortality were male sex, older age, diabetes mellitus, World Health Organization functional class III and higher pulmonary vascular resistance-either measured by catheterization or approximated from ultrasound data. Higher pulmonary vascular resistance was related to diabetes mellitus and smaller residual aortic and mitral valve areas. In turn, the latter correlated with prosthetic nominal size. Six-month changes in the composite clinical score and in the 6-minute walk test distance were related to survival. Conclusions Persistent valvular heart disease-pulmonary hypertension is an ominous disease that is almost universally associated with elevated pulmonary artery wedge pressure. Pulmonary vascular resistance is a major determinant of mortality in this condition and is related to diabetes mellitus and the residual effective area of the corrected valve. These findings have important implications for individualizing valve correction procedures. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00862043.

Indexed as

Heart Valve DiseasesHeart Valve Prosthesis ImplantationHypertension, PulmonaryLong Term Adverse EffectsPostoperative ComplicationsDiabetes MellitusDouble-Blind MethodFemaleHeart ValvesHumansMaleMiddle AgedOrgan SizePhosphodiesterase 5 InhibitorsPulmonary Wedge PressureRisk FactorsPhosphodiesterase 5 InhibitorsSildenafil Citrateheart failurepulmonary hypertensionvalvular heart disease

Identifiers

PMID33399006
PMCPMC7955299
OpenAlexW3118343199

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.