Evidence map›Paper›PMID 34706949›Full record

Trial reportBMJ open2021

Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial.

Stacey Howell, Timothy M Stivland, Kenneth Stein, Kenneth Ellenbogen, Larisa G Tereshchenko

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00677014 (SMARTDELAY Determined AV Optimization), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 18% 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.

NCT00677014 phase4completednot on this map

SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

TypeinterventionalSponsorBoston Scientific CorporationRan2008 to 2010Enrolled1,060ConditionsHeart FailureArmsAV Delay programming through cardiac resynchronization therapy
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Impact of empiric antibiotics on risk ofAntimicrobial stewardship & healthcare epidemiology : ASHE · 2025
    Article
  7. Article
  8. Article
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

5 authors at 4 institutions in 1 country.

Stacey HowellDepartment of Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.
Timothy M StivlandBoston Scientific Corp, Marlborough, Massachusetts, USA.ORCID 0000-0001-8169-1701
Kenneth SteinBoston Scientific Corp, Marlborough, Massachusetts, USA.
Kenneth EllenbogenDepartment of Medicine, Medical College of Virginia, Richmond, Virginia, USA.
Larisa G TereshchenkoDepartment of Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA tereshch@ohsu.edu.ORCID 0000-0002-6976-1313
Boston Scientific (United States) · USJohns Hopkins University · USOregon Health & Science University · USVirginia Commonwealth University Medical Center · US

Funding

Novel ECG Measures and Risk of Sudden Cardiac DeathR01HL118277 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI TERESHCHENKO, LARISA GENNADIEVNA · 2013 to 2016
$1.5M
Novel ECG measures and risk of sudden cardiac deathR56HL118277 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI TERESHCHENKO, LARISA GENNADIEVNA · 2018 to 2018
$396k
NHLBI NIH HHS R01 HL118277NHLBI NIH HHS R56 HL118277
6 · The paper itself

Abstract

objectivesThere is a controversy about whether both sexes' response to cardiac resynchronisation therapy (CRT) is similar. We aimed to assess a causal effect of sex on CRT response.

designSecondary analysis of a randomised controlled trial (RCT) data. Doubly robust augmented-inverse-probability-weighted (AIPW) estimation of sex effect on CRT response.

settingThe SmartDelay Determined Atrioventricular (AV) Optimisation (SMART-AV) RCT.

participantsThe SMART-AV RCT enrolled New York Heart Association class III-IV patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≤35% despite optimal medical therapy and QRS duration ≥120 ms, in sinus rhythm. After exclusion of those with missing outcome or covariates, 741 participants (age 66±11 years; 33% female; 78% white; LVEF 28%±9%; 58% ischaemic cardiomyopathy; 75% left bundle branch block; left ventricular end-systolic volume index (LVESVI) 65±30 mL/m

interventionsImplanted CRT defibrillator with randomly assigned AV delay as either (1) fixed at 120 ms, or (2) echocardiography-determined, or (3) SmartDelay algorithm-programmed. OUTCOME: A composite of freedom from death and HF hospitalisation and a >15% reduction in LVESVI at 6 month post-CRT was the endpoint.

resultsThe primary endpoint was met by 337 patients (45.5%); 134 were women (55.6% response) and 203 were men (40.6% response); p<0.0001. After conditioning for 33 covariates that included baseline demographic, clinical, ECG, echocardiographic and biomarker characteristics, known predictors of CRT response, logistic regression showed a higher probability for composite CRT response for women versus men (OR 1.79; 95% CI 1.08 to 2.98; p<0.0001), whereas AIPW estimation showed no difference in CRT response (average treatment effect 0.88; 95% CI 0.41 to 1.89; p=0.739). After removing colliders from the model, both logistic regression (OR 1.00; 95% CI 0.69 to 1.44) and AIPW (ATE 1.06; 95% CI 0.96 to 1.16) reported similar results.

conclusionsBoth sexes' response to CRT is similar. Sex differences in HF substrate, treatment and comorbidities explain sex disparities in CRT outcomes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier; NCT00677014.

Indexed as

Cardiac Resynchronization TherapyHeart FailureAgedBundle-Branch BlockFemaleHumansMaleMiddle AgedStroke VolumeTreatment Outcomeadult cardiologycardiomyopathyheart failurepacing & electrophysiologystatistics & research methods

Identifiers

PMID34706949
PMCPMC8552143
OpenAlexW3209652930

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.