Evidence map›Paper›PMID 34012561›Full record

ArticleJournal of thoracic disease2021

Minimally-invasive-perventricular-device-occlusion versus surgical-closure for treating perimembranous-ventricular-septal-defect: 3-year outcomes of a multicenter randomized clinical trial.

Wenxin Lu, Fengwen Zhang, Taibing Fan, Tianli Zhao, Yu Han, Xiaopeng Hu, Qi Li, Hao Shi, Xiangbin Pan

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of thoracic disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. 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

9 authors at 3 institutions in 1 country.

Wenxin LuStructural Heart Disease Center, National Center for Cardiovascular Disease and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Fengwen ZhangStructural Heart Disease Center, National Center for Cardiovascular Disease and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Taibing FanHeart Center of Henan Provincial People's Hospital, Central China Fuwai Hospital of Zhengzhou University, Zhengzhou, China.
Tianli ZhaoThe Central South University, Changsha, China.
Yu HanHeart Center of Henan Provincial People's Hospital, Central China Fuwai Hospital of Zhengzhou University, Zhengzhou, China.
Xiaopeng HuStructural Heart Disease Center, National Center for Cardiovascular Disease and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Qi LiStructural Heart Disease Center, National Center for Cardiovascular Disease and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Hao ShiStructural Heart Disease Center, National Center for Cardiovascular Disease and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xiangbin PanStructural Heart Disease Center, National Center for Cardiovascular Disease and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNHenan Provincial People's Hospital · CNCentral South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMinimally-invasive-perventricular-device-occlusion (MIPDO) combined superiority of surgical-repair and percutaneous-device-closure in treating perimembranous-ventricular-septal-defect (pmVSD). This study was to evaluate the efficacy and safety of MIPDO for treating pmVSD, comparing with surgical-repair.

methodsPatients aged ≥3 months with isolated pmVSDs were randomized to undergo either surgical or MIPDO procedure, with the median follow-up time of 49 months. The primary outcome was the rate of complete pmVSD closure at discharge. The secondary outcomes included the adverse events during hospitalization and follow-up, chest tube output volume, blood transfusion volume, procedural duration, ventilation time, hospitalization duration and hospitalization cost. Also, perioperative cardiac performance and systemic conditions were evaluated.

resultsOf the 313 patients (9 months to 42 years old; median, 4 years old) with pmVSDs recruited from 3 centers, 100 were finally enrolled and randomly allocated 1:1 into two groups. The non-inferiority (non-inferiority margin -8.0%) of MIPDO to surgical closure regarding efficacy was shown in both intention-to-treat (0, 95% CI: -0.055 to 0.055) and per-protocol populations (0.02, 95% CI: -0.018 to 0.058). Although the rate of adverse events was similar between groups, the MIPDO group showed superiority in procedural duration, ventilation time, chest tube output volume, postoperative hospitalization time and hospitalization cost compared with surgical group (P<0.05). Moreover, MIPDO method showed comparable perioperative cardiac performance with milder change of systemic condition.

conclusionsIn patients with pmVSDs, MIPDO method showed non-inferiority to surgical closure in efficacy for both intention-to-treat and per-protocol population with easier perioperative recovery, economic benefit and promising outcomes.

Indexed as

deviceminimally invasivePerventricularsurgicalventricular septal defect (VSD)

Identifiers

PMID34012561
PMCPMC8107524
OpenAlexW3159082693

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.