Evidence map›Paper›PMID 29102689›Full record

ArticleJournal of the American College of Cardiology2018

Early Experience With New Transcatheter Mitral Valve Replacement.

Vinayak Bapat, Vivek Rajagopal, Christopher Meduri, R Saeid Farivar, Antony Walton, Stephen J Duffy, Robert Gooley, Aubrey Almeida, Michael J Reardon, Neal S Kleiman and 10 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Journal of the American College of Cardiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02322840 (An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Intrepid Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation), which is not on this map. Cited by 87 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 3 pooled it
20.5field-weighted citation impact, top 1% 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.

NCT02322840 naactive not recruitingnot on this map

An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Intrepid Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

TypeinterventionalSponsorMedtronic CardiovascularRan2015 to 2028Enrolled128ConditionsMitral Valve InsufficiencyArmsTwelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 3 syntheses or guidelines pooled it, 269 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Contemporary Transcatheter Approaches to Mitral Regurgitation.Reviews in cardiovascular medicine · 2026
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  14. Article
  15. Article
  16. Review
  17. Economic Burden of Inpatient Care for Mitral Regurgitation in Maryland.Journal of the American Heart Association · 2024
    Article
  18. Review
  19. Review
  20. Transcatheter mitral valve implantation for native valve disease.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Review

27 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 12 institutions in 4 countries.

Vinayak BapatSt. Thomas' Hospital, London, United Kingdom; New York Presbyterian/Columbia University Medical Center, New York, New York.
Vivek RajagopalPiedmont Heart Institute, Atlanta, Georgia.
Christopher MeduriPiedmont Heart Institute, Atlanta, Georgia.
R Saeid FarivarAbbott Northwestern Hospital, Minneapolis, Minnesota.
Antony WaltonCardiology Department, The Alfred, Melbourne, Australia.
Stephen J DuffyCardiology Department, The Alfred, Melbourne, Australia.
Robert GooleyMonash Heart, Melbourne, Australia.
Aubrey AlmeidaMonash Heart, Melbourne, Australia.
Michael J ReardonHouston Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, Texas.
Neal S KleimanHouston Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, Texas.
Konstantinos SpargiasHygeia Hospital, Athens, Greece.
Stratis PattakosHygeia Hospital, Athens, Greece.
Martin K NgRoyal Prince Alfred Hospital, Sydney, Australia.
Michael WilsonRoyal Prince Alfred Hospital, Sydney, Australia.
David H AdamsMount Sinai Medical Center, New York, New York.
Martin LeonNew York Presbyterian/Columbia University Medical Center, New York, New York.
Michael J MackBaylor Scott & White Health, Plano, Texas.
Sharla ChenowethMedtronic, Minneapolis, Minnesota.
Paul SorajjaAbbott Northwestern Hospital, Minneapolis, Minnesota. Electronic address: paul.sorajja@allina.com.
Intrepid Global Pilot Study Investigators
Abbott Northwestern Hospital · USHouston Methodist · USHygeia Hospital · GRMonash Health · AUPiedmont Atlanta Hospital · USRoyal Prince Alfred Hospital · AUThe Alfred Hospital · AUMount Sinai Medical Center · USBaylor Scott & White Health · USColumbia University Irving Medical Center · USMedtronic (United States) · USSt Thomas' Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.

objectivesThe authors report their early experience with TMVR using a new valve system.

methodsThe valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (United States, Australia, and Europe).

resultsFifty consecutively enrolled patients (mean age: 73 ± 9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean Society for Thoracic Surgery score was 6.4 ± 5.5%; 86% of patients were New York Heart Association functional class III or IV, and the mean left ventricular ejection fraction was 43 ± 12%. Device implant was successful in 48 patients with a median deployment time of 14 min (interquartile range: 12 to 17 min). The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173 days (interquartile range: 54 to 342 days). At latest follow-up, echocardiography confirmed mild or no residual MR in all patients who received implants. Improvements in symptom class (79% in New York Heart Association functional class I or II at follow-up; p < 0.0001 vs. baseline) and Minnesota Heart Failure Questionnaire scores (56.2 ± 26.8 vs. 31.7 ± 22.1; p = 0.011) were observed.

conclusionsTMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement. These results inform trial design of TMVR in lower-risk patients with severe mitral valve regurgitation (Evaluation of the Safety and Performance of the Twelve Intrepid Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation - The Twelve Intrepid TMVR Pilot Study; NCT02322840).

Indexed as

Heart Valve Prosthesis ImplantationMitral ValvePostoperative ComplicationsAgedAged, 80 and overCardiac CatheterizationEchocardiographyFemaleHeart Valve ProsthesisHumansMaleMitral Valve InsufficiencyOutcome and Process Assessment, Health CareRisk FactorsSeverity of Illness IndexTime Factorsmitral valve regurgitationprosthesistranscatheter mitral valve replacement

Identifiers

PMID29102689
OpenAlexW2768913497

What OpenQuestion holds

Textmetadata
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.