Evidence map›Paper›PMID 30238186›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2019

Efficacy and safety of new-generation transcatheter aortic valves: insights from the Israeli transcatheter aortic valve replacement registry.

Ariel Finkelstein, Arie Steinvil, Zach Rozenbaum, Amir Halkin, Shmuel Banai, Israel Barbash, Victor Guetta, Amit Segev, Haim Danenberg, Katia Orvin and 3 more

Abstract readComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  6. Review
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  11. Kidney injury as post-interventional complication of TAVI.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Review
  12. Article
  13. Review
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  15. Observational
  16. One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.Clinical research in cardiology : official journal of the German Cardiac Society · 2019
    Article
  17. 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

13 authors.

Ariel FinkelsteinThe Cardiology Department, Tel Aviv Sourasky Medical Center, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, 6 Weizmann Street, 62439, Tel Aviv, Israel.
Arie SteinvilThe Cardiology Department, Tel Aviv Sourasky Medical Center, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, 6 Weizmann Street, 62439, Tel Aviv, Israel. arikst@tlvmc.gov.il.
Zach RozenbaumThe Cardiology Department, Tel Aviv Sourasky Medical Center, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, 6 Weizmann Street, 62439, Tel Aviv, Israel.
Amir HalkinThe Cardiology Department, Tel Aviv Sourasky Medical Center, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, 6 Weizmann Street, 62439, Tel Aviv, Israel.
Shmuel BanaiThe Cardiology Department, Tel Aviv Sourasky Medical Center, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, 6 Weizmann Street, 62439, Tel Aviv, Israel.
Israel BarbashLeviev Heart Center, Chaim Sheba Medical Center, Ramat Gan, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Victor GuettaLeviev Heart Center, Chaim Sheba Medical Center, Ramat Gan, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Amit SegevLeviev Heart Center, Chaim Sheba Medical Center, Ramat Gan, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Haim DanenbergThe Cardiology Department, Hadassah Medical Center, Jerusalem, Affiliated to the Hebrew University of Jerusalem, Jerusalem, Israel.
Katia OrvinThe Cardiology Department, Rabin Medical Center, Petach Tikva, Israel, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Hana Vaknin AssaThe Cardiology Department, Rabin Medical Center, Petach Tikva, Israel, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Abid AssaliThe Cardiology Department, Rabin Medical Center, Petach Tikva, Israel, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Ran KornowskiThe Cardiology Department, Rabin Medical Center, Petach Tikva, Israel, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare procedural outcomes of transcatheter aortic valve replacement (TAVR) patients treated with new-generation valves.

methodsWe performed a retrospective analysis on an Israeli multicenter registry comprised of four tertiary centers, comparing patient outcomes implanted with the Edwards SAPIEN S3 (ES3) vs. the Medtronic Evolut R (MER) valves.

resultsThe study population included 735 patients (ES3 n = 223; MER n = 512). The use of MER was significantly associated (p < 0.05) with higher rates of post-dilatation (35% vs. 10%), and the need for a second valve (2.7% vs. 0.5%). Procedural device success was comparable between groups (97% vs. 98%, p = 0.76); however, moderate angiographic paravalvular leak was higher (3.3% vs. 0.5%, p = 0.027) for MER vs. ES3, respectively. As compared to MER, 1 month echocardiography revealed higher peak and mean aortic valve gradients for ES3 (12/6 vs. 17/10 mmHg, p < 0.001, respectively). While the safety outcome at 1 month was lower for MER (8.8% vs. 13.9%, p = 0.035), similar 1-month, 1-year, and 3-year all-cause mortality were observed (1.9% vs. 1.3%; 8% vs. 8.5%, and 9.7 vs. 10.3%, for MER vs. ES3, respectively). In a propensity score matching analysis, there was no difference in major outcomes between the groups, including device success and the 1 month safety outcome.

conclusionAlthough favorable efficacy and safety clinical outcomes were observed in this large contemporary registry for both new-generation devices used, some procedural and post-procedural outcomes differ significantly between the two valves.

Indexed as

Heart Valve ProsthesisRegistriesAgedAged, 80 and overAortic ValveAortic Valve StenosisEchocardiographyFemaleFemoral ArteryHumansIncidenceIsraelMalePostoperative ComplicationsProsthesis DesignRetrospective StudiesMulticenter registryNew generationOutcomesTAVR

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Registered trials

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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.