Evidence map›Paper›PMID 33954997›Full record

ArticleEuropean journal of clinical investigation2021

The use of semi-compliant versus non-compliant balloon systems for predilatation during the implantation of self-expandable transcatheter aortic valves: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY).

Markus Mach, Philipp Szalkiewicz, Thomas Poschner, Waseem Hasan, Martin Andreas, Bernhard Winkler, Ena Hasimbegovic, Theresia Steinkellner, Andreas Strouhal, Christopher Adlbrecht and 2 more

Abstract readComparative Study
In one paragraph

Article in European journal of clinical investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Outcomes of Noncompliant Balloons in the Treatment of Lower Extremity Chronic Limb Threatening Ischemia: A Prospective Study.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2026
    Article
  2. Article
  3. Article
  4. Clinical Outcomes of a Non-Compliant Balloon Dilatation Catheter: MOZEC™ NC Study.International journal of environmental research and public health · 2022
    Article
  5. 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

12 authors.

Markus MachDepartment of Cardiac Surgery, Medical University of Vienna - Vienna General Hospital, Vienna, Austria.ORCID https://orcid.org/0000-0002-3184-4914
Philipp SzalkiewiczDepartment of Cardiac Surgery, Medical University of Vienna - Vienna General Hospital, Vienna, Austria.
Thomas PoschnerDepartment of Cardiac Surgery, Medical University of Vienna - Vienna General Hospital, Vienna, Austria.
Waseem HasanFaculty of Medicine, Imperial College London, London, UK.ORCID https://orcid.org/0000-0002-4740-0197
Martin AndreasDepartment of Cardiac Surgery, Medical University of Vienna - Vienna General Hospital, Vienna, Austria.
Bernhard WinklerHeart Team Vienna, Department of Cardio-Vascular Surgery, Clinic Floridsdorf and the Karl Landsteiner Institute for Cardio-Vascular Research, Vienna, Austria.
Ena HasimbegovicDepartment of Cardiac Surgery, Medical University of Vienna - Vienna General Hospital, Vienna, Austria.
Theresia SteinkellnerDivision of Anatomy, Center of Anatomy and Cell Biology, Medical University of Vienna - Vienna General Hospital, Vienna, Austria.
Andreas StrouhalDepartment of Cardiology, Clinic Floridsdorf and the Karl Landsteiner Institute for Cardiovascular and Critical Care Research, Vienna, Austria.
Christopher AdlbrechtDepartment of Cardiology, Clinic Floridsdorf and the Karl Landsteiner Institute for Cardiovascular and Critical Care Research, Vienna, Austria.
Georg Delle-KarthDepartment of Cardiology, Clinic Floridsdorf and the Karl Landsteiner Institute for Cardiovascular and Critical Care Research, Vienna, Austria.
Martin GrabenwögerHeart Team Vienna, Department of Cardio-Vascular Surgery, Clinic Floridsdorf and the Karl Landsteiner Institute for Cardio-Vascular Research, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study aimed to evaluate the differences in outcome arising from the use of semi-compliant (SCB) versus non-compliant balloon (NCB) systems for predilatation during self-expanding transcatheter aortic valve replacement (TAVR).

methods251 TAVR procedures with the implantation of self-expanding valves after predilatation were analyzed. SCB systems were used in 166 and NCB systems in 85 patients. The primary endpoint was defined as device success, a composite endpoint comprising the absence of procedural mortality, correct valve positioning, adequate valve performance and the absence of more than a mild paravalvular leak. The secondary endpoints were chosen in accordance with the valve academic research consortium (VARC-2) endpoint definitions.

resultsNo significant differences were observed with regard to procedural device success between the SCB- and NCB cohort (SCB: 142 [85.5%%] vs. NCB: 77 [90.6%]; P = .257). There was a notable difference between the rates of conversion to open surgery and the postdilatation rate, both of which were higher for the NCB group (SCB: 1 [0.6%] vs. NCB: 4 [5.1%]; P = .042; SCB: 30 [18.1%] vs. NCB: 34 [40%]; P < .001). In a multivariate logistic regression analysis, the use of semi-compliant balloon systems for predilatation was associated with a lower risk for postdilatation (OR: 0.296; 95% CI: 0.149-0.588) and conversion to open surgery (OR: 0.205; 95% CI: 0.085-0.493; P = .001) but not for device success.

conclusionWhile the balloon compliance did not affect the procedural mortality, device success or the rate of paravalvular leakage, the use of semi-compliant balloons for predilatation during TAVR should be investigated in larger randomized trials in the light of the lower rates of postdilatation and conversion to open surgery compared to their non-compliant counterparts.

Indexed as

MortalityAcute Kidney InjuryAgedAged, 80 and overAortic Valve StenosisAtrioventricular BlockBalloon ValvuloplastyBundle-Branch BlockCause of DeathConversion to Open SurgeryFemaleHumansMalePostoperative ComplicationsRegistriesTranscatheter Aortic Valve Replacementballooncompliantnon-compliantpredilatationself-expandingTAVITAVRtranscathetervalve

Identifiers

PMID33954997
PMCPMC8459263

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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.