Evidence map›Paper›PMID 31202947›Full record

Trial reportJACC. Cardiovascular interventions2019

The BASILICA Trial: Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction.

Jaffar M Khan, Adam B Greenbaum, Vasilis C Babaliaros, Toby Rogers, Marvin H Eng, Gaetano Paone, Bradley G Leshnower, Mark Reisman, Lowell Satler, Ron Waksman and 5 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in JACC. Cardiovascular interventions, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 139 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
139citing papers in PubMed, 1 pooled it
24.1field-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.

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

139 citing papers in PubMed, 1 synthesis or guideline pooled it, 256 citations in OpenAlex.

  1. Pooled it
  2. Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
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79 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 1 country.

Jaffar M KhanCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Adam B GreenbaumCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan; Structural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia.
Vasilis C BabaliarosStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia.
Toby RogersCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland; Medstar Washington Hospital Center, Washington, DC.
Marvin H EngCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan.
Gaetano PaoneCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan.
Bradley G LeshnowerStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia.
Mark ReismanUniversity of Washington, Seattle, Washington.
Lowell SatlerMedstar Washington Hospital Center, Washington, DC.
Ron WaksmanMedstar Washington Hospital Center, Washington, DC.
Marcus Y ChenCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Annette M StineCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Xin TianCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Danny DvirUniversity of Washington, Seattle, Washington.
Robert J LedermanCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: lederman@nih.gov.
National Institutes of Health · USHenry Ford Health System · USEmory University Hospital · USUniversity of Washington · USWashington Hospital · US

Funding

Novel catheter treatment of valve diseaseZIAHL006040 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI LEDERMAN, ROBERT J · 2010 to 2025
$23.6M
Cardiovascular CT Clinical ResearchZIAHL006220 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI CHEN, MARCUS · 2017 to 2025
$22.5M
MRI catheter design and fabricationZIAHL006041 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI LEDERMAN, ROBERT J · 2014 to 2025
$12.2M
Intramural NIH HHS ZIA HL006040
6 · The paper itself

Abstract

objectivesThe BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study.

backgroundCoronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction.

methodsSubjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images.

resultsBetween February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR.

conclusionsBASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk.

Indexed as

BioprosthesisHeart Valve ProsthesisProsthesis FailureAgedAged, 80 and overAortic ValveAortic Valve StenosisCoronary StenosisFeasibility StudiesFemaleHeart Valve Prosthesis ImplantationHemodynamicsHumansIatrogenic DiseaseMaleProspective Studiesbioprosthetic heart valve failurecoronary artery obstructionstructural heart diseasetranscatheter aortic valve replacementtranscatheter electrosurgery

Identifiers

PMID31202947
PMCPMC6669893
OpenAlexW2952931116

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.