Evidence map›Paper›PMID 30883058›Full record

Trial reportThe New England journal of medicine2019

Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

Michael J Mack, Martin B Leon, Vinod H Thourani, Raj Makkar, Susheel K Kodali, Mark Russo, Samir R Kapadia, S Chris Malaisrie, David J Cohen, Philippe Pibarot and 16 more

16 registry-linked trialsAbstract readComparative StudyEquivalence TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 16 registered trials, which are not on this map. Cited by 1,919 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,919citing papers in PubMed, 9 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.

NCT02675114 naactive not recruitingnot on this map

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

TypeinterventionalSponsorEdwards LifesciencesRan2016 to 2029Enrolled1,000ConditionsAortic StenosisArmsSAVR, SAPIEN 3 THV
NCT04786769 phase4unknown statusnot on this mapstarted 2022, after this paper: background citation

A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

TypeinterventionalSponsorHospital de Santa Cruz, PortugalRan2022 to 2025Enrolled2,500ConditionsAortic Stenosis, Iron-deficiencyArmsFerric carboxymaltose
NCT05075590 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Coronary ANgiography and ACCESS Following Implantation of a Supra-Annular Transcatheter Heart Valve With Commissural Alignment: The CAN-ACCESS Pilot Study

TypeinterventionalSponsorUniversity of British ColumbiaRan2021 to 2024Enrolled50ConditionsCoronary Angiography, Transcatheter Aortic Valve ReplacementArmsCoronary Angiography
NCT05082337 nacompletednot on this mapstarted 2021, after this paper: background citation

The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures: A Feasibility Study

TypeinterventionalSponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University LavalRan2021 to 2021Enrolled20ConditionsAortic Valve Disease, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Hemodynamic MeasurementArmsSAVVY guidewire
NCT05235555 recruitingnot on this map

Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry

Typeobservational_patient_registrySponsorFederico II UniversityRan2015 to 2030Enrolled1,000ConditionsAortic Stenosis, Transcatheter Aortic Valve Replacement, TAVIArmsTranscatheter heart valve (THV) with CE approval
NCT05721170 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Impact of Beta-blockers Among Patients Undergoing TAVI: a Randomized Multicenter Trial

TypeinterventionalSponsorNational and Kapodistrian University of AthensRan2024 to 2028Enrolled347ConditionsAortic Valve StenosisArmsBeta blocker
NCT05847751 active not recruitingnot on this mapstarted 2024, after this paper: background citation

The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis

Typeobservational_patient_registrySponsorCeric SàrlRan2024 to 2026Enrolled51ConditionsSevere Aortic Valve StenosisArmsAortic valve replacement
NCT06420830 recruitingnot on this mapstarted 2024, after this paper: background citation

Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

TypeobservationalSponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University LavalRan2024 to 2034Enrolled150ConditionsAortic Valve Stenosis, Transcatheter Aortic Valve ReplacementArmsSAPIEN 3 Ultra RESILIA Valve
NCT06557798 recruitingnot on this mapstarted 2024, after this paper: background citation

Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve

TypeobservationalSponsorThe Leeds Teaching Hospitals NHS TrustRan2024 to 2033Enrolled550ConditionsAortic Valve StenosisArmsAny commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication, Surgical explantation and aortic valve replacement, Conservative management
NCT06721676 nanot yet recruitingnot on this mapstarted 2024, after this paper: background citation

A Prospective, Single-center, Single-group Follow-up Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis by Peijia Medical

TypeinterventionalSponsorPeijia Medical Technology (Suzhou) Co., Ltd.Ran2024 to 2025Enrolled10ConditionsAortic Stenosis SymptomaticArmstranscatheter aortic valve replacement in severe aortic stenosis
NCT06830499 recruitingnot on this mapstarted 2025, after this paper: background citation

Safety, Effectiveness and Durability of Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

TypeobservationalSponsorXijing HospitalRan2025 to 2031Enrolled450ConditionsAORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)ArmsTranscatheter Aortic Valve Replacement (TAVR)
NCT07016789 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Cerebral Regional Oxygen Saturation During TAVI: A Prospective Comparison of Balloon-Expandable and Self-Expanding Valves

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2025 to 2026Enrolled40ConditionsAortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic ChangesArmsNear-infrared spectroscopy monitoring (NIRS) INVOS 5100C
NCT07623083 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation

TypeobservationalSponsorJosep Rodes-CabauRan2026 to 2034Enrolled300ConditionsAortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Transcatheter Aortic Valve Implantation (TAVI)
NCT07626710 recruitingnot on this mapstarted 2024, after this paper: background citation

Impact of Trans-catheter Aortic Valve Implantation on Kidney Response to Contrast Dye Administration: an Observational Registry

Typeobservational_patient_registrySponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2024 to 2033Enrolled1,000ConditionsAortic Valve Stenosis, Chronic Kidney Diseases, Renal Failure Acute ChronicArmsTrans-catheter aortic valve implantation (TAVI)
NCT07735130 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Angiotensin Receptor Blockade In Patients After Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis With Left Ventricular Hypertrophy (ARBITAR) Trial

TypeinterventionalSponsorSeoul National University HospitalRan2026 to 2030Enrolled632ConditionsTranscatheter Aortic Valve Replacement (TAVR), Left Ventricular Hypertrophy, Severe Aortic StenosisArmsAngiotensin Receptor Blocker (ARB)
NCT07738575 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial

TypeinterventionalSponsorHospital Clinic of BarcelonaRan2026 to 2029Enrolled764ConditionsAortic Stenosis, Severe, Aortic StenosisArmsSame-Day Discharge Strategy, Standard-of-Care Discharge Strategy
3 · Its place in the literature

Who cites it

1,919 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  13. Extremity Function After Transfemoral Transcatheter Aortic Valve Implantation: A TAVI XS Sub-Study.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
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1,859 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Michael J MackFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Martin B LeonFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Vinod H ThouraniFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Raj MakkarFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Susheel K KodaliFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Mark RussoFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Samir R KapadiaFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
S Chris MalaisrieFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
David J CohenFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Philippe PibarotFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Jonathon LeipsicFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Rebecca T HahnFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Philipp BlankeFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Mathew R WilliamsFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
James M McCabeFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
David L BrownFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Vasilis BabaliarosFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Scott GoldmanFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Wilson Y SzetoFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Philippe GenereuxFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Ashish PershadFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Stuart J PocockFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Maria C AluFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
John G WebbFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Craig R SmithFrom Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
PARTNER 3 Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAmong patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.

methodsWe randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population.

resultsAt 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation.

conclusionsAmong patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

Indexed as

Heart Valve ProsthesisAgedAortic ValveAortic Valve StenosisAtrial FibrillationFemaleHeart Valve Prosthesis ImplantationHumansKaplan-Meier EstimateLength of StayMalePatient ReadmissionPostoperative ComplicationsProsthesis DesignRisk FactorsStroke

Identifiers

PMID30883058

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