Clinical trial NCT01586910: Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
Official title: Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Severe Aortic Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-04-27
Enrollment: 1746
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.


Eligibility criteria: Inclusion Criteria:

* Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and \<15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
* Heart Team unanimously agree on treatment proposal and eligibility for randomization\* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
* Subject has severe aortic stenosis presenting with;

  1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND
  2. Mean gradient \> 40mmHg or Vmax \> 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization \[or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) \<55%\] or velocity ratio \< 0.25;
* Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria:

* Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
* Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
* A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
* Blood dyscrasias as defined: leukopenia (WBC \<1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
* Ongoing sepsis, including active endocarditis;
* Any condition considered a contraindication to extracorporeal assistance;
* Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization\* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
* Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization\*;
* Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
* Recent (within 6 months of randomization\*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
* Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
* Subject refuses a blood transfusion;
* Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
* Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
* Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
* Currently participating in an investigational drug or another device trial (excluding registries);
* Evidence of an acute myocardial infarction ≤30 days before the index procedure;
* Need for emergency surgery for any reason;
* True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
* Extensive mediastinal radiation;
* Liver failure (Child-C);
* Reduced ventricular function with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram;
* Uncontrolled atrial fibrillation (e.g. resting heart rate \> 120 bpm);
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
* End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min;
* Pulmonary Hypertension (systolic pressure\> 80mmHg);
* Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc;
* Frailty assessments identify:

  1. Subject is \< 80 years of age and three or more of the following apply
  2. Subject is ≥ 80 years of age and two or more of the following apply

     * Wheelchair bound
     * Resides in an institutional care facility (e.g., nursing home, skilled care center)
     * Body Mass Index \< 20 kg/m2
     * Grip Strength \< 16 kg
     * Katz Index Score ≤ 4
     * Albumin \< 3.5 g/dL;
* Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)

Note: Additional anatomical and vascular exclusion criteria may apply.

Note: \* For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.

Primary outcomes:
measure: All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Percentage of Participants With Individual MACCE Components
timeFrame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Percentage of Participants With Major Adverse Events (MAE)
timeFrame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation
timeFrame: 30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Change in NYHA Class From Baseline
timeFrame: Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Change in Distance Walked During 6-minute Walk Test (6MWT)
timeFrame: From baseline to 30 days, baseline to 12 months, and baseline to 24 months
measure: Ratio of Days Alive Out of Hospital Versus Total Days Alive
timeFrame: 12 and 24 months
measure: Quality of Life (QoL) Change From Baseline
timeFrame: Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance
timeFrame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
measure: Effective Orifice Area as an Assessment of Prosthetic Valve Performance
timeFrame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
measure: Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance
timeFrame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
measure: Percentage of Participants With Aortic Valve Disease Related Hospitalizations
timeFrame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths
timeFrame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
measure: Percentage of Participants With Stroke and TIAs
timeFrame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Peri-procedural Neurological Injury
timeFrame: discharge or 7 days post index procedure (whichever occurred first)
measure: Index Procedure Related Major Adverse Events (MAEs)
timeFrame: Procedure through 30 day visit
measure: Length of Index Procedure Hospital Stay
timeFrame: Number of days from admission to discharge (expected average of 7 days)
measure: Presence of Atrial Fibrillation
timeFrame: post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Device Success (Medtronic CoreValve® System Subjects Only)
timeFrame: Number of days from admission to discharge (expected average of 7 days)
measure: Procedural Success (Medtronic CoreValve® System Subjects Only)
timeFrame: Number of days from admission to discharge (expected average of 7 days)
measure: Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)
timeFrame: 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
measure: Percentage of Participants With Early Safety Endpoint
timeFrame: 30 Days
measure: Percentage of Participants With Clinical Efficacy (After 30 Days)
timeFrame: 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
measure: Percentage of Participants With Time-Related Safety
timeFrame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.
measure: Resheath and Recapture Success (Evolut R Only)
timeFrame: Procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Hollywood
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Pasadena
country: United States
facility: Southern California Permenente Medical Group
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Healthcare, Inc.
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Maywood
country: United States
facility: Loyola University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center / Mercy Medical Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Minneapolis
country: United States
facility: Abbott NW - MN Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - St. Mary's Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital/MAHI
state: Missouri
city: Omaha
country: United States
facility: Alegent Creighton Health Research Center
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas HealthCare System
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: The OhioHealth Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Memphis
country: United States
facility: Stern Cardiovascular
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist DeBakey Heart & Vascular Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital - Baylor Plano
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Norfolk
country: United States
facility: Sentara Cardiovascular
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital (University Health Network)
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center - Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Breda
country: Netherlands
facility: Amphia Hospital Breda
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital, R & D Cardiology
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center - Rotterdam
city: Malaga
country: Spain
facility: Servicio de Cardiologia del Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Stockholm
city: Bern
country: Switzerland
facility: Bern University Hospital
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Glenfield Hospital, Leicester, UK
city: London
country: United Kingdom
facility: St. George's Hospital London
Study officials:
affiliation: Bern University Hospital
name: Stephan Windecker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum München
name: Rüdiger Lange, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kerckhoff Klinik
name: Thomas Walther, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital Research Institute
name: Michael J. Reardon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: David H. Adams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Nicolas M. Van Mieghem, MD
role: STUDY_CHAIR
affiliation: National Heart & Lung Institute of Imperial College in London
name: Patrick W. Serruys, MD, PhD
role: STUDY_CHAIR
References:
citation: Tuttle MK, Kiaii B, Van Mieghem NM, Laham RJ, Deeb GM, Windecker S, Chetcuti S, Yakubov SJ, Chawla A, Hockmuth D, Teefy P, Li S, Reardon MJ. Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-Year Analysis From the SURTAVI Trial. JACC Cardiovasc Interv. 2022 Apr 11;15(7):728-738. doi: 10.1016/j.jcin.2022.01.284.
citation: Lanz J, Reardon MJ, Pilgrim T, Stortecky S, Deeb GM, Chetcuti S, Yakubov SJ, Gleason TG, Huang J, Windecker S. Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement. J Am Heart Assoc. 2021 Oct 5;10(19):e020368. doi: 10.1161/JAHA.120.020368. Epub 2021 Sep 28.
citation: Mumtaz M, Wyler von Ballmoos MC, Deeb GM, Popma JJ, Van Mieghem NM, Kleiman NS, Gleason TG, Chawla A, Hockmuth D, Zorn GL 3rd, Tadros P, Li S, Reardon MJ. The Impact of Transfusions on Mortality After Transcatheter or Surgical Aortic Valve Replacement. Ann Thorac Surg. 2021 Sep;112(3):778-785. doi: 10.1016/j.athoracsur.2020.09.031. Epub 2020 Nov 17.
citation: Attizzani GF, Dallan LAP, Markowitz A, Yakubov SJ, Deeb GM, Reardon MJ, Forrest JK, Mangi AA, Huang J, Popma JJ. Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve. JACC Cardiovasc Interv. 2020 Aug 10;13(15):1816-1824. doi: 10.1016/j.jcin.2020.04.028.
citation: Yakubov SJ, Van Mieghem NM, Reardon MJ, Serruys PW, Gada H, Mumtaz M, Deeb GM, Kodali S, George I, Windecker S, Kleiman N, Chetcuti SJ, Sanchez C, Dauerman HL, Li S, Popma JJ. Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial). Am J Cardiol. 2020 Sep 15;131:82-90. doi: 10.1016/j.amjcard.2020.06.051. Epub 2020 Jun 29.
citation: Van Mieghem NM, Reardon MJ, Yakubov SJ, Heiser J, Merhi W, Windecker S, Makkar RR, Cheng W, Robbins M, Fail P, Feinberg E 2nd, Stoler RC, Hebeler R, Serruys PW, Popma JJ. Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial. EuroIntervention. 2020 Nov 20;16(10):833-841. doi: 10.4244/EIJ-D-20-00303.
citation: Lindman BR, Goel K, Bermejo J, Beckman J, O'Leary J, Barker CM, Kaiser C, Cavalcante JL, Elmariah S, Huang J, Hickey GL, Adams DH, Popma JJ, Reardon MJ. Lower Blood Pressure After Transcatheter or Surgical Aortic Valve Replacement is Associated with Increased Mortality. J Am Heart Assoc. 2019 Nov 5;8(21):e014020. doi: 10.1161/JAHA.119.014020. Epub 2019 Oct 31.
citation: Sondergaard L, Popma JJ, Reardon MJ, Van Mieghem NM, Deeb GM, Kodali S, George I, Williams MR, Yakubov SJ, Kappetein AP, Serruys PW, Grube E, Schiltgen MB, Chang Y, Engstrom T. Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results From the Randomized SURTAVI Trial. Circulation. 2019 Oct 15;140(16):1296-1305. doi: 10.1161/CIRCULATIONAHA.118.039564. Epub 2019 Sep 3.
citation: Reardon MJ, Heijmen RH, Van Mieghem NM, Williams MR, Yakubov SJ, Watson D, Kleiman NS, Conte J, Chawla A, Hockmuth D, Petrossian G, Robinson N, Kappetein AP, Li S, Popma JJ. Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial. JAMA Cardiol. 2019 Aug 1;4(8):810-814. doi: 10.1001/jamacardio.2019.1856.
citation: Head SJ, Reardon MJ, Deeb GM, Van Mieghem NM, Popma JJ, Gleason TG, Williams MR, Radhakrishnan S, Fremes S, Oh JK, Chang Y, Boulware MJ, Kappetein AP. Computed Tomography-Based Indexed Aortic Annulus Size to Predict Prosthesis-Patient Mismatch. Circ Cardiovasc Interv. 2019 Apr;12(4):e007396. doi: 10.1161/CIRCINTERVENTIONS.118.007396.
citation: Durko AP, Reardon MJ, Kleiman NS, Popma JJ, Van Mieghem NM, Gleason TG, Bajwa T, O'Hair D, Brown DL, Ryan WH, Chang Y, De Leon SD, Kappetein AP. Neurological Complications After Transcatheter Versus Surgical Aortic Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol. 2018 Oct 30;72(18):2109-2119. doi: 10.1016/j.jacc.2018.07.093.
citation: Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
citation: Haussig S, Linke A. Patient selection for TAVI 2015 - TAVI in low-risk patients: fact or fiction? EuroIntervention. 2015 Sep;11 Suppl W:W86-91. doi: 10.4244/EIJV11SWA27.
citation: Piazza N, Kalesan B, van Mieghem N, Head S, Wenaweser P, Carrel TP, Bleiziffer S, de Jaegere PP, Gahl B, Anderson RH, Kappetein AP, Lange R, Serruys PW, Windecker S, Juni P. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients. JACC Cardiovasc Interv. 2013 May;6(5):443-51. doi: 10.1016/j.jcin.2013.01.136.