DR. MARK J. RUSSO, MD, MS
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(732) 235-7231
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EARLY TAVR

Asymptomatic Aortic Stenosis

Early TAVR -  Transcatheter aortic valve replacement vs OMM (randomized) for asymptomatic severe AS The EARLY TAVR trial (Edwards) looks at transcatheter aortic valve replacement (TAVR) as an effective treatment for patients with asymptomatic aortic stenosis. Patients are randomized to either treatment with TAVR or clinical surveillance until the develop symptoms, at which point they are eligible to be treated with TAVR.
https://clinicaltrials.gov/ct2/show/NCT03042104
  
Early TAVR: Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis
Sponsor: Edwards Lifesciences
To establish the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Non-randomized against medical management then TAVR when symptomatic

Randomized: TAVR vs medical management then TAVR when symptomatic
Primary endpoint: Safety and Effectiveness: Freedom from a non-hierarchical composite endpoint of all-cause death, all stroke, and unplanned cardiovascular hospitalization through 2 years The primary endpoint will be a superiority comparison using the log-rank test to compare the survival curves through 2 years.
Secondary endpoint: Death or disabling stroke.
Criteria
Inclusion Criteria:
  • Severe aortic stenosis
  • Patient is asymptomatic defined as:
    • Negative treadmill stress test OR Per physician after thorough assessment of patient history if the patient is unable to perform a stress test.
  • LV ejection fraction ≥50%
  • 65 years of age or older at time of randomization
Exclusion Criteria:
  • Patient is symptomatic.
  • Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
  • Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
  • Aortic valve is a unicuspid, bicuspid with unfavorable features for TAVR or is non-calcified.
  • Severe aortic regurgitation (>3+).
  • Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
 
More information:  https://clinicaltrials.gov/ct2/show/NCT03042104
Appointment - 732-235-7231
​Patients:   We are committed to providing you with an appointment within 7 days of your request. For your convenience, Telemedicine Consults are available.   If you have questions in the meantime, please   Ask Our Experts.
Patient   Appointments   -  732-235-7231

​ Physicians:   Our team is available 24 hours a day, 7 days a weeks, to assist in the care of your patients and to facilitate urgent, emergent and elective transfers at the local, regional, national and international levels​
RWJUH Transfer Center   -   732-427-5725
About Dr. Russo
Telemedicine
Aortic Aneurysms
Minimally Invasive Surgery
TAVR
Mitraclip
Clinical Trials

2nd Opinion
Ask Dr. Russo
Getting a second opinion can provide peace of mind and confidence that you have been diagnosed appropriately and understand of all your treatment options. 
​Send your non-urgent questions regarding your aortic,  heart, and vascular conditions via email.

Mark J Russo, MD, MS
 Chief, Cardiac Surgery

Director, Structural Heart Disease
Associate Professor of Surgery
​
​Rutgers-Robert Wood Johnson Medical School
Robert Wood Johnson
University  Hospital 
​125 Paterson St
​New Brunswick, NJ  ​08901

Office: 732-235-7231
Fax:   
732-235-8963​
Expert in Complex Aortic  Disease, Valve Surgery, Transcatheter Aortic Valve Repalcement (TAVR) , and Mitraclip
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(c) Mark Russo 2020
Dr. Russo performs the full range of cardiac surgery including  Coronary Artery Surgery - Coronary Artery Bypass Grafts; Bypass Surgery;  CABG;  Coronary Artery Surgery; Reoperation; Off Pump Bypass Surgery; Off Pump Heart Surgery; Valve Surgery - Aortic Valve Repair; Aortic Valve Replacement; Mitral Valve Repair; Mitral Valve Replacement ; Reoperatve Heart Valve Surgery;;  Endovascular and Hybrid Aortic Surgery;  Transcatheter Valve Surgery - TAVR, TAVI, ViV, MVIV, valve-in-valve; Minimally Invasive Cardiac Surgery - Minimally Invasive Mitral Valve Repair; Mitral Valve Replacement; Minimally Invasive Aortic Valve Surgery​; Aortic Surgery - Aorta Surgery; Aortic Dissection; Complex Aorta Surgery; Valve Sparing Roots, Heart Surgery for Marfan Syndrome; Aortic Root Aneurysms; Ascending Aortic Aneurysms; Aortic Arch Aneurysms; Descending Thoracic Aortic Aneurysms; Thoracoabdominal Aortic Aneurysms; Abdominal Aortic Aneurysms; Aortic Dissections, including Type A Dissections and Type B Dissections; Native Aortic and Prosthetic Graft Infections, including Endocarditis; Congenital Aortic Disease, such as Marfan's syndrome and Loeys Dietz; Transplant Surgery - Heart and Lung.  He was trained by Dr. Mehmet Oz and Craig Smith and Eric Rose.  Read about Matt Millen undergoing Heart Transplant