DR. MARK J. RUSSO, MD, MS

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What is
TAVR?

What is TAVR?

Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is a minimally invasive approach to the treatment of aortic stenosis.

In most patients (95%+), TAVR can be performed through a puncture in an artery in the leg (known as the femoral artery).   TAVR avoids the need for opening the chest, intubation (aka a breathing tube), using a heart-lung machine, and stopping the heart.  This allows for faster recovery.  

During a TAVR procedure we dont stop the heart, we dont cut out the existing valve, we put the new valve inside the existing valve.  The procedure takes 30 minutes to an hour, and patients typically (80+%) go home the following day. 

Who is a Candidate for TAVR? 

Who is a candidate for TAVR

The aortic valve become narrowed (aka aortic stenosis) preventing blood from moving forward or it may leak (aka aortic insufficiency or aortic regurgitation) allowing blood to move backwards to the heart.

Conventional surgical aortic valve replacement (SAVR)  continues to be associated with excellent outcomes.  However, catheter-based procedures are available for nearly all types of patients, including patients who are considered low-risk for traditional surgical valve replacement. 

 

TAVR is NOT experimental. TAVR is FDA approved for the treatment of severe symptomatic aortic stenosis.  More than 500,000 TAVR procedures have been performed worldwide. Dr Russo is the among experienced TAVR surgeons in U.S., and the team at RWJ achieve outcomes that exceed national benchmarks.

 

Research studies published in the New England Journal of Medicine found that patients with severe symptomatic aortic stenosis, TAVR (aka TAVI) is associated with significantly improved survival, improved symptoms, and improved quality of life. In fact, patients undergoing TAVR were nearly twice as likely to be alive at 1 year compared with those who did not.   

What is Aortic Stenosis?

Aortic valve stenosis (AS) is a disease of the aortic valve in which the opening of the valve is narrowed (stenotic). 

This typically results from calcium that is deposited in the valve  as people age. The calcium causes narrowing of the valve and prevents it from opening normally.

The normal size of the aortic valve is the size of a half dollar; a severely stenotic valve may be the size of a dime or smaller.

Treatment Options

Surgical Aortic Valve Replacement (SAVR)

Transcatheter Aortic Valve Replacement (TAVR)

Surgical Aortic Valve Replacement
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Common Patient Characteristics

Common Patient Characteristics

Primary Benefits

Recovery

Primary Benefits

What are Treatment Options for Aortic Stenosis?

Surgical Aortic Valve Replacement (SAVR)

Recovery

Primary Benefits

Typical Patient

Transcatheter Aortic Valve Replacement (TAVR)

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Recovery

Primary Benefits

Typical Patient

Frequently Asked Questions about Aortic Valve Disease

Typically patients have no new restrictions after the procedure, and (unless a mechanical valve is placed) there are no new medications that need be taken as a result of receiving the new valve.

Although they vary by patient. The risks of both procedures are death, bleeding, stroke, infection, and vascular injury. In a typical patient the risk of anyone of these complication is less than 1-2%.

Ideally, patients should be treated within 1-3 weeks. Treatment of aortic stenosis is typically not an emergency. However significant delays can pose a risk of heart failure, hospitalization, and sudden cardiac death.

If untreated, 50% of patients with severe aortic stenosis die 18 months years after symptoms are detected. And if untreated ultimately nearly all patients die from this condition within 5 years.

The likelihood of need a valve replaced depends on age at the time of initial surgery (Ann Thor Surg, 2015):

For patients < 60 years, at :

  • 10 years, 5.6% (95% CI, 4.7 to 6.8);
  • 15 years, 20% (95% CI, 17 to 23); and
  • 20 years, 45% (95% CI, 39 to 52)


60 to 80 years old, at:

  • 10 years, 1.5% (95% CI, 1.3 to 1.7);
  • 15 years, 5.1% (95% CI, 4.4 to 5.8), and
  • 20 years, 8.1% (95% CI, 6.7 to 9.7)

  • at 80+ years: unlikely
  • Transthoracic echo
  • Gated cardiac CT
  • Pre-admission testing Cardiac catheterization — for some patients
  • Cardiac CT can be performed without the need for cardiac cath


Administrative staff will help find a date for treatment Nursing coordinatots will provide instruction on preparation

To schedule an in-person or telemedicine consultation with Dr. Russo,
please call 732-235-7231 or send an email.

Commonly Performed Procedures

Minimally invasive valve surgery is a specialized approach to treating heart valve disease that avoids the need to “crack the chest.” This method uses sophisticated instruments to perform the surgery through a smaller incision at the side of the chest and offers the patients less pain and faster recovery. We perform nearly all of our isolated valve surgeries minimally invasively.

An aortic aneurysm is a bulging, weakened area in the wall of main blood vessel in the body. The risk of aortic catastrophe, including dissection and rupture, increases dramatically with an aneurysm. Surgery may be recommended when the aorta is larger than 4.5-6 cms. Factors including family history, lifestyle, and need for other heart surgery guide decisions about surgery.​​

An aortic aneurysm is a bulging, weakened area in the wall of main blood vessel in the body. The risk of aortic catastrophe, including dissection and rupture, increases dramatically with an aneurysm. Surgery may be recommended when the aorta is larger than 4.5-6 cms. Factors including family history, lifestyle, and need for other heart surgery guide decisions about surgery.​​

A “bypass” or “cabg” surgery is the most commonly performed heart surgery. It is necessary when the coronary arteries, which provide blood to the heart become narrow preventing sufficient blood from passing through, and thus depriving the heart of oxygen and nutrients. RWJUH has CABG outcomes that exceed national benchmarks.

When other treatments are insufficient, a heart transplant is a surgical procedure offered to patients with the most severe damage to the heart. RWJUH is one of a limited number of centers in the US that offer advance heart failure surgery, including heart transplant. Dr. Russo has participated in 500+ successful transplant surgeries.

When other treatments are insufficient, a heart transplant is a surgical procedure offered to patients with the most severe damage to the heart. RWJUH is one of a limited number of centers in the US that offer advance heart failure surgery, including heart transplant. Dr. Russo has participated in 500+ successful transplant surgeries.

Clinical Trials at RWJUH

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.  Read More

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis. Patients are randomized to S3 TAVR device or medical management.  Read More

ALIGN-AR evaluates the safety and probable benefit of the transfemoral JenaValve Pericardial TAVR System in patients with symptomatic severe aortic regurgitation. Patients who are high risk for open surgical aortic valve replacement/repair are eligible. RWJUH is one of only 15 centers in the U.S. that can offer this therapy that has been granted a “Breakthrough Device Designation” by the US Food and Drug Administration. This designation is reserved for investigative therapies designed to treat a serious or life-threatening disease or condition and where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

Transcatheter aortic valve replacement for severe AS with a novel deviceEvaluates the safety and efficacy of Acurate (Boston Scientific) valve for transcatheter aortic valve replacement. For patients with severe aortic stenosis who are at intermediate or greater risk for SAVR. Patients are randomized to Acurate or commerical TAVR device. Read More

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.

The SUMMIT-Tendyne trial (Abbott) evaluates the safety and effectiveness of using the Tendyne Mitral Valve System for the treatment of symptomatic mitral regurgitation or mitral annular calcification in patients who are not appropriate for conventional mitral valve surgery. In the randomized arm, patients are treated with either the Tendyne device or MitraClip, while patients in the non-randomized and MAC arms receive the Tendyne device. https://clinicaltrials.gov/ct2/show/NCT03433274

The SUMMIT-Tendyne trial (Abbott) evaluates the safety and effectiveness of using the Tendyne Mitral Valve System for the treatment of symptomatic mitral regurgitation or mitral annular calcification in patients who are not appropriate for conventional mitral valve surgery. In the randomized arm, patients are treated with either the Tendyne device or MitraClip, while patients in the non-randomized and MAC arms receive the Tendyne device. https://clinicaltrials.gov/ct2/show/NCT03433274

CLASP IID/F is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair in patients with degenerative/functional mitral regurgitation with the Edwards PASCAL Transcatheter Valve Repair System compared with the commercially available device (Abbott MitraClip).

RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).

PBS: Heart Disease OnCall

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Newest heart valve options

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Miracle transplant at RWJUH

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