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Clinician-to-Clinician Update
To schedule a consultation, referral or appointment:
or 612‑365‑6000 (Minneapolis), 952‑836‑3700 (Edina), 651-232-3700 (St. Paul)

University of Minnesota Health
Heart Care - Edina
Fairview Southdale Hospital
6405 France Ave. S., Suite W200
Edina, MN 55435

University of Minnesota Health
Heart Care - Minneapolis
Clinics and Surgery Center
909 Fulton St. SE, Suite 318
Minneapolis, MN 55455

HealthEast Heart Care
St. Joseph’s Hospital
45 W. 10th Street
Saint Paul, MN 55102

TAVR Producing Good Outcomes in Broader Patient Population

First approved in 2012 for patients deemed at high risk of complications following standard surgical repair, transcatheter aortic valve replacement (TAVR) is finding broader application among patients with aortic stenosis. Clinical trials of TAVR in symptomatic patients at intermediate-1 or high-surgical risk2 have demonstrated comparable outcomes to open surgery and faster recovery times. With recent encouraging findings, the focus now has turned to TAVR in lower-surgical risk patients. 

Valve replacement via open-chest surgery has been standard of care, with the minimally invasive TAVR approach gaining wider use the latter half of this decade. TAVR is usually conducted through the femoral artery but can also employ the subclavian or carotid arteries in reaching the affected valve. 

Heart Care surgery
University of Minnesota Health interventional cardiologist
Gregory Helmer, MD, conducts a transcatheter aortic valve
replacement procedure.
Aortic stenosis, the most common heart valve disease, accounts for approximately 35% of moderate-to-severe native heart disease, with an estimated prevalence of about 7.6 million among adults age 75 years or older in the United States and Europe.3 Valve replacement is the preferred treatment for severe aortic stenosis. No other treatment reduces disease progression or improves prognosis.4 Symptomatic severe aortic stenosis if not addressed is associated with a mortality rate of about 50% within 2 years.4 

TAVR, according to clinical outcome findings, poses advantages associated with minimally invasive surgeries, including reduced time in surgery, shorter hospital stays, fewer complications, and faster recovery times compared to open-chest procedures.5 TAVR has also demonstrated a lower risk of infection than open-chest surgery.6 

In a multicenter, randomized study of low-surgical risk patients with severe aortic stenosis published this May, the procedure was found to produce outcomes superior to those of open surgery.7 The rate of the composite death, stroke, or rehospitalization at 1 year following TAVR was deemed significantly lower than with open procedures. Rates of new onset atrial fibrillation at 30 days postprocedure were also lower.7 Part of the PARTNER 3 clinical trial, the study employed the SAPIEN 3 TAVR system and was funded by Edwards Lifesciences. Findings from another, longer-term trial in low-risk patients, which employed 3 different Medtronic valves, demonstrated TAVR’s noninferiority to open-chest procedures. With a primary end point of death or disabling stroke at 24 months, the estimated incidence was 5.3% in the TAVR group and 6.7% in the open procedure group.8 

In addition to the perhaps more well-known SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA) and the Evolut valve (Medtronic, Minneapolis, MN), new valves have become available for suitable patients5, and some provide distinct attributes. The recently approved LOTUS Edgetm Valve System (Boston Scientific, Marlborough, MA), for example, can be repositioned and recaptured once it has been fully deployed, and the SAPIEN 3 can be placed within a previously implanted bioprosthetic aortic or mitral valve. Devices are also being developed to be used with TAVR with the goal of reducing postsurgical stroke risk or sealing femoral artery punctures. 

University of Minnesota Health Heart Care physicians participated in the trial of the SAPIEN 3 valve7 as well as in those testing Boston Scientific’s Lotus EdgeTM Valve System. They have also been involved in ongoing clinical trials in patients with aortic stenosis who are at low surgical risk. University of Minnesota Health Heart Care locations are also participating institutions in several clinical trials, including an enrolling study of TAVR in low-risk adults who have asymptomatic aortic stenosis. The trial seeks to determine the optimal time to replace diseased valves. 

References

  1. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376(14):1321-1331. doi: 10.1056/NEJMoa1700456 
  2. Gleason TG, Reardon MJ, Popma JJ, et al. 5-year outcomes of self-expanding transcatheter versus surgical aortic valve replacement in high-risk patients. J Am Coll Cardiol. 2018;72:2687-2696. doi: 10.1016/j.jacc.2018.08.2146 
  3. Osnabrugge RL, Mylotte D, Heade SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62(11):1002-1012. doi: 10.1016/j.jacc.2013.05.015 
  4. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017;70(2):252-289. doi: 10.1016/jacc.2017.03.011
  5. Todaro D, Picci A, Barbanti. Current TAVR devices. Cardiac Interv Today. 2017;11(2):53-58. 
  6. Hascoet S, Mauri L, Claude C, et al. Infective endocarditis risk after percutaneous pulmonary valve implantation with the Melody and Sapien valves. JACC Cardiovasc Interv. 2017;10(5):510-517. doi: 10.1016/jcin.2016.12.012 
  7. Mack J, Leon MB, Thourani VH, et al. for the PARTNER 3 Investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705. doi: 10.1056/NEJMoa1814052 
  8. Popma JJ, Deeb GM, Yakubov SJ, et al, for the Evolut Low Risk Trial Investigators. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380(18): 1706-1715. doi: 10.1056/NEJMoa1816885

When to refer

University of Minnesota Health Heart Care provides dedicated teams of cardiologists, interventional cardiologists, surgeons, vascular medicine specialists, and advanced practitioners to care for adults with aortic diseases, including aortic stenosis. Our interventional cardiologists have conducted transcatheter aortic valve replacement (TAVR) since 2012, and University of Minnesota Health Heart Care locations are considered high-volume centers. We have also recently extended our services and now offer TAVR and other advanced interventions and services through our partner heart care teams in Saint Paul, MN. First approved for use in patients at high risk of complication from open procedures, TAVR may also be appropriate for intermediate-risk patients with symptoms of aortic stenosis. 

Our heart care teams review patient medical history and confer with patients to evaluate treatment options best suited for them. We provide a full complement of cardiovascular imaging technologies and diagnostic services. In addition to TAVR and other minimally invasive procedures, we offer patients with aortic valve disease a full range of treatments from medical management to surgical repair and replacement procedures. 

Our physicians participate in clinical trials of new valves and devices and studies into the use of TAVR in different patient populations. They are also experienced in treating atrial fibrillation and other heart valve diseases. 

To schedule a referral or consultation, contact 877-650-1555 or 612-365-6000 (Minneapolis), 952-836-3700 (Edina), 651-232-3700 (St. Paul). 

Request a free copy of the University of Minnesota Health Adult Specialty Directory

To find current clinical trials available through M Health providers visit studyfinder.umn.edu.

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