Exciting News on TAVR; Tempered by Unanswered Questions

Svensson_LarsThis post was authored by Lars G. Svensson, MBBCH, PhD, FACC, chair of the Sydell and Arnold Miller Family Heart and Vascular Institute at Cleveland Clinic in Cleveland, OH.

There are few procedures that show a benefit for patients relieving symptoms, saving lives, and improving long-term survival as aortic valve replacement (AVR). Indeed, the advent of transcatheter aortic valve replacement (TAVR) hailed a new era for valve replacement.

In 2001, Alain Cribier, MD, FACC, pioneered human implantation of percutaneous aortic valve replacement via the femoral vein, however this proved to be too high risk. The transapical approach was then implemented with a moderate risk, but shortly thereafter the transfemoral arterial approach was developed with considerably lower mortality although with complications. For example, there was about a 20 percent failure rate from failure to implant, embolization and severe perivalvular regurgitation. Nevertheless, studies in high-risk patients (PARTNER cohort A and PARTNER cohort B) showed excellent outcomes for TAVR with equivalence to open surgery.

Now findings from the PARTNER 2 trial, presented today during the ACC.16 Opening Showcase Session, have demonstrated that, for intermediate-risk patients, TAVR and surgery are equivalent. Furthermore, the data showed superiority for transfemoral procedures. The questions that are raised are many:

  1. Can we afford (particularly the Centers for Medicare and Medicaid Services) to expand TAVR into lower-risk groups, with lower reimbursements, without the MCC DRG 266 code?
  1. Will costs for the devices fall below $32,500 with the expiration of the Cribier patent?
  1. How does one answer the ethical question of where to refer your patients for either open surgery or TAVR?
  1. How do different institutional results compare between TAVR and open AVR? At the Cleveland Clinic our isolated AVR risk of death for all patients, including complete reoperation, emergencies and endocarditis for the last 5-years for 2,230 patients was 0.46 percent with the majority done as minimally invasive procedures, better than our internal TAVR or the PARTNER II A data.
  1. How will TAVR affect AVR volumes? For our Heart and Vascular Institute, our volume of isolated aortic valve has grown from 275 in 2011 to over 400 on a yearly basis for a total of 2,828 valve operations of all types done in 2015.
  1. Will the new filtration devices reduce the risk of brain showers during TAVR?
  1. The new S3 device reduces perivalvular leakage but will it increase the risk of pacemakers and valve gradients?
  1. Lastly, is it time for an all-comers comparison for lower-risk patients between surgery and TAVR? The planned PARTNER 3 trial will examine this for patients with an STS score of less than 4 percent and age over 65-years.

Get full ACC coverage of ACC.16 at ACC.org/ACC2016. Follow @ACCCardioEd on Twitter and use the hashtag #ACC16 to join the conversations.

Statements or opinions expressed in this article reflect the views of the contributor, and do not reflect the official views of the ACC, unless otherwise noted.

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