Surgical Risk Should Be ‘Off the Table’ When Deciding on Eligibility for TAVR

CHICAGO, IL—Surgical risk should no longer be the deciding factor when evaluating patient eligibility for TAVR, according to several experts who spoke here at the recent TVT 2019 meeting.

Given data from the randomized trials showing that TAVR is equivalent, if not superior to, surgical valve replacement across a full range of patients, physicians should focus primarily on anatomy, risk of complications, and comorbid conditions when selecting eligible patients and not on the patient’s risk for surgery. “Doctors are going to make their decision about valves on a multiplicity of factors,” said Michael Reardon, MD (Houston Methodist DeBakey Heart and Vascular Center, TX), “but risk, in my estimation as a surgeon, is no longer a decision-making factor.”

To TCTMD, Megan Coylewright, MD (Dartmouth-Hitchcock Medical Center, Lebanon, NH), agreed that surgical risk should no longer be the chief criteria used to select candidates for TAVR or surgery. Instead, the heart team should factor technical aspects of the procedure into their calculations before presenting treatment options to the patient.

“One of the reasons we’re taking surgical risk off the table as being a primary way to identify which therapies are open to patients is because the low-risk trials show noninferiority or superiority,” she said. “But that was in a select group of patients in whom the technical risk for TAVR was very low. I think we will be thinking about risk, but it will be more about the technical aspects of the two procedures first.”

We have to figure out what we think our patient’s survival is going to be versus what we think the valve’s survival is going to be. Michael Reardon

Coylewright pointed out that the PARTNER 3 and Evolut Low-Risk Study investigators excluded low-surgical-risk patients considered to have a risk of complications or unfavorable anatomy for TAVR. For example, several presenters noted that patients with bulky leaflet calcification, bicuspid valves, severe subannular calcification, unfavorable aortic anatomy, and borderline femoral access were not eligible for these two trials.   

Tsuyoshi Kaneko, MD (Brigham and Women’s Hospital, Boston, MA), agreed that with the success of TAVR in the low-, intermediate-, and high-risk clinical trials, surgical risk is not the lone determinant for eligibility. Instead, the heart team should consider other important variables, including anatomy as well as the risk of complications and presence of concomitant conditions. He noted that people with extensive concomitant coronary artery disease or mitral regurgitation, or cases that result in significant patient-prosthesis mismatch, might be better suited for surgery.  

“TAVR is not for everybody,” said Kaneko.

Age, Durability, Anatomy

During the session, Reardon cycled through a number of slides in support of TAVR over surgery irrespective of the patient’s baseline surgical risk. One of his first considerations when deciding between TAVR and surgery is age and life expectancy, which are important as physicians start to address valve durability and the potential need for a second procedure.

“We have to figure out what we think our patient’s survival is going to be versus what we think the valve’s survival is going to be,” he said. “The good news is that the low- and intermediate-risk trials are now 10-year trials and that’s going to give us some of the best data we have.”

Coylewright told TCTMD that the thinking has evolved where the concern now is not so much the surgical risk at the time of the procedure, but rather the technical risks. “There is a lot of discussion of risk and benefit, but how we are understanding and communicating that risk is shifting,” she said.

And while eliminating surgical risk as a deciding factor for TAVR might simplify the decision-making process at first blush, there are now other important considerations. As physicians begin treating patients at lower risk for surgery, they will be encountering younger patients, which makes it difficult to determine the appropriate lower age limit for TAVR given durability concerns. “As you get younger, there is going to be a cutoff, but where is that?” asked Reardon. “I think we’d all agree that nobody would put a TAVR in a 40-year-old patient a priori, but somewhere between 40 and 80 years there is going to be a tipping point.”

I do think surgical risk does matter, but up until now that’s the only thing we’ve been looking at. Mark Russo

Mark Russo, MD (Robert Wood Johnson University Hospital, New Brunswick, NJ), who led the screening committee for PARTNER 3, said the challenging “gray zone” patient is 60 to 70 years old. “If we do surgery on them first, they’re likely going end up with a [future] valve-in-valve procedure. But if we do TAVR on them first, how long is that valve going to last? Will they need surgery in their 80s, or will they need a TAVR-in-TAVR?”

For his part, Russo said he believes surgical risk still matters when evaluating patients for surgery but that anatomic risk is more important when considering patients for TAVR. “I think you really need to consider both of those,” said Russo. “The third component is the longevity issue. These are things we need to balance. I do think surgical risk does matter, but up until now that’s the only thing we’ve been looking at. ‘Is the patient too high risk?’ We need to consider there are TAVR risks on the flip side. There may be anatomic factors that make surgery a better option.”

During his presentation, Kaneko echoed all of these points, noting that coronary access in the event of future CAD is also a consideration when selecting patients for surgery instead of TAVR. Nonetheless, he knows surgeons face an uphill battle when trying to discuss these nuances with patients. “I do believe it’s going to be very, very hard to convince patients to undergo surgery when there all these viral videos of Mick Jagger dancing,” he said, referring to the 75-year-old rock legend’s bounce back from TAVR earlier this year. “It’s very hard to beat that.”

G. Michael Deeb, MD (University of Michigan, Ann Arbor), said there are still practical reasons for assessing surgical risk. For one, such data needs to be submitted to the Society of Thoracic Surgeons/American College of Cardiology TVT Registry. “The other time it’s very important is at the very end of spectrum,” said Deeb. “There are a certain group of patients who probably shouldn’t have a procedure.” Known as cohort C, these individuals have severe cardiovascular or comorbid conditions at baseline and are unlikely to live longer or derive any functional improvement from TAVR, he said.