TAVR: A Potential Lifesaver That Comes at a Cost

It is estimated that more than 3% of elderly patients have severe aortic stenosis. Roughly 6 in every 10 of them are candidates for surgical aortic valve replacement (SAVR), according to a 2013 systematic review published in the Journal of the American College of Cardiology.

For the remainder, the nonsurgical option—transcatheter aortic valve replacement (TAVR)—seems to be a potential lifesaver; however, the issue is not so clear-cut. A recent perspective published in JAMA Internal Medicine captured the nuances of this issue. The author, Naftali Zvi Frankel, wrote of researching options for his grandfather, afflicted with aortic stenosis. He came across a video on a leading hospital’s website that proclaimed, “The results of the [TAVR] trial are for us, as heart surgeons and cardiologists… the same as landing a man on the moon… One of the groups who have benefited the most are the older weaker members of our community… They don't have the ability to weather the storm as younger patients might.”

Yet as he further looked at outcomes data of three top surgeons, Mr Frankel found the observed mortality rate to be higher for TAVR than SAVR. His conclusion: “for ‘inoperable’ patients, TAVR is a beacon of hope and life. However, it is also an evolving procedure with risks and uncertainty.”

The Journal of the American College of Cardiology study results—which evaluated more than 9700 elderly patients—bear this out. Investigators noted that only 40% of patients who did not undergo surgery received TAVR. That leaves a substantial portion of patients who received neither, which can be viewed as somewhat of a death sentence, given the high mortality rate associated with aortic stenosis. 

Looking to the Guidelines

When it comes to making decisions on who should and should not receive TAVR, the choice seems fairly easy—look at the evidence and adhere to the recommended guidelines. Costs—which run in excess of $35,000 for the procedure itself and close to $70,000 when factoring in all expenses—pretty much dictate a strict, “cookbook medicine” approach. 

“Like many expensive procedures, payers are concerned about inappropriate utilization of [TAVR],” Gary Owens, MD, president of Gary Owens Associates, said in an interview. “Therefore, most payers have policies that limit the use to those candidates for whom the data supports use—patients at high risk for more conventional procedures and those who would be otherwise considered inoperable.” He noted that insurers also “usually require that the ejection fraction be greater than 20%.” 

Still, strict adherence to clinical guidelines and payer mandates do not change the fact that there are real people at the end of the equation whose quality of life is at stake. How do you handle the situations of those who probably will not benefit at all from TAVR? Or those whose benefit might be very small. As the baby boomer generation ages, these questions will only loom larger. 

Benefits Not Considered

“We are not yet in a position of trying to determine who is likely to benefit the most—our society is not ready for that,” Dr Owens noted. “Basically, if the patient meets the criteria, whether they just minimally meet those criteria or are the best candidate possible, they are eligible for coverage.”

The Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score is usually the starting point in determining those in need of valve replacement. But it should not stop there, especially in the elderly, where its ability to predict risk is limited, said Suzanne V Arnold, MD, MHA, a cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri. She has conducted extensive research on TAVR and SAVR, particularly as it relates to quality of life and outcomes.

“It is more complicated than just STS-PROM,” she explained, because these and other calculators, such as the new [transcatheter valve therapy (TVT)] risk score, “are for short-term mortality. Long-term mortality is more difficult to predict, as things such as functional status and frailty come into play more strongly. Advanced age, being wheelchair-bound, poor renal function, lung disease, low mean aortic gradient, and dementia are generally some of the most important factors.” Disability and unintentional weight loss should also come into play, she noted.

The American College of Cardiology/ American Heart Association Guidelines for the Management of Patients with Valvular Heart Disease takes these factors into consideration in making its TAVR-related recommendations. The guideline stresses the importance of relying on an integrated, multidisciplinary heart valve team to provide optimal care. This can help with patient selection, pre-procedural planning, and managing intra-procedural complications, Dr Arnold said. 

“Similar to the role of the heart team in complex coronary disease, collaborative efforts can be quite helpful in high-risk patients.” She explained that the ideal team should include a cardiologist, CT surgeon, nurse practitioner or nurse, and social worker. “Geriatricians can also be helpful members of the team, particularly for postprocedural care to limit delirium and optimize functional recovery.” 

Sometimes No Treatment is the Best Care

When asked about the economic burden of performing TAVR on high-risk patients, Dr Arnold aptly chose to bring the discussion from the socioeconomic stratosphere down to the level of actual care. “While both the local and societal economics support limiting treatment of [certain] patients, I think it is the patient care aspect that best supports this. Sometimes, it is in the best interest of the patient and the family not to do TAVR. It is sometimes difficult to determine when that is and also how to have that conversation, but it is important to try.”

As for the best way to proceed, Dr Arnold explained that “our CT colleagues are actually good sources of potential help for learning how to have these conversations. Informing patients that their risk is too high for a surgery is something they do quite often.” The challenging part, of course, is what comes next. “We need to have something to offer patients when TAVR is not an option.” Typically, that is palliative care and, eventually, hospice. 

She added that patients can be surprisingly realistic, and may be in step with what the evidence recommends for them. 

“Most patients are more accepting of these conversations than we expect them to be, particularly those who are of advanced age,” she said. “I think it is important to discuss the risk of the procedure, and the low likelihood that they will feel better. Patients care deeply about quality of life, and if they know they are not likely to feel better, they are likely to accept it.” 

Dr Owens agreed, adding that the issue goes beyond aortic stenosis and TAVR. “In oncology, we are learning that many patients, when given the facts [about] the unlikely response to later line therapies for metastatic disease, will often opt for less ongoing treatment and move to palliative care in hopes of preserving some quality of life.” 

However, Dr Owens noted that this is easier said than done. “These are tough conversations in a society where we have been accustomed to believing there is one more thing we can try.  Plus, physicians often don’t have the time, nor are they well-trained in how to do it correctly.”  

“Outpatient palliative care is difficult to find and often falls to the primary care providers,” Dr Arnold added. But “as it grows as a specialty, I think access will become easier.” 

A recent editorial in the JAMA drives this point home. Preeti N Malani, MD, and Eric Widera, MD, wrote that “there is an imperative to train both specialists and nonspecialists to deliver interventions proven to be effective.” They point to the Palliative Care and Hospice Education and Training Act, which, among other things, “is designed to establish a nationwide network of palliative care and hospice education centers that could expand specialist training programs and also train all clinicians in providing high-quality palliative care.”

What Contributes Most to Cost?

Few would disagree that treating patients individually and helping each arrive at the best decision for them is preferred. But that does not change the fact that behind these decisions—like it or not—dollar signs lurk that impact the health care system. We asked Dr Arnold about that, and the work she has done to identify TAVR-related complications that have the highest impact on cost, so-called “attributable costs.” Specifically, she and her team identified the incremental cost of a TAVR-related complication, as well as its frequency, to arrive at the attributable cost. Major bleeding, arrhythmia, death, and renal failure resulted in the highest attributable costs, in that order. 

“The analysis was designed more to inform practice—for example, using contrast cautiously, or creating strategies to avoid major bleeding—rather than to inform patient selection,” she noted. Still, “if you are trying to reduce the overall costs of TAVR, then focusing on the complications with the highest attributable costs would be a good strategy. They occur with enough frequency and with high enough costs to be good targets for intervention.” 

The tough issue extends beyond patients with aortic stenosis. An aging population, concerns about rising drug costs, and the rapid changes to the US health care system serve as the backdrop for this issue. In the foreground, managed care decision-makers, policy experts, clinicians, and others grapple with economic and quality of life questions related to a host of diseases and conditions in an era of limited resources. 

Dr Owens goes back to oncology, where immunotherapies can cost up to $500,000 per year, to illustrate his point. The economic realities “may ultimately drive us to reconsider how and on whom resources should be allocated.” But he was quick to point out that “this is not something payers will decide.  That will be a societal decision that payers will then likely support.” 

Aggressive Management vs Quality of Life

This begs the question: are we, as a society, ready to make cost vs life decisions?

“We are definitely behind other countries,” explained Dr Owens. “In the US, if you meet the criteria to get something done, then it is generally available and paid by either governmental or private sources. That is why we spend $3 trillion and have medical spending approaching 18% of the GDP.  We have always found the money to pay for things, regardless of the projected benefit.” 

Barney Spivack, MD, national medical director of Medicare case & condition management at OptumHealth, said that this country tends to look at the issue as one of “withholding care.” When it comes to terminal malignancies, aggressive management often appears to trump comfort and quality of life. “Some are concerned about ‘doing nothing’ or ‘not providing hope’ when they really should be promoting palliative care and hospice.” 

Then there is the delicate issue of allocating health resources disproportionately to older individuals. Norm Smith, president of Viewpoint Consulting, Inc, pointed out both sides of the debate. 

“Older patients vote, and Medicare is a middle-class benefit that we’ve all paid into, so it’s only fair that spending favors the old,” he explained. “That’s one argument. The opposite argument is that we need to invest in the health care of the young to soften the impact of diseases like diabetes and hypertension.”

Mr Smith concluded that “in the United States, there is enough wealth for everyone to ‘have health care’. The real question is ‘how much’?”