{"id":9789,"date":"2017-03-06T14:27:14","date_gmt":"2017-03-06T21:27:14","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=9789"},"modified":"2025-01-17T13:02:26","modified_gmt":"2025-01-17T20:02:26","slug":"tavr-trial-promises-wider-care-more-questions","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/tavr-trial-promises-wider-care-more-questions\/","title":{"rendered":"TAVR trial promises wider care, more questions"},"content":{"rendered":"
<\/div>

 <\/p>\n

\"This
A TAVR procedure at UCH in May 2015 during the trial of the Sapien 3 device for intermediate-risk patients. John Carroll is center.<\/figcaption><\/figure>\n

Five years ago, UCHealth University of Colorado Hospital joined a revolution in cardiac care. Interventional cardiologists and cardiothoracic surgeons worked together to replace narrowed, calcified aortic valves in two patients. That in itself was unremarkable; millions of patients have had their worn-out valves replaced with new ones. The breakthrough was the method of the procedure.<\/p>\n

A year before, the two patients would not have been on the table. They were considered too high risk for traditional open-heart surgery and would have had no options other than medication management. But they got another choice with the development of transcatheter aortic valve replacement, or TAVR. Rather than opening the chest, the specialists threaded a catheter through the femoral artery and used a special device to deliver and place a new aortic valve.<\/p>\n

These patients and hundreds who followed them had much shorter recovery times than open-heart patients, but more importantly they gained a new measure of hope that they might not only live longer but also better.<\/p>\n

One of those first two TAVR patients at UCH described the toll her heart disease took. Rarely could she leave her apartment, she recounted.<\/p>\n

\u201cI lived within those four walls except to go to the doctor,\u201d she said. \u201cI was existing. I wasn\u2019t living.\u201d<\/p>\n

Two years later, UCH joined a national trial of a new generation of TAVR devices, this one aimed at moderate-risk patients. Having helped to open the door to FDA approval for that group of patients, the hospital is now part of yet another TAVR trial, this one aimed at low-risk aortic valve disease patients. The first such procedure, trialing a device from Medtronic, was Feb. 15. UCHealth Medical Center of the Rockies performed its first TAVR procedure for a low-risk patient, using a device from Edwards Lifesciences, last August.<\/p>\n

\"This
John Carroll, MD, director of Interventional Cardiology at UCHealth University of Colorado Hospital, says clinicians will face tough choices in the years to come about using TAVR.<\/figcaption><\/figure>\n

\u201cThese are both major pivotal trials and it is spectacular that two UCHealth hospitals are in the vanguard,\u201d said John Carroll, MD<\/a>, director of Interventional Cardiology at UCH. \u201cAnd these trials will have a major impact on clinical practice.\u201d<\/p>\n

After the revolution<\/strong><\/p>\n

Carroll noted that TAVR has already transformed treatment of heart disease in the half-decade since it emerged \u2013 and not only from a clinical standpoint.<\/p>\n

\u201cIn inoperable, high-risk and now intermediate-risk patients, TAVR has taken over as the predominant form of therapy,\u201d he said. The next challenge is to figure out the consequences of that change and to answer the thorny questions it poses, Carroll said.<\/p>\n

One concern is cost. On the one hand, TAVR patients generally spend 24 to 48 hours in the hospital after their procedures and recover in about a week \u2013 far less than the five hospital days and six weeks of recovery open-heart patients can expect. But the delivery system and the valve\u00a0 from manufacturers Edwards Lifesciences and Medtronic alone cost about $30,000, Carroll said, far more than traditional surgical valves, which run roughly $5,000 or $6,000.<\/p>\n

The differences require balancing the up-front costs with savings at the back end and the even more difficult-to-quantify improvements in quality of life. But for patients whose aortic disease is inoperable, the problem is even knottier.<\/p>\n

That\u2019s because some prohibitively high-risk patients treated with TAVR \u201cclearly don\u2019t benefit,\u201d Carroll said. That opens the door to hard decisions for those considering the treatment, including weighing, for example, the benefits of palliative care over surgery, he said.<\/p>\n

Data for decisions<\/strong><\/p>\n

A growing body of data helps to guide the discussions. In 2012, the Society of Thoracic Surgeons <\/a>and the American College of Cardiology <\/a>launched a Transcatheter Valve Therapy Registry to collect data on patients who have undergone TAVR. Carroll as well as Fred Grover, MD<\/a>, of the University of Colorado School of Medicine\u2019s Department of Surgery, have served as members of the registry\u2019s national steering committee, which is composed of four cardiologist and four surgeons.<\/p>\n

Hospitals submit information on mortality, length of stay, complications, bleeding and more, said Kimberly Marshall, RN, CPHQ, AACC, clinical quality specialist with the Cardiac & Vascular Center <\/a>at UCH. As of January, the hospital had provided data to the registry on some 400 TAVR patients, Marshall said.<\/p>\n

\u201cWe\u2019ve learned a lot from the registry and there is more to learn as this treatment evolves,\u201d Carroll said, notably predicting who is likely to have good outcomes from TAVR and who is not. For example, \u201ca significant portion\u201d of those with renal failure and COPD in addition to aortic stenosis will die within one year after a TAVR procedure, the data show. That makes for discussions that are \u201cexceedingly challenging,\u201d Carroll said.<\/p>\n

\u201cThe data raise both ethical questions and issues of cost and benefit to society,\u201d he said. \u201cThe dicey issue is that we do not have a perfect \u2018crystal ball\u2019 to use in decision making with individual patients in terms of\u00a0 predicting who will be alive and improved at one year versus who will be dead or still feeling ill at one year.\u201d<\/p>\n

The next wave<\/strong><\/p>\n

The importance of patient selection only promises to increase because of a brew of nature and demographics. The most common cause of aortic stenosis, Carroll said, is aging. Think of the aortic valve as a vital piece of anatomic machinery. In an 80-year-old, that part will have opened and closed roughly 3 billion times. In many people of that age or older \u2013 more than 5 percent, Carroll said \u2013 aortic stenosis will begin to break it down.<\/p>\n

Couple that fact with an aging and populous group of baby boomers \u2013 defined as those born between 1946 and 1964 \u2013 and the result promises to be what Carroll dubbed \u201cthe second TAVR tsunami\u201d in an editorial comment that appeared last October in the Journal of the American College of Cardiology.<\/p>\n

\"This
An X-ray image from the first patient treated in the low-risk TAVR trial at UCH. It shows a 34 mm valve, which was successfully implanted in an otherwise healthy 83-year-old patient. The procedure team included physicians John Carroll, John Messenger, David Fullerton, Joseph Cleveland, Javier Valle, and Tamas Seres with the nursing and technical staff from the operating room and cardiac catheterization laboratory. (Image courtesy John Carroll.)<\/figcaption><\/figure>\n

\u201cA substantial increase in the volume of TAVR patients is likely to parallel the increase in the elderly population, especially with the arrival of the baby boomers after 2020,\u201d Carroll wrote. He noted that the 35,000 TAVR procedures performed in the United States in 2016 conceivably could quadruple by 2020.<\/p>\n

Whatever the number it will include many with aortic stenosis made frail because of a long list of conditions that will very high surgical risks or truly inoperable, Carroll said. Demographics and registry data will combine to force discussions of how to make decisions about providing TAVR and other expensive treatments to people with poor prognoses in a society with limited resources. There will be no clear or easy answers.<\/p>\n

\u201cThe questions will be how to draw the line and who will draw it,\u201d Carroll said.<\/p>\n

Carroll noted in his editorial that the link between aging and degenerative aortic valve disease makes it unlikely that the average age of TAVR patients will significantly decline even if TAVR is approved for lower risk patients. Still, the fact that moderate- and low-risk patients will have access to the treatment raises another question. How long will the new valves last in younger patients who can generally be expected to live longer after their procedures than those in the older, higher-risk group?<\/p>\n

\u201cOne of the major unanswered questions we have now is about the long-term durability of the valves \u2013 that is, beyond five to 10 years,\u201d Carroll said. The answers could come from CT scans of patients in each of the low-risk TAVR trials. \u201cWe will want to see how the valve leaflets are working for both surgical and TAVR patients at 10 years and beyond,\u201d he said.<\/p>\n

The march of medical and information technology only underscores the primacy of an individual\u2019s decision about his or her health care, Carroll said.<\/p>\n

\u201cWe can inform patients with our data, predictions and personal recommendations for care,\u201d he said. \u201cBut I have found in sitting down with them and their families that they are often very wise. Helping them to define their own goals of care is hugely important in deciding whether TAVR is appropriate for them or not.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

  Five years ago, UCHealth University of Colorado Hospital joined a revolution in cardiac care. Interventional cardiologists and cardiothoracic surgeons worked together to replace narrowed, calcified aortic valves in two patients. That in itself was unremarkable; millions of patients have had their worn-out valves replaced with new ones. The breakthrough was the method of the […]<\/p>\n","protected":false},"author":2143,"featured_media":9794,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[5],"tags":[3512,82,4822],"class_list":["post-9789","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovative-care","tag-heart-and-vascular-care-cardiovascular","tag-heart-and-vascular-care-cardiology","tag-the-tavr-program"],"acf":[],"yoast_head":"\nTAVR trial promises wider care, more questions - UCHealth Today<\/title>\n<meta name=\"description\" content=\"  Five years ago, UCHealth University of Colorado Hospital joined a revolution in cardiac care. 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