TAVR

TAVR Now Used in Almost 50% of Younger Severe Aortic Stenosis Patients

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Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR) despite guideline recommendations to the contrary, a study in a national US population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published today as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a US sample stratified by age: younger than 65 years, 65 to 80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability and the potential for subsequent TAVR procedures over time.”

Three Age Groups

In a study published in June in JACC, this group examined changes in uptake of TAVR vs SAVR in 4161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, told theheart.org | Medscape Cardiology in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 US academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from October 1, 2015, to December 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

  • Age < 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
  • Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
  • Age > 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.

Strategy Depends on More Than Age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, told theheart.org | Medscape Cardiology in an email.

“Age is only one of multiple patient characteristics that enter into consideration of TAVR vs SAVR,” said Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

TAVR associated with lower 12-month mortality rates than open-heart surgery.

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Transcatheter aortic valve replacement (TAVR) was associated with lower mortality rates than conventional open-heart surgery in high-risk patients with aortic stenosis 1 year following surgery in a US trial.

All-cause mortality at 1 year was 14.2 percent in the TAVR arm using Medtronic’s transcatheter bioprosthesis CoreValve compared with 19.1 percent in patients who underwent surgery (p<0.001 for non-inferiority, p=0.04 for superiority). [N Engl J Med 2014; doi:10.1056/NEJMoa1400590]

The rate of heart attack, stroke, or related death at 1 year also improved in the TAVR arm at 20.4 percent compared with 27.3 percent in the surgery arm (p=0.03).

Previous studies have shown TAVR procedures can improve outcomes for patients with aortic stenosis who also have an increased risk of death during surgery compared with medical management. TAVR is an alternative for those who cannot tolerate surgery – about one-third of about 300,000 people with aortic stenosis globally.

In a national US cohort of aortic stenosis patients, of average age 83, patients were randomized to TAVR with CoreValve (n=390) or surgery (n=357). Patients were included if they had at least a 15 percent risk of dying within 30 days of surgery. An extreme risk sub-cohort included patients whose risk of dying or irreversible complications within 30 days of surgery was greater than 50 percent. Both groups proceeded to the comparison portion of the trial after the TAVR arm met initial non-inferiority requirements.

The trial did not meet its secondary endpoint to reduce cardiovascular and cerebrovascular events at 30 days, and the event rate was 8.2 in the TAVR group and 10.9 in the surgery group (p=0.10).

The death rate at 30 days was 3.3 percent in the TAVR group and 4.5 in the surgery group, which was not statistically significant and which were lower than estimated in the surgery arm.

Lead investigator Dr. David Adams, professor and chairman of the Department of Cardiothoracic Surgery at Mount Sinai Medical Center in New York, New York, US, suggested that this may have been because the trial population was actually at lower risk than intended. More patients also refused surgical treatment than refused TAVR treatment.

However, more TAVR patients (22 percent) required pacemaker implants 1 year after treatment than those who were randomized to surgery did (11 percent, p<0.001).

Still, the possibility of alleviating aortic stenosis in inoperable patients led the FDA to approve Medtronic’s CoreValve early, even though the benefits for lower-risk populations remain to be seen, noted Dr. Valentin Fuster, a cardiologist at Mt. Sinai Hospital and editor-in-chief elect of the Journal of the American College of Cardiology, during a discussion of the research. Fuster was not involved in the study.

“To be able to change the valve without opening the chest, I think, is a great accomplishment,” he said.

TAVR for Aortic Regurgitation: Proceed with Caution

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According to a small, international study, the procedure can be successful in carefully selected patients with regurgitation but no stenosis who are ineligible for surgery.

Transcatheter aortic valve replacement (TAVR) is approved in the U.S. for treatment of aortic stenosis in patients who are ineligible for surgery or at high surgical risk. However, outside the U.S., TAVR is being used for a number of other conditions. In this study from 14 centers in Europe and Israel, investigators examined procedural success and outcomes with the self-expanding CoreValve device in 43 patients (mean age, 75 years; 53% women) with severe, native aortic regurgitation (AR) without aortic stenosis. All were considered unsuitable for open surgery because of comorbidities (mean Society of Thoracic Surgeons score, 10.2%).

Devices were successfully implanted in 98% of patients, 8 of whom required a second valve for residual AR (19%). One patient required conversion to surgery for severe residual AR. In the remaining patients, postprocedural AR grade was 

≤I in 79%, II in 16%, and III in 5%. At 30 days, all-cause mortality was 9%, and 2 patients had major strokes (5%). At 1 year, all-cause mortality was 21%.

Comment: This study demonstrates the feasibility of transcatheter aortic valve replacement with the CoreValve device for pure, severe native aortic regurgitation. Challenges to successful TAVR in this patient group include lack of calcification for positioning and fixation, large annulus, and relatively diverse and variable anatomy. The high mortality, frequent need for a second valve, and residual AR in this study will — for the time being — probably limit this therapy to patients with extremely high surgical risk.

Source: Journal Watch Cardiology