NEPA Vital Signs - Winter 2019 Spring 2020 - 13

WINTER 2019-2020

During a TAVR procedure, a collapsed artificial heart valve is fed via catheter through an artery in the
groin or chest to the native aortic valve. Once in place, the new valve is expanded, allowing blood to flow
freely again through the aorta. Though not without risk, the procedure's small incision and relatively short
recovery time have made it a viable option for older adults and patients with other existing conditions
who would run too high a risk with surgical valve replacement.
Severe aortic valve stenosis can lead to heart failure, stroke,
blood clots, bleeding, abnormal heart rhythm, heart infections
and death if left untreated.

Care teams will have to provide patients with all relevant
information based on their specific cases, and patients will have
more input than they have in the past, which will further increase
the patient role in the age of personal advocacy.

Prior to the FDA approval, transcatheter aortic valve replacement (TAVR) was a viable option for patients at moderate or high
risk for death or major complication from open-heart surgery,
but surgical aortic valve replacement (SAVR) was still considered
the standard for low-risk patients.

Surgery is still vital

The indication of TAVR for all risk levels does alter the landscape of cardiothoracic surgery a bit, but it doesn't mean SAVR
will become obsolete.

During a TAVR procedure, a collapsed artificial heart valve is
fed via catheter through an artery in the groin or chest to the
native aortic valve. Once in place, the new valve is expanded,
allowing blood to flow freely again through the aorta. Though
not without risk, the procedure's small incision and relatively
short recovery time have made it a viable option for older adults
and patients with other existing conditions who would run too
high a risk with surgical valve replacement.

Surgery will still be the best option for patients who have
reasons to be better treated with mechanical heart valves
rather than the biologic ones used in TAVR, for those patients
that require replacement of the aorta as well as the aortic
valve, those who require simultaneous bypass of blocked
heart arteries, and those who require operation on multiple heart valves.

Until recently, there was not enough evidence to support the
safety and effectiveness of transcatheter aortic valves in comparison to open-heart surgery. But a series of new studies has shown
outcomes for transcatheter heart valves to be similar to surgery
at an average of 15 to 17 months post procedure. This comparable
set of results has given the FDA reasonable assurance to indicate
transcatheter heart valves for low-risk patients.

And the FDA doesn't recommend TAVR for all low-risk patients
either. Patients who are adversely affected by blood-thinning
medication or have active infection in the heart or another part
of the body should not be candidates for transcatheter valve
procedures. Also, two of the approved transcatheter valves
contain titanium and nickel and should not be used in patients
with sensitivity to those metals.

The significance of approval

Ultimately, the long-term effectiveness and durability of
transcatheter heart valves has not been determined, so the
medical community still needs to establish whether surgically
implanted valves are a better lasting solution.

According to a recent article in Diagnostic and Interventional
Cardiology Magazine, the general consensus among interventional
cardiologists and cardiac surgeons at cardiology conferences over
the last several years has been that TAVR will soon be the most
appropriate option for about 75 percent of patients with aortic
valve stenosis, and surgery will be the best mode of treatment
for 25 percent.

The FDA will continue to monitor the outcomes associated
with transcatheter valves over the next 10 years to evaluate safety
and effectiveness.

Whether this estimate is accurate remains to be seen over
the next few years, but we know this ruling will considerably
expand the number of patients who can be treated by TAVR.
Also certain is that the patient-evaluation process will shift from
an assessment of risk associated with open-heart surgery to a
consideration of individual anatomy, respective risk factors, and
patient preference.
N E PA

ALFRED CASALE, M.D., is the system-wide chief medical
officer for surgery at Geisinger and chair of the Geisinger
Heart Institute.

VITAL SIGNS

NEPA Vital Signs - Winter 2019 Spring 2020

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