1. K E L S E Y T E R R E S O N , S P T
M E M O R I A L H E R M A N N S O U T H W E S T H O S P I T A L
TAVR Procedure and Physical
Therapy Implications

2. Objectives
 Know what the TAVR procedure is
 Understand the patient population that is
appropriate for a TAVR
 Understand the PT implications for patients with a
TAVR
 Know where to find more information about TAVRs

3. What is a TAVR?
 Transcatheter Aortic Valve Replacement procedure
or TAVR was approved by the FDA in 2011 to replace
the aortic valve in patients that would be considered
too risky for an open heart AVR (Surgical AVR,
SAVR or simply AVR). (1)

4. Quick Video
 Video shows the procedure
 https://www.youtube.com/watch?v=csxJYTLXNJY

5. The Replacement Valve
 Edwards SAPIEN valve is made of bovine tissue (1)

6. TAVR
 Can be performed without cardiac arrest or
cardiopulmonary bypass, so the procedure is minimally
invasive
 The artificial valve is inserted through a catheter through
a transfemoral or a transapical incision.
 Surgeon preference (2)
 State of patient vascular disease
 Transfemoral more common (2).
 As of Fall 2012, 45,000 TAVRs had been performed
worldwide (3).
 Ruben et al estimated that there are approximately 290,000 elderly
candidates for the TAVR in Europe and North America, and that
approximately 27,000 become candidates each year (4)

7. A procedure for severe Aortic stenosis…
 AS can be caused by congenital defect or rheumatic
diseases.
 In the elderly, calcium deposits can build up on the aortic
valve leaflets making it more difficult for them to open
and close. (5)
 Stenosis of the aortic valves increases the resistance the
heart has to pump against in order to pump blood to the
tissues.
 Additionally, aortic stenosis decreases the amount of
blood that can be pumped as the opening to the aorta is
narrowed
 Symptomatic patients often present with chest pain,
dizziness, and fatigue.
 Patients are not generally symtomatic until the stenosis is fairly
severe.

8. …for patients who are NOT candidates for Open
Heart Surgery
 Candidacy for open heart surgery is determined with a
thorough evaluation of risk factors, generally with the use
of the Society of Thoracic Surgeons (STS) scale.
 The scale and risk classification themselves are very
complicated.
 There AVR subportion give a patient’s relative risks and probabilites
of undergoing specific adverse events such as stroke post-operatively
or their likelhood of having a longer length of stay This is all based
on age, gender, race and an extensive look at the patient’s
comorbitities.
 In general increased age, multiple comorbities or
chronic diseases, poor health habits, and obesity
are risk factors for open heart surgery.

9. Who is a TAVR for?
 Patients with severe, symptomatic aortic stenosis
that are not appropriate for the SAVR procedure.
 Mild levels of stenosis will likely be medically managed.
Moderate levels of stenosis are sometimes medically managed
and sometimes SAVRs are done.
 These patients often have multiple other health
complications, are often in their 60s, 70s or 80s

10. Who is it NOT for?
 Patients with bleeding disorders
 Patients who can’t tolerate anticoagulant therapy
 Other heart valve disease or replacement
 Patients whose aortic valve is not calcified
 Severe pre-existing kidney disease
 Abnormal growth in their heart or abdomen

11. Additional Information
 Patients with severe symptomatic aortic stenosis that
do not receive the TAVR tend do poorly and have
extremely high mortality rates, especially in
nonsurgical groups, and loss of quality of life in
surgical groups (6)
 Compared the SAVR decreased risk of bleeding
complications (7)
 Among patients with diabetes, severe aortic stenosis
and high risk for AVR there was a decreased risk of
renal failure, survival benefit and no increase in
stroke (8)

12. Potential Complications
 Because this procedure was so recently approved the
long term complications are not fully known.
 The PARTNER I and PARTNER II trials are investigating this
 In a TAVR the stenotic valves are not removed, but
just moved aside.
 Complications include:
 Stroke 11/100 within one year (9)
 Death 31/100 within one year (9)

13. Risks within 1 Year after the TAVR (9)
TAVR Standard Medical
Therapy
Death
- From any cause
- From CV cause
- 31/100 patients
- 20/100 patients
-50/100 patients
- 42/100 patients
Repeat hospitalizations 22/100 patients 44/100 patients
Major vascular
complications
17/100 2/100
Bleeding event 17/100 2/100
Stroke 11/100 5/100

14. Physical Therapy Implications
 Patients should experience improved blood flow
immediately after the procedure. ICU and HV care
will be directed at getting the patient moving
again.(10)
 Chances are, due to to their advanced age and
comorbities will likely have other orthopedic and
potentially neurologic problems.

15. Physical Therapy Implications Continued
 Good for us to screen for gastric bleeding, as use of
ibuprofen, corticosteroids, heparin and some
antidepressants can increase the risk for generalized
bleeding when used with aspirin therapy. (11)
 Patients may be more likely to bruise.
 If they are in additional pain they can still take ibuprofen, but
they shouldn’t take it at the same time as the aspirin. (11)

16. Physical Therapy Implications Continued
 U.S. Department of Health and Human Services (12)
 Aspirin therapy increases risk for hemorrhagic stroke in males by a
factor of 1.7. Does not appear to increase the risk of hemorrhagic
stroke in females.
 Increases the risk of GI bleeding, and that risk increases with age
 Concomitant use of NSAIDS with aspirin increases the risk of GI
bleeding or GI pain by a factor of 2-3. Concomitant use increases the
risk of serious GI complication by a factor of 3-4.
 Bissonault and Meek. Risk factors for anti-inflammatory-
drug or aspirin induced gastrointestinal complications in
individuals receiving outpatient physical therapy
services. (13)
 22.3% of respondents reported concomitant use of aspirin and
ibuprofen.
 15.7% were over the age of 61

17. Where to find out more
 https://www.youtube.com/watch?v=QkQ5tdL15GI
 Interview discussing what a TAVR is, more on the patient
population, and post-op care looks like
 http://www.uclahealth.org/site.cfm?id=2139
 Information from UCLA health on the procedure, the
bioprosthesis
 Edwards Lifesciences, “Transcatheter Aortic Valve
Replacement for Patients who Cannot Have Open-
Heart Surgery”. (6)

18. Next Steps in Research
 Should evaluate and explore the effectiveness of PT
in caring for these patients post-operatively
 PARTNER Trials will continue to look at these
patients long term.

19. Summary
 TAVR is a minimally invasive procedure to correct
severe aortic stenosis
 Patients that have the TAVR procedure will be on
aspirin for the rest of their lives and therefore may be
at an increased risk for bleeding, bruising, stroke
 Patients that are candidates for the TAVR, but not
for SAVR are likely older or in generally poorer
health
 Additional information about the TAVR procedure
can be found by looking at the previous slide
 Treat the whole patient  Like always.

20. The end! Almost.
 Questions?

21. Discussion
 What would be some of your main concerns when
treating a patient with a TAVR?

22. References
 1. FDA. Medical Devices: Edwards SAPIEN Transcatheter Heart Valve (THV). FDA website. 2013. Available at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DevicesApprovalsandClearances/Recently-
ApprovedDevices/UCM280840.Accessed November 30, 2013.
 2. Walther, T., Kemfert, J. (2012). Transapical vs. transfemoral aortic valve implantation: Which approach for which patient, from a
surgeons standpoint. Annals of Cardiothoracic Surgery, 1,(2). 216-219
 3. St. Joseph’s Healthcare Services. Transcatheter Aortic Valve Replacement (TAVR) Program. St. Joseph’s Patient Care Services
website.2012. http://www.sjhsyr.org/TAVR#.UqZcT2RDsxI. Accessed December 8, 2013.
 4. Osnabrugge, R, Mylotte, D, Head, S et al. Aortic Stenosis in the elderly: Disease Prevalence and number of Candidates
Transcatheter Aortic Valve Replacement: A Meta-analysis and Modeling study. Journal of American College of Cardiology.
September 10, 2013. 62(11):1002-1012.
 5. Penn Medicine. Severe Aortic Stenosis and Transcatheter Aortic Replacement. Penn Medicine Heart Disease website. Available at:
http://www.pennmedicine.org/heart/patient/clinical-services/heart-valve-disease/tavr-faq.html. Accessed December 1, 2013.
 6. Ben-Dor, I, MD, Pichard, A, MD, et al. Correlates and Causes of Death in Patients with Severe Symptomatic Aortic Stenosis Who
are Not Eligible to Participate in a Clinical Trial of Transcatheter Aortic Valve Implantation. Circulation. 2010: 122[suppl 1]:S37–
S42.
 7.. Genereaux, P, MD, Cohen, D, MD, MSc, et al. Bleeding Complications After Surgical Aortic Valve Replacement (SAVR) versus the
Transcatheter Aortic Valve Replacement (TAVR). Journal of American College of Cardiology. Available online November 27, 2013.
 8 Selkow, W. Candidates for Open Heart Surgery or Who is Most Likely to Survive Open Heart Surgery. Simple Hand Website. 2010.
Available at http://www.simplehand.org/heart-surgery/. Accessed November 22, 2013.
 9. Edwards Lifesciences. Transcatheter Aortic Valve Replacement for Patients who Cannot Have Open-Heart Surgery. Irvine, USA.:
Edwards Lifesciences Corporation; 2011. Available at: http://www.mainehealth.org/workfiles/mmc_cardiac/TAVR-Patient-
Brochure.pdf. Accessed December 1, 2013.
 10. Lindman, M, MD, MSCI, Pibarot, P, DVM, PhD, et al. Transcatheter versus Surgical Aortic Valve Replacement in Patients with
Diabetes and Severe Aortic Stenosis at High Risk for Surgery: An Analysis of the PARTNER Trial. Journal of American College of
Cardiology. Available online November 27, 2013.
 11. Mayo Clinic. Daily aspirin therapy: Understand the risks and benefits. Mayo Clinic Heart Disease website. April 6, 2012.
http://www.mayoclinic.com/health/daily-aspirin-therapy/HB00073/NSECTIONGROUP=2. Accessed December 8,2013.
 12. U.S. Department of Human and Health Services. Using Aspirin for the Primary Prevention of Cardiovascular Disease. Agency for
Healthcare Research Quality. June 2009. http://www.ahrq.gov/professionals/clinicians-providers/resources/aspprovider.html.
Accessed December 8, 2013.
 13. Bissonault, WG, Meek, PD. Risk factors for anti-inflammatory-drug or aspirin induced gastrointestinal complications in
individuals receiving outpatient physical therapy services. Journal of Orthopedic Sports Physical Therapy. (Oct 2002). 32: 510-517.
 14. UCLA Health. Transcatheter Aortic Valve Replacement (TAVR). UCLA Health website.
http://www.uclahealth.org/site.cfm?id=2139. Accessed November 27, 2013.