Dr. John Frederik presents "CTSA Summit TAVR" at the March 4 -6, 2016 Cardiac and Thoracic Surgery Associates, Cardiovascular Summit at The Westin Riverfront Resort and Spa.

1. CTSA Cardiovascular Summit
March 5, 2016

2.  FDA approval in 2012
 New modality for aortic valve
replacement
 Valve within a stent frame
 Placed without CP bypass via
trans-apical or retrograde femoral
route
 Limited availability

3.  Implanted since 2002
 Transfemoral, transapical,
alternate access routes
 Bovine pericardium leaflets
 Cobalt-chromium balloon
expandable stent
 Annular fixation
 Sub coronary implant
 Crimped onto the catheter at time
of implantation

4.  Penrose program was the first
CoreValve program in CO, NM, UT,
WY
 Retrograde approach only
 Equine Pericardium Leaflets
 Nitinol Self-Expanding
 Annular and Supra-coronary fixation
 18fr delivery system
 Offers a 31mm valve size

5.  Medtronic CoreValve
TM
Nitinol, 23/26/29/31mm, 18Fr
 Edwards SAPIEN
TM
XT
Cobalt Chromium, 23/26/29mm,
TF: 16/18/20Fr, TA: 24/26Fr

6.  Multidisciplinary in all
aspects:
 Patient selection
 Procedure planning
 TAVR Procedure
 Post-operative care
Patient-Focused Multidisciplinary
Heart Team Approach

7. Cardiology
Chris Simpfendorfer, Clint Malone, Arash Aghel, Brian
Metz, Erik Carlson, Preetham Reddy
Cardiac Surgery
John Frederick, Betty Kim, John Mehall
Valve Coordinator
Jennifer Lynch, CRNP (TAVR Coordinator)

10.  Inclusion criteria
◦ 1. Calcific aortic valve stenosis with echo derived criteria: mean
gradient>40 mm Hg or max velocity>4.0 m/s and an initial AVA of<0.8
cm2 or indexed EOA<0.5 cm2/m2 within 45 days of implant
◦ 2. Interventionalist and 2 experienced CT surgeons agree that
medically patient is either inoperable or high risk for surgical AVR. The
surgeons’ consult notes shall specify the medical or anatomic factors
leading to that conclusion, and STS risk score must be documented.
◦ 3. Patient is deemed to be symptomatic from his/her aortic valve
stenosis, as differentiated from symptoms related to comorbid
conditions, and as demonstrated by NYHA functional class II or
greater.

11.  Exclusion criteria (candidates will be excluded if any of the
following conditions are present)
◦ 1. MI within 1 month of implant
◦ 2. Congenital unicuspid or bicuspid valve
◦ 3. Concomitant AI 3+ or greater
◦ 4. Inotropic or mechanical cardiac support, or ventilated
◦ 5. Need for emergency surgery for any reason
◦ 6. Hypertrophic cardiomyopathy with or without obstruction
◦ 7. Severe left ventricular dysfunction with LVEF<20%
◦ 8. Severe pulmonary hypertension and RV dysfunction
◦ 9. Echocardiographic evidence of intracardiac mass, thrombus or
vegetation

12.  Exclusion criteria (candidates will be excluded if any of the following
conditions are present)
◦ 10. Contraindication to anticoagulation
◦ 11. Native aortic annulus size<18 mm or>25 mm
◦ 12. CVA or TIA within 6 months of implant
◦ 13. Renal insufficiency (creatinine>3.0 mg/dL) and/or end-stage renal disease
requiring chronic dialysis at the time of screening
◦ 14. Estimated life expectancy<12 months due to noncardiac comorbid
conditions
◦ 15. Severe incapacitating dementia
◦ 16. Significant aortic disease, including abdominal aortic or thoracic aneurysm
> 5cm; marked tortuosity, aortic arch atheroma, or narrowing of the abdominal
or thoracic aorta
◦ 17. Severe mitral regurgitation

13.  Screen roughly 3 patients for each
TAVR procedure
◦ ECHO/TEE
◦ Cardiac Cath
◦ CTAngio
◦ PFTs
◦ Frailty Evaluation
◦ Carotid Duplex
 Remaining patients go to standard
AVR, BAV, or no therapy*

14.  Cardiac-gated CT is critical
 Annulus measurements done in
full systole: 30-40% R-R
intervals
 Aortic complex measurements:
 Annular area and diameter
 Sinus of Valsalva
 Sinotubular Junction
 Coronary Heights
 Leaflet lengths
 Degree of calcification and location

15.  CT Angio is the ideal
modality for assessing
access and annular
size
 Size
 Calcification
 Tortuosity

16.  Frailty is an important parameter in assessing operative risk
 Prevalence of frailty increases with aging; old age does not
necessarily equal frail
 Objective measures:
◦ Grip strength
◦ 15’ walk test
◦ Weight loss>10# in last year
◦ Exhaustion
◦ Albumin < 3.5 mg/dl
◦ DASI questionaire

17.  Transfemoral TAVR
 Transapical TAVR
 Direct Aortic TAVR
 Alternate Access
◦ Conduits
◦ Subclavian
◦ Carotid

18. We have utilized:
Direct Aortic
Aortic Conduit
Iliac Conduit

19. 2012
◦ Started the training process in September
2013
◦ First Sapien case – March 18, 2013
◦ 21 Sapien Implants in 2013
2014
◦ First CoreValve case – May 2014
◦ 29 implants
2015
◦ First Valve-in valve (aortic and mitral*), first conscious sedation
implant, first “direct to floor” implant
◦ 62 implants

20. Age: 76 DOB: 9/24/1939 Gender: F HT: 165 cm WT: 92 kg BMI: 34
PCP: Dr. CARD: Dr.
PMH: Aortic stenosis, chronic debilitating back pain, OA, HTN.
PSH: Lumbar spine 2013, Bone ware 2013, Vertebrea 2013, knee 2011.
MEDS: Calcium 500 mg daily, VitD3 1,000 BID, Lasix 40 mg BID, Ibuprofen 800 mg daily, Mag 500 mg
daily, Requip 5 mg BID, Forteo 2.4 daily, Vit B complex 500 mg daily.
ALL: NKDA Tobacco: Never
STS: Mortality: 3.5 % Morbidity: % NYHA Class: III
5M Walk: #1 - #2- #3- AVG: unable to walk (>=6 sec: Frail) Katz:
Grip: R: AVG: (<=18: Frail)
LAB: (2/6/2016) Creat: 1.08 eGFR: 56 H&H: 9/28 Albumin: BNP:
Comments: Pt is low risk AVR; however, d/t inability to walk, would be poor surgical candidate.
TTE: Date: 1/29/2016
EF: 60-65%
AVA: 0.5
MG: 51.6
PV: 455
AI: mild-moderate
TV: wnl TI: trivial
MV: wnl MI: trivial
PV: Structurally wnl PI: trivial
Carotid Duplex:
Comments: NEEDS
Pulmonary: 2/8/2016
PFTs with DLCO:
FEV1: 94%; FVC 96% FEV1/FVC: 73
DLCO: 63%
Coronary Angio: (4/30/2015)
Comments: No CAD
Pt Pic
Here
CT Results:
Heavily calcified aortic valve with vascular anatomy as
described above, some limitations in evaluation due to
extensive beam hardening, multiple hypodense lesions
within the spleen, multiple RUL pulmonary nodules, f/u
recommended.

21. Age: 82 DOB: 3/26/1933 Gender: F HT: 132 cm WT: 60 kg BMI: 34.4
PCP: Dr. Carson CARD: Dr. Jensen
PMH: Pulmonary fibrosis, left breast CA, 2-4L 02 continuous, hypoxemia, mitral valve disease, HTN, HLD,
Hypothyroidism, anemia, LVH, chronic back issues.
PSH: Tonsillectomy, hysterectomy, Mohs surgery, breast surgery, skin cancer excision,
MEDS: Aleve 220 mg daily, amiodarone 100 mg daily, antivert 12.5 mg daily, Biotin 10 mg daily, Lasix 20
mg daily, potassium chloride 10mEq, Premarin 0.625 mg daily.
ALL: Darvon, PCN, Prevnar Tobacco: Never
STS: Mortality: 9.9 % Morbidity: 32% NYHA Class: III
5M Walk: #10.86 - #2-10.13 #3-10.5 AVG: (>=6 sec: Frail) Katz: 5/6
Grip: R: 18.6, 14.1, 17.1 AVG: (<=18: Frail)
LAB: (2/24/16) Creat: 0.82 eGFR: 60 H&H: Albumin: BNP:
Comments:
TTE: Date: 9/1/2015
EF: >70%
AVA: 0.89
MG: 39.3
PV: 440
Tricuspid: normal, mild TR
Pulmonic: n/a
TEE: (2/24/16)
EF: >55%
AVA: 0.36 trace AI
Small PFO w/ left to right shunting
Carotid Duplex: (5/22/2015)
Comments: Severe stenosis of the right
external carotid artery origin.
Pulmonary: done on 2/24/16 pending
PFTs with DLCO:
Date:
FEV1: FVC % FEV1/FVC:
DLCO: %
Coronary Angio: (2016)
Comments: No CAD
Disc to arrive 2/25/16
Plan:
Pt Pic
Here
CT: 2/24/16
No significant stenosis of the aorta or iliac and
femoral arteries
Large hila hernia
Chronic interstitial lung disease

22. (719) 77MURMUR

23.  >200 patients evaluated
◦ Roughly 3:1 referral to implant, 17 crossovers
 50 TAVR Cases
◦ 2013- 21
◦ 2014- 29*
 Route
◦ TF- 31
◦ TA- 13
◦ Transaoritc- 6
 17 surgical AVR Cases
◦ 0% mortality
◦ 0% stroke

24. n %
30-Day Mortality* 2 4%
Stroke 1 2%
ARF 1 2%
PPM Required 3 6%
Vascular Access 3 6%
≥ Moderate AI 3 6%
Device Migration 1 2%
“Valve in valve” 1 2%
* No mortality in 2014

25.  Increase volume
◦ Pueblo TAVR Clinic
◦ South Denver Cardiology Group Partnership
 Increase experience with Medtronic Implant
 Streamline scheduling process with dedicated
TAVR clinic and implant day- Friday