CTSA Cardiovascular SummitMarch 5, 2016

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

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

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

Medtronic CoreValveTM

Nitinol, 23/26/29/31mm, 18Fr

Edwards SAPIENTM XTCobalt Chromium, 23/26/29mm,

TF: 16/18/20Fr, TA: 24/26Fr

Multidisciplinary in all aspects: Patient selection Procedure planning TAVR Procedure Post-operative care

Patient-Focused Multidisciplinary Heart Team Approach

CardiologyChris Simpfendorfer, Clint Malone, Arash Aghel, Brian Metz, Erik Carlson, Preetham Reddy

Cardiac SurgeryJohn Frederick, Betty Kim, John Mehall

Valve CoordinatorJennifer Lynch, CRNP (TAVR Coordinator)

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.

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

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

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*

Cardiac-gated CT is critical Annulus measurements done

in full systole: 30-40% R-R intervals

Aortic complex measurements:Annular area and diameterSinus of ValsalvaSinotubular Junction Coronary Heights Leaflet lengthsDegree of calcification and location

CT Angio is the ideal modality for assessing access and annular size

Size Calcification Tortuosity

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

Transfemoral TAVR Transapical TAVR Direct Aortic TAVR Alternate Access

◦ Conduits ◦ Subclavian◦ Carotid

We have utilized:Direct AorticAortic ConduitIliac Conduit

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

Age: 76 DOB: 9/24/1939 Gender: F HT: 165 cm WT: 92 kg BMI: 34PCP: 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: NeverSTS: 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: 1/29/2016EF: 60-65%AVA: 0.5MG: 51.6PV: 455AI: mild-moderateTV: wnl TI: trivial MV: wnl MI: trivialPV: Structurally wnl PI: trivial

Carotid Duplex: Comments: NEEDS

Pulmonary: 2/8/2016PFTs 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.

Age: 82 DOB: 3/26/1933 Gender: F HT: 132 cm WT: 60 kg BMI: 34.4 PCP: Dr. Carson CARD: Dr. JensenPMH: 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: NeverSTS: 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: 9/1/2015EF: >70%AVA: 0.89MG: 39.3PV: 440Tricuspid: normal, mild TRPulmonic: n/a

TEE: (2/24/16)EF: >55%AVA: 0.36 trace AISmall 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 CADDisc to arrive 2/25/16

Plan: Pt Pic Here

CT: 2/24/16No significant stenosis of the aorta or iliac and femoral arteriesLarge hila herniaChronic interstitial lung disease

(719) 77MURMUR

>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

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

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