How TAVR Impacts Cardiac Surgery and What the Credentials for the Surgeon Should Be Joseph E. Bavaria, M.D. Roberts-Measey Professor and Vice-Chief of Cardiovascular Surgery And Howard Herrmann, MD Professor and Chief, Interventional Cardiology (CV Service line portion) CRT Wash DC, Feb. 2013

Joseph E. Bavaria, MD Grant Support: Edwards Lifesciences, LLC Honoraria: Vascutek Off-Label: Will discuss TEVAR for off-label indications in dissections. Will discuss TAVI which is not approved at this time and is only in trial

TAVR Categories in Relation to the AS Universe This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) Operable AS patients Too Sick Inoperable High Risk Low-Intermediate Risk II A A High Risk B Extreme Risk C 90% 10% ? 20% 3

50% of the growth in valves is from TAVI Accelerated slope since initiation of TAVR program HUP – Valve primary procedure volume

Penn Heart Surgery Program FY10 2009-10 fiscal year, Penn surgeons performed 1,250 valve procedures Total N = 2400 open Heart

Cardiac Surgery and Alternate access

TF & TA Utilization Edwards Sapien Valve Europe TF 50% Importance of this slide: FDA and Cohort A

All-Cause Mortality or Stroke (AT) 34.8% 29.7% 25.7% ∆ at 1 yr: AVR - PMA-TA = –5.1% AVR - NRCA-TA = +4.0% PMA-TA - NRCA-TA = +9.1% Improvement No. at Risk AVR 92 72 67 66 63 PMA-TA 104 81 77 70 NRCA-TA 822 563 365 291 123

Actuarial 1-Yr Survival (%) Canadian Multicenter Experience (TCT 2009) 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 Actuarial 1-Yr Survival (%) 76% 75% 78% 64% 65% Survival (%) 64% All patients Transfemoral Transapical 6 12 18 24 No. of Months Patients at risk 339 166 95 39 26 205 129 53 34 162 90 60 28 22 103 73 35 25 177 75 34 11 3 101 55 17 8

Impact of Accumulated Transapical Site Experience on Stroke (AT): LOW STROKE RATES!! ∆ = 0.2% ∆ = 0.2% Sites Initiated Before Sep 2009: 14 Sites Sites Initiated After Sep 2009: 10 Sites

Cardiac Surgery and CV Service line Financial Impact

Background Is AVR Important (Financially) to Cardiovascular Surgery and the Health System? How Important?

Contribution Margin of Various Cardiac Treatments Valve procedures are highly profitable; generating a healthy average contribution margin and per case gain

Example Commercial Patient OR Supplies, driven by valve 74% of direct cost

Example Commercial Patient OR Supplies, driven by valve 78% of direct cost

Aortic Valve Replacement Germany 2000-2010 TAVR =23.9% 2011-~ 5,000 -30.8% !

Credentialing and the NCD

Transfemoral and Alternate Access Results: Real World, Large Series, Consecutive Cases (n=250)

Transcatheter Valve S. Bleiziffer, et al; (Munich, Germany); JTCVS 2010 N= 250; 82% TF/Retrograde; 85% CoreValve; 15% Sapien, Real World, all pts.included. Age= 81.4, Euroscore=24.3 Variety of Approaches: Transfemoral and Trans-iliac Transapical Trans-Subclavian Trans Ascending Aorta

Transcatheter Valve 30-day mortality = 12.4% CVA= 5.1% TF= 6.1% TA= 0% S. Bleiziffer, et al; (Munich, Germany); JTCVS 2010 30-day mortality = 12.4% CVA= 5.1% TF= 6.1% TA= 0% Pacemaker: 19.7% Arterial Access Complications needing surgical intervention: 11.7% THIS IS NOT A TOTALLY BENIGN PROCEDURE!

Transcatheter Valve Complications Needing a CV Surgeon: S. Bleiziffer, et al; (Munich, Germany); JTCVS 2010 Complications Needing a CV Surgeon: Peripheral Vascular and Dissection: 11.7% Conversion to open AVR: 0.7% (2.6% in Partner A) Circulatory Collapse requiring CPB Resucitation: 3% Pericardial Effusion > 1 cm on TEE: 3.6% Total = 19%

Post Market Europe: Standard Series: Intraoperative Procedural Complications List, Initial 170 cases: Is there a Learning Curve? .... Yes But ...... Root rupture malplacement resuscitation Pericardial effusion revalving Coronary ischemia PM implantation vascular complications Intra-operative only 80% CoreValve and 20% Sapien: General Mix S Bleiziffer, et al; AATS Boston May 2009 (n=250)

Off-label implantation was identified in 67% of patients 40% had one, 19% had two, and 8% had three or more off-label criteria.

So ….. For these reasons, CMS (and FDA) “Charged” the “Four” Societies to develop a Guideline or Credentialing document which would contribute to the NCD

Training/Credentialing Multidisciplinary Heart Team Valve Centers Training/Credentialing Multidisciplinary Heart Team National TVT Registry

TAVR approved under “coverage with evidence development” Approved for treatment of severe symptomatic aortic stenosis FDA approved indication and with an FDA approved device Two cardiac surgeons approve Performed in facility with >50surgical AVR’/year (~400); Cardiac anesthesia >1000 caths/400PCI/year Structural requirement (30-50) >20TAVR/year Mortality<15% ……. Running 1 year > 60% survival Stroke and Vascular 30 day <15% Multidisciplinary Heart Team, Institutional Committment Institutional: Hybrid Room, Mandatory National TVT Registry participation

ACC, STS, SCAI, AATS (Four Societies) Carl Tommaso and Morton Bolman III (Chairs) Ted Feldman and Joseph Bavaria (Vice-Chairs) (ACCF COI Policy) Guideline Domains: Institutional Interventional Cardiology Cardiac Surgery TAVR Program Outcomes (Quality)

Institutional Cath Lab Program with 1000 caths/400 PCI per year 50-100 (?) Structural procedures per year, 60% BAV Active Cardiac Surgery Program with > 50 AVR per year Two Institutionally based Surgeons (>50% documented time at that Hospital) 10/50 of the AVR must be STS > 6 Mandatory Participation in the National (TVT) Database Highly Recommended that a “Hybrid OR/Cath Lab” be used Mandatory Sterile Conditions /Standards Heart Team Approach (including Cardiac Anesthesia)

Surgeon 100 Career AVR or 25 AVR per year (50 past 2 yrs PRIOR to initiation of TAVR program 10 High Risk (STS > 6) Experience with peripheral CPB Experience with Retroperitoneal and Iliofemoral Artery exposure Board Certification

Interventionalist 50-100 Structural Procedures LIFETIME OR 30 Left sided Structural per year (60% BAV) Board Certification

TAVR Program Quality Parameters 30 day All-Cause mortality < 15% 30 day All-Cause Neuro events (including TIA) < 15% 30 day Major Vascular Complication Rate < 15% > 90% Institutional follow-up in database 60% 1 year survival rate for Non-op (cohort B/Extreme Risk) After program up for 2 years …. Running 2-yr average Maintain EITHER 20 TAVR procedures per year OR 40 over 2 years National TVT database

Bottom Line CMS Charge: Must have some evidence that the Institution and the Physicians: “Have some indication that they have a commitment and organized interest” in Heart valve disease

Heart Team is KEY: Weekly Penn Aortic Valve and TAVI Conference Thank You

Thomas Eakins: Gross Clinic (1878@JEFF) and Agnew Clinic (1888@PENN) Great Progress in 10 years! Thank You