Intermediate Risk TAVR:

One year later, what is the impact on CV service line outcomes?

Hemal Gada, MD, MBAMedical Director, Structural Heart Program

Staff Interventional Cardiologist

September 15, 2017

Disclaimers

▫ Please Note: The information provided is the experience of the Hemal Gada/PinnacleHealthCardioVascular Institute, and Edwards Lifesciences has not independently evaluated these data. Outcomes are dependent upon a number of facility and surgeon factors which are outside Edwards’ control. These data should not be considered promises or guarantees by Edwards that the outcomes presented here will be achieved by an individual facility.

▫ Hemal Gada is a paid consultant to Edwards Lifesciences

Post-Intermediate Risk TAVR at Pinnacle

• Healthier patients and thus better clinical outcomes presents a unique “win-win” situation▫ Referring providers are less frustrated and more

familiar with TAVR, because more patients are now eligible

▫ TAVR operators are more confident with their ability to deliver a predictably solid outcome

• Questions we needed to answer with adoption of commercial intermediate risk▫ Who gets an operation?▫ How do we handle any increase in volume?▫ How do our finances work with this expensive

technology gaining more market share?

PinnacleHealth System

• Non-profit health system in central Pennsylvania

• Eight hospitals with 1283 beds

• Harrisburg Hospital – 380 Beds

• West Shore Hospital – 102 Beds

• Community General Osteopathic Hospital – 145 Beds

• York Memorial Hospital – 100 beds

• Lancaster Regional Hospital – 150 beds

• Heart of Lancaster Regional Med Ctr – 148 beds

• Carlisle Regional Medical Center – 165 beds

• Hanover Hospital – 93 beds

Who Gets An Operation?

Intermediate Risk = Heart Team determination with guidance of

STS risk scores from ≥3%!

Who Gets An Operation?• All aortic stenosis patients proceeding to a valve

replacement are presented at our weekly Friday AM meeting

• The process and considerations have become increasingly idiosyncratic for intermediate risk patients▫ Patients with a marked preference for surgery, usually

based on concerns with valve durability▫ Multivessel coronary artery disease/multivalvular

heart disease▫ A TAVR turndown – unfavorable/off-label anatomy

Bicuspid valves Poor transfemoral access Heavy LVOT calcification

The Surgeon’s Perspective in the

Intermediate Risk Era

• “Patients are happy with TAVR”

• “We are so much more streamlined in our procedure times with TAVR”

• “This is no longer some fad; it’s the future, it’s the present”

Pictured above: MubashirMumtaz, MD (CS) and Hemal Gada, MD, MBA (IC) – Both salaried employees

The Volume Shift at Pinnacle

252 240306 312

275 267

0

100

200

300

400

CY12 CY13 CY14 CY15 CY16 CY17Projected

AllSurgicalValveCases

31 4567 71

168

258

050100150200250300

CY12 CY13 CY14 CY15 CY16 CY17Projected

TAVRCases

363% Growth

The Volume Shift at Pinnacle

Pinnacle Aortic Valves: Not So Fuzzy Math

Calendar Year Surgical Valve + TAVR Cases

2015 383

2016 443

2017 (Projected) 525

Conclusions:• Patients like TAVR• TAVR volumes grow with the expansion of commercial indications to

intermediate risk patients• Centers need to focus on TAVR operations as a stand-alone

The “Volume Shift” Creates An Earthquake

• Processes need to be developed in order to

handle the upswing in TAVR volume

▫ Hiring people, upstaffing takes time

▫ Finding cath lab/OR availability takes time

• Streamlining a minimalist approach could assist

in operational, financial, and clinical efficiency

- Local anesthesia +/- conscious sedation

- Pure percutaneous transfemoral approach

- TTE on demand

- ICU < 24h (if at all)

- Early discharge (1-3 Days)

TEEGeneral Anesthesia

Endotracheal Intubation

Additional vascular lines

(jugular vein)

Which Can Exclude

Pinnacle Efficiencies

Short procedure

Less invasive procedure

Short hospital stay

• May reduce costs of care

All While Maintaining Safety As A Priority

Pinnacle Efficiencies

Optimal Screening Is Key

• Preprocedural Angiography▫ Still useful in most circumstances

Though most providers have a high threshhold to revascularize

▫ The presence of obstructive coronary artery disease may change treatment strategy

• Preprocedural CTA Assessment▫ An absolute must for the Minimalist Approach

▫ Precise access assessment

▫ Annulus and apparatus sizing/assessment Coronary heights

Gantry angle for deployment

Scrubbed RN/Tech

Position 1

Position 2

NURSE 1

CrimpingX-Ray

Room Setup at Pinnacle

Echo

ANESTHESIA

(sedation)

Sonographer

NURSE 2

Circulator/RVP

Patient Setup at Pinnacle

Peripheral venous

line

Oxygen 1-2 L/mn

O² Saturation

EKG monitoring

No Foley CatheterValve Sheath

14/16F

6F sheath for

Pacing/Infusion

6F sheath for

Pigtail

Keys To Successful ICU Avoidance

• MOST IMPORTANT IS ADEQUATE STAFFING▫ Champions need to be identified in every phase

OR, PACU, ICU, telemetry floor

• A PACU type transition is necessary▫ 4-6 hour observation

• No neurologic events

• No drips

• No vascular complications

• No heart block▫ New LBBB can be OK

• Early ambulation protocol▫ 4 hours

• General diet▫ 4 hours

Pinnacle Administration’s View of TAVR

• It’s awesome…

• ..but I had (and have) to prove it to them

▫ Cannot use clinical outcomes alone

▫ Cannot define by cost/QALY

▫ Cannot use “everyone else is doing it, so why can’t we?”

▫ Cannot avoid putting on an “administrator” hat

Pinnacle Documentation Best Practices

• Accurately documenting patient acuity▫ Difference between DRG 266 vs 267

Acute on chronic heart failure

Protein-calorie malnutrition

▫ “If it’s not documented, it didn’t happen and / or doesn’t exist”

• Improving patient disposition and limiting ancillary services▫ Meetings with Physical/Occupational Therapy, Social

Work, and other care providers

▫ Setting expectations for patient and family pre-procedure

If no issues peri- or post-procedure, the appropriate disposition is home without services

• Utilizing outpatient evaluations to their fullest

TAVR Mean Length of Stay (Days) at Pinnacle*

*Average length of stay for SAPIEN 3 valve Intermediate Risk was 4 days (Thourani et al, Lancet 2016)

11.39

9.14

7.48

2.971.74

0

2

4

6

8

10

12

FY13 FY14 FY15 FY16 FY17

TAVR Efficiencies at Pinnacle

9% 13%22%

73%86%

0%

20%

40%

60%

80%

100%

FY13 FY14 FY15 FY16 FY17

TAVRDischargeHomew/oServices

$59,918

$52,394 $55,908

$38,090 $33,908

$0

$10,000

$20,000

$30,000

$40,000

$50,000

$60,000

$70,000

FY 13 FY 14 FY 15 FY 16 FY17

TAVR Costs Per Case

$55,133

$43,595 $48,265

$53,332 $54,796

$0

$10,000

$20,000

$30,000

$40,000

$50,000

$60,000

FY 13 FY 14 FY 15 FY 16 FY17

TAVR Net Revenue Per Case

TAVR Economics at Pinnacle

13.5% Growth

39.4% Reduction

AVR vs. TAVR Profitability Per Day at Pinnacle

$4,862

$12,004

$0

$2,000

$4,000

$6,000

$8,000

$10,000

$12,000

$14,000

AVR:$27,469MCM/5.65Days

TAVR:$20,888MCM/1.74Days

Take Home Points

• Commercial intermediate risk TAVR presents a significant opportunity to treat more patients with severe aortic stenosis▫ Quickly improve quality of life▫ Save downstream utilization of healthcare resources

• Centers need to view TAVR as a stand-alone▫ TAVR operations and efficiencies need to be TAVR-

specific▫ Comparisons to surgical AVR must be performed in

order to justify the expansion of TAVR

• The Heart Team remains essential in idiosyncratically adjudicating the best treatment option for an individual patient

Please see the important safety

information available at the podium

Edwards, Edwards Lifesciences, the stylized E logo,Edwards SAPIEN, Edwards SAPIEN XT, Edwards SAPIEN 3, SAPIEN, SAPIEN XT and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. PP--US-2343 v1.0