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
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