Is it Time for a National Network of Valve Centers?

MICHAEL MACK, MD

BAYLOR SCOTT & WHITE HEALTH 10

Potential Conflict of Interest Disclosure

•Board of Trustees American College of Cardiology

•Writing Committee Multi-Society National Systems of Care

•Co- PI of COAPT Trial of Abbott Vascular

•Steering Committee Intrepid Trial of Medtronic

•Co-PI of the PARTNER 3 Trial of Edwards Lifesciences

2,100 1,150

560 272

Cath Labs Cardiac Surgery Programs

TAVR Programs MitraClip Programs

How many of the 2,100 Cath Labs in the US Should be Treating Him ?

This is Your Frail, Elderly Father !

Barlow’s Myxoid Degeneration

5

• Thickened Leaflets – “aneurysmal pockets” • Redundant elongated chords • Bileaflet prolapse and billowing • Massively dilated annulus • Atrialized attachment of posterior leaflet • Often highly calcified annulus

How Many of the 1,150 Cardiac Surgery Programs Can Repair This Valve ?

How Many of the 272 Cath Labs Performing MitraClip Realize This is Not a Good MitraClip Case?

This Is Your Brother

This is Your 90 Year Old Mother With Severe AS with LVOT Ca++ and MAC

How Many of the 560 TAVR Programs Would You Let Her be Treated In?

2017 AATS/ACC/ASE/SCAI/STS Expert Consensus System of Care Draft Documents

(Operator and Institutional TAVR Requirements and Optimizing Care for VHD Patients)

7

Misconceptions About a Valve Network It’s all about TAVR

It’s an exclusive club

It will limit access to care

National Systems of Care

Cancer Trauma Stroke Bariatric

Surgery STEMI

1960 1976 2001 2005 2006/2007

NIH

American

College of

Surgeons

Brain Attack

Coalition

American

Society of

Bariatric

Surgery

American

College of

Surgeons

American College

of Cardiology

(D2B Alliance)

American Heart

Association

(Mission:

Lifeline)

NIH

Cancer

Centers

ACS

Trauma

Centers

Brain Attack

Coalition

Stroke Centers

ASBS

ACS

Bariatric

Centers

ACC/

AHA

STEMI

Basic Laboratory Cancer

Center

Cancer Centers

Comprehensive Cancer

Center

Level I

Level II

Level III

Level IV

Acute Stroke-

Ready hospital

Primary Stroke

Center

Comprehensive

Stroke Center

Bariatric

Surgery Center

of Excellence

STEMI-referral

hospital

(non-PCI capable)

STEMI-receiving

hospital

(PCI-capable)

National Systems of Care

Stroke Systems of Care

Comprehensive Primary ASRH

Brain Attack Coalition

National Valve System of Care

Systems of Care for VHD Rationale

The cost and complexity of diagnosis and treatment of VHD are increasing.

It is not feasible for all cardiac centers to provide the full suite of resources, infrastructure and expertise to care for patients across the entire spectrum of VHD.

The guiding principle is to optimize the care of the individual patient by providing access to the right care at the right place and time while respecting his/her preferences and values.

ESC/EACTS Comprehensive Heart Valve Centre Standards

Consideration of the volume-outcome relationship for surgical and transcather procedures is a complex, nuanced and challenging process.

“Ability to demonstrate good results is more important than mandating volume targets.”

“It is likely that [good outcomes for MV surgery] will not be attained without high individual surgeon and centre volume.”

“Large registries are expected to inform future guidance on minimal [TAVR] volumes…”

Chambers JB et al. EHJ 2017:38:2177-83

Minimum

Heart valve clinic

Multi-modality imaging

Procedures available

MDT

Processes

Data review

ESC/EACTS Comprehensive Heart Valve Centre Standards

Chambers JB et al. EHJ 2017:38:2177-83

Procedures

TAVR, Mitral Clip

All HV replacements

MVRp, TVRp

Surgery for aortic root and ascending aorta

AF ablation

Links with other centers

A Spoke-and-Hub or Tiered System of Care for Patients with Valvular Heart Disease?

CVC

PVC

PVC

Primary Valve Center Comprehensive Valve Center

Comprehensive (Level I) Valve Center Primary (Level II) Valve Center

Interventional procedures TAVR – TF TAVR – TF

BAV BAV

TAVR – alternative access

Valve-in-valve procedures

MitraClip

Paravalvular leak closure

PBMV

Surgical procedures Isolated AVR Isolated AVR

Valve-sparing aortic root procedures

AVR/Myomectomy

Root enlargement with AVR

Mitral repair for primary MR (P2 pathology) Mitral repair for primary MR (P2 pathology)

Mitral repair for complex primary MR (Barlow’s and bileaflet prolapse)

Multivalve operations

Re-operative valve surgery

Isolated tricuspid valve repair or replacement

Optimal Outcomes

Access To Care

Considerations

Quality Access

Mortality Disparities

Morbidity Geography

Durability Wait Times

Cost Follow-Up

Heart Valve

Centers

Competition, Restricted Referral

Lines, COI, AMC vs. Community,

Cultures, Payment Models Courtesy P. O’Gara

Questions •Does This Make Sense?

•Is there a volume outcome relationship for medical procedures?

•Is volume an appropriate surrogate for quality?

•How do you balance quality outcomes with access to care?

•What are the barriers of access to care

•Can every center treat every patient and do it well?

INSIDE

OUTSIDE

Premises There is a volume outcome relationship in medical procedures

The more complex the procedure, the greater that relationship

The principle is not only about the performance of the procedure but also about the care ecosystem: ◦ Diagnostic/imaging expertise ◦ Multi-disciplinary team/shared decision-making ◦ Patient selection ◦ Post-procedure care

All this has to be balanced against adequate access to care

Medical Conditions and Procedures for Which a Volume-Outcome Association Has Been Shown

MI, CVA, Heart Failure, Pneumonia

CABG, AAA Repair, CEA

MVRR, AVR

PCI, ICD

TAVR

10 Volume Pledge Procedures

Volume

O

utc

om

e

Primary MR Repair in NY State

• Wide variability • Median volume = 10 • Higher surgeon volumes

associated with better outcomes

• Re-operation less common with > 25 repairs per year

Chikwe J et al. JACC 2017; 69:2397-1706

Criteria • MV surgery volumes (surgeon and center) • Expert peri-procedural imaging • Transparency regarding outcomes: repair rates, mortality,

stroke, durability

Outcome Rate

Mortality < 1%

Major Complication < 2%

Repair rate > 90% (> 95% for P2 prolapse)

Residual MR > 2+ < 5% at 5 years

Re-operation rate

PMVL < 1% per year

AMVL < 2% per year

Standards for MV Repair for Primary MR

Chambers JB et al. EHJ 2017:38:2177-83

Recommendation COR LOE

MV repair is reasonable in asymptomatic

patients with chronic severe primary MR (stage

C1) with preserved LV function (LVEF >60% and

LVESD <40 mm) in whom the likelihood of a

successful and durable repair without residual

MR is >95% with an expected mortality <1%

when performed at a Heart Valve Center of

Excellence

IIa B

AHA/ACC 2017 Valve Disease Guideline

Nishimura RA et al. JACC 2017 doi: 10.1016/j.jacc.2017.03.011.

With experience (case volume) the risk of dying is reduced from 3.57% to 2.15%.

Dying During or Immediately After TAVR

Of 16 252 index TAVR procedures, 663 (4.1%), 3067 (18.9%), and 12 522 (77.0%) were performed at low-, medium-, and high-volume hospitals, respectively.

Thirty-day readmission rates were significantly lower in high-volume compared with medium-volume (adjusted odds ratio, 0.76; 95%CI, 0.68-0.85; P < .001) and low-volume (adjusted odds ratio, 0.75; 95%CI, 0.60-0.92; P = .007) hospitals

Khera et al. JAMA Cardiol. 2017;2(7):732-741.

Sites Participating in the STS/ACC TVT Registry

TAVR - 520 MitraClip - 212

TAVR Centers in US

Alaska: 1 Hawaii: 1

520 Centers

Sites Enrolled in TVT Registry

+96

+96 +52

+85

New Sites Added Each Year +35 520

TAVR

Valve Centers/Million Population 1.5

1.25

0.8

0.6 0.5

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

US Germany Japan Canada UK

Dallas Fort Worth Heart Surgery 2016

N=6,456 Programs =40

TAVR N=10

A Successful Pilot

Hub and spoke Shared protocols, best practices

Mentoring Communication

49

ACCF/STS

Tiered Site Certification*

• Case mix • Volume and Outcomes • Research Infrastructure • IRB/Contracting Efficiency • Clinical Infrastructure • Dataset Needs vs. Capabilities

Tier Criteria

Databases/Registries ACC NCDR

CathPCI ICD IMPACT LAAO AF Ablation PVI

STS National Database STS ACS STS CHD STS Thoracic Surgery

Joint STS and ACC TVT Aortic TVT Mitral TVT Tricuspid

*Sites apply for certification level desired for each database. Free to use certification level for each database in marketing.

Dataset Complexity & Need for Multi-

Stakeholder Support

Registry Sustainability – Fit-to-Purpose Infrastructure

Shared Benefits of Multi-Stakeholder Partnerships

John Laschinger FDA CDRH

Goal of Specialized Valve Center Care

Optimize the care of the individual patient by insuring access to the right care, in the right place, at the right time while respecting his/her values and preferences

Underlying Principles for Development of a Valve System of Care

•Optimize the care of the patient with valvular heart disease

•Increasing complexities of diagnosis and therapy require increasing levels of experience and expertise.

•Institutional commitment to excellence in care with the provision of appropriate resources to provide this care

•The Heart Valve Team utilizing a multidisciplinary approach

•Shared decision making with patient choice should be a primary goal, with clarity to the consumer

Underlying Principles for Development of a Valve System of Care

•Participation in national registries and research trials

•Participation in quality improvement initiatives

• On-going analysis of process and outcomes

•Transparency of outcomes-public reporting

•On-going education of the valve team as well as to the lines of referral

If recommended thresholds for operator and site TAVR volumes are instituted, there will be a dramatic reduction in the number of hospitals providing TAVR

# TAVR hospitals reduced from 475 in 2016, to 263

after thresholds

45%

Source: FY2016 MedPAR

Current After Thresholds

Analysis By Edwards Lifesciences

What This Is About Not every center can do everything well

A rising tide floats all boats

Is It Time For Valve Centers of Excellence? Summary

•The best initial system is probably a tiered system of valve centers

•Valve centers need to have commitment to structure, processes and outcomes

•There is a similar initiative in Europe

•This isn’t just about performing a procedure

•It’s about a comprehensive approach to treating a disease that maximizes the chance of a patient getting… … the right procedure

…at the right place

…at the right time

… with the best possible outcome

Is it Time for a National Network of Valve Centers?