Is it Time for a National Network of Valve Centers? MICHAEL MACK, MD BAYLOR SCOTT & WHITE HEALTH

Transcription

1 Is it Time for a National Network of Valve Centers? MICHAEL MACK, MD BAYLOR SCOTT & WHITE HEALTH 10

2 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

3 2,100 1,150 Cath Labs Cardiac Surgery Programs TAVR Programs MitraClip Programs

4 This is Your Frail, Elderly Father! How many of the 2,100 Cath Labs in the US Should be Treating Him?

5 This Is Your Brother 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? Barlow s Myxoid Degeneration 5

6 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?

7 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

8 Misconceptions About a Valve Network It s all about TAVR It s an exclusive club It will limit access to care

9 National Systems of Care Cancer Trauma Stroke Bariatric Surgery STEMI /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)

10 National Systems of Care NIH Cancer Centers Basic Laboratory Cancer Center Cancer Centers Comprehensive Cancer Center ACS Trauma Centers Level I Level II Level III Level IV Brain Attack Coalition Stroke Centers Acute Stroke- Ready hospital Primary Stroke Center Comprehensive Stroke Center ASBS ACS Bariatric Centers Bariatric Surgery Center of Excellence ACC/ AHA STEMI STEMI-referral hospital (non-pci capable) STEMI-receiving hospital (PCI-capable)

11 Stroke Systems of Care Comprehensive Primary ASRH Brain Attack Coalition

12 National Valve System of Care

13 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.

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15 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:

16 ESC/EACTS Comprehensive Heart Valve Centre Standards Minimum Heart valve clinic Multi-modality imaging Procedures available MDT Processes Data review Procedures TAVR, Mitral Clip All HV replacements MVRp, TVRp Surgery for aortic root and ascending aorta AF ablation Links with other centers Chambers JB et al. EHJ 2017:38:

17 A Spoke-and-Hub or Tiered System of Care for Patients with Valvular Heart Disease? Primary Valve Center PVC Comprehensive Valve Center CVC PVC

18 Comprehensive (Level I) Valve Center TAVR TF BAV TAVR alternative access Valve-in-valve procedures MitraClip Paravalvular leak closure PBMV Isolated AVR Valve-sparing aortic root procedures AVR/Myomectomy Root enlargement with AVR Mitral repair for primary MR (P2 pathology) Interventional procedures Surgical procedures Mitral repair for complex primary MR (Barlow s and bileaflet prolapse) Multivalve operations Re-operative valve surgery Isolated tricuspid valve repair or replacement Primary (Level II) Valve Center TAVR TF BAV Isolated AVR Mitral repair for primary MR (P2 pathology)

19 Optimal Outcomes Access To Care

20 Considerations Quality Access Mortality Morbidity Durability Cost Heart Valve Centers Competition, Restricted Referral Lines, COI, AMC vs. Community, Cultures, Payment Models Disparities Geography Wait Times Follow-Up Courtesy P. O Gara

21 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?

22 INSIDE OUTSIDE

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24 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

25 Outcome 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

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35 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:

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

37 Standards for MV Repair for Primary MR 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 Chambers JB et al. EHJ 2017:38:

38 AHA/ACC 2017 Valve Disease Guideline 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 Nishimura RA et al. JACC 2017 doi: /j.jacc

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40 Dying During or Immediately After TAVR With experience (case volume) the risk of dying is reduced from 3.57% to 2.15%.

41 Of index TAVR procedures, 663 (4.1%), 3067 (18.9%), and (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, ; P <.001) and low-volume (adjusted odds ratio, 0.75; 95%CI, ; P =.007) hospitals Khera et al. JAMA Cardiol. 2017;2(7):

42 Sites Participating in the STS/ACC TVT Registry TAVR MitraClip - 212

43 TAVR Centers in US Alaska: 1 Hawaii: Centers

44 Sites Enrolled in TVT Registry New Sites Added Each Year

45 TAVR

46 Valve Centers/Million Population US Germany Japan Canada UK

47 Dallas Fort Worth Heart Surgery 2016 N=6,456 Programs =40 TAVR N=10

48 A Successful Pilot Hub and spoke Shared protocols, best practices Mentoring Communication

49 Registry Sustainability Fit-to-Purpose Infrastructure Shared Benefits of Multi-Stakeholder Partnerships 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 Tier Criteria Case mix Volume and Outcomes Research Infrastructure IRB/Contracting Efficiency Clinical Infrastructure Dataset Needs vs. Capabilities ACCF/STS Tiered Site Certification* *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 John Laschinger FDA CDRH 49

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51 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

52 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

53 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

54 If recommended thresholds for operator and site TAVR volumes are instituted, there will be a dramatic reduction in the number of hospitals providing TAVR Current After Thresholds Source: FY2016 MedPAR 45% # TAVR hospitals reduced from 475 in 2016, to 263 after thresholds Analysis By Edwards Lifesciences

55 What This Is About Not every center can do everything well A rising tide floats all boats

56 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

57 Is it Time for a National Network of Valve Centers?