Larger centers produce better outcomes in pediatric cardiac surgery: Regionalization is a superior model

Transcription

1 Larger centers produce better outcomes in pediatric cardiac surgery: Regionalization is a superior model Mark Danton MD FRCS Royal Hospital for Sick Children, Glasgow No Disclosures

2 Variation in Center Size and Outcomes Number of units and procedural volume STS 120+ (< ) EACTS 100+ ( ) 30-day, Hospital mortality: RACHS 1~ 0-8%, RACHS 6 ~ 3-60%

3 STS Congenital Heart Surgery Database All patients, discharge mortality range = 1-8% Jacobs STS CHSD 2007

4 : Mortality for STAT 5 Category Risk-adjusted models Jacobs STS CHSD 2012

5 Is center size the key determinant of good outcomes? If so would fewer number of larger center produce an overall better outcomes?

6 The parameters of the debate. Regionalization Fewer number of higher-volume centers Better outcomes in pediatric cardiac surgery Universal outcomes for the CHD population

7 The parameters of the debate. Regionalization Fewer number of higher-volume centers Better outcomes in pediatric cardiac surgery Universal outcomes for the CHD population Not limited to patients who can access a particular service/center

8 The parameters of the debate. Regionalization Fewer number of higher-volume centers Better outcomes in pediatric cardiac surgery Universal outcomes for the CHD population Not limited to patients who can access a particular service/center Not restricted to 30-day, hospital survival.

9 Bigger is Better The more you do, the better you get: Surgeons, PICU etc. Sub-specialization Sustainable and consistent over time Concentration of resources, economic advantage Large patient cohort for research

10 The Size Paradox Is center size determined by Growth - good outcomes, attract more patients..or Historical designation, geographic (urban) position, population density

11 VOLUME-OUTCOME RELATIONSHIP

12 Jenkins Pediatrics 1995

13 Higher Volume Load in Congenital Heart Surgery is Associated with Better Early Outcomes. The European Prospective EACTS congenital database, ,345 procedures, 99 centers Risk-adjustment by STAT adjusted morbidity/ mortality Score Center volume categories Small <150 Medium Large V large +350 Kansy Presented EACTS 2014

14 Higher Volume Load in Congenital Heart Surgery is Associated with Better Early Outcomes. The European Prospective STAT adjusted morbidity/ mortality Score Lowest in >350 centers Kansy Presented EACTS 2014

15 Higher Volume Load in Congenital Heart Surgery is Associated with Better Early Outcomes. The European Prospective Mortality Increased in centers <250 Kansy Presented EACTS 2014

16 Higher Volume Load in Congenital Heart Surgery is Associated with Better Early Outcomes. European Prospective Major Complication Lowest center, Associated mortality lowest +350 centers Kansy Presented EACTS 2014

17 Higher Volume Load in Congenital Heart Surgery is Associated with Better Early Outcomes. European Prospective Major Complication Lowest center Associated mortality lowest +350 centers Kansy Presented EACTS 2014

18 Higher Volume Load in Congenital Heart Surgery is Associated with Better Early Outcomes. European Prospective Major Complication Lowest center Associated mortality lowest +350 centers Kansy Presented EACTS 2014

19 The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database STS database analysis operations Risk adjustment Patient, procedure Welke J Thor Cardiovasc Surg 2009

20 The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database STS database analysis operations Risk adjustment Patient, procedure Volume effect High-difficulty and Norwood Welke J Thor Cardiovasc Surg 2009

21 The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database STS database analysis operations Risk adjustment Patient, procedure Volume effect High-difficulty and Norwood Welke J Thor Cardiovasc Surg 2009

22 The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database High difficulty procedures Only when <150 case/year p=0.001 Inflection point ~ Welke J Thor Cardiovasc Surg 2009

23 The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database Norwood procedure <350 case/year sign. Welke J Thor Cardiovasc Surg 2009

24 STS database patients, 53 centers Center volume Significant <10 cases/year Pasquali. Ann Thorac Surg 2012

25 Variation between centers irrespective of volume Center Volume modest influence on risk N1 (14%) High Center Low Center volume alone as a quality metric for the Norwood operation may not be justified Pasquali. Ann Thorac Surg 2012

26 , 2375 pts, 84 centers Centers 75 [89%] <10/yr 1656 pts (69%). 9 [11%] > 10/yr ~ 747 pts [31%] Surgeons 145 (94%) <6/yr. 9 (6%) > 6/yr. Karamlou AnnThorac Surg 2014

27 Center volume <5 increased mortality 5-10 lowest mort/complication Karamlou AnnThorac Surg 2014

28 Center volume <5 increased mortality 5-10 lowest mort/complication Karamlou AnnThorac Surg 2014

29 Specific Conditions Arterial Switch-TGA Adjusted for surgeon volume: center volume had a minimal effect Surgeon volume predominates Karamlou AnnThorac Surg 2014

30 Variation in mortality within single institutions Karamlou J Thorac Cardiovasc Surg 2011

31 Variation in mortality within single institutions Karamlou J Thorac Cardiovasc Surg 2011

32 Variation in mortality within single institutions Karamlou J Thorac Cardiovasc Surg 2011

33 The Limits of the Volume Outcome Relationship Volume simplicity and readily availability surgical volume commonest cited metric All conditions or only high-risk/complex Within center variation Inflection points Surgeon or institution dependent Focus on hospital mortality limited pre-hospital or longer-term Ignores population-based outcomes Center decision making, 1 vs. 2 stage repair, risk aversion 1 vs.2 ventricle repair

34 Case/year UK and Ireland: Annual center volume centers: per annum

35 Op mort[%] UK Morality versus Volume, all cases R2=0.04, p= case volume

36 UK Norwood CCAD data

37 UK Norwood CCAD data

38 Potential disadvantages of fewer centers ACCESS

39 Mayer J Ped Surg 2008

40 Mayer J Ped Surg 2008

41 Increased risk-adjusted inhospital mortality Black, Hispanic, Regional effect Unrelated to insurance cover or biology Access to high quality services Benavides Pediatric Cardiology 2006

42 Increased risk-adjusted inhospital mortality Black, Hispanic Regional effect Unrelated to insurance cover or biology Access to high quality services Benavides Pediatric Cardiology 2006

43 Early childhood survival for TGA Significant decreased riskadjusted survival in Black vs. White TGA, TOF, PAIVS, VSD, ASD, Nemnhard Pediatrics 2011

44 Decreased survival in Hispanics HLHS, PAIVS Deficiencies in post-discharge care findings suggest a need to intensify home health care and enhance communication between the cardiac center and the families Nemnhard Pediatrics 2011

45 Ethnic disparity HLHS, PA IVS, Distance to center not sign. Regional effect in CHD mortality Border area Higher Poverty No identified referral center Fixler Pediatrics 2012

46 Ethnic disparity HLHS, PA IVS Distance to center not sign. Regional effect in CHD mortality Border area Higher Poverty No identified referral center Fixler Pediatrics 2012

47 TOO BIG: DISTANCE MATTERS

48 Does Distance Matter Travels times < 30 vs. >30 mins sign. higher mortality vs. 1.0 Longer travel times associated with more severe illness - seizures meningitis.access to care may continue to be an issue for children residing further from medical care Lorch Heath Ser Res 2009

49 Texas Birth registry Birth location and neonatal mortality in HLHS Longer driving times strongly associated with increased mortality <10 21% % >90mins - 40%, p<0.001 Morris Circulation 2014

50 >90 min 6-fold increase Pretransport mortality Limited access to care Lack of prenatal diagnosis Limited experience Beyond 30 day not considered Distance effect on post-op HLHS mortality? Morris Circulation 2014

51 Previous studies focus on in-hospital events, with limited post-discharge data 217 neonates discharged Further from center Ethnic minorities, Higher RACHS Mortality (8%) 90 mins vs : 6 vs. 15%, p=0.09 ( 2 fold increase) Pinto Ped Cardiol 2012

52 Adverse events Common, 62% Readmission 45%, Re-intervention 40% Commonest <90min cohort? Loss of follow-up in distant patients 20% families moved home to be closer to the surgical center Trend to perceived access difficulties with distant patients Pinto Ped Cardiol 2012

53 TOO BIG TO FAIL

54 Disadvantage - too big to fail All eggs in one basket Lack of alternatives Risk to CHD population Sudden Program failure Nosocomial Infection Loss of key personnel 5-Bank Asset concentration

55 too big to fail Organizations deemed to big to fail pose a risk in any industry. In healthcare systems may grow so large that they technically survive, but fail in other aspects of patient care Paul Levy CEO Beth Israel Deaconess Medical Center, Boston Large organizations might Function inside a bubble Complacent Continue status quo, oppose change Inaction on inefficiency, systemic failures Command higher prices, leverage

56 Cost variation between centers Center volume influence Only in low complex ASD, VSD No effect TOF, TGA A. ASD, B. VSD, C. TOF, D. TGA Pasquali Circ Cardiovasc Qual Outcomes 2011

57 REGIONALIZATION MODELS

58 Simulated in-hospital mortality Center volume categories <70, <170, >170 Regionalization mortality Before region = 5.34% Refer all cases = 4.08% Only High-risk (11%) = 4.6% Chang Pediatrics 2002

59 Simulated in-hospital mortality Center volume categories <70, <170, >170 Regionalization mortality <70 Before region = 5.34% Refer all cases = 4.08% Only High-risk (11%) = 4.6% Chang Pediatrics 2002

60 Simulated in-hospital mortality Center volume categories <70, <170, >170 Regionalization mortality <70 Before region = 5.34% Refer all cases = 4.08% <170 Only High-risk (11%) = 4.6% Chang Pediatrics 2002

61 Sweden, 8.9 m population 4 Units to 2 Units, 1993 Total 550 to 620 cases/yr. Increased complexity Lundstrom Pediatr Cardiol 2000

62 Sweden, 8.9 m population 4 Units to 2 Units, 1993 Total 550 to 620 cases/yr. Increased complexity Lundstrom Pediatr Cardiol 2000

63 Advantages Reduction in 30-day mortality Families preferred: results>distances However Improvement due to centralization or progress No population-based outcomes 2 units preferred over 1 Promote competition Minimize risk infection, key personnel Lundstrom Pediatr Cardiol 2000

64 ALTERNATIVE MODELS

65 Alternatives and Options Regionalization fewer larger surgical centers Status quo Natural selection Standardize, define center requirements and standards: UK model Re-distribution distubution of cases above accepted thresholds 50:400 model (US 20, 000 cases per annum) Collaborative Programs Selective referrals - Tx

66 Drivers Anticipated population growth Improve access to local community California Stanford Sutter memorial, Sacramento 2 additional programs Oakland, Fresco Mainwaring J of Cardiac Surg 2008

67 Prerequisites Affiliate model in conjunction with a university-based program Surgeon[s] appointed, on-facility Stanford Outcomes returned to STS database Mainwaring J of Cardiac Surg 2008

68 Organizational Structure Host center surgeon 1 visit per week Attending: Cardiac conference, M/M, mentoring surgery Educational program, teaching rounds, annual day symposium Patient selection /transfer to Host program determined by consensus Local experience, case complexity Mainwaring J of Cardiac Surg 2008

69 , 386 procedures 2 Deaths, 0.5% (predicted 10-17) Mainwaring J of Cardiac Surg 2008

70 Summary Volume and outcome relationships focus on short-term hospital outcomes and are influenced by case complexity, inflection points, surgeon vs. center, and unknown quality metrics Reduced access contributes to worse outcomes: geographic region, longer travel times, and ethnic/socio-economic groups Alternative models and collaborative programs have proven effective options

71 Conclusion To do the greatest good for as many patients as possible High quality universal heath care for all requires good access to quality programs. Over centralization with fewer centers might compromise this

72 Larger centers produce better outcomes in pediatric cardiac surgery: Regionalization is a superior model Mark Danton MD FRCS Royal Hospital for Sick Children, Glasgow

73 REBUTTAL

74 Variation in outcomes does exist Evidence supports a volume-outcome relationship Unequal access

75 Larger centers Have grown because good outcomes have attracted more patients Advanced the care of congenital heart disease Developing and refining surgical techniques Training and dissemination of the experience Research and innovation The other quality metrics Safety, performance and functional teams

76 Not just the 30-day outcome Congenital heart disease is a life-long condition Programs should Take responsibility for entirety of care Provide universal cover Delivery should not Focus on a procedure but the condition over time Be geographically remote nor isolated from population

77 Some Final thoughts Variation cannot be eliminated, nor should we wish to. Required to innovate, in the learning curve and part of the disease itself Regionalization, who decides and by what criteria Government, Profession or the Patient Volume, outcomes, costs, population A model incorporating both competition and collaboration

78 Many things can be reduced to football Individualistic Premier surgeons, premier units

79 Many things can be reduced to football The next evolution: Through teams and collaboration is were consistent success lies.

80 In my opinion we will improve outcomes faster if our programs spend more time sharing than competing Erle H Austin Presidential Address Congenital Heart Surgeons Society 2012 Learning collaborative initiative Defining and implementing Quality improvement metrics Multi-discipline approach Shared outcome data Round-robin visits

81 Joint programmes in paediatric cardiothoracic surgery: a survey and descriptive analysis National survey 125 paediatic CTSnet surgeons 65 analyzed, 22 (35%) in joint programs DeCampli Card Young 2011

82 Joint programmes in paediatric cardiothoracic surgery: a survey and descriptive analysis Meetings Joint Conference, 34% Joint M&M, 29% Surgeon cover No dedicated surgeon, 54% Independent 15%, Primary 27% Distance 75% <100 miles, Distribution of annual volume, % Blue- primary, red-partner DeCampli Card Young 2011

83 Joint programmes in paediatric cardiothoracic surgery: a survey and descriptive analysis Complexity Mission Improve access Increase referrals to Primary Increase surgeon volume. Failure 7 defunct programs Mission dissonance DeCampli Card Young 2011

84 Joint programs Share a common mission to improve the quality of care in the combined region Structure and process Meetings, teleconferencing, combined experience Physician cross-coverage Shared clinical databases, studies/research Administration/management Clinical mission in synchrony with strategies of business DiCampli Cardiology in young 2011

85 The limitations of evidence Study cohort Single institution Non-specialist databases Limited to a condition

86 Case/year UK and Ireland: Annual center volume

87 30 day mortality UK Norwood: Mortality vs. Total Volume R2=0.008, p= year total center volume

88 Mortality UK Norwood: mortality vs. Norwood Volume R2=0.002, p= Norwood volume

89 Annual Norwood volume UK Annual Norwood Volumes Center

90 Ideas to cover/develop What do the families want Public and government, costs, locally delivered Informed consent Larger centers closing centers which criteria to close volume, outcome Larger centers reduce competion, to big to fail, Devolution-scotland

91 Hpoplastic Left Heart Syndrome V-O

92 Mortality Deceasing over time Peaks in Infancy and adulthood NH Blacks > Whites Gilboa Circulation 2011

93 US and UK US Population, centers Funding/Philopshy UK Socialised Free-market

94 Volume: the determinant or the surrogate Pre-operative decision-making and care Intra-operative decision-making and care Post-operative in-hospital and post-discharge care Multi-disciplinary discussions Team strength, interaction and experience. Managing complications, failure to rescue Infra-structure

95 Mortality Deceasing over time Peaks in Infancy and adulthood NH Blacks > Whites Gilboa Circulation 2011

96 Mortality Deceasing over time Peaks in Infancy and adulthood NH Blacks > Whites Gilboa Circulation 2011

97 Experiences from Others

98 Regionalization Is a regulatory approach to rationalization of resource allocation, especially for highly specialized medical services or technologies

99 Conclusion of study is that distance from surgical center did not impact on post-op mortality However Authors state Findings Interpated with caution low event rates Mortality trend - x2 fold increase, 90 vs Adverse events - only 50% follow-up achieved, predominated in near patients Trend to perceived access difficulties with distant patients 20% families moved home to be closer to surgical center Pinto Ped Cardiol 2012

100 Center infrastructure Cardiac Pediatric ICU Pediatric Cardiology, Anaesthesia ECMO support Imaging facilities, CT, MRI Mainwaring J of Cardiac Surg 200

101 Local experience, case complexity Available expertise Infrastructure ECMO, imaging May include Complex surgery-neonates, Transplant/VAD, Adult congenital Mainwaring J of Cardiac Surg 200

102 Higher Volume Load in Congenital Heart Surgery is Associated with Better Early Outcomes. European Prospective Summary of data Elimination of one >350 center (in-hospital mortality =18.47%) Complexity and co-morbidity lowest in v. high volume centers Risk-adjusted mortality significant increased in centers <250 Inflection point Risk of complication higher in +350 Mortality associated with major complications lowest >350 centers [improved failure to rescue ] Kansy Presented EACTS 2014