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Analysis of Pump Thrombosis in the Intermacs Database

Analysis of Pump Thrombosis in the Intermacs Database. Michael Acker William Measey Professor of Surgery Chief of Division of Cardiovascular Surgery Director of Heart and Vascular Center University of Pennsylvania Health System. Disclosures. Consultant for Thoratec and Heartware.

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Analysis of Pump Thrombosis in the Intermacs Database

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  1. Analysis of Pump Thrombosis in the Intermacs Database Michael Acker William Measey Professor of Surgery Chief of Division of Cardiovascular Surgery Director of Heart and Vascular Center University of Pennsylvania Health System

  2. Disclosures • Consultant for Thoratec and Heartware

  3. Perceived increase in incidence of HMII pump thrombosis after 2011 by • several large VAD centers compared to HMII pivotal trial • FDA/NHLBI request Intermacs to investigate

  4. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 1 Overall Survival n=6910, deaths=1772 • Months • post implant % Survival • 1 95% • 3 91% • 6 87% • 12 80% • 24 69% • 36 58% • 48 46% % Survival Event: Death – with a device in place (censored at transplant and recovery) Months post implant

  5. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 2 No change in survival by Implant year p(overall) =.63 Implant Year n Deaths (with a device in place) 2008 459 139 2009 866 247 2010 1585 522 2011 1845 481 2012 2155 383 Totals 6910 1772 % Survival Event: Death – with a device in place (censored at transplant and recovery) Months post implant

  6. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 3 Increase in pump exchange per year p(overall) < .0001 Implant Year n Events 2008 459 38 2009 866 60 2010 1585 158 2011 1845 157 2012 2155 148 Totals 6910 561 % Freedom from Device Exchange Event: Device Exchange (censored at death, transplant and recovery) Months post implant

  7. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Table 1 Device Removal Events n Removed (exchanged) due to a problem 561 Thrombus 288 Elective 94 Emergent 177 Unknown 17 Probable Thrombus 49 Elective 25 Emergent 21 Unknown 3 Infection (Not thrombus) 76 Elective 38 Emergent 11 Unknown 27 Not Thrombus/Unknown Infection 120 Elective 52 Emergent 68 Not Thrombus/Not Infection 28 Unknown 28 Device removed due to recovery 133 Death: Device not functionally normally 98 Thrombus 27 Probable Thrombus 18 Not Thrombus 53 Totals 792 Main Event Exchanges or deaths due to thrombus n=382

  8. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 5 Increase in pump exchange/death due to thrombus or death from 1% to 6% p(overall) < .0001 % Freedom at Implant Year n Events 6 mos 12 mos 36 mos 2008 459 18 99% 98% 92% 2009 866 23 99% 99% 95% 2010 1585 88 98% 97% 90% 2011 1845 118 96% 94% ---- 2012 2155 135 94% 93% ---- Totals 6910 382 % Freedom from Device Exchange or death due to thrombus Event: Device Exchange or death due to thrombus* (censored at death, transplant and recovery) Months post implant *Thrombus events include ‘probable’ thrombus events

  9. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Table 2 Pump Exchanges due to Thrombus: n=337 Exchange Era Elective Emergent Total 2008-2010 9 (24.3%) 28 (75.7%) 37 (100.0%) 2011-2013* 110 (39.3%) 170 (60.7%) 280 (100.0%) Overall p value = .08 * 2013 includes exchanges from 01/01/2013 through 06/30/2013

  10. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 4 n=6910, events=382 Months % Freedom 6 97% 12 95% 24 92% 48 86% % Freedom from exchange or death due to thrombus Events/Month Event: Device exchange or death due to thrombus Hazard Months post Implant

  11. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 6 % Freedom by implant year p(overall) < .0001 % Freedom from Device Exchange or death due to thrombus Events/Month Event: Device Exchange or death due to thrombus* (censored at death, transplant and recovery) Hazard by implant year Months post implant *Thrombus events include ‘probable’ thrombus events

  12. Occurrence and Incidence of Confirmed Pump Thrombosis Stratified According to Implantation Date. Starling RC et al. N Engl J Med 2014;370:33-40

  13. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Risk Factors for Device Exchange or Death due to Thrombus (Time Zero = 1 Month Post Implant) Table 4 Risk Factor hazard ratio p-value Implant year (later) 1.46 < .0001 Age (younger) 1.251 < .0001 White race 1.42 .0003 BMI (larger) 1.202 .01 LVEF above 20% 1.44 .003 LDH at 1 month (higher) 3.163 < .0001 1 Hazard ratio denotes the increased risk for a 60 year compared to a 70 year old patient 2 Hazard ratio denotes the increased risk for a 10 unit increase in BMI 3 Hazard ratio denotes the increased risk for an increase in LDH from 500 to 1000 units BMI, body mass index; LVEF, left ventricular ejection fraction; LDH, lactate dehydrogenase

  14. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 13 By LDH Groups p(overall) < .0001 LDH group n Events Missing 4581 223 0-400 1318 52 401-1000 819 66 > 1000 192 41 Totals 6910 382 % Freedom from Device Exchange or Death due to Thrombus Event: Device Exchange due to Thrombus** (censored at death, transplant and recovery) Months post implant ** Thrombus events include ‘probable’ thrombus LDH, lactate dehydrogenase

  15. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 8 1st device, n=6910, deaths=1604 % Survival Exchange due to Thrombus n=337, deaths=80 p(overall) < .0001 Exchange due to Infection/Other n=224, deaths=66 Event: Death – with a device in place (censored at transplant and recovery) Months post implant

  16. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Primary Cause of Death within 3 months Table 3 After Pump Exchange or After Primary Implant*death due to Thrombus  Primary Cause of Death n % n % Circulatory Failure 217 34.7% 5 33.3% Multisystem Organ Failure 114 18.2% 6 40.0% CNS Event 88 14.1% 2 13.3% Infection 51 8.1% 1 6.7% Respiratory Failure 48 7.7% 1 6.7% Device Malfunction 11 1.8% 0 0.0% * Censored at devices exchange CNS, central nervous system

  17. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 9 n=6910, events=3206 % Freedom from Infection p = .008 n=337, events=131 Event: Time to first Infection Months post Implant

  18. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Figure 10 n=6910, events=619 n=337, events=37 % Freedom from CVA p < .0001 Event: Time to first CVA Months post Implant CVA, cerebrovascular accident

  19. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Main Event n=337: Exchanges due to Thrombus Figure 12 Median 1st Operation (prior to exchange) 2nd Operation (exchanges due to thrombus) Median Visual Analog Scale (VAS) p value .05 .72 .83 .79 .61 .31 .53 --- ---- ---- ----- ----- 1st Operation (n) 181 119 90 53 36 21 12 5 2 2 2 1 2nd Operation (n) 23 86 72 29 17 6 4 2 1 1 ---- ----

  20. INTERMACS: HeartMate II Pump Analysis Implants: April 2008 – December 2012, n=6910 Follow-up: Through June 2013 Median INR – 1month post implant forward Figure 14 INR Post Implant Follow-up by Quarter/Year INR, International normalized ratio

  21. Limitations • Pump Design/Production • Intermacs can not give granular data on subtle differences/changes in clinical practice/patient selection overtime that may affect outcome • Implantation techniques ie inflow angles • Intensity of anticoagulation; compulsive f/u • heparin bridging; • Pump speed vs AV opening • BP management

  22. Changes Over Time • GI bleeding • decrease in anticoagulation goals • Elimination of heparin bridging • Decrease rpms to allow AV opening • Pump Design/Production • 2011 changes in outflow graft ; bend relief software changes • 2011 Marked ramp up in production

  23. Summary • 6 fold Increase in Pump Exchange or death due to thrombosis in 2011 to 6% from 1% in 2009 • Early Hazard of Pump thrombosis in first 3 months after 2011 not seen prior to 2011 • Overall survival not changed (I yr 80%) BUT if you have a pump exchanged for thrombosis your survival is decrease (1 yr 70%) and your chance of stroke or infection is increased

  24. Summary • Risk factors for early Pump thrombosis is predominantly Pt year (2011) and early LDH rise after implant; other risk factors younger age; white; large BMI; LVEF > 20%

  25. Conclusions(personal not intermacs) • Most important change post 2011 is not increase rate of thrombosis but new early hazard of thrombosis< 3 months; • different than late thrombosis • Whatever is happening is happening in the OR or early postop • Importance of HMII inflow cannulae ventricular alignment; bridging heparin • Early LDH rise not seen prior to 2011—causative or result of early thrombus? • Great variations of incidence of thrombosis between sites ( 1% to >20%) • Detailed statistical review of different site practices (consortium of high and low incident sites) is needed to determine subtle difference in operative/implantation and pt care practices that may elucidate important risk factors for thrombosis • Will allow hypothesis generation to validate in prospective study (PREVENT) • Therapeutic window for HMII is more narrow now than prior to 2011 • Multifactorial etiology- pump; implantation; pump management (anticoagulation, speed); patient; patient care • ?Anticoagulation goals in high thrombosis incident sites higher now than prior to 2011 • Importance of pump flow pass the bearing to dissipate heat—rpms > 9000 if possible • Continued Thoratec review of manufacturing practices and changes made in pump in 2011

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