Medical Policy Total Artificial Hearts and Implantable Ventricular Assist Devices (VAD)

Medical Policy Total Artificial Hearts and Implantable Ventricular Assist Devices (VAD) Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies Policy: Medicare Description References Authorization Information Policy History Policy Number: 280 BCBSA Reference Number: 7.03.11 Related Policies Heart/Lung Transplant, #269 Heart Transplant, #197 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Implantable ventricular assist devices with FDA approval may be MEDICALLY NECESSARY to treat patients in the following situation or with the following conditions: In the post-cardiotomy setting or as a bridge to recovery for patients who are unable to be weaned off cardiopulmonary bypass in the postcardiotomy setting. As a bridge to transplantation for adult patients who are: o Currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained or o Undergoing evaluation to determine candidacy for heart transplantation, Biventricular failure when ALL of the following conditions are met: o There are no other reasonable medical or surgical treatment options, AND o Patient is ineligible for other univentricular or biventricular support devices, AND o Patient is currently listed as heart transplantation candidates, AND o Patient is not expected to survive until a donor heart can be obtained. Destination therapy for patients with end-stage heart failure who meet one of the following criteria: o Patient has New York Heart Association (NYHA) class IV heart failure for >60 days, OR o Patient has NYHA class III/IV heart failure for 28 days, received >14 days support with intraaortic balloon pump or dependent on IV inotropic agents, and failed 2 weaning attempts AND who are ineligibility for human heart transplantation due to one or more of the following reasons: o Age >65 years, o Insulin-dependent diabetes mellitus with end-organ damage, o Chronic renal failure (serum creatinine >2.5 mg/dl for >90 days, o Presence of other clinically significant conditions. 1

Implantable ventricular assist devices with FDA approval or clearance, including humanitarian device exemptions may be MEDICALLY NECESSARY as a bridge to transplantation in children 16 years old or younger who are: Currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, or Undergoing evaluation to determine candidacy for heart transplantation. Implantable ventricular devices or artificial hearts for any other conditions, including, but not limited to, the use of total artificial hearts as destination therapy, are INVESTIGATIONAL. Non-FDA approved or cleared implantable ventricular assist devices or total artificial hearts are INVESTIGATIONAL. Percutaneous ventricular assist devices (pvads) for all indications are INVESTIGATIONAL. Medicare HMO Blue SM and Medicare PPO Blue SM Members BCBSMA covers total artificial hearts and ventricular assist devices (VAD) for the following indications for Medicare HMO Blue and Medicare PPO Blue members in accordance with CMS NCD. Postcardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass. Bridge to transplantation when all of the following criteria are met: o The patient is approved and listed as a candidate for heart transplantation by a Medicareapproved heart transplant center, AND o The implanting site, if different than the Medicare-approved transplant center, must receive written permission from the Medicare-approved heart transplant center under which the patient is listed prior to implantation of the VAD. Destination therapy when ALL of the following criteria are met: o NYHA Class IV end-stage left ventricular failure for at least 90 days with a life expectancy of less than two years, AND o Are not candidates for human heart transplantation, AND o Heart failure symptoms have failed to respond to optimal medical management for at least 60 of the last 90 days. Management includes: Dietary salt restriction, Diuretics, Digitalis, Beta blockers, ACE inhibitors (if tolerated), AND o Left ventricular ejection fraction (LVEF) < 25%, AND o The patient has demonstrated functional limitation with a peak oxygen consumption of < 12 ml/kg/min; or the patient has a continued need for intravenous inotropic therapy owing to symptomatic hypotension, decreasing renal function, or worsening pulmonary congestion, AND o The patient has the appropriate body size (>1.5 m2) to support the VAD implantation. For a list of Medicare-approved facilities: http://www.cms.gov/medicareapprovedfacilitie/vad/list.asp#topofpage National Coverage Determination (NCD) for Artificial Hearts and Related Devices (20.9) http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=246&ncdver=5&docid=20.9&ncselection=ncd&cntrctr=205*1%7c208*1&cpthcpc scode=33975&kq=true&searchtype=advanced&bc=iaaaaagaaaaa& Prior Authorization Information Commercial Members: Managed Care (HMO and POS) Prior authorization is required. 2

Commercial Members: PPO, and Indemnity Prior authorization is required. Medicare Members: HMO Blue SM Prior authorization is required. Medicare Members: PPO Blue SM Prior authorization is required. CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes CPT codes: Code Description 33975 Insertion of ventricular assist device; extracorporeal, single ventricle 33976 Insertion of ventricular assist device; extracorporeal, biventricular 33977 Removal of ventricular assist device; extracorporeal, single ventricle 33978 Removal of ventricular assist device; extracorporeal, biventricular 33979 Insertion of ventricular assist device, implantable intracorporeal, single ventricle 33980 Removal of ventricular assist device, implantable intracorporeal, single ventricular Replacement of extracorporeal ventricular assist device, single or biventricular, 33981 pump(s), single or each pump Replacement of ventricular assist device pump(s); implantable intracorporeal, single 33982 ventricle, without cardiopulmonary bypass Replacement of ventricular assist device pump(s); implantable intracorporeal, single 33983 ventricle, with cardiopulmonary bypass Insertion of ventricular assist device, percutaneous including radiological supervision 33990 and interpretation; arterial access Insertion of ventricular assist device, percutaneous including radiological supervision 33991 and interpretation; both arterial and venous access, with transseptal puncture Removal of percutaneous ventricular assist device at separate and distinct session 33992 from insertion Repositioning of percutaneous ventricular assist device with imaging guidance at 33993 separate and distinct session from insertion Interrogation of ventricular assist device, in person, with physician analysis of device parameters (eg, drivelines, alarms, power surges), review of device function (eg, flow 93750 volume status, septum status, recovery), with programming, if performed, and report Implantation of a total replacement heart system (artificial heart) with recipient 0051T cardiectomy Replacement or repair of thoracic unit of a total replacement heart system (artificial 0052T heart) Replacement or repair of implantable component or components of total replacement 0053T heart system (artificial heart) excluding thoracic unit HCPCS Codes HCPCS Code Description 3

codes: Q0478 Q0479 Q0480 Q0481 Q0482 Q0483 Q0484 Q0485 Q0486 Q0487 Q0488 Q0489 Q0490 Q0491 Q0492 Q0493 Q0494 Q0495 Q0496 Q0497 Q0498 Q0499 Q0500 Q0501 Q0502 Q0503 Q0504 Q0506 Power adapter for use with electric or electric/pneumatic ventricular assist device, vehicle type Power module for use with electric or electric/pneumatic ventricular assist device, Driver for use with pneumatic ventricular assist device, Microprocessor control unit for use with electric ventricular assist device, replacement Microprocessor control unit for use with electric/pneumatic combination ventricular assist device, Monitor/display module for use with electric ventricular assist device, Monitor/display module for use with electric or electric/pneumatic ventricular assist device, Monitor control cable for use with electric ventricular assist device, Monitor control cable for use with electric/pneumatic ventricular assist device, Leads (pneumatic/electrical) for use with any type electric/pneumatic ventricular assist device, Power pack base for use with electric ventricular assist device, Power pack base for use with electric/pneumatic ventricular assist device, replacement Emergency power source for use with electric ventricular assist device, replacement Emergency power source for use with electric/pneumatic ventricular assist device, Emergency power supply cable for use with electric or electric/pneumatic ventricular assist device, Emergency power supply cable for use with electric or electric/pneumatic ventricular assist device, Emergency hand pump for use with electric or electric/pneumatic ventricular assist device, Battery/power pack charger for use with electric or electric/pneumatic ventricular assist device, Battery for use with electric or electric/pneumatic ventricular assist device, replacement Battery clips for use with electric or electric/pneumatic ventricular assist device, Holster for use with electric or electric/pneumatic ventricular assist device, replacement Belt/vest for use with electric or electric/pneumatic ventricular assist device, Filters for use with electric or electric/pneumatic ventricular assist device, replacement Shower cover for use with electric or electric/pneumatic ventricular assist device, Mobility cart for pneumatic ventricular assist device, Battery for pneumatic ventricular assist device,, each Power adapter for pneumatic ventricular assist device,, vehicle type Battery, lithium-ion, for use with electric or electric/pneumatic ventricular assist device, ICD-9 Procedure Codes When the following ICD 9 procedure codes are associated with the service(s) described in this document coverage for the service(s) is aligned with the policy statement. 4

ICD-9-CM procedure codes: Code Description 37.52 Implantation of total internal biventricular heart replacement system 37.53 Replacement or repair of thoracic unit of (total) replacement heart system 37.54 Replacement or repair of other implantable component of (total) replacement heart system 37.63 Repair of heart assist system 37.65 Implant of single ventricular (extracorporeal) external heart assist system 37.66 Insertion of implantable heart assist system ICD-10 Procedure Codes ICD-10-PCS procedure codes: 02RK0JZ 02HA0QZ 02HA0RS 02HA0RZ 02HA3QZ 02HA3RS 02HA3RZ 02HA4QZ 02HA4RS 02HA4RZ 02RK4JZ 02RL0JZ 02RL4JZ 02UA0JZ 02UA3JZ 02UA4JZ 02WA0JZ 02WA0QZ 02WA3QZ 02WA3RZ 02WA4QZ 5A02116 5A02216 Code Description Replacement of Right Ventricle with Synthetic Substitute, Open Insertion of Implantable Heart Assist System into Heart, Open Insertion of Biventricular External Heart Assist System into Heart, Open Insertion of External Heart Assist System into Heart, Open Insertion of Implantable Heart Assist System into Heart, Percutaneous Insertion of Biventricular External Heart Assist System into Heart, Percutaneous Insertion of External Heart Assist System into Heart, Percutaneous Insertion of Implantable Heart Assist System into Heart, Percutaneous Endoscopic Insertion of Biventricular External Heart Assist System into Heart, Percutaneous Endoscopic Insertion of External Heart Assist System into Heart, Percutaneous Endoscopic Replacement of Right Ventricle with Synthetic Substitute, Percutaneous Endoscopic Replacement of Left Ventricle with Synthetic Substitute, Open Replacement of Left Ventricle with Synthetic Substitute, Percutaneous Endoscopic Supplement Heart with Synthetic Substitute, Open Supplement Heart with Synthetic Substitute, Percutaneous Supplement Heart with Synthetic Substitute, Percutaneous Endoscopic Revision of Synthetic Substitute in Heart, Open Revision of Implantable Heart Assist System in Heart, Open Revision of Implantable Heart Assist System in Heart, Percutaneous Revision of External Heart Assist System in Heart, Percutaneous Revision of Implantable Heart Assist System in Heart, Percutaneous Endoscopic Assistance with Cardiac Output using Other Pump, Intermittent Assistance with Cardiac Output using Other Pump, Continuous Description Heart failure may be the consequence of a number of differing etiologies, including ischemic heart disease, cardiomyopathy, congenital heart defects, or rejection of a heart transplant. Mechanical devices to assist or replace a failing heart have been developed over many decades of research. The total artificial heart replaces the native heart and requires frequent recharging from an external power source. Any failure of this power source is synonymous with cardiac death. 5

A ventricular assist device (VAD) is a mechanical support attached to the native heart and does not result in certain death in the event of device failure, as the native heart may have enough residual function to carry the patient in the short term. Ventricular assist devices can be classified as internal or external, electrically or pneumatically powered, and pulsatile or continuous flow. Surgically-implanted ventricular assist devices represent a method of providing mechanical circulatory support for patients not expected to survive until a donor heart becomes available for transplant or for whom transplantation is otherwise contraindicated or unavailable. They are most comm used to support the left ventricle, but right ventricular and biventricular devices may be used. The Syncardia Temporary Total Artificial Heart from SynCardia Systems, the AbioCor Implantable Replacement Heart System from AbioMed, and the HeartMate II LVAS from Thortec are examples of bridge to transplantation or destination therapy devices. The Thoratec Ventricular Assist Device System from Thoratec Corp, the DeBakey VAD Child Device and the Berlin Heart EXCOR Pediatric VAD and Centrimag Right Ventricular Assist Device from Levitronix are examples of ventricular assist devices used as a bridge to transplantation or for destination therapy. All total hearts or ventricular assist devices for bridge to transplantation, or destination therapy are considered investigational regardless of the commercial name, the manufacturer or FDA approval status except when used for the medically necessary indications that are consistent with the policy statement. Summary A ventricular assist device (VAD) is a mechanical support attached to the native heart and vessels to augment cardiac output. The total artificial heart (TAH) replaces the native ventricles and is attached to the pulmonary artery and aorta; the native heart is typically removed. There is a substantial body of evidence from clinical trials and observational studies supporting implantable ventricular assist devices as a bridge to transplant in patients with end-stage heart failure, possibly improving mortality as well as quality of life. A well-designed clinical trial, with 2 years of follow-up data, demonstrates an advantage of implantable ventricular assist devices as destination therapy for patients who are ineligible for heart transplant. Despite an increase in adverse events, both mortality and quality of life appear to be improved for these patients. Therefore, LVADs may be considered medically necessary as a bridge to transplant and as destination therapy in patients who are not transplant candidates. The evidence for total artificial heart in these settings is less robust. However, given the limited evidence from case series and the lack of medical or surgical options for these patients, TAH is likely to improve outcomes for a carefully selected population with end-stage biventricular heart failure awaiting transplant who are not appropriate candidates for an LVAD. TAH may be considered medically necessary for this purpose. There is insufficient evidence on the use of TAH as destination therapy, and TAH is considered investigational for this purpose. The evidence on percutaneous ventricular assist devices (pvads) does not support that these devices improve health outcomes. Three randomized controlled trials of pvad versus intra-aortic balloon pump (IABP) for patients in cardiogenic shock failed to demonstrate a mortality benefit and reported higher complications associated with pvad use, and a fourth RCT was terminated early due to futility. Case series of patients with cardiogenic shock refractory to IABP have reported improved hemodynamic parameters following pvad placement. However, these uncontrolled series cannot determine if pvad improves mortality, and high rates of complications are reported with pvad use. Because of the lack of demonstrated benefits in clinical trials, and the high complication rates reported, the use of pvad for all indications is considered investigational. Policy History Date Action 7/2014 New references added from BCBSA National medical policy. Coding information clarified 6/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015.Coding information clarified 6

8/2013 BCBSA National medical policy review. Policy statement on children amended; age range changed from 5-16 to 0-16. Effective 8/1/2013. 1/2013 Updated to add new CPT codes 33990-33993. 11/2011- Medical policy ICD 10 remediation: Formatting, editing and coding updates. 4/2012 No changes to policy statements. 4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 1/2011 New policy, posted 1/2011. Same information removed from policy #388, Total Artificial Hearts and Ventricular Assist Devices. 4/2010 Reviewed - Medical Policy Group - Cardiology. No changes to policy statements. 4/2009 Reviewed - Medical Policy Group - Cardiology. No changes to policy statements. 4/2008 Reviewed - Medical Policy Group - Cardiology. No changes to policy statements. 4/2007 Reviewed - Medical Policy Group - Cardiology. No changes to policy statements. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References 1. 2008 OPTN/SRTR Annual Report 1998-2007. HHS/HRSA/HSB/DOT. 2. Shuhaiber JH, Jenkins D, Berman M et al. The Papworth experience with the Levitronix CentriMag ventricular assist device. J Heart Lung Transplant 2008; 27(2):158-64. 3. De Robertis F, Birks EJ, Rogers P et al. Clinical performance with the Levitronix Centrimag shortterm ventricular assist device. J Heart Lung Transplant 2006; 25(2):181-6. 4. De Robertis F, Rogers P, Amrani M et al. Bridge to decision using the Levitronix CentriMag shortterm ventricular assist device. J Heart Lung Transplant 2008; 27(5):474-8. 5. Birks EJ, George RS, Hedger M et al. Reversal of severe heart failure with a continuous-flow left ventricular assist device and pharmacological therapy: a prospective study. Circulation 2011; 123(4):381-90. 6. Maybaum S, Mancini D, Xydas S et al. Cardiac improvement during mechanical circulatory support: a prospective multicenter study of the LVAD Working Group. Circulation 2007; 115(19):2497-505. 7. TEC Assessment Program 1996. Ventricular assist devices in bridging to heart transplantation. Volume 11, Tab 26. 8. Goldstein DJ, Oz MC, Rose EA. Implantable left ventricular assist devices. N Engl J Med 1998; 339(21):1522-33. 9. Aaronson KD, Eppinger MJ, Dyke DB et al. Left ventricular assist device therapy improves utilization of donor hearts. J Am Coll Cardiol 2002; 39(8):1247-54. 10. Frazier OH, Rose EA, McCarthy P et al. Improved mortality and rehabilitation of transplant candidates treated with a long-term implantable left ventricular assist system. Ann Surg 1995; 222(3):327-36; discussion 36-8. 11. Bank AJ, Mir SH, Nguyen DQ et al. Effects of left ventricular assist devices on outcomes in patients undergoing heart transplantation. Ann Thorac Surg 2000; 69(5):1369-74; discussion 75. 12. Shuhaiber JH, Hur K, Gibbons R. The influence of preoperative use of ventricular assist devices on survival after heart transplantation: propensity score matched analysis. BMJ 2010; 340:c392. 7

13. Wieselthaler GM, Schima H, Lassnigg AM et al. Lessons learned from the first clinical implants of the DeBakey ventricular assist device axial pump: a single center report. Ann Thorac Surg 2001; 71(3 Suppl):S139-43; discussion S44-6. 14. Frazier OH, Gemmato C, Myers TJ et al. Initial clinical experience with the HeartMate II axial-flow left ventricular assist device. Tex Heart Inst J 2007; 34(3):275-81. 15. John R, Kamdar F, Liao K et al. Improved survival and decreasing incidence of adverse events with the HeartMate II left ventricular assist device as bridge-to-transplant therapy. Ann Thorac Surg 2008; 86(4):1227-34; discussion 34-5. 16. Miller LW, Pagani FD, Russell SD et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 2007; 357(9):885-96. 17. Patel ND, Weiss ES, Schaffer J et al. Right heart dysfunction after left ventricular assist device implantation: a comparison of the pulsatile HeartMate I and axial-flow HeartMate II devices. Ann Thorac Surg 2008; 86(3):832-40; discussion 32-40. 18. Struber M, Sander K, Lahpor J et al. HeartMate II left ventricular assist device; early European experience. Eur J Cardiothorac Surg 2008; 34(2):289-94. 19. Kirklin JK, Naftel DC, Stevenson LW et al. INTERMACS database for durable devices for circulatory support: first annual report. J Heart Lung Transplant 2008; 27(10):1065-72. 20. Starling RC, Naka Y, Boyle AJ et al. Results of the Post-U.S. Food and Drug Administration- Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation: A Prospective Study Using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Journal of the American College of Cardiology 2011; 57(19):1890-98. 21. Alba AC, McDonald M, Rao V et al. The effect of ventricular assist devices on long-term posttransplant outcomes: a systematic review of observational studies. European journal of heart failure 2011; 13(7):785-95. 22. Strueber M, O'Driscoll G, Jansz P et al. Multicenter evaluation of an intrapericardial left ventricular assist system. J Am Coll Cardiol 2011; 57(12):1375-82. 23. Aaronson KD, Slaughter MS, Miller LW et al. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation 2012; 125(25):3191-200. 24. Slaughter MS, Pagani FD, McGee EC et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant 2013; 32(7):675-83. 25. Dickstein K, Cohen-Solal A, Filippatos G et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). European heart journal 2008; 29(19):2388-442. 26. Davies RR, Russo MJ, Hong KN et al. The use of mechanical circulatory support as a bridge to transplantation in pediatric patients: an analysis of the United Network for Organ Sharing database. J Thorac Cardiovasc Surg 2008; 135(2):421-7, 27 e1. 27. Fraser CD, Jr., Jaquiss RD, Rosenthal DN et al. Prospective trial of a pediatric ventricular assist device. N Engl J Med 2012; 367(6):532-41. 28. Almond CS, Morales DL, Blackstone EH et al. Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation 2013; 127(16):1702-11. 29. TEC Assessment Program 2002. Left ventricular assist devices as destination therapy for end-stage heart failure. Volume 17, Tab 19. 30. Rose EA, Gelijns AC, Moskowitz AJ et al. Long-term mechanical left ventricular assistance for endstage heart failure. N Engl J Med 2001; 345(20):1435-43. 31. Park SJ, Tector A, Piccioni W et al. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005; 129(1):9-17. 32. Long JW, Kfoury AG, Slaughter MS et al. Long-term destination therapy with the HeartMate XVE left ventricular assist device: improved outcomes since the REMATCH study. Congest Heart Fail 2005; 11(3):133-8. 33. Rogers JG, Butler J, Lansman SL et al. Chronic Mechanical Circulatory Support for Inotrope- Dependent Heart Failure Patients Who Are Not Transplant CandidatesResults of the INTrEPID Trial. Journal of the American College of Cardiology 2007; 50(8):741-47. 8

34. Slaughter MS, Rogers JG, Milano CA et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009; 361(23):2241-51. 35. Nativi JN, Drakos SG, Kucheryavaya AY et al. Changing outcomes in patients bridged to heart transplantation with continuous- versus pulsatile-flow ventricular assist devices: an analysis of the registry of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant 2011; 30(8):854-61. 36. Pruijsten RV, Lok SI, Kirkels HH et al. Functional and haemodynamic recovery after implantation of continuous-flow left ventricular assist devices in comparison with pulsatile left ventricular assist devices in patients with end-stage heart failure. European journal of heart failure 2012; 14(3):319-25. 37. Lim KM, Constantino J, Gurev V et al. Comparison of the effects of continuous and pulsatile left ventricular-assist devices on ventricular unloading using a cardiac electromechanics model. J Physiol Sci 2012; 62(1):11-9. 38. Kato TS, Chokshi A, Singh P et al. Effects of continuous-flow versus pulsatile-flow left ventricular assist devices on myocardial unloading and remodeling. Circ Heart Fail 2011; 4(5):546-53. 39. Ventura PA, Alharethi R, Budge D et al. Differential impact on post-transplant outcomes between pulsatile- and continuous-flow left ventricular assist devices. Clin Transplant 2011; 25(4):E390-5. 40. Copeland JG, Smith RG, Arabia FA et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004; 351(9):859-67. 41. Copeland JG, Copeland H, Gustafson M et al. Experience with more than 100 total artificial heart implants. J Thorac Cardiovasc Surg 2012; 143(3):727-34. 42. FDA information: AbioCor clinical results. http://www.accessdata.fda.gov/cdrh_docs/pdf4/h040006b.pdf. Last Accessed 8/10/2010. Last accessed 8/10/2010. 43. Dowling RD, Gray LA, Jr., Etoch SW et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg 2004; 127(1):131-41. 44. Burkhoff D, Cohen H, Brunckhorst C et al. A randomized multicenter clinical study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional therapy with intraaortic balloon pumping for treatment of cardiogenic shock. American heart journal 2006; 152(3):469 e1-8. 45. Seyfarth M, Sibbing D, Bauer I et al. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol 2008; 52(19):1584-8. 46. Thiele H, Sick P, Boudriot E et al. Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock. Eur Heart J 2005; 26(13):1276-83. 47. Cheng JM, den Uil CA, Hoeks SE et al. Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock: a meta-analysis of controlled trials. Eur Heart J 2009; 30(17):2102-8. 48. Griffith BP, Anderson MB, Samuels LE et al. The RECOVER I: A multicenter prospective study of Impella 5.0/LD for postcardiotomy circulatory support. J Thorac Cardiovasc Surg 2012. 49. Kar B, Gregoric ID, Basra SS et al. The percutaneous ventricular assist device in severe refractory cardiogenic shock. J Am Coll Cardiol 2011; 57(6):688-96. 50. Dixon SR, Henriques JP, Mauri L et al. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC. Cardiovascular interventions 2009; 2(2):91-6. 51. O'Neill WW, Kleiman NS, Moses J et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation 2012; 126(14):1717-27. 52. Sjauw KD, Konorza T, Erbel R et al. Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry. J Am Coll Cardiol 2009; 54(25):2430-4. 53. Maini B, Naidu SS, Mulukutla S et al. Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: the USpella Registry. Catheter Cardiovasc Interv 2012; 80(5):717-25. 54. Yancy CW, Jessup M, Bozkurt B et al. 2013 ACCF/AHA Guideline for the Management of Heart FailureA Report of the American College of Cardiology Foundation/American Heart Association 9

Task Force on Practice Guidelines. Journal of the American College of Cardiology 2013; 62(16):e147-e239. 55. Peura JL, Colvin-Adams M, Francis GS et al. Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association. Circulation 2012; 126(22):2648-67. 56. Lindenfeld J, Albert NM, Boehmer JP et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010; 16(6):e1-194. 57. Dickstein K, Vardas PE, Auricchio A et al. 2010 Focused Update of ESC Guidelines on device therapy in heart failure: an update of the 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association. Eur Heart J 2010; 31(21):2677-87. 10