a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    The Impella or Tandem Heart pump can temporarily improve blood output from the heart through an externally introduced catheter. This technology has limited use for patients with low heart output who are having high-risk heart procedures or with shock after a heart attack or heart surgery (that has not responded to the usual measures).  Any use beyond this is experimental. It is not intended for routine heart surgeries or for routine resuscitation.

2)    All claims involving the use of Impella or Tandem Heart pumps will be reviewed for appropriateness. These are disposable supplies and should not be coded as implants or DME. Any experimental use will not be covered.

3)    Any elective use of Impella that does not have a signed informed consent, documenting discussion of potential increased risk of complications (compared to intra-aortic balloon pump) will not be covered.

QualChoice considers a FDA-approved percutaneous left ventricular assist device (pVAD) (e.g., the TandemHeart and the Impella) medically necessary for the following indications:

1)    As an adjunct to percutaneous coronary intervention (PCI) in the following high-risk patients:

a)    Persons undergoing unprotected left main or last-remaining-conduit PCI with ejection fraction less than 35 %; or

b)    Persons with three vessel disease end diastolic ejection fraction less than 30 %.

2)    Providing short-term circulatory support in cardiogenic shock refractory to vasopressor medications and intra-aortic balloon pump (IABP).

QualChoice considers pVADs experimental and investigational for all other indications because of insufficient evidence in the peer-reviewed literature. This includes the use of pVADs as an adjunct to augment or intensity ACLS or other resuscitation efforts in the face of cardiac arrest or the periarrest period.  There have been no controlled trials studying the early use of pVADs in pericardiac arrest patients or intra-arrest as a bridge to return of spontaneous circulation.

Review of the available research for use of the Impella 2.5 pVAD has resulted in a Hayes “C” rating.  “This rating reflects a low-quality body of evidence suggesting that the Impella 2.5 is at least as effective as an intra-aortic balloon pump in reducing major adverse events during high-risk PCI. This Rating also reflects considerable uncertainty regarding the comparative benefit of the Impella 2.5 versus high-risk PCI without ventricular assist devices (VADs) or with alternative VADs, long-term efficacy and safety, and optimal patient selection criteria.”

Hayes is recognized as a leader in evidence-based rating of medical technologies with the following ratings used to determine appropriate use of technology:

·         A: Established benefit

·         B: Some proven benefit

·         C: Potential but unproven benefit

·         D1: No proven benefit and/or not safe

·         D2: Insufficient evidence

FDA approval of a technology may or may not correlate with the evidence-based Hayes rating.

On 2/14/2018, the FDA expanded indications for Impella 2.5 to include high-risk PCI regardless of LV function.  Unfortunately, there is not universal agreement on what constitutes high-risk PCI (absent reduced LV function).  Therefore, given the lack of a consistent definition for high-risk PCI, the expanded FDA indications do not have clear support in the medical literature and are still considered experimental and investigational. 

Codes Used In This BI:

1)    33990 Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, arterial access only(code revised 01-01-2021)

2)    33991 Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, both arterial and venous access, with transseptal puncture (code revised 01-01-2021)

3)    33992 Removal of percutaneous left heart ventricular assist device, arterial or arterial and venous cannula(s), at separate and distinct session from insertion(code revised 01-01-2021)

4)    33993 Repositioning of percutaneous right or left heart ventricular assist device with imaging guidance at separate and distinct session from insertion (code revised 01-01-2021)

1.    Rajdev S, Krishnan P, Irani A, et al. Clinical application of prophylactic percutaneous left ventricular assist device (TandemHeart) in high-risk percutaneous coronary intervention using an arterial preclosure technique: Single-center experience. J Invasive Cardiol. 2008; 20(2):67-72.

2.    Vranckx P, Meliga E, De Jaegere PP, et al. The TandemHeart, percutaneous transseptal left ventricular assist device: A safeguard in high-risk percutaneous coronary interventions. The six-year Rotterdam experience. EuroIntervention. 2008; 4(3):331-337.

3.    Al-Husami W, Yturralde F, Mohanty G, et al. Single-center experience with the TandemHeart percutaneous ventricular assist device to support patients undergoing high-risk percutaneous coronary intervention. J Invasive Cardiol. 2008; 20(6):319-322.

4.    Vecchio S, Chechi T, Giuliani G, et al. Use of Impella Recover 2.5 left ventricular assist device in patients with cardiogenic shock or undergoing high-risk percutaneous coronary intervention procedures: Experience of a high-volume center. Minerva Cardioangiol. 2008; 56(4):391-399.

5.    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):1584-1588.

6.    Lam K, Sjauw KD, Henriques JP, et al. Improved microcirculation in patients with an acute ST-elevation myocardial infarction treated with the Impella LP2.5 percutaneous left ventricular assist device. Clin Res Cardiol. 2009; 98(5):311-318.

7.    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 Cardiovasc Interv. 2009; 2(2):91-96.

8.    Granfeldt H, Hellgren L, Dellgren G, et al. Experience with the Impella recovery axial-flow system for acute heart failure at three cardiothoracic centers in Sweden. Scand Cardiovasc J. 2009; 43(4):233-239.

9.    Cheng JM, den Uil CA, Hoeks SE, et al. Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counter pulsation for treatment of cardiogenic shock: A meta-analysis of controlled trials. Eur Heart J. 2009; 30(17):2102-2108.

10. Esfandiari S, Erickson L, McGregor M. The Impella percutaneous ventricular assist device. Report No. 37. Montreal, QC: Technology Assessment Unit of the McGill University Health Centre (MUHC); June 16, 2009.

11. Naidu SS. Novel Percutaneous Cardiac Assist Devices. Circulation. 2011;123:533-543

12. O’Neill WW 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 Clinical Perspective—The PROTECT II Study. Circulation. 2012;126:1717-1727

13. Lemaire A, Anderson MB, Lee LY, et al. The Impella device for acute mechanical circulatory support in patients in cardiogenic shock. Ann Thorac Surg. 2014; 97(1):133-138.

14. Hayes Health Technology Brief: Impella 2.5 System (Abiomed Inc.) for Emergent Hemodynamic Support in Patients with Cardiogenic Shock. 9/03/2015

15. Hayes Health Technology Brief: Impella 2.5 System (Abiomed Inc.) for Cardiac Support in Patients Undergoing High-Risk Percutaneous Coronary Intervention (PCI). 10/07/2017.

16. Myat, A, et al. Percutaneous Circulatory Assist Devices for High-Risk Coronary Intervention. JACC: Cardiovascular Interventions. 2015;8(2):229-244.

17. De Silva, Kalpa et al.  Prognostic Utility of BCIS Myocardial Jeopardy Score for Classification of Coronary Disease Burden and Completeness of Revascularization. American Journal of Cardiology, Volume 111, Issue 2, 172 – 177.

18. Sianos G, Morel MA, Kappetein AP, et al. The SYNTAX score: an angiographic tool grading the complexity of CAD. EuroInterv 2005; 1: 219-227.

19. Valgimigli M, Serruys PW, Tsuchida K, et al. Cyphering the complexity of coronary artery disease using the syntax score to predict clinical outcome in patients with three-vessel lumen obstruction undergoing percutaneous coronary intervention. Am J Cardiol 2007 Apr 15;99(8):1072-1081.

20. Amin AA, Spertus JA, Curtis JP, et al. The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support. Circulation. Nov 17, 2019.

21. Dhruva S, Ross JS, Mortazavi B, et al.  Mortality and Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Percutaneous Coronary Intervention With Impella vs Intra-Aortic Balloon Pump.  AHA Scientific Session LBS.04 Nov 17, 2019.

22. Dhruva S, Ross JS, Mortazavi B, et al. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA. 2020; 323(8):734-745.

Addendum:

Effective 4/2/2018: added ‘guidance on proper coding of disposable supplies’.

Effective 8/8/2018:  Recognition of expanded FDA indications for Impella but no change in E/I exclusions.

Effective 8/1/2019:  Added references regarding Syntax and Jeopardy scores to quantify PCI risk.

Effective 3/2/2020: Added references highlighting increased potential risks with Impella and requirement for informed consent documenting discussion of this data.

Effective 1/1/2021: Updated codes 33990, 33991, 33992, 33993.