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DISCLAIMER

This Molina Clinical Policy (MCP) is intended to facilitate the Utilization Management process. It expresses

Molina's determination as to whether certain services or supplies are medically necessary, experimental,

investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a

particular service or supply is medically necessary does not constitute a representation or warranty that this

service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit

plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and

which are subject to dollar caps or other limits. Members and their providers will need to consult the member's

benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or

supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will

govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal

government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS

website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or

Local Coverage Determination (LCD) will supersede the contents of this Molina Clinical Policy (MCP)

document and provide the directive for all Medicare members.1 2

DESCRIPTION OF PROCEDURE/SERVICE/PHARMACEUTICAL 42

Percutaneous ventricular assist devices (pVADs) have been developed for short-term use in patients who

require acute circulatory support. These devices are intended for individuals requiring partial circulatory support

using an extracorporeal; bypass control unit during procedures not requiring cardiopulmonary bypass. These

devices are placed through the femoral artery. Two different pVADs have been developed, the TandemHeart™

(Cardiac Assist™, Pittsburgh, PA), and the Impella® device (AbioMed™, Aachen, Germany). In the

TandemHeart™ system, a catheter is introduced through the femoral artery and passed into the left atrium via

transseptal puncture. Oxygenated blood is then pumped from the left atrium into the arterial system via the

femoral artery. The Impella device is also introduced through a femoral artery catheter. In this device, a small

pump is contained within the catheter that is placed into the left ventricle. Blood is pumped from the left

ventricle, through the device, and into the ascending aorta. Adverse events associated with pVAD include

access site complications such as bleeding, aneurysms, or leg ischemia. Cardiovascular complications can also

occur, such as perforation, myocardial infarction (MI), stroke, and arrhythmias.

The Impella® Recover LP 2.5 Percutaneous Cardiac Support System received FDA 510(k) approval in May

2008 for partial circulatory support using an extracorporeal bypass control unit for periods up to 6 hours. It is

also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not

requiring cardiopulmonary bypass. 3

The TandemHeart® (Cardiac Assist, Pittsburgh) received initial 510(k)

Subject: Percutaneous Ventricular Assist Devices Original Effective Date:

02/27/13

Policy Number:

MCP-132 Revision Date(s): 7/27/2016

Review Date: 12/16/15

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approval for the CardiacAssist TandemHeart pump and controller in 2000 and initial approval for the cannula

set in 2003. Subsequent approvals were issued for an updated cannula set and an updated controller in 2006.The

TandemHeart is intended to be used for partial circulatory support using an extracorporeal bypass control unit

for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6

hours) during procedures not requiring cardiopulmonary bypass.4

The Impella 5.0 Catheter Family received

510(k) substantial equivalence clearance on April 16, 2009. The IMPELLA 5.0 Catheters are intended for

circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also

intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring

cardiopulmonary bypass. 5

INITIAL COVERAGE CRITERIA 1-5 37-43

The Percutaneous Ventricular Assist Devices (pVAD) may be authorized when all of the following criteria are

met: [ALL]

The pVAD must be an FDA approved device (e.g., TandemHeart® System, Impella Recover®

LP 2.5 Percutaneous Cardiac Support System, and Impella Recover® LP 5.0 Percutaneous

Cardiac Support System); and

For partial circulatory support short term use (up to 6 hours) for any of the following clinical

indications: [ONE]

o ST segment elevation myocardial infarction (STEMI) when unable to be stabilized with

pharmacological therapy

o Refractory cardiogenic shock

o As an adjunct to PCI in carefully selected high-risk patients: [ONE]

undergoing unprotected left main or last-remaining patent conduit PCI;

severely depressed ejection fraction (< 35%) undergoing PCI of a vessel

supplying a large territory;

three vessel disease with ejection fraction < 30%;

presence of cardiogenic shock

CONTINUATION OF THERAPY

The Percutaneous Ventricular Assist Devices (pVAD) may only be used short term (for up to 6 hours).

COVERAGE EXCLUSIONS 1-5

The Percutaneous Ventricular Assist Device (pVAD) is contraindicated when any of the following conditions

are present:

Ventricular Septal Defect (VSD)

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Right Ventricular Failure

Known hemoglobin diseases such as sickle cell or thalassemia

Mural thrombus in LV (Impella)

Peripheral arterial disease (TandemHeart)

SUMMARY OF MEDICAL EVIDENCE 6-34

Cardiogenic Shock

Kar and colleagues (2011) sought to evaluate the efficacy and safety of the percutaneous ventricular assist

device (pVAD) in patients in severe refractory cardiogenic shock (SRCS) despite intra-aortic balloon pump

(IABP) and/or high-dose vasopressor support. A total of 117 patients with SRCS implanted with TandemHeart

pVAD (CardiacAssist, Inc., Pittsburgh, Pennsylvania) were studied, of whom 56 patients (47.9%) underwent

active cardiopulmonary resuscitation immediately before or at the time of implantation. Data was collected

regarding clinical characteristics, hemodynamics, and laboratory values. Eighty patients had ischemic and 37

patients had nonischemic cardiomyopathy. The average duration of support was 5.8 ± 4.75 days. After

implantation, the cardiac index improved from median 0.52 (interquartile range [IQR]: 0.8) l/(min•m(2)) to 3.0

(IQR:0.9) l/(min•m(2)) (p < 0.001). The systolic blood pressure and mixed venous oxygen saturation increased

from 75 (IQR:15) mm Hg to 100 (IQR:15) mm Hg (p < 0.001) and 49 (IQR:11.5) to 69.3 (IQR:10) (p < 0.001),

respectively. The urine output increased from 70.7 (IQR: 70) ml/day to 1,200 (IQR: 1,620) ml/day (p < 0.001).

The pulmonary capillary wedge pressure, lactic acid level, and creatinine level decreased, respectively, from

31.53 ± 10.2 mm Hg to 17.29 ± 10.82 mm Hg (p < 0.001), 24.5 (IQR: 74.25) mg/dl to 11 (IQR: 92) mg/dl (p <

0.001), and 1.5 (IQR: 0.95) mg/dl to 1.2 (IQR: 0.9) mg/dl (p = 0.009). The mortality rates at 30 days and 6

months were 40.2% and 45.3%, respectively. The authors concluded that the pVAD rapidly reversed the

terminal hemodynamic compromise seen in patients with SRCS refractory to IABP and vasopressor support. 17

Cheng and colleagues (2009) performed a meta-analysis of controlled trials to evaluate potential benefits of

percutaneous LVAD on haemodynamics and 30-day survival. Two independent investigators searched Medline,

Embase, and Cochrane Central Register of Controlled Trials for all controlled trials using percutaneous LVAD

in patients with cardiogenic shock, where after data were extracted using standardized forms. Weighted mean

differences (MDs) were calculated for cardiac index (CI), mean arterial pressure (MAP), and pulmonary

capillary wedge pressure (PCWP). Relative risks (RRs) were calculated for 30-day mortality, leg ischaemia,

bleeding, and sepsis. In main analysis, trials were combined using inverse-variance random effects approach.

Two trials evaluated the TandemHeart and a recent trial used the Impella device. After device implantation,

percutaneous LVAD patients had higher CI (MD 0.35 L/min/m(2), 95% CI 0.09-0.61), higher MAP (MD 12.8

mmHg, 95% CI 3.6-22.0), and lower PCWP (MD -5.3 mm Hg, 95% CI -9.4 to -1.2) compared with IABP

patients. Similar 30-day mortality (RR 1.06, 95% CI 0.68-1.66) was observed using percutaneous LVAD

compared with IABP. No significant difference was observed in incidence of leg ischaemia (RR 2.59, 95% CI

0.75-8.97) in percutaneous LVAD patients compared with IABP patients. Bleeding (RR 2.35, 95% CI 1.40-

3.93) was significantly more observed in TandemHeart patients compared with patients treated with IABP. The

authors concluded that although percutaneous LVAD provides superior haemodynamic support in patients with

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cardiogenic shock compared with IABP, the use of these more powerful devices did not improve early survival.

These results do not yet support percutaneous LVAD as first-choice approach in the mechanical management of

cardiogenic shock. 18

Seyfarth et al. (2008) performed a controlled study of the Impella Recover LP 2.5. This study was a randomized

controlled trial that evaluated the Impella Recover LP 2.5 for treatment of cardiogenic shock rather than as a

support during high-risk PCI. A total of 26 patients who had cardiogenic shock due to acute MI were enrolled

(19 men, 7 women; median age 66 years; mean cardiac output 3.3 L/min; mean cardiac index 1.7 L/min/m2)

and they were assigned to equal-sized treatment groups that underwent cardiac assistance with an Impella

device for a median of 25 hours (range 6-41) or an IABP device for a median of 23 hours (range 14-34). There

were no statistically significant differences between the Impella and IABP Groups at baseline. Although 1 (8%)

Impella Group patient died before device implantation, this patient was retained in the study since results were

analyzed on an intent-to-treat basis. Shortly after implantation, a statistically significant improvement was seen

in diastolic arterial pressure for the Impella Group (74 ± 17 mm Hg) versus the IABP Group (50 ± 16 mm Hg)

(P=0.002); however, due to hemolysis, the Impella device was associated with statistically significant increases

in free hemoglobin at 1, 6, 12, and 24 hours, which exceeded 40 mg/dL at peak (P<0.05). At 30 minutes after

implantation, mean cardiac index had increased 0.5 ± 0.5 L/min/m2 for the Impella Group versus 0.1 ± 0.3

L/min/m2 for the IABP Group. Although this difference was statistically significant (P=0.02), by 4 hours, the

difference in mean cardiac index had disappeared. Likewise, the Impella Group had a statistically significant

increase in cardiac power index at 30 minutes but not at 2, 4, 6, 14, or 22 hours. In addition, there were no

significant differences between the Impella and IABP Groups in mean cardiac output, arterial pressure, systolic

arterial pressure, pulmonary capillary wedge pressure, right atrial pressure, systemic vascular resistance, serum

lactate concentrations, multiple organ dysfunction scores, or sepsis-related organ failure scores. Mortality after

30 days was 46% for both the Impella and IABP Groups. 6

The prospective, randomized multicenter study by Burkhoff and colleagues (2006) compared the safety and

efficacy of the TandemHeart System with that of IABP in patients with cardiogenic shock (CS). The aim of this

prospective randomized study was to test the hypothesis that the TandemHeart (pVAD) provides superior

hemodynamic support compared with intraaortic balloon pumping (IABP). Forty-two patients from 12 centers

presenting within 24 hours of developing CGS were included in the study and treated in an initial roll-in phase

(n = 9) or randomized to treatment with IABP (n = 14) or TandemHeart pVAD (n = 19). Thirty patients (71%)

had persistent CGS despite having an IABP in place at the time of study enrollment. Cardiogenic shock was due

to myocardial infarction in 70% of the patients and decompensated heart failure in most of the remaining

patients. The mean duration of support was 2.5 days. Compared with IABP, the TandemHeart pVAD achieved

significantly greater increases in cardiac index and mean arterial blood pressure and significantly greater

decreases in pulmonary capillary wedge pressure. Overall 30-day survival and severe adverse events were not

significantly different between the 2 groups. In conclusion, in patients presenting within 24 hours of the

development of CGS, TandemHeart significantly improves hemodynamic parameters, even in patients failing

IABP. Larger-scale studies are required to assess the influence of improved hemodynamics on survival. 13

Burkhoff et al (2006) completed another study to investigate the feasibility, safety, and hemodynamic impact of

the TandemHeart percutaneous left ventricular assist device (pVAD) in CGS. Thirteen patients from five

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centers in the US with the diagnosis of CGS were enrolled in the study. Hemodynamic measurements, including

cardiac index (CI), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP), and central

venous pressure (CVP) were performed presupport, during support and after device removal. Patients were

monitored for 6 months. The pVAD was successfully implanted in all 13 patients, with duration of support

averaging 60 +/- 44 hr. During support, CI increased from 2.09 +/- 0.64 at baseline to 2.53 +/- 0.65 (P = 0.02),

MAP increased from 70.6 +/- 11.1 to 81.7 +/- 14.6 (P = 0.01), PCWP decreased from 27.2 +/- 12.2 to 16.5 +/-

4.8 (P = 0.01), and CVP from 12.9 +/- 3.7 to 12.6 +/- 3.6 (P = NS). Ten patients survived to device explant, 6 of

who were bridged to another therapy. Seven patients survived to hospital discharge and were all alive at 6

months. The two most common adverse events were distal leg ischemia (n = 3) and bleeding from the

cannulation site (n = 4). In summary, the TandemHeart PTVA System may be a useful complementary

treatment for patients with CGS, especially as a bridge to another treatment. Further study is needed to

definitively establish safety and efficacy. 24

Complex Cardiovascular Procedures

Tempelhof et al (2011) presented the clinical outcomes and safety associated with the use of TandemHeart

among a series of heterogeneous patients requiring PVAD support. They reviewed the clinical experience,

hemodynamic variables, survival outcomes, and complications associated with the implantation of

TandemHeart support device among 25 patients presenting at one institution. Indications for PVAD

implantation were cardiogenic shock (56%), ST-segment elevation myocardial infarction (STEMI) (20%),

postpericardiotomy (16%), and high-risk percutaneous coronary interventions (PCI) or ventricular tachycardia

(VT) ablation (8%). TandemHeart was used for an average of 4.8 ± 2.1 days and demonstrated significant

hemodynamic improvements (pre- and postimplantation left ventricular ejection fractions were 21.5% ± 15%

and 24.5% ± 10.5%, respectively [p = 0.06]). The cardiac index improved from a mean 2.04 ± 075 L/min/m² to

2.45 ± 073 L/min/m² (p = 0.09). The mixed venous oxygen saturation (SVO2) increased from 55.14 ± 13.34 to

66.43 ± 7.43 (p = 0.008) after implantation. TandemHeart was used as a bridge to left ventricular assist device

implantation (44%) or recovery (20%). Thirty-six percent of patients died on support or shortly after PVAD

removal. Thirty, 90-day, and long-term (>90 days) survival rates were 56%, 52%, and 36%, respectively.

Procedure-related complications were reported in 13 patients (56%), and the majority (90%) was related to

vascular access (bleeding or pseudoaneurysm). The authors concluded the TandemHeart device is a safe

therapeutic option as a bridge-to-recovery or bridge-to-bridge for patients with hemodynamic compromise

regardless of the etiology. The favorable hemodynamic profile, postimplantation survival rates, and manageable

complications support its use to assist hemodynamic recovery in patient’s refractory to conventional therapy. 20

Thomas et al (2010) sought to describe the use of the TandemHeart percutaneous left ventricular assist device

(PVAD) in a group of high-risk patients undergoing complex cardiovascular procedures. Thirty-seven high-risk

patients underwent placement of the TandemHeart PVAD during 38 separate procedures between April 2007

and April 2009. PVAD insertion was considered emergent if a patient was not expected to survive more than 6

hours without PVAD support. Technical success was defined as successful initiation of the PVAD and

completion of the intended interventional procedure. All 37 patients were in cardiogenic shock or undergoing

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complex coronary and valvular interventions with a high probability of hemodynamic collapse. The mean (+/-

standard deviation) patient age was 73 +/- 14 years; 97% were in either NYHA class III-IV heart failure or

cardiogenic shock; and the mean EuroSCORE was 11 +/- 3.4. Indications for ventricular assist device

placement included critical aortic stenosis (n = 8), severe left main coronary stenosis (n = 18), severe

multivessel coronary stenosis (n = 19) and severe cardiomyopathy (n = 23). Four patients were being managed

for fulminant myocarditis, ventricular free-wall rupture, flail mitral valve or severe paravalvular leak. Despite

their critical status and frequent (82%) need for post-procedure blood transfusion, this complex and high-risk

patient population tolerated PVAD-supported intervention well and technical success was achieved in all

patients. Seventy-one percent of patients survived to hospital discharge with improved functional status. Most

deaths occurred in patients not expected to survive due to their moribund status and multiorgan failure.

Investigators concluded this experience demonstrated the utility and effectiveness of TandemHeart PVAD

support in patients with advanced disease, critical clinical status and limited therapeutic options. 28

Percutaneous coronary intervention (PCI)

O’Neill and colleagues (2012) published the results of the PROTECT II study. This was a randomized clinical

trial hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk

percutaneous coronary intervention. 452 symptomatic patients with complex 3-vessel disease or unprotected left

main coronary artery disease and severely depressed left ventricular function were randomly assigned to intra-

aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk

percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events.

A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in

comparison with IABP, with maximal decrease in cardiac power output from baseline of -0.04±0.24 W in

comparison with -0.14±0.27 W for IABP (P=0.001). The primary end point (30-day major adverse events) was

not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P=0.227 in the intent-

to-treat population and 34.3% versus 42.2%, P=0.092 in the per protocol population. At 90 days, a strong trend

toward decreased major adverse events was observed in Impella 2.5-supported patients in comparison with

IABP: 40.6% versus 49.3%, P=0.066 in the intent-to-treat population and 40.0% versus 51.0%, P=0.023 in the

per protocol population, respectively. The authors concluded that the 30-day incidence of major adverse events

was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved

outcomes were observed for Impella 2.5-supported patients at 90 days. 14

Kovacic et al. (2015) evaluated the efficacy of Impella 2.5 compared with IABP in a subgroup of 325 patients

with 3-vessel CAD and LVEF £ 30% in an analysis of the PROTECT II study. Results of this preplanned

subgroup analysis of the PROTECT II study suggests that use of Impella 2.5 compared with IABP seems to

reduce the composite incidence of MAE at 90 days, but not at 30 days. 30

Shah et al (2012) investigated seventy-four consecutive patients undergoing high-risk PCI and those with

cardiogenic shock (CS) receiving intraaortic balloon pump (IABP), TandemHeart (TH), or Impella device

(IMP) were enrolled. Patient undergoing high-risk PCI (n=57) and those treated for CS (n=17) were analyzed as

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separate cohorts. Patients undergoing IABP-assisted PCI were compared to those undergoing PLVAD (TH and

IMP)-assisted PCI. The primary end point was in-hospital major adverse cardiovascular events, and the

secondary end point was in-hospital vascular complications. For the high-risk PCI cohort (n=57), 22 received

PLVAD and 35 received IABP. Patients receiving IABP were younger and less likely to have a prior

myocardial infarction (MI) and less likely to be on dialysis compared to those receiving PLVAD support.

Patients receiving PLVAD support had a higher baseline Syntax score, had a higher prevalence of unprotected

left main disease, underwent treatment of more coronary lesions, received more coronary stents, and more likely

received drug-eluting stents compared to those receiving IABP support. The primary and secondary end points

were similar between both groups. For the CS cohort (n=17), 4 received PLVAD and 13 received IABP.

Patients receiving PLVAD support were more likely to have a prior MI, had a lower ejection fraction,

underwent treatment of more coronary lesions, and received more coronary stents compared to those receiving

IABP support. The primary and secondary end points were similar between both groups. Investigators

concluded IABP compared with PLVAD use for high-risk PCI and CS is associated with significantly different

baseline patient, clinical, procedural, and angiographic characteristics. In-hospital clinical outcome was similar

between both groups in both the high-risk PCI and the CS cohorts. When physicians have access to each of

these devices, short-term clinical outcome appears to be similar. 23

Maini and colleagues (2012) reported on a multicenter experience of the Impella 2.5 circulatory support system

during high-risk PCI, a subset of the larger USpella Registry. 175 consecutive patients who underwent high-risk

PCI with prophylactic support of the Impella 2.5 were evaluated. The primary safety endpoint was the incidence

of major adverse cardiac events (MACE) at 30 days. Secondary endpoints included safety and efficacy related

to the device and patient outcomes, including survival at 12 months. Overall angiographic revascularization was

successful in 99% of patients and in 90% of those with multivessel revascularization, resulting in a reduction of

the mean SYNTAX score post-PCI from 36 ± 15 to 18 ± 15 (P < 0.0001) and an improvement of the ejection

fraction (from 31 ± 15% to 36 ± 14%, P < 0.0001). In 51% of patients, the functional status improved by one or

more NYHA class (P < 0.001). At 30-day follow-up, the rate of MACE was 8%, and survival was 96%, 91%,

and 88% at 30 days, 6 months, and 12 months, respectively. The use of Impella 2.5 in high-risk PCI appeared

feasible and safe in the real-world setting. The utilization of the Impella 2.5 was successful, resulting in

favorable short- and midterm angiographic, procedural and clinical outcomes. 26

Alli and colleagues (2012) performed a retrospective cross-sectional analysis of prospectively collected data in

54 patients undergoing high-risk PCI using the TandemHeart device for support. Hemodynamic and clinical

data were collected and analyzed. Baseline clinical characteristics were: mean age 72 ± 1.7 years, males 78%,

median ejection fraction 20%, mean serum creatinine 1.6 ± 0.3 2 mg/dL, recent myocardial infarction 52%,

COPD 33%, previous CABG 50%, diabetes mellitus 41%, and hypertension 83%. The median SYNTAX score

was 33, and the median Jeopardy score was 10. The predicted surgical revascularization mortality was 13% by

the Society for Thoracic Surgery risk score and 33% by Euroscore. There was a significant decrease in right and

left heart pressures (P < 0.05) with a concomitant increase in the cardiac output from 4.7 to 5.7 L/min (P = 0.03)

during TandemHeart support. Left main and multivessel PCI was performed in 62% of patients, and rotablation

was used in 48%. Procedural success rate was 97%, whereas 30-day and 6 month survival were 90% and 87%,

respectively. Major vascular complications occurred in 13% of cases. None of our patients developed contrast

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induced nephropathy or needed dialysis. The authors concluded that high-risk PCI with percutaneous left

ventricular support using TandemHeart is a viable therapeutic strategy for a select subset of patients at very

high risk with standard percutaneous revascularization techniques. 19

Kovacic et al (2011) compared the practical use, safety and clinical outcomes associated with the TandemHeart

(TH) versus Impella Recover 2.5 (IR2.5) devices when used for circulatory support during high-risk

percutaneous coronary intervention (PCI), noting these P-LVADs differ markedly in their insertion, operation

and manner of circulatory augmentation. Investigators identified 68 patients (49 males, 19 females; age

71.1±12.1 years) from a single-center database that underwent 'high-risk' PCI with P-LVAD support from

04/2005-06/2010 (32 with TH, 36 with IR2.5). Relevant data were extracted and imputed for analysis. Baseline

demographics were similar, including low LVEF (overall mean 31.0±13.7%) and elevated STS mortality risk

score (4.2±3.7%). Angiographic characteristics were also similar, with a mean of 2.4±1.0 lesions treated per

patient, and 29% undergoing left main PCI. PCI success rates were 99% in both groups, with similar in-hospital

outcomes and a combined 7% major vascular access site complication rate. A single episode of left atrial

perforation occurred during TH use. No patient required emergent CABG and no in-hospital deaths occurred.

The 30 day MACE rate (death, myocardial infarction, target lesion revascularization) was 5.8%. There were no

differences between the IR2.5 and TH groups with respect to short- or long-term clinical outcomes.

Investigators concluded the IR2.5 and TH assist devices are safe, equally effective, and associated with

acceptable short- and long-term clinical outcomes in patients undergoing 'high-risk' PCI. 16

Schwartz and colleagues (2011) performed a retrospective study to determine the baseline characteristics,

hemodynamics, and outcomes of patients treated with prophylactic percutaneous left ventricular assist devices

(PLVADs) during HR-PCI. Fifty cases were identified (5 IABP, 13 Impella, 32 TandemHeart). Mean ejection

fraction was 31 ± 17%. All devices (100%) were initiated successfully. Angiographic success was achieved in

96% (80% IABP, 100% Impella, 97% TandemHeart). Of the 38 patients not in cardiogenic shock, death

occurred in 1 (2.6%), recurrent ischemia in 3 (8%), and stroke in 0%. Shortly after device removal, systolic

blood pressure (mean increase, +5 ± 22 mmHg) and ejection fraction (mean increase, +7.4 ± 11%; p = 0.0006)

increased in all 3 groups, suggesting a beneficial effect on the myocardium. In patients undergoing HR-PCI

with Impella and TandemHeart support, angiographic success was high and major complication rates were low.

The authors concluded that a tiered approach where patients with the least, intermediate, and highest risk of left

ventricular failure are treated with an IABP, Impella, or Tandem- Heart, respectively, theoretically maximizes

appropriate hemodynamic support and minimizes complications. 27

Dixon et al. (2009) conducted an uncontrolled study of the Impella Recover LP 2.5 and it enrolled 20 patients

(17 men, 3 women; mean age 60 years; mean left ventricular ejection fraction [LVEF] 26%) who underwent

cardiac support during high-risk PCI. The mean duration of pump use was 1.7 hours (range 0.4-2.5) and during

this time, a mean of 2.4 lesions were treated. Pump implantation and operation was successful in all patients and

all patients had successful PCI procedures. During the procedures, 2 (10%) patients had MI without clinical

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sequelae and 2 (10%) other patients died on days 12 and 14 after treatment. Neither death was attributed to use

of the Impella device and no patients developed ventricular fibrillation or ventricular tachycardia during or

within a week after pump use. In addition, echocardiography in 16 (80%) of the patients indicated that no aortic

or mitral valve damage occurred during pump use. 7

Vranckx and colleagues (2009) retrospectively evaluated the short-term safety and efficacy of the TandemHeart

percutaneous transseptal left ventricular assist (PTVA) system to deliver extracorporeal circulatory support

during catheter based treatment of the unprotected left main coronary artery (ULMCA). Between July 2002 and

May 2008 the TandemHeart was used in 9 very high risk patients (Logistic Euro score: 13.64 (7.46-29.67);

Syntax score:43 (41-50); Mayo Clinic Risk score (MCRS) 7 (6-8); age: median 65 (range 55-71) undergoing

elective PCI for the novo lesions on the ULMCA. All patients were declined for CABG by a heart team. A

''true'' percutaneous insertion technique was used in all patients, technical success rate was 100%. The median

(range) time for implementation of circulatory support was 27 min (24-30). A median (range) pump flow up to

4.36 (3.40-5.54) L/min was achieved with significant reduction of left ventricular filling pressures, pulmonary

capillary wedge pressure and a small increase of systemic arterial pressures. Median (range) duration of support

was 93 min (50.4-102). Successful weaning was achieved in all patients. There was no in hospital death,

survival at 6 months was (89%), whereas vascular access site complications were seen in 4 patients (44.4%).

The authors concluded that in very high risk PCI, assisted circulation using the TandemHeart-PTVA provides

effective, total left ventricular support and may contribute to a reduced procedural risk and improved survival.

The rate of device related cardiac and vascular complications was acceptable. 22

In another small case series, Vranckx and colleagues (2008) published the results of 23 patients undergoing PCI

who were supported with the TandemHeart between September 2000 to July 2006. The TandemHeart,

supported the circulation of 23 patients (age: range 46-74, mean 59) admitted to our center for high risk, either

emergency or elective, PCI. Successful implantation was achieved in 100% of patients. The mean time for

implementation of circulatory support was 35 minutes (range 16-62). The index PCI was successful in all

patients except two. A pump flow up to 4L/min was achieved with significant reduction of left ventricular

filling pressures, pulmonary capillary wedge pressure and with significant increase of systemic arterial

pressures. Duration of support ranged from 1-222 hours (mean 31+/-49.8 hours). Five patients died with the

TandemHeart in place, four of whom were in irreversible cardiogenic shock at admission. Mild to moderate

access site bleeding was seen in 27% of patients. One patient experienced a loge syndrome of the leg. Core

temperature (Ct) decreased to <36.5 degrees C in six patients, profound hypothermia (Ct <35 degrees C) was

observed in two patients. There was no technical device failure. The authors concluded that the TandemHeart -

PTVA provides effective, total left ventricular support in very high risk PCI settings. The rate of device related

cardiac and vascular complications was acceptable. 21

Another small uncontrolled study of the Impella Recover LP 2.5 was conducted by Burzotta et al. (2008). This

study enrolled 10 male patients (mean age 64 ± 9 years, mean LVEF 31% ± 8%) who underwent high-risk PCI.

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Impella device implantation was successful and no complications arose except in 1 (10%) patient who died a

few hours after PCI due to acute stent thrombosis. The other 9 (90%) patients were all discharged ≤ 5 days after

treatment. At 10 months follow-up, LVEF had increased from 31% ± 7% to 41% ± 13% (P=0.02) and during

the 12 months following treatment, 2 (20%) patients required a second PCI. 10

Remmelink et al. (2007) conducted a smaller study that may partially or completely overlap with the 2006 study

by Henriques et al. described below. The study enrolled 11 patients (7 men, 4 women; mean age 67 ± 9 years;

mean LVEF 35% ± 11%) who underwent high-risk PCI. During use of the Impella device, statistically

significant 6% to 48% improvements were observed in mean aortic pressure, distal coronary pressure, peak

flow velocity, coronary flow velocity reserve, and coronary microvascular resistance. However, this study did

not report outcomes of the PCI procedures. 9

An earlier uncontrolled study of the Impella Recover LP 2.5 for cardiac support was performed by Henriques et

al. (2006) and it enrolled 19 patients, most of whom underwent high-risk PCI. All patients were elderly with 16

(84%) aged > 60 years (mean age was not reported), 14 (74%) had prior MI, 12 (63%) had LVEF ≤ 25%, and

all had LVEF ≤ 40%. In 17 (89%) patients, the Impella device was used during elective PCI and in the other 2

(11%) patients, it was used for urgent PCI or as a last resort cardiac support. Implantation of the Impella device

was successful in all patients; however, the latter 2 patients died 1 day after the procedure. Echocardiography or

angiography in 12 (63%) patients indicated that there were no appreciable changes in aortic valve regurgitation

after treatment and no other significant device-related adverse events occurred. 8

Valgimigli et al. (2006) performed an uncontrolled study16 that evaluated use of the Impella Recover LP 2.5

during high-risk PCI in 10 patients (mean age 62 ± 10 years, mean LVEF 37% ± 16%). The Impella device was

used for a mean of 144 ± 88 minutes. Before and at several time points up to 48 hours after device use, the

following biomarkers were measured: free Hemoglobin (fHb), B-type natriuretic peptide, catecholamines,

aldosterone, angiotensin II, and endothelin. No substantial changes were observed in these biomarkers except

for fHb, which temporarily increased 2-fold to 14-fold above the normal upper limit in 4 (40%) patients.

Although this observation suggests that the Impella device causes variable levels of hemolysis, the results did

not report whether the increase in fHb was statistically significant compared with baseline. A substantial change

was also seen in left ventricular volume loading, which increased acutely in 6 (60%) patients after device

insertion and tended to remain elevated even at the highest pump speed. Volume loading appeared to neutralize

the blood pumping action of the Impella Recover LP 2.5; however, these findings were reported in pressure-

volume graphs without quantitating the magnitude of the effect. 11

Professional Organizations 37-41

The 2015 Society for Cardiovascular Angiography and Interventions / American College of Cardiology / Heart

Failure Society of America / Society for Thoracic Surgeons (SCAI/ACC/HFSA/STS) consensus statement on

the use of percutaneous mechanical circulatory support (MCS) states that percutaneous MCS, particularly with

the Impella and TandemHeart, is superior to pharmacologic therapy for providing hemodynamic support and

these devices should be available and reimbursed (Rihal et al., 2015). One of the suggested indications for

Page 11 of 15

percutaneous MCS is for patients undergoing high-risk PCI, especially if the patient is inoperable or has a low

LVEF (< 20% to 30%) and complex CAD involving a large territory (i.e., sole remaining vessel, left main

disease, or 3-vessel disease). 39

ACCF/AHA/SCAI guideline for percutaneous coronary artery intervention. A report of the American College

of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for

Cardiovascular Angiography and Interventions indicates that elective insertion of an appropriate percutaneous

hemodynamic support device as an adjunct to PCI may be reasonable in carefully selected high-risk patients. 37

CODING INFORMATION: THE CODES LISTED IN THIS POLICY ARE FOR REFERENCE PURPOSES ONLY. LISTING OF A SERVICE OR

DEVICE CODE IN THIS POLICY DOES NOT IMPLY THAT THE SERVICE DESCRIBED BY THIS CODE IS COVERED OR NON-COVERED. COVERAGE

IS DETERMINED BY THE BENEFIT DOCUMENT. THIS LIST OF CODES MAY NOT BE ALL INCLUSIVE.

CPT Description

33990 Insertion of ventricular assist device, percutaneous including radiological supervision and

interpretation; arterial access only

33991 Insertion of ventricular assist device, percutaneous including radiological supervision and

interpretation; both arterial and venous access, with transseptal puncture

33992 Removal of percutaneous ventricular assist device at separate and distinct session from insertion

HCPCS Description

N/A

ICD-9 Description: [For dates of service prior to 10/01/2015]

37.68 Insertion of percutaneous external heart assist device

410.00-411.89 Acute myocardial infarction and other acute and subacute forms of ischemic heart disease

414.00-414.07 Coronary atherosclerosis

428.0- 428.9 Heart failure

785.51 Cardiogenic shock

ICD-10 Description: [For dates of service on or after 10/01/2015]

I20-I25.9 Ischemic Heart Disease

I50-I50.9 Heart Failure

R57.0 Cardiogenic shock

RESOURCE REFERENCES

Government Agency

1. Centers for Medicare & Medicaid Services (CMS) [website]. Percutaneous Ventricular Assist Device.

LCD L31518 Mac Part A. Revised 12/31/12. Accessed at: http://www.cms.gov/medicare-coverage-

database/

2. Centers for Medicare & Medicaid Services (CMS) [website]. Percutaneous Ventricular Assist Device.

LCD L31518 Mac Part B. Revised 12/31/12. Accessed at: http://www.cms.gov/medicare-coverage-

database/

Page 12 of 15

3. Food and Drug Administration (FDA) [website]. Center for Devices and Radiological Health (CDRH).

510(k) approvals. K063723. Impella® Recover® LP 2.5 Percutaneous Cardiac Support System. May 30,

2008. Accessed at:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/51

0kClearances/ucm081850.htm

4. Food and Drug Administration (FDA) [website]. AB-180 XC System 510(k) Summary. K991783.

November 1, 2000. Accessed at:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/51

0kClearances/ucm093399.htm

5. Food and Drug Administration (FDA) [website]. IMPELLA 5.0 Catheters 510(k) Summary.

K083111.April 16, 2009. Accessed at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K083111.pdf

Peer Reviewed Publications

6. 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.

7. Dixon SR, Henriques JPS, 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. Henriques JP, Remmelink M, Baan J Jr, et al. Safety and feasibility of elective high-risk percutaneous

coronary intervention procedures with left ventricular support of the Impella Recover LP 2.5. Am J

Cardiol. 2006;97(7):990-992.

9. Remmelink M, Sjauw KD, Henriques JP, et al. Effects of left ventricular unloading by Impella recover

LP2.5 on coronary hemodynamics. Catheter Cardiovasc Interv. 2007;70(4):532-537.

10. Burzotta F, Paloscia L, Trani C, et al. Feasibility and long-term safety of elective Impella-assisted high-

risk percutaneous coronary intervention: a pilot two-centre study. J Cardiovasc Med (Hagerstown).

2008;9(10):1004-1010.

11. Valgimigli M, Steendijk P, Serruys PW, et al. Use of Impella Recover® LP 2.5 left ventricular assist

device during high-risk percutaneous coronary interventions; clinical, haemodynamic and biochemical

findings. EuroIntervention. 2006:2(1):91-100.

12. 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):1276-1283.

13. Burkhoff D, Cohen H, Brunckhorst C, O’Neill WW; TandemHeart Investigators Group. 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. Am Heart J. 2006;152(3):469.e1-469.e8.

14. O'Neill W, et. al. PROTECT II: A Prospective Multicenter Randomized Clinical Trial of Intra-aortic

Balloon Pump vs. Impella for Hemodynamic Support During High Risk PCI. Late breaking clinical

trials-Interventional Featured Clinical Studies I- American College of Cardiology 2011.

15. Naidu, S. Novel. Percutaneous Cardiac Assist Devices: The Science of and Indications for

Hemodynamic Support. Circulation, 2011: 125:533-543.

16. Kovacic JC, Nguyen HT, Karajgikar R, Sharma SK, Kini AS. The Impella 2.5 and TandemHeart

Ventricular Assist Devices are Safe and Associated With Equivalent Clinical Outcomes in Patients

Undergoing High‐Risk Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. Catheter

Cardiovasc Interv. 2011 Jan 13.

17. Kar B, Gregoric ID, Basra SS, Idelchik GM, Loyalka P. The Percutaneous Ventricular Assist Device in

Severe Refractory Cardiogenic Shock. J Am Coll Cardiol. 2011;57:688-696.

Page 13 of 15

18. 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 Sep;30(17):2102-8. doi: 10.1093/eurheartj/ehp292. Epub 2009 Jul 18.

19. Alli OO, Singh IM et al. Percutaneous left ventricular assist device with TandemHeart for high-risk

percutaneous coronary intervention: The Mayo Clinic experience. Cath and Cardiovasc Inter.

2012;(80)5:728-734

20. Tempelhof MW, Klein L, Cotts WG, et al. Clinical experience and patient outcomes associated with the

TandemHeart percutaneous transseptal assist device among a heterogeneous patient population. ASAIO

J. 2011 Jul-Aug;57(4):254-61.

21. 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 Nov;4(3):331-7.

22. Vranckx P, Schultz CJ, Valgimigli M, et al. Assisted circulation using the TandemHeart during very

high-risk PCI of the unprotected left main coronary artery in patients declined for CABG. Catheter

Cardiovasc Interv. 2009 Aug 1;74(2):302-10

23. Shah R, Thomson A, Atianzar K, et al. Percutaneous left ventricular support for high-risk PCI and

cardiogenic shock: who gets what? Cardiovasc Revasc Med. 2012 Mar 7.

24. Burkhoff D, O'Neill W, Brunckhorst C, et al. Feasibility study of the use of the TandemHeart

percutaneous ventricular assist device for treatment of cardiogenic shock. Catheterization &

Cardiovascular Interventions. Vol. 68(2)(pp 211-217), 2006.

25. Alasnag MA, Gardi DO, Elder M, et al. Use of the Impella 2.5 for prophylactic circulatory support

during elective high-risk percutaneous coronary intervention. Cardiovasc Revasc Med. 2011 Sep-

Oct;12(5):299-303

26. 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 Nov 1;80(5):717-25. doi: 10.1002/ccd.23403. Epub 2012 Apr 25.

27. Schwartz BG, Ludeman DJ, Mayeda GS, et al. High-risk percutaneous coronary intervention with the

TandemHeart and Impella devices: a single-center experience. J Invasive Cardiol. 2011 Oct;23(10):417-

24.

28. Thomas JL, Al-Ameri H, Economides C, et al. Use of a percutaneous left ventricular assist device for

high-risk cardiac interventions and cardiogenic shock. J Invasive Cardiol. 2010 Aug;22(8):360-4.

29. Henriques JP, Ouweneel DM, Naidu SS, et al. Evaluating the learning curve in the prospective

randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in

patients undergoing high-risk percutaneous coronary intervention: a prespecified subanalysis of the

PROTECT II study. Am Heart J. 2014;167(4):472-479.e5.

30. Kovacic JC, Kini A, Banerjee S, et al. Patients with 3-vessel coronary artery disease and impaired

ventricular function undergoing PCI with Impella 2.5 hemodynamic support have improved 90-day

outcomes compared to intra-aortic balloon pump: a sub-study of the PROTECT II trial. J Interv Cardiol.

2015;28(1):32-40.

31. Shah AP, Retzer EM, Nathan S, et al. Clinical and economic effectiveness of percutaneous ventricular

assist devices for high-risk patients undergoing percutaneous coronary intervention. J Invasive Cardiol.

2015;27(3):148-154.

32. O'Neill WW, Schreiber T, Wohns DH, et al. The current use of Impella 2.5 in acute myocardial

infarction complicated by cardiogenic shock: results from the USpella Registry. J Interv Cardiol.

2014;27(1):1-11.

33. Manzo-Silberman S, Fichet J, Mathonnet A, et al. Percutaneous left ventricular assistance in post cardiac

arrest shock: comparison of intra-aortic blood pump and IMPELLA Recover LP2.5. Resuscitation.

2013;84(5):609-615.

Page 14 of 15

34. Lauten A, Engström AE, Jung C, et al. Percutaneous left-ventricular support with the Impella-2.5-assist

device in acute cardiogenic shock: results of the Impella-EUROSHOCK-Registry. Circ Heart Fail.

2013;6(1):23-30.

35. Briasoulis A, Telila T, Palla M, Mercado N et al. Meta-Analysis of Usefulness of Percutaneous Left

Ventricular Assist Devices for High-Risk Percutaneous Coronary Interventions. . Am J Cardiol. 2016

May 14. pii: S0002-9149(16)30857-8. doi: 10.1016/j.amjcard.2016.05.003.

36. Cohen MG(1), Matthews R(2), Maini B(3) et al. Percutaneous left ventricular assist device for high-risk

percutaneous coronary interventions: Real-world versus clinical trial experience. Am Heart J. 2015

Nov;170(5):872-9. doi: 10.1016/j.ahj.2015.08.009. Epub 2015 Aug 15.

Professional Society Guidelines

37. Levine G, Bates E, Blankenship J, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary

Intervention. A Report of the American College of Cardiology Foundation/American Heart Association

Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions.

Accessed at: http://www.guideline.gov/content.aspx?id=34980

38. O'Gara PT, Kushner FG, Ascheim DD, et al.; American College of Cardiology Foundation/American

Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management

of ST-elevation myocardial infarction: a report of the American College of Cardiology

Foundation/American Heart Association Task Force on Practice Guidelines. Circulation.

2013;127(4):e362-e425.

39. Rihal CS, Naidu SS, Givertz MM, et al.; Society for Cardiovascular Angiography and Interventions

(SCAI); Heart Failure Society of America (HFSA); Society for Thoracic Surgeons (STS); American

Heart Association (AHA); American College of Cardiology (ACC). 2015 SCAI/ACC/HFSA/STS

clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in

cardiovascular care (endorsed by the American Heart Association, the Cardiological Society of India,

and Sociedad Latino Americana de Cardiología Intervencionista; Affirmation of value by the Canadian

Association of Interventional Cardiology-Association Canadienne de Cardiologie d’Intervention).

Catheter Cardiovasc Interv. 2015;85(7):1112-1114. Accessed at:

http://content.onlinejacc.org/article.aspx?articleid=2240149

40. Yancy CW, Jessup M, Bozkurt B, et al.; American College of Cardiology Foundation/American Heart

Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of

heart failure: a report of the American College of Cardiology Foundation/American Heart Association

Task Force on practice guidelines. Circulation. 2013;128(16):e240-e327.

41. Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization:

The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the

European Association for Cardio-Thoracic Surgery (EACTS): Developed with the special contribution

of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J.

2014;35(37):2541-2619.

Other Resources

42. Hayes Health Technology Brief. Winifred Hayes Inc. Lansdale, PA.

Impella 2.5 System (Abiomed Inc.) for Cardiac Support in Patients Undergoing High-Risk

Percutaneous Coronary Intervention (PCI). July 2015

Impella 5.0 (Abiomed Inc.) for Emergent Hemodynamic Support in Patients with Cardiogenic

Shock. Sept. 2015

Impella 2.5 System (Abiomed Inc.) for Emergent Hemodynamic Support in Patients with

Cardiogenic Shock. Sept. 2015

Page 15 of 15

Impella 2.5 System (Abiomed Inc.) for Cardiac Support in Patients Undergoing High-Risk

Percutaneous Coronary Intervention (PCI). June, 2016

43. UpToDate: Aroesty JM, Jeevanandam V, Eisen HJ. Short-term mechanical circulatory assist devices..

2016.