Impella device
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tarek Nafee, M.D. [2]
Click here to see a case of chronic total occlusion with retrograde approach with the use of impella on Tweetbook.
Overview
The Impella device is a percutaneously inserted ventricular assist device (pVAD) that is used to temporarily support left or right ventricular function in patients with cardiogenic shock complicating acute myocardial infarction who undergo high-risk percutaneous coronary intervention (PCI) or open heart surgery. Cardiogenic shock occurs in approximately 6% to 12% of patients with STEMI[1] and 17% of patients with NSTEMI.[2] In these patients, cardiogenic shock results in a 30% to 50% in-hospital mortality after the ischemic event.[3] pVADs utilize a small mechanical pump to give short term support to the ventricles. pVADs aim to improve outcomes through three primary mechanisms: (1) increase the mean arterial pressure (2) reduce in ventricular diastolic pressure (3) increase in coronary perfusion.[4]
Structure and Function
The axial flow pumps of the Impella device are mounted on a 12Fr (Impella 2.5LP), 13Fr (Impella CP), or 21Fr (Impella 5.0) support catheter and are usually inserted through the femoral, subclavian, or axillary arteries. The micro-axial catheter is placed into the ventricle in retrograde fashion and the circulating impeller transfers oxygenated blood from the inlet in the ventricle to the outlet in the ascending aorta. This mechanism effectively and rapidly increases mean arterial pressure which increases coronary and peripheral perfusion, and unloads left ventricular volume and pressure which decreases myocardial oxygen demand.
The following video describes the function of the impella device: {{#ev:youtube|HmH709RXmNE}}
Indications
High Risk PCI Patients
Impella is used to prevent hemodynamic compromise in high-risk patients by unloading the left ventricle and reducing end-diastolic wall stress.[5] Additionally, the Impella device works to decrease the pulmonary capillary wedge pressure. Compared with the intra-aortic balloon pump, there is a trend toward improved 90-day outcomes among patients receiving the Impella 2.5 device. [6]. Studies have also shown the Impella to be effective for increasing LVEF in patients undergoing high-risk PCI. [7][8][9][10]
The PROTECT II Trial was designed to assess the differences between Impella and IABP in regard to major adverse events (MAEs) at one month in patients undergoing high-risk PCI. [6] The study demonstrated that Impella use resulted in a trend toward significance in lower out-of-hospital MAEs compared with IABP (40.6% vs 49.3%, P=0.066) in the intent-to-treat population at 90 days, whereas the per-protocol population showed significant differences between Impella and IABP (40.0% and 51.0%, respectively, P=0.023).
In patients undergoing complex revascularization, there is a risk for periprocedural and postprocedural acute kidney injury (AKI). There is a subsequent higher risk for mortality, major bleeding, and MI in these patients. Patients with low LVEF often require longer procedures and greater contrast use which places them at higher risk of acute kidney injury (AKI). One study examined AKI outcomes among patients with an average LVEF of ≤35% receiving partial Impella 2.5 hemodynamic support during high risk PCI (HRPCI). Impella support was associated with significantly fewer AKI events than control patients not receiving the device (5.2% vs 27.8%, p < 0.001).
Cardiogenic Shock
One of the prime indications for use of the Impella device is for cardiogenic shock, a condition in which the Impella has consistently demonstrated favorable post-interventional outcomes. In the USpella Registry, patients with cardiogenic shock (CS) complicating an acute myocardial infarction (AMI) receiving the Impella 2.5 prior to PCI demonstrated superior outcomes to patients receiving the device after PCI, showing the importance of early support in this setting.[11]] Patients with severe refractory cardiogenic shock may also experience a beneficial short-term effect of device placement.[12] The Impella 5.0 may also allow for more rapid weaning of inotropes in this patient population.[10]
The IMPRESS trial, a small, exploratory study comprising a heterogeneous patient population with severe cardiogenic shock complicating acute myocardial infarction, compared patients receiving either Impella CP or IABP.[13] Researchers found 30-day mortality was similar between Impella CP and IABP (46% vs 50%, respectively). The issue with this trial was its severely ill patient population. Since anoxic brain injury was the main cause of death, mechanical support may not even have been the most optimal treatment in this population. Additionally, the study didn’t take into account timing of device placement. Early Impella support prior to initiation of PCI is considered optimal for improved outcomes [cVAD] and absence of this information hinders the generalizability of the findings to clinical practice.
Bridging to Transplantation or Durable Device Placement
Impella 5.0 may provide an effective bridge to further therapy (transplantation or durable left ventricular assist device [LVAD]). A small study consisting of 40 critically ill patients with heart failure undergoing Impella 5.0 support found that 75% of patients were able to survive to next therapy with no observed events of major bleeding or stroke,[10] There was a 68% survival rate to discharge and/or 30 days, demonstrating that hemodynamic support with the Impella device may allow for an effective and safe bridge to a definitive decision strategy in heart failure patients.
Approved Devices
The following impella devices are approved for circulatory hemodynamic support:
Left Ventricular Heart Failure
- Impella 2.5 The impella 2.5 delivers a maximum of 2.5L/min of blood flow from the left ventrical to the ascending aorta. Current FDA-approved indications for temporary use include:
- Cardiogenic shock (≤4 days) that occurs <48 hours after acute myocardial infarction (MI) or open heart surgery
- Protected PCI (≤6 hours) in elective or urgent cases of hemodynamically stable patients with depressed left ventricular ejection fraction (LVEF) and severe coronary artery disease (CAD)
- Impella CP
The Impella CP received expanded FDA approval for its use in High-Risk Percutaneous Coronary Intervention (PCI) Procedures in 2016. This device pulls blood from the left ventricle into the ascending aorta at a maximum rate of 3.5L/min. The indications for use are the same for Impella 2.5 and 5.0.
- Impella 5.0
The Impella 5.0 is an intravascular microaxial blood pump that delivers up to 5.0 L/min of forward flow blood from the left ventricle to the aorta. The indications are the same as the Impella 2.5 and CP devices.
Right Ventricular Heart Failure
Impella RP The Impella RP provides right-sided support in patients who experience right-sided heart failure after either left-sided support, a heart attack, heart transplantation, or after heart surgery. This Impella device delivers blood from the inlet area in the inferior vena cava and through the cannula to the device outlet opening in the pulmonary artery.
Clinical Practice Guidelines
| Year | Guideline | Recommendation | Class | Level of Evidence |
|---|---|---|---|---|
| 2011 | ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention[14] | A hemodynamic support device is recommended for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological therapy. | I | B |
| 2012 | Recommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient Selection[15] | Urgent nondurable MCS is reasonable in hemodynamically compromised HF patients with end-organ dysfunction and/or relative contraindications to heart transplantation/durable MCS that are expected to improve with time and restoration of an improved hemodynamic profile | IIa | C |
| 2013 | AHA/ACC Guideline for the Management of ST-Elevation Myocardial Infarction[16] | The use of mechanical circulatory support is reasonable in patients with STEMI who are hemodynamically unstable and require urgent CABG. | IIa | C |
| Alternative LV assist devices for circulatory support may be considered in patients with refractory cardiogenic shock. | IIb | C | ||
| 2013 | ACCF/AHA Guideline for the Management of Heart Failure[17] | MCS is beneficial in carefully selected patients with stage D HFrEF in whom definitive management (e.g., cardiac transplantation) or cardiac recovery is anticipated or planned. | IIb | B |
| Nondurable MCS, including the use of percutaneous and extracorporeal ventricular assist devices (VADs), is reasonable as a “bridge to recovery” or “bridge to decision” for carefully selected patients with HFrEF with acute, profound hemodynamic compromise. | IIb | B | ||
| 2013 | The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support[18] | Reasonable to use temporary mechanical support for patients with heart failure awaiting transplantation who have multi organ failure. | I | - |
Alternative Devices
Left Ventricular Heart Failure
- LVAD: The Left Ventricular Assist Device is a surgically implanted device that was used as a bridge to transplantation in patients with severe heart failure. The use of LVADs has decreased significantly due to evidence of increased mortality in older high-risk patients, and due to the availability of percutaneously implantable devices.[4]
- IABP: The intra-aortic balloon pump uses a pneumatic pump that is easily placed in the aorta at bedside and inflates a balloon in the aorta during systole and deflates during diastole.[19] It has been widely used in clinical practice for decades until evidence from the SHOCK II trial demonstrated no increased benefit in 30 day or 12 month mortality with IABP compared to medical therapy alone.[20]
- VA-ECMO: Venous-arterial extracorporeal membrane oxygenator extracts venous blood from the body and returns oxygenated blood to the arterial system by use of a centrifugal pump. Inflow cannulas are typically placed in the right atrium or the inferior vena cava and outflow cannulas are placed in the femoral or subclavian artery. This system provides oxygenation and circulatory support and is widely used in clinical practice despite conflicting evidence on its benefits.[21]
- TandemHeart: The TandemHeart is an extracorporeal device that utilizes a centrifugal pump that provides a flow of 3.0 to 5.0 L/min. This system requires a transseptal puncture to bypass oxygenated blood from the inlet in the left atrium to the outlet in the femoral artery.[22]
Right Ventricular Heart Failure
- TandemHeart RVAD: This device uses a centrifugal pump to move blood from the inlet in the right atrium to the outlet in the main pulmonary artery. This action aims to bypass the poorly functioning right ventricle.[23][24][25]
Biventricular Heart Failure
- VA-ECMO: ECMO is a reasonable strategy for biventricular failure when combined with left ventricular venting to avoid distention.
- Combination strategies: Combinations of impella and TandemHeart device implantation has been described in successful procedures.
- BiPella: A procedure whereby an Impella 5.0 device is placed in the left ventricle and rapidly unloads the left ventricle and increases peripheral circulatory pressure. This also reduces the backup of blood from the left side to the right side and temporarily relieves the right ventricle but eventually leads to an increase in central venous pressure and right ventricular preload, which requires the subsequent implantation of the Impella RP device to unload the right ventricle diastolic wall pressure.[26]
Randomized Clinical Trials
PROTECT II Trial [6]
The trial was discontinued early due to futility. A press release from the manufacturer Abiomed stated the following:
"Abiomed announced completion of the PROTECT II study based on a futility determination at the planned interim analysis regarding the primary end-point, which the company views as likely to be due to unanticipated confounding variables related to the use of rotational atherectomy² in the study. The decision to end the study followed the recommendation of the Data Safety Monitoring Board. The study was designed to measure major adverse events at 30 days in high risk percutaneous coronary intervention (PCI) patients randomized to receive hemodynamic support during the procedure with the Impella versus intra-aortic balloon (IAB)."
Summary and Conclusion of Protect II:
- For the entire study population, Impella significantly reduced out of hospital major adverse events (MAE) by 52% compared to IAB for the duration of the 90 day monitoring (p=0.02, N= 302).
- There was an overall positive trend in the majority (88%, n=267) of patients in the study at the interim analysis, in which Impella reduced the major adverse event rate by 26% over the IAB (Impella 32% MAE vs. IAB 43% MAE, p=0.11).
- Impella provided a 47% reduction in major adverse events over IAB in a subgroup that represents 70% of the protocol study population (Impella 23% MAE vs. IAB 43% MAE, p=0.009). An analysis of a “PROTECT” score will be presented at the upcoming ACC in April.
- When using atherectomy, Impella significantly reduced repeat revascularization (p=0.02).
- The data revealed confounding variables in the treatment between the two arms with the most significant differences related to two times more frequent use (p=0.04) and two times the number of passes per use (p=0.003) of rotational atherectomy in the Impella arm compared to the IAB arm, accounting for 12% (n=38) of total PROTECT II patients at the interim. Use of atherectomy during PCI has been previously shown to increase CK-MB release (heart enzyme) following PCI, triggering an endpoint in PROTECT II.
“Atherectomy was an unanticipated variable which resulted from the operators’ decision to ‘do more with Impella.’ Our investigators had unblinded knowledge of the treatment arm after randomization,” said William O’Neill, M.D., University of Miami and Principal Investigator of the PROTECT II study. “It is interesting that operators felt that they could do more complex interventions once randomized to Impella and this in and of itself is an important finding.”
References
- ↑ Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S; et al. (2014). "Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States". J Am Heart Assoc. 3 (1): e000590. doi:10.1161/JAHA.113.000590. PMC 3959706. PMID 24419737.
- ↑ Jacobs AK, French JK, Col J, Sleeper LA, Slater JN, Carnendran L; et al. (2000). "Cardiogenic shock with non-ST-segment elevation myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded coronaries for Cardiogenic shocK?". J Am Coll Cardiol. 36 (3 Suppl A): 1091–6. PMID 10985710.
- ↑ Wayangankar SA, Bangalore S, McCoy LA, Jneid H, Latif F, Karrowni W; et al. (2016). "Temporal Trends and Outcomes of Patients Undergoing Percutaneous Coronary Interventions for Cardiogenic Shock in the Setting of Acute Myocardial Infarction: A Report From the CathPCI Registry". JACC Cardiovasc Interv. 9 (4): 341–351. doi:10.1016/j.jcin.2015.10.039. PMID 26803418.
- ↑ 4.0 4.1 Morine KJ, Kapur NK (2016). "Percutaneous Mechanical Circulatory Support for Cardiogenic Shock". Curr Treat Options Cardiovasc Med. 18 (1): 6. doi:10.1007/s11936-015-0426-6. PMID 26758053.
- ↑ Meyns B, Dens J, Sergeant P, Herijgers P, Daenen W, Flameng W (2003). "Initial experiences with the Impella device in patients with cardiogenic shock - Impella support for cardiogenic shock". Thorac Cardiovasc Surg. 51 (6): 312–7. doi:10.1055/s-2003-45422. PMID 14669126.
- ↑ 6.0 6.1 6.2 O'Neill WW, Kleiman NS, Moses J, Henriques JP, Dixon S, Massaro J; et al. (2012). "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. 126 (14): 1717–27. doi:10.1161/CIRCULATIONAHA.112.098194. PMID 22935569.
- ↑ Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B; et al. (2009). "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. 2 (2): 91–6. doi:10.1016/j.jcin.2008.11.005. PMID 19463408.
- ↑ Maini B, Naidu SS, Mulukutla S, Kleiman N, Schreiber T, Wohns D; et al. (2012). "Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: the USpella Registry". Catheter Cardiovasc Interv. 80 (5): 717–25. doi:10.1002/ccd.23403. PMID 22105829.
- ↑ Burzotta F, Trani C, Doshi SN, Townend J, van Geuns RJ, Hunziker P; et al. (2015). "Impella ventricular support in clinical practice: Collaborative viewpoint from a European expert user group". Int J Cardiol. 201: 684–91. doi:10.1016/j.ijcard.2015.07.065. PMID 26363632.
- ↑ 10.0 10.1 10.2 Gaudard P, Mourad M, Eliet J, Zeroual N, Culas G, Rouvière P; et al. (2015). "Management and outcome of patients supported with Impella 5.0 for refractory cardiogenic shock". Crit Care. 19: 363. doi:10.1186/s13054-015-1073-8. PMC 4600310. PMID 26453047.
- ↑ O'Neill WW, Schreiber T, Wohns DH, Rihal C, Naidu SS, Civitello AB; et al. (2014). "The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry". J Interv Cardiol. 27 (1): 1–11. doi:10.1111/joic.12080. PMC 4238821. PMID 24329756.
- ↑ Casassus F, Corre J, Leroux L, Chevalereau P, Fresselinat A, Seguy B; et al. (2015). "The use of Impella 2.5 in severe refractory cardiogenic shock complicating an acute myocardial infarction". J Interv Cardiol. 28 (1): 41–50. doi:10.1111/joic.12172. PMID 25689547.
- ↑ Ouweneel DM, Eriksen E, Sjauw KD, van Dongen IM, Hirsch A, Packer EJ; et al. (2017). "Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction". J Am Coll Cardiol. 69 (3): 278–287. doi:10.1016/j.jacc.2016.10.022. PMID 27810347.
- ↑ Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B; et al. (2011). "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". J Am Coll Cardiol. 58 (24): e44–122. doi:10.1016/j.jacc.2011.08.007. PMID 22070834.
- ↑ Peura JL, Colvin-Adams M, Francis GS, Grady KL, Hoffman TM, Jessup M; et al. (2012). "Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association". Circulation. 126 (22): 2648–67. doi:10.1161/CIR.0b013e3182769a54. PMID 23109468.
- ↑ O'Gara PT, Kushner FG, Ascheim DD, Casey DE, Chung MK, de Lemos JA; et al. (2013). "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. 127 (4): e362–425. doi:10.1161/CIR.0b013e3182742cf6. PMID 23247304.
- ↑ Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Drazner MH; et al. (2013). "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". J Am Coll Cardiol. 62 (16): e147–239. doi:10.1016/j.jacc.2013.05.019. PMID 23747642.
- ↑ Feldman D, Pamboukian SV, Teuteberg JJ, Birks E, Lietz K, Moore SA; et al. (2013). "The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary". J Heart Lung Transplant. 32 (2): 157–87. doi:10.1016/j.healun.2012.09.013. PMID 23352391.
- ↑ De Silva K, Lumley M, Kailey B, Alastruey J, Guilcher A, Asrress KN; et al. (2014). "Coronary and microvascular physiology during intra-aortic balloon counterpulsation". JACC Cardiovasc Interv. 7 (6): 631–40. doi:10.1016/j.jcin.2013.11.023. PMID 24726295.
- ↑ Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J; et al. (2012). "Intraaortic balloon support for myocardial infarction with cardiogenic shock". N Engl J Med. 367 (14): 1287–96. doi:10.1056/NEJMoa1208410. PMID 22920912. Review in: Ann Intern Med. 2012 Dec 18;157(12):JC6-11
- ↑ Cheng R, Hachamovitch R, Kittleson M, Patel J, Arabia F, Moriguchi J; et al. (2014). "Complications of extracorporeal membrane oxygenation for treatment of cardiogenic shock and cardiac arrest: a meta-analysis of 1,866 adult patients". Ann Thorac Surg. 97 (2): 610–6. doi:10.1016/j.athoracsur.2013.09.008. PMID 24210621.
- ↑ Kar B, Gregoric ID, Basra SS, Idelchik GM, Loyalka P (2011). "The percutaneous ventricular assist device in severe refractory cardiogenic shock". J Am Coll Cardiol. 57 (6): 688–96. doi:10.1016/j.jacc.2010.08.613. PMID 20950980.
- ↑ Goldstein JA, Kern MJ (2012). "Percutaneous mechanical support for the failing right heart". Cardiol Clin. 30 (2): 303–10. doi:10.1016/j.ccl.2012.03.007. PMID 22548820.
- ↑ Burkhoff D, Cohen H, Brunckhorst C, O'Neill WW, TandemHeart Investigators Group (2006). "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. 152 (3): 469.e1–8. doi:10.1016/j.ahj.2006.05.031. PMID 16923414.
- ↑ Prutkin JM, Strote JA, Stout KK (2008). "Percutaneous right ventricular assist device as support for cardiogenic shock due to right ventricular infarction". J Invasive Cardiol. 20 (7): E215–6. PMID 18599906.
- ↑ Kapur NK, Jumean M, Ghuloom A, Aghili N, Vassallo C, Kiernan MS; et al. (2015). "First Successful Use of 2 Axial Flow Catheters for Percutaneous Biventricular Circulatory Support as a Bridge to a Durable Left Ventricular Assist Device". Circ Heart Fail. 8 (5): 1006–8. doi:10.1161/CIRCHEARTFAILURE.115.002374. PMID 26374919.