General description of procedure, equipment, technique
What is percutaneous mechanical circulatory support?
Percutaneous mechanical circulatory support (pMCS) entails the use of percutaneously inserted devices and/or catheters intended to provide varying degrees of hemodynamic support to the left, right, or both ventricles temporarily as a bridge to recovery, decision, ventricular assist device (VAD) implantation, or transplantation.
The overall goals of pMCS are to: 1) maintain vital organ perfusion, 2) improve native cardiac output by reducing intracardiac filling pressures, 3) reduce left ventricular (LV) volumes, wall stress, and myocardial oxygen consumption, and 4) augment coronary perfusion.
Left ventricular support, depending on the degree of support needed and its indication, can be achieved via an intra-aortic balloon pump (IABP) counterpulsation, peripheral extracorporeal membrane oxygenation (ECMO), or the percutaneous placement of ventricular assist devices (pVAD) including the Impella Recover LP 2.5 or 5.0 systems (Abiomed, Danvers, MA), or the TandemHeart centrifugal pump (CardiacAssist, Inc., Pittsburgh, PA). Right Ventricular (RV) support and biventricular support can be achieved via the TandemHeart or via ECMO (Figure 1).
An IABP is a balloon-mounted catheter placed percutaneously via the common femoral artery into the aorta just distal to the origin of the left subclavian artery, which is connected to a pump console that inflates the balloon with helium during diastole. Balloon inflation is gated to the electrocardiogram and displaces blood volume within the descending aorta during diastole thus enhancing coronary blood perfusion, while balloon deflation creates a pressure sink in the aorta that augments LV stroke volume.
The Impella Recover LP 2.5 device is a percutaneously implanted, catheter mounted, axillary flow pump that is placed retrograde into the left ventricle across the aortic valve via the common femoral or axillary artery. Bench top testing has shown that the device can generate up to 2.5L/minute of flow. The Impella 5.0 device generates up to 5.0L/minute of flow; however, it requires a surgical vascular cut-down approach to access.
The TandemHeart centrifugal continuous flow pump generates up to 5.0L/minute of flow (depending on the outflow cannula diameter) from the left atrium to the femoral artery (LA-FA), thereby bypassing the native left ventricle. This device requires a transseptal puncture for the LV support and has been used to support the right ventricle via cannula placement in the right atrium and pulmonary artery.
ECMO is generally used for either biventricular failure and/or cardiopulmonary collapse. ECMO comprises a centrifugal pump attached to an external oxygenator, which is attached to inflow and outflow cannulas that can be placed percutaneously via the femoral vein and/or artery. Venoarterial ECMO (VA-ECMO) is commonly employed in cases of cardiac failure and impaired oxygenation, while veno-venous ECMO can be used to support primary pulmonary failure.
Indications and patient selection
Who should be considered for percutaneous mechanical circulatory support?
Both the TandemHeart and the Impella Recover LP 2.5 have been approved by the US Food and Drug Administration (FDA) for short-term (less than 6 hours) use in patients requiring circulatory support.
In general, pMCS provides short term LV, RV, or biventricular support. The devices are commonly used as a mechanism to provide short-term support as part of a bridge-to-decision, -recovery, -surgical VAD implantation, or -cardiac transplantation. The following are the major clinical scenarios where pMCS is used:
Patients with moderate to severe or refractory cardiogenic shock (CS) complicating acute myocardial infarction (AMI).
Patients with mechanical complications of AMI including ventricular septal defect and ischemic mitral regurgitation.
Patients undergoing high risk percutaneous coronary intervention (HR-PCI).
Patients with CS in the setting of acute myocarditis, postcardiotomy CS, acute decompensated heart failure (ADHF), or acute rejection postorthotopic heart transplantation.
Selected patients undergoing high risk aortic valve replacement.
Patients with refractory or recurrent ventricular fibrillation/ventricular tachycardia and in high risk ventricular tachycardia ablations.
Patient selection and criteria
Patients undergoing HR-PCI, or presenting with an AMI, ADHF, or CS often require pMCS.
Patients undergoing HR-PCI:
By definition, PCI is “high risk” since the complete intraprocedural control over the patency of coronary vasculature and preservation of the myocardium is not fully achievable. At present, no unifying definition for HR-PCI exists. However, variables that contribute to risk during PCI have been well characterized. Patient-specific variables are defined as comorbidities associated with adverse outcomes after PCI and include: increased age, impaired LV function and/or symptoms of heart failure, diabetes mellitus, chronic kidney disease, prior myocardial infarction, multivessel disease, and peripheral arterial disease. Lesion-specific variables of high risk encompass anatomic characteristics of the target lesion(s): left main stenosis, bifurcation disease, saphenous vein grafts, ostial stenoses, heavily calcified lesions, and chronic total occlusions. The clinical setting during referral for PCI also contributes to risk. For example, any acute coronary syndrome (ACS) or CS increases the risk of an adverse event associated with PCI.
Timing and patient selection for pMCS in the setting of HR-PCI remains poorly understood. Use of pMCS devices for HR-PCI depends on hemodynamic condition of the patient at the time of PCI, the anticipated risk of hemodynamic compromise during the procedure, and the need for hemodynamic support after revascularization. Risk calculators specifically designed to assess the need for pMCS during PCI do not exist and require further investigation.
Patients with CS and ADHF:
Despite multiple clinical trials showing survival benefit with pharmacologic and device interventions, more than 550,000 US patients are categorized as having advanced heart failure (HF), defined as New York Heart Association (NYHA) Class III or IV symptoms. Each year, more than 1 million individuals are hospitalized with the diagnosis of HF, which represents a spectrum of clinical conditions ranging from hemodynamically stable signs and symptoms of volume overload to more refractory HF with systemic hypoperfusion and ultimately CS. Underlying causes range from hypertensive and ischemic heart disease to valvular heart disease and primary cardiomyopathies.
CS is defined as a state of tissue hypoperfusion secondary to cardiac dysfunction despite adequate circulatory volume and LV filling pressure. Specific hemodynamic criteria for CS include: a systolic blood pressure less than 90mm Hg for more than 30 minutes or a fall in mean arterial blood pressure greater than 30mm Hg below baseline with a cardiac index (CI) of less than 1.8L/min/m2 without hemodynamic support or less than 2.2L/min/m2 with support, and a pulmonary capillary wedge pressure (PCWP) greater than 15mm Hg.
Given recent technological advances in surgical mechanical support and cardiac transplantation, the use of pMCS as a treatment strategy for patients presenting with ADHF and CS is a viable option with the primary goal of stabilizing a critically-ill patient prior to making a decision regarding durable MCS. The timing of pMCS device application in ADHF and CS also remains poorly understood, and practice varies considerably from one center to another. For patients with advanced HF (NYHA Class IIIB and IV), the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) has defined seven clinical profiles before implantation of a surgical VAD. CS is identified by INTERMACS profiles 1 and 2 where patients may be “crashing” despite aggressive therapy or “sliding fast on inotropes,” respectively. Both INTERMACS 1 and 2 subjects may be considered for temporary pMCS as a bridge to recovery, surgical VAD implantation, or cardiac transplantation.
Patients with AMI:
ACS, including non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI), remains one of the highest risk clinical scenarios for percutaneous coronary intervention (PCI). Risk in this setting is driven by ongoing myocardial ischemia, impaired LV diastolic and systolic functions, and elevated intracardiac filling pressures and volume. Furthermore, progressive coronary balloon occlusions with the risk of thrombotic embolization to subserved myocardium further increase the risk of hemodynamic decompensation and cardiovascular collapse. Finally, although standard therapy for an AMI is rapid myocardial reperfusion, several studies have shown that reperfusion itself may cause myocardial damage, known as ischemia-reperfusion injury, as well as life-threatening ventricular arrhythmias.
Whether pMCS reduces myocardial injury in the settling of reperfusion for an AMI is unknown since the success using preclinical models has not been fully achieved in several clinical trials. Most commonly in clinical practice, an IABP is deployed prior to or after PCI during an AMI to mitigate adverse outcomes due to hemodynamic collapse or coronary insufficiency. Several studies have examined the clinical utility of prophylactic IABP use in HR-PCI. However, none have demonstrated clear benefit with regards to reducing major adverse clinical events (MACE) irrespective of the timing of device implantation. Clinical investigation into the role of pMCS in the setting of AMI is ongoing.
Patients with RV failure:
RV failure commonly occurs in the setting of an AMI or after major cardiac surgery including: cardiac transplantation, surgical left ventricular assist device (LVAD) implantation, coronary artery bypass grafting (CABG), or valve replacement. Subjects with RV failure are at a considerably higher risk or morbidity and mortality when presenting with an AMI, ADHF, or CS. Use of pMCS devices for RV or biventricular support has been reported by several groups and represents an important emerging subset of patients who may benefit from this technology in the cardiac catheterization laboratory as well as in the operating room.
In cases of significant RV ischemia or primary RV dysfunction, an IABP may improve hemodynamics by enhancing coronary perfusion and indirectly unloading the RV; however, IABP is often insufficient for RV support. In such cases, either the TandemHeart device or VA-ECMO can be used to support RV function. Hemodynamic indices for RV dysfunction in AMI include measurements of RV stroke work (RVSW), right atrial to pulmonary capillary wedge pressure (RA:PCWP) ratio of greater than 0.8, and the pulmonary artery pulse pressure index (PaPi).
What are the contraindications to percutaneous mechanical circulatory support?
Contraindications common to all types of pMCS:
Prolonged cardiopulmonary resuscitation with inadequate perfusion
Existing organ dysfunction: advanced chronic obstructive pulmonary disease, interstitial lung disease, liver dysfunction (elevated liver enzymes or serum bilirubin three times the upper limit of normal or international normalized ratio [INR] >2.0), dementia, or prior stroke with significant disability
Relative contraindications to pMCS:
Contraindication to anticoagulation
Severe peripheral vascular disease (PVD)
Device specific contraindications:
Severe aortic regurgitation
Large abdominal aortic aneurysm
Impella Recover 2.5 LP:
LV mural thrombus
Aortic valve disorders: moderate to severe aortic stenosis (aortic valve area of <1.5cm2), moderate to severe aortic regurgitation, or the presence of a mechanical aortic valve
Abnormalities of the aorta: aneurysm, heavy calcification, or extreme tortuosity
Recent stroke or transient ischemic attack (TIA) in the past 3 months.
Moderate to severe aortic regurgitation
Mechanically ventilated patients for longer than 7 days.
Details of how the procedure is performed
How is a percutaneous mechanical circulatory support device implanted?
Routine preprocedural angiography of the aorta and iliofemoral vessels is recommended. Once an initial arteriotomy is made in the common femoral artery (CFA), a 7-9Fr balloon catheter (with or without a sheath) is advanced over a wire into the descending aorta and positioned distal to the origin of the left subclavian artery. IABP insertion is often performed under fluoroscopy in the catheterization laboratory or at the bedside under emergent conditions.
Balloon inflation and deflation can be gated to the electrocardiogram or to blood pressure. An IABP can be placed in 10 minutes, and can stay in place for 2 to 5 days.
Impella Recover 2.5 LP
Routine preprocedural angiography of the aorta and iliofemoral vessels is recommended. Systemic anticoagulation is required. Using a 13Fr sheath in the CFA, a pigtail catheter is inserted into the left ventricle and a 12Fr catheter-mounted pump is exchanged over a stiff 0.018 wire into the left ventricle. Careful positioning of the Impella 2.5 LP tip in the LV apex is required to optimize pump function. A pressure sensor on the proximal edge of the pump displays a tracing on the device console that confirms positioning of the device across the aortic valve. Impella Recover 2.5 LP is FDA approved for 6 hours of placement in the United States but can stay in place for up to 5 days.
A right-sided Impella device is currently under active investigation for use in acute RV failure.
TandemHeart LV Support
Routine preprocedural angiography of the aorta and ileofemoral vessels is recommended. Systemic anticoagulation is required. Femoral venous and arterial access are required. A transseptal puncture is first performed to access the left atrium with an Inoue wire. Next, the interatrial septum is dilated with a graded 21-22Fr dilator, followed by placement of a 21Fr (62 or 72cm) inflow cannula. This inflow cannula is then clamped.
Next, a 15-, 17-, or 19- Fr arterial outflow cannula is placed into the CFA using serial dilation catheters. This cannula is clamped and the pump is de-aired using heparinized saline. The inflow and outflow cannulas are then attached to the TandemHeart centrifugal pump using wet-to-wet connections. Clamps are then removed and the device is activated. Transesophageal and intracardiac echocardiography are often utilized during TandemHeart placement to guide catheter placement into the left aorta and transseptal puncture. TandemHeart, though FDA approved for 6 hours, can provide support for up to 14 days.
TandemHeart RV Support
For acute RV failure, the TandemHeart device has been used as a percutaneous or surgically implanted right ventricular assist device (RVAD). A 21Fr inflow cannula is placed in the right atrium via the common femoral vein, and a second 21Fr outflow cannula is inserted into the pulmonary artery via either the femoral vein or right internal jugular vein. TandemHeart can provide support for up to 14 days.
An 18-31Fr inflow cannula is inserted into either the right atrium or inferior vena cava via the femoral vein, and a 15-22Fr outflow cannula is inserted into the descending aorta via the femoral artery. The inflow and outflow cannulas are then attached to a centrifugal pump using wet-to-wet connections. Clamps are then removed and the device is activated. Priming of the oxygenator and strict maintenance of arterial pH, oxygen saturation, and anticoagulation are often performed by perfusion specialists or nurses trained specifically in ECMO. ECMO can provide support for several days. Placement time is 10 to 15 minutes.
Interpretation of results
How to monitor patients with implanted percutaneous mechanical circulatory support device?
Invasive and noninvasive measures of tissue perfusion such as mental status, blood pressure, peripheral cyanosis, urine output, and serum creatinine and lactate levels, along with frequent assessment via a pulmonary artery catheter (PAC) of invasive hemodynamic measures is often helpful to assess PCWP, pulmonary artery pressure, cardiac output (CO), CI, and mixed venous oxygen saturation.
Performance characteristics of the procedure (applies only to diagnostic procedures)
Outcomes (applies only to therapeutic procedures)
What are the short and long term benefits of percutaneous mechanical circulatory support?
Studies have shown that a pVAD is an effective treatment option for rapidly reversing severe refractory cardiogenic shock despite IABP and inotropic support, with more favorable hemodynamic parameters post placement. A recent meta-analysis of three randomized trials of 100 patients showed acute hemodynamic benefits with pVADs over standard IABPs; however, no significant difference in 30-day mortality using pVADs was observed when compared with IABP. Further studies to answer this question are underway.
Short term hemodynamic effects
Increase coronary perfusion
Reduce LV afterload
Reduce LV end diastolic pressure
Increase in mean arterial blood pressure
Retrospective studies and registry data demonstrated a mortality benefit using IABP in STEMI patients with CS, from which the American College of Cardiology/American Heart Association and the European Society of Cardiology endorse the use of IABP in those circumstances. The Should We Emergently Revascularize Occluded Coronary Arteries in Shock (SHOCK) trial registry as well as the National Registry of Myocardial Infarction (NRMI)-2 also show a mortality benefit of using IABP in addition to fibrinolytic therapy compared to fibrinolytic therapy alone. This synergy has also been noted in the Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries (GUSTO) I and III.
Recent trials including the Counterpulsation to Reduce Infarct Size Pre-PCI-AMI (CRISP-AMI) trial failed to demonstrate a significant mortality benefit or an impact on infarct size in stable AMI patients with provisional IABP placement prior to PCI when compared with the standard of care.
Alternative and/or additional procedures to consider
What alternative therapeutic options can be considered instead of percutaneous mechanical circulatory support?
In general, a pMCS device provides temporary hemodynamic stabilization until a definite outcome is achieved such as: a) revascularization, b) recovery, c) bridge to surgical VAD implantation, d) cardiac transplantation, or e) medical futility and hospice. For HR-PCI, alternative approaches to pMCS include hemodynamic optimization with diuretics and/or inotropes prior to PCI, CABG, or optimal medical therapy. In cases of ADHF and CS, the decision to pursue pMCS is often multidisciplinary in nature and requires input from HF specialists and cardiac surgeons. No existing algorithms or risk calculators define which patients benefit most from pMCS. This is an area of active investigation.
Complications and their management
What are the potential complications of percutaneous mechanical circulatory support?
General complications of all pMCS devices
Systemic: Infection and sepsis
Vascular: Peripheral vascular obstruction and tissue ischemia
Neurologic: Embolic stroke
Hematologic: Thrombocytopenia (including heparin-induced thrombocytopenia), hemolysis, and bleeding
Device specific complications
Malposition: Risk of obstructing subclavian, renal, or mesenteric arterial blood flow
Aortic rupture or dissection
Air or plaque embolism
Impella 2.5 LP:
Aortic valve injury
Aortic valve insufficiency
LV puncture causing tamponade/rupture
Antegrade or retrograde cannula migration (both inflow and outflow)
Left atrium puncture causing tamponade
Mechanical injury to the inferior vena cava
Potential of interatrial shunt after device removal
Thrombosis of the ECMO circuit
Systemic gas embolism
Potential for circuit rupture and hemorrhage
Upper body hypoxia due to incomplete retrograde oxygenation
Progressive LV dilation
Failure of oxygenator
What’s the evidence?
Antonelli, M, Levy, M, Andrews, P. “Hemodynamic monitoring in shock and implications for management Consensus Conference, Paris, France, 27-28 April 2006”. Intensive Care Med. vol. 33. 2007. pp. 575-90. (This reference summarizes recommendations for the definition and management of shock and specifically highlights the importance of close hemodynamic monitoring in cardiogenic shock.)
Reynolds, HR, Hochman, JS. “Cardiogenic shock: current concepts and improving outcomes”. Circulation. vol. 117. 2008. pp. 686-97. (Contemporary review of the pathophysiology and clinical management of cardiogenic shock.)
Topalian, S, Ginsberg, F, Parrillo, JE. “Cardiogenic shock”. Crit Care Med. vol. 36. 2008. pp. S66-74. (Excellent overview of the definition and management of cardiogenic shock.)
Kar, B, Gregoric, I, Basra, S, Idelchik, G, Loyalka, P. “The percutaneous ventricular assist device in severe refractory cardiogenic shock”. J Am Coll Cardiol. vol. 57. 2011. pp. 688-96. (Largest reported series of TandemHeart Implants for patients with cardiogenic shock in a single center.)
Thiele, H, Lauer, B, Hambrecht, R, Boudriot, E, Cohen, HA, Schuler, G. “Reversal of cardiogenic shock by percutaneous left atrial-to-femoral arterial bypass assistance”. Circulation. vol. 104. 2001. pp. 2917-22. (One of the first studies reporting clinical experience and hemodynamic benefit with the TandemHeart device.)
Kapur, NK, Paruchuri, V, Korabathina, R. “Effects of a percutaneous mechanical circulatory support device for medically refractory right ventricular failure”. J Heart Lung Transplant. vol. 30. 2011. pp. 1360-7. (The first report describing the hemodynamic impact of the TandemHeart device for right ventricular failure in a series of patients from a single center.)
Vrankx, P, Meliga, E, De Jaegere, PP, Van den Ent, M, Serruys, PW. “The TandemHeart, percutaneous transseptal left ventricular assist device: a safeguard in high-risk percutaneous coronary interventions. The six-year Rotterdam experience”. EuroIntervention. vol. 4. 2008. pp. 331-7. (One of the few studies describing the clinical utility of the TandemHeart device for high risk PCI in 23 patients.)
Dixon, SR, Henriques, JP, Mauri, L. “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 US experience”. JACC Cardiovasc Interv. vol. 2. 2009. pp. 91-6. (First study that established the safety profile of the Impella 2.5 LP system for high risk PCI.)
O’Neill, WW, Kleiman, NS, Moses, J. “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. vol. 126. 2012 Oct 2. pp. 1717-27. (Controversial trial of the Impella 2.5 LP versus IABP study that was terminated early due to medical futility.)
Valgimigli, M, Steendijk, P, Sianos, G, Onderwater, E, Serruys, PW. “Left ventricular unloading and concomitant total cardiac output increase by the use of percutaneous impella recover LP 2.5 assist device during high-risk coronary intervention”. Catheter Cardiovasc Interv. vol. 65. 2005. pp. 263-7. (Hemodynamic study describing the impact of the Impella 2.5 LP device in man.)
Kapur, NK, Pham, DT, Loyalka, P. “Percutaneous veno-arterial extracorporeal membrane oxygenation: another tool in the interventional-heart failure armamentarium”. J Invasive Cardiol. vol. 22. 2010. pp. 370-1. (Overview of the use of VA-ECMO for cardiogenic shock.)
Santa-Cruz, RA, Cohen, MG, Ohman, EM. “Aortic counterpulsation: a review of the hemodynamic effects and indications for use”. Catheter Cardiovasc Interv. vol. 67. 2006. pp. 68-77. (Overview of the hemodynamic impact of IABP use.)
Barron, HV, Every, NR, Parsons, LS. “The use of intra-aortic balloon counterpulsation in patients with cardiogenic shock complicating acute myocardial infarction: data from the National Registry of Myocardial Infarction 2”. Am Heart J. vol. 141. 2001. pp. 933-9. (One of the first studies showing a potential clinical benefit with IABP support in AMI treated with thrombolytics.)
Patel, MR, Smalling, RW, Thiele, H. “Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: CRISP AMI randomized trial”. JAMA. vol. 306. 2011. pp. 1329-37. (Most recent clinical trial confirming no obvious short-term benefit to IABP in AMI; however, did identify a trend toward long-term benefit.)
Evolving field of pMCS
Peura, J, Colvin-Adams, M, Francis, G. “Recommendations for the use of mechanical circulatory support: Device strategies and patient selection. A scientific statement from the Americal Heart Association”. Circulation. vol. 126. 2012. pp. 2648-2667. (The most recent AHA statement on the use of pMCS.)
Sjauw, KD, Engstrom, AE, Henrigues, JP. “Percutaneous mechanical cardiac assist in myocardial infarction. Where are we now, where are we going?”. Acute Card Care. vol. 9. 2007. pp. 222-30. (Review of the literature supporting the use of mechanical support in AMI.)
Cheng, JM, den Uil, CA, Hoeks, SE. “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. vol. 30. 2009. pp. 2102-8. (Rare meta-analysis comparing short-term and long-term benefits of various pMCS strategies.)
Desai, NR, Bhatt, DL. “Evaluating percutaneous support for cardiogenic shock: data shock and sticker shock”. Eur Heart J. vol. 30. 2009. pp. 2073-5. (Editorial accompanying the Cheng et al meta-analysis that highlights the lack of data supporting the use of percutaneous circulatory support devices and questions the economic impact of these therapies.)
Smith, SC, Feldman, TE, Hirshfeld, JQ. “ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention)”. J Am Coll Cardiol. vol. 47. 2006. pp. e1-e121. (ACC/AHA guidelines for PCI.)
Antman, EM, Anbe, DT, Armstrong, PW. “ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction)”. Circulation. vol. 110. 2004. pp. e82-e292. (ACC/AHA guidelines on management of STEMI.)
Sianos, G, Morel, MA, Kappetein, AP. “The SYNTAX score: an angiographic tool grading the complexity of coronary artery disease”. Euro Intervention. vol. 1. 2005. pp. 219-27. (Syntax score is a unique tool to assess complexity of coronary artery disease, based on angiographic data, and helps predict MACE based on revascularization strategy chosen.)
Sjauw, KD, Remmelink, M, Baan, J. “Left ventricular unloading in acute ST-segment elevation myocardial infarction patients is safe and feasible and provides acute and sustained left ventricular recovery”. J Am Coll Cardiol. vol. 51. 2008. pp. 1044-6. (A pilot study that demonstrated the safety and feasibility of Impella 2.5 with favorable outcomes in a small number of STEMI patients.)
Naidu, SS. “Novel percutaneous cardiac assist devices. The science of and indications for hemodynamic support”. Circulation. vol. 123. 2011. pp. 533-543. (Overview of the hemodynamic indices used to evaluate the effect of mechanical support devices.)
Korabathina, R, Hefernan, KS, Paruchuri, V. “The pulmonary artery pulsatility index identifies severe right ventricular dysfunction in acute inferior myocardial infarction”. Catheter Cardiovasc Interv. vol. 80. 2012. pp. 593-600. (First reference for a hemodynamic measure of RV failure in AMI termed the PAPi.)
Stevenson, LW, Pagani, FD, Young, JB. “INTERMACS profiles in advanced heartfailure: the current picture”. J Heart Lung Transplant. vol. 28. 2009. pp. 535-41. (Summary of the INTERMACS profiles used to categorize patients with advanced heart failure being evaluated for mechanical support.)
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- General description of procedure, equipment, technique
- Indications and patient selection
- Details of how the procedure is performed
- Interpretation of results
- Performance characteristics of the procedure (applies only to diagnostic procedures)
- Outcomes (applies only to therapeutic procedures)
- Alternative and/or additional procedures to consider
- Complications and their management
- What’s the evidence?