Acute Mechanical Circulatory Support


By low-output syndromes:

Cardiac arrest and cardiogenic shock acute decompensation of pre-existing chronic heart failure: non-ischemic: congenital, iron overload, amyloidosis, postviral, metabolic or ischemic cardiomyopathy, VAD failure (mechanical, electrical, pump thrombus)

 Acute myocardial infarction with right, left or biventricular pump failure

 Mechanical complications of acute myocardial infarction with CA and advanced CS before diagnose and treatment can be established: tamponade, papillary muscle rupture, stunning with severe mitral valve regurgitation, post-infarct ventricular septal defect, left ventricular free wall rupture

 Arrhythmias refractory to medications and electrotherapy: ventricular fibrillation, tachycardia, intractable atrial fibrillation with rapid rate response of supraventricular tachycardia

 Pacer refractory electrical mechanical dissociation: post myocardial infarct, intoxication, electrolyte imbalance, severe hypothermia

 Decompensated severe aortic stenosis, ventricular outflow tract obstruction before cath lab or OR can be reached or is ready to be used

 Prosthetic valve failure: fracture, thrombosis, paravalvular leak

 Restriction of ventricular filling: restrictive pericarditis, myxomas

Valvular regurgitation: endocarditis, rheumatic, traumatic, congenital

 Cardiac tamponade: posttraumatic:stab or gun shoot wounds, autoimmune disease, infection, neoplasm with good 1-year life expectancy

 Acute severe myocarditis /−necrosis: viral, carbon monoxide intoxication, sarcoidosis, autoimmune: post- partum, lupus, giant cell myocarditis

 Prolonged cardiopulmonary bypass, post cardiotomy syndrome (early, late)

 Intoxication: iatrogenic, accidental or suicide related: beta-blocker, cocaine, chemotherapy, smoke

 Cytokine storm (brain damage, sepsis immune response syndrome, chemotherapy)

 Graft failure after heart or heart lung transplantation: donor related etiology, insufficient preservation, rejection related failure (early, late)

 Hypothermia

 Hypoxemia

 Drowning

 Hypertension

 Pheocromocytoma [16]

 Takotsubo syndrome [17, 18]

 Pulmonary hypertension

 Acute right heart/biventricular failure due to pulmonary embolism


Reproduced with permission from Koerner and Jahanyar [15], Lippincott Williams & Wilkins




Table 26.2
Contraindications for peripheral percutaneous aMCS VA-ECMO support over femoral vessels to treat CS and/or CA



















 High cardiac output syndromes: overwhelming proven septicemia, thyrotoxicosis, anemia, shunt syndromes

 Aortic dissection

 Severe aortic regurgitation

 Severe known peripheral vascular occlusive disease

 Intolerance to anticoagulants (including: cerebral hemorrhage, active gastrointestinal bleeding)

Do Not Resuscitate orders

 Expected mortality >95 % (including: unrecoverable heart/lung disease while not being already identified as a transplant or VAD candidate




Prognosis of CS


Incidence and treatment of CS in a 10-year period [19], as well as 30-year trends in the magnitude of, management of, and hospital death rates associated with CS in patients with AMI and acute coronary syndrome have been analyzed recently [2022]. The systolic blood pressure, creatinine clearance, and number of vasopressors are significant predictors of mortality in patients with persistent vasopressor-dependent CS following AMI, despite a patent infarct artery. These prognostic variables may be useful for risk stratification and in selecting patients for investigation of additional therapies [23], and pro- and anti- inflammatory markers like interleukin −6, −7, −8 and −10 predict outcome in AMI complicated by CS [24].

CS is a serious disorder with a high early death rate, but one that is treatable and that, if approached proactively (“aggressively”), can result in full recovery [13, 22]. VA-ECMO is capable to obtain rapid resuscitation, stabilization, and subsequent triage to a more permanent treatment strategy [25]: “bridge-to-decision” means until neurological recovery, cardiac recovery will occur or as “bridge-to-bridge” in case a heart replacement (cardiac transplantation, total artificial heart or biventricular assist device) or LVAD may be indicated after neurological recovery, but irreversible myocardial failure, or until withdrawal of care will be requested or organ donation [26].

The results of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial show that in patients with AMI and hemodynamic compromise who undergo revascularization, the routine use of an IABP, as compared with standard therapy, does not improve survival [27]. On the basis of the findings of the IABP-SHOCK II trial one has to move forward with the understanding that a cardiovascular condition with 40 % mortality at 30 days remains unacceptable [28]. The overall 6-month-mortality of CS patients remained 50 % in accordance with other reports [29]. In case the revascularization with PCI is not successful the mortality had been described as high as 85 % [30]. The immediate use of aMCS may even become equally important as opening the occluded artery in STEMI patients with CS. Eventually, the focus of these patients may therefore shift from door-to-balloon time to door to-sufficient circulatory support time, but only in the light of clinical evidence [31]. Mitral regurgitation is an independent predictor of 1-year mortality in ST-elevation myocardial infarction patients presenting in CS on admission [32].

In regard to post-cardiotomy heart failure otherwise established markers of renal and hepatic failure seem not to be appropriate to predict mortality in the acute stage before extracorporeal life support implantation [33].


History


Based on the pioneering work of Gibbon who developed the first heart-lung machine facilitating open-heart surgery [34], Dennis reported 10 years later about the clinical use of a cannula for left heart bypass without thoracotomy in 1962 [35] followed by Kennedy reporting the use of a pump oxygenator in clinical heart failure by “femoral-vein-to-femoral-artery cannulation in 1966 [36], whereas Hill reported first clinical experience in patients assisted with extracorporeal veno-arterial and veno-venous circulation starting in 1968 [37, 38]. A battery-powered portable cardiopulmonary bypass machine had been used by Mattox in 39 patients whose condition precluded their transport to the OR [39]. Among others Dembitsky used portable ECMO devices for emergency resuscitation and trained a team of in-house personnel to emergently prepare, apply, and temporarily manage cardiopulmonary bypass until personnel with greater specialty training arrived [40].

The 2011 ACCF/AHA/SCAI guidelines present recommendations for circulatory support: “A hemodynamic support device is recommended for patients with CS after STEMI who do not quickly stabilize with pharmacological therapy.” [41] (Level of Evidence B) [13, 29, 4244]. The 2013 ACCF/AHA guidelines for the management of ST-Elevation Myocardial Infarction are stating for the treatment of CS as a Class IIa (Level of Evidence B):

“1. The use of IABP counter pulsation can be useful for patients with CS after STEMI who do not quickly stabilize with pharmacologically therapy“, and as a Class IIa (Level of Evidence C): “alternative LVADs for circulatory support may be considered in patients with refractory CS.” [45]


Indications for AMCS


An aMCS is indicated in CA (witnessed, not longer than 20 min without ROSC) and therapy-refractory CS despite conservative treatment including volume load, inotropes and IABP. The principal benefit of left ventricular assist devices (LVADs) (which encompass pVADs, as well as surgical VADs is to compensate for the loss of myocardial pump function, normalizing cardiac output and thus allowing physiologic perfusion of vital organs, especially if this can be achieved where the CA and/or CS manifested first [15, 4648]. Some pVads can only be placed with additional imaging inside a hospital or even require always a cath lab due to the need of additional imaging [49, 50]—therefore they are called here sMCS not aMCS. Peripheral VA-ECMO are shown to improve survival in AMI with CS [5154] or CA [5557].


Guidelines


Important especially for cardiologists focusing on Critical Care Cardiology [58] the 2011 ACCF/AHA/SCAI guidelines presenting straight forward recommendations for acute mechanical circulatory support: “A hemodynamic support device is recommended for patients with CS after STEMI who do not quickly stabilize with pharmacological therapy.” [41] (Level of Evidence B) [13, 29, 4244], and the 2013 ACCF/AHA guidelines for the management of ST-Elevation Myocardial Infarction are stating for the treatment of CS as a Class IIa (Level of Evidence B): “1. The use of IABP counter pulsation can be useful for patients with CS after STEMI who do not quickly stabilize with pharmacologically therapy.“, and as a Class IIb (Level of Evidence C): “alternative LVADs for circulatory support may be considered in patients with refractory CS.” [45].

Required and expected features for an excellent peripheral insertable aMCS to beat the “time is tissue” reality: easy to assemble, fast to apply, and easy, effective, as well as safe to use where and when needed (“KISS” keep it stupid simple: no paralytics, no cath lab).


Cardiac Arrest


It is being estimated that 300,000 CA occur each year in the United States, with 50 % happening out-of hospital and the other half to patients in a hospital setting [3, 59]. Based on the findings of Goldberger’s observational study which suggest that efforts to systematically increase the duration of resuscitation could improve survival in high-risk patient [60] we suggest in addition that patients who having a witnessed in-hospital CA and who do not achieve ROSC after a duration of 10 min of Advanced Cardiovascular Life Support (ACLS) based high-quality CPR should always additionally be presented to an ECMO team for possible placement of percutaneous VA-ECMO in the absence of contraindication for ECMO.


Out-of-Hospital Cardiac Arrest: Prognostic Aspects


Approximately 92 % of persons who experience a out-of-hospital CA in the US die [3]. Predictors of survival from out-of-hospital CA have been evaluated in a systematic review and meta-analysis [61]. ECMO has been proposed as the ultimate heroic rescue in prolonged CA unresponsive to conventional CPR [5557, 62, 63]. The effectiveness of ECMO in out-of-hospital CA remains debated [64, 65]. A rule for termination of CPR in out-of-hospital CA has been validated prospectively to get an universal prehospital termination of resuscitation clinical prediction rule for advanced and basic life support providers [66], but Morrison did not report that the use of an aMCS like a percutaneous VA-ECMO for some of the patients with CA had been considered to be a therapeutic option at any point before the termination of resuscitation or transport to a hospital [67].

ROSC after prolonged, complete, whole-body ischemia is an unnatural pathophysiological state created by successful CPR [68, 69]. Modest, but significant predictors of neurological outcome and mortality in patients after CA as compared to neuron-specific enolase seem circulating microRNAs to be [70]. In addition procalcitonin might be an ancillary marker for outcome prediction after CA treated by induced hypothermia [7173]. Clinical predictors for in-hospital mortality are unsuccessful angioplasty, asystole or pulse less electrical activity before ECMO introduction, and ECMO-related complications [8].

Rescue by temporary aMCS like VA-ECMO provides an ultimate therapeutic option with good outcomes in patient after a period of prolonged CA [63].

Out-of hospital percutaneous VA-ECMO implantation during refractory CA after witnessed drowning [47] (Fig. 26.1) or asystolic CA in a half-marathon runner [46] (Fig. 26.1) demonstrate the clinical potential and could be considered for protocol based prospective multicenter studies [74].

A305000_1_En_26_Fig1_HTML.gif


Fig. 26.1
Rescue by temporary aMCS like VA-ECMO provides an ultimate therapeutic option with good outcomes in patient after a period of prolonged CA [63]. Out-of hospital percutaneous VA-ECMO implantation during refractory CA after witnessed drowning (Reprinted from Arltet al. [47] © 2011, with permission from Elsevier) (a) or asystolic CA in a half-marathon runner (Reprinted from Lebreton et al. [46] © 2011, with permission from Elsevier) (b) demonstrate the clinical potential and could be considered for protocol based prospective multicenter studies [74]

Out-of hospital CA with in-hospital ECMO implantation was found to have poor outcome suggesting that the implantation and use of ECMO should be more restricted following out-of-hospital refractory CA [75]. SpvO2 was found to be useful in witnessed refractory in-or-out-of hospital CA to predict the inability of maintaining refractory CA victims on ECMO without detrimental capillary leak and multi organ failure until neurological evaluation [76]. The level of lactic acid at 48 h after CA is an independent predictor of mortality and unfavorable neurologic outcome. Persisting elevated lactic acid over 48 h predicts a poor prognosis [77]. At this point in time it is still recommended that a multimodal approach to neurologic prognostication post CA has to be utilized [78]. The ethical appropriateness of out-of-hospital use of aMCS like percutaneous VA-ECMO especially if it carries the potential not only to achieve full recovery of the patient in CA and/or CS, but also to prolong life for possible organ donation in case the individual patient may become brain dead or decease due to withdrawal of care (cardiac or circulatory death), Controlled Donation after Circulatory Death needs to be discussed [7981].


Acute Ischemic Myocardial Infarction with CS


Left main coronary artery transradial rescue percutaneous coronary intervention for AMI complicated by CS with Impella® ventricular mechanical support [82], advanced heart failure, therapy-refractory cardiogenic shock.


Right Heart Failure


As an aMCS a percutaneous centrifugal pump [83] or as sMCS the TandemHeart® [8486] or when FDA approved for sale the Impella RP RV® support system (Abiomed, Danvers, MA, USA).


Allograft Failure


Percutaneous mechanical circulatory support to treat severe allograft failure [8790].


Pulmonary Embolism


Percutaneous VA-ECMO improves prognosis of hemodynamic instable patients with massive pulmonary embolism [91] and such treated additionally with catheter-based interventions [92].


Trauma


Extracorporeal life support in patients with severe trauma evolved as an advanced treatment strategy for refractory clinical settings [93, 94].


Poisoning Induced CA and Therapy-Refractory CS


ECMO may improve survival of critically ill poisoned patients who experiencing CA and severe CS refractory to conventional treatment [63, 95, 96].


Peri- and Postpartum


Percutaneous aMCS VA-ECMO here are also lifesaving tools [97, 98].


Acute and Subacute Mechanical Circulatory Support Devices



Intra-Aortic Balloon Counter Pulsation


IABP was introduced in 1968 [99] into clinical practice. IABP has long been the mainstay of mechanical therapy in the treatment of infarction-related CS [13, 99105] and was considered to be capable to lower mortality [44], but in the randomized IABP SHOCK Trial IABP did not reduce elevated levels of IL-6 levels which is known to be a strong predictor of adverse outcome [102]. Also the results of the Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction (CRISP AMI) [106] are helping to clarify the existing controversy about observation of lack of IABP effectiveness in high-risk percutaneous coronary interventions without CS [27, 105, 107, 108].

Devices being used as aMCS and sMCS and some of their specifics are listed in Table 26.3 such as:


Table 26.3
Percutaneous placeable aMCD and sMCD to treat therapy-refractory CS and CA





















































































Device

Pump

Pump location

Flow type (l/min)

Assisted ventricle

Comment

Duration
 

Impella LP 2.5® Impella 5.0®

Axial flow

Left ventricle over transaortic valve passage

Non pulsatile (2–5)

LVAD (possible use as RVAD)

TEE, exact positioning hemolysis, hyperglycemia

Days
 

TandemHeart®

Centrifugal

Extracorporeal over femoral vein with transseptal insertion into left atrium

Nonpulsatile (2–4)

LVAD (possible use as RVAD)

cath lab, left atrial perforation/tamponade

Days
 

Biomedicus®

Centrifugal

Extracorporeal over femoral vessels possible

Nonpulsatile (5–10)

LVAD (possible use as RVAD)

Portable, hemolysis

Days
 

CentriMags®

Centrifugal

Extracorporeal over femoral vessels possible

Nonpulsatile (4–9)

LVAD (possible use as RVAD)

Portable

Weeks
 

Rotaflow®

Centrifugal

Extracorporeal over femoral vessels possible

Non pulsatile (4–5)

VA-ECMO

Portable

Weeks
 

CardioHelp®

Centrifugal

Extracorporeal over femoral vessels possible

Non pulsatile (4–5)

VA-ECMO

Portable

Days
 

LifeBridge®

Centrifugal

Extracorporeal over femoral vessels possible

Non pulsatile (4–5)

VA-ECMO

Portable

Days
 


Centrifugal Pumps

Centrifugal pumps like the Revolution Centrifugal Blood Pump® (Sorin Group Italia S.r.l.TM, Milano, Italy), the Biomedicus ® (Medtronic Inc., Minneapolis, MN, USA) [40, 46, 55, 109112], Rotaflow® pump (Maquet, Wayne, NJ, USA) [22, 63, 90] or Sarns Delphin® pump (Terumo Inc., Ann Arbor, MI) [8] are lifesaving tools which allow the time saving percutaneous placement of VA-cannulas in the femoral vessels out-of-hospitals or out-of-cath-lab to establish the necessary circulatory support.


Portable Mobile aMCS ECMO Systems

There are currently two FDA approved portable mobile aMCS ECMO systems for percutaneous use available: the CardioHelp System® (Maquet, Wayne, NJ, USA), and the LifeBridge B2T® (Lifebridge North America Inc., San Antonio, TX) [113].


CentriMag®

The CentriMag® ECMO device: The CentriMag® (Thoratec Inc., Pleasanton, CA, USA) ECMO device consists of a single use centrifugal pump, a motor, a console and a flow probe. The low-pressure drop Quadrox D® oxygenator (Maquet, Wayne, NJ, USA) is attached in the circuit [2, 114, 115]. In a multicenter trial the short-term support for patients with CS with this device demonstrated a low incidence of device-related complications and no device failures [116]. It can also be used as an aMCS as pLVAD [97] or percutaneous RVAD [83].


Devices (sMCS)



Impella®

The Impella LV® support device (Abiomed Inc., Danvers, MA, USA) uses a miniaturized axial flow pump and can be used alone [117119], combined with IABP [120, 121] or other ventricular assist devices [83, 122]. The Impella RP RV® support system design is based on the Impella 5.0® and can be used as a percutaneously applicable RVAD.


Tandem Heart®

The Tandem Heart® (Cardiac Assist Inc., Pittsburgh, PA, USA) is a useful tool in selected patients who are already hospitalized and a cath lab or an operating room is available [123, 124]. This sMCS has clearly an indication as pLVAD as a bridge to recovery from myocarditis when sufficient left ventricular unloading may not be achievable by percutaneous aMCS VA-ECMO without atrioseptostomy [125], the patient does not present with therapy-refractory CS and no concerns for relevant perforation during the atrioseptostomy due to acute inflammatory changes with possible fragile myocardium exist. Variations of placement of the TandemHeart® e.g. as pLVAD [126] or as pRVAD [8486] in combination with e.g. the Impella 2.5® percutaneous device for left ventricular unloading have been reported [89].


Future Trends


The worldwide successful use of aMCS which are peripherally percutaneously applicable as VA-ECMO to rescue patients in CA and/or therapy-refractory CS even in out-of-hospital scenarios has been performed already years ago, but evolved more within the last 5 years, passing the visionary and pioneering stage [15, 40].

A wet-primed ECMO circuit with hollow-fiber membrane oxygenator can be stored for up to 2 weeks if prepared according to the protocol recently published by Karimova [127]. Based on this information the access to rapid-response to provide an aMCS like a percutaneous VA- ECMO support for patients in CA and/or CS in a hospital, emergency room or ambulance is feasible.

Mobile ECMO teams being trained and competent in: assessing / triaging patients’ medical indication for aMCS could cover metropolitan areas 24/7, capable to insert percutaneous arterial and venous femoral cannulas to establish sufficient access: in hospital based Emergency Departments [128] or even under out-of-hospital conditions in the field (Fig. 26.1) [47], within an ambulance (Fig. 26.1) [46] where and when needed, capable to start the circuit, to adjust respirator settings and IV medications.

The availability and targeted use of aMCS like percutaneous VA-ECMO as a bridge to decision has been effective to promptly restore adequate systemic perfusion, allowing further time to evaluate cerebral and myocardial recovery or candidacy for long-term VAD, TAH, heart transplantation [129], withdrawal of care and/or donor organ preservation [130, 131]. Beside re-establishing sufficient brain and organ perfusion in a short period of time while keeping the odds and chances for neurological and organ recovery high, a safe transport of these critical ill patients on percutaneous VA-ECMO support to a regional ECMO center can be done [40, 110, 132, 133]. If necessary these transports can be performed across oceans and continents while the patients remains hemodynamically safe on VA-ECMO In case the left ventricle is not going to eject or may stop to eject under the aMCS like the VA-ECMO and developing relevant therapy-refractory pulmonary congestion and edema a percutaneous balloon atrioseptostomy can be performed. This can be done fast as needed, effective and by using minimal invasive techniques for offloading the left heart of patients with the chance of a reversible cardiac dysfunction under VA-ECMO suffering from refractory pulmonary edema [134].

Not FDA approved, but in clinical use in Europe: a minimal invasive technique for decompressing the left ventricle if high left-heart filling pressures during peripheral VA-ECMO continue to exist by using the pulsatile paracorporeal assist device, the iVAC® (PulseCath, Groningen, The Netherlands), which will be implantable through the right axillary artery with a subclavicular incision [135, 136].


Bridge to Decision


The compelling purpose of use an aMCS like a percutaneous VA-ECMO is to prevent hypoxemia and lack of organ perfusion as long as the window of opportunity is existing to prevent or minimize brain and organ dysfunction. Again “time is tissue” and an aMCS is capable to reestablish and secure cardiopulmonary function, as well as to serve as a bridge to decision in patients with refractory acute CS and CA: to decide if cardiac recovery will take place [137], if heart replacement (LVAD, BVAD, TAH, HTx) may be necessary and an appropriate option, if withdrawal of care is justified or eventually organ donation will be possible [26, 130, 131, 138]. Randomized controlled trials in the intensive care unit are lacking, but should be abandoned [139] and other study designs may be considered [74].

“To live is not merely to breathe; it is to act; it is to make use of our organs, senses, faculties – of all those parts of ourselves which give us the feeling of existence”

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Sep 30, 2017 | Posted by in CARDIOLOGY | Comments Off on Acute Mechanical Circulatory Support

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