• „ Expert opinion

Mechanical circulatory support. An expert opinion of the Association of Intensive Cardiac Care and the Association of Cardiovascular Interventions of the Polish Cardiac Society

Agnieszka Tycińska1*, Marek Grygier2*, Jan Biegus3, Tomasz Czarnik4, Maciej Dąbrowski5, Rafał Depukat6, Marek Gierlotka7, Monika Gil1, Michał Hawranek8, Tomasz Hirnle9, Marek Jemielity10, Bogusław Kapelak11, 12, Paweł Kralisz13, Wiktor Kuliczkowski3, Mariusz Kuśmierczyk14, Marcin Ligowski10, Paulina Łopatowska1, Mateusz Puślecki10, 15, Andrzej Świątkowski16, Przemysław Trzeciak8, Barbara Zawiślak17, Michał Zembala18, 19, Robert Zymliński3

Reviewers: Wojciech Wojakowski19, 20, Marek A Deja20, 21

1Department of Cardiology, Medical University of Bialystok, Białystok, Poland

21st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland

3Institute of Heart Diseases, Wroclaw Medical University, Wrocław, Poland

4Department of Anesthesiology and Intensive Care, Institute of Medical Sciences, University of Opole, Opole, Poland

5Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warszawa, Poland

6Department of Anesthesiology and Intensive Care, University Hospital, Kraków, Poland

7Department of Cardiology, Institute of Medical Sciences, University of Opole, Opole, Poland

83rd Department of Cardiology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland

9Department of Cardiac Surgery, Medical University of Bialystok, Białystok, Poland

10Department of Cardiac Surgery and Transplantology, Poznan University of Medical Sciences, Poznań, Poland

11John Paul II Hospital, Kraków, Poland

12Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland

13Department of Invasive Cardiology, Medical University of Bialystok, Białystok, Poland

14National Institute of Cardiology, Warszawa, Poland

15Department of Medical Rescue, Poznan University of Medical Sciences, Poznań, Poland

16Intensive Cardiac Care Unit, 1st Department of Cardiology and Angiology, Silesian Center of Heart Diseases, Zabrze, Poland

17Intensive Cardiac Care Unit, University Hospital, Kraków, Poland

18Department of Cardiac Surgery, Heart and Lung Transplantation and Mechanical Circulatory Support, Silesian Center For Heart Diseases, Zabrze, Poland

19Pomeranian Medical University, Szczecin, Poland

20Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

21Department of Cardiac Surgery, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland

*Both authors equally contributed to this work

Introduction

For the past 20 years, there has been an ongoing search for novel medical therapies aimed at reducing mortality in patients with cardiogenic shock (CS) and acute cardiopulmonary failure. However, as the mortality rate in this population continues to be high, reaching 40% to 50%, the next step is to develop other therapeutic methods, such as mechanical circulatory support (MCS). Unfortunately, the choice of an MCS strategy is currently not supported by a sufficient number of studies providing unequivocal data. Precise recommendations for the use of MCS are also lacking.

The multivariable risk-benefit profiling to select patients for MCS requires a multidisciplinary approach, with the involvement of a Heart Team including a general cardiologist, an invasive cardiologist, an intensivist, a cardiac surgeon, and other specialists if needed. Due to advanced technology, current MCS systems enable full recovery of circulatory function, thus improving longevity and the quality of life of patients. Guidelines developed by American and European societies support the use of MCS to achieve full or partial ventricular support and adequate end-organ perfusion in patients with acute and chronic heart failure (HF), in whom all other medical or surgical treatments have failed. The management strategy depends on disease etiology, comorbidities, social and family history, as well as the experience of the implanting center. The choice of the MCS method, including the duration (short-, mid-, or long-term), type, and the extent of support, depends primarily on the patient’s clinical status at the time of decision-making and destination therapy. In some patients, MCS is used as a bridge to transplant or a bridge to candidacy (BTC), while in others — as a bridge to recovery (BTR). Moreover, MCS may serve as a destination therapy for patients with contraindications to orthotopic heart transplantation (OHT) and as a bridge-to-decision (BTD) therapy for patients with acute HF (AHF) complicated by sudden cardiac arrest, who have an uncertain prognosis.

In this expert opinion statement, we discuss current approaches to MCS, as well as the management of intensive cardiac-care patients who require this type of treatment.

Indications for mechanical circulatory support

Patients with acute coronary syndromes complicated by cardiogenic shock

The major indication for MCS in patients with acute coronary syndrome is refractory CS complicating acute myocardial infarction (MI). Numerous MCS devices are available, with the 3 most popular being an intra-aortic balloon pump (IABP), a percutaneous ventricular assist device (VAD), such as Impella or TandemHeart, and venoarterial extracorporeal membrane oxygenation (VA-ECMO). They can be applied either alone or in combination and may provide right ventricular, left ventricular (LV), or biventricular support. According to the current European Society of Cardiology (ESC) guidelines, in patients with CS refractory to inotropic/vasopressor drugs, the early use of short-term MCS should be considered as a BTR or as a BTD on long-term VAD, OHT, or therapy withdrawal [1, 2]. IABP may be considered in patients with CS, including treatment of the mechanical complication of acute MI or as a BTD on long-term MCS or OHT. However, IABP is not routinely recommended in post-MI CS.

To date, observational and randomized studies on MCS did not reveal any notable benefits in terms of improved survival in patients with CS complicating acute MI. Therefore, while awaiting further evidence, it seems that the most appropriate approach to the selection and use of the MCS device is for each center to develop a detailed protocol for the management of patients with CS complicating acute MI. The optimal timing for the initiation of MCS seems to be “classic” CS (stage C according to the Society for Cardiovascular Angiography and Interventions classification), with lactate levels higher than 2 mmol/l and before the onset of severe multiple organ injury. The selection between a percutaneous VAD and VA-ECMO should be guided primarily by the experience of the implanting center, both in terms of device implantation skills and patient management at the intensive cardiac care unit, and secondarily, by equipment availability.

Patients with acute heart failure

According to the recent 2021 European Society of Cardiology (ESC) guidelines, in patients with AHF, short-term MCS may be necessary to increase cardiac output and improve organ perfusion. Short-term MCS can be considered as a BTR or BTD [2]. Recent studies have shown that using a “standardized team-based approach” and predefined algorithms for early MCS implantation, supported by close monitoring (invasive hemodynamics, lactate levels, markers of end-stage organ damage), may potentially improve survival [3].

Mechanical circulatory support should be first considered in patients with AHF or CS with a high potential for recovery (e.g., in the course of myocarditis, peripartum cardiomyopathy, or Takotsubo syndrome) [2]. However, selecting an appropriate device remains a challenge owing to the lack of data from large randomized controlled trials. Although the guidelines do not recommend routine use of an IABP in patients with CS [2], it may still be considered in patients with hemodynamic instability, especially that of non-ischemic etiology and refractory to drug therapy, as a BTD or BTR. Other short-term MCS devices were compared with IABP in small randomized trials with inconclusive results [4]. Impella and TandemHeart were shown to offer greater hemodynamic benefits vs IABP in patients with CS, although without effect on survival [5]. Therefore, IABP remains the most common MCS device. High-quality evidence on the use of Impella in patients with CS without acute MI is lacking.

It was shown that VA-ECMO offers a high degree of biventricular support in a wide range of clinical scenarios. Therefore, it is increasingly used as the first-line strategy in patients requiring MCS [6,7]. Aso et al. [8] reported significant benefits of VA-ECMO use in combination with IABP vs VA-ECMO alone in patients with CS, including improved survival and a higher proportion of patients weaned from VA-ECMO. The use of Impella in patients on VA-ECMO support (ECMELLA) was also reported to improve treatment outcomes [9]. The use of MCS (ECMO, Impella RP) may be also considered in isolated acute right HF [10,11].

Short-term mechanical circulatory support in interventional cardiology

In interventional cardiology, indications for percutaneous left VAD (LVAD) implantation may be both urgent and elective. Urgent indications are directly related to the patient’s clinical status and were described above. This refers primarily to patients with CS or acute ischemic HF who require concomitant coronary procedures.

The need for elective LVAD implantation results from the changing profile of patients undergoing percutaneous coronary interventions (PCIs). There is currently no universal definition of complex and high-risk indicated PCI (CHIP). Nevertheless, in recent years, a range of factors associated with higher procedural risk have been identified (Table 1) [10, 12]. In severe peripheral vascular disease, alternative access, such as a subclavian or axillary artery, may be considered. The use of axial-flow pumps is contraindicated in severe aortic stenosis or moderate/severe aortic regurgitation. Patient eligibility for percutaneous LVAD implantation during CHIP should be determined by a Heart Team. The decision-making should be guided by cardiac output, the presence of comorbidities, the duration of support, the risk of bleeding, as well as ischemic events associated with the planned coronary intervention and the type of MCS device used, including the risk of local complications.

Local complications (bleeding, hematomas, limb ischemia) constitute an important limitation to the use of percutaneous LVAD. Therefore, it is necessary to puncture properly and to secure hemostasis after the procedure. Notably, the risk of complications increases with a longer duration of LV support. Therefore, in the case of elective CHIP procedures, an optimal approach is to remove the device on completion of the procedure. A comparison of available percutaneous ventricular assist devices, their characteristics, and hemodynamic effects is presented in Table 2.

Short- and long-term mechanical circulatory support

Orthotopic heart transplantation remains the treatment of choice for patients with end-stage HF, mainly because of very good long-term outcomes. Thanks to advanced technology, the implantation of MCS devices (particularly centrifugal continuous-flow LVADs) was shown to yield similar 5-year outcomes as OHT. Considering a limited number of donors, the differences between the bridge to transplant and destination therapy strategies are becoming increasingly less distinct, and this tendency will be even more pronounced in the future. The use of MCS as a BTT therapy is summarized in Table 3.

Extracorporeal membrane oxygenation support from the perspective of an interventional cardiologist, AN intensivist, and a cardiac surgeon

Interventional cardiology

There is a general agreement that access to an effective MCS device is needed in at least 2 clinical scenarios in the setting of interventional cardiology: during a PCI in patients with MI complicated by CS and in patients undergoing CHIP. Since the publication of the IABP-SHOCK II study, which revealed significant limitations to IABP use, there has been an increasing interest in other MCS strategies, including VA-ECMO [13, 14].

Originally used in cardiac surgery, VA-ECMO has become an indispensable part of modern intensive care. In Poland, the vast majority of MCS equipment can be found at cardiac surgery and intensive care units, outside the catheterization laboratories. It is widely acknowledged that time is a key factor in interventional treatment for ST-segment elevation myocardial infarction and CS. Relocating and launching VA-ECMO in the catheterization laboratory necessitate an immediate decision and highly effective team cooperation based on simple and clear management algorithms. Unfortunately, the lack of such guidelines hinders the application of VA-ECMO. Moreover, the prolonged VA-ECMO use in patients with CS increases afterload, and, in some patients, the lack of LV decompression causes progressive distention with profound LV failure. In such cases, additional or supportive active-unloading therapy with a percutaneous axial-flow pump (ie, Impella) is mandatory. This might improve survival and reduce the long-term risk of HF caused by LV overload. However, such a combined MCS strategy for CS entails additional risk, with vascular complications in the first place. Retroperitoneal hemorrhage, arterial laceration from the use of large-bore femoral cannulas, and distal limb ischemia underlie the subsequent higher need for transfusion and the risk of acute kidney injury. Thus, meticulous use of the procedure with the help of a vascular surgeon and/or safety devices is highly recommended. All things considered, it must be emphasized that the complexity and cost-effectiveness of the combined approach are high and the number of studies reporting such benefits is limited [9, 15].

The decision on whether to use hemodynamic support in patients undergoing CHIP remains a challenge, with the widely available risk scores (Euroscore II, Syntax I, and II) being of limited supportive value for decision-making. On the one hand, the individual patient’s characteristics should be assessed, including comorbidities, LV function, previous revascularization procedures, as well as the estimated duration and complexity of PCI. On the other hand, the feasibility of the procedure in extremely difficult cases (rotational atherectomy, treatment of chronic total occlusion, or distal left main artery stenosis) has to be accurately assessed. It is important to mention the problem of limb ischemia and the possibility of its prevention (both Impella and ECMO) by puncturing the antegrade artery below the site of large vascular access and connecting the sheath with the second arterial access, which ensures the inflow of blood to the limb. It is also important to secure the removal of the device by a vascular surgeon or using a hemostatic system.

The most important aspects to consider in MCS strategy selection depending on a clinical scenario are presented in Table 4.

Intensive care

The typical indications for VA-ECMO in the intensive care setting include refractory CS, massive pulmonary embolism, an overdose of cardiotoxic drugs, or severe hypothermia [16]. The use of VA-ECMO during cardiopulmonary resuscitation in hospitalized patients was reported to increase survival from 20% to 40% [17]. While the institution of ECMO itself does not cure a patient with organ failure, it provides more time to implement therapies aimed at reversing the underlying pathological process.

The key to effective VA-ECMO therapy is a high standard of intensive care achieved and maintained by continuous medical education together with the assessment of therapy outcomes and failures [18]. The intensivist working at an ECMO unit is responsible for blood flow optimization in the ECMO system and a daily echocardiographic assessment of LV emptying. The success of VA-ECMO therapy is also determined by such factors as the availability of a protocol for LV unloading using different strategies, expertise in invasive mechanical ventilation, and the ability to identify and reverse differential hypoxia [19]. The most common modes of LV unloading during VA-ECMO are IABP, percutaneous transaortic LVAD (Impella), atrial septostomy, and direct surgical LV venting. Finally, an important determinant of VA-ECMO success is knowledge of escalation strategies (LVAD, OHT), as well as conscious decision-making skills in terms of therapy de-escalation.

High-flow oxygen therapy seems to be ineffective in the acute phase of CS but may be a useful option in the weaning phase, as it allows shortening of invasive ventilation [35, 36]. Continuous positive airway pressure is a rather simple technique that could be helpful during pre-hospital treatment and in low-equipped units [35]. Noninvasive pressure support ventilation is considered to be the most effective technique of noninvasive ventilation [34, 37], especially in patients with hypercapnia [38, 39].

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