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The Role of Large Impella Devices in Temporary Mechanical Circulatory Support for Patients Undergoing Heart Transplantation

Written By

Yukiharu Sugimura, Sebastian Bauer, Moritz Benjamin Immohr, Arash Mehdiani, Hug Aubin, Ralf Westenfeld, Udo Boeken, Artur Lichtenberg and Payam Akhyari

Submitted: November 16th, 2021 Reviewed: November 17th, 2021 Published: March 23rd, 2022

DOI: 10.5772/intechopen.101680

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Heart Transplantation - New Insights in Therapeutic Strategies Edited by Norihide Fukushima

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Heart Transplantation - New Insights in Therapeutic Strategies [Working Title]

Prof. Norihide Fukushima

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Abstract

Large microaxial pump systems (Impella 5.0, or Impella 5.5; i.e., Impella 5+) (Abiomed Inc., Danvers, MA, USA) have gained increasing levels of attendance as valuable tools of mechanical circulatory support (MCS). Patients undergoing heart transplantation (HTX) often need temporary MCS in the perioperative course, either as a preoperative bridge or occasionally in the early post-transplant period. Here we present our experience using Impella 5+ support for patients designated to undergo HTX, describe technical aspects of implantation and removal, and further analyze factors influencing the overall patient outcome. Significant factors are discussed in front of the background of contemporary international literature, and current scientific questions are highlighted.

Keywords

  • cardiogenic shock
  • heart failure
  • Impella
  • heart transplantation
  • bridge to transplant
  • temporary mechanical circulatory support

1. Introduction

Impella (Abiomed Inc., Danvers, MA, USA) is a microaxial pump catheter inserted retrogradely into the left ventricle (LV) via the aortic valve to support antegrade blood flow from LV to the ascending aorta by the lifting force of rotation. Due to less invasive closed-chest application and convenient profile, Impella 5+ has attracted an increasing level of attention and widespread use to stabilize CS patients and to provide temporary mechanical circulatory support (MCS) combined with LV unloading.

Patients undergoing heart transplantation (HTX) often need large Impella 5+ as part of temporary mechanical circulatory support (tMCS) in the perioperative course, either as a preoperative bridge or occasionally in the early post-transplant period. However, despite some observational studies the evidence supporting this is yet limited, particularly in the specific cohort of patients awaiting HTX [1]. Therefore, we summarize the reported articles that focused on large Impella for a bridge to transplantation (BTT). Further, we present our experience using Impella 5+ support for patients undergoing HTX and further analyze factors influencing the overall patient outcome.

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2. ECMELLA strategy for a bridge to candidacy

Impella 5+ plays a significant role as part of tMCS in patients considered eligible for a bridge to candidacy. In crash and burn patients suffering from acute cardiogenic shock or refractory decompensated heart failure, physicians are faced with four clinical therapy choices: (1) conservative therapy with adequate inotrope support, (2) tMCS using va-ECMO implantation, (3) tMCS by Impella implantation, and (4) the combination of the latter two represented by so-called ECMELLA concept.

Traditionally, va-ECMO is preferred as the first choice of tMCS for acute or sustained CS, e.g., in the setting of cardiopulmonary resuscitation (CPR), because of its convenience, rapid initiation effect, and stable mode of action. Moreover, patients can be not only supported hemodynamically but also regarding the respiratory situation. However, va-ECMO does not unload the left ventricle (LV), and by increasing the afterload, it may lead to LV congestion, pulmonary edema, and secondary right ventricular (RV) failure. To compensate for these limitations of va-ECMO, a large microaxial pump catheter, i.e., Impella 5+, maybe additionally administrated to obtain the concept of “ECMELLA” support. Herein, Impella enables to provide antegrade flow and unload LV to reduce myocardial oxygen consumption and increase coronary perfusion, which leads to improving pulmonary congestion [2]. Simultaneous use of Impella with va-ECMO contributes to a shift of LV pressure-volume loops to the left, which is particularly effective when a larger microaxial pump is used. This is supported by a simulation study, in which a 23% decrease in end-diastolic LV volume and a 41% decrease in pulmonary capillary wedge pressure has been demonstrated [3].

Regarding the superiority of clinical outcomes of ECMELLA over va-ECMO, a recent meta-analysis sheds new light on patient outcomes [4]. A total of 425 patients (only va-ECMO (n = 312 (73.4%)) and ECMELLA (n = 113 (26.6%)) arising from five retrospective observational comparative studies were selected for this analysis [5, 6, 7, 8, 9]. Although most of ECMELLA cohorts received “small” Impella, i.e., (Impella CP or Impella 2.5; n = 95 (84.1%), Impella 5.0; n = 18 (15.9%)), study results prompted the authors to suggest that ECMELLA strategy might contribute to lower mortality with a reasonable potential to improve the hemodynamic status and promote bridge to recovery or to the next therapy, i.e., pMCS or HTX. Further observational/meta-analysis studies support this hypothesis [10, 11, 12]. Further, the multicenter cohort study “STOP-SHOCK” shows a 21% reduction in 30-day mortality in propensity-score matched patients with LV unloading by Impella (thereof n = 14 with Impella 5.0; (5.5%)) despite a higher rate of bleeding or ischemic complications versuscontrols with ECMO alone (n = 255 per each group) [13]. At present, although no randomized, controlled trial exists, we can conclude that a growing body of evidence may favor the effectiveness of ECMELLA strategy on clinical outcomes. As far as timing of Impella implantation under va-ECMO is concerned, “STOP-SHOCK” has indicated that early LV unloading, i.e., before or within 2 hours after va-ECMO initiation, was associated with lower 30-day mortality (hazard ratio 0.76, P = 0.03). In contrast, delayed LV unloading, i.e., >2 hours post va-ECMO, revealed no significant effect of LV venting on 30-day mortality according to subanalysis. In another prospective observational study termed “HACURE” from Hannover in Germany, the efficacy and safety of early MCS escalation therapy, i.e., ECMELLA has been evaluated. Although the authors did not specify the exact time window between the first MCS device and the implementation of the second MCS device, the study showed a reasonable survival rate (survival on MCS 61%, at 30 days 49%, 6 months 40%) and acceptable safety (hemolysis in 55%, major TIMI bleeding in 1%, limb ischemia in 9%) [14]. In summary, ECMELLA strategy involving an early initiation of LV unloading with large Impella under va-ECMO is a promising approach for better clinical outcomes, and this strategy may contribute to improved progression to the next therapy step beyond “bridge to candidacy”, i.e., “bridge to pMCS” or “bridge to transplant.”

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3. Role for a bridge to pMCS/HTX strategy

In fact, how many Impella 5+ patients could be successfully bridged to pMCS/HTX? A comprehensive search of the database “Pubmed” up to September 20, 2021 in English has been conducted. Studies that focused on clinical outcomes inclusive transition to pMCS/HTX in consecutive series of adult patients (>18 years) with CS utilizing a large Impella system, i.e., Impella 5+, were included. Case reports were excluded. In the interest of comparable results, studies that did not mention the size of applied Impella were also excluded. Some studies contained patients with various sizes of Impella or with other LV unloading systems. These were also excluded because of a small cohort of large Impella systems and mixed effects. Finally, a total of 6 observational studies were signed up (Table 1) [15, 16, 17, 18, 19, 20].

PublicationPatients
AuthorYearImpellaTotalECMELLADeceased at dischargeSuccessfully weanedTransition to pMCS
TotalLVADHTX
TotalLivingTotalLiving
Chung et al.20205.010010 (10.0)38 (38.0)14 (14.0)51 (51.0)14 (14.0)11 (78.6)37 (37.0)37 (100)
Tarabichi et al.20205.0409 (22.5)21 (52.5)11 (27.5)8 (20.0)6 (15.0)N/A2 (5.0)N/A
Seese et al.20205.023614 (5.8)N/A31 (13.1)144 (61.0)87 (37.0)N/A57 (24.1)55 (96.5)
Nelson et al.20215.0344 (11.8)8 (23.5)*13 (38.2)*10 (29.4)8 (23.5)8 (100)2 (5.9)2 (100)
Bernhardt et al.20215.54614 (30.4)13 (28.3)16 (34.8)20 (43.5)19 (41.3)17 (89.5)**1 (2.2)1 (100)
Sugimura et al.20215+5038 (74.0)25 (50.0)17 (34.0)8 (16.0)6 (12.0)6 (100)2 (4.0)2 (100)

Table 1.

Overview and outcomes of large Impella with a focus on the transition to pMCS/HTX.

Data documented as n (%). ECMELLA, venous–arterial extracorporeal membrane oxygenation+Impella; HTX, heart transplantation; LVAD, left ventricular assist device; N/A, no available data; pMCS, permanent mechanical circulatory support; *, at 30 days; **, at 90 days; 5+, Impella 5.0 or 5.5.

Because the patient cohort of each study was heterogeneous, e.g., proportion of ECMELLA patients varying between 10 and 74%, the mortality rate of each study also differed (23.5–50%). However, patients who were successfully weaned from Impella 5+ were 13.1–38.2% of total patients. On the other hand, 16–61% of patients were successfully bridged to pMCS/HTX. Of note, patients who were successfully bridged to pMCS/HTX obtained favorable clinical outcomes. Strikingly, almost all patients who underwent HTX survived until discharge. Seese et al.reported that 24% (n = 57) of all patients on the waiting list for HTX being on Impella 5.0 support (n = 236) finally experienced HTX, in whom post-transplant survival rate was excellent as 96.5% at 30-day, 93.8% at 90-day, and 90.3% at 1-year follow-up [19]. Despite no information of simultaneous use of va-ECMO (ECMELLA), Lima et al.also reported that 75% of patients in the bridge to pMCS/HTX group treated with Impella 5.0 were successfully transferred to subsequent therapy (left ventricular assist device (LVAD) or HTX), and survival rate at discharge was 93% (HTX) and 87% (LVAD) in these groups, respectively [21].

As a study for the superior function of preconditioning of Impella 5+ for direct bridging to HTX, Nordan et al.performed a retrospective analysis comparing MCS by Impella with IABP support. In this study, all patients were supported with either “solo” LV unloading (most of all; Impella 5.0) or IABP. They observed that the post-transplant survival rate is comparable between Impella-bridged patients and IABP-bridged patients despite higher operative risk in Impella-bridged patients.

In summary, although there are no randomized comparative studies about clinical outcomes between groups with and without Impella 5+ in CS patients and we cannot make definitive statements in this field yet, we suppose that large Impella systems most likely offer a valuable contribution to preconditioning of CS patients and to bridging strategies to pMCS/HTX, and furthermore, these strategies are associated with excellent postoperative clinical outcome.

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4. Expected role for a bridge to recovery in post-transplant phase

After HTX, comprehensive therapy is required for recovery. We sometimes encounter life-threatening complications. Primary graft dysfunction (PGD) is one of the critical complications and might occur in 2-28% of patients in the acute phase after HTX [22]. In PGD, mortality is reported to be as high as up to 85% [22]. The primary clinical manifestation of PGD is LV failure, which is affected by various factors, e.g., age and ischemic time of donor, acute rejection [23, 24]. Thus, most patients require MCS, e.g., va-ECMO support or temporary ventricular assist device (VAD) in PGD. A recent study has indicated that va-ECMO initiation due to “early graft failure,” defined as the need of va-ECMO within the first 24-hours post-HTX, might be associated with a worse survival rate at 1 year (36%) and 5 years (28%) when compared to outcome in patients without early graft failure [25]. On the other hand, as far as temporary extracorporeal centrifugal VAD, i.e., CentriMag (Levitronix, LLC, Waltham, MA, USA) is concerned, a retrospective study of CentriMag utilization in the setting of PGD in 34 post-HTX patients reported that CentriMag support contributed to the salvage of 32% patients with severe PGD (survival rate at 30 days; 50%, at 1 year; 32%) [26].

The efficacy of Impella is theoretically comparable to that of CentriMag when used as a temporary VAD. Because of its convenient use, Impella will be the preferred system for the management of PGD. However, no studies have been yet reported, to the best of our knowledge. We suppose that Impella certainly must have been used as a bridge to recovery tool in the early post-HTX phase in clinical practice. Due to limited cases of PGD, no robust data have been published so far. More studies are warranted to evaluate the role of standard and primary utilization of Impella for PGD.

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5. Our experience

5.1 Background

At our institute, Impella 5+ has been utilized since November 2018. We reported our initial experience with the first 50 consecutive cases treated with Impella 5+, in which patients were enrolled in the observation period between November 2018 and August 2020 [15]. However, meanwhile more patients have been treated with Impella 5+ at our institution. In front of this background, we would like to discuss the clinical role and the clinical outcomes of Impella 5+ in the setting of a bridge to HTX. As described, reports on the role of Impella 5+ in the context of the bridge to HTX are still scarce. Thus, we designed a single-center observational retrospective study to identify the clinical outcome of large Impella-bridged HTX and to elucidate the usefulness of the large Impella system as a temporary MCS in a larger patient cohort.

5.2 Study population

At our institute from November 2018 up to September 2021, a total of 102 Impella 5+ were utilized for MCS in 89 patients. Finally, pMCS implantation or HTX were performed in 12 of them (13.5%), in whom 11 patients were directly bridged to pMCS/HTX under Impella 5+ support, whereas 1 patient underwent HTX after successfully weaning of Impella 5 at the current admission.

LVAD implantation as primary pMCS was performed in 8 patients whose therapy concept was “BTT” for 7 patients and “destination therapy (DT)” for 1 patient because of his advanced age (76 years old).

Direct HTX were performed in 4 patients (primary HTX; n = 3, secondly HTX; n = 1). Further, HTX following LVAD after Impella 5+ support was also performed in 5 patients, who build up 62.5% of patients who underwent LVAD implantation as primary tMCS after Impella 5+ support. Thus, a total of 9 patients (10.1%) underwent HTX after Impella 5+ support (Figure 1).

Figure 1.

Flow chart of the study population for analysis. BTT, bridge to transplant; DT, destination therapy; HTX, heart transplantation; LVAD, left ventricular assist device.

5.3 Patients characteristics

Table 2 shows baseline clinical characteristics of 11 patients (BTT n = 7, direct HTX n = 4), without 1 DT patient. The most common underlying disease for Impella implantation was ischemic cardiomyopathy (ICM) (n = 7, 63.6%), followed by dilated cardiomyopathy (DCM; n = 2, 18.2%). Three patients were post-CPR, and a combination of va-ECMO plus Impella, referred to as ‘ECMELLA’ was administrated in 7 patients (63.6%). In all eleven cases, implantation of Impella 5 was performed via the right subclavian artery.

Patients (n = 11)
Age (y)52.4 ± 9.8
Male, n (%)10 (90.9)
Arterial hypertension, n (%)5 (45.5)
Hyperlipidemia, n (%)5 (45.5)
Diabetes, n (%)4 (36.4)
Peripheral vascular disease, n (%)1 (9.1)
Arrhythmia, n (%)3 (27.3)
COPD, n (%)0 (0.0)
Nicotine abuses, n (%)5 (45.5)
Drug abuses, n (%)0 (0.0)
Dialysis, n (%)0 (0.0)
History of PCI, n (%)3 (27.3)
post CPR, n (%)3 (27.3)
Biventricular failure, n (%)7 (63.6)
ICM, n (%)7 (63.6)
DCM, n (%)2 (18.2)
Myocarditis, n (%)1 (9.1)
Heart transplant rejection, n (%)1 (9.1)
va-ECMO implantation, n (%)7 (63.6)
Upgrade from Impella CP, n (%)4 (36.4)

Table 2.

Baseline clinical characteristics.

Data documented as n (%) or mean ± standard deviation. COPD, chronic obstructive pulmonary disease; CPR, cardiopulmonary resuscitation; DCM, dilatative cardiomyopathy; ICM, ischemic cardiomyopathy; PCI, percutaneous coronary intervention; va-ECMO, venous–arterial extracorporeal membrane oxygenation.

5.4 Clinical outcomes

Table 3 shows the clinical course of MCS in 11 patients successfully bridged to pMCS/HTX. Impella 5+ support time was 17.4 ± 15.6 days (median 12 days) for bridge to pMCS/HTX in 11 patients. It means that patients underwent either LVAD implantation or HTX on average after 17.4 days following Impella 5+ initiation.

PatientPre pMCS/HTXpMCS/HTX
ECMELLAva-ECMO ex?Impella ex?tRVAD?
1YesNoNoLVAD/tRVAD(HTX)
2YesYesNoNoLVAD/tRVAD(HTX)
3NoNoLVAD(HTX)
4YesYesYesNoHTX
5YesYesNoYesHTX
6YesYesNoNoLVAD/tRVAD(HTX)
7YesNoNoLVAD/tRVAD(HTX)
8NoNoLVAD
9NoNoHTX
10NoNoLVAD
11YesYesNoNoHTX

Table 3.

Clinical course in 11 patients successfully bridged to pMCS/HTX.

ECMELLA, venous–arterial extracorporeal membrane oxygenation+Impella; ex, explantation; HTX, heart transplantation; LVAD, left ventricular assist device; pMCS, permanent mechanical circulatory support; tRVAD, temporary right ventricular assist device; va-ECMO, venous–arterial extracorporeal membrane oxygenation; −, not applicable; (HTX), indirect HTX.

In 5 of 7 ECMELLA patients, va-ECMO explanation was performed before pMCS/HTX, of whom 1 patient required a temporary right ventricular assist device (tRVAD). As described, 1 patient underwent HTX after successful weaning of Impella 5 at the same admission (patient 4).

Among LVAD patients (n = 7), simultaneous tRVAD was required in 4 patients for postoperative management.

All 11 patients survived the first 30 days after pMCS/HTX operations. However, 2 patients (patients 9, 11) died of septic shock (after 129 days, 122 days, respectively) after HTX. The latter patient was after secondly HTX due to heart transplant rejection.

As far as complications of Impella 5+, a re-implantation of Impella 5+ was necessary total in 3 patients due to (1) Impella thrombosis (n = 2), and (2) Impella dislocation (n = 1). Additionally, Impella dislocation occurred in one more patient. The patient (Patient 10. in Table 3) was directly implanted LVAD.

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6. Conclusion

Our experience shows (1) successful transition to pMCS/HTX of 13.5% (n = 12/89), (2) 30 days survival after bridging to pMCS/HTX of 100%, (3) HTX of 10.1% (n = 9/89), and (4) 30 days survival rate of 100% and in-hospital mortality of 22.2% (n = 2/9) after HTX.

According to already published articles, a large Impella system seems to contribute to preconditioning of CS patients not only for a bridge to pMCS/HTX but also for the excellent postoperative clinical outcome. This hypothesis is supported by 100% post-transplant 30 days survival rate in patients who underwent HTX on Impella 5+ in our study. Using Impella 5+ the majority of patients with ECMELLA due to CS could be successfully weaned from va-ECMO before pMCS/HTX installation. This fact also indicates favorable clinical outcomes of Impella 5+ in CS patients awaiting HTX. However, patient selection and choice of size and timing of Impella support remain the subject of future studies for bridging strategies to pMCS/HTX. As a caution, Impella dysfunction due to thrombosis or dislocation of the pump could occur with the long-term utilization of Impella 5+ for bridge to pMCS/HTX.

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Acknowledgments

We gratefully acknowledge the work of the members of the heart failure team at the University Hospital Duesseldorf.

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Conflict of interest

The authors declare no conflict of interest.

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Written By

Yukiharu Sugimura, Sebastian Bauer, Moritz Benjamin Immohr, Arash Mehdiani, Hug Aubin, Ralf Westenfeld, Udo Boeken, Artur Lichtenberg and Payam Akhyari

Submitted: November 16th, 2021 Reviewed: November 17th, 2021 Published: March 23rd, 2022