Counterpulsation: A concept with a remarkable past, an established present and a challenging future

International Journal of Cardiology 172 (2014) 318–325

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Review

Counterpulsation: A concept with a remarkable past, an established present and a challenging future Chris J. Kapelios, John V. Terrovitis, Panagiotis Siskas, Christos Kontogiannis, Evangelos Repasos, John N. Nanas ⁎ 3rd Department of Cardiology, University of Athens School of Medicine, Greece

a r t i c l e

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Article history: Received 24 June 2013 Accepted 19 January 2014 Available online 24 January 2014 Keywords: Intra-aortic balloon pump Counterpulsation Cardiogenic shock

a b s t r a c t The intra-aortic balloon pump (IABP), which is the main representative of the counterpulsation technique, has been an invaluable tool in cardiologists' and cardiac surgeons' armamentarium for approximately half a century. The IABP confers a wide variety of vaguely understood effects on cardiac physiology and mechano-energetics. Although, the recommendations for its use are multiple, most are not substantially evidence-based. Indicatively, the results of recently performed prospective studies have put IABP's utility in the setting of post-infarction cardiogenic shock into question. However, the particular issue remains open to further research. IABP support in high-risk patients undergoing PCI is associated with favorable long-term clinical outcome. In cardiac surgery, the use of IABP in cases of peri-operative low-output syndrome, refractory angina or ischemia-related mechanical complications is a usual, but poorly justified strategy. Anecdotal cases of treatment of incessant ventricular arrhythmias, reversal of right ventricular dysfunction and partial myocardial recovery have also been reported with its use. Converging data demonstrate the potential of safe long-term IABP support as a bridge to decision making or a bridge to transplantation modality in patients with heart failure. The feasibility of IABP insertion via other than the femoral artery sites enhances this potential. Despite the fact that several other counterpulsation devices have been developed and tested overtime none has managed to substitute the IABP, which continues to be most frequently used mechanical assist device. © 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction Arterial counterpulsation was first conceived in 1952 by Kantrowitz [1] who managed to increase coronary blood flow by delaying arterial pulse in animal models. Six years later Clauss et al. [2] first described the use of extracorporeal diastolic augmentation through a canula in the femoral artery for the treatment of the failing left ventricle. However, the application of this method of treatment was limited due to the necessity of arteriotomies, the massive hemolysis induced by the contracting device and the failure to corroborate the augmentation of coronary blood flow through the use of the device [3]. In the early 60s Moulopoulos et al. developed an experimental intra-aortic phase-shift balloon pump with the use of carbon monoxide (CO), the inflation and deflation of which were synchronized with the cardiac cycle [4]. Kantrowitz et al. were the first to apply the intra-aortic balloon pump in two patients with refractory cardiogenic shock [5], and one of them survived until discharge from the hospital. Until the early '80s the intra-aortic balloon required two separate surgical procedures for insertion and removal with a consequent high complication rate. However,

⁎ Corresponding author at: 3rd Department of Cardiology, University of Athens School of Medicine, 67 Mikras Asias Street, 11 527 Athens, Greece. Tel.: + 30 210 8236877; fax: +30 210 7789901. E-mail address: [email protected] (J.N. Nanas). 0167-5273/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2014.01.098

in 1980 Bregman et al. announced the successful insertion of the intra-aortic balloon (IABP) with the conventional Seldinger technique through the femoral artery of 25 patients, without any adverse events being reported [6]. The introduction of percutaneous insertion of the IAB must be regarded as a milestone in counterpulsation history. In 1985 the first pre-folded intra-aortic balloons were developed. 2. Effects of counterpulsation on cardiovascular physiology The intra-aortic balloon is inserted via the femoral artery and advanced to the descending thoracic aorta with its tip 2 to 3 cm distal to the origin of the left subclavian artery. After its placement, the IABP is programmed to inflate after the aortic valve closure and to deflate immediately prior to the opening of the aortic valve, a synchronization achieved either by ECG or systematic arterial pressure waveform triggering [7]. The effects of counterpulsation on cardiovascular mechanoenergetics have been well established based on both experimental and clinical data [8–13]. Diastolic augmentation has been proven to cause a decrease in left ventricular pressures, wall tension and work, in peak systolic arterial pressure and cardiac oxygen demand. It also causes an increase in diastolic aortic pressure and coronary blood flow, in ejection fraction and in cardiac output, while mean arterial pressure is not affected or even increases in the compromised failing heart. Moreover, counterpulsation may also lead to favorable effects on the

C.J. Kapelios et al. / International Journal of Cardiology 172 (2014) 318–325

right ventricle by complex and vaguely apprehended mechanisms, such as enhancement of the right ventricular myocardial blood flow and reduction of right ventricular afterload through the enhanced unloading of the left ventricle or dislocation of the interventricular septum. The entire range of the salutary effects of the IABP and especially the physiologic mechanisms through which they are mediated have not yet been elucidated. 3. Current use of the IABP In the United States more than 30% of the patients undergoing some complex cardiac procedure are assisted by an IABP [14], hence contributing to an annual insertion number greater than 200,000 IABPs. The current guidelines for its use regard cardiogenic shock complicating acute myocardial infarction (class I indication, level of evidence B by ACC/AHA [15] and IIb, level of evidence B by ESC [16]), severe ischemia that continues or recurs despite intensive medical therapy, hemodynamic instability in patients before or after coronary angiography and mechanical complications of MI (class IIa indication, level of evidence C by ACC/AHA) [17], as well as adjunctive treatment in cardiac surgery cases with evidence of ongoing myocardial ischemia and/or patients with a subnormal cardiac index (class IIa indication, level of evidence B by ACC/AHA) [18]. From the 16,909 cases of IABP use recorded in the Benchmark Registry [19], 20.6% regarded hemodynamic support prior to or after catheterization, 18.8% cases of cardiogenic shock, 16.1% weaning from cardiopulmonary bypass, 13% pre-operative use in high risk patients and 12.3% cases of refractory, unstable angina. Over the last 50 years remarkable decrease in the eras of acute myocardial infarction incidence and mortality has been witnessed [20], thus reflecting the efficacy of primary prevention and aggressive, invasive, myocardium salvaging techniques such as primary percutaneous coronary intervention (P-PCI) and coronary artery bypass grafting (CABG). However, during the same period, less progress has been achieved regarding cardiogenic shock that complicates myocardial infarction. The incidence of post-MI cardiogenic shock has remained relatively stable during the past decades [21], complicating approximately 5–7% of all MIs. The appearance of CS is a major prognostic factor of morbidity and short-term survival in post-MI patients. Although the in-hospital mortality trends for post-MI cardiogenic shock have shown significant decline in the past 30 years (from 76.1% in 1975 to 45.4% in 2005) [19] cardiogenic shock stays the leading cause of death in patients with AMI [22]. Moreover, the fact that among AMI patients those who survive from CS have the same long-term prognosis as patients without CS renders the timely and effective management of post-MI CS a necessity [23]. 3.1. IABP in post-MI cardiogenic shock The utilization of the IABP in the field of post-MI cardiogenic shock in the early thrombolytic days was established based basically on retrospective studies. Early institution of the IABP in patients experiencing post-MI CS seemed to confer a trend for short- and mid-term survival benefit when compared to the patients of late or no IABP use, trend which remained even after adjustment for several potential confounders (age, smoking status, infarct location, peak CPK values, performance of PTCA, CABG) [24]. Similar results were reported with the concomitant use of the IABP in patients receiving fibrinolysis within 12 h of the appearance of MI with confirmed cardiogenic shock [25]; IABP use was associated with a decrease in in-hospital and 1-year mortality when compared to patients treated with thrombolysis alone [26]. In the prospective SHOCK trial registry [27], 856 patients with postMI cardiogenic shock were evaluated as per the use of thrombolytic therapy (TT) and IABP. The patients were divided in four groups: no TT and no IABP (n = 285), only TT (n = 132), only IABP (n = 279) and both TT and IABP (n = 160). The in-hospital mortality among the

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different groups was 77%, 52%, 63% and 47%, respectively (p b 0.0001). However, the evaluation of the results is hindered by the fact that revascularization rates varied among the groups (18%, 70%, 20%, 68% respectively, p b 0.0001) and revascularization itself significantly affected survival (61% with revascularization vs. 22% without revascularization, p b 0.0001). Drakos et al. [28] essayed to shed light on the issue arising in their single-center cohort study. Eighty one consecutive patients presenting with CS complicating AMI were initially stabilized either with thrombolytic therapy adjunct to IABP or with IABP alone. The two groups had similar outcomes regarding short and mid-term mortality. However, a significant benefit on in-hospital and six-month survival arose with the application of a delayed revascularization strategy and the effect of revascularization on survival remained even after adjusting the two groups as per stabilization method. The TACTICS trial [29] was the first and sole attempt to prospectively and in a randomized manner assess the potential effect of IABP adjunct to thrombolysis in the survival of patients with post-MI CS (Table 1). Fifty seven patients with sustained hypotension or possible CS were randomized either to IABP insertion a median 30 min after thrombolysis or to thrombolysis alone. The median IABP support for the first group was 34 h. Although the 6-month all-cause mortality did not differ significantly between the two groups, when assessed for patients with Killip class III or IV a significant advantage of combined therapy arose. During the 80s and early 90s a large number of cohort studies were reported, demonstrating a significant benefit of an early revascularization strategy [30–34], particularly by means of PCI, on survival of patients presenting with post-MI CS. In the late 90s, the randomized, multicenter SHOCK trial [35] came to corroborate these findings, by demonstrating that early revascularization improves the mid-term survival of patients with AMI complicated by CS, a knowledge thereafter incorporated in the guidelines (class I indication for PCI in post-MI CS by both ACC/AHA and ESC) [16,36]. Similar findings were suggested by the Swiss Multicenter Angioplasty for Shock (SMASH) trial which [37], however, was prematurely discontinued due to slow enrollment. Moreover, after a mean follow-up of 6 years of the patients enrolled in the SHOCK trial, Hochman et al. [38] also demonstrated a significant beneficial effect of early revascularization therapy on long-term survival. These results led to significant changes in the trends of post-MI CS treatment. The reperfusion strategy among CS patients was significantly differentiated during this period, as PCI was largely implemented in the course of time (from 22% of cases in 1990–1994, to 65% in 2000– 2004), eventually marginalizing thrombolysis (from 31% to 18%) and the no-revascularization strategy (from 34% to 11% of cases) whereas the use of CABG also diminished over the same period (from 19% to 7%). The 30-day mortality during the study period decreased conversely to the coincidental increase in PCI use [39]. The current knowledge in regards to the utility of IABP adjunct to PCI in the management of post-MI cardiogenic shock patients can be characterized the least vague. Both retrospective and small prospective studies have yielded contradictive results. In a large cohort of the NRMI-2 [40], in which 750 hospitals were divided into three tertiles (low-, intermediateand high-IABP volume) according to the number of IABP insertions performed in each hospital during a year, high hospital IABP volume (OR = 0.71, 95% CI 0.56–0.90) emerged as an independent predictor of in-hospital mortality, regardless of baseline or hospital characteristics and in-hospital procedures, possibly correlating the salutary effects of the IABP use to personnel experience. As expected, the rates of IABPrelated complications (stroke and bleeding) were concomitantly higher in hospitals with frequent IABP use. Another major parameter which seems to affect the efficacy and safety of IABP use is the timing of its insertion. Patients receiving the IABP prior to intervention demonstrate significantly lower rates of 30-day mortality and major adverse cardiac and cerebrovascular events when compared to those supported by the IABP post-PCI, highlighting the notion that timely, pre-procedural introduction of the IABP and not the use in its own right is the major determinant of its utility [41].

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Table 1 Randomized trials evaluating the effect of IABP use in patients with post-MI cardiogenic shock. Trial

Number of patients

Number of enrolling sites

Time of IABP insertion

Type of reperfusion

Primary endpoint

Outcome

Within 3 h post thrombolysis Immediately after PCI

Thrombolysis

6-month all-cause mortality APACHE II score over 4 days

Before or immediately after PCI

Primary PCI

Trend for decreased 6-month mortality in patients in Killip classes III–IV treated with IABP No significant difference in changes of APACHE II score between the 2 groups Significant decrease of BNP levels when the IABP was in situ No significant difference in 30-day all-cause mortality between the two groups

TACTICS

57

18

IABP SHOCK

45

1

600

37

IABP SHOCK-II

Primary PCI

The first randomized study which investigated the effect of IABP insertion adjunct to primary PCI on multi-organ dysfunction syndrome in patients with post-MI CS was the single center IABP SHOCK trial [42]. Forty five patients with post-MI CS were randomized to receive IABP support or standard treatment on top of PCI. Importantly, IABP was introduced immediately after the execution of PCI. The study failed to demonstrate significantly greater improvement in Acute Physiology and Chronic Health Evaluation (APACHE) II score, cardiac index, inflammatory marker levels and BNP levels with the use of the IABP. Interestingly, while the IABP was still in situ in all patients-until day 3-BNP values were significantly decreased compared to baseline, effect that could no longer be apparent at day 4, when the IABP was removed from most patients. The first large scale randomized trial that attempted to address the issue of the true value of the IABP in the setting of post-MI CS was the ‘Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic Shock’ trial (IABP-SHOCK-II) [43]. Six hundred patients with post-MI CS were randomized in a 1:1 manner to either receive primary coronary intervention alone or combined with IABP support. The implementation of the IABP did not confer any benefit with regard to 30-day all-cause mortality (39.7% in the IABP group vs 41.3% in the control group, Relative Risk with the IABP = 0.96, p = 0.69) and all other secondary endpoints (bleeding complications, re-infarctions, strokes, sepsis). Nevertheless, several arguments regarding the design and reported results of the trial arise. The timing of the IABP implantation, the significance of which has been aforementioned, was not determined by the study protocol but was at the discretion of each investigator. As a result, only 13.4% of the patients in the intervention group received the IABP pre-procedurally. The subgroup analysis between the patients supported with the IABP pre- and post-procedurally showed no difference in 30-day mortality (36.4% vs 36.8%, respectively, p = 0.96), however, the unbalanced allocation of patients between the two groups hinders the evaluation of the results. Moreover, the baseline characteristics of the patients in these two groups are not reported, in this way rendering the comprehension of the IABP implantation timing choice impossible. Nevertheless, it is reasonable to assume that the patients in who the IABP was implanted prior to reperfusion might have been more gravely ill. Additionally, a notable percentage of 10% of the patients randomly allocated to the control group were crossed-over to the IABP group. Interestingly, the mortality rates reported in the control group (41.3%) are slightly lower than those previously reported in other studies and registries. When also taking into account that approximately half of the patients included in the trial (290 patients) were recruited over a 28 month period in 32 different centers, adding up to a mean annual insertion rate of 1.7 IABPs per center, a selection bias in favor of milder cases of CS might have occurred, leading more severe cases to non-randomized use of the IABP. What so ever, a low annual insertion rate of the IABP by itself is independently correlated with higher in-hospital mortality, as previously mentioned, and could have affected the outcome of patients in the IABP group. Furthermore, details on the patients' death in the IABP arm, particularly time of IABP support until death, cause of death and whether death occurred while on IABP support are also necessary. As previously demonstrated in experimental data the use of the IABP enhances the effect of reperfusion on salvaging critical

30-day all-cause mortality

mass of the myocardium, only when it is performed within a specific time frame [44]. Delayed implementation of the IABP, let alone reperfusion by its own, is not expected to affect the clinical course of CS complicating MI. Moreover, since the majority of patients presented with a TIMI flow ≤ I, the IABP would also be expected to confer trivial results if revascularization was implemented very promptly (b 2 h) [45]. In this notion, important data of the study which are not reported such as symptom-toreperfusion time and left ventricular ejection fraction at discharge, which could serve as a marker of the extent of rescued myocardium, should be known in order to evaluate the results. Until recently, the lack of hard evidence determining the conditions under which the IABP induces its salutary effects must be regarded as the reason for which the use of the IABP varies in the setting of postMI CS among different registries and trials [23]. Importantly, several issues regarding the results of the IABP-SHOCK II trial need to be elucidated in order to apprehend to which questions and to what an extent the study answers. Nevertheless, for the time being, the use of the IABP seems unlikely to lose its popularity among physicians for the treatment of patients with post-MI CS. 3.2. IABP in high risk MI The need of IABP as an adjunctive therapy to PTCA in the setting of uncomplicated, but high risk MI has also failed to be proven. Nanas et al. demonstrated in an experimental canine model that IABP in addition to reperfusion had a beneficial effect on the size of myocardial infarction, calculated as a percentage of the area at risk when compared both to a non-reperfusion and a reperfusion alone strategy [44]. In another study of patients having undergone successful angioplasty, the subsequent support for 48 h with the IABP was associated with a significantly lower incidence of infarct-responsible artery re-occlusion and the composite clinical endpoint of death, stroke, reinfarction, need for emergency revascularization or recurrent ischemia compared to those who did not receive IABP support post-PCI [46]. However, two other prospective trials failed to demonstrate an effect of arterial counterpulsation on reducing the rates of several clinical endpoints, among which reocclusion, reinfarction or survival, while its use was accompanied by a significantly higher incidence of stroke or major, IABP-related, complications [47,48]. In another cohort [49], the significance of IABP insertion timing on the potential salutary effects in the high risk MI population was examined. One hundred and fourteen coronary patients were treated with an IABP, either prior to angiogram or upon indication due to an intraprocedural complication. The patients in the prophylactic use group required a significantly shorter period of IABP support and had significantly lower rates of 30-day and six month mortality and major bleeding complications. Moreover, after adjustment for all confounders, preprocedural insertion of IABP was recognized as the unique predictor of freedom from major cardiac adverse event at six months (HR = 0.20, 95% CI 0.04–0.89). The Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction (CRISP-AMI) trial attempted to compare the effect of preinterventional insertion and support with an IABP plus PCI versus PCI alone on the myocardial infarct size, measured by means of magnetic

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resonance imaging, in patients with anterior MI without CS [50]. The two groups did not differ significantly as per infarct size, TIMI score flows and median time from symptom onset to first coronary device at baseline. The incidence of bleeding and vascular complications was similar across the two groups as was the infarct size at 30 days. However, it must be noted that median time from onset of symptoms to first device was 202.5 min in the IABP group, in this way significantly impeding the potential effects of the use of IABP on myocardium salvage and infarct size [51]. Nevertheless, 8.5% of patients in the PCI alone group crossed over to IABP support and importantly 26.6% of these patients died. A non-significant, but important difference in terms of overall mortality rate at 6 months was witnessed (1.9% vs. 5.2%, p = 0.12) in favor of the combined treatment strategy. Moreover, the incidence of the exploratory endpoint of time to death, shock or new or worsening heart failure was significantly higher in the PCI alone group (5% vs 12%, log rank test p = 0.03) in comparison to the IABP plus PCI strategy. Furthermore, the Balloon-Pump Assisted Coronary Intervention Study (BCIS-1) [52] – another large, randomized, multicenter trial handling with the issue – also failed to give compelling answers. BCI-S randomized 301 high-risk (LVEF ≤ 30%, Jeopardy Score ≥ 8/12) coronary patients either to receive PCI with elective IABP insertion or PCI with no planned IABP insertion. The two strategies applied did not differ significantly in terms of major adverse cardiac and cardiovascular events (MACCE) and myocardial infarction incidence. Importantly, the incidence of procedural complications was higher in the non-planned IABP support group due to which 12% of the patients of this group required a rescue IABP insertion, while the elective IABP group had a significantly higher rate of minor bleeding events. The 6-month mortality of the elective IABP insertion group was lower by an absolute 2.8% (4.6% vs 7.4%, p = 0.32) although not significant as the study was not powered to detect a difference in mortality between the two groups. However, the recently published results of long-term follow-up of the patients enrolled in the study were surprising for most [53]. During a median of 51 months of follow-up 100 patients (33%) died, among whom significantly more were allocated in the group of no prophylactic IABP support (58 vs 42 deaths in the group of planned IABP use). Characteristically, the pre-procedural insertion of the IABP was associated with a 34% reduction of the risk of death at 51 months of follow-up (HR = 0.66, 95% CI 0.44–0.98, p = 0.039). 3.3. IABP in cardiac surgery In the era of cardiac surgery, IABP use has been long established with the main indication of peri-operatively supporting patients with a low output syndrome intractable to standard inotropic treatment. Furthermore, IABP has also been used pre-operatively in cardiac surgical patients with post-MI mechanical complications or refractory unstable angina [17,18,54]. The data derived from cardiac surgery patients converging to the utility of pre-procedural or even prophylactic institution of IABP are constantly increasing. Pre-operative insertion of the IABP is associated with significantly lower in-hospital mortality than those receiving the IABP intra- or postoperatively, results constant across several cohort populations [55,56], while timing of IABP insertion has been highlighted as a predictor of early death. Moreover, 10-year survival was also significantly higher in patients having received the IABP pre-operatively compared to those receiving it intra- or postoperatively (41.5% vs. 20.8% and 20.3% respectively, p b 0.02) [57]. A systematic meta-analysis [58] of studies assessing the effectiveness of pre-operative introduction of IABP in high-risk patients undergoing CABG, which included four randomized controlled trials (RCTs) and 6 cohort studies for a total of 2363 patients, demonstrated a positive effect of pre-operative use of the IABP on in-hospital mortality (pooled OR = 0.41, 95% CI, 0.21–0.82, p = 0.01). In the four RCTs (n = 198 patients), where heterogeneity was not a cofounder (p = 0.93) pooled OR for hospital mortality with pre-operative IABP use was 0.18 (95% CI, 0.06–0.57; p = 0.003), while among the 69 patients of the control

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group who were not programmed to receive an IABP, 56.5% eventually required the introduction of an IABP either intra- or post-operatively. Moreover, the patients in the IABP group experienced a lower incidence of low-output syndrome and had a shorter cardiopulmonary by-pass time and hospital stay, results also reported by several case control studies [59,60]. Conversely, only two cardiac surgery studies have failed to correlate timing of IABP support to survival. Specifically, Gutfinger et al. [61] reported no benefit in 30-day mortality rate of ninety seven elderly patients undergoing isolated CABG with cardiopulmonary bypass under IABP support from a single surgeon over a 44 month period. However, the striking discrepancy between the two groups regarding preoperative co-morbidities such as the incidence of MI and congestive heart failure or the LVEF, all in favor of the control group, must be underlined, especially when some of these parameters have been reported as independent predictors of mortality by other authors. In the other observational, case control study [62], patients undergoing a CABG procedure who prophylactically received an IABP were matched according to a propensity score as per baseline characteristics and comorbidities with 550 patients, who consisted the control group. No significant difference was yielded in terms of short and long term survival between the two groups. Prophylactic IABP use showed a sole beneficial effect regarding last of in-hospital stay. However, a selection bias on behalf of the authors must be noted as a total 1391 patients with cardiogenic shock and/or mechanical ventilation as well as those undergoing urgent CABG and those having received a PTCA within a 6 h or having experienced a recent MI (within 3 days) were excluded from the analysis, as the authors considered the use of an IABP for them as a therapeutic and not a prophylactic measure. 3.4. IABP and arrhythmias In the era of managing incessant ventricular arrhythmias with underlying myocardial ischemia by the use of IABP, which is accompanied by a class IIa indication by the ACC/AHA, few data are available. Fotopoulos et al. [63] retrospectively analyzed the outcomes of 21 patients with refractory to medical treatment ventricular arrhythmias who underwent IABP support during a 5 year period. Of the patients studied, 18 had a background of coronary artery disease whereas all had severe left ventricular dysfunction. Eleven patients presented with paroxysmal ventricular tachycardia or ventricular fibrillation, while ten with incessant monomorphic ventricular tachycardia. The introduction of IABP led to successful control of the arrhythmia in 18 patients and 13 were weaned off the IABP, from which 10 retained the result with only medical treatment while one patient required endocardial resection. 4. Future prospects 4.1. IABP in right sided heart failure With regard to the utility of IABP in the setting of predominantly right ventricular failure only few things are known. Darrah et al. [64] examined the potential benefit of appliance of an IABP in an experimental model of acute right ventricular failure propagated by volume overload. The commencement of IABP circulatory support resulted in a significant increase in mean arterial pressure, cardiac index and right ventricular ejection fraction. Arafa et al. [65] analyzed the hemodynamic variables of five patients presenting with low cardiac output syndrome after cardiac transplantation attributable predominantly to right ventricular failure, who were supported by means of IABP. Within a single hour of IABP introduction significant increases in mean arterial pressure and cardiac index were witnessed, accompanied by a decrease in the values of right atrial pressure. The magnitude of these hemodynamic alterations was enhanced at twelve hours post IABP support. All five patients survived till hospital discharge and four of them were alive a full year

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after transplantation, time at which the previous hemodynamic values did not differ from the time of IABP support. Furthermore, prolonged IABP support has been demonstrated to induce significant amelioration of right ventricular hemodynamics and contractility in a small cohort of gravely ill patients with bi-ventricular end-stage heart failure [66]. The patients consisting this cohort were ineligible for long-term mechanical support with a left ventricular assist device, either as a bridge to heart transplant or as destination therapy. The use of the IABP led to impressive reversal of RV dysfunction, in this way rendering these patients suitable candidates for therapeutic options associated with more favorable outcome.

4.2. IABP as a bridge to decision making/transplantation The gold standard treatment for end-stage chronic heart failure patients is heart transplantation. However, the number of such patients has been constantly increasing, whereas the number of donor grafts and therefore heart transplantations has reached a plateau during the past years [67]. These facts render the need for more effective and long lasting mechanic circulatory support of patients awaiting transplantation inevitable. Many efforts in this direction have been made during the past years (Table 2). Freed et al. [68] analyzed the data of 733 consecutive patients supported by means of IABP during the period 1967–1982. Of these, 27 patients were supported for 20 or more days (mean period of counterpulsation 33 days; range 20–71 days). The complication rate within this long-term assist group was significant greater than in the group of less than 20 days of support as per infections, bleeding and vascular complications. However, no difference could be demonstrated in terms of survival between the prolonged and short-term IABP groups. From the 17 patients in the group of long-term assistance that were discharged from hospital, 8 survived for more than 2 years while the other 9 died within the first semester post-discharge. Among the 8 patients with a survival greater than 24 months, only one had congestive heart failure as primary indication for IABP insertion. In the cohort of Cochran et al. [69] the potential of long-term circulatory support with an IABP inserted via the axillary artery with a modified ambulatory technique was evaluated. Four patients with ischemic cardiomyopathy as primary cause of their end-stage heart failure were successfully bridged to transplantation being supported for a mean 37 days (range from 12 to 70 days). The hemodynamic effects of the IABP use were significant; cardiac output showed an increase of 57% while PCWP decreased by a mean of 25%. This ambulatory IABP strategy also seemed to be cost-effective when compared to standard ventricular assist device use as it translated to 10- to 50-fold savings for each patient.

Gjesdal et al. [70] retrospectively compared the outcome of patients bridged to transplantation via an IABP with those not needing circulatory support in the pre-transplant period during a seven year period (2001–07). Forty patients underwent IABP support prior to transplantation with the indication of severe hypoperfusion. Of these patients, seven needed supplementary support for deteriorating hemodynamics after a mean 25 ± 21 days of IABP use via extracorporeal membrane oxygenation (n = 3) or left ventricular assist device (n = 4) while one died 35 after the insertion of the IABP during plasmapheresis and immunosuppression delivered due to panel reactive antibodies. Finally 80% (32/40 patients) were successfully transplanted under IABP after a mean duration of support of 21 ± 16 days. The use of the IABP significantly ameliorated the patients' biochemistry values (creatinine, urea, liver function enzymes, sodium) in comparison to baseline, reaching, in the immediate pre-transplant period, the levels of the patients in the control group. With regard to mortality, the rates between the IABP and control groups did not differ at 30-day, 1-year and 3-year followup post-transplant. As for the patients requiring additional support, the mortality rates at 30-days and 1-year were 17% and 33% respectively. The post-transplant survival was stable across the IABP group and irrespective of the duration of IABP support. The hemodynamic and echocardiographic parameters were similar between the two groups when assessed at 30 days and 1 year post-transplant. Terrovitis et al. demonstrated that the long-term circulatory support (75 ± 44 days) with the IABP of patients with idiopathic dilated cardiomyopathy in Interagency Registry for Mechanically Assisted Circulatory Support profile 2 (“sliding on inotropes”) could ameliorate hemodynamics and cardiac and peripheral organ function and reverse contraindications for cardiac surgery [71]. Five patients were successfully bridged to surgery, whereas the remaining two demonstrated significant improvement of clinical status, were weaned from the IABP and remained asymptomatic for 2 and 18 months thereafter, respectively. 4.3. New devices Numerous novel counterpulsation devices have been developed during the past decades in an attempt to be proven superior to the IABP and substitute it in everyday clinical practice (Table 3). Nanas et al. were the first to attempt such an effort in the mid 1980s with the introduction of the para-aortic counterpulsation device (PACD) [72,73]. This device consisted of a round valveless, pumping chamber connected via a 3–5 cm graft to the right lateral wall of the ascending aorta, in which it is anastomosed with only partial clamping of the aorta. The PACD had a stroke volume of 100 mL at full inflation and an ejection fraction of 65%. The blood compartment is separated from the air compartment by a triple-filament bio-compatible material. The pumping chamber is connected via a gas conduit to a driving system

Table 2 Feasibility of prolonged IABP support as bridge to transplantation/decision making. Investigators Years

Number Underlying disease of patients

Mean duration Complications of support [range]

Outcome

Kantrowitz

1967–1982

27

37% CHF

33 [20–71]

63% discharged from hospital 30% survived for N2 years.

Cochran

07/2000–11/2001

4

100% CHF

[12–70]

Simonsen

2001–2007

40

100% CHF

21 [3–66]

Terrovitis

Not reported

12

100% CHF (idiopathic 76 dilated cardiomyopathy)

Vascular 37% Infection 67% Bleeding 26% Two patients required balloon exchanges due to IABP-related problems Local arterial injury (7.5%) Septicemia (5%) Bowel paralysis (2.5%) Leg ischemia in four patients (33%) in cardiogenic shock

All patients were successfully bridged to orthotopic heart transplantation. One patient died on the IABP. Seven patients (17.5%) needed additional mechanical support. The remaining 32 (80%) were successfully transplanted. All five patients in INTERMACS I category died. From the seven patients in INTERMACS category II: five (71.5%) were successfully bridged to surgery and two (28.5%) experienced recovery and were weaned from the IABP.

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323

Table 3 Counterpulsation devices developed and used overtime. Device name

Stroke volume (mL)

Implant site

Number of patients tested

Hemodynamic effects

Outcomes

PACD

65

Ascending aorta

Three

Superior hemodynamic effect than 20-mL IABP in canine model of CS

Kantrowitz CardioVAD CPD

60

Five

32

Descending thoracic aorta Axillary artery

C-Pulse

20–30

Around the ascending aorta

One

Improved hemodynamics and peripheral organ function between baseline and 30 days Compared to 40-mL IABP in bovine model of diminished cardiac function: • Superior in reducing left ventricular myocardial oxygen consumption • Inferior in decreasing aortic end-diastolic pressure Significant decrease of pulmonary capillary wedge pressure and systolic pulmonary arterial pressure

One patient died 4 hours post implantation due to vasoparalysis induced anesthesia. The other two died 8 and 54 days post implantation from septic shock. One patient died intra-operatively. The remaining four survived for at least 30 days. –

None

which is triggered to fill the air compartment with a driving pressure of 7–8 Pi during cardiac diastole, hence ejecting in the ascending aorta the blood that has entered the chamber during systole when the pressure inside the chamber would be near zero. The hemodynamic effects of PACD were evaluated and compared to those of a 20 mL IAB in a canine experimental model of cardiogenic shock. PACD had significantly beneficial effects on all examined hemodynamic parameters (mean reduction of LV and aortic end-diastolic pressure by 44.3% and 60.2%, p b 0.001, increase of cardiac index by 155.8%, p b 0.004) when compared to the controls, contrary to the IABP which did not provoke significant alteration. PACD was also implemented in 3 patients suffering from CS refractory to conventional treatment, including IABP. One patient died 4 h after the device implantation due to peripheral vasoparalysis induced by the anesthesia, while the other two died due to septic shock 8 and 54 days after implantation, respectively. Jeevanandam et al. [74] presented the Kantrowitz CardioVAD device comprising a 60-cm3 pumping chamber, a percutaneous access device (PAD) and an external controller. The device is electrically powered with the chamber introduced by thoracotomy under cardiopulmonary bypass (CPB) and sutured in the descending thoracic aorta, whereas the PAD is inserted into a subcutaneous pocket in the right upper quadrant. The device's basic principle is similar to that of IABP, providing diastolic augmentation and systolic unloading to the failing heart. Kantrowitz CardioVAD was tested on 5 patients with end stage cardiomyopathy refractory to pharmacological treatment. Mean time on CPB during implantation was 157 min, whereas mean cross-clamp time was 101 min, decreasing by 50% between first and last patients. The first patient died intra-procedurally due to technical difficulties, whereas the other 4 survived to the first endpoint of 30 days. Due to the beneficial impact of CardioVAD on patient's circulation, the values of serum creatinine and blood urea nitrogen at day 30 were significantly decreased (1.5 ± 0.1 mg/dL vs.2.6 ± 0.6 mg/dL and 34 ± 4 mg/dL vs. 58 ± 25 mg/dL respectively) while hemodynamics were significantly improved (right atrial pressure 9 ± 2 mm Hg vs. 19 ± 1 mm Hg, pulmonary capillary wedge pressure 14 ± 5 mm Hg vs. 32 ± 3 mm Hg and cardiac index 2.6 ± 0.4 L/min/m2 vs. 1.7 ± 0.7 L/min/m2, p b 0.05) in comparison to baseline. However, a selection bias of the patients must be underlined as prior to the introduction of the CardioVAD all five patients showed to also respond to the hemodynamic support of the IABP. Koenig et al. [75] proposed the use of a 32-mL stroke volume implantable counter-pulsation device (CPD). The CPD is a valveless, single chamber device designed to be anastomosed to the right human axillary artery by a minimal invasive, surface surgical procedure via a graft. The CPD consists of a blood chamber, a plastic graft-connector and pneumatic driveline intended to be connected to an external pneumatic driver. The device is designed to simulate the basic principles of IABP counterpulsation, thus removing blood from the circulation at systole, via air evacuation and replacing it during diastole through air ejection. The

Death from septic shock 6 months and 27 days post implantation

hemodynamic effects of CPD support were evaluated and contrasted to those provoked by the use of a standard 40-mL IABP in an experimental large animal model of toxin-induced (via monensin) diminished cardiac function (DCF), which was considered as baseline. The CPD appeared to be superior to the IABP in reducing the left ventricular myocardial oxygen consumption (13% vs. 9%, p b 0.05) and increasing the ratio of diastolic coronary artery flow to left ventricular external work (15% vs. 4%, p b 0.05) and inferior to the IABP in decreasing the aortic end-diastolic pressure (8% vs. 19%, p b 0.05) when compared to baseline values. Concerning all other studied parameters, such as mean arterial pressure, cardiac output, mean diastolic coronary artery flow and LV peak systolic pressure, both CPD and IABP produced similar and significantly beneficial changes in comparison to baseline. Mitnovetski et al. [76] described the implementation of an implantable extra-aortic counterpulsation device (C-Pulse) on a 73-year old man with refractory to standard therapy end-stage chronic heart failure. The device consisted of a cuff that was via mid-sternotomy applied around the ascending aorta of the patient, a bipolar epicardial lead attached to the right ventricular outflow tract for electrocardiographic sensing, gas lines subcutaneously tunneled to the patient's abdominal wall and a controller with the capability of connecting to either a battery-powered or a line-powered driver. The stroke-volume produced by the cuff inflation was approximately 20–30 cm3. In this case surgical procedure and post-operative in-hospital stay were uncomplicated whereas the commencement of counterpulsation via the C-Pulse device caused an early decrease in systolic pulmonary pressure from 70 mm Hg to 57 mm Hg, in pulmonary capillary wedge pressure from 20 mm Hg to 13 mm Hg and in mitral regurgitation from moderately severe to moderate while increasing cardiac output from 2.3 to 3.9 L/min/m2, changes consistent across the 6-month period of counterpulsation. The systolic pulmonary pressure was further reduced at six-month assessment at a value of 28 mm Hg. The patient presented with significantly ameliorated heart failure symptoms during the overall device support period before succumbing due to septic shock originating from exit site infection 6 months and 27 days after implantation. 5. Conclusions The IABP was introduced to clinical practice at a time when extensive and thorough testing of the safety and efficacy of modalities via randomized trials in large populations were not necessitated. Although the lack of hard evidence supporting the beneficiary effects of the use of IABP on survival has occasioned the emergence of some controversy and distrust overtime, IABP continues to be the most commonly used mechanical cardiac assistance device in the catheterization laboratory [77]. The fact that the results derived from the recent, randomized trials are inconclusive about the specific characteristics of patients in whom

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IABP support yields benefits suggests that the frequency and the indications of its use will remain for the time being subject to physicians' biases and experience. Although new randomized trials aspire to give definite answers with regard to the appropriate use of the IABP, the nonsuperiority of all other known temporary circulatory assist devices in terms of cost, clinical availability, ease of insertion and efficacy combined with the incompetence of comprehension of the full range of mechanisms through which the IABP induces its actions render its substitution a remote prospect. Besides, as a Greek saying goes: ‘Nothing is more permanent than the temporary’.

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