A 20-year multicentre outcome analysis of salvage mechanical circulatory support for refractory cardiogenic shock after cardiac surgery

Journal of Cardiothoracic Surgery, Nov 2016

Background Refractory post-cardiotomy cardiogenic shock (PCCS) is a relatively rare phenomenon that can lead to rapid multi-organ dysfunction syndrome and is almost invariably fatal without advanced mechanical circulatory support (AMCS), namely extra-corporeal membrane oxygenation (ECMO) or ventricular assist devices (VAD). In this multicentre observational study we retrospectively analyzed the outcomes of salvage venoarterial ECMO (VA ECMO) and VAD for refractory PCCS in the 3 adult cardiothoracic surgery centres in Scotland over a 20-year period. Methods The data was obtained through the Edinburgh, Glasgow and Aberdeen cardiac surgery databases. Our inclusion criteria included any adult patient from April 1995 to April 2015 who had received salvage VA ECMO or VAD for PCCS refractory to intra-aortic balloon pump (IABP) and maximal inotropic support following adult cardiac surgery. Results A total of 27 patients met the inclusion criteria. Age range was 34–83 years (median 51 years). There was a large male predominance (n = 23, 85 %). Overall 23 patients (85 %) received VA ECMO of which 14 (61 %) had central ECMO and 9 (39 %) had peripheral ECMO. Four patients (15 %) were treated with short-term VAD (BiVAD = 1, RVAD = 1 and LVAD = 2). The most common procedure-related complication was major haemorrhage (n = 10). Renal failure requiring renal replacement therapy (n = 7), fatal stroke (n = 5), septic shock (n = 2), and a pseudo-aneurysm at the femoral artery cannulation site (n = 1) were also observed. Overall survival to hospital discharge was 40.7 %. All survivors were NYHA class I-II at 12 months’ follow-up. Conclusion AMCS for refractory PCCS carries a survival benefit and achieves acceptable functional recovery despite a significant complication rate.

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A 20-year multicentre outcome analysis of salvage mechanical circulatory support for refractory cardiogenic shock after cardiac surgery

Khorsandi et al. Journal of Cardiothoracic Surgery A 20-year multicentre outcome analysis of salvage mechanical circulatory support for refractory cardiogenic shock after cardiac surgery Maziar Khorsandi 0 Scott Dougherty 1 Andrew Sinclair Keith Buchan Fiona MacLennan Omar Bouamra Philip Curry Vipin Zamvar 0 Geoffrey Berg Nawwar Al-Attar 0 Department of Cardiothoracic Surgery, Royal Infirmary of Edinburgh , 51 Little France Crescent, old Dalkeith road, Edinburgh EH16 4SA , UK 1 Department of Cardiology, Ninewells University Hospital , Dundee DD2 1UB Background: Refractory post-cardiotomy cardiogenic shock (PCCS) is a relatively rare phenomenon that can lead to rapid multi-organ dysfunction syndrome and is almost invariably fatal without advanced mechanical circulatory support (AMCS), namely extra-corporeal membrane oxygenation (ECMO) or ventricular assist devices (VAD). In this multicentre observational study we retrospectively analyzed the outcomes of salvage venoarterial ECMO (VA ECMO) and VAD for refractory PCCS in the 3 adult cardiothoracic surgery centres in Scotland over a 20-year period. Methods: The data was obtained through the Edinburgh, Glasgow and Aberdeen cardiac surgery databases. Our inclusion criteria included any adult patient from April 1995 to April 2015 who had received salvage VA ECMO or VAD for PCCS refractory to intra-aortic balloon pump (IABP) and maximal inotropic support following adult cardiac surgery. Results: A total of 27 patients met the inclusion criteria. Age range was 34-83 years (median 51 years). There was a large male predominance (n = 23, 85 %). Overall 23 patients (85 %) received VA ECMO of which 14 (61 %) had central ECMO and 9 (39 %) had peripheral ECMO. Four patients (15 %) were treated with short-term VAD (BiVAD = 1, RVAD = 1 and LVAD = 2). The most common procedure-related complication was major haemorrhage (n = 10). Renal failure requiring renal replacement therapy (n = 7), fatal stroke (n = 5), septic shock (n = 2), and a pseudo-aneurysm at the femoral artery cannulation site (n = 1) were also observed. Overall survival to hospital discharge was 40.7 %. All survivors were NYHA class I-II at 12 months' follow-up. Conclusion: AMCS for refractory PCCS carries a survival benefit and achieves acceptable functional recovery despite a significant complication rate. Extracorporeal circulation; Heart-assist devices; Post-cardiotomy; Shock - Background Cardiogenic shock following cardiac surgery can affect as many as 2–6 % of patients undergoing routine surgical coronary revascularization or valve surgery [1–4]. Although the majority of these patients respond to inotropic support and/or intra-aortic balloon pump counter pulsation (IABP) support, 0.5–1.5 % of patients demonstrate a rapid and progressive decline in their haemodynamic parameters in the immediate aftermath of cardiopulmonary bypass [5]. The occurrence of post-cardiotomy cardiogenic shock (PCCS) can be unpredictable and can occur in patients with normal preoperative myocardial function as well as those with pre-existing impaired function [6]. Refractory PCCS leads to vital organ hypoperfusion and is almost universally fatal [4, 7–9] without the use of advanced mechanical circulatory support (AMCS) devices such as extracorporeal membrane oxygenation (ECMO) or ventricular assist devices (VAD). © The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. In our previous study we looked at the outcomes of AMCS utilization at the Edinburgh heart center’s cardiothoracic surgery department (a non-transplant, intermediate-sized, adult cardiothoracic surgery centre) in Scotland [10]. This current multicentre observational study aims to consolidate our previous findings and looks at the 20-year outcomes of AMCS utilization to salvage refractory PCCS patients in all the 3 cardiothoracic surgery centres in Scotland. Methods Scottish adult cardiothoracic surgical services are provided by three regional centres covering a population of 5.2 million individuals [11]. The relevant data was collected from the databases of the Royal Infirmary of Edinburgh (surgical case load ≈ 900/year), the Golden Jubilee National Hospital in Glasgow (surgical case load ≈ 1300/year), and the Aberdeen Royal Infirmary (surgical case load ≈ 500/year). Our inclusion criteria included any adult patient from April 1995 to April 2015 who had received salvage VA ECMO or VAD for PCCS refractory to IABP and inotropic support following adult cardiac surgery. We acquired information regarding the patients’ 12 month follow-up status by accessing the cardiology follow-up clinic letters on the TrakCareR system in Edinburgh, the AMCS database in Glasgow, and through making direct enquiries with the surgeons involved in the long-term outcomes of the patients in Aberdeen via email and telephone communications. The AMCS devices utilised at the Royal Infirmary of Edinburgh over the defined study period were LevitronixR CentriMag II for ECMO and Medtronic BioMedicusR 560 for short-term VAD support. Over the same time period, the AMCS devices used at the Golden Jubilee National Hospital in Glasgow and the Aberdeen Royal Infirmary cardiac surgical units was the CentriMag device for both VA ECMO and short-term VAD support. Results A total of 28 patients met the inclusion criteria with one patient excluded due to lack of recorded information in the TrakCareR database regarding the type of AMCS support used, any potential complications and the short and the long-term outcomes of this individual. Overall, 16 patients from the Royal Infirmary of Edinburgh met the inclusion criteria, 8 patients from the Golden Jubilee National Hospital in Glasgow and 3 patients from Aberdeen Royal Infirmary cardiothoracic surgery unit. The reason why more cases belonged to Edinburgh rather than Glasgow, despite the latter being a larger unit, was because AMCS was rarely used to salvage refractory PCCS patients in the west of Scotland prior to 2007 (the year of the merger between Glasgow Royal Infirmary and the Glasgow Western Infirmary forming the Golden Jubilee National Hospital). Of the total 27 patients from the 3 centres, the age range was 34–83 years (median 59 years). There was a large male predominance of 23 (85 %). Four patients (15 %) had undergone re-operative cardiac surgery. One patient (3.7 %) had undergone AMCS following the repair of a traumatic ascending aortic transection after a road traffic accident. Overall, 23 patients (85 %) had received a single run of VA ECMO of which 14 (61 %) had received central ECMO and 9 (39 %) had received peripheral ECMO. Four patients (15 %) had short-term VADs (1 BiVAD, 1 RVAD and 2 LVAD). The mean duration of AMCS was approximately 5.43 days (Range < 1 day– 33 days). The most common procedure-related complication was major haemorrhage (37 %). Renal failure requiring renal replacement therapy (26 %), stroke (19 %) and peripheral limb ischaemia (15 %, Fig. 1) were also recorded. Logistic EuroSCORE ranged from 2.08 to 73.26. More detailed patient baseline characteristics are tabulated in Table 1. The most common cause of death (COD) was refractory biventricular failure that failed to recover sufficiently to allow weaning from AMCS (22.2 %, Fig. 2). In these patients care was withdrawn. One patient died due to a combination of biventricular failure and haemorrhagic shock and another patient died from a combination of biventricular failure and septic shock whilst on VA ECMO. The survival rate to hospital discharge was 40.7 % (Fig. 3). The follow-up data showed that the survivors were all NYHA class I-II functional status at 12 months. Statistical analysis Statistical analysis was performed using the Fisher’s exact and Pearson’s chi2 tests. Univariate analysis was performed. Table 2 demonstrates the baseline statistics data and the analytical methods used in this study. Discussion Our study demonstrates that AMCS used for the treatment of refractory PCCS can lead to good outcomes for a significant number of patients, with 40.7 % surviving to hospital discharge and all surviving patients were graded as either NYHA class I or II at 12 months’ postdischarge. Without AMCS, it is likely that the vast majority of these patients would have died. Ours is also the first multi-centre study of its kind to emerge from the UK and one of the few studies to examine functional outcomes post AMCS utilisation for refractory PCCS. Recent evidence has demonstrated that modern, continuous-flow AMCS devices, such as the CentriMagR that was used in our centres, can lead to improved survival in patients with PCCS [12–14]. In the largest Fig. 1 Bar chart illustrating the number and nature of complications within cohort cohort, Hernandez et al. [3] collated data from 5735 patients who underwent salvage VAD for refractory PCCS. They reported a 54.1 % survival rate to hospital discharge and concluded that VAD is a valuable, life-saving therapeutic manoeuvre. By comparison, the survival rate in our study was lower but firm conclusions are difficult given the low number of patients in our cohort. However, other smaller studies (relative to the Hernandez study) [5, 15–18] all using either ECMO or VAD for refractory PCCS, reported less impressive survival to hospital discharge rates of 24.8 %–37 % and a 5 year survival of 13.7 %–16.9 %. Unfortunately, we do not have long-term survival data as many of the survivors were ultimately discharged from the outpatient clinics when no further medical or surgical interventions were required, hence longer term follow up data post out-patient clinic discharge had not been recorded in the database. We identified advanced age to be a factor leading to an adverse outcome, although again, owing to our smaller numbers, this did not reach statistical significance. Most (64 %) of the survivors were under 60 years of age. Furthermore, the emergent nature of surgery and pre-existing, preoperative severe left ventricular impairment were also identified as probable factors leading to an adverse outcome. Evidence suggests that early device implantation [6] and appropriate patient selection through a multidisciplinary team approach is paramount to an optimal outcome [10]. There are no national or local protocols for identifying suitable patients for AMCS with refractory PCCS in Scotland: instead, decisions are based on a case-by-case assessment involving a multidisciplinary team (cardiac surgeon, department head, anaesthetist, and perfusionist) in each of the three hospital sites. We continue to believe that this is the best approach to patient selection rather than a standardised algorithmic approach because it ensures an ethically appropriate decision for the patient whilst optimising the cost-benefit equation. The decision regarding when to initiate AMCS support was made for most patients whilst in theatre in those whom weaning from CPB was not possible, although a few were commenced AMCS whilst in ICU. The time to AMCS and how this correlates to survival is an important variable that regrettably was not consistently recorded in our patient cohort. AMCS devices are expensive [9, 19, 20] and this, coupled with a potentially prolonged length of stay in ICU, means that cost is an important factor in the decision-making process, particularly within the UK NHS. Indeed, decision-makers have opted to centralise AMCS funding to a restricted number of the larger cardiothoracic centres [21], invariably depriving other units of this potentially life-saving resource. Understandably, this has led to expressions of consternation [21]. In our cohort, the longest duration on AMCS was 33 days (patient 7). This patient was successfully weaned from VA ECMO but died whilst in critical care from a stroke, which may have been a complication from AMCS employment. The NYHA functional outcomes for our patients were also very positive. Unfortunately, many previous AMCS studies for refractory PCCS do not report such findings, although we did identify two studies, each with similar outcomes to ours. Ko et al. [17] detailed a cohort of 76 patients undergoing ECMO support for refractory PCCS. They reported that all survivors were of NYHA classes I or II at 32 +/− 22 month follow-up. Pennington et al. [15] reported on refractory PCCS support with VAD and found that all survivors were “leading active lives”. In 72.7 % of their survivors, ejection fraction had normalized on follow-up echocardiography. Clearly, given that we only identified 27 patients undergoing AMCS over a 20-year period, and despite our pooled hospital case volume, we acknowledge that Table 1 Patient baseline characteristics Age & Gender 76 year old male Re-do sternotomy and AVR Duration and Mode of AMCS AMCS Complication/s Salvage peripheral VA ECMO due to postoperative pulmonary haemorrhage and cardiogenic shock Femoral artery cannulation site pseudoaneurysm 40 year old male Re-do, Re-do sternotomy for type A aortic dissection: Bentall procedure Salvage RVAD due to VF arrest and severe LVSD after weaning from CPB 82 year old male MV Repair and CABG 72 year old Female 71 year old male CABG and AVR 83 year old female MVR and CABG 70 year old male Re-do sternotomy and AVR 72 year old male Re-do sternotomy and AVR 51 year old male Re-suspension of Aortic valve and repair of type A aortic dissection 34 year old female IVC Leiomyosarcoma resection 3 Days 65 year old male 3 Days 9 Days 2 Days 1 Day VA ECMO as unable to wean from CPB VA ECMO as unable to come off CPB Peripheral VA ECMO as unable to come off CPB Peripheral VA ECMO as unable to wean from CPB VA ECMO for cardiac failure. Successfully weaned from ECMO Peripheral VA ECMO for cardiogenic shock VA ECMO for postoperative cardiogenic shock for intraoperative MI 2 Days Salvage VA ECMO for cardiogenic shock VA ECMO after iatrogenic aortic dissection leading to cardiogenic shock during Femoral cannulation for Major haemorrhage CPB Major haemorrhage from cannulation site Major haemorrhage and reexploration in the operating theatre Renal failure a None Major CVA ECMO cannulation site bleeding and haematoma explored Major cannulation site haemorrhage Renal failurea Pulmonary oedema Outcome NYHA I (No breathlessness of exertion, back to work) Died in CTICU COD: BiVent failure Died in CTICU COD: Septic shock Died in CTICU Died in CTICU COD: BiVent failure Died in HDU Died in CTICU COD: Major CVA Died in CTICU COD: Haemorrahgic shock and BiVent failure Died in CTICU Died in CTICU Table 1 Patient baseline characteristics (Continued) Patient 12 71 year old male 2015 CABG Patient 13 49 year old male 3 Days VA ECMO as unable to wean from CPB Patient 14 69 year old male MVR and CABG for mitral valve IE VA ECMO as unable to wean from CPB Type A aortic dissection Patient 15 41 year old female Patient 16 59 year old male Patient 17 21 year old male Patient 18 51 year old male Patient 19 46 year old male Patient 21 56 year old male Patient 22 64 year old male Patient 23 52 year old male Patient 24 64 year old male Patient 20 54 year old male CABG and AVR 2 Days Peripheral VA ECMO as unable to wean from CPB 3 days Peripheral VA ECMO Major haemorrhag e: Re-opening Died in CTICU for bleeding x4 COD: biventricular failure limb ischaemia and septic shock Note recorded Alive (Died 2004) NYHA II CVA and seizures Alive Renal failure a NYHA II Not recorded Alive NYHA I Not recorded Died COD: Bivent failure ECMO cannulation site bleeding- Alive required re-exploration NYHA I Cardiac tamponade CVA and Seizures Died in ICU limb ischaemia COD: status epilepticus Major haemorrahage Died in ICU Limb ischaemia/compartment COD: MODS syndrome-bilateral fasciotomies Renal failurea SVT/VT Alive Major intra-abdominal haemor- NYHA II (Neuropathic leg rhage requiring laparotomy pain) Limb ischaemia CVA (occipital infarcts) Vasoplegia MODS MODS None Alive Table 1 Patient baseline characteristics (Continued) Patient 25 50 year old male 2014 AVR Patient 26 54 year old male 61 year old male LVAD acute LV failure LVAD for acute LV failure Renal failurea Haemothorax/mediastinal collection requiring re-operation Renal failure pleasea Respiratory failure Renal failurea Alive NYHA I COD: MODS Alive NYHA II Fig. 2 Bar chart illustrating the number and causes of death within cohort. AV: atrioventricular the Scottish approach to institution of AMCS for refractory PCCS has been relatively conservative. This can partly be explained by the fact that salvage AMCS was not employed in the west of Scotland until 2007. Also, our general approach to institution of AMCS dictates that such modalities are instituted only if there is a reversible cause of the cardiogenic shock, which is reflected by our reasonable survival rate. Other possible reasons for underutilization may include: scarcity of resources, prohibitive costs, and lack of consistent evidence for the benefit of AMCS. The decision to institute AMCS must also be balanced with due consideration of the associated risks of this invasive modality, many of which are potentially life-threatening. Common device-related complications include: haemorrhage, thrombus formation and embolization, stroke, device-related infection, limb ischaemia, and multi-organ dysfunction syndrome/failure Type of center Prev. cardiac surgery First time surgery Surgical complexity Complex surgery Type of Support Duration of Support Support complications Major haemorrhage No major haemorrhage No major CVA No renal failure Log. EuroSCORE Score not available 2.8 (0.362853–33.74714) 1.928571 (0.1270413–112.3145) 0.625 (0.0921389–4.488993) 0.5333333 (0.0335265–8.873345) 1.05 (0.1662785–7.107629) 0.1458333 (0.0026189–2.352801 0.5333333 (0.0335265 8.873345) 0.4166667 (0.0620347–2.804408) 2.769231 (0.2140667–151.2664) 0.7179487 (0.0910803–6.420841) 0.36 (Pearson’s chi2 test) [1, 2, 15, 17, 22, 23]. In our cohort, the most common procedure-related complication was major haemorrhage. Renal failure requiring renal replacement therapy, stroke, and peripheral limb ischaemia also occurred with comparable rates to previous studies. Given the scarcity of donor hearts in the UK, research continues to focus on implantable AMCS devices as a bridge to recovery, bridge to transplant, or as destination therapy [19]. However, none of our patients were transplanted during the study period and none had implantable long-term VADs. Finally, this study is limited by the small number of subjects (as previously discussed) and its retrospective nature. It nevertheless reaffirms the findings of our previous study, which reported a good survival rate and acceptable quality of life for patients who received AMCS for refractory PCCS and survived to hospital discharge. Conclusions AMCS devices can be used to salvage a significant proportion of patients with refractory PCCS who would otherwise not survive. These patients are also likely to enjoy a reasonable quality of life. However, ACMS devices are associated with high rates of severe, systemic and device-related complications as well as being costly. Multidisciplinary teams experienced with patient selection and decisionmaking are imperative to help ensure appropriate use of AMCS and the best patient outcomes. Abbreviations ACS: Acute coronary syndrome; AF: atrial fibrillation; AMCS: Advanced mechanical circulatory support; AVR: Aortic valve replacement; CABG: Coronary artery bypass grafting surgery; CPB: Cardiopulmonary bypass; COD: Cause of death; BiVent failure: BiVentricular failure; MVR: Mitral valve replacement; IE: Infective endocarditis; CVA: Cerebrovascular accident; IVC: Inferior vena-cava; NYHA: New York Heart Association; CTICU: Cardiothoracic Intensive care unit; HDU: High dependency unit; ICD: Implantable cardioverter defibrillator; MI: Myocardial infarction; LVSD: Left ventricular systolic dysfunction; TVD: triple vessel coronary artery disease; LV: left ventricular; MR: Mitral regurgitation; PVD: Peripheral vascular disease; MODS: Multi-organ dysfunction syndrome; VF: Ventricular fibrillation; VAD: Ventricular assist device; VA: Veno-Arterial Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Availability of data and materials The data gathered for this study can be retrieved from the Royal Infirmary of Edinburgh, Golden Jubilee National Hospital and Aberdeen Royal Infirmary cardiothoracic surgery databases and TrakCareR databases. The raw data can be requested from the corresponding author (M. Khorsandi). Authors’ contributions MK principal investigator, manuscript preparation and drafting, data collection, SD: manuscript drafting, AS manuscript drafting and assistance with data collection, KB: manuscript drafting, FM: assistance with data collection, OB: statistical analysis, PC: manuscript drafting, VZ: manuscript drafting, GB: manuscript drafting, NAA: project supervisor and manuscript drafting. All authors read and approved the final manuscript. Competing interest The authors declare that they have no competing interests. Consent for publication Not applicable. Ethics approval and consent to participate Not applicable. 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Maziar Khorsandi, Scott Dougherty, Andrew Sinclair, Keith Buchan, Fiona MacLennan, Omar Bouamra, Philip Curry, Vipin Zamvar, Geoffrey Berg, Nawwar Al-Attar. A 20-year multicentre outcome analysis of salvage mechanical circulatory support for refractory cardiogenic shock after cardiac surgery, Journal of Cardiothoracic Surgery, 2016, 151, DOI: 10.1186/s13019-016-0545-5