Interventional procedure overview of VA ECMO for postcardiotomy cardiogenic shock in adults
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Evidence summary
Population and studies description
This interventional procedure overview is focused on VA ECMO in postcardiotomy cardiogenic shock. Two additional overviews have been developed focusing on VA ECMO use in severe acute heart failure and as extracorporeal cardiopulmonary resuscitation (ECPR). Some of the evidence includes a mix of indications and has been presented in more than one overview.
This interventional procedures overview is based on approximately 46,300 people from 4 systematic reviews (Biancari 2018, Wang 2018, Kowalewski 2020, Alba 2021), 2 retrospective registry studies (Kowalewski 2021, Loungani 2021), 1 multicentre retrospective study (Bonacchi 2020) and 3 single centre retrospective studies (Chen 2017, Chen 2020, Danial 2023). There were 29 overlaps accounting for 3,830 people in primary studies included across 4 systematic reviews (Biancari 2018, Wang 2018, Kowalewski 2020, Alba 2021). No primary studies included in the key evidence were also included in the systematic reviews. This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 10 studies as the key evidence in table 2 and table 3, and lists 16 other relevant studies in table 5.
The 4 systematic reviews of observational studies included in the key evidence included studies from Asia, Australia, Europe, North America and South America (Wang 2018, Alba 2021), however 2 systematic reviews did not report study location (Biancari 2018, Kowalewski 2020). Registry studies in the key evidence were done from the Extracorporeal Life Support Organization (ELSO) which collates data worldwide (Kowalewski 2021), and from the RESCUE registry collating data from 3 centres across the US. The included propensity matched retrospective study was done at a single centre in Taiwan (Chen 2017), and the 2 other single-centre studies included were done in China and France (Chen 2020, Danial 2023). A multicentre retrospective study from Europe (Bonacchi 2020) was also included.
All key evidence studies included people who needed VA ECMO after cardiac surgery. Two systematic reviews (Wang 2018, Kowalewski 2020), 1 registry study (Kowalewski 2021) and 1 single centre retrospective study (Chen 2020) specifically reported on patients with postcardiotomy cardiogenic shock (PCS). One systematic review (Alba 2021), and 1 single centre retrospective study (Danial 2023) included people with cardiogenic shock of multiple aetiologies, and 1 registry study included people who had VA ECMO for several aetiologies (Loungani 2021).
The systematic review by Biancari et al. (2018) included 31 observational studies reporting on 2,986 adults needing VA ECMO after cardiac surgery. Most primary studies included in this study had populations with a mix of cardiac surgery procedures (29 studies) and 2 studies included isolated coronary surgery patients. The mean age was 58 years and 31% of the population were female. Meta-analyses of the studies pooled survival outcomes from studies with follow-ups of 30 days and hospital discharge.
The systematic review by Wang et al. (2018) included 20 observational studies reporting on 2,877 people with postcardiotomy cardiogenic shock who had ECMO treatment. Risk of bias across studies included in the review was considered high as all studies were retrospective in nature. The baseline characteristics (age and percentage male) of the people in the included studies was not reported. Meta-analyses of the studies reported pooled survival outcomes at hospital discharge, at 1-year, and midterm survival (defined as 3 to 5 years).
The systematic review by Kowalewski et al. (2020) included 54 observational studies reporting on 4,421 people with postcardiotomy refractory cardiogenic shock. It included people who had CABG, valvular surgery and combined surgery at specialist heart transplant and non-heart transplant centres. Studies were considered to have a moderate to severe risk of bias. The age of people included in the studies ranged from 41 to 77 years, and 49% to 93% of the population were female. Meta-analyses of the studies pooled survival outcomes from studies with follow-up to hospital discharge.
The systematic review by Alba et al. (2021) included 306 observational studies reporting on 29,289 people with cardiogenic shock of any aetiology. This included 8,231 people with postcardiotomy cardiogenic shock. Risk of bias across studies was considered low in 219 (72%), moderate in 81 (26%), and high in 6 (2%) studies. The age of people included in the studies ranged from 47 to 61 years, and 22% to 59% of the population were female. Meta-analyses of the studies pooled short-term outcomes from studies with follow-ups of 30 days and hospital discharge.
The single centre retrospective study by Chen et al. (2017) was the only comparative study included in the key evidence. It used propensity score matching (PSM) to compare outcomes between people admitted for cardiac surgery (CABG or valve surgery) who had PCS and ECMO (n=1,137) and those who did not have PCS (or ECMO) following cardiac surgery (n=5,685). The mean age was 64 years and 71% of the population were male. Outcomes were reported for a follow-up period until hospital discharge and up to 10 years.
The retrospective ELSO registry study by Kowalewski et al. (2021) reported efficacy and safety outcomes for 7,185 adults having VA ECMO for intra-operative failure to wean from CPB due to right, left or biventricular failure, and post-operative refractory cardiogenic shock or cardiac arrest during the hospitalisation after the surgical procedure. This included people whose primary procedure was CABG, valvular surgery, heart transplant and combined surgery. The mean age was 56 years and 68% of the population were male. Outcomes were reported for a follow-up period until hospital discharge.
The retrospective RESCUE registry study by Loungani et al. (2021) reported efficacy and safety outcomes for 723 adults treated with VA ECMO, including those with persistent circulatory failure postcardiotomy (31%). The mean age was 57 years and 70% of the population were male. Outcomes were reported for a follow-up period until hospital discharge.
The single centre retrospective study done in France by Danial et al. (2023) included 1,253 adults treated with peripheral VA ECMO for cardiogenic shock, 297 of which were postcardiotomy patients (excluding primary graft dysfunction [PGF] following heart transplant). The mean age was 55 years and 30% of the population were female. Outcomes were reported for a follow-up period until hospital discharge and 5 years.
The single centre retrospective study done in China by Chen et al. (2020) included 121 people who had VA ECMO for postcardiotomy cardiogenic shock following CABG surgery. ECMO was needed for delayed cardiogenic shock in the ICU for 63 people, inability to wean from CPB in 39 people, and cardiac arrest in 19 people. The median age was 62 years and 79% of the population were male. Outcomes were reported for a follow-up period until hospital discharge and 36 months.
The multicentre retrospective study done in Europe by Bonacchi et al (2020) included 209 adults having ECLS following cardiac surgery. Prior to having ECMO, 17% people had thoracic aortic surgery, 14% CABG, 13% CABG plus mitral valve surgery, amongst other procedure types. The mean age was 68 years and 30% of the population were female. Outcomes were reported for a median follow-up period of 39 months (range 1 to 168 months).
Table 2 presents study details.
Study no. | First author, date country | Characteristics of people in the study (as reported by the study) | Study design | Inclusion criteria | Intervention | Follow up |
|---|---|---|---|---|---|---|
1 | Biancari, 2018 Countries not reported | n=2,986 Mean age=58.1 years Female= 30.9% Procedure types prior to ECMO:
| Systematic review and meta-analysis of 31 studies. Search date: Sept 2016 | Adults who required VA ECMO after cardiac surgery procedure. | VA ECMO | 1 year |
2 | Wang 2018, USA, Taiwan, Germany, Italy, China | n=2,877 Mean age not reported Male % not reported Procedure types prior to ECMO:
| Systematic review and meta-analysis of 20 retrospective studies. | People after cardiac surgery with postcardiotomy cardiogenic shock (PCS). | VA ECMO | In-hospital, 1 year |
3 | Kowalewski 2020 Countries not reported | n=4,421 Age (years): Range 41 to 77 Male %: Range 49 to 93 Procedure types prior to ECMO:
| Systematic review and meta-analysis of 54 retrospective studies. Search date: March 2018 | Postcardiotomy refractory cardiogenic shock | VA ECMO | In-hospital |
4 | Alba, 2021 Europe, Asia, North America, South America, Australia | n=29,289 Age (years): Range 47 to 61 Female %: Range 22 to 59 Indication
Pulmonary embolism: 221 (10 cohorts) | Systematic review and meta-analysis of 306 observational studies. Search date: June 2019 | Adults (aged 18 and over) with cardiogenic shock of any aetiology, with VA ECMO implantation. | VA ECMO Concomitant IABP: Range 20 to 67% | 30 day or in-hospital |
5 | Chen, 2017 Taiwan | n=1,137 ECMO (5,685 propensity matched cohort) Mean age (years)=63.8 (SD 13.2) Male=71.2% Procedure types prior to ECMO:
| Propensity score-matched retrospective single centre study. | Adults (aged over 18 years) admitted for cardiac surgery (CABG or valve surgery) | Intervention: VA ECMO (people with PCS) Comparator: No VA ECMO (people without PCS) (propensity score matched) | In-hospital, 10 years |
6 | Kowalewski, 2021 Worldwide | n=7,185 Mean age (years)=56.3 (range 18 to 86) Male=67.5% Procedure types prior to ECMO:
| Retrospective ELSO Registry study Search date: 2010 to 2018 | Adults over 18 years old undergoing a single run VA ECMO for refractory PCS. People with pre-operative ECMO were excluded. | VA ECMO initiated for intra-operative failure to wean from CPB due to right, left or biventricular failure, and post-operative refractory cardiogenic shock or cardiac arrest during the hospitalisation after the surgical procedure. | In-hospital |
7 | Loungani, 2021 US | n=723 Median age (years)=57 Male=69.6% Indication
| Retrospective RESCUE Registry study Search date: 2007 to 2017 | Adult patients (over 18 years old) treated with ECMO. | VA ECMO | In-hospital |
8 | Danial, 2023 France | n=1,253 (n=297 postcardiotomy excluding PGF) Mean age (years)=54.8 (SD:14.9) Female=30% Indication
| Single centre retrospective study Search date: 2015 to 2018 | Adult patients (over 18 years old) treated with peripheral VA ECMO for cardiogenic shock. | VA ECMO | In-hospital, 5 year |
9 | Chen, 2020 China | n=121 Median age (years)=62 (IQR: 55 to 67) Male=79% Indication
| Single centre retrospective study. Search date: 2012 to 2016 | People post-CABG who had VA ECMO for PCS. | VA ECMO | Discharge, 36 months |
10 | Bonacchi, 2020 Europe | n=209 Mean age (years)=67.52 (SD:15.8) Female=30.1% Procedure types prior to ECMO:
| Multicentre retrospective study. Search date: 2004 to 2018 | Adults (18 years old and over) having post-cardiac surgery ECLS | ECLS | Median follow-up was 38.8 (1 to 168) months |
Procedure technique
Of the 10 studies, none detailed the ECMO device or combination of devices used. VA ECMO was inserted during the initial cardiac surgery in the cases of circulatory instability during or immediately after weaning from CPB in 2 systematic reviews and 1 single centre study ([54%] Biancari 2018, [43%] Kowalewski 2020, Chen 2020). One study noted that the exact timing of ECMO implantation was unavailable, so the study authors presumed that most ECMO implantation occurred after cardiac surgery (Chen 2017). One study stated that ECLS was initiated after an evaluation of cardiac performance by transoesophageal echocardiography (TOE) and intraoperative cardiac catheterisation (Bonacchi 2020). Three studies noted the location of ECMO initiation as either the operating room, intensive care unit, catheterisation laboratory, emergency department, or transferred from other institutions already on ECMO support (Kowalewski 2020, Loungani 2021, Danial 2023).
Peripheral cannulation was preferred and most common strategy for VA ECMO in the 7 studies that detailed cannulation procedure (Biancari 2018, Bonacchi 2020, Chen 2020, Danial 2023, Kowalewski 2020, Kowalewski 2021, Loungani 2021), however 46% of people included in the Kowalewski et al. (2021) registry study were noted to be centrally cannulated. Left ventricular unloading using concomitant IABP was used in 31% (Kowalewski 2021), 62% (Biancari 2018), over 90% (Chen 2020), and 100% of people (Bonacchi 2020). Of the 10 studies, 4 detailed the median length of time on ECMO (Chen 2020, Kowalewski 2020, Kowalewski 2021, Loungani 2021), which ranged from 4 days (Chen 2020) to 6 days (Kowalewski 2021).
Efficacy
Survival
In-hospital survival
Of the 10 key evidence studies, 7 reported the in-hospital survival of people having ECMO postcardiotomy.
In meta-analyses from 3 systematic reviews, pooled in-hospital survival ranged from 34 to 36% (Biancari 2018, Wang 2018, Kowalewski 2020). Meta-regression analysis by Biancari (2018) showed a trend toward lower hospital survival in studies with higher mean age (p=0.064). The pooled analysis of 12 studies showed that hospital survivors (n=387) were significantly younger than people who died after VA ECMO (pooled mean age, 56 versus 64 years; mean difference, -7.223 years, 95% CI -9.777 to - 4.669, I2=53%, p=0.015)
In the registry study of 7,185 people with refractory PCS, in-hospital survival was 42% (Kowalewski 2021). In the registry study of 723 adults treated with VA ECMO (31% postcardiotomy), the survival in the overall population was 40% and 36% in postcardiotomy patients (Loungani 2021).
In the single centre retrospective study of people treated with VA ECMO for cardiogenic shock, among those with PCS (n=297), in-hospital survival was 35% (Danial 2023). In-hospital survival was 42% in the multicentre retrospective study of 209 adults having ECLS following cardiac surgery (Bonacchi 2020).
1-year survival
Of the 10 key evidence studies, 4 reported the 1-year survival of people having ECMO postcardiotomy.
In the systematic review of 31 studies of people who required VA ECMO following cardiac surgery, the pooled 1-year survival in a meta-analysis was 31% (95% CI 24.3 to 37.5), I2=82% (11 studies [n=1,290]; Biancari 2018). In the systematic review of 20 studies of people having ECMO for PCS following cardiac surgery, the pooled 1-year survival in a meta-analysis was 24% (95% CI 19 to 30), I2=76% (6 studies [n=1,860]; Wang 2018).
The cumulative 1-year survival using Kaplan-Meier estimate was 32% (SD 3.2) in the multicentre retrospective study of 209 adults having ECLS following cardiac surgery (Bonacchi 2020).
In the propensity score-matched study of people admitted for cardiac surgery who had VA ECMO (n=1,137), the cumulative 1-year survival using Kaplan-Meier estimate was 24% (95% CI 21.6 to 26.6) in those who had ECMO for PCS (Chen 2017).
Mid-term survival
Of the 10 key evidence studies, 1 study reported the 3- to 5- year survival and 3 studies reported the 5-year survival of people having ECMO postcardiotomy.
In the systematic review of 20 studies of people with PCS following cardiac surgery, the pooled 3- to 5- year survival in a meta-analysis was 18% (95% CI 11 to 27), I2=77% (4 studies [n=742]; Wang 2018). In the single centre retrospective study of 1,253 people treated with VA ECMO for cardiogenic shock (297 with PCS), the 5-year survival for people postcardiotomy (excluding PGF) was 33% (Danial 2023). The cumulative 5-year survival using Kaplan-Meier estimate was 25% (SD 3.01) in the multicentre retrospective study of 209 adults having ECLS following cardiac surgery (Bonacchi 2020). Cox regression analysis demonstrated that younger age (less than 35 years) was a strong independent predictor of 5-year survival (HR 0.4, 95% CI: 0.2 to 0.8; p=0.021).
In the propensity score-matched study of people admitted for cardiac surgery who had VA ECMO (n=1,137), the cumulative 5-year survival using Kaplan-Meier estimate was 18% (95% CI 14.7 to 20.7) (Chen 2017). The authors note that although the risk of all-cause mortality was greater in the group receiving ECMO for PCS than in the group without PCS (non-ECMO) (p<0.001) in the first year of follow-up, no difference was observed after the first year of follow-up (p=0.209; Chen 2017).
Long-term survival
Of the 10 key evidence studies, 1 reported the 10-year survival of people having ECMO postcardiotomy. In the propensity score-matched study of 6,822 people admitted for cardiac surgery with (n=1,137) or without (n=5,685) VA ECMO, the cumulative 10-year survival using Kaplan-Meier estimate was 10% (95% CI 4.0 to 15.5) in those who had ECMO for PCS following cardiac surgery compared to 50% (95% CI 46.7 to 53.7) in those who did not (Chen 2017). Again, the authors note that although the risk of all-cause mortality was greater in the ECMO for PCS group than in the non-PCS group (p<0.001) in the first year of follow-up, no difference was observed after the first year of follow-up (p=0.209; Chen 2017).
Successful weaning from ECMO
Of the 10 key evidence studies, 4 reported the proportion of people successfully weaned from ECMO postcardiotomy. In the systematic review of 31 studies of people who required VA ECMO following cardiac surgery, the pooled proportion successfully weaned in a meta-analysis was 60% (95% CI 54.6 to 64.3), I2=77% (24 studies [n=2,049]; Biancari 2018). In the systematic review of 54 studies reporting on 4,421 people with refractory PCS, 55% (31 to 100%) of people were successful weaned from ECMO (Kowalewski 2020). In the registry study of 7,185 people with refractory PCS, 56% were successfully weaned, and 64% were successfully weaned in the single centre retrospective study of 121 people undergoing CABG who had ECMO for PCS (Kowalewski 2021, Chen 2020).
Bridged to heart transplant
Of the 10 key evidence studies, 3 reported the proportion of people bridged to heart transplant following ECMO. The pooled rate of heart transplantation post-ECMO from a meta-analysis of 21 studies (n=1,685) was 2% (95% CI 1.0 to 2.8, I2=50%) in the systematic review of people who required VA ECMO following cardiac surgery (Biancari 2018). Of these heart transplant recipients, 66% (95% CI 48.2 to 84.1, I2=0%) survived until hospital discharge (Biancari 2018). In the systematic review of 54 studies reporting on 4,421 people with refractory PCS, the pooled rate of heart transplantation was 3.5% (95% CI 1.8 to 6.6) (Kowalewski 2020). The pooled rate of heart transplantation in those with PCS was 0.4% (95% CI 0.0 to 1.1) in a meta-analysis of 34 studies in the systematic review by Alba et al. (2021).
Bridged to long term VAD
Of the 10 key evidence studies, 3 reported the proportion of people bridged to a ventricular assist device (VAD) using ECMO. The pooled rate of VAD implantation post-ECMO from a meta-analysis of 21 studies (n=1,685) was 2% (95% CI 1.3 to 3.4, I2=57%) in the systematic review of people who required VA ECMO following cardiac surgery (Biancari 2018). Of these VAD recipients, 46% (95% CI 28.0 to 63.1, I2=43%) survived until hospital discharge (Biancari 2018). In the systematic review of 54 studies reporting on 4,421 people with refractory PCS, the pooled rate of heart transplantation was 4.3% (95% CI 2.8 to 6.5) (Kowalewski 2020). The pooled rate of heart transplantation in those with PCS was 0.8% (95% CI 0.2 to 1.8) in a meta-analysis of 35 studies in the systematic review by Alba et al. (2021).
Mortality
Of the 10 key evidence studies, 5 reported on mortality. In the registry study of 7,185 people with refractory PCS, in-hospital mortality by primary surgery type was 65% for CABG, 70% for vascular aortic surgery and 46% for heart transplant surgery (Kowalewski 2021). Older age was significantly associated with in-hospital mortality. Of the patients aged over 70 years, 70% did not survive to discharge compared to 55% those younger than 70 years (p<0.001).
In the systematic review of 306 studies of CS of any aetiology, the pooled overall short-term mortality (30-day and in-hospital) for those with PCS was 59% (95% CI 56 to 63, I2=87%, 64 studies). Univariate meta regression analysis stratified by aetiology also showed an 8% increase in mortality per 10-year increase in cohort's age (Alba 2021).
In the registry study of 723 adults treated with VA ECMO (31% postcardiotomy), 64% postcardiotomy patients died during ECMO or hospitalisation (Loungani 2021). Multivariable regression analysis identified older age as a risk factor for mortality on ECMO (OR 1.26; 95% CI 1.12 to 1.42, p<0.001). Mortality rates while on ECMO support increased from 26% in those aged 35 to 44 years to 54% in those 75 years or older (Loungani 2021).
In the propensity score-matched study of 6,822 people admitted for cardiac surgery with (n=1,137) or without (n=5,685) VA ECMO, in-hospital mortality was 62% in those who had ECMO for PCS following cardiac surgery compared to 7% in those who did not have PCS or ECMO (OR 22.34, 95% CI 19.06 to 26.18, p<0.001; Chen 2017). All-cause mortality was reported in the single centre retrospective study of 121 people undergoing CABG who had ECMO for PCS as 36% for those on ECMO, 54% during hospitalisation, 55% within 1 month, 59% within 12 months, 64% within 24 months, and 66% within 36 months (Chen 2020). Older age was an independent risk factor associated with 36-month mortality (HR 1.06; 95% CI 1.03 to 1.10; p<0.001).
Safety
Bleeding
Of the 10 key evidence studies, 8 reported bleeding adverse events or complications. In the propensity score-matched study of 6,822 people admitted for cardiac surgery with (n=1,137) or without (n=5,685) VA ECMO, re-exploration for bleeding was statistically significantly higher in those on ECMO for PCS (11.3% [129 of 1,137]) compared to those who did not have PCS or ECMO (2.5% [141 of 5,685], OR 5.04, 95% CI 3.93 to 6.45, p<0.001; Chen 2017). Massive blood transfusion (PRBC more than 8 Units) was also statistically significantly higher in those on ECMO for PCS (79% [899 of 1,137]) compared to those who did not have PCS or ECMO (15% [870 of 5,685], OR 21.25, 95% CI 18.09 to 24.96, p<0.001; Chen 2017).
In the systematic review of 31 studies of people who required VA ECMO following cardiac surgery, the pooled rate of reoperation for bleeding was 43% (95% CI 34.2 to 51.5, I2=93%) in the meta-analysis of 18 studies (n=1,779; Biancari 2018). In the systematic review of 20 studies of people with PCS following cardiac surgery, the pooled rate of reoperation for bleeding was 50% (95% CI 32 to 68, I2=97%, 10 studies, n=1,268; Wang 2018). The pooled rate of reoperations for bleeding was 41% (95% CI 35.6 to 47.1) in the meta-analysis of 33 studies (n=2,832) from the systematic review of people with refractory PCS (Kowalewski 2020).
In the registry study of people with refractory PCS, haematological complications were reported in 43% of people (3,052 of 7,185), including surgical site bleed 26% (1,897), cannulation site bleed 16% (1,130), mediastinal cannulation bleeding 1% (98), cardiac tamponade 8% (547), GI bleeding 4% (298), and haemolysis 4% (290) (Kowalewski 2021). In the registry study of adults treated with VA ECMO, major bleeding was reported in 36% (261 of 723), clinically significant coagulopathy in 14% (103 of 723), and disseminated intravascular coagulopathy in 2% (16 of 723) of the overall population (Loungani 2021).
In the single centre retrospective study general bleeding was reported for 34% (101 of 297) of people with PCS (Danial 2023). Rates of re-thoracotomy for bleeding were 37% (76 of 209) in the multicentre retrospective study of adults having ECLS following cardiac surgery (Bonacci 2020).
Neurological events
Of the 10 key evidence studies, 8 reported neurological adverse events or complications. The pooled neurological complication rates reported in 3 systematic reviews, were 11% (95% CI 7.8 to 14.8, I2=79%, 16 studies [n=1,736]; Biancari 2018), 16% (95% CI 13 to 20, I2=61%, 12 studies [n=1,341]; Wang 2018) and 14% (95% CI 11.8 to 16.8, 33 studies [n=2,730]; Kowalewski 2020).
In the registry study of people with refractory PCS, the rate of neurological complications was 9% (654 of 7,185). This included clinically determined seizures 1% (78), brain death 3% (18), haemorrhage confirmed by US/CT/MRI 2% (122), and infarction confirmed by US/CT/MRI 5% (326; Kowalewski 2021). In the registry study of adults treated with VA ECMO, diffuse cerebral oedema or hypoxic encephalopathy occurred in 4% (28 of 723) of the overall population (Loungani 2021).
In the single centre retrospective study of people with PCS, rates of neurological adverse events were 14% (41 of 297). This included sensory-motor deficit 3% (5), intracranial bleeding 4% (13), brain oedema 1% (2) and brain death 5% (16) (Danial 2023). Rates of anoxic encephalopathy were 3% (4 of 121) in the single centre retrospective study of people undergoing CABG who had ECMO for PCS (Chen 2020). Rates of cerebral bleeding were 25% (53 of 209) and cerebral ischaemia were 18% (38 of 209) in the multicentre retrospective study of adults having ECLS following cardiac surgery (Bonacci 2020).
Limb complications
Of the 10 key evidence studies, 9 reported limb adverse events or complications. The pooled limb complication rates reported in 3 systematic reviews, were 11% (95% CI 8.0 to 13.5, I2=70%, 16 studies [n=1,909]; Biancari 2018), 14% (95% CI 10 to 20, I2=75%, 11 studies [n=945]; Wang 2018) and 13% (95% CI 32.5 to 38.2, 30 studies [n=2,766]; Kowalewski 2020).
In the registry study of people with refractory PCS, rates of limb complications were 6% (456 of 7,185), including ischaemia 4% (312) and limb compartment syndrome 2% (106) (Kowalewski 2021). In the registry study of adults treated with VA ECMO 12% (88 of 723) of the overall population were reported with limb ischaemia (Loungani 2021).
In the single centre retrospective study of people with PCS, rates of limb ischaemia were 11% (34 of 297; Danial 2023). This was 10% (12 of 121) in the single centre retrospective study of people undergoing CABG who had ECMO for PCS (Chen 2020), and 7% (11 of 169) in the multicentre retrospective study of adults having ECLS following cardiac surgery (Bonacci 2020).
Rates of limb fasciotomy were 2% (143 of 7,185) in the registry study of people with refractory PCS, and 4% (25 of 723) in the overall population in the registry study of adults treated with VA ECMO (Loungani 2021), and 3% (4 of 169) in the single centre retrospective study of people undergoing CABG who had PCS (Bonacci 2020).
In the propensity score-matched study of 6,822 people admitted for cardiac surgery with or without VA ECMO, statistically significantly more people were reported with limb fasciotomy or amputation on ECMO for PCS 2% (26 of 1,137), than those not on ECMO without PCS 1% (47 of 5,685), OR 2.81 (95% CI 1.73 to 4.56, p<0.001; Chen 2017). The pooled rate of lower limb amputation was 1% (95% CI 0.0 to 2.3, I2=0% in a meta-analysis of 5 studies (n=330) in the systematic review of people who required VA ECMO following cardiac surgery (Biancari 2018), and the registry study of people with refractory PCS by Kowalewski et al. (2021) also reported amputation rates of 1% (43 of 7,185).
Infection and sepsis
Of the 10 key evidence studies, 8 reported infection or sepsis events or complications. In the propensity score-matched study of 6,822 people admitted for cardiac surgery with or without VA ECMO, significantly more people were reported with post-operative infection on ECMO for PCS 13% (150 of 1,137), than those not on ECMO without PCS 5% (256 of 5,685), OR 3.23 (95% CI 2.61 to 4.00, p<0.001; Chen 2017). In the systematic review of people who required VA ECMO following cardiac surgery, the rate of deep sternal wound infection or mediastinitis was 15% (95% CI 4.0 to 25.4, I2=92%) in a meta-analysis of 4 studies (n=490; Biancari 2018). Pooled systemic infection rates were 31% (95% CI 22 to 41, I2=79%) in the systematic review of people with PCS following cardiac surgery (9 studies [n=598]; Wang 2018). In the registry study of adults treated with VA ECMO (31% postcardiotomy), infection rates were 21% (154 of 723) (Loungani 2021). Site infection occurred in 13% (37 of 297) of people with PCS in the French single centre retrospective study (Danial, 2023).
In the systematic review of people with refractory PCS, pooled rates of sepsis were 21% (95% CI 17.0 to 24.9) in a meta-analysis of 29 studies (n=1,860; Kowalewski 2020). Rates of sepsis were reported as 12% (871 of 7,185) in the registry study of people with refractory PCS (Kowalewski 2021), and 28% (59 of 209) in the single centre study of adults having ECLS following cardiac surgery (Bonacci 2020).
Renal complications
Of the 10 key evidence studies, 9 reported renal adverse events or complications. In the propensity score-matched study of 6,822 people admitted for cardiac surgery with or without VA ECMO, statistically significantly more people were reported with acute renal failure and need for haemodialysis on ECMO for PCS 33% (374 of 1,137), than those not on ECMO 7% (418 of 5,685), OR 6.26 (95% CI 5.34 to 7.35, p<0.001; Chen 2017).
The pooled rates of RRT, renal failure, or acute kidney injury were reported in 3 systematic reviews. Rates were 47% (95% CI 38.9 to 55.2, I2=92%, 19 studies [n=1,979]; Biancari 2018), 57% (95% CI 47 to 66, I2=87%, 12 studies [n=1,279]; Wang 2018) and 47% (95% CI 41.5 to 53.1, 34 studies [n=3,199]; Kowalewski 2020), respectively.
In the registry study of people with refractory PCS, rates of kidney failure were 49% (3,510 of 7,185), and rates of RRT were 36% (2,593 of 7,185; Kowalewski 2021). Acute renal dysfunction was reported as 36% (257 of 723) in the registry study of adults treated with VA ECMO (31% postcardiotomy) (Loungani 2021).
Renal failure requiring haemodialysis was reported in 58% (170 of 297), and RRT 36% (44 of 121) in the single centre retrospective studies of people with PCS in France (Danial 2023) and China (Chen 2020), respectively. Acute kidney injury occurred at rate of 64% (134 of 209), and continuous veno-venous haemodialysis 54% (112 of 209) in the multicentre retrospective study of adults having ECLS following cardiac surgery, (Bonacchi 2020).
Stroke
Of the 10 key evidence studies, 4 reported stroke events. In the propensity score-matched study of 6,822 people admitted for cardiac surgery with or without VA ECMO, rates of new onset ischaemic stroke were 3% (36 of 1,137) for those on ECMO for PCS, compared to 4% (201 of 5,685) in those not on ECMO (OR 0.89, 95% CI 0.62 to 1.28, p=0.534; Chen 2017). Rates of new onset haemorrhagic stroke for those on ECMO for PCS were 1% (12 of 1,137), compared to less than 1% (23 of 5,685) in those not on ECMO without PCS (OR 2.63, 95% CI 1.30 to 5.29, p=0.007; Chen 2017).
Intracranial haemorrhage or haemorrhagic stroke and ischaemic stroke or embolisation were both reported as 3% (17 of 723) in the registry study of adults treated with VA ECMO (31% postcardiotomy) (Loungani 2021).
Ischaemic stroke was reported in 6% (18 of 297), and stroke 10% (12 of 121) in the single centre retrospective studies of people with PCS in France (Danial 2023) and China (Chen 2020), respectively. Stroke occurred at rate of 11% (24 of 209) in the multicentre retrospective study of adults having ECLS following cardiac surgery, (Bonacchi 2020).
Cardiovascular complications
Of the 10 key evidence studies, 2 reported cardiovascular adverse events or complications. In one registry study, cardiovascular complications occurred in 54% (3,894 of 7,185) of people with refractory PCS (Kowalewski 2021). These included cardiac arrhythmia 16% (1,141), CPR required more than 3 times 3% (206), hypotension requiring vasodilators 3% (222), and inotropes on ECMO 45% (3,196) (Kowalewski 2021). In the multicentre retrospective study of 209 adults having ECLS following cardiac surgery, cardiovascular events included arrhythmia 63% (131), vasoplegic syndrome 11% (22), and severe RV dysfunction 38% (80) (Bonacci 2020).
Metabolic complications
Of the 10 key evidence studies, 1 registry study reported metabolic adverse events or complications in 27% (1,934 of 7,185) of people with refractory PCS. These included glucose levels below 40 (1%, n=104), glucose levels greater than 240 (11%, n=758), hyperbilirubinemia (13%, n=941), pH lower than 7.2 (9%, n=620), and pH higher than 7.6 (3%, n=208) (Kowalewski 2021).
Pulmonary complications
Of the 10 key evidence studies, 4 reported pulmonary adverse events or complications. In one registry study, pulmonary complications occurred in 4% (271 of 7,185) of people with refractory PCS, including pneumothorax 1% (91), and pulmonary haemorrhage 3% (187) (Kowalewski 2021). In other registry study of 723 adults treated with VA ECMO (31% postcardiotomy), complications included pulmonary embolism less than 1% (3), haemothorax 4% (25), and pneumothorax 3% (22) (Loungani 2021). Hydrostatic pulmonary oedema was reported in 6% (17 of 297) of people with PCS, in the single centre retrospective study done in France (Danial 2023). Pulmonary complications reported in the multicentre retrospective study of 209 adults having ECLS following cardiac surgery included respiratory insufficiency 24% (50), pneumonia 18% (37), and ARDS 17% (36) (Bonacci 2020).
GI complications
Of the 10 key evidence studies, 1 multicentre retrospective study reported GI complications in 16% (34 of 209) of people having ECLS following cardiac surgery. It also reported bowel ischaemia in 9% (19 of 209) (Bonacchi 2020).
Hepatic complications
Of the 10 key evidence studies, 1 multicentre retrospective study reported hepatic complications in 6% (13 of 209) of people having ECLS following cardiac surgery (Bonacchi 2020).
Technical complications
Of the 10 key evidence studies, 2 reported technical adverse events or complications. In 1 registry study of adults treated with VA ECMO (31% postcardiotomy), oxygenator failure rates were 1% (8 of 723), and air embolism, cannula dislodgement, pump malfunction and tubing rupture were reported in less than 1% of the overall population (Loungani 2021). In the single centre retrospective study of 297 people with PCS, vascular cannulation and decannulation adverse event rates were 3% (9) and 9% (16), respectively (Danial 2023).
Anecdotal and theoretical adverse events
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they had never happened (theoretical).
They listed the following anecdotal and theoretical adverse events:
Left ventricle overloading
Deep vein thrombosis
Arteriovenous fistula
Pseudoaneurysm
Harlequin syndrome
Haemolysis
Intra-cerebral haemorrhage
Major pulmonary bleed
Failure to cannulate during cardiac arrest
Malposition of the cannula
Device clotting
Differential oxygenation
Lower body hyperoaxemia/hypocapnia
Air entrapment
Embolism
Oxygenator failure
Consumption coagulopathy
Acquired Von Willebrand syndrome
Systemic inflammatory response syndrome (SIRS)
Multi-organ failure including kidney, liver, and pancreas.
Sixteen professional expert questionnaires were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
Most studies included in the key evidence had a large number of participants from a variety of countries, although no UK-specific studies were included.
Due to the nature of the procedure, randomised controlled trials in the postcardiotomy population are not possible. There was therefore a lack of comparative studies included in the key evidence. Chen et al. (2017) was the only comparative study. This study compares those who had ECMO for PCS following cardiac surgery, to a propensity matched sample with the same cardiac surgery who did not have PCS or ECMO. This comparison is a clinically lower risk group compared to those who had ECMO.
Some studies did not include definitions of PCS or qualifying clinical reasons for requiring ECMO postcardiotomy.
The studies included people with a mix of primary surgery types and no studies were identified that stratified outcomes by primary surgery type.
Many studies lacked pre-, intra-, and postoperative information including differences between institutions in terms of patient selection, volume and expertise, treatment strategy as well as availability of ventricular assist devices and heart transplantation, which may impact outcomes.
Follow-up for most studies was short, reporting key efficacy outcomes at hospital discharge. Four studies had a 5-year follow-up period, and 1 study had a 10-year follow up period.
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