**3. PCI + ECMO vs. CABG for NSTE-ACS patients with multivessel disease**

This study had patients at high risk of adverse events for any type of revascularization (CABG and PCI). This is the largest series of consecutive high CABG risk chronic CAD patients who underwent ECMO in the elective pre-procedural manner. The main hypothesis of the study was that PCI + ECMO may be a feasible strategy of revascularization for **stable angina** patients

BARC: Bleeding Academic Research Consortium, MI: myocardial infarction, TVR: target vessel revascularization.

**Variables Stable CAD patients**

Mean bypass duration (min) 115.6 ± 43.7 Mean total time of PCI (min) 98.6 ± 31.1 Mean № of stents 3.6 ± 1.2 Mean diameter of stents 3.25 ± 0.5 Mean length of stents (mm) 75.8 ± 23.4 Bleeding (BARC≥3) 6 (37.5%) Complete revascularization 6 (37.5%) Residual SYNTAX score 8.5 ± 10.8 Hospital stay (days) 12.6 ± 4.8

**In-hospital outcomes**

40 Advances in Extra-corporeal Perfusion Therapies

**12-month outcomes**

MACCE • Death • Stroke • MI • TVR

MACCE • Death • Stroke • MI • TVR

**PCI+ ECMO (n = 16)**

4 (25%) 4 (25%) 1 (6.2%) 3 (18.7%) 2 (12.5%)

All the patients had severe multivessel disease involving LMCA, poor left ventricular fraction as a result of a prior MI and underwent challenging PCI with ECMO support as an adjunct modality in the elective pre-procedural setting, which allowed to complete a successful revascularization without hemodynamic disturbances and to wean from ECMO immediately after PCI. The hospital results looked satisfactory. There were no serious cardiac adverse outcomes. Hemorrhagic complications were not fatal, although it is necessary to note a high incidence of

at a high risk for CABG or PCI only.

**Table 2.** Procedural characteristics and study end points.

We followed NSTE-ACS multivessel coronary artery disease (MVCAD) patients consecutively admitted to our hospital from 2012 to 2015 and undergone revascularization with highrisk PCI + ECMO support or CABG. The study included 53 patients (PCI + ECMO, n = 23, and CABG, n = 30). It was a single-center registry, which compared 12-month outcomes. Inclusion criteria were significant multivessel coronary disease and/or stenosis of the left main coronary artery (LMCA) ≥50%. The PCI + ECMO group of NSTE-ACS patients had an intermediate risk of adverse cardiovascular outcomes (mean GRACE score 117.3 ± 19.4, mean EuroScore II 4.3 ± 3.9%), and a high SYNTAX Score: 33.3 ± 8.3. Significant LMCA stenosis was diagnosed in 60.7% of patients. Every third patient had diabetes mellitus, a prior myocardial infarction was observed in 56.4% cases, peripheral artery disease was diagnosed in 60.7% of patients of the study population. High-risk PCI was defined as having two of the three parameters: (1) left ventricular ejection fraction less than 35%; (2) a large amount of myocardium at risk (Jeopardy Score 8 and more [2]) and (3) complex PCI. An indication for high-risk PCI with ECMO support was based on the heart team decision for those patients, who were not suitable for some types of revascularization (CABG or PCI) and who had two of the three parameters of high-risk PCI.

The CABG group patients also had a moderate risk of adverse cardiovascular outcomes (mean GRACE score 97.5 ± 15.0, mean EuroScore II 2.7 ± 2.1%), and an intermediate-high SYNTAX Score: 29.7 ± 8.3. Significant LMCA stenosis was diagnosed in 36.6% of patients. Diabetes mellitus was present in 16.6% of patients, 60% of patients had a prior myocardial infarction and in every third patient of the study population, peripheral artery disease was diagnosed. Thus, there were no statistically significant differences between the groups in terms of the baseline clinical characteristics, but the PCI + ECMO group had a potentially slightly poorer prognosis compared with the CABG group (**Table 3**).

Implanted stents mean length and diameter were 54.6 ± 25.3 mm and 3.28 ± 0.4 mm, respectively. During the PCI procedure, 2.8 ± 1.1 DES were implanted. The average number of grafts

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43

The study endpoints included death, myocardial infarction, stroke, repeated unplanned revascularization and the combined endpoint of death, myocardial infarction, stroke, and

It is important to note, that the in-hospital mortality in the PCI + ECMO group was 4.3% and the combined endpoint of adverse events (MACE) (death, MI, stroke, repeated revascularization) was 8.7%. We observed a high rate of significant hemorrhagic complications (BARC 3) caused by the use of the ECMO cannula: up to 47.8%. Despite this, after 12 months of followup, mortality and MACE increased only to 8.7 and 17.4%, respectively. Repeated revascularization was required only in 1 (4.3%) case. These results make it clear that the revascularization approach is justified when PCI is performed on severe stenotic lesions in the large proximal

parts of the coronary arteries that supply significant areas of the viable myocardium.

The in-hospital results in the CABG group were characterized by a high mortality level (9.99%). MACE in the hospital period reached 13.3%. Significant hemorrhagic complications (BARC 3–4) occurred in 26.6% of cases, which was the expected outcome in the group of open surgical treatment. Mortality and MACE in the CABG group increased to 13.3 and 23.3%, respectively, after 12 months of follow-up. The analysis of the results shows a high proportion of in-hospital and long-term adverse events, which is caused by a high risk of the open surgery in NSTE-ACS MVCAD patients with a high SYNTAX score. These results should not be considered as unfavorable because according to the data of our Registry [25], the prognosis in this group of patients was extremely poor in the absence of revascularization (mortality

The comparison of the PCI + ECMO and CABG results of in NSTE-ACS MVCAD patients showed no significant differences in the study endpoints at 12-month follow-up (**Table 4**) despite a potentially poorer prognosis in the PCI + ECMO group compare to the CABG group

Thus, PCI + ECMO may be an alternative to the CABG revascularization strategy for NSTE-ACS MVCAD patients with a high surgical risk. Although CABG remains the conventional

**Variables PCI + ECMO (n = 23) CABG (n = 30) Р** Death 2 (8.7%) 4 (13.3%) 0.27 Myocardial infarction 2 (8.7%) 2 (6.6%) 0.77 Stroke 1 (4.3%) 0 0.26 Revascularization (unplanned) 1 (4.3%) 2 (6.6%) 0.7 MACE (death, MI, stroke, repeated revascularization) 4 (17.4) 7 (23.3%) 0.6

in the CABG group was 2.8 ± 0.6.

revascularization.

rate reached 28%).

based on baseline clinical characteristics.

**Table 4.** Twelve-month outcomes of various treatment strategies.

In order to perform PCI + ECMO, we used 21–23 Fr venous cannula for the right common femoral vein with a surgical technique. For the iliac artery—17-18 Fr arterial cannula was used. The mean ECMO flow was about 2.5 L/min/m2 with a duration of 95.4 ± 25.2 min. During PCI all patients received unfractionated heparin, and acetylsalicylic acid before PCI. About 42%of patients received the loading dose of clopidogrel before PCI. After the surgical cannulation wound closure, the remaining patients received the loading dose of clopidogrel. We connected ECMO ("RotaFlow System" developed by the MAQUET Getinge Groupe, Hirrlingen, Germany) before the start of PCI.

The patients in both groups were waiting for revascularization for about 2 weeks. About 89.9% of the CABG patients had complete revascularization. There were significantly fewer patients having had complete revascularization in the PCI + ECMO group: 30.3% (p = 0.0001).


**Table 3.** Baseline characteristics of the study groups.

Implanted stents mean length and diameter were 54.6 ± 25.3 mm and 3.28 ± 0.4 mm, respectively. During the PCI procedure, 2.8 ± 1.1 DES were implanted. The average number of grafts in the CABG group was 2.8 ± 0.6.

The CABG group patients also had a moderate risk of adverse cardiovascular outcomes (mean GRACE score 97.5 ± 15.0, mean EuroScore II 2.7 ± 2.1%), and an intermediate-high SYNTAX Score: 29.7 ± 8.3. Significant LMCA stenosis was diagnosed in 36.6% of patients. Diabetes mellitus was present in 16.6% of patients, 60% of patients had a prior myocardial infarction and in every third patient of the study population, peripheral artery disease was diagnosed. Thus, there were no statistically significant differences between the groups in terms of the baseline clinical characteristics, but the PCI + ECMO group had a potentially slightly poorer prognosis

In order to perform PCI + ECMO, we used 21–23 Fr venous cannula for the right common femoral vein with a surgical technique. For the iliac artery—17-18 Fr arterial cannula was used. The mean ECMO flow was about 2.5 L/min/m2 with a duration of 95.4 ± 25.2 min. During PCI all patients received unfractionated heparin, and acetylsalicylic acid before PCI. About 42%of patients received the loading dose of clopidogrel before PCI. After the surgical cannulation wound closure, the remaining patients received the loading dose of clopidogrel. We connected ECMO ("RotaFlow System" developed by the MAQUET Getinge Groupe, Hirrlingen,

The patients in both groups were waiting for revascularization for about 2 weeks. About 89.9% of the CABG patients had complete revascularization. There were significantly fewer patients having had complete revascularization in the PCI + ECMO group: 30.3% (p = 0.0001).

(45–75)

0.125

**Variables PCI + ECMO (n = 23) CABG (n = 30) Р**

Male 15 (65.2%) 19 (63.3%) 0.9 Mean left ventricular ejection fraction 47.5 ± 12.8% 54.4 ± 10.0% 0.069 Left ventricular ejection fraction ≤40% 9 (39%) 1 (3.3%) 0.001 Mean GRACE SCORE 117.3 ± 19.4 97.5 ± 15.0 0.205 LMCA stenosis ≥50% 14 (60.7%) 11 (36.6%) 0.08 Diabetes mellitus 8 (34.7%) 5 (16.6%) 0.13 Prior myocardial infarction 13 (56.4%) 18 (60%) 0.8 Arterial hypertension 22 (95.4%) 27 (89.9%) 0.5 Peripheral artery disease 14 (60.7%) 11 (33.3%) 0.049 Prior stroke 2 (8.6%) 2 (6.6%) 0.8 EuroScore II 4.3 ± 3.9% 2.7 ± 2.1 0.01 SYNTAX Score 33.3 ± 8.3 29.7 ± 8.3 0.062 Jeopardy score 10.6 ± 1.8 10.6 ± 1.7 0.876

Mean age 67.5 ± 8.5 (48–82) 64.4 ± 7

compared with the CABG group (**Table 3**).

42 Advances in Extra-corporeal Perfusion Therapies

Germany) before the start of PCI.

**Table 3.** Baseline characteristics of the study groups.

The study endpoints included death, myocardial infarction, stroke, repeated unplanned revascularization and the combined endpoint of death, myocardial infarction, stroke, and revascularization.

It is important to note, that the in-hospital mortality in the PCI + ECMO group was 4.3% and the combined endpoint of adverse events (MACE) (death, MI, stroke, repeated revascularization) was 8.7%. We observed a high rate of significant hemorrhagic complications (BARC 3) caused by the use of the ECMO cannula: up to 47.8%. Despite this, after 12 months of followup, mortality and MACE increased only to 8.7 and 17.4%, respectively. Repeated revascularization was required only in 1 (4.3%) case. These results make it clear that the revascularization approach is justified when PCI is performed on severe stenotic lesions in the large proximal parts of the coronary arteries that supply significant areas of the viable myocardium.

The in-hospital results in the CABG group were characterized by a high mortality level (9.99%). MACE in the hospital period reached 13.3%. Significant hemorrhagic complications (BARC 3–4) occurred in 26.6% of cases, which was the expected outcome in the group of open surgical treatment. Mortality and MACE in the CABG group increased to 13.3 and 23.3%, respectively, after 12 months of follow-up. The analysis of the results shows a high proportion of in-hospital and long-term adverse events, which is caused by a high risk of the open surgery in NSTE-ACS MVCAD patients with a high SYNTAX score. These results should not be considered as unfavorable because according to the data of our Registry [25], the prognosis in this group of patients was extremely poor in the absence of revascularization (mortality rate reached 28%).

The comparison of the PCI + ECMO and CABG results of in NSTE-ACS MVCAD patients showed no significant differences in the study endpoints at 12-month follow-up (**Table 4**) despite a potentially poorer prognosis in the PCI + ECMO group compare to the CABG group based on baseline clinical characteristics.

Thus, PCI + ECMO may be an alternative to the CABG revascularization strategy for NSTE-ACS MVCAD patients with a high surgical risk. Although CABG remains the conventional


**Table 4.** Twelve-month outcomes of various treatment strategies.

method of revascularization for patients with complex coronary disease including multivessel and LMCA disease, PCI + ECMO is a technique that improves the access to revascularization for high-risk patients who are often refused a CABG surgery.

**Author details**

**References**

Vladimir I. Ganyukov<sup>1</sup>

\*, Roman S. Tarasov2

for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia

1 Interventional Cardiology Laboratory, State Research Institute for Complex Issues of

3 Critical Conditions Laboratory, State Research Institute for Complex Issues of

2 Reconstructive Surgery Laboratory, Cardiac Surgery Department, State Research Institute

[1] Rihal CS, Naidu SS, Givertz MM, et al. SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care (endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiología Intervencionista; affirmation of value by the Canadian Association of Interventional Cardiology—Association Canadienne de Cardiologie d'intervention). Journal of the American College of Cardiology. 2015;**65**(19):2140-2141 [2] Califf RM, Phillips HR, Hindman MC, et al. Prognostic value of a coronary artery jeop-

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Surgery Forum. 2017;**20**(6):E274-E277. DOI: 10.1532/hsf.1635

[3] Ghodsizad A, Singbartl K, Loebe M, et al. Extracorporeal membrane oxygenation (ECMO): An option for cardiac Reccovery from advanced cardiogenic shock. The Heart

[4] van den Brink FS, Magan AD, Noordzij PG, et al. Veno-arterial extracorporeal membrane oxygenation in addition to primary PCI in patients presenting with ST-elevation myocardial infarction. Netherlands Heart Journal. 2017. DOI: 10.1007/s12471-017-1068-y

[5] Basir MB, Schreiber T, Dixon S, et al. Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: The Detroit cardiogenic shock initiative. Catheterization and Cardiovascular Interventions. 2017. DOI:

[6] Tsao NW, Shih CM, Yeh JS, et al. Extracorporeal membrane oxygenation-assisted primary percutaneous coronary intervention may improve survival of patients with acute myocardial infarction complicated by profound cardiogenic shock. Journal of Critical

\*Address all correspondence to: ganyukov@mail.ru

Cardiovascular Diseases, Kemerovo, Russia

Cardiovascular Diseases, Kemerovo, Russia

[Epub ahead of print]

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Care. 2012;**27**(5):530.e1-530.11

, Ivan E. Vereshchagin<sup>1</sup>

Long-Term Outcome of High-Risk Percutaneous Coronary Interventions with Extracorporeal…

and Dmitry L. Shukevich<sup>3</sup>

45

http://dx.doi.org/10.5772/intechopen.75881

In our study, we included patients with a high risk of adverse outcomes for any type of revascularization (CABG and PCI). We assume that PCI + ECMO is a possible strategy of revascularization for high-risk NSTE-ACS patients. These patients usually have diffuse coronary artery disease involving LMCA. PCI with ECMO support makes it possible to perform a successful revascularization with no hemodynamic instability.

The present study had several limitations. First of all, it was not randomized. A very critical clinical and angiographic status of the PCI patient group gave us the opportunity to test ECMO as a method of PCI support in a high-risk cohort of NSTE-ACS patients. It is necessary to conduct randomized trials to answer the question on the role of ECMO support for highrisk PCI in NSTE-ACS patients.
