Long-term outcomes of high-risk percutaneous coronary interventions under extracorporeal membrane oxygenation support: An observational study

INTRODUCTION

The use of percutaneous coronary intervention (PCI) has shown an increasing trend worldwide due to the anatomic and clinical complexity of cases experiencing coronary artery disease[1,2]. Coronary artery bypass graft (CABG) represents the first revascularization strategy recommended for patients with an acceptable surgical risk and multivessel disease in line with myocardial revascularization guidelines[3]. However, due to severe clinical and anatomic conditions, CABG is not possible in some patients. In such cases, PCI is the only available revascularization strategy. High-risk PCI can cause hemodynamic instability

procedure-induced cardiac ischemia, especially in the case of coronary dissection with noreflow or vascular closure. Therefore, temporary circulatory support is required in the perioperative period if high-risk PCI is planned. Impella CP and Impella 2.5 have been reported to be safe, feasible, and potentially beneficial support devices for high-risk PCI[4-6]. However, the cost of Impella is higher than that of extracorporeal membrane oxygenation (ECMO) and is not covered in public medical insurance in most regions of China, thereby restricting the use of this device. Some studies have reported the feasibility of ECMO application in high-risk PCI, and showed good short-term outcomes in patients[7-11]. However, the long-term outcomes among cases undergoing high-risk PCI supported by ECMO have not been studied. Therefore, this work focused on the long-term outcomes of patients who underwent high-risk PCI supported by venoarterial ECMO (VA-ECMO).

MATERIALS AND METHODS

Study population

In the present unicentric, retrospective, and observational cohort study, 61 patients who received VAECMO-supported high-risk PCI at the Sixth Medical Center of Chinese People’s Liberation Army General Hospital between April 2012 and January 2020 were enrolled. High-risk PCI was defined according to the patient’s hemodynamic status (shock or dysfunction of the left ventricle), clinical features, and underlying diseases such as heart failure, diabetes mellitus (DM), peripheral vascular disease, advanced chronic kidney disease (CKD), prior history of cardiac surgery, chronic obstructive pulmonary disease (COPD), or coronary anatomy/lesion complexities such as saphenous vein graft degeneration, unprotected three-vessel or left main vessel disease, last patent conduit, severe calcified lesions, and chronic total occlusions (CTO) among multivessel disease patients[12].

Procedure for venoarterial extracorporeal membrane oxygenation

The VA-ECMO support (Bio-Medicus, Medtronic Inc., Minneapolis, MN, United States) comprises a circuit constituted by arterial and venous cannulas, a membrane oxygenator used for gas exchange and a centrifugal pump used for blood propulsion. VA-ECMO cannulation was performed by cardiothoracic surgeons in the catheterization laboratory using Seldinger’s technique. The tips of venous and arterial cannulas were placed in the inferior vena cava and descending aorta, respectively. The patients were administered heparin to achieve and maintain an activated clotting time of > 300 s after ECMO cannulation. The ECMO flow in the arterial line was maintained at 1.5-2 L/min during the PCI procedure. If the patient had severe hypotension, a higher flow of ECMO was considered. The concomitant use of an intra-aortic balloon pump (IABP) was determined by the operator.

With the rapid development in PCI technology, more and more high-risk cases are being treated worldwide[1,14]. High-risk PCI is usually defined by three aspects: Patient characteristics, lesion characteristics, and clinical presentation[15-17]. These characteristics pose a great challenge to cardiologists not only because of the risk of peri-procedural complications but also because of poor outcomes. In our study, most patients were elderly with several comorbidities, including DM, hypertension, prior myocardial infarction, CKD, serious peripheral arterial disorders, and left ventricular dysfunction. The anatomical complexity of the coronary artery and high SYNTAX score made surgical intervention difficult. Moreover, all the patients had acute coronary syndrome, and the GRACE score was high, which indicated poor outcomes in these patients[18].

Procedure for percutaneous coronary intervention

The revascularization strategy was developed by a multidisciplinary heart team consisting of cardiologists, cardiothoracic surgeons, anesthesiologists, perfusionists, critical care physicians, as well as specialized nurses. All the patients were considered unsuitable for surgery according to the heart team and were approved to undergo high-risk PCI under VA-ECMO hemodynamic support. Dualantiplatelet treatment (loading doses: Aspirin: 300 mg; ticagrelor: 180 mg; or P2Y

receptor inhibitor clopidogrel (300/600 mg) was initiated prior to coronary angiography. Guidewires, balloons, and stents were selected by the operator.

Study definitions and endpoint determination

Intraoperative hypotension was diagnosed according to the threshold of systolic blood pressure (SBP) below 90 mmHg or a reduction in the baseline SBP of more than 40 mmHg, without any other cause of hypotension. PCI success was defined as the residual diameter of stenosis < 30% (according to visual estimation) with translesional pressure gradient with hemodynamic significance or flow-limiting dissection. Patients with cardiac shock after receiving PCI under VA-ECMO support were defined as rescue VA-ECMO use.

Table 1 shows baseline clinical features of the patients who underwent high-risk PCI supported by VAECMO. The age of the patients ranged from 64 to 79 years (median: 74 years), and most patients (73.8%) were male. The average body mass index (BMI) and median left ventricular ejection fraction (LVEF) were 25.0 ± 3.4 kg/m

and 42% (32%-49%), respectively. The LVEF was 42% (32%-49%), and 32.8% (

= 20) of patients had a LVEF ≤ 35%. Approximately 29.5% of patients (

= 18) were admitted for STelevation myocardial infarction. Twenty cases (32.8%) had a myocardial infarction history. Eleven patients (18.0%) had previously received CABG. The mean SYNTAX score was 42.5 ± 10.0 in patients who had never undergone CABG (

= 50). The majority of patients had a high risk for cardiac surgery with a median EuroSCORE of 12 (10-15). Most patients had a poor prognosis with a median GRACE score of 163 (145-195).

“六書”一詞最早出現(xiàn)于《周禮·地官·保氏》：“保氏掌諫王惡，而養(yǎng)國子以道，乃教之六藝：一曰五禮；二曰六樂；三曰五射；四曰五馭；五曰六書”；六曰九數(shù)”，“六書”有詞無義，也就是說，《周禮》提出來“六書”一說，但是并沒有對(duì)“六書”做進(jìn)一步的解釋。所以我國歷史上最早出現(xiàn)的“六書”有其詞而無其義。

采用Fox 4000對(duì)檸檬果醋的整體氣味進(jìn)行區(qū)分，該電子鼻系統(tǒng)包括18根傳感器[13]，包括A組：T30/1，P10/1，P10/2，P40/1，T70/2，PA/2；B組：P30/1，P40/2，P30/2，T40/2，T40/1，TA/2；C組：LY2/LG，LY2/G，LY2/AA，LY2/GH，LY2/gCTL，LY2/gCT。

The present work was performed according to the Helsinki declaration. Informed consent was obtained from each patient who participated in the study.

Statistical analysis

The total in-hospital mortality was 23% (

= 14). Of which, ten patients died due to cardiac shock, three due to septic shock, and one patient succumbed to early stent thrombosis. Post-operative cerebral infarction occurred in four patients (6.6%) because of hypoperfusion caused by cardiac or septic shock. The overall mortality was 31.1% at one-year follow-up. Prophylactic VA-ECMO support (

= 52) resulted in lower in-hospital mortality (13.5%

77.8%,

= 0.000) and 1-year mortality (21.2%

77.8%,

= 0.002) compared with patients who received rescue VA-ECMO support.

RESULTS

Baseline features

We determined SYNTAX score by adopting the SYNTAX online score calculator (http://www.syntaxscore.com/calculator/start.htm)[13]. EuroSCORE was prospectively evaluated to assess perioperative risk of mortality (http://www.euroscore.org/calc.html). We also determined the GRACE score by adopting the GRACE online score calculator (https://www.merckmanuals.com/medicalcalculators/GRACEScore.htm). Baseline characteristics, procedural and vascular access complications were recorded. Patient follow-up consisted of phone calls, hospital record reviews, or outpatient visits.

Procedural characteristics

Femoral-femoral VA-ECMO cannulation was performed in all patients. Fifty-two patients (85.2%) received prophylactic VA-ECMO before PCI, whereas nine patients (14.8%) received rescue VA-ECMO support. Twenty-five patients (41.9%) underwent IABP insertion. The stent was not implanted in three patients (4.9%) due to CTO with severely calcified lesions. One patient (1.6%) was intolerant to ECMO because of increased left ventricular afterload. PCI was successfully performed in 93.4% (

= 57) of patients, and the median number of stents implanted per patient was two (1-3). The median amount of contrast was 120 (95-161) mL. The median ECMO run was 1.6 (1.2-2.4) h. The mean residual SYNTAX score after PCI under VA-ECMO support was 18.9 ± 13.1 in patients without CABG (Table 2).

Fifteen patients (24.6%) experienced intraoperative hypotension, and surgery was performed safely by increasing the ECMO flow. One patient (1.6%) received antegrade perfusion of the leg due to lower extremity ischemia. Hemorrhagic complications occurred in eight patients (13.1%), and six of these patients required blood transfusion (9.8%). The median length of stay was 20 (13-29) d, and the median cardiac care unit stay was 7 (3-18) d. The median hospitalization costs were ￥153000 (￥118000-￥216000) (approximately $24000).

Clinical outcomes

Results were analyzed using SPSS 26.0 for Windows (SPSS Inc., Chicago, IL, United States). Categorical variables are presented as percentages and counts. Continuous variables with normal distribution are expressed as mean ± SD, whereas abnormally distributed variables are shown as medians (interquartile range). Fisher’s exact test or Pearson's

test was performed to compare categorical variable frequencies. Each test was two-sided.

value < 0.05 was considered statistically significant.

The long-term survival rate was 45.9%, and the median follow-up period was 38.6 (8.6-62.1) mo. Two patients (3.3%) required further revascularization owing to unstable angina at one-year follow-up. One patient was re-admitted due to symptomatic heart failure (Table 3).

DISCUSSION

Based on our results, high-risk PCI can be considered safe under VA-ECMO support with a promising long-term survival. VA-ECMO can provide hemodynamic support during high-risk PCI, and allows sufficient time to complete the PCI procedure when profound hypotension occurs.

角色中涉及的動(dòng)畫主要通過Unity 中內(nèi)置的動(dòng)畫狀態(tài)機(jī)Animator 實(shí)現(xiàn)對(duì)動(dòng)畫片段的邏輯管理和統(tǒng)一管理。Animator 方便的圖形化界面可以讓角色控制更為清晰，也直接利于代碼的管理和編寫。通過對(duì)Animation 和邏輯狀態(tài)統(tǒng)一管理，利用腳本就可以管理整個(gè)Animator 實(shí)現(xiàn)角色的一系列動(dòng)作，從而實(shí)現(xiàn)系統(tǒng)中角色執(zhí)行相應(yīng)的漫游和展示動(dòng)作。Animator 利于把抽象的邏輯關(guān)系重新組合，能大幅度增加角色的真實(shí)性和沉浸感。

Coronary revascularization minimizes unfavorable clinical events in high-risk cases and improves life quality[19-21]. Selecting revascularization strategies (PCI or CABG) should be performed by a heart team considering both risks and benefits[22]. As suggested by the existing myocardial revascularization guidelines[23], when CAD is anatomically complex (namely, unprotected three-vessel or left main vessel disease), CABG can be considered the first choice for treating patients with a SYNTAX score of more than 32. However, CABG is not recommended in patients with frailty, severe underlying diseases, and a prior history of cardiac surgery due to the risk of high postoperative mortality. PCI under temporary mechanical circulatory support (MCS) could be considered another option for high-risk cases.

At present, large-scale randomized trials are not available to compare the application of prophylactic ECMO with the standby strategies, and no consensus has been reached regarding the optimal timing of ECMO cannulation. Elvis

[30] reported the application of prophylactic ECMO in high-risk patients who received coronary combined with structural percutaneous interventions. The procedure was reported to be safe and successful, considering favorable in-hospital as well as mid-term outcomes. In a study on high-risk coronary angioplasty, Teirstein

[31] reported that standby cardiopulmonary support is preferable to prophylactic cardiopulmonary support due to fewer complications with standby cardiopulmonary support. Moreover, those with compromised left ventricular function can gain benefits from prophylactic cardiopulmonary support. Our study found that prophylactic VAECMO resulted in low in-hospital and one-year mortality compared with rescue VA-ECMO support. Although the prophylactic group had a lower rate of cardiac shock, early intervention with MCS may prevent progression to cardiac shock in high-risk patients.

At present, the percutaneous MCS instruments are Impella, TandemHeart, and VA-ECMO. Hemodynamic support should have four major objectives, including ventricular unloading, circulatory support, end-organ perfusion, and coronary perfusion[24]. The Impella device is an axial-flow pump that provides 2.5-5 L cardiac output with rapidly decreasing left ventricular preload. In March 2015, the United States Food and Drug Administration approved the Impella 2.5 as a transitory ventricular support device for patients undergoing high-risk PCI. As reported in the PROTECT series of studies, Impella 2.5 can offer favorable hemodynamic support during high-risk PCI and better outcomes than those with IABP support[25,26]. Some studies performed with a large-sample size reported that Impella is related to a higher incidence of side effects and massive bleeding among patients receiving PCI under MCS[27,28]. Furthermore, the application of Impella is associated with higher hospital costs[27,29]. Currently, the cost of the Impella device is $37000 (approximately ￥240000) in China, which is a tremendous burden in high-risk patients, especially in developing countries. Therefore, VA-ECMO should be considered an alternative to the MCS device in high-risk PCI.

VA-ECMO is an extracorporeal life support, which can provide partial respiratory and circulatory support. F. S. van den Brink and colleagues reported on a few cases who had stable coronary artery disease who received prophylactic VA-ECMO-supported PCI and showed good short-term outcomes[7]. Salvatore and coworkers[9] reported 12 patients who underwent elective ECMO-supported highrisk PCI, and were at high risk for CABG who achieved favorable and immediate mid-term outcomes. However, long-term survival in ECMO-supported PCI has not yet been reported. As demonstrated in this work, high-risk PCI may be feasible with VA-ECMO support and can lead to good long-term outcomes. Cardiac death occurred in 29.5% (

= 18) of cases with a median follow-up time of 38.6 (8.6-62.1) mo, and most events occurred within a year.

High-risk PCI can result in hemodynamic instability during the perioperative period, especially when managing complex coronary anatomy (

degenerated saphenous vein grafts, unprotected left main vessel disease, last patent conduit, severely calcified lesions with a need for rotational atherectomy, and CTO with multivessel disease). In the present study, 15 patients (24.6%) experienced intraoperative hypotension after a guidewire was placed through the lesion or balloon dilation. Fortunately, VAECMO offered cardio-cerebral perfusion and arterial oxygenation during hypotension. Therefore, hemodynamic support was crucial in these patients during high-risk PCI procedures.

（2）實(shí)現(xiàn)教育培訓(xùn)和市場需求的有機(jī)結(jié)合，人力資源開發(fā)中教育培訓(xùn)發(fā)揮著巨大的作用，根據(jù)我國經(jīng)濟(jì)社會(huì)發(fā)展現(xiàn)狀應(yīng)以市場需求為目標(biāo)，構(gòu)建一個(gè)完善的教育培訓(xùn)體系，解決各大組織廣泛存在的人才與職業(yè)、崗位不適應(yīng)的問題，促進(jìn)人員就業(yè)、升職；

VA-ECMO provides retrograde aortic flow for maintaining vital organ perfusion. Such a strategy is significantly limited by its increased left ventricular afterload, resulting in increased left ventricular enddiastolic pressure, aortic and mitral regurgitation, and pulmonary edema[32]. Blood stasis occurred in one patient in our study after VA-ECMO cannulation due to impaired left ejection fraction. VA-ECMO was immediately removed, and IABP was inserted in the contralateral femoral. The strategies to reduce left ventricular afterload include decreased pump flow, inotropes, concomitant use of IABP or Impella, and left ventricular venting[33]. As suggested by a meta-analysis, left ventricular unloading is related to reduced mortality among adult cases who have cardiogenic shock and receive VA-ECMO treatment[34]. Therefore, left ventricular unloading is probably adopted in some patients who have severe impaired left ejection fraction.

通過實(shí)驗(yàn)過程也可以看出，實(shí)驗(yàn)班的同學(xué)積極性比較高，能夠在組長帶領(lǐng)下互相監(jiān)督、相互協(xié)作，提高了練習(xí)的密度，尤其在進(jìn)行小組競賽的時(shí)候，表現(xiàn)積極。相反，傳統(tǒng)的教學(xué)方法，學(xué)生被動(dòng)地接受教師的講解示范，體育鍛煉興趣較低，這也是導(dǎo)致對(duì)照班身體素質(zhì)項(xiàng)目提高幅度比實(shí)驗(yàn)班小的原因。

CONCLUSION

Huang YX, Chen Y, and Li TC designed the study; Huang YX drafted the manuscript; Cao Y, Qiu YG, Liu YM, and He JC revised it critically for important intellectual content; Xu ZM, Zhao L, and Zhang PY contributed to the analysis and interpretation of data; Li TC, the corresponding author of this manuscript, gave final approval of the manuscript submitted.

ARTICLE HIGHLIGHTS

FOOTNOTES

VA-ECMO can be used as a support in patients undergoing high-risk PCI as it confers good long-term survival.

The study was reviewed and approved by the Sixth Medical Center of PLA General Hospital Institutional Review Board (Beijing).

All study participants, or their legal guardian, provided informed written consent prior to study enrollment.

從研究的時(shí)間、力度和成效來看，“翻譯詩學(xué)”研究在中國翻譯界仍屬較為前沿和年輕的領(lǐng)域，因此劉華文教授傾注十余年心血完成的《翻譯詩學(xué)》具有開拓意義。該書體現(xiàn)了學(xué)科交叉性原則、主題相關(guān)性原則、中西比較性原則和脈絡(luò)回溯性原則。

There are no conflicts of interest to report.

Technical appendix, statistical code, and dataset are available from the corresponding author at itc909@163.com.

The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.

鑒于此，筆者建議將隱喻分析進(jìn)一步應(yīng)用于大學(xué)生的心理健康狀況調(diào)查，以探知其心理健康水平，也可運(yùn)用于與學(xué)生群體緊密相關(guān)的對(duì)教師群體進(jìn)行調(diào)查分析，更好地發(fā)揮隱喻的社會(huì)功能，應(yīng)用并服務(wù)于教育領(lǐng)域。

This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BYNC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is noncommercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

當(dāng)前，云南正處于制造業(yè)追趕、現(xiàn)代服務(wù)業(yè)加快發(fā)展以及工業(yè)化、城鎮(zhèn)化雙加速的階段，處于發(fā)展方式轉(zhuǎn)變、優(yōu)勢(shì)充分釋放的關(guān)鍵時(shí)期，處于體制機(jī)制變革、發(fā)展階段躍升的重要關(guān)口，面臨著速度變化、結(jié)構(gòu)優(yōu)化、動(dòng)力轉(zhuǎn)化等多重壓力，云南長期以來以資源開發(fā)和規(guī)模擴(kuò)張為主導(dǎo)的產(chǎn)業(yè)發(fā)展方式已難以為繼。

China

Yi-Xiong Huang 0000-0003-4936-1934; Zheng-Ming Xu 0000-0002-2125-5972; Li Zhao 0000-0003-3043-0194; Yi Cao 0000-0002-5561-1162; Yu Chen 0000-0001-7959-2691; Yi-Gang Qiu 0000-0002-7692-7588; Ying-Ming Liu 0000-0002-5160-6593; Peng-Yu Zhang 0000-0003-4541-5536; Jiang-Chun He 0000-0003-0254-7379; Tian-Chang Li 0000-0003-4503-0089.

Chen YL

Webster JR

3)在高頻近似分析下，花崗巖中頻率衰減因子α(ω)和波數(shù)k(ω)均與圓頻率ω近似成線性關(guān)系，但由不同相鄰位置實(shí)測(cè)的粒子速度信息得到的α(ω)和k(ω)各不相同；

Chen YL

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