Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction without On-Site Cardiac Surgery A Single Hospital Experience in Taitung

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1 Original Acta Cardiol Sin 2007;23:160 8 Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction without On-Site Cardiac Surgery A Single Hospital Experience in Taitung Hsiao-Yang Cheng, 1 Hung-I Yeh, 2 Charies Jai-Yin Hou, 2 Cheng-Ho Tsai 2 and Kuangte Wang 1 Primary percutaneous coronary intervention (PCI) provides outcomes superior to fibrinolytic therapy in acute myocardial infarction (AMI), but no registry or study in Taiwan has demonstrated its use in hospital without on-site cardiac surgery. Objectives: To investigate the safety and outcome of primary PCI for AMI without on-site cardiac surgery. Methods: Between September 2003 and September 2005, 175 patients were diagnosed as AMI in the Mackay Memorial Hospital, Taitung Branch, in which there was no on-site cardiac surgical backup. Of them, those whose electrocardiograms showed ST-elevation or new left bundle branch block (LBBB) presented within 12 hours of symptom onset and treated with primary PCI and fibrinolysis were enrolled into the study. Data of clinical course and angiographic characteristics were recorded and analyzed. Results: There were 38 patients (64 13 years old, 6 females) treated with primary PCI for infarct-related artery (IRA), among which were left anterior descending artery (LAD), 40%, left circumflex artery (LCX), 5%, and right coronary artery (RCA), 55%. The stent rate was 82%, and no emergency coronary artery bypass graft (CABG) was needed. The angiographic success rate was 92%, and the procedural success rate was 97%. All patients survived at least 1 year, except 1 (3%), who died due to sepsis on day 46 of admission. Within 1 year of the PCI, 3 (8%) patients were transferred out for elective CABG, 3 (8%) patients had non-fatal MI, and 7 (18%) patients had re-ira PCI, including 5 (13%) patients with in-stent restenosis, leaving the clinical success rate 71% at 1 year. There were 5 patients treated with fibrinolysis among which were left main (LM), 20%, LAD, 60%, and RCA, 20%. One of them underwent elective PCI to LAD. All patients survived at least 1 year, except 1 (20%), who had LM disease, was transferred to a tertiary center for emergency CABG at the next day of index MI, and died due to ventricular arrhythmia on day 44 post-operation. Conclusions: Primary PCI for patients with AMI having ST-elevation or new LBBB is a safe and effective strategy in Mackay Memorial Hospital, Taitung Branch, even without on-site cardiac surgery. Key Words: Acute myocardial infarction Primary percutaneous coronary intervention On-site cardiac surgery Received: December 25, 2006 Accepted: September 10, Section of Cardiology, Department of Internal Medicine, Mackay Memorial Hospital, Taitung Branch; 2 Section of Cardiology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan. Address correspondence and reprint requests to: Dr. Kuangte Wang, Section of Cardiology, Department of Internal Medicine, Mackay Memorial Hospital, Taitung Branch, No. 1, Lane 303, Changsha St., Taitung, Taiwan. Tel: ; Fax; ; kuangtewang@yahoo.com.tw INTRODUCTION Reperfusion therapy with primary percutaneous coronary intervention (PCI) or intravenous thrombolysis has been considered as the preferred approach for treatment of acute myocardial infarction (AMI). In large real world studies such as GOUST IIb, NRMI 1, 2, 3, Acta Cardiol Sin 2007;23:

2 Primary PCI without On-Site Cardiac Surgery and 4, MITRA, MIT, and the French study, both primary PCI and thrombolysis for AMI had excellent results. 1-4 Compared to fibrinolytic therapy, primary PCI has been demonstrated to reduce the rate of death, stroke, reinfarction, and recurrent ischemia in acute and long-term follow-up in several randomized trials in which appropriate facilities and skilled personnel were available. 5-7 Primary PCI also achieved higher patency rate and less re-occlusion. 8,9 Wharton summarized 15 studies of primary PCI at hospitals without on-site cardiac surgery. Emergency CABG for failed PCI was 0.67%. 10 For concern about efficient volume of PCI program and realistic strategy to transfer, it is class IIb indication in the ACC/AHA Guidelines for the Management of Patients With ST Elevation Myocardial Infarction and ACC/AHA/SCAI 2005 Guideline Update for Primary PCI Without Onsite Cardiac Surgery. 11,12 In Taitung County before mid-2003, therapy for ST-elevation MI (STEMI) was restricted to either intravenous thrombolysis or transfer to tertiary centers for primary PCI. Wang et al. reviewed 440 patients presenting with AMI between 1994 and 2001 in the Mackay Memorial Hospital, Taitung Branch, the in-hospital mortality was 26%. 13 Since September 2003, the Mackay Memorial Hospital, Taitung Branch has offered a 24-hour primary PCI service on a routine basis for patients with acute STEMI without on-site cardiac surgery. We designed this study to investigate the safety and outcome of primary PCI for STEMI in Mackay Memorial Hospital, Taitung Branch. METHODS Patients between September 2003 and September 2005 having symptom onset within 12 hours and either ST-segment elevation of 1mmin 2 contiguous leads or presumed new left bundle branch block (LBBB) in electrocardiogram (ECG) who were treated with primary PCI were enrolled. Data collection and statistical analyses This was a retrospective, observational analysis. Records from the patient s chart regarding the AMI and subsequent visits and hospitalizations were obtained for review. All patients were interviewed in person or by telephone contact within 12 months after the index MI. Comparison for categorical variables was analyzed using Chi-Square test; those for continuous variables were analyzed using Student t-test. All statistical tests were two-sided, and a p value of < 0.05 was considered significant. All statistical analyses were performed using the statistical package program SPSS 11.5 (SPSS Inc., Chicago, IL, USA). RESULTS A total of 175 consecutive patients were diagnosed as AMI between September 2003 and September Excluding 88 patients with non-st-elevation MI (NSTEMI), there were 87 patients with STEMI, of whom 38 patients underwent primary PCI, 5 patients underwent fibrinolytic therapy with alteplas, recombinant human tissuetype plasminogen activator (rt-pa), 1 of them underwent elective PCI, 36 patients underwent only rescue or elective PCI because of symptoms onset more than 12 hours, and leaving 8 patients, with symptom onset more than 12 hours, did not undergo any reperfusion therapy. In Table 1, the patients baseline characteristics are depicted and compared with those reported by Wang et Table 1. Baseline characteristics of patients Primary PCI rt-pa Numbers of patients 38 5 Age, yrs Male gender, n (%) 32 (84.2) 4 (80) Diabetes, n (%) 10 (26.3) 2 (40) Hypertension, n (%) 22 (57.8) 1 (20) Hyperlipidemia, n (%) 13 (34.2) 0 (0)0 Total cholesterol (mg/dl) Triglyceride (mg/dl) LDL-cholesterol (mg/dl) HDL-cholesterol (mg/dl) Current smoker, n (%) 18 (47.3) 2 (40) PriorMI,n(%) 1(2.6) 0(0)0 Prior stroke, n (%) 04 (10.5) 0(0)0 Prior CABG, n (%) 1 (2.6) 0 (0)0 Renal disease(cr 3.0), n (%) 2 (5.2) 0 (0)0 Body mass index (BMI) LVEF* *, measured using cardiac ultrasound. 161 Acta Cardiol Sin 2007;23:160 8

3 Hsiao-Yang Cheng et al. al. 10 For each variable, no significant difference was found between the two groups of patients in age, gender, diabetes, hypertension, total cholesterol, triglyceride, current smoker, prior MI, prior CABG, BMI, and LVEF. The clinical characteristics are shown in Table 2. Five patients including one female were aborigines. The percentage of patients treated in off-time periods (5 pm to 8 am during Monday to Friday, 12 am Saturday to 8 am Monday and holidays) was 45%. Anti-platelet agents were given in all patients, with loading dose of aspirin mg in 36 (95%) patients and Clopidogrel 300 mg in 36 (95%) patients regardless of previous use. Anti-coagulants (unfractionated heparin and/or enoxaparin) were used in all patients. Glycoprotein IIb/IIIa antagonists were infused in 33 (87%) patients (Tirofiban 6, Abciximab 27). Time to treatment and angiographic characteristics are reported in Tables 3 and 4. Half of our patients were transferred from other hospitals or clinics. Of them, 15 were from community hospitals without intervention facilities and 4 were from regional physicians. Seven (18%) patients achieved door-to-balloon time < 90 minutes, and only 2 (5%) patients achieved total ischemic time < 120 minutes. Regarding the outcome (Table 5), 1 (3%) patient died due to sepsis on day 46 of admission. Three (8%) patients had re-infarction with NSTEMI within 6 months, and one of them had non-ira involvement but 2 of them had IRA in-stent restenosis (ISRS), in whom 1 was in-stent subacute thrombus (SAT) and the other was instent total occlusion. Nine (24%) patients had IRA re- PCI, in whom 4 were RCA lesions and 5 were LAD lesions, and 8 of them were performed within 6 months after the index MI. No emergency CABG was required. Three patients underwent elective CABG. Two of them were triple-vessel disease (TVD) receiving bypass within Table 3. Time to treatment of primary PCI Intervals (min) Mean SD Median Symptom onset-to-arrival Door-to-balloon Total ischemic time Cath Lab = Catheterization Laboratory; CAG = Coronary angiography. Table 2. Clinical characteristics Numbers of patients (%) Primary PCI rt-pa Chest pain 20 (53) 05 (100) with radiation 12 (32) 1 (20) Breathlessness 17 (45) 1 (20) Cold sweating and/or diaphoresis 23 (61) 3 (60) Syncope 04 (11) 1(20) SBP<100mmHgbeforeCathLab/onarrival 13(44)/8(21) 1(20)/1(20) Ventricular arrhythmia with electric cardioversion before Cath Lab 04 (11) 0 (0)0 Symptomatic bradycardia or high-degree AV block with pacing before Cath Lab 05 (13) 0 (0)0 TPM (prophylactic and therapeutic) 14 (37) 0 (0)0 IABP 19 (50) 1 (20) Ventricular arrhythmia post-electric cardioversion (in Cath Lab) 05 (13) 0 (0)0 Progressive unstable angina as aura 11 (29) 2 (40) male 9/33 (27) 2/4 (50) female 2/5 (40) 0/0 (0) Anterior MI 14 (37) 4 (80) Inferior MI 22 (58) 1 (20) RV infarction 7 0 LBBB MI 2(5) 0(0)0 Killip I 13 (34) 3 (60) II 07 (18) 0 (0)0 III 3(8) 1(20) IV 15 (39) 1 (20) TPM = temporary pacemaker; IABP = intraaortic balloon pump; Cath Lab = catheterization laboratory. Acta Cardiol Sin 2007;23:

4 Primary PCI without On-Site Cardiac Surgery Table 4. Angiographic characteristics Pre-procedure: numbers of patients (%) Primary PCI rt-pa Infarct-related artery (IRA) Leftmain 0(0) 1(20) LAD 16(40) 3(60) LCX 2 (5) 0 (0)0 RCA 21 (55) 1 (20) TIMI flow grade (68) 0 (0)0 2 2 (5) 0 (0) (26) 05 (100) CAD Leftmain(LM) 0(0) 1(20) Single-vessel disease (SVD) 10 (26) 2 (40) Double-vessel disease (DVD) 16 (42) 2 (40) Triple-vessel disease (TVD) 08 (21) 0 (0)0 LM+SVD 0(0) 0(0)0 LM+DVD 2(5) 0(0)0 LM+TVD 2(5) 0(0)0 Post-procedure TIMI flow grade 3 35 (92) Angiographic finding of primary PCI Mean SD Median Pre-procedure Diameter of reference vessel (mm) Minimal diameter of lesion in IRA (mm) Stenosis rate of lesions (%) Maximum balloon size (mm) Stent size (mm) Stent length (mm) Maximum deployment pressure (atm) Stent rate 84% Post-procedure Maximum of reference diameter (min) Minimal diameter of IRA (min) LAD = left anterior descending coronary artery; LCX = left circumflex coronary artery; RCA = right coronary artery; TIMI = Thrombolysis In Myocardial Infarction. Table 5. Clinical outcomes Primary PCI rt-pa Outcome In-hospital 1-month 6-month 1-year In-hospital 1-month 6-month 1-year Death 1 (3)* 1 0* 1 1 (3) 1 (3) 0 1 (20) 1 (20) 1 (20) Re-infarction (8) 3(8) Stroke 1 (3)0. 1(3) 1(3) 1(3) IRA re-pci 0 2 (5) 0..7(18)* (24)* Emergency CABG 0 1 (20) ElectiveCABG 0 2(5) 3(8) 3(8) Needed blood transfusion 5 (13) 0 Combined (death, re-infarction, 2(5)0 1 (3) 13 (34) 15 (39) stroke, IRA re-pci, CABG) Wang et al 10 (n = 440), death 116 (26) Numbers in parentheses are percentages. * 1 Patient died due to sepsis on 46 th day of admission. * 2 Two of them were NSTEMI with in-stent restenosis within 6 months of the index MI. 163 Acta Cardiol Sin 2007;23:160 8

5 Hsiao-Yang Cheng et al. 1 month; another one was left main disease with doublevessel disease (DVD) receiving bypass 3 months later after the index MI. Angiographic success, with TIMI flow grade 3 post-procedure, was 92%. Procedure success, free of survival at discharge, was 92%. Clinical outcome showed that 1-year mortality was 3%, re-infarction 8%, IRA re-pci 24%, and elective CABG 8%. The combined end points of death, non-fatal infarction, non-fatal stroke, IRA re-pci, and CABG were 5% in hospital, 11% in 1 month, 34% in 6 months and 39% in 1 year. Five patients were treated with fibrinolysis, among whom were left main (LM), 20%, LAD, 60%, and RCA, 20%. One of them underwent elective PCI to LAD. All patients survived at least 1 years, except 1 (20%), who had LM disease, was transferred under biphase positive airway pressure (BIPAP) and IABP support, and received emergent CABG at a tertiary center on the next day after the index MI, but died due to ventricular arrhythmia and cardiogenic shock on day 44 post-cabg. The 4 survivors were free of re-infarction, IRA-PCI, CABG, death and stroke within 1 year. DISCUSSION Before the catheterization laboratory was available in Mackay Memorial Hospital, Taitung Branch in April 2003, the distance from our hospital to the nearest tertiary centers providing primary PCI service with on-site cardiac surgery at either Hualien or Kaohsiung, about 180 km, took more than 2 hours by ambulance transportation. It was further and took more time compared to those reported in the trials of LIMI (25-50 km, mean 20 minutes), Air-PAMI (10-69 km, mean 33 minutes), PRAGUE-1 (5-74 km, mean 35 min), PRAGUS-2 (5-120 km, mean min), DIANAMI-2 (3-150 km, mean 67 min ), and NRMI 3/4 (initial hospital door-to- PCI hospital door time: mean 120 min) Dalby et al. described a trend toward reduction in all-cause mortality for transfer to primary PCI compared to on-site thrombolysis, but in their report, the time-to-pci from randomization was min. 20 Keeley et al. contended that all high-risk STEMI patients with symptoms > 1 hour who present to community hospitals that are not highvolume primary PCI centers should be transferred to a PCI center, provided that the transfer delay is 2 hours. 21 In the present study the symptom onset-to-arrival time was over 3 hours. In addition, almost half of our patients presented with hemodynamic and/or electrical instability. The more than 2-hour transfer time to centers with on-site cardiac surgery outside Taitung county could result in a high mortality rate. The occurrence of emergency CABG for failed primary angioplasty is unusual Yang et al. compared the incidence of emergency CABG in the pre-stent era ( ), initial stent era ( ), and current stent era ( ) and found it was decreased, respectively, from 4% to 2% to 0.65%. 23 In randomized, controlled trials, the reported rate of emergency CABG was as low as 0.31%. 24 Wharton summarized 15 studies of primary PCI at hospitals without on-site cardiac surgery. Totally, the PCI success rate was 94%, in-hospital mortality was 6.0% (4.0% in non-shock group, 32% in shock group), and emergency CABG for failed PCI was 0.67%. 10 Singh s review and several recent reports also concluded similar excellent outcome and demonstrated the safety and efficacy of primary PCI for STEMI. 25 The possible indications of emergent CABG during primary PCI for acute STEMI are those hemodynamic instability requiring surgical intervention, angiographic accidents requiring surgical intervention including some left main coronary dissection, coronary perforation or rupture, and device complications even with current interventional techniques. The others are mechanical complications including valve dysfunction or aortic dissection requiring surgical intervention. The first step in hospital without on-site cardiac surgery support to manage critically ill patients is use of a fully array the interventional equipment to salvage complications by catheter-based techniques, including a broad range of catheters, guidewires, stents, and other devices (e.g., IABP), and experienced operators and an experienced laboratory technical staff. When life-threatening complication occur, provide a hemodynamic support and proven plan for rapid transfer to surgical center. Among patients with STEMI treated with primary PCI, the procedure can be started within 2 hours of symptom onset in < 15% of patients. 26 The key step for the delay is the door-to-decision time. In Mackay Memorial Hospital, Taitung Branch, the first-line physicians in the emergency room include cardiology specialists. Although the presentation of AMI with typical chest Acta Cardiol Sin 2007;23:

6 Primary PCI without On-Site Cardiac Surgery pain in our study was only 54%, the participation of cardiology specialists in the emergency room largely avoided the delay to primary PCI. In the present study, 16 (42%) patients were Killip IV. Age in the cardiogenic shock group was elderly (69 11 years). Their symptom onset-to-arrival times were shorter (129 61, median 123 min) and all within 4 hours. Half of them (8 patients) had shock on arrival. Four patients developed shock in our emergency room, including two who developed after electric cardioversion due to ventricular arrhythmia. Four patients had inferior MI and symptomatic bradycardia or high-degree AV block. One patient had inferior MI with RV infarction. Three patients had inferior MI with bradycardia and RV infarction. Three patients receiving elective CABG and one patient with in-hospital mortality were all in the shock group. McNamara et al. emphasized that intra-aortic balloon pump (IABP) plays an important role in the treatment and stabilization of patients with AMI who present to community hospitals, and its early use in high-risk AMI patients before triage to primary PCI will improve patient outcomes and survival. 27 In the present study, there was a higher rate of IABP use. It might be due to several reasons: (1) nearly one third of patients presented with hemodynamic (SBP 90 mmhg with shock) or electric (ventricular arrhythmia or high-degree AV block) instability; (2) our data did not exclude elderly (10 (26%) patients > 75 years old) and post-resuscitation patients who developed the disease in or out of our hospital; and (3) 2 patients had no reflow during PCI. Glycoprotein IIb/IIIa antagonists, as adjunctive therapy in primary PCI, may have effects in reducing distal embolization and improving myocardial perfusion and longterm survival. 28 Luca et al. showed the benefits particularly in high-risk patients. 29,30 Regarding stent implantation, Berger et al. reported that stent use was associated with a 50% decrease in risk of in-hospital mortality in a community-based practice. 31 Klein et al. also identified predictors of death, including no use of stent and glycoprotein IIb/IIIa antagonists during PCI. 32 The rates of stent and glycoprotein IIbIIIa antagonist use in our study were as high as 84% and 87%, respectively, which may contribute to the excellent outcome of the present study. Primary PCI for STEMI could be offered to less than one fourth of the patients in NRMI 3,4 and 1~29% in GRACE because of regional logistical constraints and the limited availability of catheterization facilities. 2,33 Politi et al. concluded no relationship between operator volume over the threshold indicated by guidelines and early outcomes and complications in primary PCI for STEMI. 34 We have offered primary PCI as routine firstline treatment to near 90% of patients with acute STEMI in Mackay Memorial Hospital, Taitung Branch since September The total volume of PCI procedures per year performed at our Taitung branch was around 250 in 2003 and graduate increased to nearly 400 in Although the number of patients in our study is too small to conclude the safety and efficacy of this approach and we still have to improve the organization in hospital to shorten the delay from door to balloon, our experience is in agreement with recent reports that primary PCI appears to be safe and effective and is the best reperfusion therapy in qualified community hospitals. 35 ACKNOWLEDGMENTS The authors thank all physicians as well as nursing and technical staff in the catheterization laboratory and intensive care unit at Mackay Memorial Hospital, Taitung Branch for providing excellent care to the patients. REFERENCES 1. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction: The Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) Angioplasty Substudy Investigators. N Engl J Med 1997;336: Gibson CM. NRMI and current treatment patterns for STelevation myocardial infarction. Am Heart J 2004;148:S Zahn R, Schiele R, Schneider S, et al. Decreasing hospital mortality between 1994 and 1998 in patients with acute myocardial infarction treated with primary angioplasty but not in patients treated with intravenous thrombolysis: results from the pooled data of Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Registry and the Myocardial Infarction Registry (MIR). J Am Coll Cardiol 2000;36: Treatment of acute myocardial infarction by primary coronary angioplasty or intravenous thrombolysis in the Real World : One-Year Results From a Nationwide French Survey. Circulation 1999;99: Acta Cardiol Sin 2007;23:160 8

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9 Original Acta Cardiol Sin 2007;23:160 8 急性心肌梗塞予以無心臟外科在場之立即性經皮冠狀動脈介入性治療 在台東之單一醫院經驗 1 鄭曉揚 2 葉宏一 2 侯嘉殷 2 蔡正河 1 王光德 台東市馬偕紀念醫院台東分院心臟內科 1 台北市馬偕紀念醫院心臟內科 2 立即性經皮冠狀動脈介入性治療對急性心肌梗塞提供優於血栓溶解劑之預後 但是在台灣缺乏任何研究顯示, 在無心臟外科在場之醫院, 予以立即性經皮冠狀動脈介入性治療對急性心肌梗塞之價值 目的對於急性心肌梗塞予以無心臟外科在場之立即性經皮冠狀動脈介入性治療, 調查其安全性及結果 方法在 2003 年 9 月至 2005 年 9 月間, 無心臟外科在場之馬偕紀念醫院台東分院共有 175 名診斷為急性心肌梗塞之病患, 凡心電圖顯示 ST 段上升或新發現左側束枝傳導阻滯, 於症狀發生 12 小時內接受立即性經皮冠狀動脈介入性治療者, 納入本研究 臨床病程及血管攝影特徵之資料均予以記錄及分析 結果有 38 名 (64 ± 13 歲, 含 6 名女性 ) 急性心肌梗塞之病患接受立即性經皮冠狀動脈介入性治療 心肌梗塞相關之動脈為左前降支佔 40% 左迴旋支佔 5% 右冠狀動脈佔 55% 支架置放率為 82% 無緊急接受冠狀動脈繞道手術之需求發生 血管攝影介入性治療成功率為 92% 經介入性治療過程成功出院之比例為 97% 1 名 (3%) 病患於住院第四十六天敗血症死亡, 其餘皆存活一年以上 這一年內,3 名 (8%) 病患轉院接受選擇性冠狀動脈繞道手術,3 名 (8%) 病患發生非致死性心肌梗塞,7 名病患 (18%, 含 5 名發生支架內再狹窄 ) 再度接受心肌梗塞相關動脈之介入性治療 一年臨床成功率為 71% 有 5 名急性心肌梗塞之病患接受血栓溶解劑治療, 其心肌梗塞相關之動脈為左主幹佔 20% 左前降支佔 60% 右冠狀動脈佔 20% 1 名病患接受對左前降支之選擇性介入性治療 除了 1 名左主幹冠狀動脈病變之病患於心肌梗塞翌日轉院接受緊急冠狀動脈繞道手術, 術後 44 日因心室性心律不整死亡, 其餘皆存活一年以上 結論在馬偕紀念醫院台東分院, 無心臟外科在場之立即性經皮冠狀動脈介入性治療, 對於 ST 段上升或左側束枝傳導阻滯之急性心肌梗塞, 是安全且有效之策略 關鍵詞 : 急性心肌梗塞 立即性經皮冠狀動脈介入性治療 無心臟外科在場 168