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ORIGINAL ARTICLE
Year : 2020  |  Volume : 13  |  Issue : 4  |  Page : 362-367  

Study of primary angioplasty in hospital not having onsite cardiac catheterization facility


1 Department of Medicine, Army College of Medical Sciences, Delhi, India
2 Senior Consultant & Director, Cardiology Narayana Hospital, Gurgaon, Haryana, India
3 Department of Cardiology, Cardiac Catheterization Lab, Command Hospital WC, Chandimandir, Panchkula Haryana, India

Date of Submission19-Aug-2019
Date of Decision29-Dec-2019
Date of Acceptance11-Mar-2020
Date of Web Publication20-Jul-2020

Correspondence Address:
Anil Kumar
Cardiac Catheterization Lab, Command Hospital WC, Chandimandir, Panchkula, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mjdrdypu.mjdrdypu_112_19

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  Abstract 


Objectives: The aim of this study is to evaluate the appropriateness of use and quality as well as outcomes of primary angioplasty for acute myocardial infarction (MI) in a single center without percutaneous coronary intervention (PCI) capability. Background: Primary percutaneous transluminal coronary angioplasty (PTCA) increases the rates of patency of the infarcted artery, improves survival rates, and reduces the rates of reinfarction and strokes as compared to thrombolysis. Methods: This is a hospital-based prospective study involving 77 patients. Primary PTCA was done by emergency transfer to PCI center at earliest. Results: Male patients outnumbered females (77% vs. 22%). Patients in the age group of 45–69 years constituted around 70.0% of the total ST-elevation MI patients. Majority of the patients (90%) presented with chest pain. During coronary angiography, it was found that the major culprit coronary was the right coronary (42.85%) followed by the left anterior descending artery (36.36%). A majority of the patients in the study group were found to have single-vessel disease (57.14%), and only five of the patients had triple-vessel disease (06.49%). Glycoprotein IIb/IIIa inhibitors were given to 41 patients (53.24%) as an adjuvant therapy. Conclusion: Primary angioplasty is very appropriate and feasible with a good outcome for the management of patients with acute ST-elevation MI even in a center where the facility of cardiac catheterization is not available. Our patients with acute ST-elevation myocardial infarction who were shifted to a center having cardiac catheterization laboratory and subsequently managed with primary angioplasty showed good response and outcome in terms of mortality and morbidity over a follow-up of 1 year.

Keywords: Acute ST-elevation, myocardial infarction, primary angioplasty


How to cite this article:
Singh R, Hemant Madan V S, Kumar A. Study of primary angioplasty in hospital not having onsite cardiac catheterization facility. Med J DY Patil Vidyapeeth 2020;13:362-7

How to cite this URL:
Singh R, Hemant Madan V S, Kumar A. Study of primary angioplasty in hospital not having onsite cardiac catheterization facility. Med J DY Patil Vidyapeeth [serial online] 2020 [cited 2020 Aug 8];13:362-7. Available from: http://www.mjdrdypv.org/text.asp?2020/13/4/362/290154




  Introduction Top


Acute myocardial infarction (AMI) is one of the most common diagnoses in hospitalized patients in industrialized countries. Despite impressive strides in diagnosis and management over the past four decades, AMI continues to be a major health problem in the industrialized world and becoming an increasingly important problem in developing countries.[1],[2] The early (30 days) mortality rates from AMI is about 30%, with more than half of these deaths occurring before the stricken individual reaches the hospital. Approximately one of every 25 patients who survive the initial hospitalization dies in the 1st year after AMI. Although the death rates from AMI have declined by approximately 30% over the past decade, its development is still a fatal event in approximately one-third of patients.

Coronary artery occlusion due to thrombosis is the cause of most cases of AMI accompanied by ST-segment elevation;[3] rapid restoration of blood flow to the jeopardized myocardium limits necrosis and reduces mortality. Timely reperfusion of jeopardized myocardium represents the most effective way of restoring the balance between myocardial oxygen supply and demand, which can be accomplished medically, with a thrombolytic agent, or mechanically with so-called primary balloon angioplasty with or without stenting.

The treatment of myocardial infarction (MI) has evolved considerably over the past decades. Reported mortality has fallen as a result of a variety of factors, including early diagnosis and treatment of the acute event, improved management of complications such as recurrent ischemia and heart failure, and general reliability of pharmacological treatment. Most attention, however, has been focused on treatment that may restore ante-grade coronary blood flow in the culprit artery of the patient with evolving MI. The two methods to achieve the goal are thrombolytic treatment and immediate coronary angiography followed by a coronary angioplasty if appropriate. The extent of protection appears to be related directly to the rapidity with which reperfusion is implemented after the onset of coronary occlusion.[4]

Primary percutaneous coronary intervention (PCI) has gained widespread acceptance as the preferred approach for treating acute ST-elevation MI (STEMI) when it can be performed rapidly at qualified centers. Primary PCI is superior to thrombolytic therapy in fibrinolytic-eligible patient with STEMI; it reduces the rates of death, reinfarction, cerebral bleeding, reocclusion of the infarct artery, and recurrent ischemia as compared with fibrinolytic therapy. Primary PCI is potentially applicable to a much broader spectrum of patients with STEMI than is fibrinolytic therapy.

Studies have demonstrated that transfer of patients with STEMI for PCI yields superior outcomes compared with local fibrinolytic therapy. Lack of on-site PCI program need not prevent a hospital from offering treatment with primary PCI. Early and rapid transfer for the primary PCI yields superior outcomes compared with local fibrinolytic therapy in most patients with STEMI who presents to non-interventional centers.

The aims and objective of this study are to demonstrate the feasibility and outcomes of primary PCI for patients with STEMI who were transferred for the same from a hospital not having on-site PCI program.


  Material and Methods Top


This was a hospital-based prospective study involving 77 patients with Acute STEMI attending Command Hospital Air Force, Bangalore. Approval was taken for the study from the Institutional Ethical Committee of Air Force Hospital Bangalore, on October 27, 2017.

Inclusion criteria

The diagnosis of STEMI in the patients included was based on the following criteria:

  1. Clinical presentation with chest pain which may or may not be associated with angina accompaniments or equivalent and
  2. Electrocardiographic findings of acute STEMI.


These details were recorded as per the pro forma attached as annexure. The data collected were subjected to statistical analysis for determining the significance of the results. The following data were collected:

Clinical history

Age and gender, history of angina pain with or without angina accompaniments, associated comorbidities such as diabetes, hypertension, hyperlipidemia, history of smoking, family history of CAD, diabetes, hypertension, hyperlipidemia, and past history of coronary artery disease. Detail general physical examination and complete systemic examination were carried out to assess hemodynamic stability. Complete blood count with blood grouping and cross-matching was calculated. Routine and microscopic urine analysis was performed. Patients who were detected to have acute STEMI on ECG with chest pain were fully examined for any associated complications or signs of hemodynamic instability. Serum creatinine, blood urea nitrogen liver function tests (serum bilirubin, aspartate aminotransferase, alanine aminotransferase, and serum alkaline phosphatase), random blood sugar levels, serum creatine kinaseMB and lactic dehydrogenase were done and coronary angiogram was performed later after transferring to cath lab. All patients were given 300 mg of clopidogrel and 300 mg of aspirin immediately after the initial evaluation and subsequently transferred to the center where the facilities for the cardiac catheterization laboratory were available (located at a distance of 4–5 km). Patients were taken up for coronary angiogram and subsequent primary angioplasty after stabilization of homodynamic parameters. An experienced cardiologist performed coronary angiogram and subsequent primary angioplasty. Angiographic findings used to perform primary angioplasty were more than 70% stenosis of coronary artery lumen (more than 50% stenosis is case of the left main coronary artery). Target of the intervention was to achieve a coronary blood flow of TIMI 3 grade at the end of the procedure either by simple balloon dilatation or clot suction or by angioplasty with the placement of the stent at the stenosed lesion. These patients were periodically followed up in the cardiology outpatient department. A cardiac stress test was performed for each patient after 6 months of primary angioplasty to look for exercise effort tolerance and inducible ischemia.

Statistical methods

Descriptive statistical analysis has been carried out in the present study. Z-test has been carried out to find the significance of the present study with the study findings.

Statistical software

The statistical software, SPSS 15.0 (IBM-Newyork USA) Stata – Stata Corp College station Texas USA MedCalc 9.0.1- MedCalc Software Belgium Systat 11.0- Systac software Inc Chicago Illinosis USA used for the analysis of the data, and Microsoft Word and Excel have been used to generate graphs, tables, etc.


  Results Top


In the present study, out of 77 patients, 17 were female and 60 were male. Female-to-male ratio was 0.28:1. Dyslipidemia and smoking were the risk factors in the majority of the patients constituting 49 patients (63.63%) and 42 patients (54.54%), respectively; in the study group, 25 of the patients (32.46%) had diabetes mellitus [Table 1].
Table 1: Coronary artery disease risk factor data in the study patient

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Majority of the patients presented with a complaint of chest pain (90.9%). Breathlessness was the presenting complaint in about 31.2%. Hypotension was detected in 14 patients (18.2%); LV dysfunction in four patients (5.2%) and mitral regurgitation in 06 patients (Group II to Group III) [Figure 1].
Figure 1: Symptoms and signs at presentation

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Acute IWMI was detected on ECG in the majority of the patients in the study group comprising 62.33%. Only 37.7% of patients had ECG findings suggestive of acute anterior wall myocardial infarction (AWMI). Two of the patients had both inferior wall and anterior wall MI.

The majority of the acute MI in the study group was due to the involvement of the single coronary artery (57.1%). Double-vessel disease was detected in 28 patients comprising 36.4% of patients in the study group. Only five patients had a significant blockade of three vessels (triple-vessel disease) [Table 2].
Table 2: Angiography findings (n=77)

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Coronary angiogram revealed that the majority of the patients in the study group had single coronary artery involvement (single-vessel disease) with predominant involvement of the right coronary artery (RCA) accounting for the 42.9% followed by the left anterior descending (LAD) coronary artery (36.4%). The left circumflex coronary artery was the third-most common cause of single-vessel disease comprising 9.1% of the total patients in the study group [Table 2].

About 53.2% of the patients in the study group were managed with glycoprotein IIb/IIIa inhibitors before and during the procedure (facilitated PCI), which was continued in the postoperative period also. Two patients in the study group were managed by intra-aortic balloon counterpulsation assistance as they developed severe hypotension during the procedure. Two patients in the study group developed severe bradycardia followed by complete heart block and were successfully managed by temporary pacemaker implantation [Table 3] and [Figure 2].
Table 3: Procedure and adjuvant therapy (n=77)

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Figure 2: Procedure and adjuvant therapy

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Three patients in the study group achieved TIMI 3 flow after suctioning of clot from the culprit coronary artery during the procedure. Two patients were found to have triple-vessel coronary disease not amenable to angioplasty and were subsequently taken up for CABG successfully.

One patient in the study group had massive upper gastrointestinal bleeding half an hour after the primary angioplasty following one episode of vomiting. He was found to have  Mallory-Weiss syndrome More Details on the upper gastroenterologist endoscopy and was successfully managed with blood transfusion and endoscopic sclerotherapy. One patient was found to have stent thrombosis during follow-up and was managed medically. Two deaths occurred in the study group, one due to severe left ventricular (LV) dysfunction followed by cardiogenic shock before the primary angioplasty procedure and the second death occurred due to intraoperative hypotension associated with severe bradycardia requiring DC shock and ionotropic support throughout the procedure.

Sixty-eight patients were followed up at 6 weeks, 6 months, and 1-year post angioplasty.(nine patients were lost to follow-up as being government service they were posted to different units in India). Echocardiogram was done at all follow-up, and treadmill stress test (TMT) was done in all patients because in service they have to upgraded in medical category (its protocol in services to do TMT before upgrading medical category). Four patients had moderate LV dysfunction (All anterior wall MI), LV ejection fraction (EF) improved to normal (50%–65%) after 6 months in two of these rest two had LVEF 40% at 1-year post angioplasty in follow-up echocardiography. Mitral regurgitation maximum Group II was found in six patients (four patients had RCA involvement, two patients had LCX involvement), but was reduced in degree compared to what it was at presentation. TMT was found to be mildly positive in five patients, and check angiogram revealed patent stent in three patients and maximum 40% binary stenosis in two patients (functionally insignificant).TMT positivity was attributable to distal disease in two patients, and other three itwas false positive.


  Discussion Top


Primary PCI has gained widespread acceptance as the preferred approach for treating STEMI when it can be performed rapidly at qualified centers. Primary PCI is superior to thrombolytic therapy in fibrinolytic-eligible patients with STEMI; it reduces the rates of death, reinfarction, cerebral bleeding, reocclusion of the infarct artery, and recurrent ischemia as compared with fibrinolytic therapy. Primary PCI is potentially applicable to a much broader spectrum of patients with STEMI than is fibrinolytic therapy.

The literature clearly indicates that STEMI patients presenting to hospitals without PCI capability who have a contraindication to thrombolytic therapy or who are hemodynamically unstable and in cardiogenic shock should be transferred quickly to a hospital that can perform primary PCI. It has also been shown that the patients presenting with STEMI complicated by congestive heart failure have a greater mortality benefit with primary PCI than with thrombolytic therapy. The most important determinant of how the patient with STEMI is treated is whether or not primary PCI is readily available. Most patients with AMI present to community hospitals[5] where primary PCI is generally not available and is even prohibited in many states.

To date, there are no randomized controlled trials directly comparing primary PCI in community hospitals (with or without on-site cardiac surgery) with emergent transfer to high volume primary PCI center. Therefore, the data regarding treatment delay and its impact on clinical outcomes come from studies of primary PCI versus thrombolytic therapy. Our study now supports the strategy of transferring thrombolytic-eligible patients to primary PCI centers instead of treating them with on-site thrombolytic therapy.

Modern trials of mechanical reperfusion strategies (trials such as PRAGUE, C-PORT, and DANAMI – 2 trials)[6],[7] need to take account of logistics, transfer times, and adjunctive drugs treatment during transfer (facilitated PCI). At present, for most patients with acute AMI, PCI is the best reperfusion strategy. The randomized trials reaching this conclusion were conducted at experienced interventional centers, without long transfer times. However, in the best-resourced healthcare system, only a minority of patients with AMI present initially to such centers. Overall, these trials indicate that transfer for primary PCI is probably the best option even if the significant distance is involved.

Thus, availability and quality of transfer become key determinates in the revascularization strategy. The primary aspect of transfer is speed, care during transfer, and the ability to deliver the patient directly to a well-trained cardiac catheterization laboratory. In this study, we have used a clean and fast service of transferring patients to the center having the facilities of the cardiac catheterization laboratory. Our ambulance with ECG monitoring and defibrillator, physician, and nursing assistant on board, deliver the patient rapidly (within 25 min) to the cardiac catheterization laboratory without consuming much time in emergency departments or coronary care units after giving conventional drugs and facilitating agents in the emergency department.

In the present study, the diagnosis of AMI was based entirely on the clinical presentation and the ECG findings of STEMI. In our study, male patients outnumbered females (77% vs. 22%). This is akin to many studies that have reported a higher prevalence in males. The mean age of the patients in our study was 48 years, and patients in the age group 51–70 years constituted around 66.0% of the total STEMI patients. Most of the previous studies also have found a higher prevalence of AMI in the middle age groups. Majority of the patients in our study presented with of chest pain (90%) as chief complain. From our 77 patients, 23 (approximately 31%) presented with breathlessness, and nineteen (approximately 25%) had combined presented of chest pain with breathlessness. Hypotension was detected in 18% and features of LV dysfunction in 10% patients, respectively, at the time of presentation. Two of the 77 patients had been blocks (one had second-degree AV block, and another had CHB). These results were comparable to earlier studies [Table 4].
Table 4: Comparison of outcome (mortality and morbidity) of the present study with other studies

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Majority of the patient in the study group presented to the emergency room (MI) within 06 h of index chest pain similar to PRAGUE-2 study, in which presentation was between 3 and 12 h.[7] All the patients were stabilized hemodynamically and were clinically assessed within 5 min of presentation to MI room. Majority of them were found to have acute inferior wall MI (62%) on ECG. A big-bore intravenous catheter was secured in all the patients. All the patients received tablet aspirin 300 mg (chewed) and 300 mg of tablet clopidogrel.

All the patients with acute STEMI were transported to the hospital having the facility of cardiac catheterization laboratory (located at a distance of 4-5 km) with a mean transfer time of 25 min (as compared to the Danish Multicentre Randomized Study on Thrombolytic Therapy versus Coronary Angioplasty in AMI, i. e., DANAMI-2 trial, in which the median transfer time was 67 min and median transfer distance was 50 km).[8] A majority of the patients were found to have single-coronary vessel disease (57%) during coronary angiography involving RCA in 43% and LAD coronary artery in 36% patients, respectively. Forty-one patients (53%) in the study group received glycoprotein IIb/IIIa inhibitors as an adjuvant therapy (facilitated PCI).

Mortality rate was 2.6% in the study group [as compared to 04% in a large study conducted at the Immanuel St. Joseph's Hospital-Mayo Health System in Mankato, Minnesota, including 1007 patients from March 1999 to August 2005. Furthermore, compared with a mortality of 06% in Primary Angioplasty in AMI Patients From General Community Hospitals Transported to percutaneous transluminal coronary angioplasty (PTCA) Units vs. Emergency Thrombolysis, i. e., PRAGUE-2 trials].[7] Deaths in the study group were not related to a procedural complication or absence of onsite cardiac surgery. Morbidity in the form of stent thrombosis and major bleed was noticed in 3.9% of patients.

No patients undergoing primary PCI required emergent CABG.

In conclusion, most of our 77 patients with Acute STEMI had a good outcome after primary PTCA conducted at center (cardiac catheterization laboratory) situated away from our hospital 4–5 km. Therefore, shifting the patients with acute STEMI in other centers having the facilities of cardiac catheterization laboratory for primary PTCA has shown good outcomes in the form of mortality as well as morbidity.


  Conclusion Top


This is a hospital-based prospective study in a single center, to determine the appropriateness and outcome of primary PTCA for acute STEMI in a center where the facilities of the cardiac catheterization laboratory are not available.

All our patients who presented to the hospital MI room with the symptoms of coronary artery disease confirmed on ECG (acute STEMI) were subsequently transferred to nearby hospital (located at 4-5 km distance) having the facility of cardiac catheterization laboratory for conducting primary PTCA. Transfer was fast consuming and average transfer time of 25 min. All the patients had shown very good outcome after primary PTCA both in terms of mortality as well as morbidity during the follow-up of 1 year.

Therefore, all high-risk patients with symptoms for more than 1 h who present to community hospitals that do not have on-site cardiac catheterization laboratory should be transferred to a PCI center provided that transfer delay is <2 h. To decrease delays, if the patient arrives by ambulance, the diagnosis of STEMI should be verified while the patient is still on the stretcher in the ambulance; in this way, immediate transfer to a PCI center can be achieved much more quickly.

Simultaneous activation of the cardiac catheterization laboratory on-call team during the transfer period is crucial in minimizing further treatment delay. The STEMI patient should be preregister while in transfer to keep a ready-and-waiting cardiac catheterization laboratory. The suspected infarct-related coronary artery should be engaged directly with a catheter to expedite the PCI procedure and achieve reperfusion as quickly as possible. Steps required for implementing transfer strategies include (1) designation of centers proven to have expertise in primary PCI that are located within a reasonable distance from the referral hospitals; (2) development of STEMI team at community hospitals that accurately identify STEMI patients, provide appropriate medications, and rapidly transfer patients to the PCI center; (3) central coordination and management of care at the community and tertiary hospitals; (4) continual quality assurance monitoring; (5) development of a clinical research networks to extend STEMI research into community hospitals and provide a structure to prospectively evaluate transfer strategies and adjunctive pharmacological regimen.

At last, it is concluded that the lack of an on-site PCI program need not prevent a hospital from offering treatment with primary PCI.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Rogers WJ, Canto JG, Lambrew CT, Tiefenbrunn AJ, Kinkaid B, Shoultz DA, et al. Temporal trends in the treatment of over 1.5 million patients with myocardial infarction in the US from 1990 through 1999: The National Registry of Myocardial Infarction 1, 2 and 3. J Am Coll Cardiol 2000;36:2056-63.  Back to cited text no. 1
    
2.
Kesteloot H, Sans S, Kromhout D. Evolution of all-causes and cardiovascular mortality in the age-group 75-84 years in Europe during the period 1970-1996; a comparison with worldwide changes. Eur Heart J 2002;23:384-98.  Back to cited text no. 2
    
3.
Davies MJ, Woolf N, Robertson WB. Pathology of acute myocardial infarction with particular reference to occlusive coronary thrombi. Br Heart J 1976;38:659-64.  Back to cited text no. 3
    
4.
Lange RA, Hills LD. Reperfusion therapy in AMI. N Engl J Med 2002;346:954-55.  Back to cited text no. 4
    
5.
Mehta RH, Stalhandske EJ, McCargar PA, Ruane TJ, Eagle KA. Elderly patients at highest risk with acute myocardial infarction are more frequently transferred from community hospitals to tertiary centers: Reality or myth? Am Heart J 1999;138:688-95.  Back to cited text no. 5
    
6.
Widimský P, Groch L, Zelízko M, Aschermann M, Bednár F, Suryapranata H. Multicentre randomized trial comparing transport to primary angioplasty vs immediate thrombolysis vs combined strategy for patients with acute myocardial infarction presenting to a community hospital without a catheterization laboratory. The PRAGUE study. Eur Heart J 2000;21:823-31.  Back to cited text no. 6
    
7.
Widimský P, Budesínský T, Vorác D, Groch L, Zelízko M, Aschermann M, et al. Long distance transport for primary angioplasty vs immediate thrombolysis in acute myocardial infarction. Final results of the randomized national multicentre trial—PRAGUE-2. Eur Heart J 2003;24:94-104.  Back to cited text no. 7
    
8.
Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, et al. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med 2003;349:733-42.  Back to cited text no. 8
    


    Figures

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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