Keywords primary angioplasty - performance measures - COVID-19 outbreak
During the coronavirus disease 2019 (COVID-19) outbreak, the hospital admissions for
acute coronary syndrome (ACS) including ST-segment elevation myocardial infarction
(STEMI) have significantly declined.[1 ]
[2 ] Whether the declining cases of STEMI during the COVID-19 outbreak associate with
the performance of primary percutaneous coronary intervention (PCI) for STEMI has
not much been studied. The aim of the present analysis is to investigate the performance
of primary PCI for STEMI during the early months of the COVID-19 outbreak in Jakarta,
Indonesia, which at the time of analysis, Jakarta, is the epicenter of the COVID-19
outbreak in the country.
Methods
Study Design, Population, and Settings
We performed a retrospectively analysis of the Jakarta Acute Coronary Syndrome (JAC)
registry, which is an observational, prospective registry, collecting data on consecutive
patients with ACS (STEMI, non-STEMI, and unstable angina pectoris) who are admitted
to the emergency department (ED) of a receiving primary PCI hospital. The hospital
is a tertiary care academic cardiovascular center, which is located at Jakarta, Indonesia,
and is hosting the STEMI network in the metropolitan area. Details of the JAC registry
have been previously described.[3 ]
[4 ] Data collection and accuracy were evaluated on a regular basis, and all authors
wrote the manuscript and aware for the completeness and data accuracy, and analyses.
The study approved by the institutional review board of the National Cardiovascular
Center Harapan Kita, Jakarta. In this registry, the informed consent was waived, and
data were analyzed anonymously.
In this study, we included all consecutive patients with STEMI who were admitted to
the hospital during the COVID-19 outbreak (March 1, 2020 to May 31, 2020) and before
the outbreak (March 1, 2019 to May 31, 2019).
We compared the clinical and angiographic characteristics of patients with STEMI between
the two periods. The comparison period (March 1, 2019 to May 31, 2019) was selected
to appropriately describe the profile of the real-world STEMI patients admitted to
the hospital within the similar observation period used during the COVID-19 outbreak.
STEMI Network in Jakarta
The JAC registry is routinely being used as the performance measures for the regional
STEMI network in the metropolitan area of Jakarta, Indonesia.[3 ]
[4 ]
[5 ] The STEMI network in Jakarta is hosted by the ED team of our hospital, offering
24/7 primary PCI service, and is the largest cardiovascular center in the region.
In 2019, the hospital performs ∼600 primary PCI procedures. Currently, there are ∼
100 health centers involved in the regional STEMI network in Jakarta and the surrounding
area.
Primary PCI Procedure
Primary PCI procedure in our hospital has been previously described.[6 ] In brief, all patients were pretreated with 160 to 320 mg acetylsalicylic acid and
600 mg clopidogrel or 180 mg ticagrelor (peroral). Unfractionated heparin (100 IU/kg)
was administered intravenously in the catheterization laboratory after sheath insertion.
During primary PCI, an initial coronary angiogram was performed to assess the infarct-related
artery (IRA), and baseline thrombolysis in myocardial infarction (TIMI) flow. After
primary PCI, the final TIMI flow was evaluated using standard projection.
COVID-19 Outbreak in Jakarta
Jakarta covers 662 km2 (256 sq mi) of land area, and ∼ 11 million population reside with the population
density of ∼ 15,000 people/km2 .[7 ] The first two cases of COVID-19 in Indonesia were confirmed in Jakarta in March
2, 2020, which were increased to 2902 in April 18, 2020, and reached 3,832 cases by
April 26, 2020, and making Jakarta as the epicenter of COVID-19 outbreak in the country.[8 ]
Data Collection and Quality Control
Data were collected from the JAC registry electronic dataset including sex and age
of the patient, diagnosis, coronary artery disease risk factors, Killip classifications,
TIMI risk score, source of referral, blood test results, left ventricular ejection
fraction from echocardiography, final TIMI flow after primary PCI, ischemic time metrics
for primary PCI, and in-hospital mortality. All data were checked for accuracy, and
if the main data was incomplete, the data were checked again and then completed.
Outcome Measures
The primary outcome measure was the performance of primary PCI as defined by the door-to-device
(DTD) time, and achievement of final TIMI 3 flow after PCI. Secondary outcomes included
the symptom onset-to-PCI hospital admission time, total ischemic time, and in-hospital
mortality.
Study Definitions
The diagnosis of STEMI was made based on the presence of ischemic symptoms (>20 minutes)
and persistent ST-segment elevation in at least two contiguous leads, a new left bundle-branch
block, or a true posterior myocardial infarction confirmed by posterior leads from
the electrocardiography (ECG).[9 ]
DTD time was calculated as time period between ED admission at the PCI center and
first device introduction in an attempt to reopen the occluded IRA.[9 ] Total ischemic time was defined as time period between start of the symptom (symptom
onset) and first device introduction during primary PCI after the coronary guide wire
has crossed the culprit lesion.[10 ] Symptom-to-PCI center admission time was defined as time from the first symptom
onset to admission at the ED of the PCI center.
Statistical Analysis
Patient characteristics and the study outcomes between the two admission times (during
and before the COVID-19 outbreak) were compared with the use of Mann–Whitney U test for continuous variables and chi-squared or Fisher's exact tests for categorical
variables.
All statistical analyses were performed with the use of the IBM SPSS statistical package,
version 25.0 (Chicago, IL). All tests were two-tailed, and p -values of less than 0.05 were considered statistically significance.
Results
Study Population
Of 324 patients with acute STEMI recorded, 116 patients were admitted during the COVID-19
outbreak, and 208 patients were admitted before the COVID-19 outbreak period. Of these,
70 and 141 patients who received primary PCI were included the final analysis ([Fig. 1 ]).
Fig. 1 Patients included in the analysis. STEMI, ST-segment elevation myocardial infarction;
PCI, percutaneous coronary intervention.
Patient Characteristics
Characteristics of patients who received primary PCI between the two periods are shown
in [Table 1 ]. The median age was 55 years in the group of during the COVID-19 outbreak and 54
years in the group of before the outbreak; the percentage of male patients was ∼90%
in both groups. During the COVID-19 outbreak period, the admission of STEMI patients
through interhospital transfer dropped by 74% (24 vs. 94 patients), the percentage
of smoker and median creatinine level at admission were lower (35.7 vs. 65.2%, p < 0.001; and 0.94 vs. 1.03 mg/dl, p = 0.006, respectively), but the uptake of radial access and left anterior descending
IRA were similar as compared with before the COVID-19 outbreak period (90 vs. 89.4%,
and 54.3 vs. 58.9%, respectively).
Table 1
Characteristics of patients with acute STEMI treated by primary PCI (n = 211)
Variables
Missing data, n (%)
During the outbreak (n = 70)
Before the outbreak (n = 141)
p -Value
Age, y
0
55 (46–60)
54 (48–59)
0.43
Male, n (%)
0
64 (91.4)
131 (92.9)
0.70
Off-hour admission, n (%)
0
31 (44.3)
70 (49.6)
0.46
Anterior MI, n (%)
0
37 (52.9)
82 (58.2)
0.46
Symptom onset, n (%)
≤ 2 h
0
2 (2.9)
9 (6.4)
0.34
> 2–6 h
0
36 (51.4)
71 (50.4)
0.88
6–12 h
0
28 (40)
56 (39.7)
0.96
> 12 h
0
4 (5.7)
5 (3.5)
0.48
Cardiovascular risk factors, n (%)
Smoker
0
25 (35.7)
92 (65.2)
<0.001
Hypertension
0
34 (48.6)
84 (59.6)
0.13
Diabetes mellitus
0
19 (27.1)
55 (39)
0.08
Dyslipidemia
0
11 (15.7)
23 (16.3)
0.91
Family history
0
8 (11.4)
12 (8.5)
0.49
Source of referral, n (%)
Interhospital referral
0
24 (34.3)
94 (66.7)
< 0.001
Killip classification, n (%)
I
0
62 (88.6)
116 (82.3)
0.23
II
0
4 (5.7)
15 (10.6)
0.23
III
0
2 (2.9)
4 (2.8)
1.0
IV
0
2 (2.9)
6 (4.3)
1.0
TIMI risk score >4, n (%)
0
21 (30)
44 (31.2)
0.85
Antiplatelet therapy within 24 h, n (%)
Salicylic acid
0
69 (98.6)
140 (99.3)
1.0
Clopidogrel
0
56 (80)
110 (78)
0.74
Blood tests
Hemoglobin (g/dL)
0
14.7 (12.975–15.625)
14.6 (13.3–15.45)
0.84
Leukocyte (/µL)
0
13,102.5 (10,880–15,402)
13,300 (10,780–16,080)
0.69
Initial troponin T (ng/L)
15 (7.109)
323.5 (106–1241)
273 (66.5–840)
0.84
Creatinine level (mg/dL)
0
0.94 (0.825–1.1)
1.03 (0.85–1.245)
0.006
Admission blood glucose, (mg/dL)
1 (0.4734)
133 (120.75–55.75)
147 (122.5–214.5)
0.005
Echocardiography variables
LVEF (%)
21 (9.952)
45 (35–54)
45 (36–51)
0.76
Primary PCI procedural characteristics
Balloon predilatation, n (%)
0
69 (98.6)
130 (92.2)
0.06
Use of drug-eluting stent, n (%)
0
67 (95.7)
134 (95)
1.0
Transradial access, n (%)
0
63 (90)
126 (89.4)
0.88
Infarct-related artery, n (%)
Left main
0
1 (1.4)
0
0.33
Left anterior descending
0
38 (54.3)
83 (58.9)
0.52
Left circumflex
0
2 (2.9)
4 (2.8)
1.0
Right coronary artery
0
29 (41.4)
54 (38.3)
0.66
Coronary artery involvement, n (%)
Single vessel disease
0
32 (45.7)
55 (39)
0.35
Two vessel disease
0
21 (30)
35 (24.8)
0.42
Three vessel disease
0
17 (24.3)
51 (36.2)
0.08
Left main disease
0
2 (2.9)
8 (5.7)
0.5
Medication at discharged, n (%)
Salicylic acid
0
65 (92.9)
130 (92.2)
0.86
Clopidogrel
0
46 (65.7)
103 (73)
0.27
ACE/ARB inhibitors
0
58 (82.9)
122 (86.5)
0.47
Beta blocker
0
59 (84.3)
119 (84.4)
0.98
Simvastatin
0
65 (92.9)
130 (92.2)
0.86
Length of stay, d
0
5 (4–7)
5 (4–6)
0.55
Abbreviations: ACE, angiotensin converting enzyme; ARB, angiotensin receptor blocker;
LVEF, left ventricular ejection fraction; MI denotes myocardial infarction; NA, not
analyzed; PCI, percutaneous coronary intervention; TIMI, thrombolysis in myocardial
infarction.
Outcomes
Study outcomes are displayed in [Table 2 ]. Compared with the period before the COVID-19 outbreak, patients with STEMI who
were admitted to the PCI hospital during the COVID-19 outbreak had longer median DTD
time (104 vs. 81 minutes, p < 0.001), and longer total ischemia time (475.5 vs. 449 minutes, P = NS). However,
the symptom onset-to-PCI center admission time was similar (360 minute for each group),
and so were the achievement of TIMI 3 flow after primary PCI (87.1 vs. 87.2%), and
in-hospital mortality (5.7 vs. 7.8%).
Table 2
Study outcomes
During the outbreak
(n = 70)
Before the outbreak
(n = 141)
p -Value
Symptom onset-to-PCI hospital admission, min
360 (240–540)
360 (270–480)
0.84
Door-to-device time, min
104 (79.50–149.25)
81 (67–111)
<0.001
Total ischemic time, min
475.5 (354–679.5)
449 (356.5–585.5)
0.43
Final TIMI flow, n (%)
0
1 (1.4)
1 (0.7)
1.0
1
0 (0)
1 (0.7)
1.0
2
8 (11.4)
16 (11.3)
0.98
3
61 (87.1)
123 (87.2)
0.98
In-hospital mortality, n (%)
4 (5.7)
11 (7.8)
0.77
Discussion
In our analysis of data from a registry in a primary PCI hospital in Jakarta, we found
that the hospital admission for patients with STEMI has dramatically declined during
the COVID-19 outbreak. Importantly, the DTD was longer, but the achievement of final
TIMI 3 flow and in-hospital mortality were similar compared with before the COVID-19
outbreak, and deserve further discussion.
The results of this study suggest that it is still feasible to perform primary PCI
during the COVID-19 pandemic with expected delays in reperfusion time that partly
due to the COVID-19 screening at the ED. However, the delays should not reduce the
utilization of primary PCI, indicating that during the COVID-19 pandemic, primary
PCI should continue to be the standard of care for patients with definite STEMI, particularly
when patients are presenting to a primary PCI center. However, during the COVID-19
pandemic, all primary PCI procedures should be performed in the way of safest environment,
indicating that all patients with STEMI should be treated as possible COVID-19 at
presentation.
A recent protocol from China[11 ] suggests use of fibrinolytic therapy as the initial treatment for patients with
acute STEMI within 12 hours of symptom onset during the pandemic. However, the protocol
should not be generalized to all STEMI care during the pandemic since the success
rate of fibrinolytic therapy in restoring the flow of the IRA is lower than primary
PCI, and this was associated with a worse clinical outcome in patients who receive
fibrinolytic therapy as compared with primary PCI.[12 ] However, in some cases of highly expected delays for primary PCI due to COVID-19
assessment or establishing the STEMI diagnosis, it is reasonable to initiate fibrinolytic
therapy, particularly for those patients who first presented to a non-PCI center with
possible prolonged door-in to door-out time. In our study, fibrinolytic therapy was
successfully initiated in four patients during the study period. Fibrinolytic therapy
was indicated due to the expected delay for primary PCI related to the COVID-19 assessment
at the ED, and was administered during the early weeks of the COVID-19 outbreak.
In our study, the DTD time was longer during the COVID-19 outbreak that related to
the COVID-19 screening at the ED including the epidemiology screening, chest X-ray,
severe acute respiratory syndrome coronavirus 2 antibody evaluation, and additional
blood test measurement (lymphocyte and C-reactive protein). The COVID-19 screening
at the ED should be effective and efficient, and this can be achieved by a good collaboration
between the staff at the ED, imaging, laboratory department, and the interventional
cardiologists on duty. In certain circumstances, there will be longer time needed
to assess the COVID-19 possible such as in patients with unclear STEMI diagnosis that
potentially increases the delay in transferring the patient to the catheterization
laboratory that also leads to a longer DTD time. Early activation of the catheterization
laboratory is also crucial in maintaining the recommended DTD time during the pandemic
to prepare the safest environment during the interventional procedures. In our center,
all staff involved in the interventional procedure followed the use of standard personal
protective equipment including use of gown, N95, face shield, and covered shoes. We
also used a dedicated catheterization laboratory room to perform primary PCI cases
during the study period. It is also suggested to avoid unnecessary X-ray projections
during coronary angiography of primary PCI to minimize the total procedural time.
In addition, the number of interventional cardiologists in the hospital should be
appropriate to allow the operator working within shift and avoid excessive exposure
to the primary PCI procedures. Currently, there are 15 interventional cardiologists
who are responsible for primary PCI in the hospital that work within a daily shift
and to ensure adequate time for recovery, and perhaps related to the high achievement
of TIMI 3 flow after PCI during the COVID-19 outbreak in ∼ 90% of cases, and this
was similar to the achievement of before the outbreak ([Table 2 ]).
During the COVID-19 outbreak, the utilization of primary PCI in our hospital was lower
than before the outbreak (51.4 vs. 74%), and this was partly associated with an overall
41% drop of the STEMI admissions in the hospital, whereas admission through interhospital
hospital reduced by 74% ([Table 1 ]). Other possible reasons for the lower uptake of primary PCI in the hospital during
the COVID-19 outbreak were related to patients who had complete resolution of ST-segment
elevation at presentation, thus treated conservatively. Several speculations were
described to explain the dramatic reduction in admission of STEMI patients from interhospital
transfer in the region during the COVID-19 outbreak such as people are afraid of getting
infected by COVID-19 when visiting the EDs of the primary hospitals, and the strict
regulations to stay and work from home, social distancing, large scale social restriction,
and self-isolation may partly prevent patients going to hospital to seek help for
their health conditions.
A recent recommendation emphasizes the use of primary PCI in definite STEMI patients,
and primary PCI should be the standard of care for STEMI patients during the COVID-19
pandemic with some important caveats, and all patients presenting with a suspected
STEMI should be considered as COVID-19 positive,[13 ] which is a reasonable guide for our daily clinical practice during this pandemic.
All health-care providers should prepare for the unexpected arrival of the delayed
presentation of patients with ACS during the pandemic, which are probably associated
with severe complications such as acute heart failure, arrhythmia, and mechanical
complications. Furthermore, it also important that all hospitals should prepare for
the possible increase in hospital visits by patients with cardiovascular disease soon
after the COVID-19 outbreak has been controlled.
Finally, the regional systems of care for STEMI patients should be able to provide
a simple and efficient protocol to transfer patients from non-PCI hospitals to a primary
PCI hospital within the reasonable time delay, and if possible introduce the fibrinolytic
therapy protocol immediately after admission at the non-PCI centers in patients with
STEMI who presented early after symptom onset, before transferring the patient to
a PCI center.
Study Limitation
This study has several limitations. First, this was a single-center study with relatively
small sample size. Second, we did not record the time delay at the first hospital
before the transfer process in patients who admitted from interhospital transfer process.
Finally, we did not evaluate other system-related delay at our hospital including
the time from ECG recording to STEMI diagnosis, and from STEMI diagnosis to catheterization
arrival.
Conclusion
During the COVID-19 outbreak, we found a longer DTD time for primary angioplasty,
but the achievement of final TIMI 3 flow and in-hospital mortality were similar as
compared with before the COVID-19 outbreak. Thus, primary angioplasty should remain
the standard of care for STEMI during the COVID-19 outbreak, and it should be performed
with several precautions and within the safest environment.
