ABSTRACT
Background
Effective myocardial reperfusion in ST-Elevation Myocardial Infarction (STEMI) remains challenging despite advancements in primary percutaneous coronary intervention (PCI). This study evaluates the impact of thrombus aspiration (TA) and saline autotransfusion (SAT) compared to standard PCI (NOTA) on coronary flow dynamics and myocardial perfusion.
Research Design and Method
This prospective cohort study enrolled 157 STEMI patients who underwent primary PCI. Participants were divided into two groups: TA+SAT (n = 80) and NOTA (n = 77). Clinical parameters such as blood pressure, ejection fraction, ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grades, corrected TIMI frame count (CTFC), and myocardial infarction (MI) location were assessed.
Results
Patients in the TA+SAT group exhibited significantly better short-term myocardial reperfusion, as indicated by superior ST-segment resolution (p = 0.010) and lower CTFC values (p < 0.001). Blood pressure was significantly lower in the TA+SAT group (p = 0.042). However, ejection fraction improvement at one month was not statistically significant. TIMI and TMPG flow grades were comparable between groups.
Conclusion
The TA+SAT approach demonstrated improved coronary flow dynamics and better short-term myocardial reperfusion in STEMI patients without additional pharmacological interventions. These findings suggest that TA+SAT may serve as a valuable adjunct to PCI, warranting further investigation into its long-term clinical benefits.
KEYWORDS: ST-elevation myocardial infarction, primary percutaneous coronary intervention, STEMI, thrombus aspiration, ST-segment resolution, saline autotransfusion
Plain Language Summary
ST-segment elevation myocardial infarction (STEMI) is a type of heart attack caused by a blocked artery that stops blood from reaching the heart. Immediate treatment is crucial to restore blood flow and prevent heart damage. The most common treatment is primary percutaneous coronary intervention (PPCI), a procedure that uses a thin tube (catheter) to open the blocked artery and insert a stent to keep it open. However, blood clots and debris from the blockage can sometimes reduce the effectiveness of this treatment.
In this study, we compared two treatment approaches in 157 patients with STEMI to see if adding two extra steps – thrombus aspiration (TA) and saline autotransfusion (SAT) – could improve heart recovery. Thrombus aspiration is a technique where a special suction tool removes the clot before placing the stent. Saline autotransfusion is a method where a saltwater solution is injected into the artery to wash away small debris and improve blood flow.
We divided the patients into two groups:
Group1 (TA+SAT): Patients received both thrombus aspiration and saline autotransfusion.
Group2 (NOTA): Patients received the standard treatment without these additional steps.
Key Findings:
Patients in the TA+SAT group had better short-term blood flow improvement in their heart arteries compared to the NOTA group.
Their ST-segment resolution (a sign of improved heart recovery) was significantly better.
Their blood pressure was lower, which may indicate better heart function after treatment.
Their ejection fraction (heart pumping ability) improved slightly after one month, but the difference between groups was small.
These findings suggest that thrombus aspiration and saline autotransfusion may help improve short-term blood flow and heart recovery after a heart attack. However, more research is needed to confirm whether these benefits translate to better long-term outcomes.
1. Introduction
ST-elevation myocardial infarction (STEMI), among the most severe and life-threatening cardiovascular conditions, involves the thrombotic blockage of a coronary artery due to plaque rupture. Prompt and efficient reperfusion is paramount for STEMI patients, with Rapid primary percutaneous coronary intervention (PPCI) proving advantageous in their management [1]. A poor prognosis could result from PPCI, though, as the thrombus might separate from its original position and migrate toward a distal vessel [2].
A significant proportion of patients undergoing primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) exhibit impaired microvascular perfusion, despite successful restoration of epicardial blood flow. This compromised microvascular perfusion is associated with increased mortality rates.
Notably, research has established a link between thrombus burden during primary PCI and adverse outcomes. A study of 812 consecutive STEMI patients revealed that those with a higher thrombus load had poorer myocardial blush grade (MBG) scores, with only 35% achieving grade 3 MBG compared to 53% in patients with lower thrombus loads (p < 0.001). Furthermore, these patients experienced higher rates of stent thrombosis (8.2% vs. 1.3%, p = 0.001) and increased mortality at one year (12.9% vs. 7.8%, p = 0.025) [3].
According to the 2013 American College of Cardiology (ACC) Foundation/American Heart Association (AHA) guidelines for the management of STEMI, hydration is recommended for the prevention of Contrast-Induced Nephropathy in patients with STEMI undergoing angiography and intervention [4]. One such approach under investigation is saline autotransfusion, which involves the intracoronary administration of saline during PCI [5]. When a person receives an autotransfusion, their own blood is used for transfusion. It is typically utilized when blood loss exceeds 1000 mL [6,7]. This method is especially helpful when the patient has an atypical blood type, when there’s a possibility that an infectious disease will spread, or there is a limited supply of homologous blood. This method aims to enhance the hydration process and potentially improve patient outcomes during the intervention [8].
Furthermore, saline autotransfusion could improve myocardial perfusion during PCI. By providing an adequate volume of saline directly into the coronary arteries, this method may help to optimize blood flow and reduce the risk of ischemic complications. Improved perfusion can lead to better oxygen delivery [9] to the myocardial tissue, potentially enhancing the overall outcomes of the PCI procedure.
As this study investigates the potential benefits of saline autotransfusion, a novel approach involving the intracoronary administration of saline during PCI, to enhance hydration and improve myocardial perfusion. We hypothesize that saline autotransfusion will improve angiographic outcomes and tissue reperfusion in STEMI patients undergoing PPCI, thereby reducing the risk of ischemic complications and improving clinical outcomes.
By exploring the potential benefits of saline autotransfusion, this study seeks to contribute to the development of adjunctive therapies that can enhance reperfusion strategies and improve clinical outcomes in STEMI patients, shedding light on its potential role as adjunctive therapy in enhancing reperfusion strategies and improving clinical outcomes in this high-risk patient population.
2. Methodology
2.1. Study design
This prospective cohort study investigates individuals who underwent primary PCI for STEMI within the Department of Cardiology. The study duration spans from April 2021 to April 2023, focusing on analyzing the outcomes and characteristics of these patients during this timeframe. Ethical clearance for patient recruitment was obtained from the Institutional Ethics Committee (IEC539/2018), and the study adheres to regulatory requirements by being registered with the Clinical Trials Registry-India (CTRI) (CTRI/2019/02/017520).
The study enrolled patients referred for primary PCI within 24 hours of symptom onset, who exhibited TIMI 0 or 1 flow on angiography, were aged 18 years or older, and met the criteria for acute myocardial infarction (MI) as defined by the ACC and the AHA. Patients with a history of prior stent implantation, fibrinolytic therapy for STEMI, or coronary artery bypass surgery were excluded from participation. Data collection encompassed patient demographics, Etiology, blood investigation profiles, cardiac biomarkers, 12-lead electrocardiograms (ECG), echocardiography (ECHO), and angiographic findings, all documented within a predefined format.
2.2. Patient selection and randomization
The selected individuals were divided into two distinct groups based on the procedural approach: Group A, the primary PCI procedure involves inserting a guidewire into the coronary artery through a femoral or radial artery access site via a guiding catheter. Under fluoroscopic guidance, the guidewire crosses the occluded segment. Followed by, a thrombus aspiration catheter is advanced over the wire to the site of occlusion, aspirating thrombotic material until none remains. After successful thrombus aspiration, a stent is deployed at the site of occlusion to restore normal blood flow. At each stage of the procedure (before and after thrombus aspiration, stent deployment) a bolus of saline is injected through the guiding catheter to auto-perfuse the distal coronary segment, flushing out debris and thrombotic material, about 100 ml of saline was injected in total. Where as in group B, the primary PCI procedure involves inserting a guidewire into the coronary artery through a femoral or radial artery access site via a guiding catheter. Under fluoroscopic guidance, the guidewire crosses the occluded segment. Followed by, stent deployment at the site of occlusion to restore normal blood flow (Direct Stenting) with out aspirating the thrombus and with saline injection.
TA + SAT (Group A): This group consisted of 80 patients who received both thrombus aspiration (TA) and saline autotransfusion (SAT).
NOTA (Group B): This group consisted of 77 patients who did not receive the thrombus aspiration and saline autotransfusion treatments.
2.3. Statistical analysis
Quantitative variables in the data were expressed as Mean ± Standard Deviation (SD), providing a measure of the central tendency and variability within the dataset. For qualitative variables, results were presented as proportions accompanied by percentages, offering insights into the distribution and frequency of categorical data across different groups.
Statistical analyses included Chi-square tests, Fisher’s exact tests, t-tests, and Mann-Whitney U tests. These methods were employed to evaluate various aspects such as associations between categorical variables, differences in means between two independent groups, and comparisons of non-parametric data distributions. To determine significant interactions, all statistical tests were conducted at a significance level of 0.05. This approach ensured rigorous examination of relationships and differences within the data, helping to draw meaningful conclusions from the study findings.
Microsoft Excel and the Statistical Package for Social Sciences (SPSS) version 25 (IBM Corp., Armonk, NY, USA) were the tools utilized for data cleaning and analysis, respectively.
3. Results
3.1. Demographic and clinical features
The mean age of participants in the TA+SAT group was 61.3 ± 10.7 years, while in the NOTA group, it was 61.6 ± 11.8 years. Systolic blood pressure (SBP) was significantly (p-value: 0.014) lower in the TA+SAT group (127.1 ± 27.25 mmHg) compared to the NOTA group (137.9 ± 27.2 mmHg). Similarly, diastolic blood pressure (DBP) was significantly (p-value: 0.042) lower in the TA+SAT group (79.37 ± 15.6 mmHg) compared to the NOTA group (84.4 ± 15.2 mmHg) (Table 1).
Table 1.
Demographics associated with each treatment group.
| Variable | Treatment group |
p-value | |
|---|---|---|---|
| TA + SAT (n,80) |
NOTA (n,77) |
||
| Age | 61.3 ± 10.7 | 61.6 ± 11.8 | 0.891 |
| Systolic blood pressures | 127.1 ± 27.25 | 137.9 ± 27.2 | 0.014 |
| Diastolic blood pressures | 79.37 ± 15.6 | 84.4 ± 15.2 | 0.042 |
| Ejection Fraction at presentation | 46.85 ± 7.67 | 46.72 ± 7.82 | 0.921 |
| Ejection Fraction at 1 month follow-up | 50.93 ± 8.18 | 49.14 ± 8.20 | 0.191 |
| ST-segment elevation | 5.60 ± 2.20 | 4.90 ± 2.26 | 0.051 |
| ST-segment resolution | 2.17 ± 2.00 | 1.41 ± 1.60 | 0.010 |
| Drugs used to treat slow flow | 34 (21.8) | 28 (17.9) | 0.432 |
| Gender | 0.084 | ||
| Male | 61 (20) | 49 (16.1) | |
| Female | 19 (18.6) | 28 (27.5) | |
| Smoking | 27 (27.8) | 12 (12.4) | 0.008 |
| Alcohol | 24 (23.5) | 9 (8.8) | 0.005 |
| Risk Factors | |||
| Hypertension | 38 (21.3) | 39 (21.9) | 0.693 |
| Diabetes Mellitus | 26 (17.2) | 35 (23.2) | 0.096 |
| Glucometer random blood sugars | 214.71 ± 96.0 | 241.18 ± 107.7 | 0.106 |
| TIMI flow | 0.980 | ||
| Less than grade 3 | 23(28.7) | 22(28.6) | |
| TIMI 3 grade | 57(71.3) | 55(71.4) | |
| TMPG | 0.212 | ||
| Less than grade 3 | 20(25.0) | 13(16.9) | |
| TMPG 3 grade | 60(75.0) | 64(83.1) | |
| CTFC before drugs | 24.82 ± 14.6 | 34.22 ± 17.06 | 0.098 |
| CTFC after drug | 24.91 ± 9.88 | 32.40 ± 15.50 | 0.001 |
| MI Location | 0.030 | ||
| Anterior wall MI | 44 (21.4) | 39 (18.9) | |
| Inferior wall MI | 36 (20.8) | 38 (12.5) | |
| Infract Related Vessel | 0.214 | ||
| Left anterior descending artery | 44 (21.3) | 39 (18.8) | |
| Right coronary artery | 32 (21.3) | 28 (18.7) | |
| Left circumflex artery | 4 (8) | 10 (20) | |
| CAD Status | 0.933 | ||
| Single vessel disease | 40 (18.7) | 42 (19.6) | |
| Double vessel disease | 23 (18.7) | 21 (17.1) | |
| Triple vessel disease | 15 (18.1) | 14 (15.6) | |
| KILLIP class | 0.524 | ||
| I | 50 (19.4) | 51 (19.8) | |
| II | 14 (19.4) | 12 (16.7) | |
| III | 4 (13.3) | 7 (23.3) | |
| IV | 12 (25.5) | 7 (14.9) | |
| Time of Presentation | 0.434 | ||
| <6 hours | 46 (16.8) | 50 (18.3) | |
| 6–12 hours | 23 (22.5) | 21 (20.6) | |
| >12 hours | 11 (34.4) | 6 (18.8) | |
| MACE overall | 5 (17.2) | 5 (17.2) | 0.946 |
MI- Myocardial Infarction; CAD- Coronary artery diseases; TIMI – Thrombolysis is Myocardial infarction; TMPG- TIMI myocardial perfusion grade; CTFC- corrected TIMI frame counts; MACE- major advance cardiac events.
The ejection fraction at presentation was comparable between the two groups, with the TA+SAT group having a mean of 46.85 ± 7.67% and the NOTA group having a mean of 46.72 ± 7.82% (p-value: 0.921). At the one-month follow-up, the TA+SAT group showed a mean ejection fraction of 50.93 ± 8.18%, while the NOTA group had a mean of 49.14 ± 8.20% (p-value: 0.191) (Table 1).
Non-significantly (p-value: 0.051) but ST-segment elevation was higher in the TA+SAT group (5.60 ± 2.20) compared to the NOTA group (4.90 ± 2.26). ST-segment resolution was significantly (p-value: 0.010) better in the TA+SAT group (2.17 ± 2.00) compared to the NOTA group (1.41 ± 1.60) (Table 1).
Smoking (p-value: 0.008) and alcohol (p-value: 0.005) consumption were significantly more in the TA+SAT group, with smoking observed in 27 patients (27.8%) compared to 12 patients (12.4%) in the NOTA group, and alcohol use in 24 patients (23.5%) in the TA+SAT group compared to 9 patients (8.8%) in the NOTA group (Table 1).
Risk factors such as hypertension (HTN) and diabetes mellitus (DM) did not show significant differences between the groups, with HTN present in 38 patients (21.3%) in the TA+SAT group and 39 patients (21.9%) in the NOTA group (p-value: 0.693), and DM present in 26 patients (17.2%) in the TA+SAT group and 35 patients (23.2%) in the NOTA group (p-value: 0.096) (Table 1).
TIMI flow and TMPG grades were similar across the groups. The corrected TIMI frame count (CTFC) before and after drug administration showed significant differences. (Table 1).
MI location showed significant (p-value: 0.030) differences, with anterior wall MI (AWMI) observed in 44 patients (21.4%) in the TA+SAT group and 39 patients (18.9%) in the NOTA group, and inferior wall MI (IWMI) observed in 36 patients (20.8%) in the TA+SAT group and 38 patients (12.5%) in the NOTA group (Table 1).
3.2. Angiographic outcomes
Before drug administration, TIMI 3 flow was similar between the groups (NOTA: 71.4%, TA+SAT: 71.3%, p-value: 0.980). With drug administration, TIMI 3 flow was also comparable (NOTA: 85.7%, TA+SAT: 85.3%, p-value: 0.963). Without drug administration, the flow remained almost the same (NOTA: 98.0%, TA+SAT: 97.8%, p-value: 0.964) (Table 2).
Table 2.
Comparison of angiographic outcomes between NOTA group and treatment group 2 (TA+SAT).
| NOTA (n,77) versus TA+SAT (n, 80) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|
| Before drug |
With drug |
Without drug |
|||||||
| Angiographic Outcomes | NOTA | TA+SAT | P value | NOTA | TA+SAT | P value | NOTA | TA+SAT | P value |
| TIMI 3 flow n (%) | 55 (71.4) | 57 (71.3) | 0.980 | 24 (85.7) | 29 (85.3) | 0.963 | 48 (98.0) | 45 (97.8) | 0.964 |
| TMPG 3 flow n (%) | 64 (83.10) | 60 (75.0) | 0.212 | 24 (85.7) | 24 (70.6) | 0.156 | 47 (95.9) | 43 (93.5) | 0.595 |
| CTFC (Mean ± SD) | 34.2 ± 17.06 | 29.8 ± 14.6 | 0.098 | 38.2 ± 20.5 | 30.2 ± 10.40 | 0.054 | 29.08 ± 12.7 | 21.1 ± 7.561 | <0.001 |
NOTA: No thrombus aspiration; TA+SAT-Thrombus aspiration + Saline autotransfusion;TIMI – Thrombolysis is Myocardial infarction; TMPG- TIMI myocardial perfusion grade; CTFC- corrected TIMI frame counts.
For TMPG 3 flow, no significant differences were observed before (NOTA: 83.1%, TA+SAT: 75.0%, p-value: 0.212), with (NOTA: 85.7%, TA+SAT: 70.6%, p-value: 0.156), or without drug administration (NOTA: 95.9%, TA+SAT: 93.5%, p-value: 0.595), suggesting similar myocardial perfusion outcomes (Table 2).
The corrected TIMI frame count (CTFC) showed significant differences. Before drug administration, the mean CTFC was similar (NOTA: 34.2 ± 17.06, TA+SAT: 29.8 ± 14.6, p-value: 0.098). With drug administration, the TA+SAT group showed a trend toward better performance (NOTA: 38.2 ± 20.5, TA+SAT: 30.2 ± 10.40, p-value: 0.054). Without drug administration, the TA+SAT group had a significantly lower CTFC (NOTA: 29.08 ± 12.7, TA+SAT: 21.1 ± 7.561, p-value: <0.001), indicating improved coronary flow dynamics (Table 2).
The TA+SAT group had significantly higher ST segment elevation compared to the NOTA group (p = 0.040).There was no significant difference in ST segment regression between the two groups (p = 0.103).The mean difference between ST segment elevation and regression was similar in both groups, suggesting that the treatment effects on regression were comparable (Table 3).
Table 3.
ST segment regression at 90 mins after PCI, p value signifying tests of within-subjects effects (time vs. treatment group).
| ST Segment | Treatment groups |
P value | |
|---|---|---|---|
| TA+SAT (n, 80) |
NOTA (n, 77) |
||
| (a) Elevation | 5.60 ± 2.20 | 4.90 ± 2.26 | 0.040 |
| (b) Regression |
2.17 ± 2.00 |
1.41 ± 1.60 |
0.103 |
| Mean Difference (a-b) | |||
| TA+SAT | NOTA | ||
| 3.42 ± 2.02 | 3.48 ± 1.93 | ||
NOTA: No thrombus aspiration; TA+SAT-Thrombus aspiration + Saline autotransfusion.
3.3. Ejection fraction outcome
There was no significant difference in EF pre-treatment between the two groups which was measured at the time of presentation (p = 0.996) also there was no significant difference in EF post-treatment between the two groups which was assessed at one month follow-up (p = 0.556). The mean difference in EF pre- to post-treatment was higher in the TA+SAT group (3.86 ± 7.51) compared to the NOTA group (1.55 ± 4.91), but the clinical significance of this finding is unclear (Table 4).
Table 4.
Ejection fraction measured at the time of presentation to one-month follow-up across the treatment groups.
| Ejection Fraction | Treatment groups |
P value | |
|---|---|---|---|
| TA+SAT (n, 80) |
NOTA (n, 77) |
||
| (a) Pre | 47.07 ± 7.52 | 47.59 ± 6.97 | 0.996 |
| (b) Post |
50.93 ± 8.18 |
49.14 ± 8.20 |
0.556 |
| Mean Difference (a-b) | |||
| TA+SAT | NOTA | ||
| 3.86 ± 7.51 | 1.55 ± 4.91 | ||
NOTA: No thrombus aspiration; TA+SAT-Thrombus aspiration + Saline autotransfusion.
4. Discussion
This study provides a comprehensive evaluation of the outcomes associated with TA combined with SAT compared to standard treatment in patients undergoing primary PCI for STEMI.The mean age of participants in both groups was comparable, with the TA+SAT group averaging 61.3 ± 10.7 years and the NOTA group 61.6 ± 11.8 years. However, significant differences were observed in blood pressure measurements. The TA+SAT group had significantly lower systolic blood pressure (SBP) (127.1 ± 27.25 mmHg) compared to the NOTA group (137.9 ± 27.2 mmHg) (p-value: 0.014). Similarly, diastolic blood pressure (DBP) was significantly lower in the TA+SAT group (79.37 ± 15.6 mmHg) compared to the NOTA group (84.4 ± 15.2 mmHg) (p-value: 0.042).
The ejection fraction at presentation was comparable between the two groups. At the one-month follow-up, the TA+SAT group demonstrated a slightly improved mean ejection fraction of 50.93 ± 8.18%, compared to 49.14 ± 8.20% in the NOTA group (p-value: 0.191). Although the improvement was not statistically significant, the trend suggests a potential benefit of the TA+SAT intervention in myocardial recovery post-PCI. This finding aligns with the study by Grancini et al. [10], the left ventricular ejection fraction at discharge did not show statistically significant differences between the groups receiving the SALINE technique and standard care treatments (SCT) (52.9% ± 8.8% v/s. 55.6% ± 11.4%, p = 0.478). Similarly, the peak levels of high-sensitivity troponin I (Hs-TnI) were not significantly different between the SALINE and SCT groups (76.821 ± 69.402 ng/dL v/s. 79.989 ± 78.261 ng/dL) (p = 0.720).
The management of microvascular obstruction (MVO) in STEMI patients undergoing primary PCI (pPCI) remains a critical area of research, with various strategies being explored to optimize outcomes.
The randomized TAPAS trial [11] provided evidence that TA before stenting increased the resolution of ST-segment elevation when compared to the standard primary PCI. However, most patients in this trial (90%) were also treated with Abciximab, indicating that the combination of TA and GpIIb/IIIa inhibitors might help reduce MVO. Despite this, significant ST-segment resolution was demonstrated in only 50% of these patients, and it was not associated with a significant reduction in infarct size. In the REOPEN-AMI trial, Niccoli et al. [12] compared the high-dose intracoronary administration of adenosine (AD) to nitroprusside in preventing MVO in STEMI patients treated with primary PCI, TA, and Abciximab within 12 hours of symptom onset. The study demonstrated that intracoronary AD, but not nitroprusside, safely improved microcirculatory perfusion. This improvement was assessed by greater resolution of ST-segment elevation, particularly in patients with early onset of symptoms.
In the present study ST-segment elevation was higher in the TA+SAT group (5.60 ± 2.20) compared to the NOTA group (4.90 ± 2.26), though this difference was not statistically significant (p-value: 0.051). However, ST-segment resolution was significantly better in the TA+SAT group (2.17 ± 2.00) compared to the NOTA group (1.41 ± 1.60) (p-value: 0.010). Improved ST-segment resolution in the TA+SAT group indicates more effective myocardial reperfusion, suggesting that this combined intervention might enhance the restoration of blood flow to the affected myocardial tissue.
In the present study we evaluated the angiographic outcome across the two groups and found that TIMI flow and TMPG grades were similar across the groups, indicating comparable immediate angiographic outcomes post-PCI. However, significant differences were noted in the corrected TIMI frame count (CTFC) before and after drug administration, highlighting the potential impact of TA+SAT on improving microvascular perfusion. The location of myocardial infarction (MI) showed significant differences between the groups. Anterior wall MI (AWMI) was observed in 44 patients (21.4%) in the TA+SAT group and 39 patients (18.9%) in the NOTA group, while inferior wall MI (IWMI) was present in 36 patients (20.8%) in the TA+SAT group and 38 patients (12.5%) in the NOTA group (p-value: 0.030).
The study compared the TIMI 3 flow and TMPG 3 flow between the NOTA and TA+SAT groups before, during, and without drug administration. The TIMI 3 flow was similar between the groups at all time points. Specifically, before drug administration, TIMI 3 flow was 71.4% in the NOTA group and 71.3% in the TA+SAT group, with a p-value of 0.980. With drug administration, the flow remained comparable (NOTA: 85.7%, TA+SAT: 85.3%, p-value: 0.963). Similarly, without drug administration, TIMI 3 flow was 98.0% in the NOTA group and 97.8% in the TA+SAT group, with a p-value of 0.964.
For TMPG 3 flow, no significant differences were observed between the groups at any time point. Before drug administration, the TMPG 3 flow was 83.1% in the NOTA group and 75.0% in the TA+SAT group (p-value = 0.212). With drug administration, the values were 85.7% for NOTA and 70.6% for TA+SAT, with a p-value of 0.156. Without drug administration, TMPG 3 flow was 95.9% in the NOTA group and 93.5% in the TA+SAT group (p-value = 0.595). These results suggest that myocardial perfusion outcomes were similar between the two groups.
In comparing our results with a recent study [10], SALINE was linked to a greater likelihood of achieving a final TIMI flow grade 3 (MBG >1), observed in 87.5% of patients (14 out of 16), versus only 43.8% in the SCT group (7 out of 16), with a statistically significant p-value of < 0.03. This suggests that SALINE may be more effective in attaining optimal TIMI flow grades and MBG, potentially leading to better myocardial perfusion and clinical outcomes compared to SCT. Ishii et al.‘s [13] findings indicate that administering intravenous nicorandil before revascularization not only enhanced TIMI flow post-procedure but also led to significantly reduced clinical complication rates over a 2.4-year follow-up period.
In the present study the corrected TIMI frame count (CTFC) presented significant differences between the groups. Before drug administration, the mean CTFC was similar, with 34.2 ± 17.06 for NOTA and 29.8 ± 14.6 for TA+SAT (p-value: 0.098). During drug administration, there was a trend toward better performance in the TA+SAT group (NOTA: 38.2 ± 20.5, TA+SAT: 30.2 ± 10.40, p-value: 0.054). Without drug administration, the TA+SAT group showed significantly lower CTFC (NOTA: 29.08 ± 12.7, TA+SAT: 21.1 ± 7.561, p-value: <0.001), indicating improved coronary flow dynamics.
The data indicate a trend toward improved outcomes in the TA+SAT group compared to the NOTA group, though the differences were not statistically significant. Additionally, the mean difference in ejection fraction pre- and post-treatment was 3.86 ± 7.51 in the TA+SAT group, indicating a notable improvement. In contrast, the NOTA group had a mean difference of only 1.55 ± 4.91. This suggests that patients in the TA+SAT group experienced a more substantial increase in ejection fraction following treatment compared to those in the NOTA group.
The study’s limitations include a small sample size and potential confounding factors such as higher smoking and alcohol consumption in the TA+SAT group. These factors need to be controlled or accounted for in future studies.
This study provides a novel evaluation of the angiographic outcomes associated with thrombus aspiration (TA) combined with saline autotransfusion (SAT) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. By exploring the benefits of SAT in conjunction with TA, this research addresses a critical knowledge gap in the management of STEMI patients, offering new insights into the potential of this combined intervention to enhance myocardial reperfusion and improve clinical outcomes.
5. Study limitations
Initially designed as a randomized controlled trial, ethical concerns necessitated a shift to an observational study design. While the small cohort size presented challenges in matching populations across all characteristics, these limitations will be addressed in a forthcoming large-scale study employing similar methodologies.
6. Conclusion
In this comparative analysis of the TA+SAT and NOTA treatment regimens, several notable differences emerged. Although TIMI and TMPG flow grades were similar between the groups, the TA+SAT regimen was associated with significantly lower blood pressure and better coronary flow dynamics as indicated by the CTFC, especially without drug administration. Additionally, the TA+SAT group exhibited significantly better ST-segment resolution, though ST-segment elevation was slightly higher. The higher rates of smoking and alcohol consumption in the TA+SAT group highlight potential confounding factors that could impact outcomes. Overall, while both treatments were effective in achieving myocardial reperfusion, the TA+SAT approach showed a trend toward improved coronary flow dynamics and myocardial perfusion. Future research should focus on validating these findings and exploring their implications for long-term patient outcomes.
Acknowledgments
Meta AI, with Llama 3.2 was used for editing the language and grammar corrections.
Funding Statement
This paper was not funded.
Article highlights
ST-Elevation Myocardial Infarction (STEMI) is a severe heart attack caused by a blocked coronary artery, requiring urgent intervention.
This study compares the effectiveness of thrombus aspiration (TA) and saline autotransfusion (SAT) versus standard primary PCI (NOTA) in STEMI patients.
Patients in the TA+SAT group showed better short-term coronary flow improvement as measured by ST-segment resolution and corrected TIMI frame count (CTFC).
Blood pressure was significantly lower in the TA+SAT group, potentially indicating improved heart function.
Ejection fraction improved slightly after one month in the TA+SAT group, but the difference was not statistically significant.
ST-segment resolution was significantly better in the TA+SAT group, suggesting improved myocardial reperfusion.
Despite similar TIMI and TMPG flow grades across both groups, the TA+SAT regimen showed better coronary flow dynamics without drug administration.
Findings suggest that TA+SAT could be a promising adjunctive therapy for improving myocardial perfusion in STEMI patients.
Author contributions statement
Rekha V – Made a significant contribution to the work reported study design, execution, acquisition of data, analysis and interpretation and writing.
Dr. Sudhakar Rao – Made a significant contribution to the work reported in the conception, study design, execution.
Dr. Krishnananda Nayak – Made a significant contribution to the work reported study design, execution, substantially revised.
Ms. Manjoosha M – Made a significant contribution to the work reported in the execution, acquisition of data, analysis.
Ms. Jyothi Samanth – Made a significant contribution to the work reported in the execution, acquisition of data, analysis.
Dr. Padmakumar R – Made a significant contribution to the work reported in the conception, study design, execution and critically reviewed the article
All the above listed authors have agreed on the journal to which the article will be submitted. All authors reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage. Also, all agreed to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.
Declaration of Interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Ethical Disclosure
The study was approved by the Kasturba Medical College and Kasturba Hospital Institutional Ethics committee under reference number IEC539/2018. We have obtained consent from the patients, and for those unable to provide it, we have obtained consent from their carers.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
Upon request, data will be provided.
References
Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Upon request, data will be provided.
