Journal of Clinical and Preventive Cardiology

ORIGINAL ARTICLE
Year
: 2019  |  Volume : 8  |  Issue : 4  |  Page : 161--165

Can Shorter Fluoroscopic Time Obviates the Need of Routine Heparin Use in Coronary Angiography via Femoral Route? A Prospective Study


Om Murti Anil1, Nabin Chaudhary1, Arun Sayami2, Saheb Kumar Jayswal1, Naresh Maharjan1, Bhawani Manandhar1, Paras Koirala1, Ujit Kumar Karmacharya1,  
1 Depaertment of Cardiology, Grande International Hospital, Maharajgunj, Kathmandu, Nepal
2 Department of Cardiology, Manmohan Cardiothoracic Vascular and Transplant Centre, Maharajgunj, Kathmandu, Nepal

Correspondence Address:
Dr. Om Murti Anil
Grande International Hospital, Dhapasi, Kathmandu
Nepal

Abstract

Background: The use of heparin in coronary angiography (CAG) through radial route is a well-known practice. However, the prophylactic use of heparin following the femoral arterial sheath insertion is still controversial, so we aimed to assess the safety of CAG without the use of heparin through femoral approach by minimizing fluoroscopy time. Methods: All patients undergoing diagnostic CAG through femoral approach were enrolled in our study. Heparin was not given after femoral sheath insertion contrary to the usual practice. Depending on the fluoroscopy time, patients were divided into three groups: (a) group with fluoroscopy time <2 min, (b) group with fluoroscopy time 2–5 min, and (c) group with fluoroscopy time 5–10 min. The study patients were prospectively assessed for any thrombus formation or embolic event. Femoral puncture site and other complications were also studied simultaneously. Patients with primary/elective angioplasty and longer fluoroscopy time (>10 min) were excluded from the study as well as those who received heparin. Results: Altogether, 1550 patients were enrolled in the study over a period of 3 years. The mean age of the study population was 57.0 ± 12.5 years; 71% of the patients were male. Fluoroscopy time was <2 min in 63% of the patients, 2–5 min in 33% of the patients, and 4% of the patients had fluoroscopy time of 5–10 min. No thromboembolic clinical events were recorded in the entire population during the study. Femoral sheath thrombus was seen in only 2.9% of the patients, and all of these cases had a fluoroscopy time of 𕟷 min. Conclusion: CAG can be safely performed through femoral route without the use of heparin and without any associated thromboembolic complications if fluoroscopy time is <10 min.



How to cite this article:
Anil OM, Chaudhary N, Sayami A, Jayswal SK, Maharjan N, Manandhar B, Koirala P, Karmacharya UK. Can Shorter Fluoroscopic Time Obviates the Need of Routine Heparin Use in Coronary Angiography via Femoral Route? A Prospective Study.J Clin Prev Cardiol 2019;8:161-165


How to cite this URL:
Anil OM, Chaudhary N, Sayami A, Jayswal SK, Maharjan N, Manandhar B, Koirala P, Karmacharya UK. Can Shorter Fluoroscopic Time Obviates the Need of Routine Heparin Use in Coronary Angiography via Femoral Route? A Prospective Study. J Clin Prev Cardiol [serial online] 2019 [cited 2020 Feb 27 ];8:161-165
Available from: http://www.jcpconline.org/text.asp?2019/8/4/161/275165


Full Text



 Introduction



Coronary angiography (CAG) is the gold standard test for identifying the presence and extent of coronary artery disease (CAD). It is a relatively safe diagnostic procedure with <0.1% of major complications, i.e., death, stroke, and myocardial infarction (MI).[1]

To prevent thromboembolic complications, heparin is routinely used during the diagnostic CAG procedure. However, in contrast, the use of heparin potentially increases the possibility of retroperitoneal hemorrhage, local vascular, and hemorrhagic complications.[1],[2],[3] It may also increase the potential of bleeding from various organs as well as risk of heparin-induced thrombocytopenia.[4]

The safety of angiography without routine use of heparin has not been well-established. Few studies regarding the safety of CAG procedure without routine use of heparin have been published in literature, but there is a lack of robust evidence.[5],[6]

Therefore, we aimed to prospectively evaluate the safety of CAG without the routine use of heparin through femoral artery by minimizing the fluoroscopy time (≤10 min).

 Methods



This is a prospective study evaluating the incidence of thromboembolic and bleeding complications in all adult patients (>18 years) undergoing diagnostic CAG through femoral approach at two centers (one government and another private) in Kathmandu. We routinely perform all diagnostic CAGs without heparin through femoral route at our centers, except a few exclusions as mentioned below.

Inclusion criteria

All patients undergoing diagnostic CAG through femoral approach. Patients with increased risk of developing thrombotic or bleeding events were defined as a high-risk category. These high-risk patients were included in this study to represent real-world cases.

High-risk patients

Platelet count 50,000–100,000/mm3International normalized ratio 1.5–2.0Severe left ventricular (LV) dysfunction (LV ejection fraction <30%)Chronic obstructive pulmonary disease with severe airflow obstructionRenal impairment (creatinine clearance rate <60 ml/min)Elderly (>80 years)Received low-molecular-weight heparin <12 h.

Exclusion criteria

Patients undergoing primary or ad hoc angioplastyPatients undergoing radial angiographyPatients who received heparin during angiography for the following reasons:

Prolonged procedure (fluoroscopy time >10 min) due to difficulty in engaging coronary ostiaDifficult access through tortuous atherosclerotic iliac artery and aorta causing prolonged procedureNeed of catheter exchange multiple times due to difficulty in engagementDifficult femoral access with multiple puncture attempts and guidewire coming out of arterial lumen in false passageThe use of long vascular sheath due to long tortuous segmentPostcoronary artery bypass surgery cases.

Arterial access was obtained through femoral approach by the standard technique. We used 5F radiopaque polyurethane sheaths in majority of the cases; in cases where ad hoc angioplasty was anticipated, 6F sheaths were used. Puncture of the anterior wall of femoral artery was attempted whenever possible, and posterior wall (double) puncture was avoided as far as possible. The duration of the procedure was recorded from Cath Lab Computer by recording the total fluoroscopy time. Fluoroscopy time was divided into three groups: <2 min, 2–5 min, and 5–10 min. Fluoroscopy time of >10 min was defined as long procedure, and these cases were excluded from the study since they received heparin.

The femoral sheath was aspirated and flushed after each catheter exchange; and at the end of the procedure before removing the sheath, to remove any possible thrombus. Flushing of the sheath was done by first aspirating about 5 ml of blood and followed by flushing with 5 ml of heparinized saline. Clean and white gauze was used to determine the presence of any thrombus. If thrombi were noticed, further aspiration was performed followed by a saline flush. Thrombus of any size, as seen by the naked eye, was considered positive for a thrombotic (sheath thrombosis) event, regardless of any clinical event.

The patients were assessed and evaluated clinically during their hospital stay for the presence of any leg ischemia, femoral and pedal pulses, and local hematoma or bleeding. Femoral sheath of all patients was removed in recovery room and received manual groin compression for 15–30 min carefully, followed by mild compression for another 30–60 min with close supervision of vital signs and the puncture site. All patients were immobilized for 4–8 h depending on the risk of bleeding and local complication.

Definitions

Bleeding events were defined as local femoral access site bleeding or clinically detectable hematoma that may or may not be associated with drop-in hemoglobin or need for blood transfusion.

Thrombotic events were defined as any visible thrombus detected during sheath blood aspiration at any stage of the procedure (arterial sheath thrombi) or over the surface of the wire or inside the lumen of catheter.

Embolic events were defined as new-onset ischemic stroke, new ST-T changes in electrocardiogram (ECG) suggestive of myocardial ischemia, or appearance of symptoms and signs of acute limb ischemia (e.g., acute leg pain and loss of pedal pulses that result in interventional or surgical exploration). The diagnosis of embolization was made clinically (loss of arterial pulse or evidence of leg ischemia) and confirmed by Doppler studies when appropriate.

Outcomes

The incidence of any thromboembolic event was considered as the primary endpoint, whereas the incidence of any bleeding event was taken as the secondary endpoint of the study. Patients were monitored for embolic and bleeding events until hospital discharge and also at the time of the first follow-up.

Primary endpoint

The incidence of any thrombotic event, presumed to be associated with “not using heparin,” was considered as the primary endpoint of this study. Primary endpoints were grouped into three categories: major, intermediate, and minor.

Major: All thrombotic events which were considered life-threatening, and required immediate treatment in the form of medical, minimal invasive or surgical, were considered as major primary end-points. This included death, MI, and ischemic strokeIntermediate: Thrombotic events which were considered non lifethreatening but increase hospital stay for observation or medical treatment with anticoagulants were considered as intermediate primary end-point. This included thrombotic occlusion of femoral artery, absent or diminished distal pulse with evidence of ischemia, unstable angina, and transient ischemic attack. Minor: All thrombotic complications which were considered non lifethreatening, did not increase hospital stay, required only observation and no medical treatment were considered as minor primary end-point. This included femoral arterial sheath-thrombus formation and transient absent of distal pulse.

Secondary endpoint

Groin hematoma, pseudoaneurysm, arteriovenous (AV) fistula or any other significant bleeding events were considered as secondary endpoint of the study.

Follow-up

All patients came for follow-up after 1 week of discharge in the outpatient department. All patients were evaluated for any complications, particularly thromboembolic and bleeding events. All findings suggestive of primary and secondary endpoints were identified and noted by Cath lab cardiology residents and confirmed by the primary operator.

Statistical analysis

Data analysis was performed using Data analysis was performed using SPSS Statistics for Windows, Version 20.0 (SPSS Inc., IBM, Chicago, USA). Descriptive analysis of numerical data was expressed as mean ± standard deviation.

 Results



A total of 1825 CAG were performed during the study of 3 years (November 2012–October 2015) by a single operator. After carefully excluding cases based on exclusion criteria, 1550 patients were enrolled in this study. The mean age of the study population was 57.0 ± 12.5 years, and it ranged from 23 to 89 years. Male patients comprised 71% of the 1550 patients. Hypertension was present in 52%, diabetes in 18%, smoking in 21%, dyslipidemia in 57%, overweight and obesity in 32%, family history of CAD in 7%, and old MI in 7%. High-risk features were present in 18% of the patients, based on the criteria mentioned in methodology. Among them about 8% of patients had higher risk of bleeding due to abnormal blood coagulation parameters. The frequencies of other risk factors were presented in [Table 1], and at higher risk of bleeding was 8%. The frequencies of other risk factors are presented in [Table 1].{Table 1}{Table 1}

The right femoral approach was used in 98% of the cases and left femoral in 2%. Those patients who underwent radial procedure due to a failed femoral approach (0.2%) were excluded from the study. Angiographic findings showed normal coronaries in 22%, insignificant CAD (defined as obstruction <50%) in 17%, and significant CAD (defined as obstruction 󖾦%) in 61%. Most of the patients were discharged on the same day (96.5%) of the procedure.

Most of the procedures (63%) were carried out in <2 min of fluoroscopy time; 33% of the procedures were performed in 2–5 min; and in only 4% of the cases, fluoroscopy time was long due to difficulty in approach and engaging the coronary arteries. Among these three groups, 151 patients with high-risk features were presented in <2 min of fluoroscopy time group, 78 patients in 2–5 min fluoroscopy time group, and 50 patients in 5–10 min fluoroscopy time group. [Table 2]{Table 2}

Mean fluoroscopy time of the study population was 105 ± 15 s, and it ranged from 28 s to 9 min and 45 s.

No clinically detectable embolic or ischemic complication was observed during and after the procedure in the study population. There was no incident of death, cerebrovascular accident, and MI during the procedure, after the procedure, and until the first follow-up done in the 1st week after discharge. None of the patients required coronary care unit admission for monitoring of hemodynamic decompensation or angioplasty for precipitation of acute coronary syndrome due to procedure-related complications. However, chest pain during the procedure or transient ECG change was observed in 0.3%. None of the patients developed hemodynamically significant or persistent arrhythmia during or after the procedure. Vasovagal reaction during and/or after the procedure was observed in 3% of the cases and was treated successfully with intravenous fluid and mephentermine.

No case of iatrogenic coronary emboli (air or thromboembolic) was seen. No event of femoral, iliac, aortic, or coronary artery dissection was detected. Only 2.9% of the patients developed visually detectable femoral sheath thrombi which identified during sheath aspiration at the end of the procedure, 0.51% developed visible thrombus over the wire, and 0.45% had thrombus inside the catheter identified during routine flushing. No clinical limb ischemia or femoral embolization was observed in the study population. All the cases with femoral arterial sheath thrombi had longer fluoroscopy time (>5 min).

No patients had AV fistula. Pseudoaneurysm at femoral puncture site was seen in only one patient and was successfully treated by manual compression under ultrasonographic guidance. Surgical intervention was not required in any of the patients for any vascular issue. No case of retroperitoneal hematoma was observed during the study. Hemorrhage occurred at the site of catheterization after initial hemostasis in 0.77% of the patients. Groin hematoma occurred in 65 (4.2%) patients. Large-sized hematomas (>5 cm in diameter) were seen in only four patients. Two of these patients had a fall in hemoglobin by 1–2 g/L, but none of them required a blood transfusion. All these cases were managed conservatively and discharged after an average hospital stay of 3 days. Medium-sized hematomas (2–5 cm in diameter) were seen in 11 patients. None of these patients had a significant drop in hemoglobin. Surgical intervention or blood transfusion was not required. They responded to prolonged bed rest with limited mobilization. These patients were observed for 48–72 h before discharge. Small-sized hematomas (<2 cm in diameter) were seen in 50 patients. Twelve of these patients were observed overnight before discharge. [Table 3].{Table 3}

 Discussion



Our study clearly demonstrated the safety of this procedure throughout the study in patients who underwent CAG through femoral route without routine use of heparin provided the fluoroscopy time is <5 min. There was not a single life-threatening thromboembolic event in the form of stroke, acute MI, or death in the study population. Furthermore, there was no clinically detectable arterial thrombosis, embolic event, or limb ischemia. In addition to that, patients undergoing CAG showed a lower incidence of local and systemic bleeding complications.

The main reason for lower rate of thrombosis in our study compared to previous studies was shorter procedure duration. In our study, most of the procedures (63%) were carried out in <2 min fluoroscopy time, 33% in 2–5 min time, and in only 4% cases, the fluoroscopy time was between 5 min and 10 min. The mean fluoroscopy time was only 105 ± 15 s.

So far, we have not found any literature showing shorter procedure duration than our study. Louvard et al.[7] reported that fluoroscopy time in femoral CAG group was 3.1 ± 1.7 min and was slightly higher 4.5 ± 3.7 in octogenarians.[8] Kawashima et al.[9] reported the fluoroscopy time of 3.7 ± 2.5 in radial angiography. Behan et al.[10] reported the median fluoroscopy time was 4.4 min.

According to Datta et al.,[5] an observational study conducted in 3780 patients undergoing CAG, in which 1180 patients did not receive heparin, reported no periprocedural ischemic complications during angiography in patients without heparin use.

Local bleeding complications were lowest in no heparin group. There was no incidence of stroke, catheter-related thrombosis, and acute MI in no heparin group. Blood transfusion requirements and surgical interventions were lowest in no heparin group. Author emphasized that CAG through the femoral artery could be performed without heparin. Safety of not using heparin during CAG demonstrated in this study was similar to our study, and bleeding complications in no heparin group were also similar to that of our study. However, bleeding complications in the heparin group in this study were much higher than nonheparin group.

Wang et al. first reported successful CAG without heparin. The mean operation time in this study was 17.9 ± 11.3 min which is longer than in our study. Subcutaneous hematomas occurred in 1.8% cases and AV malformation in 0.07% cases. There was no MI, stroke, and peripheral arterial thrombotic events in this study.[6] Safety in this study was similar to our study in terms of no major thromboembolic complications. The bleeding rate in this study was comparable to our study. A study which was conducted on 322 patients to assess hematoma and its risk factors reported that the use of anticoagulant agents might increase the risk of the occurrence of hematoma.[11]

Our study has shown a 2.9% incidence of visible sheath-thrombus formation, which is much lower than what had been reported in the past (20%–54%).[12],[13] In our study, cases with fluoroscopy time of 𕟷 min were only associated with higher sheath-thrombus formation.

The clinical events of thrombotic vascular occlusion are less common and were found in 0.5%–1.4% of cases.[14],[15],[16] Postcardiac catheterization femoral arterial thrombosis requiring surgical thrombectomy was reported in 0.2%–2.5%,[1],[13] but in our study, no such complication was detected. Lower incidence of thromboembolic events in our study can be explained by very short procedure duration than previous studies. Since the rate of thrombus formation was related with the duration of procedure in the past study.[12]

It is not clear whether adding heparin in these patients would have further reduced the incidence of thrombosis. Even if sheath-thrombus formation is reduced by adding heparin, exact clinical benefit is still not known since clinically significant and detectable embolic events are very low even if incidence of sheath thrombosis is high.[14],[15],[16] The addition of heparin might have further decreased the incidence of thrombosis in our cohort, but would not have made any impact on clinical events since there was no embolic event detected in our study.

Local complications in the form of hematoma, pseudoaneurysm, and hemorrhage were only 2.9% in our study. The incidence of these local complications was higher in previous studies where heparin was given. The incidence of local hematoma in our cohort was 1.8%, which is similar to previous studies done without routine use of heparin, but the incidence of AV fistula, dissection, thrombosis, and pseudoaneurysm was lower than previous studies.[5],[6],[11]

Limitations

Our study was nonrandomized, and all CAG procedures were done by a single operator. Moreover, in our study since heparin was not used as a routine, lower rate of bleeding complication can be easily understood, but we could not compare the difference in bleeding complications with or without heparin in this study population due to lack of a control arm with the use of heparin.

This study had a special group of patients who had high-risk features for developing thromboembolic and hemorrhagic complications. In this study, 18% of participants had high-risk features, but overall bleeding and thrombotic events were similar to the entire population. Despite the inclusion of these high-risk patients in our study, overall bleeding complications and thrombosis rate were quite low.

 Conclusion



CAG without the use of heparin can be safely performed through femoral route without any thromboembolic complication provided that the procedure time is short. In addition, avoiding the use of heparin can decrease the number of bleeding complications.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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