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Research Article | DOI: https://doi.org/10.31579/2641-0419/314
1 Interventional Cardiovascular Consultant & Hypertension Specialist Downriver, Heart& Vascular Specialists USA.
2 SlemaniShar Cardiac Center hospital Iraq.
3 Wayne State University School of Medicine USA.
*Corresponding Author: Aubin Sandio, Wayne State University School of Medicine, USA.
Citation: Kamaran Al Qaradaghi, Asan Hasan, Aubin Sandio, Kawa Rahim, Sarkawt Abba, et all, (2023), Safety, Efficacy, Feasibility of Trans Radial Approach compared with Transfemoral Approach in Patients Undergoing Coronary Catheterization. J. Clinical Cardiology and Cardiovascular Interventions, 6(4); DOI:10.31579/2641-0419/314
Copyright: © 2023 Aubin Sandio. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Received: 14 March 2023 | Accepted: 07 April 2023 | Published: 24 April 2023
Keywords: trans radial; transfemoral; safety; feasibility; efficacy
Background: Percutaneous Coronary Intervention has been done traditionally through Transfemoral route. Trans Radial route is coming up in the practice. We compared Trans Radial with Transfemoral accesses for ease of operability, time of procedure, complications, and failure rates through a cross sectional study.
Objectives: To evaluate the safety, efficacy, feasibility and procedural variables in Trans radial approach compared with the Transfemoral Approach in patients undergoing coronary catheterization.
Methods: A total of 180 patients with both chronic and acute coronary syndromes were enrolled in this study , 140cases with Radial , 28 of whom were crossed to Femoral access(hence 112 Radials with 108 Right Radial and 4 Left Radial)and 68 cases with Femoral access.
Results: Procedural time between Trans Radial and Transfemoral accesses were similar (17.39±10.33 vs 19.68±16.62 minutes p 0.36) respectively while among Femoral crossover group was higher (33.50±20.30 minutes p0.01). Fluoroscopy time was (5.51±4.70 in Trans Radial Vs. 7.18 ±7.65 minutes in Transfemoralp 0.07) were similar in both groups. Post procedure access site complications seen in (9% in Trans Radial compared to 7.35% in Transfemoral P 0.048), Access site Hematoma being the most common one (6.25% in Trans Radial vs 4.4% in Transfemoral), Non-flow limiting dissections occurred in (0.89% in Trans Radial VS 1.4% Transfemoral), Radial artery perforation occurred in 1.78%,1.4% of patients in Femoral group had Femoral artery perforation and had major bleeding.
Conclusion: The overall local complications were lower in Transfemoral access, except for major bleeding which is still a big concern. both vascular Access techniques should not be considered opposite or mutually exclusive, but rather provide the Interventionist a wide spectrum of the therapeutic options.
Cardiovascular diseases are among the most common causes of noncommunicable disease deaths. It numbers at 17.7 million annually all over the world, particularly in low- middle in come countries, it ranks first as a cause of disease-related death in Iraq (1,2,3,4). Coronary artery disease has had high morbidity and mortality for a long time. To date percutaneous Coronary Artery angiography(CAG) and Percutaneous Coronary Intervention(PCI) are standard diagnostic and therapeutic strategies for coronary artery disease respectively (5).Transfemoral Approach(TFA)is considered as a classical one over Trans radial approach (TRA),because it has a large caliber that makes it easily accessible, multiple repetition of puncturing, less radiation time and less contrastus age. Bleeding is the most common complication of TFA and is associated with poor clinical outcomes. In the last two decades, TRA emerged as mostly being used for the interventional and diagnostic approach in cardiology (6,7,8,9). Following the first report of radial CAG by Campeau in 1989 and radial PCI by Kiemeneij et al. in 1992, there is an increase in use of TRA because of lower access site bleeding, patient preference and satisfaction, early ambulation, reduced morbidity, and lower procedural cost over TFA around the world (10,11,12). Although TRA has a lot of benefits, it has a longer learning curve for the operator making it more challenging. devices which are used like temporary pacemakers, intra-aortic balloon pumps and larger devices for coronary interventions cannot be inserted through(13).in our locality the preferred vascular route access is being radial artery over the last 5-10 years.
Design. It isa cross sectional study, conducted in Slemani Cardiac Center and shar hospital. The study was approved by the “Scientific and Ethical Committee” of KBMS in September 2021. Informed written consent toparticipate in the study was provided by all participants. Over a 6-month period (August 2021 to February 2022),180 patients were admitted to Slemani cardiac Center and Shar hospital and under wenttrans radial or Transfemoral CAG and/or PCI by different operators.
Procedure. Enrolled patients where those whom have been admitted in both hospitals, either as a case of acute coronary syndrome (ACS) or as an elective case. Diagnostic CAG done as a part of their diagnostic procedure and some underwent subsequent PCI. Patients with lack of informed consent, severe sepsis, access site infection, previous contrast allergy, coagulopathy (International normalized ratio > 2) were excluded from the study. Exclusion Criteria for TFA was the same as TRA and included peripheral vascular disease including (Iliofemoral disease). The choices between TFA or TRA was Operator’s preference, or difficulties related to the Radial access that made the Operator to change the access site to Femoral, with right Radial approach being the preferred one. TFA was done for patients with absent right Radial pulse, instant or previous Radial cannulation failure, failure of previous Radial approach other than cannulation failure and with coronary artery bypass grafts (CABG). For the Radial approach, the wrist was sterilized and draped. Hyperextension over an arm board was done, skin over the puncture sitesterilized and anesthetized with (2 ml Xylocaine 5%), Radial artery accessgained using the transradial kit (Prelude, Merit Medical company) which is a 21-gauge needle, 0.018guide-wire, and a short (7cm long) sheathusing Seldinger technique. after sheath insertion,200 μg nitroglycerin and 5000 IU unfractionated heparin (UFH) was injected into the Radial artery. For TFA the groin was sterilized, draped and the site was punctured after anesthetizing the skin with 10 ml of 1%Xylocaine.For diagnostic CAG, the following catheters were used:6F or 5F Tiger (TIG) catheter (Terumo, Japan company) or 6FUltimate catheter (Merit Medical company) to cannulate both left and right coronary arteries or Judkin’s left (JL 6/3.5 and6/4) and Judkin’s right (JR 6/4 and 6/3.5) catheters tocannulate the left and right coronary artery respectively. For patients with PCI, Judkin’s guiding catheters (JL6/3.5 and JR 6/4) and extra back-up (EBU) guiding catheter(6/3.5) were used for coronary engagement. All patients were loaded with dualantiplatelet drugs (300 mg aspirin and 300 mg clopidogrel for elective PCI, or 300 mg aspirin and 180 mg Ticagrelor for patients with ACS). UFH (70-100 IU/kg) used as a standard anticoagulation. A drugelutingstent (DES) (“Xience”, Abbott Vascular or “Resolute”, Medtronic companies) were used whenever stenting is required. Radial sheath was removed immediately after the procedure and compression done for 2 hours with radial compression device (TR band; Terumo) using the “paten the mostas is” protocol proximal to puncture site. TR band was inflated with 15–20 mL of air. Radial artery patency was checked at least once every 15 minutes by observing the color and temperature of the hand, it was removed 2 hours after the sheath removal. Light pressure bandage was applied at the end of the procedure. femoral sheath was removed directly after the procedure if no anticoagulation is used and kept in place for 4 hours in contrary, manual compression was done untilsat is factory hemostasis had been achieved followed by placement of compressive bandage with dynaplast for 6 hours.
According to the Arterial Access, we categorized the patients in to 4 groups, (TRA, TFA, crossover to Right Femoral Artery and Left distal Radial accesses).
Crossover to Femoral or left distal Radial accesses was defined as failure tocannulate through right radial route and classified into the follow ingfoursubgroups:
1-Puncture failure (inability to canulate radial Artery)
2-Radial and Brachial failure (severe spasm, tortuosity, loopsor other anomalies)
3-Epiaortic failure (severesubclavian or aortic tortuosity).
4-Coronary cannulation failure
Procedural duration was defined as time between the first needleskin contact to removal of last catheter. Total fluoroscopy time and the amount of contrast were recorded. Most of the elective PCI patients were discharged on the same day provided that no complications occurred in the first 6 hours after the procedure. Patients with primary PCI were discharged after 24-48 hours when they were stable. The site of Radial and Femoral punctures was examined before discharge.
Statistical Evaluation. Statistical analyses were performedusing the SPSS 21.0 (SPSS Inc., Chicago, Illinois).Continuous variables were expressed as mean ± standard deviation (SD), Categorical variables as numbers (n.) and percentages. Independent t-test was used for comparing group means for continuous variables, and Pearson’s chi square was used to determine correlation between nominal variables. A p value of ≤ 0.05 was set to be statistically significant. Binary logistic regression analysis was used to identify predictors (OR) of radial approach abandonment.
Between August 2021 to February 2022, a total of 180 patients with both chronic coronary syndrome (CCS) and ACS were enrolled in this study at Slemani Cardiac Center and Shar Hospital .140 cases with Radial access, 28 of whom were crossed to Femoral access(hence 112 Radial with 108 Right radial and 4 Left Radial)and 68 cases with Femoral access as shown in(table 2). The baseline characteristics of the patients were relatively similar in both groups (Table 1). The mean (and SD) Age of the patients with Radial access was 59.38±9.55 years and those assigned to Femoral access was 58.94±11.46 years, with 104(57.78%) being male and 76(42.22%) being female patients.
| Table 1: Baseline Characteristics | |||||
Characteristic
|
| Radial access n=112(108 RR+4 LR). | Femoralaccess n=68 | p-value | |
| Age year (mean±SD) | 59.38±9.55 | 58.94±11.46 | 0.087 | ||
Gender Male Female |
|
68(60.7%) 44(39.3%) |
|
36(53%) 32(47%) |
0.3 |
| HTN | 57(51%) | 32(47%) | 0.64 | ||
| DM | 34(30%) | 19(28%) | 0.8 | ||
| Dyslipidemia | 15(13%) | 12(17.6%) | 0.52 | ||
| Smoking | 16(14%) | 4(5.9%) | 0.1 | ||
| HF | 2(1.8%) | 1(1.5%) | 0.87 | ||
| CKD | 5(4.5%) | 3(4.4%) | 0.9 | ||
Presentation: ACS CCS |
|
17(15%) 95(85%) |
|
4(5.9%) 64(94.1%) | |
Procedural characteristics are shown in (Table 2). in the Radial access group, 64 patients (57%) underwent diagnostic CAG, 42 patients (37.5%) CAG& PCI and 6 patients (5.35%) underwent PCI, and the Femoral access group 36 (53%) had diagnostic CAG, 20(30%) CAG&PCI, and 12(17%) patients underwent PCI. The number of cases with crossover from Radial to Femoral access was 24, and 4 cases to left Radial in patients assigned to radial access. Among the crossover groups the main reason was Radio brachial failure in 14 patients (50%) mostly due to Radial artery spasm and Radial artery loop. puncture failure (35.7%) mostly in those who had previous radial artery punctures followed by Epiaortic failure (7.1%) and (7.1%) for difficult catheter engagement. The mean fluoroscopy time was not significantly different between the two access sites which was 5.51±4.70 for Radial and 7.18 ±7.65 for Femoral group(p-value 0.07), the same is applicable for total contrast volume used 88.88±59.25 vs 99.71±73 p-value 0.28. The mean time spent in the procedures was not significantly different in Femoral compared to Radial groups, 19.68 ±16.62 vs 17.39±10.33 p-value 0.36 respectively, however those who had Femoral crossover had a statistically significant longer time 33.50±20.30 minutes (p-value 0.01).
| Table 2: Procedural Characteristics | |||
| Procedural Characteristic | Radial access n=112(108 RR+4 LR) | Femoral access n=68 | p-value |
Procedure(n.)(%) Diagnostic CAG CAG&PCI PCI |
64(57%) 42(37.5%) 6(5.35%) |
36(53%) 20(30%) 12(17%) |
0.026 |
| Fluoroscopy time(mint)mean±SD | 5.51±4.70
| 7.18 ±7.65
| 0.07
|
| Duration(mint) mean±SD | 17.39±10.33 | 19.68±16.62 (Femoral) 33.50±20.30 (Crossover to Femoral). | 0.36 between Femoral and Radial 0.01 among 3 groups |
| Contrast(ml) mean±SD | 88.88±59.25 | 99.71±73 | 0.28 |
Access site Complications: Hematoma Major bleeding Dissection Perforation
| 10(9%)
7 0 1 2 | 5(7.35%)
3 1 1 0 |
0.048 |
Table (3) shows causes and numbers of prior attempts among patients who crossed to Femoral or left Radial.
| Table 3: Crossover to Femoral or Left Radial | |||
| Variable | Cross to Femoral | Cross to Left Radial | |
| n=24 | n=4 | ||
Causes: Puncture Failure Radiobrachial failure Epiaortic Aortic failure Coronary canulationfailure
|
8
13
2 2 |
2
1
0 0 |
|
Puncture Failure(n=10)
1st Radial attempt 2nd Radial attempt 3rd Radial attempt |
2 5 1 |
0 2 0 |
p-value <0> |
A model of binary logistic regression analysis was run to identify predictors of Radial abandonment to Femoral access, in our study however male Gender and prior Radial attempt were associated with increased risk of Radial failure (OR 3.91, CI :1.39-10.96, P-value 0.01)and (OR 2.71, CI 1.543.99,P-VALUE 0.038) respectively as shown in table 4.
B: Coefficient for constant (intercept)
S.E:Standard of error
Exp(B):Exponentiation of B coefficient(Odd Ratio).
CI: Confidence interval
TRA for cardiac catheterization is an appealing alternative to TFA for both diagnostic and therapeutic purposes though it requires a steep learning curve initially. Because of the Radial artery anatomy, there are technical challenges to over come. In our study the overall success rate for CAG and PCI through TRA was 80%, which is lower than other studies like in Agostoni et al (14) which was 92.7%, while we had 100% success in femoral access which is as near as to the Brueck et al which was 99.8%(15).This may be related to our low sample size compared to the other studies and our Operator higher experience with Femoral access.
Access failure
Radial artery access has been associated with a greater accesscrossover rate, which was reported to be 4% to 7% in variousstudies (16,17,18). Louvard et al (19) reported the crossover from TRA to TFA in 8.9%, while in our study the rate was 20% (85.7% to Right Femoral and 14.3% to Left Radial). In our study the most common cause for Femoral cross over was Radiobrachial failure (50%) cases with spasm being the most common cause despite intraarterial nitrates, followed by Radial loop, Radial artery perforation and dissection and this is near to the Brueck et al(18)results, Puncture failure being second most common cause (35.7%). being male and having previous radial artery access was risk factors, with 25% of patients had previous Radial artery canulation with p value of 0.01,7% of the patients had tortuosity of the subclavian artery and aorta and same number of patients had difficulty in coronary artery cannulations. This may be due to improper selection of suitable radial cases, inaccurate puncture techniques, coarse maneuvers of catheters, and improper methods for dealing with tortuous Epiaortic anatomy. Radial artery is a small vessel, it is prone to spasm. Wrist pain at puncture site is an important factor leading to radial spasm and puncture failure. As puncture is the gateway of radial access, it should be near perfect. Also, improvements in device technology and increase in expertise should narrow the gap of access site crossover from the earlier period of TRA to the modern era.
Procedural duration:
In our study the mean procedural time was (17.39±10.33) minutes for TRA and (19.68±16.62) minutes for TFA, although the procedure time was higher in TFA but this was statisticallynon-significant(p value of 0.36) and this matches with Louvard et al(19) and santosh et al (20)studies. which reported the procedural duration (from first puncture attempt to removal of last catheter) without any significant differences between the Femoral and Right Radial approaches. While the Femoral cross over group had significantly higher procedural time (33.50±20.30) minutes with p value of 0.01. While the procedure time was more in TRA group compared to TFA group confirmed by Saleem Kassman et al (21) and Ferdinand Kiemeneij et al (22) .
Fluoroscopy time and Contrast volume:
Fluoroscopy time in our study for both Radial and Femoral approaches was not significantly different (5.51±4.70 vs 7.18 ±7.65 minutes respectively, P =0.07). this result matches with those of santosh et al (20) and Osama et al (23). Louvard et al (24)reported that fluoroscopy time was longer in TRA than TFA (4.5 ±3.7 versus 6.0 ± 4.4 minutes
In our study in addition to that TRA was not superior to TFA in so many characteristics like (contrast volume and fluoroscopy time), yet another conclusion to be mentioned that the TRA is limited by significant higher rates of procedural failure, either due to Operator factors like inpuncture failure, or patient or anatomical factors like (being male, repeated punctures, Radio brachial failure and Aortic arch geometry that may affect Catheter advancement and Engagement).moreover the overall local complications were lower in TFA, except for major bleeding which is still a concern in Femoral access. now we concluded that both vascular Access techniques should not be considered opposite or mutually exclusive, but rather provide the Interventionist a wide spectrum of the therapeutic options, with the choice based on logical risk to benefit ratio judgment.
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