Table 1. Comparison of the prevalence of radial artery spasm among patients with different drug adm...

Table 2. Rate of radial artery spasm based on age group.

Table 3. Comorbidities and cardiovascular risk factors in patients with radial artery spasm.

Table 4. Pharmacological treatment during the study in patients with radial artery.

INTRODUCTION

Traditionally we know that since the first time the cardiovascular system was approached via radial access back in 1948(1)—at the time only to monitor invasive arterial pressure—this route of access has been widely used and perfected within the field of cardiac interventional procedures to the point that, to this date, it is access route of choice,(2-6) and has displaced the femoral access widely used before.(7,8) This tendency has been gaining traction for several reasons, among them, the lower rate of bleeding complications reported, its use in patients who require anticoagulant and antiplatelet agents like GPIIbIIIa, and the shorter time by these patients need to stay at the hospital.(9-11) It is also a good alternative for patients with occlusive disease, tortuosity, and aneurysms in the aorto-ilio-femoral axis, particularly in elderly patients.(11,12)

The radial artery consists of concentrical smooth muscle layers and has a high density of adrenergic alpha-1 receptors that can cause arterial spasm, which is one of the most common complications when using it as an access route to perform maneuvers with catheters. Arterial spasm is defined as the difficulty and/or entrapment and/or pain when moving the catheter and/or introducer sheath that obstructs and/or complicates the procedure.(13,14)

In the medical literature available there are several studies like the SPASM 1, 2, and 3, the studies conducted by Vuurmans and Hilton and Deftereos et al., that compared different groups of drugs and strategies to reduce this risk to a minimum. (15-18)

However, even in highly experienced centers, the rate of radial spasm goes from 10% to 30% of all procedures performed through this access, a situation especially uncomfortable for the patient that is associated with a risk of procedural failure, and even with the need to cross over to the femoral access.(15,19,20,23-25)

In most endovascular procedures performed via radial arterial access, the early step is the administration of lidocaine as the local anesthetic before starting the procedure. In time it became necessary to coadjuvate this drug to reduce the risk of spasm even further. It is at this point when numerous studies start combining drugs such as nitrites, opioids, benzodiazepines, and calcium channel blockers through different routes of administration—subcutaneous, oral, sublingual, IV, and intra-arterial—in an attempt to avoid this painful complication for patient and operator.(9,14,16,18,20-25)

This study main objective was to assess the association between the administration of drug combinations (Lidocaine / Lidocaine + Diltiazem / Lidocaine + Nitroglycerine) before cardiac catheterization, as well as the prevalence of radial artery spasm in patients from the unit of hemodynamics at Hospital Municipal “Pedro Orellana”, City of Trenque Lauquen, Buenos Aires, Argentina from October 2019 through February 2020.

The study specific endpoint was to assess the presence of radial artery spasm based on sex, age group, body mass index (BMI), cardiovascular risk factors, comorbidities, and pharmacological treatment of patients during the time of the study.

MATERIALS AND METHODS

Design and study population. Experimental, analytical, cross-sectional study including adult patients with an indication for left heart catheterization and/or angiography of lower extremities or neck vessels treated with cine coronary arteriography, angiography of the neck vessels, angiography of lower extremities and/or angioplasty via radial access at the unit of hemodynamics from Hospital Municipal “Pedro Orellana”, City of Trenque Lauquen, Buenos Aires, Argentina between October 2019 and February 2020.

The exclusion criteria were hypersensitivity or known adverse events to Lidocaine, Diltiazem, and Nitroglycerine, positive or abnormal Allen test (lack of capillary refill for more than 10 seconds after the simultaneous compression of the radial and cubital arteries followed by the release of the cubital artery), non-palpable pulse, patients with AV fistulae of the upper extremities for dialysis or eligible for dialysis, patients in cardiogenic shock or with acute respiratory failure, patients with end-stage acute renal failure or chronic kidney disease, and patients with an ongoing acute myocardial infarction.

Surgical techniques. The patients included in the study were treated with the following medication through the wrist anterior region corresponding to the radial access after pulse was controlled with a 22 mm x 0.6 mm subcutaneous needle, and 5 minutes before starting the procedure:

• Lidocaine 2% 2cc subcutaneous via radial artery (Group #1 or control group).
• Lidocaine 2% 2cc (subcutaneous via radial artery) + Diltiazem 5 mg (intra-arterial) (Group #2).
• Lidocaine 2% 2cc + Nitroglycerine (NTG) 200 ugr subcutaneous via radial artery (Group #3).

  Patients were randomized in each of the 3 drug groups. All procedures were performed by the same operator.

  Afterwards, an Aboccath 20G needle and the Jelco® IV Catheter Radiopaque (Smith Medical) were used to puncture the radial artery with a 0.018 in hydrophilic coated floppy guidewire (Terumo Medical Corporation) using the Seldinger technique. Once the arterial access was conquered, a 6-Fr Radiofocus hydrophilic introducer sheath (Terumo Medical Corporation) was used. Before insertion, the introducer sheaths were soaked in a heparinized physiological solution. A total of 5000 IU of sodium heparin were injected through the introducer sheath for diagnostic purposes followed by 10 000 IU for the angioplasties.

  Cardiac catheterizations were performed using a 6-Fr Judkins right 3.5 catheter, and a Judkins left 4.0 catheter (ConcierGE® Merit Medical Systems). The 6-Fr Amplatz catheter (ConcierGE® Merit Medical Systems) was required in 1 patient only since the origin of coronary arteries complicated selective cannulation. To perform the angiography of the neck vessels, a 5-Fr Simmons 2 catheter was used (ConcierGE® Merit Medical Systems). To perform the angiography of the lower extremities a 6-Fr 125 mm multipurpose catheter was used (ConcierGE® Merit Medical Systems.) A 0.035 in Wholley guidewire (Terumo Medi-Tech Inc.) was used in all procedures to reach the ascending aorta.

  At the beginning and end of each procedure, 2 to 3 mL of blood were drawn through the collateral of the introducer sheath to prevent distal embolization. Afterwards, the introducer sheath was removed at the cath lab, compressive bandage was applied with an elastic wrist band for 60 minutes with partial decompression after 30 minutes, and cath lab follow-up for the next 4 hours. The introducer sheath was removed from the femoral punctures 2 hours into the procedure with a 5-hour follow-up. Once the procedure was completed, all patients were discharged from the hospital.

  Techniques used for data curation. The following study variables were included in a database:

• Age (in years).
• Sex (F/M).
• BMI: Low weight/Normal weight/Overweight/Obesity.
• Type of drug: Lidocaine / Lidocaine + Diltiazem / Lidocaine + NTG.
• Presence and type of complication associated with the cardiac catheterization procedure: radial artery spasm/Hematomas > 3 cm in diameter and/or access site bleeding/local ischemia or embolic events.
• Presence and type of comorbidities.
• Cardiovascular risk factors.
• Pharmacological treatment patients were on at the time of the study.

  Statistical method. The complication reported during cardiac catheterization (radial artery spasm) was described as a 2-state nominal qualitative variable (presence/absence) and then compared statistically among the 3 pharmacological groups (Lidocaine / Lidocaine + Diltiazem / Lidocaine + NTG) using the Bayesian approach to compare proportions. Noninformative beta prior distributions and 50 000 iterations were used. The statistical software package RStudio was used, and P values < .05 were considered statistically significant.

  RESULTS

  We studied a total 83 adult patients with an indication for left heart catheterization and/or angiography of the lower extremities or neck vessels treated with cardiac catheterization via radial access using Lidocaine alone in 32.5% of the cases (n = 27), Lidocaine + Diltiazem in 33.75% (n = 28), and Lidocaine + NTG in 33.75% of the patients (n = 28).

  The patients’ mean age was 65.7 years (SD, 12.3) from 33 to 91 years.

  A total of 53% of the cases (n = 44) were male patients with a mean age of 64.8 years (SD, 12.3) from 33 to 87 years. The remaining 47% cases (n = 39) were female patents with a mean age of 66.7 years (SD, 12.3) from 43 to 91 years

  Procedural complications associated with cardiac catheterization were reported in 25.3% of the patients (n = 21) in whom only radial artery spasm was described. No hematomas, access site swelling or thrombosis were reported.

  Population with radial artery spasm

  Radial artery spasm was reported in 33.3% of the patients from the control group (Lidocaine), 32.1% of the patients treated with Lidocaine + Diltiazem, and 10.7% of the patients treated with Lidocaine + NTG. The prevalence of radial artery spasm was significantly lower in patients treated with Lidocaine + NTG compared to the group of patients treated with Lidocaine + Diltiazem or Lidocaine alone. No significant differences were reported between the administration of Lidocaine and the administration of Lidocaine + Diltiazem (see table 1).

  Radial artery spams occurred in 30.8% of women (n = 12) and 20.5% (n = 9) of men.

  Regarding the presence of radial artery spasm based on age group, the age of 57.1% of the patients was above 60. Patients > 71 years were more common (33.3%) followed by the group of patients from 61 to 70 years (23.8%) (see table 2).

  Regarding the BMI, 66.7% of the patients (n = 14) were overweight, 19% (n = 4) were obese, and 14.3% (n = 3) had normal weight. There were no patients with low weigh.

  Regarding comorbidities, 42.9% of the patients had peripheral disease followed by previous acute myocardial infarction and previous cerebrovascular evens. The incidence rate of both these events was 19% (see table 2). No events associated with myocardial revascularization surgery, chronic stable angina pectoris or aortic disease were reported.

  Regarding the cardiovascular risk factors, the predominant factors were dyslipidemia (76.2%), sedentary lifestyle (71.4%), and arterial hypertension (61.9%) (see table 3).

  Regarding the pharmacological drugs received by the patients during the study, the most common of all were statins (66.7%), and ACEI and/or ARAII (61.9%) followed—with the same rate reported of 52.4%—by beta-blockers, acetylsalicylic acid (ASA), and clopidogrel (see table 4).

  DISCUSSION

  Manipulating the radial artery is a free ticket for the appearance of complications, particularly spasm, due to the great concentric smooth muscle component involved. We should not forget the unfavorable anatomy we can encounter at the cath lab. The objective of this study was to compare different combinations of Lidocaine to establish which are associated with a lower prevalence of radial artery spasms.

  The aforementioned characteristic of the radial artery together with its high density of alpha-adrenergic receptors has led to testing different drugs in different combinations and protocols to minimize the appearance of spasm.(9,20,22-25)

  Several predisposing factors have been suggested that happen to be consistent with our findings such as feminine sex, overweight, pan-vascular disease: peripheral arterial disease, previous myocardial infarction, and past medical history of cerebrovascular events, age (> 70 years), presence of cardiovascular risk factors like dyslipidemia, sedentary lifestyle, arterial hypertension, smoking, and diabetes mellitus being the former 3 the most common of all.

  Over half of the patients with radial artery spasm were on statins, ACEI and/or ARAII, beta-blockers, ASA, and clopidogrel during the study.

  In the studies conducted by Ruiz-Salmerón R.J. et al. that compared the administration of phentolamine and verapamile, and previous oral sedation with Diazepam, the presence of spasms was less common in the latter group.(9)

  On the other hand, Mont´Alverne et al. conducted a study of 50 patients who were categorized into 2 different groups: one group was treated with Diltiazem and the other one with placebo. No spasms were reported in the former group.(22)

  Coppola et al. compared the administration of nitroglycerine alone, sodium nitroprusside alone, and the combination of both. Based on their results, the administration of both reduced radial artery spasm by 9.5% compared to groups that used these drugs separately.(20)

  In the study conducted by Ouadhour et al., the subcutaneous administration of Lidocaine was compared to the administration of Lidocaine + Nitroglycerine. It concluded that in the group that used this latter drug combination, the prevalence of spasm was 2.4% only.(23)

  Therefore, we see that in our study 2 drugs like Diltiazem and Nitroglycerine were used which, associated with Lidocaine gave good results since the prevalence of spasm found in all the procedures performed was 25.3% (n = 21), a value that is within the range described by the current medical literature (10% to 30%).

  The prevalence of spam in groups treated with Lidocaine alone and Lidocaine + Diltiazem was > 30% with values of 33.3% and 32.1%, respectively; on the other hand, while in the group treated with Lidocaine + NTG, the prevalence of spasm was 10.7%, after comparing Lidocaine alone to other drug combinations, it seems obvious that Lidocaine + NTG has the lowest prevalence of spasms among the patients.

  CONCLUSION

  The prevalence of radial artery spasm with the use of Lidocaine 2% + Nitroglycerine in doses of 200 mcg administered subcutaneously via radial access is significantly lower compared to the administration of Lidocaine + Diltiazem or Lidocaine alone.

  Ethical considerations. This study was approved by Hospital Municipal Pedro Orellana ethics committee (Trenque lauquen, Buenos Aires, Argentina) in full observance of all national and international regulations. All the patients were informed on the characteristics and utility of the study, as well as on the procedures that would be performed. All questions asked were duly answered. All patients included in the study gave their written informed consent.

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Association between variations in the combination of lidocaine and the prevalence of arterial spasm in procedures performed via radial access

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