Needle versus cannula over needle for radial artery cannulation during transradial coronary angiography and interventions

Abstract

Purpose

To evaluate the efficacy of radial artery cannulation with needle versus cannula over needle during transradial coronary angiography and intervention.

Methods

Five hundred patients scheduled to undergo transradial catheterization were randomized between the two methods. Primary endpoint of the study was the combined endpoint of switching to another access site due to inability of successful sheath insertion or switching to another method of cannulation (from needle to cannula over needle and vice versa).

Results

The primary end point was met in 12 patients (4.8%) from the needle group and 14 patients (5.6%) from the cannula over needle group (p = 0.695). There were no differences in switching of cannulation method [10 (4.0%)% versus 11 (4.4%), p = 0.831], switching of access site [6 (2.8%) versus 9 (3.6%), p = 0.441), time for artery cannulation [1.20 (0.80–2.20) min versus 1.26 (1.01–2.39) min, p=0.152], total procedure time [15.05 (9.47–29.03) min versus 19.14 (10.13–32.02) min, p=0.112] number of attempts [2 (1–4) versus 2 (1–5), p=0.244] and number of skin punctures [1 (1–2) versus 1 (1–2), p=0.399] before successful radial artery cannulation. There were no differences recorded in the safety endpoints of EASY grade III or more radial hematomas [2 (0.8%) versus 1 (0.4%), p = 1.000] or the incidence of radial artery occlusion after the procedure [9 (3.6% versus 16 (6.8%), p = 0.358].

Conclusion

Radial artery cannulation with needle and cannula over needle seems to be equal in terms of efficacy and safety.

Highlights

•

Radial access for cardiac catheterization is growing all over the world compared to the traditional femoral approach.
•

There is great interest on improving routines during transradial approach.
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This study shows that radial artery cannulation with needle and with cannula over needle have no differences in terms of efficacy and safety.

1 Introduction

Transradial approach for cardiac catheterization is a world-wide growing technique. The advantages of this technique compared to the traditional transfemoral approach are the reduced rates of access site complications , the reduced mortality in high risk patients with ST elevation myocardial infarction and the increased patient comfort due to faster mobilization .

There are different type of radial sheaths available in the market: hydrophilic and non-hydrophilic, short (7 cm), longer (11 cm) and very long (24 cm) with diameter from 4Fr to 6Fr.

There are two different ways to perform radial artery cannulation: cannulation with a needle (modified Seldinger technique) and with a cannula over needle (Seldinger technique). These methods are both widely adopted and that is why there are radial access kits available in the market for both techniques.

Pancholy et al. compared these two methods in patients undergoing coronary angiography with 5Fr sheaths and showed that although there were no differences in the incidence of hematoma or radial artery occlusion (RAO), the puncture with needle was associated with less access time, total procedural time and attempts needed to establish access compared to the puncture with cannula over needle. However, the fact that there were only two operators that enrolled all patients is a major limitation of this study.

The aim of this study is to evaluate these two methods of radial artery cannulation in terms of efficacy and safety.

2 Methods

Five hundred patients scheduled to undergo transradial cardiac catheterization in five different Greek hospitals were enrolled in this study. Inclusion was performed between January 2016 and June 2016. Patients that underwent coronary angiography with or without ad hoc percutaneous coronary intervention (PCI) were included in the study. Randomization was performed with closed envelopes. All participating centers used the same needle (21G), cannula over needle (Polywin i.v. cannula without wings, 20G), guiding wire to insert the radial artery (0.021″, stainless steel with atraumatic tip, KDL, China) and introducer (5Fr, 11 cm long hydrophobic sheath, KDL, China). All operators were high volume operators (more than 200 procedures per year for the last five years), highly experienced in radial approach (more than 80% of their procedures were performed transradially) and experienced in both ways of puncture.

The protocol of radial puncture has been described previously . Barbeaux’s test was performed in all patients after randomization and before entering the laboratory, as part of the study protocol. The results of these tests were recorded but were not taken into clinical consideration, since neither the Barbeaux, nor the Allen’s test have proved to have any clinical significance and are not part of our clinical routine any longer.

For patients randomized in the needle group, the radial artery was punctured directly with the 21G needle, the 0.021″ guidewire was inserted and then the study introducer was advanced. For patients randomized in the cannula over needle group, the artery was punctured with the cannula over needle using the Seldinger technique (through and through puncture technique). After radial artery posterior wall puncture the stylet was removed. The plastic part of the cannula was slowly withdrawn until pulsative flow was observed. Then the 0.021″ guidewire was advanced and the study introducer was inserted in the radial artery.

Successful sheath insertion was documented with arterial blood back flow from sheath side branch and with arterial pressure waveform documentation. In case of failure to cannulate the radial artery, the operating physician had the option of switching cannulation method (from needle to cannula over needle and vice verca) or switching access site.

After successful radial artery cannulation all patients received vasodilatation with verapamil 5 mg intrasheath and 50 IU/kg unfractionated heparin intravenous. Additional vasodilatation could be administered according to treating physician’s discretion. If ad hoc PCI was decided, then additional unfractionated heparin was administered in order to reach 100 IU/kg. Other anticoagulation medication, like bivalirudin or glycoprotein IIb–IIIa inhibitors were not administered routinely, but only as bail out therapies and according to the treating physicians.

If during the procedure there was need for a larger introducer, the exchange was performed over a 0.038″ wire and a 6Fr or 7Fr femoral introducer (Cordis, USA) was introduced in the radial artery according to the treating physician discretion.

Hemostasis was achieved with different radial closure devices and patent hemostasis was aimed in all patients.

Before discharge ultrasound examination was performed in all patients in order to evaluate postprocedural radial artery occlusion (RAO).

2.1 Endpoints

Primary endpoint of the study was the combined endpoint of switching cannulation method or switching access site, due to failure of radial artery cannulation. Secondary efficacy endpoints of the study were the separate endpoints of the primary endpoint (switch of cannulation method and switch of access site), time for cannulation, total procedure time, number of attempts (defined as forward passes separated by pullbacks) for successful cannulation, and number of skin punctures (this is different from attempts, since several attempts can be performed through a single skin puncture). Safety endpoints were the incidence of hematomas EASY class III or more and the incidence of RAO at discharge, documented with duplex ultrasonography. If an access site switch was performed, despite successful sheath insertion, due to radial artery spasm, tortuosity or other reasons, this was recorded, but not considered as an endpoint.

2.2 Statistical analysis

Continuous parameters are reported as mean ± standard deviation or as median (interquartile range) and compared using one-way ANOVA, student t test or U test as appropriate. Categorical variables were reported as percentages and compared using the chi-square test or the Fisher’s exact test, as appropriate. All statistical analyses were performed using SPSS 20.0 (IBM, Armonk, New York) and Prism 6.0 (GraphPad Software, La Jolla, California). A p value less than 0.05 was considered statistically significant.