Abstract
Background
While the uptake of transradial access site is growing, there are concerns about associated radial injury. We report a feasibility study of a technique that enables both 5Fr diagnostic and PCI cases to be undertaken without an arterial sheath using conventional diagnostic and guide catheters with a modified balloon assisted tracking (BAT) technique.
Methods
We performed a prospective single center pilot study to assess the feasibility and effectiveness of sheathless radial artery access and BAT to perform coronary angiography and angioplasty using conventional 5 Fr diagnostic and guide catheters. We assessed for successful acquisition of good quality angiogram, completion of the angioplasty and access site complications.
Results
5 Fr sheathless cardiac catheterization was undertaken in diagnostic (55%) and PCI cases (45%, all indications) in 60 consecutive patients (mean age 62.8 ± 11.4 years) using conventional catheters. The procedure was successfully performed via the radial artery using a sheathless technique with BAT in 93.3% of patients. All patients had a patent radial artery following removal of the Helix device and there were no recorded access site complications.
Conclusions
Trans-radial cardiac catheterisation for diagnostic and PCI cases using 5F Sheathless catheters (whose outer diameter is smaller than a 3Fr introducer sheath) with BAT appears feasible and allows both cardiac catheterization for diagnostic and PCI indications to be undertaken safely using conventional catheters through the radial route, with high success rates
Highlights
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Transradial catheterization is associated with radial injury and there is a move to downsizing procedures to minimize complications.
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For the first time in the literature, we report a feasibility study of a sheathless technique that enables both 5Fr diagnostic and PCI cases using balloon assisted tracking (BAT) technique.
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This technique was prospectively performed in 60 consecutive patients using conventional catheters.
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The procedure was successfully performed via the radial artery using a sheathless technique with BAT in 93.3% of patients.
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All patients had a patent radial artery following removal of the Helix device and there were no recorded access site complications.
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We have shown that our virtual 3Fr sheathless technique using BAT is feasible with success rates of >90%.
1
Introduction
The transradial access site (TRA) has been increasingly adopted as the default approach for percutaneous coronary intervention in Europe and Asia with growing uptake in the United States . TRA is associated with reduced access site related bleeding complications and mortality in high-risk patient groups undergoing PCI . Recently, there has been increasing awareness that cardiac catheterization undertaken through the TRA may be associated with radial injury, particularly in patients with small radial artery diameters with intimal tears and medial dissections observed in up to two thirds of patients undergoing transradial cardiac catheterization in OCT studies and radial occlusion rates of 7% reported in a recent meta-analysis of over 30,000 patients . Use of smaller French sized catheters has been shown to reduce radial injury and radial occlusion , suggesting that downsizing equipment has potential clinical benefits. The outer diameter of radial sheaths is typically 1- or 2F sizes larger than the outer diameter of the equivalent catheter, and use of “sheathless” systems can minimize the size of equipment used within the radial artery. Our group was the first to report the use of a dedicated TRA 6Fr sheathless guide catheter system in PCI in the literature . More recently, several groups have reported use of smaller diameter 5Fr sheathless systems for PCI , whose outer diameter is smaller than a 3-Fr introducer sheath.
Whilst sheathless guide catheter systems offer obvious advantages in minimizing the diameter of the equipment “footprint” at the radial puncture site and within the radial artery, their uptake has been limited by the fact that none of the sheathless systems currently available offer diagnostic catheter options, meaning that their use has been limited to PCI. A significant proportion of PCI undertaken in contemporary practice, particularly in patients presenting with ACS occurs following diagnostic cardiac catheterization that requires use of conventional diagnostic catheters with introducer sheaths. Hence any potential benefit of undertaking PCI through 5Fr sheathless systems would be lost unless diagnostic angiography was undertaken through conventional 3Fr introducer sheaths. Furthermore, many operators have not fully adopted sheathless systems due to unfamiliarity with the available guide catheter shapes and the specific features of sheathless guide catheter performance. The design of sheathless systems often necessitates stiffer guide catheters with several cases published reporting an increased risk of coronary dissection . Here we describe and report a feasibility study of a technique that enables both 5Fr diagnostic and PCI cases to be undertaken without an arterial sheaths using conventional diagnostic and guide catheters with a modified balloon assisted tracking (BAT) technique.
2
Methods
2.1
Study design
We performed a prospective single center pilot study to assess the feasibility and effectiveness of sheathless radial artery access and BAT to perform coronary angiography and angioplasty using conventional diagnostic and guide catheters. We used this technique in consecutive patients on an “all comer” basis and no exclusion criteria were applied.
2
Methods
2.1
Study design
We performed a prospective single center pilot study to assess the feasibility and effectiveness of sheathless radial artery access and BAT to perform coronary angiography and angioplasty using conventional diagnostic and guide catheters. We used this technique in consecutive patients on an “all comer” basis and no exclusion criteria were applied.
3
5 Fr sheathless access and balloon assisted tracking technique
Sheathless access was attempted in the right or left radial artery. A radial puncture was performed in a standard manner using an open needle system (Terumo corporation, Japan) with a 0.025″ wire introduced through the needle ( Fig. 1 a ). The needle was then removed and the tract dilated with a 5Fr introducer sheath dilator (diameter 0.7 mm) ( Fig. 1 b). After removal of the initial 0.025″ wire, a 0.014″ coronary wire was then introduced through the dilator into the aortic root under fluoroscopic guidance ( Fig. 1 c). The dilator was then removed, leaving the coronary wire in the radial artery. An assistant compressed the radial artery. BAT was then used to allow sheathless entry of the required diagnostic or guide catheter. To perform BAT, a compliant 2.0 mm by 15 mm balloon was inserted into the relevant 5Fr diagnostic or guiding catheter and advanced until the distal one third of the balloon protruded outside the tip of the catheter ( Fig. 1 d). The balloon was then inflated to low pressure (6 atm). The balloon and guiding catheter were then loaded onto the back of the coronary wire and then advanced over the wire and down into the aortic root ( Fig. 1 e). The wire and balloon were then removed to leave the catheter in the aortic root ( Fig. 1 f). Any catheter exchanges were performed using the same balloon assisted technique, with an assistant compressing the radial artery during catheter changes. Subsequent coronary angiography and angioplasty were performed using standard techniques. At the end of the procedure, the catheter was removed and a Helix device (Vascular Perspectives, UK) used ( Fig. 1 g and h). Initially standard rapid exchange 2 × 15 mm balloons were used in the study. This required use of Radifocus Optitorque diagnostic catheters (Terumo Corporation, Japan) whose larger internal diameter (1.20 mm) meant that the 0.014′ coronary wire and 5Fr balloon could easily be advanced within the 5Fr diagnostic catheters. In latter cases, a 2 × 15 over the wire balloon was used that meant that the procedure was compatible with other makes including the Expo diagnostic catheters (Boston Scientific, USA) with smaller intraluminal diameters (1.14 mm). PCI procedures were performed using standard double antiplatelet therapy, 70–100 U/kg of heparin, and drug eluting stent implantation with third generation DES in all cases. Patients undergoing only coronary angiography had 2500 units of heparin. Radial artery spasmolytics were not used.
3.1
End points
The primary outcome measure was the successful acquisition of a good quality angiogram or completion of the angioplasty procedure using our sheathless technique with BAT. Secondary outcome measures were access site complications defined as hematoma >5 cm and radial artery occlusion prior to hospital discharge confirmed by reverse Barbeau test.
4
Results
Three senior operators at our institution: MAM (30 cases); KR (14 cases); JN (16 cases); prospectively used sheathless radial artery access and BAT in 60 consecutive patients. All 60 sheathless cases were undertaken with 5Fr diagnostic or guide catheters. The clinical characteristics of all patients are shown in Table 1 . The majority of patients (76.7%) were male with an average age of 62.8 ± 11.4 years. Procedural details are shown in Table 2 . Just over half of cases were planned elective procedures (55%) with the remainder being performed for unstable angina and NSTEMI (41.7%) and STEMI (3.3%). The vast majority were performed via the right radial artery (95%). 45% of all those who underwent angiography also went on to have PCI. The majority of patients underwent diagnostic angiography using a Tiger catheter (79.3%) whilst the remaining was performed using Judkins right and left catheters. On average 1.5 ± 0.7 (range 1–3) catheters were used during each procedure. The radiation dose was 2459.9 ± 2142.8 with fluoroscopy times of 7.1+/−6.8 min. The average procedure time was 39.3 ± 24.9 min. The procedure was successfully performed via the radial artery using a sheathless technique with BAT in 93.3% of patients. There were 3 patients where the technique was unsuccessful. One patient developed profound radial artery spasm that did not respond to analgesia and intra-arterial nitrate and the catheter could not be advanced, so the procedure was completed via the femoral artery. In a second patient the operator had difficulty in advancing the wire following puncture of the right radial artery and chose to perform the procedure via a 5Fr sheath in the left radial artery. The third patient had a tortuous subclavian and attempts to manipulate/torque the catheter by the operator resulted in kinking of several guide catheters close to the point of insertion and the operator subsequently chose to insert a radial sheath to successfully complete the procedure. All patients had a patent radial artery following removal of the Helix device and there were no recorded access site complications. Whilst radial compression times were not formally assessed in the study, 6 patients had the Helix device removed within 30 min after the end of the procedure, with no bleeding complications.
| Number of patients | 60 |
| Age (mean ± SD) | 62.8 ± 11.4 years |
| Sex | Male 76.7% |
| Female 23.3% | |
| Ethnicity | Caucasian 98.3% |
| Asian 1.7% | |
| Coronary risk factors | Diabetes 8.3% |
| Hypertension 45.0% | |
| Hypercholesterolemia 23.3% | |
| Previous PCI | 16.7% |
| Previous CABG | 0% |
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