Technical Success and Long-Term Experience of a Novel Radial Guide-Catheter Shape: The JCLRAD

Objectives. Percutaneous coronary intervention (PCI) via the transradial route has been widely adopted over the transfemoral route, but guide catheter selection remains limited. We present our experience with a novel guide catheter design, the Judkin’s Curve Left- Radial (JCLRAD, Medtronic), which is optimized for transradial PCI to the left coronary system.

Methods. Sequential patients who underwent PCI using the JCLRAD catheter over a 3-year period (October 1, 2017 to November 1, 2020) were included in the analysis. Prospectively collected data were extracted from the institutional NCDR CathPCI registry with supplemental medical record review to collect clinical and procedural data.

Results. PCI was performed in 2347 patients and 4070 lesions using the JCLRAD guide catheter. The mean age was 65.5 ± 11.7 years, and 72.1% of the population were male; 52.5% of patients presented with acute coronary syndrome. The lesion complexity was high (66.7% Class B2/C by ACCAHA classification) with a 7% use of atherectomy. Procedural success was 99.6% with no identified cases of iatrogenic catheter-induced coronary dissection.

Conclusions. In this single-center retrospective study, the use of the JCLRAD was associated with a high success rate and low rates of complications, including no guide catheter-induced dissection in a cohort of patients with complex coronary anatomy. This is the first-reported large clinical experience with this novel radial left coronary system guide catheter.

The use of transradial (TR) access for percutaneous coronary interventions (PCI) in the United States has continued to grow over the past decade. This is mainly due to evidence supporting reduced recovery time, better quality of life, and better outcomes, especially in patients with acute coronary syndrome (ACS).^1-5 In light of this evidence, the American Heart Association has recommended a “radial -first” strategy for patients with ACS.⁶ Initially, TR access was limited to the utilization of guide catheters that were developed for use through femoral access. However, navigating through the right innominate artery and angulation with the ascending aorta is frequently an obstacle faced by radial operators. In many cases, due to the curvature, guide support for left main engagement is compromised. It is recommended to downsize the Judkins’ curve catheters by 0.5 when using the right radial artery.⁷

Longer-tip catheters have been recommended and evaluated in the past.⁸ However, utilizing the same catheters that are used for femoral access interventions may potentially increase the risk of complications and stent loss.^9,10 To avoid this risk, prior attempts at developing catheters for TR interventions have been performed and analyzed.^11-13 These catheters improved the success rates of the engagement of the left coronary artery, but back-up support remained an issue.¹⁴ With the increase of intervention complexity, including an increase in the prevalence of calcified vessels, back-up support is of paramount importance, as is co-axial alignment, ease of coronary intubation, and safety profile.

The development of novel guide catheter shapes is technically difficult and there are few studies addressing the relevant mechanics. Experimental studies using in vitro coronary artery tree models are hampered by limited anatomical samples and poor reproducibility, while the complex geometry of guide catheters and variability in aortic root anatomy and coronary ostial location complicates the performance of computer modelling development. Due to these factors, the understanding and improvement of guide catheter mechanics relies on clinical and angiographic data as well as the expertise of interventional cardiologists. To this end, one of the authors (K.B.) collaborated with a large medical equipment manufacturer (Medtronic) to develop a novel TR guide catheter shape for left coronary system PCI: the Judkin’s Curve Left- Radial (JCLRAD). The catheter has been approved, manufactured, and in clinical use since August 2010, predominantly at our cardiac catheterization laboratory. The JCLRAD catheter shares manufacturing features with the rest of the Launcher family of guide catheters and is available in 2 French (Fr) sizes (5 Fr and 6 Fr) and 3 size curve sizes (3.5, 4.0, 4.5). The aim of this study is to present our long-term experience in performing PCI using this novel TR guide catheter.

Study sample and settings. We retrospectively identified patients who underwent PCI at the UMass Memorial Medical Center Cardiac Catheterization Laboratory between October 1, 2017, and November 1, 2020, using the novel JCLRAD guide catheter. Consecutive patients (n = 2347) who underwent PCI were identified from the local National Cardiovascular Data Registry (NCDR)–CathPCI registry. Patients with both stable coronary artery disease (CAD) and acute coronary syndromes were included in the study. The study was approved by the UMass Chan Medical School Institutional Review Board, and informed consent was waived due to the retrospective and anonymized nature of the study. 

Data collection. Guide catheter utilization during the PCI procedure was obtained by cross-referencing the CathPCI data with the Cardiac Catheterization Laboratory Structured Reporting system (Cupid, Epic Systems Corp). Additional targeted retrospective medical record review and data collection from the electronic medical record were performed for clarifications/omissions. Specific endpoints were the success of the procedure (defined as PCI with no complications), length of stay, procedural time, radiation exposure, and periprocedural complications.

Transradial access catheterization. TR access was obtained using the modified Seldinger technique with ultrasound guidance as needed following administration of local anesthesia, according to standard clinical protocols. A 6-Fr, 25-cm hydrophilic sheath was used in all radial cases. A 6-Fr sheath was used for transfemoral cases.

Statistical analysis. Baseline characteristics and results are expressed in proportions of mean ± standard deviation for continuous variables, while categorical data are presented as percentages.

Clinical and procedural data for these patients, including demographics, cardiovascular risk factors, target vessel, lesion characteristics, type of stent, procedural success, and complications, were expressed as frequency and percentages. Each epicardial lesion was classified as Type A, B1, B2, or C according to the definitions by the American College of Cardiology/American Heart Association. The success of the procedure was defined as the achievement of a stenosis with a diameter of less than 20%, with a Thrombolysis in Myocardial Infarction (TIMI) Score of 3 flow in the target vessel.

The novel JCLRAD guide catheter was used in 2347 patients during the study inclusion period, and PCI was performed on 4070 lesions. The mean age was 65.5 ± 11.7 years, and 72.1% of the population were male. One thousand one hundred-fifteen patients (47.5%) presented with stable CAD, while the remainder had an ACS presentation. Study population demographics are shown in Table 1 and lesion data in Table 2. Most cases were performed via radial access (91.5%); the catheter was also used via the femoral approach in the remaining cases (procedural characteristics in Table 3).

The target vessel was the left anterior descending artery (LAD) or its diagonal branches in 56.5%, the left circumflex artery or its branches in 37.1%, the ramus intermedius in 2.3%, and the left main stem in 4.1% of the cases. Chronic total occlusions were treated in 4.2% of the cases.  Lesion complexity was high with most of the lesions (66.7%) classified as Class B2 or C according to the ACC/AHA classification. Atherectomy was performed for severe calcific stenoses in 7% of the cases. Guide catheter extensions were used in 11.9% of PCIs and there was a 99.4% success rate for stent implantation.

Adverse events. Coronary artery perforation occurred in 0.4% of the cases and iatrogenic coronary artery dissection in 1% of the cases. All cases of dissection were related to distal wire or angioplasty with no proximal or ostial iatrogenic catheter-induced dissections.

To our knowledge, this is the first report of a large clinical experience using the novel radial shape guide catheter JCLRAD. In this series, we reported a high success rate and low rates of complications, including no guide catheter-induced dissection, in a cohort of patients with complex coronary anatomy.

Guide catheter selection undoubtedly constitutes the bedrock of a successful PCI, second only to patient selection. Guide catheters provide the required backup support for the introduction of coronary equipment along with coaxial vessel engagement to minimize the risk of proximal vessel trauma. There can be significant differences in the performance of different guide catheters when used from the TR rather than the transfemoral approach. A prior study of the Judkins L catheter, for example, demonstrated that the catheter loses its passive support backup force by approximation to the opposing wall of the aorta when applied in TR interventions.⁷ This has led physicians and medical device manufacturers to modify catheters to improve their TR performance, such as the modification of the Judkins L catheter for TR, and to the development of the Ikari L catheter, which provides improved angulation for backup support by using the opposing wall of the aorta.¹⁵

Passive support catheters provide extra backup (eg, XB or EBU) from the contralateral aortic wall or aortic valve. These are long-tip catheters, engagement of which is more difficult and deep insertion is often inevitable, particularly when withdrawing interventional equipment from the coronary tree. Poor alignment of the catheter with the left main stem (LMS) increases the risk of proximal vessel injury, particularly in cases with significant proximal disease. The JCLRAD presents a modification of the extra-backup JCL catheter with an additional alignment angle near the catheter tip and added shaft curvature proximal to the secondary curve to improve TR performance (Figure 1). The catheter can be engaged directly to the left main in a conventional superior approach and when using a caudal sinus of Valsalva approach (Figure 2).

In the latter method, the tip of the catheter is placed in the left coronary cusp below the LMS. Following removal of the guidewire and catheter flushing, the catheter may be advanced further into the aortic root. This leads to cephalad displacement of the catheter tip, allowing controlled engagement of the LMS. The catheter can then be withdrawn to optimize coaxial engagement (Video 1).  In this catheter position, support is provided by the contralateral aortic wall and is sufficient for most coronary interventions. The catheter remains stable without deep engagement and, as devices are advanced down the coronaries, any resistive force is transmitted along with axis of the catheter to the supporting contralateral wall, providing stable support. Examples of difficult anatomies wherein this is very helpful is when the LM rises almost vertically to the aortic root or when the dual ostia/short left main is encountered (Video 2). Atherectomy and intracoronary imaging devices do not have an issue navigating the curve of the JCLRAD.

An additional benefit of the short tip and angulation of this catheter is that it keeps the tip from abutting the roof of the left main, a common cause of dissection as observed with EBU catheters. This benefit is especially helpful for left circumflex interventions in which EBU or XB catheters point toward the LAD and JCLRAD can non-traumatically and preferentially intubate the left circumflex coaxially by rotating counterclockwise while withdrawing (Video 3).

In extremely complex lesions where significant additional backup may be required, the JCLRAD may be advanced to a “power position” by further advancement into the aortic root (Video 4). This brings the catheter’s secondary curve in the coronary cusp, allowing for additional support against the aortic valve. In patients with an enlarged aortic root, the use of a guide catheter extension such as a GuideLiner (Teleflex) or Telescope (Medtronic) may be necessary to extend the tip of the guide to the LMS ostium, thereby providing a hybrid system with a high level of backup and proximal vessel safety without the need for deep guide catheter active engagement. When additional support is no longer required, the catheter may be withdrawn to the standard operating position to reduce the risk of acute aortic valve regurgitation.

The JCLRAD is a novel guide catheter design based on a modification of the extra-backup JCL guide. In this series of 2347 cases, we identified no instances of proximal vessel guide-catheter dissection and high success rates in complex lesions, suggesting that the catheter is easy to use, supportive, and safe. The JCLRAD catheter provides backup similar to that of long-tipped catheters, demonstrates a very low risk of proximal vessel dissection, and allows the operator a choice of power positions depending on the PCI complexity.

Waqas Qureshi, MD, MS^1,2; Summer Aldrugh, MD¹; Jeffrey Rade, MD¹; Craig Smith, MD¹; Alvaro Alonso, MD, MSc¹; Youssef Rahban, MD¹; Kurt G Barringhaus, MD³; Nikolaos Kakouros, MBBS, MD(Res), PhD¹

From the ¹University of Massachusetts Medical School, Department of Cardiovascular Medicine, Worcester, Massachusetts, USA; ²Houston Methodist Baytown, Baytown, Texas, USA; ³University of South Carolina School of Medicine, South Carolina, USA.

Disclosures: Dr. Qureshi has received grant funding from CSI Inc. Dr. Kakouros has served as a clinical proctor for Edwards Life Sciences. The remaining authors report no financial relationships or conflicts of interest regarding the content herein.

Address for correspondence: Nikolaos Kakouros, MBBS, PhD, MD(Res), FRCP, FACC, FSCAI, Division of Cardiovascular Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655, USA. Email: Nikolaos.Kakouros@UMassMed.edu