Vascular Complications of Percutaneous Coronary Intervention Via Distal Radial Artery Approach in Patients With Acute Myocardial Infarction With and Without ST-Segment Elevation

Abstract

Objectives. Distal radial artery (DRA) access is a novel alternative to conventional radial artery access for coronary catheterization. This study investigated the incidence of vascular complications with percutaneous coronary intervention (PCI) from DRA access among patients with acute myocardial infarction (AMI) with and without ST-segment elevation. Methods. Between April 2018 and October 2019, a total of 131 consecutive patients underwent primary PCI for AMI, among whom DRA access was used in 116 (88.5%), comprising 77 with ST-segment elevation myocardial infarction (STEMI) and 39 with non-ST–segment elevation myocardial infarction. The mean patient age was 70.4 ± 12.9 years and 71.6% were male. Right DRA was used in 110 patients (94.8%). A 5 or 6 Fr sheath was used in the PCI procedure. Patient backgrounds, procedural characteristics, and procedural complications were retrospectively analyzed. Patency of the radial artery was examined using Doppler ultrasound. Results. Minor bleeding (Bleeding Academic Research Consortium [BARC] 2) was observed in 2 patients (1.7%) while no major bleedings (BARC 3a, 3b, 3c, and 5) were observed. On the Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) hematoma scale, a grade III hematoma (≥10 cm) was observed in 1 patient (0.9%), and no patients with hematoma were > grade IV. Doppler ultrasound of the radial artery was performed on 95 patients (81.9%). The incidence of radial artery occlusion was 1.1% (n = 1). The door-to-balloon time for STEMI patients was 40.0 ± 30.8 minutes. Conclusions. The current study demonstrated that DRA access was associated with a low incidence of access-site complications within optimal revascularization time among patients with AMI who underwent PCI.

J INVASIVE CARDIOL 2022;34(4):E259-E265. Epub 2022 February 18.

Key words: distal radial artery, radial artery occlusion, vascular complication

The radial approach for percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) has demonstrated advantages over the femoral approach. These advantages include a lower incidence of bleeding complications, reduced mortality, increased comfort, and early ambulation of the patients.¹ Accordingly, the latest European Society of Cardiology/European Association for Cardiothoracic Surgery guidelines recommended using the radial artery as the standard puncture site for primary PCI.²

Recently, the distal radial artery (DRA) puncture site was introduced as an alternative to the conventional radial artery site that uses the distal lateral radial access, also known as snuffbox access. The advantage of this approach was that, at least initially, it was considered to preserve the forearm radial artery for future use. However, several recent reports have suggested that this access site displays a lower incidence of radial artery occlusion (RAO). Furthermore, bleeding complications occurred less frequently using this approach when compared with conventional radial artery punctures.^3,4 These results suggest that DRA access, when applied to patients with AMI, may further reduce access-site complications compared with the conventional radial approach. Apart from the positive aspects of DRA access, the possible disadvantages are also to be clarified, particularly regarding the procedure time, which is crucial for the treatment of ST-segment elevation myocardial infarction (STEMI).

In the current study, we sought to investigate the impact of the DRA approach on access-site complications after PCI for patients with AMI.

Methods

Study design and population. This was a single-center, retrospective study of 131 consecutive patients who underwent primary PCI between April 2018 and October 2019. Of those, 9 patients presenting with no pulsation in the snuffbox at the time of puncture were treated with the ipsilateral forearm radial artery, and 2 patients receiving hemodialysis were treated at the femoral puncture site. For the remaining 120 patients, DRA access was attempted. Among those patients, we analyzed 116 patients (96.7%) for whom the sheath introducer was successfully inserted. Four failed cases that demonstrated occlusion at the forearm radial artery due to previous catheterization with the conventional radial approach were converted to a transfemoral approach (n = 2) or transbrachial approach (n = 2). All data were retrospectively collected from the emergency medical system and hospital records, including the catheter laboratory database.

Hemorrhagic complication and RAO after primary PCI were evaluated. The RAO after PCI was examined using Doppler ultrasound during a remote follow-up outpatient period. Patients’ baseline characteristics and procedural indices, including door-to-balloon time, 30-day mortality rate, peak creatinine phosphokinase (CPK) value, and use of hemodynamic support devices were evaluated.

Distal radial approach. After skin anesthesia with lidocaine, the DRA was punctured in the anatomical snuffbox with a 20-gauge Surflo IV catheter (Terumo). Puncture was performed with either digital palpation or sonographic guide at the operator’s discretion; when puncture with digital palpation failed, an ultrasound-guided puncture was carried out. Furthermore, for patients with cardiogenic shock or cardiac arrest, sonographic guide with a high-frequency linear transducer with a short footprint (10 mm) was used for the initial attempt. A Logiq E ultrasound scanner (GE Healthcare) with an L10-22-RS linear probe (22 MHz) was used for this purpose. Furthermore, in the cases where backflow of blood was not observed after sonography-guided penetration of the needle to the artery wall, suction or negative pressure was applied by pulling back on the plunger of the syringe that was connected to the puncture needle to prove the puncture success. After successful puncture, a dedicated 0.025˝ mini-guidewire was inserted up to the brachial artery, and the sheath introducer (5-Fr Glidesheath Slender, 6-Fr Glidesheath Slender, or conventional 6-Fr Radifocus sheath introducer; Terumo) was advanced into the radial artery over the guidewire. The right distal radial artery was the primary puncture site in the current study.

Hemostasis and hemorrhagic complication. After the primary PCI procedure was completed, a Stepty hemostatic pad (Nichiban), developed for stopping the flow of blood using pressure immobilization with a 6-mm thick pad at the central portion, was applied at the puncture site before sheath removal. The operators pressed the pad lightly with their thumb and removed the catheter, then wrapped an elastic bandage around the hand. The compression site was checked by nurses after 3 hours for hemostasis. If the routine check-up revealed no bleeding or hematoma, the compression bandage was released. In cases for which bleeding at the puncture site or swelling with hematoma was detected, additional compression and an elastic bandage were applied until hemostasis was achieved. Bleeding complication was evaluated using Bleeding Academic Research Consortium (BARC) and Thrombolysis in Myocardial Infarction (TIMI) definitions, and local extension of subcutaneous hemorrhage and hematoma was classified according to the Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) hematoma scale.⁵ Hematoma limited to the dorsum of the hand, which was specifically observed after DRA access, was defined as a modified EASY classification of “grade 0.”

Evaluation of RAO. The patency of both forearms and distal radial artery was assessed for 94 patients in a follow-up outpatient period (283 ± 183 days after the primary PCI procedure) using Doppler ultrasound.

Ethical considerations. This study was performed in accordance with the Declaration of Helsinki principles, and ethical approval was obtained from the institutional review board of the authors’ hospital.

Statistical analyses. Categorical variables are expressed as numbers and percentages, and continuous variables are expressed as mean ± standard deviation. After testing for normal distributions, differences were compared using the unpaired Student’s t test or the Mann–Whitney U test, as appropriate. All statistical analyses were performed using EZR (Saitama Medical Center, Jichi Medical University; http://www.jichi.ac.jp/saitama-sct/SaitamaHP.files/statmedEN.html), which is a graphical user interface for R (The R Foundation for Statistical Computing, version 2.13.0). More precisely, it is a modified version of R commander (version 1.6-3) that was designed to add statistical functions frequently used in biostatistics.⁶P-values <.05 were considered significant.

Results

Patient characteristics. The mean age of patients was 70.4 ± 12.9 years and 71.6% were male. The mean height was 162.8 ± 8.8 cm and mean weight was 63.9 ± 13.5 kg. Eight patients (6.9%) had a history of previous myocardial infarction, and the radial artery was previously punctured using the conventional radial approach (at just proximal to the styloid process of the radius) in 11 patients (9.5%). Seven patients (6.0%) presented with cardiogenic shock and 11 patients (9.5%) with cardiac arrest on arrival at the hospital (Table 1).

Procedural characteristics. Right DRA access was performed for 110 patients (94.8%). The puncture site was converted to the left side of the DRA in 2 patients (1.7%) because of multiple unsuccessful punctures on the right side. An ultrasound-guided puncture was performed in 68.1% of patients. Overall puncture success was achieved in 116 of the 120 patients (96.7%). The target activated clotting time (ACT) was 300 seconds or longer during the PCI procedure. A total of 11,983 ± 3238 units of unfractionated heparin were administered during the PCI procedure. The size of the sheath introducer was a conventional 6-Fr, 6-Fr slender sheath, or 5-Fr slender sheath in 63 (54.3%), 50 (43.1%), and 3 patients (2.6%), respectively. Hemodynamic support was provided for patients with hemodynamic instability; intra-aortic balloon pump (IABP) was used in 21 patients (18.1%), and extracorporeal membrane oxygenation (ECMO) was used in 9 patients (7.8%) (Table 2). The mean door to balloon time and 30-day mortality rate in STEMI patients were 40.0 ± 30.8 minutes and 2.6%, respectively (Table 3).

Antithrombotic regimen after the primary PCI was single-antiplatelet therapy (SAPT), dual-antiplatelet therapy (DAPT), SAPT + oral anticoagulant (OAC), or DAPT + OAC in 1 patient (0.9%), 109 patients (94.0%), 2 patients (1.7%), and 4 patients (3.4%), respectively. As for P2Y₁₂ inhibitor, prasugrel (loading dose of 20 mg and maintenance dose of 2.5-3.75 mg/day) was prescribed for 111 patients, while clopidogrel (loading dose of 300 mg and maintenance dose of 75 mg) was prescribed for 3 patients.

RAO. When evaluating for RAO in the remote period, 21 patients were excluded because 10 patients were deceased, 7 patients were followed by their own physician, 2 patients were transferred to another hospital for other comorbidities, and 3 patients did not show up for follow-up appointments. For the remaining 95 patients, sonographic evaluation was conducted and both distal and forearm radial arteries were patent in 94 patients. The remaining patient displayed occlusion of the distal and forearm radial arteries (Table 4 and Table 5).

Hemostatic time and complications. The mean time to complete hemostasis was 5.0 ± 4.1 hours. Minor bleeding (BARC type 2) was observed in 2 patients (1.7%) and there were no cases of major bleeding (BARC type 3a, 3b, 3c, and 5). According to the TIMI bleeding classification, minor bleeding was observed in 2 patients (1.7%) and no major bleeding was observed. According to the EASY hematoma scale, grade III subcutaneous hemorrhage (≥10 cm) was observed in 1 patient (0.9%), and no patients had hematomas > grade IV (extending above the elbow or compartment syndrome). Hematoma of grade I and II (<10 cm) was observed in 14 patients (12.1%) and 9 patients (7.8%), respectively, and hematoma limited to the dorsum of the hand (modified EASY classification grade 0) was detected in 9 patients (7.8%). Among the 21 patients who required mechanical hemodynamic support with IABP and/or ECMO, femoral access complications were observed in 3 patients, ie, continuous blood oozing from the side of the ECMO arterial cannula in 2 patients who required suturing around the puncture site, and access-site hematoma after retrieval of ECMO arterial cannula in 1 patient (Table 3).

Discussion

The current study demonstrated the following for AMI patients who were treated with DRA access: (1) minor bleeding (BARC type 2) was observed in 2 patients (1.7%), and major bleeding (BARC type 3a, 3b, 3c) was not observed; (2) grade III subcutaneous hemorrhage according to the EASY bleeding classification was observed in 1 patient (0.9%) and no patients had hematomas > grade IV; (3) the mean door to balloon time was 40.0 ± 30.8 minutes and 30-day mortality rate was 2.6% in STEMI patients; and (4) DRA access was successfully performed in 88.5% of the entire AMI cohort during the study period. Puncture success rate, when attempted for the DRA, was 96.7%.

Since the introduction of DRA access, its use for AMI patients was one of its major points of interest and a possible goal for coronary interventionalists; several initial reports indicated that DRA access was likely to be less invasive compared with conventional radial artery access. However, its use for primary PCI seemed problematic for several reasons. First, DRA access in an emergency clinical setting is technically far more challenging and requires an additional learning curve when compared with its use for elective cases due to the relatively small-sized artery. We initiated primary use of the DRA approach for coronary angiography (CAG) and PCI in November 2017, and 1928 cases were completed by the end of November 2019. In April 2018, after gaining experience with more than 270 cases utilizing DRA access, we began its routine use for emergency cases. In the current series of cases, puncture success rate was 96.7%, which also included the cases that required access-site conversion from right to left distal radial artery. This success rate was similar to the success rate in recent reports on conventional radial approach among STEMI patients,^7-9 where the crossover rate for radial to femoral access ranged from 3.7%-9.4%. Therefore, we consider DRA access equally feasible for primary PCI as compared with conventional radial artery access.

Although RAO has similar issues when compared with the conventional radial approach, with DRA, the smaller vessel size has been considered disadvantageous. In the case of conventional radial access, the incidence of RAO ranged from 1%-10%.¹⁰ This wide range of RAO is attributed to various factors, including heparin dose, sheath size, usage of vasodilators, and hemostatic condition. Furthermore, recent studies have suggested that damage in the arterial wall and subsequent changes including medial dissection, intimal tear, and thrombus formation have been predominantly observed at the puncture site;^11,12 this may contribute to the subsequent retrograde thrombus formation and total occlusion of the radial artery. From this point of view, an occlusion at the DRA still maintains antegrade flow from the proximal branch to the superficial palmar arch, which reduces the risk of retrograde thrombus formation in the forearm radial artery. Accordingly, the DRA approach potentially maintains the integrity of the forearm radial artery and preserves the forearm radial artery for a future attempt. In fact, Kaledin et al reported no incidence of RAO among 656 patients in the forearm radial artery, and an incidence rate of 1.5% in the puncture site of the DRA;¹³ the same holds true for multiple recent studies.^3,4 Our previous study indicated that among the Japanese population, the incidence of RAO in the forearm radial artery was observed in 0.4% of patients. In the current study, which evaluated RAO in an emergency setting, RAO was observed in 1 of 95 patients (1.1%). Thus, although the sonographic follow-up rate could not meet high standards in the current study, distal radial puncture is considered to preserve the forearm radial artery together with DRA.

In the conventional transradial approach, the substantial reduction of major bleeding related to the access site has previously been confirmed.¹⁴ For the local extension of hematoma, the EASY trial, which used radial access and heparin + abciximab in all comers, reported that the incidence of hematoma <5 cm (grade 1) was 5.3%, <10 cm (grade II) was 2.5%, distal to the elbow (grade III) was 1.6%, and proximal to the elbow (grade IV) was 0.1%, with an incidence of TIMI major bleeding in 1.4%.¹⁵ Furthermore, recent research evaluating hematoma formation after conventional radial approach indicated that the incidence of hematoma grade I, grade II, grade III, and grade IV was 4.2 %, 1.7%, 3.5%, and 0.8%, respectively.¹⁶ In the current study, TIMI major bleeding was not observed. According to the EASY hematoma scale, grade III subcutaneous hemorrhage (≥10 cm) was observed in 1 patient (0.9%) and no patient had a hematoma > grade IV. Thus, the bleeding complication was less likely to occur in DRA access when compared with the conventional radial approach.

One possible drawback of DRA access was the time taken to complete revascularization, since there was technical difficulty associated with puncturing the artery, advancing the guidewire, and guiding catheters in a rather complicated anatomical configuration. The door to balloon time for STEMI patients in the current study was 40.0 ± 30.8 minutes. During the period when we used the conventional radial approach (January 2016 to December 2017; n = 103), the door to balloon time was 42.6 ± 31.8 minutes (P=.52) (Table 6). Although a direct comparison with a historical control is problematic, door to balloon time per se in the current study was considered acceptable according to the guidelines for STEMI,¹⁷ and we could not find any reason to stop the use of DRA for primary PCI.

Study limitations. There are several limitations to the current study. First, it is a single-center, retrospective study, which implies that the results of the study may be biased by the operators’ and institutional expertise. Second, because of the nature of a single-arm study, we were unable to distinguish differences between the conventional radial approach and the DRA in primary PCI. Third, RAO and hemorrhagic complications are known to be affected by the protocol and devices used for hemostasis. Therefore, the findings in this study are not necessarily applicable to every hospital conducting PCI. Furthermore, a large-scale, randomized study is needed to evaluate the possible advantages of the DRA approach over the conventional approach in primary PCI.

Conclusion

PCI using DRA is safe and applicable to patients with AMI. It also offers a viable alternative to the use of conventional radial access. The advent of DRA access may provide further reduction in access-site complications; in particular, hematoma formation in the forearm with a low RAO rate in both the forearm and the anatomical snuffbox.

Affiliations and Disclosures

From the Cardiovascular Department, Sakurakai Takahashi Hospital, Hyogo, Japan.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript accepted March 28, 2021.

Address for correspondence: Akihiko Takahashi, MD, Cardiovascular Department, Sakurakai Takahashi Hospital, 5-18-1 Oikecho, Suma-ku, Kobe, Hyogo 654-0026, Japan. Email: a-takahashi@wine.ocn.ne.jp

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