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"Virtual" 3 Fr Transradial Coronary Stenting With the 5 Fr Meito Masamune Sheathless Guiding Catheter: Feasibility and Safety in an Outpatient Setting
Abstract: Aim. To assess the safety and feasibility of “virtual 3 Fr” transradial percutaneous coronary intervention (TRA-PCI) in an outpatient setting. Methods and Results. A retrospective analysis of a single-operator log-book, for the first 2 months after its CE-mark approval, identified 11/52 patients (21%; 6/11 males; mean age, 64 ± 10 years) who had undergone: (1) an elective TRA-PCI; (2) in an outpatient setting; and (3) with the sheathless 5 Fr Meito-Masamune guiding catheter (Medikit Co, Ltd). Procedural success was 96% (25/26 lesions), mean procedural time and contrast usage were 26 ± 15 minutes and 94 ± 69 mL, respectively. Patent hemostasis was successful in 10/11 patients, all patients were discharged home within 6 hours, and no acute radial artery occlusion occurred. Conclusions. Virtual 3 Fr TRA-PCI in highly selected patients seems feasible and safe when performed in an outpatient setting.
J INVASIVE CARDIOL 2016;28(3):109-114. Epub 2015 December 15.
Key words: transradial, percutaneous coronary intervention, outpatient, slender, sheathless
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The transradial approach (TRA) has proven to be safe and effective in preventing bleeding complications, and to reduce adverse events after percutaneous coronary intervention (PCI).1 TRA also contributes to immediate mobilization and allows safe same-day discharge in a broad selection of patients.2
Postprocedural radial artery occlusion (RAO) occurs, unfortunately, in 5%-10% of patients.3 RAO is rarely symptomatic and never life threatening, but it hinders repeated intervention through the same radial artery. RAO usually starts as a fresh thrombotic occlusion, and will later evolve into a chronic fibrotic tissue. Radial artery/catheter mismatch, together with aggressive radial compression, are the strongest predictors of RAO.4-6 On the other hand, the occurrence of vascular complications, a major determinant for prolonged in-hospital stay after successful PCI, declines linearly with the caliber of the guiding catheter.7 At present, 6 Fr guiding catheters represent the standard for TRA-PCI.8 A conventional guiding catheter, however, requires the insertion of a compatible arterial sheath with an outer caliber that is 0.5-1.5 Fr bigger than the corresponding guiding catheter. Approximately 20%-40% of patients may have a radial artery with an inner diameter that is smaller than a conventional 6-Fr compatible sheath.9 The use of 5 Fr guiding catheters could help overcome this limitation, and their use in TRA has indeed proven to be safe and effective in selected patients undergoing PCI.10 Another viable option is to avoid the use of a sheath and insert the guiding catheter directly through the skin (the “sheathless” technique).11 The 6.5 Fr sheathless guiding catheters have also proven to be safe and effective for TRA-PCI.12
A unique 5 Fr sheathless guiding catheter has been recently developed in Japan; by combining a 5 Fr outer diameter with a sheathless technique, this guiding catheter has, in fact, the outer diameter of a 3-Fr compatible sheath (and has been therefore deemed “virtual 3 Fr” PCI).13 This device has proven to be feasible and safe in selected patients undergoing TRA-PCI.14 This guiding catheter received CE approval in late 2014. In the present study, we assessed its feasibility and safety in elective patients undergoing TRA-PCI at the Outpatient Department of Interventional Cardiology (the so-called “PCI lounge”) at Onze Lieve Vrouwe Gasthuis (OLVG) Amsterdam in The Netherlands.
Methods
Study design. This is a retrospective analysis of the first series of consecutive patients who underwent the virtual 3 Fr TRA-PCI procedure at OLVG Amsterdam.
Study patients. Procedural and in-hospital data were extracted from medical records using the following search criteria: (1) elective PCI procedures performed by the study investigator (GA); (2) PCI procedures performed in an outpatient setting; and (3) PCI procedures performed using the virtual 3 Fr technique. Standard exclusion criteria for a day-care treatment at OLVG Amsterdam are: acute coronary syndrome (ACS); non-ST elevation myocardial infarction or ST-elevation myocardial infarction; severely impaired left ventricular function (ejection fraction <30%); severe kidney failure (glomerular filtration rate <30 mL/min/1.73m2); or patient non-compliance. Patients with unstable angina without ACS may undergo a day-care treatment when fulfilling the other criteria.
Data were stored as part of routine diagnosis and treatment, and patients had given consent for the procedures. Patients were made fully anonymous for the purpose of this study.
Guiding catheter and sheathless technique. The 5 Fr Meito-Masamune guiding catheter (Medikit Co, Ltd) is a hydrophilic-coated guiding catheter, with an inner lumen of 0.059˝ (1.5 mm), provided with a long inner dilator that allows direct insertion of the catheter through the skin incision (“sheathless”). The catheter is available in various curves, and is supplied together with the puncture kit (Figure 1).
Standard exclusion criteria for the use of this catheter are: acute myocardial infarction; ad hoc PCI; chronic total occlusions; heavily calcified lesions; bifurcation lesions with planned treatment of the side branch; no radial artery pulsation (bilateral); or use of oral anticoagulation.
At OLVG Amsterdam, the pulsations of both the left and right radial arteries are assessed before the procedure. Right TRA, when feasible, is the preferred route. The Allen’s test is no longer routinely performed, because of the following reasons: (1) the extremely low incidence of ischemic complications in cases of RAO; and (2) the Allen’s test poorly correlates with the incidence of ischemic events.15
After subcutaneous injection of lidocaine (2 mL), radial artery puncture is performed with the 22 gauge needle with cannula (included in the puncture kit). The radial artery is transfixed, the needle removed, and the cannula retracted until good blood backflow is achieved. The 0.025˝, 45 cm-long wire, which is also supplied with the puncture kit, is then inserted into the cannula, the cannula is removed, and the 5 Fr, 15 cm-long dilator is inserted over the wire.
Through the dilator, heparin (100 IU/kg) and a cocktail of nitrates (0.2 mg) and verapamil (5 mg) is administered into the radial artery. A 0.025˝, 150 cm-long wire (not supplied with the puncture kit) is then inserted and the dilator removed.
The 5 Fr Meito-Masamune guiding catheter in the curve of choice is introduced onto the long wire and advanced up to the ascending aorta, where the inner dilator and the wire are removed before engaging the coronary ostia (Figure 2).
In cases of multivessel PCI of both the right and left coronaries, cannulation of both ostia is sought with the same catheter; during manipulation of the catheter, the inner dilator is reinserted (without extruding from the tip of the catheter) in order to confer extra support to the system.
Deep seating of the guiding catheter (onto the wire, the balloon, and/or the stent) can be sought in order to achieve extra support, such as when attempting direct stenting.
At OLVG Amsterdam, contrast injections are performed by means of the Acist CVi variable-flow contrast injector (Acist Medical Systems) with the following presets for 5 Fr catheters: pressure, 300 psi; flow, 2.0 mL/s; volume max, 6 mL; and delay, 0.5 s.
Procedural success was defined as a residual lesion after PCI (with or without stent placement) of <20%, a final TIMI-3 flow, no major dissection or side-branch occlusion, and no major clinical complications.
Radial artery compression and discharge. The 5 Fr Meito-Masamune guiding catheter is removed immediately at the end of the procedure, and hemostasis is achieved by means of an inflatable plastic bracelet, the TR Band (Terumo), inflated at 13 cc. Hand blood supply from the radial artery is assessed after 15-30 minutes of compression by means of a pulsoxymeter placed on the thumb, and during compression of the ulnar artery. In case of occlusive compression (no pulse/blood supply), the TR band is deflated in order to restore pulse/blood supply, and to achieve so-called “patent” hemostasis. In the absence of bleeding complications, the radial compression is removed after 2 hours.
PCI lounge and same-day discharge. Patients undergoing outpatient TRA-PCI at our institution are admitted at the PCI lounge, where patients are supervised by Nurse Specialists (AvD, PW, MvD) only, according to prevalidated protocols of care, and in an environment specifically designed for TRA-PCI post-care. Patients are neither monitored nor confined to bed, and are free to move around the different settings of the lounge, including lounge chairs, a television corner, and a reading/eating table. The PCI lounge is equipped with toilets, a kitchenette, and a nursing room for emergencies, treatments, and discharge interviews (Figure 3).
Before discharge (4-6 hours after removal of the guiding catheter), radial artery patency is assessed by means of the reverse Allen’s test, ie, by checking (either manually or by pulsoxymeter) pulse/blood supply to the thumb in the absence of any compression to the radial artery while applying pressure on the ulnar artery.
Patients without procedural and/or bleeding complications are discharged on the same day of the procedure, within 6 hours after completion of the PCI procedure and at least 2 hours after removal of the compression band.
Descriptive statistics. Data are reported as mean ± standard deviation for continuous variables, and as percentages for discrete variables.
Results
The study operator (GA) performed 52 elective procedures in the period under analysis (September-October 2014): 11 out of 52 patients (21%) were treated by means of the 5 Fr Meito-Masamune guiding catheter in an outpatient setting, 6 of the 11 patients were male, and mean age was 64 ± 10 years. In total, 26 lesions were treated. Patient and lesion characteristics and outcomes are provided in Table 1.
Procedural results. All procedures were successfully performed by the TRA approach (10 right, 1 left radial). The PCI procedure was successful in 25 out of 26 lesions (96%). Direct stenting was possible in 16 out of 26 lesions, and 7 out of 26 lesions required predilation before stenting. Balloon-only dilatation was performed in 2 out of 26 lesions; in both cases, this was due to inability to advance the stent (1 case because of coronary tortuosity and 1 case because of another protruding stent from the side-branch position). One lesion was not accessible for stenting or for balloon angioplasty because of extreme tortuosity, and was treated conservatively. The success of stent placement was, therefore, 23 out of 26 lesions (88%).
In 10 out of 11 patients, the procedure was successfully accomplished with a 5 Fr Meito-Masamune guiding catheter, and in 3 out of 10 patients the same guiding catheter was used for engaging both the left and right coronary artery (Multipurpose once, JL 3.5 twice) (Figure 4).
In 1 out of 11 patients, the 5 Fr Meito-Masamune guiding catheter (Amplatz left 1 curve) used to engage the right coronary artery kinked at the brachiocephalic level due to tortuosity. The procedure was further and uneventfully accomplished after inserting a 5-Fr compatible Radifocus sheath (Terumo), and exchanging for a conventional Heartrail 5 Fr, Judkins right 4 guiding catheter (Terumo).
Mean procedural time (from arterial puncture to catheter removal) and contrast usage were 26 ± 15 minutes and 94 ± 69 mL, respectively.
Postprocedural care, compression, and discharge. Patent hemostasis was achieved in 10 out of 11 patients; in these patients, the compression band could be removed after 2.5 ± 1 hours. In 1 out of 11 patients, multiple attempts to deflate the TR Band resulted in bleeding from the puncture site, and therefore occlusive hemostasis was maintained for 4 hours. The radial artery was patent in 11 out of 11 patients after compression removal.
The first 3 of the 11 patients experienced hematomas <2 cm at the puncture site; 1 of these patients also had a hematoma >2 cm at the elbow site. The problem was likely due to the difficulties in catheter advancement and manipulation onto the hydrophilic 0.025˝ Radifocus wire. In fact, this complication was no longer reported after a 0.025˝ PTFE fixed core wire (Boston Scientific) was adopted, without any bleeding complications in the following 8 patients.
All patients could be discharged home within 6 hours after the end of the procedure.
Discussion
This is the first virtual 3 Fr TRA-PCI series performed outside Japan with the 5 Fr Meito-Masamune guiding catheter. Furthermore, this is the first series worldwide conducted in an outpatient setting and with systematic patent hemostasis. The feasibility and safety of this approach were confirmed in our highly-selected series of patients.
Takeshita et al13 were the first to report on the feasibility of virtual 3 Fr TRA-PCI in Japanese patients. In their study, the need for downsizing was mainly driven by small wrist anatomy (common in East-Asian patients), in order to reduce radial-catheter mismatch. This study was the basis for the establishment of the Slender Club Japan, and later also the Slender Club Europe, both aimed at downsizing techniques and materials for TRA-PCI. Among so-called “slender” procedures, the use of 0.010˝ compatible balloons, stents-on-a-wire, 5-Fr compatible intravascular ultrasound, and optical coherence tomography techniques have proven to be both safe and feasible.16
While the same anatomical limitations will apply for Western patients from Asian descent, in most Caucasians, the anatomical need for downsizing and slender TRA-PCI is less urgent due to larger radial arteries.17 Nevertheless, slender techniques, such as virtual 3 Fr TRA-PCI, will also facilitate a successful patent hemostasis in “normal” wrist anatomy by minimizing the radial artery trauma and therefore contributing less to RAO14 and resulting in faster discharge.
In our study, patent hemostasis was indeed successful in 10 out of 11 patients, and none of the patients showed acute RAO after the procedure.
Oupatient TRA-PCI has proven to be safe and feasible in selected patient groups. At our department in Amsterdam, most of the elective patients undergo transradial PCI in an outpatient setting. Still, bleeding complications and/or unexpectedly longer compression times after the procedure can result in the need for overnight stay. Virtual 3 Fr technology minimizes the trauma both at the puncture site and en route to the coronary ostia, and therefore helps further reduce bleeding complications and shorten compression times, and thus favors shorter stays and same-day discharge. Indeed, all patients in our series could be discharged home on the same day of the procedure within 6 hours.
At present, the most important limitation of virtual 3 Fr technology is the unavailability of compatible devices (particularly in cases of acute or complex PCI). Currently, 5 Fr guiding catheters, and therefore also the virtual 3 Fr guiding catheters, are compatible with all commercially-available drug-eluting stents, electronic intravascular ultrasound catheters, single-layer covered stents, bioabsorbable scaffolds up to 3.0, and all kinds of buddy wires, while thromboaspiration catheters, self-expandable stents, mesh-covered stents, bifurcation stents, optical coherence tomography catheters, and kissing-balloon techniques are not 5 Fr compatible. The lack of support in case of challenging coronary anatomy is also a potential limitation.
Both of these issues explain the high selection bias found in our study (21% of otherwise suitable patients), as well as the failure of stent implantation in 3 out of 26 lesions. However, overall procedural success (25 out of 26 lesions; 96%) and procedural performance in terms of procedural times and x-ray exposure seemed unaffected by the virtual 3 Fr strategy, given the careful patient selection beforehand. Indeed, the use of smaller catheters can be advantageous when navigating through complex upper-limb anatomy, such as arterial loops or high take-off of the radial artery,18 and in reducing the amount of contrast medium, at no cost to angiographic quality, particularly when a variable-flow injector is used.19 Schobel et al20 have proven that more than one-half of contemporary PCIs can, in fact, be accomplished by means of 5 Fr guiding catheters; further downsizing of devices such as balloons, stents, and thromboaspiration catheters will likely help increase the penetration of 5 Fr TRA-PCI. Given the limitations of the virtual 3 Fr guiding catheter in terms of device compatibility and support, it is probably not advisable to systematically attempt ad hoc PCI with this device. However, virtual 3 Fr ad hoc PCI may be attempted in selected patients who have undergone a diagnostic catheterization with 4 Fr angiographic catheters.
The favorable procedural and post-care results shown in this series can be partly explained both by the experience of the study operator with TRA, 5 Fr guiding catheters, and sheathless procedures, and by the expertise of the personnel at our PCI lounge, The question can be raised whether these results are reproducible by other operators and in other settings. On one hand, many studies21 have proven that all TRA techniques can be safely and successfully undertaken by most operators, given the necessary learning curve and when pursued routinely; on the other hand, we feel that outpatient TRA-PCI can be safely performed only with trained nurse personnel, under detailed preprocedural and postprocedural protocols, and in an adequate hospital setting.
Conclusion
Novel techniques like virtual 3 Fr PCI, combined with the preservation of established best practices such as transradial approach, promise significant patient-centered improvements in interventional techniques.
Indeed, when performed by an experienced operator, and with the back-up of dedicated personnel, outpatient virtual 3 Fr TRA-PCI is a feasible and safe option in highly-selected patients. Virtual 3 Fr TRA-PCI may facilitate patent hemostasis, and therefore help reduce access-site complications, in particular RAO, as well as compression times.
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From the Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Amoroso reports speaker fees from Medikit. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript submitted May 21, 2015 and accepted July 23, 2015.
Address for correspondence: Dr Giovanni Amoroso, Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Oosterpark 9, 1091 AC Amsterdam, The Netherlands. Email: g.amoroso@olvg.nl
