Simultaneous Triple-Balloon Inflation Technique within a 6 Fr Guiding Catheter for a Trifurcation Lesion

Percutaneous coronary intervention of bifurcation lesions is associated with lower procedural success rates and an increased incidence of subsequent major adverse cardiac events and restenosis.^1,2 Several reasons may be offered. The implantation of a stent in a main branch may cause severe stenosis or even occlusion at the ostium of the side branch. On the other hand, if the struts of a stent are opened toward the side branch, this may result in subsequent stent deformation at the main branch.³ To protect the side branch, a two-stent strategies such as crush stenting, Y-stenting or T-stenting were proposed. However, these complex strategies did not improve the outcome for bifurcation lesions.^4–6 In order to secure the ostial lumen dimension of both branches, final simultaneous kissing-balloon inflation is preferable according to the current consensus. In actual clinical settings, we occasionally encountered trifurcation lesions, especially around the left main coronary artery (LMCA) According to the SYNergy between PCI with TAXUS and cardiac surgery (SYNTAX) score, which indicates the complexity of coronary artery disease, trifurcation lesions have a higher score than bifurcation lesions, thus they are presumed difficult to treat.⁷ A few challenging case reports included a simultaneous triple-balloon inflation technique (the so-called “ménage à trois”).^8–10 One of potential limitations of simultaneous triple-balloon inflation is the requirement of a larger guiding catheter that can accommodate three guidewires and balloons. Recently, several types of 0.010 inch guidewires and 0.010 inch guidewire-compatible balloon catheters that potentially allow for downsizing the catheter systems have become available in Japanese centers.
Here we report two cases of trifurcation lesions that were successfully treated via simultaneous triple-balloon inflation using a 6 Fr guiding catheter with these “slender devices” via a transradial approach.

Procedural materials and methods. In this study, we selected a small-sized device, the Ikazuchi-X balloon catheter, which is compatible with a 0.010 inch guidewire and consists of a rapid-exchange balloon catheter component.¹¹ Every part in this system is smaller than that of conventional 0.014 inch-compatible products. The maximum outer diameter of this balloon is 2.1 Fr compared with 2.4 Fr in the smallest 0.014 inch-compatible balloon catheters. Consequently, it is possible to insert 3 balloons and 3 wires together within the 6 Fr-sized guiding catheter, and 2 balloons and 2 wires together within the 5 Fr-sized guiding catheter (Figure 1). For our two cases, we used the following three types of 0.010 inch guidewires: the Athlete slender 01, the Athlete eel slender (both from Japan Life Line Inc., Tokyo, Japan), and the Asahi Decillion FL (Asahi Intec Co., Ltd., Nagoya, Japan).
Additionally, intravascular ultrasound (IVUS) was performed to evaluate the geometry and magnitude of the resultant stent expansion. After the final simultaneous balloon inflation, IVUS images were acquired throughout the stented segment using a 40 MHz mechanical transducer catheter (Boston Scientific Corp., Natick, Massachusetts) with motorized pullback operating at the speed of 0.5 mm/second. Detailed three-dimensional IVUS assessments were performed to investigate actual stent expansion using commercially available software (EchoPlaque2, Indec Systems, Mountain View, California). After digitization of IVUS recordings at a frame rate of 30 images per second, stent contours were manually traced at 16-frame intervals, and interpolated measurements of the remaining frames were automatically generated, providing stent area for the entire stent length. Stent symmetry was calculated as minimum stent diameter divided by maximum stent diameter on a frame-by-frame basis.

Case Reports

Case 1. A 68-year-old male was admitted to our hospital because of progressive precordial pain (Canadian Cardiovascular Society [CCS] class III–IV) lasting for 7 days. His coronary risk factors included hypertension and hypercholesterolemia. The electrocardiogram showed marked ST-segment depression in leads V2–V6, with prolonged chest pain. Coronary angiography revealed 90% diameter stenosis in the proximal left anterior descending artery (LAD) and 75% diameter stenosis in the ostium of the diagonal branch. A non-stenotic left circumflex artery (LCx) was located very close to the lesion (Figures 2 A and B). His left ventricular ejection fraction was normal. Although we strongly recommended coronary bypass surgery, the patient refused and requested interventional treatment instead. We therefore performed elective percutaneous coronary intervention in the following manner. A 6 Fr sheath introducer (Terumo, Tokyo, Japan) was inserted into the right radial artery and a 6 Fr Heartrail-II Ikari-Left (IL) 4.0 guiding catheter with an inner diameter of 0.071 inch (Terumo, Tokyo, Japan) was inserted into the left coronary artery. Initially, two 0.010 inch guidewires — Athlete Slender 01 and Athlete eel slender — were inserted into the LAD and the diagonal branch, respectively. A Cypher™ stent (3.5 x 28 mm; Cordis Corp., Miami Lakes, Florida) was implanted directly from the left main coronary artery (LMCA) to the LAD, crossing over the LCx and the diagonal branch at an inflation pressure of 16 atm (Figure 2C). We re-crossed the guidewire to the diagonal branch through the stent strut and added another 0.010 inch guidewire (Asahi Decillion FL) as it advanced into the LCx. In order to prevent occlusion of these branches as well as to obtain adequate stent expansion in the LMCA, simultaneous triple-balloon inflation was performed at 8 atm with 3 Ikazuchi-X balloons which measured 2.5 x 15 mm in the LAD, 2.0 x 15 mm in the diagonal branch, and 3.0 x 15 mm in the LCx (Figure 2D). The 6 Fr guiding catheter accepted three times the simultaneous balloon inflation pressure using the Ikazuchi-X balloon. The final angiogram revealed excellent results, as shown in Figures 2 E and F. No adverse complications occurred during or after the procedures. Because of a less invasive approach via the radial artery, the patient returned to his room in a wheelchair and was discharged the next morning. The patient had remained angina-free at 6-month follow up.
Case 2. A 48-year-old male with a history of hypertension and diabetes mellitus was admitted to a local hospital because of unstable angina. He was given intravenous heparin and nitrates, however, he had recurring chest pain at rest with ST-segment depression in leads I, aVL and V4–V6. He was transferred to our hospital for emergent coronary angiography. A 6 Fr sheath introducer was inserted into the right radial artery. Angiography showed a tight stenosis in the distal LMCA to the proximal LCx and the intermediate branch artery (Figures 3 A and B). He refused bypass surgery and urgent angioplasty was performed.
The left coronary artery was engaged using a 6 Fr IL 4.0 guiding catheter. Two 0.010 inch Asahi Decillion FL guidewires were advanced into the LAD and LCx. A single 3.5 x 23 mm Cypher stent was directly deployed at 16 atm from the LMCA to the LCx, crossing over the LAD and the intermediate branch artery at (Figure 3C). Next, we re-crossed the guidewire to the intermediate branch through the stent strut, and another 0.010 inch guidewire (Asahi Decillion FL) was advanced into the LAD. Simultaneous triple-balloon inflation at 8 atm was performed as a post-dilatation with the use of 3 Ikazuchi-X balloons, which measured 3.0 x 15 mm in the LCx, 2.0 x 15 mm in the intermediate branch, and 2.5 x 15 mm in the LAD (Figure 3D). The 3 balloons were inflated simultaneously 4 times. Contrast was injected through the 6 Fr guiding catheter without difficulty and the balloon catheters were easily removed. The final angiographic results are shown in Figures 3 E and F. There were no complications during the procedures or the hospital stay. After this procedure, the patient did not complain of any chest symptoms and was discharged the next morning. The patient continued to be angina-free at 6-month follow up.
Intravascular ultrasound findings. The resultant stent expansion was evaluated by volumetric IVUS assessments. Surprisingly, representative IVUS images of the two cases indicated that configurations of the stent within the left main trunk, simultaneously dilated with 3 balloons, appeared as nearly-round circles on cross-sectional view (Figures 4 and 5), which is different from the elliptically dilated stents commonly seen after two-balloon kissing inflation. Actually, stent symmetry appeared almost identical between the LMCA and the main branch (average stent symmetry was 0.90 in each case); the measurements were 0.89 in Case 1, and 0.93 in Case 2, which suggested that simultaneous triple-balloon inflation may provide relatively “round” stent expansion at the hugging balloon segments, similar to the stent symmetry achieved when dilatation is performed with a single balloon. Furthermore, the stent area at the LMCA was reasonably expanded compared with that seen at the main branch (stent area: 11.1 versus 7.1 mm², p < 0.0001 in Case 1 and 13.9 versus 10.3 mm², p < 0.0001 in Case 2). Therefore, simultaneous triple-balloon inflation appears to provide a dimensionally adequate stent expansion at the confluent portion.

Discussion. Treatment of bifurcation lesions remains a challenging undertaking in coronary angioplasty.^12–16 In bifurcation lesions, kissing-balloon inflation has been considered important to restore optimal stent/vessel wall apposition of the main branch as well as to achieve better ostial scaffolding and stent apposition at the side branch.^17–19 Furthermore, trifurcation lesions are more difficult targets for preserving patency of the ostium of each branch. It is likely that simultaneous triple-balloon inflation is required to improve these problems, corresponding to the requirement of the kissing balloon technique for bifurcation lesions. Otherwise, the operator is obliged to ignore the intermediate branch stenosis/occlusion in trifurcation lesions.
To the best of our knowledge, only a few reports describing this method are available in the literature.^8–10 These techniques exclusively utilized an 8 Fr guiding catheter with a transfemoral approach. Basically, further improvements of the interventional devices and understanding of the essential mechanisms of simultaneous triple-balloon inflation are necessary.
Recently, we described a new PCI system consisting of 0.010 inch guidewires and compatible balloon catheters that can be employed using the kissing-balloon technique with a 5 Fr guiding catheter.¹¹ Using this system, no friction occurred between the 3 balloon catheters within a 6 Fr guiding catheter and blood pressure monitoring was possible without any problems. These low-profile devices may potentially change the triple-balloon technique as a standard procedure for trifurcation lesions, overcoming the complexity of this technique. Another benefit of simultaneous triple-balloon inflation is better and more rounded stent expansion, as shown in the IVUS images. Despite a limited number of cases evaluated thus far, simultaneous triple-balloon inflation appears to be superior to double-balloon inflation in terms of achievement of: 1) “roundness” of stent expansion; and 2) reasonable stent dimension achieved by the meeting of the three branches in the main trunk portion.
Furthermore, we can enumerate other advantages for using this low profile system, such as lower incidence of vascular complications,^20,21 smaller amount of contrast media,²² and increased patient comfort because of a transradial approach.²³ To use 6 Fr-sized system allows transradial approach nearly for all cases.²⁴ Potential precautions or limitations of this technique include: 1) the need for careful manipulation to prevent tangled guidewires; and 2) limited transmitting torque of the guidewire.
This particular method using 0.010 inch guidewire and balloon systems was named the “King Ghidorah Technique” (KGT) after the Japanese legendary three-headed monster in order to differentiate the former case reports using 0.014 inch systems. In summary, we described two cases of trifurcation lesions involving a LMCA stenosis treated with stent implantation and simultaneous triple-balloon inflation using a slender system and a 6 Fr guiding catheter.

References

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