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Figure 1. Schematic representation (above) and bench visualization (below) of each step of the proximal optimization with kissing balloon inflation7️⃣ (POKI) technique. I) The stent is implanted in main vessel (MV). Stent sizing is performed according to the distal reference7️⃣ diameter. II) Proximal optimization balloon is inflated in the proximal MV. The exact positioning is made by placing the distal7️⃣ balloon marker proximal from the carina tip. The proximal optimization technique (POT) balloon is inflated several times to ensure complete7️⃣ stent strut apposition in proximal region. III) The balloon positioning for POKI — in MV the distal balloon marker touches7️⃣ the carina tip, the side branch balloon is positioned with proximal marker exactly at the stent struts borders. The proximal7️⃣ SB balloon marker and MV balloon distal marker could be in parallel or MV balloon marker could be a little7️⃣ bit distally in the direction to the carina tip (depending on anatomy in practice). IV) During balloon inflation the stent7️⃣ is optimally deformed to achieve maximum apposition to the side branch ostium. V) Final result.
The main findings of the present7️⃣ study are the following: i) A novel stent optimization technique combining proximal optimization balloon inflation and kissing balloon technique was7️⃣ introduced and was found to be feasible both in bench-test and in-vivo evaluation; ii) Procedural and angiographic success after POKI7️⃣ in the current patient series, was excellent; iii) The immediate angiographic result after the procedure was significantly better compared with7️⃣ previously reported data assessing stent optimization techniques in bifurcation lesions.
Stent underexpansion and malapposition are responsible for unsatisfactory post-PCI results and7️⃣ are associated with target lesion failure and stent thrombosis, therefore contemporary interventional practice uses stent optimization techniques to prevent these7️⃣ events [14, 15]. Current expert recommendations accept POT as mandatory step in bifurcation PCI as it enhances stent apposition in7️⃣ the proximal MV, and reduces stent deformation [4, 16]. However, inappropriate distal positioning of the POT balloon bears the risk7️⃣ of distal MV overstretch and carina shift to the SB. On the other hand, incorrect proximal positioning may lead to7️⃣ stent malapposition and underexpansion near the carina [17]. The present analysis demonstrated that POT could be a source of additional7️⃣ ostial SB stenosis, due to ostial stretch in elliptical fashion [11]. Concerning carina shift, KBI has shown to have an7️⃣ advantage over POT followed by SB balloon dilation [18]. However, KBI bears a risk of ellipsoid stent distortion of proximal7️⃣ MV and its overexpansion [19], which has been associated with higher rates of MV reintervention [20]. Furthermore, randomized clinical trials7️⃣ comparing provisional stent strategies with or without KBI failed to report any advantage on clinical outcomes for KBI [21, 22].7️⃣ Finally, when comparing KBI and POT with a consequent SB dilation, randomized multicenter trial failed to show significant advantage for7️⃣ any of the two techniques over the other [23]. In the present view, these results could be justified by the7️⃣ improper choice of balloon diameters or inadequate balloon positioning which lead to insufficient correction of the stent deformation. The POT7️⃣ — SB dilatation — POT technique sounds logical, but in practice, as already mentioned, it did not correct SB ostial7️⃣ compromise. As mentioned above, POT at the level of SB ostium stretches SB perimeter in ellipse, which eliminates the positive7️⃣ effect of POT on carina shifting. Thus, in the end, regarding SB compromise, the final effect could be neutral.
Therefore, the7️⃣ current findings have important clinical implications. This novel stent optimization technique combines the benefits from POT and KBI and may7️⃣ provide improved post-PCI results in bifurcation lesions. POKI technique shortens the procedure time by combining POT and KBI in a7️⃣ one-step approach. The operator should not be concerned about further carina shifting as SB ostium is dilated simultaneously. Furthermore, the7️⃣ visualization of the SB balloon at the stent border provides a firm marker of the carina position and facilitates the7️⃣ positioning of the MV POT balloon. If during inflation the POT balloon slips proximally, it should be positioned one marker7️⃣ distally after deflation, without doubting excessive carina shifting.
The study has the following limitations to be considered: first, bench models fail7️⃣ to truly replicate the geometry and elasticity of diseased coronary vessels. Balloon inflation in diseased coronary vessels with differential distribution7️⃣ of fibrosis and calcification may behave differently to silicon. However, the results from this in-vivo evaluation were confirmatory of the7️⃣ on-bench findings. Second, the findings include a relatively low sample size of 41 vessels. Third, for the present study intravascular7️⃣ imaging was not performed. Lastly, presented herein are the immediate angiographic and QCA results after the index procedure. Further follow-up7️⃣ study with intravascular ultrasound assessment is currently performed to evaluate the long-term procedural result.
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