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For the bench visualization custom bifurcated silicone model, with proximal MB internal diameter (ID) 3.5 mm, distal MB ID 3.02️⃣ mm, SB ID 2.5 mm, and 3.0 mm. Three types of models were used according to distal branching angle —2️⃣ 30°, 45° and 60° models. The POKI technique has been simulated using a dedicated 3.5 mm diameter to 6 mm2️⃣ length non-compliant POT balloon (Brosmed, China). The balloon is specifically designed for the POT technique with shortened balloon shoulders and2️⃣ specific cylindrical shape. This prevents inappropriate stent deformations at the place of inflation. Following deployment, the models were visualized using2️⃣ fluoroscopy and fluorography (Innova, GE Healthcare).
In-vivo procedure
Stent underexpansion and malapposition are responsible for unsatisfactory post-PCI results and are associated with2️⃣ target lesion failure and stent thrombosis, therefore contemporary interventional practice uses stent optimization techniques to prevent these events [14, 15].2️⃣ Current expert recommendations accept POT as mandatory step in bifurcation PCI as it enhances stent apposition in the proximal MV,2️⃣ and reduces stent deformation [4, 16]. However, inappropriate distal positioning of the POT balloon bears the risk of distal MV2️⃣ overstretch and carina shift to the SB. On the other hand, incorrect proximal positioning may lead to stent malapposition and2️⃣ underexpansion near the carina [17]. The present analysis demonstrated that POT could be a source of additional ostial SB stenosis,2️⃣ due to ostial stretch in elliptical fashion [11]. Concerning carina shift, KBI has shown to have an advantage over POT2️⃣ followed by SB balloon dilation [18]. However, KBI bears a risk of ellipsoid stent distortion of proximal MV and its2️⃣ overexpansion [19], which has been associated with higher rates of MV reintervention [20]. Furthermore, randomized clinical trials comparing provisional stent2️⃣ strategies with or without KBI failed to report any advantage on clinical outcomes for KBI [21, 22]. Finally, when comparing2️⃣ KBI and POT with a consequent SB dilation, randomized multicenter trial failed to show significant advantage for any of the2️⃣ two techniques over the other [23]. In the present view, these results could be justified by the improper choice of2️⃣ balloon diameters or inadequate balloon positioning which lead to insufficient correction of the stent deformation. The POT — SB dilatation2️⃣ — POT technique sounds logical, but in practice, as already mentioned, it did not correct SB ostial compromise. As mentioned2️⃣ above, POT at the level of SB ostium stretches SB perimeter in ellipse, which eliminates the positive effect of POT2️⃣ on carina shifting. Thus, in the end, regarding SB compromise, the final effect could be neutral.
Therefore, the current findings have2️⃣ important clinical implications. This novel stent optimization technique combines the benefits from POT and KBI and may provide improved post-PCI2️⃣ results in bifurcation lesions. POKI technique shortens the procedure time by combining POT and KBI in a one-step approach. The2️⃣ operator should not be concerned about further carina shifting as SB ostium is dilated simultaneously. Furthermore, the visualization of the2️⃣ SB balloon at the stent border provides a firm marker of the carina position and facilitates the positioning of the2️⃣ MV POT balloon. If during inflation the POT balloon slips proximally, it should be positioned one marker distally after deflation,2️⃣ without doubting excessive carina shifting.
The study has the following limitations to be considered: first, bench models fail to truly replicate2️⃣ the geometry and elasticity of diseased coronary vessels. Balloon inflation in diseased coronary vessels with differential distribution of fibrosis and2️⃣ calcification may behave differently to silicon. However, the results from this in-vivo evaluation were confirmatory of the on-bench findings. Second,2️⃣ the findings include a relatively low sample size of 41 vessels. Third, for the present study intravascular imaging was not2️⃣ performed. Lastly, presented herein are the immediate angiographic and QCA results after the index procedure. Further follow-up study with intravascular2️⃣ ultrasound assessment is currently performed to evaluate the long-term procedural result.
