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Results: In total 41 vessels were evaluated. The target vessel was left main in 9 (22.0%) patients, left anterior descending 😗 artery — in 26 (63.4%), left circumflex artery — in 4 (9.8%) and right coronary artery — in 2 (4.9%). 😗 The predominant type of bifurcation was Medina 1-1-1 (61.8%). Baseline proximal MV DS% was 60.0 ± ٢٣.٧٪, distal MV DS٪ 😗 — 58.8 ± 28.9% and SB DS% 53.0 ± 32.0%. The application of POKI was feasible in 41 (100%) of 😗 the vessels. Post-PCI residual DS at proximal MV was 11.5 ± 15.4%, distal MV — 6.6 ± 9.3%, and SB 😗 — 22.9 ± 28.5%. Both procedural and angiographic success was 100%.
Methods: Bench and in-vivo evaluations were performed. For the bench 😗 visualization bifurcated silicone mock vessel was used. The POKI technique was simulated using a 3.5 mm POT balloon. For the 😗 in-vivo evaluation patients with angiographic bifurcation lesions in a native coronary artery with diameter ≥ 2.5 mm and ≤ 4.5 😗 mm, SB diameter ≥ 2.0 mm, and percentage diameter stenosis (%DS) more than 50% in the main vessel (MV) were 😗 included. Provisional stenting was the default strategy.
Background: Percutaneous coronary interventions (PCI) of bifurcation lesions poses a technical challenge with a 😗 high complication rate. Kissing balloon inflation (KBI) and proximal optimization technique (POT) are used to correct bifurcation carina after stenting. 😗 However, both may still lead to uncomplete strut apposition to the side branch (SB) lateral wall. Proposed herein, is a 😗 new stent-optimization technique following bifurcation stenting consisting of a combination of POT and KBI called proximal optimization with kissing balloon 😗 inflation (POKI).
This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license, allowing 😗 to download articles and share them with others as long as they credit the authors and the publisher, but without 😗 permission to change them in any way or use them commercially.
The article is accompanied by the editorial on page 894
Introduction
Coronary 😗 bifurcation lesions correspond to nearly 20–25% of all percutaneous coronary interventions (PCI) [1, 2]. Interventions in this subset of lesions 😗 pose a technical challenge with high early and late complication rates [3]. PCI of bifurcation lesions can be performed using 😗 a variety of techniques, depending on the plaque distribution across the main and daughter branches, and the bifurcation geometry [4]. 😗 The fractal geometry of coronary bifurcations defines a discrepancy in diameters between the proximal main vessel (MV) and the daughter 😗 branches — the distal MV (main branch, MB) and side branch (SB) [5]. Kissing balloon inflation (KBI) has been one 😗 of the first proposed stent-optimization techniques specific for bifurcation lesions and continues to play an essential role in bifurcation PCI 😗 by optimizing stent apposition and improving SB access. However, the application of KBI requires SB recrossing after main vessel stenting, 😗 which adds additional procedure and fluoroscopy time, as well as contrast. It also requires certain operator experience, especially in cases 😗 with SB occlusion after stenting. Additional disadvantages of KBI are the elliptical deformation of the proximal MV, which can further 😗 compromise long-term results [6]. Proximal optimization technique (POT) has been proposed as a stent-optimization technique able to adjust the tubular 😗 design of the coronary stent to the natural bifurcation anatomy [7]. It was expected that POT could correct stent apposition, 😗 respecting fractal vessel anatomy, without compromising and even improving SB patency. However, studies demonstrated that for the preservation of SB 😗 patency, without any functional vessel flow compromise, an additional SB balloon dilation is required [8]. The optimal result of POT 😗 is highly dependent on the precise balloon positioning, and inaccurate placing of the balloon may lead to uncomplete strut apposition 😗 to the SB lateral wall [9, 10]. Moreover, it is currently demonstrated that even an appropriately positioned POT balloon (according 😗 to the current criteria [4]) could cause further elliptical deformation at SB ostium thus additionally stenosing it [11]. Therefore, proposed 😗 herein is a new stent-optimization technique following bifurcation stenting consisting of a combination of POT and kissing-balloon inflation.
Methods
Proximal optimization with 😗 kissing balloon inflation (POKI) technique
After stent deployment in MV (sized according to the distal vessel diameter) the POKI technique includes 😗 the following steps: (1) Proximal optimization technique with a non-compliant (NC) balloon sized according to the proximal MV diameter; (2) 😗 SB recrossing with a wire and removal of jailed wire; (3) Kissing balloon inflation using a NC balloon in the 😗 SB, with proximal marker of the balloon into the stent borders and an NC POT balloon in the MV, with 😗 distal balloon marker positioned parallel to carina tip.
Bench visualization
For the bench visualization custom bifurcated silicone model, with proximal MB internal 😗 diameter (ID) 3.5 mm, distal MB ID 3.0 mm, SB ID 2.5 mm, and 3.0 mm. Three types of models 😗 were used according to distal branching angle — 30°, 45° and 60° models. The POKI technique has been simulated using 😗 a dedicated 3.5 mm diameter to 6 mm length non-compliant POT balloon (Brosmed, China). The balloon is specifically designed for 😗 the POT technique with shortened balloon shoulders and specific cylindrical shape. This prevents inappropriate stent deformations at the place of 😗 inflation. Following deployment, the models were visualized using fluoroscopy and fluorography (Innova, GE Healthcare).
In-vivo procedure
Stable patients with angiographic bifurcation lesions 😗 in a native coronary artery with diameter ≥ 2.5 mm and ≤ 4.5 mm and SB diameter ≥ 2.0 mm 😗 and percentage diameter stenosis (%DS) more than 50% in MV were included. PCI was performed according to the current guidelines 😗 [12]. Provisional stenting was the default PCI procedure in all patients. All lesions were stented with second-generation drug-eluting stents. Angiographic 😗 success was defined as end procedural MV %DS < 20% and SB stenosis < 50% without significant dissection and flow 😗 impairment. Procedure success included angiographic success in the absence of in-hospital major adverse cardiac events (MACE; death, stroke, and myocardial 😗 infarction). All patients received double antiplatelet therapy with acetylsalicylic acid 75–100 mg and a P2Y2 inhibitor (clopidogrel, prasugrel, or ticagrelor).
Angiographic 😗 analysis
Dedicated bifurcation quantitative coronary angiography (QCA) analysis was performed according to the recommendation of the consensus on QCA methods for 😗 bifurcation lesions using General Electric QCA software and MicroDicom QCA software [13]. True bifurcation lesions were defined as visual percent 😗 diameter stenosis (%DS) > 50% at the SB. The minimal luminal diameter (MLD), reference vessel diameter (RVD), and %DS were 😗 measured for every segment of the bifurcation (i.e., proximal, and distal MV and SB) pre-and post-intervention. Lesion length was measured 😗 from the proximal main vessel to the distal main branch (i.e., we considered beginning and ending points where hypothetically the 😗 stent will be implanted). SB lesion length was measured from the ostium to the first normal-appearing part of the vessel. 😗 All analyzes were performed by two investigators (N.M. and P.P.) and in case of disagreement, a consensus was formed with 😗 additional analysis from the first author (D.V.).
Statistical analysis
Normality distribution of continuous variables was assessed visually with histograms and with the 😗 Shapiro–Wilk test. Continuous variables were summarized using the median and interquartile range. Categorical variables are presented as frequency counts and 😗 percentages. An independent sample T-test was performed to assess the difference between the study group and previously reported data. A 😗 p value < 0.05 was considered statistically significant. The study was investigator-initiated, funded by the local institution. The local ethics 😗 committee approved the study. All statistical calculations were performed via SPSS version 23 (SPSS, PC version, Chicago, IL, USA).
Results
Bench simulation
The 😗 POKI procedure was performed adhering to the following steps:
Step I: The stent is implanted in MV. Stent sizing is performed 😗 according to the distal reference diameter.
Stent sizing is performed according to the distal reference diameter. Step II: POT in proximal 😗 MV. Proximal optimization balloon is inflated in proximal MV. The exact positioning is made by placing the distal balloon marker 😗 proximal from the carina tip. The POT balloon is inflated several times to ensure complete stent strut apposition in the 😗 proximal region.
Proximal optimization balloon is inflated in proximal MV. The exact positioning is made by placing the distal balloon marker 😗 proximal from the carina tip. The POT balloon is inflated several times to ensure complete stent strut apposition in the 😗 proximal region. Step III: Balloon’s positioning for POKI. In MV the distal balloon marker is exactly at the carina tip. 😗 SB balloon is positioned with proximal marker exactly at the stent struts borders. The proximal SB balloon marker and MV 😗 balloon distal marker could be in parallel or MV balloon marker could be a little bit distally in the direction 😗 to the carina tip (depending on the specific anatomy).
In MV the distal balloon marker is exactly at the carina tip. 😗 SB balloon is positioned with proximal marker exactly at the stent struts borders. The proximal SB balloon marker and MV 😗 balloon distal marker could be in parallel or MV balloon marker could be a little bit distally in the direction 😗 to the carina tip (depending on the specific anatomy). Step IV: Simultaneous balloon inflation. During balloon inflation the stent is 😗 optimally deformed to achieve maximum apposition to the SB. A schematic representation of the POKI procedure is illustrated in Figure 😗 1.
Figure 1. Schematic representation (above) and bench visualization (below) of each step of the proximal optimization with kissing balloon inflation 😗 (POKI) technique. I) The stent is implanted in main vessel (MV). Stent sizing is performed according to the distal reference 😗 diameter. II) Proximal optimization balloon is inflated in the proximal MV. The exact positioning is made by placing the distal 😗 balloon marker proximal from the carina tip. The proximal optimization technique (POT) balloon is inflated several times to ensure complete 😗 stent strut apposition in proximal region. III) The balloon positioning for POKI — in MV the distal balloon marker touches 😗 the carina tip, the side branch balloon is positioned with proximal marker exactly at the stent struts borders. The proximal 😗 SB balloon marker and MV balloon distal marker could be in parallel or MV balloon marker could be a little 😗 bit distally in the direction to the carina tip (depending on anatomy in practice). IV) During balloon inflation the stent 😗 is optimally deformed to achieve maximum apposition to the side branch ostium. V) Final result.
In-vivo evaluation
In total 41 patients (41 😗 vessels) were evaluated. Two case examples are illustrated in Figure 2. The mean age was 72.5 ± 8.4, and 70.6% 😗 were males. Patient clinical characteristics are shown in Table 1. The target vessel was left main in 9 (22.0%) patients, 😗 left anterior descending artery — in 26 (63.4%), left circumflex artery — in 4 (9.8%) and right coronary artery — 😗 in 2 (4.9%). The predominant type of bifurcation lesion was Medina 1-1-1 (62.6%). Eight (19.5%) patients presented with chronic total 😗 occlusions of the target vessels. Patient procedural characteristics are shown in Table 2.
Figure 2. Clinical examples of proximal optimization with 😗 kissing balloon inflation (POKI) procedures. A. Percutaneous coronary intervention (PCI) of right coronary artery; B. PCI of left anterior descending 😗 artery. Procedural steps are the same as described in Figure 1.
Table 1. Patient demographic and clinical characteristics. Variables Overall (n 😗 = 41) Age [years] 72.5 ± 8.40 Sex, male 24 (70.6%) Body mass index [kg/m2] 29.7 ± 5.86 Dyslipidemia 38 😗 (92.7%) Hypertension 41 (100.0%) Diabetes mellitus 13 (31.7%) Current smoker 10 (24.4%) Previous MI 11 (26.8%) Previous PCI in non-target 😗 vessel 22 (53.7%) Cerebro-vascular disease 4 (9.8%) Peripheral-artery disease 2 (4.9%) Clinical presentation: Stable angina CCS II 2 (6%) Stable 😗 angina CCS III 16 (47%) Stable angina CCS IV 15 (44%) Acute coronary syndrome 1 (3%) Non-anginal symptoms 10 (50.0%) 😗 Creatinine clearance 74.8 ± 10.1 LVEF 51.7 ± 11.0 Hospitalization days 2.62 ± 0.88
Table 2. Patient’s procedural characteristics. Variables Value 😗 Target vessel: 41 LM 9 (22.0%) LAD 26 (63.4%) LCX 4 (9.8%) RCA 2 (4.9%) Multivessel disease 34 (82.9%) Radial 😗 access 38 (92.7%) SYNTAX 17.1 ± 6.66 Contrast 252.5 ± 82.6 Procedural time 91.6 ± 24.5 Scopic time 22.6 ± 😗 11.0 Number of stents 1.5 ± 0.78 Stent length 11.25 ± 3.21 Stent diameter 6.65 ± 1.35
The mean MV lesion 😗 length was 38.6 ± 20.5 and the mean SB lesion length was 9.18 ± 2.24. Baseline proximal MV DS% was 😗 60.0 ± 23.7%, distal MV DS% — 58.8 ± 28.9% and SB DS% 53.0 ± 32.0%. The application of the 😗 POKI technique was feasible in 41 (100%) of the vessels. Post-PCI residual DS at proximal MV was 11.5 ± ± 😗 15.4%, distal MV — 6.6 ± 9.3%, and SB — 22.9 ± 28.5% (Fig. 3). Patient QCA characteristics are shown 😗 in Table 3. Both procedural and angiographic success were 100%.
Figure 3. Changes in percentage diameter stenosis before and after percutaneous 😗 coronary intervention (PCI) in the main vessel ( A ), main branch ( B ), and side branch ( C 😗 ) of the bifurcation lesion; %DS — percentage diameter stenosis.
Table 3. Patient’s procedural characteristics. Variables Value MV lesion length 38.6 😗 ± 20.5 SB lesion length 9.18 ± 2.24 MV MLD [mm] 1.31 ± 0.23 MV RVD [mm] 3.20 ± 0.46 😗 MV DS [%] 60.0 ± 23.7 MB MLD [mm] 1.36 ± 0.45 MB RVD [mm] 2.23 ± 0.35 MB DS 😗 [%] 58.8 ± 28.9 SB MLD [mm] 1.44 ± 0.51 SB RVD [mm] 2.33 ± 0.44 SB DS [%] 53.0 😗 ± 32.0 POKI MB balloon diameter 3.65 ± 0.5 POKI MB balloon length 10.3 ± 5.2 POKI SB balloon diameter 😗 2.60 ± 0.42 POKI SB balloon length 18.3 ± 4.97 Maximum pressure 16 ± 1.7 Post-PCI MV MLD [mm] 2.20 😗 ± 0.32 MV RVD [mm] 3.40 ± 0.40 MV DS [%] 11.5 ± 15.4 MB MLD [mm] 1.99 ± 0.35 😗 MB RVD [mm] 2.31 ± 0.30 MB DS [%] 6.6 ± 9.3 SB MLD [mm] 2.34 ± 0.37 SB RVD 😗 [mm] 2.47 ± 0.52 SB DS [%] 22.9 ± 28.5
Discussion
The main findings of the present study are the following: i) 😗 A novel stent optimization technique combining proximal optimization balloon inflation and kissing balloon technique was introduced and was found to 😗 be feasible both in bench-test and in-vivo evaluation; ii) Procedural and angiographic success after POKI in the current patient series, 😗 was excellent; iii) The immediate angiographic result after the procedure was significantly better compared with previously reported data assessing stent 😗 optimization techniques in bifurcation lesions.
Stent underexpansion and malapposition are responsible for unsatisfactory post-PCI results and are associated with target lesion 😗 failure and stent thrombosis, therefore contemporary interventional practice uses stent optimization techniques to prevent these events [14, 15]. Current expert 😗 recommendations accept POT as mandatory step in bifurcation PCI as it enhances stent apposition in the proximal MV, and reduces 😗 stent deformation [4, 16]. However, inappropriate distal positioning of the POT balloon bears the risk of distal MV overstretch and 😗 carina shift to the SB. On the other hand, incorrect proximal positioning may lead to stent malapposition and underexpansion near 😗 the carina [17]. The present analysis demonstrated that POT could be a source of additional ostial SB stenosis, due to 😗 ostial stretch in elliptical fashion [11]. Concerning carina shift, KBI has shown to have an advantage over POT followed by 😗 SB balloon dilation [18]. However, KBI bears a risk of ellipsoid stent distortion of proximal MV and its overexpansion [19], 😗 which has been associated with higher rates of MV reintervention [20]. Furthermore, randomized clinical trials comparing provisional stent strategies with 😗 or without KBI failed to report any advantage on clinical outcomes for KBI [21, 22]. Finally, when comparing KBI and 😗 POT with a consequent SB dilation, randomized multicenter trial failed to show significant advantage for any of the two techniques 😗 over the other [23]. In the present view, these results could be justified by the improper choice of balloon diameters 😗 or inadequate balloon positioning which lead to insufficient correction of the stent deformation. The POT — SB dilatation — POT 😗 technique sounds logical, but in practice, as already mentioned, it did not correct SB ostial compromise. As mentioned above, POT 😗 at the level of SB ostium stretches SB perimeter in ellipse, which eliminates the positive effect of POT on carina 😗 shifting. Thus, in the end, regarding SB compromise, the final effect could be neutral.
Therefore, the current findings have important clinical 😗 implications. This novel stent optimization technique combines the benefits from POT and KBI and may provide improved post-PCI results in 😗 bifurcation lesions. POKI technique shortens the procedure time by combining POT and KBI in a one-step approach. The operator should 😗 not be concerned about further carina shifting as SB ostium is dilated simultaneously. Furthermore, the visualization of the SB balloon 😗 at the stent border provides a firm marker of the carina position and facilitates the positioning of the MV POT 😗 balloon. If during inflation the POT balloon slips proximally, it should be positioned one marker distally after deflation, without doubting 😗 excessive carina shifting.
What would be the clinical consequences and if a better angiographic result translates into better clinical result is 😗 currently under investigation by the present group.
Limitations of the study
The study has the following limitations to be considered: first, bench 😗 models fail to truly replicate the geometry and elasticity of diseased coronary vessels. Balloon inflation in diseased coronary vessels with 😗 differential distribution of fibrosis and calcification may behave differently to silicon. However, the results from this in-vivo evaluation were confirmatory 😗 of the on-bench findings. Second, the findings include a relatively low sample size of 41 vessels. Third, for the present 😗 study intravascular imaging was not performed. Lastly, presented herein are the immediate angiographic and QCA results after the index procedure. 😗 Further follow-up study with intravascular ultrasound assessment is currently performed to evaluate the long-term procedural result.
Conclusions
Proximal optimization with KBI is 😗 a novel stent-optimization technique for bifurcation lesions. It showed excellent feasibility and success-rate both in bench and in-vivo evaluation.
Funding
The study 😗 was investigator-initiated, and funded by the local institution (Medica Cor Hospital, Russe, Bulgaria).
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