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Double-Kissing Nanocrush for Bifurcation Lesions: Development, Bioengineering, Fluid Dynamics, and Initial Clinical Testing.

ABSTRACT: BACKGROUND:When possible, a single-stent technique to treat coronary bifurcation disease is preferable. However, when 2 stents are required, there is scope to improve on existing techniques. The crush technique has already been improved with the introduction of double-kissing (DK) and minicrush. We sought to refine and simplify the minicrush technique, retaining its advantages while avoiding its disadvantages, by developing a DK nanocrush technique. METHODS:The DK nanocrush method allows complete lesion coverage of a bifurcation lesion without excessive metal layers. This is achieved by positioning the side branch (SB) stent with minimal protrusion into the main branch (MB), implantation of the SB stent with an undeployed balloon in the MB, immediate kissing-balloon inflation with formation of a minimal neocarina, stenting the MB, recrossing the proximal part of the SB without crossing a double metal layer, and final kissing. We demonstrate this technique with benchtop implantation, microscopic computed tomographic reconstruction, computational fluid dynamics (CFD) modelling, and clinically with the use of angiographic and intravascular imaging. RESULTS:The DK nanocrush was practically feasible and resulted in full ostial coverage. CFD analysis demonstrated minimally disturbed blood flow. The technique was successfully utilised in 9 patients with bifurcation lesions with excellent angiographic outcomes and no adverse events over 12 months. CONCLUSIONS:The DK nanocrush technique may represent the ultimate refinement of the original crush technique with a number of practical and theoretical advantages. It remains to be tested against other bifurcation techniques in prospective trials.

SUBMITTER: Morris PD

PROVIDER: S-EPMC7308801 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Double-Kissing Nanocrush for Bifurcation Lesions: Development, Bioengineering, Fluid Dynamics, and Initial Clinical Testing.

Morris Paul D PD Gosling Rebecca R Rothman Alex A Iqbal Javaid J Chiastra Claudio C Colombo Monika M Migliavacca Francesco F Banning Amerjeet A Gunn Julian P JP

The Canadian journal of cardiology 20190830 6

<h4>Background</h4>When possible, a single-stent technique to treat coronary bifurcation disease is preferable. However, when 2 stents are required, there is scope to improve on existing techniques. The crush technique has already been improved with the introduction of double-kissing (DK) and minicrush. We sought to refine and simplify the minicrush technique, retaining its advantages while avoiding its disadvantages, by developing a DK nanocrush technique.<h4>Methods</h4>The DK nanocrush method ...[more]

PMID: 32088059

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Project description:BackgroundThere is a debate regarding the best stent strategy for unprotected distal left main (LM) bifurcation disease. Among two-stent techniques, double-kissing and crush (DKC) is favored in current guidelines but is complex and requires expertise. Reverse T and Protrusion (rTAP) was shown to be a comparable strategy regarding short-term efficacy and safety, but with reduced procedural complexity.AimTo compare rTAP vs. DKC by optical coherence tomography (OCT) on the intermediate term.Methods52 consecutive patients with complex unprotected LM stenoses (Medina 0,1,1 or 1,1,1) were randomized to either DKC or rTAP and followed-up for a median of 189[180-263] days for clinical and OCT outcomes.ResultsAt follow-up OCT showed similar change in the side branch (SB) ostial area (primary endpoint). The confluence polygon showed a higher percentage of malapposed stent struts in the rTAP group that did not reach statistical significance (rTAP: 9.7[4.4-18.3] % vs. DKC: 3[0.07-10.9] %; p = 0.064). It also showed a trend towards larger neointimal area relative to the stent area (DKC: 8.8 [6.9 to 13.4] % vs. rTAP: 6.5 [3.9 to 8.9] %; p = 0.07), and smaller luminal area (DKC: 9.54[8.09-11.07] mm2 vs. rTAP: 11.21[9.53-12.42] mm²; p = 0.09) in the DKC group. The minimum luminal area in the parent vessel distal to the bifurcation was significantly smaller in the DKC group (DKC: 4.64 [3.64 to 5.34] mm² vs. rTAP: 6.76 [5.20 to 7.29] mm²; p = 0.03). This segment also showed a trend for smaller stent areas (p = 0.05 to 0.09), and a bigger neointimal area relative to the stent area (DKC: 8.94 [5.43 to 10.5]% vs. rTAP: 4.75 [0.08 to 8.5]%; p = 0.06) in the DKC patients. The incidence of clinical events was comparably low in both groups.ConclusionAt 6-months, OCT showed a similar change in the SB ostial area (primary endpoint) in rTAP compared to DKC. There was also a trend for smaller luminal areas in the confluence polygon and the distal parent vessel, and a larger neointimal area relative to the stent area, in DKC, along with a tendency for more malapposed stent struts in rTAP.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03714750, identifier: NCT03714750.

Project description:Side-branch occlusion is a serious complication of provisional one-stent strategies used to treat coronary bifurcation lesions. The aim of the study was to compare the short- and long-term clinical outcomes between the balloon-stent kissing technique (BSKT) and jailed wire technique (JWT) in patients with non-left coronary bifurcation lesions.This prospective, double-blinded, randomized controlled study enrolled 89 consecutive patients (aged 18-85 years) with 90 true bifurcation lesions (hemadostenosis ≥70%; bifurcation angle <90°; Medina classification 1.1.1, 1.0.1, or 0.1.1) who underwent percutaneous coronary intervention (PCI) at the Zhongshan Hospital Affiliated to Dalian University (China) between January 2013 and May 2016. The patients were randomly divided into the BSKT (44 patients, 45 lesions) and JWT (45 patients, 45 lesions) groups. The intervention was conducted according to technical requirements using a single-stent strategy. Operative success rate, occurrence of complications, postoperative quantitative coronary angiography, and incidence of perioperative and long-term major adverse cardiovascular events (MACEs) were compared between groups.The intervention success rate was 100% in both groups. After main-branch stenting, the BSKT was associated with significantly lower rates of side-branch occlusion (0% vs 15.6%, P < .05) and side-branch post-processing (8.9% vs 26.7%, P < .05) than the JWT. The BSKT was associated with significantly lower degrees of postoperative proximal main-branch residual stenosis (6.1 ± 5.1% vs 9.6 ± 8.6%, P < .05) and side-branch ostial stenosis (51.6 ± 20.6% vs 70.3 ± 20.8%, P < .05) than the JWT. The incidence of perioperative MACEs was significantly lower in the BSKT group than in the JWT group (0% vs 13.3%, P < .05). Patients were followed for a mean duration of 19.0 ± 6.1 months. The occurrence rates of long-term MACEs, angina of Canadian Cardiovascular Society grade ≥2, and severe heart failure were not significantly different between groups.The BSKT is a safe and effective technique that may have advantages over the JWT with regard to protection of the side-branch during PCI for bifurcation lesions.

Project description:Background and objectiveThe modified double-stent and provisional stenting strategies have been widely used in patients with coronary bifurcation lesions, but what is the optimization has not been clearly defined. This meta-analysis is to elucidate the benefits from modified double-stent and provisional stenting strategies in patients with coronary bifurcation lesions.MethodsElectronic databases were searched to identify studies comparing the modified double-stent and provisional stenting strategies in patients with coronary bifurcation lesions. The clinical outcomes were divided into early (≤6 months) and late (>6 months) events according to the follow-up duration. The early endpoints included cardiac death, myocardial infarction, target lesion revascularization or target vessel revascularization, and major adverse cardiac events (MACE), and the late endpoints also include stent thrombosis in addition to the early endpoints index. The angiographic endpoint was in-stent restenosis. Data were analyzed by the statistical software RevMan (version 5.3).ResultsA total of 6 studies involving 1683 patients with coronary bifurcation lesions were included in this meta-analysis, which found that the modified double-stent strategy was associated with a lower risk of cardiac death (odds ratio [OR] = 0.29, 95% confidence intervals [CI] 0.11-0.78, P = .01), myocardial infarction (OR = 0.41, 95% CI 0.21-0.82, P = .01), target lesion revascularization or target vessel revascularization (OR = 0.31, 95% CI 0.15-0.63, P = .001), and MACE (OR = 0.41, 95% CI 0.22-0.74, P = .003) compared with provisional stenting in the early follow-up endpoint events, while the risk of cardiac death and stent thrombosis were similar between both strategies (OR = 0.59, 95% CI 0.31-1.10, P = .09; and OR = 0.62, 95% CI 0.34-1.15, P = .13; respectively) in the late follow-up endpoint events. There were significant differences between both strategies in myocardial infarction (OR = 0.42, 95% CI 0.24-0.75, P = .003), MACE (OR = 0.44, 95% CI 0.31-0.62, P < .00001), and target lesion revascularization or target vessel revascularization (OR 0.35, 95% CI 0.25-0.49, P < .00001) between both strategies in the late follow-up endpoint events. The risk of in-stent restenosis favored the modified double-stent strategy (OR 0.29, 95% CI 0.20-0.43, P < .00001).ConclusionThe modified double-stent strategy is associated with excellent clinical and angiographic outcomes except for the occurrence of cardiac death and stent thrombosis late-term outcome compared with provisional stenting strategy in patients with coronary bifurcation lesions. These findings suggest that the modified double-stent strategy can be recommended as an optimization in patients with coronary bifurcation lesions.

Dataset Information

Double-Kissing Nanocrush for Bifurcation Lesions: Development, Bioengineering, Fluid Dynamics, and Initial Clinical Testing.

Publications

Double-Kissing Nanocrush for Bifurcation Lesions: Development, Bioengineering, Fluid Dynamics, and Initial Clinical Testing.

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