Abstract Objectives This study used a fractal bifurcation bench model to compare 6 optimization sequences for coronary bifurcation provisional stenting, including 1 novel sequence without kissing ...balloon inflation (KBI), comprising initial proximal optimizing technique (POT) + side-branch inflation (SBI) + final POT, called “re-POT.” Background In provisional bifurcation stenting, KBI fails to improve the rate of major adverse cardiac events. Proximal geometric deformation increases the rate of in-stent restenosis and target lesion revascularization. Methods A bifurcation bench model was used to compare KBI alone, KBI after POT, KBI with asymmetric inflation pressure after POT, and 2 sequences without KBI: initial POT plus SBI, and initial POT plus SBI with final POT (called “re-POT”). For each protocol, 5 stents were tested using 2 different drug-eluting stent designs: that is, a total of 60 tests. Results Compared with the classic KBI-only sequence and those associating POT with modified KBI, the re-POT sequence gave significantly (p < 0.05) better geometric results: it reduced SB ostium stent-strut obstruction from 23.2 ± 6.0% to 5.6 ± 8.3%, provided perfect proximal stent apposition with almost perfect circularity (ellipticity index reduced from 1.23 ± 0.02 to 1.04 ± 0.01), reduced proximal area overstretch from 24.2 ± 7.6% to 8.0 ± 0.4%, and reduced global strut malapposition from 40 ± 6.2% to 2.6 ± 1.4%. Conclusions In comparison with 5 other techniques, the re-POT sequence significantly optimized the final result of provisional coronary bifurcation stenting, maintaining circular geometry while significantly reducing SB ostium strut obstruction and global strut malapposition. These experimental findings confirm that provisional stenting may be optimized more effectively without KBI using re-POT.
Provisional side branch stenting for the treatment of bifurcation lesions Lefèvre, Thierry; Darremont, Olivier; Albiero, Remo
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,
12/2010, Volume:
6 Suppl J
Journal Article
Abstract Objectives The aim of this fractal bifurcation bench study was to compare provisional bifurcation stenting with a “re-POT” sequence, comprising a proximal optimizing technique (POT), side ...branch inflation, and final POT, between a bioresorbable vascular scaffold (BVS) and a metallic stent. Background Re-POT proved significantly better than kissing balloon inflation in maintaining circular geometry without overstretch in metal stents, while significantly reducing side branch ostium strut obstruction and global strut malapposition. This should be useful for BVSs, which are more easily breakable. Methods Twenty left main–like and 20 left anterior descending–like fractal coronary bifurcation bench models used 10 each 2.5 × 24 mm and 3.5 × 24 mm Absorb (Ab) BVSs and 10 each 2.5 × 24 mm and 3.5 × 24 mm XIENCE Xpedition (XX) metal stents, implanted by re-POT, with optical coherence tomographic analysis at each step and micro–computed tomographic analysis of Ab devices to detect strut fracture. Results With Ab devices, re-POT reduced percentage strut malapposition close to XX rates (0.8 ± 0.7% vs. 0.0 ± 0.0%, p < 0.05; 3.5 ± 1.7% vs. 0.3 ± 0.6%, p < 0.05), conserving proximal circularity (elliptical ratio, 1.04 vs. 1.03 and 1.04 vs. 1.04; p = NS). Mean post-re-POT proximal expansion was 0.6 ± 0.1 mm (+21.6 ± 2.1%) for 2.5-mm and 1.0 ± 0.1 mm (+23.6 ± 2.2%) for 3.5-mm Ab devices, with only 1 strut fracture (left anterior descending–like bench). Side branch ostium strut obstruction was greater with Ab scaffolds than XX stents: 41.1 ± 9.4% versus 16.4 ± 8.1% (p < 0.05) and 31.8 ± 3.2% versus 10.0 ± 5.3% (p < 0.05), respectively, for 2.5- and 3.5-mm scaffolds and stents. Ab scaffolds showed 2 ± 1% moderate but significant late recoil as of 1 h, reaching 4 ± 2% by 24 h (p < 0.05). Conclusions Re-POT optimized most Ab provisional bifurcation treatments, without fracture, respecting fractal geometry, and without exceeding 1.0-mm proximal differential diameter.
This study used a fractal bifurcation bench model to compare 6 optimization sequences for coronary bifurcation provisional stenting, including 1 novel sequence without kissing balloon inflation ...(KBI), comprising initial proximal optimizing technique (POT) + side-branch inflation (SBI) + final POT, called "re-POT."
In provisional bifurcation stenting, KBI fails to improve the rate of major adverse cardiac events. Proximal geometric deformation increases the rate of in-stent restenosis and target lesion revascularization.
A bifurcation bench model was used to compare KBI alone, KBI after POT, KBI with asymmetric inflation pressure after POT, and 2 sequences without KBI: initial POT plus SBI, and initial POT plus SBI with final POT (called "re-POT"). For each protocol, 5 stents were tested using 2 different drug-eluting stent designs: that is, a total of 60 tests.
Compared with the classic KBI-only sequence and those associating POT with modified KBI, the re-POT sequence gave significantly (p < 0.05) better geometric results: it reduced SB ostium stent-strut obstruction from 23.2 ± 6.0% to 5.6 ± 8.3%, provided perfect proximal stent apposition with almost perfect circularity (ellipticity index reduced from 1.23 ± 0.02 to 1.04 ± 0.01), reduced proximal area overstretch from 24.2 ± 7.6% to 8.0 ± 0.4%, and reduced global strut malapposition from 40 ± 6.2% to 2.6 ± 1.4%.
In comparison with 5 other techniques, the re-POT sequence significantly optimized the final result of provisional coronary bifurcation stenting, maintaining circular geometry while significantly reducing SB ostium strut obstruction and global strut malapposition. These experimental findings confirm that provisional stenting may be optimized more effectively without KBI using re-POT.
No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has ...been conducted to date.
From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality.
In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 95% CI, 1.46-1.91;
<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 95% CI, 1.63-2.22;
<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 95% CI, 1.07-1.66;
=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 95% CI, 1.06-1.29;
=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis.
The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV.
https://www.clinicaltrials.gov. Unique identifier: NCT01777828.
The 2017 European Bifurcation Club (EBC) meeting was held in Porto (Portugal) and allowed a multidisciplinary international faculty to review and discuss the latest data collected in the field of ...coronary bifurcation interventions. In particular, the topic of percutaneous coronary intervention (PCI) on left main coronary artery (LM) disease was highlighted as a contemporary priority. Herein, we summarise the key LM anatomy features, the diagnostic modalities and available data that are relevant for a patient's procedural management. Since the clinical outcomes of patients undergoing PCI on LM disease may depend on both PCI team organisation and PCI performance, the optimal catheterisation laboratory set-up and the rationales for device and technique selection are critically reviewed. The best lesion preparation modalities, the different DES implantation technique choices and the strategies to be considered during PCI on unprotected LM for optimal PCI results are reviewed step by step.
We compared the mechanical and physical properties and the safety from strut fracture of side branch and post-dilatation strategies for the Absorb and DESolve bioresorbable scaffolds with the durable ...metallic drug-eluting XIENCE Xpedition stent using largely independent bench testing.
The strut thickness and crossing profile of the polymeric scaffolds was greater than those of the metallic drug-eluting stent. While all three devices recoiled after deployment, the DESolve enlarged between 10 mins and one hour returning to the immediate post-deployment diameter ("self-correction"). In 3.0 mm stents/scaffolds, the main branch post-dilatation safe threshold without fracture for Absorb was 3.8 mm at 20 atm, for DESolve was 5.0 mm at 20 atm whereas the ML8 did not fracture. For side branch dilatation with a 3.0 mm non-compliant balloon, the threshold before the Absorb fractured was 10 atm whereas the DESolve and ML8 did not fracture at 22 atm. The safe threshold for mini-kissing balloon post-dilatation in 3.0 mm scaffolds/stents with 3.0 mm non-compliant balloons was 5 atm for the Absorb whereas the DESolve and ML8 did not fracture up to 20 atm.
The metallic stent has thinner struts, lower profile, and greater radial strength than the polymeric scaffolds. Different safe pressure thresholds exist for different scaffolds/stents. Unlike the others, the DESolve showed "self-correction" or enlargement after initial recoil.
Stepwise layered provisional stenting (PS) is the most commonly used strategy to treat coronary bifurcation lesions (CBL). The term 'stepwise layered' emphasises the versatility of this approach that ...allows the adjustment of the procedure plan according to the CBL complexity, starting with stent implantation in one branch and implantation of a second stent in the other branch only when required. A series of refinements have been implemented over the years to facilitate the achievement of predictable procedural results using this approach. However, despite its simplicity and versatility, operators using this technique require full knowledge of the pitfalls of each procedural step. Part I of this 16
European Bifurcation Club consensus paper provides a detailed step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the first stent using the PS strategy for the treatment of CBL.
The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary ...lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.
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•There is a paucity of standardization and comparability across studies involving coronary bifurcation lesions.•This document provides standardized definitions and criteria for use in studies of such lesions, from diagnosis through follow-up.•Implementation of these recommendations in clinical trials will improve their relevance and improve the quality of care for patients with bifurcation coronary artery disease.
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