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Journal ArticleDOI

Plaque modification of severely calcified coronary lesions by scoring balloon angioplasty using Lacrosse non-slip element: insights from an optical coherence tomography evaluation

15 Mar 2019-Cardiovascular Intervention and Therapeutics (Cardiovasc Interv Ther)-Vol. 34, Iss: 3, pp 242-248

TL;DR: The thickness and shape of calcifications were predictors of successful lesion modification after Lacrosse NSE angioplasty and receiver-operating characteristic curve analysis showed that calcification thickness < 565 μm was the best predictor of completely disrupted calcification.
Abstract: Percutaneous coronary intervention (PCI) for heavily calcified lesions is challenging because these lesions are resistant to balloon dilatation and stenting. Lacrosse non-slip element (NSE) may have the potential to dilate heavily calcified lesions. We aimed to investigate predictors of successful lesion modification using Lacrosse NSE angioplasty via optical coherence tomography (OCT)-guided PCI. We investigated 32 patients with severe target lesion calcification treated with OCT-guided PCI. Successful lesion modification was defined as the complete fracture of calcification after Lacrosse NSE angioplasty. Before PCI, 172 segments with calcification were identified. After pre-dilatation using Lacrosse NSE, successful lesion modification was achieved in 117 segments (68.0%). Calcification was significantly thinner in successfully disrupted segments than in non-disrupted segments (p < 0.001). Calcification angle tended to be larger in disrupted than in non-disrupted segments (p = 0.08). Convex types were less frequently observed in disrupted than in non-disrupted segments (p < 0.001). At minimal lumen area sites, 26 segments (81.3%) were successfully modified. Similar to the overall results, the disrupted group had significantly thinner calcification than the non-disrupted group (p < 0.001). The angle of the calcified plaque was similar between the 2 groups (p = 0.39). Convex-type calcifications were less frequently observed in the disrupted group than in the non-disrupted group (p = 0.05). Receiver-operating characteristic curve analysis showed that calcification thickness < 565 μm was the best predictor of completely disrupted calcification. The thickness and shape of calcifications were predictors of successful lesion modification after Lacrosse NSE angioplasty.
Topics: Calcification (54%), Lesion (50%)

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様式第5 号(第 9条関係)
論文内容の要旨
報告番号
氏名
菅原裕
Plaque Modification of Severely Calcified Coronary Lesions by Scoring Balloon Angioplasty Using
Lacrosse Non-slip Elemen
t: Insights from an Optical Coherence Tomography Evaluation
(和訳)
冠動脈高度石灰化病変に対するスコアリングバルーンラクロス
Non -Slip Element を用い
た冠動脈形成術一光干渉断層法による有用性の評価
論文内容の要旨
背景
冠動脈インターベンョンにおいて、高度石灰化プラー を有する冠動脈病変拡張は時に困難を
伴う場合がある。高度石灰化病変をバルーンによる前拡張なしにステントを留置するとステント拡
張不全やステント内血栓症の原因となる スコアリングバルーンであるラクロス
Non-Slip
Elemenet (NSE)
は高度石灰化病変を拡張するのに適しているといわれている光干渉断層法 (OCT)
冠動脈プラークの組織性状を明瞭に評価出来る。今回、我々はラクロス
NSE で有効な前拡張可能な
石灰化病変の特徴を明らかにするために、
OCT を用いて検討を行った。
方法
ラクロス
NSE を用いて冠動脈形成術を施行した、高度石灰化病変 32 例に対しに対し OCT を行い、
術前後の病変を評価した。対象冠動脈プラークのうち、内腔断面積が最も小さ 部位で、石灰化プ
ラークが完全に離断しているものを拡張成功と定義した。高度石灰化プラークを有する
172 断面を
評価対象とした
結果
ラクロス NSE による拡張で全体の 68 出にあたる 117 断面で拡張成功がみられた拡張不成功群と比
較して拡張成功群は石灰化プラークの厚みが有意に薄かった
(p 0.001) 。石灰化プラークの角度は
拡張成功群の方が大きい傾向があったが有意差はみられなかった
(p=0.08) 拡張不成功群は拡張成
功群と比較して血管内腔に向かつて凸型の石灰化が多く みら れた
(p 0.001) 対象プラークの 内腔
断面積が最も小さい部位部分において
26 病変 (8 1. 3略)がラクロス NSE での拡張が得られた 内腔が
最も小さい部位でも拡張成功群と不成功群を比較すると、拡張成功群は石灰化の厚みが薄かった
(p O. 001) 。石灰化の角度は拡張成功群と不成功群で、差はなかった (p=O. 39) 。内向きに凸の石灰化
は拡張不成功群で有意に多くみられた
(p=O. 05) 0 ROC 曲線解析によれば、ラクロス NSE による冠動
脈拡張が得られるカ トオフ値は石灰化の厚さが 56511m 以下であった。また,石灰化の角度が
270 。以上の病変に限定すると、そのカ トオフ値は石灰化厚さが 53511m 以下で、あった。
結論
冠動脈プラークの石灰化の厚みと石灰化の形態がラクロス
NSE による冠動脈拡張成功の予測に有用
であった。石灰化の厚みが
56511m 以下で、血管内腔に向かつて凸ではない形態の石灰化であればラ
クロス
NSE による冠動脈拡張成功が得られる可能性が高い
Citations
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18 Nov 1998
Abstract: Although significant coronary artery (CA) calcification is believed to affect stent deployment, the exact impact on stent deployment after high‐pressure balloon inflations is unknown. Intracoronary intravascular examination (ICUS) was performed in 27 moderate‐severe calcified CA lesions before and after stent implantation. In case of unsatisfactory results (in‐stent area < 90%, minimal in‐stent diameter/maximal in‐stent diameter < 0.8), further inflations up to 20 atm guided by ICUS were applied. Initially, stent expansion was adequate in 10 stents (37%) and symmetric in 19 (70%). After inflation at 20 atm, stents with adequate expansion increased to 16 (59%, P = 0.0036), but stents with symmetry decreased to 13 (48%, P = 0.0045). Stent expansion was inversely correlated to the arc of calcium (r = ‐0.8, P < 0.0001). There were five patients with clinical restenosis at 6 months (18%). Increases in stent lumen area with high‐pressure balloon inflations in moderate‐severe calcified CA lesions are at the expense of symmetry. This may affect clinical restenosis. Cathet Cardiovasc Intervent 2001;52:164–172. © 2001 Wiley‐Liss, Inc.

73 citations


Journal ArticleDOI
TL;DR: The routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.
Abstract: Scoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty. We studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292). A total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901). The routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

4 citations


Journal ArticleDOI
Abstract: Moderate or severe calcification is present in approximately one third of coronary lesions in patients with stable ischemic heart disease and acute coronary syndromes and portends unfavorable procedural results and long-term outcomes. In this review, we provide an overview on the state-of-the-art in evaluation and treatment of calcified coronary lesions. Intravascular imaging (intravascular ultrasound or optical coherence tomography) can guide percutaneous coronary intervention of severely calcified lesions. New technologies such as orbital atherectomy and intravascular lithotripsy have significantly expanded the range of available techniques to effectively modify coronary calcium and facilitate stent expansion. Calcium fracture improves lesion compliance and is essential to optimize stent implantation. Intravascular imaging allows for detailed assessment of patterns and severity of coronary calcium that are integrated into scoring systems to predict stent expansion, identifying which lesions require atherectomy for lesion modification. Guided by intravascular imaging, older technologies such as rotational atherectomy and excimer laser can be incorporated with newer technologies such as orbital atherectomy and intravascular lithotripsy into an algorithmic approach for the safe and effective treatment of patients with heavily calcified coronary lesions.

3 citations


Journal ArticleDOI
Saki Iwai1, Makoto Watanabe1, Akihiko Okamura1, Atsushi Kyodo1  +7 moreInstitutions (2)
Abstract: Background Optical coherence tomography (OCT) has the potential to characterize the detailed morphology of calcified coronary plaques. This study examined the prognostic impact of calcified plaque morphology in patients with coronary artery calcification (CAC) who underwent newer-generation drug-eluting stent (DES) implantation.Methods and Results:In all, 251 patients with moderate to severe CAC who underwent OCT-guided DES implantation were reviewed retrospectively and divided into 3 groups according to OCT findings of the target lesion: 25 patients (10.0%) with calcified nodules (CN), 69 patients (27.5%) with calcified protrusion (CP) without CN, and 157 patients (62.5%) with superficial calcific sheet (SC) without CN and CP. The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). Kaplan-Meier survival analysis revealed that, among the 3 groups, the rates of MACE-free survival (log-rank test, P=0.0117), myocardial infarction (log-rank test, P=0.0103), and TLR (log-rank test, P=0.0455) were significantly worse in patients with CN. Multivariate Cox proportional hazards analysis demonstrated that CN was an independent predictor of MACE (hazard ratio 4.41; 95% confidence interval 1.63-10.8; P=0.0047). Conclusions Target lesion CN was associated with higher cardiac event rates in patients who underwent newer-generation DES implantation for lesions with moderate to severe CAC.

1 citations


Journal ArticleDOI
Abstract: Percutaneous coronary intervention is the most common mode of revascularization and is increasingly undertaken in high-risk subsets, including the elderly. The presence of coronary artery calcification is increasingly observed and significantly limits technical success. The mechanisms for this are multi-factorial, including increased arterial wall stiffness and impaired delivery of devices, leading to suboptimal stent delivery, deployment, and expansion which are harbingers for increased risk of in-stent restenosis and stent thrombosis. Although conventional balloon pretreatment techniques aim to mitigate this risk by modifying the lesion before stent placement, many lesions remain resistant to conventional strategies, due to the severity of calcification. There have been several substantial technological advancements in calcium modification methods in recent years, which have allowed improved procedural success with low periprocedural complication rates. This review will summarize the current adjunctive modification technologies that can be employed to improve technical outcomes in percutaneous coronary intervention in calcific disease and the evidence supporting these tools.

1 citations


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Abstract: Background— High-resolution visualization of atherosclerotic plaque morphology may be essential for identifying coronary plaques that cause acute coronary events. Optical coherence tomography (OCT) is an intravascular imaging modality capable of providing cross-sectional images of tissue with a resolution of 10 μm. To date, OCT imaging has not been investigated in sufficient detail to assess its accuracy for characterizing atherosclerotic plaques. The aim of this study was to establish objective OCT image criteria for atherosclerotic plaque characterization in vitro. Methods and Results— OCT images of 357 (diseased) atherosclerotic arterial segments obtained at autopsy were correlated with histology. OCT image criteria for 3 types of plaque were formulated by analysis of a subset (n=50) of arterial segments. OCT images of fibrous plaques were characterized by homogeneous, signal-rich regions; fibrocalcific plaques by well-delineated, signal-poor regions with sharp borders; and lipid-rich plaques by signal...

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Duk-Woo Park1, Seong Wook Park1, Kyoung Ha Park1, Bong Ki Lee1  +5 moreInstitutions (1)
TL;DR: Stent thrombosis occurred in 0.8% after DES implantation during long-term follow-up, similar to that for bare metal stents, and independent predictors were premature antiplatelet therapy interruption, primary stenting in acute myocardial infarction, and total stent length.
Abstract: Despite concerns regarding the long-term safety of drug-eluting stent (DES) implantation because of late-onset stent thrombosis, the actual incidence of stent thrombosis after 1 year is unknown. We investigated the incidence, risk factors, and association of antiplatelet therapy interruption for the development of stent thrombosis after DES implantation during long-term follow-up. A total of 1,911 consecutive patients with DES implantation were enrolled (sirolimus-eluting stents in 1,545 patients, 2,045 lesions; paclitaxel-eluting stents in 366 patients, 563 lesions). During long-term follow-up (median 19.4 months, interquartile range 15.3 to 24.3), 15 patients (0.8%, 95% confidence interval 0.5% to 1.3%) developed stent thrombosis within 6 hours to 20.4 months. Eleven patients (0.6%, 95% confidence interval 0.3% to 1.0%) had late thrombosis (median 6.1 months). The incidence of stent thrombosis was 3.3% (4 of 121 patients) in patients with complete interruption of antiplatelet therapy (vs 0.6% in those without, p = 0.004) and 7.8% (5 of 64 patients) with premature interruption of aspirin or clopidogrel, or both (vs 0.5% in those without, p <0.001). Independent predictors of stent thrombosis were premature antiplatelet therapy interruption, primary stenting in acute myocardial infarction, and total stent length. Stent thrombosis also developed while patients were on dual antiplatelet therapy (all patients with acute/subacute stent thrombosis and 36% of those with late stent thrombosis; 47% of total with stent thrombosis). In conclusion, stent thrombosis occurred in 0.8% after DES implantation during long-term follow-up. The incidence of late stent thrombosis was 0.6%, similar to that for bare metal stents. The predictors of stent thrombosis were premature antiplatelet therapy interruption, primary stenting in acute myocardial infarction, and total stent length.

449 citations


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Shinjo Sonoda1, Yoshihiro Morino1, Junya Ako1, Mitsuyasu Terashima1  +8 moreInstitutions (3)
TL;DR: In this SIRIUS IVUS substudy, SES reduced both biologic variability and restenosis, resulting in increased predictability of long-term stent patency with postprocedure MSA.
Abstract: Objectives We assessed the predictive value of minimum stent area (MSA) for long-term patency of sirolimus-eluting stents (SES) implantation compared to bare metal stents (BMS). Background Although MSA is a consistent predictor of in-stent restenosis, its predictive value in BMS is still limited because of biologic variability in the restenosis process. Methods From the SIRolImUS (SIRIUS) trial, 122 cases (SES: 72; BMS: 50) with complete serial intravascular ultrasound (IVUS) (baseline and 8-month follow-up) were analyzed. Postprocedure MSA and follow-up minimum lumen area (MLA) were obtained. Based on previous physiologic studies, adequate stent patency at follow-up was defined as MLA >4 mm2. Results In both groups, a significant positive correlation was observed between baseline MSA and follow-up MLA (SES: p < 0.0001, BMS: p < 0.0001). However, SES showed higher correlation than BMS (0.8 vs. 0.65) with a higher regression coefficient (0.92 vs. 0.59). The sensitivity and specificity curves identified different optimal thresholds of MSA to predict adequate follow-up MLA: 5 mm2for SES and 6.5 mm2for BMS. The positive predictive values with these cutoff points were 90% and 56%, respectively. Conclusions In this SIRIUS IVUS substudy, SES reduced both biologic variability and restenosis, resulting in increased predictability of long-term stent patency with postprocedure MSA. In addition, SES had a considerably lower optimal MSA threshold compared to BMS.

384 citations


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TL;DR: Stent underexpansion is a significant cause of failure after sirolimus-eluting stent (SES) implantation treatment of in-stent restenosis (ISR).
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243 citations


Journal ArticleDOI
TL;DR: On comparison with angiography, the vast majority of stents associated with subsequent thrombosis have at least one abnormal feature by intravascular ultrasound at the time of stent deployment.
Abstract: Aims To investigate whether intravascular ultrasound provides additional information regarding the prediction of stent thrombosis, a retrospective multicentre registry was designed to enrol patients with stent thrombosis following stent deployment under ultrasound guidance. Methods and Results A total of 53 patients were enrolled (mean age 61±9 years) with stable angina (43%), unstable angina (36%), and post-infarct angina (21%) who underwent intracoronary stenting. The majority had balloon angioplasty alone prior to stenting (94%) with 6% also undergoing rotational atherectomy. The indication for stenting was elective (53%), suboptimal result (32%) and bailout (15%). There were 1·6±0·8 stents/artery with 87% undergoing high-pressure dilatation (≥14 atmospheres). The minimum stent area was 7·7±2·8mm2with a mean stent expansion of 81·5±21·9%. Overall, 94% of cases demonstrated one abnormal ultrasound finding (stent under-expansion, malapposition, inflow/outflow disease, dissection, or thrombus). Angiography demonstrated an abnormality in only 32% of cases (chi-square=30·0, P <0·001). Stent thrombosis occurred at 132±125h after deployment. Myocardial infarction occurred in 67% and there was an overall mortality of 15%. Conclusion On comparison with angiography, the vast majority of stents associated with subsequent thrombosis have at least one abnormal feature by intravascular ultrasound at the time of stent deployment.

242 citations