Shunsuke Kubo

Optical Coherence Tomography Findings in Lesions After Sirolimus-Eluting Stent Implantation With Peri-Stent Contrast Staining

Background—We have sometimes noted abnormal angiographic coronary dilatation, <50% of the reference vessel, at the site of sirolimus-eluting stent implantation, suggesting contrast staining outside the stent struts and named this finding peri-stent contrast staining (PSS). Little was known about optical coherence tomography findings of lesions with PSS. Methods and Results—Between May 2008 and March 2010, we performed optical coherence tomography for 90 in-stent restenosis lesions after sirolimus-eluting stent implantation. We found PSS in 20 of the 90 lesions by coronary angiography. The differences in optical coherence tomography findings, including incomplete stent apposition, multiple interstrut hollows (MIH), strut coverage, and thrombus, were compared between lesions with PSS and those without PSS. PSS is defined as contrast staining outside the stent contour extending to >20% of the stent diameter measured by quantitative coronary angiography. MIH is defined as multiple hollows (the maximum depth >0.5 mm) existing between and outside well-apposed stent struts. Both incomplete stent apposition (60.0% versus 10%; P<0.001) and MIH (85.0% versus 25.7%; P<0.001) were frequently observed in lesions with PSS than in lesions without PSS. Among the 20 lesions with PSS, there was only 1 lesion in which we found neither MIH nor incomplete stent apposition, but only minor dissection. Uncovered struts (11.6% versus 3.9%; P=0.001), malapposed struts (2.0% versus 0.0%; P<0.001), and red thrombus (35% versus 10%; P=0.012) were frequently observed in lesions with PSS than in lesions without PSS. Conclusions—PSS might be closely associated with 2 different optical coherence tomography findings, MIH and incomplete stent apposition, in lesions after sirolimus-eluting stent implantation.

Association between tissue characteristics assessed with optical coherence tomography and mid-term results after percutaneous coronary intervention for in-stent restenosis lesions: a comparison between balloon angioplasty, paclitaxel-coated balloon dilatation, and drug-eluting stent implantation

AIMS Morphological assessment of neointimal tissue using optical coherence tomography (OCT) is important for clarifying the pathophysiology of in-stent restenosis (ISR) lesions. The aim of this study was to determine the impact of OCT findings on recurrence of ISR after various types of percutaneous coronary intervention (PCI) including plain old balloon angioplasty (POBA), paclitaxel-coated balloon (PCB) dilatation, and drug-eluting stent (DES) implantation. METHODS AND RESULTS Between June 2008 and August 2013, we performed PCI for 428 ISR lesions in 379 patients using POBA (78 lesions, POBA group), PCB dilatation (202 lesions, PCB group), and DES implantation (148 lesions, DES group). Morphological assessment of neointimal tissue at the minimum lumen area site to determine restenotic tissue structure (homogeneous, heterogeneous, or layered type) using OCT was performed. We examined the association between tissue structure and midterm results including ISR and target lesion revascularization (TLR) rates. The patients were 308 men and 71 women with a mean age of 68.9 ± 9.4 years. The mean follow-up period was 211 ± 40 days. ISR and TLR rates of lesions with a homogeneous structure were significantly higher in the POBA group than in the PCB group (ISR: 54.8 vs. 19.1%, P < 0.001; TLR: 38.7 vs. 10.6%, P < 0.001) and DES group (ISR: 54.8 vs. 19.6%, P = 0.002; TLR: 38.7 vs. 10.7%, P = 0.005), whereas there were no differences in ISR and TLR rates between the three groups in lesions with a heterogeneous structure. CONCLUSION Morphological assessment of ISR tissue using OCT might suggest favourable types of PCI for ISR lesions.

Everolimus-eluting stent implantation versus repeat paclitaxel-coated balloon angioplasty for recurrent in-stent restenosis lesion caused by paclitaxel-coated balloon failure.

AIMS Although paclitaxel-coated balloon (PCB) angioplasty has been reported to be effective for in-stent restenosis (ISR) lesions, the optimal treatment for recurrent ISR lesions caused by PCB failure remains unclear. This study compared clinical and angiographic outcomes after everolimus-eluting stent (EES) implantation and repeat PCB angioplasty for PCB failure. METHODS AND RESULTS From November 2008 to October 2011, we performed PCB angioplasty for 599 ISR lesions, of which 93 recurrent ISR lesions underwent EES implantation (53 lesions, 52 patients) or repeat PCB angioplasty (40 lesions, 37 patients). The choice of treatment strategy was decided at the operatorÕs discretion. Angiographic outcomes were evaluated by follow-up angiography at six to eight months after procedure. The baseline characteristics were similar between the two groups. At follow-up angiography (93.5% of all lesions), minimum lumen diameter was significantly larger and the binary restenosis rate was significantly lower after EES implantation than after repeat PCB angioplasty (2.08±0.79 mm vs. 1.45±0.68 mm, p<0.001; 20.0% vs. 54.1%, p=0.001; respectively), whereas late lumen loss was not different between the two groups (0.49±0.62 mm vs. 0.59±0.74 mm, p=0.47). At two years, the incidences of both target lesion revascularisation (TLR) and clinically driven TLR were significantly lower after EES implantation than after repeat PCB angioplasty (17.9% vs. 57.5%, p=0.001; 5.9% vs. 18.1%, p=0.01; respectively). CONCLUSIONS EES implantation was more effective for PCB failure in preventing subsequent TLR than repeat PCB angioplasty because of better angiographic results.

Association between tissue characteristics evaluated with optical coherence tomography and mid-term results after paclitaxel-coated balloon dilatation for in-stent restenosis lesions: a comparison with plain old balloon angioplasty

AIMS Morphological assessment of neointimal tissue using optical coherence tomography (OCT) is important for clarifying the pathophysiology of in-stent restenosis (ISR) lesions. The aim of this study was to determine the impact of OCT findings on recurrence of ISR after paclitaxel-coated balloon (PCB) dilatation compared with plain old balloon angioplasty (POBA). METHODS AND RESULTS Between July 2008 and May 2012, we performed percutaneous coronary intervention for 214 ISR lesions using POBA + PCB (146 lesions, PCB group) or POBA only (68 lesions, POBA group). Morphological assessment of neointimal tissue using OCT, including assessment of restenotic tissue structure and restenotic tissue backscatter, was performed. We examined the association between lesion morphologies and mid-term (6-8 months) results including ISR and target lesion revascularization (TLR) rates. Both ISR and TLR rates of lesions with a homogeneous structure were significantly lower in the PCB group than those in the POBA group (ISR: 20.0 vs. 55.6%, P = 0.002, TLR: 12.7 vs. 37.0%, P = 0.019), but there was no difference between the two groups in ISR and TLR rates of lesions with a heterogeneous or layered structure. Both ISR and TLR rates of lesions with high backscatter were significantly lower in the PCB group than those in the POBA group (ISR: 19.8 vs. 52.5%, P < 0.001, TLR: 13.6 vs. 42.5%, P = 0.001), but there was no difference between the two groups in ISR and TLR rates of lesions with low backscatter. CONCLUSION Morphological assessment of ISR tissue using OCT might be useful for identifying ISR lesions favourable for PCB dilatation.

Postprocedural Changes of Tricuspid Regurgitation After MitraClip Therapy for Mitral Regurgitation

The effect of percutaneous mitral valve repair using the MitraClip system on tricuspid regurgitation (TR) has not been well investigated. We retrospectively analyzed 102 consecutive patients who underwent the successful MitraClip procedure, and who also had a preprocedural and 1-year follow-up transthoracic echocardiography. TR severity was graded by standard guideline-recommended criteria. At 1 year after the MitraClip procedure, the degree of TR regressed (at least 1 grade) in 23% of the patients, was unchanged in 62% of the patients, and progressed in 16% of the patients. Compared with patients in the other groups, the patients with TR regression had a greater severity of TR at baseline. The TR regression group showed a significant reduction in the systolic pulmonary artery pressure (sPAP) (49 ± 13 to 37 ± 11 mm Hg, p <0.05), a right-sided cardiac reverse remodeling (right ventricular diameter: 41 ± 7 to 39 ± 7 mm, tricuspid annular diameter: 48 ± 8 to 46 ± 9 mm, both p <0.05), and an increase in the right ventricular fractional area change (38 ± 7 to 40 ± 7%, p <0.05). In the multivariate analysis, the decrease in sPAP was the only independent parameter change associated with TR regression. In conclusion, TR regression was observed in 23% of the patients after the successful MitraClip procedures, and favorable echocardiographic parameter changes were detected in this group. Only a reduction in sPAP was independently associated with TR regression.

Incidence, predictive factors, and clinical impact of stent recoil in stent fracture lesion after drug-eluting stent implantation

BACKGROUND Stent fracture (SF) after drug-eluting stent (DES) implantation was reported to be associated with target lesion revascularization (TLR). We have noted abnormal late acquired stent axial deformation in lesions after DES implantation, especially in SF lesions, and defined it as stent recoil (SR). We evaluated the incidence, predictive factors, and clinical impact of SR in SF lesions. METHODS Between 2003 and 2012, 5456 patients (11,712 lesions) underwent DES implantations and follow-up angiography within one year after the index procedure. SR was defined as an axial recoil deformation less than 80% of the stent diameter and SF was defined as the separation of stent segments or stent struts. SF and SR were confirmed by follow-up angiography. The primary endpoint was defined as clinically driven TLR. RESULTS SF was observed in 494 lesions (4.2%) and SR in 138 of SF lesions (27.9%). According to multinomial logistic regression analyses, severe calcification and ostial lesion in the right coronary artery were stronger predictive factors of SF with SR lesions. The cumulative incidences of any and clinically driven TLR at 5years were both significantly higher in the SF with SR group than in the SF without SR group (51.7% versus 35.0%, P<0.001; 22.2% versus 12.8%, P=0.019; respectively). CONCLUSIONS SR in SF lesions after DES implantation could be related to the lesion characteristics. SF with SR was highly associated with subsequent TLR compared with SF without SR.

Late Restenosis After Both First-Generation and Second-Generation Drug-Eluting Stent Implantations Occurs in Patients With Drug-Eluting Stent Restenosis

Background—There are currently inadequate data about whether late restenosis occurs after drug-eluting stent (DES) implantation in patients with DES restenosis. Methods and Results—We collected data for 608 patients who received revascularization for DES restenosis between 2004 and 2012 and analyzed 688 lesions: 359 lesions treated with a first-generation DES (first DES) and 329 lesions treated with a second-generation DES (second DES). Two serial angiographic follow-ups were routinely planned for the patients (at 8 and 20 months after the procedure). Early follow-up angiography was performed for 620 lesions (90.1%), and recurrent restenosis occurred in 84 lesions (25.8%) in the first DES group and in 72 lesions (24.5%) in the second DES group (P=0.78). Target lesion revascularization was performed for 69 lesions (21.2%) in the first DES group and for 48 lesions (16.3%) in the second DES group (P=0.15). Late follow-up angiography was performed for 438 (87.1%) of the remaining 503 lesions (excluding target lesion revascularization lesions), and late restenosis was found in 35 lesions (15.8%) in the first DES group and in 28 lesions (14.7%) in the second DES group (P=0.79). Nonfocal-type restenosis, percentage diameter stenosis after the procedure, previous stent size ⩽2.5 mm, and right coronary artery ostial lesion were independent predictors of early restenosis. Nonfocal-type restenosis, percentage diameter stenosis at early follow-up, and stent fracture were independent predictors of late restenosis. Conclusions—Late restenosis occurs after both first DES implantation and second DES implantation for DES restenosis.

Different indicators for postprocedural mitral stenosis caused by single- or multiple-clip implantation after percutaneous mitral valve repair

BACKGROUND Postprocedural mitral stenosis (MS) is a main limitation for MitraClip™ (Abbot Vascular, Inc., Santa Clara, CA, USA) procedure. The purpose of this study was to detect the preprocedural predictors of high transmitral pressure gradient (TMPG) after MitraClip™ implantation, which indicated postprocedural mitral stenosis (MS). METHODS We studied 79 patients who were implanted with MitraClip™ in our institute. Before the procedure, mitral valve orifice area (MVOA), and anterior-posterior (AP) and medial-lateral (ML) mitral annular diameters were measured at diastole using three-dimensional (3D) transesophageal echocardiography (TEE) data set. After the procedure, the mean TMPG was assessed using continuous-wave (CW) Doppler by periprocedural TEE. RESULTS Preprocedural MVOA, and AP and ML diameter of left ventricular (LV) inflow orifices were larger in patients with mean TMPG ≤4mmHg than in patients with TMPG >4mmHg after 1-and 2-clip implantation. The large MVOA and ML diameter of LV inflow orifice strongly correlated with the low TMPG after 1- and 2-clip implantation. As a result of the receiver operating characteristic curve analysis, the preprocedural MVOA predicted the low postprocedural TMPG more accurately than the ML diameter of LV inflow orifice after 1-clip implantation either in the degenerative or functional mitral regurgitation (MR) patients. After 2-clip implantation, however, the preprocedural ML diameter of LV inflow orifice predicted it more accurately than the MVOA in the degenerative and functional MR patients. CONCLUSIONS 3D TEE derived MVOA predicts the postprocedural MS after 1-clip implantation, however, preprocedural ML diameter of LV inflow orifice is more useful to predict after 2-clip implantation.

Long-term (8–10 years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation

Objective Efficacy and safety data on biodegradable polymer-coated biolimus-eluting stent (BP-BES) are currently limited to 5 years. We evaluated longer term (8–10 years) clinical and angiographic outcomes after BP-BES implantation. Methods Between 2005 and 2008, 243 patients (301 lesions) underwent BP-BES implantation. The primary clinical outcome measure was defined as any target lesion revascularisation (TLR). Absolute serial angiographic studies without any concomitant TLR within 2 years after the procedure were performed in 55 patients (65 lesions) at postprocedure, mid-term (within 1 year), late term (between 1 and 2 years) and very late term (beyond 2 years). Results The median follow-up duration was 9.4 years (IQR 8.2–10.2 years). The 8-year cumulative incidence of any TLR was 20.3%. The increase rate was approximately 7% per year in the first 2 years, but decelerated to approximately 1.2% per year beyond 2 years after the procedure. The minimal lumen diameter significantly decreased from postprocedure (2.63±0.44 mm) to mid-term (2.43±0.59 mm, p=0.002) and from late term (2.27±0.63 mm) to very late term (1.98±0.73 mm, p=0.002). The 8-year cumulative incidences of definite or probable stent thrombosis (ST) and major bleeding (Bleeding Academic Research Consortium (BARC) ≥3) were 0.5% and 12.0%, respectively. Definite ST was none within 10 years in the entire cohort. Conclusions The long-term clinical outcomes after BP-BES implantation were favourable, although angiographic late progression of luminal narrowing did not reach a plateau. The incidence of ST remained notably low, whereas that of major bleeding gradually increased.

Leaflet protrusion into left main coronary artery detected by intravascular ultrasound after transcatheter aortic valve implantation with SAPIEN 3

An 83-year-old man was referred for management of symptomatic severe aortic stenosis. The heart team concluded that transcatheter aortic valve implantation (TAVI) using SAPIEN 3 was preferable because of his age and frailty. Preprocedural computed tomography showed a high left coronary ostial height and a sufficiently sized sinus of Valsalva. However, a left coronary cusp leaflet was longer than the left coronary height (we routinely perform this measurement) (A). In this case, coronary protection with a guidewire was performed because a long leaflet can be a risk factor of coronary obstruction. Coronary angiography showed no atherosclerotic plaque in the left main coronary artery (LMCA) (B). In aortography during predilatation with a 25mm balloon, the leaflet tip seemed to have been dislodged close to the ostial LMCA, but coronary flow was maintained (C). Then, a 29-mm SAPIEN 3 was deployed under rapid pacing. Post-deployment coronary angiography revealed a wedge-shaped filling defect in the LMCA (D; Supplementary data online, Movie S1). Intravascular ultrasound (IVUS) was performed, and a mixed structure of high-echoic calcification and low-echoic soft tissue continuing from the mid-portion to outside of the LMCA was detected, indicating a native valve leaflet tip (E; Supplementary data online, Movie S2). Blood pressure was maintained, while ST-depression was seen in V3-6. To prevent subsequent coronary events, a drug-eluting stent was implanted. No apparent defect of the LMCA was observed in the final coronary angiography (F), and an IVUS image confirmed adequate stent apposition with the leaflet dislodged by the stent. Coronary obstruction is a serious complication of TAVI and occurs mainly due to the displacement of a native calcified valve. However, a valve leaflet tip telescoping into the coronary artery had never been detected. In this case, we successfully observed a leaflet protrusion into the LMCA by IVUS after SAPIEN 3 implantation. Long leaflet length is a potential risk of this complication.