Long-Term Clinical Outcomes After Filter Protection During Percutaneous Coronary Intervention in Patients With Attenuated Plaque　- 1-Year Follow up of the VAMPIRE 3 (Vacuum Aspiration Thrombus Reemoval 3) Trial.

BACKGROUND: Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.Methods and Results:Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial. MACE at 1 year occurred in 12 patients (12.2%) in the DP group and 3 patients (3.1%) in the CT group (P=0.029), which was driven by a higher risk of TVR (11 [11.2%] vs. 2 [2.1%], P=0.018). In patients treated with bare-metal stents (n=42), MACE occurred in 25.0% of the patients in the DP group and in none of the patients in the CT group (P=0.029), whereas in patients treated with drug-eluting stents (n=151), rates of MACE were similar in the groups (8.1% vs. 3.9%, P=0.32). CONCLUSIONS: In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group. This effect might be mitigated by the use of drug-eluting stents.

Predictive value of the geriatric nutritional risk index in percutaneous coronary intervention with rotational atherectomy.

The prognostic value of the geriatric nutritional risk index (GNRI) in patients undergoing percutaneous coronary intervention (PCI) with rotational atherectomy (RA) remains unknown. Therefore, we aimed to clarify whether the GNRI could predict major adverse cardiac events (MACE) in patients undergoing PCI with RA. A total of 206 patients who underwent PCI with RA from January 2009 to December 2017 were retrospectively tracked. The patients were divided into 2 groups based on the GNRI value on admission. MACE comprised all-cause death, target lesion revascularization (TLR), target vessel revascularization (TVR), and myocardial infarction. One year of follow up was completed in 95.6% of patients. During this period, 50 cases of MACE were observed (all-cause death, 32 cases; TLR, 21 cases; and TVR, 2 cases). Patients with a low GNRI (< 98) had a significantly higher incidence of MACE than did patients with a high GNRI (≥ 98) (37.9% vs. 15.5%, log-rank p < 0.05). The GNRI was an independent predictor of MACE (hazard ratio, 0.94; 95% confidence interval [CI], 0.92-0.97). Furthermore, the GNRI had better predictive power than did its components alone (i.e. body mass index and serum albumin level) (net-reclassification improvement, 0.39; 95% CI, 0.07-0.71; p = 0.01; integrated discrimination improvement, 0.02; 95% CI, - 0.01-0.04; p = 0.07). The GNRI on admission is a predictor of MACE after PCI with RA. Further studies are required to determine whether intensive medical therapy could improve clinical events, particularly cardiovascular death and revascularization, in this population.

Long-Term Clinical and Angiographic Outcomes After Implantation of New-Generation Drug-Eluting Stents for Patients on Maintenance Hemodialysis.

Prior research has revealed poorer clinical outcomes after drug-eluting stent (DES) implantation for hemodialysis patients. This study aims to investigate the long-term clinical and angiographic outcomes after new-generation DES implantation for hemodialysis patients.We retrospectively enrolled 91 consecutive patients (118 lesions) who underwent successful new-generation DES (everolimus-, zotarolimus-, and biolimus-eluting stents) implantation for the first time. We measured the serum calcium and phosphorus levels in the blood samples obtained just before hemodialysis. The follow-up period of clinical events was, at least, 1.5 years. In this study, major adverse cardiac and cerebrovascular events (MACCE) and clinically driven target lesion revascularization were reported in 36 (39.6%) and 11 (12.1%) patients, respectively. The prevalence of peripheral artery disease was significantly higher in the MACCE group (41.7% versus 14.5%, P = 0.006). The serum calcium level was significantly higher in the MACCE group (9.34 ± 0.92 mg/dL versus 8.77 ± 0.88 mg/dL; P = 0.004). The multivariate Cox proportional hazards model revealed that the serum calcium level (hazard ratio, 1.86; 95% confidence interval [CI]: 1.26-2.77; P = 0.002), suboptimal (over 55 mg2/dL2) calcium-phosphorus product (hazard ratio, 3.27; 95% CI: 1.41-7.61; P = 0.006) and the coexistence of peripheral artery disease (hazard ratio, 3.15; 95% CI: 1.49-6.65; P = 0.003) were independent predictors of MACCE.For hemodialysis patients, MACCE remains a frequent occurrence after new-generation DES implantation and is associated with calcium-phosphate metabolism and peripheral artery disease.

Clinical Characteristics and Long-Term Outcomes of Rotational Atherectomy　- J2T Multicenter Registry.

BACKGROUND: Rotational atherectomy (RA) is an adjunct tool for the management of heavily calcified coronary lesions during percutaneous coronary intervention (PCI), but the long-term clinical outcomes of RA use remain unclear in this drug-eluting stent era.Methods and Results:This multi-center registry assessed the characteristics and outcomes of patients treated by RA for calcified coronary lesions between 2004 and 2015. Among 1,090 registered patients, mean age was 70±10 years and 815 (75%) were male. Sixty percent of patients had diabetes mellitus and 27.7% were receiving hemodialysis. The procedure was successful in 96.2%. In-hospital death occurred in 33 patients (3.0%), and 14 patients (1.3%) developed definite/probable stent thrombosis. During the median follow-up period of 3.8 years, the incidence of major adverse cardiac events (MACE), defined as all-cause death, acute coronary syndrome, stent thrombosis, target vessel revascularization and stroke, was 46.7%. On multivariable Cox hazard analysis, hemodialysis (HR, 2.08; 95% CI: 1.53-2.86; P<0.0001) and age (HR, 1.03; 95% CI: 1.01-1.04; P<0.0001) were strong independent predictors of MACE. Conversely, statin treatment was associated with lower incidence of MACE (P=0.035). CONCLUSIONS: This study has provided the largest Japanese dataset for long-term follow-up of RA. Although RA in calcified lesions appears feasible with a high rate of procedural success, a high incidence of MACE was observed.

Quantified frequency-domain optical coherence tomography analysis for the thin-high signals on restenotic tissue after paclitaxel-coated balloon angioplasty.

Thin-high signals (THS), detectable by optical coherence tomography (OCT), represent the paclitaxel coverage of in-stent restenotic tissue. This study was conducted to assess the relationship between THS and angiographic outcomes by means of quantified post-procedural frequency-domain OCT (FD-OCT) analysis. From January 2014 to July 2016, 41 patients underwent FD-OCT-guided percutaneous coronary intervention using paclitaxel-coated balloon (PCB) to prevent in-stent restenosis. Of these, we retrospectively enrolled 32 patients (38 lesions) who underwent a 6- to 9-month follow-up angiogram. THS were assessed quantitatively, as THS length and lumen perimeter length were measured using semi-automated software; %THS was calculated by the following formula; total THS area/lumen perimeter area × 100. THS were detected in all 38 lesions that had undergone PCB angioplasty. THS and %THS were significantly higher in lesions without binary restenosis (3.34 ± 2.11 vs. 11.48 ± 8.53 mm2, p = 0.001 and 1.49 ± 0.73 vs. 4.42 ± 2.71%, p = 0.001, respectively). Values for THS, which indicates the paclitaxel coverage on restenotic tissue, are associated with reducing restenosis after PCB for in-stent restenosis.

Incidence, Predictors, and Midterm Clinical Outcomes of Myocardial Injury After Transcatheter Aortic-Valve Implantation.

Our aim was to assess the clinical effects of myocardial injury after transcatheter aortic-valve implantation (TAVI). Between October 2013 and July 2016, 157 patients underwent TAVI with Sapien XT, Sapien 3, or CoreValve prostheses at our institute. Of these, 130 patients for whom the transapical approach was not used were included in this study. Myocardial injury was defined as a peak troponin I level of ≥1.5 ng/mL within 48 hours after TAVI. We evaluated the predictors of myocardial injury and compared the clinical outcomes of 82 patients classified as the myocardial injury group and 44 patients classified as the non-myocardial injury group. The patients were aged 85 ± 6 years. Myocardial injury occurred in 82 patients (65.1%). Age (per 1 increase) (odds ratio [OR]: 1.11, 95% confidence interval [CI]: 1.01-1.22, P = 0.041), female sex (OR: 3.88, 95% CI: 1.23-12.22, P = 0.021), valve type (Sapien XT; OR: 4.22, 95% CI: 1.15-15.47, P = 0.03, Core valve; OR: 18.12, 95% CI: 2.86-114.59, P = 0.002), balloon aortic valvuloplasty as a bridge therapy (OR: 0.10, 95% CI: 0.02-0.42, P = 0.002), and left ventricular end-diastolic volume (LVEDV) (per 1 increase) (OR: 0.97, 95% CI: 0.95-0.99, P = 0.003) were associated with myocardial injury in a multivariate model. The myocardial injury group did not have a higher rate of midterm (365-day) mortality (log-rank test P = 0.57) than the non-myocardial injury group on Kaplan-Meier analysis. Myocardial injury after TAVI was not associated with midterm mortality.

Three-Year Clinical and Angiographic Outcomes After Everolimus-Eluting Stent Implantation in Patients With a History of Coronary Artery Bypass Grafting.

The clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stent (EES) implantation in patients with a history of coronary artery bypass grafting (CABG) have yet to be fully investigated. The aim of the present study was to investigate 3-year clinical outcomes after EES implantation in patients with a history of CABG.We retrospectively enrolled 176 consecutive patients who had undergone EES implantation. Three-year clinical follow-up data were obtained from all patients. Follow-up angiograms and serial quantitative coronary angiography analysis (QCA) were performed for 139 (79.0%) patients. Patients from the prior CABG (+) group (n = 17; 9.7%) had higher incidences of target lesion revascularization (TLR; 41.2% versus 3.8%, P < 0.001) and major adverse cardiac events (47.1% versus 15.1%, P = 0.004). A landmark analysis conducted 1 year into our study showed a higher incidence of TLR in the prior CABG (+) group (20.0% versus 3.0%, P = 0.017).The reason for EES implantation in the prior CABG (+) group was saphenous vein graft (SVG) failure in 19 (79.2%) lesions, although the target vessel was the SVG in 8 (33.3%) lesions. There were no significant differences in clinical and follow-up QCA data between the native vessel and SVG PCI groups.This study revealed that a history of CABG was a risk factor for TLR after EES implantation. The major reason for PCI after CABG was SVG failure; both native vessel and SVG PCI showed poor outcomes. Further investigations may be warranted to determine which interventions are most effective in this high-risk subset.

Quantitative optical coherence tomography analysis for late in-stent restenotic lesions.

Coronary optical coherence tomography (OCT) has the potential to identify in-stent neoatherosclerosis, which is a possible risk factor for late acute coronary events after drug-eluting stent implantation. The purpose of this study was to investigate differences between mid-term and late in-stent restenosis after stent implantation by quantitative and semiautomated tissue property analysis using OCT. In total, 1063 OCT image frames of 16 lesions in 15 patients were analyzed. This included 346 frames of 6 lesions in late in-stent restenosis, which was defined as restenosis that was not detected at 6 to 12 months but ≥ 12 months after follow-up coronary angiography. Signal attenuation was circumferentially analyzed using a dedicated semiautomated software. Attenuation was assessed along 200 lines delineated radially for analysis of the in-stent restenotic lesions (between the lumen and stent contours). All lines were anchored by the image wire to avoid artifacts resulting from wire location. Stronger signal attenuation at the frame level (2.46 ± 0.78 versus 1.47 ± 0.32, P < 0.001) and higher maximum signal intensity at the lesion level (9.19 ± 0.19 versus 8.84 ± 0.32, P = 0.018) were observed in late in-stent restenotic lesions than in mid-term in-stent restenotic lesions. OCT demonstrated stronger signal attenuation and higher maximum signal intensity in late in-stent restenotic lesions than in mid-term in-stent restenotic lesions, indicating the possibility of neoatherosclerosis.

Impact of acute gain on clinical outcomes of patients treated with sirolimus-eluting stent. - A sub-analysis study from the STLLR trial-.

BACKGROUND: Geographical miss (GM), representing suboptimal drug-eluting stent deployment, is associated with an increased risk of target lesion revascularization (TLR) and myocardial infarction. The impact of suboptimal stenting techniques on clinical outcomes in diabetics remains unknown. METHODS AND RESULTS: Stent deployment Techniques on cLinicaL outcomes of patients treated with the cypheR(TM) stent (STLLR) is the first multicenter, large trial to prospectively evaluate outcomes associated with sirolimus-eluting stent (SES) deployment techniques. Axial GM and longitudinal GM (LGM), defined as a balloon injured segment or a diseased segment not covered by a SES, were assessed by an independent core laboratory. One-year outcomes between diabetics and non-diabetics and their relationship with GM were assessed. This substudy included 1,336 patients, 28.8% with diabetes. In non-LGM patients, TLR was similarly low in both diabetics and non-diabetics (2.0% vs. 2.0%, P=NS). However, TLR increased 4.1 times in diabetics (8.0%) and 1.9 times in non-diabetics (3.8%) in the presence of LGM (P=0.03). Axial GM had no impact on outcomes. By univariate analysis, stent length, acute gain, and LGM were the predictors of TLR in the total cohort. However, by multivariate analysis, acute gain was the only predictor of TLR (P=0.03), independently of LGM or diabetes. CONCLUSIONS: Acute gain is the exclusive predictor of TLR after SES implantation. Particularly in diabetics, the negative impact of LGM on TLR seems to be amplified. Diligent SES deployment for larger acute gain is critical to improve clinical outcomes.

Online three-dimensional OFDI-guided versus angiography-guided PCI in bifurcation lesions: design and rationale of the randomised OPTIMUM trial.

AIMS: The feasibility of offline optical coherence tomography (OCT) guidance in bifurcation (with either two-dimensional or three-dimensional images) and its potential benefits have been demonstrated in retrospective studies; however, these have not yet been investigated prospectively. The aim of this trial is to determine the superiority of online three-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition (ISA) at the bifurcation segment. METHODS AND RESULTS: The OPTIMUM trial is a randomised, superiority, multicentre clinical trial. The primary endpoint of this trial is the post-procedural percentage of malapposed struts assessed by OFDI in the main branch bifurcation region after final kissing balloon dilatation (FKBD). A total of 106 patients will be randomly allocated to either 3D-OFDI guidance or angiography guidance PCI. Bifurcation lesions will be treated with a provisional single-stent strategy using the Ultimaster sirolimus-eluting stent. Patients randomised to the 3D-OFDI guidance arm will undergo OFDI assessment in the main branch (MV) after rewiring into the jailed side branch following stent implantation, while in the angiography guidance arm re-crossing of a wire into the side branch will be performed using conventional fluoroscopic/angiographic guidance. In patients in the 3D-OFDI guidance arm, if the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm the re-crossing position. The proximal optimisation technique and FKBD are mandatory in this trial. The study will provide a 90% power to show superiority of 3D-OFDI guidance PCI compared with angiography-guided PCI. CONCLUSIONS: The OPTIMUM trial will be the first prospective, randomised trial to evaluate the efficacy and safety of online 3D-OFDI-guided PCI in bifurcation lesions. ClinicalTrials.gov Identifier: NCT02972489.

Sex differences in clinical outcomes after rotational atherectomy of calcified coronary stenoses: from multicenter registry.

BACKGROUND: Recent improvements in devices and medications may diminish the risk of adverse events following percutaneous coronary intervention (PCI) in women. However, complex calcified coronary lesions are increasingly being encountered in clinical practice, which remain challenging for contemporary PCI. Rotational atherectomy (RA) of severely calcified lesions is an option that facilitates the technical success of PCI. We aimed to examine sex differences in long-term clinical prognoses after PCI with RA in the drug-eluting stent (DES) era. METHODS AND RESULTS: We evaluated J2T ROTA registry data from 1,090 patients with severely calcified de novo coronary artery stenoses who underwent PCI using RA at 3 hospitals between 2004 and 2015. After excluding patients who received regular hemodialysis, 788 patients, including 570 men and 218 women, were ultimately analyzed. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE), which included death, acute coronary syndrome (ACS), and stroke. The women were significantly older, and presented more frequently with chronic kidney disease, ACS, atrial fibrillation, lower body mass indexes, and worse lipid profiles than the men. During the observation period, MACCE occurred in 197 patients (25%) (118 deaths, 29 strokes, and 50 ACS). In the unmatched population, women had a higher MACCE rate than men (hazard ratio: 1.48, [95% confidence interval: 1.07-2.06]). However, sex was not associated with MACCE in the propensity score-matched population. CONCLUSION: In the DES era, differences between sexes were not observed in relation to long-term MACCE in patients undergoing PCI with RA for severely calcified coronary artery stenoses.

Gender Differences in the Circadian and Seasonal Variations in Patients with Takotsubo Syndrome: A Multicenter Registry at Eight University Hospitals in East Japan.

Objective The aim of this study was to clarify the circadian and seasonal variations in addition to identify sex-based differences in Japanese patients with Takotsubo syndrome (TTS). Methods The authors conducted a retrospective observational study to analyse the differences between the groups based on sex. Patients The patients were registered out of each institute registry of the acute coronary syndrome (ACS) which contains a total of 10,622 cases in eight academic hospitals in east Japan. Results Data for 344 consecutive TTS (73 male and 271 female) were extracted from each hospital registry. In-hospital mortality was higher in the male group than in the female group (18% vs. 7%; p=0.005). With regard to the circadian variations in all study patients, TTS events occurred most often in the afternoon and least often during the night. Moreover, the patterns of circadian variations in the female and male groups were the same as that of all study patients. TTS events occurred most frequently in the autumn and least often in the spring in the whole study cohort. Moreover, the seasonal variation in the female group showed the same pattern as that of the whole cohort. However, there were no significant seasonal differences in the incidence of TTS in the male group. Conclusion In a multicenter study in Japan, seasonal variation was observed in the female group but not in the male group. Circadian variation was observed in both groups. These results suggested that the pathogenesis and clinical features of TTS might therefore differ according to sex.

A Randomized Trial Evaluating Online 3-Dimensional Optical Frequency Domain Imaging-Guided Percutaneous Coronary Intervention in Bifurcation Lesions.

BACKGROUND: Clinical implications of online 3-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting for bifurcation lesions have not been investigated in the randomized controlled trials. The purpose of this study was to determine whether online 3D-OFDI-guided stenting is superior to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition at the bifurcation segment. METHODS: The OPTIMUM trial (Online 3-Dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent) was a randomized, multicenter clinical trial. Eligible patients had an angiographically significant stenosis in the bifurcation lesion treated with a provisional single stent strategy using the Ultimaster sirolimus eluting stent. Patients were randomly allocated to either online 3D-OFDI-guided or angiography-guided PCI. Patients randomized to 3D-OFDI guidance underwent online 3D-OFDI assessment after rewiring into the jailed side branch after stenting and proximal optimization technique, while in the angiography guidance arm, rewiring was performed using conventional fluoroscopic/angiographic guidance. The primary end point of this trial was the postprocedural average percentage of malapposed struts per lesion assessed by OFDI in the confluence zone of the main and side branches. RESULTS: Between June 8, 2017 and September 26, 2018, 110 patients with 111 bifurcation lesions were randomized at 4 Japanese centers. Of these, 56 patients with 57 lesions were treated with 3D-OFDI-guided PCI, whereas 54 patients with 54 lesions were treated with angiography-guided PCI. In the 3D-OFDI guidance arm, the feasibility of online 3D-OFDI was 98.2%. The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, P=0.008). The superiority of the 3D-OFDI guidance arm was also confirmed in the strut level analysis (odds ratio: 0.54 [95% CI, 0.36-0.81]; P=0.003). CONCLUSIONS: Online 3D-OFDI-guided bifurcation PCI was superior to angiography-guided bifurcation PCI in terms of acute incomplete stent apposition at bifurcation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02972489.

Prognostic Impact of Scoring Balloon Angioplasty After Rotational Atherectomy in Heavily Calcified Lesions Using Second-Generation Drug-Eluting Stents: A Multicenter Registry-Based Study.

BACKGROUND: We aimed to assess the impact of scoring balloon angioplasty (SBA) after rotational atherectomy (RA) on long-term clinical outcomes in patients who underwent percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DES). The long-term outcomes associated with SBA after RA in severely calcified lesions is unknown. METHODS: Using the J2T ROTA registry data, we evaluated the clinical events of patients who underwent PCI using RA for heavily calcified lesions from January 2004 to December 2015. A total of 307 patients who underwent PCI with second-generation DES were analyzed and divided into the SBA (n = 96) and conventional balloon angioplasty (CBA) groups (n = 211). Eighty-two and 189 patients comprised the "SBA after small burr (SBA-SB)" and "CBA after small burr (CBA-SB)" subgroups, respectively, for the subgroup analysis. Study endpoints were incidence of 3-year major adverse cardiac events (MACE), target vessel revascularization (TVR), and target lesion revascularization (TLR). RESULTS: Kaplan-Meier analysis revealed that the incidence of 3-year cumulative MACE, TVR, and TLR were comparable between groups, and that the incidences of 3-year cumulative MACE, TVR, and TLR were significantly lower in the SBA-SB subgroup than in the CBA-SB subgroup (log-rank p = 0.008; log-rank p = 0.047; log-rank p = 0.045; respectively). Multivariate Cox regression model indicated that SBA after RA was an independent predictor of MACE (hazard ratio: 0.337; 95% confidence interval: 0.139 to 0.817; p = 0.016). CONCLUSIONS: Additional SBA following RA was associated with lower MACE incidence in patients undergoing RA with a small-sized burr.

Long-term cardiovascular prognosis after rotational atherectomy in hemodialysis patients: Data from the J2T multicenter registry.

BACKGROUND: Hemodialysis (HD) patients have heavy calcium deposits in their stenotic coronary arteries and worse post-percutaneous coronary intervention (PCI) prognoses than those who do not undergo HD. Rotational atherectomy (RA) facilitates PCI success in severely calcified lesions. We aimed to identify clinical and procedural characteristics that predict HD patients' long-term prognoses after PCI that included RA in the drug-eluting stent (DES) era. METHODS: This study included 302 patients who underwent regular HD from J2T Multicenter Registry database of 1090 consecutive patients who underwent RA to treat de novo calcified lesions at three university hospitals between 2004 and 2015. The primary endpoint was cardiovascular (CV) death. RESULTS: During the 5-year observation period, 59 CV deaths (19.5%) occurred. The CV death group and non-CV death group had comparable profiles except significantly lower left ventricular ejection fraction, higher brain natriuretic peptide (BNP), lower rate of RA burr upsizing, and lower rate of final thrombolysis in myocardial infarction (TIMI) 3 flow achievement in the CV death group. Cox regression analysis revealed that increasing ablation burr size (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.13-0.81), final TIMI 3 flow (HR: 0.07; 95% CI: 0.02-0.28), lower BNP level, and optimal medication were independently associated with better CV mortality in HD patients. CONCLUSION: In the DES era, oral medications at the time of PCI and stepwise calcium ablation were associated with improved long-term CV mortality in HD patients who are scheduled to undergo RA to treat severely calcified coronary artery stenoses, as therapeutic strategies.

Efficacy and safety of transcatheter aortic valve implantation with Edwards SAPIEN 3 and XT in smaller Asian anatomy.

We aimed to compare the efficacy and safety of transcatheter aortic valve implantation (TAVI) using Edwards SAPIEN 3 (S3) valve and SAPIEN XT) in smaller anatomy. The new generation S3 TAVI device has been used worldwide; however, its efficacy and safety in smaller Asian anatomy remain unknown. Between February 2014 and March 2017, 166 consecutive patients (S3, 54; XT, 112) were treated with balloon-expandable TAVI in a single center and their outcomes were analyzed. Median patient age was 85 (range: 81-88) years and mean body surface area was 1.41 ± 0.15 m2. A 23-mm size valve was used in S3 and XT groups (70 vs. 62%, p = 0.224). The transfemoral approach was more frequently used in the S3 than in the XT group (96 vs. 72%, p < 0.001). Although, the minimal luminal diameter of the femoral artery was smaller in the S3 group (5.9 vs. 6.4 mm, p = 0.001), the rates of major (2 vs. 11%, p = 0.226) and minor (11 vs. 5%, p = 0.107) vascular complications did not increase. The frequency of paravalvular leaks (PVL) ≥ 2 was significantly reduced in the S3 group (11 vs. 61%, p < 0.001); however, pre- (24 vs. 91%, p < 0.001) and post- (4 vs. 19%, p < 0.001) dilatations were less frequently performed. Pacemaker implantation incidence did not increase (4 vs. 5%, p = 1.0) and peak velocity of the transcatheter heart valve was significantly higher in the S3 group (2.3 vs. 2.2 m/s, p = 0.046). Device success was high (89 vs. 93%, p = 0.387) while the 30-day all-cause mortality was low (2 vs. 1%, p = 0.583) in both groups. TAVI with the S3 device was safe and effective, with low incidence of vascular complications and reduced PVL, in smaller body-sized Asians.

A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound.

OBJECTIVES: The aim of this study was to evaluate the utility of distal protection during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes at high risk for distal embolization. BACKGROUND: The results of previous clinical trials indicated that the routine use of distal protection in patients with ST-segment elevation myocardial infarction did not improve clinical outcomes. However, selective use of distal protection by means of a filter-based distal protection system has not been evaluated. METHODS: Two hundred patients with acute coronary syndromes who had native coronary artery lesions and attenuated plaque with longitudinal length ≥5 mm on pre-PCI intravascular ultrasound were randomly assigned to undergo PCI with distal protection or conventional treatment. RESULTS: The primary endpoint (no-reflow phenomenon) occurred in 26 patients (26.5%) in the distal protection group and 39 patients (41.7%) in the conventional treatment group (p = 0.026), and the corrected TIMI (Thrombolysis In Myocardial Infarction) frame count after revascularization was significantly lower in the distal protection group (23 vs. 30.5; p = 0.0003). The incidence of cardiac death, cardiac arrest, cardiogenic shock after revascularization requiring defibrillation, cardiopulmonary resuscitation, or extracorporeal membrane oxygenation was significantly lower in the distal protection group than in the conventional treatment group (0% vs. 5.2%; p = 0.028). CONCLUSIONS: The use of distal embolic protection applied with a filter device decreased the incidence of the no-reflow phenomenon and was associated with fewer serious adverse cardiac events after revascularization than conventional PCI in patients with acute coronary syndromes with attenuated plaque ≥5 mm in length. (Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome [ACS] [VAMPIRE3]; NCT01460966).

Angiographic and clinical characteristics associated with the removable plaque components by means of thrombectomy catheters in patients with myocardial infarction.

BACKGROUND: Previous studies have demonstrated that atheroembolism during percutaneous coronary intervention is associated with myocardial damage. The purpose of this study is to investigate the clinical and angiographic characteristics related to removable plaque elements in patients undergoing thrombectomy for myocardial infarction. METHODS: Eighty consecutive lesions in 80 patients (M/F=58/22, age 65.5+/-11.6 years) with myocardial infarction who underwent thrombectomy (TVAC system, Nipro, Osaka, Japan) prior to mechanical dilatation (balloon angioplasty and/or stent implantation) were investigated. Visible debris was collected and plaque elements (cholesterol clefts and/or foamy cells) were investigated pathologically. Baseline angiographic characteristics [baseline thrombolysis in myocardial infarction (TIMI) grade, culprit lesion, haziness, lesion length, ostium, bifurcation, calcification, eccentricity, thrombus, and multivessel] were analyzed, and predictive angiographic and clinical factors for plaque elements were investigated. RESULTS: There were no complications related to thrombectomy. Final TIMI grade 3 and blush grade 2 or 3 were achieved in 75 (94%) and 66 (83%) patients, respectively. Visible debris specimens were obtained in 49 (61%) patients. Histological plaque elements (cholesterol clefts and/or foamy cells) were observed in 27 out of 49 patients with debris specimens. There was no significant difference in the clinical characteristics between the groups of patients with (group P) and without (group NP) plaque elements. Aspirated plaque elements were more frequently observed in discrete and eccentric lesions (group P vs. group NP: discreteness, 52% vs. 28%, P<.05; eccentricity, 67% vs. 36%, P<.05). CONCLUSIONS: This study demonstrated the clinical characteristics associated with removable plaque components in patients with myocardial infarction undergoing thrombectomy by means of the TVAC system. Discreteness and eccentricity were more frequently observed in lesions with removable plaque elements.