Outcomes of paclitaxel-coated balloon angioplasty for in-stent calcified nodule: An optical coherence tomography study.

BACKGROUND: Paclitaxel-coated balloon (PCB) angioplasty emerges as an effective therapeutic option for in-stent restenosis (ISR). However, whether PCB angioplasty would be effective for in-stent calcified nodule (ISCN) lesions remain fully understood. This study aimed to evaluate the frequency and outcomes of ISCN in patients undergoing PCB angioplasty for ISR after second-generation drug-eluting stents (G2-DES) implantation. METHODS: This study enrolled 179 lesions (160 patients) undergoing PCB angioplasty for G2-DES restenosis with optical coherence tomography guidance. According to the presence of ISCN at the minimum lumen area, the lesions were divided into two groups: the ISCN (n = 16) and the non-ISCN groups (n = 163). The primary study endpoint was the cumulative 3-year incidence of target lesion failure (TLF; a composite of cardiac death, clinically driven target vessel revascularization, and definite stent thrombosis) on a lesion basis. RESULTS: ISCN was observed in 16 of 179 lesions (8.9%). Cumulative 3-year incidence of TLF was significantly higher in the ISCN group than in the non-CN group (85.3% vs. 16.9%, inverse probability weighted hazard ratio [HR] 4.46, 95% confidence intervals [CIs]: 2.42-8.22, p < 0.001). Risk factors associated with TLF were ISCN (HR 4.55, 95% CI: 1.56-13.3, p = 0.005), recurrent ISR (HR 2.82, 95% CI: 1.50-3.30, p = 0.001), and early ISR (HR 2.18, 95% CI: 1.21-3.92, p = 0.009). CONCLUSION: ISCN was observed in 8.3% of G2-DES restenosis. PCB angioplasty had little effect on ISCN lesions compared with non-ISCN lesions, suggesting the need for careful clinical follow-up of patients with ISCN lesions after PCB angioplasty.

Clinical impact of calcified nodule in patients with heavily calcified lesions requiring rotational atherectomy.

OBJECTIVES: We sought to evaluate the incidence and clinical impact of calcified nodule (CN) in patients with heavily calcified lesions requiring rotational atherectomy (RA). BACKGROUND: It remains unclear whether CN impacts adversely on clinical outcomes in patients with heavily calcified lesions. METHODS: Between January 2011 and February 2014, 264 patients after second-generation drug-eluting stent (DES) implantation following RA were retrospectively enrolled. CN was defined as a convex shape of the luminal side of calcium as assessed by intravascular ultrasound. The primary endpoint was the cumulative 5-year incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, clinically driven target lesion revascularization (CDTLR), and definite stent thrombosis (ST). RESULTS: CN was observed in 128 patients (48.5%) with heavily calcified lesions. Cumulative 5-year incidence of MACE was significantly higher in the CN group than in the non-CN group, mainly driven by a higher rate of CDTLR and ST (35.4% vs. 18.8%, p < .001; 23.2% vs. 7.9%, p < .001; 7.0% vs. 0.93%, p = .009, respectively). Independent risk factors of 5-year MACE included hemodialysis (hazard ratio [HR] = 3.39, 95% confidence intervals [CI]: 2.00-5.73, p < .001), CN (HR = 2.53, 95% CI: 1.49-4.27, p < .001), ostial lesion (HR = 3.02, 95% CI: 1.58-5.78, p = .001), left ventricular ejection fraction ≤40% (HR = 2.17, 95% CI: 1.27-3.70, p = .005), and right coronary artery lesion (HR = 1.82, 95% CI: 1.07-3.11, p = .03). CONCLUSIONS: CN was observed in 48.5% of heavily calcified lesions, resulting in unfavorable long-term clinical outcomes after second-generation DES implantation following RA.

Clinical Outcomes After Percutaneous Coronary Intervention in Patients With Cancer.

BACKGROUND: The aim of this study is to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with cancer.Methods and Results:Cancer screening was recommended before PCI in consecutive 1,303 patients who underwent their first PCI. By using cancer screening, cancer was diagnosed in 29 patients (2.2%). In total, 185 patients had present or a history of cancer. Patients with cancer more often suffered from non-cardiac death than those without (4.4% vs. 1.5%, P=0.006), and patients with cancer requiring ongoing therapy (n=18) more often suffered from major bleeding compared with those with recently (≤12 months) diagnosed cancer who do not have ongoing therapy (n=59) (16.7% vs. 3.4%, P=0.049). During the 1-year follow up, 25 patients (2.0%) were diagnosed as having cancer, in which 48.0% of bleeding events led to a cancer diagnosis. Patients with high bleeding risk according to the Academic Research Consortium for high bleeding risk (ARC-HBR) were associated with a greater 1-year major bleeding risk than those without high bleeding risk in patients with (7.9% vs. 0.0%, P=0.02) and without cancer (7.1% vs. 2.5%, P<0.001), respectively. CONCLUSIONS: Cancer was diagnosed in 2.2% of 1,303 unselected patients before PCI by cancer screening and in 2.0% within 1-year after PCI. Cancer was associated with a greater risk of non-cardiac death, whereas ongoing active cancer was associated with greater risk of major bleeding. ARC-HBR criteria successfully identified high-bleeding risk patients, irrespective of the presence or absence of cancer.

Five-Year Clinical Outcomes After Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions.

BACKGROUND: Percutaneous coronary intervention for heavily calcified lesions requires rotational atherectomy (RA). Long-term clinical outcomes after drug-eluting stent (DES) implantation following (RA) for heavily calcified lesions remain unclear. We assessed 5-year clinical outcomes after DES implantation following RA.Methods and Results:Between March 2006 and September 2011, 219 consecutive patients with 219 lesions treated with DES following RA, were retrospectively enrolled. The cumulative 5-year incidence of target-lesion revascularization (TLR) and definite stent thrombosis (ST) were assessed. The cumulative incidence of TLR within (≤) the first year was 18.6%. Late TLR beyond (>) 1 year continued to occur at 1.9% per year without a decrease in the rate (5-year incidence, 26.0%). The cumulative incidence of definite ST at 30 days, 1 and 5 years was 0.9%, 2.3% and 2.9%, respectively. The annual rate of definite ST beyond 1 year was 0.15%. On multivariate analysis, the significant predictor of TLR within 1 year was use of first-generation DES (hazard ratio [HR], 2.09; 95% CI: 1.10-4.03, P=0.02) and that of TLR beyond 1 year was hemodialysis (HR, 3.29; 95% CI: 1.06-10.55, P=0.04). CONCLUSIONS: Late TLR beyond 1 year continued to occur up to 5 years at a constant annual incidence, whereas very late ST was rare. Careful long-term clinical follow-up is continually needed in patients who have already received DES following RA for heavily calcified lesions.

Impact of lesion complexity on long-term vascular response to cobalt-chromium everolimus-eluting stent: five-year follow-up optical coherence tomography study.

The impact of lesion complexity on long-term vascular response to cobalt-chromium everolimus-eluting stent (CoCrEES) remains unclear. We sought to evaluate them using optical coherence tomography (OCT). A total of 47 patients with 58 lesions treated only with CoCrEES and no target-vessel events within 5 years after implantation were prospectively enrolled and underwent 5-year follow-up OCT. Quantitative parameters and qualitative characteristics of the neointima were evaluated using multilevel logistic or linear regression models with random effects at three levels: lesion, cross-section (CS), and strut. According to the lesion complexity, the lesions were classified into the two groups: the complex lesion (CL) and non-CL group. The CL was defined as having at least 1 high-risk feature such as acute coronary syndrome lesion, lesion length > 20 mm, severe calcification requiring rotational atherectomy, and chronic total occlusion at the index procedure. A total of 11,034 struts (CL, n = 6240; non-CL, n = 4794) and 1202 (CL, n = 683; non-CL, n = 519) CSs were analyzed. The percentage of uncovered and malapposed struts did not differ significantly between the CL and non-CL groups (0.90 vs. 0.54%, P = 0.78; 0.56 vs. 0.10%, P = 0.16, respectively). The incidence of neoatherosclerosis was comparable between both groups in the CS- and lesion-level analysis (3.5 vs. 4.6%, P = 0.91; 32.0 vs. 24.2%, P = 0.52, respectively). At 5 years, CoCrEES shows an excellent vascular healing and similar frequency of neoatheroslerosis in patients without target-vessel events, regardless of the lesion complexity.

Difference of Tissue Characteristics Between Early and Late Restenosis After Second-Generation Drug-Eluting Stents Implantation　- An Optical Coherence Tomography Study.

BACKGROUND: The mechanism and time course of in-stent restenosis (ISR) after implantation of second-generation DES have not yet been fully elucidated. We sought to evaluate the differences in tissue characteristics between the different phases of ISR after second-generation DES implantation using optical coherence tomography (OCT).Methods and Results:From June 2010 to December 2015, 324 consecutive patients with 337 ISR lesions underwent OCT. Of these, we analyzed 53 lesions in 53 patients who had their first ISR after second-generation DES implantation and underwent OCT before any procedures. According to the timing of ISR, the patients were divided into the early group (within 1 year: E-ISR, n=30) and late group (beyond 1 year: L-ISR, n=23). Quantitative parameters and qualitative characteristics of the neointima were evaluated. In the minimum lumen area site analysis, the E-ISR group had more frequently homogeneous intima than the L-ISR group (26.7% vs. 4.4%, P=0.02). The frequencies of neointima with lipid-laden, thin-cap fibroatheroma, neovascularization and macrophage infiltration were significantly higher in the L-ISR group than in the E-ISR group (30.0% vs. 69.6%, P<0.01; 0.0% vs. 26.1%, p <0.01; 6.7% vs. 26.1%, P=0.049; 3.3% vs. 26.1%, P=0.01, respectively). CONCLUSIONS: Neointimal tissue characteristics differed between E-ISR and L-ISR after second-generation DES implantation. E-ISR was mainly caused by neointimal hyperplasia, whereas neoatherosclerosis was the main mechanism of L-ISR.

Two-Year Clinical Outcomes of Newer-Generation Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions.

BACKGROUND: Clinical outcomes of implantation of the newer-generation drug-eluting stent (DES) following rotational atherectomy for heavily calcified lesions remain unclear in the real-world setting. METHODS AND RESULTS: We enrolled 252 consecutive patients (273 lesions) treated with newer-generation DES following rotational atherectomy. The primary endpoint was the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as cardiac death, myocardial infarction, clinically-driven target lesion revascularization, and definite stent thrombosis. Complete clinical follow-up information at 2-year was obtained for all patients. The mean age was 73.2±9.0 years and 155 patients (61.5%) were male. Cumulative 2-year incidence of MACE (cardiac death, myocardial infarction, clinically-driven target lesion revascularization and definite stent thrombosis) was 20.3% (7.0%, 2.1%, 18.1% and 2.1%, respectively). Predictors of MACE were presenting with acute coronary syndrome (hazard ratio [HR]: 3.80, 95% confidence interval [CI]: 1.29-11.2, P=0.02), hemodialysis (HR: 1.93, 95% CI: 1.04-3.56, P=0.04) and previous coronary artery bypass graft (HR: 2.26, 95% CI: 1.02-5.00, P=0.045). CONCLUSIONS: PCI for calcified lesions requiring rotational atherectomy is still challenging even in the era of newer-generation DES.

Prognostic significance of baseline low-density lipoprotein cholesterol in patients undergoing coronary revascularization; a report from the CREDO-Kyoto registry.

BACKGROUND: The impact of very low baseline levels of low-density lipoprotein cholesterol (LDL-C) on patients with coronary artery disease remains unclear. METHOD: We enrolled 39,439 patients of the pooled population from the CREDO-Kyoto registries Cohorts 1, 2, and 3. The study population consisted of 33,133 patients who had undergone their first coronary revascularization. We assessed the risk for mortality and cardiovascular events according to quintiles of the baseline LDL-C levels. RESULTS: Patients in the very low LDL-C quintile (<85 mg/dL) had more comorbidities than those in the other quintiles. Lower LDL-C levels were strongly associated with anemia, thrombocytopenia, and end-stage renal disease. The cumulative 4-year incidence of all-cause death increased as LDL-C levels decreased (very low: 19.4 %, low: 14.5 %, intermediate: 11.1 %, high: 10.0 %, and very high: 9.2 %; p < 0.001), which was driven by both the early and late events. After adjusting for baseline characteristics, the adjusted risks of the very low and low LDL-C quintiles relative to the intermediate LDL-C quintile remained significant for all-cause death (very low: HR 1.29, 95 % CI 1.16-1.44, p < 0.001; low: HR 1.15, 95 % CI 1.03-1.29, p = 0.01). The excess adjusted risks of the lowest LDL-C quintile relative to the intermediate LDL-C quintile were significant for clinical outcomes such as cardiovascular death (HR 1.17, 95 % CI 1.01-1.35), non-cardiovascular death (HR 1.35, 95 % CI 1.15-1.60), sudden death (HR 1.44, 95 % CI 1.01-2.06), and heart failure admission (HR 1.11 95 % CI 1.01-1.22), while there was no excess risk for the lowest LDL-C quintile relative to the intermediate LDL-C quintile for myocardial infarction and stroke. CONCLUSIONS: Lower baseline LDL-C levels were associated with more comorbidities and a significantly higher risk of death, regardless of cardiovascular or non-cardiovascular causes, in patients who underwent coronary revascularization.

Efficacy of fluid assessment based on intrathoracic impedance monitoring in patients with systolic heart failure.

BACKGROUND: Previous studies have demonstrated that intrathoracic impedance monitoring (IIM) is associated with fluid overload. However, it remains unclear whether this new technology can predict heart failure (HF) before deterioration. Whether fluid status based on IIM predicts HF in patients with left ventricular (LV) systolic dysfunction was investigated. METHODS AND RESULTS: A prospective clinical observational study of 123 patients implanted with IIM-capable cardiac devices was carried out. The primary endpoint was the positive predictive value (PPV) at 12 months. Secondary endpoints were a correlation between onset of HF and IIM, optimal threshold of fluid index and duration between the alert and HF. Complete follow-up clinical data were obtained from 111 patients. During the observational period, 168 alerts were confirmed from 68 patients. In patient-based analysis (alert-based analysis), PPV was 33.8% (33.9%). Sensitivity, specificity and false positive was 67.6% (83.8%), 49.4% (28.4%) and 50.6% (71.6%), respectively. Mean duration between the alert and HF event was 21.4 ± 6.1 days. On multivariate logistic analysis, maximum fluid index, LV ejection fraction and atrial fibrillation were independent predictors of HF events. The optimal cut-off value determined by receiver operating characteristic curve was 114-ohm·day with sensitivity and specificity of 89.5% and 73.0%, respectively. CONCLUSIONS: IIM-based fluid index in patients with HF due to LV systolic dysfunction was effective in predicting worsening HF.

Transient Asystole From Pacing Inhibition During Percutaneous Coronary Intervention.

A 68-year-old man with a biventricular implantable cardioverter-defibrillator who was pacemaker dependent was admitted for percutaneous coronary intervention. The patient had an asystolic cardiac arrest as a result of electromagnetic interference during an orbital atherectomy. We should keep electromagnetic interference from the machine in mind when performing orbital atherectomy. (Level of Difficulty: Beginner.).

Frailty and Bleeding After Percutaneous Coronary Intervention.

The aim of this study was to evaluate the predictive ability of frailty for bleeding after percutaneous coronary intervention (PCI). In 2439 patients who underwent their PCI, frailty was prospectively assessed according to the Canadian Study of Health and Aging clinical frailty scale (CFS). Patients were divided into three groups according to the CFS: low (CFS levels 1 to 3; 1748 patients, 71.7%), intermediate (CFS levels 4 to 6; 519 patients, 21.3%), and high CFS groups (CFS levels 7 to 9; 172 patients, 7.1%). Academic Research Consortium High Bleeding Risk (ARC-HBR) was present in 47.3% in the low CFS group, in 83.2% in the intermediate CFS group and in 89.0% in the high CFS group (p <0.001). Patients in the intermediate and high CFS groups were associated with higher 1-year major bleeding risk after PCI in the overall cohort (HR 3.82, 95% CI 2.65 to 5.51, p <0.001, and HR 7.81, 95% CI 5.07 to 12.0, p <0.001, respectively). Patients in the high CFS group were also associated with higher 1-year major bleeding risk regardless of having the high bleeding risk (HBR) according to ARC-HBR. In conclusion, the association of frailty with 1-year major bleeding was consistently observed in patients with and without HBR, indicating that frailty per se might be a predictor for major bleeding after PCI on top of HBR criteria.

The impact of frailty according to Clinical Frailty Scale on clinical outcome in patients with heart failure.

AIMS: There is currently no gold standard in evaluating frailty in patients with heart failure (HF), and the prognostic value of frailty according to the Canadian Study of Health and Aging Clinical Frailty Scale (CFS) on mortality in patients with HF is still unknown. METHODS AND RESULTS: Among consecutive 596 patients after their discharge from HF in Kokura Memorial Hospital (Kitakyushu, Japan) during 2015, their frailty at discharge was assessed according to CFS. Patients were classified into three groups: low (N = 232, 38.9%), intermediate (N = 230, 38.6%), and high (N = 134, 22.5%). The primary endpoint was defined as 2 year all-cause death. The mean age was 76.6 ± 10.1 years, and 55.3% were men in entire cohort. There were significant differences in age, living environment, and dementia among low, intermediate, and high CFS groups. Left ventricular ejection fraction (LVEF) and co-morbidities such as severe renal failure and severe anaemia tended to increase with frailty severity, while body mass index (BMI) and albumin level tended to decrease with frailty severity. Two year cumulative incidences of all-cause death for the three groups were 12.8%, 25.4%, and 52.7% (P < 0.001), respectively. This significant difference in the risk for all-cause death among the CFS groups was driven by the risk for cardiac (8.6%, 14.2%, and 31.0%, respectively, P < 0.001) and non-cardiac death (4.6%, 13.0%, and 31.4%, respectively, P < 0.001). The multivariate analysis showed that high frailty was independently associated with all-cause death (intermediate CFS group: adjusted hazard ratio, 1.43, 95% confidence interval, 0.86-2.36, P = 0.16; high CFS group: adjusted hazard ratio, 3.90, 95% confidence interval, 2.32-6.55, P < 0.001), and this result was consistent, irrespective of stratification based on age, sex, BMI, and LVEF without significant interaction. CONCLUSIONS: The simple CFS tool was successful in predicting the risk for all-cause death in patients with HF, and frailty according to CFS was independently associated with all-cause death irrespective of stratification based on age, sex, BMI, and LVEF without significant interaction. The CFS is a valuable prognostic tool in clinical settings.

Clinical significance of the summating potential-action potential ratio and the action potential latency difference for condensation and rarefaction clicks in Meniere's disease.

OBJECTIVES: This study was aimed to elucidate the diagnostic significance of the summating potential (SP)-action potential (AP) ratio and the AP latency difference between condensation and rarefaction clicks (AP con-rar difference) in Meniere's disease. METHODS: The AP and SP were recorded transtympanically in 67 patients with definite Meniere's disease. The SP/AP ratio and the AP con-rar difference were assessed in terms of 1) their interrelationship, 2) their relationship to hearing level, and 3) the rate of occurrence of abnormal values according to the stages of Meniere's disease. RESULTS: No correlation was found between the SP/AP ratio and the AP con-rar difference. Neither the SP/AP ratio in general nor the AP con-rar difference was correlated with the hearing level. However, enhanced values of the SP/AP ratio (0.35 or higher) were moderately correlated with the hearing level (r = 0.51), and their occurrence rate was 55.2%. An increased AP con-rar difference (0.13 ms or longer) was not correlated with the hearing level, and its occurrence rate was 50.2%; it appeared most frequently at stage 3 (p <0.05). CONCLUSIONS: An enhanced SP/AP ratio might not always indicate the presence of endolymphatic hydrops associated with an increase in endolymphatic pressure. An increased AP con-rar difference might reflect the presence of a biased basilar membrane resulting from an increased endolymphatic pressure, and hence it is diagnostically essential to simultaneously evaluate the SP/AP ratio and the AP con-rar difference.

Impact of preprocedural atrial fibrillation on immediate and long-term outcomes after successful percutaneous mitral valvuloplasty of significant mitral stenosis.

Optimal time to perform percutaneous mitral valvuloplasty (PMV) for patients with significant mitral stenosis (MS) and atrial fibrillation (AF) remains controversial. We sought to identify prognostic factors and evaluate long-term clinical outcomes after PMV of 77 consecutive patients with MS with a mitral valve area (MVA) <1.5 cm2. According to baseline heart rhythm, these patients were divided into sinus rhythm (SR; n = 24) and AF (n = 53) groups. The study endpoint was defined as a composite of all-cause mortality, admission for heart failure, mitral valve surgery, repeated PMV, and major cerebral vascular accident during follow-up. After successful PMV, there was no significant difference between the two groups in post-MVA and post-mitral mean pressure gradient. However, the New York Heart Association Functional Classification post-procedure was worse in the AF group (p < 0.01). In the AF group, event-free survival during follow-up was significantly lower compared with that of the SR group (p = 0.016). Independent predictors of clinical events were AF [hazard ratio (HR), 2.73; 95 % confidence interval (CI), 1.04-9.36; p = 0.03] and pulmonary artery systolic pressure (HR 2.57; 95 % CI 1.18-5.47; p = 0.017). Patients with AF at baseline were significantly associated with worse symptoms and higher event rates after successful PMV compared with those with SR. The clinical benefit of PMV may be considered for patients with MVA <1.5 cm2 before the onset of AF.

Impact of Baseline Thrombocytopenia on Bleeding and Mortality After Percutaneous Coronary Intervention.

It is still controversial whether baseline thrombocytopenia is independently associated with adverse events after percutaneous coronary intervention. We evaluated the influence of baseline thrombocytopenia against ischemic, bleeding and mortality among the 19,353 patients whose baseline platelet counts were available in the pooled database from the 3 studies in Japan. Baseline thrombocytopenia was classified as follows: mild, ≥100 and <150 × 109/L; moderate, ≥50 and <100 × 109/L; and severe, <50 × 109/L. Primary ischemic outcome measure was defined as composite of myocardial infarction and ischemic stroke, and primary bleeding outcome measure was defined by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded arteries trial as moderate or severe bleeding. There were 2,590 patients (13.4%) with baseline thrombocytopenia comprising 292 patients (1.5%) with moderate/severe (moderate: 277 and severe: 15) thrombocytopenia and 2,298 patients (11.9%) with mild thrombocytopenia, whereas 16,763 patients (86.6%) had no thrombocytopenia. During 3-year follow-up, the adjusted risks of moderate/severe and mild thrombocytopenia relative to none were neutral for primary ischemic outcome (hazard ratio [HR] 1.07 [95% confidence interval [CI] 0.72 to 1.60], p = 0.74, and HR 0.93 [0.79 to 1.09], p = 0.37, respectively) but were significantly higher for primary bleeding outcome (HR 2.35 [1.80 to 3.08], p <0.001, and HR 1.20 [1.03 to 1.40], p = 0.02), and for mortality (HR 2.34 [1.87 to 2.93], p <0.001, and HR 1.26 [1.11 to 1.43], p <0.001). In conclusion, patients with baseline thrombocytopenia, even a mild one, had a higher risk of bleeding events and all-cause death, but not for ischemic events after percutaneous coronary intervention.

Incidence and Long-Term Clinical Impact of Late-Acquired Stent Fracture After Sirolimus-Eluting Stent Implantation in Narrowed Coronary Arteries.

The incidence and long-term clinical impact of stent fracture (SF) occurred beyond 1 year after sirolimus-eluting stent (SES) implantation remains unclear. From April 2004 to March 2008, 985 consecutive patients with 1,307 lesions were treated only with SES. Of these, 868 patients (88.1%) with 1,140 lesions underwent follow-up angiography within 1 year after the index procedure, and 646 patients (65.6%) with 872 lesions underwent it both within and beyond 1 year after the index procedure. According to the diagnosed timing of SF, we divided the patients into the 2 groups: early SF (<1 year after the index procedure) and late-acquired SF (>1 year after the index procedure). Early- and late-acquired SFs were observed in 64 of 868 patients (7.4%) and 66 of 1,140 lesions (5.8%); 12 of 646 patients (1.9%) and 12 of 872 lesions (1.4%), respectively. Cumulative 10-year incidence of clinically driven target lesion revascularization and definite stent thrombosis were numerically higher in the early- and late-acquired SF groups than in the non-SF group (41.6% vs 45.5% vs 19.0%; 8.0% vs 8.3% vs 2.0%, respectively). In conclusion, late-acquired SF after SES implantation occurred in 1.4% of lesions, which was lower than that of early SF. However, both early- and late-acquired SFs appeared to be associated with clinically driven target lesion revascularization and stent thrombosis during the long-term follow-up.

Incidence and Clinical Impact of Stent Fracture After PROMUS Element Platinum Chromium Everolimus-Eluting Stent Implantation.

OBJECTIVES: This study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES). BACKGROUND: SF remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era. METHODS: From March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure. RESULTS: SF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio [OR]: 14.2, 95% confidence intervals [CI]: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%). CONCLUSIONS: SF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization.

Video-assisted submandibular sialadenectomy using an ultrasonic scalpel.

OBJECTIVE: To evaluate the benefits in video-assisted submandibular sialadenectomy by using an ultrasonically activated scalpel (HS: Harmonic Scalpel(R), Ethicon, Somerville, NJ) and a special handmade lifting device. METHODS: The study cohort consisted of four male patients. We considered that the intraglandular part sialolithiasis of the submandibular glands was the main indicator for this technique. Under general anesthesia, a 15-20 mm skin incision was performed just above the inferior margin of the submandibular gland lying parallel to the mandible. We used a 4 mm diameter endoscope that we normally use for paranasal sinus surgery. Appropriate working space was created using a special handmade lifting device that was constructed from a wooden tongue depressor. By using HS, we dissected between the capsule and the circumferential tissue in order to minimize the possibility of damage to the facial nerve and lingual nerve. The submandibular gland was pulled out through the surgical wound, and Wharton's duct was then suture-ligated and resected. RESULTS: Endoscopic operation without recourse to conventional open surgery was achieved in all patients. No patients suffered any complications, such as functional disorder of the marginal mandibular, hypoglossal and lingual nerves, or wound hematoma formation. Excellent cosmesis was obtained in all patients. The amount of intraoperative bleeding ranged from 10 to 60 ml (mean: 38.0 ml). The operating time ranged from 175 to 250 min (mean: 232.5 min). CONCLUSIONS: We applied two useful devices to achieve the endoscopic submandibular surgery: an HS and a special handmade lifting device. Excellent cosmesis was obtained in all patients without complications. The disadvantage of this method is that the surgery is more time-consuming than conventional open methods.