Effect of QRS Morphology and Duration on Clinical Outcomes After Cardiac Resynchronization Therapy　- Analysis of Japanese Multicenter Registry.

BACKGROUND: QRS duration (QRSd) and morphology are established response predictors of cardiac resynchronization therapy (CRT). However, evidence in Japanese populations is lacking.Methods and Results:We retrospectively analyzed the Japanese multicenter CRT database. We divided patients according to their intrinsic QRSd and morphology, and assessed echocardiographic responses and clinical outcomes. The primary endpoint was a composite of all-cause death or hospitalization because of heart failure. A total of 510 patients were enrolled: 200 (39%) had left bundle branch block (LBBB) and QRSd ≥150 ms; 80 (16%) had LBBB (QRSd: 120-149 ms); 61 (12%) had non-LBBB (NLBBB) (QRSd: ≥150 ms); 54 (11%) had NLBBB (QRSd: 120-149 ms); 115 (23%), narrow (<120 ms). The proportion of echocardiographic responders was higher in LBBB (QRSd ≥150 ms) [74% vs. 51% vs. 38% vs. 52% vs. 50%, LBBB (QRSd ≥150 ms) vs. LBBB (QRSd 120-149 ms) vs. NLBBB (QRSd ≥150 ms) vs. NLBBB (QRSd 120-149 ms) vs. narrow, respectively, P<0.001]. During follow-up (3.2±1.5 years), the incidence of the primary endpoint was lowest in the LBBB group (QRSd ≥150) (28.6% vs. 42.3% vs. 45.9% vs. 55.6% vs. 55.3%, respectively, P<0.001). This difference was still significant after adjusting for other baseline characteristics. CONCLUSIONS: In this Japanese patient population, LBBB intrinsic QRS morphology and prolonged QRSd (≥150 ms) exhibited the best response to CRT.

Vascular response after Zilver PTX stent implantation for superficial femoral artery lesions: serial optical coherence tomography findings at 6 and 12 months.

PURPOSE: To compare the vascular response after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation for superficial femoral artery lesions after 6 and 12 months using optical coherence tomography (OCT). METHODS: Serial OCT examinations were performed in 5 patients (4 men; mean age 78.4 ± 6.8 years) with 9 Zilver PTX stents at 6- and 12-month follow-up. Variables evaluated included neointimal thickness and apposition on each strut, the incidence of extrastent lumen (ESL), peristrut low-intensity area (PLIA), and neovascularization at 1-mm intervals. RESULTS: A total of 249 matched cross-section images were evaluated and included 4788 and 4826 struts at 6 and 12 months, respectively. Mean neointimal thickness significantly increased from 480 to 540 µm between 6 and 12 months (p < 0.001). The percentage of uncovered struts tended to decrease at 12 months (3% vs. 2.3%, p = 0.054), whereas the percentage of malapposed struts were similar at both examinations (0.2% vs. 0.2%, p > 0.99). Although the incidence of ESL in cross sections was not different (35% vs. 31%, p = 0.29), median ESL area significantly increased from 6 to 12 months [0.12 (0.04-0.36) vs. 0.31 (0.14-0.59) mm(2), p = 0.003)]. The presence of PLIA (29% vs. 44%, p < 0.001) and neovascularization (14% vs. 27%, p < 0.001) increased from 6 to 12 months. CONCLUSION: These findings suggest that delayed vascular healing and persistent peristent inflammation may be present even at 12 months after Zilver PTX implantation.

Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.

BACKGROUND: There is a scarcity of long-term data from large-scale drug-eluting stent registries with a large enough sample to evaluate low-frequency events such as stent thrombosis (ST). METHODS AND RESULTS: Five-year outcomes were evaluated in 12 812 consecutive patients undergoing sirolimus-eluting stent (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30 day, 0.3%; 1 year, 0.6%; and 5 years, 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after sirolimus-eluting stent implantation (0.26%/y). Cumulative incidence of target lesion revascularization within the first year was low (7.3%). However, late target lesion revascularization beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/y). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting the presence of different pathophysiological mechanisms of ST according to the timing of ST onset: acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST; side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST; and current smoking and total stent length >28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization. CONCLUSION: Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.

Impact of post-challenge hyperglycemia on clinical outcomes in Japanese patients with stable angina undergoing percutaneous coronary intervention.

BACKGROUND: Post-challenge hyperglycemia (PH) is well-established as one of risk factors for coronary artery disease. However, it remains unclear whether PH affects clinical outcomes in patients with stable angina undergoing percutaneous coronary intervention (PCI). METHODS: A total of 828 patients with stable angina undergoing PCI were retrospectively analyzed. Of these, 452 patients with previously diagnosed diabetes mellitus (DM) or fasting plasma glucose (PG) ≥126 mg/dl and HbA1c ≥6.5% were defined as known DM. The remaining 376 patients were divided into the two groups according to 2-h PG: PH (2-h PG ≥140 mg/dl, n=236) and normal glucose tolerance (NGT, 2-h PG <140 mg/dl, n=140). We assessed the rate of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, and clinically-driven revascularization. RESULTS: During the median follow-up of 4.3 years, the MACE rate was significantly higher in the DM and PH groups than the NGT group (39.3% vs. 20.7%, P <0.001; 31.4% vs. 20.7%, P=0.044, respectively). Compared with the NGT group, the cumulative incidence of revascularization was significantly higher in the DM group (35.1% vs. 18.5%, P <0.001) and tended to be higher in the PH group (27.1% vs. 18.5%, P=0.067). In the multivariate analysis, known DM (Hazard ratio [HR]: 2.16, 95% confidence interval (CI): 1.49-3.27, P < 0.001), PH (HR: 1.62, 95% CI: 1.07-2.53, P = 0.023), LDL-C >100 mg/dl (HR: 1.62, 95% CI: 1.26 to 2.10, P < 0.001), and previous stroke (HR: 1.47, 95% CI: 1.03-2.04, P = 0.034) were predictors of MACE. CONCLUSION: PH is associated with future cardiovascular events in patients with stable angina undergoing PCI.

Prevalence and clinical outcome of polyvascular atherosclerotic disease in patients undergoing coronary intervention.

BACKGROUND: The goal of this study was to evaluate the prevalence and outcomes of polyvascular disease (polyVD; defined as lower extremity artery disease, carotid artery disease, renal artery disease, or abdominal aortic aneurysm) in patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: The subjects were 1,597 patients who underwent PCI and who were prospectively enrolled in the study. The carotid, renal and peripheral arteries and abdominal aorta were simultaneously evaluated using duplex ultrasound and ankle-brachial index to evaluate the presence of polyVD. The primary endpoint was major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction [MI], and stroke). PolyVD was found in 446 of 1,597 patients (27.9%). MACE were significantly higher in the polyVD group compared to those with coronary artery disease (CAD) alone (n=1,151; 12.1% vs. 3.8%, P<0.0001). The incidence of cardiovascular death and stroke were significantly higher in the polyVD group (7.9% vs. 1.6%, P<0.0001; 3.6% vs. 1.2%, P=0.006, respectively). The incidence of MI was similar in the 2 groups (3.7% vs. 1.3%, P=0.08). The adjusted hazard ratios for MACE in patients with 1, 2, and 3 arterial beds (compared with CAD alone) increased from 1.64 to 1.74 to 10.62 (P<0.0001). CONCLUSIONS: There was a high incidence of MACE in patients with polyVD undergoing PCI and this incidence increased with the number of arterial beds.

Long-term prognosis of patients with Kawasaki disease complicated by giant coronary aneurysms: a single-institution experience.

BACKGROUND: Some patients with Kawasaki disease develop giant coronary aneurysms and coronary stenosis, leading to ischemic heart disease. The aim of this study was to determine the long-term prognosis of patients with Kawasaki disease with giant aneurysms. METHODS AND RESULTS: From our institutional database, 76 patients (57 men and 19 women) who developed giant aneurysms after January 1, 1972, were identified. Information on patient demographics, catheter and surgical interventions, and most recent status was collected from medical charts and patients' contacts. From these data, we calculated the survival rate and cumulative coronary intervention rate. The average age at onset was 2.9±2.9 years, and the median observational period was 19 years. During this period, 7 patients died and 1 patient underwent a heart transplantation, resulting in 95%, 88%, and 88% survival rates at 10, 20, and 30 years after the onset of KD, respectively. On the other hand, catheter and surgical coronary interventions (median, 1 intervention; range, 1 to 7 interventions) were performed to alleviate coronary ischemia in 46 patients (61%) at 1 month to 21 years (mode at 1 month) after onset, resulting in 28%, 43%, and 59% cumulative coronary intervention rates at 5, 15, and 25 years after onset, respectively. CONCLUSIONS: The long-term survival of patients with Kawasaki disease complicated by giant coronary aneurysms is moderately good with multiple catheter and surgical interventions. Further research should focus on the prevention of coronary vascular remodeling and on the indications for and effectiveness of percutaneous and surgical coronary interventions.

Restenosis after stent implantation for superficial femoral artery disease in patients treated with cilostazol.

BACKGROUND: Restenosis after endovascular treatment for superficial femoral artery (SFA) disease remains a significant clinical issue. We assessed whether cilostazol reduce restenosis after SFA stenting with self-expandable nitinol stent. METHODS: The study was a multicenter, prospective maintained database, retrospective analysis. From April 2004 to December 2009, 861 consecutive patients (mean age 71 years, 71% male) who underwent successful stenting for de novo lesions were retrospectively identified. Of them, 492 received cilostazol (cilostazol(+)) and 369 did not receive cilostazol (cilostazol(-)) after procedure. Propensity-score analyses matched 281 cilostazol(+) with 281 cilostazol (-) group. Primary endpoint was binary restenosis rate. Secondary endpoints were reocclusion, all-cause mortality and limb salvage in patients with critical limb ischemia (CLI). Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex. RESULTS: Mean follow-up period was 25 months. According to analysis of matched pairs, binary restenosis rates were significantly lower (31.2% vs. 42.9% at 5-year, P = 0.02). In-stent re-occlusion rate tended to be lower in patients who received cilostazol (10.8% vs. 18.2% at 5-year, P = 0.09) compared with control. No significant difference of all-cause mortality (21.4% vs. 18.3% at 5-year, P = 0.84) and limb salvage rate in patients with CLI (86.2% vs. 78.5% at 5-year, P = 0.29) was found between both groups. After adjustment for prespecified risk factors, cilostazol was an independent negative predictor of restenosis. In subgroup analysis, male, age <75 years, claudicant patients, TASCII C/D, small vessels and poor runoff vessel was significantly lower in binary restenosis. CONCLUSIONS: Cilostazol reduced restenosis after SFA stenting with self-expandable nitinol stent and it seems to be more effective in high-risk patients for restenosis.

Primary percutaneous coronary intervention for acute myocardial infarction in the elderly aged ≥75 years.

OBJECTIVES: We aimed to see whether primary percutaneous coronary intervention (PCI) benefits for ST-segment elevation myocardial infarction (STEMI) in the aged could be validated. BACKGROUND: Primary PCI benefits in elderly patients with STEMI remain uncertain. METHODS: We reviewed 947 consecutive patients treated with primary PCI for STEMI: 331 were aged ≥75 years (older) and 616 <75 years (younger). RESULTS: The older group had higher percentage of renal insufficiency (7.9% vs. 3.1%, P = 0.0010), prior stroke (9.4% vs. 3.9%, P = 0.0006), 30-day mortality rate (7.6% vs. 3.9%, P = 0.015), and cardiac mortality rate (6.6% vs. 3.7%, P = 0.045). Successful reperfusion rates were similarly high in both groups (90.0% and 92.7%, P = 0.16), despite the higher proportion of patients with door-to-balloon time >90 min (15% vs. 8.4%, P = 0.0016) in older patients. Successful compared with unsuccessful PCI significantly decreased 30-day mortality rates in the older group (6.0% vs. 21%, P = 0.0018) and in the younger group (2.8% vs. 18%, P < 0.0001). When reperfusion was successful, cardiac mortality rate in older patients was not significantly greater than in younger patients (5.4% vs. 2.8%, P = 0.057). By multivariate analysis, unsuccessful reperfusion independently predicted 30-day mortality (odds ratio, 4.04; 95% confidence interval, 1.79-9.12; P = 0.0008), whereas age ≥75 years (odds ratio, 1.00; 95% confidence interval, 0.41-2.41; P = 0.99) and door-to-balloon time >90 min (odds ratio, 1.78; 95% confidence interval, 0.76-4.20; P = 0.19) did not. CONCLUSIONS: Pre-existing comorbidities characterize older patients developing STEMI. Aggressive PCI in older patients improves prognosis, and short door-to-balloon time is an important parameter conditioning the prognosis.

Ratio of serum n-3 to n-6 polyunsaturated fatty acids and the incidence of major adverse cardiac events in patients undergoing percutaneous coronary intervention.

BACKGROUND: The relationship between major adverse cardiac events (MACE) and serum polyunsaturated fatty acid (PUFA) parameters has not been well documented in patients who have undergone percutaneous coronary intervention (PCI). The aim of the present study was to investigate this relationship. METHODS AND RESULTS: A total of 284 consecutive patients who underwent elective PCI were enrolled and stratified according to median serum levels of n-6 PUFAs (arachidonic acid [AA]), n-3 PUFAs (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]), and serum EPA/AA and DHA/AA ratios. The relationship between these PUFA parameters and the incidence of MACE including cardiac death, acute coronary syndrome, PCI for de novo lesions, and coronary artery bypass grafting, was analyzed. Multivariate analysis showed that among the PUFA parameters, only a high serum EPA/AA ratio was significantly associated with a low incidence of MACE in all the models tested (model A, without adjusted variables: hazard ratio [HR], 0.52; 95% confidence interval [CI]: 0.27-0.99, P = 0.048; model B, adjusted for age and diabetes: HR, 0.51; 95%CI: 0.26-0.98, P = 0.043; model C, adjusted for age, sex, diabetes, hypertension, smoking, and low-density lipoprotein cholesterol: HR, 0.49; 95%CI: 0.25-0.94, P = 0.033). CONCLUSIONS: The incidence of MACE in patients who have undergone PCI is significantly associated with serum EPA/AA ratio.

Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery.

BACKGROUND: The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable nitinol stent in the superficial femoral artery (SFA). METHODS: This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful nitinol stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group. RESULTS: The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P < .0001 and P < .0001, respectively). Overall survival rates were 96.8%, 89.5%, and 81.8% in the low-risk group; 91.5%, 74.4%, and 68.7% in the moderate-risk group; and 78.2%, 63.2%, and 48.7% in the high-risk group at 1, 3, and 5 years, respectively. There were also significant differences in mortality (P < .0001). CONCLUSIONS: New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable nitinol stenting for SFA disease.

Impact of cilostazol after endovascular treatment for infrainguinal disease in patients with critical limb ischemia.

BACKGROUND: Cilostazol reduces restenosis and repeat revascularization after endovascular therapy (EVT) in claudicant patients with femoropopliteal lesions. However, the efficacy of cilostazol in patients with critical limb ischemia (CLI) is unclear. Therefore, we investigated the effect of cilostazol on outcomes in patients with CLI. METHODS: From January 2004 to December 2009, 618 patients (30.8% women, 356 treated with cilostazol, 72.4 ± 7.3 years old) with CLI underwent EVT for de novo infrainguinal lesions. Their data were retrospectively analyzed. The primary outcome measure was amputation-free survival (AFS), The secondary outcome measures were overall survival, limb salvage, freedom from repeat revascularization, and freedom from surgical conversion. Mean follow-up was 21 ± 14 months. RESULTS: AFS and the limb salvage rate at 5 years were significantly higher in the cilostazol-treated group (47.7% vs 32.7%, P < .01; 86.6% vs 75.3%, P < .01; respectively). However, overall survival and freedom from repeat revascularization at 5 years did not differ significantly between the two groups (43.9% vs 46.0%, P = .24; 39.9% vs 31.8%, P = .21, respectively). Freedom from surgical conversion at 5 years was significantly higher in the cilostazol-treated group (91.0% vs 81.2%, P < .01). After correcting all end points with baseline variables, cilostazol was effective for prevention of AFS (hazard ratio [HR], 0.67; 95% confidential interval [CI], 0.49-0.91; adjusted P = .01) and improvement of limb salvage rate (HR, 0.42; 95% CI, 0.25-0.69; adjusted P < .01). There was no significant difference in overall survival, repeat revascularization, and surgical conversion between the groups. CONCLUSIONS: Cilostazol may improve AFS and limb salvage rate after EVT for infrainguinal disease in patients with CLI.

Long-term outcomes and risk stratification of patency following nitinol stenting in the femoropopliteal segment: retrospective multicenter analysis.

PURPOSE: To investigate the long-term outcomes of nitinol stenting in femoropopliteal lesions and to determine the factors associated with restenosis. METHODS: Between December 2003 and December 2009, 861 patients (603 men; mean age 72 years) underwent nitinol stenting of the femoropopliteal segment in 1017 limbs. A quarter (26%) of the patients had critical limb ischemia. Mean lesion length was 152±93 mm. Stent patency was assessed by either duplex ultrasound or angiography and analyzed by Kaplan-Meier estimation. The determinants of restenosis were explored with Cox proportional hazard regression analyses; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Risk stratification of primary patency was subsequently analyzed using a score based on the significant prognostic factors identified in the multivariate model. RESULTS: Stent fracture occurred in 10% (104 limbs) of the lesions. At 1, 3, and 6 years, the primary patency rates were 77%, 67%, and 63%; secondary patency rates were 91%, 87%, and 87%; freedom from femoropopliteal bypass grafting was 99%, 97%, and 96%, respectively. Multivariate Cox regression analysis identified female gender (HR 1.899; 95% CI 1.318 to 2.737, p<0.001), ankle-brachial index <0.6 (HR 1.921; 95% CI 1.348 to 2.736, p<0.001), TASC II C/D lesion (HR 2.068; 95% CI 1.346 to 3.177, p = 0.0009), stent fracture (HR 1.937; 95% CI 1.203 to 3.118, p = 0.006), and the absence of cilostazol administration (HR 2.102; 95% CI 1.394 to 3.172, p<0.001) as strong independent factors associated with restenosis. After assigning a risk score based on the outcomes of the multivariate regression analysis (1 each for female gender, ABI <0.6, TASC II C/D, stent fracture, and absence of cilostazol therapy), primary patency was found to be lower in limb groups with a higher cumulative score (12-month primary patency: score 0: 93%, score 1: 80%, score 2: 73%, score 3; 47%, score 4: 0%, respectively; p<0.001). CONCLUSION: Endovascular therapy using nitinol stents for FP lesions yielded acceptable outcomes up to 6 years. Risk stratification for patency can play an important role in estimating future occurrence of restenosis after nitinol stent implantation in FP lesions.

Safety and efficacy of exercise training after coronary stenting in patients with stable coronary artery disease.

BACKGROUND: Exercise training (ET) after coronary stenting is considered to have a risk of stent thrombosis (ST). The present study investigated whether ET increases the incidence of ST in patients undergoing coronary stenting. METHODS AND RESULTS: The current study was a prospective observational study. We enrolled 3,672 patients who underwent successful coronary stenting. Patients decided whether to participate in exercise and were divided into an ET group (n=1,592) and a control group (n=2,080). The primary endpoint was the incidence of ST. Secondary endpoints were major adverse cardiovascular events (MACE: death, myocardial infarction, and stroke) and unscheduled hospital visits for angina. The incidence of ST and MACE were similar in both groups (1.8% vs. 2.0%, P=0.73, 14.9% vs. 15.0%, P=0.97, respectively). Unscheduled hospital visits were significantly lower in the ET group (20.2% vs. 27.2%, P<0.0001). After adjusting for baselines, the ET group had no significant increase in ST (hazard ratio (HR) 0.86, adjusted P=0.56) and MACE (HR 0.98, adjusted P=0.83). The ET was effective to prevent an unscheduled hospital visits for worsening angina (HR 0.67, adjusted P<0.0001). CONCLUSIONS: Moderate ET after successful coronary stenting does not increase the incidence of ST and MACE, and was effective in reducing unscheduled hospital visits for angina.

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.

Long-term results of the S.M.A.R.T. Control(TM) stent for superficial femoral artery lesions, J-SMART registry.

BACKGROUND: The use of a stent in the treatment of lesions of the superficial femoral artery (SFA) remains controversial. Although some reports have suggested that use of a nitinol stent in conjunction with aggressive medical management is effective for long SFA lesions, few long-term, large-scale studies have been done. METHODS AND RESULTS: A retrospective analysis was conducted of data from a multicenter study in which the S.M.A.R.T. Control(TM) stent was used for treatment of de novo SFA lesions. A total of 528 lesions in 432 patients were included. Mean patient age was 72.5±9.1 years; mean stent length was 15.7±8.1cm; 259 lesions (49%) were classified as C/D according to the TransAtlantic Inter-Society Consensus (TASC) II classification. Primary and secondary patency at 4 years was 66% and 87%, respectively. No cilostazol administration (41% re-stenosis group vs. 29% no-restenosis group, P<0.01), female gender (42% vs. 26%, P<0.01), younger age (70.7±9.3 years vs. 72.9±9.0 years, P<0.05), and chronic total occlusion (CTO; 72% vs. 52%, P<0.01) were independent predictors of re-stenosis. CONCLUSIONS: The S.M.A.R.T. Control(TM) stent provided good long-term durability in the treatment of SFA lesions, and no cilostazol administration, female gender, younger age and CTO were associated with re-stenosis.

Retrospective multicentre analysis of S.M.A.R.T. vs. Luminexx nitinol stent implantation for superficial femoral artery lesions (REAL SL) Registry. 5 years' experience.

BACKGROUND: The nitinol stent has proven superior primary patency than balloon angioplasty in superficial femoral artery (SFA) lesions, but a systematic comparison of the patency of 2 different nitinol stents (S.M.A.R.T. and Luminexx) in patients with SFA lesions has not been done. METHODS AND RESULTS: A multicenter, prospective database that included 511 consecutive patients who had undergone endovascular therapy with nitinol stenting for 638 limbs (S.M.A.R.T.: n=503; Luminexx: n=135) was retrospectively analyzed. Patency was assessed by duplex ultrasound. Outcomes were compared between the groups by the Kaplan-Meier and log-rank methods. To minimize the differences between each group, propensity-matched analysis was also performed. Stent fracture occurred in 11% (57/503) of the S.M.A.R.T. and 23% (31/135) of the Luminexx stents (P=0.0005). Despite a higher prevalence of chronic total occlusion (55% vs. 40%, P=0.002) and longer lesions (154±93mm vs. 135±71mm, P=0.03) in the S.M.A.R.T. group, there was no significant difference in patency for up to 5 years (P=0.50). When 119 lesions per group were assessed after propensity-matched analysis, the 5-year patency rate was 74% for the S.M.A.R.T. and 65% for the Luninexx stent (P=0.10). CONCLUSIONS: Despite a different stent fracture rate, there was no significant difference in terms of patency between the S.M.A.R.T. and Luninexx stents for up to 5 years.

Feasibility evaluation of a remote monitoring system for implantable cardiac devices in Japan.

The number of implanted cardiac devices has been growing steadily over the last several years. Systems to monitor device data remotely have been introduced with the goal of reducing follow-up burden for both patients and physicians. Since the introduction of telemedicine depends greatly on the situations that are unique to each country, the acceptance of cardiac device remote monitoring in Japan was analyzed.A total of 203 patients who had previously undergone cardiac device implantation were enrolled. The subjects were provided with a CareLink Monitor that performed interrogation and transmission of device data at home, and then the physicians reviewed the data via a website at one and 3 months after baseline visits. A total of 470 transmissions were made. Questionnaires were completed by subjects and physicians to evaluate acceptance, ease of use, and satisfaction with the system. More than 87% of the subjects felt the Monitor was easy to use and nearly all of the physicians were satisfied with the system. A majority of patients felt reassured by having their devices assessed from a remote location and preferred the decreased number of clinic visits that were possible when using the Monitor. The patients spent an average of 168.2 minutes per clinic visit, whereas follow-up time was reduced to 13.0 minutes by remote monitoring. Physician consultation time was reduced by 2.7 minutes.The CareLink Network was well accepted by both the patients and physicians. Underlying issues did emerge, but once they are overcome, the system appears to have great potential to improve the quality of care given by healthcare providers.

Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation.

BACKGROUND: The influences of antiplatelet therapy discontinuation on the risk of stent thrombosis and long-term clinical outcomes after drug-eluting stent implantation have not yet been addressed adequately. METHODS AND RESULTS: In an observational study in Japan, 2-year outcomes were assessed in 10 778 patients undergoing sirolimus-eluting stent implantation. Data on status of antiplatelet therapy during follow-up were collected prospectively. Incidences of definite stent thrombosis were 0.34% at 30 days, 0.54% at 1 year, and 0.77% at 2 years. Thienopyridine use was maintained in 97%, 62%, and 50% of patients at 30 days, 1 year, and 2 years, respectively. Patients who discontinued both thienopyridine and aspirin had a significantly higher rate of stent thrombosis than those who continued both in the intervals of 31 to 180 days, 181 to 365 days, and 366 to 548 days after stent implantation (1.76% versus 0.1%, P<0.001; 0.72% versus 0.07%, P=0.02; and 2.1% versus 0.14%, P=0.004, respectively). When discontinuation of aspirin was taken into account, patients who discontinued thienopyridine only did not have an excess of stent thrombosis in any of the time intervals studied. Adjusted rates of death or myocardial infarction at 24 months were 4.1% for patients taking thienopyridine and 4.1% for patients not taking thienopyridine (P=0.99) in the 6-month landmark analysis. CONCLUSIONS: Discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine therapy only, was associated with an increased risk of stent thrombosis. Landmark analysis did not suggest an apparent clinical benefit of thienopyridine use beyond 6 months after sirolimus-eluting stent implantation.

Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent.

BACKGROUND: Long-term clinical outcomes after femoropopliteal (FP) stenting with nitinol stents have not yet been clear. We investigated the mid-term efficacy of FP stenting with nitinol stents. METHODS: This study was a multicenter retrospective study. From April 2004 to December 2008, 511 consecutive patients (639 limbs; mean age 71 +/- 7 years; 71% male) who underwent successful FP stenting with nitinol stents for de novo lesions were retrospectively selected and analyzed in this multicenter study. All patients had a minimum follow-up of 6 months. Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex or >50% stenosis by angiogram. Primary patency was defined as treated vessels without restenosis and repeat revascularization. Secondary patency was defined as target vessels that become totally occluded and are reopened by repeat revascularization. RESULTS: Sixty-one percent of the patients had diabetes, 76% were claudicant, and 20% were on hemodialysis. Mean lesion length was 151 +/- 75 mm. Mean follow-up period was 22 +/- 11 months. Primary patency was 79.8%, 66.7%, and 63.1%, and secondary patency was 90.4%, 87.3%, and 86.2% at 1, 3, and 5 years, respectively. During the follow-up period, 53 patients (10%) died. Of them, cardiovascular death was 38% and stent fracture had occurred in 14%. On multivariate analysis by Cox proportional hazard ratio, cilostazol administration (hazard ratio [HR], 0.52;P < .0001), stent fracture (HR, 1.6; P = .03), hemodialysis (HR, 1.7; P = .01), and Trans Atlantic Inter-Society Consensus (TASC) II class C/D (HR, 2.4; P < .0001) were the independent predictors of primary patency after successful FP stenting. CONCLUSION: Clinical efficacy of nitinol stent implantation for FP disease was favorable for up to 5 years.

PCI using a 4-Fr "child" guide catheter in a "mother" guide catheter: Kyushu KIWAMI® ST registry.

OBJECTIVES: With the development of PCI techniques, the indications for stents have been expanding as well. On the other hand, we often encounter the situations where deploying a stent/stents by the conventional method is technically challenging. We report a novel stent delivery system using a newly developed 4Fr. straight catheter with Mother-and-Child method. METHODS AND RESULTS: We collected the data on coronary angioplasty in which we experienced the difficulty to deliver coronary stents and used 4Fr. KIWAMI ST01. The case number amounts to 32 cases over a six-month period from October 2009 through March 2010. The angioplasty was performed for lesions in the RCA in 9 patients (28%), lesions in the LAD in 15 patients (47%), lesions in the LCX in 5 patients (16%), lesions in the saphenous vein grafts in 2 patients (6%), and lesions in the internal thoracic artery (LITA) grafts in 1 patient (3%). And the reasons for the difficult stent delivery by the conventional methods were as follows: severe calcification in 12 patients (37%), intense tortuosity in 7 patients (22%), poor backup support for guide catheter in 8 patients (25%), and trapping of the stent proximal to the target lesion in 5 patients (16%). The dislodgment of stent did not happened in all cases. CONCLUSIONS: KIWAMI® ST01 stent delivery system is feasible, safer, and effective in cases where stent delivery is difficult by the conventional method.