Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea).

Reports detailing the response of hypertensive patients to renal denervation (RDN) in Asian patients are limited. We evaluated 6- and 12-month outcomes after RDN in an Asian population and compared outcomes to a primarily Caucasian population. The Global SYMPLICITY Registry (GSR) is a prospective, all-comer, worldwide registry that evaluates the safety and effectiveness of RDN and includes the Korean registry substudy (GSR Korea) and a Caucasian subset (GSR Caucasian). Given differences in baseline characteristics among GSR Korea (n=93) as compared with GSR Caucasian (n=169) patients, including lower baseline office systolic blood pressure (SBP), lower body mass index and differences in medications, propensity score adjustment was performed when comparing the change in SBP between subsets. The 6- and 12-month change in SBP in GSR Korea was -19.4±17.2 and -27.2±18.1 mm Hg, respectively (P<0.001 for both vs baseline). GSR Caucasian had a SBP change similar to GSR Korea at 6 months (-20.9±21.4 mm Hg, unadjusted P=0.547, adjusted P=0.998), whereas at 12 months the change was significantly less pronounced (-20.1±23.9 mm Hg, unadjusted P=0.004, adjusted P=0.002). There were no protocol-defined procedure-related adverse events and no chronic adverse events associated with the device in an Asian population. RDN provided a significant reduction in 6- and 12-month office SBP among Asian patients, with a favorable safety profile. The 12-month SBP reduction was larger than that observed in Caucasian patients.

Homologous expression and quantitative analysis of T3SS-dependent secretion of TAP-tagged XoAvrBs2 in Xanthomonas oryzae pv. oryzae induced by rice leaf extract.

Xanthomonas oryzae pv. oryzae (Xoo) produces a putative effector, XoAvrBs2. We expressed XoAvrBs2 homologously in Xoo with a TAP-tag at the C-terminus to enable quantitative analysis of protein expression and secretion. Addition of rice leaf extracts from both Xoo-sensitive and Xoo-resistant rice cultivars to the Xoo cells induced expression of the XoAvrBs2 gene at the transcriptional and translational levels, and also stimulated a remarkable amount of XoAvrBs2 secretion into the medium. In a T3SS-defective Xoo mutant strain, secretion of the TAPtagged XoAvrBs2 was blocked. Thus, we elucidated the transcriptional and translational expressions of the XoAvrBs2 gene in Xoo was induced in vitro by the interaction with rice and the induced secretion of XoAvrBs2 was T3SSdependent. It is the first report to measure the homologous expression and secretion of XoAvrBs2 in vitro by rice leaf extract. Our system for the quantitative analysis of effector protein expression and secretion could be generally used for the study of host-pathogen interactions.

10-Gb/s transmission over 20-km single fiber link using 1-GHz RSOA by discrete multitone with multiple access.

We demonstrate a novel 10.5-Gbit/s transmission scheme over 20-km single fiber link by using a remotely fed 1-GHz reflective semiconductor optical amplifier (RSOA). Discrete multitone (DMT) modulation with adaptive bit-/power-loading is applied to overcome the bandwidth limitation of the RSOA. Transmission performance of the proposed scheme is analyzed in terms of various system parameters, such as the nonlinearity of the RSOA, optical signal-to-noise ratio of the optical seed carrier, the overhead size impact on dispersion, the number of DMT subcarriers, and the reflection noise from the single fiber link. We also report flexible-bandwidth-allocated multiple access operation based on the proposed scheme. The throughput for all cases is approximately 10 Gbit/s with BER < 10(-3).

Optical coherence tomography evaluation of zotarolimus-eluting stents at 9-month follow-up: comparison with sirolimus-eluting stents.

OBJECTIVE: To evaluate the vascular response at 9 months after zotarolimus-eluting stent (ZES; Endeavor) implantation using optical coherence tomography (OCT). These findings were compared with those after implantation of a sirolimus-eluting stent (SES; Cypher Select). DESIGN: Cross-sectional observational study with prospective OCT registry. SETTING: Nine months after ZES or SES implantation. PATIENTS AND METHODS: A total of 68 patients (32 ZES and 36 SES) underwent OCT at 9 months after stent implantation. The neointima hyperplasia (NIH) thickness inside each strut and percentage of NIH area at every 1 mm cross section were measured. MAIN OUTCOME MEASUREMENT: The degree of neointimal coverage and the prevalence of malapposition at 9 months after ZES and SES implantation using OCT. RESULTS: The mean (SD) NIH thickness (251.2 (110.0) mum vs 85.5 (53.3) mum, p<0.001) and percentage of NIH area (27.9 (9.1)% vs 11.2 (7.1)%, p<0.001) were significantly greater in ZES than in SES. The prevalence of uncovered strut as well as malapposed strut was significantly lower in ZES than in SES (0.3% vs 12.3%, p<0.001 and 0.08% vs 2.6%, p<0.001). Thrombus was not observed in ZES (0.0% in ZES vs 27.8% in SES, p = 0.001). CONCLUSIONS: Neointimal coverage in ZES was almost complete and malapposition was very rare at 9-months' follow-up.

The limits of competing interest disclosures.

OBJECTIVE: To assess the effectiveness of conflict of interest disclosure policies by comparing a competing interests disclosure statement that met the requirements established by the journal in a 2003 article on health effects of secondhand smoke based on the American Cancer Society CPS-I dataset with internal tobacco industry documents describing financial ties between the tobacco industry and authors of the study. DESIGN: Descriptive analysis of internal tobacco industry documents retrieved from the Legacy Tobacco Documents Library, University of California, San Francisco. RESULTS: Meeting the requirements for financial disclosure established by the journal did not provide the reader with a full picture of the tobacco industry's involvement with the study authors. The tobacco industry documents reveal that the authors had long standing financial and other working relationships with the tobacco industry. CONCLUSION: These findings are another example of how simply requiring authors to disclose financial ties with the tobacco industry may not be adequate to give readers (and reviewers) a full picture of the author's relationship with the tobacco industry. The documents also reveal that the industry funds research to enhance its credibility and endeavours to work with respected scientists to advance its goals. These findings question the adequacy of current journal policies regarding competing interest disclosures and the acceptability of tobacco industry funding for academic research.

Identification of a new analogue of sildenafil added illegally to a functional food marketed for penile erectile dysfunction.

A new analogue of sildenafil was discovered to have been added illegally to a functional food marketed for penile erectile dysfunction. The structure of the analogue was established by various NMR spectroscopic techniques (including DEPT, COSY, TOCSY, HMQC, HMBC). Because of the addition of a methylene group to sildenafil, the main ingredient of Viagra(R), it was given the name homosildenafil, and this has never been reported previously. An analytical method using HPLC was proposed. Homosildenafil was added as a new inspection item and other foods have since been discovered to contain it.

Intravascular Ultrasound Assessment of the Mechanisms and Predictors of Restenosis Following Coronary Angioplasty.

Restenosis occurs after 30% to 50% of transcatheter coronary procedures; its mechanisms remain incompletely understood. Intravascular ultrasound (IVUS) studies were analyzed in 360 nonstented native coronary artery lesions in which follow-up quantitative angiographic and/or IVUS data was available. Pre-intervention, post-intervention, and follow-up, the external elastic membrane (EEM) and lumen cross-sectional areas (CSA) were measured; plaque+media (P+M=EEM Ð lumen CSA), and cross-sectional narrowing (CSN=P+M/EEM CSA) were calculated. The anatomic slice selected for serial analysis had an axial location within the lesion at the smallest follow-up lumen CSA. At follow-up, 73% of the decrease in lumen CSA was due to a decrease in EEM CSA; 27% was due to an increase in P+M CSA. The change in lumen CSA correlated more strongly with the change in EEM CSA than with the change in P+M CSA. The change in EEM CSA was bidirectional; 47 lesions (22%) showed an increase in EEM CSA. Despite a greater increase in P+M CSA, lesions exhibiting an increase in EEM CSA had (1) no change in lumen CSA, (2) decreased restenosis, and (3) a 49% frequency of late lumen gain. The independent clinical, angiographic, and IVUS predictors of angiographic restenosis (³ 50% diameter stenosis at follow-up) were the IVUS reference lumen CSA, angiographic pre-intervention diameter stenosis, and post-intervention IVUS CSN. Restenosis appeared to be determined primarily by the direction and magnitude of the change in EEM CSA. An increase in EEM CSA was adaptive while a decrease in EEM CSA contributed to restenosis. The most powerful predictor of restenosis was the IVUS post-procedural CSN. The importance of the post-procedural CSN was related to the change in EEM CSA as a mechanism of restenosis.

Late Clinical Outcome after Intracoronary Palmaz-Schatz Stenting with High Pressure Balloon Dilation without Anticoagulation.

In recent studies, the technique of high pressure balloon dilation for stent optimization has been shown to improve procedural success and to reduce subacute closure after stenting. The late clinical outcome, however, is still uncertain after stenting with high pressure balloon dilation. Therefore, we evaluated the effect of high pressure balloon dilation on the subsequent clinical course in patients after intracoronary stenting. One-hundred ninety patients with 197 lesions were treated with Palmaz-Schatz stent implantation. Intracoronary stenting without high pressure balloon dilation and with anticoagulation was performed in 55 patients with 55 lesions (phase 1), whereas intracoronary stenting with high pressure balloon dilation, without anticoagulation was done in 135 patients with 142 lesions (phase 2). We compared the angiographic and clinical results immediately and at follow-up in both phase 1 and phase 2. Coronary angiography was repeated at 6 months in 147 patients (79%) and 150 lesions (77%). The overall incidence of angiographic restenosis was 24% (31% in phase 1 and 21% in phase 2). Angiographic restenosis occurred in 18% of elective stenting on de novo lesions (23% in phase 1 and 15% in phase 2). The target lesion revascularization rate was 19% (26% in phase 1 and 16% in phase 2). The restenosis rate was significantly reduced with high pressure balloon dilation in the infarct-related artery and for a stent size of ³ 4.0 mm (p < 0.05). In conclusion, intracoronary stenting using high pressure balloon dilation technique without anticoagulation has good immediate results, negligible stent thrombosis and may have a tendency towards lower rates of restenosis.

Intravascular Ultrasound Assessment of the Mechanisms and Predictors of Restenosis Following Coronary Angioplasty.

Restenosis occurs after 30% to 50% of transcatheter coronary procedures; its mechanisms remain incompletely understood. Intravascular ultrasound (IVUS) studies were analyzed in 360 non-stented native coronary artery lesions in which follow-up quantitative angiographic and/or IVUS data was available. Pre-intervention, post-intervention, and follow-up, the external elastic membrane (EEM) and lumen cross-sectional areas (CSA) were measured; plaque + media (P + M = EEM - lumen CSA), and cross-sectional narrowing (CSN = P + M/EEM CSA) were calculated. The anatomic slice selected for serial analysis had an axial location within the lesion at the smallest follow-up lumen CSA. At follow-up, 73% of the decrease in lumen CSA was due to a decrease in EEM CSA; 27% was due to an increase in P+M CSA. The change in lumen CSA correlated more strongly with the change in EEM CSA than with the change in P + M CSA. The change in EEM CSA was bidirectional; 47 lesions (22%) showed an increase in EEM CSA. Despite a greater increase in P + M CSA, lesions exhibiting an increase in EEM CSA had (1) no change in lumen CSA, (2) decreased restenosis, and (3) a 49% frequency of late lumen gain. The independent clinical, angiographic, and IVUS predictors of angiographic restenosis (³ 50% diameter stenosis at follow-up) were the IVUS reference lumen CSA, angiographic pre-intervention diameter stenosis, and post-intervention IVUS CSN. Restenosis appeared to be determined primarily by the direction and magnitude of the change in EEM CSA. An increase in EEM CSA was adaptive while a decrease in EEM CSA contributed to restenosis. The most powerful predictor of restenosis was the IVUS post-procedural CSN. The importance of the post-procedural CSN was related to the change in EEM CSA as a mechanism of restenosis.

Angiographic Results and Late Clinical Outcomes Utilizing a Stent Synergy (Pre-Stent Atheroablation) Approach in Complex Lesion Subsets.

To investigate the strategy of ÒdebulkingÓ in complex lesions before stent implantation (stent synergy) to improve procedural safety and achieve optimal acute and long-term results, we reviewed our experience in 389 patients with 504 lesions undergoing a combined stent procedure (45% rotational atherectomy, 24% laser angioplasty, 20% directional atherectomy, and 11% transluminal extraction atherectomy before stent implantation). Procedural success was achieved in 94.5%, with 4% major ischemic complications (1.1% death, 1.9% Q-wave myocardial infarction, and 2.3% emergency coronary artery bypass surgery). Overall, subacute stent thrombosis occurred in 1.5% of patients. Target-lesion revascularization during follow-up was required in 9.8% of the patients. We conclude that a strategy of selective pre-stent atheroablation in complex lesion subsets results in excellent procedural outcomes with acceptable complications and favorable long-term results.

Carotid Stent-Assisted Angioplasty: Preliminary Technique, Angiography, and Intravascular Ultrasound Observations.

Currently, surgical carotid endarterectomy has been the standard therapy for symptomatic and asymptomatic patients with significant carotid artery stenoses. However, there are high surgical risk and other patient subsets, wherein a Òlesser invasiveÓ catheter-based procedure may be worthwhile. Carotid stent-assisted angioplasty (CSSA) is a percutaneous interventional treatment approach for appropriately selected patients with common and internal carotid artery lesions. The present report discusses preliminary technique-related, angiographic, and intravascular ultrasound observations of CSSA. Five symptomatic patients (with six carotid stenoses) with other co-morbid states were treated by a multidisciplinary team under the aegis of an approved protocol using conventional equipment and available Palmaz tubular slotted stents. On-line quantitative angiography and intravascular ultrasound imaging was performed to guide stent insertion and monitor results. There were no procedure-related complications and angiographic results were excellent (final mean diameter stenosis 5%). Intravascular ultrasound imaging was feasible and safe. In two cases, the findings obtained from ultrasound images assisted in subsequent operator decisions. Thus far, there have been no additional clinical sequelae in these patients (@ 30 days). This preliminary experience with CSSA indicates that interventional neurovascular therapies may provide a useful alternative for selected patients requiring endoluminal reconstruction of carotid stenoses. Extensive additional studies are required to establish the appropriate clinical application of this technique.