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.

Intracoronary radiation decreases the second phase of intimal hyperplasia in a repeat balloon angioplasty model of restenosis.

PURPOSE: Repeat balloon angioplasty is likely to induce intimal proliferation, which is associated with a higher restenosis rate. This study examined the effect of intracoronary ionizing radiation on restenotic lesions using repeat balloon injury in a normolipemic swine. METHODS AND MATERIALS: Eight domestic normolipemic pigs underwent overstretch balloon angioplasty with a 3.5 mm balloon in the LAD and LCX, followed by repeat balloon injury at the same sites 4 weeks after the initial injury. At that time a high activity 192Iridium source was introduced immediately after the angioplasty by random assignment to deliver 14 Gy at 2 mm in eight of the injured coronary arteries (LAD and LCX). One month later the animals were killed and the coronary arteries pressure perfusion fixed. Serial sections were stained with H&E and VVG, then evaluated by histopathologic and morphometric techniques. Maximal intimal thickness (MIT), intimal area (IA), and intimal area corrected for the extent of injury (IA/FL) were measured in the irradiated and control arteries and were compared to control arteries with single injuries from previous studies. RESULTS: Repeat balloon injury induced significant additional medial damage, which was associated with marked intimal hyperplasia in a concentric pattern. Intracoronary irradiation significantly decreased the total of neointima area formation (IA 93 + 0.35 mm2 compared to control 1.38 + 0.33 mm2 p < 0.01) and the MIT was also significantly reduced in the irradiated vessels (0.57 + 0.18 mm vs. 0.71 + 0.08 mm, p = 0.05). CONCLUSIONS: Intracoronary irradiation immediately after the second balloon dilatation inhibits the intimal hyperplasia due to that injury. However, there was no effect on the existing neointima from the initial injury.

Long-term angiographic and clinical outcome after percutaneous transluminal coronary angioplasty and intracoronary radiation therapy in humans.

BACKGROUND: Ionizing radiation has been shown to reduce neointimal formation after balloon angioplasty in experimental models of restenosis. This study was designed to evaluate the feasibility, safety, and effectiveness of intracoronary radiation therapy (ICRT) after percutaneous transluminal coronary angioplasty (PTCA) for preventing restenosis in human coronary arteries. METHODS AND RESULTS: Twenty-one patients (22 arteries) with unstable angina underwent standard balloon angioplasty. ICRT was performed with the use of an 192Ir source wire that was hand delivered to the angioplasty site. Angiographic follow-up was performed at 24 hours, between 30 and 60 days, and at 6 months. Angioplasty was successful in 19 of 22 lesions, and insertion of the radioactive source wire was successful at all treated sites. Angiographic study at 24 hours demonstrated early late loss of the luminal diameter from 1.92+/-0.55 to 1.40+/-0.27 mm. Between 30 and 60 days, repeat angiography demonstrated total occlusion in 2 arteries, a new pseudoaneurysm in 1 artery, and significant dilatation at the treatment site in 2 additional vessels. At > or = 6 months' follow-up, all remaining arteries (n=20) maintained patent, with a mean lumen diameter of 1.65+/-0.8 mm. The calculated late lumen loss was 0.27+/-0.56 mm, and the late loss index was 0.19. Clinical events at 1 year included myocardial infarction in 1 patient, repeat angioplasty to the treated site in 3 patients, and persistent angina in 7 patients. CONCLUSIONS: These preliminary results demonstrate that ICRT after coronary intervention is feasible and is associated with an acceptable degree of complications and lower rates of angiographic restenosis indexes.

Intracoronary stent implantation using a single high-pressure perfusion balloon catheter.

Currently, the recommended strategy for Palmaz-Schatz intracoronary stent implantation is to use two balloons: an undersized balloon for predilation to facilitate a channel for the stent and a high pressure balloon for postdilation to obtain good apposition of the struts into the vessel wall. We reported our experience using the perfusion balloon as the initial balloon to dilate intracoronary lesions and demonstrated a reduction in the total number of balloons used per angioplasty procedure. The objective of this study was to examine whether a single balloon could effectively be used for stent implantation. The study population included 95 patients who underwent elective intracoronary stent placement to 100 lesions using 110 Palmaz-Schatz stents by nine individual operators. Lesions were predilated with an ACS RX LIFESTREAM balloon at a low pressure of 4-6 atm (mean 5.7 +/- 2.6). After stent deployment, the same balloon was used at a high pressure (mean 16.2 +/- 1.2). Mean balloon size, which was chosen as the stent size, was 3.4 +/- 0.4 mm. Comparison of this strategy with the recommended strategy of 68 consecutive elective stent deployments at a single center during the same time was performed. Stent implantation using a single balloon strategy was angiographically successful in 99 of 100 (99.0%) lesions. The single balloon strategy was associated with a balloon burst rate of 9.1%. The number of balloons used per stent deployment was 1.2 vs. 2.4 using the recommended strategy (P < 0.0001). There was no evidence of stent thrombosis, any MI, or target lesion revascularization during the procedure and hospitalization. One in-hospital death as a result of nonhemorrhagic stroke was documented in the treated group. We concluded that using a single high pressure perfusion balloon for pre and postdilation in patients undergoing elective stent placement is safe and reduces the number of balloons used per procedure.

A clinical consideration of systemic embolism complicated to infective endocarditis in Korea.

OBJECTIVES: Infective endocarditis is still one of the important fatal diseases in Korea, especially when systemic embolisms are supervene. So, identification of patients who are in the high risk of embolism and who can be helped by early surgical intervention is very important. Considering these, we tried to elaborate the risk factors for the systemic embolism in patients with an infective endocarditis and the influence of systemic embolism on the mortality and morbidity in patients with an infective endocarditis. METHODS: We retrospectively reviewed the clinical records of 97 patients who were admitted with the infective endocarditis between January 1983 and October 1993. RESULTS: Among 97 patients, 80 patients met our diagnostic criteria. The mean age of patients was 38 years old. There were 43 males and 37 females. The mean duration of fever since the fever developed by history was 38 days. Valvular heart disease was the most frequent underlying heart disease. Mitral regurgitation and aortic regurgitation were the most common among valvular heart diseases. Pneumonia and acute pharyngotonsillitis were the most frequent predisposing factors of infective endocarditis. Blood cultures were positive in 51 patients (63.8%). Streptococcus viridans was the organism isolated most frequently, and Staphylococcus aureus was the second most frequently isolated one. Vegetations were detected in 58 patients (76.3%) by an echocardiography. Mitral valve and aortic valve were the most frequently involved incidence rate of embolism was 50% and the most frequent embolism site was the central nervous system and extremities were the next. Embolism occurred at the mean of 37 days after onset of fever. Overall in-hospital mortality rate was 26.3% and a cardiac-origin was the major cause of death. The only statistically significant risk factor for mortality was systemic embolism. The analysis of the relation between an incidence of embolism and the multivariables (age, presence of vegetation, location of vegetation, size of vegetation, causative organisms) showed that only the growth of Staphylococcus aureus had a significant trend toward a risk of subsequent systemic embolism. CONCLUSION: This study suggests that systemic emboli increases the mortality rate in patients with infective endocarditis. Age of patients, presence of vegetation, size and location of vegetation are not the risk factors for embolism, while certain organism, especially Staphylococcus aureus, could be a risk factor for the systemic embolism.