Clinical outcomes of an ultrathin-strut sirolimus-eluting stent in all-comers population: Thailand Orsiro registry.

BACKGROUND: Despite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro SES, Biotronik AG), the generalizability of the study results remains unclear in the Asian population. We sought to evaluate the clinical outcomes of the Orsiro SES in unselected Thai population. METHODS: The Thailand Orsiro registry was a prospective, open-label clinical study evaluating all patients with obstructive coronary artery disease implanted with Orsiro SES. The primary endpoint was target lesion failure (TLF) at 12 months. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), emergent coronary artery bypass graft (CABG), and clinically driven target lesion revascularization (CD-TLR). Patients with diabetes, small vessels (≤ 2.75 mm), chronic total occlusions (CTOs), and acute myocardial infarction (AMI) were pre-specified subgroups for statistical analysis. RESULT: A total of 150 patients with 235 lesions were included in the analysis. Half of the patients (53.3%) presented with AMI, and 24% had diabetes. Among 235 lesions, 93(39.4%) were small vessels, and 24(10.2%) were chronic total occlusions. The primary endpoint, TLF at 12 months, occurred in eight patients (5.3%), predominately caused by cardiac death. By contrast, the incidences of TVMI and CD-TLR were null. The outcomes in pre-specified subgroup were not different from the overall population (all p > 0.05). One definite late stent thrombosis(0.7%) was incidentally observed during primary percutaneous coronary intervention to the non-target vessel. CONCLUSION: The safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in the Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population. Trial Registration TCTR20190325001.

Clinical results of large secundum atrial septal defect closure in adult using percutaneous transcatheter Cocoon atrial septal occluder.

BACKGROUND: Atrial septal defect (ASD) is a common congenital heart disease in adults. Amplatzer septal occluder is one of the most common devices used for transcatheter closure due to its high success rate and ease to implant. Cocoon atrial septal occluder is a new nitinol-based device, its shape resembles Amplatzer septal occluder but coated with platinum to prevent nickel release. Little is known about clinical outcomes of large ASD closure using Cocoon atrial septal occluder OBJECTIVE: To review our experience in closure of secundum ASD in adults by Cocoon septal occluder and to compare the clinical outcomes and results of the patients who had ASD closure with a device greater than or equal to 30 mm and less than 30 mm. MATERIAL AND METHOD: Between November 2005 and October 2008, 63 consecutive patients underwent transesophageal echocardiography (TEE)--guided transcatheter closure of secundum ASD. The patients were divided into two groups (Groups' 1 and 2) according to device diameter that is greater than or equal to 30 mm (n = 31) and less than 30 mm (n = 32), respectively. Clinical outcomes, complications, and transthoracic echocardiography (TTE) before hospital discharge, one to three months, and one-year were analyzed. RESULTS: Device implantations were successful in 27 patients (87.1%) in group 1 and 31 patients (96.9%) in group 2 (p = 0.196). The maximum size of secundum ASD in group 1 determined by TTE, TEE, and balloon sizing diameter (BSD) were 22.6 +/- 5.0 mm (range 15-32), 28.1 +/- 4.8 mm (range 19-39), and 31 +/- 3.5 mm (range 23-38) respectively. The maximum size of secundum ASD in group 2 determined by TTE, TEE, and BSD were 19.7 +/- 4.4 mm (range 12-31), 20.4 +/- 3.4 mm (range 13-26), and 23.1 +/- 2.9 mm (range 15-30) respectively. The mean device size in groups 1 and 2 were 33.5 +/- 3.1 mm and 24.6 +/- 3.3 mm, respectively. Four patients (12.9%) in group 1 had unsuccessful implantations. All of them were in the first 15 cases of using large device and two of them had device embolization requiring surgical removal. One patient (3.1%) in group 2 had an unsuccessful implantation and had device embolization requiring surgical removal. The patients in both groups gradually improved in clinical symptoms with decreased RVsystolic pressure and decreased RV size with complete ASD closure at one year CONCLUSION: Transcatheter closure of large secundum ASD by Cocoon septal occluder is feasible with hemodynamic benefit. However complication rates are higher with large ASD closure with device size greater than or equal to 30 mm especially during the early "learning curve" period. With experience, the complication rate declines and the success rate is no different from the group with smaller device size.

2022 Renal denervation therapy for the treatment of hypertension: a statement from the Thai Hypertension Society.

Hypertension remains a significant risk factor for major cardiovascular events worldwide. Poor adherence to treatment is extremely common in clinical practice, leading to uncontrolled hypertension. However, some patients with resistant hypertension still have uncontrolled blood pressure despite good medical compliance. A specific group of patients also develop adverse reactions to many blood pressure-lowering medications. These scenarios indicate that innovative strategies to lower blood pressure in challenging cases of hypertension are needed. The blood pressure-lowering efficacy of catheter-based renal denervation therapy to decrease sympathetic tone has been confirmed in many publications in recent years. Apart from both the invasiveness and the expensiveness of this technology, appropriate case selection to undergo this procedure is still developing. The utilization of renal denervation therapy for hypertension treatment in Thailand has lasted for 10 years with a good response in most cases. Currently, only certain interventionists at a few medical schools in Thailand can perform this procedure. However, more physicians are now interested in applying this technology to their patients. The Thai Hypertension Society Committee has reviewed updated information to provide principles for the appropriate utilization of renal denervation therapy. The blood pressure-lowering mechanism, efficacy, suitable patient selection, pre- and postprocedural assessment and procedural safety of renal denervation are included in this statement.

Comparison of original and generic clopidogrel 600 mg loading dose in the patients who planned undergoing coronary angiography.

OBJECTIVE: To compare the efficacy and safety of original (Plavix) and generic (Apolets) clopidogrel 600 mg loading in patients planning to undergo coronary angiography. MATERIAL AND METHOD: This is an experimental design, parallel, randomized-controlled study. Coronary artery disease patients planned for cardiac catheterization were recruited Patients were randomized to receive either original or generic clopidogrel 600 mg loading dose. Platelet aggregation induced by 5 micromol/L and 20 micromol/L adenosine diphosphate (ADP) was measured by light transmission aggregometry (LTA) at baseline and 6 hours after clopidogrel 600 mg administration. RESULTS: Forty-nine patients were enrolled, 24 patients received original clopidogrel, and 25 patients received generic clopidogrel. After six hours of loading, there was significantly reduction in platelet aggregation induced by adenosine 5 micromol/L from 41.08 +/- 3.04% to 19.50 +/- 1.68% (p < 0.001) in original group compared to 36.76 +/- 2.66% to 21.32 +/- 2.60% (p < 0.001) in generic group. When induced by 20 micromol/L, the platelet aggregation was reduced from 58.50 +/- 2.09% to 32.25 +/- 2.30% (p < 0.001) in original group and from 61.12 +/- 2.54% to 30.04 +/- 3.14% (p < 0.001) in generic group. There was no significant difference between original and generic clopidogrel in reducing platelet aggregation induced by both adenosine 5 and 20 micromol/L. Groin hematoma was found in one case (4.2%) in the original clopidogrel group. CONCLUSION: Generic clopidogrel (Apolets) 600 mg loading dose is as effective as original clopidogrel (Plavix) in term of platelet aggregation inhibition.

Clinical Characteristics and In-Hospital Mortality in Patients with STEMI during the COVID-19 Outbreak in Thailand.

Background: Nowadays, current evidence on the effects of the COVID-19 outbreak on ST-elevation myocardial infarction (STEMI) patients is discrepant. The aim of this study was to compare and identify any changes in STEMI patients between the pre-COVID-19 period and during the COVID-19 outbreak. Methods: We conducted a retrospective cohort study to evaluate consecutive STEMI patients admitted from 1 September 2018 to 30 September 2021. We designated 14 March 2020 as the commencement of the COVID-19 outbreak in Thailand. Results: A total of 513 consecutive STEMI patients were included in this study: 330 (64%) admitted during the pre-COVID-19 outbreak period and 183 (36%) admitted during the COVID-19 outbreak. There was a significant 45% decline in the number of STEMI cases admitted during the COVID-19 outbreak period. During the outbreak, STEMI patients had significantly increased intra-aortic balloon pump (IABP) insertion (23% vs. 15%, p-value = 0.004), higher high-sensitivity troponin T level (11,150 vs. 5213, p-value < 0.001), and lower pre- and post-PCI TIMI flow. The time-to-diagnosis (59 vs. 7 min, p-value < 0.001), pain-to-first medical contact (FMC) time (250 vs. 214 min, p-value = 0.020), FMC-to-wire-crossing time (39 vs. 23 min, p-value < 0.001), and pain-to-wire-crossing time (292 vs. 242 min, p-value = 0.005) were increased in STEMI patients during the outbreak compared with pre-outbreak. There was no statistical difference in in-hospital mortality between both periods (p-value = 0.639). Conclusions: During the COVID-19 outbreak, there was a significant decline in the total number of admitted STEMI cases. Unfortunately, the time-to-diagnosis, pain-to-FMC time, FMC-to-wire-crossing time, and pain-to-wire-crossing time were significantly delayed during the COVID-19 outbreak. However, in-hospital mortality showed no significant differences between these two time periods. Highlights: 45% decline in the number of STEMI cases admitted and a significant delay in the treatment timeline during the COVID-19 outbreak. In-hospital mortality showed no significant difference between these two periods. Our study will motivate healthcare professionals to optimize treatments, screenings, and infectious control protocols to reduce the time from the onset of chest pain to wire crossing in STEMI patients during the outbreak.

Hypertension Subtypes among Thai Hypertensives: An Analysis of Telehealth-Assisted Instrument in Home Blood Pressure Monitoring Nationwide Pilot Project.

BACKGROUND: White-coat hypertension (HT), masked HT, HT with white-coat effect, and masked uncontrolled HT are well-recognized problems of over- and undertreatment of high blood pressure in real-life practice. However, little is known about the true prevalence in Thailand. OBJECTIVES: To examine the prevalence and characteristics of each HT subtype defined by mean home blood pressure (HBP) and clinic blood pressure (CBP) using telemonitoring technology in Thai hypertensives. METHODS: A multicenter, observational study included adult hypertensives who had been diagnosed for at least 3 months based on CBP without the adoption of HBP monitoring. All patients were instructed to manually measure their HBP twice a day for the duration of at least one week using the same validated automated, oscillometric telemonitoring devices (Uright model TD-3128, TaiDoc Corporation, Taiwan). The HBP, CBP, and baseline demographic data were recorded on the web-based system. HT subtypes were classified according to the treatment status, CBP (≥or <140/90 mmHg), and mean HBP (≥or <135/85 mmHg) into the following eight subtypes: in nonmedicated hypertensives, there are four subtypes that are normotension, white-coat HT, masked HT, and sustained HT; in treated hypertensives, there are four subtypes that are well-controlled HT, HT with white-coat effect, masked uncontrolled HT, and sustained HT. RESULTS: Of the 1,184 patients (mean age 58 ± 12.7 years, 59% women) from 46 hospitals, 1,040 (87.8%) were taking antihypertensive agents. The majority of them were enrolled from primary care hospitals (81%). In the nonmedicated group, the prevalence of white-coat and masked HT was 25.7% and 7.0%, respectively. Among the treated patients, the HT with white-coat effect was found in 23.3% while 46.7% had uncontrolled HBP (a combination of the masked uncontrolled HT (9.6%) and sustained HT (37.1%)). In the medicated older subgroup (n = 487), uncontrolled HBP was more prevalent in male than in female (53.6% vs. 42.4%, p=0.013). CONCLUSIONS: This is the first nationwide study in Thailand to examine the prevalence of HT subtypes. Almost one-fourth had white-coat HT or HT with white-coat effect. Approximately half of the treated patients especially in the older males had uncontrolled HBP requiring more intensive interventions. These results emphasize the role of HBP monitoring for appropriate HT diagnosis and management. The cost-effectiveness of utilizing THAI HBPM in routine practice needs to be examined in the future study.

In-hospital and mid-term outcomes of stent implantation in patients with protected and unprotected left main coronary artery disease; King Chulalongkorn Memorial Hospital experiences.

BACKGROUND: Left Main Coronary Artery (LMCA) disease is now uniformly treated with coronary artery by pass grafting (CABG). However some patients with LMCA disease did not receive CABG because of high operative risks as well as those who refused CABG Recent studies demonstrated the feasibility of stenting for LM stenosis, although data remain limited. OBJECTIVE: To evaluate in-hospital and mid-term outcomes of using bare metal stent (BMS) and drug eluting stent (DES) in protected and unprotected left main coronary artery disease at King Chulalongkorn Memorial Hospital. MATERIAL AND METHOD: Retrospective, single-center study. The authors reviewed the outcomes of patients who underwent percutaneous coronary intervention on left main coronary artery lesions in our hospital from July 2000 to August 2007. In-hospital data and clinical follow-up outcomes were analyzed and determined as in-hospital and mid-term mortality, major adverse cardiac event (MACE). RESULTS: In eight years the authors reviewed 64 consecutive protected and unprotected LMCA patients who underwent PCI with stent placement. Altogether left main coronary artery stents were successfully deployed in all patients. DES usage was 64%. Bifurcation technique for distal left main coronary artery was executed in 32 patients (50%), included single stent in 62 (97%), two stents in 2(3%). Final kissing ballon inflation was done in 14 (21.9%). In-hospital mortality was 4.7% (three patients), two patients died from cardiac origin. The total in-hospital major adverse cardiac event (MACE) was 4.7%. Clinical follow-up of 6 months was completed in 100% of patients. Fifty percent of patients had angiographic follow-up and in-stent restenosis rate was 9.7%. No further death was noted and MACE at 6 months was 9.4%. Moreover, overall mean and median follow-up period were 31 +/- 25 months (range, 6-93 months) and 26 months respectively. CONCLUSION: Stent Implantation was technically feasible and safely applied for the treatment ofprotected and unprotected left main coronary artery lesions in patients, with acceptable in-hospital and mid-term outcomes. More randomized and controlled clinical trials are needed to confirm the long-term effects of stents for LMCA disease.

Comparison of official hours versus non-official hours: percutaneous coronary intervention in acute ST-elevation myocardial infarction patients.

BACKGROUND: Percutaneous coronary intervention (PCI) is now a favorable treatment for acute ST elevation myocardial infarction (STEMI). However, in non-official hours (non-OH), this modality of treatment has a questionable outcome because of the treatment delay. OBJECTIVE: To compare the outcomes of PCI during official hours (OH) with non-OH in acute STEMI patients. MATERIAL AND METHOD: A prospective consecutive registry of PCI in acute ST-elevation MI patients at King Chulalongkorn Memorial Hospital from May 1999 to December 2003 were analyzed. Kaplan Meier survival analysis was used to determine the in-hospital mortality. Multivariate analysis was used to determine the prognostic factors for in-hospital mortality. RESULTS: Two hundred and fifty six consecutive patients (OH-107, non-OH-149) who underwent PCI for acute STEMI were enrolled. Their mean age (61.9 +/- 12.2 vs 60.6 +/- 12.8 y, p = ns), male gender (73.8% vs 73.2%, p = ns), history of diabetes (30.2% vs 33.8%, p = ns), severity of the patients (percent of patients in Killip IV--22.4 vs 21.5, p = ns), ejection fraction (48.7 +/- 15.1 vs 45.9 +/- 14.7, p = ns), cardiopulmonary resuscitation prior PCI (15.0% vs 14.2%, p = ns), anterior MI (55.1% vs 51.0%, p = ns) were similar in both groups. Hypertension was slightly less common (39.6% vs 52.7%, p = 0.04) but smoking was more common (62.6% vs 49.0%, p = 0.03) in OH group. Door to balloon time and decision to balloon time were significantly shorter in the OH group than the non-OH group (67.9 +/- 47 vs 119.6 +/- 83 min, p < 0.001 and 60.8 +/- 35 vs 98.3 min, p < 0.001). However, the total delayed time was not statistically significantly different (402 +/- 316 vs 424 +/- 215, p = 0.55). Angiographic success rate was achieved in 98.1% for the OH group and 94.7% in the non-OH group (p = ns). In-hospital mortality rate was 10.3% and 10.7% respectively. CONCLUSION: The door to balloon time for PCI in acute STEMI patients in the non-OH group was longer than the OH group; however, the total delayed time was not different. The in-hospital mortality rate was similar.

Feasibility and effectiveness of a novel vascular hemostatic device (Chula-clamp) after coronary angiography or percutaneous coronary intervention.

BACKGROUND: Chula-clamp is a newly hydraulic vascular hemostatic device. The advantages of the device are convenience, reusability, and lessen patient discomfort and vascular complication. Furthermore, the device is assembled with a recycled balloon inflator and other locally made components, which make it less expensive than other commercially available hemostatic devices. The present study was conducted to compare the effectiveness of Chula-clamp with standard manual compression. MATERIAL AND METHOD: This is a prospective, quasi-randomized controlled clinical trial comparing effectiveness of Chula-clamp to conventional manual compression for attaining femoral artery hemostasis after coronary angiography (CAG) or percutaneous coronary intervention (PCI). Effectiveness was determined by femoral vascular complications rate. The primary endpoint was severe femoral vascular complications (the formation of a groin hematoma, femoral artery thrombosis, pseudoaneurysm, and arteriovenous fistula). RESULTS: One hundred and forty patients scheduled for percutaneous coronary intervention or coronary angiogram in King Chulalongkorn Memorial hospital were enrolled (70 patients for each group). The baseline characteristics were similar in both groups. There was no serious vascular complication detected in either group. In addition, there was no statistical difference in minor complications at the access site between the two groups. [e.g., swelling (1.4% in standard manual compression group vs. 2.9% in Chula-clamp, p = 0.56) and ecchymosis (8.57% in both groups)]. CONCLUSION: Chula-clamp, a novel hydraulic vascular hemostatic device, is feasible, safe, and effective for femoral artery hemostasis (after CA G or PCI via femoral artery). Its effectiveness is not different from standard manual compression.

Worse prognosis for women who underwent primary percutaneous coronary intervention for acute ST-elevation myocardial infarction.

BACKGROUND: Many reports have shown that female gender carries a worse prognosis when developing acute myocardial infarction (MI), whether or not reperfusion therapy is used. The primary percutaneous coronary intervention (1-PCI) is currently a preferable treatment for acute ST-elevation MI. However, the data concerning the difference between the outcomes in the treatment of the disease in men and women in Thailand is still insufficient. MATERIAL AND METHOD: A prospective registry of acute ST-elevation MI patients who underwent 1-PCI at King Chulalongkorn Memorial Hospital from June 1999 to December 2002 were analyzed. Kaplan Meier survival analysis is used to determine the in-hospital mortality. RESULTS: The consecutive 184 (F-52, M-131) patients who underwent 1-PCI were recruited. Female subjects were older (66.6 +/- 12 y versus 59.0 +/- 11.6 y, p < 0.01); they also had higher percentage of diabetes (45.1 versus 27.1, p < 0.01), but a fewer number of smoker (17.7 versus 66.2, p < 0.001). The percentage of patients who had cardiogenic shock tended to be higher in women (34.6 versus 19.9, p = 0.08); however, the number of anterior wall MI and ejection fraction were not different. The mean door to balloon time (109 +/- 95 versus 99 +/- 68 minutes) and pain to balloon time (454 +/- 271 versus 372 +/- 298 minutes) were not different in both groups. The angiographic success with TIMI 3 flow was achieved in 92.3% for females and 86.9% for the males. The in-hospital mortality was significantly higher in females (23.1 versus 6.1, p = 0.002). Univariate analyses demonstrated that the feminine gender, cardiogenic shock, smoking, ejection fraction less than 40, cardiac arrest prior PCI and angiographic were the predictors for in-hospital mortality. When using multivariate analyses by Cox proportional model, only cardiogenic shock, history of hypertension and angiographic success were the significant predictors. Women had 2.15 times of in-hospital mortality higher than males; however, the confidence interval cross-over 1 (0.74-6.42) and p value was 0.16. CONCLUSION: Females tend to have a poor prognosis when they develop acute ST-elevation MI which requires treatment with 1-PCI.