Chien-Jen Chen

Feasibility and safety of transbrachial approach for patients with severe carotid artery stenosis undergoing stenting.

Although sporadic successful cases using the transradial approach (TRA) for carotid stenting have been reported, the safety and feasibility of carotid stenting using either TRA or a transbrachial approach (TBA) have not been fully investigated. Recently, we have developed a safe and feasible method of TRA for cerebrovascular angiographic studies. This study investigated whether a TBA approach using a 7‐French (F) Kimny guiding catheter for carotid stenting is safe and feasible for patients with severe carotid stenosis. Thirteen patients were enrolled into this study (age range, 63–78 years). Seven of these 13 patients had severe peripheral vascular disease. A retrograde‐engagement technique, involving looping 6‐F Kimny guiding catheter, was utilized for carotid angiographic study. For carotid stenting, the 6‐F Kimny guiding catheter was replaced with a 7‐F Kimny guiding catheter, and the procedure was performed as the follows. First, an extra‐support wire was inserted into the middle portion of external carotid artery (ECA). Second, a 0.035‐inch Teflon wire was advanced into the common carotid artery. Then, the 6‐F guiding catheter was exchanged for a 7‐F Kimny guiding catheter. Third, if the first and second steps did not provide adequate support for exchanging the guiding catheter, a PercuSurge GuardWire™ was inserted into the ECA, followed by distal balloon inflation for an anchoring support. FilterWire EX™ was used in 9 patients and PercuSurge GuardWire in 4 patients to protect from distal embolization during the procedure. The procedure was successful in all patients. No neurological or vascular bleeding complications were observed and all patients were discharged uneventfully. The TBA for carotid stenting was safe and effective, providing a last resort for patients unsuited to femoral arterial access and surgical intervention.

Feasibility and safety of transradial artery approach for selective cerebral angiography.

The transradial artery (TRA) approach is a conventional means of diagnostic cardiac catheterization and catheter‐based coronary intervention. However, to our knowledge, the safety and feasibility of cerebrovascular angiographic studies using the TRA approach for patients with brain ischemia has not been reported. This study investigated whether the TRA approach using 6 Fr Kimny guiding catheter for both extracranial and intracranial angiographies is safe and effective for patients with a history of stroke, transient ischemic attack, or significant carotid stenosis. From February 2003 to June 2004, a total of 46 consecutive patients with an age range from 50 to 83 years were enrolled into the study. The retrograde engagement technique that involved lopping the guiding catheter was utilized. Outpatient carotid angiography was performed in 40% of the study patients. The overall procedural success (defined as completely evaluating both carotid and vertebral arteries and intracranial vessels) was 93.5% (n = 43) using the Kimny guiding catheter. Significant cerebrovascular stenosis (> 50%), including carotid artery in 52.2% (n = 24), vertebral artery in 15.2% (n = 7), and intracranial major artery in 15.2% (n = 7), was found in 82.6% of the patients. Notably, 17 (37.0%) of these patients with severe carotid stenosis (≥ 70%) required staged carotid stenting. Concomitant vertebral artery stenting was performed in four (8.7%) patients because of severe stenosis (≥ 70%) of these vessels. Two patients experienced transient dizziness (duration < 30 min) following the procedure. TRA approach for selective cerebral angiography is safe and feasible in patients with a history of brain ischemia.

Transradial application of PercuSurge GuardWire device during primary percutaneous intervention of infarct-related artery with high-burden thrombus formation.

A large infarct‐related artery (IRA), which mostly contains high‐burden thrombus formation (HBTF) and lipid pool‐like plaque contents, has been suggested to play a pivotal role in the no‐reflow phenomenon during primary percutaneous coronary intervention (p‐PCI). To reduce the thrombus burden of the IRA using the PercuSurge GuardWire device before intervention may be of crucial importance to preventing no‐reflow. The purposes of this study were to test the transradial application (TRA) of this new mechanical device and to determine its impact on prevention of no‐reflow during p‐PCI. From May to September 2002, the PercuSurge GuardWire device was utilized in 42 consecutive patients with acute myocardial infarction and large IRA (vessel size ≥ 3.5 mm with HBTF; group 1). From January to December 2000, p‐PCI was performed in large IRA (vessel size ≥ 3.5 mm) with HBTF using tranfemoral arterial approach in 101 consecutive patients (group 2). The angiographic and clinical outcomes of the two groups were compared in a chronologically consecutive manner. Successful reperfusion (final TIMI‐3 flow) was significantly higher in group 1 than in group 2 patients (95.2% vs. 79.1%; P = 0.005). Moreover, the combined incidence of vascular complications, post‐PCI thromboembolisms (defined as a distal embolism and a post‐PCI residual thrombus score of ≥ 3), and combined 30‐day major adverse cardiac events were significantly lower in group 1 than in group 2 patients (all P values < 0.05). In group 1 patients, post‐p‐PCI myocardial blush (MB) of ≥ 2 grades was found to be more than 88.0%. Furthermore, when compared with preintervention, thrombus scores were significantly reduced after aspiration (P = 0.0001), whereas the minimal lumen diameter (P = 0.0001), TIMI flow grade (P = 0.0001), and MB grade (P = 0.0001) had all significantly increased after aspiration using Export Aspiration Catheter. There were no significant differences in corrected TIMI frame count (P = 0.42), TIMI flow grade (P > 0.5), or MB grade (all P values > 0.5) between postaspiration and post‐PCI. The TRA of the PercuSurge GuardWire device during primary intervention of large IRA with HBTF was safe and feasible and provided benefits to patients. The initial successful reduction of the thrombus burden with this mechanical device before intervention can be translated into increased final TIMI‐3 flow, a combined MB of ≥ 2 grades, and fewer final thromboembolic events. Catheter Cardiovasc Interv 2004;61:503–511.

Six-month angiographic results of primary angioplasty with adjunctive PercuSurge GuardWire device support: evaluation of the restenotic rate of the target lesion and the fate of the distal balloon occlusion site.

Recently, the combination of primary percutaneous coronary intervention (PCI) and adjunctive PercuSurge device support has been reported to be superior to conventional primary PCI in terms of immediate angiographic results. However, there are no data regarding 6‐month angiographic results for either the treatment site or the site of the distal protection balloon. The purpose of this study was to address these two issues. Between May and November 2002, a total of 74 patients who had experienced acute myocardial infarction (AMI) underwent either primary PCI (48 patients within 12 hr of AMI) or elective PCI (26 patients with AMI of > 12 hr and < 72 hr) using the PercuSurge device through a transradial approach. The final TIMI 3 flow and myocardial blush grade ≥ 2 achieved were 94% and 93%, respectively. Of these patients, three died in the hospital, two died in the third month after discharge, and the remainder of the patients were followed up in our outpatient department for a mean of 13 ± 2.9 months. Six‐month angiographic follow‐up was performed in 85.5% (59/69) of patients. The angiographic restenotic rate (defined as ≥ 50% restenosis at the target lesion site) was 22.0% (13/59) of patients. However, only 11.9% (7/59) of patients required repeat target vessel revascularization. Moderate obstruction at the site of the distal protection balloon was found in 5.1% (n = 3) of patients during PCI. Six‐month angiographic results demonstrated that all three patients had significant stenosis at the site of the distal protection balloon that required PCI. PercuSurge device utilization during PCI in the clinical setting of AMI yielded a substantially higher rate of immediate final TIMI 3 flow in epicardial vessels and increased the integrity of the microvasculature. Combined therapy of PCI with the PercuSurge device appeared to have favorable late angiographic results at the target site. Late significant stenosis occurred at the site of the distal protection balloon if a preexisting moderate or more advanced atherosclerotic lesion was present there. Catheter Cardiovasc Interv 2005;64:35–42.

Balance between plasma levels of tumor necrosis factor-α and interleukin-10 in rheumatic mitral stenosis

The study population consisted of 16 patients with rheumatic mitral stenosis undergoing percutaneous transluminal mitral valvuloplasty (group 1). The plasma levels of tumor necrosis factor-α (TNF-α) and interleukin-10 (IL-10) in the femoral vein and the right and left atria before valvuloplasty were determined by ELISA. Additionally, we measured plasma concentrations of TNF-α and IL-10 in the venous blood obtained from 19 control patients, including 12 healthy volunteers in sinus rhythm (group 2) and 7 patients in permanent lone atrial fibrillation (group 3). The venous plasma levels of TNF-α were significantly elevated in group 1 patients compared with group 2 patients (p < 0.002). Correlation analysis demonstrated that there was a significantly direct relationship between the plasma TNF-α and IL-10 concentrations in the left atrial, right atrial and peripheral venous blood (p < 0.008, r = 0.640; p < 0.04, r = 0.538; p< 0.03, r = 0.571, respectively). In conclusion, the plasma concentrations of TNF-α of patients with rheumatic mitral stenosis were significantly higher than those of healthy volunteers. In addition, there was a significantly direct relationship between the soluble TNF-α and IL-10 concentrations in the atrial and peripheral venous blood, indicating a balance between circulating TNF-α and IL-10 levels in patients with rheumatic mitral stenosis.

Effects and safety of intracoronary thrombectomy using transradial application of the percusurge distal balloon protection system in patients with early or recent myocardial infarction

Background: Distal embolization and no reflow are likely during primary percutaneous coronary intervention (PCI) on the large infarct-related artery (IRA), which mostly contains high-burden thrombus formation (HBTF) and plaque burden. Mechanical devices to prevent distal atheroembolism may be of importance for preserving reperfusion and microvascular integrity in IRA. Methods and Results: Between May 2002 and December 2002, transradial application (TRA) of the PercuSurge GuardWire™ device with 7-french arterial sheath was performed in 39 consecutive patients who experienced early (>12 h and ≤7 days) or recent (>7 days and <14 days) myocardial infarction (MI) associated with large IRA (vessel size ≧3.5 mm with HBTF; group 1). Between January 2001 and April 2002, 64 consecutive patients who had early or recent MI associated with HBTF in IRA of a vessel size ≧3.5 mm received TRA of PCI with adjunctive tirofiban therapy but without using the adjunctive PercuSurge GuardWire device (group 2). The angiographic and clinical outcomes of both groups were compared in a chronologically consecutive manner. The procedural success rate and post-PCI myocardial blush grades were significantly higher in group 1 than in group 2 patients (all p values <0.05), whereas a combined incidence of vascular and bleeding complications and 30-day major adverse cardiac events (defined as death, reinfarction and repeated PCI of IRA) were significantly higher in group 2 than in group 1 patients (all p values <0.05). Conclusions: Our data suggested that TRA using the PercuSurge GuardWire device during PCI for patients with early or recent MI and HBTF in IRA was safe and feasible. This mechanical device provided more additional benefit to patients in this clinical setting than a combination of conventional PCI and tirofiban therapy.