Femoral micropuncture or routine introducer study (FEMORIS).

OBJECTIVES: The Micropuncture® 21-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture. METHODS: This was a single-center, multiple-user trial. Four hundred and two patients undergoing possible or definite percutaneous coronary intervention (PCI) were randomized 1:1 to an 18-gauge versus a 21-gauge needle. Patients and personnel pulling the sheaths and performing the follow-up were blinded. The primary end point was a composite of access bleeding. Events were tabulated following sheath removal, ≤ 24 h after the procedure and at the follow-up (at 1-2 weeks). End points were blindly adjudicated. RESULTS: The event rate overall was 12.4% and did not differ significantly between groups, although the 21-gauge needle was found to reduce events by more than one third. An exploratory subgroup analysis of prespecified variables indicated that: patients who did not undergo PCI or elective procedures, female patients and those with a final sheath size of ≤ 6 Fr all had a significant or near-significant reduction of complications with Micropuncture. CONCLUSIONS: Although no significant differences between the use of the 18- and 21-gauge needles were observed, there was a 50-75% reduction with Micropuncture in several subgroups. The study was terminated prematurely. Access site complications may be reduced by the use of the 21-gauge needle, particularly when the risk of bleeding is not high. Further multicenter data will be required to confirm these hypothesis-generating observations.

Prevalence of hepatitis B virus (HBV) infection among Hmong immigrants in the San Joaquin Valley.

Chronic hepatitis B infection (HBV) is the major cause of primary liver cancer worldwide and Asians are disproportionately affected. The prevalence of HBV among most Asian American groups has been well documented, except in Hmong immigrants in the United States. The aim of this study was to determine the prevalence of HBV among Hmong immigrants in the San Joaquin Valley of California. A convenient sample of 534 Hmong age ≥18 years was recruited at various locations throughout Fresno County. Blood samples from study participants were collected and tested for hepatitis B surface antigen (HBsAg) by enzyme-immunoassay. Two hundred and eighty-nine females and 245 males of Hmong descent (mean age, 43.93) were screened. Eighty-nine (41 males and 48 females) were positive for HBsAg, which accounts for a prevalence of 16.7% (95% C.I. 13.5-19.9). The majorities of HBsAg positive patients were ≥40 years (64.2%), married (66.7%), born in Laos (87.3%), and had lived in the United States ≥20 years (62.5%). Only 37.5% of the participants reported having a primary care physician. Our study revealed that approximately one out of every six Hmong immigrants screened was infected with HBV. Based on our findings, more than one-third of these infected patients have no primary care physician to provide further treatment, surveillance for liver cancer, or vaccination of their families. This supports the Institute of Medicine's recent recommendations to the Center for Disease Control to engage in a national Hepatitis B surveillance system.

Frequency of elevated troponin I and diagnosis of acute myocardial infarction.

This study evaluated the incidence and type of acute myocardial infarction (AMI) in a consecutive population with increased troponin I (TnI). AMI has recently been redefined and subclassified. Incidence, demographic data, angiographic findings, and hospital mortality of patients with various AMI subtypes or an increased TnI in the absence of AMI have not been previously reported in a prospective study. Over a 3-month period, all patients admitted from an emergency room or from in-patient services with >1 TnI level >0.04 ng/ml were evaluated and subclassified in AMI subgroups. In-hospital or recent coronary angiograms were reviewed. In-hospital mortality was noted. Of 2,944 patients with serial TnI measurements, 728 had an increased TnI and 701 (23.8%) were evaluated. Two hundred sixteen (30.8% with increased TnI and 42.7% with "rule-out MI" on admission) met criteria for AMI. One hundred forty-three (20.4%) had type 1, 64 (9.1%) had type 2, whereas 461 (65.8%) did not meet criteria for AMI. On multivariate analysis, use of angiography, peak TnI level, hyperlipidemia, and illicit drug use were independently associated with the diagnosis of AMI. TnI of 0.28 ng/ml had a 70% sensitivity and specificity for AMI diagnosis. In conclusion, a minority admitted with increased TnI have AMI by the universal definition. Type 1 is the most common AMI and is associated with higher TnI values and these patients are more likely to undergo angiography. Type 2 AMI is often associated with illicit drug use.

Elective percutaneous coronary intervention without on-site surgical backup: a community hospital experience.

CONTEXT: The American College of Cardiology guidelines consider elective percutaneous coronary intervention (PCI) without on-site surgical backup (OSB) a Class-III indication. OBJECTIVE: Our objective was to determine the safety of elective PCI without OSB. DESIGN: The study is a prospective analysis of a cohort of patients who underwent elective PCI without OSB at our institution. All patients were at our community satellite institution in Beloit, Wis. Three hundred twenty-one elective interventions were performed (mean age 64 +/-12, 68% male). The prevalence of diabetes and hypertension was 28% and 82.5% respectively. INTERVENTION: A predefined protocol was designed to transfer patients to a cardiac surgical facility if necessary. An experienced interventional cardiologist reviewed the diagnostic angiograms. Patients with complex lesions were excluded from the study. MAIN OUTCOME MEASURE: Any procedure-related death or emergency coronary artery bypass graft surgery. RESULTS: Three hundred eighty-two vessels were stented. Multi-vessel intervention was performed in 61 patients (19%). Only 5% of lesions were type C. Four hundred thirty-seven stents were deployed. IIb-IIIa inhibitors were used in 77 (24%) cases. Procedural success was 99.7%. There were no deaths, myocardial infarctions nor need for urgent target vessel revascularization at 6 months. CONCLUSION: With careful patient/lesion selection, an experienced interventional cardiologist and a predefined transfer protocol, elective PCI without OSB can be performed safely.

Endovascular intervention of aortoiliac occlusive disease in high-risk patients using the kissing stents technique: long-term results.

Endovascular intervention deploying a kissing stents (KS) technique has been used as an alternative to surgical intervention in treating symptomatic aortoiliac occlusive disease. However, the long-term results on high-risk patients are unknown. We retrospectively analyzed data on high-risk patients who underwent endovascular intervention using the KS technique at our institution. Fifty high-risk patients aged 62 +/- 6.4 years with severe aortoiliac stenosis underwent stent-supported angioplasty using the KS technique. Thirty percent of the patients had total occlusion of the distal aorta and/or the iliac arteries. Twelve patients received thrombolytics prior to stenting. The procedure was successful in all 50 patients. There was a 4% acute complication rate (distal embolization). However, there were no vascular complications, myocardial infarction, or perioperative death. Primary patency during follow-up of 20 +/- 12.3 months was 92%, while secondary patency rate was 100%. Amputation-free survival was 100%. Ninety-two percent remained free of lifestyle-limiting claudication.