Bivalirudin versus Unfractionated Heparin during Percutaneous Coronary Intervention in Patients at High Risk for Bleeding.

Low/medium-bleeding-risk populations undergoing percutaneous coronary intervention (PCI) show significantly less bleeding with bivalirudin (BIV) than with unfractionated heparin (UFH), but this has not been established for high-risk patients. We performed a randomized double-blind prospective trial comparing efficacy and safety of BIV versus UFH combined with dual antiplatelet therapy during PCI among 100 high-risk patients with non-ST elevation myocardial infarction (NSTEMI) or angina pectoris. The baseline characteristics were similar in both treatment arms. A radial approach was used in 84% of patients with a higher rate in the BIV group (90 vs. 78%, p < 0.05). Study end points were: major and minor bleeding, port-of-entry complications, major adverse cardiac events (MACE) in-hospital, and at long-term follow-up. There was one case of major gastrointestinal bleeding in the BIV group and 7% minor bleeding complications in both categories. Rate of periprocedural myocardial infarction (PPMI) in the BIV group was twice that in the UFH group (20 vs. 10%, p < 0.16). In-hospital MACE rate was higher in BIV patients as well (12 vs. 2%, p = 0.1). By univariate analysis, the femoral approach was the predictor of PPMI and in-hospital MACE. In a multivariate model, the independent predictor of PPMI was previous MI (odds ratio, 7.7; p < 0.0158). PPMI was 49.7 times more likely with the femoral approach plus BIV than the nonfemoral approach plus UFH (p < 0.0021). At 41.5 ± 14 months' follow-up, end points did not significantly differ between the groups. In patients at high risk for bleeding undergoing PCI, BIV was not superior to UFH for bleeding complications, and early and late clinical outcomes.

Catheter Aspiration after Every Stage during Primary Percutaneous Angioplasty; ADMIT Trial.

We assess the epicardial and microcirculation flow characteristics, and clinical outcome by using catheter aspiration after each stage of primary percutaneous coronary intervention (PPCI). Conflicting data are reported regarding early and late benefit of using aspiration catheter in the initial phase PPCI. A total of 100 patients with ST-segment elevation acute myocardial infarction (STEMI) were included: 51 underwent PPCI without using an aspiration device (SA group) and 49 underwent PPCI by activating an aspiration catheter after each stage of procedure; wiring, ballooning and stenting, respectively (MA group). Thrombolysis in myocardial infarction (TIMI) flow grade, TIMI frame counts and myocardial blush grade (MBG) were evaluated in each group during every stage of procedure. Major adverse cardiac events were evaluated in the index hospitalization and during 30 and 180 days of follow-up. A TIMI flow grade 2-3 was more prevalent in the MA group compared with the SA group only after wiring: 65.9 versus 39.1% (p = 0.01), but TIMI frame counts were lower in the MA versus SA group throughout all procedural steps. MBG 2-3 was statistically higher in the MA group compared with the SA group mainly after wiring. After stenting there were no significant changes in both epicardial and microcirculation flow parameters. There were no significant differences between the groups in early and late clinical outcomes. Improved flow parameters were noticed in the MA group only by activating the aspiration device after wiring. This early advantage disappeared after stenting. The initial better flow characteristic in the MA group was not translated into a better early or late clinical outcome.

Transradial diagnosis and intervention of supraaortic vessels.

BACKGROUND: The transradial approach (TRA) is becoming widespread, mainly for coronary interventions, but it has rarely been used for diagnosis and even less for therapeutic treatment of supraaortic arterial vessel (SAAV) atherosclerotic disease. OBJECTIVES: We report our last year's experience in both diagnostic and therapeutic endovascular procedures for SAAV atherosclerotic disease using the TRA. METHODS: The TRA was used in 20 diagnostic and 18 therapeutic procedures for SAAV atherosclerotic disease performed on 26 males and 12 females with a mean age of 65 ± 7 years. Indications for diagnostic or therapeutic procedures were: clinical findings; and symptoms related to SAAV disease. Indications for the TRA were: no option of femoral approach (9/38); hostile arch anatomy (3/38); technical failure via femoral approach (4/38); ostial vertebral disease (6/38); or patient preference (16/38). All diagnostic procedures were undertaken using 5 Fr catheters. Treated vessels were: brachiocephalic; subclavian; carotid; vertebral; extracranial segments V1 and V2; and intracranial segment V4 and basilar arteries. Technical success was achieved in 17/18 therapeutic procedures (95%). We switched to the femoral approach in 1 patient with right-sided carotid disease where the distal protection device could not be propagated cranial to the narrowed segment. No vascular or neurological complications were recorded in any of the procedures. Patients were discharged the same day after diagnostic procedure and 1 day after therapeutic procedure. At a mean 7-month follow-up exam, neither neurological symptoms nor clinical restenosis were detected. CONCLUSIONS: Diagnostic and therapeutic procedures involving SAAV can be safely and successfully performed via the TRA by experienced interventional cardiologists.

Cardiovascular diseases in the elderly in a consultant outpatient cardiac clinic.

BACKGROUND: The incidence of cardiovascular disease increases with age, and visits by elderly patients to the outpatient cardiac clinic are becoming more frequent. OBJECTIVES: To characterize cardiovascular pathologies of patients 70 years of age and over who visit the outpatient cardiac clinic. METHODS: We investigated cardiovascular pathologies, risk factors, and medications in new patients over a 2 month period. RESULTS: The study population comprised 290 patients: 139 (47.9%) were older than 70 years. Among the cardiovascular pathologies, aortic stenosis, angina pectoris, congestive heart failure, s/p coronary artery bypass graft, and stroke were more frequent in the elderly patients than in those under age 70. Among the risk factors for ischemic heart disease, only hypertension was more frequent in the elderly population, whereas fewer in this group were active smokers. The mean number of medications administered was 3.51 +/- 1.63 among the elderly patients compared to 1.99 +/- 1.7 among the younger ones (P = 0.0001). Beta-blockers were the most frequently used cardiovascular drugs both in the elderly (59.7%) and in the younger patients (43%) (P = 0.0046). CONCLUSIONS: Patients over age 70 represent about half the visits in our outpatient clinic. Their multiple cardiovascular pathologies and therapeutic requirements raise the issue of developing the cardiology service to meet the special needs of geriatric patients.

[Transradial diagnostic and interventional cardiac catheterization in daily practice: advantages, efficacy and safety].

UNLABELLED: The transfemoral approach is still considered as the standard technique for cardiac catheterization. The transradial approach is associated with a lower incidence of vascular access site complications and shorter hospital stay, although it is more demanding and requires a longer learning curve. AIMS: To assess advantages, efficacy and safety of the transradial versus transfemoral cardiac catheterization in patients with high risk to develop vascular complications. METHODS: Single center, case series study. Catheterization data, vascular complications and rehospitalizations were collected prospectively. The site of access was determined by the operator preference, patient suitability and the risk for local bleeding. RESULTS: From November 2005 through August 2007 a total of 3084 consecutive cardiac catheterization were performed: 871 (28%) transradial and 2213(72%) transfemoral. The transradial group included higher rates of patients with high risk to develop entry site vascular complications (obese, anticoagulation therapy and peripheral vascular disease) than the femoral group (p < 0.0001). Crossover to alternative access site was 4.5% in the radial versus 0.03% in the femoral group (OR 3.17, CI 95% 2.78 to 3.60, p < 0.0001). Fluoroscopy time was 2 minutes higher in the radial group (p = 0.043). Entry site vascular complications were significantly lower in the radial compared to femoral group, 0.03% versus 3.1% respectively (OR 0.1, CI 0.06 to 0.35, p < 0.0001). Hospital stay was 1.32 days shorter in the radial group (p < 0.0001). The increased number of radial catheterization was correlated significantly with decreased incidence of vascular complications (Pearson's rp = -0.927, p < 0.0001). CONCLUSION: Transradial cardiac catheterization is a safe and effective approach to reduce vascular complications in high risk patients.

Feasibility, safety, and morphologic predictors of outcome of repeat percutaneous balloon mitral commissurotomy.

Early and mid-term results of repeat percutaneous balloon mitral commissurotomy (PBMC) were analyzed in 35 patients with symptomatic valvular restenosis: 12 patients (34%) after first successful PBMC and 23 patients (66%) after successful surgical closed mitral commissurotomy. Twenty-one patients had bilateral fused commissures, and 14 patients had unilateral or bilateral split commissures. Mitral valve area gain was significantly greater in the group with fused commissures compared with the group with split commissures (0.6 +/- 0.2 vs 0.3 +/- 0.2 cm(2), respectively, p = 0.04).

A nursing home in Arab-Israeli society: targeting utilization in a changing social and economic environment.

This article is a case study of the first 10 years of operation (1992-2002) of the Dabouriya Home for the Aged, the first publicly funded culturally adapted nursing home for Israeli citizens of Arab descent. Although 44% of Arab Israelis and 26% of Jewish Israelis aged 65 and older are disabled, in 1999, 4.3% of the Jewish population but only 0.7% of the Arab-Israeli population aged 65 or older lived in long-term care institutions; disabled Arab-Israeli elderly were mainly cared for by families. As Arab-Israeli society modernizes and traditional caregiving is reduced, alternatives must be found for this growing, disabled population. Medical and administrative records of 404 people admitted consecutively to a 136-bed facility over 10 years were analyzed. Two distinct segments of the needy population were served: people with independent activity of daily living (ADL) function but little or no family to provide help with intermediate ADLs and those dependent in ADLs and with health problems, especially dementia. Economic, demographic, and social changes in Arab-Israeli society may mean that traditional caregivers will not be able to adequately care for this highly disabled population. Administrators of the public health system in Israel should be aware of the underutilization of publicly funded long-term care by disabled Arab Israelis and the lack of care alternatives for the population that does use nursing homes, because there may be severe consequences in terms of caregiver burden and social stress when disabled elderly people remain in unsuitable environments.

Percutaneous balloon mitral valvuloplasty in patients with severe mitral stenosis and low transmitral diastolic pressure gradient.

An elevated left atrial pressure and high diastolic pressure gradient (DPG) across the mitral valve are the major hemodynamic abnormalities in mitral stenosis (MS). However, a subgroup of patients with severe MS is characterized by low initial DPG. The authors reviewed the clinical, echocardiographic and hemodynamic data as well as procedural results in 180 patients who underwent percutaneous balloon mitral valvuloplasty (PBMV). An initial mean DPG > 10 mmHg was found in 144 patients (80%) (group A) and mean DPG < or = 10 mmHg in 36 patients (20%) (group B). Patients in group A had higher left ventricular ejection fraction (LVEF) than in group B (61 +/- 5% versus 42 +/- 6%, respectively) and higher cardiac index (2.8 +/- 0.4 versus 2.0 +/- 0.3 l/min/m(2) ). In group B 12 patients (33%) had normal LVEF, whereas 24/36 (67%) had reduced LVEF. All the latter had wall motion abnormalities on ventriculography. Unlike group A, intraprocedural echocardiography was essential for monitoring and evaluating immediate results of PBMV in group B. On follow-up of three years, 75% of group A patients and 55% in group B were in functional class I (p < 0.05). PBMV did not significantly improve symptoms in patients in group B who had preprocedure LVEF < or = 35%.

Diagnostic and therapeutic percutaneous cardiac interventions without on-site surgical backup--review of 11 years experience.

BACKGROUND: Current clinical guidelines restrict catheterization laboratory activity without on-site surgical backup. Recent improvements in technical equipment and pharmacologic adjunctive therapy increase the safety margins of diagnostic and therapeutic cardiac catheterization. OBJECTIVE: To analyze the reasons for urgent cardiac surgery and mortality in the different phases of our laboratory's activity in the last 11 years, and examine the impact of the new interventional and therapeutic modalities on the current need for on-site cardiac surgical backup. METHODS: We retrospectively reviewed the mortality and need for urgent cardiac surgery (up to 12 hours post-catheterization) through five phases of our laboratory's activity: a) diagnostic (years 1989-2000), b) valvuloplasties and other non-coronary interventions (1990-2000), c) percutaneous-only balloon angioplasty (1992-1994), d) coronary stenting (1994-2000), and e) use of IIb/IIIa antagonists and thienopiridine drugs (1996-2000). RESULTS: Forty-eight patients (0.45%) required urgent cardiac surgery during phase 1, of whom 40 (83%) had acute coronary syndromes with left main coronary artery stenosis or the equivalent, and 8 (17%) had mechanical complications of acute myocardial infarction. Two patients died (0.02%) during diagnostic procedures. In phase 2, eight patients (2.9%) were referred for urgent cardiac surgery due to either cardiac tamponade or severe mitral regurgitation, and two patients (0.7%) died. The combined need for urgent surgery and mortality was significantly lower in phase 4 plus 5 as compared to phase 3 (3% vs. 0.85%, P = 0.006). CONCLUSION: In the current era using coronary stents and potent antithrombotic drugs, after gaining experience and crossing the learning curve limits, complex cardiac therapeutic interventions can safely be performed without on-site surgical backup.