Early exercise after coronary stenting is safe.

OBJECTIVES: In this study, we sought to assess safety of symptom-limited exercise stress tests the day after coronary stenting. BACKGROUND: Isolated cases of coronary stent thrombosis have been linked to early exercise stress testing, thereby questioning the safety of unrestricted physical activity after the coronary procedure. METHODS: At a single center, 1,000 patients were randomized to a symptom-limited stress test the day after coronary stenting or no stress test. The antiplatelet regimen consisted of acetylsalicylic acid and postprocedural ticlopidine or clopidogrel. The primary end point of the study was the incidence of clinical stent thrombosis at 14 days. The secondary end point was the occurrence of access site complications. RESULTS: Clinical stent thrombosis occurred in five patients (1%) undergoing stress test and in five patients (1%) randomized to no stress test (p = 1.0). Access site complications were detected in 4% and 5.2% of cases, respectively (p = 0.37). CONCLUSIONS: Symptom-limited exercise stress testing the day after coronary stenting does not increase the risk of clinical stent thrombosis or access site complications. Further investigations on safety of early vigorous exercise after coronary stenting in a non-supervised setting are warranted.

Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures.

BACKGROUND: The wide range of closure devices for arterial access sites still leaves room for improvement. METHODS AND RESULTS: We report our initial experience with a novel, cost-effective, suture-mediated device (6 French X-PRESS device, X-SITE Medical, Blue Bell, Pennsylvania) for closure of the arterial access site after both diagnostic and therapeutic interventions. A total of 51 consecutive patients are reported. The closure was performed immediately after the procedure. No patient had more than 5,000 U heparin administered during the procedure. The closure device was used in 36 patients (73%) after diagnostic angiography and in 15 patients (27%) after therapeutic intervention. The device could be successfully deployed in 48 patients (94%). In the remaining 3 cases (6%), hemostasis was achieved with standard manual compression without any further event. Immediate total hemostasis was achieved with the device in 44 of 48 patients (92%). Four devices (8%) could not be deployed correctly due to technical problems and the patients needed additional manual compression. The average time to achieve complete hemostasis was 5.5 +/- 3.5 minutes (range, 3-26 minutes). The patients were ambulated after a period of 1.3 +/- 0.4 hours of bedrest (range, 0.8-3.5 hours). Time to possible discharge was 4.2 +/- 3.4 hours (range, 0.9-12.5 hours). One patient experienced a minor complication (hematoma < 6 cm) and was treated with manual compression without clinical sequelae. Telephone follow-up was carried out 2 weeks after deployment and revealed no sequelae. CONCLUSION: The 6 French X-PRESS device is safe and effective in providing rapid hemostasis following interventional or diagnostic catheterization procedures. Use of the device is associated with a low rate of complications and facilitates quick hemostasis, mobilization and discharge.

Effects of non-ionic iodinated contrast media on patient heart rate and pressures during intra-cardiac or intra-arterial injection.

PURPOSE: To compare the effects on heart rate (HR), on left ventricular (LV) or arterial pressures, and the general safety of a non-ionic low-osmolar contrast medium (CM) and a non-ionic iso-osmolar CM in patients undergoing cardiac angiography (CA) or peripheral intra-arterial digital subtraction angiography (IA-DSA). MATERIALS AND METHODS: Two double-blind, randomized studies were conducted in 216 patients who underwent CA (n=120) or peripheral IA-DSA (n=96). Patients referred for CA received a low-osmolar monomeric CM (iomeprol-350, n=60) or an iso-osmolar dimeric CM (iodixanol-320; n=60). HR and LV peak systolic and end-diastolic pressures were determined before and after the first injection during left and right coronary arteriography and left ventriculography. Monitoring for all types of adverse event (AE) was performed for 24 h following the procedure. t-tests were performed to compare CM for effects on HR. Patients referred for IA-DSA received iomeprol-300 (n=49) or iodixanol-320 (n=47). HR and arterial blood pressure (BP) were evaluated before and after the first 4 injections. Monitoring for AE was performed for 4 h following the procedure. Repeated-measures ANOVA was used to compare mean HR changes across the first 4 injections, whereas changes after the first injection were compared using t-tests. RESULTS: No significant differences were noted between iomeprol and iodixanol in terms of mean changes in HR during left coronary arteriography (p=0.8), right coronary arteriography (p=0.9), and left ventriculography (p=0.8). In patients undergoing IA-DSA, no differences between CM were noted for effects on mean HR after the first injection (p=0.6) or across the first 4 injections (p=0.2). No significant differences (p>0.05) were noted in terms of effects on arterial BP in either study or on LV pressures in patients undergoing CA. Non-serious AE considered possibly CM-related (primarily headache and events affecting the cardiovascular and digestive systems) were reported more frequently by patients undergoing CA and more frequently after iodixanol (14/60 [23.3%] and 2/47 [4.3%]; CA and IA-DSA, respectively) than iomeprol (10/60 [16.7%] and 1/49 [2%], respectively). CONCLUSIONS: Iomeprol and iodixanol are safe and have equally negligible effects on HR and LV pressures or arterial BP during and after selective intra-cardiac injection and peripheral IA-DSA. CLINICAL APPLICATION: Iomeprol and iodixanol are safe and equally well tolerated with regard to cardiac rhythm and clinical preference should be based on diagnostic image quality alone.

Recurrent coronary artery stenosis: assessment with three-dimensional MR imaging.

PURPOSE: To assess the diagnostic value of three-dimensional coronary magnetic resonance (MR) angiography with fat saturation and navigator echo in the setting of restenosis after percutaneous transluminal coronary angioplasty (PTCA). MATERIALS AND METHODS: Thirty consecutive patients who had PTCA and were referred for elective coronary reangiography underwent MR imaging and coronary angiography. The pulse sequence was a cardiac triggered, single-slab, three-dimensional, gradient-echo sequence, employing a spin-echo navigator echo measurement to track the variation of the diaphragm during the scan. The following segments of the coronary arteries were included in this prospective study: left main coronary artery, proximal and middle left anterior descending, proximal and middle left circumflex, proximal and middle right coronary artery, and intermediate branch, if present. The quality of the MR images was graded from 0 to 5. RESULTS: In total, 221 coronary artery segments could be identified. Mean image quality was 3.3. Overall accuracy for segments with an image quality of grade 2 or more was 90%. To achieve a positive predictive value >70% for a significant stenosis/restenosis, only segments with quality >/=3 could be assessed, whereas an acceptable negative predictive value could be achieved for nearly all segments. CONCLUSION: Our preliminary data suggest that MR coronary angiography may be most helpful as a screening test in selected patients to exclude clinically relevant stenoses or to assess restenoses after PTCA or in patients in whose coronary angiography is relatively contraindicated.

Heparin and coumadin versus acetylsalicylic acid for prevention of restenosis after coronary angioplasty.

The purpose of the present study was to determine whether postprocedural antithrombotic therapy with prolonged heparin infusion followed by 6 months of oral anticoagulation in addition to acetylsalicylic acid (ASA) reduces the incidence of angiographic restenosis after successful PTCA. One hundred ninety-one patients with uncomplicated PTCA were randomized into two groups: one group was discharged with ASA 100 mg only (G1) and the other group was additionally treated with 12-24 hr of heparin infusion and overlapping oral anticoagulation with coumadin for 6 months (G2). The two groups were comparable with respect to age, gender, coronary risk profile, clinical presentation, and angiographic lesion characteristics. Stents were implanted in 33% and 36% of the G1 and G2 patients, respectively. In-hospital myocardial infarction occurred in 4% of the G1 and 3% of the G2 patients. One patient in G1 died of subacute stent thrombosis (day 3). Six-month angiographic follow-up was obtained in 90% of G1 patients and 94% of G2 patients. Restenosis occurred in 30% and 33% of the patients and mean diameter stenoses at follow-up were 40% +/- 28% and 39% +/- 24%, respectively. Thrombin inhibition with heparin infusion followed by 6 months of oral anticoagulation did not reduce angiographic restenosis among patients undergoing PTCA with or without stent implantation. The occurrence of acute ischemic complications was also comparable in the two groups.

Four French catheters for diagnostic coronary angiography.

A randomized study was conducted to assess the feasibility of 4 Fr catheters for diagnostic coronary angiograms. A total of 1,114 consecutive patients were randomized to 4 or 5 Fr catheters. Ease of use of catheters was subjectively assessed by the primary operator and the picture quality was assessed by two independent observers with a good interobserver variability (r = 0.94; P < 0.001). Predischarge local complications were recorded by the attending physician. No statistically significant difference was observed in the picture quality for the left coronary artery, right coronary artery, aorta, left ventricle, venous grafts, or renal arteries between the two groups. Fluoroscopy time (7.1 +/- 5.6 for 4 Fr vs. 6.7 +/- 5.7 min for 5 Fr) and contrast quantity (140 +/- 58 vs. 144 +/- 57 ml) were comparable between the two groups. There was a statistically significant difference in favor of the 5 Fr group as regards maneuverability of catheters (93% vs. 79%; P < 0.001), and 5 Fr pigtail catheters crossed the aortic valve easier than the 4 Fr pigtail catheters (91% vs. 81%; P < 0.001). Crossover to the other catheter size or a larger sheath was more frequent with 4 Fr catheters (33/522 vs. 3/592; P < 0.001). Median time to hemostasis was 9 min for 4 Fr and 14 min for 5 Fr (P < 0.001). Of the 4 Fr patients, 84% could be mobilized at 1 hr and 86% of 5 Fr patients at 2 hr. Significant hematomas were observed in 2% with 4 Fr or 5 Fr and small hematomas in 10% and 16%, respectively (P = NS). Time to discharge was comparable in both groups (4.0 +/- 3.2 with 4 Fr vs. 4.3 +/- 3.7 hr with 5 Fr). The 4 Fr catheters are a good alternative for diagnostic coronary angiograms. The increased difficulty in maneuverability and a need for catheter changes in 70% are compensated for in part by easier hemostasis. With increasing use and finesse of these catheters, the difficulty in maneuverability are likely to be overcome.