The safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study.

BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial. METHODS: A total of 17 U.S. sites enrolled 596 subjects with 483 subjects randomized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. A substudy of the CLIP interventional arm evaluated DUS images of the closure site at five study sites, targeting 100 subjects at day 30 following hemostasis. The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence of iatrogenic vascular injuries: hematoma, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial/venous thrombosis or stenosis using 2-dimensional gray scale, color, and focused Doppler images. RESULTS: DUS of 96 subjects randomized to StarClose (n = 71) and compression (n = 25) were performed and evaluated. There was no evidence of hematoma, PSA, or AVF observed in the StarClose group. No StarClose subjects in the substudy had a PSA or AVF. All patients in the substudy demonstrated patency of the access site artery and vein without thrombosis or stenosis. Finally, in the entire study cohort, no clinically-driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients. CONCLUSION: DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.

The 6Fr Angio-Seal arterial closure device: results from a multimember prospective registry.

Femoral closure devices help early ambulation after cardiac catheterization without incurring additional risk to the patients. This report summarizes the safety and efficacy data of the 6Fr Angio-Seal device.

Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER multicenter registry.

The BARASTER registry was formed to evaluate the initial success and long-term results of rotational atherectomy in the management of in-stent restenosis. Rotational atherectomy was used in 197 cases of in-stent restenosis: 46 with stand-alone rotational atherectomy or at most 1 atmosphere of balloon inflation (Rota strategy), and 151 with rotational atherectomy and adjunctive balloon angioplasty <1 atmosphere (Combination strategy). These were compared with 107 episodes of in-stent restenosis treated with balloon angioplasty alone. In this observational study, the use of Combination therapy was associated with a slightly higher initial success rate (95% vs. 87% with the Rota strategy and 89% with Balloons, P = 0.08). There was a reduction in one year clinical outcomes (death, myocardial infarction or target lesion revascularization) in the combination group (38% vs. 60% with Rota and 52% with balloons, P = 0.02). These data support a benefit of the strategy of debulking with rotational atherectomy followed by adjunctive balloon angioplasty, in the management of in-stent restenosis.

Optimum percutaneous transluminal coronary angioplasty compared with routine stent strategy trial (OPUS-1): a randomised trial.

BACKGROUND: Whether routine implantation of coronary stents is the best strategy to treat flow-limiting coronary stenoses is unclear. An alternative approach is to do balloon angioplasty and provisionally use stents only to treat suboptimum results. We did a multicentre trial to compare the outcomes of patients treated with these strategies. METHODS: We randomly assigned 479 patients undergoing single-vessel coronary angioplasty routine stent implantation or initial balloon angioplasty and provisional stenting. We followed up patients for 6 months to determine the composite rate of death, myocardial infarction, cardiac surgery, and target-vessel revascularisation. RESULTS: Stents were implanted in 227 (98.7%) of the patients assigned routine stenting. 93 (37%) patients assigned balloon angioplasty had at least one stent placed because of suboptimum angioplasty results. At 6 months the composite endpoint was significantly lower in the routine stent strategy (14 events, 6.1%) than with the strategy of balloon angioplasty with provisional stenting (37 events, 14.9%, p=0.003). The cost of the initial revascularisation procedure was higher than when a routine stent strategy was used (US$389 vs $339, p<0.001) but at 6 months, average per-patient hospital costs did not differ ($10,206 vs $10,490). Bootstrap replication of 6-month cost data showed continued economic benefit of the routine stent strategy. INTERPRETATION: Routine stent implantation leads to better acute and long-term clinical outcomes at a cost similar to that of initial balloon angioplasty with provisional stenting.

Genomewide search for type 2 diabetes susceptibility genes in four American populations.

Type 2 diabetes is a serious, genetically influenced disease for which no fully effective treatments are available. Identification of biochemical or regulatory pathways involved in the disease syndrome could lead to innovative therapeutic interventions. One way to identify such pathways is the genetic analysis of families with multiple affected members where disease predisposing genes are likely to be segregating. We undertook a genomewide screen (389-395 microsatellite markers) in samples of 835 white, 591 Mexican American, 229 black, and 128 Japanese American individuals collected as part of the American Diabetes Association's GENNID study. Multipoint nonparametric linkage analyses were performed with diabetes, and diabetes or impaired glucose homeostasis (IH). Linkage to diabetes or IH was detected near markers D5S1404 (map position 77 cM, LOD = 2.80), D12S853 (map position 82 cM, LOD = 2.81) and GATA172D05 (X-chromosome map position 130 cM, LOD = 2.99) in whites, near marker D3S2432 (map position 51 cM, LOD = 3.91) in Mexican Americans, and near marker D10S1412 (map position 14 cM, LOD = 2.39) in African Americans mainly collected in phase 1 of the study. Further analyses showed evidence for interactions between the chromosome 5 locus and region on chromosome 12 containing the MODY 3 gene (map position 132 cM) and between the X-chromosome locus and region near D12S853 (map position 82 cM) in whites. Although these results were not replicated in samples collected in phase 2 of the GENNID study, the region on chromosome 12 was replicated in samples from whites described by Bektas et al. (1999).

Post-Mustard procedure pulmonary venous obstruction: An opportunity for anatomic correction with a one-stage arterial switch.

A 14-year-old boy after a Mustard procedure for transposition of the great arteries developed pulmonary hypertension secondary to baffle obstruction. This occurred over several years without apparent significant symptomatology. Systemic-level pressure prevailed in the left (pulmonary) ventricle and provided an opportunity to perform a successful one-stage arterial switch.

Analysis of low-speed rotational atherectomy for the reduction of platelet aggregation.

Platelet activation is an important determinant of acute outcomes of percutaneous intervention. The objective of this study was to assess the effect of rotational atherectomy on platelet activation in an in vitro model. Freshly collected heparinized porcine blood was exposed to a 2.0-mm Rotablator burr rotating at one of three speeds: 180,000, 140,000, or 0 rpm. The specimens were analyzed immediately for concentration and size of platelet aggregates and plasma-free hemoglobin. There were significantly more platelet aggregates of >20-microm diameter at higher speeds (7,434+/-2,193 at 180,000, vs. 2,269+/-627 at 140,000, vs. 633+/-258 aggregates/ml at 0 rpm; P < 0.001). Plasma-free hemoglobin, a simple measure of cell damage, decreased with decreasing rotational speed (429+/-168 mg/dl at 180,000, vs. 88+/-44 mg/dl at 140,000, vs. 9+/-9 mg/dl at 0 rpm; P < 0.0001). In vitro, platelet activation decreases with decreasing burr speed, suggesting that the use of the Rotablator system at its minimum approved speed (140,000 rpm) could prove clinically beneficial.

Analysis of heat generation during rotational atherectomy using different operational techniques.

Rotational atherectomy can generate heat from the friction of the burr as it ablates atherosclerotic plaque. The objective of this study is to correlate Rotablator technique and heat generation using two experimental models. First, 2.0 mm burrs were advanced through a lesion model derived from bovine bone implanted with thermal probes. Intermittent ablation with minimal decelerations resulted in a smaller temperature increase than continuous ablation with maximal decelerations (2.6 +/- 1.3 vs. 13.9 +/- 1.0 degrees C, respectively, P < 0.01). The second model used porcine femoral arteries cradled in constricting polyethylene grafts with thermal probes in contact with the adventitia. As the burr advanced through the segment, RPM decreases of 5-7 k resulted in a temperature rise of 4.1 +/- 1.2 degrees C, whereas decelerations of 10-20 k resulted in a 11.3 +/- 6.2 degrees C temperature increase. We conclude that excessive drops in speed and aggressive advancement of the burr are related to significant increases in temperature and potential thermal injury.

Quantitative angiography of coronary artery dimensions 24 hours after rotational atherectomy.

Rotational atherectomy results in platelet activation and heat generation, which may impact artery size immediately after treatment. In addition, arteries treated with balloon angioplasty may exhibit recoil within 24 hours. In this study, arteries treated with rotational atherectomy, with and without adjunctive balloon angioplasty, were analyzed by quantitative coronary angiography to determine the effect of rotational atherectomy on the dynamic behavior of the arterial wall within 24 hours after the procedure. Quantitative coronary angiography was performed at a core laboratory. Coronary angiogram acquisitions were preceded by intracoronary nitroglycerin injections and were repeated using identical angles of projection. Proximal and distal reference vessel diameters were 2.55 +/- 0.60 and 2.28 +/- 0.51 mm, respectively, and did not change from pre- to postprocedure. Both were larger the following day increasing to 2.72 +/- 0.65 and 2.52 +/- 0.52 mm, respectively, (p <0.001). Minimum luminal diameter (MLD) increased from 0.70 +/- 0.28 mm before to 1.49 +/- 0.34 mm after the procedure and to 1.72 +/- 0.37 mm at 24-hour follow-up (p <0.001). Subset analysis of patients treated with rotational atherectomy alone or rotational atherectomy with adjunctive balloon angioplasty revealed that the increase in luminal diameters occurred in both subsets. Patients treated with adjunctive angioplasty had a smaller initial MLD, a larger postprocedure MLD, and no difference in MLD at 24-hour follow-up compared with stand-alone rotational atherectomy. Subset analysis of 100 patients who had 6-month follow-up angiography revealed that both a calculated acute gain and chronic late loss, based on a 24-hour film, differed significantly from values using a film acquired immediately after the procedure. However, the slope of the linear regression between acute gain and chronic late loss did not differ. Coronary arteries treated with rotational atherectomy with or without adjunctive balloon angioplasty increase significantly in size during the first 24 hours after the procedure. This phenomenon has implications for the calculation of absolute gain and chronic late loss, but not for the linear relation between the 2 quantitative outcomes.

Rotablator plus stent therapy (rotastent).

Over 400,000 percutaneous transluminal coronary angioplasties (PTCAs) are currently performed annually in the United States. Approximately 10% of these procedures include rotational atherectomy, although the national average rate of stent placements continues to increase in some centers to as high as 75%. The combination of rotational atherectomy and intra-coronary stent placement is between 2% and 7.5% of interventional procedures per year in the United States. This article reviews the existing literature on rotational atherectomy and stent implantation for complex lesions and describes the upcoming prospective, multicenter randomized Stent Implantation, Postrotational Atherectomy (SPORT) trial.

Comparison of patients with either < 70% diameter narrowing or > or = 70% narrowing of the right coronary artery when performing rotational atherectomy on > or = 1 narrowing in the left coronary arteries.

This study compares the complication rates of patients undergoing rotational atherectomy of the left coronary system who had either minimal or significant narrowing of the right coronary artery (RCA). A series of 1,872 patients from a multicenter registry who were treated for left coronary artery disease were divided into <70% diameter stenosis (mild) and > or = 70% stenosis (severe) of the RCA. The patient demographics, lesion characteristics, and frequency of procedural complications for each group were compared. Of the 1,872 patients undergoing rotational atherectomy of the left coronary system, 86.3% (n = 1,616) had mild RCA disease and 13.7% (n = 256) had severe RCA disease. Comparing the mild and severe groups, death (0.8% vs 3.1%, p <0.005), non-Q-wave myocardial infarction (5.1% vs 8.6%, p <0.04), and bypass surgery (2.7% vs 5.8%, p <0.02) were increased in the severe group. Within the severe group, 7 of 8 deaths were in the 128 patients with total occlusion of the RCA. Multivariate analysis demonstrated that RCA stenosis increases the risk of death by 4.9, bypass surgery by 2.6, and non-Q-wave myocardial infarction by 1.8. Patients treated for left coronary disease who have > or = 70% stenosis of the RCA have increased complications during rotational atherectomy.

Comparison of early and recent results with rotational atherectomy.

OBJECTIVES: We compared an early registry of rotational atherectomy with a recent registry to examine the evolution of patient profiles, lesion characteristics and procedural outcomes for patients treated with rotational atherectomy. BACKGROUND: With increased experience, the selection of patients and lesions treated with a device matures. This study documents the changes in the application of rotational atherectomy. METHODS: The patient characteristics and procedural outcomes from two multicenter patient registries-Registry I: 2,953 procedures, 3,717 lesions from 1988 to 1993; and Registry II: 200 procedures, 268 lesions from 1994-were analyzed and compared. RESULTS: There was an increase in the average age of the patients (63 vs. 65 years, p < 0.02) and the proportion of patients with unstable angina (42.9% vs. 56.5%, p < 0.01) or previous coronary artery bypass graft surgery (18.8% vs. 24.5%, p < 0.05) in Registry II. Registry II included fewer left anterior descending coronary lesions (46.5% vs. 32.8%, p < 0.01), more type B and C lesions (83.1% vs. 91.8%, p < 0.01), more eccentric lesions (69.0% vs. 79.5%, p < 0.01) and more calcified lesions (50.3% vs. 69.4%, p < 0.01). Complications, including urgent bypass surgery, Q and non-Q wave myocardial infarction, dissection, acute occlusion and perforation, were similar in the two groups. However, mortality increased from 1.0% to 3.0% (p < 0.05) in Registry II. CONCLUSIONS: Comparison of recent and early patients treated with rotational atherectomy revealed an increase in the complexity of patients and lesions. Although the rate of death was increased, the overall rate of major complications was not significantly changed (4.7% vs. 6.0%, p = NS).

Technique and strategy of rotational atherectomy.

Atherosclerotic plaque heterogeneity has created the need for the development of second generation devices aimed specifically at lesions where PTCA has been shown to be suboptimal. The Rotablator system represents one of the newer technologies which utilizes plaque ablation to achieve larger lumens. The device is a high speed "rotary sander," which requires the interventional cardiologist to be keenly aware of the mechanical implications while advancing the device through the coronary vasculature. The objective of this article is to review the most recent technique refinements and strategies for rotational atherectomy as well as the available clinical data and ongoing clinical trials.

Guidewire bias: potential source of complications with rotational atherectomy.

The guidewire in rotational atherectomy is an integral component in the ablative process. It functions not only to deliver the device but sets the cutting vector when the burr advances. Since the guidewire is a stiff stainless steel monofilament and the vessels are frequently tortuous and angulated, the guidewire may not be centrally oriented, but may bias preferentially to one side of the arterial wall. This may result in tangential or radial cutting. The following cases illustrate the dependence of the ablative process on the lie of the guidewire and the importance of integrating this factor in proper use of the Rotablator system.

Rotational ablation. The Rotablator catheter.

High-speed rotational ablation addresses specific limitations inherent in conventional methods of percutaneous revascularization. The Rotablator system represents an alternative mechanism to achieve restoration of luminal dimensions by removing atherosclerotic plaque. This article summarizes results, identifies indications, and discusses potential applications of rotational ablation in the treatment of coronary artery disease.

Pediatric hypospadias surgery.

The pediatric health care practitioner is a valuable resource of information for the family of an infant with hypospadias prior to the child and family's first visit to the pediatric urologist. Pediatric nurses are involved in the preoperative and postoperative care of children with surgical correction of hypospadias and should be aware of the newest advances in surgical techniques and improvements in postoperative care, particularly dressings and urethral stents. These advances have improved the outcome for children, including diminished pain and discomfort, minimal hospital stay and decreased complications. Minimal postoperative intervention is required. The current management of these children will ensure the optimum resolution with minimum physical and psychological problems for the child and family.

Grading nephroureteral dilatation detected in the first year of life: correlation with obstruction.

To understand better the significance of pediatric idiopathic nephroureteral dilatation the renal ultrasound images of patients less than 1 year old with hydronephrosis or hydroureteronephrosis were graded and compared to the radiological diagnosis of obstruction as determined by diuresis renography and/or urography. The study included 73 boys and 30 girls with hydronephrosis (76 patients) or hydroureteronephrosis (27). For hydronephrosis obstruction was diagnosed in 56 children (74%) and involved 61 of 97 kidneys (63%). For obstructed kidneys the mean grade of hydronephrosis (3.4 +/- 0.7 standard deviation) was statistically different from that of nonobstructed kidneys (1.6 +/- 0.8 standard deviation) (p less than 0.05). When the value to predict obstruction was set at grade 3 hydronephrosis or greater there was an 88% sensitivity and 95% specificity. For hydroureteronephrosis obstruction was diagnosed in 15 of 27 children (56%) and involved 17 of 34 kidneys (50%). The degree of dilatation was weighted as a score to assess the grades of hydronephrosis and ureteral dilatation, namely hydroureteronephrosis score equals grade of hydronephrosis plus grade of ureteral dilatation. In obstructed megaureters the mean hydroureteronephrosis score (5.8 +/- 1.0) was statistically different from that for nonobstructed megaureters (mean hydroureteronephrosis score 2.7 +/- 1.9) (p less than 0.001). When the value to predict obstruction was set at hydroureteronephrosis score of 5 or greater there was a 94% sensitivity and 80% specificity. Although ultrasound examination alone cannot be used to diagnose urinary obstruction, the radiological diagnosis of obstruction is linked with the grade of hydronephrosis or score of hydroureteronephrosis.

Glucan-induced keratoderma in acquired immunodeficiency syndrome.

Six of 20 patients with acquired immunodeficiency syndrome (AIDS) or AIDS-related complex receiving intravenous infusions of soluble glucan (beta-1-3 polyglucose) developed a keratoderma of the palms and soles. The eruption began during the first two weeks of therapy and resolved two to four weeks after its discontinuation. The eruption was different in appearance from our previously reported keratoderma blennorrhagica in AIDS-associated psoriasis. None of the other 735 patients with AIDS or AIDS-related complex not treated with soluble glucan developed a similar keratoderma. The correlation between receiving glucan and the hyperkeratosis is highly significant. Since glucan is a naturally occurring component of the cell walls of yeast, fungus, and some bacterial organisms, recognition of its ability to induce such a striking reaction pattern may be of general significance and interest, although the reaction itself may be limited to patients with AIDS.