Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials.

Despite advances in other aspects of cardiac catheterization, manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management. Suture-mediated closure may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial (STAND I) evaluated the 6Fr Techstar device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 515 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS). Major complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05). Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significantly shorter for suture-mediated closure. Suture-mediated closure of the arterial puncture site thus affords reliable immediate hemostasis and shortens the time to ambulation without significantly increasing the risk of local complications.

New intracoronary stent designs: form follows function versus function follows form.

Intracoronary stenting improves the acute and long-term safety and efficacy of percutaneous coronary interventions by minimizing the risks of abrupt closure and late restenosis. Enhanced designs of new coronary stents will continue to expand the spectrum of coronary anatomy and clinical settings amenable to nonsurgical revascularization. Improvements in deliverability, application to complex lesions, and durability of results are direct effects of improved design characteristics. Future design features may also include incorporating adjunctive therapies such as antithrombotic or antiproliferative agents with stent-based delivery systems. Results of new stent registries and randomized clinical trials are reviewed.

Comparison of six-month outcome of coronary artery stenting in patients <65, 65-75, and >75 years of age.

We studied 1,238 patients receiving 1,880 coronary stents. In-hospital outcomes were divided by age into <65 years (n = 747, group 1), 65 to 75 years (n = 326, group 2), and >75 years (n = 165, group 3). Procedural success was 97.2%, 95.1%, and 98.8% in groups 1, 2, and 3, respectively (p = NS). There was 1 death (group 1). Myocardial infarction occurred in 1.2%, 2.8%, and 1.8%, bypass surgery occurred in 0.9%, 1.8%, and 1.2%, and repeat balloon angioplasty in 0.3%, 0.6%, and 0% of patients in groups 1, 2, and 3, respectively (p = NS for all comparisons). Vascular complications occurred in 2.8%, 4.9%, and 6.1% in groups 1, 2, and 3, respectively (p <0.05). Six-month follow-up of patients was divided by age: <65 years (n = 564, group 1); 65 to 75 years (n = 221, group 2); and >75 years (n = 122, group 3). Event-free survival was 94.5%, 90.5%, and 89.3% for groups 1, 2, and 3, respectively (p = NS). Death occurred in 0.4%, 0.5%, and 1.6%; myocardial infarction occurred in 1.2%, 2.3%, and 1.6%, and target vessel revascularization in 4.3%, 8.6%, and 7.4% for groups 1, 2, and 3, respectively (p = NS for all comparisons). Thus, coronary stenting produced favorable in-hospital and 6-month outcomes in all 3 age groups. Age itself should not preclude patients from undergoing coronary stenting.

Abrupt (< 1 day), acute (< 1 week), and early (< 1 month) vessel closure at the angioplasty site. Morphologic observations and causes of closure in 130 necropsy patients undergoing coronary angioplasty.

While abundant clinical and angiographic data are available regarding features of acute or abrupt closure at the site of balloon angioplasty, little morphologic information is available. This study discusses morphologic-histologic causes for acute closure after angioplasty in 130 necropsy patients. Intimal-medial flaps, elastic recoil, and primary thrombosis were the three leading morphologic causes for closure. Data were subdivided into time categories: abrupt (< 1 day), acute (< 1 week), and early (< 1 month). Intimal-medial flaps remained the most common cause for angioplasty closure despite time from angioplasty to documented occlusion. Morphologic recognition of types and frequencies of angioplasty closure are discussed, and specific mechanical, pharmacologic, or combined treatments are reviewed.

Late coronary artery stenosis regression within the Gianturco-Roubin intracoronary stent.

The late angiographic outcome of the Gianturco-Roubin intracoronary stent has not been well defined. To investigate serial changes within the stent, we studied 23 patients (15 men and 8 women, median age 63) who had late angiographic follow-up ( > 1 year) after undergoing Gianturco-Roubin stenting for angioplasty-associated acute or threatened native coronary artery closure. Coronary angiography before and after stenting, at 6-month follow-up, and at late return was analyzed with quantitative coronary angiography. The median time from stent deployment to late angiographic follow-up was 27 months. As expected, stenting significantly increased the median minimal lumen diameter (MLD) acutely from 1.0 to 2.46 mm. Median percent diameter stenosis decreased from 66% to 18%. Although at 6 months there was a significant loss of the acute gain (median MLD decreased from 2.46 to 1.9 mm), with a corresponding increase in percent stenosis from 18% to 31%, late angiography demonstrated lesion regression, median MLD increasing from 1.9 to 2.15 mm (p = 0.004), and percent stenosis decreasing from 31% to 21% (p = 0.0026). No patient had a significant decline in minimal lesion diameter, and 5 patients had a > 50% increase in MLD at late follow-up. Linear regression analysis of 6-month MLD and late lumen gain suggested that lesions with the greatest regression were those with the lowest lumen diameters at 6-month angiography. Late angiographic analysis demonstrated significant lesion regression within the Gianturco-Roubin stent, which was sometimes dramatic. In suggesting that coronary arteriography at 6 months may underestimate the late angiographic benefit of intracoronary stenting, these data have important clinical implications, and imply that patients with a stable clinical course and angiographic stent restenosis may often be followed rather than routinely redilated.

Indications for and applications of the Gianturco-Roubin coronary stent.

The Gianturco-Roubin coronary stent is approved for and effective in the management of acute or threatened closure after unsuccessful coronary intervention. Factors critical to successful stenting include patient and lesion selection, preprocedure identification of patients in potential need of stenting, selection of stent-compatible ancillary equipment, appropriate antiplatelet and anticoagulant therapy, postdeployment stent dilatation, and careful sizing of stents. Further refinements of technique and adjunctive drug therapy should continue to improve results and avoid acute complications. Published clinical experience and potential future applications are discussed.

Major clinical events after coronary stenting. The multicenter registry of acute and elective Gianturco-Roubin stent placement. The Gianturco-Roubin Intracoronary Stent Investigator Group.

BACKGROUND: Abrupt vessel closure and early reocclusion remain the principal vascular events underlying early recurrent ischemia complicating elective percutaneous transluminal coronary angioplasty (PTCA). Intracoronary stenting has been used to circumvent emergency bypass surgery after acute vessel closure and as an adjunct for the elective treatment of restenosis. The initial multicenter experience with the Gianturco-Roubin stent is presented, and predictors for early recurrent ischemic events are identified. METHODS AND RESULTS: Data accrued from 639 serial patients undergoing emergency stenting for abrupt closure (n = 415; 65%) or elective deployment for restenosis (n = 224; 35%) from October 1989 through May 1991 were analyzed. The incidence of subsequent ischemic events, including death, nonfatal myocardial infarction, and bypass surgery referral within 90 days of the procedure, was higher after acute deployment (20%) compared with elective stenting (9%; P = .0004). Although mortality within the two cohorts was the same (3%; P = NS), there were significant differences in the incidence of nonfatal myocardial infarction (5% versus 0.5%; P = .002) and bypass surgery (12% versus 6%; P = .02) between the acutely and electively stented patients, respectively. These events were significantly more common when the stent was undersized to the target vessel diameter (stent:artery ratio for event, 0.95 +/- 0.14 versus no event, 1.04 +/- 0.22; P = .0001) or when there was less expansion of the lesion by the deployed device (stent-to-lesion diameter ratio for event, 6.6 +/- 9.2 versus no event, 11.0 +/- 21.4; P = .0001). In a stepwise logistic regression model, acute stenting (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.3 to 2.4), multivessel disease (OR, 1.4; CI, 1.1 to 1.8), larger target lesion diameter (OR, 2.1; CI, 1.4 to 3.2), larger target vessel (OR, 2.9; CI, 1.7 to 4.7), and smaller stent size (OR, 6.1; CI, 3.0 to 12.3) were independent predictors of early, recurrent ischemic events. The presence of thrombus was associated with a higher event rate after elective stenting (OR, 2.3; CI, 1.06 to 5.4) but was not associated with a higher early event rate after acute stenting. CONCLUSIONS: Early ischemic events are more common after acute stenting for abrupt or threatened closure than after elective deployment. These events may be avoided with careful attention to morphometric characteristics to avoid undersizing the stent to the target vessel and ensure adequate lesion expansion.

Histologic analysis of directional coronary atherectomy samples. A review of findings and their clinical relevance.

Histologic analysis of atherectomy samples from > 400 patients who received directional coronary atherectomy at 3 separate institutions disclosed 2 major categories of tissue: atherosclerotic plaque (with or without thrombus) and intimal proliferation (hyperplasia, with or without thrombus). The predominant tissue type in atherectomy samples from native, primary, or de novo coronary artery stenoses was atherosclerotic plaque. The predominant tissue type in atherectomy samples from restenosis lesions (prior balloon angioplasty, atherectomy, or both) was intimal proliferation with variable amounts of atherosclerotic plaques (with or without thrombus). Deep vessel wall components (media, adventitia) were identified at varying frequencies. The clinical relevance of atherectomy tissue is reviewed.

Multicenter investigation of coronary stenting to treat acute or threatened closure after percutaneous transluminal coronary angioplasty: clinical and angiographic outcomes.

OBJECTIVES: This study reports on the initial experience with the Gianturco-Roubin flexible coronary stent. The immediate and 6-month efficacy of the device and the incidence of the complications of death, myocardial infarction, emergency coronary artery bypass surgery and recurrent ischemic events are presented. BACKGROUND: Abrupt or threatened vessel closure after coronary angioplasty is associated with increased risk of myocardial infarction, emergency coronary artery bypass graft surgery and in-hospital death. When dissection or prolapse of dilated plaque into the lumen is unresponsive to additional or prolonged balloon catheter inflation, coronary stenting offers a nonsurgical mechanical means to rapidly restore stable vessel geometry and adequate coronary blood flow. METHODS: From September 1988 through June 1991, 518 patients underwent attempted coronary stenting with the 20-mm long Gianturco-Roubin coronary stent for acute or threatened vessel closure after angioplasty. In 494 patients, one or more stents were deployed. Thirty-two percent of patients received stents for acute closure and 69% for threatened closure. RESULTS: Successful deployment was achieved in 95.4% of patients. Overall, stenting resulted in an immediate angiographic improvement in the diameter stenosis from 63 +/- 25% before stenting to 15 +/- 14% after stenting. Emergency coronary artery bypass graft surgery was required in 4.3% (21 of 493 patients). The incidence of in-hospital myocardial infarction (Q wave and non-Q wave) was 5.5% (27 of 493 patients). At 6 months, myocardial infarction was infrequent, occurring in 1.6% (8 of 493 patients). The incidence of in-hospital death was 2.2% (11 of 493 patients). Late death occurred in 7 patients (1.4%) and 34 patients (6.9%) required later bypass graft surgery. Complications included blood loss, primarily from the arterial access site, and subacute thrombosis of the stented vessel in 43 patients (8.7%). CONCLUSIONS: The early multicenter experience suggests that this stent is a useful adjunct to coronary angioplasty to prevent or minimize complications associated with flow-limiting coronary artery dissections previously correctable only by surgery. Although this study was not randomized, it demonstrated a high technical success rate and encouraging results with respect to the low incidence of emergency coronary artery bypass graft surgery and myocardial infarction.

A comparison of directional atherectomy with coronary angioplasty in patients with coronary artery disease. The CAVEAT Study Group.

BACKGROUND: Directional coronary atherectomy is a new technique of coronary revascularization by which atherosclerotic plaque is excised and retrieved from target lesions. With respect to the rate of restenosis and clinical outcomes, it is not known how this procedure compares with balloon angioplasty, which relies on dilation of the plaque and vessel wall. We compared the rate of restenosis after angioplasty with that after atherectomy. METHODS: At 35 sites in the United States and Europe, 1012 patients were randomly assigned to either atherectomy (512 patients) or angioplasty (500 patients). The patients underwent coronary angiography at base line and again after six months; the paired angiograms were quantitatively assessed at one laboratory by investigators unaware of the treatment assignments. RESULTS: Stenosis was reduced to 50 percent or less more often with atherectomy than with angioplasty (89 percent vs. 80 percent; P < 0.001), and there was a greater immediate increase in vessel caliber (1.05 vs. 0.86 mm, P < 0.001). This was accompanied by a higher rate of early complications (11 percent vs. 5 percent, P < 0.001) and higher in-hospital costs ($11,904 vs $10,637; P = 0.006). At six months, the rate of restenosis was 50 percent for atherectomy and 57 percent for angioplasty (P = 0.06). However, the probability of death or myocardial infarction within six months was higher in the atherectomy group (8.6 percent vs. 4.6 percent, P = 0.007). CONCLUSIONS: Removing coronary artery plaque with atherectomy led to a larger luminal diameter and a small reduction in angiographic restenosis, the latter being confined largely to the proximal left anterior descending coronary artery. However, atherectomy led to a higher rate of early complications, increased cost, and no apparent clinical benefit after six months of follow-up.

Quantitative analysis of factors influencing late lumen loss and restenosis after directional coronary atherectomy.

Although encouraging initial results have been demonstrated after directional atherectomy, the mechanisms and predictors of late lumen loss and restenosis after this procedure have not been evaluated. To examine these issues, clinical and angiographic follow-up were obtained in 262 (96%) and 212 (77%) of 274 patients undergoing successful directional coronary atherectomy. Symptom recurrence developed in 87 (33%) patients and angiographic restenosis was found in 93 (44%). Restenosis was highest in re-stenotic lesions in saphenous vein grafts (78% [95% confidence interval (CI): 56 to 100%]) and lowest in new-onset lesions in the left anterior descending (27% [95% CI: 15 to 39%]) and circumflex (14% [95% CI: 0 to 43%]) coronary arteries. Residual lumen diameter immediately after atherectomy was smaller in re-stenotic lesions (p = 0.002) and in lesions > or = 10 mm in length (p = 0.02). Late lumen loss was associated with the minimal lumen diameter immediately after atherectomy (p < 0.001), saphenous vein graft lesion location (p = 0.008), and male gender (p = 0.02). Re-stenotic lesions (p < 0.001), lesions > or = 10 mm in length (p = 0.018), saphenous vein graft lesion location (p = 0.025) and male gender (p = 0.045) were independent predictors for restenosis. It is concluded that restenosis after directional atherectomy is related both to factors resulting in a suboptimal initial result and to factors contributing to excessive late lumen loss. These results may have implications for lesion selection in patients undergoing directional coronary atherectomy.

Anatomy, histology, and pathology of coronary arteries: a review relevant to new interventional and imaging techniques--Part IV.

In the last 15 years, intense interest has focused on various interventional pharmacologic and mechanical forms of therapy for the treatment of atherosclerosis coronary artery disease. Many techniques and devices (dilating balloons, perfusion catheters, thermal probes and balloons, lasers, atherectomy devices, stents, intravascular ultrasound) have been used or are under study for future use. Many of these techniques and devices require an understanding of histologic and pathologic features of the coronary arteries and diseases which affect them. This article reviews selective areas of anatomy, histology, and pathology relevant to the use of various new interventional techniques. Part IV of this review will focus on congenital coronary artery anomalies, myocardial bridges, coronary aneurysm, emboli, and dissection and clinical implications regarding echocardiographic imaging techniques.

Anatomy, histology, and pathology of coronary arteries: a review relevant to new interventional and imaging techniques--Part III.

In the last 15 years, intense interest has focused on various interventional, pharmacologic, and mechanical forms of therapy for the treatment of atherosclerotic coronary artery disease. Many techniques and devices (dilating balloons, perfusion catheters, thermal probes and balloons, lasers, atherectomy devices, stents, intravascular ultrasound) have been used or are under study for future use. Many of these techniques and devices require an understanding of histologic and pathologic features of the coronary arteries and diseases which affect them. This article reviews selective areas of anatomy, histology, and pathology relevant to the use of various new interventional techniques. Part III of this four-part review focuses on eccentric and concentric plaques, formation of coronary thrombus, and status of the "infarct artery" after mechanical and pharmacologic forms of acute reperfusion therapy.

Anatomy, histology, and pathology of coronary arteries: a review relevant to new interventional and imaging techniques--Part II.

In the last 15 years, intense interest has focused on various interventional, pharmacologic, and mechanical forms of therapy for the treatment of atherosclerotic coronary artery disease. Many techniques and devices (dilating balloons, perfusion catheters, thermal probes and balloons, lasers, atherectomy devices, stents, intravascular ultrasound) have been used or are under study for future use. Many of these techniques and devices require an understanding of histologic and pathologic features of the coronary arteries and diseases which affect them. This article reviews selective areas of anatomy, histology, and pathology relevant to the use of various new interventional techniques. Part II of this four-part review will focus on aging changes seen in the epicardial coronary arteries and will review selected features of atherosclerotic plaque, including fissure and topography.

Anatomy, histology, and pathology of coronary arteries: a review relevant to new interventional and imaging techniques--Part I.

In the last 15 years, intense interest has focused on various interventional pharmacologic and mechanical forms of therapy for the treatment of atherosclerosis coronary artery disease. Many techniques and devices (dilating balloons, perfusion catheters, thermal probes and balloons, lasers, atherectomy devices, stents, intravascular ultrasound) have been used or are under study for future use. Many of these techniques and devices require an understanding of histologic and pathologic features of the coronary arteries and diseases which affect them. This article reviews selective areas of anatomy, histology, and pathology relevant to the use of various new interventional techniques. Part I of this review will focus on anatomic aspects of the epicardial coronary artery system, coronary arterial distribution, myocardial supply, and histologic features of the normal coronary artery.

Abrupt vessel closure after directional coronary atherectomy. The U.S. Directional Atherectomy Investigator Group.

From October 1, 1986 to December 31, 1989 directional coronary atherectomy was performed during 1,020 procedures (1,140 lesions) at 14 clinical centers. Abrupt vessel closure, defined as a total coronary occlusion or subtotal occlusion associated with clinical evidence of myocardial ischemia, occurred in 43 procedures (4.2%). It developed in the catheterization laboratory in 34 patients, but was delayed 1 to 96 h after directional atherectomy in 9 patients. By univariate analysis the incidence of abrupt closure was higher in directional atherectomy of de novo lesions (p less than 0.001), lesions in the right coronary artery (p = 0.001) and diffuse lesions (p = 0.04). The incidence of abrupt closure tended to be lower in directional atherectomy of saphenous vein grafts as opposed to native coronary arteries (1.6% vs. 4.4%; p = 0.08). Clinical findings during abrupt closure included severe angina in 26 patients, myocardial infarction in 17 patients, hypotension in 5 patients and death in 2 patients. Balloon angioplasty was attempted in 32 patients after abrupt vessel closure. In 16 patients balloon angioplasty resulted in initial resolution of the closure episode, although 1 patient died 96 h after the procedure. Fifteen of 16 patients without initial improvement after balloon angioplasty underwent coronary bypass operation; 9 additional patients with abrupt closure were referred directly for bypass operation. It is concluded that abrupt vessel closure develops relatively infrequently after directional coronary atherectomy. In the absence of severe coronary dissection, abrupt closure after directional atherectomy may be effectively managed with balloon angioplasty in some cases, although coronary bypass operation is often required.

Clinical angiographic and histologic correlates of ectasia after directional coronary atherectomy.

Directional coronary atherectomy can cause ectasia (final area stenosis less than 0%), presumably due to an excision deeper than the angiographically "normal" arterial lumen. In a multicenter series in which quantitative coronary arteriography was performed after directional atherectomy in 382 lesions (372 patients), ectasia after atherectomy occurred in 50 (13%) lesions. By univariate analysis, ectasia was seen more often within the circumflex coronary artery (p = 0.008), in complex, probably thrombus-containing lesions (p = 0.015), and with higher device:artery ratios (p less than 0.001). Ectasia occurred less often in lesions within the right coronary artery (p = 0.008). Histologic analysis demonstrated adventitia or media, or both, in all patients with angiographic ectasia. Repeat angiography was performed in 188 of 271 eligible patients (69%) 6.1 +/- 2.4 months after atherectomy. Restenosis, defined as a follow-up area stenosis greater than or equal to 75%, was present in 50% of patients without procedural ectasia and in 70% of patients with marked ectasia (residual area stenosis less than -20%; p = 0.12). It is concluded that excision beyond the normal arterial lumen may occur after directional coronary atherectomy, related, in part, to angiographic and procedural features noted at the time of atherectomy. Restenosis tends to occur more often in patients with marked ectasia after coronary atherectomy.

Disruption of a coronary stent during atherectomy for restenosis.

Directional coronary atherectomy is being used in the treatment of atherosclerotic lesions in coronary vessels and vein grafts. This report describes the use of atherectomy for the treatment of restenosis of a coronary stent. The procedure was complicated by disruption of the stent which was snared by the atherectomy cutter.