Search PubMed⌕ Search

Biomedical subjects

K M Kent

Publications and source records attributed to K M Kent.

At least 145 records · Page 8Linked to original sources
PubMed1995

Comparison of clinical and angiographic outcomes after saphenous vein graft angioplasty using coronary versus 'biliary' tubular slotted stents.

BACKGROUND: Saphenous vein graft (SVG) angioplasty using 15-mm articulated, tubular slotted stents results in low (0% to 20%) residual diameter stenoses and infrequent (< 5%) major complications. A "biliary" stent design with greater radial compressive strength, enhanced visibility, and more variable sizing (diameter and length) has been approved for noncoronary indications. A comparison of outcomes after coronary versus biliary stent placement in SVG stenoses has not been performed. The purpose of this study was to compare the angiographic and clinical results after SVG angioplasty using these two balloon-expandable, tubular slotted stent designs. METHODS AND RESULTS: During a 3-year period, 231 patients with 305 SVG lesions were treated using Palmaz-Schatz coronary (n = 108) or biliary (n = 123) stents. Cineangiograms were reviewed using qualitative morphological and quantitative angiographic methods. Time-dependent clinical outcome (freedom from death, Q-wave myocardial infarction, or the need for repeat coronary bypass surgery or SVG angioplasty) was assessed using Kaplan-Meier life-table methods. Unstable angina (P < .001) and recent myocardial infarction (P = .001) were present more often in patients undergoing biliary stent versus coronary stent placement. Biliary stent-treated SVG lesions were more frequently de novo (P = .001), ostial in location (P = .002), > or = 10 mm in length (P = .009), thrombus containing (P = .001), and ulcerated (P < .001) than coronary stent-treated SVG lesions. Angiographically, biliary stent-treated lesions had larger reference vessel diameter (3.43 +/- 0.59 mm versus 3.10 +/- 0.64 mm, P < .001), higher balloon-to-artery ratio (1.15 +/- 0.16 mm versus 1.07 +/- 0.19, P = .0001), and lower residual diameter stenosis (6 +/- 17% versus 14 +/- 11% in coronary stent-treated patients; P < .001). Procedural success rates were high (95%), in-hospital major complications were uncommon (< 3%), and follow-up clinical outcomes were favorable (6-month event-free survival approximately 80%) in both groups. CONCLUSIONS: Despite frequent short-term ischemic syndromes and unfavorable lesion characteristics, both biliary and coronary cohorts have similarly favorable short-term procedural results and long-term clinical outcomes. The increased strut thickness of the biliary stent confers greater fluoroscopic visibility and radial compressive strength in exchange for decreased stent flexibility and added technical demand in stent deployment. Extreme caution is recommended with biliary stent placement in the treatment of SVG lesions as clinical results are highly operator dependent.

Aged↗
PubMed1995

Can coronary flow parameters after stent placement predict restenosis?

Intracoronary stent was used to treat a dissection resulting from balloon angioplasty. Coronary flow parameters measured with Doppler Flowire pre- and post-stenting suggested abnormal coronary flow even after stenting. The patient returned 4 months later with an instent restenosis. This case suggests the intriguing possibility of coronary flow parameters obtained immediately after new device angioplasty in predicting restenosis.

Aortic Dissection↗
PubMed1995

Coronary artery morphologic features after coronary rotational atherectomy: insights into mechanisms of lumen enlargement and embolization.

The coronary arteries and myocardium from two patients who died after coronary rotational atherectomy were analyzed to gain insights into the mechanisms of lumen enlargement and to document embolization of calcified plaque. Rotational atherectomy resulted in sharp cuts in plaque, producing a relatively smooth luminal surface. When extensive nodular calcific atherosclerosis was present, the luminal surface was focally uneven with exposure of jagged calcified plaque to blood flow. Deep plaque fissures and medial dissections were also seen. These fissures may have been created by the rotoblator or by adjunctive balloon angioplasty. Multiple calcific atheroemboli were present after rotoblator use in plaques containing extensive nodular calcification; in moderately calcified plaque only one small atheroembolus was found. Thus embolization of calcified plaque can occur after rotational atherectomy and may correlate with the severity of plaque calcification. Rotational atherectomy produces a focally smooth, sharp-edged, luminal surface, a lumen enlargement mechanism different from balloon angioplasty.

Aged↗
PubMed1995

Multivariate predictors of intravascular ultrasound end points after directional coronary atherectomy.

OBJECTIVES: This study attempted to identify the clinical, angiographic, procedural and intravascular ultrasound predictors of directional atherectomy results assessed by intravascular ultrasound. BACKGROUND: Several angiographic and intravascular ultrasound variables have been associated with the outcome of directional coronary atherectomy. No study has incorporated both modalities into a predictive model. METHODS: One hundred seventy patients were analyzed using preintervention and postintervention intravascular ultrasound and quantitative angiography. Clinical and procedural variables were collected by independent chart review. Quantitative and qualitative angiographic analysis was performed by a core laboratory in blinded manner. Intravascular ultrasound was performed using a transducer-tipped catheter, rotating within a stationary imaging sheath, and withdrawn automatically at 0.5 mm/s. Clinical, procedural, angiographic and ultrasound variables were tested in a multivariate linear regression model. Dependent ultrasound variables included postatherectomy lumen cross-sectional area and percent cross-sectional narrowing (plaque plus media/external elastic membrane cross-sectional area) and, in a subgroup of 47 patients studied using volumetric analysis, percent plaque volume removal. RESULTS: By multivariate stepwise linear regression analysis, predictors of residual lumen cross-sectional area (correcting for reference lumen area) included arc of calcium and preatherectomy plaque plus media cross-sectional area; predictors of residual cross-sectional narrowing were arc of calcium, preatherectomy plaque plus media cross-sectional area and lesion length; and predictors of percent plaque volume removal were arc of calcium and atherectomy device size. CONCLUSIONS: The preintervention lesion arc of calcium measured by intravascular ultrasound is the most consistent predictor of the effectiveness and results of directional coronary atherectomy.

Atherectomy, Coronary↗
PubMed1995

Atherosclerosis in angiographically "normal" coronary artery reference segments: an intravascular ultrasound study with clinical correlations.

OBJECTIVES: This study evaluated the magnitude, patterns and clinical correlates of atherosclerosis in angiographically "normal" reference segments in patients undergoing transcatheter therapy for symptomatic coronary artery disease. BACKGROUND: Pathologic studies indicate that the extent of coronary atherosclerosis is underestimated by visual analysis of angiographically normal coronary artery segments. Intravascular ultrasound allows detailed, high quality cross-sectional imaging of the coronary arteries in vivo. METHODS: Intravascular ultrasound was used to study angiographically normal coronary artery reference segments in 884 patients evaluated for transcatheter therapy for symptomatic native coronary artery disease. The reference segment was the most visually normal intravascular ultrasound cross section within 10 mm proximal to the target lesion but distal to any major side branch. Results are presented as mean value +/- 1 SD. RESULTS: Only 60 (6.8%) of 884 angiographically normal reference segments were normal by intravascular ultrasound. Reference segment percent cross-sectional narrowing measured 51 +/- 13% and correlated poorly with the target lesion percent cross-sectional narrowing (r = 0.166, p < 0.0001). Reference segments contained less calcific and dense fibrotic plaque and proportionately more soft plaque elements. Independent predictors of reference segment percent cross-sectional narrowing were male gender, patient age, diabetes mellitus, hypercholesterolemia and presence of multivessel disease. Independent predictors of reference segment calcification were patient age and serum creatinine levels. Reference segment percent cross-sectional narrowing in 723 patients undergoing transcatheter therapy was similar to that in patients studied for diagnostic purposes; however, reference segment arc of calcium was greater in treated patients (43 +/- 81 vs. 25 +/- 57, p = 0.015). Reference segment disease was not an independent predictor of subsequent angiographic restenosis or clinical events within 12 months of follow-up. CONCLUSIONS: Atherosclerosis is ubiquitous in angiographically normal coronary artery reference segments. Reference segment disease parallels the severity of target lesion disease and is associated with many of the conventional risk factors for coronary artery disease. Because of its sensitivity in detecting atherosclerosis in angiographically normal reference segments, intravascular ultrasound should enhance the study of risk factors for atherosclerosis and the results of therapies to control disease progression.

Age Factors↗
PubMed1995

Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device.

OBJECTIVES: This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath. BACKGROUND: Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure, rapid methods of obtaining hemostasis at the time of sheath removal. METHODS: We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group I); 217 patients were assigned to the manual pressure control group (group II). RESULTS: There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 +/- 15.2 vs. 15.3 +/- 11.7 min [mean +/- SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group. CONCLUSIONS: This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.

Aneurysm, False↗
PubMed1995

Small stent size and intimal hyperplasia contribute to restenosis: a volumetric intravascular ultrasound analysis.

OBJECTIVES: The purpose of this study was to use volumetric intravascular ultrasound analysis of Palmaz-Schatz stents to assess the in-stent restenotic process. BACKGROUND: By reducing lesion elastic recoil and chronic arterial remodeling, stents improve the long-term results of coronary angioplasty. However, stents are prone to the development of neointimal hyperplasia. Angiographic studies of stent restenosis have suggested that these hyperplastic responses are the cause of in-stent restenosis; however, it is difficult to visualize the radiolucent Palmaz-Schatz stent by angiography. Intravascular ultrasound provides detailed cross-sectional imaging of the coronary arteries, especially the intense metallic reflection of endovascular stents. METHODS: Forty-four patients with 60 Palmaz-Schatz stents underwent intravascular ultrasound imaging at follow-up ([mean +/- SD] 8.8 +/- 7.2 months after implantation). Thirty-four stents were placed in saphenous vein grafts and 26 in native coronary arteries; 30 were placed in restenotic lesions. Intravascular ultrasound with automatic transducer pullback at 0.5 mm/s allowed measurement of stent, lumen and intimal hyperplasia cross-sectional areas at 1-mm axial increments within the stents. Using Simpson's rule, stent, lumen and intimal hyperplasia volumes were calculated. Patterns of in-stent restenosis were then identified. RESULTS: Restenotic stents had smaller stent volumes (120 +/- 41 vs. 147 +/- 43 mm3, p = 0.016) and lumen volumes (62 +/- 28 vs. 118 +/- 42 mm3, p < 0.0001) but larger intimal hyperplasia volumes (58 +/- 36 vs. 29 +/- 18 mm3, p < 0.001) than nonrestenotic stents. A focal restenosis pattern was more common (20 [77%] of 26) than a diffuse restenosis pattern (6 [23%] of 26). Stents with focal restenosis and stents with diffuse restenosis had equally small stent volumes (120 +/- 44 vs. 120 +/- 31 mm3, respectively, p = NS); however, stents with diffuse restenosis had larger intimal hyperplasia volumes (84 +/- 30 vs. 50 +/- 34 mm3, p < 0.05). Focal restenosis was most commonly located at the central articulation (45%); the location of focal restenosis was related to the focal accumulation of neointimal tissue. CONCLUSIONS: Stent volume and magnitude and distribution of intimal hyperplasia are important in the development of in-stent restenosis. Stent volume was smaller and intimal hyperplasia volume greater in restenotic stents. Stent restenosis is more commonly focal in nature and located at the central articulation.

Aged↗
PubMed1995

A modified directional atherectomy catheter for resection of calcified atherosclerotic plaques.

BACKGROUND: The purpose of this study was to determine the feasibility of resecting calcified atherosclerotic plaques in human cadaveric vessels by using a modified directional coronary atherectomy catheter and to correlate these results with bench tests using an in-vitro sea coral model. METHODS: The conventional directional coronary atherectomy catheter was modified by changing the cutter blade to a tungsten carbide material and by increasing the torsional strength of the drive cable. The performance of the modified directional coronary atherectomy (DCA) catheter was compared with the conventional catheter using a sea coral model to simulate calcified material. Then, 10 human ex-vivo arteries (eight with calcification) were treated with both conventional and modified catheters, and the results studied with intravascular ultrasound and confirmed by histologic examination. RESULTS: Using the modified directional coronary atherectomy catheter it was possible to perform effective and consistent longitudinal cutting, and to resect a significantly larger amount of coral (1.0 +/- 0.1 mm2 versus 0.2 +/- 0.1 mm2 with conventional cutter, P < 0.0001). In heavily calcified ex-vivo arteries, the modified catheter was more effective in removing calcified plaques (13 +/- 11 mg versus 3.7 +/- 1.4 mg with conventional cutter, P = 0.07). Intravascular ultrasound confirmed the effective atherectomy (residual area stenosis 28 +/- 16% versus 47 +/- 10% with the conventional device, P < 0.05), and histologic examination showed calcified nodules in the atherectomy samples obtained with the modified cutter (area of calcium 1.43 +/- 0.89 mm2 versus 0.93 +/- 0.83 mm2 with the conventional cutter). CONCLUSIONS: The modified directional coronary atherectomy catheter effectively removed both non-calcified and calcified plaques in the ex-vivo human cadaveric arteries, thus demonstrating the feasibility of directional coronary atherectomy of calcified plaques. This modified device shows promise for treating calcified coronary lesions, especially in larger vessels.

Animals↗
PubMed1994

The contribution of tissue removal to lumen improvement after directional coronary atherectomy.

The contribution of tissue removal to lumen improvement after directional coronary atherectomy remains controversial. The purpose of this study was to validate the intravascular ultrasound measurement of plaque volume and use it to study the contribution of tissue removal to lumen improvement after directional coronary atherectomy. With use of intravascular ultrasound, 12 human coronary vessels were imaged in vitro. With use of computer-assisted planimetry, the external elastic membrane and lumen cross-sectional areas were manually traced and the plaque+media area was calculated at 1 mm axial intervals. Then, plaque+media volume was calculated by Simpson's rule. After imaging, ultrasound measurements of plaque+media volume were compared with histologic measurements. Similarly, volumetric intravascular ultrasound imaging was performed before and after directional atherectomy in 47 patients. In vitro, the mean plaque+media volume measured by intravascular ultrasound was 134.0 +/- 94.8 mm3 and compared well with that derived by histology (187.4 +/- 128.8 mm3, r = 0.96, p < 0.001). In vivo, the lumen volume increased from 27.2 +/- 12.3 to 58.7 +/- 30.3 mm3, and the mean plaque+media volume decreased from 122.0 +/- 74.0 to 97.5 +/- 63.5 mm3. The mean intravascular ultrasound atherectomy index was 76 +/- 23%. In 11 of the 47 patients (23.4%), tissue removal alone accounted for lumen improvement. Volumetric intravascular ultrasound image analysis indicates that the mechanism of directional coronary atherectomy primarily is tissue removal. As a result, the contribution of arterial remodeling (expansion and dissection) probably is less important.

Aged↗
PubMed1994

Limitations of angiography for analyzing coronary atherosclerosis progression or regression.

PURPOSE: To analyze the utility and limitations of serial coronary angiography for determining atherosclerosis progression and regression. DATA SOURCES: A MEDLINE search of the English-language literature (1966 to January 1994) using the keywords atherosclerosis regression, atherosclerosis progression, lipid reduction therapy, and coronary angiography. STUDY SELECTION: Selected articles on the effects of cholesterol reduction and lifestyle modification on angiographic coronary artery disease, on the animal models of atherosclerosis progression and regression, and on the limitations of coronary angiography. DATA EXTRACTION: Independent extraction by two authors. RESULTS: Although several studies have reported that the rate of atherosclerosis progression, defined by serial coronary angiography, can be reduced and that luminal diameter can be improved somewhat by aggressive lipid modification, the reported changes are small (0.3 mm or 10% change) and have required a prolonged study duration (range, 1 to 10 years). More importantly, angiography simply does not measure atherosclerosis and cannot assess lesion composition. Angiography also underestimates the extent of atherosclerosis, especially in angiographically normal segments. In addition, difficulties with data acquisition, such as substantial variabilities in serial measurements of percent diameter stenosis and minimal luminal diameters, require large sample sizes to show statistically significant regression, even with computerized quantification. CONCLUSIONS: Given its current limitations, serial coronary angiography is not a satisfactory means of detecting atherosclerosis progression or regression.

Anticholesteremic Agents↗
PubMed1994

Impact of preintervention intravascular ultrasound imaging on transcatheter treatment strategies in coronary artery disease.

Preintervention intravascular ultrasound (IVUS) imaging was performed in 313 target lesions in 301 patients. Revascularization strategy intended before imaging was compared with the treatment actually performed; there was a change in therapy in 124 lesions (40%) in 121 patients (40%). This included: (1) assessment of lesion severity leading to revascularization when none had been planned (n = 20, 6%), (2) avoiding surgery or catheter-based revascularization that had originally been planned (n = 21, 7%), and (3) assessment of lesion composition leading to a change in revascularization strategy (n = 20, 6%) or for selecting the revascularization strategy (n = 63, 20%). Nine of these 121 patients were referred for coronary artery bypass graft surgery. IVUS minimal lumen diameter correlated well with angiography (r = 0.83); however, a disagreement was the reason for deciding to perform or not to perform revascularization in 41 lesions (13%). IVUS assessment of target lesion calcification, eccentricity and unusual morphology were the reasons for changing or selecting specific devices: (1) concentric and eccentric lesions with significant superficial calcium were treated with rotational atherectomy, excimer laser angioplasty or surgery; (2) eccentric lesions that did not contain significant superficial calcium were treated with directional atherectomy; (3) dissections and true aneurysms were treated with stent placement even if calcified; (4) thrombus-containing lesions in vein grafts were treated with thrombolytic therapy or extraction atherectomy, or both; and (5) fibrotic vein graft lesions were treated with balloon angioplasty or stent placement.

Adult↗
PubMed1994

A dual-purpose angioplasty-drug infusion catheter for the treatment of intragraft thrombus.

An investigational angioplasty-drug infusion catheter (Transport, CardioVascular Dynamics, Irvine, CA) was used to treat a saphenous vein graft stenosis associated with a thrombus. The catheter was successfully used both to infuse urokinase at the site of angioplasty and to perform effective angioplasty, demonstrating the feasibility and utility of a dual-purpose angioplasty catheter capable of angioplasty and/or local drug infusion with the same catheter.

Angioplasty, Balloon, Coronary↗
PubMed1994

Coronary artery lumen volume measurement using three-dimensional intravascular ultrasound: validation of a new technique.

OBJECTIVE: To validate an automated algorithm for the measurement of lumen volumes of coronary arteries. BACKGROUND: Current intravascular ultrasound systems use absolute measurements of and changes in areas and diameters for the assessment of coronary artery disease. However, the coronary artery is a three-dimensional structure of complex geometry and volume. METHODS: We used a comprehensive imaging system designed to reconstruct planar intravascular ultrasound images in three dimensions. This system consisted of a 25 MHz transducer-tipped rigid probe (for in vitro studies) or a 25 MHz transducer-tipped catheter within a 3.9F monorail imaging sheath (for in vivo studies), a motorized catheter pullback device that withdrew the transducer at 0.5 mm/sec, and an image processing computer that stacked 15 image slices/mm of vessel axial length and then performed threshold-based three-dimensional image rendering and lumen volume measurement. We imaged 13 human coronary vessels (6 RCA, 6 LAD, 1 LCX) in vitro and 16 vessels (8 LAD, 6 RCA, 2 SVG) in vivo. RESULTS IN VITRO STUDIES: Lumen volumes derived by three-dimensional intravascular ultrasound were 171 +/- 121 mm3 and compared very well with those derived by histology (160 +/- 109 mm3, r = 0.97, SEE = 29 mm3, P < 0.001) and with those derived by manual planimetry of planar intravascular ultrasound images (150 +/- 106 mm3, r = 0.97, SEE = 30 mm3, P < 0.001). In vivo studies: Lumen volumes derived by three-dimensional intravascular ultrasound were 74 +/- 35 mm3 and compared well with those derived by quantitative angiography (52 +/- 20 mm3, r = 0.71, SEE = 25 mm3, P < 0.002). CONCLUSIONS: Three-dimensional intravascular ultrasound is a new technique that can accurately measure coronary artery lumen volumes. Further technical improvements may help to establish this technique as the new standard for lumen volume measurement.

Adult↗
PubMed1994

Clinical significance of distal embolization after transluminal extraction atherectomy in diffusely diseased saphenous vein grafts.

Standard balloon angioplasty of degenerated saphenous vein graft lesions may be complicated by distal embolization, particularly in the presence of intragraft thrombus. Transluminal extraction atherectomy may be useful in this setting because of its ability to remove particulate debris. This study was designed to identify the incidence and prognostic significance of distal embolization after transluminal extraction atherectomy in high-risk saphenous vein graft lesions. To address these issues the clinical course of 65 consecutive patients (86 high-risk saphenous vein graft lesions) was reviewed after extraction atherectomy. Distal embolization occurred in 11 (12.8%) of 86 high-risk lesions. The majority (63.6%) of these episodes occurred after adjunct balloon dilatation following uncomplicated use of the extraction atherectomy catheter. Correlates of distal embolization included patient age and the presence of intragraft thrombus. Major in-hospital complications developed more often in patients with distal embolization (46% vs 2% in those without distal embolization, p < 0.001), resulting in a reduced procedural success rate in this group (55% vs 91%, p = 0.01). We conclude that the risk of distal embolization after saphenous vein graft angioplasty, although potentially reduced, is not eliminated with transluminal extraction atherectomy, particularly in lesions with superimposed thrombus.

Aged↗
PubMed1994

1-[((S)-2-hydroxy-2-oxo-1,4,2-dioxaphosphorinan-5-yl)methyl] cytosine, an intracellular prodrug for (S)-1-(3-hydroxy-2-phosphonylmethoxypropyl)cytosine with improved therapeutic index in vivo.

1-[((S)-2-hydroxy-2-oxo-1,4,2-dioxaphosphorinan-5-yl)methyl]cytosi ne (cyclic [cHPMPC]) was evaluated as a novel antiviral agent in comparison with (S)-1-(3-hydroxy-2-phosphonylmethoxypropyl)cytosine (HPMPC). Evaluation for in vitro activity against herpes simplex virus type 2 in MA-104 and MRC-5 cells showed that both cHPMPC and HPMPC have comparable activities and cytotoxicities. cHPMPC was found to be stable on incubation in human plasma and human liver homogenates. Intracellular metabolism studies revealed that cHPMPC was converted inside of the cells to HPMPC and then to the monophosphate, the diphosphate, and the monophosphate choline metabolites. In a mouse herpes simplex virus type 2 encephalitis model, both cHPMPC and HPMPC exhibited similar potencies in vivo. Nephrotoxicity, which is the dose-limiting toxicity of HPMPC, was assessed in a 14-day repeated-dose toxicity study in rats; cHPMPC has an improved safety margin of > or = 13-fold over that of HPMPC.

Animals↗
PubMed1994

Evaluating new devices. Acute (in-hospital) results from the New Approaches to Coronary Intervention Registry.

BACKGROUND: To be used optimally, new interventional devices (stent, lasers, atherectomy catheters) must be carefully evaluated in terms of optimal patient and lesion selection, technique of use, expected acute success and complications, and long-term results. Sources for that information include single-center and multicenter (single-device) reports, although randomized trials may then be performed to provide a more definitive picture of any clinical benefits. One interim option, however, consists of carefully collected registry data. The purpose of this article is to review data collected in the National Heart, Lung, and Blood Institute-funded New Approaches to Coronary Intervention (NACI) Registry and to compare them with existing reports. METHODS AND RESULTS: NACI is an independent, investigator-driven effort that seeks to collect uniform data on patients undergoing treatment with one of several investigational devices and thereby provide an unbiased report of procedure outcome. Between November 1990 and November 1992, 36 participating centers treated a total of 3201 lesions in 2835 patients, using one of seven study devices: directional atherectomy (1084 lesions), transluminal extraction atherectomy (240 lesions), rotational atherectomy (349 lesions), Palmaz-Schatz stent (674 lesions), Gianturco-Roubin stent (213 lesions), and the Advanced Interventional Systems (474 lesions) or Spectranetics (167 lesions) excimer lasers. Data on each procedure were recorded on a unique modular database that captured the reason for (and interim result after) each device use. Device success (defined here as stenosis improvement by > or = 20% and a residual stenosis < 50% after new device use) was 66.5% overall. Adjunctive angioplasty was used in 75.5% of lesions, either before (25.9%) or after (43.5%) new device use, yielding an overall lesion success (> or = 20% stenosis improvement with a final residual stenosis < 50% after all devices) of 92.2%. Adjunctive angioplasty after new device use produced further enlargement in minimal lumen diameter (from 2.2 to 2.7 mm) and further reduction in residual stenosis (26.4% to 16.1%) compared with the results present after use of the new devices themselves. Major complications consisting of death (1.6%), Q-wave myocardial infarction (1.3%), or emergency bypass surgery (1.7%) occurred in 4.0% of patients (range, 2.6% to 8.7% across devices). Procedural success, defined as lesion success in all new device-treated lesions without a major complication, was achieved in 90.8% of patients, with a median length of hospital stay of 4 days. CONCLUSIONS: NACI illustrates the type of information that can be obtained in a registry format that examines the acute angiographic and clinical results of new devices according to uniform definitions. Although no registry can substitute for formal interdevice trials, registries such as this can supplement earlier single-center and multicenter reports. In doing so, they can help focus subsequent randomized interdevice comparisons on lesion types for which two or more devices have promising acute results. Given the substantial interdevice differences in baseline patient and lesion characteristics found in NACI, simple "head-to-head" comparison of the results of different devices might give misleading impressions and should be avoided unless such comparisons are restricted to carefully matched patient and lesion subgroups.

Angioplasty, Laser↗