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Biomedical subjects

J J Popma

Publications and source records attributed to J J Popma.

At least 91 records · Page 5Linked to original sources
PubMed1998

Prospective, multicenter study of the safety and feasibility of primary stenting in acute myocardial infarction: in-hospital and 30-day results of the PAMI stent pilot trial. Primary Angioplasty in Myocardial Infarction Stent Pilot Trial Investigators.

OBJECTIVES: The goals of this study were to examine the safety and feasibility of a routine (primary) stent strategy in acute myocardial infarction (AMI). BACKGROUND: Limitations of reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) in AMI include in-hospital recurrent ischemia or reinfarction in 10% to 15% of patients, restenosis in 37% to 49% and late infarct-related artery reocclusion in 9% to 14%. By lowering the residual stenosis and sealing dissection planes created by PTCA, primary stenting may further improve short- and long-term outcomes after mechanical reperfusion. METHODS: Three hundred twelve consecutive patients treated with primary PTCA for AMI at nine international centers were prospectively enrolled. After PTCA, stenting was attempted in all eligible lesions (vessel size 3.0 to 4.0 mm; lesion length < or = 2 stents; and the absence of giant thrombus burden after PTCA, major side branch jeopardy or excessive proximal tortuosity or calcification). Patients with stents were treated with aspirin, ticlopidine and a 60-h tapering heparin regimen. RESULTS: Stenting was attempted in 240 (77%) of 312 patients, successfully in 236 (98%), with Thrombolysis in Myocardial Infarction grade 3 flow restored in 230 patients (96%). Patients with stents had low rates of in-hospital death (0.8%), reinfarction (1.7%), recurrent ischemia (3.8%) and predischarge target vessel revascularization for ischemia (1.3%). At 30-day follow-up, no additional deaths or reinfarctions occurred among patients with stents, and target vessel revascularization was required in only one additional patient (0.4%). CONCLUSIONS: Primary stenting is safe and feasible in the majority of patients with AMI and results in excellent short-term outcomes.

Aged↗
PubMed1998

Myonecrosis after revascularization procedures.

The detection of elevated cardiac enzyme levels and the occurrence of electrocardiographic (ECG) abnormalities after revascularization procedures have been the subject of recent controversy. This report represents an effort to achieve a consensus among a group of researchers with data on this subject. Creatine kinase (CK) or CK-MB isoenzyme (CK-MB) elevations occur in 5% to 30% of patients after a percutaneous intervention and commonly during coronary artery bypass graft surgery (CABG). Although Q wave formation is rare, other ECG changes are common. The rate of detection is highly dependent on the intensity of enzyme and ECG measurement. Because most events occur without the development of a Q wave, the ECG will not definitively diagnose them; even the ECG criteria for Q wave formation signifying an important clinical event have been variable. At least 10 studies evaluating > 10,000 patients undergoing percutaneous intervention have demonstrated that elevation of CK or CK-MB is associated not only with a higher mortality, but also with a higher risk of subsequent cardiac events and higher cost. Efforts to identify a specific cutoff value below which the prognosis is not impaired have not been successful. Rather, the risk of adverse outcomes increases with any elevation of CK or CK-MB and increases further in proportion to the level of intervention. This information complements similar previous data on CABG. Obtaining preprocedural and postprocedural ECGs and measurement of serial cardiac enzymes after revascularization are recommended. Patients with enzyme levels elevated more than threefold above the upper limit of normal or with ECG changes diagnostic for Q wave myocardial infarction (MI) should be treated as patients with an MI. Patients with more modest elevations should be observed carefully. Clinical trials should ensure systematic evaluation for myocardial necrosis, with attention paid to multivariable analysis of risk factors for poor long-term outcome, to determine the extent to which enzyme elevation is an independent risk factor after considering clinical history, coronary anatomy, left ventricular function and clinical evidence of ischemia. In addition, tracking of enzyme levels in clinical trials is needed to determine whether interventions that reduce periprocedural enzyme elevation also improve mortality.

Angioplasty, Balloon, Coronary↗
PubMed1998

Remodeling after directional coronary atherectomy (with and without adjunct percutaneous transluminal coronary angioplasty): a serial angiographic and intravascular ultrasound analysis from the Optimal Atherectomy Restenosis Study.

OBJECTIVES: The intravascular ultrasound (IVUS) substudy of OARS (Optimal Atherectomy Restenosis Study) was designed to assess the mechanisms of restenosis after directional coronary atherectomy (DCA). BACKGROUND: Recent serial IVUS studies have indicated that late lumen loss after interventional procedures was determined primarily by the direction and magnitude of arterial remodeling, not by cellular proliferation. METHODS: Complete quantitative coronary angiography (QCA) and IVUS were obtained in 104 patients before and after intervention and during follow-up. All studies were performed after administration of 200 microg of intracoronary nitroglycerin. Angiographic measurements included minimum lumen diameter (MLD), interpolated reference diameter and diameter stenosis (DS). Intravascular ultrasound measurements included lesion and reference external elastic membrane (EEM), lumen and plaque+media cross-sectional area (CSA). The axial location of the lesion site was at the smallest follow-up lumen CSA; the reference segment was the most normal-looking cross section within 10 mm proximal to the lesion but distal to any major side branch. Results are reported as mean +/- one standard deviation. RESULTS: The QCA reference decreased from 3.51 +/- 0.46 mm to 3.22 +/- 0.44 mm; the MLD decreased from 3.22 +/- 0.47 mm to 2.03 +/- 0.72 mm; and the DS increased from 8 +/- 10% to 38 +/- 20%. On IVUS, the decrease in lumen CSA (from 8.8 +/- 2.5 mm2 to 5.5 +/- 4.0 mm2) was associated with a significant decrease in EEM (from 19.7 +/- 5.6 mm2 to 16.9 +/- 6.2 mm2); there was no significant increase in P+M (from 10.9 +/- 4.2 mm2 to 11.3 +/- 3.9 mm2). A change in lumen correlated with a change in EEM (r = 0.790, p < 0.0001), not with a change in P+M (r = 0.133, p = 0.2258). A decrease in reference EEM (from 19.1 +/- 7.7 mm2 to 17.6 +/- 8.0 mm2) also correlated with a decrease in lesion EEM (r = 0.665, p < 0.0001). Results in restenotic lesions were similar. CONCLUSION: Restenosis after optimal DCA is caused primarily by a decrease in EEM CSA that extends into contiguous reference segments.

Anatomy, Cross-Sectional↗
PubMed1998

The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation.

OBJECTIVES: We compared the clinical outcomes following coronary stent implantation in insulin-treated diabetes mellitus (IDDM), non-IDDM patients, and nondiabetic patients. BACKGROUND: Diabetic patients have increased restenosis and late morbidity following balloon angioplasty. The impact of diabetes mellitus (DM), especially IDDM, on in-stent restenosis is not known. METHODS: We studied 954 consecutive patients with native coronary artery lesions treated with elective Palmaz-Schatz stents implantation using conventional coronary angiographic and intravascular ultrasound methodology. Procedural success, major in-hospital complications, and 1-year clinical outcome were compared according to the diabetic status. RESULTS. In-hospital mortality was 2% in IDDM, significantly higher (p <0.02) compared with non-IDDM (0%) and nondiabetics (0.3%). Stent thrombosis did not differ among groups (0.9% in IDDM vs. 0% in non-IDDM and 0% in nondiabetics, p >0.1). During follow-up, target lesion revascularization (TLR) was 28% in IDDM, significantly higher (p <0.05) compared with non-IDDM (17.6%) and nondiabetics (16.3%). Late cardiac event-free survival (including death, myocardial infarction [MI], and any coronary revascularization procedure) was significantly lower (p=0.0004) in IDDM (60%) compared with non-IDDM (70%) and nondiabetic patients (76%). By multivariate analysis, IDDM was an independent predictor for any late cardiac event (OR=2.05, p=0.0002) in general and TLR (odds ratio=2.51, p=0.0001) in particular. CONCLUSIONS. In a large consecutive series of patients treated by elective stent implantation, IDDM patients were at higher risk for in-hospital mortality and subsequent TLR and, as a result, had a significantly lower cardiac event-free survival rate. On the other hand, acute and long-term procedural outcome was found to be similar for non-IDDM compared with nondiabetic patients.

Adult↗
PubMed1998

Validation of the in vivo intravascular ultrasound measurement of in-stent neointimal hyperplasia volumes.

OBJECTIVES: This study was undertaken to validate the in vivo intravascular ultrasound (IVUS) measurement of in-stent neointimal hyperplasia (IH) volumes. BACKGROUND: Because stents reduce restenosis compared to balloon angioplasty, stent use has increased significantly. As a result, in-stent restenosis is now an important clinical problem. Serial IVUS studies have shown that in-stent restenosis is secondary to intimal hyperplasia. To evaluate strategies to reduce in-stent restenosis, accurate measurement of in-stent neointimal tissue is important. METHODS: Using a porcine coronary artery model of in-stent restenosis, single Palmaz-Schatz stents were implanted into 16 animals with a stent:artery ratio of 1.3:1. Intravascular ultrasound imaging was performed at 1 month, immediately prior to animal sacrifice. In vivo IVUS and ex vivo histomorphometric measurements included stent, lumen and IH areas; IH volumes were calculated with Simpson's rule. RESULTS: Intravascular ultrasound measurements of IH (30.4+/-11.0 mm3) volumes correlated strongly with histomorphometric measurements (26.7+/-8.5 mm3, r=0.965, p < 0.0001). The difference between the IVUS and the histomorphometric measurements of IVUS volume was 4.1+/-2.7 mm3 or 15.8+/-11% (standard error of the estimate=0.7). Both histomorphometry and IVUS showed that IH was concentric and uniformly distributed over the length of the stent. Intravascular ultrasound detected neointimal thickening of < or =0.2 mm in 5 of 16 stents. Sample size calculations based on the IVUS measurement of IH volumes showed that 12 stented lesions/arm would be required to show a 50% reduction in IVUS-measured IH volume and 44 stented lesions/arm would be required to show a 25% reduction in IH volume. CONCLUSION: In vivo IVUS measurement of IH volumes correlated strongly with ex vivo histomorphometry. Using volumetric IVUS end points, small sample sizes should be necessary to demonstrate effectiveness of strategies to reduce in-stent restenosis.

Angioplasty, Balloon, Coronary↗
PubMed1998

Serial volumetric (three-dimensional) intravascular ultrasound analysis of restenosis after directional coronary atherectomy.

OBJECTIVES: We report the use of three-dimensional (volumetric) intravascular ultrasound (IVUS) analysis to assess serial changes after directional coronary atherectomy (DCA). BACKGROUND: Recent serial planar IVUS studies have described a decrease in external elastic membrane (EEM) area following catheter-based intervention as an important mechanism of late lumen renarrowing. METHODS: Thirty-one patients with de novo native coronary lesions treated with DCA in the Serial Ultrasound Restenosis (SURE) Trial and in Optimal Atherectomy Restenosis Study (OARS) were enrolled in this study. Serial IVUS was performed before and after intervention and at 6 months' follow-up. In a subgroup of 18 patients from the SURE trial, IVUS was also performed at 24 h and at 1 month postintervention. Segments, 20-mm-long (200 image slices), were analyzed using a previously validated three-dimensional, computerized, automated edge-detection algorithm. The EEM, lumen, and plaque+media (P+M = EEM-lumen) volumes were calculated. RESULTS: At follow-up, lumen volume was smaller than at postintervention (159+/-69 mm3 vs. 179+/-49 mm3, p = 0.0003). From postintervention to follow-up, there was a decrease in EEM volume (377+/-107 to 352+/-125 mm3, p < 0.0001), but no change in P+M volume (p = 0.52). The delta lumen volume correlated strongly with deltaEEM volume (r = 0.842, p < 0.0001), but not with deltaP+M volume. In the 18 patients from the SURE Trial, the decrease in lumen and EEM volumes occurred late, between 1 month and 6 months of follow-up. CONCLUSIONS: Volumetric IVUS analysis demonstrated that late lumen volume loss following DCA was a result of a decrease in EEM volume. This was a late event, occurring between 1 and 6 months' postintervention.

Aged↗
PubMed1998

Treatment of calcified coronary lesions with Palmaz-Schatz stents. An intravascular ultrasound study.

AIMS: To evaluate the result of coronary stenting in calcified lesions and to find morphological and procedural factors influencing the final result. METHODS AND RESULTS: Three hundred and twenty three native coronary artery lesions in 303 patients (197 men, mean age 63.9 +/- 11.5 years) treated with Palmaz-Schatz stents were differentiated into four groups depending on their degree of circumferential calcification as defined by intravascular ultrasound [0-90 degrees (n=120), 91-180 degrees (n=58, 181-270$ (n=71) and 271-360 degrees n=74)]. In 117 lesions rotational atherectomy was used prior to stent placement. Intravascular ultrasound and quantitative angiography were performed prior to treatment and after stent placement to measure minimal and maximal lumen diameter and lumen cross-sectional area at the lesion site and the reference segments. Acute lumen gain and eccentricity index were calculated. Although higher balloon pressures were used than in the minimally calcified lesions. the final angiographic minimal lumen diameter decreased with increasing arc of calcification (3.01 +/- 0.47, 3.04 +/- 0.43, 2.85 +/- 0.53, 2.83 +/- 0.40 mm, respectively, P=0.0320) resulting in a decrease in acute diameter gain with increasing arc of calcification (2.06 +/- 0.51, 1.91 +/- 0.46, 1.81 +/- 0.56, 1.78 +/- 0.51 mm, respectively, P=0.0067). Adjunctive rotational atherectomy prior to stent placement resulted in a greater acute diameter and a greater lumen cross-sectional area gain, coupled with less final residual stenosis than pre-treatment with balloon angioplasty. CONCLUSION: Implantation of stents in calcified lesions results in less optimal stent expansion, especially in lesions with thick, eccentric calcific plaque layers. Use of adjunctive rotational atherectomy before stent placement may improve the procedural result.

Aged↗
PubMed1998

Atherosclerotic coronary lesions with inadequate compensatory enlargement have smaller plaque and vessel volumes: observations with three dimensional intravascular ultrasound in vivo.

OBJECTIVE: To compare vessel, lumen, and plaque volumes in atherosclerotic coronary lesions with inadequate compensatory enlargement versus lesions with adequate compensatory enlargement. DESIGN: 35 angiographically significant coronary lesions were examined by intravascular ultrasound (IVUS) during motorised transducer pullback. Segments 20 mm in length were analysed using a validated automated three dimensional analysis system. IVUS was used to classify lesions as having inadequate (group I) or adequate (group II) compensatory enlargement. RESULTS: There was no significant difference in quantitative angiographic measurements and the IVUS minimum lumen cross sectional area between groups I (n = 15) and II (n = 20). In group I, the vessel cross sectional area was 13.3 (3.0) mm2 at the lesion site and 14.4 (3.6) mm2 at the distal reference (p < 0.01), whereas in group II it was 17.5 (5.6) mm2 at the lesion site and 14.0 (6.0) mm2 at the distal reference (p < 0.001). Vessel and plaque cross sectional areas were significantly smaller in group I than in group II (13.3 (3.0) v 17.5 (5.6) mm2, p < 0.01; and 10.9 (2.8) v 15.2 (4.9) mm2; p < 0.005). Similarly, vessel and plaque volume were smaller in group I (291.0 (61.0) v 353.7 (110.0) mm3, and 177.5 (48.4) v 228.0 (92.8) mm3, p < 0.05 for both). Lumen areas and volumes were similar. CONCLUSIONS: In lesions with inadequate compensatory enlargement, both vessel and plaque volume appear to be smaller than in lesions with adequate compensatory enlargement.

Coronary Angiography↗
PubMed1997

Successful directional atherectomy of de novo coronary lesions assessed with three-dimensional intravascular ultrasound and angiographic follow-up.

Recent histopathologic and intravascular ultrasound (IVUS) data indicate that inadequate compensatory enlargement of atherosclerotic lesions contributes to the development of significant arterial stenoses. Such lesions may contain less plaque, which may have implications for atheroablative interventions. In this study, we compared lesions with (group A, n = 16) and without inadequate compensatory enlargement (group B, n = 30) as determined by IVUS. The acute results and the follow-up lumen dimensions of angiographically successful directional coronary atherectomy procedures were compared. Inadequate compensatory enlargement was considered present when the preintervention arterial cross-sectional area at the target lesion site was smaller than that at the (distal) reference site. Three-dimensional IVUS analysis and quantitative angiography were performed in 46 patients before and after intervention. IVUS measurements included the arterial, lumen, and plaque (arterial minus lumen) cross-sectional areas at the target lesion site (i.e., smallest lumen site) and the (distal) reference site. Angiographic follow-up was performed in 42 patients. Preintervention and postintervention angiographic measurements and IVUS lumen cross-sectional area measurements were similar in both groups. However, at follow-up, the angiographic minimum lumen and reference diameters were significantly smaller in group A compared with group B (1.71 +/- 0.47 mm vs 2.14 +/- 0.73 mm, p <0.03, and 2.97 +/- 0.29 mm vs 3.39 +/- 0.76 mm, p <0.02; group A vs B). The data of this observational study suggest that lesions with inadequate compensatory enlargement, as determined by IVUS before intervention, may have less favorable long-term lumen dimensions after directional coronary atherectomy procedures.

Adult↗
PubMed1997

Problems in the evaluation of new devices for coronary intervention: what have we learned since 1989?

The objectives of this study are to review the problems associated with the evaluation of new devices, the progress made in that evaluation process since 1989, and the role played by the New Approaches to Coronary Intervention (NACI) registry. In 1988-1989, the first wave of new coronary devices (stents, atherectomy, laser catheters) were entering clinical investigation. It seemed unlikely that the small manufacturer-run registries used to gain approval for earlier balloon catheters would be adequate to evaluate the host of complex new devices, each of which might be used for a restricted set of anatomic indications. Moreover, the wide range of arbitrary definitions then in use for fundamental outcomes (such as success, complication, and restenosis), effectively precluded meaningful device-to-device comparisons. Against this backdrop, the NACI registry was formed with National Heart, Lung, and Blood Institute funding to provide an independent and standardized evaluation of the first 8 new devices under evaluation in the United States, across the broad range of their application. The registry employed a unique modular form set to track the sequence of events during complex cases in which serial new devices and balloon angioplasty might be used, either in a planned way, or an unplanned way (to treat complications or suboptimal results). Outcomes were subjected to standardized criteria for (1) the reason for device use (planned, unplanned); (2) success (device, lesion, and procedural success); (3) complications (a) major (death, Q-wave myocardial infarction, and emergency coronary artery bypass grafting); or (b) other (groin complications, non-wave myocardial infarction, etc.); and (4) clinical restenosis (any subsequent revascularization, target lesion revascularization). Separate funding for an angiographic core laboratory was obtained in 1992, which analyzed 3,936 (88.9%) of the 4,429 films obtained on patients enrolled between November 1990 and March 1994. The NACI registry has addressed a broad range of problems inherent in the evaluation of new devices for coronary intervention. Whereas the approval process has moved progressively towards randomized clinical trials (and away from registries), the NACI registry offers a unique view of current practice, outside the narrow scope of the limited number of randomized trials that have been performed to date. This article shows, however, that we have learned about more than the devices themselves since 1989-we have also learned about the importance of knowing the reason for device use, using precise definitions of endpoint variables, understanding the financial and reimbursement ramifications of new device trials, and upholding strict investigator ethics during the conduct of such evaluations.

Angioplasty↗
PubMed1997

New Approaches to Coronary Intervention (NACI) registry: history and methods.

The New Approaches to Coronary Intervention (NACI) registry was funded in 1990 by the National Heart, Lung, and Blood Institute to evaluate the safety and efficacy of new coronary interventional devices. The registry collected data from 39 clinical centers on 8 new devices: 3 atherectomy devices, 2 stents, 2 laser devices and the laser balloon. The original funding called for a total of 500 patients to be recruited for each device. One device (the laser balloon) was removed from use early in the recruitment period. Subsequent funding was obtained for an additional 500 patients treated with directional atherectomy, and 500 additional female patients who were recruited when the main recruitment had finished. When all recruitment was finished in March 1994, a total of 4,429 patients had been recruited. Consecutive patients treated with a new device at each clinical site were recruited regardless of underlying clinical condition or result. Patients were followed for 1 year by telephone contact at 6 weeks, 6 months and 1 year. Overall 1-year follow-up compliance was excellent at 96% of patients. The NACI database was designed to allow analysis of the complex relationships between patient, lesion and device. In particular, the mode of use of each device, the treatment order, and the outcome after each device attempt were recorded. All in-hospital clinical events were recorded as well as an assessment of the success of the procedure by the operator. The results of each telephone follow-up included any interim cardiac events, anginal status, and results of any subsequent angiograms or exercise test. Any repeat percutaneous procedures or bypass surgery on an NACI patient were recorded in the same detail as the original procedure. All data collected were subjected to extensive editing at the coordinating center to ensure both internal and external consistency. An angiographic core laboratory was also funded for NACI in 1992 to provide uniform analyses of procedural angiograms. Measurements were made at each step of the procedure, that is preprocedure, after each device use, and postprocedure. Both quantitative and qualitative measurements were made at each step using standardized definitions, enabling a complete description of the procedure to be analyzed. Angiograms were made available to the core laboratory for 89% of all initial procedures.

Aged↗
PubMed1997

Reliability of the quantitative angiographic measurements in the New Approaches to Coronary Intervention (NACI) registry: a comparison of clinical site and repeated angiographic core laboratory readings.

To assess the agreement of clinical site and angiographic core laboratory readings obtained in the New Approaches to Coronary Intervention (NACI) registry, we reviewed the angiographic results obtained in 787 lesions assessed both by the sites and the core laboratory, including 135 lesions analyzed twice (> or =2 months apart) by the angiographic core laboratory. Although moderate agreement was demonstrated between the clinical site and angiographic core laboratory for qualitative lesion morphology such as lesion calcium (kappa [kappa] = 0.42), only fair agreement was found between site and core laboratory estimation of lesion ulceration (kappa = 0.33); thrombus (kappa = 0.30); and eccentricity (kappa = 0.27); with poor agreement for angulation (kappa = 0.16); and proximal vessel tortuosity (kappa = 0.03). Agreement for qualitative morphology was better for repeated core laboratory readings of lesion eccentricity (kappa = 0.75); angulation (kappa = 0.72); thrombus (kappa = 0.68); proximal vessel tortuosity (kappa = 0.66); and calcification (kappa = 0.64). Quantitative angiographic measurements correlated moderately between the clinical site using the digital caliper method and the core laboratory using the automated edge-detection method, including preprocedural percentage diameter stenosis (intraclass correlation [R] = 0.50) and postprocedural percentage diameter stenosis (R = 0.63). Repeated core laboratory readings had almost perfect agreement, with R ranging from 0.88 for postprocedural percentage diameter stenosis to 0.93 for reference vessel diameter and pre- and postprocedural minimal lumen diameters. Repeated angiographic core laboratory readings provided highly consistent quantitative and qualitative morphologic results in the NACI registry, but the core laboratory readings varied substantially from those obtained at the clinical site. More standardized angiographic analytic criteria and core laboratory feedback to investigators may improve agreement between the clinical sites and the angiographic core laboratory in subsequent studies.

Angioplasty, Balloon, Coronary↗
PubMed1997

Influence of gender on in-hospital clinical and angiographic outcomes and on one-year follow-up in the New Approaches to Coronary Intervention (NACI) registry.

Higher complication rates and lower success rates for treatment of women compared with men have been reported in prior studies of coronary angioplasty and in most early reports of outcome with new coronary interventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. These results are reflected in the current guidelines for coronary angioplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these differences on the outcome of new-device interventions have not been adequately evaluated. This article evaluates the influence of gender on clinical and angiographic characteristics, interventional procedure and complications, angiographic success, and clinical outcomes at hospital discharge and 1-year follow-up, as observed in the New Approaches to Coronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focuses on the 90% of patients-975 women and 1,880 men-who had planned procedures with a single new device and also had angiographic core laboratory readings. Women compared with men were older, had more recent onset of coronary ischemic pain that was more severe and unstable, and had more frequent histories of other adverse clinical conditions. The distributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new-device intervention, with or without balloon angioplasty, was significantly less in women (1.38 mm) than in men (1.53 mm; p < 0.001); this 0.15 mm difference is consistent with the 0.16-mm smaller reference vessel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Among procedural complications, only treatment for hypotension, blood transfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to emergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on leaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emergent CABG (1.5% vs 1.0%, for women and men, respectively) were not significantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p < 0.05) and length of hospital stay after device intervention was longer (4.4 days vs 3.8 days in men; p < 0.01). In both univariate and multivariate analyses gender did not emerge as a significant variable in relation to the combined endpoint, death, Q-wave MI, or emergent CABG at hospital discharge. At 1-year follow-up more women than men reported improvement in angina (70% vs 62%) and fewer women than men had had repeat revascularization (32% vs 36%). Similar proportions were alive and free of angina, Q-wave MI and repeat revascularization (46% of women vs 45% of men). Although several procedure-related complications were more frequent in women than men after coronary interventions with new devices, no important disadvantages were observed for women in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate the complex interplay of clinical, vessel, and lesion characteristics on success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gender specific interventional strategies may be beneficial.

Aged↗
PubMed1997

Frequency and predictors of major in-hospital ischemic complications after planned and unplanned new-device angioplasty from the New Approaches to Coronary Intervention (NACI) registry.

The purpose of this study was to determine the frequency and predictors of major in-hospital ischemic complications after planned and unplanned procedures with new angioplasty devices from the New Approaches to Coronary Intervention (NACI) registry. The NACI registry is a multicenter, voluntary reporting of consecutive patients undergoing new-device angioplasty procedures using atherectomy catheters, stents, or lasers. This registry affords the opportunity to evaluate the performance of new angioplasty devices during elective and urgent circumstances. The study population consisted of 3,340 patients with 3,733 lesions (2,921 in native coronary arteries and 812 in saphenous vein grafts [SVGs], who were treated with new devices over a 3.5-year period and had their angiograms analyzed independently at a central angiographic core laboratory. Their in-hospital course and multivariate predictors of the complications in planned and unplanned procedures, further divided into native and SVG lesions, were evaluated. In 82.2% of native coronary artery lesions and 96.9% of SVG lesions, the procedure with a device had been planned due to unfavorable lesion characteristics for PTCA. In the remaining lesions, device use was unplanned, and was performed mainly to treat a suboptimal result (59-80.4%) after percutaneous transluminal coronary angioplasty (PTCA), and less frequently after important complications of PTCA including abrupt closure and PTCA failure. In native artery cohort, major in-hospital ischemic complications (death, Q-wave myocardial infarction [MI], or emergency coronary artery bypass surgery) occurred in 2.7% of the planned and 9.9% of the unplanned procedures (p < 0.001), whereas in SVG such complications occurred in 3.6% of the planned and 8.7% of unplanned procedures (p = 0.21). Multivariate analysis revealed several predictors of major ischemic complications from planned native coronary artery device use: post-MI angina (odds ratio = 2.83); severe concomitant noncardiac disease (odds ratio = 2.5); multivessel disease (odds ratio = 1.75); and de novo lesions (odds ratio = 2.3). Multivariate predictors of major complications in unplanned native coronary artery procedures included high surgical risk (odds ratio = 3.08), and tortuous lesion (odds ratio = 2.41). In SVG lesions, the independent predictors of major complications for planned procedures included age (odds ratio = 1.09), high surgical risk (odds ratio = 4.34), and thrombus (odds ratio = 2.62). In native and SVG lesions, rates of major complications of planned procedures was acceptable (2.7-3.67%), but unplanned use of a new device was associated with a significantly higher rate of in-hospital complications (approximately 9%). Multivariate predictors for major ischemic complications included both clinical and lesion characteristics, and differed for native versus SVG lesions, as well as for planned versus unplanned procedures.

Aged↗
PubMed1997

Directional coronary atherectomy (DCA): a report from the New Approaches to Coronary Intervention (NACI) registry.

Directional coronary atherectomy (DCA) with the Simpson coronary atherocath seeks to debulk rather than simply displace obstructive tissue and is a means of enlarging the stenotic coronary lumen. This report from the New Approaches to Coronary Intervention (NACI) registry describes the experience of 1,196 patients who underwent DCA as the sole treatment for either native vessel or vein graft lesions. Device success (post-DCA residual stenosis <50% and > or =20% improvement) was achieved in 87.8%, with a lesion success rate (postprocedural residual stenosis <50% and > or =20% improvement) of 94.0%. The mean resultant stenosis after all interventions (by core laboratory) was 19%. Significant in-hospital complications occurred in 2.8% of patients with DCA attempts, including death 0.6%, Q-wave myocardial infarction (MI) 1.5%, and emergent coronary artery bypass graft surgery (CABG) 2.8%. At 1-year follow-up, cumulative mortality was 3.6%, with repeat revascularization in 28% (repeat percutaneous transluminal coronary angioplasty, 20.1%; CABG, 10.6%). This reflected percutaneous or surgical revascularization of the original lesion (target lesion revascularization) in 22.6% of patients. Subgroup analysis showed a lower lesion success rate and an increased complication rate for unplanned use, vein graft treatment, and treatment of a de novo (vs a restenotic) lesion. Multivariate analysis shows that diabetes mellitus, unstable angina, treatment of a restenotic lesion, and greater residual stenosis after the initial procedure were independent predictors of the composite endpoint of death/Q-wave MI/target lesion revascularization by 1-year follow-up. Among these generally favorable acute and 1-year results, the NACI directional atherectomy data confirm the "bigger is better" hypothesis: that lesions with a lower residual stenosis after a successful procedure had significantly fewer target lesion revascularizations between 30 days and 1 year, with no increase in major adverse events.

Atherectomy, Coronary↗