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D S Baim

Publications and source records attributed to D S Baim.

At least 55 records · Page 3Linked to original sources
PubMed1998

Quantitative coronary angiographic and intravascular ultrasound assessment of a new nonarticulated stent: report from the Advanced Cardiovascular Systems MultiLink stent pilot study.

OBJECTIVES: The purpose of this study was to evaluate the safety, feasibility, optimal deployment technique and 1-year clinical outcome for the Advanced Cardiovascular Systems (ACS) MultiLink stent. BACKGROUND: Optimal stent deployment assessed by quantitative coronary angiography and intravascular ultrasound (IVUS) is associated with improved clinical outcome. METHODS: Forty-nine consecutive patients with a discrete stenosis in a native coronary artery 3 to 4 mm in diameter were treated with the new, balloon-expandable ACS MultiLink stent. Stent expansion was assessed in all patients using quantitative coronary angiography and serial IVUS imaging after 8-, 12- and 16-atm inflations. Clinical follow-up was obtained at 30 days and 1 year. RESULTS: All 49 patients had successful placement of a MultiLink stent without death, emergency coronary artery bypass graft surgery or Q wave myocardial infarction. After placement of the MultiLink stent, the minimal lumen diameter increased from 1.24 to 2.98 mm (p < 0.001), and diameter stenosis decreased from 61% to 7% (p = 0.001). Minimal lumen cross-sectional area by IVUS increased progressively after 8, 12 and 16 atm (5.6 to 6.8 to 7.4 mm2, respectively, p < 0.001). However, only 64% of stents achieved a lumen/reference area ratio > or = 70%. No adverse clinical events occurred by 30 days, and by 1 year only one patient (2.0%) required revascularization of the stented artery. CONCLUSIONS: Treatment of stenoses in native coronary arteries with the MultiLink stent is associated with a high success rate and a low incidence of adverse events by 1 year, despite the fact that the majority of stents did not meet IVUS-defined criteria for "optimal stenting" derived from first-generation devices.

Aged↗
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

Mechanical debulking versus balloon angioplasty for the treatment of true bifurcation lesions.

OBJECTIVES: The purpose of this study was to compare the immediate angiographic and long-term results of debulking versus balloon angioplasty for treatment of true bifurcation lesions. BACKGROUND: Previous studies have shown true bifurcation lesions to be a high risk morphological subset for percutaneous transluminal coronary angioplasty (PTCA). Although atherectomy devices have been used to treat bifurcation lesions, no studies have compared the outcomes of these alternative treatment modalities. METHODS: Between January 1992 and May 1997, we treated 70 consecutive patients with true bifurcation lesions (defined as a greater than 50% stenosis in both the parent vessel and contiguous side branch) with conventional PTCA (n = 30) or debulking (with rotational or directional atherectomy) plus adjunctive PTCA (n = 40). Paired angiograms were analyzed by quantitative angiography, and clinical follow-up was obtained in all patients. RESULTS: Acute procedural success was 73% in the PTCA group and 97% in the debulking group (p = 0.01). Major in-hospital complications occurred in two patients in the PTCA group and one in the debulking group. Treatment with atherectomy plus PTCA resulted in lower postprocedure residual stenoses than PTCA alone (16+/-15% vs. 33+/-17% in the parent vessel, and 6+/-15% vs. 39+/-22% in the side branch; p < 0.001 for both comparisons). At 1 year follow-up, the incidence of target vessel revascularization (TVR) was 53% in the PTCA group as compared with 28% in the debulking group (p = 0.05). Independent predictors of the need for repeat TVR were side branch diameter >2.3 mm, longer lesion lengths, and treatment with PTCA alone. CONCLUSIONS: For the treatment of true bifurcation lesions, atherectomy with adjunctive PTCA is safe, improves acute angiographic results, and decreases target vessel revascularization compared to PTCA alone. The benefits of debulking for bifurcation lesions were especially seen in lesions involving large side branches.

Aged↗
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

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↗
PubMed1997

Predictors of acute and long-term outcome with transluminal extraction atherectomy: the New Approaches to Coronary Intervention (NACI) registry.

The New Approaches to Coronary Intervention (NACI) registry was established to define the role of new coronary devices in overcoming the limitations of balloon angioplasty. The purpose of the present study was to evaluate the acute and long-term efficacy of the transluminal extraction catheter (TEC) device utilizing data from the NACI registry and identify clinical and anatomic patient subsets who may benefit from this device. From 1990-1994, >4,300 patients from 39 clinical sites enrolled consecutive patients treated with one of the 7 new devices to the NACI registry. The study population consists of 331 patients (385 lesions) treated with planned TEC as the sole new device. Of these patients, 243 (292 lesions) were treated for saphenous vein graft (SVG) disease and 88 (93 lesions) for native disease. Patients undergoing SVG treatment were older and more likely to be male. They had lower ventricular function, more unstable angina, and a higher incidence of congestive heart failure. Multivessel disease was more prevalent in the SVG cohort, as was evidence of thrombus before treatment. Although device success was achieved in 50% of SVG lesions and 41% of native lesions, lesion success was achieved in 90% and 78%, respectively, after adjunctive balloon angioplasty, and procedure success rates were 86% and 79%, respectively. The in-hospital major complication (death/Q-wave myocardial infarction/emergency coronary artery bypass graft [CABG] surgery) rate was higher in the SVG cohort (6.2% vs 2.3%), mainly due to higher mortality rate (5.3% vs 1.1%). Multivariate analysis showed that SVG was not an independent predictor for either an in-hospital major complication or clinical failure. The risk factors for major in-hospital complications were history of congestive heart failure (odds ratio = 3.17) and thrombus (odds ratio = 3.36). For clinical failure the risk factors were diabetes (odds ratio = 1.88), thrombus (odds ratio = 2.08), and calcium (odds ratio = 3.09). One-year rates of death, Q-wave myocardial infarction, or any repeat revascularization were 51% in the SVG cohort and 41% in the native cohort. Following adjustment, patients treated for SVG disease did not have a higher risk when compared with those treated for native disease. The factors significantly associated with this composite event at 1 year are male (relative risk = 1.41), patients with history of congestive heart failure (relative risk = 1.56), and total occlusions (relative risk = 1.52). This study shows that for both SVG and native cohorts, device success rates were low with TEC alone, but acceptable lesion success rates were achieved when adjunctive PTCA was used. In-hospital as well as 1-year major complications were higher in the SVG cohort. However, after adjusting for other risk factors, SVG attempt was not significantly associated with either in-hospital or 1-year events.

Aged↗
PubMed1997

Acute and long-term outcome after Palmaz-Schatz stenting: analysis from the New Approaches to Coronary Intervention (NACI) registry.

The randomized Stent Restenosis Study (STRESS) and Belgium Netherlands Stent (Benestent) trials established that elective use of Palmaz-Schatz stents (PSSs) in native coronary arteries with de novo lesions is associated with increased procedural success and reduced restenosis. However there are other clinical indications for which stents are commonly used (unplanned use, vein grafts, restenosis lesions) that are not addressed in these studies. From 1990-1992, 688 lesions in 628 patients were treated with PSSs in the New Approaches to Coronary Intervention (NACI) registry. Angiographic core laboratory readings were available for 543 patients (595 lesions, of which 106 were stented for unplanned indications, 239 were in saphenous vein bypass grafts, and 296 were previously treated). The cohort of patients in whom stents were placed for unplanned indications had more women, current smokers, and had a higher incidence of recent myocardial infarction (MI). Patients who underwent stenting of saphenous vein grafts were older, had a higher incidence of diabetes mellitus, unstable angina, prior MI, and congestive heart failure. Lesion success was similar in all cohorts (98%), but procedural success was significantly higher for planned stenting (96% vs 87%; p < 0.01). Predictors of adverse events in-hospital were presence of a significant left main stenosis and stenting for unplanned indication. The incidence of target lesion revascularization by 30 days was significantly higher for patients undergoing unplanned stenting due to a higher risk for stent thrombosis. Recent MI, stenting in native lesion, and small postprocedural minimum lumen diameter independently predicted target lesion revascularization at 30 days. Independent predictors of death, Q-wave myocardial infarction, or target lesion revascularization at 1 year included severe concomitant disease, high risk for surgery, left main disease, stenting in the left main coronary artery, and low postprocedure minimum lumen diameter.

Aged↗
PubMed1997

Rescue angioplasty in the thrombolysis in myocardial infarction (TIMI) 4 trial.

Rescue percutaneous transluminal coronary angioplasty (PTCA) has been used to establish reperfusion after failed thrombolysis, and the goal of this study was to examine the angiographic and clinical outcomes after rescue PTCA performed for an occluded artery 90 minutes after thrombolysis. Four hundred two patients with acute myocardial infarction were randomized to receive either anistreplase (APSAC), recombinant tissue plasminogen activator, or their combination in the Thrombolysis in Myocardial Infarction (TIMI) 4 trial. The angiographic and clinical outcomes of patients with a patent artery 90 minutes after thrombolysis were compared with those of patients with an occluded artery treated in a nonrandomized fashion with either rescue or no rescue PTCA. At 90 minutes, the number of frames required to opacify standard landmarks (corrected TIMI frame count) was significantly lower (i.e., flow was faster) after successful rescue PTCA (27 +/- 11) than that in patent arteries after successful thrombolysis (39 +/- 20, p < 0.001), and the incidence of TIMI grade 3 flow was correspondingly higher after successful rescue PTCA (87% vs 65%, p = 0.002). In-hospital adverse outcomes (death, recurrent acute myocardial infarction, severe congestive heart failure, cardiogenic shock or an ejection fraction <40%) occurred in 29% of successful rescue PTCAs and in 83% of failed rescue PTCAs (p = 0.01). Among all patients in whom rescue PTCA was performed (successes and failures combined), 35% of patients experienced an adverse outcome, which was the same as the 35% incidence observed in patients not undergoing rescue PTCA (p = NS) and tended to be higher than the 23% incidence observed in patients with patent arteries (p = 0.07). Although successful rescue PTCA for an occluded artery at 90 minutes results in restoration of flow that is superior to that of successful thrombolysis, the incidence of adverse events for the strategy of rescue PTCA as a whole was the same as that of undertaking no PTCA.

Age Factors↗
PubMed1997

Effect of continuous quality improvement analysis on the delivery of primary percutaneous transluminal coronary angioplasty for acute myocardial infarction.

A successful primary percutaneous transluminal coronary angioplasty (PTCA) program requires a learning process whereby the efficiency of the cardiac catheterization laboratory to deliver prompt intervention can be refined. The purpose of this study was to (1) quantify this learning process in terms of shortening the time to reperfusion, (2) examine the changes in strategy that allowed for this, and (3) determine if expedited reperfusion by primary PTCA improved patient outcomes. A database of all primary PTCA procedures was established in February 1, 1994. Continuous quality assurance analysis was performed, and program modifications introduced as needed. Patients were separated into early (group A = February 1, 1994 through January 31, 1995) and late (group B1 = February 1, 1995 through June 31, 1995, and group B2 = July 1, 1995 through December 31, 1995) cohorts. Time intervals to certain treatment landmarks were compared among groups. In-hospital outcomes were tabulated. Fifty-two consecutive patients were included (group A = 19, group B1 = 17, group B2 = 16). Time intervals shortened significantly (group A vs group B1 vs group B2) with the time from hospital presentation to first balloon inflation decreasing progressively (from 205 to 119 to 97 minutes; p <0.001). Most of this decrease was obtained by shortening the time from hospital presentation to xylocaine administration (158 to 85 to 72 minutes; p <0.005), although the time from xylocaine to first balloon inflation also decreased (from 47 to 33 to 24 minutes; p <0.005). Parallel decreases for in-hospital mortality (26% vs 0%; p = 0.004), adverse events (47% vs 18%; p = 0.05), and length of hospital stay (13.3 +/- 13.7 vs 8.4 +/- 4.4 days; p = NS) were demonstrated for groups A versus B1 and B2. A learning effect following initiation of a primary PTCA program is demonstrated in which reperfusion was more rapidly achieved as the result of procedural changes directed by quality improvement analysis with a concurrent improvement in in-hospital outcomes.

Adrenergic beta-Antagonists↗
PubMed1997

The impact of optimal stenting techniques on cardiac catheterization laboratory resource utilization and costs.

Coronary stenting has been shown to reduce angiographic restenosis and improve clinical outcomes compared with conventional balloon angioplasty, but at greater in-lab cost. Recent studies have suggested that "optimal" stent deployment can eliminate the need for intensive oral anticoagulation after stenting, with the potential to reduce vascular complications, length of stay, and hospital cost. Between January and June 1995, we performed elective 1-vessel coronary stenting in 78 patients with a single, discrete (< 15 mm) coronary stenosis (optimal single-lesion group) and in 30 patients with either a single, long stenosis or serial discrete lesions (optimal multilesion group). Compared with stent patients from the Stent Restenosis Study (STRESS) economic substudy, optimal single-lesion stenting required more stents (1.3 +/- 0.6 vs 1.1 +/- 0.4, p <0.01) and more adjunctive angioplasty balloons per patient (2.5 +/- 1.0 vs 2.0 +/- 0.9, p <0.01). As a result, catheterization laboratory costs for single-lesion stenting increased by nearly $600 between 1993 and 1995 ($4,619 +/- $1,120 [median $4,435] to $5,209 +/- $1,697 [median $4,6731, p <0.01). Compared with the STRESS angioplasty group, optimal coronary stenting increased catheterization laboratory costs by nearly $2,200 ($3,012 +/- $1,382 [median $2,548] vs $5,209 +/- $1,697 [median $4,673], p <0.01). Optimal stenting of long lesions or multiple discrete stenoses increased catheterization laboratory costs by an additional $2,000 compared with optimal single-lesion stenting ($7,201 +/- $2,428 [median $6,887] vs $5,209 +/- $1,697 [median $4,673], p <0.01). These findings demonstrate that optimal coronary stenting increases in-lab procedural resource utilization and costs compared with historical stenting techniques. Based on the downstream cost savings seen in the STRESS trial ($1,400/patient), it is unlikely that current optimal stenting techniques will result in an overall cost savings compared with balloon angioplasty.

Aged↗
PubMed1997

Health after coronary stenting or balloon angioplasty: results from the Stent Restenosis Study.

This study was designed to compare health-related quality of life (HRQOL) in patients undergoing coronary stenting or balloon angioplasty in the randomized Stent Restenosis Study. The study sample was drawn from patients at nine U.S. clinical sites of the Stent Restenosis Study, a randomized trial comparing Palmaz-Schatz coronary stent implantation with conventional balloon angioplasty. One hundred ninety-nine consecutive patients were sent surveys 6 to 18 months after enrollment and 160 (80%) were returned. The survey sent to the patients included the Medical Outcomes Study 36-Item Short-Form Health Survey, the Canadian Cardiovascular Society Classification, and the Duke Activity Status Index. Although patients who underwent stenting had less angiographic restenosis and a tendency for fewer ischemic events, there were few differences in HRQOL after a mean of 456 days after randomization. The group that underwent stenting reported significantly less bodily pain than the group that underwent angioplasty (p = 0.02). Otherwise, there were no significant differences in generic or disease-specific measures. In a rating of their overall health, 47% of the group that underwent stenting and 45% of the group that underwent percutaneous transluminal coronary angioplasty reported very good or excellent health. In each group, 60% of the patients reported being symptom free from a cardiovascular perspective. This survey revealed no marked differences in long-term HRQOL between patients who underwent Palmaz-Schatz coronary stenting compared with those who underwent conventional angioplasty.

Aged↗
PubMed1997

Percutaneous treatment of protected and unprotected left main coronary stenoses with new devices: immediate angiographic results and intermediate-term follow-up.

OBJECTIVES: We sought to evaluate the immediate angiographic results and intermediate-term follow-up after percutaneous treatment of left main coronary stenoses in the new device era. BACKGROUND: Historically, balloon angioplasty of left main coronary stenoses has been associated with high procedural morbidity and poor long-term results. It is not clear whether new devices are more effective in this anatomic setting. METHODS: Between July 1993 and July 1995, we performed initial left main coronary interventions on 46 patients (mean age 67 +/- 12 years, 26% women). Quantitative angiography was available for 42 of 46 interventions, and clinical follow-up was obtained for all patients at 1 month, 6 months and 1 year after initial revascularization. RESULTS: Most interventions (42 of 46) were performed in patients with "protected" coronary stenoses to the left coronary system owing to the presence of one or more patent left main coronary grafts. Seventy-seven percent of screened patients were deemed unsuitable for repeat coronary artery bypass surgery. Procedures performed included stenting in 73% of patients (alone in 30% and after rotational atherectomy in 43%), rotational atherectomy in 58% (alone in 15% and before stenting in 43%), directional atherectomy in 4% and angioplasty alone in 7%. Initial procedural success was achieved in all interventions, with no deaths, myocardial infarctions (creatine kinase, MB fraction > 50 IU/liter) or emergent bypass surgery. Follow-up data to date (median duration 9 months, range 6 to 19) demonstrate a 98% overall survival rate and a 6-month event-free survival rate of 78% (six target vessel revascularizations [TVRs], four non-TVRs). CONCLUSIONS: Treatment of protected left main coronary artery stenoses can be accomplished safely and effectively with new device technology. Intermediate-term follow-up demonstrates an acceptably low rate of death, myocardial infarction or repeat revascularization at 6 months and 1 year.

Aged↗