Use and perceived effectiveness of non-analgesic medical therapies for chronic pancreatitis in the United States.

BACKGROUND: Effectiveness of medical therapies in chronic pancreatitis has been described in small studies of selected patients. AIM: To describe frequency and perceived effectiveness of non-analgesic medical therapies in chronic pancreatitis patients evaluated at US referral centres. METHODS: Using data on 516 chronic pancreatitis patients enrolled prospectively in the NAPS2 Study, we evaluated how often medical therapies [pancreatic enzyme replacement therapy (PERT), vitamins/antioxidants (AO), octreotide, coeliac plexus block (CPB)] were utilized and considered useful by physicians. RESULTS: Oral PERT was commonly used (70%), more frequently in the presence of exocrine insufficiency (EI) (88% vs. 61%, P < 0.001) and pain (74% vs. 59%, P < 0.002). On multivariable analyses, predictors of PERT usage were EI (OR 5.14, 95% CI 2.87-9.18), constant (OR 3.42, 95% CI 1.93-6.04) or intermittent pain (OR 1.98, 95% CI 1.14-3.45). Efficacy of PERT was predicted only by EI (OR 2.16, 95% CI 1.36-3.42). AO were tried less often (14%) and were more effective in idiopathic and obstructive vs. alcoholic chronic pancreatitis (25% vs. 4%, P = 0.03). Other therapies were infrequently used (CPB - 5%, octreotide - 7%) with efficacy generally <50%. CONCLUSIONS: Pancreatic enzyme replacement therapy is commonly utilized, but is considered useful in only subsets of chronic pancreatitis patients. Other medical therapies are used infrequently and have limited efficacy.

Effect of enhanced external counterpulsation on medically refractory angina patients with erectile dysfunction.

Patients with refractory angina often suffer from erectile dysfunction. Enhanced external counterpulsation (EECP) decreases symptoms of angina, and increases nitric oxide release. This study evaluated the effect of EECP on sexual function in men with severe angina. The International Index of Erectile Function (IIEF) was used to assess erectile function of severe angina patients enroled in the International EECP Patient Registry. Their symptom status, medication use, adverse clinical events and quality of life were also recorded before and after completing a course of EECP. A cohort of 120 men (mean age 65.0+/-9.7) was enroled. The men had severe coronary disease with 69% having a prior myocardial infarction, 90% prior coronary artery bypass graft or percutaneous coronary intervention, 49% with three vessel coronary artery disease, 86% were not candidates for further revascularisation, 71% hypertensive, 83% dyslipidaemia, 42% diabetes mellitus, 75% smoking and 68% using nitrates. Functional status was low with a mean Duke Activity Status Inventory score of 16.6+/-14.8. After 35 h of EECP anginal status improved in 89%, and functional status in 63%. A comparison of the IIEF scores pre- and post-EECP therapy demonstrated a significant improvement in erectile function from 10.0+/-1.0 to 11.8+/-1.0 (p=0.003), intercourse satisfaction (4.2+/-0.5 to 5.0+/-0.5, p=0.009) and overall satisfaction (4.7+/-0.3 to 5.3+/-0.3, p=0.001). However, there were no significant changes in orgasmic function (4.2+/-0.4 to 4.6+/-0.4, p=0.19) or sexual desire (5.3+/-0.2 to 5.5+/-0.2). The findings suggest that EECP therapy is associated with improvement in erectile function in men with refractory angina.

Enhanced external counterpulsation as initial revascularization treatment for angina refractory to medical therapy.

Enhanced external counterpulsation (EECP) is effective in patients with angina refractory to medical therapy or revascularization. However, as a noninvasive treatment it should perhaps be considered the first-line treatment with invasive revascularization reserved for EECP failures or high-risk patients. The International EECP Patient Registry was used to analyze a cohort of patients with prior percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) (n = 4,454) compared with a group of patients (PUMPERS) who were candidates for PCI and/or CABG and chose EECP as their initial revascularization treatment (n = 215). The PUMPERS responded to treatment with EECP with decreased anginal episodes and nitroglycerin use and with improvement in their Canadian Cardiovascular Society functional class, similarly to previously revascularized patients. Treatment with EECP resulted in sustained, and often progressive, reduction in angina over the succeeding 6 months. Given the findings of this study, it is interesting to speculate on the possibility of using EECP as the primary revascularization intervention after medical therapy proves unsatisfactory.

Benefit and safety of enhanced external counterpulsation in treating coronary artery disease patients with a history of congestive heart failure.

Enhanced external counterpulsation (EECP) is used to noninvasively treat refractory angina patients, including those with a history of heart failure. The International EECP Patient Registry was used to examine the benefit and safety of EECP treatment, including a 6-month follow-up, in 1,957 patients, 548 with a history of heart failure. The heart failure cohort was older, with more females, a greater duration of coronary artery disease, more prior infarcts and revascularizations. Significantly fewer heart failure patients completed the course of EECP, and exacerbation of heart failure was more frequent, though overall major adverse cardiac events (MACE, i.e. death, myocardial infarction, revascularization) during treatment were not significantly different. The angina class improved in 68%, with comparable quality of life benefit, in the heart failure cohort. At 6 months, patients with congestive heart failure maintained their reduction in angina but were significantly more likely to have experienced a MACE end point.

Differences in heart valve procedures between North American and European centers: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT).

BACKGROUND AND AIM OF THE STUDY: Differences in heart valve procedures between North American (NA) and European (EU) centers were evaluated in a multicenter trial. METHODS: Between July 1998 and January 2000, 807 patients from 12 NA (n = 446) and seven EU centers (n = 361) were randomized to receive either Silzone or conventional valves in the Artificial Valve Endocarditis Reduction Trial (AVERT). Subanalysis was performed to compare demographics, patient risk profile, surgical techniques and perioperative management of patients in NA and EU centers. RESULTS: Mean age was significantly younger and body mass index higher in NA. Patients' risk profiles showed significantly higher incidences of previous myocardial infarction, congestive heart failure, angina, prior cardiovascular surgery, and history of smoking in NA. A different distribution of implant position was observed between groups: aortic valve/mitral valve/double valve replacement in 54.0, 35.7 and 10.3% in NA, and 64.5, 27.4 and 8.0% in EU (p <0.01). Concomitant coronary artery bypass grafting was performed in 31.6% of NA patients and 19.4% of EU patients (p <0.001). Timing of surgery showed a higher incidence of urgent procedures in NA centers. Distribution of valve sizes and perioperative complication rate were similar, but length of hospital stay was longer in EU centers. CONCLUSION: Surprisingly, surgeons in NA and EU centers are faced by different patient populations requiring mechanical heart valve replacement. NA patients were younger, but required more extensive surgery. Surgical technique and perioperative management appear to differ in NA and EU centers. These differences in reporting heart valve procedures might have been influenced by variable interpretations of definitions and different patient expectations, although a uniform study protocol with consistent definitions was used at all sites.

The International EECP Patient Registry (IEPR): design, methods, baseline characteristics, and acute results.

BACKGROUND: In 1998, the International EECP Patient Registry (IEPR) was organized to document patient characteristics, safety, and efficacy during the treatment period, and long-term outcomes. All centers with EECP facilities were invited to join the voluntary Registry. The Registry population comprises all patients starting EECP therapy for treatment of angina pectoris in participating centers. HYPOTHESIS: The study was undertaken to determine whether EECP is a safe and effective treatment for patients with angina pectoris regardless of their suitability for revascularization by more conventional techniques. METHODS: After 18 months of operation, 43 clinical centers representing over half of clinical sites using the EECP system contributed cases. The data reported here were collected before the first EECP treatment and upon completion of final treatment. EECP can be used for patients ineligible for either coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), as well as for those who prefer noninvasive treatment to avoid or delay revascularization. In this report, patients considered to be candidates for revascularization are compared with those not considered suitable. RESULTS: Of the 978 patients analyzed, 70% had Canadian Cardiovascular Society Classification class III or IV angina before starting treatment, and 62% used nitroglycerin. Most (81%) had been previously revascularized, and 69% were considered unsuited for either PCI or CABG at the time of starting EECP. A full treatment course (usually 35 h) was completed in 86%, of whom 81% reported improvement of at least one angina class immediately after the last treatment. CONCLUSION: In a broad patient population, EECP has been shown to be a safe and effective treatment.

Does higher diastolic augmentation predict clinical benefit from enhanced external counterpulsation?: Data from the International EECP Patient Registry (IEPR).

BACKGROUND: Enhanced external counterpulsation (EECP) has been demonstrated to be an effective treatment for stable angina in patients with coronary disease. The hemodynamic effects of EECP are maximized when the ratio of diastolic to systolic pressure area is in the range of 1.5 to 2.0. HYPOTHESIS: It is hypothesized that patients undergoing EECP who are able to achieve higher diastolic augmentation (DA) ratios may derive greater clinical benefit. This study examines the relationship between the DA ratio and clinical outcomes in patients undergoing EECP. METHODS: We analyzed demographic, noninvasive hemodynamic, and clinical outcome data on 1,004 patients enrolled in the International EECP Patient Registry (IEPR) for treatment of chronic angina between January 1998 and August 1999. Blood pressure waveforms were recorded from finger plethysmography. Six-month clinical outcomes were obtained by telephone interview. RESULTS: At the end of EECP treatment, 370 (37%) patients had a higher DA ratio (defined as > or = 1.5) and 634 (63%) had a lower DA ratio (defined as < 1.5). Factors associated with a lower DA ratio included age > or =65 years (p <0.001), female gender (p < 0.001), left ventricular ejection fraction < 35% (p < 0.05), hypertension (p < 0.01), prior coronary bypass surgery (p < 0.01), noncardiac vascular disease (p < 0.001), multivessel disease (p < 0.01), congestive heart failure (p < 0.01), current smoking (p < 0.01), unsuitability for further revascularization (p < 0.001), and higher baseline angina class (p < 0.001). There were no significant differences regarding diabetes mellitus, prior coronary angioplasty, prior myocardial infarction, or antianginal medication use between patients with higher or lower DA ratios. Based on a multiple logistic regression model, independent predictors of a DA ratio < 1.5 at the end of EECP included current smoking (odds ratio 3.3; 95% confidence intervals 2.0-5.4); multivessel disease (1.7; 1.3-2.3); female gender (2.2; 1.7-3.0); no prior EECP (1.9; 1.1-3.3); noncardiac vascular disease (2.3; 1.7-2.9); age > or = 65 years (1.7; 1.4-2.2), and patients not suitable for revascularization (1.6; 1.2-2.0). By the end of therapy, there were no significant differences in myocardial infarction, revascularization rates, or nitroglycerin use with respect to higher DA ratios. At 6-month follow-up, patients with higher DA had a trend toward a greater reduction in angina class compared with those with lower DA (p = 0.069). There was a significantly higher rate of unstable angina and congestive heart failure in the group not achieving higher augmentation (p < 0.05). CONCLUSIONS: Patients who are younger, male, nonsmoking, and without multivessel coronary or noncardiac vascular disease are most likely to have higher DA with EECP. Patients with higher DA tended to have a greater reduction in angina class at 6-month follow-up compared with those with lower DA ratios. There is evidence that higher DA ratios are associated with improved short- or long-term clinical outcomes, suggesting that clinical benefit from EECP is associated with the magnitude of DA.

Relation of coronary artery size to one-year clinical events after new device angioplasty of native coronary arteries (a New Approach to Coronary Intervention [NACI] Registry Report).

The influence of vessel size on clinical and angiographic outcomes after new device angioplasty has not been well documented. We reviewed clinical and angiographic outcomes of 2,044 patients undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Quantitative angiography was performed using standard methods. Patients were divided into 3 groups according to reference vessel diameter (RVD) (<2.75, 2.75 to 3.25, and >3.25 mm). Patients with the smallest vessels had a higher incidence of diabetes (26% vs. 16%, p<0.01), multivessel disease (50% vs. 45%, p<0.01), left anterior descending coronary artery disease (61% vs. 39% p<0.01), and in general, more severe baseline lesion characteristics than patients with larger (>3.25 mm) vessels. Absolute baseline and final minimal lumen diameter (MLD) was also smaller in patients with RVD <2.75 mm despite similar final percent diameter stenosis. Although in-hospital events were similar, patients who underwent interventions in vessels <2.75 mm had an increased incidence of death (p<0.01), surgical revascularization (p<0.05), and target lesion revascularization (TLR) (p<0.01) at 1 year. Multivariate analysis by vessel size showed a stepwise increase in the risk of TLR by 1 year in patients with the smaller RVD (p = 0.0001) and the combined end point of 1 year death/Q wave-myocardial infarction/TLR (p = 0.02). Thus, despite similar early clinical events among patients undergoing new device angioplasty, patients who underwent treatment of smaller vessels had a significantly increased risk of major adverse clinical events and particularly TLR by 1 year after new device angioplasty of native coronary arteries.

Race, baseline characteristics, and clinical outcomes after coronary intervention: The New Approaches in Coronary Interventions (NACI) registry.

BACKGROUND: The impact of race and sex on clinical outcomes after percutaneous coronary interventions remains incompletely understood. Specific data on patient demographics, lesion characteristics, and outcomes of black versus white patients are poorly described. To further evaluate these issues, we analyzed the New Approaches in Coronary Interventions (NACI) registry. METHODS: Patients (200 black, 4279 white) undergoing coronary interventions in the NACI trial were compared. A Cox proportional hazards model was used to determine which baseline demographics were independent risk factors for the combined end point of death, Q-wave myocardial infarction, and coronary artery bypass grafting at 1 year. RESULTS: Black patients were significantly younger (age 59 +/- 11 vs 63 +/- 11 years; P <.001), more often obese (29.6 +/- 6 vs 27.5 +/- 4.8 kg/m(2); P <.001), female (50% vs 34%; P <.001), diabetic (34% vs 21%; P <.001), and hypertensive (71% vs 52%; P <.001). Black patients were significantly more likely to have single-vessel disease (48% vs 40%; P <.05) and less likely to have undergone coronary artery bypass grafting (26% vs 34%; P <.05). Blacks were significantly more likely to have a discrete lesion (85% vs 62%; P <. 001) with less thrombus (7% vs 12%; P <.05), tortuosity (17% vs 25%; P <.05), and an ulcerated appearance (5% vs 10%; P <.05). Despite these significant baseline differences, no significant difference was seen in the procedural success (80% vs 82%) or major adverse events (death, Q-wave myocardial infarction, any revascularization) at 1 year (39% vs 34%). Predictors of adverse events for white patients included diabetes (relative risk [RR] = 1.24; confidence intervals [CI], 1.0-1.5) and high-risk status (RR = 1.58; CI, 1.26-1. 91). Predictive characteristics of adverse events for black patients included only sex (RR = 3.45; CI, 1.27-9.35; P =.02). CONCLUSIONS: There are significant differences in baseline characteristics of black patients compared with white patients. Despite these differences in traditional risk factors, they do not affect procedural success or 1-year outcome. In black patients, only sex predicted adverse events. Additional investigation is required to understand the mechanisms for this difference.

Importance of lesion length on new device angioplasty of native coronary arteries. NACI Investigators. New Approaches to Coronary Interventions.

The influence of lesion length on early and late outcomes after new device angioplasty has not been well documented. We reviewed the clinical and angiographic outcomes of 2,980 patients (3,902 lesions) undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Patients were divided into three groups according to the longest lesion length (< 10, 10-20, and > 20 mm) treated. Patients with the longest lesions had more multivessel disease (56.9% vs. 49.0%, P<0.05), right coronary artery disease (52.7% vs. 32.0%, P<0.001), and total occlusions (19.1% vs. 2.5%, P<0.001) than patients with shorter lesions. Longest lesions had the smallest minimal lumen diameter (P<0.001) at baseline and at the end of the procedure. Although in-hospital events were similar, there were differences in clinical outcomes at 1 year due mainly to more target lesion revascularization in the longest lesion group (P<0.01). Multivariate analysis showed that each 1-mm increase in lesion length was associated with an increase relative risk of 1.014 (95% CI, 1.004-1.025) for target lesion revascularization at 1 year. We conclude that despite similar early clinical events, patients undergoing new device angioplasty of longer lesions have more target lesion revascularization at 1 year.

One-year follow-up of the Stent Restenosis (STRESS I) Study.

We present the completed 1-year follow-up results of the original Stent Restenosis Study (STRESS I), in which 407 patients with symptomatic ischemic heart disease and new lesions of the native coronary circulation were randomly assigned to treatment with either the Palmaz-Schatz coronary stent or conventional percutaneous transluminal coronary angioplasty (PTCA). The present study compares the safety of elective stenting to balloon angioplasty (PTCA) in terms of freedom from clinical events up to 1 year after treatment. Patients were enrolled and treated from January 1991 through February 1993, and follow-up data were collected and verified until July 1995. Ninety-seven percent of all patients had complete follow-up (deceased or alive with known clinical status) beyond 8 months, and 94% beyond 11 months. Anginal status between 9 to 15 months postprocedure was available for 78% of patients. At 1 year, 154 patients (75%) assigned to stent implantation and 141 (70%) to PTCA were free of all clinical events (death, myocardial infarction, or any revascularization procedure), and 162 stent patients (79%) and 149 PTCA patients (74%) were free from death, myocardial infarction, or target lesion revascularization. Symptom-driven target lesion revascularization occurred in 12% of the stent group versus 17% of the PTCA group. None of these differences in clinical events was statistically significant. Only 2 patients in the stent group and 7 in the PTCA group had a first event after 239 days, and freedom from angina at 1 year was reported in equal frequency in both groups (84%). There appear to be no late adverse effects of stent implantation. However, these results are limited by low statistical power, narrow patient selection, and the anticoagulation regimen used in the early experience with this device.

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.

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.

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.

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.

Bailout and corrective use of Gianturco-Roubin flex stents after percutaneous transluminal coronary angioplasty: operator reports and angiographic core laboratory verification from the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention Registry.

OBJECTIVES: We sought to determine the in-hospital clinical outcome and angiographic results of patients prospectively entered into the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention (NHLBI/NACI) Registry who received Gianturco-Roubin stents as an unplanned new device. BACKGROUND: Between August 1990 and March 1994, nine centers implanted Gianturco-Roubin flex stents as an unplanned new device in the initial treatment of 350 patients (389 lesions) who were prospectively enrolled in the NHLBI/NACI Registry. METHODS: Patients undergoing implantation of the Gianturco-Roubin flex stent were prospectively entered into the Gianturco-Roubin stent portion of the NHLBI/NACI Registry. Only subjects receiving the Gianturco-Roubin stent as a new device in an unplanned fashion are included. RESULTS: The mean age of the patient group was 61.8 years, and the majority of the patients were men. A history of percutaneous transluminal coronary angioplasty (PTCA) was present in 35.4% of the group, and 16.9% had previous coronary artery bypass graft surgery. Unstable angina was present in 67.7%. Double- or triple-vessel coronary artery disease was present in 55.4%, and the average ejection fraction was 58%. The presence of thrombus was noted in 7.3%, and 7.2% had moderate to severe tortuosity of the lesion. The angiographic success rate was 92%. Individual clinical sites reported that 66.3% of the stents were placed after suboptimal PTCA, 20.3% for abrupt closure and 13.4% for some other technical PTCA failure. Major in-hospital events occurred in 9.7% of patients, including death in 1.7%, Q wave myocardial infarction in 3.1% and emergency bypass surgery in 6%. Abrupt closure of a stented segment occurred in 3.1% of patients at a mean of 3.9 days. Cerebrovascular accident occurred in 0.3%, and transfusion was required in 10.6%. Vascular events with surgical repair occurred in 8.6% of patients. CONCLUSIONS: Despite these complications, the use of this device for the treatment of a failed or suboptimal PTCA result remains promising given the adverse outcome of abrupt closure with conventional (nonstent) treatment.

Baseline characteristics and therapeutic goals in the New Approaches to Coronary Intervention (NACI) registry.

BACKGROUND: The New Approaches to Coronary Intervention (NACI) voluntary registry was designed to study the use, safety, and efficacy of new percutaneous transluminal interventional devices including directional coronary atherectomy, the transluminal extraction catheter, the rotablator, the Palmaz-Schatz stent, the Gianturco-Roubin stent, the Advanced Interventional Systems (AIS) laser, and the spectranetics laser. METHODS: To date, more than 3800 consecutive patients treated for the first time with a new device at 41 centers have been entered into the registry. Complete detailed information about the patient, lesions, device characteristics, reasons for device selection, and procedural data, such as adjunctive use of conventional balloon angioplasty (PTCA), was available for the first 2835 patients. RESULTS: The registry shows that 88% of the 3233 attempts with a new device were intended as a definitive treatment of target lesions, frequently in combination with adjunctive PTCA. The remaining 12% of attempts with a new device were unplanned, prompted by unexpected complications, unsuccessful attempts, or suboptimal results with PTCA. Although there was some overlap in the indications for selecting a given interventional device, the variation from device to device was sufficiently large to caution users against any direct comparison of either safety or efficacy between devices without careful attention to the differences in baseline patient and lesion characteristics, treatment plans, and the circumstances of device use. CONCLUSION: This report provides the first comprehensive overview of how new interventional devices are currently being used in the treatment of coronary artery lesions at the 41 centers participating in the NACI registry.

Community mental health accreditation: a pilot study.

The Balanced Services System is the conceptual framework for the newly initiated community mental health accreditation program sponsored by the Joint Commission on Accreditation of Hospitals (JCAH). The program design and performance of CMH systems are reviewed and judged according to a series of evaluation criteria that prescribe the desired operating state for each functional area in the center.