Elizabeth D. Kennard

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.

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.

Enhanced External Counterpulsation in the Treatment of Chronic Refractory Angina: A Long-term Follow-up Outcome from the International Enhanced External Counterpulsation Patient Registry

The management of patients who suffer from medically refractory angina and are unsuitable for conventional revascularization therapy is often unsatisfactory. Enhanced external counterpulsation (EECP) is a noninvasive treatment that is safe and effective immediately after a course of treatment. However, the duration of benefit is less certain.

Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT

BACKGROUND The Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare endocarditis rates in Silzone versus conventional valves. Recruitment ended January 21, 2000, because of higher rates of paravalvular leakage in patients receiving the Silzone prosthesis. The present analysis determined late event rates that might be used in the management of approximately 36,000 patients who have received the Silzone prosthesis. METHODS A total of 807 patients in 19 centers in North America and Europe were randomized. Mean age was 61+/-11 years; 41% were women. Operations included aortic valve replacement in 59%, mitral valve replacement in 32%, and aortic and mitral valve replacements in 9%; 41% had concomitant operations (26% coronary artery bypass grafting). RESULTS Major paravalvular leakage (followed by repair, explant, or mortality) occurred in 18 of 403 patients receiving Silzone valves and 4 of 404 patients without Silzone valves (2-year event-free rates: 91.1% versus 98.9% conventional, p < 0.003). Similarly, 2-year freedom from any explant was lower in the Silzone arm (19 versus 2 events; 90.1% versus 99.4%, p = 0.0002). Rates of mortality and stroke were similar during follow-up. CONCLUSIONS Continued follow-up of AVERT supports the conclusion that the Silzone prosthesis has increased risk of paravalvular leakage requiring reoperation. Overall survival is similar in the two groups.

Physical and mental quality of life in chronic pancreatitis: a case-control study from the North American Pancreatitis Study 2 cohort.

Objectives The objective of this study was to define the quality of life (QOL) in patients with chronic pancreatitis (CP). Methods We studied 443 well-phenotyped CP subjects and 611 control subjects prospectively enrolled from 20 US centers between 2000 and 2006 in the North American Pancreatitis Study 2. Responses to the SF-12 questionnaire were used to calculate the mental (MCS) and physical component summary scores (PCS) with norm-based scoring (normal ≥50). Quality of life in CP subjects was compared with control subjects after controlling for demographic factors, drinking history, smoking, and medical conditions. Quality of life in CP was also compared with known scores for several chronic conditions. Results Both PCS (38 [SD, 11.5] vs 52 [SD, 9.4]) and MCS (44 [SD, 11.5] vs 51 [SD, 9.2]) were significantly lower in CP compared with control subjects (P < 0.001). On multivariable analyses, compared with control subjects, a profound decrease in physical QOL (PCS 12.02 points lower) and a clinically significant decrease in mental QOL (MCS 4.24 points lower) was seen due to CP. Quality of life in CP was similar to (heart, kidney, liver, lung disease) or worse than (nonskin cancers, diabetes mellitus, hypertension, rheumatoid arthritis) other chronic conditions. Conclusions The impact of CP on QOL appears substantial. The QOL in CP subjects appears to be worse or similar to the QOL of many other chronic conditions.

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.

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.

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.

Primer: practical approach to the selection of patients for and application of EECP

Over the past decade, the frequency of use of enhanced external counterpulsation (EECP®) has increased in patients with angina, irrespective of medical therapy and coronary revascularization status. Many patients referred for EECP® have one or more comorbidities that could affect this treatments efficacy, safety, or both. By use of data from more than 8,000 patients enrolled in the International EECP® Patient Registry, we provide practical guidelines for the selection and treatment of patients. We have focused on considerations for patients who have one or more of the following characteristics: age older than 75 years, diabetes, obesity, heart failure, and peripheral vascular disease. We have also reviewed outcomes and treatment recommendations for individuals with poor diastolic augmentation during treatment, for those with atrial fibrillation or pacemakers, and for those receiving anticoagulation therapy. Lastly, we examined relevant data regarding extended courses of EECP®, repeat therapy, or both. While clinical studies have demonstrated the usefulness of EECP® in selected patients, these guidelines permit recommendations for the extended application of this important treatment to subsets of patients excluded from clinical trials.

Relation of the pattern of diastolic augmentation during a course of enhanced external counterpulsation (EECP) to clinical benefit (from the International EECP Patient Registry [IEPR])

E external counterpulsation (EECP) is a noninvasive counterpulsation technique that reduces angina and extends time to exercise-induced ischemia in patients with symptomatic stable angina. In addition to relieving myocardial ischemia, EECP is associated with improved quality of life. It uses a sequential inflation of 3 sets of pneumatic cuffs wrapped around the lower extremities. The cuffs are inflated sequentially at the onset of diastole, producing aortic counterpulsation, diastolic augmentation (DA), and increased venous return. At the onset of systole, external pressure in the cuffs is released, producing a decrease in systolic pressure (systolic unloading). These hemodynamic effects are monitored noninvasively by assessing the finger plethysmographic waveforms. A typical course of EECP involves 1 to 2 hours/day for a total of 35 hours of therapy. It has been hypothesized that the sustained benefits of EECP result from effective DA, which promotes coronary collateral formation or recruitment. A previous study has demonstrated that patients who are younger, male, nonsmoking, and without multivessel coronary or noncardiac vascular disease are most likely to have higher DA at the end of an EECP treatment course. Patients with higher DA ratios at the end of EECP tended to have a greater reduction in angina class than those with lower DA ratios, suggesting that clinical benefit from EECP is associated with the magnitude of DA. That initial study was limited by assessing the DA ratios on the final day of EECP therapy. This present analysis further investigates the role of DA in EECP by assessing the impact of DA levels both at the first and last treatment session with EECP.