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.     

Coronary revascularization in diabetic patients: a comparison of the randomized and observational components of the Aypass Angioplasty Revascularization Investigation (BARI)

BACKGROUND: Patients with treated diabetes in the randomized-trial segment of the Bypass Angioplasty Revascularization Investigation (BARI) who were randomized to initial revascularization with PTCA had significantly worse 5-year survival than patients assigned to CABG. This treatment difference was not seen among diabetic patients eligible for BARI who opted to select their mode of revascularization. We hypothesized that differences in patient characteristics, assessed and unmeasured, together with the treatment selection in the registry, at least partially account for this discrepancy. METHODS AND RESULTS: Among diabetics taking insulin or oral hypoglycemic drugs at entry, angiographic and clinical presentations were comparable between randomized and registry patients. However, more registry patients were white, and registry diabetics tended to be more educated and more physically active and to report better quality of life. Procedural characteristics and in-hospital complications were comparable. The 5-year all-cause mortality rate was 34.5% in randomized diabetic patients assigned to PTCA versus 19.4% in CABG patients (P=0.0024; relative risk [RR]=1.87); corresponding cardiac mortality rates were 23.4% and 8.2%, respectively (P=0.0002; RR=3.10). The CABG benefit was more apparent among patients requiring insulin. In the registry, all-cause mortality was 14.4% for PTCA versus 14.9% for CABG (P=0.86, RR=1.10), with corresponding cardiac mortality rates of 7.5% and 6. 0%, respectively (P=0.73; RR=1.07). These RRs in the registry increased to 1.29 and 1.41, respectively, after adjustment for all known differences between treatment groups. CONCLUSIONS: BARI registry results are not inconsistent with the finding in the randomized trial that initial CABG is associated with better long-term survival than PTCA in treated diabetic patients with multivessel coronary disease suitable for either surgical or catheter-based revascularization.     

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.     

Isolation of human intestinal defensins from ileal neobladder urine

Restenosis is a major limitation of percutaneous transluminal coronary angioplasty (PTCA). In this study, we assessed the impact of restenosis on PTCA with reference to coronary angioplasty bypass grafting (CABG). In the Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI) PTCA population, those who had restenosis were defined as those needing a second revascularization at a site revascularized at the initial procedure. The 1-year clinical outcome of the nonrestenotic group (n=437) was compared with those who underwent CABG (n=453). There was no difference in deaths. In the nonrestenotic PTCA group, the incidence of more infarctions was insignificant (relative risk [RR] 1.9, 95% confidence intervals [CI] 0.96 to 3.75, p=0.064), there was a much greater need for repeat revascularization (RR 8.6, CI 5.14 to 14.41, p <0.0005), and patients had a poorer angina status (RR 1.46, CI 1.01 to 2.13, p=0.046). Using 2 measures of coronary disease, the degree of pre- and postrevascularization disease was compared between groups. There were no differences in prerevascularization disease. However, using either measure, residual postrevascularization disease was more frequent in the nonrestenotic PTCA group. Restenosis only partially accounts for the greater morbidity seen after PTCA, compared with CABG, in multivessel disease. The greater likelihood of residual disease post-PTCA may contribute to this greater morbidity.     

Revascularization in patients with prior coronary bypass surgery

Increasingly over the past several years, patients have returned after coronary surgery for reintervention procedures. This reflects immediate postsurgical complications and the relentless progression of coronary artery disease in the native circulation and in the bypass grafts. Although there are randomized comparative data for coronary bypass surgery (CABG) versus percutaneous transluminal coronary angioplasty (PTCA) and medical therapy, these trials have always excluded patients with previous (GABG). OBJECTIVES: We attempted to compare the risks and benefits of percutaneous transluminal coronary angioplasty (PTCA) and repeat coronary artery bypass grafting (re-CABG) in patients with previous coronary bypass surgery (CABG). METHODS AND RESULTS: This study examines follow up data (15.4 +/- 11.0 months) from 130 patients with previous CABG, who required either PTCA (Group A, n = 73) or re-CABG (Group B; n = 57) at a single center from 1994 to 1997. Follow up data were obtained from subsequent office visits and telephone calls. The PTCA and re-CABG groups were similar with respect to gender (86% vs 94% males), mean age (62 +/- 9 vs 59 +/- 10 years), angina CCS classes 3 and 4 (73% vs 69%), diminished left ventricular function (23% vs 26%), risk factors such as diabetes (19% vs 17%), hypercolesterolemia (49% vs 45%) and smoking (48% vs 39%) and three-vessel native coronary artery disease (67% vs 72%). The symptomatic status prior to the revascularization procedure was similar in both groups. Complete and functional revascularization was achieved in 85% of the PTCA group and in 92% of those with re-CABG (p = NS). During the hospital stay the complication rates were lower in the PTCA group. Actuarial survival was different at follow up (p = 0.04). Both PTCA and re-CABG groups resulted in equivalent event-free survival (freedom from death, myocardial infarction, unstable angina and urgent revascularization). The need for repeat revascularization at follow up was significantly higher in the PTCA group (PTCA 28% vs re-CABG 10%, p < 0.01). CONCLUSIONS: In this non-randomized study of patients with previous CABG requiring revascularization procedures, PTCA resulted in lower procedural morbidity and mortality risks. At follow up, both PTCA or CABG were similar for event-free survival; PTCA offered lower overall mortality, although it is associated to a greater need for subsequent revascularization procedures.     

Indications, practice, and procedural outcomes of percutaneous transluminal coronary angioplasty in northern New England in the early 1990s. The Northern New England Cardiovascular Disease Study Group

We conducted a prospective cohort study from October 1, 1989 to December 31, 1993 of the current indications, practices and procedural outcomes of percutaneous transluminal coronary angioplasty (PTCA) in Northern New England to determine how it compared with reports from other regions and registries. Thirty-five cardiologists contributed data on 12,232 admissions for PTCA performed at all hospitals in New Hampshire and Maine, plus 1 in Massachusetts, supporting PTCA. Mean patient age was 61.1 years, 67.5% were men, and 38.5% had multivessel disease. Unstable (45.6%), stable (22.9%), and postinfarction angina (21.0%) were common indications for the procedure. Of all patients, 86.9% had 1-vessel PTCA, including 65.7% of those with multivessel disease. Angiographic success was 90.4%, and 88.1% of patients had > or = 1 lesion successfully dilated and no adverse clinical event. The risk of death, nonfatal acute myocardial infarction, or coronary artery bypass grafting was 5.7%. The practice and outcomes of PTCA in Northern New England were somewhat similar to reports from other regional registries but different from a registry of select institutions. We conclude that PTCA as performed in Northern New England is safe and effective.     

One-year outcomes of diabetic versus nondiabetic patients with non-Q-wave acute myocardial infarction treated with percutaneous transluminal coronary angioplasty

Risk factors and outcomes associated with non-Q-wave myocardial infarction (MI) in diabetics and nondiabetics were analyzed for 376 consecutive patients, 77 with diabetes (20%) and 299 nondiabetics (80%), who had non-Q-wave MI and had percutaneous transluminal coronary angioplasty (PTCA) performed before discharge from hospital during the period from January 1992 to February 1996. Diabetics were slightly older (64 +/- 10 years vs 61 +/- 12 years, p <0.053), had more prior coronary artery bypass grafting (CABG) surgery (27% vs 12%, p <0.001), and hypertension (77% vs 49%, p <0.001). There was no significant difference in unstable angina, saphenous vein graft PTCA, single versus multiple vessel disease, or history of MI. PTCA success rates for diabetics versus nondiabetics were similar (96% vs 97%, p = NS). In-hospital complications such CABG, recurrent MI, repeat PTCA, stroke, and death were not statistically significant between the 2 groups. At 1-year follow-up, survival in diabetics (92%) was similar to nondiabetics (94%, p = NS), although event-free survival (PTCA, CABG, MI, death) was worse in diabetics (55% vs 67% for nondiabetics, p <0.05). Although diabetic patients with non-Q-wave MI represent a cohort with more risk factors for poor outcome, aggressive in-hospital revascularization with PTCA results in an excellent short-term outcome as well as 1-year survival similar to the nondiabetic patients. However, total events at 1-year follow-up are more common in the diabetic patients, suggesting that more aggressive screening and therapy in follow-up may be warranted, and that a diabetic with non-Q-wave MI will require increased utilization of cardiovascular resources in the first year after the event.     

Coronary angioplasty versus repeat coronary artery bypass grafting for patients with previous bypass surgery

OBJECTIVES: We attempted to determine the relative risks and benefits of percutaneous transluminal coronary angioplasty (PTCA) and repeat coronary artery bypass grafting (re-CABG) in patients with previous coronary bypass surgery (CABG). BACKGROUND: Due to an expanding population of patients with surgically treated coronary artery disease and the natural progression of atherosclerosis, an increasing number of patients with previous CABG require repeat revascularization procedures. Although there are randomized comparative data for CABG versus medical therapy and, more recently, versus PTCA, these studies have excluded patients with previous CABG. METHODS: We retrospectively analyzed data from 632 patients with previous CABG who required either elective re-CABG (n = 164) or PTCA (n = 468) at a single center during 1987 through 1988. The PTCA and re-CABG groups were similar with respect to gender (83% vs. 85% male), age > 70 years (21% vs. 23%), mean left ventricular ejection fraction (46% vs. 48%), presence of class III or IV angina (70% vs. 63%) and three-vessel coronary artery disease (77% vs. 74%). RESULTS: Complete revascularization was achieved in 38% of patients with PTCA and 92% of those with re-CABG (p < 0.0001). The in-hospital complication rates were significantly lower in the PTCA group: death (0.3% vs. 7.3%, p < 0.0001) and Q wave myocardial infarction (MI) (0.9% vs. 6.1%, p < 0.0001). Actuarial survival was equivalent at 1 year (PTCA 95% vs. re-CABG 91%) and 6 years (PTCA 74% vs. re-CABG 73%) of follow-up (p = 0.32). Both procedures resulted in equivalent event-free survival (freedom from dealth or Q wave MI) and relief of angina; however, the need for repeat percutaneous or surgical revascularization, or both, by 6 years was significantly higher in the PTCA group (PTCA 64% vs. re-CABG 8%, p < 0.0001). Multivariate analysis identified age > 70 years, left ventricular ejection fraction < 40%, unstable angina, number of diseased vessels and diabetes mellitus as independent correlates of mortality for the entire group. CONCLUSIONS: In this nonrandomized series of patients with previous CABG requiring revascularization, an initial stategy of either PTCA or re-CABG resulted in equivalent overall survival, event-free survival and relief of angina. PTCA offers lower procedural morbidity and mortality risks, although it is associated with less complete revascularization and a greater need for subsequent revascularization procedures.     

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results

OBJECTIVE: This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography. BACKGROUND: Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate. METHODS: To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n=57) or to optimal PTCA (n=59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). RESULTS: Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63+/-0.59 vs. 0.26+/-0.44, respectively; p=0.01). Hence, net gain with both techniques was similar (1.32< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA groups, respectively; p=NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p=NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p=NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p=NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02). CONCLUSIONS: The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.     

Late results of percutaneous transluminal coronary angioplasty of two or more major native coronary arteries

Of 613 consecutive patients with multivessel coronary artery disease (CAD) undergoing revascularization, 521 patients (85%) underwent primary management with percutaneous transluminal coronary angioplasty (PTCA). To examine long-term outcome in a series of patients often referred for coronary artery bypass graft (CABG) surgery, all patients undergoing multivessel dilations were identified for late follow-up analysis (n = 161). Mean age was 65 years; 54 patients (34%) were women. Four hundred fifty-five of 502 lesions (90.6%) were successfully dilated. Major in-hospital procedural complications occurred in 6 patients (3.7%), including death in 3 (1.9%), nonfatal Q-wave myocardial infarction in 2 (1.2%), and CABG in 1 (0.6%). Final follow-up data were available in 159 patients (99%) at a mean of 39 +/- 18 months. Including in-hospital events, actuarial 3-year survival was 93%, and 3-year infarct-free survival was 90%. At final follow-up, 143 of 146 patients alive (98%) were angina free. Crossover to CABG was required in 25 patients (16%). Repeat PTCA was performed in 67 patients (42%) (mean 1.7 PTCAs/patient, range 1 to 7). PTCA is an effective therapeutic alternative in the management of most patients with multivessel CAD requiring revascularization. A strategy using multiple repeated PTCA procedures when necessary results in prolonged infarct-free survival, with long-term freedom from angina and limited crossover to CABG.     

The effects of pictorial versus tangible stimuli in stimulus-preference assessments

OBJECTIVES: The purpose of this study was to compare 3-year risk-adjusted survival in patients undergoing coronary artery bypass graft (CABG) surgery and percutaneous transluminal coronary angioplasty. BACKGROUND: Coronary artery bypass graft surgery and angioplasty are two common treatments for coronary artery disease. For referral purposes, it is important to know the relative pattern of survival after hospital discharge for these procedures and to identify patient characteristics that are related to survival. METHODS: New York's CABG surgery and angioplasty registries were used to identify New York patients undergoing CABG surgery and angioplasty from January 1, 1993 to December 31, 1995. Mortality within 3 years of undergoing the procedure (adjusted for patient severity of illness) and subsequent revascularization within 3 years were captured. Three-year mortality rates were adjusted using proportional hazards methods to account for baseline differences in patients' severity of illness. RESULTS: Patients with one-vessel disease with the one vessel not involving the left anterior descending artery (LAD) or with less than 70% LAD stenosis had a statistically significantly longer adjusted 3-year survival with angioplasty (95.3%) than with CABG surgery (92.4%). Patients with proximal LAD stenosis of at least 70% had a statistically significantly longer adjusted 3-year survival with CABG surgery than with angioplasty regardless of the number of coronary vessels diseased. Also, patients with three-vessel disease had a statistically significantly longer adjusted 3-year survival with CABG surgery regardless of proximal LAD disease. Patients with other one-vessel or two-vessel disease had no treatment-related differences in survival. CONCLUSIONS: Treatment-related survival benefit at 3-years in patients with ischemic heart disease is predicted by the anatomic extent and specific site of the disease, as well as by the treatment chosen.     

Percutaneous transluminal coronary angioplasty in patients with multivessel coronary disease: does complete revascularization improve the long-term survival?

The influence of complete revascularization on long-term outcome of patients with multivessel coronary artery disease undergoing percutaneous transluminal coronary angioplasty (PTCA) was determined by analysis of 10-year survival in 167 consecutive patients treated at Juntendo University Hospital during 1984-1993. Forty-nine patients were completely revascularized and 118 had incomplete revascularization according to the anatomical classification. Among patients with anatomically incomplete revascularization, 56 were categorized as functionally adequate revascularization and 62 as functionally inadequate revascularization according to Faxon's criteria. Baseline characteristics showed incompletely revascularized patients had a higher incidence of prior myocardial infarction triple-vessel disease and/or chronic total occlusion in at least one lesion. The 10-year survival was slightly better in patients with complete (100%) than in those with incomplete revascularization (79%), but not statistically significant (p = 0.089). Event-free survival was not significantly different between the two groups. However, the need for coronary artery bypass surgery was higher in the incomplete revascularization group than that in the complete revascularization group (100% vs 81%, p = 0.013). The influence of the degree of functional revascularization on outcome was not clear in the present study. Long-term survival appeared to be better in patients with complete revascularization than that in patients with incomplete revascularization, but even in the latter, coronary artery bypass grafting in the later period could improve outcome. The effect of functional revascularization status should be further investigated in a larger population.     

Predictors of CABG within one year of successful PTCA: a retrospective, case-control study

BACKGROUND: We previously have established characteristics predictive of the need for coronary artery bypass grafting (CABG) over many years after successful percutaneous transluminal coronary angioplasty (PTCA). In this study, we examined the factors associated with the need for CABG within 1 year of successful PTCA, and the recent impact of newer, catheter-based technologies. METHODS: From January 1982 through December 1995, 234 patients underwent CABG within 1 year of a successful "index" PTCA at our hospital. Emergency operations within 12 hours of index PTCA were excluded. These cases were matched with 234 controls who underwent a successful index PTCA but did not require a subsequent CABG during the next year. Cases were matched by the date of their index PTCA, and 1-year follow-up was complete for all patients. RESULTS: Before index PTCA there were no differences between the groups in terms of age, sex, diabetes, prior myocardial infarction, ejection fraction, duration of anginal symptoms, hypertension, hyperlipidemia, family history, or obesity (all nonsignificant). At index PTCA the cases had a greater mean number of lesions measuring 70% or greater compared with the controls (2.8 versus 1.8, respectively; p < 0.0001). The cases were more likely to have critical (70% or greater) proximal left anterior descending artery, proximal first obtuse marginal artery, and right posterior descending artery stenoses. The use of stents or atherectomy devices was not significantly more common among the controls (21% of controls versus 17.1% of cases; p = 0.35). Complete revascularization was achieved in significantly fewer of the cases than the controls (91 versus 156, respectively; p < 0.0001). The cases underwent CABG at a mean of 3 months (86% within 6 months) after PTCA. Among those who had a diagnostic catheterization, 52% of the patients had both restenosis of a dilated lesion and progression of other disease. Only 5 of 75 patients who had restenosis of a dilated lesion had a stent or an atherectomy device used at index PTCA. Of note, 13% (30 of 234) required an emergency operation, with an overall operative mortality rate of 3% (7 of 234). CONCLUSIONS: Although the likelihood of local restenosis is decreased by newer interventional techniques, the need for CABG within 1 year after successful PTCA is not diminished. The number of critical lesions and their location are the best predictors of the need for early CABG. If early post-PTCA CABG is to be avoided, patients who cannot be completely revascularized by PTCA should be revascularized by CABG.     

Paradigms and expectations: the nature of research and diagnostics

OBJECTIVES: Our purpose was to evaluate the long-term benefit of myocardial viability assessment for stratifying risk and selecting patients with low ejection fraction for coronary artery bypass grafting and to determine the relation between the severity of anginal symptoms, the amount of ischemic myocardium, and clinical outcome. METHODS: We studied 93 consecutive patients with severe coronary artery disease and low ejection fraction (median, 25%) who underwent positron emission tomography to delineate the extent of perfusion-metabolism mismatch (reflecting hibernating myocardium) for potential myocardial revascularization. Median follow-up was 4 years (range, 0 to 6.2 years). RESULTS: Fifty patients received medical therapy, and 43 patients underwent bypass grafting. In Cox survival models, heart failure class, prior myocardial infarction, and positron emission tomographic mismatch were the best predictors of survival. Patients with positron emission tomographic mismatch receiving bypass grafting had improved 4-year survival compared with those on medical therapy (75% versus 30%; P =.007) and a significant improvement in angina and heart failure symptoms. In patients without positron emission tomographic mismatch, bypass grafting tended to improve survival and symptoms only in those patients with severe angina (100% versus 60%; P =.085), whereas no survival advantage was apparent in patients with minimal or no anginal symptoms (63% versus 52%; P =.462). CONCLUSIONS: Patients with low ejection fraction and evidence of viable myocardium by positron emission tomography have improved survival and symptoms with coronary bypass grafting compared with medical therapy. In patients without evidence of viability, survival and symptom improvement with bypass grafting are apparent only among those patients with severe angina.     

Safety and cost-effectiveness of MIDCABG in high-risk CABG patients

BACKGROUND: Myocardial revascularization without cardiopulmonary bypass has been proposed as a potential therapeutic alternative in high-risk patients undergoing coronary artery bypass grafting. To evaluate this possibility we compared 15 high-risk (HR) patients in whom minimally invasive direct coronary artery bypass grafting was used as the method of revascularization with 41 consecutive patients who underwent conventional coronary artery bypass grafting during 1 month. METHODS: Patients undergoing myocardial revascularization without cardiopulmonary bypass were significantly older than their low-risk (LR) counterparts (72.2 +/- 11.6 versus 63.3 +/- 9.7 years, p = 0.006). The demographic profile for HR versus LR patients was as follows: female patients, 60.0% versus 26.8%, p = 0.02; diabetes, 20.0% versus 24.4%, p = 0.7; prior stroke, 33.3% versus 7.4%, p = 0.03; chronic obstructive pulmonary disease, 60.0% versus 9.8%, p < 0.0001; peripheral vascular disease, 33.3% versus 12.2%, p = 0.03, congestive heart failure, 26.6% versus 9.8%, p = 0.09; impaired left ventricular (ejection fraction < 0.40), 40.0% versus 17.0%, p = 0.07; urgent operation, 86.6% versus 46.3%, p < 0.0001; and redo operation, 20.0% versus 0%, p = 0.003. RESULTS: There were no deaths in the HR group and one death in the LR group. The average intensive care unit stay was 1.1 +/- 0.5 days in HR patients versus 1.6 +/- 1.6 days in LR individuals (p = 0.2), and the average hospital stay was 6.1 +/- 1.8 versus 7.3 +/- 4.4 days, respectively (p = 0.3). We used an acuity risk score index developed by the Adult Cardiac Care Network of Ontario to predict outcome in the HR group. The expected intensive care unit stay in HR patients was 4.1 +/- 1.2 days (versus the observed stay of 1.1 +/- 0.5 days, p < 0.0001), and the expected hospital stay was 12.5 +/- 1.5 days (versus the observed stay of 6.1 +/- 1.8 days, p < 0.0001). The expected mortality in the HR group was 6.1% versus 0%, p = 0.3. A cost regression model was used to examine predicted versus actual cost (in Canadian dollars) for the HR patient cohort (based on Ontario Ministry of Health funding). The expected cost for the HR cohort would have been $11,997 per patient. In contrast, the average cost for these 15 patients was $5,997 per patient, an estimated cost saving of 50%. CONCLUSIONS: Myocardial revascularization without cardiopulmonary bypass appears to be a safe and cost-effective therapeutic modality for HR patients requiring myocardial revascularization.     

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.     

Health service costs of coronary angioplasty and coronary artery bypass surgery: the Randomised Intervention Treatment of Angina (RITA) trial

For some patients with coronary artery disease, percutaneous transluminal coronary angioplasty (PTCA) is an alternative to coronary artery bypass grafting (CABG). We report comparative health service costs of these interventions within the Randomised Intervention Treatment of Angina (RITA) trial. Medications were costed at published UK prices; other resource use was costed with a set of unit costs estimated at two recruiting centres to the RITA trial, one in London and one outside. Over 2-year follow-up of 1011 patients, the estimated mean additional cost for those randomised to CABG compared with PTCA was 1050 pounds (95% CI 621 pounds-1479 pounds), with unit costs from the non-London centre, and 1823 pounds (1202 pounds-2444 pounds), with unit costs from the London centre. The initial average cost of treating a patient randomised to PTCA is about 52% of that of CABG, but after 2 years this increased to about 80% because of the greater need for subsequent interventions. The balance of advantage between PTCA and CABG may change after several years: funding has been obtained to continue RITA follow-up for 10 years. However, on the basis of patients' status at 2 years, the cost advantages of PTCA cannot be ignored. Further research is necessary to assess whether the advantage of PTCA in terms of cost is translated into one of cost-effectiveness.     

Intra-arterial blood pressure during exercise and left ventricular indices in normotension and borderline and mild hypertension

OBJECTIVE: To determine whether a sex-related difference in outcome is present among patients who undergo percutaneous transluminal coronary angioplasty (PTCA) for unstable angina. DESIGN: We retrospectively analyzed the results after PTCA was performed between January 1981 and June 1993 in a series of 2,073 men and 941 women with unstable angina and rest pain. RESULTS: The success rates of PTCA were similar for women and men (87.9% and 87.2%, respectively), as were the in-hospital mortality rates (4.1% and 3.2%, respectively) and the need for emergency coronary artery bypass operation (3.1% and 3.5%, respectively). Fewer women than men had Q-wave myocardial infarction (0.5% versus 1.6%; P = 0.02). During the follow-up period (mean, 4 years), no significant differences were noted between women and men in overall survival (81% and 85% at 6 years, respectively) or survival free of Q-wave myocardial infarction (81% and 83% at 6 years, respectively) with use of the Kaplan-Meier method. Women were less likely than men to have had coronary artery bypass grafting (19% versus 22% at 6 years; P = 0.02), and the occurrence of severe angina was higher in women than in men (52% versus 44% at 6 years; P = 0.001). A subgroup analysis of patients who had myocardial infarction within 7 days preceding PTCA showed a similar pattern of results. CONCLUSION: After PTCA performed for unstable angina and rest pain, survival rates were excellent in both women and men, and no difference was observed in subsequent myocardial infarction rates. During follow-up, however, women were more likely to have severe angina and were less likely to have had coronary artery bypass grafting. Concerns about possible sex-related complications should not dissuade physicians from performing PTCA when clinically indicated for unstable angina and rest pain.     

Coronary surgery without extracorporeal circulation. Indications, methods and results. Apropos of 224 cases

Coronary revascularization without cardiopulmonary bypass is evolving as an important technique. From January 1988 to September 1997, 224 patients underwent consecutively coronary artery bypass grafting without cardiopulmonary bypass in our institution. Indications for this type of revascularization were essentially: patients with a single coronary lesion and patients which presented an increased risk for extra-corporeal circulation. Follow-up was complete. The majority of patients were men (176) and the median age was 62 years. Most patients were in CCS III and IV (79%). Unstable angina was found in 19%, 4% had a recent trans mural infarction (< or = 48 hr), and 36% had an older infarct (> 48 hr). 8% were operated in emergency, 29% presented a restenosis following angioplasty, with 4% having a complication from angioplasty, and 0.8% were operated in cardiogenic shock. Redo surgery was seen in 4% of patients. 12% of patients had an ejection fraction less than 30%, 47% an ejection fraction between 30 et 49%, and 40% patients an ejection fraction greater than 50%. Mean Parsonnet score was 10. 185 patients (82.5%) underwent single bypass, and 39 patients (17%) multiple bypasses. Ten patients (4.4%) underwent hybrid revascularization with primarily surgical grafting followed by angioplasty. Postoperative outcome included: myocardial infarction in 16 patients (7.1%), 8 patients (3.5%) were reoperated for tamponade or bleeding, 2 patients (0.8%) developed a mediastinitis, and 1 patient (0.4%) had a neurological event. Hospital mortality was 4% (9 patients). Univariate and multivariate analysis identified two risks factors: age greater than 70 (OR 4.2, CI 1-18.4), and an ejection fraction less than 30% (OR 5, CI 1.2-21.6). Survival was 99.1% at 1 year, 94% at 3 years and 83.2% at 7 years. Post operative angina occurred in 33 patients, linked to a coronary anastomosis dysfunction in 9 patients (4.1%). A significant reduction of cost was found, compared to patients operated with extra-corporeal circulation. We conclude that coronary revascularization without cardiopulmonary bypass can provide satisfactory results, for patients with single coronary lesion, or for patients with an increased risk and multiple coronary lesions.     

Primary culture and transfection of epithelial cells of human small intestine

OBJECTIVE: To evaluate perioperative and long-term morbidity in patients undergoing selective evaluation of coronary artery disease prior to abdominal aortic aneurysm (AAA) repair. DESIGN: Case series. SETTING: University and Veterans' Administration medical centers. PATIENTS: One hundred eighty-nine consecutive patients undergoing AAA repair between January 1989 and September 1996 were selectively evaluated for coronary artery disease and assigned to 1 of 3 groups: group 1, no abnormal cardiac history, normal electrocardiogram; group 2, minimal symptoms, history of myocardial infarction (MI), older than 70 years, diabetes mellitus, or congestive heart failure; or group 3, severe or unstable angina, ventricular dysfunction. INTERVENTIONS: Group 1 patients proceeded to AAA repair without further workup. Group 2 patients underwent pharmacologic or exercise stress testing followed by coronary angiography and intervention as required. Group 3 patients went directly to coronary angiography and intervention as needed. MAIN OUTCOME MEASURES: Perioperative MI, arrhythmias, or death. Long-term follow-up measures included MI and death. RESULTS: Adequate documentation was available on 171 patients. Twenty-four patients (14%) were in group 1. Of 136 patients (79.5%) in group 2, coronary angiography was performed in 36 (26%), followed by percutaneous transluminal coronary angioplasty (PTCA) in 9 (7%) and coronary artery bypass (CAB) in 5 (4%). Of 11 patients in group 3, 3 (27%) each received PTCA and CAB. Remote CAB or PTCA had been performed in 32 (19%) and 12 (7%) patients, respectively. Two perioperative deaths (1.1%) occurred in the 189 patients, one due to MI in a group 2 patient. There were 2 (1%) nonfatal MIs, both in group 2 patients who had no preoperative intervention. Arrhythmias and/or congestive heart failure occurred in 17 (9%) cases, 7 (39%) having had recent coronary revascularization (P = .001). By univariate analysis, only preoperative renal dysfunction predicted perioperative complications (P = .03) Overall survival by lifetable analysis was 87.9% and 69.7% at 3 and 5 years, respectively. CONCLUSION: Coronary artery disease is common in patients undergoing AAA repair, with 35.7% having preoperative coronary revascularization at some point. Selective preoperative coronary artery disease screening achieves excellent perioperative and late results in this population.