Application of the New York State PTCA mortality model in patients undergoing stent implantation.

BACKGROUND: This study applied the New York State conventional coronary angioplasty (PTCA) model of clinical outcomes to evaluate whether it has relevance in the current era of stent implantation. The model was developed in 62 670 patients treated with conventional PTCA from 1991 to 1994 to risk adjust mortality and bypass surgery after PTCA. Since then, stents have become the dominant form of intervention. Whether that model remains relevant is uncertain. METHODS AND RESULTS: All patients undergoing stenting at the Mayo Clinic from 1995 to 1998 were analyzed for in-hospital mortality, bypass surgery performed after attempted stenting, and longer-term mortality. No patients were excluded. The New York model was used to risk adjust and predict in-hospital and follow-up mortality. There were 3761 patients with 4063 procedural admissions for stenting; 6,472 target vessel segments were attempted, and 96.1% of procedures were successful. With the New York multivariable risk factor equation, 79 in-hospital deaths were expected (1.95%); 66 deaths (1.62%) were observed. The New York model risk score in a logistic regression model was the most significant factor associated with in-hospital mortality (OR, 1.86; P<0.001). During a mean follow-up of 1.2+/-1.0 years, there were 154 deaths. Multivariable analysis documented 6 factors associated with subsequent mortality; New York risk score was the most significant (chi(2)=16.64, P=0.0001). CONCLUSIONS: Although the New York mortality model was developed in an era of conventional angioplasty, it remains relevant in patients undergoing stenting. The risk score derived from that model is the variable most significantly associated with not only in-hospital but also longer-term outcome.

Outcome > or = 10 years after successful percutaneous transluminal coronary angioplasty.

Patients (n = 611) after successful percutaneous transluminal coronary angioplasty were prospectively followed over 10 to 16 years for major adverse events. The effect of gender, extent of coronary artery disease, left ventricular dysfunction, and age on occurrence of adverse events were analyzed in detail. The incidence of death, Q-wave myocardial infarction, and coronary bypass surgery was 23.1%, 3.9%, and 32.7%, respectively. Men and women had similar mortality (p = 0.13) and Q-wave myocardial infarction (p = 0.57), but men had more coronary bypass surgery (p = 0.06). Patients with multivessel disease had higher mortality (p < 0.0001), and patients with 3-vessel disease had a higher incidence of Q-wave myocardial infarction (p = 0.04) and coronary bypass surgery (p < 0.001). Left ventricular dysfunction was associated with higher mortality (p < 0.0001) and coronary bypass surgery (p = 0.045), but not Q-wave myocardial infarction (p = 0.99). Mortality was higher in elderly patients (p < 0.0001), but the incidence of Q-wave myocardial infarction was similar (p = 0.64). Older patients underwent coronary bypass surgery less often (p = 0.004). By multivariate analysis, only the extent of coronary disease (relative risk [RR] 1.71, confidence interval [CI] 1.34 to 2.19; p = 0.0001), diabetes mellitus (RR 1.82, CI 1.28 to 2.59; p = 0.001), hypertension (RR 1.30, CI 1.08 to 1.96, p = 0.009), male gender (RR 1.30, CI 0.99 to 1.71, p = 0.058), and prior myocardial infarction (RR 1.44, CI 1.14 to 1.81, p = 0.002) independently influenced the incidence of major adverse events. We conclude that it is possible to identify patients with worse long-term prognosis after percutaneous transluminal coronary angioplasty based on clinical and angiographic parameters.

Interventional cardiology and intracoronary stents--a changing practice: approved vs. nonapproved indications.

Our objective was to document change in stent usage in a single practice over time and to study "off-label" compared to Food and Drug Administration (FDA)-approved indications. Although only two intracoronary stents have been approved by the FDA, the relatively limited approved indications do not account for the dramatic increase in stent implantation. This increase has important implications for patient health care delivery. This study of stent usage in a single center over a 36-mo period included all patients treated with coronary stents at the Mayo Clinic from January 1993-December 1995, and evaluated the relative difference in frequency between "off-label" and FDA-approved indications for implantation. During the 36-mo period of study, 3,614 interventional procedures were done and one or more stents were placed in 25.4% of patients. The proportion of patients receiving stents increased throughout this time: during the first 6-mo period, stents were placed in 6.2% of procedures; during the last 6-mo period, stents were placed in 46.3% of procedures, an eightfold increase. During the final 6 mo, an unapproved device or an unapproved indication for an approved device constituted 59.4% of all stent procedures. In addition, use of the non-FDA-approved adjunctive treatment regimen without warfarin increased from 2.9% in the first 6-mo period of observation to 82.7% in the last 6 mo. The use of stents increased strikingly over a 36-mo period, from 6% to 46% of all procedures. The majority of implantations were performed either for an "off-label" unapproved indication or with an unapproved device.

Long-term follow-up of patients undergoing closed transventricular mitral commissurotomy: a useful surrogate for percutaneous balloon mitral valvuloplasty?

OBJECTIVE: The aim of this study was to determine the long-term outcome and multivariate predictors of late events in patients who underwent transventricular mitral commissurotomy at the Mayo Clinic in the early 1960s. BACKGROUND: Percutaneous balloon mitral valvuloplasty is an important new procedure for which long-term follow-up data are not yet available. However, such data do exist for patients who have undergone transventricular mitral commissurotomy, a similar but older and more invasive procedure. METHODS: Follow-up data (mean duration 13.9 years) for 207 women and 60 men who underwent transventricular mitral commissurotomy were obtained from medical records, referring physicians, questionnaires and telephone interviews. Survival and survival free of repeat commissurotomy or mitral valve surgery were estimated with the Kaplan-Meier method. Cox proportional hazards model was used to determine predictors of survival and repeat mitral valve surgery. RESULTS: Postoperatively, 92% of patients had symptomatic improvement, which was sustained for at least 3 to 4 years in 78%. At 10, 15 and 20 years postoperatively, 79%, 67% and 55%, respectively, of patients were alive and 57%, 36% and 24%, respectively, were alive and free of repeat mitral valve surgery. At 10 years, 90% of all patients were free of transient or fixed cerebrovascular events. In multivariate analyses, atrial fibrillation, age and male gender were independently associated with death, whereas mitral valve calcification, cardiomegaly and mitral regurgitation independently predicted repeat mitral valve surgery. CONCLUSIONS: Long-term results after transventricular mitral commissurotomy are excellent in selected patients with symptomatic mitral stenosis. Because of similarities in patient selection and mechanisms of mitral valve dilation, similar favorable long-term outcomes may be expected after percutaneous balloon mitral valvuloplasty.

Repeat balloon coronary angioplasty for symptomatic restenosis: a note of caution.

Of 694 patients in whom percutaneous transluminal coronary angioplasty was attempted for palliation of symptomatic coronary artery disease, 74 subsequently underwent a repeat procedure because of symptomatic restenosis. The repeat dilatation was successful in 55 patients (74%). The primary success rate and the incidence of major complications were similar for initial and repeat procedures. Complications of the repeat procedure included major dissection (14%), acute occlusion (7%) and emergency coronary bypass surgery (12%). After a mean follow-up period of 113 weeks (range, 15-309 weeks), 33 patients (60%) were asymptomatic; angina recurred in 22 (40%). In our hands, the success rate, complication rate, and long-term results of repeat percutaneous transluminal coronary angioplasty were similar to those associated with the initial procedure.

Coronary artery thrombus as a risk factor for acute vessel occlusion during percutaneous transluminal coronary angioplasty: improving results.

Early experience with percutaneous transluminal coronary angioplasty (from October 1979 to March 1983 inclusive) showed that pre-existing coronary artery thrombus was associated with a significant increase in the incidence of acute coronary occlusion during angioplasty. Acute occlusion occurred in 11 (73%) of 15 patients with pre-existing thrombus compared with 18 (8%) of 223 patients without thrombus. The effect of improved technology (steerable guiding systems) and altered dilatation strategy (full intravenous heparinisation for 24 hours after the procedure and more intensive use of antiplatelet medications) was studied by review of angiograms from 297 consecutive patients without evidence of acute myocardial infarction who underwent angioplasty from April 1983 to March 1985 inclusive. Coronary artery thrombus was present in 34 (11%) patients, eight (24%) of whom had complete occlusion during or immediately after the procedure compared with 34 (13%) of 263 patients without thrombus. Patients with pre-existing coronary artery thrombus continue to be at greater risk of complete occlusion than patients without thrombus, but this risk has declined significantly since the modification of the angioplasty procedure.

Follow-up clinical results in patients undergoing percutaneous transluminal coronary angioplasty.

Complete follow-up data were obtained from 229 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) between 1979 and 1982 (mean follow-up 14 months, range 6 to 37). Single-vessel disease was present in 143 and multivessel disease in 86. PTCA was successful in 153 patients (67%). Failure was followed initially by bypass surgery in 59 and by continued medical therapy in 17. After successful PTCA, 90% of patients were improved subjectively and 74% were asymptomatic at follow-up. After unsuccessful PTCA but prompt bypass, 90% were improved subjectively and 85% were asymptomatic. Among the 229 patients, 39 (17%) required an additional intervention because of angina during follow-up; 15 of these had repeat PTCA and 18 had bypass surgery. Among patients with successful PTCA, revascularization was complete in 77% and partial in 23%. The completeness of revascularization with PTCA had a significant impact on follow-up. The follow-up data of patients with successful single-vessel PTCA and of those with multivessel disease with complete revascularization were similar. When the patients with complete revascularization were compared with those with multivessel disease but incomplete revascularization, the follow-up data were characterized by a higher incidence of angina or need for bypass surgery in the latter group (63%) than in the former group (29%); those with incomplete revascularization also had a significantly reduced event-free survival.

Employment and recreation patterns in patients treated by percutaneous transluminal coronary angioplasty: a multicenter study.

Employment and recreational patterns were analyzed in 279 patients who underwent percutaneous transluminal coronary angioplasty (PTCA) for treatment of symptomatic coronary artery disease. PTCA was successful in 180 patients (65%). When it was unsuccessful, coronary artery bypass graft surgery was usually performed (80%). Return-to-work rates were high irrespective of the outcome of PTCA. Of patients employed full-time or part-time before treatment, 98.5% of those who had successful PTCA alone and 97% of those whose PTCA was unsuccessful but who underwent uncomplicated coronary artery bypass surgery maintained or improved their work status. In a subgroup of men who had been employed in occupations requiring physical labor, 85% of the men whose PTCA was successful returned to work, compared with 68% of those whose PTCA was unsuccessful. The interval from attempted PTCA to return to work was significantly shorter in the successfully treated group; in patients with successful PTCA, the median time to return to work was 14 days, compared with 60 days in patients in whom PTCA was unsuccessful (p less than 0.001). During follow-up, patients with successful PTCA had less angina and were more active in recreational activities than patients who required alternative treatments.

Employment status after coronary artery bypass surgery.

Factors that influence the effect of coronary artery bypass graft surgery (CABG) on employment were examined in 1427 2-year survivors from entry into the nonrandomized Mayo Clinic portion of the National Heart, Lung, and Blood Institute's prospective Coronary Artery Surgery Study. Five hundred seventy-nine patients (41%) were treated medically, 769 (54%) were treated surgically and 79 (5%) were initially treated medically but later had CABG. All groups were similar at entry with respect to age and percent working, retired or quitting work for cardiac reasons. There was a similar decline in employment from entry to 2 years in all three groups. The number who quit work for cardiac reasons was twice the number of previously disabled workers who returned to work with all three modes of therapy. Univariate and multivariate analyses were used to test the independent prognostic values of a number of variables for subsequent employment in the largest homogeneous surgical subset--496 nonretired males. Postoperative angina was the most powerful factor reducing postoperative employment. Postoperative employment was also lower if the patient was not working before surgery, was a laborer, or older than age 55 years (all p less than 0.01). Although the level of nonwork physical activity was generally increased after CABG, there was no relationship between physical activity and employment. This study confirms that employment declines after CABG, but three of the four most powerful prognostic variables were not related to surgery.