[Show abstract][Hide abstract] ABSTRACT: OBJECTIVES: To ascertain causes of death and the incidence of percutaneous coronary intervention (PCI) related mortality within 30 days. BACKGROUND: Public reporting of 30-day mortality after PCI without clearly identifying the cause may result in operator risk avoidance and impact hospital reputation and reimbursements. Death certificates, utilized by previous reports, have poor correlation with actual cause of death and may be inadequate for public reporting. METHODS: All patients who died within 30 days of a PCI from January 2009 to April 2011 at a tertiary care center were included. Causes of death were identified through detailed chart review using Academic Research Consortium consensus guidelines and compared to reported death certificates. The causes of death were divided into cardiac and non-cardiac and PCI and non PCI-related categories. RESULTS: Of the 4078 PCIs, 81 deaths (2%) occurred within 30 days. Of these, 58% died of cardiac and 42% of non-cardiac causes. However, only 42% of 30-day deaths were attributed to PCI-related complications. Compared to PCI-related, patients with non PCI-related death presented with a higher incidence of cardiogenic shock (15/47 (32%) versus 2/34 (6%); p < 0.01) and cardiac arrest (19/47 (40%) versus 1/34 (3%); p < 0.01). Death certificates had only 58% accuracy (95% CI, 45%-72%) for classifying patients as experiencing cardiac versus non-cardiac death. CONCLUSIONS: Less than half of 30-day deaths are attributed to a PCI-related complication. Death certificates are inaccurate and do not report PCI-related deaths, which may represent a better marker of PCI quality.
Full-text · Article · May 2013 · Journal of the American College of Cardiology
[Show abstract][Hide abstract] ABSTRACT: To determine the role of percutaneous coronary intervention (PCI) and its impact on mortality in coronary artery disease (CAD).
It's unclear whether PCI provides benefit in patients with CAD outside of acute settings. We sought to determine the role of PCI and its effect on mortality in patients with similar entry criteria to prior RCTs and compare outcomes with medical treatment.
Using institutional diagnostic catheterization database of consecutive patients undergoing coronary angiography from 1/2004 to 1/2010, we examined records for patients with a positive stress test and >70% coronary stenosis or symptoms of angina and >80% coronary stenosis. We excluded those with acute coronary syndromes, low ejection fraction (EF), history of CABG, and CABG following index catheterization. We stratified patients by treatment and performed unadjusted and propensity matched analyses. The outcome was all-cause mortality obtained from the social security death index.
We identified 3,375 patients using study inclusion criteria. Mean age was 65 ± 11 years and 69% (n = 2,332) were men. Mean EF was 55% ± 8%. In the unadjusted cohort, 1,265 patients received medical management and 2,110 received PCI. The unadjusted analysis revealed significantly better survival in PCI patients (P < 0.0001) (HR: 0.51; 95% confidence interval (CI), 0.41–0.63). Propensity matching was performed for 1,580 patients and analysis showed better survival among patients receiving PCI (0 = 0.04) (HR: 0.74; 95% CI, 0.55–0.98). PCI continued to show better survival after excluding patients with malignancy (P = 0.03) and unstable angina (P = 0.007).
This single center registry analysis demonstrated better survival in stable CAD patients undergoing PCI compared to medical management alone. These data suggest there may be a benefit of PCI beyond symptom relief. Future randomized trials are needed to further understand the role of PCI in broader patient populations.
No preview · Article · Jan 2013 · Catheterization and Cardiovascular Interventions
[Show abstract][Hide abstract] ABSTRACT: Femoral closure devices help early ambulation after cardiac catheterization without incurring additional risk to the patients. This report summarizes the safety and efficacy data of the 6Fr Angio-Seal device.
No preview · Article · Apr 2001 · The American Journal of Cardiology
[Show abstract][Hide abstract] ABSTRACT: We compared in-hospital femoral complications of Angio-Seal, Perclose, and manual compression in consecutive patients who underwent percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet inhibition. Femoral closure devices have a similar overall risk profile as manual compression, even in patients treated with glycoprotein IIb/IIIa platelet inhibition, although certain rare complications such as retroperitoneal hemorrhage and severe access-site infection may be more common with the use of these devices.
No preview · Article · Nov 2000 · The American Journal of Cardiology
[Show abstract][Hide abstract] ABSTRACT: A collagen hemostatic puncture closure device has been developed as an alternative to traditional manual pressure techniques for achieving effective femoral arterial hemostasis after coronary angiography. The purpose of the current study was to determine if patients receiving this device can ambulate safely at 1 hour compared with patients receiving traditional manual pressure and bed rest after sheath removal for diagnostic cardiac catheterization. Patients (n = 304) were randomized to either the device group (n = 202) with ambulation at 1 hour after sheath removal or to the manual pressure control group (n = 102) with ambulation at 4 to 6 hours after sheath removal. The device group achieved earlier time to hemostasis (0.9 +/- 3 vs 17.0 +/- 8 minutes, p = 0.0001) and faster time to outpatient discharge (5.0 +/- 4 vs 7.7 +/- 4 hours, p = 0.0001) compared with the control group. There were bleeding or vascular complications in 19 patients (9%) in the device group and in 6 patients (6%) in the manual pressure group (p = 0.397). In patients undergoing diagnostic coronary angiography, this device, compared with traditional techniques for achieving hemostasis after sheath removal, allows for faster time to effective hemostasis with resultant earlier discharge from the hospital.
No preview · Article · Mar 1998 · The American Journal of Cardiology
[Show abstract][Hide abstract] ABSTRACT: A collagen hemostatic puncture closure device has been developed as an alternative to traditional manual pressure techniques for achieving effective femoral arterial hemostasis after coronary angiography. The purpose of the current study was to determine if patients receiving this device can ambulate safely at 1 hour compared with patients receiving traditional manual pressure and bed rest after sheath removal for diagnostic cardiac catheterization. Patients (n = 304) were randomized to either the device group (n = 202) with ambulation at 1 hour after sheath removal or to the manual pressure control group (n = 102) with ambulation at 4 to 6 hours after sheath removal. The device group achieved earlier time to hemostasis (0.9 ± 3 vs 17.0 ± 8 minutes, p = 0.0001) and faster time to outpatient discharge (5.0 ± 4 vs 7.7 ± 4 hours, p = 0.0001) compared with the control group. There were bleeding or vascular complications in 19 patients (9%) in the device group and in 6 patients (6%) in the manual pressure group (p = 0.397). In patients undergoing diagnostic coronary angiography, this device, compared with traditional techniques for achieving hemostasis after sheath removal, allows for faster time to effective hemostasis with resultant earlier discharge from the hospital.
[Show abstract][Hide abstract] ABSTRACT: Clinical studies have demonstrated the efficacy of intravenous administration of agents that block platelet glycoprotein IIb/IIIa receptors in the setting of percutaneous coronary revascularization. Although the optimal duration of treatment has not been determined, more prolonged receptor blockade has been associated with increased efficacy. Orally active glycoprotein IIb/IIIa receptor antagonists may be advantageous and required for chronic therapy.
Thirty patients with unstable angina who were undergoing percutaneous coronary interventions were randomized to placebo or Xemilofiban 35 mg orally before and 20 to 25 mg TID for 30 days after angioplasty. Bleeding events, platelet aggregation, and pharmacokinetic and hematologic parameters were assessed during hospitalization and at 2 and 4 weeks after drug initiation. Xemilofiban produced a rapid, sustained, marked inhibition of platelet aggregation. ADP-induced platelet aggregation at 2 hours after the initial dose at 2 and 4 weeks was 15%, 8%, and 11% in the Xemilofiban group compared with 80%, 68%, and 69% in the placebo group. Among 20 patients randomized to Xemilofiban there was 1 death after emergency coronary bypass surgery complicated by severe bleeding diathesis, and 3 patients had major bleeding events. Patients on Xemilofiban for 30 days reported episodes of mild mucocutaneous bleeding.
Xemilofiban, an orally active glycoprotein IIb/ IIIa receptor inhibitor, produced rapid, sustained, extensive inhibition of platelet aggregation for a period of up to 30 days. At the dose initially tested, however, acute major bleeding and mucocutaneous bleeding during chronic administration were encountered.
[Show abstract][Hide abstract] ABSTRACT: In summary, the occurrence of angina or myocardial infarction within 1 year after coronary bypass is associated with a high incidence of significant angiographic abnormalities. Early angiography is necessary to identify high-risk patients who could undergo revascularization. Patients with other markers of ischemia should have a noninvasive approach (stress imaging test) as initial evaluation, before coronary angiography is considered. When technically feasible, coronary angioplasty can be performed safely and with a high success rate. Repeat coronary bypass in this group of patients is associated with higher in-hospital complications. Patients with less compromised coronary anatomy can be treated medically with a good long-term outcome.
No preview · Article · Dec 1995 · The American Journal of Cardiology
[Show abstract][Hide abstract] ABSTRACT: Objectives.This study sought to evaluate the short-term results and long-term outcome of percutaneous revascularization of ostial saphenous vein graft stenoses in a large patient series.Background.Previous studies have demonstrated that the results of balloon angioplasty for native coronary ostial stenoses are significantly worse than those for nonostial lesions. However, it is controversial whether interventions in patients with ostial saphenous vein grafts carry a similar prognosis.Methods.We identified 68 consecutive patients with ostial (group I) and 72 consecutive patients with proximal, nonostial (group II) saphenous vein graft stenoses who underwent percutaneous angioplasty or directional atherectomy for a single new stenosis at the Cleveland Clinic between 1986 and 1992.Results.Success was achieved in 61 patients (89.7%) in group I and 64 (88.9%) in group II (p = 0.88). There were no differences in major procedural complications (death, Q wave infarction and bypass surgery) between the two groups. At a mean (±SD) follow-up of 23 ± 17 months, 36 patients (64%) in group I had one or more adverse events (death, infarction, repeat coronary revascularization or cardiac-related hospital admission) compared with 34 patients (58%) in group II (p = 0.87). Twenty-eight patients (50%) were angina free in group I compared with 33 (56%) in group II (p = 0.65). During the follow-up period in group I, 7 patients died (13%), 10 had a myocardial infarction (18%), 11 had repeat bypass surgery (20%), 8 had repeat percutaneous interventions (14%), and 30 had one or more cardiac-related hospital admissions (54%). The incidence of these events was similar in group II except for a slightly higher incidence of myocardial infarction: 6 patients died (10%), 3 had a myocardial infarction (5%), 12 had repeat bypass surgery (20%), 12 had repeat percutaneous interventions (20%), and 26 had one or more cardiac-related hospital admissions (44%).Conclusions.Unlike ostial native coronary disease, the clinical, procedural and follow-up profile of ostial saphenous vein graft revascularization is not significantly worse than proximal nonostial disease. This finding may be related to the overall suboptimal results of percutaneous revascularization in saphenous vein grafts compared with native coronary arteries or to the unfavorable intrinsic properties of ostial native coronary arteries compared with ostial vein grafts.
Full-text · Article · Nov 1995 · Journal of the American College of Cardiology
[Show abstract][Hide abstract] ABSTRACT: Cardiogenic shock remains a frequently lethal complication of acute myocardial infarction. Early revascularization of the infarct-related artery by coronary angioplasty has been suggested to significantly improve patient survival. In-hospital and 1-year survival was assessed in 50 patients hospitalized for acute myocardial infarction complicated by cardiogenic shock. All patients received medical treatment and intraaortic balloon pump support. Thirty-three patients underwent coronary angioplasty (PTCA group), while 17 patients remained on conventional therapy (no PTCA group). The two groups were comparable for all baseline characteristics. Survival was significantly better in the PTCA group than in the no PTCA group: 64% versus 24% in-hospital survival (p = 0.007) and 52% versus 12% at 1 year (p = 0.006). When angioplasty was successful in achieving reperfusion, survival was further enhanced: in-hospital survival rate was 76% versus 25% in patients with unsuccessful angioplasty and 60% versus 25% at 1 year.
No preview · Article · Oct 1995 · American Heart Journal
[Show abstract][Hide abstract] ABSTRACT: Objectives. To determine whether excision of complex, ulcerated plaque improves the risk of patients with unstable angina to the level of those with stable angina, the results of directional coronary atherectomy were compared in patients with these two syndromes.Background. The procedural results of angioplasty in the setting of unstable angina are not as favorable as those observed for chronic stable angina, presumably because thrombus-associated plaque augments the risk of abrupt closure.Methods. Two hundred eighty-seven consecutive patients who had undergone directional atherectomy for a single new stenosis were studied. Seventy-seven patients had stable angina (Group I); 110 patients had progressively worsening angina hi the absence of rest or postinfarction angina (Group II); and 100 patients had rest or postinfarction angina, or both (Group III).Results. Major behende complications (death, Q wave infarction, emergency bypass surgery) occurred more frequently in Group m (1.3% [Group I] vs. 0.9% [Group II] vs. 7% (Group III], p = 0.036). This difference was largely due to a higher incidence of emergency surgery in Group III (1.3% [Group I] vs. 0% [Group II] vs. 5% [Group III], p = 0.05). Clinical follow-up was obtained in 97% of successful procedures for a mean followup period of 22 months (range 9 to 52) and revealed a higher incidence of hospital admission for angina (p = 0.05) and a trend toward more bypass surgery (p = 0.09) and myocardial infarction (p = 0.16) in Group III. There was no difference in repeat percutaneous interventions among the three groups (range 19% to 24%, p = 0.75).Conclusions. These results show that the definition of unstable angina is important in determining the immediate outcome of directional atherectomy. In the absence of rest or postinfarction angina, the immediate results are not significantly different from those obtained in stable angina. Our results also suggest that both the immediate and short-term outcome in unstable angina are not greatly influenced by atherectomy but more so by the pathophysiology of unstable angina, which increases the complications of percutaneous interventions.
Full-text · Article · Aug 1994 · Journal of the American College of Cardiology
[Show abstract][Hide abstract] ABSTRACT: We attempted to develop a statistical model to facilitate risk stratification for long-term outcome after elective coronary angioplasty.
Our understanding of factors related to long-term outcome after coronary angioplasty is limited. Adequate assessment of risk indexes could potentially lead to more appropriate use of percutaneous revascularization.
We studied 5,000 consecutive patients and assessed 19 clinical and anatomic variables as predictors of long-term event-free survival. Events were defined as death of any cause, myocardial infarction, bypass surgery or repeat percutaneous transluminal coronary angioplasty. Cox proportional hazards models were used to develop an equation for predicting event-free survival in a subset of 4,000 patients. The equation was validated with the remaining 1,000 patients. Variables that were significantly associated with an adverse outcome in the multivariate model included age > 60 years, extent of disease, Canadian Cardiovascular Society functional class, previous coronary angioplasty, male gender, history of diabetes mellitus, history of hypertension and history of congestive heart failure.
The statistical model was used to develop a simplified scoring system, and the patients were assigned to three risk subgroups. Event-free survival curves for the three groups were significantly different (p = 0.0001). High risk patients had worse outcomes for each of the end points compared with low and moderate risk patients (p < 0.02).
We demonstrated that clinical and anatomic variables can be used to risk-stratify long-term outcome after angioplasty, that a simplified scoring system can be used for risk stratification and that high risk patients have a low event-free survival.
Preview · Article · Jul 1994 · Journal of the American College of Cardiology
[Show abstract][Hide abstract] ABSTRACT: The in-hospital cost for 126 consecutive patients undergoing 1-vessel, single-lesion coronary atherectomy (atherectomy group) beginning January 1, 1991, was reviewed (65 directional, 44 rotational, and 17 extractional atherectomies), and compared with the cost for 126 consecutive patients matched by sex and age who underwent 1-vessel, single-lesion standard balloon coronary angioplasty (angioplasty group). The in-hospital cost for each patient was determined using charges divided by a correction factor for each hospital department involved. Six different cost fields were created. The overall cost/charge ratio was 0.72. Angiographic and clinical success was 91% and 90% in the angioplasty group and 93% and 90% in the atherectomy group, respectively. Patients who underwent angioplasty required 1.3 +/- 0.6 devices/procedure, as compared with those who underwent atherectomy (2.4 +/- 1 devices/procedure) (p < 0.0001). The mean cost of angioplasty was $7,301 +/- $4,637 and of atherectomy devices $9,345 +/- $8,856 (28% increase). The difference was principally related to an increase in cost of supplies: angioplasty $2,028 +/- $1,196 versus atherectomy $3,632 +/- $1,525 (79% increase). There were no significant differences in hospitalization cost, procedure-room cost, and pharmacy and laboratory costs. Thus, higher risk morphologic lesions can be approached with new atherectomy devices with clinical and complication rates similar to coronary angioplasty. However, these results were obtained at a 28% increase in cost.
No preview · Article · Jul 1994 · The American Journal of Cardiology
[Show abstract][Hide abstract] ABSTRACT: To determine if differences in early and late outcome after angioplasty were related to gender or body surface area, 5,000 consecutive patients (1,274 women and 3,726 men) were studied. Baseline variables, procedural outcome, and long-term and event-free survival were assessed. Baseline variables included age, history of hypertension, diabetes mellitus, heart failure, myocardial infarction, prior angioplasty or bypass surgery, familial coronary disease, Canadian heart classification, extent of angioplasty, left ventricular function, and body surface area. Overall and event-free survival (freedom from infarction, repeat angioplasty, bypass surgery and death) were assessed at follow-up. The results showed that, compared with men, women were older (p < 0.0001), had a higher prevalence of diabetes (p < 0.0001), familial coronary disease (p = 0.002), hypertension (p < 0.0001), prior infarction (p = 0.004), and more involvement of the anterior descending artery (p = 0.017). Whereas men had similar extents of angioplasty and worse left ventricular function (p = 0.012), women more often had unstable angina (p < 0.0001). The success rates were similar, yet women had a higher procedural mortality (1.1% women, 0.3% men, p = 0.001). When corrected for body surface area, however, women were at no greater risk than men. Follow-up was complete for 97.4% of patients (mean 4 +/- 2 years). Event-free survival was significantly better in women, even after correcting for body surface area. Men were at higher risk for late death and repeat angioplasty on follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)
No preview · Article · Jul 1994 · The American Journal of Cardiology
[Show abstract][Hide abstract] ABSTRACT: Patients with significant coronary artery disease are at increased risk for myocardial infarction and death when undergoing major noncardiac surgery, particularly vascular, thoracic and upper abdominal procedures. Revascularization with coronary bypass surgery has shown to be effective in reducing perioperative coronary events in such patients. Little data is available on the role of preoperative coronary angioplasty in this setting. The objective of this study was to determine the perioperative cardiac outcome in patients undergoing coronary angioplasty within six weeks of major noncardiac surgery. We analyzed our experience with 108 consecutive patients (85 males) with a mean age of 68 years (range 41-83) who underwent coronary angioplasty within 42 days of a major operative procedure, which was defined as either a vascular, thoracic or upper abdominal procedure. Multivessel disease was present in 48% of patients. Angioplasty success rate was 97% with 33 (31%) patients having more than one lesion dilated. Angioplasty complications included 1 stroke and 4 non-Q wave myocardial infarctions. The mean time from angioplasty to operative procedure was 14.5 days (range 0-41 days). Ninety six (91%) of the patients underwent vascular surgery--including 42 abdominal aneurysm repairs, 29 carotid endarterectomies, 21 lower extremity bypass operations and four renal artery bypass procedures. Eight patients had major abdominal surgery and one patient had a thoracic procedure. Postoperative cardiac complications included three non-Q wave myocardial infarctions and one Q-wave myocardial infarction which resulted in the only cardiac death (0.9%). There were no sustained ventricular arrhythmias.(ABSTRACT TRUNCATED AT 250 WORDS)
No preview · Article · Jul 1993 · The Journal of invasive cardiology
[Show abstract][Hide abstract] ABSTRACT: The optimal level of heparin anticoagulation for elective PTCA is unknown. To determine if PTCA complications are related to the level of anticoagulation, serial ACT values were prospectively measured in 189 patients undergoing 201 elective PTCA procedures. The mean heparin dose before balloon inflation (pre-inflation) was 10,100 units, and the mean dose per procedure was 13,200 units. The mean pre-inflation ACT was 295 sec, but was < 300 sec in more than 50% of patients. Acute complications were not related to any ACT parameter and the development of new intracoronary thrombus was not observed. In elective PTCA procedures, the routine monitoring of ACT values is unnecessary when standard heparin doses are used.
No preview · Article · Apr 1993 · Catheterization and Cardiovascular Diagnosis
[Show abstract][Hide abstract] ABSTRACT: To determine the efficacy of multivessel coronary angioplasty, 569 consecutive patients undergoing multivessel angioplasty were compared with 569 age- and sex-matched control patients undergoing single-vessel angioplasty. Baseline variables were similar except for number of diseased vessels and greater left ventricular dysfunction in the multivessel group. Major in-hospital complication rates (death, 0% vs 0.5%; Q wave myocardial infarction, 0.5% vs 0.9%; emergency bypass surgery, 2.5% vs 3.2%) were similar for multivessel and single-vessel angioplasty. The 5-year actuarial survival rate was 93% for multivessel angioplasty and 92% for single-vessel angioplasty. Event-free survival was similar except that patients undergoing multivessel angioplasty had an 8% higher incidence of repeat coronary angioplasty in the first year of follow-up (p = 0.03). Multivessel coronary angioplasty can be performed with results comparable to those of single-vessel angioplasty with the exception of a higher incidence of repeat angioplasty.
No preview · Article · Aug 1992 · American Heart Journal
[Show abstract][Hide abstract] ABSTRACT: Repeat coronary angioplasty has become the standard approach to a first restenosis. However, the long-term outcome of such a strategy is not well defined. In the present study, 465 patients (mean age 58 years [range 27 to 79], 53% with multivessel disease) underwent a second angioplasty procedure at the same site. The procedure was successful in 96.8% with a 1.5% rate of in-hospital bypass surgery, a 0.9% incidence rate of myocardial infarction and no procedural deaths. Four hundred sixty-three patients (99.6%) were followed up for a mean of 40.5 months. Forty-nine patients (10.6%) underwent a third angioplasty procedure at the same site, 55 (11.8%) had coronary bypass surgery and 33 (7.1%) underwent angioplasty at a different site. During follow-up, 12 patients (2.6%) sustained a myocardial infarction and 21 (4.5%) died including 13 (2.8%) with cardiac death. Of the 442 surviving patients, 88% experienced sustained functional improvement and 78% were free of angina. The actuarial 5-year cardiac survival rate was 96% and the rate of freedom from cardiac death and myocardial infarction was 92%.
Full-text · Article · Jun 1992 · Journal of the American College of Cardiology
[Show abstract][Hide abstract] ABSTRACT: The influence of coronary artery stenoses on patient survival and event-free survival is known, but no studies have reported the long-term outcome of patients with stenoses in saphenous vein bypass grafts. We retrospectively studied 723 patients who underwent a postoperative angiographic study that documented a stenosis of 20% to 99% in at least one saphenous vein graft and who did not undergo reoperation or percutaneous transluminal coronary angioplasty within 1 year after that catheterization. The mean follow-up interval was 83 months (range 1 to 237 months). For comparison, a group of 573 patients who underwent a postoperative catheterization that did not show any vein graft stenosis were also followed up. Cox regression analyses were used to identify predictors of late survival, reoperation-free survival, and event-free survival. For the entire group of patients with stenotic vein grafts, moderate or severe impairment of left ventricular function (p less than 0.001), interval between operation and catheterization (p less than 0.001), older age (p = 0.001), triple-vessel or left main coronary artery disease (p = 0.004), and stenosis of the vein graft to the left anterior descending coronary artery (p = 0.09) were associated with decreased late survival. Patients with an operation-to-catheterization interval greater than or equal to 5 years were at particularly high risk, and multivariate analyses of that subgroup confirmed that a stenotic graft to the left anterior descending artery was a strong predictor of decreased survival (p less than 0.001), decreased reoperation-free survival (p less than 0.001), and decreased event-free survival (p less than 0.001). Patients greater than or equal to 5 years postoperatively with greater than or equal to 50% stenosis of vein grafts to the left anterior descending artery had survival of 70% and 50% at 2 and 5 years after catheterization, compared with 97% and 80% for those with greater than or equal to 50% stenosis of the native left anterior descending artery (p = 0.002). Late vein graft stenoses are more dangerous than native coronary stenoses. Late stenoses in saphenous vein grafts to the left anterior descending coronary artery predict a high rate of death and cardiac events and are an indication for reoperation.
No preview · Article · Jun 1992 · Journal of Thoracic and Cardiovascular Surgery