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Biomedical subjects

S G Ellis

Publications and source records attributed to S G Ellis.

At least 127 records · Page 7Linked to original sources
PubMed1995

Percutaneous revascularization of ostial saphenous vein graft stenoses.

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.

Angioplasty, Balloon, Coronary↗
PubMed1995

A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice.

BACKGROUND: Animal experiments and epidemiological studies have suggested that coronary disease could be prevented, arrested, or even reversed by maintaining total serum cholesterol levels below 150 mg/dL (3.88 mmol/L). In 1985, we began to study how effective one physician could be in helping patients achieve this cholesterol level and what the associated effect of achieving and maintaining this cholesterol level has on coronary disease. METHODS: The study included 22 patients with angiographically documented, severe coronary artery disease that was not immediately life threatening. These patients took cholesterol-lowering drugs and followed a diet that derived no more than 10% of its calories from fat. Disease progression was measured by coronary angiography and quantified with the percent diameter stenosis and minimal lumen diameter methods. Serum cholesterol was measured biweekly for 5 years and monthly thereafter. RESULTS: Of the 22 participants, 5 dropped out within 2 years, and 17 maintained the diet, 11 of whom completed a mean of 5.5 years of follow-up. All 11 of these participants reduced their cholesterol level from a mean baseline of 246 mg/dL (6.36 mmol/L) to below 150 mg/dL (3.88 mmol/L). Lesion analysis by percent stenosis showed that of 25 lesions, 11 regressed and 14 remained stable. Mean arterial stenosis decreased from 53.4% to 46.2% (estimated decrease = 7%; 95% confidence interval [CI], 3.3 to 10.7, P < .05). Analysis by minimal lumen diameter of 25 lesions found that 6 regressed, 14 remained stable, and 5 progressed. Mean lumen diameter increased from 1.3 mm to 1.4 mm (estimated increase = 0.08 mm; 95% CI, -0.06 to 0.22, P = NS). Disease was clinically arrested in all 11 participants, and none had new infarctions. Among the 11 remaining patients after 10 years, six continued the diet and had no further coronary events, whereas the five dropouts who resumed their prestudy diet reported 10 coronary events. CONCLUSIONS: A physician can influence patients in the decision to adopt a very low-fat diet that, combined with lipid-lowering drugs, can reduce cholesterol levels to below 150 mg/dL and uniformly result in the arrest or reversal of coronary artery disease.

Adult↗
PubMed1995

Mucous retention cyst of the soft palate: a case presentation.

This article describes a mucous retention cyst of the soft palate associated with an over-extended complete maxillary denture. The clinical and anatomical relevance of the fovea palatinae are discussed with respect to the posterior palatal seal and post-dam positioning.

Aged↗
PubMed1994

Long-term angiographic and clinical outcome after implantation of a balloon-expandable stent in the native coronary circulation. Palmaz-Schatz Stent Study Group.

OBJECTIVES: The purpose of this study was to examine the long-term clinical and angiographic outcome after coronary stent implantation. BACKGROUND: Previous reports have shown a discordance between the excellent initial angiographic results and subsequent adverse clinical events after coronary artery stenting. METHODS: Single Palmaz-Schatz stents were electively implanted in the native coronary arteries of 300 consecutive patients. Angiograms were obtained at baseline, after balloon angioplasty, after stent implantation and at 6 months after implantation. Films were analyzed by a panel of angiographers utilizing an automated edge detection program. Clinical events, including death, myocardial infarction, coronary bypass surgery and repeat angioplasty, were recorded for 1 year. RESULTS: Although there were no acute in laboratory vessel closures, stent thrombosis occurred in 14 patients (4.7%) at a mean +/- SD of 5 +/- 3 days after implantation. Two hundred fifty-eight (90%) of 286 eligible patients had follow-up angiography at 6.1 +/- 2.2 months after stent implantation. Minimal lumen diameter increased from 0.80 +/- 0.39 mm at baseline to 1.65 +/- 0.51 mm after angioplasty and further increased to 2.55 +/- 0.49 mm after stent placement (p = 0.0001). At follow-up there was a 0.85-mm late loss in lumen diameter, with a final minimal lumen diameter at 6 months of 1.70 +/- 0.71 mm. Restenosis, defined as > or = 50% diameter stenosis at follow-up, occurred in 14% of patients with previously untreated lesions and in 39% of patients with previous angioplasty (p < 0.001). Clinical events after 1 year for the entire group of 300 patients included death in 0.7%, myocardial infarction in 3.7%, bypass grafting in 8% and repeat angioplasty in 13%. Freedom from any adverse clinical event was 80% for all treated patients and 87% for those with previously untreated lesions. CONCLUSIONS: Elective use of this balloon-expandable stent in the native coronary circulation is associated with a low restenosis rate by quantitative angiography in previously untreated lesions and a favorable clinical outcome with an excellent event-free survival rate at 1 year.

Angioplasty, Balloon, Coronary↗
PubMed1994

Randomised trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at six months. The EPIC Investigators.

Restenosis after coronary angioplasty occurs in at least 30% of patients in the first six months and, as yet, there is no known treatment to decrease this event. We tested a monoclonal antibody Fab fragment (c7E3) directed against the platelet glycoprotein IIb/IIIa integrin, the receptor mediating the final common pathway of platelet aggregation, to see whether it reduced the frequency of clinical restenosis. Patients who had unstable angina, recent or evolving myocardial infarction, or high-risk angiographic morphology, were randomised to receive c7E3 bolus and a 12 hour infusion of c7E3 (708 patients), c7E3 bolus and placebo infusion (695 patients), or placebo bolus and placebo infusion (696 patients). With maintenance of the double-blind state, patients were followed-up for at least 6 months to determine the need for repeat angioplasty or surgical coronary revascularisation and the occurrence of ischaemic events. By 30 days, 12.8% of placebo bolus/placebo infusion patients had had a major ischaemic event (death, myocardial infarction, urgent revascularisation), compared with 8.3% of c7E3 bolus/c7E3 infusion patients, yielding a 4.5% difference (35% reduction, p = 0.008). At 6 months, the absolute difference in patients with major ischaemic event or elective revascularisation was 8.1% between placebo bolus/placebo infusion and c7E3 bolus/c7E3 infusion patients (35.1% vs 27.0%; 23% reduction p = 0.001). The favourable long-term effect was mainly due to less need for bypass surgery or repeat angioplasty in patients with an initial successful procedure, since need for repeat target vessel revascularisation was 26% less for c7E3 bolus/c7E3 infusion than for placebo treatment (16.5% vs 22.3%; p = 0.007). The c7E3 bolus/placebo infusion group had an intermediate outcome which was not significantly better than that of the placebo bolus/placebo infusion group. These results extend the benefit of c7E3 bolus/c7E3 infusion from reducing abrupt closure and acute-phase adverse outcomes to a diminished need for subsequent coronary revascularisation procedures. Because this therapy carries a risk of bleeding complications and has been studied only in high-risk angioplasty patients, further evaluation is needed before it can be applied to other patient groups.

Angioplasty, Balloon, Coronary↗
PubMed1994

Comparison of three coronary stents: clinical and angiographic outcome after elective placement in 134 consecutive patients.

One hundred and thirty-four consecutive patients undergoing elective coronary stenting were studied to assess the relative performance of Palmaz-Schatz (PS), Gianturco-Roubin (GR), and Wiktor (W) stents. Eighty-six percent of patients underwent follow-up angiography. Initial and follow-up angiograms were assessed by a central angiographic core laboratory. Attempts were made to place 81 Palmaz-Schatz (PS) stents, 21 Gianturco-Roubin (GR), and 32 Wiktor (W) stents. PS stents were less frequently successfully deployed (88% PS vs. 100% GR vs. 97% W; P = 0.03). The final percent stenosis was greater with the GR stent (32% GR vs. 14% PS vs. 19% W; P < 0.001). The restenosis rate was lower in the PS group (PS 48.2% vs. GR 66.7% and W 68.4%; P = 0.044). After accounting for the effect of prior restenosis (P = 0.005) and saphenous vein site (P = 0.006) in multivariate testing, lesion severity at follow-up was still less with the Palmaz-Schatz stent (P = 0.037).

Aged↗
PubMed1994

Directional coronary atherectomy in unstable angina.

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 in the absence of rest or postinfarction angina (Group II); and 100 patients had rest or postinfarction angina, or both (Group III). RESULTS: Major ischemic complications (death, Q wave infarction, emergency bypass surgery) occurred more frequently in Group III (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 follow-up 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.

Analysis of Variance↗
PubMed1994

The role of angioplasty after successful thrombolysis for acute myocardial infarction.

Soon after the efficacy of thrombolytic agents in recanalizing totally occluded arteries in the setting of AMI was shown, angiographic studies revealed a residual high-grade stenosis in a majority of these patients. To improve clinical outcome further, the role of coronary angioplasty at varying time intervals after myocardial infarction has been examined. In all studies examining the role of immediate angioplasty, no definite advantage was observed with the invasive strategy. In one study, a higher mortality rate was observed in the invasive group, whereas all studies demonstrated a significant increase in the number of non-fatal ischemic adverse events after PTCA. Although differences in clinical outcomes were noted, no difference in left ventricular function, the primary endpoint of all three studies, was demonstrated. Similar results were obtained in the randomized trials of delayed (< 48 h) or late (> 48 h) angioplasty versus conservative management. The majority of these latter trials suffer from the lack of a true control arm, as many patients in the conservative arms undergo PTCA. Observational series in conservatively treated patients after thrombolysis suggest that the coronary plaque remains unstable for several weeks after myocardial infarction. Pacifying the unstable plaque either by medical therapies or by PTCA with adjunctive therapies may in the future be the way to improve outcome in the post-infarction period. In the acute phase, aortic counterpulsation has been found to reduce ischemic events after PTCA in a randomized trial [36].(ABSTRACT TRUNCATED AT 250 WORDS)

Angioplasty, Balloon, Coronary↗
PubMed1994

Randomized evaluation of coronary angioplasty for early TIMI 2 flow after thrombolytic therapy for the treatment of acute myocardial infarction: a new look at an old study. The Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) Study Group.

BACKGROUND: Patients who have suffered acute myocardial infarction (AMI) and have been treated with intravenous thrombolytic agents resulting in early 'patent' [Thrombolysis in Myocardial Infarction (TIMI) 2-3 flow grade] arteries have been shown not to benefit from early percutaneous transluminal coronary angioplasty (PTCA). Recent data, however, suggest that the clinical outcome of patients with early TIMI 2 flow is decidedly inferior to that of patients with TIMI 3 flow, raising the question whether early PTCA might be beneficial for patients with TIMI 2 flow. The clinical utility of PTCA for this particular subset of patients has never been assessed. METHODS: We analyzed left ventricular ejection fraction (LVEF) recovery by contrast ventriculography and clinical outcome in Thrombolysis and Angioplasty in Myocardial Infarction Phase I (TAMI-I) study patients with initial TIMI 2 flow grade, determined by blinded core laboratory analysis. RESULTS: No differences were observed between baseline demographic data for the 49 patients randomly assigned to undergo early PTCA compared with that from the 59 patients randomly assigned to receive early medical therapy. Patients were 56 +/- 11 years of age (mean +/- SD), 80% were men, the time from onset of chest pain to catheterization was 268 +/- 71 min, 42% had anterior AMI, and 42% had multivessel disease. Ninety minute baseline LVEF to prehospital discharge LVEF was minimally better in the group randomly assigned to undergo PTCA (51 +/- 12 to 52 +/- 11% versus 55 +/- 10 to 53 +/- 12%, P = 0.06). This contrasted with findings in patients with TIMI 3 flow grade at baseline, which showed a relative benefit for patients randomly assigned to receive early medical therapy (54 +/- 10 to 54 +/- 8% for PTCA, versus 55 +/- 10 to 58 +/- 8% for medical therapy, P = 0.01). Among patients with TIMI 2 flow grade there were no differences in in-hospital death or congestive heart failure (6.1 versus 1.7%, P = 0.25 and 18.4 versus 23.7%, P = 0.50, PTCA versus medical therapy, respectively). CONCLUSION: We conclude that (1) PTCA of infarct-related arteries with TIMI 2 flow grade may modestly improve recovery of left ventricular function, and (2) widespread application of PTCA in this setting should be deferred, pending demonstration that this benefit outweighs the risks of PTCA.

Aged↗
PubMed1994

Relation of clinical presentation, stenosis morphology, and operator technique to the procedural results of rotational atherectomy and rotational atherectomy-facilitated angioplasty.

BACKGROUND: Rotational atherectomy using the Rotablator has recently become available to treat coronary stenoses. This study was performed to determine the relation of patient characteristics, stenosis morphology, and operator technique to procedural outcome to gain insight into which patients might be best treated with this device. METHODS AND RESULTS: Four hundred stenoses from 316 patients randomly selected from the initial Rotablator experience at three major referral institutions were analyzed. Angiographic data were assessed at a central angiographic laboratory using standardized morphological criteria and caliper measurement. Patients were somewhat more elderly than most percutaneous transluminal coronary angioplasty (PTCA)-treated groups (mean age, 64 +/- 11 years), 74% were men, and the lesions treated were often complex (modified American College of Cardiology/American Heart Association lesion type A, 24%; B1, 40%; B2, 30%; and C, 6%). Elective adjunctive PTCA was used for 82% of stenoses treated. Procedural success was achieved in 89.8% of stenoses (93.5% if results with creatine kinase two to three times normal are not counted as failures), and major ischemic complications (death, 0.3%; non-Q-wave myocardial infarction, 5.7%; Q-wave myocardial infarction, 2.2%; or emergency bypass surgery, 0.9%) occurred in 8.9% of patients. Complications were due to epicardial coronary obstruction in 3.8% of patients and to delayed coronary runoff ("slow reflow") in 5.1% of patients. Procedural failure was correlated independently with outflow obstruction (success rate, 64%; odds ratio for failure, 5.4; multivariate P = .002), lesion irregularity (76%; odds ratio, 3.3; P = .003), stenosis bend > or = 60 degrees (73%; odds ratio, 3.7; P = .03), and female sex (84%; odds ratio, 2.4; P = .03). Ischemic complications were correlated independently with lesion length (> or = 50% narrowing) > or = 4 mm (complication rate, 12%; odds ratio, 3.6; multivariate P = .005), right coronary artery stenosis (13%; odds ratio, 2.4; P = .02), stenosis bend > or = 60 degrees (27%; odds ratio, 6.1; P = .03), and female sex (13%; odds ratio, 3.0; P = .04). Slow reflow was correlated with total burring duration (odds ratio, 1.005/s; multivariate P = .001), right coronary artery stenosis (incidence, 17%; odds ratio, 4.5; P = .009), and to a lesser extent with recent myocardial infarction in the treated territory (44%; odds ratio, 4.3; P = .08). CONCLUSIONS: The procedural outcome of rotational atherectomy is highly correlated with stenosis morphology and location and sex of the patient. After stratification for these parameters, overall outcome with the Rotablator appears to be similar to that with balloon angioplasty and other competing techniques. Short-term outcome with specific subsets of patients may be superior with the Rotablator (calcified stenoses), but this technique might best be avoided in some patients (those with irregular or possibly thrombus-containing stenoses, highly angulated stenoses, and possible right coronary artery stenoses or those associated with impaired distal runoff caused by a recent myocardial infarction or manifest by a fixed thallium defect).

Aged↗
PubMed1994

Major clinical events after coronary stenting. The multicenter registry of acute and elective Gianturco-Roubin stent placement. The Gianturco-Roubin Intracoronary Stent Investigator Group.

BACKGROUND: Abrupt vessel closure and early reocclusion remain the principal vascular events underlying early recurrent ischemia complicating elective percutaneous transluminal coronary angioplasty (PTCA). Intracoronary stenting has been used to circumvent emergency bypass surgery after acute vessel closure and as an adjunct for the elective treatment of restenosis. The initial multicenter experience with the Gianturco-Roubin stent is presented, and predictors for early recurrent ischemic events are identified. METHODS AND RESULTS: Data accrued from 639 serial patients undergoing emergency stenting for abrupt closure (n = 415; 65%) or elective deployment for restenosis (n = 224; 35%) from October 1989 through May 1991 were analyzed. The incidence of subsequent ischemic events, including death, nonfatal myocardial infarction, and bypass surgery referral within 90 days of the procedure, was higher after acute deployment (20%) compared with elective stenting (9%; P = .0004). Although mortality within the two cohorts was the same (3%; P = NS), there were significant differences in the incidence of nonfatal myocardial infarction (5% versus 0.5%; P = .002) and bypass surgery (12% versus 6%; P = .02) between the acutely and electively stented patients, respectively. These events were significantly more common when the stent was undersized to the target vessel diameter (stent:artery ratio for event, 0.95 +/- 0.14 versus no event, 1.04 +/- 0.22; P = .0001) or when there was less expansion of the lesion by the deployed device (stent-to-lesion diameter ratio for event, 6.6 +/- 9.2 versus no event, 11.0 +/- 21.4; P = .0001). In a stepwise logistic regression model, acute stenting (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.3 to 2.4), multivessel disease (OR, 1.4; CI, 1.1 to 1.8), larger target lesion diameter (OR, 2.1; CI, 1.4 to 3.2), larger target vessel (OR, 2.9; CI, 1.7 to 4.7), and smaller stent size (OR, 6.1; CI, 3.0 to 12.3) were independent predictors of early, recurrent ischemic events. The presence of thrombus was associated with a higher event rate after elective stenting (OR, 2.3; CI, 1.06 to 5.4) but was not associated with a higher early event rate after acute stenting. CONCLUSIONS: Early ischemic events are more common after acute stenting for abrupt or threatened closure than after elective deployment. These events may be avoided with careful attention to morphometric characteristics to avoid undersizing the stent to the target vessel and ensure adequate lesion expansion.

Angioplasty, Balloon, Coronary↗
PubMed1994

Pharmacodynamics of chimeric glycoprotein IIb/IIIa integrin antiplatelet antibody Fab 7E3 in high-risk coronary angioplasty.

BACKGROUND: Thrombosis has been implicated as central to the clinical complications of coronary angioplasty (PTCA). Chimeric monoclonal 7E3 Fab (c7E3 Fab) is the first of a new class of antiplatelet drugs directed at the platelet glycoprotein IIb/IIIa integrin. This study was performed to determine the pharmacodynamics of c7E3 Fab administration during PTCA and to gain an initial clinical experience with this novel agent. METHODS AND RESULTS: The study was a multicenter, open-label, dose-escalation study conducted in two stages. Enrollment included 56 patients scheduled for elective PTCA who were estimated to be at moderate to high risk of sustaining ischemic complications. All patients were given aspirin and heparin. The study drug was given at least 10 minutes before PTCA. In stage 1, increasing bolus doses of c7E3 Fab were given to 15 patients; a bolus dose of 0.25 mg/kg was found to result in blockade of > 80% of the receptors and reduce platelet aggregation to < 20% compared with baseline, establishing this dose as that necessary to sufficiently suppress platelet activity. In stage 2, additional c7E3 Fab was administered by continuous infusion to 32 patients for progressively longer periods of time (up to 24 hours) to confirm that platelet inhibition could be maintained with prolonged drug infusion. Also, 9 patients otherwise meeting entry criteria were given placebo. There were no thrombotic events among patients receiving c7E3 Fab. Overall procedural and clinical success and complication rates as well as rates of bleeding were statistically similar among groups. However, minor bleeding was more frequent with administration of the active drug. CONCLUSIONS: The novel antiplatelet agent c7E3 Fab can be administered during PTCA in combination with aspirin and heparin. Suppression of platelet activity is dose dependent and can be maintained for up to 24 hours. Further evaluation will be required to determine the extent of improvement in ischemic complication and restenosis rates and to provide additional insight into the safety profile of this potent monoclonal platelet antibody.

Abciximab↗
PubMed1994

Randomized comparison of rescue angioplasty with conservative management of patients with early failure of thrombolysis for acute anterior myocardial infarction.

BACKGROUND: When used in the setting of acute myocardial infarction, intravenous thrombolytic agents fail to achieve early infarct artery patency in 15% to 50% of patients. We tested the hypothesis that immediate balloon angioplasty applied to patients with failed early reperfusion would improve left ventricular function and clinical outcome at 30 days compared with conservative management alone. METHODS AND RESULTS: One hundred fifty-one patients with first anterior wall infarction treated with any accepted intravenous thrombolytic regimen and angiographically demonstrated to have an occluded infarct vessel within 8 hours of chest pain onset were randomized to aspirin, heparin, and coronary vasodilators (conservative therapy) or to this therapy and balloon angioplasty supplemented by further thrombolytic therapy as needed. Left ventricular function was assessed using multiple-gated equilibrium radionuclide technique to determine ejection fraction, and adverse clinical outcome was assessed evaluating death, ventricular tachycardia, and class III or IV heart failure at 30 days. Seventy-three patients were randomized to conservative therapy and 78 to angioplasty. The two groups were well balanced for patient age (59 +/- 11 years), sex (82% were male), and time to randomization (4.5 +/- 1.9 hours). Angioplasty was technically successful in 72 of 78 randomized patients (92%). Two patients randomized to conservative therapy crossed over to angioplasty within 72 hours. Resting 30-day ejection fraction was 40 +/- 11% in the angioplasty group and 39 +/- 12% in the conservative group (P = .49), but ejection fraction with exercise was 43 +/- 15% and 38 +/- 13% for the angioplasty and conservatively treated groups, respectively (P = .04). Adverse clinical outcomes included death in 5% and 10% (P = .18), severe heart failure in 1% and 7% (P = .11), and either death or severe heart failure in 6% and 17% (P = .05) of the angioplasty and conservatively managed groups, respectively. CONCLUSIONS: When applied to patients with first anterior infarction, rescue angioplasty appears to be useful in the prevention of death or severe heart failure, with improvement in exercise, but not resting, ejection fraction. This strategy deserves further study and highlights the potential advantage of early mechanical restoration of infarct vessel patency when thrombolytic therapy has failed.

Aged↗
PubMed1994

Increased coronary perforation in the new device era. Incidence, classification, management, and outcome.

BACKGROUND: The incidence of coronary perforation using new percutaneous revascularization techniques may be increased compared with PTCA. Still, perforation is uncommonly reported, and the optimal management and expected outcome remain unknown. The objectives of the study were to determine the incidence of coronary perforation using balloon angioplasty (percutaneous transluminal coronary angioplasty, PTCA) and new revascularization techniques and to develop optimal strategies for its management based on classification and outcome. METHODS AND RESULTS: Eleven sites with frequent use of new revascularization devices and prospective coding of consecutive procedures for coronary perforation during 1990 to 1991 contributed to a perforation registry. Patients with perforation were matched by device with an equal-sized cohort without perforation. Data were collected centrally, and all procedural cineangiograms were reviewed at a core angiographic laboratory. A classification scheme based on angiographic appearance of the perforation (I, extraluminal crater without extravasation; II, pericardial or myocardial blushing; III, perforation > or = 1-mm diameter with contrast streaming; and cavity spilling) was evaluated as a predictor of outcome and as a basis for management. Perforation was observed in 62 of 12,900 procedures reported (0.5%; 95% confidence interval, 0.4% to 0.6%), more commonly with devices intended to remove or ablate tissue (atherectomy, laser) than with PTCA (1.3%, 0.9% to 1.6% versus 0.1%, 0.1% to 0.1%; P < .001). The perforation population was notable for its advanced age (67 +/- 10 years) and high incidence of female sex (46%) (both P < .001 compared with patients without perforation). Perforation could be treated expectantly or with PTCA but without cardiac surgery in 85%, 90%, and 44% of class I, II, and III perforations, respectively. Class I perforations (n = 13, 21%) were associated with death in none, myocardial infarction in none, and tamponade in 8%. The incidences of these adverse events were 0%, 14%, and 13% in class II perforations (n = 31, 50%) and 19%, 50%, and 63% in non-cavity spilling class III perforations, respectively (n = 16, 26%). Two of the 15 instances of cardiac tamponade (13%) were delayed, occurring within 24 hours after dismissal from the catheterization laboratory. CONCLUSION: The incidence of perforation, while low, is increased with new devices. Women and the elderly are at highest risk. The clinical risk after perforation can be classified angiographically, but even low-risk perforations occasionally have poor clinical outcome. Patients should be observed for delayed cardiac tamponade for at least 24 hours.

Aged↗