Normal flow (TIMI-3) before mechanical reperfusion therapy is an independent determinant of survival in acute myocardial infarction: analysis from the primary angioplasty in myocardial infarction trials.

BACKGROUND: Whereas survival after lytic therapy for myocardial infarction is strongly dependent on early administration, it is unknown whether the otherwise excellent outcomes in patients undergoing primary PTCA for acute myocardial infarction, in whom TIMI-3 flow rates of >90% may be achieved, can be further improved by early reperfusion. METHODS AND RESULTS: Among 2507 patients enrolled in 4 PAMI trials undergoing primary PTCA, spontaneous reperfusion (TIMI-3 flow) was present in 16% at initial angiography. Compared with patients without TIMI-3 flow, those with TIMI-3 flow before PTCA had greater left ventricular ejection fraction (57+/-10% versus 53+/-11%, P=0.003) and were less likely to present in heart failure (7.0% versus 11.6%, P=0.009). Patients with initial TIMI-3 flow had significantly lower in-hospital rates of mortality, new-onset heart failure, and hypotension and had a shorter hospital stay. Cumulative 6-month mortality was 0.5% in patients with initial TIMI-3 flow, 2.8% with TIMI-2 flow, and 4.4% with initial TIMI-0/1 flow (P=0.009). By multivariate analysis, TIMI-3 flow before PTCA was an independent determinant of survival (odds ratio 2.1, P=0.04), even when corrected for by postprocedural TIMI-3 flow. CONCLUSIONS: Patients undergoing primary PTCA in whom TIMI-3 flow is present before angioplasty present with greater clinical and angiographic evidence of myocardial salvage, are less likely to develop complications related to left ventricular failure, and have improved early and late survival. These data warrant prospective randomized trials of pharmacological strategies to promote early reperfusion before definitive mechanical intervention in acute myocardial infarction.

Predictors of long-term survival after percutaneous aortic valvuloplasty: report of the Mansfield Scientific Balloon Aortic Valvuloplasty Registry.

Percutaneous balloon aortic valvuloplasty was used to prospectively treat 492 elderly, symptomatic, nonsurgical patients suffering from severe aortic stenosis in 27 centers in North America and Europe. At 1 year the overall survival rate was 64% and the event-free survival rate (survival free of valve replacement or repeat valvuloplasty) was 43%. Clinical, catheterization and procedural variables were assessed to define prognostic variables. Univariate analysis revealed that patients who survived had a lesser frequency of previous myocardial infarction (2% versus 6%, p less than 0.005), lower incidence of severe ventricular dysfunction (22% versus 48%, p less than 0.001) and lower incidence of symptoms of heart failure (60% versus 75%, p less than 0.02). History of angina (56% versus 45%, p = NS) and syncope (23% versus 16%, p = NS) were similar for both groups. Values obtained at cardiac catheterization that differed in survivors and nonsurvivors included lower pulmonary artery systolic pressure (43 +/- 1 versus 54 +/- 2 mm Hg, p less than 0.001), lower mean pulmonary artery pressure (28 +/- 1.0 versus 36 +/- 1.0 mm Hg, p less than 0.001) and larger initial valve area (0.52 +/- 0.01 versus 0.47 +/- 0.02 cm2, p = 0.006). Discriminate function analysis was performed to identify variables that independently predicted improved probability of survival. Eight variables were significantly and independently predictive. These included age, initial cardiac output, initial left ventricular systolic pressures, initial left ventricular end-diastolic pressures, presence of coronary artery disease, New York Heart Association dyspnea classification, number of balloon inflations and final valve area.(ABSTRACT TRUNCATED AT 250 WORDS)

Cardiologist versus internist management of patients with unstable angina: treatment patterns and outcomes.

OBJECTIVES: This study sought to assess the impact of generalist versus specialist direction on the pattern of care and outcome in patients admitted to the hospital for unstable angina. BACKGROUND: Physicians trained as internists or as cardiologists may have different approaches to treating patients with unstable angina. METHODS: We reviewed a prospectively collected cohort of patients discharged with a diagnosis-related group (DRG) diagnosis of unstable angina from William Beaumont Hospital, a large community-based hospital in southeast Michigan. Of 890 consecutive patients, 225 were treated by internists and 665 by cardiologists. We compared these two groups with respect to patterns of use of established pharmacotherapies for unstable angina, diagnostic testing and clinical outcome. RESULTS: Patients treated by internists less often had a previous cardiac history (53% vs. 80%, p < or = 0.0001). Internists were less likely to use aspirin (68% vs. 78%, p = 0.032), heparin (67% vs. 84%, p < or = 0.001) or beta-adrenergic blocking agents (18% vs. 30%, p < or = 0.004) in their initial management. Exercise tests were performed more frequently by internist-treated patients (37% vs. 22%, p < or = 0.001), but catheterization (27% vs. 61%, p < or = 0.0001) and angioplasty (7% vs. 40%, p < or = 0.0001) were utilized less frequently. The incidence of myocardial infarction was similar (11% vs. 9%) in the two groups, but the mortality rate tended to be higher (4.0% vs. 1.8%, p = 0.06) in the internist group. CONCLUSIONS: Patients with unstable angina treated by internists were less likely to receive effective medical therapy or revascularization procedures and experienced a trend to poorer outcome. This study does not support a positive gatekeeper role for generalists in the treatment of unstable angina.

Multicenter registry of angioplasty therapy of cardiogenic shock: initial and long-term survival.

This retrospective multicenter study reviews the role of acute percutaneous transluminal coronary angioplasty in the treatment of cardiogenic shock complicating acute myocardial infarction to determine whether early reperfusion affects in-hospital and long-term survival. From 1982 to 1985, 69 patients were treated with emergency angioplasty to attempt reperfusion of the infarct-related artery. Balloon angioplasty was unsuccessful in 20 patients (group 1) and successful in 49 patients (group 2). Initial clinical and angiographic findings in the groups with unsuccessful and successful angioplasty were similar with respect to age (60.5 +/- 2.3 versus 57 +/- 1.8 years), infarct location (65% versus 65% anterior) and gender (65% versus 67% male). Hemodynamic variables in the two groups, including systolic blood pressure (68 +/- 4.3 versus 73 +/- 1.6 mm Hg), left ventricular end-diastolic pressure (24.4 +/- 2.4 versus 27 +/- 1.0 mm Hg) and initial ejection fraction (28.5 +/- 4% versus 32 +/- 2%), were also similar. Twenty-nine patients received thrombolytic therapy with streptokinase; the overall rate of reperfusion was 34%. Group 1 patients had a short-term survival rate of 20%, compared with 69% in group 2 patients (p less than 0.0005). Thirty-eight patients survived the hospital period and were followed up for 24 to 54 months (mean 32.5 +/- 2.4). Five patients (all in group 2) died during follow-up. The long-term incidence rate of congestive heart failure was 19%, arrhythmia 21%, need for repeat angioplasty 17% and coronary artery bypass grafting 26%. Twenty-four month survival was significantly better in group 2 patients (54%) versus group 1 patients (11%, p = 0.003).(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term clinical outcome and predictors of major adverse cardiac events after percutaneous interventions on saphenous vein grafts.

OBJECTIVES: The purpose of this study was to examine the long-term clinical outcome after percutaneous intervention of saphenous vein grafts (SVG) and to identify the predictors of major adverse cardiac events (MACE). BACKGROUND: Percutaneous interventions of SVGs have been associated with more procedural complications and higher restenosis rates compared with interventions on native vessels. METHODS: From 1993 to 1997, 1,062 patients underwent percutaneous intervention on 1,142 SVG lesions. Procedural, in-hospital and long-term clinical outcomes were recorded in a database and analyzed. RESULTS: In-hospital MACE occurred in 137 patients (13%) including death (8%), Q-wave myocardial infarction (MI) (2%) and coronary artery bypass surgery (3%). Late MACE occurred in 565 patients (54%) including death (9%), Q-wave MI (9%) and target vessel revascularization (36%). Any MACE occurred in 457 (43%) patients. Follow-up was available in 1,056 (99%) patients at 3 +/- 1 year. Univariate predictors were restenotic lesion (odds ratio [OR]: 2.47, confidence interval [CI]: 1.13 to 3.85, p = 0.0003), unstable angina (OR: 1.99, CI: 1.27 to 2.91, p = 0.04) and congestive heart failure (CHF) (OR: 1.97, CI: 1.14 to 3.24, p = 0.02) for in-hospital MACE, and peripheral vascular disease (PVD) (OR: 2.18, CI: 1.34 to 3.44, p = 0.002), intra-aortic balloon pump placement (OR: 2.08, CI: 1.13 to 3.85, p = 0.02) and previous MI (OR: 1.97, CI: 1.14 to 3.25, p = 0.007) for late MACE. Independent multivariate predictors for late MACE were restenotic lesion (relative risk [RR] 1.33, p = 0.02), PVD (RR: 1.31, p = 0.01), CHF (RR: 1.42, p = 0.01) and multiple stents (RR: 1.47, p = 0.004). Angiographic follow-up was available for 422 patients. Angiographic restenosis occurred in 122 (29%) of stented SVGs and 181 (43%) of nonstented SVGs (p = 0.04). Stent implantation did not confer a survival benefit. CONCLUSIONS: Despite the use of new interventional devices, SVG interventions are associated with significant morbidity and mortality; SVG stenting is not associated with better three-year event-free survival. This may be due to progressive disease at nonstented sites.

Are residual stenoses after excimer laser angioplasty and coronary atherectomy due to inefficient or small devices? Comparison with balloon angioplasty.

OBJECTIVES: The purpose of this study was to determine whether residual stenoses after excimer laser angioplasty and atherectomy were due to inefficient tissue ablation/removal or to undersized devices. BACKGROUND: Significant residual stenoses are commonly observed after use of laser and atherectomy devices. It is not known whether these residual stenoses are due to inefficient or undersized devices. METHODS: To determine the relative contribution of these factors, the minimal lumen diameter, percent diameter stenosis and normal reference diameter were measured immediately before and after coronary interventions in 696 lesions, including transluminal extraction atherectomy, high speed mechanical rotational atherectomy, excimer laser angioplasty and conventional balloon angioplasty. The ratio of the diameter of the device to the normal reference diameter (D/A, a measure of device sizing) and the ratio of the residual lumen diameter after use of the device to the device diameter (RLD/D, a measure of the efficiency of lumen enlargement) were calculated. RESULTS: Baseline diameter stenoses were similar for all interventions. The percent diameter stenoses were greater immediately after extraction atherectomy (60 +/- 21%), rotational atherectomy (54 +/- 23%) and excimer laser angioplasty (61 +/- 18%) compared with balloon angioplasty (26 +/- 12%, p < 0.001). The D/A ratio was smaller after extraction atherectomy (0.63 +/- 0.14), rotational atherectomy (0.59 +/- 0.17) and excimer laser angioplasty (0.51 +/- 0.11) compared with balloon angioplasty (1.05 +/- 0.13, p < 0.001). The RLD/D ratio was similar after extraction atherectomy (0.73 +/- 0.24) and balloon angioplasty (0.71 +/- 0.11) but was greater after rotational atherectomy (0.92 +/- 0.16, p < 0.001) and excimer laser angioplasty (0.85 +/- 0.30, p < 0.01) compared with balloon angioplasty. CONCLUSIONS: Residual stenoses after extraction atherectomy, rotational atherectomy and excimer laser angioplasty were more severe than after balloon angioplasty but were due to undersized devices (low D/A ratio), not to inefficient devices (low RLD/D ratio). Rotational atherectomy and excimer laser angioplasty were more efficient (higher RLD/D) than balloon angioplasty, whereas extraction atherectomy and balloon angioplasty were similar.

Prophylactic versus standby cardiopulmonary support for high risk percutaneous transluminal coronary angioplasty.

OBJECTIVES: Data from a national registry of 23 centers using cardiopulmonary support (CPS) were analyzed to compare the risks and benefits of prophylactic CPS versus standby CPS for patients undergoing high risk coronary angioplasty. BACKGROUND: Early data from the CPS registry documented a high angioplasty success rate as well as a high procedural morbidity rate. Because of this increased morbidity some high risk patients were placed on standby CPS instead of prophylactic CPS. METHODS: Patients in the prophylactic CPS group had 18F or 20F venous and arterial cannulas inserted and cardiopulmonary bypass initiated. Patients in the standby CPS group were prepared for institution of cardiopulmonary bypass, but bypass was not actually initiated unless the patient sustained irreversible hemodynamic compromise. RESULTS: There were 389 patients in the prophylactic CPS group and 180 in the standby CPS group. The groups were comparable with respect to most baseline characteristics, except that left ventricular ejection fraction was lower in the prophylactic CPS group. Thirteen of the 180 patients in the standby CPS group sustained irreversible hemodynamic compromise during the angioplasty procedure. Emergency institution of CPS was successfully initiated in 12 of these 13 patients in < 5 min. Procedural success was 88.7% for the prophylactic and 84.4% for the standby CPS group (p = NS). Major complications did not differ between groups. However, 42% of patients in the prophylactic CPS group sustained femoral access site complications or required blood transfusions, compared with only 11.7% of patients in the standby CPS group (p < 0.01). Among patients with an ejection fraction < or = 20%, procedural morbidity remained significantly higher in the prophylactic CPS group (41% vs. 9.4%, p < 0.01), but procedural mortality was higher in the standby group (4.8% vs. 18.8%, p < 0.05). CONCLUSIONS: Patients in the standby and prophylactic CPS groups had comparable success and major complication rates, but procedural morbidity was higher in the prophylactic group. When required, standby CPS established immediate hemodynamic support during most angioplasty complications. For most patients, standby CPS was preferable to prophylactic CPS during high risk coronary angioplasty. However, patients with extremely depressed left ventricular function (ejection fraction < 20%) may benefit from institution of prophylactic CPS.

Effect of peripheral cardiopulmonary bypass on left ventricular size, afterload and myocardial function during elective supported coronary angioplasty.

Although cardiopulmonary bypass support has been increasingly used for high risk coronary angioplasty, few data exist regarding its effects on left ventricular function. Accordingly, in 20 patients changes in left ventricular size, afterload and myocardial function were assessed by continuous hemodynamic monitoring and simultaneous two-dimensional echocardiography during cardiopulmonary bypass-supported high risk angioplasty. The cross-sectional left ventricular area during bypass support remained unchanged during diastole, whereas during systole it decreased (from 29.6 +/- 11.4 to 27.6 +/- 10.4 cm2, p less than 0.05). Global left ventricular function expressed as fractional area change remained unchanged from baseline to bypass support but decreased during balloon inflation (from 0.27 +/- 0.11 to 0.17 +/- 0.09, p less than 0.001). The end-systolic meridional wall stress decreased during bypass support (from 141 +/- 75 to 110 +/- 58 x 10(3) dynes/cm2, p less than 0.02). Regional myocardial function was assessed by a wall motion score (0 = normal, 1 = hypokinesia, 2 = akinesia and 3 = dyskinesia). Regions supplied by a stenotic (greater than or equal to 50% diameter) vessel deteriorated during bypass support (score from 0.9 +/- 0.8 to 1.06 +/- 0.8, p less than 0.01), whereas regions supplied by a nonstenotic vessel did not. Regions supplied by the target vessel deteriorated further during balloon inflation (score from 0.7 +/- 0.6 to 1.7 +/- 0.75, p less than 0.001). Thus, although left ventricular size and global function remain unchanged and afterload decreases during bypass support, myocardial dysfunction in regions supplied by a stenotic vessel may occur. Furthermore, regional and global left ventricular dysfunction still occur with angioplasty balloon inflation during cardiopulmonary bypass support.

Detailed clinical and angiographic analysis of transluminal extraction coronary atherectomy for complex lesions in native coronary arteries.

OBJECTIVES: The purpose of this study was to describe the results of transluminal extraction coronary atherectomy in native coronary arteries. BACKGROUND: Transluminal extraction coronary atherectomy was approved by the Food and Drug Administration for use in native coronary arteries and vein grafts. METHODS: Between December 1988 and July 1992, transluminal extraction coronary atherectomy was performed in 181 native coronary arteries in 175 patients. A detailed angiographic and clinical assessment was performed. RESULTS: Quantitative angiography (mean +/- SD) revealed an increase in minimal lumen diameter from 1.0 +/- 0.6 mm before to 1.3 +/- 0.7 mm after atherectomy, to 2.1 +/- 0.8 mm after final treatment (p < 0.001), corresponding to a diameter stenosis of 70 +/- 16%, 61 +/- 21% and 36 +/- 21%, respectively (p < 0.001). Final procedural success (final diameter stenosis < 50%, no major complications) was achieved in 84%. Adjunctive angioplasty was used after atherectomy in 152 lesions (84%) to further enlarge lumen dimensions (130 lesions, 72%), salvage technical failures (2 lesions, 1%) and reverse atherectomy-induced abrupt closures (20 lesions, 11%). Clinical complications included death (2.3%), Q wave myocardial infarction (3.4%) and emergency bypass surgery (2.8%). The strongest independent correlate of major clinical complications was development of abrupt closure immediately after atherectomy (p = 0.01). Clinical follow-up of 92% of eligible patients revealed clinical restenosis (repeat intervention, late bypass surgery, myocardial infarction or death) in 28.5%. Angiographic follow-up of 83% of eligible lesions revealed a restenosis rate (diameter stenosis > 50%) of 61%. CONCLUSIONS: Transluminal extraction coronary atherectomy is limited by a modest degree of lumen enlargement, frequent need for adjunctive angioplasty and a high restenosis rate. For complex lesions in native coronary arteries, transluminal extraction coronary atherectomy appears to offer no advantage over conventional balloon angioplasty.

Comparative results of transluminal extraction coronary atherectomy in saphenous vein graft lesions with and without thrombus.

OBJECTIVES: The purpose of this retrospective study was to compare the results of transluminal extraction coronary atherectomy in saphenous vein graft lesions with and without angiographic thrombus. BACKGROUND: Percutaneous interventions in lesions with thrombus are associated with reduced procedural success and increased risk of complications. Use of the transluminal extraction catheter, which cuts and aspirates atheroma and thrombus, has been advocated as a potential revascularization strategy for lesions with thrombus. METHODS: Baseline patient characteristics, lesion morphology, immediate angiographic results, in-hospital complications and follow-up were prospectively entered into an interventional cardiology data base. The results of transluminal extraction coronary atherectomy in saphenous vein bypass grafts with angiographic thrombus were compared with results in similar grafts without angiographic thrombus. RESULTS: Transluminal extraction coronary atherectomy was performed in 175 patients with 183 vein graft lesions, including 59 lesions (32%) with thrombus (Group 1) and 124 (68%) without thrombus (Group 2). Compared with lesions in Group 2, lesions in Group 1 were associated with a higher incidence of baseline total occlusion, diffuse disease and abnormal Thrombolysis in Myocardial Infarction (TIMI) grade flow (p < 0.05); more severe diameter stenosis at baseline, after atherectomy and after final angiography (p < 0.05); a lower rate of clinical success (69% vs. 88%, p < 0.01); and more angiographic and clinical complications, including no reflow (p < 0.05), vascular repair (p < 0.05) and Q wave myocardial infarction (p = 0.09). CONCLUSIONS: In transluminal extraction coronary atherectomy of saphenous vein bypass grafts, the presence of thrombus is associated with more baseline lesion complexity, reduced clinical success and increased risk of no reflow, Q wave myocardial infarction and vascular repair.

Randomized prospective evaluation of prolonged versus abbreviated intravenous heparin therapy after coronary angioplasty.

OBJECTIVES: This study was designed to prospectively evaluate the routine use of continuous heparin therapy after successful uncomplicated coronary angioplasty. BACKGROUND: The use of such therapy varies among institutions and may increase the incidence of complications. Evaluation of the risks and benefits of abbreviated heparin therapy combined with early sheath removal after coronary angioplasty is necessary to determine optimal postprocedure care. METHODS: We prospectively studied 284 patients who were scheduled for elective coronary angioplasty. Historical, clinical, physiologic and angiographic data were gathered. All patients received an initial bolus of heparin and then were randomized during the procedure to receive either no additional heparin therapy or an adjusted 24-h infusion. On the basis of specific criteria, additional heparin was not withheld if procedural results suggested an increased risk for complications. RESULTS: Two hundred thirty-eight patients completed the study; 46 others were excluded in the catheterization laboratory because of unfavorable procedural results. The patients with abbreviated (n = 118) and 24-h (n = 120) therapy did not differ with respect to demographic and angiographic findings. However, the former had fewer bleeding complications (0% vs. 7%, p < 0.001) and were discharged earlier (mean +/- SD 23 +/- 11 h vs. 42 +/- 24 h, p < 0.001). One patient in this group had a major complication shortly after angioplasty. The mean savings in hospital charges in the abbreviated therapy group was $1,370 ($6,093 +/- $1,772 vs. $7,463 +/- $1,782, p < 0.001). CONCLUSIONS: Omission of routine heparin therapy after successful coronary angioplasty reduces bleeding complications without increasing patient risk. Earlier discharge and significant cost savings are possible under proper conditions.

Prevention of subsequent exercise-induced periinfarct ischemia by emergency coronary angioplasty in acute myocardial infarction: comparison with intracoronary streptokinase.

To compare the efficacy of emergency percutaneous transluminal coronary angioplasty and intracoronary streptokinase in preventing exercise-induced periinfarct ischemia, 28 patients presenting within 12 hours of the onset of symptoms of acute myocardial infarction were prospectively randomized. Of these, 14 patients were treated with emergency angioplasty and 14 patients received intracoronary streptokinase. Recatheterization and submaximal exercise thallium-201 single photon emission computed tomography were performed before hospital discharge. Periinfarct ischemia was defined as a reversible thallium defect adjacent to a fixed defect assessed qualitatively. Successful reperfusion was achieved in 86% of patients treated with emergency angioplasty and 86% of patients treated with intracoronary streptokinase (p = NS). Residual stenosis of the infarct-related coronary artery shown at predischarge angiography was 43.8 +/- 31.4% for the angioplasty group and 75.0 +/- 15.6% for the streptokinase group (p less than 0.05). Of the angioplasty group, 9% developed exercise-induced periinfarct ischemia compared with 60% of the streptokinase group (p less than 0.05). Thus, patients with acute myocardial infarction treated with emergency angioplasty had significantly less severe residual coronary stenosis and exercise-induced periinfarct ischemia than did those treated with intracoronary streptokinase. These results suggest further application of coronary angioplasty in the management of acute myocardial infarction.

A prospective randomized trial of prevention measures in patients at high risk for contrast nephropathy: results of the P.R.I.N.C.E. Study. Prevention of Radiocontrast Induced Nephropathy Clinical Evaluation.

OBJECTIVES: This study was done to test the hypothesis that a forced diuresis with maintenance of intravascular volume after contrast exposure would reduce the rate of contrast-induced renal injury. BACKGROUND: We have previously shown a graded relationship with the degree of postprocedure renal failure and the probability of in-hospital death in patients undergoing percutaneous coronary intervention. Earlier studies of singular prevention strategies (atrial natriuretic factor, loop diuretics, dopamine, mannitol) have shown no clear benefit across a spectrum of patients at risk. METHODS: A prospective, randomized, controlled, single-blind trial was conducted where 98 participants were randomized to forced diuresis with intravenous crystalloid, furosemide, mannitol (if pulmonary capillary wedge pressure <20 mm Hg), and low-dose dopamine (n = 43) versus intravenous crystalloid and matching placebos (n = 55). RESULTS: The groups were similar with respect to baseline serum creatinine (2.44+/-0.80 and 2.55+/-0.91 mg/dl), age, weight, diabetic status, left ventricular function, degree of prehydration, contrast volume and ionicity, and extent of peripheral vascular disease. The forced diuresis resulted in higher urine flow rate (163.26+/-54.47 vs. 122.57+/-54.27 ml/h) over the 24 h after contrast exposure (p = 0.001). Two participants in the experimental arm versus five in the control arm required dialysis, with all seven cases having measured flow rates <145 ml/h in the 24 h after the procedure. The mean individual change in serum creatinine at 48 h, the primary end point, was 0.48+/-0.86 versus 0.51+/-0.87, in the experimental and control arms, respectively, p = 0.87. There were no differences in the rates of renal failure across six definitions of renal failure by intent-to-treat analysis. However, in all participants combined, the rise in serum creatinine was related to the degree of induced diuresis after controlling for baseline renal function, r = -0.36, p = 0.005. The rates of renal failure in those with urine flow rates greater than 150 ml/h in the postprocedure period were significantly lower, 8/37 (21.6%) versus 28/61 (45.9%), p = 0.03. CONCLUSIONS: Forced diuresis with intravenous crystalloid, furosemide, and mannitol if hemodynamics permit, beginning at the start of angiography provides a modest benefit against contrast-induced nephropathy provided a high urine flow rate can be achieved.

Four-year follow-up of patients undergoing percutaneous balloon mitral commissurotomy. A report from the National Heart, Lung, and Blood Institute Balloon Valvuloplasty Registry.

OBJECTIVES: This study reports the long-term outcome of patients undergoing percutaneous balloon mitral commissurotomy who were enrolled in the National Heart, Lung, and Blood Institute (NHLBI) Balloon Valvuloplasty Registry. BACKGROUND: The NHLBI established the multicenter Balloon Valvuloplasty Registry in November 1987 to assess both short- and long-term safety and efficiency of percutaneous balloon mitral commissurotomy. METHODS: Between November 1987 and October 1989, 736 patients > or = 18 years old underwent percutaneous balloon mitral commissurotomy at 23 registry sites in North America. The maximal follow-up period was 5.2 years. RESULTS: The actuarial survival rate was 93 +/- 1% (mean +/- SD), 90 +/- 1.2%, 87 +/- 1.4% and 84 +/- 1.6% at 1, 2, 3 and 4 years, respectively. Eighty percent of the patients were alive and free of mitral surgery or repeat balloon mitral commissurotomy at 1 year. The event-free survival rate was 80 +/- 1.5% at 1 year, 71 +/- 1.7% at 2 years, 66 +/- 1.8% at 3 years and 60 +/- 2.0% at 4 years. Important univariable predictors of actuarial mortality at 4 years included age > 70 years (51% survival), New York Heart Association functional class IV (41% survival) and baseline echocardiographic score > 12 (24% survival). Multivariable predictors of mortality included functional class IV, higher echocardiographic score and higher postprocedural pulmonary artery systolic and left ventricular end-diastolic pressures (p < 0.01). CONCLUSIONS: Percutaneous balloon mitral commissurotomy has a favorable effect on the hemodynamic variables of mitral stenosis, and long-term follow-up data suggest that it is a viable alternative with respect to surgical commissurotomy in selected patients.

Do excimer laser angioplasty and rotational atherectomy facilitate balloon angioplasty? Implications for lesion-specific coronary intervention.

OBJECTIVES: This study sought to determine whether adjunctive balloon angioplasty after rotational atherectomy and excimer laser angioplasty provides better lumen enlargement ("facilitated angioplasty") than angioplasty alone. BACKGROUND: Adjunctive angioplasty is often used immediately after atherectomy and laser angioplasty to further enlarge lumen dimensions, but it is not known whether this practice is superior to angioplasty alone. METHODS: Balloon angioplasty was performed in 1,266 native coronary lesions alone (n = 541) or after extraction atherectomy (n = 277), rotational atherectomy (Rotablator) (n = 211) or excimer laser angioplasty (n = 237). Quantitative angiographic analysis included final lumen diameter, final diameter stenosis and efficiency of balloon-mediated lumen enlargement. RESULTS: Compared with angioplasty alone (33 +/- 12% [mean +/- SD]), final diameter stenosis was higher for adjunctive angioplasty after extraction atherectomy (37 +/- 16%, p < 0.001) and excimer laser angioplasty (37 +/- 16%, p < 0.001) and lower after rotational atherectomy (27 +/- 15%, p < 0.001). However, there was significant undersizing of balloons after all three devices. To correct for differences in balloon size, the efficiency index (final lumen diameter/balloon diameter ratio) was calculated and was higher for adjunctive angioplasty after the Rotablator (0.78 +/- 0.14, p < 0.001) than after angioplasty alone (0.69 +/- 0.12). The efficiency indexes suggested facilitated angioplasty after rotational atherectomy for ostial, eccentric, ulcerated and calcified lesions and lesions > 20 mm long. Facilitated angioplasty was also observed after extraction atherectomy and excimer laser angioplasty for ostial lesions, but not for any other lesion subsets. CONCLUSIONS: Rotational atherectomy, extraction atherectomy and excimer laser angioplasty can facilitate the results of balloon angioplasty. However, the extent of facilitated angioplasty is dependent on the device and baseline lesion morphology, consistent with the need for lesion-specific coronary intervention.

Heparin after percutaneous intervention (HAPI): a prospective multicenter randomized trial of three heparin regimens after successful coronary intervention.

OBJECTIVES: The purpose of this study was to determine the incidence of bleeding, vascular, and ischemic complications using three different heparin regimens after successful intervention. BACKGROUND: The ideal dose and duration of heparin infusion after successful coronary intervention is unknown. METHODS: Patients were randomized to one of three heparin strategies after coronary intervention: Group 1 (n = 157 patients) received prolonged (12 to 24 h) heparin infusion followed by sheath removal; Group 2 (n = 120 patients) underwent early removal of sheaths, followed by reinstitution of heparin infusion for 12 to 18 h; Group 3 (n = 137 patients) did not receive any further heparin after intervention with early sheath removal. The primary end point of the study was the combined incidence of in-hospital bleeding and vascular events. Secondary end points included in-hospital ischemic events, length of stay, cost and one-month outcome. RESULTS: After successful coronary intervention, 414 patients were randomized. Unstable angina or postinfarction angina was present in 83% of patients before intervention. The combined incidence of bleeding and vascular events was 21% in Group 1, 14% in Group 2 and 8% in Group 3 (p = 0.01). The overall incidence of in-hospital ischemic complications was 2.2%; there were no differences between groups. Length of hospital stay was shorter (p = 0.033) and adjusted hospital cost was lower (p < 0.001) for Group 3. At 30 days, the incidence of delayed cardiac and vascular events was similar for all three groups. CONCLUSIONS: Heparin infusion after successful coronary intervention is associated with more minor bleeding and vascular injury, prolonged length of stay and increased cost. In-hospital and one-month ischemic events rarely occur after successful intervention, irrespective of heparin use. Routine postprocedure heparin is not recommended, even in patients who present with unstable ischemic syndromes.

Predictors of success for coronary angioplasty performed for acute myocardial infarction.

To evaluate the predictors and likelihood of success for coronary angioplasty performed in the setting of acute myocardial infarction, 300 consecutive patients with 321 coronary stenoses were studied retrospectively. Success was defined as final diameter stenosis less than 70% and Thrombolysis in Myocardial Infarction (TIMI) flow grade greater than or equal to 2. Nine clinical variables and 15 angiographic variables were assessed. Seventy-nine percent of patients were men; the mean age was 56 +/- 11 years, and 54% of patients also received thrombolytic therapy. The mean left ventricular ejection fraction was 46 +/- 11%, and 18 patients (6%) were in cardiogenic shock. Angioplasty success in the infarct-related artery was achieved in 240 patients (80%). In 177 total occlusions (TIMI flow grade less than or equal to 1), the success rate was 75.7% and success was independently predicted by 1) an ejection fraction greater than 30% (p = 0.001); 2) no arterial bend greater than or equal to 45 degrees at the site of angioplasty (p = 0.008); and 3) no triple vessel disease (p = 0.014). In 144 subtotal occlusions (TIMI flow grade greater than or equal to 2), procedural success was achieved in 84.7% and was predicted by 1) absence of thrombus greater than 5 mm (p = 0.023), and 2) absence of other stenoses greater than or equal to 50% in the same artery (p = 0.043), whereas patency without further emergency intervention was achieved in 71.7% and was predicted only by patient age less than or equal to 60 years and absence of cardiogenic shock.(ABSTRACT TRUNCATED AT 250 WORDS)

Quantitative measurement of coronary flow during medical revascularization (thrombolysis or angioplasty) in patients with acute infarction.

This study quantitatively evaluated the change in myocardial blood flow resulting from medical revascularization in patients with acute anterior myocardial infarction. Changes in great cardiac vein flow were measured using a thermodilution technique in 13 patients with acute infarction; 3 received intracoronary streptokinase and 10 percutaneous transluminal angioplasty. Average great cardiac vein flow during left anterior descending coronary artery occlusion was 62 +/- 6 ml/min and increased to 70 +/- 7 ml/min (p = 0.039) after arterial recanalization. There was significant individual variability in the great cardiac vein flow increments that was highly predictive of functional recovery as expressed by the change in ejection fraction at 7 to 10 days (r = 0.93, p = 0.0008). Incremental great cardiac vein flow was inversely correlated with the degree of residual stenosis and the duration of ischemia (r = 0.88, p = 0.0007). Patients with residual stenosis less than or equal to 50% had a significantly larger increase in great cardiac vein flow (14 +/- 5 ml/min) than did those with residual stenosis greater than 50% (0 +/- 2 ml/min, p = 0.026). Neither preinterventional left ventricular ejection fraction, hemodynamics nor age predicted incremental great cardiac vein flow. Therefore, quantitative measurements of great cardiac vein flow during medical revascularization in patients with an acute anterior myocardial infarction demonstrate variable reflow that is physiologically significant. A high grade residual stenosis and prolonged period of ischemia limit large increases in flow and prevent functional recovery. This study emphasizes the fact that recanalization in itself cannot be used as an indicator of the success of interventions designed to produce myocardial reperfusion.

Role of myocardial ischemia during programmed stimulation in survivors of cardiac arrest with coronary artery disease.

The role of ischemia in the induction of ventricular tachycardia during programmed stimulation was studied in 19 patients who survived a cardiac arrest and were found to have a significant stenosis in at least one branch of the left coronary artery. The arterial-coronary sinus lactate difference was measured during electrophysiologic testing, before the induction of ventricular tachycardia. Ventricular tachycardia was induced in 15 patients; it was sustained and unimorphic in 6 patients and polymorphic in 9. Myocardial ischemia, as reflected by net myocardial lactate production, was present within 60 seconds before the induction of ventricular tachycardia in 8 of the 15 patients with inducible ventricular tachycardia. In 9 of the 15 patients, programmed stimulation was repeated after a 15 minute rest period, with the same coupling intervals that had induced ventricular tachycardia previously. Net myocardial lactate production was not present in any patient during this repeat attempt. In three patients without evidence of ischemia during the first induction of ventricular tachycardia, the arrhythmia was induced again by the specific coupling intervals that had induced it previously. However, in five of six patients with net myocardial lactate production during the first induction of ventricular tachycardia, the same coupling intervals that had induced the arrhythmia in the presence of ischemia no longer induced it in the absence of ischemia. The results of this study suggest that myocardial ischemia may be a requirement for the induction of ventricular tachycardia in some patients with coronary artery disease who survive a cardiac arrest.

Implications for patient triage from survival and left ventricular functional recovery analyses in 500 patients treated with coronary angioplasty for acute myocardial infarction.

The in-hospital course of 500 consecutive patients treated with coronary angioplasty for acute myocardial infarction was reviewed in relation to their clinical and angiographic presentation and angioplasty outcome to determine which patients benefit most from successful angioplasty in this setting. Patient age was 56 +/- 11 years (mean +/- SD) and 78% were men; 46% had anterior myocardial infarction, 49% received concomitant intravenous thrombolytic therapy, left ventricular ejection fraction was 47 +/- 11% and median time to angioplasty was 4.7 h (range 1 to 24). Angioplasty was successful in 78% of patients and partially successful in 7% of patients; the overall in-hospital mortality rate was 10.2%. Multivariate analysis found six independent correlates (p less than 0.05) of in-hospital mortality: left ventricular ejection fraction less than or equal to 30%, lack of postangioplasty infarct artery patency, age greater than 65 years, recurrent ischemia after successful angioplasty, emergency bypass surgery and arterial pressure on admission to the catheterization laboratory less than 100 mm Hg. After consideration of these predictors of survival in multivariate analyses, angioplasty success still was independently correlated with improved in-hospital survival for patients with cardiogenic shock (p = 0.002) and anterior myocardial infarction (p = 0.007). A trend toward an independent beneficial effect of successful angioplasty on survival was also noted in patients with inferior wall infarction and precordial ST segment depression (p = 0.063) and for all patients who were hypotensive on admission to the catheterization laboratory, regardless of the infarct site (p = 0.057).(ABSTRACT TRUNCATED AT 250 WORDS)