The 6Fr Angio-Seal arterial closure device: results from a multimember prospective registry.

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.

Long-term outcome after primary angioplasty: report from the primary angioplasty in myocardial infarction (PAMI-I) trial.

OBJECTIVES: This study sought to compare the two-year outcome after primary percutaneous coronary angioplasty or thrombolytic therapy for acute myocardial infarction. BACKGROUND: Primary angioplasty, that is, angioplasty without antecedent thrombolytic therapy, has been shown to be an effective reperfusion modality for patients suffering an acute myocardial infarction. This report reviews the two-year clinical outcome of patients randomized in the Primary Angioplasty in Myocardial Infarction trial. METHODS: At 12 clinical centers, 395 patients who presented within 12 h of the onset of myocardial infarction were randomized to undergo primary angioplasty (195 patients) or to receive tissue-type plasminogen activator (t-PA) (200 patients) followed by conservative care. Patients were followed by physician visits, phone call, letter and review of hospital records for any hospital admission at one month, six months, one year and two years. RESULTS: At two years, patients undergoing primary angioplasty had less recurrent ischemia (36.4% vs. 48% for t-PA, p = 0.026), lower reintervention rates (27.2% vs. 46.5% for t-PA, p < 0.0001) and reduced hospital readmission rates (58.5% vs. 69.0% for t-PA, p = 0.035). The combined end point of death or reinfarction was 14.9% for angioplasty versus 23% for t-PA, p = 0.034. Multivariate analysis found angioplasty to be independently predictive of a reduction in death, reinfarction or target vessel revascularization (p = 0.0001). CONCLUSIONS: The initial benefit of primary angioplasty performed by experienced operators is maintained over a two-year follow-up period with improved infarct-free survival and reduced rate of reintervention.

Analysis of the relative costs and effectiveness of primary angioplasty versus tissue-type plasminogen activator: the Primary Angioplasty in Myocardial Infarction (PAMI) trial. The PAMI Trial Investigators.

OBJECTIVES: We sought to determine the relative cost and effectiveness of two different reperfusion modalities in patients with acute myocardial infarction (AMI). BACKGROUND: Recent studies have found superior clinical outcomes after reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) compared with thrombolytic therapy. The high up-front costs of cardiac catheterization may diminish the relative advantages of this invasive strategy. METHODS: Detailed in-hospital charge data were available from all 358 patients with AMI randomized to tissue-type plasminogen activator (t-PA) or primary PTCA in the United States from the Primary Angioplasty in Myocardial Infarction trial. Resource consumption during late follow-up was estimated by assessment of major clinical events and functional status. RESULTS: Compared with t-PA, primary PTCA resulted in reduced rates of in-hospital mortality (2.3% vs. 7.2%, p = 0.03), reinfarction (2.8% vs. 7.2%, p = 0.06), recurrent ischemia (11.3% vs. 28.7%, p < 0.0001) and stroke (0% vs. 3.9%, p = 0.02) and a shorter hospital stay (7.6 +/- 3.3 days vs. 8.4 +/- 4.7 days, p = 0.04). Despite the initial costs of cardiac catheterization in all patients with the invasive strategy, total mean (+/- SD) hospital charges were $3,436 lower per patient with PTCA than with t-PA ($23,468 +/- $13,410 vs. $26,904 +/- $18,246, p = 0.04), primarily due to the reduction in adverse in-hospital outcomes. However, professional fees were higher after primary PTCA ($4,185 +/- $3,183 vs. $3,322 +/- $2,728, p = 0.001), and thus total charges, although favoring PTCA, were not significantly different ($27,653 +/- $13,709 vs. $30,227 +/- 18,903, p = 0.21). At a mean follow-up time of 2.1 +/- 0.7 years, no major differences in postdischarge events or New York Heart Association functional class were present between PTCA- and t-PA-treated patients, suggesting similar late resource consumption. Including in-hospital events, 83% of PTCA-treated patients were alive and free of reinfarction at late follow-up, compared with 74% of t-PA-treated patients (p = 0.06). CONCLUSIONS: Compared with t-PA, reperfusion by primary PTCA improves clinical outcomes with similar or reduced costs. These findings have important clinical implications in an increasingly cost-conscious health care environment.

Outcome of different reperfusion strategies in patients with former contraindications to thrombolytic therapy: a comparison of primary angioplasty and tissue plasminogen activator. Primary Angioplasty in Myocardial Infarction (PAMI) Investigators.

High-risk patients have been excluded from most thrombolytic trials because of concern over hemorrhagic complications or lack of efficacy. However, based on several recent studies suggesting that patients with relative thrombolytic contraindications may also benefit from reperfusion, recommendations have been made to broadly expand the eligibility criteria for thrombolytic therapy, despite higher absolute complication rates. Primary percutaneous transluminal coronary angioplasty (PTCA) may be an attractive alternative for patients presenting at appropriately equipped hospitals who would otherwise remain at high risk after thrombolytic therapy. In the Primary Angioplasty in Myocardial Infarction (PAMI) trial, 395 patients with acute myocardial infarction were randomized to tissue plasminogen activator (t-PA) or primary PTCA. Conditions were present in 151 patients (38%) which formerly would have contraindicated thrombolytic therapy (age > 70 yr, symptom duration > 4 hr, or prior bypass surgery). In-hospital mortality was 4.3-fold higher in patients with former thrombolytic contraindications compared to lytic-eligible patients (8.6% vs. 2.0%, P = .002). Lytic-eligible patients treated with t-PA and PTCA had similar in-hospital mortality (1.7% vs. 2.4%, P = NS). In contrast, both in-hospital (2.9% vs. 13.2%, P = .025) and 6-mo mortality (2.9% vs. 15.7%, P = .009) were significantly reduced in patients with former thrombolytic contraindications treated by primary PTCA compared to t-PA. By logistic regression analysis, treatment by PTCA rather than t-PA was the strongest predictor of survival in patients with former thrombolytic contraindications. We conclude that patients with conditions formerly contraindicating thrombolytic therapy constitute a high-risk group with significant morbidity and mortality after lytic reperfusion. Our data suggest that patients with former contraindications to thrombolytic therapy may benefit by preferential management with primary PTCA without antecedent thrombolysis.

Influence of acute myocardial infarction location on in-hospital and late outcome after primary percutaneous transluminal coronary angioplasty versus tissue plasminogen activator therapy.

In the Primary Angioplasty in Myocardial Infarction trial, 395 patients with acute myocardial infarction (AMI) were prospectively randomized to tissue plasminogen activator (tPA) or primary percutaneous transluminal coronary angioplasty (PTCA). In 138 patients with anterior wall AMI, in-hospital mortality was significantly reduced by treatment with PTCA compared with tPA (1.4% vs 11.9%, p = 0.01). PTCA also resulted in lower rates of death or reinfarction (1.4% vs 18.0%, p = 0.0009), recurrent myocardial ischemia (11.3% vs 28.4%, p = 0.01), and stroke (0.0% vs 6.0%, p = 0.037) in anterior wall AMI. The independent beneficial effect of treatment with primary PTCA rather than tPA in anterior wall AMI was confirmed by multivariate analysis and interaction testing. The in-hospital mortality of 257 patients with nonanterior wall AMI was similar after PTCA and tPA (3.2% vs 3.8%, p = 0.82). Compared with tPA, however, primary PTCA resulted in a markedly lower rate of recurrent myocardial ischemia (9.7% vs 27.8%, p = 0.0002), fewer unscheduled catheterization and revascularization procedures, and a shorter hospital stay (7.0 vs 8.6 days, p = 0.01) in nonanterior wall AMI. Thus, compared with tPA, primary PTCA in patients with anterior wall AMI results in significantly improved survival, with lower rates of stroke, reinfarction, and recurrent myocardial ischemia. In nonanterior wall AMI, treatment with PTCA and tPA results in similar early mortality, although PTCA-treated patients have a more stable hospital course characterized by reduced recurrent ischemia, fewer subsequent invasive procedures, and earlier discharge.

Six month outcome and determinants of adverse clinical events after successful excimer laser coronary angioplasty. ELCA A.I.S. Multicenter Registry.

OBJECTIVE: To describe the six month outcome and predictors of adverse clinical events following successful excimer laser coronary angioplasty (ELCA). DESIGN: Retrospective analysis of comprehensive data collected at time of initial procedure and during planned follow-up intervals. SETTING: There were 35 participating institutions throughout the United States. PATIENTS: The study population was comprised of 3,069 patients who had successful ELCA and completed follow-up at 6 months, representing 91% of eligible cases. Forty percent had prior balloon angioplasty and 34% had prior bypass surgery. MEASUREMENTS: Patient symptomatology was assessed by Canadian Cardiovascular Society functional (CCSF) class. Interim adverse clinical events [death, Q wave myocardial infarction (QMI), repeat intervention, bypass surgery, and a composite end-point] were tracked. Twenty-six pre-ELCA clinical, angiographic and procedural variables were evaluated to assess their ability to predict outcome. RESULTS: At 6 months, there was 2.8% mortality, 2.5% incidence of QMI, and 28.7% required either repeat intervention or bypass surgery. Overall, 69.2% of patients had no adverse event. In this cohort, the pre-ELCA CCSF class grade was 2.7 +/- 1.2, but at 6 months, it was 0.7 +/- 1.1 (p < 0.001). The multivariate predictors of the composite end point were gender, stenosis location, and rest and unstable angina. CONCLUSIONS: There is an excellent 6 month outcome after successful ELCA in this selected population with complex coronary artery disease. The majority of patients without interim events enjoy significant alleviation of symptoms. The predictors of adverse events are clinical rather than angiographic.

Implications of recurrent ischemia after reperfusion therapy in acute myocardial infarction: a comparison of thrombolytic therapy and primary angioplasty.

OBJECTIVES: The purpose of this study was to examine the incidence and implications of recurrent ischemia after different reperfusion strategies in acute myocardial infarction. BACKGROUND: The rates and effects of recurrent ischemia after reperfusion with thrombolytic therapy and with primary percutaneous transluminal coronary angioplasty have not been compared. METHODS: At 12 centers 395 patients presenting within 12 h of the onset of acute myocardial infarction were prospectively randomized to receive recombinant tissue-type plasminogen activator (rt-PA) or primary coronary angioplasty. Sixteen clinical variables were examined by using univariate and multiple logistic regression analysis to identify the predictors of recurrent ischemia. The relation of recurrent ischemic events to patient outcome was analyzed. RESULTS: Recurrent ischemia developed in 76 patients (19.2%) before hospital discharge, resulting in reinfarction in 18 patients (4.6%) and death in 5 (2.6%). Recurrent ischemia occurred in 56 patients (28.0%) after rt-PA but in only 20 patients (10.3%) after coronary angioplasty (p < 0.0001), directly contributing to a higher rate of death or reinfarction (7.5% vs. 3.1%, p = 0.05), catheterization and revascularization procedures and prolonged hospital stay after thrombolysis. By multivariate analysis, treatment with coronary angioplasty rather than rt-PA was the strongest predictor of freedom from recurrent ischemia. Although the incidence of recurrent ischemia after angioplasty and after rt-PA was similar within the 1st 2 days of admission (9.2% vs. 14.5%, p = 0.11), after hospital day 2 recurrent ischemia occurred in only 2 patients who received primary angioplasty compared with 27 patients who received rt-PA (1.1% vs. 13.5%, p < 0.0001). CONCLUSIONS: The development of recurrent ischemia adversely affects patient outcome, increasing morbidity, mortality and resource utilization. The much lower rate of recurrent ischemia after primary coronary angioplasty than after rt-PA results in improved survival without reinfarction and allows a shorter, less complicated hospital stay. Given the extremely low rate of recurrent ischemia after hospital day 2, safe early discharge on day 3 after primary coronary angioplasty should be feasible in selected patients with acute myocardial infarction.

Predictors of restenosis after excimer laser coronary angioplasty.

One hundred twenty-five lesions successfully treated with excimer laser coronary angioplasty at 3 centers were analyzed in a central core laboratory using detailed quantitative angiographic analysis. Sixty-seven narrowings had restenosis (> or = 50% diameter stenosis at restudy). Correlates of restenosis were as follows: baseline diameter stenosis was 79% in the restenosis group versus 71% in the group without restenosis (p = 0.0002), baseline minimal diameter stenosis was 0.55 mm in the restenosis group versus 0.72 mm in the group without restenosis (p = 0.006), final diameter stenosis was 40% in the restenosis group versus 32% in the group without restenosis (p = 0.002), lesion length > or = 7 mm was present in 43% of the restenosis group versus 21% in the group without restenosis (p = 0.009), and Thrombolysis in Myocardial Infarction trial flow 0 to 2 was 33% in the restenosis group versus 15% in the group without restenosis (p = 0.025). The strongest multivariate correlate of restenosis was the baseline diameter stenosis (p = 0.003). Whereas most predictors were not controllable, achieving a low residual diameter stenosis that is operator-dependent can favorably influence the restenosis rate.

Comparison of in-hospital outcome in men versus women treated by either thrombolytic therapy or primary coronary angioplasty for acute myocardial infarction.

At 12 centers, 395 patients, including 288 men (73%) and 107 women (27%) with acute myocardial infarction (AMI), were prospectively randomized to treatment with tissue plasminogen activator (t-PA) or primary percutaneous transluminal coronary angioplasty (PTCA). Compared with men, women were older (65.7 vs 57.7 years, p < 0.0001), more often had diabetes mellitus (19% vs 10%, p = 0.03), systemic hypertension (54% vs 39%, p = 0.005), prior congestive heart failure (5% vs 0%, p = 0.002), and presented later after symptom onset (229 vs 174 minutes, p = 0.0004). The in-hospital mortality in women was 3.3-fold higher than men (9.3% vs 2.8%, p = 0.005). After adjustment for comorbid baseline characteristics, however, only advanced age independently correlated with mortality. Among t-PA-treated patients, mortality was significantly higher in women than in men (14.0% vs 3.5%, p = 0.006). Intracranial hemorrhage after t-PA was also more common in women than in men (5.3% vs 0.7%, p = 0.037). In contrast, women and men had similar in-hospital mortality after primary PTCA (4.0% vs 2.1%, respectively, p = 0.46). No intracranial bleeding occurred in PTCA-treated patients. A univariate trend was present for reduced in-hospital mortality in women treated with PTCA rather than t-PA (4.0% vs 14.0%, p = 0.07). By multiple logistic regression analysis of 15 clinical variables, treatment with PTCA rather than t-PA, as well as younger age, were independently predictive of in-hospital survival in women.(ABSTRACT TRUNCATED AT 250 WORDS)

Predictors of in-hospital and 6-month outcome after acute myocardial infarction in the reperfusion era: the Primary Angioplasty in Myocardial Infarction (PAMI) trail.

OBJECTIVES: This study examined the predictors of in-hospital and 6-month outcome after different reperfusion strategies in acute myocardial infarction. BACKGROUND: Thrombolytic therapy and primary angioplasty are both widely applied as reperfusion modalities in patients with myocardial infarction. Although it is accepted that restoration of early patency of the infarct-related artery can reduce mortality and salvage myocardium, the optimal reperfusion strategy remains controversial, and the predictors of outcome in the reperfusion era have been incompletely characterized. METHODS: At 12 centers, 395 patients presenting within 12 h of onset of acute transmural myocardial infarction were prospectively randomized to receive tissue-type plasminogen activator (t-PA) or undergo primary angioplasty without antecedent thrombolysis. Sixteen clinical variables were examined with univariate and multiple logistic regression analysis to identify the predictors of clinical outcome. RESULTS: By univariate analysis, in-hospital mortality was increased in the elderly, women, patients with diabetes and in patients treated with t-PA as opposed to angioplasty. Only advanced age and treatment by t-PA versus angioplasty independently correlated with increased in-hospital mortality (6.5% vs. 2.6%, respectively, p = 0.039 by multiple logistic regression analysis). Similarly, the only variables independently related to in-hospital death or nonfatal reinfarction were advanced age and treatment by t-PA versus angioplasty (12.0% vs. 5.1%, p = 0.02). The reduction in in-hospital death or reinfarction with angioplasty versus t-PA was particularly marked in patients > or = 65 years of age (8.6% vs. 20.0%, p = 0.048). Furthermore, primary management with angioplasty versus t-PA was the most powerful multivariate correlate of freedom from recurrent ischemic events (10.3% vs. 28.0%, p = 0.0001). The independent beneficial effect of angioplasty on freedom from death or reinfarction was maintained at 6-month follow-up (8.2% vs. 17.0%, p = 0.02). CONCLUSIONS: In the reperfusion era, the two most powerful determinants of freedom from death, reinfarction and recurrent ischemia after myocardial infarction are young age and treatment by primary angioplasty.

Assessment of the results of percutaneous transluminal coronary angioplasty using an integrated ultrasound imaging-angioplasty catheter.

To evaluate the results percutaneous transluminal coronary angioplasty (PTCA), intravascular ultrasound imaging was performed in 32 proximal coronary arterial segments and in 16 atherosclerotic lesions after PTCA in 13 patients using a 5 Fr balloon catheter with an ultrasound transducer mounted just proximal to the balloon. Simultaneous angiographic measurements of vessel diameter were also performed using electronic calipers from contrast cine angiograms. There was good correlation between ultrasound and angiographic minimum luminal diameters of the normal proximal vessel (y = 0.59x + 1.49, r = 0.70, P < 0.01, n = 32). However, the luminal diameter measured by intravascular ultrasound was significantly greater than when measured by contrast angiography (2.81 +/- 0.10 vs. 2.34 +/- 0.12mm, n = 16, P < 0.001, mean +/- SEM). Post-PTCA, there was good correlation between ultrasound and angiographic minimum luminal diameters of the lesion (y = 0.62x + 1.42, r = 0.76, P < 0.001, n = 16), but again luminal diameters were significantly greater when measured by intravascular ultrasound compared to contrast angiography (2.61 +/- 0.08 vs. 1.89 +/- 0.10mm, n = 16, P < 0.001). Furthermore, residual stenosis was significantly less when determined by intravascular ultrasound than by contrast angiography (7.3 +/- 2.0 vs. 18.1 +/- 2.1%, n = 16, P < 0.001). Intravascular ultrasound was able to detect coronary calcification that was not evident by contrast coronary angiography in 8 of 16 lesions. Post-PTCA, dissection was evident in four lesions by ultrasound, whereas dissection was appreciated in only three lesions by contrast angiography.(ABSTRACT TRUNCATED AT 250 WORDS)

Recombinant human superoxide dismutase (h-SOD) fails to improve recovery of ventricular function in patients undergoing coronary angioplasty for acute myocardial infarction.

BACKGROUND: Animal studies have demonstrated a burst of oxygen free radical generation after reperfusion of ischemic myocardium that could be blocked by administration of the free radical scavenger recombinant human superoxide dismutase (h-SOD). A multicenter, randomized, placebo-controlled clinical trial was designed to test the hypothesis that free radical-mediated reperfusion injury could be reduced by intravenous administration of h-SOD begun before percutaneous transluminal coronary angioplasty (PTCA) in patients with acute transmural myocardial infarction. METHODS AND RESULTS: One hundred twenty patients were randomized to receive placebo (n = 59) or h-SOD (n = 61) given as a 10-mg/kg intravenous bolus followed by a 60-minute infusion of 0.2 mg.kg-1.min-1. Left ventricular function was analyzed via paired contrast left ventriculograms performed before PTCA and after 6 to 10 days and paired radionuclide ventriculograms performed within 24 hours of PTCA and after 4 to 6 weeks. Both h-SOD- and placebo-treated patients showed improvement in global and regional left ventricular function after successful reperfusion. Compared with the placebo group, no additional improvement was observed in the patients treated with h-SOD. CONCLUSIONS: The results of this clinical trial failed to demonstrate a beneficial effect of h-SOD on global or regional left ventricular function in patients who underwent successful PTCA for treatment of acute myocardial infarction.

Percutaneous excimer laser coronary angioplasty: results in the first consecutive 3,000 patients. The ELCA Investigators.

OBJECTIVES: We report the comprehensive results of the first consecutive 3,000 patients treated in an excimer laser coronary angioplasty registry. BACKGROUND: Excimer laser coronary angioplasty involves the use of a pulsed, 308-nm ultraviolet laser transmitted by optical fibers to reduce coronary stenoses. Preliminary reports have described safety and efficacy profiles in small numbers of patients. METHODS: Patients were enrolled in a prospective, nonrandomized manner. The catheters used were 1.3, 1.6, 2.0, 2.2 and 2.4 mm in diameter, at energy densities up to 70 mJ/mm2. Procedures were performed by standard angioplasty technique with conventional guide catheters. RESULTS: Seventy-five percent of patients were male, 68% were in Canadian Cardiovascular Society functional class III or IV and the cohort included 3,592 lesions. Procedural success (final stenosis < or = 50% without in-hospital Q wave myocardial infarction, coronary artery bypass surgery or death) was 90% and did not differ between the first 2,000 and the last 1,000 patients treated. There was no significant difference in success or complication rates with respect to lesion length, nor were there differences between selected complex and simple lesions. Complications included in-hospital bypass surgery (3.8%), Q wave myocardial infarction (2.1%) and death (0.5%). Coronary artery perforation occurred in 1.2% of patients (1% of lesions) but significantly decreased to 0.4% in the last 1,000 patients (0.3% of lesions). Angiographic dissection occurred in 13% of lesions, transient occlusion in 3.4% and sustained occlusion in 3.1%. Comprehensive lesion morphologic data collected in the latter portion of the study showed the procedure predominantly limited to American College of Cardiology-American Heart Association type B2 and C lesions, with no significant difference in short-term outcome between groups. CONCLUSIONS: Excimer laser angioplasty can be safely and effectively applied, even in a variety of complex lesions not well suited for percutaneous transluminal coronary angioplasty. These types may include aorto-ostial, long lesions, total occlusions crossable with a wire, diffuse disease and vein grafts. Most recent data show a trend for the selection of predominantly complex lesions and a reduction in the incidence of perforation. This procedure may broaden the therapeutic window for the interventional treatment of selected complex coronary artery disease.

Treatment of refractory coronary occlusions with a new excimer laser catheter: preliminary clinical observations.

BACKGROUND: Total coronary occlusion is a frequent cause of procedural failure after coronary angioplasty, often because of the inability to recanalize the occluded segment with a conventional coronary guidewire. The novel excimer laser catheter described in this report contains a highly efficient, pulsed excimer laser guidewire designed to create a small channel within the occluded coronary segment. A preliminary report of the safety and efficacy of this excimer laser catheter is provided. METHODS: Ten patients with refractory coronary occlusions that could not be crossed by experienced operators using conventional guidewire techniques were treated using a novel laser catheter system. The laser catheter consisted of a densely packed, multiple fiber, helical guidewire measuring 0.020 inches (0.51 mm) in diameter, interfacing a 308 nm excimer laser system and delivering 70-80 mJ/mm2 of energy to the output surface. After the laser guidewire had been advanced to the occlusion site, laser energy was applied to ablate a channel as the wire was advanced through the occlusion. Once the occlusion had been recanalized, standard concentric laser or balloon angioplasty was performed. RESULTS: Complete recanalization was achieved in three total occlusions, and partial recanalization was established in a further three; thus, normal coronary perfusion was attained in six out of 10 patients after adjunct excimer laser or balloon angioplasty. The final minimum lumen diameter averaged 1.51 mm and the final residual stenosis diameter was 27%. In two patients the procedure was unsuccessful but without significant complications; two other patients developed limited coronary perforations without clinical sequelae. CONCLUSION: Refractory coronary occlusions were successfully recanalized in six out of 10 patients using a novel excimer laser catheter. Treatment failures in four patients were not associated with major complications, although limited coronary perforation occurred in two patients.

Radiation exposure: comparison of rapid exchange and conventional over-the-wire coronary angioplasty systems.

The growth of coronary angioplasty has resulted in increased fluoroscopy time to patients, staff, and physicians. Rapid exchange-type catheters have purported to reduce fluoroscopy time and procedure time compared to conventional over-the-wire systems. Of 150 consecutive patients, 54 were treated solely with rapid-exchange catheters and 84 were treated solely with over-the-wire catheters. Excluding 12 cases treated with fixed wire or combination catheters, the following data were found: [table: see text] Overall procedural success was obtained in 98.5% (136/138) of patients, 1.5% (2) requiring emergency coronary artery bypass graft surgery. A significant 35% reduction in fluoroscopy time and 13% reduction in procedure time were found when rapid-exchange catheters were used, with identical success rates, number of balloons used per case, and complication rates compared to over-the-wire catheters. Rapid-exchange catheters should be considered as part of an overall effort to reduce radiation exposure in the interventional cardiology laboratory.

Comparison of results of percutaneous balloon valvuloplasty in patients with mild and moderate mitral stenosis to those with severe mitral stenosis. The North American Inoue Balloon Investigators.

Most reported studies of percutaneous balloon valvuloplasty in adults with acquired mitral stenosis have used patients with severely stenosed valves. The risks and benefits of valvuloplasty were examined in a multicenter registry of patients to determine whether balloon valvuloplasty can effectively dilate less severely obstructed valves, and to clarify the role of this procedure in symptomatic patients with mild and moderate mitral stenosis. The study groups were derived from the North American Inoue Balloon Valvuloplasty Registry. Full hemodynamic data were available in 264 patients; 45 (17%) with mild or moderate mitral stenosis (mitral valve area > or = 1.3 cm2) were compared with the remaining 219 with severe mitral stenosis (valve area < 1.3 cm2). Percutaneous balloon valvuloplasty was performed using the anterograde transseptal technique with an Inoue balloon. The mean age of patients with mild and moderate mitral stenosis was 53 +/- 13 years, and all were symptomatic with a mean New York Heart Association functional class of 2.9 +/- 0.7. Balloon valvuloplasty resulted in an increase in calculated mitral valve area from 1.4 +/- 0.1 to 2.3 +/- 0.7 cm2 (p < 0.05), and a final valve area > or = 1.9 cm2 was achieved in 37 patients (82%). There were no procedural deaths, but complications included right atrial perforation, transient ischemic attack and emergency surgery for severe mitral regurgitation. One-year follow-up evaluation revealed symptomatic improvement in most patients (mean New York Heart Association class 1.4 +/- 0.6; p < 0.0001). However, 2 patients needed repeat valvuloplasty for restenosis, and 5 had mitral valve replacements.(ABSTRACT TRUNCATED AT 250 WORDS)

Successful excimer laser angioplasty following unsuccessful primary balloon angioplasty.

We report five patients where excimer laser coronary angioplasty facilitated successful balloon dilatation of heavily calcified lesions that could not be dilated by conventional angioplasty techniques alone. In each case, the lesion was crossed successfully with a guide wire. Conventional angioplasty failed because of inability to cross the lesion with a balloon (four lesions) or inability to dilate the lesion with balloon inflation (two lesions). These cases illustrate an indication for excimer laser coronary angioplasty as an adjunctive procedure in heavily calcified coronary stenoses.

A comparison of immediate angioplasty with thrombolytic therapy for acute myocardial infarction. The Primary Angioplasty in Myocardial Infarction Study Group.

BACKGROUND: The success of thrombolytic therapy for acute myocardial infarction is limited by bleeding complications, the impossibility of reperfusing all occluded coronary arteries, recurrent myocardial ischemia, and the relatively small number of patients who are appropriate candidates for this therapy. We hypothesized that these problems could be overcome by the use of immediate percutaneous transluminal coronary angioplasty (PTCA), without previous thrombolytic therapy. METHODS: At 12 clinical centers, 395 patients who presented within 12 hours of the onset of myocardial infarction were treated with intravenous heparin and aspirin and then randomly assigned to undergo immediate PTCA (without previous thrombolytic therapy, 195 patients) or to receive intravenous tissue plasminogen activator (t-PA, 200 patients) followed by conservative care. Radionuclide ventriculography was performed to assess ventricular function within 24 hours and at six weeks. RESULTS: Among the patients randomly assigned to PTCA, 90 percent underwent the procedure; the success rate was 97 percent, and no patient required emergency coronary-artery bypass surgery. The in-hospital mortality rates in the t-PA and PTCA groups were 6.5 and 2.6 percent, respectively (P = 0.06). In a post hoc analysis, the mortality rates in the subgroups classified as "not low risk" were 10.4 and 2.0 percent, respectively (P = 0.01). Reinfarction or death in the hospital occurred in 12.0 percent of the patients treated with t-PA and 5.1 percent of those treated with PTCA (P = 0.02). Intracranial bleeding occurred more frequently among patients who received t-PA than among those who underwent PTCA (2.0 vs. 0 percent, P = 0.05). The mean (+/- SD) ejection fractions at rest (53 +/- 13 vs. 53 +/- 13 percent) and during exercise (56 +/- 13 vs. 56 +/- 14 percent) were similar in the t-PA and PTCA groups at six weeks. By six months, reinfarction or death had occurred in 32 patients who received t-PA (16.8 percent) and 16 treated with PTCA (8.5 percent, P = 0.02). CONCLUSIONS: As compared with t-PA therapy for acute myocardial infarction, immediate PTCA reduced the combined occurrence of nonfatal reinfarction or death, was associated with a lower rate of intracranial hemorrhage, and resulted in similar left ventricular systolic function.

Chronic total obstruction and short-term outcome: the Excimer Laser Coronary Angioplasty Registry experience.

Percutaneous transluminal coronary angioplasty for chronic total obstructions is associated with significantly decreased success rates in comparison with those for dilation of subtotal stenoses. Failure usually results from inability to cross the occlusive lesion with a guidewire, although it may result from inability to pass the balloon catheter after the guidewire has been passed. In the Excimer Laser Coronary Angioplasty Registry, 172 chronic total obstructions were treated in 162 patients (10.3% of the 1,569 patients entered). For chronic total obstructions, passage of a guidewire is a prerequisite for laser angioplasty. Once a guidewire crossed an occlusion, the overall laser success rate for treatment of chronic total obstructions was 83%; the extent of stenosis decreased from 100% to 55 +/- 26%. Success was independent of length of the occlusive lesion. In 74% of patients, adjunctive percutaneous transluminal coronary angioplasty was used after laser angioplasty. A final procedural success, defined as residual stenosis of less than 50% and no major complication (coronary artery bypass grafting, myocardial infarction, or death), was achieved in 90%. Major complications were infrequent; 1.2% of patients required coronary artery bypass grafting, and 1.9% had a Q-wave myocardial infarction. Only one death occurred. The use of laser angioplasty may be of particular value when chronic total obstructions can be crossed with a guidewire but not with a conventional balloon catheter or when the occlusion is confirmed to be extremely long.

Intravascular ultrasound imaging combined with coronary angioplasty.

A novel catheter combining ultrasound imaging and coronary balloon angioplasty was used in the treatment of 69 coronary-artery lesions in 51 patients. The ultrasound transducer enables real-time cross-sectional imaging and qualitative and quantitative assessment of the vessel wall before and after angioplasty. The combination catheter successfully dilated 67 lesions. There was a characteristic three-layered appearance, representing intima, media, and adventitia, in 60 cases. Intravascular imaging provided information on the vessel wall unobtainable by standard contrast angiography in 28 cases and influenced our management in 6 cases.