Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study.

BACKGROUND: Intravascular ultrasound (IVUS) can assess stent geometry more accurately than angiography. Several studies have demonstrated that the degree of stent expansion as measured by IVUS directly correlated to clinical outcome. However, it is unclear if routine ultrasound guidance of stent implantation improves clinical outcome as compared with angiographic guidance alone. METHODS AND RESULTS: The CRUISE (Can Routine Ultrasound Influence Stent Expansion) study, a multicenter study IVUS substudy of the Stent Anti-thrombotic Regimen Study, was designed to assess the impact of IVUS on stent deployment in the high-pressure era. Nine centers were prospectively assigned to stent deployment with the use of ultrasound guidance and 7 centers to angiographic guidance alone with documentary (blinded) IVUS at the conclusion of the procedure. A total of 525 patients were enrolled with completed quantitative coronary angiography, quantitative coronary ultrasound, and clinical events adjudicated at 9 months for 499 patients. The IVUS-guided group had a larger minimal lumen diameter (2.9+/-0.4 versus 2.7+/-0. 5 mm, P<0.001) by quantitative coronary angiography and a larger minimal stent area (7.78+/-1.72 versus 7.06+/-2.13 mm(2), P<0.001) by quantitative coronary ultrasound. Target vessel revascularization, defined as clinically driven repeat interventional or surgical therapy of the index vessel at 9 month-follow-up, occurred significantly less frequently in the IVUS-guided group (8.5% versus 15.3%, P<0.05; relative reduction of 44%). CONCLUSIONS: These data suggest that ultrasound guidance of stent implantation may result in more effective stent expansion compared with angiographic guidance alone.

Clinical and angiographic follow-Up after primary stenting in acute myocardial infarction: the Primary Angioplasty in Myocardial Infarction (PAMI) stent pilot trial.

BACKGROUND: Restenosis has been reported in as many as 50% of patients within 6 months after PTCA in acute myocardial infarction (AMI), which necessitates repeat target-vessel revascularization (TVR) in approximately 20% of patients during this time period. Routine (primary) stent implantation after PTCA has the potential to further improve late outcomes. METHODS AND RESULTS: Primary stenting was performed as part of a prospective study in 236 consecutive patients without contraindications who presented with AMI of <12 hours' duration at 9 international centers. A mean of 1.4+/-0.7 stents were implanted per patient (97% Palmaz-Schatz) at 17.3+/-2.4 atm. During a clinical follow-up period of 7.4+/-2.6 months, death occurred in 4 patients (1.7%), reinfarction occurred in 5 patients (2.1%), and TVR was required in 26 patients (11.1%). By Cox regression analysis, small reference-vessel diameter and the number of stents implanted were the strongest determinants of TVR. Angiographic restenosis occurred in 27.5% of lesions. By multiple logistic regression analysis, the number of stents implanted and the absence of thrombus on the baseline angiogram were independent determinants of binary restenosis. CONCLUSIONS: A strategy of routine stent implantation during mechanical reperfusion of AMI is safe and is associated with favorable event-free survival and low rates of restenosis compared with primary PTCA alone.

Prospective, multicenter study of the safety and feasibility of primary stenting in acute myocardial infarction: in-hospital and 30-day results of the PAMI stent pilot trial. Primary Angioplasty in Myocardial Infarction Stent Pilot Trial Investigators.

OBJECTIVES: The goals of this study were to examine the safety and feasibility of a routine (primary) stent strategy in acute myocardial infarction (AMI). BACKGROUND: Limitations of reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) in AMI include in-hospital recurrent ischemia or reinfarction in 10% to 15% of patients, restenosis in 37% to 49% and late infarct-related artery reocclusion in 9% to 14%. By lowering the residual stenosis and sealing dissection planes created by PTCA, primary stenting may further improve short- and long-term outcomes after mechanical reperfusion. METHODS: Three hundred twelve consecutive patients treated with primary PTCA for AMI at nine international centers were prospectively enrolled. After PTCA, stenting was attempted in all eligible lesions (vessel size 3.0 to 4.0 mm; lesion length < or = 2 stents; and the absence of giant thrombus burden after PTCA, major side branch jeopardy or excessive proximal tortuosity or calcification). Patients with stents were treated with aspirin, ticlopidine and a 60-h tapering heparin regimen. RESULTS: Stenting was attempted in 240 (77%) of 312 patients, successfully in 236 (98%), with Thrombolysis in Myocardial Infarction grade 3 flow restored in 230 patients (96%). Patients with stents had low rates of in-hospital death (0.8%), reinfarction (1.7%), recurrent ischemia (3.8%) and predischarge target vessel revascularization for ischemia (1.3%). At 30-day follow-up, no additional deaths or reinfarctions occurred among patients with stents, and target vessel revascularization was required in only one additional patient (0.4%). CONCLUSIONS: Primary stenting is safe and feasible in the majority of patients with AMI and results in excellent short-term outcomes.

Stents in acute myocardial infarction.

It has been widely reported throughout studies comparing mechanical reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) with thrombolytic therapy in acute myocardial infarction (AMI) that PTCA results in reduced rates of in-hospital mortality, reinfarction, recurrent ischemia, and stroke, allowing earlier hospital discharge with similar total costs. The attraction of primary PTCA is its relative simplicity and predictability with operators who have a wide range of experience with PTCA. With these results, it is legitimate to wonder what, if any, possible advantages other reperfusion approaches, such as stenting, might offer compared with primary PTCA. In addition, there is concern that newer reperfusion modalities may complicate an otherwise straightforward procedure and increase hospital expenditures. However, as effective as primary PTCA is, there is still room for improvement. Limitations of reperfusion by primary PTCA in AMI include recurrent ischemia in 10% to 15% of patients, restenosis in 37% to 49%, and late infarct artery reocclusion in 9% to 14%. By reducing the residual stenosis and sealing dissection planes created by PTCA, primary stenting may further improve short- and long-term outcomes after mechanical reperfusion. Consequently, interest in using stents in the setting of AMI has increased dramatically in the past several years. The results of various recent clinical studies confirm that primary stenting is safe and reasonable in the majority of patients with AMI and produces short-term outcomes superior to experience with primary PTCA.

Excimer laser coronary angioplasty: the New Approaches to Coronary Intervention (NACI) experience.

In the New Approaches to Coronary Intervention (NACI) registry, 887 patients were electively treated with excimer laser coronary angioplasty (ELCA) for coronary artery disease. The Advanced Interventional System (AIS) system was used in 487 cases; the Spectranetics system, in 400. The mean age was 63.4 years. Most patients had unstable angina (60.3%); 43.7% had a prior myocardial infarction; and 18.6% were high risk or inoperable patients. Mean ejection fraction was 55.4%. A total of 1,000 lesions were treated in the 887 patients. Of the 1,000 lesions treated with ELCA in the 887 patients, 36% were in the right coronary artery; 33%, left anterior descending; 13%, circumflex; 3%, left main; and 16.6%, vein graft. By angiographic core laboratory analysis available for 752 (85%) patients with 839 lesions, lesions were 12.76 mm long. The minimum lumen diameter increased to 1.29 mm after the laser and finally to 1.95 mm after adjunctive percutaneous transluminal coronary angioplasty (PTCA) (which was performed in 93% of all lesions), with a final residual stenosis of 32.1% and Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow in 95%. Dissections of grades B, C, or D were seen after 22.0% of initial laser attempts, and postlaser perforations were noted in 2.6%. Additional such dissections accumulated after adjunctive PTCA but the perforation rate remained low. Procedural success was achieved in 84% of patients, but 1.2% died, 0.7% experienced Q-wave myocardial infarction (MI), and 2.7% required emergency bypass surgery. Multiple logistic regression analysis could not identify any independent predictors of these in-hospital complications. One-year mortality was 5.7% and the cumulative incidence of Q-wave MI was 1.5%. Coronary artery bypass graft (CABG) surgery was performed in 15.0% of patients whereas 25.5% required repeat percutaneous intervention with a target lesion revascularization rate of 31%. Independent predictors of death, Q-wave MI, or target lesion revascularization (which, combined, occurred in 35.6% of patients) were the absence of prior MI, ELCA in the circumflex, perforation after the procedure, and small (<2 mm) final minimal lumen diameter. Considering the large number of patients with high-risk lesions, laser angioplasty was performed with excellent procedural success rates and a reasonable incidence of major complications.

Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. Saphenous Vein De Novo Trial Investigators.

BACKGROUND: Treatment of stenosis in saphenous-vein grafts after coronary-artery bypass surgery is a difficult challenge. The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in patients with obstructive disease of saphenous-vein grafts. METHODS: A total of 220 patients with new lesions in aortocoronary-venous bypass grafts were randomly assigned to placement of Palmaz-Schatz stents or standard balloon angioplasty. Coronary angiography was performed during the index procedure and six months later. RESULTS: As compared with the patients assigned to angioplasty, those assigned to stenting had a higher rate of procedural efficacy, defined as a reduction in stenosis to less than 50 percent of the vessel diameter without a major cardiac complication (92 percent vs. 69 percent, P<0.001), but they had more frequent hemorrhagic complications (17 percent vs. 5 percent, P<0.01). Patients in the stent group had a larger mean (+/-SD) increase in luminal diameter immediately after the procedure (1.92+/-0.30 mm, as compared with 1.21+/-0.37 mm in the angioplasty group; P<0.001) and a greater mean net gain in luminal diameter at six months (0.85+/-0.96 vs. 0.54+/-0.91 mm, P=0.002). Restenosis occurred in 37 percent of the patients in the stent group and in 46 percent of the patients in the angioplasty group (P=0.24). The outcome in terms of freedom from death, myocardial infarction, repeated bypass surgery, or revascularization of the target lesion was significantly better in the stent group (73 percent vs. 58 percent, P = 0.03). CONCLUSIONS: As compared with balloon angioplasty, stenting of selected venous bypass-graft lesions resulted in superior procedural outcomes, a larger gain in luminal diameter, and a reduction in major cardiac events. However, there was no significant benefit in the rate of angiographic restenosis, which was the primary end point of the study.

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.

Emergency use of cardiopulmonary bypass.

Emergency cardiopulmonary support has been used in the United States since 1986. Physicians at participating centers for the National Registry of Elective Supported Angioplasty have contributed data on emergent cardiopulmonary support from their institutions. Results were analyzed to assess the benefits of cardiopulmonary support in patients with hemodynamic collapse. Patients with either cardiac arrest or hemodynamic collapse with cardiogenic shock unresponsive to pressor agents were placed emergently on cardiopulmonary support. Subsequent treatment comprised either angioplasty or surgical revascularization. Patients placed on cardiopulmonary support in < 20 minutes experienced a 41% survival rate across the entire registry of the participating centers of the National Cardiopulmonary Bypass Registry. Two centers with considerable experience demonstrated a 69% survival rate. Patients treated with emergency cardiopulmonary support because of hemodynamic collapse showed improved survival over any other hemodynamic support system. Results have improved for survival with increased operator experience, particularly in the early application group.

Regional flow adjusted hemoperfusion during coronary angioplasty: circulatory support/myocardial protection.

Routine percutaneous transluminal coronary angioplasty catheters are adequate and demonstrate high success rates in balloon angioplasty with stable patients. Active hemoperfusion seems to offer an advantage in patients with hemodynamic instability. Active hemoperfusion provides myocardial protection during coronary interventions and can be applied in conjunction with routine angioplasty equipment. When compared with other devices demonstrating clinical utility in a supported angioplasty setting, this flow adjustable active antegrade hemoperfusion pump appears reliable, simple to use, cost-effective, and requires much less instrumentation than the more bulky CPS systems.

Technical aspects in the performance of primary PTCA.

More than 2,000 angioplasties have been performed in our institutions either during or surrounding acute myocardial infarction. We will review the practical aspects of the performance of primary percutaneous transluminal coronary angioplasty with outlines for implementation of the angiogram, conducting angioplasty, giving adjunctive therapies, care of the patient after the intervention and the potential need for subsequent coronary bypass surgery. The rationale for risk stratification with angiography, order and technical aspects of the performance of percutaneous transluminal coronary angioplasty, need for adjunctive medical therapy and details of after care will be fundamentally outlined.

Initiation and operation of a primary PTCA program.

Since beginning primary angioplasty in the early eighties we have used angioplasty in or related to acute myocardial infarction in over 2,300 patients. We will review here the use of direct, immediate, rescue and deferred or elective angioplasty in acute myocardial infarction. Organization of the cardiac catheterization laboratory staff, transport programs, and planning for surgical stand-by have all contributed to patient benefit in our program and will be outlined. Our acute MI approach both for angioplasty and for follow-up surgery will be reviewed.

Emergency cardiopulmonary support with circulatory support devices.

Emergency cardiopulmonary support has been used in the United States since 1986, mainly by physicians at participating centers for the National Registry of Elective Supported Angioplasty. Data from the National Registry as well as the experience in three institutions from a number of operators were analyzed to assess the benefits of the emergency cardiopulmonary support application in patients with hemodynamic collapse. Patients who had experienced either cardiac arrest or hemodynamic collapse with cardiogenic shock unresponsive to pressors were placed emergently on cardiopulmonary support. They were either then treated with angioplasty or with revascularization surgery. Patients placed on cardiopulmonary support in less than 15 min experienced a 48% survival rate across the whole registry of the participating centers of the National Cardiopulmonary Bypass Registry. A two-center experience has demonstrated a 69% survival rate. Patients treated with emergency cardiopulmonary support who have experienced hemodynamic collapse have improved survivorship over any other hemodynamic support system. With increasing experience by the operators, the results have improved for survivorship, particularly in the early application group.

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.

Outcome of urgent percutaneous transluminal coronary angioplasty in acute myocardial infarction: comparison of single-vessel versus multivessel coronary artery disease.

Despite recent clinical trials of percutaneous transluminal coronary angioplasty (PTCA) in acute myocardial infarction, specific groups of patients that may benefit from adjunctive or alternative therapy have yet to be adequately characterized. The in-hospital outcome of 151 consecutive patients treated for acute myocardial infarction with urgent PTCA of the infarct-related artery was studied to identify a subgroup of patients at high risk. Patients were divided into two groups based on the angiographic presence of either single-vessel (n = 86) or multivessel (n = 65) coronary artery disease. Despite PTCA of only the infarct-related artery and similar baseline clinical characteristics such as age, peak serum creatine kinase concentration, left ventricular ejection fraction, and time from the onset of chest pain to arrival at the hospital, the group with multivessel disease had a lower rate of successful angioplasty (75% vs 92%, p < 0.005), with higher incidences of persistent total occlusion of the infarct-related artery (14% vs 3%, p < 0.02) and procedural complications during PTCA (28% vs 13%, p < or = 0.02), and were more likely to have multiple complications (12% vs 1%, p < 0.004). In addition, the group with multivessel disease had a higher rate of urgent (< or = 24 hours) coronary artery bypass graft surgery (13% vs 2%, p < 0.05) and a trend toward a higher in-hospital mortality rate (6% vs 1%, p < or = 0.17). By stepwise logistic regression, only the presence of single-vessel versus multivessel disease was predictive of PTCA success (p < 0.005).(ABSTRACT TRUNCATED AT 250 WORDS)

Improved patient survival after cardiac arrest using a cardiopulmonary support system.

A portable cardiopulmonary bypass system that can be rapidly deployed in a nonsurgical setting using nursing staff was used in 38 patients with cardiovascular collapse refractory to ACLS protocol. Percutaneous or cutdown cannulation sites were: femoral vein-femoral artery (n = 18), right internal jugular vein-femoral artery (n = 2), right atrium-ascending aorta (n = 12), or a combination approach (n = 4). Two patients could not be cannulated. Patient diagnoses were pulmonary emboli (n = 3), failed coronary angioplasty (n = 7), myocardial infarction with cardiogenic shock (n = 5), trauma (n = 7), aortic stenosis (n = 2), postcardiotomy deterioration (n = 10), deterioration after cardiac transplantation (n = 2), cardiomyopathy with shock (n = 1), and ruptured ascending aortic dissection (n = 1). Ninety-five percent of patients (36 of 38) were successfully resuscitated to a stable rhythm. Eight diagnostic procedures (coronary angiography, n = 4; pulmonary angiography, n = 3; and aortography, n = 1) were performed while patients were on cardiopulmonary support. Early deaths resulted from massive hemorrhage (n = 8), inability to cannulate (n = 2), and irreversible myocardial injury (n = 10). Sixty-six percent (24 of 36) of patients successfully cannulated underwent conversion to standard cardiopulmonary bypass with attendant operative procedure or placement of ventricular assist device or total artificial heart. Fifty percent (18 of 36) of patients cannulated were successfully weaned from cardiopulmonary support, and 17% (6/36) are long-term survivors.(ABSTRACT TRUNCATED AT 250 WORDS)

Cardiac complications of Wegener granulomatosis: a case report of complete heart block and review of the literature.

Wegener granulomatosis is a necrotizing vasculitis whose target organs are classically the upper and lower respiratory tracts and the kidneys. There has been other end-organ involvement documentation, emphasizing the disseminated nature of this disease, but the literature concerning cardiac involvement is limited. The few case reports and general reviews show that the two most common histologic cardiac manifestations are pericarditis and coronary arteritis, each occurring in 50% of the reported cases. The most frequent clinical manifestation is cardiac arrhythmias that are manifested as supraventricular tachyarrhythmias. We report an unusual cardiac manifestation, a case of complete heart block, occurring during the active stage of Wegener granulomatosis. The problem this case presented and the management are reported. The literature dealing with the cardiac involvement in Wegener granulomatosis is reviewed, and the specific histopathologic findings and the pathophysiologic mechanisms of this involvement are discussed.