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Aim: Balloon aortic valvuloplasty (BAV) has reemerged with transcatheter valve therapy. Cylindrical balloons have been the device of choice despite limitations. An hour glass shaped balloon may permit enhanced fixation and broader leaflet opening without annular compromise., Methods: We report our initial BAV experience using the V8 balloon (InterValve Inc.) in 20 consecutive patients compared to 20 patients from a 403-patient BAV database using cylindrical balloons. Patients were propensity matched on a 1:1 basis by age, gender, left ventricular ejection fraction (LVEF), baseline aortic valve area (AVA) and Society of Thoracic Surgery (STS) mortality risk score. End points included change in AVA and aortic insufficiency (AI) by echocardiography. New atrioventricular conduction defects (AVCD), need for post procedure pacemaker were documented. Major adverse events (MAE) included procedure related death, emergency surgery or stroke., Results: V8 and cylindrical balloon groups were similar across age, gender, LVEF, AVA and STS score. The change in AVA from baseline to post-procedure strongly trended towards being larger in the V8 group than cylindrical balloon group (mean [SD]; 0.30±0.23 cm2 vs. 0.17±0.21 cm2; P=0.063). There were no differences in outcomes for degree of AI, AVCD, need for pacemaker or MAE., Conclusion: Preliminary findings in this small experience suggest an advantage for enhancing AVA when using the V8 compared with cylindrical balloons. Additionally, there was no evidence of increased AI, AVCD or MAE.

The aim of this first U.S. feasibility study was to investigate the safety and efficacy of a novel vascular sealing device, Duett, following percutaneous endovascular procedures. Immediately following a catheterization procedure, the sealing device was deployed at the femoral arterial access site in 43 patients (diagnostic 29, intervention 11, intervention + abciximab 3). Patients were followed up at 1 month with clinical assessment, ankle-brachial index measurement, and Doppler ultrasound of the treated femoral artery puncture site. Successful hemostasis was achieved with the Duett alone in 42/43 (97.7%) patients. There was one uncomplicated crossover to manual compression. The time to hemostasis was 4.0+/-1.5, 6.9+/-4.2, and 5.8+/-1.2 min for diagnostic, interventional, and abciximab patients, respectively. At 1-month follow-up, one patient (2.3%) required ultrasound-guided compression for treatment of a pseudoaneurysm. There were no other major complications. This novel vascular sealing device appears to achieve rapid and safe hemostasis successfully immediately following a wide range of percutaneous endovascular procedures.

Background: Coronary artery bypass surgery (CABG) has been considered the therapy of choice for patients with unprotected left main (ULMT) coronary stenoses. Selected single-center reports suggest that the results of percutaneous intervention may now approach those of CABG., Methods and Results: To assess the results of percutaneous ULMT treatment from a wide variety of experienced interventional centers, we requested data on consecutive patients treated after January 1, 1994, from 25 centers. One hundred seven patients were identified who were treated either electively (n=91) or for acute myocardial infarction (n=16). Of patients treated electively, 25% were considered inoperable, and 27% were considered high risk for bypass surgery. Primary treatment included stents (50%), directional atherectomy (24%), and balloon angioplasty (20%). Follow-up was 98.8% complete at 15+/-8 months. Results varied considerably, depending on presentation and treatment. For patients with acute myocardial infarction, technical success was achieved in 75%, and survival to hospital discharge was 31%. For elective patients, technical success was achieved in 98.9%, and in-hospital survival was strongly correlated with left ventricular ejection fraction (P=.003). Longer-term event (death, infarction, or bypass surgery) -free survival was correlated with ejection fraction (P<.001) and was inversely related to presentation with progressive or rest angina (P<.001). Surgical candidates with ejection fractions > or = 40% had an in-hospital survival of 98% and a 9-month event-free survival of 86+/-5%, whereas patients with ejection fractions < 40% had 67% and 22+/-12% in-hospital and 9-month event-free survivals, respectively. Nine hospital survivors (10.6%) experienced cardiac death within 6 months of hospital discharge., Conclusions: While results for selected patients appear promising, until early post-hospital discharge cardiac death can be better understood and minimized, percutaneous revascularization of ULMT stenosis should not be considered an alternative to bypass surgery for most patients. When percutaneous revascularization of ULMT is required, directional atherectomy and stenting appear to be the preferred techniques, and follow-up angiography 6 to 8 weeks after treatment is probably advisable.

Minimally invasive direct coronary artery bypass grafting offers mortality and morbidity advantages to selected patients. To broaden indications for such, an appropriate and combined disciplinary approach using angioplasty and minimally invasive direct coronary artery bypass grafting is described in a patient requiring reoperative grafting. Documentation of patency of new left internal mammary artery-to-left anterior descending artery anastomoses performed without the use of cardiopulmonary bypass was obtained intraoperatively using a Thermal Imaging Camera.

Objectives: We hypothesized that atherectomy would be superior to balloon angioplasty for ostial and nonostial left anterior descending coronary artery lesions., Background: Balloon angioplasty of ostial coronary artery lesions has been associated with a lower procedural success rate and a higher rate of complications and of restenosis than angioplasty of nonostial stenoses. Directional coronary atherectomy has been proposed as an alternative therapy for ostial lesions., Methods: In the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), 1,012 patients were randomized to undergo either procedure; 563 patients had proximal left anterior descending coronary artery lesions, of which 74 were ostial. We compared balloon angioplasty with directional atherectomy for early and 6-month results for ostial as well as nonostial proximal left anterior descending coronary artery lesions., Results: Directional atherectomy led to an initially higher gain in minimal lumen diameter for ostial lesions (1.13 vs. 0.56 mm, respectively, p < 0.001) but a higher rate of adjudicated non-Q wave myocardial infarction (24% vs. 13%, respectively, p < 0.001) than balloon angioplasty and no improvement in restenosis rates (48% vs. 46%, respectively). In the nonostial proximal left anterior descending coronary artery lesions, angiographic restenosis was reduced (51% vs. 66%, p = 0.012), but this was also associated with a higher rate of periprocedural myocardial infarction (8% vs. 2%, p = 0.008 by site and 24% vs. 8%, p < 0.001 by adjudication) and no difference in the need for subsequent coronary artery bypass surgery (7.3% vs. 8.4%, respectively) or repeat percutaneous coronary intervention (24% vs. 26%, respectively)., Conclusions: For ostial left anterior descending coronary artery stenoses, both procedures yielded similar rates of initial success and restenosis, but atherectomy was associated with more non-Q wave myocardial infarction. In this trial the predominant angiographic benefit (increased early gain and less angiographic restenosis) of atherectomy for the left anterior descending coronary artery was in proximal nonostial lesions. However, the tradeoffs for this angiographic advantage were more in-hospital myocardial infarctions and no decrease in clinical restenosis.

Lipids play a vital role in normal metabolic function in mammals. However, dyslipoproteinemias have been implicated in the pathophysiologic process of atherogenesis, thrombogenesis and restenosis after interventional procedures. Lipoproteins provide important chemical linkages among these three complex phenomena. Lipoproteins participate in atherogenesis and play a major role in plaque fissuring, the pathophysiologic common denominator of acute ischemic syndromes. Thrombogenesis is majoraly affected by the action of lipids on platelets, coagulation and fibrinolysis. LDL tend to destabilize platelet membrane activity, macrophages, endothelial and smooth muscle cell function; HDL tend to reverse these abnormalities. The metabolism of arachidonic acid, a metabolite of the essential polyunsaturated lipoprotein, linoleic acid, is integral to platelet and endothelial cell membrane formation, via the cyclooxygenase-prostanoid pathway. Arachidonic acid also is metabolized by the lipoxygenase-leukotreine pathway in neutrophils and monocytes. The relationship of dyslipoproteinemias (increased LDL and Lp(a); decreased HDL) to restenosis after angioplasty has been reported, though there is not universal agreement about causality. Lipid lowering regimens and other pharmacotherapy have had favorable effect slowing the rate of atherogenesis, decreasing the frequency of cardiac events (perhaps by "stabilizing" vulnerable plaques) and causing regression in some atheromata. The salutary effect of lipid-lowering agents upon the incidence of restenosis after angioplasty is problematic. Some investigators have found a statistically significant correlation, while others have not; but studies have not been standardized. In conclusion, the study of lipid metabolism across a wide range of physiochemical activities and the interaction of these phenomena describe complex, genetically determined linkages which instruct (and often humble) investigators in their study of lipids in health and disease.

The percutaneous treatment of complex stenoses, specifically long lesions, has improved substantially during the past decade. To determine the success of directional atherectomy in the treatment of long lesions, a cohort of 88 patients with lesions greater than 10 mm were evaluated and compared to 376 patients with long lesions treated with conventional balloon angioplasty. Directional atherectomy was successful in 97% and PTCA was successful in 93% of patients with long lesions. There were no differences in complication rates for these cohorts (< 2%). Directional atherectomy and PTCA appear to have safely and successfully broadened the percutaneous treatment of coronary disease to include long coronary stenoses.

To determine whether transesophageal echocardiography (TEE) is useful in ruling out the presence of atrial thrombus, we performed TEE in 20 patients immediately before valve replacement or valve repair and within 3 days of an autopsy in one patient. Mitral stenosis was the predominant lesion in three patients, mitral regurgitation was seen in 11 patients, five patients had mitral prosthesis malfunction, one patient had a tricuspid prosthesis malfunction, and one patient had aortic stenosis. Eight patients were in atrial fibrillation. Four patients demonstrated spontaneous contrast in the associated atria. Nine patients were receiving oral anticoagulation. Mean left atrial diameter was 5.3 +/- 1.3 mm. TEE revealed no evidence for atrial thrombus in 18 of the 21 patients; this finding was confirmed by careful inspection of the atria including the appendages. TEE demonstrated a left atrial thrombus in two patients and a right atrial thrombus in another (confirmed at the time of surgery or at autopsy). In all cases transthoracic echocardiography was negative. Our data suggest that TEE is useful in ruling out atrial thrombus, and therefore may be a useful test preceding interventions associated with an increased risk of embolism from the atria such as cardioversion, mitral valvuloplasty, or valve replacement.

The safety and efficacy of percutaneous transluminal coronary angioplasty (PTCA) for stenoses involving ulcerative lesions were retrospectively studied. Seventy-seven patients (62 men and 15 women, mean age 62 +/- 10 years) representing 3.4% of 2,250 patients treated with PTCA during the period January 1, 1988 and June 30, 1990, had pre-PTCA stenoses defined as ulcerated. Twenty-eight (36%) of the stenoses were localized in the left anterior descending coronary artery, 9 (12%) in the left circumflex and 40 (52%) in the right coronary artery. During angioplasty, percent diameter stenosis was reduced from 73 +/- 14% to 22 +/- 13% and transstenotic gradient decreased from 48 +/- 18 to 12 +/- 6 mm Hg. Clinical success (freedom from angina at discharge without coronary bypass surgery, infarction or death) was achieved in 70 patients (90.9%). There were seven unsuccessful cases: three underwent elective coronary bypass surgery, one was managed medically, and three developed a major flow interrupting dissection during the procedure requiring emergency coronary bypass surgery. There were no deaths. At mean follow-up of 7.6 months, 45 of 61 patients (73.7%) remained asymptomatic. One patient needed an elective coronary bypass surgery and five patients had a successful repeat PTCA. In conclusion, PTCA for an ulcerated stenosis can be performed safely with a high primary success rate and a favorable early clinical course.

The Ultra Select¿ guidewire is a solid nitinol core torque wire that recently became available for use in coronary angioplasty. This wire has near one-to-one torque with kink resistant axial strength. The wire is radioopaque and highly visible. It is effective in negotiating severe tortuosity. Nitinol (nickel-titanium alloy) has unique properties that allow for specific performance advantages for use in coronary angioplasty. This report discusses this new guidewire and its use in coronary angioplasty.

To determine if morphology of procedure-associated dissections could help predict clinical outcome, angiograms of 691 coronary artery dissections resulting from percutaneous transluminal coronary angioplasty were categorized according to the National Heart, Lung, and Blood Institute classification system. Classes of dissection were then correlated with clinical outcome: 543 patients with type B dissections had no increase in morbidity and mortality when compared with patients without dissection, with a similar success rate of 93.7%. Complications in this group were low and compared favorably with complication rates in procedures not associated with dissection. One hundred forty-eight procedures associated with dissections of types C to F had a significant increase in in-hospital complications, including acute closure (31%), need for emergency coronary bypass surgery (37%), myocardial infarction (13%) and repeat angioplasty (24%). The overall clinical success rate for those with types C to F dissection was 38%. The differences in clinical success and acute complications between type B and types C to F dissections were statistically significant at p less than 0.0005 for all variables studied. The angiographic morphology of a dissection during coronary angioplasty can predict clinical outcome, aiding in selection of effective therapy.

To determine if transesophageal echocardiography provides better visualization of valvular vegetations than transthoracic echocardiography, we used both methods to evaluate 24 consecutive patients (mean age, 54 years; 15 female patients and nine male patients) referred for symptoms suggestive of infectious endocarditis. Ten of the 24 patients had one or more valvular prostheses. Echocardiograms were classified as positive or negative based on visualization of valvular vegetations or abscesses. Of ten patients with a final diagnosis of infectious endocarditis on extended follow-up, transthoracic echocardiography was positive in five patients. Transesophageal echocardiography not only yielded abnormal findings in all ten of these patients, but also revealed additional information in four of the five patients with abnormal transthoracic echocardiographic examinations. Among the 14 patients who, on subsequent follow-up, were found not to have infectious endocarditis, transthoracic echocardiography was normal in 13 and falsely abnormal in one. Transesophageal echocardiography revealed no evidence of infectious endocarditis in any of these patients. The ten patients who were determined to have infectious endocarditis all had positive blood cultures and no alternative cause for their clinical presentation; in seven patients in this group who underwent operative or postmortem evaluation, infectious endocarditis was confirmed. All patients without infectious endocarditis were demonstrated to have other causes for their clinical presentation. We conclude that transesophageal echocardiography is a highly valuable test in the work-up of patients with suspected infectious endocarditis, especially those patients with inconclusive or normal transthoracic echocardiograms. In addition, transesophageal echocardiography may be of benefit to patients with previously documented infectious endocarditis and a complicated clinical course in whom additional cardiac lesions are suspected but not demonstrated by transthoracic echocardiography.

Transesophageal color flow Doppler findings are reported in 36 patients with a St. Jude Medical mechanical mitral valve prosthesis who had no auscultatory evidence for prosthetic valve dysfunction. Multiple jets consistent with mitral regurgitation originating from the central and lateral portion of the prosthesis were found in all patients. Maximum jet length ranged from 11 to 51 mm (mean 21 +/- 9 mm). Maximum jet area ranged from 0.2 to 4.1 cm3 (mean 1.2 +/- 0.9 cm2). The color M-mode Doppler interrogation showed two distinct components of the regurgitant jet: brief early systolic flow consistent with valve closure followed by holosystolic regurgitant flow consistent with transvalvular leakage. Four patients (11%) had a maximum regurgitant jet length exceeding 30 mm and absence of early systolic closure regurgitant flow by M-mode color imaging, suggesting clinically silent paravalvular leakage. Two pin-sized paravalvular suture line defects were confirmed in one patient at cardiac transplantation. We conclude that transesophageal echocardiography is a highly sensitive method for detection of mitral regurgitation in the St. Jude Medical mitral prosthesis. Clinically silent paravalvular leakage should be suspected if the maximum jet length exceeds 30 mm and color M-mode interrogation fails to demonstrate an early systolic closure regurgitant flow component.

Seismocardiography, a new noninvasive technique, detects low-frequency cardiac vibrations on the chest wall during ventricular contraction and during both early and late ventricular filling. To evaluate the ability of seismocardiography to detect ischemia caused by decreased coronary blood flow, 35 patients were studied during coronary angioplasty. Seismocardiograms and electrocardiograms were recorded twice at baseline, with the catheter across the lesion before first inflation (n = 15), every 30 seconds during the first inflation, 1 and 2 minutes after the first inflation and greater than or equal to 5 minutes after the final inflation. For comparison, sequential seismocardiograms were also obtained from 15 healthy volunteers. Electrocardiograms were blindly scored for ST change from baseline (0 = none, 1 = 0.5 mm ST depression, 2 = greater than or equal to 1.0 mm ST depression, 3 = ST elevation). Seismocardiograms were blindly scored for change from baseline (0 = none, 1 = mild, 2 = moderate, 3 = marked) for both the systolic and diastolic waves. The average maximal systolic seismocardiographic score was 2.5 +/- 0.8 for patients who had undergone angioplasty and 1.0 +/- 0.9 for volunteers (p less than 0.001). The average maximal diastolic seismocardiographic score was 2.3 +/- 0.8 for angioplasty patients and 0.7 +/- 0.9 for volunteers (p less than 0.001). The percentage of angioplasty patients with electrocardiographic, systolic and diastolic seismocardiographic scores greater than or equal to 2 was, respectively: 0, 11 and 14% at second baseline; 23, 67 and 53% with catheter across the lesion; 44, 75 and 59% after 30 seconds of inflation; 42, 71 and 61% after 60 seconds of inflation; 23, 74 and 61% after 1 minute of deflation; and 0, 71 and 47% 5 minutes after final inflation.(ABSTRACT TRUNCATED AT 250 WORDS)

The efficacy and safety of coronary angioplasty for stenoses adjacent to coronary aneurysms were studied in 25 patients (19 men and 6 women, mean age 62 +/- 11 years). The study represented 1.1% of patients undergoing coronary angioplasty during the study time period. The aneurysm diameter exceeded 1.8 +/- 0.2 times the normal artery diameter. Eleven (44%) of these aneurysms were localized in the left anterior descending, 3 (12%) in the circumflex and 11 (44%) in the right coronary artery. Percent diameter stenosis was reduced from 72 +/- 10% to 23 +/- 19%, and transstenotic gradient from 51 +/- 13 to 15 +/- 9 mmHg when measured. Clinical success (absence of pain on discharge without coronary bypass surgery, death, or infarction) was achieved in 24 (96%) patients. In one patient acute vessel closure occurred. No embolic events or coronary artery rupture occurred. Seventeen (71%) of the 24 successful patients remained asymptomatic at clinical follow-up (mean = 7.7 +/- 5.0 months). At late follow-up, one patient had sustained a myocardial infarction, two had elective bypass surgery, and two had successful repeat angioplasty. The data from this small patient population suggest that angioplasty for a stenosis adjacent to a coronary aneurysm can be performed safely with a high primary success rate.

The authors of this study hypothesized that percutaneous transluminal coronary angioplasty of a stenosis at the ostium of a branch vessel, whether isolated or associated with a bifurcation stenosis, was associated with reduced procedural success and increased in-hospital complications. One hundred six patients with 119 ostial branch stenoses were compared with 1,168 patients who underwent angioplasty of nonostial branch stenoses. An ostial branch stenosis was defined as a stenosis in the proximal 3 mm of a major branch vessel (diagonal [n = 58], posterior descending [n = 21], obtuse marginal [n = 34] and intermediate [n = 6]). The ostial branch stenosis was isolated in 61% of the patients and associated with a bifurcation stenosis in 39%. Despite a balloon to artery ratio of 1.05:1, angiographic success was 74% of ostial branch stenoses versus 91% of nonostial stenoses (p less than 0.01). Furthermore, angioplasty of ostial branch stenoses resulted in a complication rate of 13 versus 5% for angioplasty of nonostial branch stenoses (p less than 0.01). Therefore, angioplasty of ostial branch stenoses results in decreased procedural success and significant residual stenosis despite adequate balloon sizing, suggesting arterial elastic recoil and a significant increase in complications.

Emergency percutaneous cardiopulmonary bypass support was instituted in 11 patients in cardiac arrest refractory to conventional resuscitation measures. Emergency percutaneous cardiopulmonary bypass support was used in five patients in whom cardiac arrest occurred as a result of a complication in the cardiac catheterization laboratory (group 1) and in six other patients in cardiac arrest (group II). A 21F cannula and a 17F cannula were percutaneously inserted into the femoral vein and artery. Flow rates of 3 to 5 L/min were achieved with restoration of mean arterial pressure to 70 mm Hg (range 50 to 75). The status of all 11 patients was improved initially both clinically and hemodynamically with percutaneous cardiopulmonary bypass. Of the group II patients, three had anatomy unsuitable for percutaneous transluminal coronary angioplasty or coronary bypass grafting, could not be weaned from cardiopulmonary support, and died; three of these patients had coronary artery bypass grafting and two survived. All five group I patients underwent successful coronary bypass grafting and survived. Of the seven patients with anatomically correctable disease, all seven were discharged from the hospital. With conventional management nearly all seven of these patients would have died. Nine of 11 patients underwent a cardiac operation and seven of the nine survived. The operative mortality rate was 22% and the overall survival rate was 64%. At follow-up (mean 7 months), all seven patients are alive and six have resumed a normal and active life-style. In conclusion, emergency percutaneous cardiopulmonary bypass support is a powerful resuscitative tool that may stabilize the condition of patients in cardiogenic shock and cardiac arrest to allow for definitive intervention.

Percutaneous cardiopulmonary bypass support was electively instituted prior to coronary angioplasty in 16 patients at high risk for hemodynamic collapse. In all cases the dilated artery supplied greater than 2/3 of the functioning myocardium. Eight patients had moderate LV dysfunction with ejection fraction 25-40%. Eight patients had an ejection fraction less than 20%. A 21 French cannula and a 17 French cannula were percutaneously inserted into the femoral vein and artery. Cardiopulmonary bypass support was instituted using a Bio-Medicus centrifugal pump just prior to coronary angioplasty at flow rates of 3.5-5 liters/minute. Thirteen patients had single vessel angioplasty and three patients had multivessel angioplasty. Complete loss of systolic function was observed in 9 (56%) patients. This finding when present confirms the absolute requirement for cardiopulmonary support. Technical success was achieved in all 16 patients (100%), clinical success was achieved in 14 patients (88%). Patient followup (mean 10 months) revealed 3 patients with class I-II angina and 10 patients were asymptomatic. There was one late death. In conclusion, percutaneous cardiopulmonary bypass support for carefully selected high risk patients may allow coronary angioplasty to be performed safely and effectively despite complete loss of systolic function during balloon inflation.

Recent advances in hemodynamic support can allow patients at high risk for cardiovascular collapse to become candidates for coronary interventions. A new axial blood flow pump has recently been developed and made available for clinical testing. This intravascular pump utilizes an Archimedes screw pump rotating at 25,000 rpms to provide a flow of 2 to 3.5 liters/minute. The 7 mm inlet cannula of the cable driven pump is delivered across the aortic valve. The pump discharges blood into the descending aorta. This design does not require a membrane oxygenator. This pump would be expected to: 1) provide circulatory support irrespective of heart arrhythmias; 2) provide left ventricular unloading and 3) lack the fluid and coagulation abnormalities of prolonged cardiopulmonary bypass. This unique device offers great promise to the interventional cardiologist.

A two-center elective coronary angioplasty experience with intra-aortic balloon pump support for patients with severe left ventricular dysfunction is reported. To prevent hemodynamic collapse, an intra-aortic balloon pump was inserted percutaneously before coronary angioplasty in 97 patients with a left ventricular ejection fraction less than 35% (26% of whom had ejection fractions less than 25%). The cohort was predominantly male (71%) with a mean age of 64 +/- 9 years. Angioplasty was successfully performed in 83 (85.6%) patients and 80 (82.5%) of these successful patients were discharged from the hospital. Seven patients had unsuccessful angioplasty without a major cardiac event. Seven patients (7.2%) suffered a major cardiac event; 4 had emergent coronary bypass surgery with q-wave infarction, 2 had uneventful emergency coronary bypass surgery, and one patient died in the operating room after a failed angioplasty. Using logistic regression analysis, the presence of multivessel disease and a history of prior myocardial infarction were associated with more complications during angioplasty (p less than 0.05). Intra-aortic balloon pump placement did not interfere with the angioplasty procedure. Two patients had limb ischemia which resolved when the intra-aortic balloon pump was removed. Of the 80 successful patients discharged, 72 were followed for a mean of 22 months. At the latest follow-up, 52 had not suffered a myocardial infarction and were alive. Of the 20 late deaths, 16 were cardiac and 4 non-cardiac.(ABSTRACT TRUNCATED AT 250 WORDS)

Between March 1978 and July 1981, 217 symptomatic patients underwent coronary angioplasty as an alternative to coronary bypass surgery. Angioplasty was successful in 143 patients (66%), unsuccessful but uncomplicated in 65 (30%) and complicated in 9 (4%) by one or more of the following criteria: Q wave myocardial infarction (2%), emergency surgery (4%) or death (0.5%). Late follow-up evaluation was obtained in 213 patients at a mean of 9 +/- 1 years. Of patients in whom angioplasty was successful, 59 (42%) of 140 required another revascularization procedure (repeat angioplasty in 26% and bypass surgery in 16%). The actuarial survival rate at 5, 9 and 10 years after successful angioplasty was 98%, 93% and 92%, respectively. Of the 65 patients with unsuccessful and uncomplicated angioplasty (usually as a result of technical factors), 58 underwent elective bypass surgery within 2 months and 56 survived. These 56 surgical patients were compared with the 140 patients with successful angioplasty. Univariate analysis of prognostic factors did not reveal significant differences between these two groups. At late follow-up study, the successful angioplasty and the successful surgical groups had similar rates of survival (93% versus 95%, p = NS) and of death or infarction, or both (11% versus 12.5%, p = NS). Repeat revascularization was required more frequently after successful angioplasty than after surgery (42% versus 18%, p less than 0.001). Crossover from angioplasty to surgery occurred slightly more often than from surgery to angioplasty (16% versus 12.5%, p = NS). The time to crossover from angioplasty to surgery occurred earlier than from surgery to angioplasty (mean 21 versus 76 months, p less than 0.001).

The Monorail Piccolino coronary angioplasty balloon catheter (MBC) was evaluated on 118 patients at two centers. Technical success was achieved in 110 patients (93%). Time for catheter exchange and total fluoroscopy time were significantly lower for the Monorail catheter than with standard equipment (exchange time 97 vs. 170 seconds P less than .05 and fluoroscopy time 17 vs. 88 seconds P less than .001). The advantages of rapid exchange and the ability of utilize 2 Monorail balloon catheters through one 9F guiding catheter for simultaneous inflations allowed for maximal flexibility in treating patients with bifurcation lesions. The double wire approach utilizing one Monorail balloon catheter with a 7F guiding catheter was also technically successful. The Monorail Piccolino balloon catheter has unique features that allow for greater ease of operator use, rapid catheter exchange, and optimal angiographic visualization. It is felt that this catheter design provides distinct advantages over standard angioplasty equipment.

A cohort of 112 consecutive patients with angiographically defined intracoronary thrombi was treated with percutaneous transluminal coronary angioplasty and followed prospectively to determine early and late outcomes. Coronary angioplasty using a treatment modality of intravenous and intracoronary heparin, antiplatelet agents and prolonged inflations with oversized balloons (balloon:vessel ratio, 1.2:1) resulted in clinical success in 103 patients (92%) at hospital discharge. No periprocedural thrombolytic therapy was used and prolonged pretreatment with heparin was not routinely used. Four patients (3.5%) required elective coronary bypass surgery, and 4 patients (3.5%) required emergency coronary artery bypass grafting because of abrupt closure. Late clinical follow-up (mean 7 months) was available in 99 of the 103 successfully treated patients (96%). Seventy-three percent of patients were asymptomatic at follow-up, and 27% had class I or II angina. No patients had a late myocardial infarction. Elective coronary artery bypass surgery was required in 3 patients (3%) and repeat coronary angioplasty in 17 patients (17%). There were 2 late cardiac deaths at 7 months. Ninety-four patients (95%) had an event free follow-up defined as absence of coronary artery bypass surgery, myocardial infarction or death. In conclusion, coronary angioplasty alone, using intracoronary heparin and prolonged balloon inflations with relatively oversized balloons may be helpful to achieve a high initial success rate, low incidence of in-hospital complications and excellent long-term results in patients with intracoronary thrombus.

We have described the major steps required to open a new ICPCU. The unit allows for a comprehensive standardized approach to the education of patients undergoing interventional cardiology procedures and offers the optimal setting for nursing research in the field of interventional cardiology and cardiovascular nursing. Primarily, the advent of this unit has supported the implementation of primary nursing, allowed for optimal continuity of patient care, and contributed to a decrease in the length of hospital stay of these patients and an increase in patient and family satisfaction.

A new ultra-low-profile coronary angioplasty device, a "balloon probe," is presented. This device consists of a balloon on a coronary guidewire and is the lowest profile dilatation system presently available. The balloon material is polyethylene terephthalate, a new polymer with high inflation pressure limits and very low compliance. This report discusses this device and its usage in coronary artery disease.