Improvement in aortic valve area using a new "hour glass" shaped valvuloplasty balloon compared with standard cylindrical balloons in severe aortic stenosis patients.

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.

Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: initial U.S. feasibility trial using the Duett vascular closure device.

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.

Contemporary percutaneous treatment of unprotected left main coronary stenoses: initial results from a multicenter registry analysis 1994-1996.

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.

Revascularization using angioplasty and minimally invasive techniques documented by thermal imaging.

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.

Rotablation and stent placement in an unprotected left main coronary ostial stenosis.

We report the case of a patient with postinfarction rest angina, high grade ostial left main (LM) stenosis, and right and circumflex coronary occlusion. Coronary artery bypass was performed, yet all grafts failed within 2 months of surgery. We elected to proceed with coronary intervention on the ostial LM lesion with intracoronary ultrasound lesion characterization and percutaneous cardiopulmonary bypass support. Rotablation followed by stent deployment achieved a successful angiographic outcome with no associated clinical complications. At 1-year follow-up, the patient remains stable with evidence of mild restenosis. Interventional approaches in unprotected LM coronary stenoses are associated with high procedural risk. Combined atherectomy/ablation with stent placement guided by intracoronary ultrasound may enhance procedural and long-term outcome.

Directional atherectomy versus balloon angioplasty for coronary ostial and nonostial left anterior descending coronary artery lesions: results from a randomized multicenter trial. The CAVEAT-I investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial.

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.

Dyslipoproteinemias in atherosclerosis, thrombosis and restenosis after coronary angioplasty.

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.

Directional atherectomy for long lesions: improved results.

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.

Randomized trial of late elective angioplasty versus conservative management for patients with residual stenoses after thrombolytic treatment of myocardial infarction. Treatment of Post-Thrombolytic Stenoses (TOPS) Study Group.

BACKGROUND: After thrombolytic therapy for patients with acute myocardial infarction (MI), percutaneous transluminal coronary angioplasty (PTCA) is frequently performed because of the presence of a "significant" infarct vessel stenosis demonstrated at predischarge coronary angiography. Several studies have shown PTCA performed early after thrombolysis to be unnecessary or even harmful. However, PTCA in these trials was generally performed 1-3 days after MI, when the milieu in the infarct artery may be unsuited for PTCA, and the incidence of major ischemic complications was high. To date, no trial has assessed whether delayed PTCA (4-14 days) should be performed in patients without evidence of ischemia on stress testing. METHODS AND RESULTS: To test the hypothesis that delayed PTCA might provide clinical benefit compared with medical therapy alone, 87 patients treated within 6 hours of chest pain onset with thrombolytic therapy and with negative functional test were randomized between PTCA to be performed 4-14 days after MI versus no PTCA. Both groups received medical therapy. Patients with postinfarct angina or prior Q wave infarction in the infarct distribution were excluded. The primary study end point was increase in left ventricular ejection fraction with exercise measured by radionuclide studies 6 weeks after MI, a parameter known from other studies to correlate inversely with future ischemic events. Clinical outcome was also monitored for 12 months. There were no differences between the study groups for any prerandomization variable recorded. Mean age was 57 +/- 10 years, 84% of patients were male, 21% had prior MI, 36% had anterior MI, 7% had multivessel disease, and the infarct stenosis measured 70 +/- 17% before randomization. PTCA was successful in 38 of 42 patients (88%) but resulted in non-Q wave MI due to acute closure of the treated site in three of 42 (9.5%). There was no difference in 6-week resting ejection fraction or increase in ejection fraction with exercise between the two groups (47 +/- 12% and 6 +/- 8%, respectively, in the PTCA group; 49 +/- 10% and 5 +/- 9% in the no-PTCA group; p = NS for both.) There were no deaths in either group. Actuarial 12-month infarct-free survival was 97.8% in the no-PTCA group and 90.5% in the PTCA group (p = 0.07). CONCLUSIONS: There was no functional or clinical benefit from routine late PTCA after MI treated with thrombolytic therapy in this relatively low-risk cohort of patients. These data strongly suggest that patients with an uncomplicated MI after thrombolytic therapy, even if they have a "significant" residual stenosis of the infarct vessel, should be treated medically if they are without evidence of ischemia on stress testing before hospital discharge.

Exclusion of atrial thrombus by transesophageal echocardiography.

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.

Angioplasty in ulcerative coronary artery disease: acute results and early follow-up.

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.

Use of a morphologic classification to predict clinical outcome after dissection from 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.

Value of transesophageal echocardiography as an adjunct to transthoracic echocardiography in evaluation of native and prosthetic valve endocarditis.

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 Doppler echocardiography of the normal St. Jude Medical mitral valve prosthesis.

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.

The Ultra-Select guidewire: a new nitinol guidewire for coronary angioplasty.

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.

Seismocardiographic changes associated with obstruction of coronary blood flow during balloon angioplasty.

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)