Katherine B. Kisslo

Balloon aortic valvuloplasty in adults: Failure of procedure to improve long-term survival

OBJECTIVES This study sought to determine the long-term outcome of adult patients undergoing percutaneous balloon aortic valvuloplasty. BACKGROUND Percutaneous balloon aortic valvuloplasty has been offered as an alternative to aortic valve replacement for selected patients with valvular aortic stenosis. Although balloon aortic valvuloplasty produces an immediate reduction in the transvalvular aortic gradient, a high incidence of restenosis frequently leads to recurrent symptoms. Therefore, it is unclear whether balloon aortic valvuloplasty impacts on the long-term outcome of these patients. METHODS Clinical, hemodynamic and echocardiographic data were collected at baseline in 165 patients undergoing balloon aortic valvuloplasty and examined for their ability to predict long-term outcome. RESULTS The median duration follow-up was 3.9 years (range 1 to 6). Ninety-nine percent follow-up was achieved. During this 6-year period, 152 patients (93%) died or underwent aortic valve replacement, and 99 (60%) died of cardiac-related causes. The probability of event-free survival (freedom from death, aortic valve replacement or repeat balloon aortic valvuloplasty) 1, 2 and 3 years after valvuloplasty was 40%, 19% and 6%, respectively. In contrast, the probability of survival 3 years after balloon aortic valvuloplasty in a subset of 42 patients who underwent subsequent aortic valve replacement was 84%. Survival after aortic valvuloplasty was poor regardless of the presenting symptom, but patients with New York Heart Association functional class IV congestive heart failure had events earliest. Univariable predictors of decreased event-free survival were younger age, advanced congestive heart failure symptoms, lower ejection fraction, elevated left ventricular end-diastolic pressure, presence of coronary artery disease and increased left ventricular internal diastolic diameter. Stepwise multivariable logistic regression analysis found that only younger age and a lower left ventricular ejection fraction contributed independent adverse prognostic information (chi-square 14.89, p = 0.0006). CONCLUSIONS Long-term event-free and actuarial survival after balloon aortic valvuloplasty is dismal and resembles the natural history of untreated aortic stenosis. Aortic valve replacement may be performed in selected subjects with good results. However, the prognosis for the remainder of patients who are not candidates for aortic valve replacement is particularly poor.

In vivo validation of compensatory enlargement of atherosclerotic coronary arteries

Necropsy examinations and epicardial ultrasound studies have suggested that atherosclerotic coronary arteries undergo compensatory enlargement. This increase in vessel size may be an important mechanism for maintaining myocardial blood flow. It also is of fundamental importance in the angiographic study of coronary disease progression and regression. The purpose of this study was to determine, using intracoronary ultrasound, whether coronary arteries undergo adaptive expansion in vivo. Forty-four consecutive patients were studied (30 men, 14 women; mean age 56 +/- 10 years). Eighty intravascular ultrasound images were analyzed (32 left main, 23 left anterior descending and 25 right coronary arteries). Internal elastic lamina area, a measure of overall vessel size increased as plaque area expanded (r = 0.57, p = 0.0001, SEE = 5.5 mm2). When the left main, left anterior descending and right coronary arteries were examined individually, there continued to be as great or greater positive correlation between internal elastic lamina and plaque area (left anterior descending: r = 0.75, p = 0.0001; right coronary arteries: r = 0.63, p = 0.0007; left main: r = 0.56, p = 0.0009), implying that each of the vessels and all in aggregate underwent adaptive enlargement. When only those vessels with < 30% area stenosis were examined, internal elastic lamina correlated well with plaque area (r = 0.79, and p = 0.0001), and for each 1 mm2 increase in plaque area, internal elastic lamina increased 2.7 mm2. This suggests that arterial enlargement may overcompensate for early atherosclerotic lesions.(ABSTRACT TRUNCATED AT 250 WORDS)

Mechanisms of balloon angioplasty and directional coronary atherectomy as assessed by intracoronary ultrasound

OBJECTIVE This study was designed to use intracoronary ultrasound imaging to elucidate the physical effects of balloon angioplasty and directional coronary atherectomy in vivo in humans. BACKGROUND The proposed mechanisms of coronary artery interventions such as balloon angioplasty and directional atherectomy are based on animal studies or pathologic findings and these data may not be applicable to living patients. Intracoronary ultrasound findings correlate highly with pathologic results and may allow in vivo assessment of the mechanisms of such interventions in humans. METHODS Intracoronary ultrasound imaging was performed in 45 patients after a successful coronary intervention (balloon angioplasty in 30, directional coronary atherectomy in 15). Ultrasound images obtained at the treatment site and at an adjacent angiographically normal references site were analyzed quantitatively for minimal lumen diameter, cross-sectional lumen area, are enclosed by the internal elastic lamina, plaque area (internal elastic lamina area--lumen area) and percent area stenosis (plaque area/internal elastic lamina area). Qualitative analysis included assessment of presence of dissection, plaque composition and plaque topography. RESULTS The results of the two procedures were similar with respect to minimal lumen diameter (angioplasty 2.6 +/- 0.5 vs. atherectomy 2.6 +/- 0.3 mm, p = NS), lumen area (0.07 +/- 0.03 vs. 0.07 +/- 0.02 cm2, p = NS) and percent area stenosis (59 +/- 14% vs. 51 +/- 21%, p = NS). However, after angioplasty, the internal elastic lamina area was significantly larger at the treated site than at the reference site (delta = +0.03 +/- 0.04 cm2, p = 0.01). There was no significant difference between the two sites after atherectomy (delta = -0.01 +/- 0.05 cm2, p = NS). In addition, dissection was seen significantly more often after balloon angioplasty than after atherectomy (50% vs. 7%, p less than 0.01). The results were similar when stratified for plaque composition and morphology. These data were confirmed in six additional patients who underwent ultrasound imaging before and after the intervention. CONCLUSIONS Thus, the improvement in lumen dimensions after coronary balloon angioplasty is a result of both vessel stretch, demonstrated by a larger internal elastic lamina area at the treated site, and dissection. Both vessel stretch and dissection are uncommon after atherectomy, a finding consistent with plaque removal as the major mechanism for improved lumen area after this procedure.

Unrecognized left main coronary artery disease in patients undergoing interventional procedures

Selective, coronary arteriographic, catheter-based, intravascular ultrasound images were obtained to determine the presence and extent of angiographically undetected or underestimated left main (LM) coronary arterial narrowing in patients receiving coronary interventional therapy. Coronary arteriograms were determined to be either normal or abnormal by visual inspection. Abnormal arteriograms were digitized and quantitated using a semiautomated edge-detection algorithm. Thirty-eight patients receiving percutaneous treatment of stenoses in the left coronary artery system were studied. Optimal LM coronary angiograms were obtained in 2 views, and intravascular ultrasound images were obtained after the coronary interventional procedure. Intravascular ultrasound detected plaque in 24 of 27 angiographically normal LM arteries (89%), whereas narrowing was observed in 11 of 11 angiographically abnormal LM arteries (100%). Eight of 38 patients (21%) had > 40% area stenosis by intravascular ultrasound. In patients with angiographic disease, there was no correlation between quantitative angiographic and ultrasound percent area stenosis (r = 0.12; p = 0.72; SEE 19%). The median plaque area was not different between angiographically normal (0.05 cm2; 0.03, 0.08 [25th, 75th percentile]) and abnormal (0.06 cm2; 0.03, 0.1) patients. The median percent area stenosis in arteriographically normal subjects (26%; 14, 32%) was less than that in abnormal ones (37%; 20, 46%) (p = 0.03). Unrecognized LM disease is widespread and often underestimated in patients with normal LM angiograms undergoing interventional procedures. Plaque area is similar for angiographically normal and insignificantly abnormal vessels. This study suggests that intravascular ultrasound overcomes the limitations of silhouette imaging and can be a clinically useful, adjunctive method to evaluate LM coronary artery disease.

Thrombotic and cardiovascular complications related to nonionic contrast media during cardiac catheterization: Analysis of 8,517 patients

The incidence of major complications associated with nonionic contrast media has not been defined in a large study. Accordingly, cardiovascular complications, especially thrombotic events, were prospectively evaluated in 8,517 consecutive patients undergoing diagnostic cardiac catheterization with either iopamidol (n = 6,293) or iohexol (n = 2,224). Thrombotic events were defined as coronary embolus, coronary occlusion, transient ischemic attack or stroke occurring at the time of catheterization. Thrombotic events occurred in 15 patients (0.18%). Coronary thrombus or embolus occurred in 7 patients, a thromboembolus from the ventricular catheter occurred in 1 patients and transient ischemic attack or stroke occurred in 7 patients. Six of 15 patients with thrombotic events were premedicated with heparin. Thrombotic events were unusual in that they tended to occur in clusters within short time intervals. On 1 occasion, a thrombus was observed in the catheter tip before embolization. Other cardiovascular complications were similarly low with an incidence of ventricular tachycardia/fibrillation of 0.1%, profound bradycardia of 0.2% and prolonged angina of 0.3%. There were 2 deaths unrelated to thrombotic events. Although the clinical thrombotic events associated with nonionic contrast have an unusual temporal clustering and may result in major complications, the overall incidence (0.18%) of these thrombotic complications with nonionic contrast agents is quite similar to that reported with ionic contrast media.

Intracoronary ultrasound predictors of adverse outcomes after coronary artery interventions

OBJECTIVES The purpose of this study was to determine the association between qualitative and quantitative lesion characteristics as assessed by intracoronary ultrasound imaging and adverse outcomes after coronary artery interventions. BACKGROUND Restenosis and other adverse outcomes after coronary artery interventions may be difficult to predict from clinical or angiographic data. Intracoronary ultrasound imaging provides additional data that could prove useful. METHODS Immediately after successful coronary artery interventions (angiographic residual stenosis < or = 50%), 69 patients underwent intracoronary ultrasound imaging. Images were assessed qualitatively for plaque composition and topography and for dissection. Quantitative data included measurement of minimal lumen diameter, lumen area, plaque area and percent area stenosis at the treatment and adjacent reference sites. Adverse outcome was defined as death, coronary bypass surgery, myocardial infarction or angiographic restenosis. RESULTS Of the 69 patients, 1 died, 3 had bypass surgery and 1 had a myocardial infarction before planned 6-month repeat catheterization. Two patients were lost to follow-up study. Of the remaining 62 patients, 56 (90%) agreed to follow-up catheterization and 25 (45%) of the 56 had restenosis. Thus, 30 patients had an adverse outcome and 37 had no adverse event. The incidence of dissection detected by ultrasound imaging after an intervention was significantly greater in patients with than in those without a subsequent adverse event (63% vs. 35%, p < 0.05). The severity of dissection also appeared to be related to outcome (p < 0.05). Other qualitative and quantitative variables were not significantly different between the two patient groups. CONCLUSIONS Dissection, as assessed by intracoronary ultrasound imaging after a coronary artery intervention, can identify patients at increased risk of subsequent adverse events. Additional studies are warranted to explore whether such imaging may allow modification of interventional procedures to improve outcome.

Intracoronary ultrasound evaluation of interventional technologies.

The feasibility and applicability of intravascular ultrasound (IVUS) of the coronary arteries were evaluated in 65 patients undergoing 70 coronary interventional procedures. Morphologic and quantitative analyses were performed with a mechanically rotated IVUS catheter (4.8Fr, 20 MHz) and with orthogonal view cineangiography. A semiautomated edge-detection algorithm was used for cineangiographic quantification. Coronary interventions included 45 percutaneous transluminal coronary angioplasties, 9 excimer lasers, 11 directional coronary atherectomies, 3 rotational atherectomies and 2 stents. Most lesions consisted of a mixture of plaque composition (hard, n = 30; soft, n = 64). Other unique morphologic data by IVUS were plaque topography (eccentric, n = 34; concentric, n = 36) and vessel dissection (IVUS [n = 29] versus angiography [n = 14], p less than 0.05). Postprocedure minimal lumen diameter and cross-sectional area measured by IVUS were larger and poorly correlated with angiography (r = 0.28, standard error of the estimate = 0.52 mm; r = 0.08, standard error of the estimate = 1.0 cm2, respectively). IVUS is more sensitive than angiography when assessing postintervention lesion characteristics including vessel dissection and plaque morphology. Catheter-based ultrasound appears to be a useful adjunct to contrast angiography when evaluating and comparing the therapeutic impact of conventional percutaneous transluminal coronary angioplasty with new technologies.

Comparison of preload recruitable stroke work, end-systolic pressure-volume and dPdtmax-end-diastolic volume relations as indexes of left ventricular contractile performance in patients undergoing routine cardiac catheterization☆

The end-systolic pressure-volume relation, the relation between stroke work and end-diastolic volume, termed the preload recruitable stroke work relation, and the relation between the peak of the first derivative of left ventricular pressure (dP/dtmax) and end-diastolic volume have been employed as linear indexes of left ventricular contractile performance in laboratory animals. The purpose of this study was to examine the relative utility of these indexes during routine cardiac catheterization in seven human subjects (mean age 48 +/- 18 [SD] years) with a normal left ventriculogram and coronary angiogram. Left ventricular pressure was recorded continuously with a micromanometer catheter, and left ventricular volume was derived from digital subtraction contrast ventriculograms obtained at 30-ms intervals. Transient occlusion of the inferior vena cava with a balloon-tipped catheter was employed to obtain beat to beat reductions in left ventricular pressure and volume over 8.7 +/- 1.7 cardiac cycles. Stroke work declined by 49 +/- 13% during vena caval occlusion, but end-systolic pressure fell by only 26 +/- 11%, and changes in dP/dtmax were small and inconsistent (12 +/- 22%). Consequently, the range of data available for determination of the preload recruitable stroke work relation greatly exceeded that for the end-systolic pressure-volume relation and the dP/dtmax-end-diastolic volume relation, and much less linear extrapolation from the measured data was required to determine the volume-axis intercept. Preload recruitable stroke work relations were highly linear (r = 0.95 +/- 0.07), and much more so than end-systolic pressure-volume relations (r = 0.79 +/- 0.23).(ABSTRACT TRUNCATED AT 250 WORDS)

Balloon angioplasty of coarctation of the aorta evaluated with intravascular ultrasound imaging

Intravascular ultrasound images were employed to evaluate aortic coarctation before and after balloon angioplasty. Measurements obtained with use of an ultrasound imaging catheter correlated well with measurements made with digital aortography, both in the area of coarctation and in areas proximal and distal to it. The intravascular ultrasound images dramatically revealed dissection of the aortic wall and an intimal flap that was not appreciated on cineaortography or digital subtraction angiography. Intravascular ultrasound imaging may yield important morphologic information unavailable by other imaging techniques. Such information may allow more precise definition of the results of intravascular procedures and improve understanding of lesion characteristics predictive of a successful outcome.

Comparison of intravascular ultrasound, external ultrasound and digital angiography for evaluation of peripheral artery dimensions and morphology

Validation of catheter-based intravascular ultrasound imaging has been based on comparisons with histology and digital angiography, each of which may have limitations in the assessment of arterial size and morphology. External, high-frequency ultrasound can accurately determine vessel dimensions and morphology and because, like ultravascular ultrasound, it also provides cross-sectional arterial ultrasound images, it may be a more appropriate technique for the in vivo comparison of arterial dimensions and morphology determined by intravascular ultrasound. Thus, intravascular ultrasound, external 2-dimensional ultrasound, Doppler color-flow imaging and digital angiography were compared for assessment of arterial dimensions and wall morphology at 29 femoral artery sites in 15 patients. Intravascular ultrasound and the other 3 imaging modalities correlated well in determination of lumen diameter (2-dimensional, r = 0.98, standard error of the estimate [SEE] = 0.14; Doppler color flow, r = 0.91, SEE = 1.11; angiography, r = 0.95, SEE = 0.91) and cross-sectional area (2-dimensional, r = 0.97, SEE = 0.04; Doppler color flow, r = 0.92, SEE = 0.14; angiography, r = 0.96, SEE = 0.08). However, lumen size measured by Doppler color flow was consistently smaller than that measured by the other 3 imaging modalities. Intravascular ultrasound detected arterial plaque at 15 sites, 5 of which were hypoechoic (soft) and 10 hyperechoic with distal shadowing (hard). Plaque was identified at 12 of 15 sites by Z-dimensional imaging (p = 0.30 vs intravascular ultrasound), but at only 6 of 15 sites by angiography (p = 0.003 vs intravascular ultrasound), only 1 of which was thought to be calcified plaque.(ABSTRACT TRUNCATED AT 250 WORDS)