Percutaneous in situ coronary venous arterialization: report of the first human catheter-based coronary artery bypass.

Diffuse coronary artery disease is frequently untreatable by coronary artery bypass or angioplasty. Many such "no-option" patients have been subjects for trials of angiogenesis using growth factor manipulation or laser injury. We think these novel revascularization strategies are limited by insufficient inflow to putative areas of new microvasculature and thus seek a more mechanical solution. We report the use of a catheter-based system for arterializing the adjacent anterior cardiac vein in a patient with chronic total occlusion of the left anterior descending coronary artery. A composite catheter system (phased-array ultrasound imaging system mounted on a catheter with extendable nitinol needle) was used to deliver an exchange-length intracoronary guidewire from the proximal left anterior descending coronary artery into the parallel anterior interventricular vein. Using standard angioplasty techniques, a fistula was then constructed from the proximal artery to the coronary vein using a self-expanding connector. The proximal vein was blocked with a novel self-expanding "blocker," thus precluding "steal" through the coronary sinus and forcing retroperfusion of the anterior wall. The procedure was completed without complication, and a follow-up angiogram at 3 months confirmed continued patency of the arteriovenous connection. This patient, who had severe angina before the procedure, has been asymptomatic for 12 months. Percutaneous in situ venous arterialization may be an effective therapy for diffuse, "untreatable" coronary disease by supplying a robust inflow of arterialized blood via retroperfusion to severely ischemic myocardium.

Determinants of coronary remodeling in transplant coronary disease: a simultaneous intravascular ultrasound and Doppler flow study.

BACKGROUND: Coronary remodeling plays a significant role in lumen loss in transplant allograft vasculopathy (TxCAD), but the determinants of remodeling are unknown. We assessed the relationship between remodeling and plaque topography, coronary compliance, and blood flow in TxCAD. METHODS AND RESULTS: One artery in each of 27 transplant patients was investigated with simultaneous intravascular ultrasound and coronary flow measurements (basal and hyperemic by Doppler flow wire). At 4 to 8 different cross sections (mean 5.1+/-1. 2), plaque topography (concentric or eccentric) was determined, and total vessel area, lumen area, and intimal/medial area (IMA) were measured. Mean remodeling ratio (vessel area/IMA) in eccentric lesions (E, n=28) was significantly larger than that in concentric lesions (C, n=70) (E 5.87+/-0.93 versus C 3.58+/-0.62; P<0.001), despite similar IMA (E 3.89+/-0.68 versus C 3.90+/-0.41; P=NS) and distribution of imaged segments. Remodeling ratio was consistently larger in eccentric lesions in all 3 vessel segments when analyzed separately, and mean remodeling ratio for each artery was larger in vessels with predominantly eccentric lesions. Coronary compliance ([Delta lumen area/diastolic lumen area]/Delta mean arterial pressure x 10(3)) was also significantly greater in eccentric lesions versus concentric lesions (proximal 1.00+/-0.39 versus 0.22+/-0.04; mid 0.71+/-0.17 versus 0.21+/-0.10; distal 0.43+/-0.13 versus 0. 01+/-0.08; all P<0.01). Coronary flow reserve was also significantly higher in coronary arteries with primarily eccentric lesions (E 2. 49+/-0.64 versus C 1.87+/-0.28; P<0.01). CONCLUSIONS: Vessel remodeling in transplant vasculopathy is significantly greater in eccentric lesions than in concentric lesions, possibly due to greater coronary compliance and resistive vessel function.

Inhibition of restenosis with beta-emitting radiotherapy: Report of the Proliferation Reduction with Vascular Energy Trial (PREVENT).

BACKGROUND: Intracoronary gamma- and beta-radiation have reduced restenosis in animal models. In the clinical setting, the effectiveness of beta-emitters has not been studied in a broad spectrum of patients, particularly those receiving stents. METHODS AND RESULTS: A prospective, randomized, sham-controlled study of intracoronary radiotherapy with the beta-emitting (32)P source wire, using a centering catheter and automated source delivery unit, was conducted. A total of 105 patients with de novo (70%) or restenotic (30%) lesions who were treated by stenting (61%) or balloon angioplasty (39%) received 0 (control), 16, 20, or 24 Gy to a depth of 1 mm in the artery wall. Angiography at 6 months showed a target site late loss index of 11+/-36% in radiotherapy patients versus 55+/-30% in controls (P:<0.0001). A low late loss index was seen in stented and balloon-treated patients and was similar across the 16, 20, and 24 Gy radiotherapy groups. Restenosis (>/=50%) rates were significantly lower in radiotherapy patients at the target site (8% versus 39%; P:=0.012) and at target site plus adjacent segments (22% versus 50%; P:=0.018). Target lesion revascularization was needed in 5 radiotherapy patients (6%) and 6 controls (24%; P:<0.05). Stenosis adjacent to the target site and late thrombotic events reduced the overall clinical benefit of radiotherapy. CONCLUSIONS: beta-radiotherapy with a centered (32)P source is safe and highly effective in inhibiting restenosis at the target site after stent or balloon angioplasty. However, minimizing edge narrowing and late thrombotic events must be accomplished to maximize the clinical benefit of this modality.

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.

Catheter-based percutaneous myocardial laser revascularization in patients with end-stage coronary artery disease.

OBJECTIVES: This study evaluates the feasibility and safety of a catheter-based laser system for percutaneous myocardial revascularization and analyses the first clinical acute and long-term results in patients with end-stage coronary artery disease (CAD) and severe angina pectoris. BACKGROUND: In patients with CAD and intractable angina who are not candidates for either coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA), transmyocardial laser revascularization (TMR) has been developed as a new treatment that results in reduced angina pectoris and increased exercise capacity. However, surgical thoracotomy is required for TMR with considerable morbidity and mortality. METHODS: A catheter-based system has been developed that allows creation of laser channels in the myocardium from within the left ventricular cavity. Laser energy generated by a Holmium: YAG (Cardiogenesis Corporation, Sunnyvale, California) laser was transmitted to the myocardium via a flexible optical fiber capped by an optic lens. The optical fiber was maneuvered to the target area under biplane fluoroscopy through a coaxial catheter system permitting movement in three dimensions. RESULTS: Thirty-four patients with severe CAD not amenable to either CABG or PTCA and refractory angina pectoris (Canadian Cardiologic Society [CCS] Angina Scale Class III-IV) were included in the study. Ischemic regions were identified by coronary angiography and confirmed by thallium scintigraphy. The percutaneous myocardial revascularization (PMR) procedure was successfully completed in all patients. In 29 patients, one vascular territory of the left ventricle and in 5 patients, two vascular territories were treated. Eight to fifteen channels were created in each ischemic region. Major periprocedural complications were limited to an episode of arterial bleeding requiring surgical repair. There was one death early after PMR, due to a myocardial infarction (MI) in a nontreated region. Clinical follow-up at 6 months (17 patients) demonstrated significant improvement of angina pectoris (CCS class before PMR: 3.0+/-0.0, six months after PMR: 1.3+/-0.8, p<0.0001) and increased exercise capacity (exercise time on standard bicycle ergometry before PMR: 384+/-141 s, six months after PMR: 514+/-158 s, p<0.05), but thallium scintigraphy failed to show improved perfusion of the laser treated regions. CONCLUSIONS: Percutaneous myocardial revascularization is a new safe and feasible therapeutic option in patients with CAD and severe angina pectoris not amenable to either CABG or PTCA. Initial results show immediate and significant improvement of symptoms and exercise capacity but evidence of improved myocardial perfusion is still lacking.

Quantification of ischaemia induced vulnerability by precordial T wave alternans analysis in dog and human.

OBJECTIVE: The aim was to examine the regional specificity of T wave alternans and the value of precordial ECG monitoring for non-invasive tracking of cardiac vulnerability during acute coronary artery occlusion and reperfusion in animals and humans. METHODS: The left ventricular ECG was monitored during two acute occlusions of the left anterior descending coronary artery and subsequent reperfusion in each of 61 chloralose anaesthetised dogs, and over 150,000 beats were analysed. In subgroups of these animals, lead II and precordial lead V5 were monitored or epicardial electrograms were recorded. In seven patients, lead II and precordial leads V1-6 were monitored during angioplasty. T wave alternans magnitude was quantified by complex demodulation. The same recording equipment and analytical methods were used in the clinical and experimental studies. RESULTS: A close temporal correspondence and linear correlation was found between T wave alternans magnitude--but not ST segment depression or ventricular premature beat incidence--and the incidence of spontaneous ventricular tachycardia and fibrillation during acute coronary artery occlusion and reperfusion. Epicardial electrograms showed alternans to be regionally specific, occurring in the ischaemic but not in the normal zones, and to predict spontaneous ventricular fibrillation and ventricular tachycardia (sensitivity = 79%, specificity = 86%). A significant linear relationship (r2 = 0.86, p < 0.01) between alternans magnitude detected in V5 and the left ventricular intracavitary lead indicates that the precordial leads could be used to assess cardiac vulnerability from the body surface. Lead V5 showed greater resolution than lead II. In humans, the precordial leads overlying the ischaemic zone were superior to lead II or Frank leads for alternans detection during both the occlusion and the reperfusion phases. In both animals and humans, alternation invariably occurred during the first half of the T wave, coinciding with the vulnerable period of the cardiac cycle and suggesting an important electrophysiological link to cardiac vulnerability. CONCLUSIONS: Alternans is regionally specific and is linearly projected to the precordium. Quantification of its magnitude in the precordial ECG may provide a non-invasive means for tracking cardiac vulnerability during acute myocardial ischaemia and reperfusion in both animals and humans.

Angioplasty techniques for stenoses involving coronary artery bifurcations.

Branch occlusion during coronary angioplasty is an infrequent but potentially serious complication. The overall incidence of branch occlusion during dilatation of a primary vessel is 5%. Branch vessels most jeopardized by dilatation generally have a complex plaque that not only involves the target vessel but also extends into the origin of the branch vessel. Branches free of pathology at their origin generally have an exceedingly low incidence of occlusion during adjacent balloon dilatation. Side branches at risk for occlusion should be "protected" if the branch vessel is of an important size that could be dilated with a conventional dilatation catheter. The advent of lower profile dilatation catheters and guidewires has provided an opportunity to introduce several pieces of dilatation hardware into the coronary system through a single guiding catheter. Several techniques are described for both "protecting" and dilating side branches, either simultaneously or secondarily, after balloon dilatation of a primary vessel.

Routine platelet transfusion in patients undergoing emergency coronary bypass surgery after receiving abciximab.

Abciximab has been shown to reduce the ischemic complications of high-risk angioplasty procedures. The appropriate management of patients who have received abciximab and require emergency coronary artery bypass surgery after failed coronary angioplasty is as yet undetermined. We present the outcomes of a small series of such patients who were given platelet transfusions before or during cardiopulmonary bypass.

Initial results of laser-based percutaneous myocardial revascularization for angina pectoris.

Results of a 30-patient pilot study of a recently developed percutaneous myocardial revascularization approach are described. The feasibility and positive safety profile of percutaneous myocardial revascularization are clearly demonstrated, with no mortality associated with the treatment or in the immediate post-treatment period and an incidence of only 1 major complication.

Outcome of narrowing related side branches after high-speed rotational atherectomy.

High-speed rotational atherectomy (HSRA) is advocated for calcified and diffusely narrowed coronary arteries. There are often side branches involving these kinds of lesions. The presence of significant lesion-related side branches has been considered a relative contraindication to rotational atherectomy. This study was performed to determine the rate, predictors, and outcome of side branch occlusion after HSRA. The angiograms of 418 patients were examined with 320 side branches in 240 target vessels of > or = 1 mm in diameter being identified. Vessels were scored as either perfused (Thrombolysis In Myocardial Infarction 2 or 3 flow) or occluded (Thrombolysis In Myocardial Infarction 0 or 1 flow before and after the procedure. A detailed quantitative angiographic analysis was performed on a total of 108 side branches including all cases of branch occlusion. Clinical outcomes were determined in all cases with side branch loss. There were 24 occlusions in 21 patients after the procedure, giving a rate of branch loss of 7.5%. Follow-up angiography of > or = 24 hours was available for 13 of the occluded branches and 12 were found to be patent. In the 21 patients with branch occlusion, 6 sustained a myocardial infarct (of which 5 were non-Q-wave), 2 underwent coronary artery bypass grafting, and 2 died. There are frequently lesion-associated side branches in the types of vessels to undergo HSRA. These branches remained patent 92.5% of the time, with occlusion occurring infrequently and usually being transient. When occlusion did occur, there was a 29% incidence of myocardial infarction.

Early systolic mitral leaflet "loitering" during acute ischemic mitral regurgitation.

BACKGROUND: The mechanism by which incomplete mitral leaflet coaptation develops during ischemic mitral regurgitation is debated, with recent studies suggesting that incomplete mitral leaflet coaptation may be due to apically displaced papillary muscle tips. Yet quantitative in vivo three-dimensional mitral leaflet motion during ischemic mitral regurgitation has never been described. METHODS: Radiopaque markers (sutured around the mitral anulus, to the central free mitral leaflet edges, and to both papillary muscle tips and bases) were imaged with the use of biplane videofluoroscopy in six closed-chest, sedated sheep before (control) and during induction of acute ischemic mitral regurgitation. Leaflet coaptation was defined as the minimum distance measured between edge markers during control conditions. RESULTS: During control, leaflet coaptation occurred 23 +/- 7 msec (mean +/- standard error of the mean) after end-diastole, when left ventricular pressure was 27 +/- 6 mm Hg. During ischemic mitral regurgitation, coaptation was delayed to 115 +/- 19 msec after end-diastole (p < or = 0.01 vs control [n = 4]) when left ventricular pressure was 88 +/- 4 mm Hg. At end-diastole during ischemic mitral regurgitation, the mitral anulus area was 14% +/- 2% larger than control (7.4 +/- 0.3 cm2 vs 6.5 +/- 0.2 cm2, p < or = 0.005) as the result of the lengthening of muscular annular regions (76.0 +/- 2.5 mm vs 70.5 +/- 1.4 mm, p < or = 0.01). Mitral anulus shape (ratio of two diameters) at end-diastole was more circular during ischemic mitral regurgitation (0.79 +/- 0.01 vs 0.71 +/- 0.02, p < 0.01). At end-diastole during ischemic mitral regurgitation, the posterior papillary muscle tip was displaced 1.5 +/- 0.5 mm laterally and 2.0 +/- 0.6 mm posteriorly (p < or = 0.02 vs control), but there was no apical displacement of either papillary muscle tip. CONCLUSIONS: Incomplete mitral leaflet coaptation during acute ischemic mitral regurgitation occurred early in systole, not at end-systole, and was due to "loitering" of the leaflets associated with posterior mitral anulus enlargement and circularization, as well as some posterolateral, but not apical, posterior papillary muscle tip displacement. These data suggest that early systolic mitral anulus dilatation and shape change and altered posterior papillary muscle motion are the primary mechanisms by which incomplete mitral leaflet coaptation occurs during acute ischemic mitral regurgitation.

Beyond stents: third-generation coronary devices.

Despite extraordinary growth in percutaneous transluminal coronary angioplasty (>400,000 cases in United States in 1997) patients are still routinely referred for bypass grafting in large numbers. Why? Second-generation devices (directional coronary atherectomy, high-speed rotational atherectomy [Rotablator], and stents) have expanded the application of percutaneous catheter treatment of coronary disease. Specifically, highly eccentric lesions in large vessels, heavily calcified lesions, and coronary dissections can be effectively treated with these devices. Stents have substantially reduced the incidence of restenosis, but this benefit is largely confined to vessels more than 3 mm in diameter and stenoses less than 20 mm in length. A third generation of coronary devices has evolved in the late 1990s in response to continuing failures of conventional balloon angioplasty, atherectomy, and stenting. The failures of the 1990s were (1) restenosis, including in-stent restenosis, (2) chronic total occlusions, (3) diffuse small-vessel disease, and (4) aged vein graft disease. In response to these challenges novel devices are being developed: (1) for restenosis, intracoronary radiation therapy (brachytherapy); (2) for chronic total occlusions, Prima Laser wire; (3) for diffuse small-vessel disease, percutaneous myocardial laser revascularization; and (4) for aged vein grafts, antiembolization devices. Each of these new catheter technologies will need to be economically and clinically reconciled with the multitude of minimally invasive surgical revascularization techniques that are rapidly evolving.

Three-dimensional dynamics of the canine mitral annulus during ischemic mitral regurgitation.

BACKGROUND: It has been suggested that ischemic mitral regurgitation results, at least in part, from generalized end-systolic mitral annulus (MA) dilatation, but the role of the MA is incompletely understood and the segmental dynamics of the MA during left ventricular ischemia have not been described. METHODS: We used radiopaque markers and simultaneous biplane videofluoroscopy to measure three-dimensional in vivo lengths of eight MA segments in 7 sedated dogs before and after induction of ischemic MR (produced by circumflex coronary artery balloon occlusion and verified by Doppler echocardiography). As viewed from the left atrium, the MA segment between markers 1 and 2 (S12) was defined as starting at the posteromedial commissure, and remaining segments were numbered sequentially clockwise around the MA (ie, the posterior MA encompassed S12, S23, S34, S45,; the anterior MA included S56, S67, S78, S81). Marker images obtained 7 to 12 days after implantation were used to construct x, y, and z coordinates of each marker at end-diastole and end-systole. RESULTS: During regional (posterolateral walls) left ventricular ischemia, the end-systolic MA area increased (4.9 +/- 0.8 cm2 [control] versus 5.9 +/- 0.6 cm2; p = 0.005). End-systolic MA segment lengths were as follows (control, ischemia [mm, mean +/- standard deviation]): S12 = 9 +/- 2, 10 +/- 3; S23 = 10 +/- 2, 12 +/- 3; S34 = 13 +/- 1, 15 +/- 1; S45 = 8 +/- 2, 9 +/- 2; S56 = 11 +/- 2, 11 +/- 2; S67 = 12 +/- 2, 12 +/- 2; S78 = 10 +/- 3, 11 +/- 2; and S81 = 11 +/- 1, 12 +/- 1. Values for S12, S23, S34, and S81 were significant (p < or = 0.05 for control versus ischemia by paired t test). CONCLUSIONS: During ischemic mitral regurgitation, the MA enlarged at end-systole, but in an asymmetric manner; most posterior annular segments lengthened, whereas most anterior annular segment lengths did not change. These data suggest that alterations in regional MA mechanics may be important in the pathogenesis of ischemic mitral regurgitation. Further three-dimensional studies of MA dynamics and shape should be conducted so that new knowledge may result in improved mitral valve surgical techniques.

Distribution and morphologic features of coronary artery disease in cardiac allografts: an intracoronary ultrasound study.

The longitudinal distribution and circumferential pattern of coronary intimal proliferation were studied with intravascular ultrasonography in 135 patients after heart transplantation. Eighty-seven (64%) of 135 patients had significant intimal thickening, with most lesions (63%) concentric and free of fibrosis or calcification. Both diffuse and nonuniform longitudinal patterns of intimal thickening were found.

Significant atheromatous debris following uncomplicated vein graft direct stenting: evidence supporting routine use of distal protection devices.

We present the case of an angiographically uncomplicated direct stent vein graft intervention in which the Percusurge embolization containment device was used. We performed histological examination of the resulting debris and observed massive particulate atheromatous material. This case illustrates the severity of distal embolization that can go clinically unnoticed after direct stenting and also supports the routine use of distal protection devices for vein graft intervention.

Precordial ST elevation with acute conus branch occlusion.

A 70-year-old man developed anterior precordial ST elevation during coronary angiography in the presence of a normal left coronary artery. Injection of a proximally totally occluded right coronary artery caused occlusion of the conus branch. The electrocardiographic findings are shown, and the pathogenesis is discussed.

Percutaneous transmyocardial revascularization.

Transmyocardial revascularization (TMR) is a potential therapy for patients with severe angina pectoris and coronary anatomy deemed unsuitable for traditional revascularization techniques. Investigations of TMR are reviewed with emphasis on studies relevant to the development of a percutaneous, catheter-based transmyocardial revascularization procedure (PMR). The results of the preliminary animal studies and description of the PMR procedure are discussed. The recently initiated human PMR protocol is summarized and possible future investigative directions are outlined.

Thromboembolic complications of percutaneous transluminal coronary angioplasty for myocardial infarction.

To determine the incidence of thromboembolic complications of percutaneous transluminal coronary angioplasty (PTCA) in the setting of recent and acute myocardial infarction, the clinical sequelae and coronary angiographic findings were examined in a series of 13 patients who underwent PTCA either as acute intervention during the infarction or as treatment for recurrent myocardial ischemia that occurred soon after the initial completed infarction. In all cases, the angiographic appearance in the infarct-related artery was that of thrombus in the setting of total or subtotal occlusion. Balloon dilatation without antecedent thrombolytic therapy, was performed in 14 arteries and was successful in establishing reperfusion with reduction of the degree of intraluminal narrowing to less than 50% in all cases. Residual thrombus at the site of inflation was noted in two cases (15%), and embolization was noted in four cases (29%), for an incidence of complication of 44%. In five of six instances in which either residual thrombus or embolization were noted, the initial infarction had occurred greater than 24 h before. In only one of seven cases in which PTCA was used as acute intervention during infarction of less than 4 h duration was the presence of residual thrombus noted after PTCA. Therefore, these findings suggest that thromboembolic complications after PTCA in the setting of recent or acute myocardial infarction are uncommon when the syndrome is less than 4 h duration; however, complications are relatively frequent when infarction has occurred greater than 24 h before. PTCA as a primary intervention in this latter setting should be approached cautiously.