Initial results of the Quanam drug eluting stent (QuaDS-QP-2) Registry (BARDDS) in human subjects.

Thirty-two patients presenting with varied coronary syndromes and anatomy were treated with a new coronary multisleeve drug delivery coronary stent (QuaDS-QP-2) containing up to 4,000 microg of a taxol-derived lipophilic microtubule inhibitor (QP2). The device was successfully implanted in 32 patients who have been followed for up to 2 years. Twenty-five patients have undergone stress ECHO or SPECT Thallium and all are currently asymptomatic. Thirteen patients have already been restudied angiographically, by IVUS and/or by SPECT Thallium testing and are detailed in this report. Angiographic, IVUS, and SPECT Thallium have been controlled at a mean of 11.2 months (range, 6-15 months) in this 13-patient cohort. Although all 13 QuaDS-QP-2 (QDES) stents were angiographically and IVUS patent, two reinterventions have been required in the 32-patient study group thus far, both relate to either new disease or to distal, small-vessel disease beyond the stent. There was no evidence of significant proliferation in the QDES devices. On the basis of this preliminary data and a European pilot study, a controlled randomized trial (SCORE) is currently in progress in western Europe.

Novel drug-delivery stent: intravascular ultrasound observations from the first human experience with the QP2-eluting polymer stent system.

BACKGROUND: The aim of this study was to use serial intravascular ultrasound (IVUS) to evaluate the long-term effect of stent-based 7-hexanoyltaxol (QP2, a taxane analogue) delivery on neointimal tissue growth within the stent and on vessel dimensions at the adjacent reference segments. METHODS AND RESULTS: Serial IVUS analyses (immediately after intervention and at follow-up at 8.3 months) were performed in 15 native coronary lesions treated with the QuaDS-QP2 stent. IVUS measurements were performed at 8 cross-sections in each target segment (4 cross-sections within the stent and 2 cross-sections in each reference segment). At baseline, no significant plaque protrusion or thrombus was detected in the target segment. Mild incomplete stent apposition and edge dissection were observed in one and two cases, respectively. Percent expansion of the stent (minimum stent area/average reference lumen area) was 96.0+/-21.7%. At follow-up, mean neointimal area within the stent was 1.2+/-1.3 mm(2), and mean cross-sectional narrowing (neointimal area/stent area) was 13.6+/-14.9%. At the vessel segments immediately adjacent to the stent, a significant increase in plaque area (1.9+/-2.6 mm(2), P=0.001) was observed, but vessel area remained unchanged. However, no patients showed clinically significant in-stent or edge restenosis (diameter stenosis >/=50%) during the follow-up period. CONCLUSIONS: The first human experience with the new drug-delivery stent showed a minimal amount of neointimal proliferation in the stented segment. Late lumen loss at the reference sites adjacent to the stent was acceptable and predominantly due to plaque proliferation.

Coronary stents: In vitro aspects of an angiographic and ultrasound quantification with in vivo correlation.

BACKGROUND: The validity of quantitative coronary angiography (QCA) after stent placement has been questioned because the optical density of a metallic stent, added to the density of a contrast-filled lumen, could affect border definition. METHODS AND RESULTS: We deployed 3.0- and 4.0-mm Palmaz-Schatz, Wiktor, Multilink, NIR, and InStent stents in precision-cast phantoms. Central lumens of 2.0 mm were created. There was no difference between the "true" diameters of any stented lumen by both QCA and quantitative ultrasonic (QCU) measurement poststenting. QCA systematic error (SE) varied from 0.01 for the Wiktor stents to 0.14 mm for the Palmaz-Schatz stents; the random error (RE) was 0.03 to 0.14 mm. QCU SE varied from 0.05 to 0.11 mm, and RE ranged from 0.01 to 0.07 mm. At the next stage, 4.0-mm Wiktor and Palmaz-Schatz stents were deployed into the phantom lumens; 1.5-, 2.0-, 2.5- and 3.0-mm lumens were created inside the stents. QCA and QCU measurements of 1.5- to 2.5-mm residual lumens were overestimated by 0.1 to 0.3 mm. In the 3. 0-mm residual lumen within the Wiktor stent, QCA underestimated the luminal size by -0.1 mm. There was no QCA inaccuracy for a 3.0-mm lumen within the Palmaz-Schatz stent. In patients, in 25 stented segments in both the Palmaz-Schatz and Wiktor groups, there was no difference between QCA and QCU diameters. CONCLUSIONS: QCU is sufficiently precise for the assessment of the coronary lumen after stenting. QCA can be used as an accurate method of poststent assessment, except when a very mild recurrence within a highly opaque stent is measured. In that instance, QCA may underestimate the luminal diameter.

The stent decade: 1987 to 1997. Stanford Stent Summit faculty.

In January 1997, experts from the United States, Europe, and Japan gathered at Stanford University to review their collective experience with intracoronary and noncoronary stenting and to identify and prioritize issues requiring further clinical investigation. This report summarizes the discussions that took place during this stent summit. Knowledge of stent-tissue interaction from animal and human pathologic specimens was reviewed in the context of evolving stent designs. The relative merits of coil and slotted tubular stent designs were discussed. Stent deployment routines, including self-expansion, balloon expansion, and high-pressure delivery were debated. The potential for covered stents and coated stents was explored. Problems surrounding the routine deployment of stents were identified: small vessel disease, long lesions, bifurcation stenoses, vein graft disease, ostial disease, left main stenoses, and intrastent restenosis. The value of intravascular ultrasound, as an adjunct to stenting, was explored and debated. An algorithm for "provisional stenting" based on ultrasound criteria was developed. Noncoronary stenting of the aorta, iliacs, and carotids were discussed. Clinical applications that may lead to randomized clinical trials were identified.

Coronary AVE micro stents: serial quantitative angiography and histology in a canine model.

The AVE Micro Stent (AVE Inc., Santa Rosa, CA) is composed of helically welded 3 mm long, zigzag crowns with stent lengths from 6 to 39 mm and diameters from 2.5 to 4.5 mm. Quantitative coronary angiography and histologic analyses of acute and chronic implantation were obtained in 52 stented coronary segments of 18 dogs. Three hearts with 8 stented coronary segments were harvested after 24 hr, 3 hearts with 9 stented segments were harvested after 2 weeks, 6 hearts with 15 stented segments were harvested at 8 weeks, and 6 hearts with 20 stented segments were harvested at 24 weeks post-deployment. There were no procedural complications, deaths, or acute vessel closures. The average lumen diameter of the stented segment was largest at 2 weeks (3.3 +/- 0.3 mm). The smallest average diameters were observed at 8 weeks after the stent deployment (2.7 +/- 0.4, P < 0.05) with an increase again at 24 weeks (2.9 +/- 0.6). The pre-explant percent of stenosis was <30% in all animals. Histologically, a peak of inflammation was visible at 2 weeks; however, the extent of luminal narrowing reached its peak at 8 weeks and the lumen dimension increased somewhat at 24 weeks. The degree of intimal thickening remained relatively constant throughout the different time points (<200 microm). Overall, these data suggest that constrictive remodeling within the stented segment occurs at 8 weeks in this animal model. The later increase of the stented segment dimensions as well as higher net gain at 24 weeks compared to 8 weeks after deployment suggests that this constriction is a transitory phenomenon.

High-speed rotational atherectomy: six-month serial quantitative coronary angiographic follow-up.

One hundred twenty-three patients treated with high-speed rotational atherectomy (HSRA) were restudied 6.9 +/- 1.2 months later. At the follow-up, the number of focal concentric lesions increased from 32.2 percent to 63.0 percent, p<0.01, with decrease of type C lesions from 54.8 percent to 30.8 percent, p<0.05. Comparison of the degree of the net gain (NG) showed more severe baseline lesions in the high-gain group (NG >20 percent) compared with the moderate-gain group (20 percent > NG > 0 percent) and to the loss group (minimal luminal diameter [MLD] 0.8 +/- 0.4 mm vs 1.0 +/ 0.4 mm, p<0.05; and 1.2 +/- 0.5 mm; p<0.01, respectively). Highest initial gain (36.5 percent +/- 26.2 percent vs 24.5 percent +/- 18.1 percent; p<0.015; and 19.0 percent +/- 23.2 percent; p<0.001) as well as lowest late loss (1.8 percent +/- 21.7 percent vs 14.0 percent +/-18.4 percent; p<0.01 and 28.1 percent +/- 25.0 percent; p<0.01) were found in the high NG group. A higher interaction between burr and atheroma resulted in the lowest restenosis rate of 6 percent.

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.

Effects of technique modification on immediate results of high speed rotational atherectomy in 710 procedures on 656 patients.

Seven hundred ten high speed rotational atherectomy (HSRA) procedures were performed in a single consecutive series of 656 patients. Stand alone HSRA was performed in 253 patients (35%). HSRA with adjunctive low pressure (< or = 2 ATM) balloon angioplasty (LP BA) was performed in 221 patients (31%), and HSRA with adjunctive high pressure (> or = 4 ATM) balloon angioplasty (HP BA) was performed in 236 patients (34%). Prognostically unfavorable Type B2 and C lesions dominated the study group (74.7%). Procedural success rate was 96%. Emergency coronary artery bypass surgery was performed in 1.4% of cases, Q wave myocardial infarction occurred in 3.4% and death, related to procedure, was consequent in 0.5% of cases. Incidence of flow limiting dissections was 3.1%, distal spasm was 5.3%, and "no reflow" phenomenon was 1.8%. The recent technique modifications included continuous advancer/guiding catheter infusion of the nitroglycerin-verapamil mixture, limitation of duration of lesion engagement by the burr, stepwise increase in the burr size, decrease of rotational speed, and strict control of rpm drop during lesion ablation. Evolution of the interventional technique involved trends towards decrease of the use of HP BA in conjunction with steady increase in the percentage of SA and LP BA procedures over time. These technique changes resulted in complete absence of "no reflow" in 1994, as well as a generalized decrease in overall coronary vascular reactivity from all burr passes.

Quantitative left ventriculography: methods of assessment of the regional contractility.

To compare different approaches to the quantitative analysis of regional left ventricular (LV) function, six different protocols with various long axis definitions, with or without alignment, with radial or hemiaxial segmental definitions were used. Study group consisted of 20 patients with single vessel coronary artery disease after Q-wave anterior myocardial infarction (MI) and 20 patients after Q-wave diaphragmatic MI. Control group consisted of 100 patients. Analytic protocol with the long axis drawn between the apex of the LV and the center of aortic valve plane, radial coordinate system originating from the midpoint of the long axis and alignment of the long axes in systole and diastole, was found to be most sensitive and specific for detection of both anterior and diaphragmatic contraction abnormalities. Original method to measure both severity and length of the regional contraction abnormality is suggested.

Comparative study of the angiographic morphology of coronary artery lesions treated with PTCA, directional coronary atherectomy, or high-speed rotational ablation.

To evaluate trends in morphology-based intervention selection, series of 110 consecutive procedures of each of three devices, percutaneous transluminal balloon coronary angioplasty (PTCA), directional coronary atherectomy (DCA), or high-speed rotational ablation (HSRA), were reviewed. PTCA was used mainly in discrete, concentric, smooth, ACC/AHA type A and B1 lesions. PTCA was used less frequently on a bend, branching points or in calcified lesions. Using PTCA as a reference, DCA was used more often for the treatment of discrete, proximal, eccentric, and noncalcified lesions, often complicated with thrombus and located on straight segments. HSRA was used more frequently in diffuse, calcified multiple complicated and B2+C type lesions with frequent side branches and bend points. These results suggest that directional atherectomy and rotational ablation may be helpful in expanding the capacity of the operator to approach prognostically unfavorable lesions.

Triple vessel revascularization: coronary angioplasty versus coronary artery bypass surgery: initial results and five-year follow-up. Comparative costs and loss of working days and wages.

OBJECTIVES: The purpose of this study was to compare early and late outcomes in patients undergoing PTCA or CABG for triple vessel disease. BACKGROUND: Although early results of PTCA/CABG randomized trials have recently become available, at present little data exists on long-term medical and socioeconomic effects of these treatment modalities in patients with triple vessel revascularization. METHODS: During 1986-87, 76 patients undergoing triple vessel PTCA and 85 patients having triple vessel CABG were selected from a consecutive series of patients having multivessel revascularization. Initial results and 5 year outcome, hospital stay and charges and out-of-work time were assessed from prospectively collected data. RESULTS: Clinical and morphological factors were similar in the PTCA and CABG groups. Hospital success and complications were also similar, except for higher mortality in the CABG cohort (0 vs. 3.5%). Five year follow-up showed no differences in survival, nonfatal infarction and angina-free status; however, there was a difference in need for repeat revascularization (PTCA 55.4% vs. CABG 6.3%, p less than 0.001). Repeat PTCA accounted for 49% of the revascularization in the PTCA cohort. Crossovers were similar (PTCA[CABG 6.8%; CABG[PTCA 6.3%, pNS). Predictors of late death in the entire population were female gender (p less than 0.0001), diabetes (p<0.05) and depressed LVEF (p less than 0.05). The choice of revascularization procedure (PTCA vs. CABG) was not an independent predictor of late death or MI. Analysis of initial hospital charges showed a 2:1 advantage in favor of PTCA but this advantage was lost in late followup due to the need for repeat revascularization in the PTCA group. However, the PTCA cohort lost fewer working days than CABG patients (3017 vs 5874 days) and therefore, lost less wages ($7,022 vs. $14,685). CONCLUSIONS: The study shows that for selected triple vessel disease patients, PTCA and CABG results are comparable after 5 years, though repeat revascularization (mainly due to restenosis) was necessary in the PTCA group to maintain these favorable results. After 5 years, hospital charges are similar in the 2 groups, though out-of-work time and lost wages were 2:1 in favor of PTCA.

Coronary stenting with a new ultra-short balloon expandable device: early and late animal results.

The early and late effects of a new balloon-expandable coronary stent (Boneau II) were studied in 16 adult mongrel dogs. Thirty-three balloon-expandable stents were deployed using standard transfemoral coronary angioplasty technique. Single stents were placed in eight dogs and multiple (two to four) stents were placed in eight dogs. Intravenous heparin (3,000 units) was administered at the beginning of the procedure. Aspirin, dipyridamole, dextran, and warfarin were not administered before or after the procedure. All stent deployments were successful. Angiographic or pathologic examinations were performed within 24 hr of deployment on two of the dogs, at 2 weeks on two of the dogs, at 2 months on three of the dogs, at 6 months on six of the dogs, and at 1 year on three of the dogs. All successfully deployed stents were noted to be widely patent. There was no evidence of side-branch vessel occlusion. There was no evidence of acute or late vessel thrombosis. Histologic examination at 2 months showed a mean intimal thickness of 153 microns. The stainless steel Boneau II coronary stent is relatively short and easily deployed. This balloon-expandable coronary stent was successfully deployed in normal canine arteries without the use of anticoagulation or antiplatelet therapy before or after the procedure. The Boneau II intracoronary stent has a very low thrombogenic potential in dogs.

Late outcome of multivessel coronary artery disease after angioplasty or bypass surgery.

Background. Results from randomized trials to determine optimal treatment for patients with multivessel coronary disease are not yet available. Thus, the early and late outcomes of 191 PTCA and 221 CABG patients done in 1985-86 were evaluated. Methods and Results. CABG patients selected had more coronary risk factors and more severe coronary artery disease compared to PTCA patients. Comparison of the initial outcome showed that clinical success without major cardiovascular events was similar (93.7% for PTCA vs. 90.0% for CABG; p=n.s.). Five year followup was obtained in 99.0% of PTCA patients and 94.4% of CABG patients. In the PTCA group, 89.8% were alive, 4.8% had sustained an MI, and repeat revascularization was required in 46.8%. In the CABG group, 87.1% were alive, 3.2% had had a MI, and 3.5% required repeat revascularization. Statistical comparison demonstrated no difference between the groups in survival or late cardiac events, but rate of repeat revascularization was significantly higher for PTCA patients (p less than 0.0001). Incompleteness of revascularization (p<0.01) was independently associated with an increased need for repeat revascularization in the PTCA group. In the CABG group, depressed left ventricular function (p less than 0.001) and female sex (p<0.01) were associated with lower survival rates. An analysis of cost per patient showed that the strategies were comparable. Conclusions. PTCA and CABG in multivessel disease patients have similar early results and comparable rates of survival and late cardiac events. Significantly more repeat revascularization is required in PTCA patients to maintain these results.(ABSTRACT TRUNCATED AT 250 WORDS)

The evolution of a clinical database to evaluate the treatment of coronary artery disease.

BACKGROUND: The field of invasive cardiology has evolved rapidly since the initial use of catheters for treatment of coronary artery disease in the late 1970's. The pace of this change coupled with the complexity of the clinical setting and proliferation of devices and drugs used for therapy have made it extremely difficult to construct and maintain a viable clinical database. METHODS: Using a standard hardware and software system with the direct clinical input from a multidisciplinary team of physicians, nurses and biostatisticians, a clinical database was developed that is capable of tracking complex in-hospital and longterm follow-up data in patients undergoing treatment of coronary artery disease. RESULTS: The database has provided the basis for in-depth analysis of angioplasty results in patients with vessels and lesions of varying morphology, showing greater than 90% success in most complex lesion morphology using contemporary balloon technology and/or new devices. Longterm analysis (14 years) of patients after angioplasty has demonstrated that 76% survived without major cardiac events. Other analyses of various clinical and morphologic subsets have shown favorable results with angioplasty. The databases for angioplasty and coronary bypass surgery have been combined, showing comparable survival and freedom from cardiac events in multivessel disease patients treated with these procedures. CONCLUSIONS: The development of a dynamic and clinically relevant database that has evolved has contributed valuable information to the understanding and effective management of patients with coronary artery disease.(ABSTRACT TRUNCATED AT 250 WORDS)

Digital supine bicycle stress echocardiography: a new technique for evaluating coronary artery disease.

OBJECTIVES: The objective of this study was to determine the accuracy of digital supine bicycle stress echocardiography, a new technique for evaluating coronary artery disease during peak exercise. BACKGROUND: Prior stress echocardiographic techniques have not utilized peak exercise imaging to determine the extent and location of coronary artery disease. METHODS: Two-hundred twenty-two patients were studied: 180 underwent both supine bicycle stress echocardiography and coronary arteriography; 42 had a < 5% likelihood of disease. Forty-three patients had normal coronary arteries, 55 had single-vessel, 42 had double-vessel and 40 had triple-vessel coronary artery disease. RESULTS: Supine bicycle stress echocardiography was 93% sensitive, 86% specific and 92% accurate for identifying patients with coronary artery disease irrespective of prior myocardial infarction or achievement of > or = 85% maximal predicted heart rate. The "normalcy" rate in the low probability group was 100%. Supine bicycle stress echocardiography was 87% sensitive, 89% specific and 88% accurate for specific vessel identification. The sensitivity was greatest for the left anterior descending compared with the right coronary artery and the left circumflex coronary artery (95% vs. 81% vs. 78%, p < 0.01) and for vessels in patients with double- and triple-vessel compared with single-vessel disease (90% vs. 89% vs. 78%, p < 0.05). The procedure was significantly more sensitive for detection of vessels with 90% to 100% compared with 50% to 70% diameter stenosis (91% vs. 81%, p < 0.05) and was 88% correct in the prediction of multivessel disease. CONCLUSIONS: Supine bicycle stress echocardiography is a highly accurate tool for evaluating coronary artery disease, identifying both the patient with coronary artery disease and the location and extent of disease.

Prophylactic versus standby cardiopulmonary support for high risk percutaneous transluminal coronary angioplasty.

OBJECTIVES: Data from a national registry of 23 centers using cardiopulmonary support (CPS) were analyzed to compare the risks and benefits of prophylactic CPS versus standby CPS for patients undergoing high risk coronary angioplasty. BACKGROUND: Early data from the CPS registry documented a high angioplasty success rate as well as a high procedural morbidity rate. Because of this increased morbidity some high risk patients were placed on standby CPS instead of prophylactic CPS. METHODS: Patients in the prophylactic CPS group had 18F or 20F venous and arterial cannulas inserted and cardiopulmonary bypass initiated. Patients in the standby CPS group were prepared for institution of cardiopulmonary bypass, but bypass was not actually initiated unless the patient sustained irreversible hemodynamic compromise. RESULTS: There were 389 patients in the prophylactic CPS group and 180 in the standby CPS group. The groups were comparable with respect to most baseline characteristics, except that left ventricular ejection fraction was lower in the prophylactic CPS group. Thirteen of the 180 patients in the standby CPS group sustained irreversible hemodynamic compromise during the angioplasty procedure. Emergency institution of CPS was successfully initiated in 12 of these 13 patients in < 5 min. Procedural success was 88.7% for the prophylactic and 84.4% for the standby CPS group (p = NS). Major complications did not differ between groups. However, 42% of patients in the prophylactic CPS group sustained femoral access site complications or required blood transfusions, compared with only 11.7% of patients in the standby CPS group (p < 0.01). Among patients with an ejection fraction < or = 20%, procedural morbidity remained significantly higher in the prophylactic CPS group (41% vs. 9.4%, p < 0.01), but procedural mortality was higher in the standby group (4.8% vs. 18.8%, p < 0.05). CONCLUSIONS: Patients in the standby and prophylactic CPS groups had comparable success and major complication rates, but procedural morbidity was higher in the prophylactic group. When required, standby CPS established immediate hemodynamic support during most angioplasty complications. For most patients, standby CPS was preferable to prophylactic CPS during high risk coronary angioplasty. However, patients with extremely depressed left ventricular function (ejection fraction < 20%) may benefit from institution of prophylactic CPS.

Usefulness of supine bicycle stress echocardiography for detection of restenosis after percutaneous transluminal coronary angioplasty.

The role of supine bicycle stress echocardiography (SBSE) for detecting restenosis after percutaneous transluminal coronary angioplasty (PTCA) was evaluated in 80 patients: 41 (51%) with single and 39 (49%) with multivessel PTCA (total 129 dilated vessels). Total revascularization was performed in 54 (68%) and partial revascularization in 26 (32%) patients. Restenosis was angiographically demonstrated in 60 patients (75%) and in 72 vessels (56%) 6.1 +/- 2.9 months after PTCA. The results for detecting restenosis were: (1) SBSE versus exercise electrocardiographic sensitivity, 87 versus 55% (p < 0.001); (2) specificity, 95 versus 79%; and (3) accuracy, 89 versus 61% (p < 0.001). SBSE was 83% sensitive, 95% specific and 88% accurate for restenosis detection in specific vessels with comparable results for single versus multivessel PTCA and total versus partial revascularization. Sensitivity, specificity and accuracy were: 91, 93 and 91% for the left anterior descending coronary artery; 77, 94 and 85% for the right coronary artery; and 76, 96 and 88% for the left circumflex coronary artery. Ninety-four percent of the nondilated diseased vessels were correctly identified. It is concluded that SBSE is an excellent tool for identifying restenosis after PTCA.

Coronary rotational ablation: initial experience in 302 procedures.

OBJECTIVES: The aim of this study was to assess the utility of percutaneous transluminal coronary rotational ablation in the treatment of coronary artery disease. BACKGROUND: Although numerous advances have been made in the treatment of coronary artery disease, there are lesions with complex morphology that are not amenable to current intravascular therapy. METHODS: A consecutive series of 242 patients having 302 coronary rotational ablation procedures was analyzed. One hundred nineteen (49%) of the patients had previously undergone attempted coronary angioplasty, which was unsuccessful in 31 patients (13%). The left ventricular ejection fraction was normal in 196 patients (81%). The ablation procedure was attempted in 308 vessels and 346 lesions. Of the 346 lesions treated, 26 (7.5%) were classified as American College of Cardiology/American Heart Association type A, and 320 (92.5%) as either type B or type C. RESULTS: Procedural success was achieved in 284 (94%) of the 302 procedures and 330 (95.4%) of the 346 lesions in which ablation was attempted. Five procedures (1.7%) were unsuccessful, but no cardiac event occurred during the hospital stay. A major cardiac event occurred in 13 cases (4.3%); 9 (3%) of these complications were due to the ablation procedure. Six patients sustained a Q wave myocardial infarction alone, two had a Q wave infarction and required emergency surgery and one needed emergency surgery but did not have a Q wave infarction. No procedural deaths were attributed to the ablation procedure. Follow-up has been obtained in 182 of the 242 patients at a mean interval of 9 +/- 5 months. Of the 182 patients, 174 (95.6%) were alive and free of myocardial infarction. Angiographic follow-up is available thus far in 87 patients. By combining angiographic and clinical outcome, an overall estimated restenosis rate of 37.4% (68 of 182) was calculated. CONCLUSIONS: These data suggest that coronary rotational ablation can be performed on lesions with a variety of morphologic features with high initial success rates. The overall rate of restenosis is similar to that of balloon angioplasty.

High speed rotational atherectomy in coronary artery disease.

Despite major advances in its diagnosis and management, coronary artery disease remains the major cause of death accounting for 45.3 percent of all deaths in the United States. One of the major milestones in the treatment of coronary artery disease has been the introduction of non-surgical revascularization in the form of percutaneous transluminal coronary angioplasty by Andreas Gmentzig in 1977. In the early years, PTCA could only be performed in proximal, discrete, non-calcified lesions. Over the last decade, major advances in the catheter, balloon and guide wire technology as well as increased operator experience extended the benefits of PTCA to patients with more complex lesions and multivessel coronary artery disease. Although the initial impetus for the development of newer devices has been to address the problem of restenosis, they are proving to be useful in treating lesions that are inadequately treated or subject to increased incidence of complications. The high speed rotational atherectomy is a valuable addition with its ability to treat long, calcified lesions. This report will describe the technical aspects of the Rotablator®, the procedure of high speed rotational atherectomy and its clinical applications.