Donald R. Ricci

A Randomized Comparison of Coronary-Stent Placement and Balloon Angioplasty in the Treatment of Coronary Artery Disease

BACKGROUND Coronary-stent placement is a new technique in which a balloon-expandable, stainless-steel, slotted tube is implanted at the site of a coronary stenosis. The purpose of this study was to compare the effects of stent placement and standard balloon angioplasty on angiographically detected restenosis and clinical outcomes. METHODS We randomly assigned 410 patients with symptomatic coronary disease to elective placement of a Palmaz-Schatz stent or to standard balloon angioplasty. Coronary angiography was performed at base line, immediately after the procedure, and six months later. RESULTS The patients who underwent stenting had a higher rate of procedural success than those who underwent standard balloon angioplasty (96.1 percent vs. 89.6 percent, P = 0.011), a larger immediate increase in the diameter of the lumen (1.72 +/- 0.46 vs. 1.23 +/- 0.48 mm, P < 0.001), and a larger luminal diameter immediately after the procedure (2.49 +/- 0.43 vs. 1.99 +/- 0.47 mm, P < 0.001). At six months, the patients with stented lesions continued to have a larger luminal diameter (1.74 +/- 0.60 vs. 1.56 +/- 0.65 mm, P = 0.007) and a lower rate of restenosis (31.6 percent vs. 42.1 percent, P = 0.046) than those treated with balloon angioplasty. There were no coronary events (death; myocardial infarction; coronary-artery bypass surgery; vessel closure, including stent thrombosis; or repeated angioplasty) in 80.5 percent of the patients in the stent group and 76.2 percent of those in the angioplasty group (P = 0.16). Revascularization of the original target lesion because of recurrent myocardial ischemia was performed less frequently in the stent group than in the angioplasty group (10.2 percent vs. 15.4 percent, P = 0.06). CONCLUSIONS In selected patients, placement of an intracoronary stent, as compared with balloon angioplasty, results in an improved rate of procedural success, a lower rate of angiographically detected restenosis, a similar rate of clinical events after six months, and a less frequent need for revascularization of the original coronary lesion.

Percutaneous Transarterial Aortic Valve Replacement in Selected High-Risk Patients With Aortic Stenosis

Background— Percutaneous aortic valve replacement represents an endovascular alternative to conventional open heart surgery without the need for sternotomy, aortotomy, or cardiopulmonary bypass. Methods and Results— Transcatheter implantation of a balloon-expandable stent valve using a femoral arterial approach was attempted in 50 symptomatic patients with severe aortic stenosis in whom there was a consensus that the risks of conventional open heart surgery were very high. Valve implantation was successful in 86% of patients. Intraprocedural mortality was 2%. Discharge home occurred at a median of 5 days (interquartile range, 4 to 13). Mortality at 30 days was 12% in patients in whom the logistic European System for Cardiac Operative Risk Evaluation risk score was 28%. With experience, procedural success increased from 76% in the first 25 patients to 96% in the second 25 (P=0.10), and 30-day mortality fell from 16% to 8% (P=0.67). Successful valve replacement was associated with an increase in echocardiographic valve area from 0.6±0.2 to 1.7±0.4 cm2. Mild paravalvular regurgitation was common but was well tolerated. After valve insertion, there was a significant improvement in left ventricular ejection fraction (P<0.0001), mitral regurgitation (P=0.01), and functional class (P<0.0001). Improvement was maintained at 1 year. Structural valve deterioration was not observed with a median follow-up of 359 days. Conclusion— Percutaneous valve replacement may be an alternative to conventional open heart surgery in selected high-risk patients with severe symptomatic aortic stenosis.

Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery

Background— Percutaneous aortic valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic aortic valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic aortic valve implantation via the femoral arterial approach is described and the initial experience reported. Methods and Results— The valve prosthesis is constructed from a stainless steel stent with an attached trileaflet equine pericardial valve and a fabric cuff. After routine aortic balloon valvuloplasty, a 22F or 24F sheath is advanced from the femoral artery to the aorta. A steerable, deflectable catheter facilitates manipulation of the prosthesis around the aortic arch and through the stenotic valve. Rapid ventricular pacing is used to reduce cardiac output while the delivery balloon is inflated to deploy the prosthesis within the annulus. Percutaneous aortic prosthetic valve implantation was attempted in 18 patients (aged 81±6 years) in whom surgical risk was deemed excessive because of comorbidities. Iliac arterial injury, seen in the first 2 patients, did not recur after improvement in screening and access site management. Implantation was successful in 14 patients. After successful implantation, the aortic valve area increased from 0.6±0.2 to 1.6±0.4 cm2. There were no intraprocedural deaths. At follow-up of 75±55 days, 16 patients (89%) remained alive. Conclusions— This initial experience suggests that percutaneous transarterial aortic valve implantation is feasible in selected high-risk patients with satisfactory short-term outcomes.

A Comparison of Directional Atherectomy with Balloon Angioplasty for Lesions of the Left Anterior Descending Coronary Artery

BACKGROUND Restenosis is a major limitation of coronary angioplasty. Directional coronary atherectomy was developed with the expectation that it would provide better results than angioplasty, including a lower rate of restenosis. We undertook a randomized, multicenter trial to compare the rates of restenosis for atherectomy and angioplasty when used to treat lesions of the proximal left anterior descending coronary artery. METHODS Of 274 patients referred for first-time, non-surgical revascularization of lesions of the proximal left anterior descending coronary artery, 138 were randomly assigned to undergo atherectomy and 136 to undergo angioplasty; 257 of 265 eligible patients (97 percent) underwent follow-up angiography at a median of 5.9 months. Computer-assisted quantitative measurements of luminal dimensions were determined from the angiograms obtained before and immediately after the procedure and at follow-up. The primary end point of restenosis was defined as stenosis of more than 50 percent of the vessels diameter at follow-up. RESULTS Quantitative analysis showed that the procedural success rate was higher in patients who underwent atherectomy than in those who had angioplasty (94 percent vs. 88 percent, P = 0.061); there was no significant difference in the frequency of major in-hospital complications (5 percent vs. 6 percent). At follow-up, the rate of restenosis was 46 percent after atherectomy and 43 percent after angioplasty (P = 0.71). Despite a larger initial gain in the minimal luminal diameter with atherectomy (mean [+/- SD], 1.45 +/- 0.47 vs. 1.16 +/- 0.44 mm; P < 0.001), there was a larger late loss (0.79 +/- 0.61 vs. 0.47 +/- 0.64 mm; P < 0.001), resulting in a similar minimal luminal diameter in the two groups at follow-up (1.55 +/- 0.60 vs. 1.61 +/- 0.68, P = 0.44). The clinical outcomes at six months were not significantly different between the two groups. CONCLUSIONS The role of atherectomy in percutaneous coronary revascularization remains to be fully defined. However, as compared with angioplasty, atherectomy did not result in better late angiographic or clinical outcomes in patients with lesions of the proximal left anterior descending coronary artery.

Spontaneous Coronary Artery Dissection : Prevalence of Predisposing Conditions Including Fibromuscular Dysplasia in a Tertiary Center Cohort

OBJECTIVES We sought to evaluate the prevalence of fibromuscular dysplasia (FMD) and other predisposing conditions among spontaneous coronary artery dissection (SCAD) patients. BACKGROUND Spontaneous coronary artery dissection is considered rare. However, we observed many young women with SCAD and concomitant FMD. METHODS Spontaneous coronary artery dissection patients were identified prospectively and retrospectively at Vancouver General Hospital over the past 6 years. Coronary angiograms were meticulously reviewed by 2 senior interventional cardiologists. Identified patients were contacted for prospective evaluation at our SCAD clinic, and screening for FMD of renal, iliac, and cerebrovascular arteries was performed with computed tomography angiography or magnetic resonance angiography, if not already screened during the index angiogram. Potential predisposing and precipitating conditions for SCAD were extracted from clinical history. RESULTS We identified 50 patients with nonatherosclerotic SCAD from April 2006 to March 2012. Average age was 51.0 years, and almost all were women (98.0%). All presented with myocardial infarction (MI), 30.0% had ST-segment elevation, and 70.0% had non-ST-segment elevation MI. Only 1 was postpartum, and 2 were involved in intense isometric exercises. Emotional stress was reported in 26.0% before the MI. Twelve percent had >1 dissected coronary artery. Most SCAD patients had FMD of ≥1 noncoronary territory (86.0%): 25 of 43 (58.1%) renal, 21 of 43 (48.8%) iliac, and 20 of 43 (46.5%) cerebrovascular (6 of 43, 14.0% had intracranial aneurysm). Five had incomplete FMD screening. CONCLUSIONS Nonatherosclerotic SCAD predominantly affects women, and most have concomitant FMD. We suspect these patients have underlying coronary FMD that predisposed them to SCAD, but this requires proof from histology or intracoronary imaging of the affected coronary arteries.

Spontaneous Coronary Artery Dissection Association With Predisposing Arteriopathies and Precipitating Stressors and Cardiovascular Outcomes

Background—Nonatherosclerotic spontaneous coronary artery dissection (NA-SCAD) is underdiagnosed and an important cause of myocardial infarction in young women. The frequency of predisposing and precipitating conditions and cardiovascular outcomes remains poorly described. Methods and Results—Patients with NA-SCAD prospectively evaluated (retrospectively or prospectively identified) at Vancouver General Hospital were included. Angiographic SCAD diagnosis was confirmed by 2 experienced interventional cardiologists and categorized as type 1 (multiple lumen), 2 (diffuse stenosis), or 3 (mimic atherosclerosis). Fibromuscular dysplasia screening of renal, iliac, and cerebrovascular arteries were performed with angiography or computed tomographic angiography/MR angiography. Baseline, predisposing and precipitating conditions, angiographic, revascularization, in-hospital, and long-term events were recorded. We prospectively evaluated 168 patients with NA-SCAD. Average age was 52.1±9.2 years, 92.3% were women (62.3% postmenopausal). All presented with myocardial infarction. ECG showed ST-segment elevation in 26.1%, and 3.6% had ventricular tachycardia/ventricular fibrillation arrest. Fibromuscular dysplasia was diagnosed in 72.0%. Precipitating emotional or physical stress was reported in 56.5%. Majority had type 2 angiographic SCAD (67.0%), only 29.1% had type 1, and 3.9% had type 3. The majority (134/168) were initially treated conservatively. Overall, 6 of 168 patients had coronary artery bypass surgery and 33 of 168 had percutaneous coronary intervention in-hospital. Of those treated conservatively (n=134), 3 required revascularization for SCAD extension, and all 79 who had repeat angiogram ≥26 days later had spontaneous healing. Two-year major adverse cardiac events were 16.9% (retrospectively identified group) and 10.4% (prospectively identified group). Recurrent SCAD occurred in 13.1%. Conclusions—Majority of patients with NA-SCAD had fibromuscular dysplasia and type 2 angiographic SCAD. Conservative therapy was associated with spontaneous healing. NA-SCAD survivors are at risk for recurrent cardiovascular events, including recurrent SCAD.

Improved Clinical Outcome after Widespread Use of Coronary-Artery Stenting in Canada

Background The introduction and refinement of coronary-artery stenting dramatically changed the practice of percutaneous coronary revascularization in the mid-1990s. We analyzed one-year follow-up data for all percutaneous coronary interventions performed in a large, unselected population in Canada to determine whether the use of coronary stenting has been associated with improved outcomes. Methods Prospectively collected data on all percutaneous coronary interventions performed on residents of British Columbia, Canada, between April 1994 and June 1997 were linked to province-wide health care data bases to provide the date of the following end points: subsequent target-vessel revascularization, myocardial infarction, and death. Base-line characteristics and procedural variables were identified and Kaplan–Meier survival curves were generated for 9594 procedures divided into seven groups, one for each sequential half-year period. Results The overall burden of coexisting illnesses remained stable throughout ...

Abciximab and bleeding during coronary surgery: results from the EPILOG and EPISTENT trials ∗

BACKGROUND Abciximab during percutaneous coronary revascularization reduces ischemic complications, but concern exists regarding increased bleeding risk should emergency coronary surgical procedures be required. METHODS Outcomes were assessed among 85 patients who required coronary artery bypass grafting operations after coronary intervention in two randomized placebo-controlled trials of abciximab. Comparisons were made between patients in the pooled placebo and abciximab groups. RESULTS The incidence of coronary surgical procedures was 2.17% and 1.28% among patients randomized to placebo and abciximab, respectively (p = 0.021). Platelet transfusions were administered to 32% and 52% of patients in the placebo and abciximab groups, respectively (p = 0.059). Rates of major blood loss were 79% and 88% in the placebo and abciximab groups, respectively (p = 0.27); transfusions of packed red blood cells or whole blood were administered in 74% and 80% of patients, respectively (p = 0.53). Surgical reexploration for bleeding was required in 3% and 12% of patients, respectively. Death and myocardial infarction tended to occur less frequently among patients who had received abciximab. CONCLUSIONS Urgent coronary artery bypass grafting operations can be performed without an incremental increase in major hemorrhagic risk among patients on abciximab therapy.

Left ventricular abnormalities in arrhythmogenic right ventricular dysplasia

Abstract Right ventricular (RV) dysplasia is a condition in which the RV myocardium is partially or totally absent and replaced with fibrous or fatty tissue. Dysplasia may be mild or there may be total absence of myocardium, with apposition of endocardium to epicardium.1–4 When associated with ventricular arrhythmias the condition has been termed arrhythmogenic RV dysplasia.4 This condition was believed to involve exclusively the right ventricle.5,6 Recently, however, left ventricular (LV) abnormalities have been described in association with RV dysplasia.7 From patients presenting over a 2-year period to the electrophysiology service at our institution, we identified 4 patients with recurrent ventricular tachycardia (VT) of RV origin and morphologic features typical of RV dysplasia. This report describes our findings (Table I).

A novel endovascular clip system for the treatment of intracranial aneurysms: technology, concept, and initial experimental results. Laboratory investigation.

OBJECT The authors describe a novel device for the endovascular treatment of intracranial aneurysms, the endovascular clip system (eCLIPs). Descriptions of the device and its delivery system as well as the results of flow model tests and the treatment of experimental aneurysms are provided. METHODS The eCLIPs comprises a flexible hybrid implantable device (an anchor and a covered leaf) and a balloon catheter delivery system, designed to be positioned and activated in the parent vessel in such a way that the covered portion will abut the aneurysm neck. The eCLIPs was subjected to testing in glass, elastomeric, and cadaveric flow models to determine its navigability, orientation, and activation compared with commercially available stents. In a second experiment, 8 carotid artery sidewall aneurysms in swine were treated using eCLIPs. The degree of occlusion was observed on angiography immediately following and 30 days after device activation, and a histological analysis was performed at 30 days. RESULTS The device could navigate tortuous glass models and human cadaveric vessels. Compared with commercially available stents, the eCLIPs performed well. It could be navigated, oriented, and activated easily and reliably. With regard to the 8 porcine experimental aneurysms, immediate postactivation angiograms confirmed complete occlusion of 4 lesions and near occlusion of the other 4. Angiographic follow-up at 30 days postactivation showed occlusion of all 8 aneurysms and patency of all parent vessels. Histopathological analysis revealed aneurysm healing, with smooth-muscle cells growing across the lesion neck to allow reendothelialization. CONCLUSIONS Aneurysm occlusion with a single extrasaccular endovascular device has potential advantages. The authors believe that eCLIPs may prove to be a useful tool in the endovascular treatment of cerebral aneurysms. The system should reduce risks associated with coiling, procedure time, costs, and radiation exposure. The device satisfactorily occluded 8 experimental sidewall aneurysms. The observed healing pattern is similar to that seen after microsurgical clipping.