J. Jeffrey Marshall

Clinical outcomes, angiographic patency, and resource utilization in 200 consecutive off-pump coronary bypass patients

BACKGROUND This retrospective study compared clinical outcomes and resource utilization in patients having off-pump coronary artery bypass grafting (OPCAB) versus conventional coronary artery bypass grafting (CABG). Angiographic patency was documented in the OPCAB group. METHODS From April 1997 through November 1999, OPCAB was performed in 200 consecutive patients, and the results were compared with those in a contemporaneous matched control group of 1,000 patients undergoing CABG. Patients were matched according to age, sex, preexisting disease (renal failure, diabetes, pulmonary disease, stroke, hypertension, peripheral vascular disease, previous myocardial infarction, and primary or redo status. Follow-up in the OPCAB patients was 93% and averaged 13.4 months. RESULTS Hospital death (1.0%), postoperative stroke (1.5%), myocardial infarction (1.0%), and re-entry for bleeding (1.5%) occurred infrequently in the OPCAB group. There were reductions in the rates of transfusion (33.0% versus 70.0%; p < 0.001) and deep sternal wound infection (0% versus 2.2%; p = 0.067) in the OPCAB group compared with the CABG group. Angiographic assessment of 421 grafted arteries was performed in 167 OPCAB patients (83.5%) prior to hospital discharge. All but five were patent (98.8%) (93.3% FitzGibbon A, 5.5% FitzGibbon B, 1.2% FitzGibbon O). All 163 internal mammary artery grafts were patent. Off-pump coronary artery bypass grafting reduced postoperative hospital stay from 5.7 +/- 5.3 days in the CABG group to 3.9 +/- 2.6 days (p < 0.001), with a decrease in hospital cost of 15.0% (p < 0.001). CONCLUSIONS Off-pump coronary artery bypass grafting reduces hospital cost, postoperative length of stay, and morbidity compared with CABG on cardiopulmonary bypass. Off-pump coronary bypass grafting is safe, cost effective, and associated with excellent graft patency and clinical outcomes.

Design, Progress and Challenges of a Double-Blind Trial of Warfarin versus Aspirin for Symptomatic Intracranial Arterial Stenosis

Background and Relevance: Atherosclerotic stenosis of the major intracranial arteries is an important cause of transient ischemic attack (TIA) or stroke. Of the 900,000 patients who suffer a TIA or stroke each year in the USA, intracranial stenosis is responsible for approximately 10%, i.e. 90,000 patients. There have been no prospective trials evaluating antithrombotic therapies for preventing recurrent vascular events in these patients. The main objective of this trial is to compare warfarin [International Normalized Ratio (INR) 2–3] with aspirin (1,300 mg/day) for preventing stroke (ischemic and hemorrhagic) and vascular death in patients presenting with TIA or stroke caused by stenosis of a major intracranial artery. Study Design: Prospective, randomized, double-blind, multicenter trial. The sample sizerequired will be 403 patients per group, based on stroke and vascular death rates of 33% per 3 years in the aspirin group vs. 22% per 3 years in the warfarin group, a p value of 0.05, power of 80%, a 24% rate of ‘withdrawal of therapy’, and a 1% rate of ‘lost to follow-up’. Conduct of Trial: Patients with TIA or nondisabling stroke caused by ≧50% stenosis of a major intracranial artery documented by catheter angiography are randomized to warfarin or aspirin. Patients are contacted monthly by phone and examined every 4 months until a common termination date. Mean follow-up in the study is expected to be 3 years. Conclusion: This study will determine whether warfarin or aspirin is superior for patients with symptomatic intracranial arterial stenosis. Furthermore, it will identify patients whose rate of ischemic stroke in the territory of the stenotic intracranial artery on best medical therapy is sufficiently high to justify a subsequent trial comparing intracranial angioplasty/stenting with best medical therapy in this subset of patients.

Safety and Feasibility of Robotic Percutaneous Coronary Intervention : PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study

OBJECTIVES The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic-assisted percutaneous coronary intervention. BACKGROUND Robotic systems have been suggested to enhance the performance of cardiovascular procedures, as well as to provide protection from the occupational hazards that are associated with interventional practice. METHODS Patients with coronary artery disease and clinical indications for percutaneous intervention were enrolled. The coronary intervention was performed with the CorPath 200 robotic system, which consists of a remote interventional cockpit and a bedside disposable cassette that enables the operator to advance, retract, and rotate guidewires and catheters. The primary endpoints were clinical procedural success, defined as <30% residual stenosis at the completion of the robotic-assisted procedure without major adverse cardiovascular events within 30 days, and device technical success, defined as the successful manipulation of the intracoronary devices using the robotic system only. RESULTS A total of 164 patients were enrolled at 9 sites. Percutaneous coronary intervention was completed successfully without conversion to manual operation, and device technical success was achieved in 162 of 164 patients (98.8%). There were no device-related complications. Clinical procedural success was achieved in 160 of 164 patients (97.6%), whereas 4 (2.4%) had periprocedural non-Q-wave myocardial infarctions. No deaths, strokes, Q-wave myocardial infarctions, or revascularization occurred in the 30 days after the procedures. Radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position. CONCLUSIONS This pivotal multicenter study with a robotic-enhanced coronary intervention system demonstrated the safety and feasibility of the system. The robotic remote-control procedure met the expected technical and clinical performance, with significantly lower radiation exposure to the operator. (Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions [PCI] [PRECISE]; NCT01275092).

Effect of Percutaneous Coronary Intervention on Quality of Life: A Consensus Statement from the Society for Cardiovascular Angiography and Interventions

Percutaneous coronary intervention (PCI) decreases ischemic complications of acute coronary syndromes. The benefits of PCI in stable ischemic heart disease (SIHD) depend on its effect on quality of life (QoL), including angina, physical activity, and emotional well‐being. PCI decreases angina and the need for anti‐anginal medications, and increases exercise capacity and QoL, compared with baseline status and compared with medical therapy without PCI. These benefits are greater when QOL is markedly impaired by severe angina before the procedure. When considering treatment options for symptomatic SIHD, physicians should consider and provide objective data regarding QoL effects for each treatment strategy. QoL outcomes should be considered in clinical trials, appropriate use criteria, practice guidelines, and reimbursement policies for PCI.

Acute renal artery thrombosis treated by percutaneous rheolytic thrombectomy

Renal artery thrombosis or embolus is a rare condition that may lead to hypertension and renal failure. Treatment options in the past have had limited success. We present a case which demonstrates the use of percutaneous rheolytic therapy with the Angiojet atherectomy catheter to treat this condition in the acute setting. Cathet Cardiovasc Intervent 2002;56:66–68.

Interoperator and intraoperator (in)accuracy of stent selection based on visual estimation

The objectives of this study were to evaluate the ability of interventional cardiologists to accurately measure lesion length and select appropriate stents.Objectives The objectives of this study were to evaluate the ability of interventional cardiologists to accurately measure lesion length and select appropriate stents. Background Inaccurate measurement of lesion length during percutaneous coronary intervention (PCI) increases the risk of restenosis. Methods Interventional cardiologists (n = 40) evaluated 25 matched orthogonal angiographic images that were prescored using quantitative coronary angiography (QCA) by a core laboratory. Visual estimates of lesion length and stent length selection were compared to the maximum QCA value. A 2–4 mm stent overlap of both the proximal and distal lesion edges was considered to be optimal. Based on optimal stent overlap, accurate lesion lengths were those measured from −1 to +4 mm from the QCA. Likewise, appropriate stent lengths were those that measured between +4 mm to +8 mm from the QCA value. Five images were repeated to assess intrarater variability. Results Lesion length measurements were short and long for 51.1% (95% CI 47.6–54.6%) and 19.0% (95% CI 16.3–21.9%) of the images, respectively. Stent length selections that were short and long were recorded for 55.0% (95% CI 51.5–58.5%) and 22.8% (95% CI 19.9–25.8%) of the images, respectively. Intrarater variability evaluation indicated that 38.5% (95% CI 31.7–45.6%) of lesion length measurements and 37.5% (95% CI 30.8–44.6%) of stent length selections were >3 mm different between the first and second evaluation of repeated images. Conclusions Visual estimation of coronary lesion length has a high degree of variability, which may lead to inappropriate stent selection. Improving the accuracy of lesion length measurement may improve patient outcomes.

The association between experience and proficiency with robotic-enhanced coronary intervention—insights from the PRECISE multi-center study

Abstract Objectives: The PRECISE multi-center study demonstrated the safety and feasibility of robotic-enhanced coronary intervention (PCI). We studied the learning curve associated with the robotic PCI approach. Methods: The CorPath 200 robotic system was used to perform clinically indicated PCI. The first 3 cases performed by each interventional cardiologist were considered early-experience cases and subsequent procedures were regarded as advanced-experience cases. We compared procedure efficiency, patient radiation exposure, and clinical outcomes in early and advanced-experience cases. Results: A total of 164 robotic-enhanced PCI procedures were performed, with 60 early-experience cases. Advanced-experience cases were associated with shorter procedure duration (51.3 ± 25.5 min vs. 42.2 ± 16.4 min, P = 0.008) and fluoroscopy time (12.9 ± 7.8 min vs. 10.1 ± 4.8 min, 0.009) as compared to early-experience cases. Conclusions: After performing 3 cases, interventionalists were able to complete robotic-enhanced PCI faster, with reduced radiation, and without compromising safety. The steep learning curve highlights the easy adoption of remote-control robotic technology for PCI.

The use of intrastent peripheral stent in large coronary arteries: Report of three cases

We report three cases of coronary angioplasty using the IntraTherapeutics Intrastent biliary stent. We describe a technique utilizing routine coronary angioplasty equipment including 8 Fr guiding catheters and 0.014″ guidewires. This technique can be easily performed in large‐diameter coronary arteries. Cathet. Cardiovasc. Intervent. 50:498–501, 2000.

President's page: public reporting of cardiovascular care: an opportunity to shape the future.

![Figure][1] It is increasingly uncommon for someone to make an expensive purchase or choose a contractor for a major project without some thoughtful research. Decisions about health care and who provides it should be no different, but reliable information about the quality of health care

Public Reporting of Cardiovascular Care: An Opportunity to Shape the Future

William A. Zoghbi MD, FACC ACC President The unstated rationale for public reporting is that this information has impacts on market forces, payers, and practitioners to improve health care quality and reduce costs. In one of the first public reporting efforts, the Health Care Financing Administration (HCFA) published hospital mortality rates for Medicare patients undergoing coronary artery bypass graft surgery (CABG) (1). These data, derived from administrative and claims information, were not originally intended for this use and the report was criticized by hospitals and providers because they feared that the risk adjustment models were inadequate. Although adjustments were made, the usefulness of these reports has never been established, and many express negative opinions about these data (2). The HCFA experience led to the development of several private quality improvement registries and public state-wide reporting systems, such as the Northern New England Cardiovascular Study Group and the Society of Thoracic Surgeons (STS) National Adult Cardiac Surgery Database (3). New York, Pennsylvania, Massachusetts, and California subsequently developed public reporting mechanisms for cardiac surgical outcomes (4–7). Some states even report physician-specific data and have expanded reporting to include percutaneous coronary interventions (PCI) (8). In 2005, the Centers for Medicare and Medicaid Services (CMS) launched the Hospital Compare website to publicly report hospital quality information derived from several sources (9). Certain core measures are reported for cardiac patients along with risk-adjusted mortality and readmission rates for acute myocardial infarction and heart failure derived from Medicare enrollment and claims data. The site also reports the results of patient surveys about their hospitalization and is considering adding measures from the Hospital Value Based Purchasing Program. The number of resources currently devoted to public reporting is unknown, but public reporti ng initiatives continue to proliferate with additional state initiatives, reports from payers that focus on costs, and reports from business consumer groups (10). There are now several internet-based forums where patients can report their individual experiences with physicians, both good and bad, in an unregulated and nonscientific manner. This, in turn, has resulted in some physicians requiring patients to agree to not participate in such activities before any treatment is provided. January 2011, under the authority of the Patient Protection and Affordable Care Act of 2010 (PPACA), CMS implemented the Physician Compare website (11). Several benchmarks for this effort were established: 1) providing information on the performance of physicians (and other health care providers) enrolled in Medicare; 2) reporting to Congress on the plans to use these data for value-based purchasing and consumer choice; and 3) demonstrating how financial incentives will be applied to beneficiaries who use “high-quality physicians.”