Dale R. Tavris

Association Between Endoscopic vs Open Vein-Graft Harvesting and Mortality, Wound Complications, and Cardiovascular Events in Patients Undergoing CABG Surgery

CONTEXT The safety and durability of endoscopic vein graft harvest in coronary artery bypass graft (CABG) surgery has recently been called into question. OBJECTIVE To compare the long-term outcomes of endoscopic vs open vein-graft harvesting for Medicare patients undergoing CABG surgery in the United States. DESIGN, SETTING, AND PATIENTS An observational study of 235,394 Medicare patients undergoing isolated CABG surgery between 2003 and 2008 at 934 surgical centers participating in the Society of Thoracic Surgeons (STS) national database. The STS records were linked to Medicare files to allow longitudinal assessment (median 3-year follow-up) through December 31, 2008. MAIN OUTCOME MEASURES All-cause mortality. Secondary outcome measures included wound complications and the composite of death, myocardial infarction, and revascularization. RESULTS Based on Medicare Part B coding, 52% of patients received endoscopic vein-graft harvesting during CABG surgery. After propensity score adjustment for clinical characteristics, there were no significant differences between long-term mortality rates (13.2% [12,429 events] vs 13.4% [13,096 events]) and the composite of death, myocardial infarction, and revascularization (19.5% [18,419 events] vs 19.7% [19,232 events]). Time-to-event analysis for those patients receiving endoscopic vs open vein-graft harvesting revealed adjusted hazard ratios [HRs] of 1.00 (95% CI, 0.97-1.04) for mortality and 1.00 (95% CI, 0.98-1.05) for the composite outcome. Endoscopic vein-graft harvesting was associated with lower harvest site wound complications relative to open vein-graft harvesting (3.0% [3654/122,899 events] vs 3.6% [4047/112,495 events]; adjusted HR, 0.83; 95% CI, 0.77-0.89; P < .001). CONCLUSION Among patients undergoing CABG surgery, the use of endoscopic vein-graft harvesting compared with open vein-graft harvesting was not associated with increased mortality.

Sex‐Based Differences in Outcomes After Percutaneous Coronary Intervention for Acute Myocardial Infarction: A Report From TRANSLATE‐ACS

Background Data regarding sex‐based outcomes after percutaneous coronary intervention (PCI) for myocardial infarction are mixed. We sought to examine whether sex differences in outcomes exist in contemporary practice. Methods and Results We examined acute myocardial infarction patients undergoing PCI between April 2010 and October 2012 at 210 US hospitals participating in the Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE‐ACS) observational study. Outcomes included 1‐year risk of major adverse cardiac events and bleeding according to Global Utilization of Strategies To Open Occluded Arteries (GUSTO) and Bleeding Academic Research Consortium (BARC) definitions. Among 6218 patients, 27.5% (n=1712) were female. Compared with men, women were older, had more comorbidities, and had lower functional status. Use of multivessel PCI and drug‐eluting stents was similar between sexes, while women received less prasugrel. Unadjusted cumulative incidence of 1‐year major adverse cardiac events was higher for women than for men (15.7% versus 13.6%, P=0.02), but female sex was no longer associated with higher incidence of major adverse cardiac events after multivariable adjustment (hazard ratio 0.98, 95% CI 0.83 to 1.15). Female sex was associated with higher risks of post‐PCI GUSTO bleeding (9.1% versus 5.7%, P<0.0001) and postdischarge BARC bleeding (39.6% versus 27.9%, P<0.0001). Differences persisted after adjustment (GUSTO: hazard ratio 1.32, 95% CI 1.06 to 1.64; BARC: incidence rate ratio 1.42, 95% CI 1.27 to 1.56). Conclusions Female and male myocardial infarction patients undergoing PCI differ regarding demographic, clinical, and treatment profiles. These differences appear to explain the higher observed major adverse cardiac event rate but not higher adjusted bleeding risk for women versus men.

The public health impact of the MiniMed Continuous Glucose Monitoring System (CGMS)-an assessment of the literature.

The Medtronic MiniMed (Northridge, CA) Continuous Glucose Monitoring System (CGMS) was approved by the U. S. Food and Drug Administration in 1999, for the continuous tracking of glucose concentration. The rationale for the use of this device is that frequent glucose measurements allow a more precise understanding of daily glucose fluctuations, without the inconvenience of frequent needle sticks. A review of the medical literature was undertaken to assess the public health impact of this device. Glucose readings from the MiniMed CGMS were found to correlate well with blood glucose (r = 0.73-0.92) and with hemoglobin A(1c) (HBA(1c)) (r = 0.53-0.59). Most important from a public health standpoint is the ability of the MiniMed device to detect episodes of asymptomatic hypoglycemia, and to lower HBA(1c) (absolute decline of 0.3%), as compared with controls. If these findings hold, the use of the MiniMed CGMS could result in a substantial reduction of morbidity and mortality associated with diabetes. The limitations of this analysis, most importantly the paucity of controlled studies that assess the ability of this device to result in improved control of diabetes over long periods of time, are discussed.

Medical device epidemiology and surveillance: patient safety is the bottom line

(2004). Medical device epidemiology and surveillance: patient safety is the bottom line. Expert Review of Medical Devices: Vol. 1, No. 1, pp. 1-2.

Arteriotomy closure devices-the FDA perspective.

In this issue of the Journal , Dangas et al. [(1)][1]assessed the incidence of vascular complications at the Washington Hospital Center following percutaneous coronary interventions (PCI) when arteriotomy closure devices (ACD) were used to achieve hemostasis of the femoral artery versus when manual

Clinical study: interventional cardiology: editorial commentArteriotomy closure devices—the FDA perspective∗

In this issue of the Journal , Dangas et al. [(1)][1]assessed the incidence of vascular complications at the Washington Hospital Center following percutaneous coronary interventions (PCI) when arteriotomy closure devices (ACD) were used to achieve hemostasis of the femoral artery versus when manual

TransRadial Education And Therapeutics (TREAT): Shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: A report from the Cardiac Safety Research Consortium

Percutaneous coronary intervention (PCI) is an integral part of the treatment of coronary artery disease. The most common complication of PCI, bleeding, typically occurs at the vascular access site and is associated with short-term and long-term morbidity and mortality. Periprocedural bleeding also represents the primary safety concern of concomitant antithrombotic therapies essential for PCI success. Use of radial access for PCI reduces procedural bleeding and hence may change the risk profile and net clinical benefit of these drugs. This new drug-device safety interaction creates opportunities to advance the safe and effective use of antithrombotic agents during PCI. In June 2010 and March 2011, leaders from government, academia, professional societies, device manufacturing, and pharmaceutical industries convened for 2 think tank meetings. Titled TREAT I and II, these forums examined approaches to improve the overall safety of PCI by optimizing strategies for antithrombotic drug use and radial artery access. This article summarizes the content and proceedings of these sessions.

Long-Term Outcomes After Transmyocardial Revascularization

BACKGROUND Two independent reports documented substantially higher operative mortality associated with transmyocardial revascularization (TMR) when used in isolation than that reported in the premarket clinical trials. To clarify the state of the art, this article assesses temporal trends in the use of TMR, short-term and long-term outcomes, and outcomes stratified by procedure type (TMR only and TMR + coronary artery bypass graft [CABG]) and by the 2 specific TMR devices. METHODS The study population included all patients undergoing TMR in isolation or in combination with CABG at 435 cardiothoracic hospitals in the United States participating in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) from January 2000 through November 2006 (n = 15,386). Analysis of long-term outcomes was accomplished through linkage to Medicare claims data. Short-term and long-term (7 years) adverse outcomes were assessed and compared between the 2 TMR device types. RESULTS The use of TMR in conjunction with CABG surgery is increasing. This study showed modest differences in short-term morbidity and mortality between the 2 devices. In combination with CABG, after risk adjustment, patients treated with the holmium:YAG laser (experienced a higher rate of operative mortality (3.5% vs 2.5%; adjusted hazard ratio 1.39, 95% confidence level 1.03 to 1.87) but no difference in the composite short-term rate of major morbidity or mortality, compared with the Heart Laser CO2 transmyocardial revascularization system (PLC Medical Systems, Inc, Milford, MA). However, there were no clinically meaningful differences in long-term results. CONCLUSIONS Modest differences in short-term morbidity and mortality between the 2 devices suggest the usefulness of further research.

Gender differences in correlates of troponin assay in diagnosis of myocardial infarction.

Cardiac troponins are the most sensitive and specific biomarker for myocardial infarction (MI) diagnosis. If there is a gender bias in MI diagnosis, it could be reduced by more consistently applying objective diagnostic criteria to improve womens outcomes. This study set out to assess the accuracy and correlates of the cardiac troponin I (cTnI) assay in the diagnosis of non-ST-segment elevation MI, to determine how the assay accuracy and correlates vary by gender, and to explore the interaction between factors that may influence cTnI accuracy and affect gender differences in diagnosis. The data were obtained from the CHECKMATE study. It included 924 patients with possible myocardial ischemia excluding subjects with ST-segment elevation. The Dade-Behring Stratus CS STAT near-patient instrument (Dade Behring, Inc, Newark, Del) was used to measure cTnI. We assessed baseline troponin accuracy using a standard MI definition. There were 125 subjects with a definite MI diagnosis. Baseline troponin was 44% sensitive and 97% specific in predicting MI, with no significant gender differences. In contrast, other positive cardiac markers, namely rising or falling creatine-kinase MB fraction and positive electrocardiogram, occurred more frequently in men. Sensitivity (SE) of baseline troponin was higher in subjects where baseline troponin was obtained longer than 2 hours after the chest pain onset. The study did not observe a significant difference in the assay SE or specificity by gender. This observation, plus the fact that other positive cardiac markers occurred more frequently in men, suggest the troponin test may help to improve the diagnosis of MI in women.

Aneurysm-Related Mortality Rates in the US AneuRx Clinical Trial

BACKGROUND The AneuRx (Medtronic) stent graft was approved by the FDA in September 1999. The purpose of this study was to ascertain the aneurysm-related mortality rate of a subgroup of the patient cohort from Medtronics investigational premarket study. STUDY DESIGN There were 931 study subjects, from 19 medical centers, who were followed for an average of 3.48 years. Abdominal aortic aneurysm (AAA)-related mortality rates were examined, using death certificates and medical records. RESULTS The 1-month postimplant death rate was 1.61%. Not counting deaths related to the initial implant, there was an increase in the rate of AAA-related mortality after 3 years, from an average of 0.18% in the first 3 years to an average of 1.39% in years 4 and 5. CONCLUSIONS Mortality in patients implanted with an AneuRx graft (as determined in this study) probably exceeds that of open procedure patients (based on medical literature) at some point in time, likely within 4 years after implant.