Multivessel percutaneous coronary intervention without contrast agents.

Contrast-induced nephropathy (CIN) following coronary angiography is associated with significant morbidity and mortality. Contrast media volume is the key risk factor for CIN in patients with chronic kidney disease undergoing coronary angiography and interventions. Very often, coronary interventions are avoided in such high-risk patients because of possible significant adverse clinical outcomes. We present a case demonstrating use of intravascular ultrasound (IVUS) to guide multivessel percutaneous coronary intervention (PCI) performed without any contrast administration in a patient with extreme risk for CIN. With the availability of advanced imaging of the coronary arteries such as high definition IVUS, contrast free PCI is a feasible approach and is associated with significant advantages of reducing or eliminating the development of CIN following PCI. This case report highlights the key practical aspects of performing contrast-free PCI and the challenges associated with such approach. © 2015 Wiley Periodicals, Inc.

Vascular closure device failure in contemporary practice.

OBJECTIVES: The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs. BACKGROUND: VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications. METHODS: From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n = 18,533), a nitinol clip-based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis. RESULTS: Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug-based, 6.1% of suture-based, 9.5% of nitinol clip-based VCDs). Patients with VCD failure had an excess risk of "any" (7.7% vs. 2.8%; p < 0.001), major (3.3% vs. 0.8%; p < 0.001), or minor (5.8% vs. 2.1%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score-adjusted analysis, when compared with collagen plug-based VCD (reference odds ratio [OR] = 1.0), nitinol clip-based VCD had 2-fold increased risk (OR: 2.0, 95% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD. CONCLUSIONS: VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes.

Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing.

BACKGROUND: Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery. METHODS: A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year. RESULTS: We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100% (5/5) and specificity of 98.8% (79/80). CONCLUSIONS: The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions.

Efficacy and safety of the nitinol clip-based vascular closure device (Starclose) for closure of common femoral arterial cannulation at or near the bifurcation: a propensity score-adjusted analysis.

OBJECTIVES: To evaluate the efficacy and safety of the nitinol clip-based closure device (Starclose®, Abbott Vascular, Santa Clara, California) in patients with femoral arterial cannulation at the common femoral artery bifurcation. BACKGROUND: Femoral artery puncture at the bifurcation of common femoral artery is a relative contraindication for the use of vascular closure devices with intravascular components, and patients with bifurcation cannulation were excluded from the pivotal trials of these devices. The nitinol clip-based closure device (Starclose) is extravascular and is sometimes used in such patients; however, the efficacy and safety of this approach is unknown. METHODS: We evaluated consecutive patients undergoing deployment of a Starclose device following a coronary procedure via the femoral artery approach. Quantitative femoral angiographic analyses were performed using a hand caliper. The distance of the artery puncture site from the bifurcation was recorded in each patient. Any arterial cannulation ≤ 3 mm from the bifurcation was categorized as a bifurcation cannulation (as the outer diameter of the nitinol clip of Starclose is 4 mm). RESULTS: Among 1096 patients who underwent deployment of a Starclose device, 217 (20%) were within 3 mm of the bifurcation. Starclose deployment at the bifurcation was not associated with a significant increase in the risk of any (0.9% vs. 1.0%; p = 0.892) major (0.0% vs. 0.3%; p = 0.389) or minor vascular complications (0.9% vs. 0.7%; p = 0.711) compared to deployment for non-bifurcation cannulations (both for diagnostic and percutaneous coronary interventional procedures). The results were unchanged in both a regression model adjusted for a propensity score (41 baseline covariates) as well as a propensity score-matched cohort (217 bifurcation cannulations vs. 217 non-bifurcation cannulations). CONCLUSION: In a select group of patients, vascular closure using a extravascular closure device (Starclose) appears to be safe for arterial cannulations at or near the bifurcation.

An evaluation of a distributed medical device safety surveillance system: the DELTA network study.

BACKGROUND: Post-market medical product safety surveillance is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies to identify low frequency safety threats and risk communication. PURPOSE: To review the design of the DELTA (Data Extraction and Longitudinal Trend Analysis) network study of the medical device safety surveillance. METHODS: This is a multicenter prospective observational study designed to evaluate the safety of new cardiovascular devices used during percutaneous coronary intervention (PCI) performed through continuous analysis of the routinely collected American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) data elements. The primary endpoint of the study is detection of adverse event rates specific to several classes of new medical devices, including drug eluting coronary stents, embolic protection devices, and vascular closure devices in patients undergoing PCI. Secondary endpoints include the time-savings between the DELTA network detection of a true device safety alert and the time taken to detect the same outcome using conventional retrospective data analysis, overall sensitivity, specificity, positive predictive value and negative predictive value of the DELTA network surveillance system. RESULTS: The details of the study are described including system design, eligibility criteria, methods and components of data collection, data security and statistical methods. In addition, the methods of adjudication and verification following an adverse event alert, overall study outcomes, end points, limitations and potential advantages are discussed. CONCLUSION: This report describes the first multicenter prospective study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices.

Validation of long-term benefits of bivalirudin versus unfractionated heparin in routine clinical practice after percutaneous coronary intervention.

Randomized controlled trials have shown improved short-term bleeding outcomes for bivalirudin compared to unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI) for stable angina and acute coronary syndrome. This study analyzed the impact of bivalirudin-based anticoagulation strategy versus UFH-based anticoagulation strategy on long-term bleeding complications and major adverse cardiac events in patients undergoing PCI in routine clinical practice. From September 2005 to April 2009, 3,367 consecutive patients who underwent PCI for stable angina or non-ST-segment elevation acute coronary syndrome at Brigham and Women's Hospital were studied. Of these patients, 2,228 patients (66%) received UFH and 1,139 (34%) received bivalirudin. Bleeding complication and major adverse cardiac event rates were compared at discharge, 30 days, and 1 year. In a propensity-score matched analysis, bivalirudin-based anticoagulation strategy was associated with lower bleeding complications at 30 days (7.0% vs 13.7%, p = 0.001) and 1 year (12.7% vs 18.9%, p = 0.013). Major adverse cardiac event rates were not significantly different between groups at discharge, 30 days, and 1 year (6.4% vs 8.3%, p = 0.103; 9.4% vs 10.9%, p = 0.449; 12.1% vs 14.8%, p = 0.235, respectively). There was no difference in all-cause mortality rates between the 2 groups (0.9% vs 0.8%, p = 0.808, at discharge; 1.9% vs 3.6%, p = 0.112, at 30 days; 3.6% vs 5.5%, p = 0.195, at 1 year). In conclusion, in a real-world cohort of patients undergoing PCI, bivalirudin-based anticoagulation strategy is associated with a significant decrease in risk of bleeding complications after 30 days and 1 year compared to a UFH-based anticoagulation strategy with no increase in risk for major adverse cardiac events.