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.

Testosterone supplementation in heart failure: a meta-analysis.

BACKGROUND: Low testosterone is an independent predictor of reduced exercise capacity and poor clinical outcomes in patients with heart failure (HF). We sought to determine whether testosterone therapy improves exercise capacity in patients with stable chronic HF. METHODS AND RESULTS: We searched Medline, Embase, Web of Science, and Cochrane Central Register of Controlled Trials (1980-2010). Eligible studies included randomized controlled trials (RCTs) reporting the effects of testosterone on exercise capacity in patients with HF. Reviewers determined the methodological quality of studies and collected descriptive, quality, and outcome data. Four trials (n=198; men, 84%; mean age, 67 years) were identified that reported the 6-minute walk test (2 RCTs), incremental shuttle walk test (2 RCTs), or peak oxygen consumption (2 RCTs) to assess exercise capacity after up to 52 weeks of treatment. Testosterone therapy was associated with a significant improvement in exercise capacity compared with placebo. The mean increase in the 6-minute walk test, incremental shuttle walk test, and peak oxygen consumption between the testosterone and placebo groups was 54.0 m (95% CI, 43.0-65.0 m), 46.7 m (95% CI, 12.6-80.9 m), and 2.70 mL/kg per min (95% CI, 2.68-2.72 mL/kg per min), respectively. Testosterone therapy was associated with a significant increase in exercise capacity as measured by units of pooled SDs (net effect, 0.52 SD; 95% CI, 0.10-0.94 SD). No significant adverse cardiovascular events were noted. CONCLUSIONS: Given the unmet clinical needs, testosterone appears to be a promising therapy to improve functional capacity in patients with HF. Adequately powered RCTs are required to assess the benefits of testosterone in this high-risk population with regard to quality of life, clinical events, and safety.

Quantifying the learning curve in the use of a novel vascular closure device: an analysis of the NCDR (National Cardiovascular Data Registry) CathPCI registry.

OBJECTIVES: This study sought to quantify the learning curve for the safety and effectiveness of a newly introduced vascular closure device through evaluation of the NCDR (National Cardiovascular Data Registry) CathPCI clinical outcomes registry. BACKGROUND: The impact of learning on the clinical outcomes complicates the assessment of the safety and efficacy during the early experience with newly introduced medical devices. METHODS: We performed a retrospective analysis of the relationship between cumulative institutional experience and clinical device success, defined as device deployment success and freedom from any vascular complications, for the StarClose vascular closure device (Abbott Vascular, Redwood City, California). Generalized estimating equation modeling was used to develop risk-adjusted clinical success predictions that were analyzed to quantify learning curve rates. RESULTS: A total of 107,710 procedures used at least 1 StarClose deployment, between January 1, 2006, and December 31, 2007, with overall clinical success increasing from 93% to 97% during the study period. The learning curve was triphasic, with an initial rapid learning phase, followed by a period of declining rates of success, followed finally by a recovery to a steady-state rate of improved device success. The rates of learning were influenced positively by diagnostic (vs. percutaneous coronary intervention) procedure use and teaching status and were affected inversely by annual institutional volume. CONCLUSIONS: An institutional-level learning curve for the initial national experience of StarClose was triphasic, likely indicating changes in patient selection and expansion of number of operators during the initial phases of device adoption. The rate of learning was influenced by several institutional factors, including overall procedural volume, utilization for percutaneous coronary intervention procedures, and teaching status.

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.

Clinical characteristics of tako-tsubo cardiomyopathy.

Tako-tsubo cardiomyopathy (TTC) is increasingly diagnosed in the United States, especially in the Caucasian population. To evaluate the clinical features and outcome of patients with TTC, we evaluated 34 patients (32 women and 2 men) 22 to 88 years of age (mean 66 +/- 14) who fulfilled the following criteria: (1) akinesia or dyskinesia of the apical and/or midventricular segments of the left ventricle with regional wall motion abnormalities that extended beyond the distribution of a single epicardial vessel and (2) absence of obstructive coronary artery disease. Twenty-five patients (74%) presented with chest pain, 20 patients (59%) presented with dyspnea, and 8 patients (24%) presented with cardiogenic shock. Twenty-two patients (65%) had ST-segment elevation and 14 patients (41%) had T-wave inversion on presentation. Twenty-five patients (74%) reported a preceding stressful event. Cardiac biomarkers were often mildly increased, with a mean troponin I (peak) of 13.9 +/- 24. Mean +/- SD left ventricular ejection fractions were 28 +/- 10% at time of presentation and 51 +/- 14 at time of follow-up (p <0.0001). Two patients (6%) died during the hospital stay. Average duration of hospital stay was 6.6 +/- 6.2 days. In conclusion, TTC is common in postmenopausal women with preceding physical or emotional stress. It predominantly involves the apical portion of the left ventricle and patients with this condition have a favorable outcome with appropriate medical management. The precise cause remains unclear.

Hydropneumopericardium presenting as an acute coronary syndrome: a rare complication of paraesophageal hernia.

Hydropneumopericardium is a very rare complication of long-standing paraesophageal hernia, occurring as a result of rupture of the intrathoracic gastric volvulus into the pericardium. A chronic paraesophageal hernia that is complicated by gastric volvulus can develop into such surgical emergencies as acute gastric obstruction, strangulation, perforation, and rupture into adjacent structures. Subsequent hydropneumopericardium constitutes an acute emergency that requires immediate surgical treatment and pericardial drainage. Herein, we discuss what we believe to be the 1st reported case of hydropneumopericardium that presented as an acute coronary syndrome in a patient who had a chronic paraesophageal hernia (as a result of rupture of the gastric volvulus into the pericardium). The 80-year-old patient did not survive the condition.

Tako-tsubo syndrome following a difficult urinary catheterization.

Tako-tsubo syndrome is a cardiac syndrome triggered by emotional or physical stress and characterized by acute extensive but reversible akinesia of the apex and mid part of the left ventricle (LV) in the absence of obstructive coronary artery disease. It typically presents with chest pain and/or dyspnea and may mimic an acute coronary syndrome (ACS) with ischemic changes in the electrocardiogram and elevated cardiac biomarkers. The precise etiology remains unknown, but prognosis is generally excellent. This is the first reported case of Tako-tsubo syndrome following a difficult outpatient cystoscopic procedure for urinary retention.