Association of CHA2 DS2 -VASc Score with Stroke, Thromboembolism, and Death in Hip Fracture Patients.

OBJECTIVES: Patients undergoing hip fracture surgery have a 10 times increased risk of stroke compared with the general population. We aimed to evaluate the association between the CHA2 DS2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes, previous stroke/TIA [transient ischemic attack]/systemic embolism (2 points), vascular disease, age 65-74 years, and female sex) score and the risk of stroke, thromboembolism, and all-cause mortality in patients with hip fracture with or without atrial fibrillation (AF). DESIGN: Nationwide prospective cohort study. SETTING: Danish hospitals. PARTICIPANTS: Subjects were all incident hip fracture patients in Denmark age 65 years and older with surgical repair procedures between 2004 and 2016 (n = 78,096). Participants were identified using the Danish Multidisciplinary Hip Fracture Registry. MEASUREMENTS: We calculated incidence rates, cumulative incidences, and hazard ratios (HRs) with 95% confidence intervals (CIs) by CHA2 DS2 -VASc score, stratified on AF history. RESULTS: The cumulative incidence of ischemic stroke 1 year after hip fracture increased with ascending CHA2 DS2 -VASc score, and it was 1.9% for patients with a score of 1 and 8.6% for patients with a score above 5 in the AF group. Corresponding incidences in the non-AF group were 1.6% and 7.6%. Compared with a CHA2 DS2 -VASc score of 1, adjusted HRs were 5.53 (95% CI = 1.37-22.24) among AF patients and 4.91 (95% CI = 3.40-7.10) among non-AF patients with a score above 5. A dose-response-like association was observed for all cardiovascular outcomes. All-cause mortality risks and HRs were substantially higher for all CHA2 DS2 -VASc scores above 1 in both the AF group and the non-AF group. CONCLUSION: Among patients with hip fracture, a higher CHA2 DS2 -VASc score was associated with increased risk of stroke, thromboembolism, and death. This finding applied both to patients with and without AF. Patients with high CHA2 DS2 -VASc scores had almost similar absolute risks for cardiovascular outcomes, irrespective of AF. J Am Geriatr Soc 68:1698-1705, 2020.

Prophylactic Inferior Vena Cava Filters Prior to Bariatric Surgery: Insights From the National Inpatient Sample.

OBJECTIVES: The aim of this study was to determine in-hospital mortality, post-surgical thromboembolic events, and health care costs associated with the placement of prophylactic inferior vena cava filters (IVCFs) prior to bariatric surgery. BACKGROUND: The role of prophylactic IVCFs prior to bariatric surgery is controversial, and the nationwide clinical outcomes associated with this practice are unknown. METHODS: This observational study used the National Inpatient Sample database to identify obese patients who underwent bariatric surgery from January 2005 to September 2015. Using propensity score matching, outcomes associated with patients receiving prophylactic IVCFs prior to their bariatric surgery were compared with those among patients who did not receive IVCFs. RESULTS: A total of 258,480 patients underwent bariatric surgery, of whom 1,047 (0.41%) had prophylactic IVCFs implanted. Patients with prophylactic IVCFs compared with those without IVCFs had a significantly higher rate of the combined endpoint of in-hospital mortality or pulmonary embolism (1.4% vs. 0.4%; odds ratio: 3.75; 95% confidence interval [CI]: 1.25 to 11.30; p = 0.019). Additionally, prophylactic IVCFs were associated with higher rates of lower extremity or caval deep vein thrombosis (1.8% vs. 0.3%; odds ratio: 6.33; 95% CI: 1.87 to 21.4; p < 0.01), length of stay (median 3 days vs. 2 days; p < 0.01), and hospital charges (median $63,000 vs. $37,000; p < 0.01). CONCLUSIONS: In this nationwide observational study, prophylactic IVCF implantation prior to bariatric surgery was associated with worse clinical outcomes and increased health care resource utilization.

Risk assessment in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

BACKGROUND: Current pulmonary hypertension treatment guidelines recommend use of a risk stratification model encompassing a range of parameters, allowing patients to be categorised as low, intermediate or high risk. Three abbreviated versions of this risk stratification model were previously evaluated in patients with pulmonary arterial hypertension (PAH) in the French, Swedish and COMPERA registries. Our objective was to investigate the three abbreviated risk stratification methods for patients with mostly prevalent PAH and chronic thromboembolic pulmonary hypertension (CTEPH), in patients from the PATENT-1/2 and CHEST-1/2 studies of riociguat. METHODS: Risk was assessed at baseline and at follow-up in PATENT-1 and CHEST-1. Survival and clinical worsening-free survival were assessed in patients in each risk group/strata. RESULTS: With all three methods, riociguat improved risk group/strata in patients with PAH after 12 weeks. The French non-invasive and Swedish/COMPERA methods discriminated prognosis for survival and clinical worsening-free survival at both baseline and follow-up. Furthermore, patients achieving one or more low-risk criteria or a low-risk stratum at follow-up had a significantly reduced risk of death and clinical worsening compared with patients achieving no low-risk criteria or an intermediate-risk stratum. Similar results were obtained in patients with inoperable or persistent/recurrent CTEPH. CONCLUSIONS: This analysis confirms and extends the results of the registry analyses, supporting the value of goal-oriented treatment in PAH. Further assessment of these methods in patients with CTEPH is warranted.

CHA2DS2-VASc score as a predictor of long-term cardiac outcomes in elderly patients with or without atrial fibrillation.

BACKGROUND: The CHA2DS2-VASc score is often used for stroke risk stratification in atrial fibrillation (AF) patients. However, its usefulness in patients ≥75 years of age with or without AF is unclear. OBJECTIVE: We aimed to investigate whether the CHA2DS2-VASc score can predict ischemic stroke (IS), transient ischemic attack, thromboembolism (TE), and mortality in elderly patients with and without AF. MATERIALS AND METHODS: During 2013-2014, 1,071 patients (36.3% with concomitant AF) at least 75 years old were enrolled, and the follow-up ended on July 15, 2017. Variables included sociodemographic characteristics, complications, drugs taken, laboratory results, and echocardiographic parameters. The primary end points were IS, transient ischemic attack, and TE, expressed as IS/TE. All-cause mortality was a secondary end point. Survival curves and mortality risks were assessed via Kaplan-Meier survival analysis and compared by log-rank tests. RESULTS: The average follow-up duration was 2.57±1.37 years. Overall, 167 patients (5.6%) died and 77 (7.2%) developed IS/TE. The CHA2DS2-VASc score was associated with IS/TE in patients 75 years or older with and without AF, and patients with a CHA2DS2-VASc score ≥5 had a higher risk of stroke. However, the CHA2DS2-VASc score was not related to all-cause mortality. CONCLUSION: The CHA2DS2-VASc score can predict IS/TE, but not mortality, in elderly patients (≥75 years) with or without AF.

Health Care Costs and Thromboembolic Events in Hydroxyurea-Treated Patients with Polycythemia Vera.

BACKGROUND: Patients with polycythemia vera (PV) are at increased risk of thromboembolic events (TEs), which are key contributors to reduced overall survival compared with the age- and sex-matched general population. In addition to aspirin and phlebotomy to maintain hematocrit level < 45%, many patients receive cytoreduction with hydroxyurea (HU), which is associated with improved survival and may reduce the risk of cardiovascular events and TEs. However, 1 in 4 patients become resistant to or intolerant of HU. In the general population, prophylaxis and treatment following arterial and venous thromboses are associated with increased health care resource utilization and costs. OBJECTIVE: To describe the health care resource utilization and costs associated with TEs in patients with PV treated with HU in the United States. METHODS: This retrospective cross-sectional analysis of the Truven Health Analytics MarketScan Research Databases included adult patients with a PV diagnosis who were newly treated with HU and continuously enrolled in medical and pharmacy benefit plans for ≥ 12 months pre- and post-index. HU treatment administration, persistence, adherence, and related adverse events, as well as TEs, were reported during the 12-month follow-up period. HU treatment patterns were further analyzed in a subgroup analysis comparing patients with and without a ≥ 45-day gap in HU treatment. Health care resource utilization and costs were analyzed in a subgroup analysis comparing patients who had TEs in the 12-month follow-up period with those who did not. Tests for statistically significant differences across the comparison groups were conducted, including chi-square tests for categorical variables and t-tests for continuous variables. RESULTS: The records of 1,322 patients with PV were included in this study. Mean age was 66.0 years; 51.3% were men; and 14.0% had a history of TEs. During the first year of HU treatment, 764 (57.8%) patients had a treatment gap of ≥ 45 days; however, treatment adherence was similar between those with and those without a gap (85.2% vs. 90.7%, respectively). TEs occurred in 216 (16.3%) patients within 12 months of HU initiation. Health care resource utilization was higher for patients with TEs versus those without, including the proportion of patients requiring inpatient services (50.9% vs. 18.4%; P < 0.001) and emergency room visits (48.1% vs. 26.3%; P < 0.001) and the mean number of inpatient admissions (1.7 vs. 1.3; P = 0.004); office visits (18.9 vs. 14.1; P < 0.001); and prescriptions (45.8 vs. 36.2; P<0.001). In addition, total mean health care costs ($45,040 vs. $16,438; P < 0.001); inpatient costs ($18,952 vs. $4,794; P < 0.001); outpatient costs ($20,844 vs. $8,046; P < 0.001); and outpatient pharmacy costs ($5,244 vs. $3,598; P = 0.002) were higher among patients with TEs than those without. CONCLUSIONS: Patients with PV receiving treatment with HU remain at risk for TEs. The occurrence of TEs during the 12-month follow-up in this patient population was associated with higher health care resource utilization and costs. DISCLOSURES: This study was funded by Incyte Corporation. Parasuraman and Paranagama are employees and stockholders of Incyte Corporation. Shi and Bonafede are employees of Truven Health Analytics, which was awarded a research contract to conduct this study with and on behalf of Incyte Corporation. Study concept and design were contributed by all of the authors, who also interpreted the data and wrote and revised the manuscript. Bonafede and Shi collected the data. This study was presented as an abstract at the Academy of Managed Care Pharmacy NEXUS Annual Meeting on October 26-29, 2015, in Orlando, Florida.

Assessment of the CHA2DS2-VASc Score in Predicting Ischemic Stroke, Thromboembolism, and Death in Patients With Heart Failure With and Without Atrial Fibrillation.

IMPORTANCE: The CHA2DS2-VASc score (congestive heart failure, hypertension, age ≥75 years [doubled], diabetes, stroke/transient ischemic attack/thromboembolism [doubled], vascular disease [prior myocardial infarction, peripheral artery disease, or aortic plaque], age 65-75 years, sex category [female]) is used clinically for stroke risk stratification in atrial fibrillation (AF). Its usefulness in a population of patients with heart failure (HF) is unclear. OBJECTIVE: To investigate whether CHA2DS2-VASc predicts ischemic stroke, thromboembolism, and death in a cohort of patients with HF with and without AF. DESIGN, SETTING, AND POPULATION: Nationwide prospective cohort study using Danish registries, including 42 987 patients (21.9% with concomitant AF) not receiving anticoagulation who were diagnosed as having incident HF during 2000-2012. End of follow-up was December 31, 2012. EXPOSURES: Levels of the CHA2DS2-VASc score (based on 10 possible points, with higher scores indicating higher risk), stratified by concomitant AF at baseline. Analyses took into account the competing risk of death. MAIN OUTCOMES AND MEASURES: Ischemic stroke, thromboembolism, and death within 1 year after HF diagnosis. RESULTS: In patients without AF, the risks of ischemic stroke, thromboembolism, and death were 3.1% (n = 977), 9.9% (n = 3187), and 21.8% (n = 6956), respectively; risks were greater with increasing CHA2DS2-VASc scores as follows, for scores of 1 through 6, respectively: (1) ischemic stroke with concomitant AF: 4.5%, 3.7%, 3.2%, 4.3%, 5.6%, and 8.4%; without concomitant AF: 1.5%, 1.5%, 2.0%, 3.0%, 3.7%, and 7% and (2) all-cause death with concomitant AF: 19.8%, 19.5%, 26.1%, 35.1%, 37.7%, and 45.5%; without concomitant AF: 7.6%, 8.3%, 17.8%, 25.6%, 27.9%, and 35.0%. At high CHA2DS2-VASc scores (≥4), the absolute risk of thromboembolism was high regardless of presence of AF (for a score of 4, 9.7% vs 8.2% for patients without and with concomitant AF, respectively; overall P<.001 for interaction). C statistics and negative predictive values indicate that the CHA2DS2-VASc score performed modestly in this HF population with and without AF (for ischemic stroke, 1-year C statistics, 0.67 [95% CI, 0.65-0.68] and 0.64 [95% CI, 0.61-0.67], respectively; 1-year negative predictive values, 92% [95% CI, 91%-93%] and 91% [95% CI, 88%-95%], respectively). CONCLUSIONS AND RELEVANCE: Among patients with incident HF with or without AF, the CHA2DS2-VASc score was associated with risk of ischemic stroke, thromboembolism, and death. The absolute risk of thromboembolic complications was higher among patients without AF compared with patients with concomitant AF at high CHA2DS2-VASc scores. However, predictive accuracy was modest, and the clinical utility of the CHA2DS2-VASc score in patients with HF remains to be determined.

High-sensitivity troponin I for risk assessment in patients with atrial fibrillation: insights from the Apixaban for Reduction in Stroke and other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial.

BACKGROUND: High-sensitivity troponin-I (hs-TnI) measurement improves risk assessment for cardiovascular events in many clinical settings, but the added value in atrial fibrillation patients has not been described. METHODS AND RESULTS: At randomization, hs-TnI was analyzed in 14 821 atrial fibrillation patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial comparing apixaban with warfarin. The associations between hs-TnI concentrations and clinical outcomes were evaluated by using adjusted Cox analysis. The hs-TnI assay detected troponin (≥1.3 ng/L) in 98.5% patients, 50% had levels >5.4, 25% had levels >10.1, and 9.2% had levels ≥23 ng/L (the 99th percentile in healthy individuals). During a median of 1.9 years follow-up, annual rates of stroke or systemic embolism ranged from 0.76% in the lowest hs-TnI quartile to 2.26% in the highest quartile (>10.1 ng/L). In multivariable analysis, hs-TnI was significantly associated with stroke or systemic embolism, adjusted hazard ratio 1.98 (1.42-2.78), P=0.0007. hs-TnI was also significantly associated with cardiac death; annual rates ranged from 0.40% to 4.24%, hazard ratio 4.52 (3.05-6.70), P<0.0001, in the corresponding groups, and for major bleeding hazard ratio 1.44 (1.11-1.86), P=0.0250. Adding hs-TnI levels to the CHA2DS2VASc score improved c-statistics from 0.629 to 0.653 for stroke or systemic embolism, and from 0.591 to 0.731 for cardiac death. There were no significant interactions with study treatment. CONCLUSIONS: Troponin-I is detected in 98.5% and elevated in 9.2% of atrial fibrillation patients. The hs-TnI level is independently associated with a raised risk of stroke, cardiac death, and major bleeding and improves risk stratification beyond the CHA2DS2VASc score. The benefits of apixaban in comparison with warfarin are consistent regardless of hs-TnI levels. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984.

Patient outcomes using the European label for dabigatran. A post-hoc analysis from the RE-LY database.

In the RE-LY trial dabigatran 150 mg twice daily (D150) showed significantly fewer strokes, and 110 mg (D110) significantly fewer major bleeding events (MBE) compared to well-controlled warfarin in patients with atrial fibrillation (AF). The European (EU) label currently recommends the use of D150 in AF patients who are aged < 80 years without an increased risk for bleeding (e.g. HAS-BLED score <3) and not on concomitant verapamil. In other patients, D110 is recommended. In this post-hoc analysis of the RE-LY dataset, we simulated how dabigatran (n=6,004) would compare to well-controlled warfarin (n=6,022) used according to the EU label. "EU label simulated dabigatran treatment" was associated with significant reductions in stroke and systemic embolism (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.60-0.91), haemorrhagic stroke (HR 0.22; 95%CI 0.11-0.44), death (HR 0.86; 95%CI 0.75-0.98), and vascular death (HR 0.80; 95%CI 0.68-0.95) compared to warfarin. Dabigatran was also associated with less major bleeding (HR 0.85; 95%CI 0.73-0.98), life-threatening bleeding (HR 0.72; 95%CI 0.58-0.91), intracranial haemorrhage (HR 0.28; 95%CI 0.17-0.45), and "any bleeds" (HR 0.86; 95%CI 0.81-0.92), but not gastrointestinal major bleeding (HR 1.23; 95%CI 0.96-1.59). The net clinical benefit was significantly better for dabigatran compared to warfarin. In conclusion, this post-hoc simulation of dabigatran usage based on RE-LY trial dataset indicates that "EU label simulated dabigatran treatment" may be associated with superior efficacy and safety compared to warfarin, and are in support of the EU label and the 2012 European Society of Cardiology AF guideline recommendations. Thus, adherence to European label/guideline use results in a clinically relevant benefit for dabigatran over warfarin, for both efficacy and safety.

Determinants of in-hospital death after acute spinal cord injury: a population-based study.

OBJECTIVES: First, to evaluate the influence of comorbid diseases and concomitant injuries on the risk of in-hospital death after traumatic spinal cord injury (TSCI). Second, to identify the risk characteristics of TSCI patients with likelihood of death. STUDY DESIGN: Population-based retrospective cohort study. SETTING: Sixty-two acute care hospitals in South Carolina, USA. METHODS: Records of 3389 TSCI patients hospitalized with acute TSCI were evaluated. Days elapsing from the date of injury to date of death established the survival time (T). Cox regression examined risk of in-hospital death as a function of counts of comorbid conditions and injuries along with their joint effects controlling for other covariates. RESULTS: Counts of comorbid conditions and injuries showed dose-dependent risk of death while in-hospital independent of demographical and clinical covariates. Hazard ratios (HR) for counts 3+, 2 and 1 comorbid conditions were 2.19 (P<0.001), 1.73 (P=0.005) and 1.20 (P=0.322), respectively. For counts of 4+, 3 and 2 other injuries were 1.85 (P<0.001), 1.81 (P<0.001) and 1.46 (P=0.022), respectively. The joint effect of the two was transadditive with statistically significant HR ranging from 1.72-3.14. CONCLUSION: Counts of comorbid conditions and injured body regions strongly indicate risk of in-hospital death after TSCI and their joint effects elicited dose-dependent gradient independent of demographical and clinical covariates. Assessing risk of in-hospital death based on joint use of counts of comorbid diseases and injuries is highly informative to target TSCI patients at high risk of dying.

Outcomes associated with warfarin use in older patients with heart failure and atrial fibrillation and a cardiovascular implantable electronic device: findings from the ADHERE registry linked to Medicare claims.

BACKGROUND: Warfarin use and associated outcomes in patients with heart failure and atrial fibrillation and a cardiovascular implantable electronic device have not been described previously. HYPOTHESIS: We hypothesized that warfarin is underused and is associated with lower risks of mortality, thromboembolic events, and myocardial infarction. METHODS: Using data from a clinical registry linked with Medicare claims, we examined warfarin use at discharge and 30-day and 1-year Kaplan-Meier estimates of all-cause mortality and cumulative incidence rates of mortality, thromboembolic events, myocardial infarction, and bleeding events in patients 65 years or older, with a history of atrial fibrillation and a cardiovascular implantable electronic device admitted with heart failure between 2001 and 2006, who were naïve to anticoagulation therapy at admission. We compared outcomes between patients who were or were not prescribed warfarin at discharge and tested associations between treatment and outcomes. RESULTS: Of 2586 eligible patients in 252 hospitals, 2049 were discharged without a prescription for warfarin. At 1 year, the group discharged without warfarin had a higher mortality rate after discharge (37.4% vs 28.8%; P < 0.001) but similar rates of thromboembolism, myocardial infarction, and bleeding events. After adjustment, treatment with warfarin was associated with lower risk of all-cause death 1 year after discharge (hazard ratio: 0.76, 95% confidence interval: 0.63-0.92). CONCLUSIONS: Among older patients with heart failure and atrial fibrillation and a cardiovascular implantable electronic device, 4 of 5 were discharged without a prescription for warfarin. Warfarin nonuse was associated with a higher risk of death 1 year after discharge. Clin. Cardiol. 2011 DOI: 10.1002/clc.22064 Damon M. Seils, MA, Duke University, assisted with manuscript preparation. Mr. Seils did not receive compensation for his assistance apart from his employment at the institution where the study was conducted. This study was supported by a research agreement between Duke University and Janssen Pharmaceuticals. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Percutaneous left atrial appendage closure for stroke prevention in patients with atrial fibrillation: an assessment of net clinical benefit.

AIMS: The PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) trial found left atrial appendage (LAA) closure an alternative to anticoagulation in selected patients with non-valvular atrial fibrillation (AF). We aim to estimate the net clinical benefit (NCB) of percutaneous LAA closure. METHODS AND RESULTS: Post hoc analysis of outcomes among 707 adults with AF in the PROTECT-AF trial and 566 in the Continued Access (CAP) registry undergoing LAA closure with the Watchman device compared with sustained anticoagulation. Outcomes were ischaemic stroke, intracranial haemorrhage, major bleeding, pericardial effusion, and death, weighted to reflect the relative impact in terms of death and disability. Net clinical benefit was calculated as the sum of annualized rates of these outcomes after intervention minus rates on warfarin. The NCB of LAA closure during 1623 person-years follow-up in the trial was 1.73%/year (95% CI: -0.54 to 4.39%/year) and during 741 patient-years in the registry was 4.97%/year (95% CI: 3.07-7.15%/year). Among patients with a history of ischaemic stroke, the NCB was greater in the registry (8.68%/year, CI: 2.82-14.92%/year) than the trial (4.30%/year, CI -2.07 to 11.25%/year). In the registry, the NCB of LAA closure increased from 2.22%/year (CI: 0.27-6.01%/year) in patients with CHADS(2) scores = 1 to 6.12%/year (CI: 3.19-8.92%/year) in those with scores ≥2. CONCLUSION: Combining rates of thrombo-embolism, intracranial haemorrhage, major adverse events, and death allows objective comparison of the benefit and risk of device therapy vs. anticoagulation in patients with AF. The NCB of LAA closure is greatest for patients at a higher risk of stroke.

Incidence of venous thromboembolism among chemotherapy-treated patients with lung cancer and its association with mortality: a retrospective database study.

Cancer patients, especially those with lung cancer and undergoing chemotherapy, have an elevated risk for venous thromboembolism (VTE). This study assessed incidence, timing, and risk factors for VTE (specifically receipt of chemotherapy), along with the association between VTE and survival among lung cancer patients receiving chemotherapy. Using Florida Medicaid administrative claims data (2000-2008), patients with any diagnosis of primary lung cancer were selected. Patients with recent prior VTE and those enrolled in Medicare or an HMO were excluded. Crude rates of VTE per 100 person years were estimated, and Cox proportional hazards models were developed to assess risk factors for VTE in the lung cancer population, and the association between VTE and survival among patients undergoing chemotherapy. Of 15,749 lung cancer patients, 7,052 (2,242 receiving chemotherapy and 4,810 not receiving chemotherapy) met cohort selection criteria. The incidence of VTE was 10.8 per 100 person-years (PYs) in the chemotherapy cohort and 6.8 per 100 PYs in the non-chemotherapy cohort. Among patients on chemotherapy developing VTE, median time to occurrence was 109 days, with 61 and 82 % of patients experiencing an event within six and 12 months, respectively. In multivariate analyses, the adjusted risk of VTE was 30 % higher among patients undergoing chemotherapy. Comorbidity and the presence of a central venous catheter also were significantly associated with a greater risk of developing VTE. Moreover, patients in the chemotherapy cohort who developed VTE had a significantly faster time-to-death (adjusted hazard ratio [HR] = 1.97; 95 % CI 1.69-2.29).VTE was common among lung cancer patients, especially among patients receiving chemotherapy, with the majority of VTE events occurring within 6 months of initiation of chemotherapy. The presence of a VTE event was significantly associated with an increased risk of mortality.

Are thromboembolic and bleeding complications a drawback for composite aortic root replacement?

BACKGROUND: Valve-preserving aortic root reconstruction is being performed with increasing frequency. Independent of durability concerns, enthusiasm for retaining the native valve is often championed on the presumption that composite graft replacement of the aorta will be complicated by thromboembolism and bleeding. Our goal in this late follow-up study is to determine if thromboembolism or bleeding, or both, are indeed problematic after composite aortic root replacement. METHODS: Between 1995 and 2011, 306 patients (mean age, 56±14 years) underwent composite graft replacement of the aorta. St. Jude mechanical valve conduits (St. Jude Medical, St Paul, MN) were used in 242 patients, and 64 received a biologic conduit. Long-term postoperative follow-up (mean, 56 months; range, 1 to 97 months) was performed through our Aortic Database, supplemented by patient interviews and use of the Social Security Death Index. RESULTS: Hospital mortality was 2.9% overall and 1.4% in the last 8 years. Kaplan-Meier curves showed freedom (±standard deviation) from bleeding, stroke, and distal embolism as 94.3%±1.7% at 5 years and 91.3%±2.4% at 10 years. Survival was 93.5%±1.8% at 5 years and 80.9%±4.6% at 10 years, which was not statistically different from that for an age- and sex-matched population in Connecticut. Freedom from reoperation of the aortic root was 99% at 10 years. CONCLUSIONS: Patients had excellent survival and few thromboembolic and bleeding complications after composite aortic root replacement. These data supporting minimal morbidity in the setting of well-established durability should be used to put alternative procedures, such as valve-preserving aortic root reconstruction, into context.

Cancer and coagulation.

Thromboembolism, including both venous and arterial events, occurs commonly amongst patients with cancer. The occurrence of thromboembolism has significant consequences for cancer patients, including direct and indirect associations with mortality, morbidity, requirement for long-term anticoagulant therapy and consumption of healthcare resources. Recent studies have resulted in a better understanding of clinical risk factors and biomarkers of cancer-associated thrombosis, and a risk assessment model incorporating both has now been validated in multiple settings. Thromboprophylaxis with either unfractionated heparin or low-molecular-weight heparins (LMWHs) has been shown to be safe and effective in high-risk settings such as hospitalization for medical illness and the postsurgical period. Emerging new data from randomized studies have focused on outpatient prophylaxis, suggesting potential benefits in this setting as well. Treatment of cancer-associated thrombosis requires long-term anticoagulation with LMWH. Results from ongoing and planned trials of novel anticoagulants in the cancer setting are awaited.

ASPIRE registry: assessing the Spectrum of Pulmonary hypertension Identified at a REferral centre.

Pulmonary hypertension (PH) is a heterogeneous condition. To date, no registry data exists reflecting the spectrum of disease across the five diagnostic groups encountered in a specialist referral centre. Data was retrieved for consecutive, treatment-naïve cases diagnosed between 2001 and 2010 using a catheter-based approach. 1,344 patients were enrolled, with a mean follow-up of 2.9 yrs. The 3-yr survival was 68% for pulmonary arterial hypertension (PAH), 73% for PH associated with left heart disease, 44% for PH associated with lung disease (PH-lung), 71% for chronic thromboembolic PH (CTEPH) and 59% for miscellaneous PH. Compared with PAH, survival was inferior in PH-lung and superior in CTEPH (p<0.05). Multivariate analysis demonstrated that diagnostic group independently predicted survival. Within PAH, Eisenmenger's survival was superior to idiopathic PAH, which was superior to PAH associated with systemic sclerosis (p<0.005). Within PH-lung, 3-yr survival in sleep disorders/alveolar hypoventilation (90%) was superior to PH-lung with chronic obstructive pulmonary disease (41%) and interstitial lung disease (16%) (p<0.05). In CTEPH, long-term survival was best in patients with surgically accessible disease undergoing pulmonary endarterectomy. In this large registry of consecutive, treatment-naïve patients identified at a specialist PH centre, outcomes and characteristics differed between and within PH groups. The current system of classification of PH has prognostic value even when adjusted for age and disease severity, emphasising the importance of systematic evaluation and precise classification.

Bleeding with anticoagulant treatments.

Anticoagulation with vitamin K antagonists (VKAs) is effective in the prevention and treatment of thrombotic complications in many clinical conditions, including atrial fibrillation (that represents today the most frequent indication for anticoagulant treatment), venous thromboembolism, acute coronary syndromes and after invasive cardiac procedures. Bleeding is the most important complication of VKAs and a major concern for both physicians and patients, limiting a more widespread prescription of the treatment. As a result, a non negligible proportion of all the subjects who would have a clear clinical indication for anticoagulation do not receive an effective treatment. This review analyses the treatment- and person-associated risk factors for bleeding during VKAs. New oral anticoagulant drugs seems to overcome at least some of the limitations of VKAs. Potentially, they can allow a less demanding and more stable anticoagulant treatment, with less side-effects allowing that more patients can receive an appropriate anticoagulant treatment. Based on the so far available phase III clinical studies, it is possible to assume that these new drugs are associated with a risk of bleeding, that is probably related to the intensity of treatment.

Morbidity and mortality associated with antireflux surgery with or without paraesophogeal hernia: a large ACS NSQIP analysis.

BACKGROUND: Surgical repair of paraesophageal hernias (PEH) represents a considerable technical challenge in patients who are older and have multiple comorbidities. We sought to identify factors associated with increased rates of mortality and morbidity in these patients. METHODS: We performed a retrospective analysis of the National Surgical Quality Improvement Program from 2005 through 2007. Patients who underwent an antireflux operation or repair of PEH and with a primary diagnosis of PEH or GERD were included. Primary outcome was 30-day mortality. Secondary outcomes included intraoperative blood transfusion (BT) and standard comorbidities. Multivariate analyses were performed, adjusting for factors of age and BMI. RESULTS: A total of 3518 patients were identified, including 1290 PEH patients. Compared to GERD patients, PEH patients were significantly older and had more comorbidities. On adjusted analysis for PEH patients only, BT and age ≥70 years were significantly associated with multiple outcome variables, including pulmonary complications and venous thromboembolism (VTE), but had no association with mortality. BMI was not found to be associated with any of our outcome measures. CONCLUSION: Despite higher rates of complications, notably pulmonary and VTE, PEH can be repaired in the elderly with mortality rates comparable to those in younger populations. BMI does not adversely impact any short-term outcome measures in patients undergoing PEH repair.

Assessment of left atrial appendage function during sinus rhythm in patients with hypertrophic cardiomyopathy: transesophageal echocardiography and tissue doppler study.

BACKGROUND: The incidence of systemic thromboembolism is high in patients with hypertrophic cardiomyopathy (HCM). The authors hypothesized that vulnerability to such vascular events could be caused by depressed left atrial appendage (LAA) function during normal sinus rhythm (SR). The aim of this cross-sectional study was to investigate LAA contractile function during SR in patients with HCM. METHODS: LAA function was assessed in 62 patients with HCM in SR and compared with that in 53 age-matched and sex-matched controls. Patients with histories of atrial fibrillation and documented episodes of paroxysmal atrial fibrillation on 24-hour Holter monitoring and depressed left ventricular ejection fractions (<50%) were excluded. Multiplane transesophageal echocardiography was performed for determination of the morphology and function of the LAA. RESULTS: LAA thrombi were present in five patients (8%) with HCM. LAA emptying and filling Doppler velocities were significantly depressed in the HCM group. LAA emptying and filling velocities were negatively correlated with age in controls (r = -0.4, P = .005), but these velocities were not associated with age in the HCM group. Moreover, LAA velocities were not associated with left ventricular mass index, left ventricular outflow tract gradient, or the degree of diastolic dysfunction in the HCM group. All Doppler tissue imaging velocities obtained from LAA walls were also significantly depressed in the HCM group. CONCLUSIONS: LAA thrombus formation was not rare in this patient population. The significantly depressed LAA filling and emptying velocities in SR may predispose patients with HCM to thromboembolic events. The depressed Doppler tissue imaging LAA parameters in patients with HCM may indicate the presence of a possible intrinsic atrial myopathy. Thromboembolic risk should be taken into account, and the evaluation of LAA morphology and function by transesophageal echocardiography might become a component of routine workup in patients with HCM in the future.