Although the activated partial thromboplastin time (aPTT) has historically been the method of choice for anticoagulation monitoring in patients undergoing mechanical circulatory support with intravenous unfractionated heparin, it is being progressively superseded by the anti-factor Xa (anti-Xa) method. A retrospective single-arm, single-centre analysis of 20 patients who underwent total artificial heart implantation entailed simultaneous determinations of aPTT and anti-Xa. Agreement between these parameters was assessed using the Bland-Altman method. Despite a positive correlation between aPTT and anti-Xa, normal target ranges were poorly aligned: from 5th to 30th postoperative day, for anti-Xa values of 0.2 and 0.4 U/ml corresponding aPTT values were 52.1 and 65.2 s, 7.9 and 14.8 lower than predicted values, respectively. This was not associated with thromboembolic sequalae. It was not possible to demonstrate a significant relationship between the predictor variables (postoperative day; white blood cell count; C-reactive protein concentration; alanine transaminase and alkaline phosphatase level; bilirubin; haemoglobin; albumin and total protein concentration) and the agreement between aPTT and anti-Xa levels. In summary, when anti-Xa levels were used to guide anticoagulation therapy, corresponding aPTT levels were low with respect to target range. Methodology applied in this study is generalizable to other forms of mechanical circulatory support.
We sought to identify baseline demographics and procedural factors that might independently predict in‐hospital stroke following transcatheter aortic valve implantation (TAVI).
Objectives: To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort. Background: New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge. Methods: We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively. Results: Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation. Conclusions: A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI.
Background. We investigated changes in estimated glomerular filtration rate (eGFR) after left ventricular assist device (LVAD) implant and the impact on long-term outcomes. Methods. A retrospective analysis was conducted for 255 patients with LVADs, divided into 2 groups based on preimplant eGFR (<60 or >60 mL/min/1.73 m(2)) and into 6 grades (grade 1, >90 mL/min/1.73 m(2) normal; grade 2, 60-89 mild dysfunction; grade 3, 45-59 moderate; grade 4, 30-44 moderate to severe; grade 5, 15-29 severe; or grade 6, <15 kidney failure). Changes in eGFR and the impact on long-term outcome and survival were analyzed. Results. One-month postimplant eGFR of the total cohort increased from a baseline of 75.19 +/- 34.35 to 118.97 +/- 67.62 mL/min/1.73 m(2) (P < .001). eGRF 4 years postimplant was higher than baseline but not significantly (P = .48). Patients with a preimplant eGFR > 60 followed the same pattern as the entire cohort. The preimplant eGFR < 60 group had a significant increase at 1 month (P < .001), eGFR remained significantly higher than baseline 4 years postimplant (P = .032), and there was a sustained transition to improved distribution of renal function grade after LVAD implant. Post-LVAD implant survival at 1, 3, and 5 years for baseline eGFR > 60 was 76%, 54%, and 48% and for eGFR < 60 was 71%, 60%, and 48%, respectively (P = .92). Conclusions. Patients with a low preimplant eGFR derive benefit from LVAD therapy, with eGFR remaining elevated above preimplant levels. Preimplant renal dysfunction did not impact negatively on long-term morbidity and mortality. (C) 2021 by The Society of Thoracic Surgeons
Objective Octogenarians are a high-risk group presenting for percutaneous coronary intervention (PCI). We aimed to create a 30-day mortality risk model for octogenarians presenting with both acute coronary syndrome (ACS) and chronic stable angina (CSA), using comprehensive mandatory UK data submissions to the UK National database. Background Octogenarians are a high-risk group presenting for percutaneous coronary intervention, and decisions on whether or not to undertake intervention in this cohort can be challenging. The increasing number of octogenarians in the general population means they represent an important high-risk subgroup of patients. Methods The data group consisted of 425,897 PCI procedures undertaken in the UK between 2008 and 2012 during which time there was comprehensive data linkage to mortality via the Office of National Statistics. Of these procedures, 44,221 (10.4%) were in patients aged >= 80. These comprised the model group. Logistic regression was used to create a predictive score which ultimately consisted of the following weightings: age 80-89 (n = 1); age > 90 (n = 2); unstable angina/non-ST-elevation myocardial infraction (NSTEMI) (n = 1); STEMI (n = 2); creatinine >200 mmol/L (n = 1); preprocedural ventilation (n = 1); left ventricular ejection fraction <30% (n = 1); cardiogenic shock (n = 2). Multiple imputation was used to account for missing data. Results The patient cohort was divided into a derivation (n = 22,072) and a validation dataset (n = 22,071). Receiver operating characteristic analyses were used to derive the area-under-the-curve to assess properties of the score. The scoring system generated an AUC 0.83, (95% CI 0.80-0.85) suggesting high sensitivity and specificity. Scores of 1-4 were associated with good survival but scores >= 5 were associated with an estimated likelihood of death within 30 days of >= 40%. Conclusions This octogenarian risk score maybe a useful tool to determine the chance of a successful outcome in elderly patients presenting for PCI.
Cardiogenic shock remains the most serious complication of patients hospitalized with acute myocardial infarction (AMI). Early revascularization is the cornerstone of invasive therapy, while mechanical support with intra-aortic balloon pump (IABP) is debatable. From our institutional shock registry we sought to determine predictors of in-hospital mortality—including the aspect of IABP timing—and to develop a clinical risk score for shock patients with AMI.
AIMS:The HORIZONS trial reported a survival advantage for bivalirudin over heparin-with-glycoprotein inhibitors (GPIs) in primary PCI for ST elevation myocardial infarction. This drove an international shift in clinical practice. Subsequent studies have produced divergent findings on mortality benefits with bivalirudin. We investigated this issue in a larger population than studied in any of these trials, using the United Kingdom national PCI registry. METHODS AND RESULTS:61 136 primary PCI procedures were performed between January 2008 and January 2012. Demographic and procedural data were obtained from the registry. Mortality information was obtained through the UK Office of National Statistics. Multivariable logistic regression and propensity analysis modelling were utilized to study the association of different anti-thrombotic strategies with outcomes. Unadjusted data demonstrated near-identical survival curves for bivalirudin and heparin-plus-GPI groups. Significantly higher early and late mortality was found in patients treated with heparin alone ( ITALIC! P < 0.0001) but this group had a markedly higher baseline risk. After propensity matching, the bivalirudin vs. heparin-plus-GPI groups still demonstrated very similar adjusted mortality (odds ratio 1.00 at 30 days, and 0.96 at 1 year). Patients treated with heparin alone continued to show higher mortality after adjustment, although effect size was considerably diminished (odds ratio vs. other groups 1.17-1.24 at 30 days). CONCLUSIONS:Analysis of recent UK data showed no significant difference in short- or medium-term mortality between ST elevation myocardial infarction patients treated with bivalirudin vs. heparin-plus-GPI at primary PCI.
Objectives The aim of this study was to determine whether drug-eluting stents (DES) are superior to bare-metal stents (BMS) in octogenarian patients with angina.Background Patients >= 80 years of age frequently have complex coronary disease warranting DES but have a higher risk of bleeding from prolonged dual antiplatelet therapy.Methods This multicenter randomized trial was conducted in 22 centers in the United Kingdom and Spain. Patients >= 80 years of age underwent stent placement for angina. The primary endpoint was a 1-year composite of death, myocardial infarction, cerebrovascular accident, target vessel revascularization, or major hemorrhage.Results In total, 800 patients (83.5 +/- 3.2 years of age) were randomized to BMS (n = 401) or DES (n = 399) for treatment of stable angina (32%) or acute coronary syndrome (68%). Procedural success did not differ between groups (97.7% for BMS vs. 95.4% for DES; p = 0.07). Thirty-eight percent of patients had >= 2-vessel percutaneous coronary intervention, and 66% underwent complete revascularization. Patients who received BMS had shorter stent implants (24.0 +/- 13.4 mm vs. 26.6 +/- 14.3 mm; p = 0.01). Rates of dual antiplatelet therapy at 1 year were 32.2% for patients in the BMS group and 94.0% for patients in the DES group. The primary endpoint occurred in 18.7% of patients in the BMS group versus 14.3% of patients in the DES group (p = 0.09). There was no difference in death (7.2% vs. 8.5%; p = 0.50), major hemorrhage (1.7% vs. 2.3%; p = 0.61), or cerebrovascular accident (1.2% vs. 1.5%; p = 0.77). Myocardial infarction (8.7% vs. 4.3%; p = 0.01) and target vessel revascularization (7.0% vs. 2.0%; p = 0.001) occurred more often in patients in the BMS group.Conclusions BMS and DES offer good clinical outcomes in this age group. DES were associated with a lower incidence of myocardial infarction and target vessel revascularization without increased incidence of major hemorrhage. (Xience or Vision Stent-Management of Angina in the Elderly [XIMA]; ISRCTN92243650) (C) 2014 by the American College of Cardiology Foundation
IntroductionDuration of dual antiplatelet therapy (DAPT) following drug eluting stent (DES) implantation remains poorly defined. Endothelialisation of biodegradable polymer biolimus-eluting stents occurs early, and 6 months DAPT may be adequate.AimsWe evaluated long term outcome in patients treated with biolimus-eluting stents who were treated with 6 months DAPT. Endpoints included cardiac death and non-fatal stent thrombosis occurring 6 to 12 months after stent implantation.Methods692 patients (77.2% male), aged 65.6±12.5years received biolimus-eluting DES (March 2008 –November 2011). Vital status was tracked through the Medical Research Information Service. Episodes of non-fatal stent thrombosis, (Academic Research Consortium definition) between months 6 and 12 were tracked via systematic database searches (5 PCI centres).ResultsPresentations included acute coronary syndrome (47.2%) and stable coronary disease (52.8%). Vessels treated included left main stem (6.8%), left anterior descending (37.4%), circumflex (19.1%), right coronary artery (34.5%) and saphenous vein graft (2.1%) respectively. High-risk subsets included diabetes (15.6%); AHA type C lesions (35.1%) and chronic total occlusions (12.8%). During median follow-up of 700 days (0 to 1392) there were 42 deaths (6.1%); 4.2% at 0–6months, 1.0% at 6–12months and 0.9% at >12months. Of the 7 deaths between 6 and 12months, one death was adjudicated as possible stent thrombosis. There were no cases of non-fatal known stent thrombosis. All cause mortality accrued with smooth decremental incidence. Statistical examination showed no evidence of event clustering between 6 and 12 months.ConclusionsAfter implantation of biodegradable polymer biolimus-eluting coronary stents, 6 months DAPT appears to be adequate, safe and effective.
Introduction: Rotational atherectomy (RA) is widely used for treating calcified coronary lesions. Clinical data however remain limited.Methods: We assessed outcome and survival among patients undergoing percutaneous coronary intervention (PCI) with or without RA in the UK between September 2007 and March 2011.Results: Data from 221,669 percutaneous coronary intervention (PCI) procedures were analysed; 2152 patients (0.97%) underwent RA (RA+); the remainder underwent conventional PCI (RA-). RA+ patients were older (71.7 +/- 9.6 vs. 64.1 +/- 12.8 year; p < 0.001), and had a higher incidence of diabetes (26.4% vs. 18.0%; p < 0.001), hypertension, (61.9% vs. 49.4%; p < 0.001), peripheral vascular disease (9.9% vs. 4.2%, p < 0.001), cerebrovascular disease (5.5% vs. 3.4%, p < 0.001), renal impairment (3.4% vs. 1.5%, p < 0.001) and poor left ventricular function (11.4% vs. 4.3%, p < 0.001). Procedural success was lower among RA+ patients (90.3% vs 94.6%; p < 0.001) and procedural complications were more frequent (9.7% vs 5.4%; p < 0.001). After 2.4 +/- 1.2 years follow-up, unadjusted Cox proportional hazard modeling demonstrated poorer survival for RA+ patients (HR 2.21, 95% CI 1.97-2.49; p < 0.0001). This disadvantage remained after adjustment for adverse variables (HR 1.26, 95% CI 1.11-1.44; p = 0.0004) and following propensity analysis. There was evidence however of improved survival for RA+ patients with left main stem disease (HR 0.52, 95% CI 0.35-0.75, p < 0.0001), and peripheral vascular disease (HR 0.65, 95% CI 0.43-0.98, p < 0.0005).Conclusions: Rotational atherectomy was undertaken in patients with higher pre-procedural risk. Medium term survival was worse among patients undergoing rotational atherectomy, and this survival disadvantage remained after correction for available adverse factors. Rotational atherectomy however remains clinically useful for patients with calcified coronary lesions. (C) 2013 Elsevier Ireland Ltd. All rights reserved.
Preformed donor HLA-specific antibodies are a known indicator for poor patient survival after cardiac transplantation. The role of de novo donor-specific antibodies (DSA) formed after cardiac transplantation is less clear. Here we have retrospectively analyzed 243 cardiac transplant recipients, measuring HLA antibody production every year after transplantation up to 13 years post-transplant. Production of de novo DSA was analyzed in patients who had been negative for DSA prior to their transplant. DSA including transient antibodies were associated with poor patient survival (p = 0.0018, HR = 3.198). However, de novo and persistent DSA was strongly associated with poor patient survival (p = 0.0001 HR = 4.351). Although complement fixing persistent DSA correlated with poor patient survival, this was not increased compared to noncomplement fixing persistent DSA. Multivariable analysis indicated de novo persistent DSA to be an independent predictor of poor patient survival along with HLA-DR mismatch and donor age. Only increasing donor age was found to be an independent risk factor for earlier development of CAV. In conclusion, patients who are transplanted in the absence of pre-existing DSA make de novo DSA after transplantation which are associated with poor survival. Early and regular monitoring of post-transplant DSA is required to identify patients at risk of allograft failure.
Journal of the Royal Statistical Society: Series A (Statistics in Society)Volume 172, Issue 4 p. 939-939 Introductory Statistics with R Derek Robinson, Derek Robinson University of Sussex Brighton E-mail: D.R.Robinson@susx.ac.ukSearch for more papers by this author Derek Robinson, Derek Robinson University of Sussex Brighton E-mail: D.R.Robinson@susx.ac.ukSearch for more papers by this author First published: 28 September 2009 https://doi.org/10.1111/j.1467-985X.2009.00614_8.xCitations: 1Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume172, Issue4October 2009Pages 939-939 RelatedInformation
Statistics in MedicineVolume 27, Issue 8 p. 1326-1327 Book Review Statistical analysis of medical data using SAS. Geoff Der and Brian S. Everitt, Chapman & Hall/CRC, Boca Raton, FL, 2006. No. of pages: 428. Price: $79.95. ISBN 978-1-58488-469-X Derek Robinson, Derek Robinson Department of Mathematics, University of Sussex, Sussex, U.K.Search for more papers by this author Derek Robinson, Derek Robinson Department of Mathematics, University of Sussex, Sussex, U.K.Search for more papers by this author First published: 27 February 2008 https://doi.org/10.1002/sim.3009Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume27, Issue815 April 2008Pages 1326-1327 RelatedInformation
Background. Transplant-associated coronary artery disease (TxCAD) is the most serious long-term complication after cardiac transplantation. Anti-endothelial antibodies are associated with disease, and one of the major endothelial antigens recognized in the sera of patients has been shown to be the protein filament vimentin. In this study, we investigated whether antivimentin antibodies are associated with TxCAD and whether their presence can be used to identify patients at high risk of developing angiographically detectable TxCAD. Methods. Up to 5 years after transplantation, 880 sequential sera (7.07±1.8 samples/patient) were collected retrospectively from 109 patients; the majority were collected in the first 2 years. Sera were assessed for antivimentin antibodies using ELISA. TxCAD was assessed by annual angiography. Results. Mean titres of antivimentin antibodies, calculated up to 1, 2, and 5 years, were significantly higher in patients who developed TxCAD than those who remained disease free (P <0.0001, P <0.0038, and P <0.0001, respectively). A predictive test based on the first-year mean vimentin titre alone (≥120) produced a test with 63% sensitivity and 76% specificity. Inclusion of persistent rejection or high 1-year mean titre (≥270) as a risk factor produced a test with 66% sensitivity and 82% specificity. Multivariate analysis of time to occurrence of transplant vasculopathy showed that mean titre at 1 or 2 years was an independent predictor of time until disease in the presence of all other variables. Conclusions. Antivimentin antibodies are an independent predictor of TxCAD and can be used to identify some of the patients who are at high risk of developing this complication.