Abstract Background Identifying transcatheter aortic valve replacement (TAVR) patients at high risk for cerebrovascular events (CVE) is of major clinical relevance. However, predictors have varied ...across studies. Objectives The purpose of this study was to analyze the predictors of 30-day CVE post-TAVR. Methods A systematic review of studies that reported the incidence of CVE post-TAVR while providing raw data for predictors of interest was performed. Data on study, patient, and procedural characteristics were extracted. Crude risk ratios (RRs) and 95% confidence intervals for each predictor were calculated. Results Sixty-four studies involving 72,318 patients (2,385 patients with a CVE within 30 days post-TAVR) were analyzed. Incidence of CVE ranged from 1% to 11% (median 4%) without significant differences between single and multicenter studies, or according to CVE adjudication availability. The summary RRs indicated lower risk for men (RR: 0.82; p = 0.02) and higher risk for patients with chronic kidney disease (RR: 1.29; p = 0.03) and with new-onset atrial fibrillation post-TAVR (RR: 1.85; p = 0.005), and for procedures performed within the first half of center experience (RR: 1.55; p = 0.003). The use of balloon post-dilation tended to be associated with a higher risk of CVE (RR: 1.43; p = 0.07). Valve type (balloon-expandable vs. self-expandable, p = 0.26) and approach (transfemoral vs. nontransfemoral, p = 0.81) did not predict CVE. Conclusions Female sex, chronic kidney disease, enrollment date, and new-onset atrial fibrillation were predictors of CVE post-TAVR. This study provides effect estimates to identify high-risk TAVR patients for early CVE, providing possible guidance for tailored preventive strategies.
Abstract Background Data regarding the mid- to long-term cognitive trajectory of transcatheter aortic valve (TAVR) recipients are scarce. Objectives Changes in global cognition and specific cognitive ...domains up to 1 year post-TAVR were evaluated. Methods Fifty-one patients (median age 80.0 interquartile range: 72.0 to 85.0 years; 37% women) underwent TAVR and prospective assessment of cognitive function using the Montreal Cognitive Assessment (MoCA) at baseline, short-term (30 days), and 1 year post-TAVR. Processing speed and executive cognitive functions were further evaluated with the digit-symbol substitution test (DSST), Trail Making Tests (TMT), and verbal fluency tests at the same time points. Cognitive decline (CD) was determined by changes in mean scores and as a rate using practice-corrected reliable change index (RCI). Results The baseline mean total MoCA score was 22.71 ± 3.84. Twenty patients (39.2%) were considered cognitively impaired using a cutoff of <23 of 30 points. Mean total MoCA score improved at short-term post-TAVR and remained stable at 1 year (p = 0.022). On the basis of the RCI of total MoCA score, 4 patients (7.8%) presented with short-term CD, which persisted at 1 year in 1 patient (2.0%). Four patients (7.8%) exhibited cognitive improvement at 1 year, increasing to 15% among those with baseline cognitive impairment. No significant changes were observed over time in the mean DSST, TMT, and verbal fluency test scores. On the basis of the RCI, 10 of 40 patients (25%) presented with a reduction in performance of at least 1 test at 30 days that persisted at 1 year in 4 patients (10%). Conclusions TAVR was associated with global improvement in cognitive status, more pronounced among those with cognitive impairment pre-TAVR. However, early decline in some complex cognitive functions was observed in one-quarter of TAVR recipients, persisting at 1 year in 10% of patients.
Abstract Objectives The study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve ...replacement (TAVR) with concomitant atrial fibrillation (AF). Background Guidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation AF) with a vitamin K antagonist (VKA) are scarce. Methods A multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (n = 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; n = 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or life-threatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used. Results During a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between groups in the rate of stroke (MT: 5%, MAT: 5.2%; adjusted hazard ratio HR: 1.25; 95% confidence interval CI: 0.45 to 3.48; p = 0.67), major adverse cardiovascular events (MT: 13.9%, MAT: 16.3%; adjusted HR: 1.33; 95% CI: 0.75 to 2.36; p = 0.33), and death (MT 22.8%, MAT: 19.2%; adjusted HR: 0.93; 95% CI: 0.58 to 1.50; p = 0.76). A higher risk of major or life-threatening bleeding was found in the MAT group (MT: 14.9%, MAT: 24.4%; adjusted HR: 1.85; 95% CI: 1.05 to 3.28; p = 0.04). These results remained similar when patients receiving VKA plus only 1 antiplatelet agent (n = 463) were evaluated. Conclusions In TAVR recipients prescribed VKA therapy for AF, concomitant antiplatelet therapy use appears not to reduce the incidence of stroke, major adverse cardiovascular events, or death, while increasing the risk of major or life-threatening bleeding.
Summary Background In patients with heart failure, interventions to reduce elevated left atrial pressure improve symptoms and reduce the risk of hospital admission. We aimed to assess the safety and ...potential efficacy of therapeutic left-to-right interatrial shunting in patients with heart failure with reduced ejection fraction. Methods We did this proof-of-principle cohort study at one centre in Canada. Patients (aged ≥18 years) with New York Heart Association (NYHA) class III chronic heart failure with reduced ejection fraction were enrolled under the Canadian special access programme. Shunt implants were done after transseptal catheterisation with transoesophageal echocardiographic guidance under general anaesthesia. Patients had clinical and echocardiography evaluations at baseline and months 1 and 3 after shunt implantation. Findings Between Oct 10, 2013, and March 27, 2015, we enrolled ten patients. The device was successfully implanted in all patients; no device-related or procedural adverse events occurred during follow-up. Transoesophageal echocardiography at 1 month showed that all shunts were patent, with no thrombosis or migration. From baseline to 3 month follow-up, we recorded improvements in NYHA classification (from class III to class II in seven 78% of nine patients, from class III to class I in one 11% patient, and no change in one 11% patient; p=0·0004); quality of life, as assessed by the Duke Activity Status Index (from a mean score of 13 SD 6·2 to 24·8 12·9; p=0·016) and the Kansas City Cardiomyopathy Questionnaire (from a mean score of 44·3 SD 9·8 to 79·1 13·0; p=0·0001); and 6 min walk test distance (from a mean of 244 m SD 112 to 318 m 134; p=0·016). Pulmonary capillary wedge pressure was reduced from a mean of 23 mm Hg (SD 5) at baseline to 17 mm Hg (8) at 3 months (p=0·035), with no changes in right atrial pressure, pulmonary arterial pressure, or pulmonary resistance. No patient was admitted to hospital for worsening heart failure. One (10%) patient was admitted to hospital with gastrointestinal bleeding at month 1; one (10%) patient died after incessant ventricular tachycardia storm, which led to terminal heart failure 2 months post-procedure. Interpretation This first-in-man experience with an implanted left-to-right interatrial shunt demonstrates initial safety and early beneficial clinical and haemodynamic outcomes in patients with heart failure with reduced ejection fraction. Further large-scale randomised studies are warranted. Funding V-Wave.
Left atrial appendage occlusion (LAAO) is emerging as a promising alternative to oral anticoagulation. Because aged patients present a greater risk of not only cardioembolic events but also major ...bleeding, LAAO might represent a valid alternative as this would allow oral anticoagulation cessation while keeping cardioembolic protection. The objective of the study was to explore the safety and efficacy of LAAO in elderly patients. Data from the AMPLATZER Cardiac Plug multicenter registry were analyzed. The cohort was categorized in 2 groups (<75 vs ≥75 years). A total of 1,053 subjects were included in the registry. Of them, 219 were excluded because of combined procedures. As a result, 828 subjects were included (54.6% ≥75 years). Procedural success was high and similar in both groups (97.3%). Acute procedural major adverse events were not statistically different among groups (3.2% in <75 years vs 5.1%; p = 0.17) although stratified analysis showed a higher incidence of cardiac tamponade in elderly patients (0.5% vs 2.2%; p = 0.04). With a median follow-up of 16.8 months, no significant differences in stroke/TIA (1.9% vs 2.3%; p = 0.89) and major bleeding (1.7% vs 2.6%; p = 0.54) were observed. In conclusion, LAAO was associated with similar procedural success in patients aged <75 and ≥75 years although older patients had a higher incidence of cardiac tamponade. At follow-up, stroke and major bleeding rates were similar among groups.
Abstract The recommendations for antithrombotic treatment post-left atrial appendage closure (LAAC) remain empirical, and no data exist on the changes in hemostatic markers associated with LACC. The ...objective of this study was to determine the presence, degree and timing of changes in the markers of platelet and coagulation activation following LAAC. Forty-three patients (mean age: 76±9 years, 23 men) with atrial fibrillation who underwent successful LACC with the Watchman (n=27) or Amplatzer Cardiac Plug (n=16) devices were included in the study. Patients received antiplatelet therapy post-LAAC (aspirin + clopidogrel: 27 patients; single anti-platelet therapy with aspirin or clopidogrel: 16 patients). Prothrombin fragment 1+2 (F1+2) and thrombin-antithrombin III (TAT) were used as markers of coagulation activation, and soluble P-selectin and soluble CD40 ligand were used as markers of platelet activation. Measurements of all hemostatic markers were performed at baseline just prior to the procedure, followed by days 7, 30, and 180 post-LAAC. F1+2 and TAT levels increased from 0.27 nmol/L and 4.68 ng/mL, respectively, at baseline to peak values of 0.43 nmol/L and 9.76 ng/mL, respectively, at 7 days, partially returning to baseline levels at days 30 and 180 post-LAAC (p<0.001 for both markers). No clinical or procedural factors were associated with a greater increase in the markers of coagulation activation post-LAAC. Levels of soluble P-selectin and soluble CD40 ligand did not change at any time following LAAC. In conclusion, transcatheter LAAC is associated with significant activation of the coagulation system, yet without evidence of significant platelet activation.
...single antiplatelet therapy after LAAC in patients with a high risk of bleeding is associated with a low rate of cardioembolic and bleeding complications at a median follow-up of 19 months. ...Watchman (Boston Scientific, Natick, Massachusetts); Amplatzer Cardiac Plug/Amulet (St. Jude Medical, Minneapolis, Minnesota).CHA2DS2-VASc = congestive heart failure, hypertension, age >=75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism, vascular disease, age 65-74 years, sex category (female); CHADS2 = congestive heart failure, hypertension, age >=75 years, diabetes mellitus, prior stroke or transient ischemic attack; HAS-BLED = hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol; LAA = left atrial appendage; TEE = transesophageal echocardiography; TIA = transient ischemic attack.
The inclusion of patients who are not at risk for this specific complication may have translated into a significant underestimation of the real incidence of PPM following TAVR, and introduces a major ...bias when informing patients about the real risks of PPM following the TAVR procedure. ...this study's objective was to estimate the "real" incidence of PPM following TAVR and to compare it with the incidence reported by the TAVR studies. Controversy still exists regarding the long-term impact of new PPM post-TAVR (2,3), but the short- and long-term risks and morbidity associated with PPM are well known (4,5). ...it would be important to consider these results in future TAVR studies especially with the shift towards implanting newer generation devices within lower-risk patients.
Abstract Transcarotid transcatheter aortic valve replacement (TAVR) is a new alternative in patients with contraindications to other approaches. We report results in 5 patients who underwent TAVR ...using the common carotid artery approach. Intraprocedural evaluation of the integrity of the circle of Willis was performed by measuring backflow pressure and cerebral oximetry. All patients underwent successful TAVR, without any cerebrovascular or access-related complications. Patient mobilization occurred early postprocedure and 4 of the 5 patients were discharged 3 days after the TAVR procedure. In conclusion, these results suggest that transcarotid access is a safe and feasible secondary TAVR approach.
OBJECTIVE To investigate comorbid conditions with prognostic influence in non–ST-segment elevation acute coronary syndrome (NSTEACS). PATIENTS AND METHODS The study group consisted of a derivation ...cohort of 1017 patients (admitted from October 1, 2002, through October 1, 2008) and an external validation cohort of 652 patients (admitted from February 1, 2006, through September 30, 2009). Comorbid conditions, including risk factors and components of the Charlson comorbidity index (ChCI) and coronary artery disease–specific index, were recorded. The main outcome was one-year mortality. RESULTS During follow-up, 103 patients died. After adjusting for variables associated with NSTEACS characteristics (base model), 5 comorbid conditions predicted mortality: severe or mild renal failure (hazard ratio HR, 2.9 and HR, 1.6, respectively), dementia (HR, 3.1), peripheral artery disease (HR, 2.0), previous heart failure (HR, 2.6), and previous myocardial infarction (HR, 1.4). A simple comorbidity index (SCI) was developed using these variables, (per point: HR, 1.6; 95% confidence interval, 1.4-1.8; P =.0001). Adding the SCI, Charlson comorbidity index, or coronary artery disease–specific index to the base model resulted in a gain of 6.58%, 5.00%, and 4.04%, respectively, in discriminative ability ( P =.001), without significant differences among the 3 indices. In patients with comorbid conditions, the highest risk period was in the first weeks after NSTEACS. The strength of the association between SCI and mortality rate was similar in the external validation cohort (HR, 1.3; 95% confidence interval, 1.1-1.6; P =.001). CONCLUSION Renal dysfunction, dementia, peripheral artery disease, previous heart failure, and previous myocardial infarction are the comorbid conditions that predict mortality in NSTEACS. A simple index using these variables proved to be as accurate as the more complex comorbidity indices for risk stratification. In-hospital management of patients with comorbid conditions merits further investigation.
PDF
