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.
Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the ...international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously.
Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively 11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01. Surgical mitral valve repair or replacement was performed earlier than PMVR median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01).
Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.
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.
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.
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.
The aim of our study was to assess the anatomical changes of the mitral valve apparatus after percutaneous repair with the MitraClip® system. We included consecutive patients who underwent MitraClip® ...implantation in our center. Patients were assessed by 2- and 3-dimensional transesophageal echocardiography, acquired before and immediately after MitraClip® implantation. Off-line images analysis was performed to assess mitral annular diameters (antero-posterior and inter-commisural), area and circumference. Mitral tenting distance, area and volume were evaluated for functional mitral regurgitation. Patients had a 2-dimensional transthoracic echocardiography at follow-up (8 months). 38 patients with successful results (residual mitral regurgitation grade ≤ II) were included. The anteroposterior annulus diameter (ADP) decreased (from 35 ± 5 to 28 ± 5 mm, p < 0.001) with smaller decreases in the annular area and circumference and in the inter-commissural diameter. Annular ellipticity improved. The reduction in APD and tenting distance was sustained at follow-up. Successful percutaneous mitral valve repair with the MitraClip® system induces a stable change in mitral valve geometry mainly at the ADP, suggesting a significant annuloplasty that contributes to the reduction of mitral regurgitation.
Thrombocytopenia after transcatheter aortic valve implantation (TAVI) is common and has been related to worse clinical outcomes. Comparison of platelet kinetics among different types of valves is ...limited. Our objectives were to analyze the differences in drop platelet count (DPC) between balloon-expandable valves (BEVs) and self-expanding valves and their prognostic implications after TAVI. Patients who underwent transfemoral TAVI from 2008 to 2016 were included. Exclusion criteria were severe baseline thrombocytopenia and periprocedural death. Postprocedural platelet counts were collected. Two groups were created: DPC ≤30 and DPC >30%. Valve Academic Research Consortium-2 criteria were used to define outcomes. Study population included 609 patients (age 84.7 ± 6.0, 46.6% males). The mean DPC was 32.5 ± 13.9%. The DPC was higher in the BEV arm (33.9 ± 14.2 vs 30.7 ± 13.4%, p = 0.006), and the nadir was reached later in comparison to the self-expanding valve arm (3.0 ± 1.3 vs 2.5 ± 1.1 days, p <0.001). After multivariable analysis, the use of BEV, known coronary artery disease, and left ventricle ejection fraction were the factors associated with a higher rate of DPC >30%. At 30 days, the DPC >30% was related with a higher rate of life-threatening and/or major bleeding (6.8 vs 2.1%, p = 0.009) and death (3.5 vs 0.8%, p = 0.036). At 1 year, the difference in mortality disappeared. In conclusion, in this cohort of patients, the use of BEV seems to be associated with a higher risk of DPC after TAVI. A DPC ≥30% was related with increased risk of life-threatening and/or major bleeding and death at 30 days. Larger and prospective studies are needed to understand this phenomenon.
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.
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