Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk.
The aim of ...this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria.
In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD.
At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89).
In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173)
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BACKGROUND:The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 ...years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.
METHODS:Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.
RESULTS:Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% versus 36.3%, log-rank test P=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm versus 1.2 cm, P<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg, P<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%, P<0.001) and a new pacemaker (43.7% versus 8.7%, P<0.001). Four patients had prosthetic reintervention and no difference was found for functional outcomes.
CONCLUSIONS:These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR.
CLINICAL TRIAL REGISTRATION:URLhttps://clinicaltrials.gov. Unique identifierNCT01057173.
CONTEXT The need for anticoagulation after surgical aortic valve replacement (AVR) with biological prostheses is not well examined. OBJECTIVE To perform a nationwide study of the association of ...warfarin treatment with the risk of thromboembolic complications, bleeding incidents, and cardiovascular deaths after bioprosthetic AVR surgery. DESIGN, SETTING, AND PARTICIPANTS Through a search in the Danish National Patient Registry, 4075 patients were identified who had bioprosthetic AVR surgery performed between January 1, 1997, and December 31, 2009. Concomitant comorbidity and medication were retrieved. Poisson regression models were used to determine risk. MAIN OUTCOME MEASURES Incidence rate ratios (IRRs) of strokes, thromboembolic events, cardiovascular deaths, and bleeding incidents by discontinuing warfarin as opposed to continued treatment 30 to 89 days, 90 to 179 days, 180 to 364 days, 365 to 729 days, and at least 730 days after surgery. RESULTS The median duration of follow-up was 6.57 person-years. Estimated rates of events per 100 person-years in patients not treated with warfarin compared with those treated with warfarin with comparative absolute risk were 7.00 (95% CI, 4.07-12.06) vs 2.69 (95% CI, 1.49-4.87; adjusted IRR, 2.46; 95% CI, 1.09-5.55) for strokes; 13.07 (95% CI, 8.76-19.50) vs 3.97 (95% CI, 2.43-6.48; adjusted IRR, 2.93; 95% CI, 1.54-5.55) for thromboembolic events; 11.86 (95% CI, 7.81-18.01) vs 5.37 (95% CI, 3.54-8.16; adjusted IRR, 2.32; 95% CI, 1.28-4.22) for bleeding incidents; and 31.74 (95% CI, 24.69-40.79) vs 3.83 (95% CI, 2.35-6.25; adjusted IRR, 7.61; 95% CI, 4.37-13.26) for cardiovascular deaths within 30 to 89 days after surgery; and 6.50 (95% CI, 4.67-9.06) vs 2.08 (95% CI, 0.99-4.36; adjusted IRR, 3.51; 95% CI, 1.54-8.03) for cardiovascular deaths within 90 to 179 days after surgery. CONCLUSION Discontinuation of warfarin treatment within 6 months after bioprosthetic AVR surgery was associated with increased cardiovascular death.
Abstract
Aims
The aims of the study were to compare clinical outcomes and valve durability after 8 years of follow-up in patients with symptomatic severe aortic valve stenosis at low surgical risk ...treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).
Methods and results
In the NOTION trial, patients with symptomatic severe aortic valve stenosis were randomized to TAVI or SAVR. Clinical status, echocardiography, structural valve deterioration, and failure were assessed using standardized definitions. In total, 280 patients were randomized to TAVI (n = 145) or SAVR (n = 135). Baseline characteristics were similar, including mean age of 79.1 ± 4.8 years and a mean STS score of 3.0 ± 1.7%. At 8-year follow-up, the estimated risk of the composite outcome of all-cause mortality, stroke, or myocardial infarction was 54.5% after TAVI and 54.8% after SAVR (P = 0.94). The estimated risks for all-cause mortality (51.8% vs. 52.6%; P = 0.90), stroke (8.3% vs. 9.1%; P = 0.90), or myocardial infarction (6.2% vs. 3.8%; P = 0.33) were similar after TAVI and SAVR. The risk of structural valve deterioration was lower after TAVI than after SAVR (13.9% vs. 28.3%; P = 0.0017), whereas the risk of bioprosthetic valve failure was similar (8.7% vs. 10.5%; P = 0.61).
Conclusions
In patients with severe aortic valve stenosis at low surgical risk randomized to TAVI or SAVR, there were no significant differences in the risk for all-cause mortality, stroke, or myocardial infarction, as well as the risk of bioprosthetic valve failure after 8 years of follow-up.
Clinical trial registration
URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.
Graphical Abstract
Clinical and aortic bioprosthetic valve failure 8 years after transcatheter and surgical aortic valve replacement. CI, confidence interval; HR, hazard ratio.
The risk of stroke after coronary artery bypass grafting (CABG) is known to increase dramatically with age. During recent years, the age of patients operated on has increased and concomitant therapy ...has changed. Therefore, we have re-evaluated the risk of stroke after CABG.
Through the Danish National Hospital Register, we identified all 25 159 patients with isolated CABG from 1997 through 2006. Stroke, comorbidities, and medication were further obtained. Risk factors of stroke were determined through regression models.
Overall, 1901 patients (7.6%) suffered a stroke after surgery, 477 patients (2.0%) within 30 days after CABG. Rates of stroke per 100 person-years (95% CI) within 30 days after surgery increased with age: <60 years, 10.1 (7.8-13.0); 60 to 64 years, 18.4 (14.3-23.5); 65 to 69 years, 27.7 (23.0-33.3); 70 to 74 years, 36.0 (30.4-42.6); 75 to 79 years, 36.1 (29.1-44.7); ≥80 years, 38.0 (25.2-57.1). Risks of stroke within 30 days after surgery adjusted for age (reference: age <60 years), sex, relevant comorbidities, and selected medication included: 60 to 64 years: HR, 1.7 (P=0.005; 95% CI, 1.2-2.4), 65 to 69 years: HR, 2.4 (P=0.001; 95% CI, 1.7-3.3), 70 to 74 years: HR, 2.8 (P=0.001; 95% CI, 2.1-3.8), 75 to 79 years: HR, 2.8 (P=0.001; 95% CI, 2.0-4.0), ≥80 years: HR, 3.0 (P=0.001; 95% CI, 1.8-4.9), previous stroke: HR, 4.2 (P=0.001; 95% CI, 3.3-5.4), diabetes: HR, 1.3 (P=0.019; 95% CI, 1.1-1.7), hypertension: HR, 1.4 (P=0.003; 95% CI, 1.1-1.7), peripheral vascular disease: HR, 1.6 (P=0.001; 95% CI, 1.3-2.1), renal failure: HR, 1.7 (P=0.012; 95% CI, 1.1-2.5), statins: HR, 0.8 (P=0.049; 95% CI, 0.7-1.0), clopidogrel: HR, 0.6 (P=0.032; 95% CI, 0.4-1.0).
The increase in stroke with age after CABG is moderate and the relation uncertain in ages older than 70 years. Declining CABG in elderly patients because of risk of stroke purely on the basis of high age is debatable.
Rehabilitation of patients following coronary artery bypass grafting (CABG) has been widely studied; however, research into early rehabilitation after CABG is sparse. The aim of this trial was to ...assess the impact of early rehabilitation, compared with usual care in patients following CABG.
Randomized controlled trial.
A total of 326 patients treated with CABG.
Patients treated with CABG were randomized 1:1 to 4 weeks of comprehensive early rehabilitation or usual care. The primary outcome was the Six Minute Walk Test (6MWT). Secondary outcomes were mental health and physical activity (Medical Outcome Study Short Form; SF-12); anxiety and depression (Hospital Anxiety and Depression Scale; HADS); physical and emotional scores; sleep (Pittsburgh Sleep Quality Index; PSQI); pain (Örebro Musculoskeletal Screening Questionnaire; ÖMSQ) and muscle endurance (Sit-To-Stand test).
Sixteen patients dropped out. No significant differences between groups in the primary outcome (6MWT) were found after 4 weeks (p = 0.27). For secondary outcomes the odds ratio of HADS-D ≥ 8 decreased in favour of the experimental intervention (p = 0.04). There was non-adherence to parts of the intervention. Per-protocol analysis showed differences between groups for the 6MWT (p = 0.02) and the Sit-To-Stand test (p = 0.046).
In general, the intervention had no effect on the 6MWT, or secondary outcomes, except for depressive symptoms. However, in adherent participants, the intervention had a positive effect for the primary and several secondary outcomes.
Abstract
OBJECTIVES
Hospitalizations are a major burden for both patients and society and are potentially preventable. However, data on the burden and causes for hospitalizations after coronary ...artery bypass grafting (CABG) are sparse. We examined hospitalizations within 1 year after CABG and associated factors.
METHODS
Using the Danish nationwide registries, we identified 36 475 patients who underwent first-time isolated CABG (1998–2014) and were discharged alive. Subsequent hospitalizations were classified as cardiovascular or non-cardiovascular according to discharge diagnosis codes. Factors associated with any hospitalization were identified using the Cox regression.
RESULTS
Thirty-day hospitalization risks for all-cause, cardiovascular and non-cardiovascular reasons were 16.7%, 12.4% and 4.2%, respectively. The corresponding 1-year hospitalization risks were 40.2%, 28.6% and 11.5%. Among patients who survived the first year, 7877 (22.1%) patients were admitted once, 3198 (9.0%) patients were admitted twice and 2844 (8.0%) patients were admitted 3 or more times within the first year. Ischaemic heart disease (15.6%), angina pectoris (9.8%), atrial fibrillation (AF) (8.7%) and heart failure (8.0%) were the most frequent reasons for hospitalization. Factors associated with any hospitalization were lower income level, a history of stroke, heart failure, AF, diabetes, malignancy, chronic renal failure, chronic obstructive pulmonary disease, longer length of stay, postoperative AF and stroke.
CONCLUSIONS
Within 1-year post-CABG, 40% of patients had at least 1 hospitalization, and approximately 70% of all hospitalizations were attributed to a cardiovascular cause. Lower socioeconomic status, preoperative comorbidities, postoperative complications during index admission and a longer length of stay were associated with hospitalization.
Introduction: Earlier studies have shown that re-operation for bleeding after cardiac surgery is associated with increased mortality and morbidity in both acute and elective patients. The aim of the ...study was to assess the effect of re-operation for bleeding on short- and long-term survival and the causes of re-operation on an exclusively elective population. Methods: This was a single-center, retrospective study conducted at the Department of Cardiothoracic Surgery at Copenhagen University Hospital. Rigshospitalet, Denmark. We included all elective patients undergoing first-time coronary bypass, valve surgery or combinations hereof between January 1998 and February 2014. Data was obtained from the electronic patient records on demographics, cardiological risk profile, blood transfusion and surgical record. Results: A total of 11813 patients were included in the analysis of whom 626 (5.3%) patients underwent re-operation for bleeding. Patients were divided into two groups; non re-operated (NRO) and re-operated(RO). Baseline characteristics were comparable. Median survival was lover in the RO group (142 vs 160months (P = 0.001)). Morbidity and 30 day mortality was significantly higher in the RO group. Cox-regression analysis showed a significantly increased age-adjusted risk of death in the RO group (HR 1.21(1.07-1.37). P = 0.003). In 85% of the patients the site of bleeding was found during the re-operation. Conclusion: We found both short and long-term survival to be lower in the RO group. A surgical cause for re-operation was found in the majority of cases. The study shows the importance of meticulous hemostasis during cardiac surgery.
Objectives Outcome in patients with acute coronary syndrome (ACS) is improved with dual antiplatelet therapy (DAPT). Patients with acute aortic dissection type A (AAD) often present with similar ...symptoms and may therefore be prescribed DAPT before diagnosis. The aim of this study was to evaluate the use of antiplatelet therapy (APT) prior to AAD surgery and patient outcome, including indications according to the European Society of Cardiology’s (ESC) recent guidelines. Design A retrospective, observational study. Setting A tertiary University Hospital, Rigshospitalet, Heart Centre, Copenhagen, Denmark. Participants The study included 171 patients operated for AAD during 2010 to 2014. Interventions The independent relationship of preoperative APT was explored on 30-day mortality, intraoperative bleeding and perioperative transfusion requirements. Furthermore, the indications for APT were obtained. Measurements and Main Results Patients receiving APT (n = 73) did not have an increased 30-day mortality (29% v 20%, p = 0.18). However, APT increased intraoperative bleeding by 45% (p<0.001) and increased perioperative transfusion of red blood cells by 71%, fresh frozen plasma by 52%, and platelets by 56% (p = 0.002). Among patients receiving APT preoperatively, 26 patients received acetylsalicylic acid (ASA) alone and 46 patients received DAPT. Bleeding was significantly more pronounced in patients receiving DAPT (5.6±4.1 L), compared to ASA alone (3.6±3.1 L) and no APT (3.3±4.8 L) (p<0.001). However, there was no significant difference in mortality between groups. DAPT, including ticagrelor, increased intraoperative bleeding by 62% compared to DAPT with clopidogrel (p = 0.004). Among patients receiving DAPT, only 30% of the patients fulfilled ESC criteria for ACS treatment. Conclusions The use of APT was associated with increased intraoperative bleeding and transfusion requirement; however, it was not associated with a statistically significant increased mortality. Only a minority of patients fulfilled ESC criteria for ACS treatment with DAPT.
Purpose
Autoregulation is essential for a constant circulation of O2. The apparent dissimilarity of vulnerability towards increased intraocular pressure in patients with normal‐tension glaucoma ...(NTGs) and individuals with ocular hypertension (OHTs) has been linked to disturbed autoregulation. The retina is particularly O2‐dependent and susceptible towards oxidative stress. The purpose was to evaluate the impact of a fluctuating O2 level on retinal vessel diameters and plasma levels of vasoregulators, nitric oxide (NO) and endothelin‐1 (ET‐1), and total antioxidant capacity (TAC) in strictly characterized NTGs, OHTs and age‐matched controls.
Methods
NTGs (n = 10–16), OHTs (n = 9–10) and controls (n = 9–14) were exposed to 2 h of hypoxia followed by 30 min of normoxia. Fundus pictures and blood samples were taken before hypoxia (“baseline”), during hypoxia (“hypoxia”) and after hypoxia (“recovery”). NO, ET‐1 and TAC was measured in plasma. Retinal arterial and vein diameters were measured with MATLAB.
Results
Retinal arteries dilated in NTGs and OHTs during hypoxia, while controls constricted. No significant changes were seen in retinal veins. During hypoxia controls and NTGs increased plasma levels of ET‐1 and NTGs sustained a high level in recovery. OHTs did not regulate ET‐1 but maintained a lower level compared to NTGs during hypoxia and recovery. No significant differences were seen in NO. OHTs had a higher TAC compared to NTGs and controls throughout the experiment.
Conclusions
The present study suggests a link between NTG and dysfunctional autoregulation. ET‐1 increase in controls and NTGs during hypoxia. As a vasoconstrictor, a vascular constriction is expected as evident in controls. The observed dilation in NTGs therefore might indicate that molecular mechanisms for vasoregulation are abolished. Surprisingly, OHTs present a similar pattern of autoregulation to NTGs but there is a prominent difference in the TAC. The higher level of TAC in OHTs compared to NTGs and controls indicates that the antioxidant defence might be important in providing resistance towards glaucomatous neurodegeneration.
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