Transcatheter aortic valve replacement (TAVR) is an effective treatment for severe symptomatic aortic stenosis (AS) in patients who are inoperable or at high risk for surgery. However, the ...intermediate- to long-term mortality is high, emphasizing the importance of patient selection. We, therefore, sought to evaluate the prognostic value of frailty in older recipients of TAVR, hypothesizing that frail patients would experience a higher mortality rate and a higher likelihood of poor outcome 1 year after TAVR. This substudy of the Placement of Aortic Transcatheter Valves trial was conducted at 3 high-enrolling sites where frailty was assessed systematically before TAVR. In total, 244 patients received TAVR at the participating sites. Frailty was assessed using a composite of 4 markers (serum albumin, dominant handgrip strength, gait speed, and Katz activity of daily living survey), which were combined into a frailty score. The cohort was dichotomized at median frailty score. Outcomes measures were the time to death from any cause for >1 year of follow-up and poor outcome at 1 year. Poor outcome was defined as (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score <60, or (3) decrease of ≥10 points in the KCCQ-OS score from baseline to 1 year. At 1 year, the Kaplan-Meier–estimated all-cause mortality rate was 32.7% in the frail group and 15.9% in the nonfrail group (log-rank p = 0.004). At 1 year, poor outcome occurred in 50.0% of the frail group and 31.5% of the nonfrail group (p = 0.02). In conclusion, frailty was associated with increased mortality and a higher rate of poor outcome 1 year after TAVR.
Intermediate-risk patients with aortic stenosis were randomly assigned to undergo either transcatheter or surgical aortic-valve replacement. At 5 years, there was no significant difference between ...the two groups in the incidence of death or disabling stroke. The incidence of aortic regurgitation was higher with transcatheter AVR.
Abstract Background The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown. Objectives The aim of this study was to ...identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR. Methods Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER (Placement of Aortic Transcatheter Valves) trial were analyzed after stratifying by the occurrence of MLBCs. Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed. Results Among 2,401 patients who underwent TAVR and survived to 30 days, MLBCs occurred in 142 (5.9%) at a median time of 132 days (interquartile range: 71 to 230 days) after the index procedure. Gastrointestinal complications (n = 58 40.8%), neurological complications (n = 22 15.5%), and traumatic falls (n = 11 7.8%) were identified as the most frequent types of MLBCs. Independent predictors of MLBCs were the presence of low hemoglobin at baseline, atrial fibrillation or flutter at baseline or 30 days, the presence of moderate or severe paravalvular leak at 30 days, and greater left ventricular mass at 30 days. MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year (adjusted hazard ratio: 3.91; 95% confidence interval: 2.67 to 5.71; p < 0.001). Conclusions MLBCs after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )
In a randomized trial involving more than 2000 patients, transcatheter aortic-valve replacement was noninferior to surgical replacement in the primary end point of death from any cause or disabling ...stroke at 2 years.
Transcatheter aortic-valve replacement (TAVR) is a new therapy for patients with severe aortic stenosis who are not candidates for surgery
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or who are at high risk for complications due to surgery.
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The acceptance of the use of TAVR in high-risk patients was based on evidence from clinical trials
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that used early-generation TAVR devices; these procedures were associated with considerable procedure-related complications.
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Recently, increased operator experience and enhanced transcatheter valve systems have led to a worldwide trend to use TAVR in patients who are at low or intermediate risk.
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This trend has been evaluated in small . . .
Summary Background The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement ...(TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. Methods We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov , number NCT00530894. Findings We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86–1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003). Interpretation Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes. Funding Edwards Lifesciences.
Objectives This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR). Background VC after ...TF-TAVR are frequent and may be associated with unfavorable prognosis. Methods From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B inoperable and 242 from cohort A operable high-risk) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. Results Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio HR: 2.31 95% confidence interval (CI): 1.08 to 4.98, p = 0.03). Major VC (HR: 2.31 95% CI: 1.20 to 4.43, p = 0.012), and renal disease at baseline (HR: 2.26 95% CI: 1.34 to 3.81, p = 0.002) were identified as independent predictors of 1-year mortality. Conclusions Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.
Valvular Heart Disease in Patients ≥80 Years of Age Kodali, Susheel K.; Velagapudi, Poonam; Hahn, Rebecca T. ...
Journal of the American College of Cardiology,
05/2018, Letnik:
71, Številka:
18
Journal Article
Recenzirano
Odprti dostop
In the United States, the octogenarian population is projected to triple by 2050. With this aging population, the prevalence of valvular heart disease (VHD) is on the rise. The etiology, approach to ...treatment, and expected outcomes of VHD are different in the elderly compared with younger patients. Both stenotic and regurgitant lesions are associated with unfavorable outcomes if left untreated. Surgical mortality remains high due to multiple co-morbidities, and long-term survival benefit is dependent on many variables including valvular pathology. Quality of life is an important consideration in treatment decisions in this age group. Increasingly, octogenarian patients are receiving transcatheter therapies, with transcatheter aortic valve replacement having the greatest momentum. Numerous transcatheter devices for management of other valve lesions are currently in early clinical trials. This review will describe the epidemiology, etiology, diagnosis, and therapeutic options for VHD in the oldest old, with a focus on transcatheter technologies.
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Transcatheter aortic valve replacement (TAVR) has become a safe and effective therapy for patients with severe aortic stenosis (AS). In recent trials, the hemodynamic performance and clinical ...outcomes of the latest generation of TAVR devices demonstrated at least parity with surgical outcomes in patients of similar risk. Many initial obstacles with TAVR have largely been overcome, including frequent access site complications and concerns about strokes and paravalvular leaks. Using a multidisciplinary heart team approach, patient selection, procedural planning, and device implantation have been refined and optimized such that clinical outcomes are generally predictable and reproducible. Future research will focus on the durability of TAVR devices, further enhancements in clinical outcomes, and adjunctive therapies. On the basis of initial results from ongoing clinical trials, the indication for TAVR will likely expand to lower-risk patients. This review provides an overview of recent progress in this field, and highlights future opportunities and directions.
Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS).
This study sought to compare the procedural and clinical outcomes ...in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry.
Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria.
Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28).
Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices.
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The right ventricular (RV)-pulmonary arterial (PA) coupling ratio relates the efficiency with which RV stroke work is transferred into the PA. Lower ratios indicate an inadequate RV contractile ...response to increased afterload.
This study sought to evaluate the prognostic significance of RV-PA coupling in patients with tricuspid regurgitation (TR) who were undergoing transcatheter tricuspid valve repair or replacement (TTVR).
The study investigators calculated RV-PA coupling ratios for patients enrolled in the global TriValve registry by dividing the tricuspid annular plane systolic excursion (TAPSE) by the PA systolic pressure (PASP) from transthoracic echocardiograms performed before the procedure and 30 days after the procedure. The primary endpoint was all-cause mortality at 1-year follow-up.
Among 444 patients analyzed, their mean age was 76.9 ± 9.1 years, and 53.8% of the patients were female. The median TAPSE/PASP ratio was 0.406 mm/mm Hg (interquartile range: 0.308-0.567 mm/mm Hg). Sixty-three patients died within 1 year of TTVR, 21 with a TAPSE/PASP ratio >0.406 and 42 with a TAPSE/PASP ratio ≤0.406. In multivariable Cox regression analysis, a TAPSE/PASP ratio >0.406 vs ≤0.406 was associated with a decreased risk of all-cause mortality (HR: 0.57; 95% CI: 0.35-0.93; P = 0.023). In 234 (52.7%) patients with echocardiograms 30 days after TTVR, a decline in RV-PA coupling was independently associated with reduced odds of all-cause mortality (odds ratio OR: 0.42; 95% CI: 0.19-0.93; P = 0.032). The magnitude of TR reduction after TTVR (≥1+ vs <1+; OR: 2.53; 95% CI: 1.06-6.03; P = 0.037) was independently associated with a reduction in post-TTVR RV-PA coupling.
RV-PA coupling is a powerful, independent predictor of all-cause mortality in patients with TR undergoing TTVR. These data suggest that the TAPSE/PASP ratio can inform patient selection and prognostication following TTVR.
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