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1.
Background:Presently, transcatheter aortic valve replacement (TAVR) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, after surgical aortic valve replacement (SAVR) and TAVR, the incidence of new-onset atrial fibrillation (NOAF) is prevalently found. This meta-analysis was designed to comprehensively compare the incidence of NOAF at different times after TAVR and SAVR for patients with severe aortic disease.Methods:A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVR and SAVR in the treatment of severe aortic disease. The primary outcomes were the incidence of NOAF with early, midterm and long term follow-up. The secondary outcomes included permanent pacemaker (PM) implantation, myocardial infarction (MI), cardiogenic shock, as well as mortality and other complications. Two reviewers assessed trial quality and extracted the data independently. All statistical analyses were performed using the standard statistical procedures provided in Review Manager 5.2.Results:A total of 16 studies including 13,310 patients were identified. The pooled results indicated that, compared with SAVR, TAVR experienced a significantly lower incidence of 30-day/in-hospital, 1-year, 2-year, and 5-year NOAF, with pooled risk ratios (RRs) of 0.31 (95% confidence interval [CI] 0.23–0.41; 5725 pts), 0.30 (95% CI 0.24–0.39; 6321 pts), 0.48 (95% CI 0.38–0.61; 3441 pts), and 0.45 (95% CI 0.37–0.55; 2268 pts) respectively. In addition, TAVR showed lower incidence of MI (RR 0.62; 95% CI 0.40–0.97) and cardiogenic shock (RR 0.34; 95% CI 0.19–0.59), but higher incidence of permanent PM (RR 3.16; 95% CI 1.61–6.21) and major vascular complications (RR 2.22; 95% CI 1.14–4.32) at 30-day/in-hospital. At 1- and 2-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of neurological events, transient ischemic attacks (TIA), permanent PM, and major vascular complications, respectively. At 5-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of TIA and re-intervention respectively. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVR and SAVR.Conclusions:Our analysis showed that TAVR was superior to SAVR in decreasing the both short and long term postprocedural NOAF. TAVR was equal to SAVR in early, midterm and long term mortality. In addition, TAVR showed lower incidence of 30-day/in-hospital MI and cardiogenic shock after procedure. However, pooled results showed that TAVR was inferior to SAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications, and re-intervention.  相似文献   

2.

Background

The concomitant presence of mitral stenosis (MS) in the setting of symptomatic aortic stenosis represent a clinical challenge. Little is known regarding the outcome of mitral stenosis (MS) patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Therefore, we sought to study the outcome of MS patients undergoing aortic valve replacement (AVR).

Method

Using weighted data from the National Inpatient Sample (NIS) database between 2011 and 2014, we identified patients who were diagnosed with MS. Patients who had undergone TAVR as a primary procedure were identified and compared to patients who had SAVR. Univariate and multivariate logistic regression analysis were performed for the outcomes of in‐hospital mortality, length of stay (LOS), blood transfusion, postprocedural hemorrhage, vascular, cardiac and respiratory complications, permanent pacemaker placement (PPM), postprocedural stroke, acute kidney injury (AKI), and discharge to an outside facility.

Results

A total of 4524 patients were diagnosed with MS, of which 552 (12.2%) had TAVR and 3972 (87.8%) had SAVR. TAVR patients were older (79.9 vs 70.0) with more females (67.4% vs 60.0%) and African American patients (7.7% vs 7.1%) (P < 0.001). In addition, the TAVR group had more comorbidities compared to SAVR in term of coronary artery disease (CAD), congestive heart failure (CHF), chronic lung disease, hypertension (HTN), chronic kidney disease (CKD), and peripheral vascular disease (PVD) (P < 0.001 for all). Using Multivariate logistic regression, and after adjusting for potential risk factors, TAVR patients had lower in‐hospital mortality (7.9% vs 8.1% adjusted Odds Ratio [aOR], 0.615; 95% confidence interval [CI], 0.392–0.964, P = 0.034), shorter LOS. Also, TAVR patients had lower rates of cardiac and respiratory complications, PPM, AKI, and discharge to an outside facility compared with the SAVR group.

Conclusion

In patients with severe aortic stenosis and concomitant mitral stenosis, TAVR is a safe and attractive option for patients undergoing AVR with less complications compared with SAVR.
  相似文献   

3.

Objectives

This study sought to evaluate the long-term clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR).

Background

Conduction disturbances leading to PPI are common following TAVR. However, no data exist regarding the impact of PPI on long-term outcomes post-TAVR.

Methods

This was a multicenter study including a total of 1,629 patients without prior PPI undergoing TAVR (balloon- and self-expandable valves in 45% and 55% of patients, respectively). Follow-up clinical, echocardiographic, and pacing data were obtained at a median of 4 years (interquartile range: 3 to 5 years) post-TAVR.

Results

PPI was required in 322 (19.8%) patients within 30 days post-TAVR (26.9% and 10.9% in patients receiving self- and balloon-expandable CoreValve and Edwards systems, respectively). Up to 86% of patients with PPI exhibited pacing >1% of the time during follow-up (>40% pacing in 51% of patients). There were no differences between patients with and without PPI in total mortality (48.5% vs. 42.9%; adjusted hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 0.95 to 1.39; p = 0.15) and cardiovascular mortality (14.9% vs. 15.5%, adjusted HR: 0.93; 95% CI: 0.66 to 1.30; p = 0.66) at follow-up. However, patients with PPI had higher rates of rehospitalization due to heart failure (22.4% vs. 16.1%; adjusted HR: 1.42; 95% CI: 1.06 to 1.89; p = 0.019), and the combined endpoint of mortality or heart failure rehospitalization (59.6% vs. 51.9%; adjusted HR: 1.25; 95% CI: 1.05 to 1.48; p = 0.011). PPI was associated with lesser improvement in LVEF over time (p = 0.051 for changes in LVEF between groups), particularly in patients with reduced LVEF before TAVR (p = 0.005 for changes in LVEF between groups).

Conclusions

The need for PPI post-TAVR was frequent and associated with an increased risk of heart failure rehospitalization and lack of LVEF improvement, but not mortality, after a median follow-up of 4 years. Most patients with new PPI post-TAVR exhibited some degree of pacing activity at follow-up.  相似文献   

4.

Background

Patients undergoing surgical aortic valve replacement (SAVR) are considered at high risk of infective endocarditis (IE). However, data on the risk of IE following transcatheter aortic valve replacement (TAVR) are sparse and limited by the lack of long-term follow-up as well as a direct comparison with patients undergoing SAVR.

Objectives

This study sought to investigate the long-term incidence of IE in patients undergoing TAVR and to compare the long-term risk of IE with patients undergoing isolated SAVR.

Methods

In this nationwide observational cohort study, all patients undergoing TAVR and isolated SAVR from January 1, 2008, to December 31, 2016, with no history of IE and alive at discharge were identified using data from Danish nationwide registries.

Results

A total of 2,632 patients undergoing TAVR and 3,777 patients undergoing isolated SAVR were identified. During a mean follow-up of 3.6 years, 115 patients (4.4%) with TAVR and 186 patients (4.9%) with SAVR were admitted with IE. The median time from procedure to IE hospitalization was 352 days (25th to 75th percentile: 133 to 778 days) in the TAVR group and 625 days (25th to 75th percentile: 209 to 1,385 days) in the SAVR group. The crude incidence rates of IE were 1.6 (95% confidence interval [CI]: 1.4 to 1.9) and 1.2 (95% CI: 1.0 to 1.4) events per 100 person-years in TAVR and SAVR patients, respectively. The cumulative 1-year risk of IE was 2.3% (95% CI: 1.8% to 2.9%) and 1.8% (95% CI: 1.4% to 2.3%) in TAVR and SAVR patients, respectively. Correspondingly, the cumulative 5-year risk of IE was 5.8% (95% CI: 4.7% to 7.0%) and 5.1% (95% CI: 4.4% to 6.0%), respectively. In multivariable Cox proportional hazard analysis, TAVR was not associated with a statistically significant different risk of IE compared with SAVR (hazard ratio: 1.12; 95% CI: 0.84 to 1.49).

Conclusions

The 5-year incidence of IE following TAVR was 5.8% and not significantly different than the incidence following SAVR.  相似文献   

5.
ObjectivesThis study sought to evaluate racial disparities in the performance and outcomes of transcatheter aortic valve replacement (TAVR).BackgroundRacial disparities in cardiovascular diseases are well described. Whether the racial disparities observed in surgical aortic valve replacement also exist with TAVR remains unknown.MethodsPatients undergoing TAVR between November 2011 and June 2016 were identified in the American College of Cardiology/Society of Thoracic Surgeons/Transcatheter Valve Therapy Registry. We described the racial distribution, and the risk-adjusted in-hospital morbidity, and mortality stratified by race. We evaluated 1-year outcomes in a subset of patients via linkage to Medicare (Centers for Medicare and Medicaid Services) claims.ResultsAmong the 70,221 included patients, 91.3% were white, 3.8% were black, 3.4% were Hispanic, and 1.5% were of Asian/Native American/Pacific Islander race. This represented significant underrepresentation of nonwhite patients compared with their proportion of the population. After risk-adjustment, there was no difference in the rates of in-hospital mortality, myocardial infarction, stroke, major bleeding, vascular complications, or new pacemaker requirements among the 4 racial groups. Among 29,351 patients with Centers for Medicare and Medicaid Services linkage, 1-year adjusted mortality rates were similar in blacks and Hispanics compared with whites, but lower among patients of Asian/Native American/Pacific Islander race (adjusted hazard ratio: 0.71; 95% confidence interval: 0.55 to 0.92; p = 0.028). Black and Hispanic patients had more heart failure hospitalizations compared with whites (adjusted hazard ratio: 1.39; 95% confidence interval: 1.16 to 1.67; p < 0.001; and adjusted hazard ratio: 1.37; 95% confidence interval: 1.13 to 1.66; p = 0.004, respectively). These differences persisted after additional risk-adjustment for socioeconomic status.ConclusionsRacial minorities are underrepresented among patients undergoing TAVR in the United States, but their adjusted 30-day and 1-year clinical outcomes are comparable with those of white race.  相似文献   

6.
BackgroundCurrent guidelines recommend oral anticoagulation (OAC) following transcatheter aortic valve replacement (TAVR) in patients with clinical indication, but the optimal antithrombotic regimen remains uncertain. We aimed to compare the efficacy and safety of non‐vitamin K oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in patients undergoing TAVR with concomitant indication of OAC.HypothesisComparing with VKAs therapy, NOACs are similar in reducing the all‐cause mortality and major bleeding in post‐TAVR patients requiring OAC medication.MethodsWe searched the databases of PubMed, Embase, and Cochrane library databases to identify studies that investigated NOACs versus VKAs after TAVR in patients with another indication of OAC, which were published before 28th September 28, 2021. The effectiveness of outcomes was all‐cause mortality and stroke or systemic embolism, while the main safety outcome was major and/or life‐threatening bleeding. The hazard ratio (HR) with 95% confidence interval (CI) was used as a measure of treatment effect.ResultsOur search identified eight studies. We included 4947 post‐TAVR patients with another indication of OAC allocated to the NOAC (n = 2146) or VKA groups (n = 2801). There were no significant differences in the all‐cause mortality (HR: 0.91, 95% CI: 0.77–1.08, p = .29, I 2 = 47%), stroke or systemic embolism (HR: 0.96, 95% CI: 0.68–1.37, p = .84, I 2 = 0%), and major and/or life‐threatening bleeding (HR: 1.09, 95% CI: 0.89–1.32, p = .40, I 2 = 30%) in both groups.ConclusionAmong post‐TAVR patients who required OAC therapy, NOACs therapy compared to VKAs is similar in reducing the all‐cause mortality, stroke or systemic embolism, and major and/or life‐threatening bleeding events.  相似文献   

7.
BackgroundDialysis is associated with higher rate of aortic valve calcification and higher cardiovascular mortality. Transcatheter aortic valve replacement (TAVR) is an established alternative for surgical aortic valve replacement (SAVR) in patients with higher and intermediate co-morbidities including dialysis.MethodsTwo independent investigators systematically searched Medline, Cochrane, and Web of Science. The ROBINS-I tool was used to analyze and assess the bias from the selected studies.ResultsThe search resulted in 4 observational studies with a total of 966 patients. TAVR in dialysis patients was associated with no significant difference in in-hospital mortality [8.1% vs 10.3%; OR (95% CI) 0.74 (0.35, 1.60), I2 = 50%, P = 0.45], risk-of-strokes at 30 days [2% vs 4.4%; OR (95% CI) 0.49 (0.22, 1.09), I2 = 0%, P = 0.08], vascular complications [12.7% vs 13.2%; OR (95% CI) 0.96 (0.55, 1.67), I2 = 0%, P = 0.89], need of blood transfusion [43.1% vs 66.4%; OR (95% CI) 0.27 (0.05, 1.39), I2 = 89%, P = 0.12], or bleeding risk [5.6% vs 6.8%; OR (95% CI) 0.91 (0.18, 4.64), I2 = 5%, P = 0.91] when compared to SAVR. TAVR was associated with significantly shorter length of stay [8.5 days vs 14.2 days; mean difference (95% CI) ?5.89 (?9.13, ?2.64), I2 = 76%, P < 0.0001] and higher pacemaker implantation [11.4% vs 6.8%; OR (95% CI) 1.74 (1.07, 2.81), I2 = 5%, P = 0.02].ConclusionTAVR outcomes were comparable to SAVR but had a significantly shorter length of stay and a higher pacemaker implantation rate in dialysis patients.  相似文献   

8.
9.

Objectives

The aim of this study was to further evaluate clinical outcomes in patients with and without PCS.

Background

Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear.

Methods

In the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial, 2,032 patients with severe aortic stenosis at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30 days and 2 years were compared using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The primary endpoint of the PARTNER 2 trial was all-cause death and disabling stroke.

Results

Five hundred nine patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting. There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; whereas no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio: 2.66; 95% confidence interval: 1.68 to 4.22), the opposite was true for patients with PCS (adjusted hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.66) (pinteraction <0.0001). A similar interaction was observed for life-threatening or disabling bleeding.

Conclusions

In the PARTNER 2A trial of intermediate-risk patients with severe aortic stenosis undergoing SAVR versus TAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS.  相似文献   

10.

Background

Prior studies have shown that late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR) can detect focal fibrosis in aortic stenosis (AS), suggesting that it might predict higher mortality risk.

Objectives

This study was conducted to evaluate whether LGE-CMR can predict post-operative survival in patients with severe AS undergoing aortic valve replacement (AVR).

Methods

We prospectively evaluated survival (all-cause and cardiovascular disease related) according to LGE-CMR status in 154 consecutive AS patients (96 men; mean age: 74 ± 6 years) without a history of myocardial infarction undergoing surgical AVR and in 40 AS patients undergoing transcatheter aortic valve replacement (TAVR).

Results

LGE was present in 29% of patients undergoing surgical AVR and in 50% undergoing TAVR. During a median follow-up of 2.9 years, 21 patients undergoing surgical AVR and 20 undergoing TAVR died. In surgical AVR, the presence of LGE predicted higher post-operative mortality (odds ratio: 10.9; 95% confidence interval [CI]: 1.2 to 100.0; p = 0.02) and worse all-cause survival (73% vs. 88%; p = 0.02 by log-rank test) and cardiovascular disease related survival (85% vs. 95%; p = 0.03 by log-rank test) on 5-year Kaplan-Meier estimates of survival after surgical AVR. Multivariate Cox analysis identified the presence of LGE (hazard ratio: 2.8; 95% CI: 1.3 to 6.9; p = 0.025) and New York Heart Association functional class III/IV (hazard ratio: 3.2; 95% CI: 1.1 to 8.1; p < 0.01) as the sole independent predictors of all-cause mortality after surgical AVR. The presence of LGE also predicted higher all-cause mortality (p = 0.05) and cardiovascular disease related mortality (p = 0.03) in the subgroup of patients without angiographic coronary artery disease (n = 110) and higher cardiovascular disease related mortality in 25 patients undergoing transfemoral TAVR.

Conclusions

The presence of LGE indicating focal fibrosis or unrecognized infarct by CMR is an independent predictor of mortality in patients with AS undergoing AVR and could provide additional information in the pre-operative evaluation of risk in these patients.  相似文献   

11.
ObjectivesThis study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients.BackgroundEarly results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement.MethodsThe LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration–approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year.ResultsThe LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53).ConclusionsTAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.  相似文献   

12.
BackgroundTranscatheter aortic valve replacement (TAVR) is regarded as the most superior alternative treatment approach for patients with aortic stenosis (AS) who are associated with high surgical risk, whereas the effectiveness of TAVR vs surgical aortic valve replacement (SAVR) in low to intermediate surgical risk patients remained inconclusive. This study aimed to determine the best treatment strategies for AS with low to intermediate surgical risk based on published randomized controlled trials (RCTs).Hypothesis and MethodsRCTs that compared TAVR vs SAVR in AS patients with low to intermediate surgical risk were identified by PubMed, EmBase, and the Cochrane library from inception till April 2019. The pooled relative risks (RRs) with 95% confidence intervals (CIs) were calculated for the data collected using random‐effects models.ResultsSeven RCTs with a total of 6929 AS patients were enrolled. We noted that TAVR significantly increased the risk of transient ischemic attack (TIA) (RR: 1.43; 95%CI: 1.04‐1.96; P = .029), and permanent pacemaker implantation (RR: 3.00; 95%CI: 1.70‐5.30; P < .001). However, TAVR was associated with lower risk of post‐procedural bleeding (RR: 0.57; 95%CI: 0.33‐0.98; P = .042), new‐onset or worsening of atrial fibrillation (RR: 0.32; 95%CI: 0.23‐0.45; P < .001), acute kidney injury (RR: 0.40; 95%CI: 0.25‐0.63; P < .001), and cardiogenic shock (RR: 0.34; 95%CI: 0.19‐0.59; P < .001). The risk of aortic‐valve reintervention at 1‐ (RR: 2.63; 95%CI: 1.34‐5.15; P = .005), and 2 years (RR: 3.19; 95%CI: 1.63‐6.24; P = .001) in low to intermediate surgical risk patients who received TAVR was significantly increased than those who received SAVR.ConclusionsThese findings indicated that low to intermediate surgical risk patients who received TAVR had low risk of complications, whereas the risk of TIA, permanent pacemaker implantation, and aortic‐valve reintervention was increased.  相似文献   

13.
This systematic review and meta‐analysis sought to summarize the available evidence on the use of transcatheter aortic valve replacement (TAVR) in patients with Native Aortic Valve Regurgitation (NAVR) and compare outcomes between first and second generation valves. Owing to the improvements in transcatheter heart valve design and procedural success, TAVR has become increasingly performed in broader aortic valve pathologies. We searched Medline, Embase, Cochrane, and Scopus databases from 2007 to 2018 and performed a systematic review on reports with at least 10 patients with aortic valve regurgitation undergoing TAVR procedure. The main outcome of interest was all‐cause mortality at 30 days. A total of 638 patients across 12 studies were included. Mean age ranged from 68 to 84. Society of Thoracic Surgeons score ranged from 5.4% to 13.1% and Logistic EuroSCORE ranged from 18.2% to 33%. The incidence rate of all‐cause mortality at 30 days was found to be 11% (95% CI 7%‐16%; I2 = 20.86%). All‐cause mortality at 30 days for first generation valves had an incidence rate of 15% (95% CI 10%‐20%; I2 = 10%) compared to 7% (95% CI 3%‐13%; I2 = 37%) in second generation valves with subgroup interaction analysis P = 0.059. Device success incidence rate in second generation valves was 92% (95% CI 83%‐99%; I2 = 67%) vs 68% (95% CI 59%‐77%; I2 = 53%) in first generation valves with P = 0.001. TAVR appears to be a feasible treatment choice for NAVR patients at high risk for surgical valve replacement. Second generation valves show promising results in terms of short‐term outcomes.  相似文献   

14.

Objectives

The authors aimed to determine the procedural learning curve and minimum annual institutional volumes associated with optimum clinical outcomes for transcatheter aortic valve replacement (TAVR).

Background

Transcatheter aortic valve replacement (TAVR) is a complex procedure requiring significant training and experience for successful outcome. Despite increasing use of TAVR across institutions, limited information is available for its learning curve characteristics and minimum annual volumes required to optimize clinical outcomes.

Methods

The study collected data for patients at 16 centers participating in the international TAVR registry since initiation of the respective TAVR program. All cases were chronologically ordered into initial (1 to 75), early (76 to 150), intermediate (151 to 225), high (226 to 300), and very high (>300) experience operators for TAVR learning curve characterization. In addition, participating institutions were stratified by annual TAVR case volume into low-volume (<50), moderate-volume (50 to 100), and high-volume (>100) groups for comparative analysis. Procedural and 30-day clinical outcomes were collected and multivariate regression analysis performed for 30-day mortality and the early safety endpoint.

Results

A total of 3,403 patients comprised the study population. On multivariate analysis, all-cause mortality was significantly higher for initial (odds ratio [OR]: 3.83; 95% confidence interval [CI]: 1.93 to 7.60), early (OR: 2.41; 95% CI: 1.51 to 5.03), and intermediate (OR: 2.53; 95% CI: 1.19 to 5.40) experience groups compared with the very high experience operators. In addition, the early safety endpoint was significantly worse for all experience groups compared with the very high experience operators. Low annual volume (<50) TAVR institutions had significantly higher all-cause 30-day mortality (OR: 2.70; 95% CI: 1.44 to 5.07) and worse early safety endpoint (OR: 1.60; 95% CI: 1.17 to 2.17) compared with the moderate- and high-volume groups. There was no difference in patient outcomes between intermediate and high annual volume groups.

Conclusions

TAVR procedures display important learning curve characteristics with both greater procedural safety and a lower mortality when performed by experienced operators. In addition, TAVR performed at low annual volume (<50 procedures) institutions is associated with decreased procedural safety and higher patient mortality. These findings have important implications for operator training and patient care at centers performing TAVR.  相似文献   

15.
ObjectivesThis study sought to determine the incidence, clinical impact, and changes over time of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR).BackgroundFew data exist on the clinical impact and changes in severity over time of MR in patients with LFLG-AS undergoing TAVR.MethodsA total of 308 TAVR candidates with LFLG-AS were included. Patients were categorized according to MR severity at baseline, and presence of MR improvement at 12-month follow-up. Clinical outcomes were assessed at 1 and 12 months (+ echocardiography), and yearly thereafter.ResultsBaseline mild and moderate-to-severe MR were present in 118 (38.3%) and 115 (37.3%) patients, respectively. MR was of functional and mixed etiology in 77.2% and 22.7% of patients, respectively. A total of 131 patients (42.5%) died after a median follow-up of 2 (1 to 3) years. Baseline moderate-or-greater MR had no impact on mortality (hazard ratio [HR]: 1.34; 95% confidence interval [CI]: 0.72 to 2.48) or heart failure hospitalization (HR: 1.02; 95% CI: 0.49 to 2.10). At 1-year follow-up, MR improved in 44.3% of patients and remained unchanged/worsened in 55.7%. The lack of MR improvement was associated with a higher risk of all-cause and cardiac mortality (HR: 2.02; 95% CI: 1.29 to 3.17; HR: 3.03; 95% CI: 1.27 to 7.23, respectively), rehospitalization for cardiac causes (HR: 1.50; 95% CI: 1.04 to 2.15), and an increased overall-mortality/heart failure rehospitalization (HR: 1.94; 95% CI: 1.25 to 3.02). A higher baseline left ventricular end-diastolic diameter and a higher increase in left ventricular ejection fraction were found to be independent predictors of MR improvement at 1-year follow-up (odds ratio: 0.69; 95% CI: 0.51 to 0.94; and odds ratio: 0.81; 95% CI: 0.67 to 0.96, respectively).ConclusionsMost TAVR candidates with LFLG-AS had some degree of MR, of functional origin in most cases. MR improved in about one-half of patients, with larger left ventricular size and a higher increase in left ventricular ejection fraction post-TAVR determining MR improvement over time. The lack of MR improvement at 1 year was associated with poorer outcomes.  相似文献   

16.

Background and objectives

The secular trend toward dialysis initiation at progressively higher levels of eGFR is not well understood. This study compared temporal trends in eGFR at dialysis initiation within versus outside the Department of Veterans Affairs (VA)—the largest non–fee-for-service health system in the United States.

Design, setting, participants, & measurements

The study used linked data from the US Renal Data System, VA, and Medicare to compare temporal trends in eGFR at dialysis initiation between 2000 and 2009 (n=971,543). Veterans who initiated dialysis within the VA were compared with three groups who initiated dialysis outside the VA: (1) veterans whose dialysis was paid for by the VA, (2) veterans whose dialysis was not paid for by the VA, and (3) nonveterans. Logistic regression was used to estimate average predicted probabilities of dialysis initiation at an eGFR≥10 ml/min per 1.73 m2.

Results

The adjusted probability of starting dialysis at an eGFR≥10 ml/min per 1.73 m2 increased over time for all groups but was lower for veterans who started dialysis within the VA (0.31; 95% confidence interval [95% CI], 0.30 to 0.32) than for those starting outside the VA, including veterans whose dialysis was (0.36; 95% CI, 0.35 to 0.38) and was not (0.40; 95% CI, 0.40 to 0.40) paid for by the VA and nonveterans (0.39; 95% CI, 0.39 to 0.39). Differences in eGFR at initiation within versus outside the VA were most pronounced among older patients (P for interaction <0.001) and those with a higher risk of 1-year mortality (P for interaction <0.001).

Conclusions

Temporal trends in eGFR at dialysis initiation within the VA mirrored those in the wider United States dialysis population, but eGFR at initiation was consistently lowest among those who initiated within the VA. Differences in eGFR at initiation within versus outside the VA were especially pronounced in older patients and those with higher 1-year mortality risk.  相似文献   

17.
Objective : To describe the clinical and procedural outcomes of patients treated with the valve‐in‐valve technique for severe aortic insufficiency (AI) after balloon‐expandable transcatheter aortic valve replacement (TAVR). Background : Severe AI immediately after valve implantation is a notable complication of TAVR. It can be treated with a valve‐in‐valve technique which involves deploying a second valve within the first one to crush the leaflets of the first implant leaving a new functional valve. Methods : We analyzed data on 142 consecutive patients at our institution undergoing TAVR with the Sapien valve between November of 2007 and April of 2011. Etiologies of acute AI, procedural and intermediate term clinical outcomes were reported for those in whom a valve‐in‐valve procedure was necessary. Post‐hoc analysis of these cases with C‐THV imaging (Paieon Medical Ltd.) was performed to elucidate the mechanism for successful AI treatment. Results : A total of 5 of 142 (3.5%) patients were treated with the valve‐in‐valve technique. Etiologies of the aortic valve insufficiency included bioprosthesis malposition (n = 3), valve dysfunction (n = 1), and valve undersizing (n = 1). With placement of the second valve, the first valve dimensions increased to approach the nominal valve size while the second valve size remained less than nominal. Conclusions : The valve‐in‐valve technique is an appropriate bailout measure for patients with acute valvular AI after balloon‐expandable TAVR. © 2012 Wiley Periodicals Inc.  相似文献   

18.

Objectives

This study sought to determine the impact of left ventricular diastolic dysfunction (LVDD) on clinical outcomes in patients undergoing transcatheter aortic valve replacement (TAVR).

Background

Left ventricular (LV) hypertrophy in response to afterload increase promotes the development of LVDD and represents an early stage in the progression to valvular heart failure.

Methods

In a consecutive cohort of 777 aortic stenosis patients undergoing TAVR, LVDD was categorized according to the latest guidelines. The primary endpoint was 1-year all-cause mortality.

Results

There were 545 (70.1%) patients with LVDD. Ninety-eight (18.0%), 198 (36.3%), and 104 (19.1%) patients were classified as LVDD grades I, II, and III, respectively. In 145 (26.6%) patients, LVDD grade could not be determined because of only 1 or 2 discrepant variables. One-year all-cause mortality was higher in patients with LVDD grades I (16.3%; adjusted hazard ratio [HR]adj: 2.32; 95% confidence interval [CI]: 1.15 to 4.66), II (17.9%; HRadj: 2.58; 95% CI: 1.43 to 4.67), and III (27.6%; HRadj: 4.21; 95% CI: 2.25 to 7.86) than in those with normal diastolic function (6.9%). The difference in clinical outcome emerged within 30 days, was driven by cardiovascular death, and maintained in a sensitivity analysis of patients with normal systolic LV function. Furthermore, LVDD grades I (HRadj: 2.36; 95% CI: 1.17 to 4.74), II (HRadj: 2.58; 95% CI: 1.42 to 4.66), and III (HRadj: 4.41; 95% CI: 2.37 to 8.20) were independent predictors of 1-year mortality.

Conclusions

Advancing stages of LVDD are associated with an incremental risk of all-cause mortality after TAVR, driven by cardiovascular death and taking effect as early as 30 days after the intervention.  相似文献   

19.

Objectives

The authors sought to examine outcomes and identify independent predictors of mortality among patients undergoing urgent/emergent transcatheter aortic valve replacement (TAVR).

Background

Data on urgent/emergent TAVR as a rescue therapy for decompensated severe aortic stenosis (AS) are limited.

Methods

The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry linked with Centers for Medicare & Medicaid Services claims was used to identify patients who underwent urgent/emergent versus elective TAVR between November 2011 and June 2016. Outcomes assessed were device success rate, in-hospital major adverse events, and 30-day and 1-year mortality. Independent predictors of mortality after urgent/emergent TAVR were examined.

Results

Of 40,042 patients who underwent TAVR, 3,952 (9.9%) were urgent/emergent (median STS PROM score 11.8 [interquartile range: 7.6 to 17.9]). Device success rate was statistically lower, but not clinically different after urgent/emergent versus elective TAVR (92.6% vs. 93.7%; p = 0.007). Rates of major and/or life-threatening bleeding, major vascular complications, myocardial infarction, stroke, new permanent pacemaker placement, conversion to SAVR, and paravalvular regurgitation were similar between the 2 groups. Compared with elective TAVR, patients undergoing urgent/emergent TAVR had higher rates of acute kidney injury and/or new dialysis (8.2% vs. 4.2%; p < 0.001), 30-day mortality (8.7% vs. 4.3%, adjusted hazard ratio: 1.28, 95% confidence interval: 1.10 to 1.48), and 1-year mortality (29.1% vs. 17.5%, adjusted hazard ratio: 1.20, 95% confidence interval: 1.10 to 1.31). In patients undergoing urgent/emergent TAVR, non-femoral access and cardiopulmonary bypass were associated with increased risk, whereas use of balloon-expandable valve was associated with decreased risk of 30-day and 1-year mortality.

Conclusions

Urgent/emergent TAVR is feasible with acceptable outcomes and may be a reasonable option in a selected group of patients with severe AS.  相似文献   

20.
ObjectivesThis study sought to use a national representative database to assess the incidence, predictors, and outcomes of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve replacement (TAVR) in contemporary practice.BackgroundNationwide data on the use and outcomes of BAV as a bridge to TAVR are limited.MethodsPatients who underwent BAV between January and June in 2015 and 2016 were identified in the National Readmission Database. We assessed rate of subsequent TAVR following BAV, and predictors and timing of subsequent TAVR. We then identified a group of patients who had direct TAVR (without prior BAV) in the original 2015 to 2016 National Readmission Database dataset. We compared in-hospital outcomes following TAVR between patients with prior bridging BAV and those undergoing direct TAVR.ResultsAmong the 3,691 included patients 1,426 (38.6%) had subsequent TAVR. Timing of TAVR was pre-discharge in 7.4%, within 30 days in 35%, between 31 and 90 days in 47%, between 91 and 180 days in 14%, and >180 days in 4%. Negative predictors of subsequent TAVR included prior defibrillator (odds ratio [OR]: 0.56; 95% confidence interval [CI]: 0.36 to 0.85), dementia (OR: 0.60; 95% CI: 0.46 to 0.79), malnutrition (OR: 0.64; 95% CI: 0.45 to 0.90), and malignancy (OR: 0.62; 95% CI: 0.47 to 0.82). In propensity-score matched cohorts of patients who underwent direct TAVR versus those with prior BAV, in-hospital mortality during TAVR admission was similar (3.7% vs. 3.5%; p = 0.91). Major complications, length of stay, and discharge disposition were also comparable. However, cost of the hospitalization was higher in the direct TAVR group.ConclusionsAbout 40% of BAV patients undergo subsequent TAVR mostly within 90 days. In-hospital outcomes of TAVR in these patients were comparable with propensity-score matched patients who underwent TAVR without prior BAV. Further investigations are needed to define the role of BAV in contemporary practice.  相似文献   

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