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1.
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   

2.
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   

3.

Background

Given conflicting findings of previous studies, much remains to be understood regarding a volume-outcomes relationship (VOR) in transcatheter aortic valve replacement (TAVR).

Objectives

The purpose of this study was: 1) to determine if, after the initial learning curve (LC), a VOR for balloon-expandable (BE) TAVR persisted; and 2) to determine if LCs and VORs differed across different device generations.

Methods

Data collected by the TVT registry for BE valve implants from November 2011 through January 2017 were included in this analysis (n = 61,949). Primary outcomes included 30-day all-cause mortality, stroke, and major vascular complications. For each center, all implants were ordered chronologically according to case sequence number (CS#). To determine where the learning curve terminated (LCT), a grid search analysis was applied across a range of CS# from 10 to 300 by increments of 1. After LCT, the VOR was assessed by examining case volume/month by center. This analysis was performed separately for: 1) all BE valve types; 2) Sapien 3 (S3) only; and 3) S3 in BE valve naïve sites.

Results

In experience with all commercially available BE valve types, there was an initial LC that terminates around case #201. After the initial LC, a volume–outcomes relationship was no longer evident. In analysis limited to S3, there was no demonstrable LC or VOR. Likewise, there was no demonstrable LC or VOR with S3 for BE valve naïve sites.

Conclusions

After a case experience of 200 cases, there was LCT; subsequent to initial learning, a VOR was no longer evident. In the S3-only analysis, there was no LC or no demonstrable VOR. With current-generation BE-TAVR, centers should expect to achieve consistently excellent outcomes even during early case experience.  相似文献   

4.

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   

5.

Objectives

The authors sought to assess the distribution and prognostic significance of habitual physical activity (HPA) in older adults undergoing transcatheter aortic valve replacement (TAVR).

Background

Low HPA is associated with mortality and disability in community-dwelling older adults. In the setting of TAVR, it is unclear whether low HPA is a risk factor for downstream morbidity or a byproduct of severe aortic stenosis that improves following its correction.

Methods

Older adults undergoing TAVR in the prospective multicentre FRAILTY-AVR (Frailty in Aortic Valve Replacement) study were interviewed to quantify their HPA in kilocalories/week using a validated questionnaire at baseline and follow-up. The primary endpoint was all-cause mortality at 12 months.

Results

The cohort consisted of 755 patients with a median age of 84.0 years (interquartile range [IQR]: 80.0 to 87.0 years). At baseline, median HPA was 1,116 kcal/week (IQR: 227 to 2,715 kcal/week) with 73% of patients performing <150 min/week of moderate or vigorous HPA. Sedentary patients were more likely to be older, female, frail, cognitively impaired, depressed, and have multimorbidity, although they had similar left ventricular function and aortic stenosis severity. In the logistic regression model adjusting for these covariates, HPA was found to be associated with mortality at 12 months (odds ratio: 0.84/100 kcal; 95% confidence interval: 0.73 to 0.98). HPA was associated with longer length of stay, discharge to health care facilities, and disability. At 12 months, median HPA among survivors was 933 kcal/week (IQR: 0 to 2,334 kcal/week) with pre-existing frailty being independently predictive of worsening HPA following TAVR.

Conclusions

Sedentary patients have a higher risk of mortality and functional decline following TAVR.  相似文献   

6.
Historically, many patients with severe senile calcific aortic valve stenosis (AS) were not offered surgery, largely due to the perception that the risks of operation were prohibitive. Such patients have subsequently been formally designated as ‘high risk’ or ‘inoperable’ with respect to their suitability for surgical aortic valve replacement (SAVR) in the evolving lexicon of heart valve disease. The recent availability of transcatheter aortic valve replacement (TAVR) represents an alternative treatment option, and permits the opportunity to re-examine algorithms for assessing operative risk. As the experience with TAVR grows, expanded use in new patient populations can be anticipated. While TAVR in high risk AS patients has demonstrated benefits, the emerging indication in intermediate AS is less clear and conclusions will necessarily await the availability of results from ongoing clinical trials. This article will discuss current outcomes for SAVR among high- and intermediate-risk patients with AS as a barometer in assessing the results of nascent percutaneous therapies.  相似文献   

7.
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8.

Objectives

The authors sought to determine baseline neurocognition before transcatheter aortic valve replacement (TAVR) and its correlations with pre-TAVR brain imaging.

Background

TAVR studies have not shown a correlation between diffusion-weighted image changes and neurocognition. The authors wanted to determine the extent to which there was already impairment at baseline that correlated with cerebrovascular disease.

Methods

SENTINEL (Cerebral Protection in Transcatheter Aortic Valve Replacement) trial patients had cognitive assessments of attention, processing speed, executive function, and verbal and visual memory. Z-scores were based on normative means and SDs, combined into a primary composite z-score. Brain magnetic resonance images were obtained pre-TAVR on 3-T scanners with a T2 fluid-attenuated inversion recovery (FLAIR) sequence. Scores ≤?1.5 SD below the normative mean (7th percentile) were considered impairment. Paired t tests compared within-subject scores, and chi-square goodness-of-fit compared the percentage of subjects below ?1.5 SD. Correlation and regression analyses assessed the relationship between neurocognitive z-scores and T2 lesion volume.

Results

Among 234 patients tested, the mean composite z-score was ?0.65 SD below the normative mean. Domain scores ranged from ?0.15 SD for attention to ?1.32 SD for executive function. On the basis of the ≥1.5 SD normative reference, there were significantly greater percentages of impaired scores in the composite z-score (13.2%; p = 0.019), executive function (41.9%; p < 0.001), verbal memory (p < 0.001), and visual memory (p < 0.001). The regression model between FLAIR lesion volume and baseline cognition showed statistically significant negative correlations.

Conclusions

There was a significant proportion of aortic stenosis patients with impaired cognition before TAVR, with a relationship between baseline cognitive function and lesion burden likely attributable to longstanding cerebrovascular disease. These findings underscore the importance of pre-interventional testing and magnetic resonance imaging in any research investigating post-surgical cognitive outcomes in patients with cardiovascular disease.  相似文献   

9.
BackgroundRecent analyses of the volume-outcome relationship for percutaneous coronary intervention (PCI) have suggested a less robust association than previously reported. It is unknown if novel factors such as lifetime operator experience influence this relationship.ObjectivesTo assess the relationship between annual volumes and outcomes for PCI and determine whether lifetime operator experience modulates the association.MethodsAnnual PCI volumes for facilities and operators within the Veterans Affairs Healthcare System and their relationship with 30-day mortality following PCI were described. The influence of operator lifetime experience on the volume-outcome relationship was assessed. Hierarchical logistic regression was used to adjust for patient and procedural factors.Results57,608 PCIs performed from 2013 to 2018 by 382 operators and 63 institutions were analyzed. Operator annualized PCI volume averaged 47.6 (standard deviation [SD] 49.1) and site annualized volume averaged 189.2 (SD 105.2). Median operator experience was 9.0 years (interquartile range [IQR] 4.0–15.0). There was no independent relationship between operator annual volume, institutional volume, or operator lifetime experience with 30-day mortality (p > 0.10). However, the interaction between operator volume and lifetime experience was associated with a marginal decrease in mortality (odds ratio [OR] 0.9998, 95% CI 0.9996–0.9999).ConclusionsThere were no significant associations between facility or operator-level procedural volume and 30-day mortality following PCI in a nationally integrated healthcare system. There was a marginal association between the interaction of operator lifetime experience, operator annual volume, and 30-day mortality that is unlikely to be clinically relevant, though does suggest an opportunity to explore novel factors that may influence the volume-outcome relationship.  相似文献   

10.

Objectives

The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus.

Background

TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice.

Methods

The RESPOND (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data.

Results

One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients).

Conclusions

One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302)  相似文献   

11.
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12.

Objectives

This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex–specific characteristics on composite 1-year clinical outcomes.

Background

Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex.

Methods

The WIN-TAVI (Women’s INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods.

Results

A total of 1,019 intermediate to high-risk women, with mean age 82.5 ± 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I 17.8 ± 11.7% and mean Society of Thoracic Surgeons score 8.3 ± 7.4% were enrolled. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. The primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients. Prior coronary revascularization (hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.52; p = 0.006) and EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.027) were independent predictors of the VARC-2 efficacy endpoint. Similarly, EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.013), baseline atrial fibrillation (HR: 1.58; 95% CI: 1.07 to 2.33; p = 0.022), and prior percutaneous coronary intervention (HR: 1.50; 95% CI: 1.03 to 2.19; p = 0.035) were independent predictors of 1-year death or stroke. After adjustment, no significant association was observed between history of pregnancy or any sex-specific factors and 1-year TAVR outcomes.

Conclusions

Intermediate to high-risk women enrolled in this first ever all-women contemporary TAVR registry experienced a 1-year VARC-2 composite efficacy endpoint of 16.5%, with a low incidence of 1-year mortality and stroke. Prior revascularization and EuroSCORE I were independent predictors of the VARC-2 efficacy endpoint, whereas EuroSCORE I, baseline atrial fibrillation, and prior percutaneous coronary intervention were independent predictors of the 1-year death or stroke.  相似文献   

13.

Objectives

The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).

Background

In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation.

Methods

Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups.

Results

Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes.

Conclusions

Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.  相似文献   

14.

Objectives

The goal of this study was to investigate the trends, predictors, and outcomes of delayed discharge (>72 h) after transcatheter aortic valve replacement.

Background

Length of stay post–transcatheter aortic valve replacement may have significant clinical and administrative implications.

Methods

Data from the Transcatheter Valve Therapy Registry were used to identify patients undergoing nonaborted transfemoral transcatheter aortic valve replacement who survived to discharge, and data linked from the Centers for Medicare & Medicaid Services were used to provide 1-year events. Patients were categorized to early discharge (≤72 h) versus delayed discharge (>72 h). The trends, predictors, and adjusted 1-year outcomes were compared in both groups.

Results

From 2011 to 2015, a total of 13,389 patients (55.1%) were discharged within 72 h, whereas 10,896 patients (44.9%) were discharged beyond 72 h. There was a significant decline in rates of delayed discharge across the study period (62% vs. 34%; p < 0.01). This remained unchanged when stratified by Transcatheter Valve Therapy risk scores. Several factors were identified as independent predictors of early and delayed discharge. After adjustment for in-hospital complications, delayed discharge was an independent predictor of 1-year all-cause mortality (hazard ratio: 1.45; 95% confidence interval: 1.30 to 1.60; p < 0.01).

Conclusions

Rates of delayed discharge have declined from 2011 to 2015. Delayed discharge is associated with a significant increase in mortality even after adjusting for in-hospital complications. Further work is necessary to determine if predictors of early discharge could be used to develop length of stay scores that might be instrumental in administrative, financial, or clinical policy development.  相似文献   

15.

Objectives

The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway.

Background

Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines.

Methods

Patients were enrolled from 6 low-volume (<100 TAVR/year), 4 medium-volume, and 3 high-volume (>200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR.

Results

Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15).

Conclusions

Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.  相似文献   

16.

Background

Transcatheter aortic valve replacement (TAVR) is a novel less-invasive therapy for high-risk patients with severe aortic stenosis (AS). Despite the impressive clinical growth of TAVR, there are many challenges as well as future opportunities.

Results

The heart valve team serves as the central vehicle for determining appropriate case selection. Considerations which impact clinical therapy decisions include frailty assessments and defining clinical “futility”. There are many controversial procedural issues; choice of vascular access site, valve sizing, adjunctive imaging, and post-dilatation strategies. Complications associated with TAVR (strokes, vascular and bleeding events, para-valvular regurgitation, and conduction abnormalities) must be improved and will require procedural and/or technology enhancements. TAVR site training mandates a rigorous commitment to established society and sponsor guidelines. In the future, TAVR clinical indications should extend to bioprosthetic valve failure, intermediate risk patients, and other clinical scenarios, based upon well conducted clinical trials. New TAVR systems have been developed which should further optimize clinical outcomes, by reducing device profile, providing retrievable features, and preventing para-valvular regurgitation. Other accessory devices, such as cerebral protection to prevent strokes, are also being developed and evaluated in clinical studies.

Summary

TAVR is a worthwhile addition to the armamentarium of therapies for patients with AS. Current limitations are important to recognize and future opportunities to improve clinical outcomes are being explored.  相似文献   

17.

Objectives

The aim of this study was to analyze the frequency and outcomes of patients who underwent transsubclavian or transaxillary (TAx) transcatheter aortic valve replacement (TAVR) using the balloon-expandable SAPIEN 3 prosthesis compared with traditional alternative access, transapical (TA) and transaortic (TAo).

Background

The transsubclavian and TAx approaches for TAVR are rapidly growing alternatives in the setting of hostile iliofemoral arteries, yet few data exist.

Methods

The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was queried for all patients undergoing TAx TAVR with the SAPIEN 3 prosthesis from June 2015 to February 2018. Secular trends over time were evaluated. Logistic regression analyses used to assess risk-adjusted outcomes. Propensity score matching was used to compare TAx access with TA and TAo access.

Results

In total, 3,628 patients (5.7%) underwent nontransfemoral access with the SAPIEN 3. Overall, TAx TAVR accounted for 1,249 of these patients (34.4%). There has been rapid recent growth in TAx TAVR (from 20.2% in the third quarter of 2015 to 49.0% in the fourth quarter of 2017; p < 0.001 for trend) and a concomitant decrease in TA and TAo access (from 61.9% in the third quarter of 2015 to 35.3% in the fourth quarter of 2017; p < 0.001 for trend). The median number of TAx TAVR cases per hospital during the study period was 2, and 78.2% of centers performed ≤5 TAx TAVR procedures. The device success rate was 97.3%, and the major vascular complication rate was 2.5%. After propensity matching, TAx access had lower 30-day mortality (5.3% vs. 8.4%; p < 0.01), shorter lengths of intensive care unit and hospital stay, but a higher stroke rate (6.3% vs. 3.1%; p < 0.05) compared with TA and TAo access.

Conclusions

TAx access has become the most frequent alternative access route for balloon-expandable TAVR procedures. Outcomes following TAx TAVR appear positive despite the relatively early experience of most centers performing these cases.  相似文献   

18.
Transcatheter aortic valve replacement (TAVR) is a transformative technology for the treatment of aortic stenosis, requiring a multidisciplinary collaboration in the form of a “heart team” that includes interventional cardiologists and cardiac surgeons. As this new technology continues to disperse rapidly, its proper therapeutic role evolves and leads to important questions regarding who should perform the procedure, where it should be performed, and who should pay for it. Herein, we review the most recent guidelines governing the use of TAVR in the United States and Europe. We then summarize the available registry data, which, despite its limitations, presents the clearest picture of TAVR in clinical use. Finally, we discuss the costs and relative cost-effectiveness of TAVR. Taken together, these are the elements from which the larger questions surrounding TAVR must be answered.  相似文献   

19.
BackgroundPre-procedural anemia is associated with increased bleeding and mortality post-percutaneous coronary intervention (PCI). The effect of trans-radial PCI (TR-PCI) in improving outcomes compared to trans-femoral PCI (TF-PCI) in anemic patients is not known.ObjectiveThe aim of this study was to evaluate the association between arterial access site (radial versus femoral) and outcomes in anemic Veterans undergoing PCI.MethodsPatients with baseline anemia, undergoing PCI at Veterans Affairs (VA) facilities between 2009 and 2015, were divided into two groups based on primary radial or femoral access. The association between anemia and access site with in-hospital and one-year adverse outcomes was evaluated using multivariable analysis.Results7330 veterans were included in the analysis, with 1712 (23%) treated via radial access. Baseline anemia was independently associated with in-hospital major bleeding (OR 3.8, 95% CI 2.5–5.6 for moderate anemia, OR 18.6, 95% CI 11.6–29.7 for severe anemia), and in-hospital mortality (OR 3.2, 95% CI 1.8–5.8 for moderate anemia, OR 7.9, 95% CI 3.7–16.8 for severe anemia). Anemia was also associated with increased one-year MACE and mortality. PCI performed via radial access was not associated with different outcomes compared with femoral access in the presence of anemia. Comparable results were noted when analysis was restricted to only patients with acute coronary syndrome (ACS).ConclusionsModerate and severe anemia were strongly associated with increased in-hospital and one-year mortality in a large healthcare system, though there was no interaction between arterial access site for PCI and clinical outcomes among patients with moderate or severe anemia.  相似文献   

20.
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