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1.

Objectives

The authors sought to collect data on contemporary practice and outcome of transcatheter aortic valve replacement (TAVR) in oncology patients with severe aortic stenosis (AS).

Background

Oncology patients with severe AS are often denied valve replacement. TAVR may be an emerging treatment option.

Methods

A worldwide registry was designed to collect data on patients who undergo TAVR while having active malignancy. Data from 222 cancer patients from 18 TAVR centers were compared versus 2,522 “no-cancer” patients from 5 participating centers. Propensity-score matching was performed to further adjust for bias.

Results

Cancer patients’ age was 78.8 ± 7.5 years, STS score 4.9 ± 3.4%, 62% men. Most frequent cancers were gastrointestinal (22%), prostate (16%), breast (15%), hematologic (15%), and lung (11%). At the time of TAVR, 40% had stage 4 cancer. Periprocedural complications were comparable between the groups. Although 30-day mortality was similar, 1-year mortality was higher in cancer patients (15% vs. 9%; p < 0.001); one-half of the deaths were due to neoplasm. Among patients who survived 1 year after the TAVR, one-third were in remission/cured from cancer. Progressive malignancy (stage III to IV) was a strong mortality predictor (hazard ratio: 2.37; 95% confidence interval: 1.74 to 3.23; p < 0.001), whereas stage I to II cancer was not associated with higher mortality compared with no-cancer patients.

Conclusions

TAVR in cancer patients is associated with similar short-term but worse long-term prognosis compared with patients without cancer. Among this cohort, mortality is largely driven by cancer, and progressive malignancy is a strong mortality predictor. Importantly, 85% of the patients were alive at 1 year, one-third were in remission/cured from cancer. (Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis [TOP-AS]; NCT03181997)  相似文献   

2.

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   

3.

Objectives

This study sought to assess the clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) with early discharge (ED) versus standard discharge (SD) pathways.

Background

Minimalist approaches for TAVR have been developed targeting different aspects of the procedure such as local anesthesia or sedation, intraprocedural imaging, vascular access, post-operative monitoring and care, and discharge planning. Their incorporation into routine clinical practice aims to reduce length of hospital stay and health care cost utilization without adversely affecting outcomes when compared with standard approaches.

Methods

The authors conducted a search of MEDLINE and EMBASE to identify studies that investigated ED (≤3 days) versus SD in TAVR patients. Random-effects meta-analyses were used to estimate the effect of ED compared with SD with regard to 30-day mortality after discharge, 30-day readmission rate, and need for permanent pacemaker implantation (PPI) following discharge.

Results

Eight studies including 1,775 participants (ED, n = 642) fulfilled the inclusion criteria. The mean age was 82.4 years and STS score was 6.7. Meta-analyses evaluating discharge to 30-day mortality (odds ratio [OR]: 0.65; 95% confidence interval [CI]: 0.23 to 1.82; I2 = 0%) and discharge to 30-day new PPI (OR: 1.61; 95% CI: 0.19 to 13.71; I2 = 40%) showed no significant difference in an ED compared with a SD strategy. Notably, ED patients were less likely to be readmitted after ED when compared with SD patients (OR: 0.63; 95% CI: 0.41 to 0.98; p = 0.04, I2 = 0%).

Conclusions

ED following uncomplicated TAVR is safe in terms of discharge to 30-day mortality or need for PPI following discharge. Moreover, ED patients experienced a lower rate of readmissions. These data support the safety of programs aiming an ED pathway in selected TAVR patients. Institutional protocols with the input from different members of the multidisciplinary heart team should be devised to optimize discharge processes to improve health care resource utilization.  相似文献   

4.

Objectives

This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice.

Background

The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking.

Methods

This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms.

Results

The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%.

Conclusions

The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)  相似文献   

5.

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   

6.
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   

7.

Objectives

The aim of this study was to assess mortality and rehospitalization in patients with new bundle branch block (BBB) and/or permanent pacemaker (PPM) after transcatheter aortic valve replacement (TAVR).

Background

Previous studies have provided inconsistent results on the clinical impact of new BBB or new PPM after TAVR.

Methods

A total of 816 consecutive patients without pre-procedural BBB or PPM undergoing TAVR between 2007 and 2017 were followed for 5 years or until data extraction in September 2017. Data on vital status and hospitalization were obtained through national registries.

Results

Within 30 days post-TAVR, new BBB without PPM and new PPM occurred in 247 (30.3%) and 132 (16.2%) patients, respectively, leaving 437 patients (53.6%) without conduction abnormalities. Median follow-up was 2.5 years (interquartile range: 1.0 to 4.9 years). One-year all-cause mortality was increased for new BBB (hazard ratio [HR]: 2.80; 95% confidence interval [CI]: 1.18 to 3.67) but not for new PPM (HR: 1.64; 95% CI: 0.72 to 3.74) compared with patients with no conduction abnormalities. The risk for late all-cause mortality (≥1 year after TAVR) was higher both for patients with new BBB (HR: 1.79; 95% CI: 1.24 to 2.59) and for those with new PPM (HR: 1.58; 95% CI: 1.01 to 2.46) compared with patients with no conduction abnormalities. Patients with new BBB (HR: 1.47; 95% CI: 1.02 to 2.12) and new PPM (HR: 1.66; 95% CI: 1.09 to 2.54) had a higher risk for heart failure hospitalization and reduced left ventricular ejection fraction (p < 0.0001 for both groups) during follow-up.

Conclusions

New BBB and new PPM developed frequently after TAVR. New BBB was associated with increased early and late all-cause mortality, whereas new PPM was associated with late all-cause mortality. Furthermore, both new BBB and new PPM increased the risk for heart failure hospitalizations.  相似文献   

8.

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   

9.
ObjectivesThis study evaluated the feasibility and safety of same-day discharge (SDD) following transfemoral transcatheter aortic valve replacement (TF-TAVR) compared with next-day discharge (NDD).BackgroundReducing hospital length of stay is an important goal for patients and hospitals. Cleveland Clinic implemented a post-TAVR SDD pathway beginning in March 2020.MethodsThe study retrospectively analyzed patients who underwent “minimalist” outpatient TF-TAVR in 2019 to 2020. SDD was applied to patients who met the predefined criteria. Outcomes included in-hospital and 30-day events and were compared between SDD and NDD (during and prior to availability of the SDD pathway).ResultsIn 2020, SDD and NDD accounted for 22.1% (n = 114 of 516) and 63.8% (n = 329 of 516) of outpatient TF-TAVR, respectively. SDD patients in 2020, compared with NDD patients in 2019 (n = 481), were younger, were more often male, and had a lower surgical risk. There were no significant differences in in-hospital events and 30-day readmissions (cardiovascular readmission: 3.5% vs 6.2%; P = 0.37; noncardiovascular readmission: 2.6% vs 4.0%; P = 0.78), and there were no deaths after SDD. These outcomes remained consistent after propensity score matching. Only 1 (0.9%) patient required pacemaker implantation after SDD (post-TAVR day 25). As expected based on SDD criteria, multivariable logistic regression analysis identified procedure end-time as the strongest predictor of SDD (adjusted OR: 7.74; 95% CI: 4.39-13.63), while male sex and baseline hemoglobin level were also associated with SDD.ConclusionsSDD after TF-TAVR was feasible in this early experience without impairing post-discharge safety. Our SDD pathway may serve as a useful strategy to improve bed utilization and reduce hospital stay for TAVR recipients.  相似文献   

10.

Objectives

This study sought to investigate predictors and safety of next-day discharge (NDD) after transcatheter aortic valve replacement (TAVR).

Background

Information about predictors and safety of NDD after TAVR is limited.

Methods

The study reviewed 663 consecutive patients who underwent elective balloon-expandable TAVR (from July 2014 to July 2016) at our institution. We first determined predictors of NDD in patients who underwent minimalist transfemoral TAVR. After excluding cases with complications, we compared 30-day and 1-year outcomes between NDD patients and those with longer hospital stay using Cox regression adjusting for the Predicted Risk of Mortality provided by the Society of Thoracic Surgeons. The primary endpoint was the composite of mortality and readmission at 1 year.

Results

A total of 150 patients had NDD after TAVR and 210 patients had non-NDD. Mean age and the Society of Thoracic Surgeons Predicted Risk of Mortality were 80.7 ± 8.8 years and 6.6 ± 3.7%, respectively. Predictors of NDD were male sex (odds ratio [OR]: 2.02; 95% confidence interval [CI]: 1.28 to 3.18), absence of atrial fibrillation (OR: 1.62; 95% CI: 1.02 to 2.57), serum creatinine (OR: 0.71; 95% CI: 0.55 to 0.92), and age (OR: 0.95; 95% CI: 0.93 to 0.98). As expected, 84% of patients with complications had non-NDD. After excluding cases with complications, there was no difference in hazard rates of the 30-day composite outcome between NDD and non-NDD (hazard ratio: 0.62; 95% CI: 0.20 to 1.91), but the hazard of the composite outcome at 1 year was significantly lower in the NDD group (hazard ratio: 0.47; 95% CI: 0.27 to 0.81). This difference in the composite outcome can be explained by the lower hazard of noncardiovascular related readmission in the NDD group.

Conclusions

Factors predicting NDD include male sex, absence of atrial fibrillation, lower serum creatinine, and younger age. When compared with patients without complications with a longer hospital stay, NDD appears to be safe, achieving similar 30-day and superior 1-year clinical outcomes.  相似文献   

11.
ObjectivesThe aim of this study was to determine the safety and efficacy of same-day discharge (SDD) after transcatheter aortic valve replacement (TAVR) during the COVID-19 pandemic.BackgroundThe COVID-19 pandemic has placed significant stress on health care systems worldwide. SDD in highly selected TAVR patients can facilitate the provision of essential cardiovascular care while managing competing COVID-19 resource demands.MethodsPatient selection for SDD was at the discretion of the local multidisciplinary heart team, across 7 international sites. The primary outcome was a composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new permanent pacemaker (PPM) implantation.ResultsFrom March 2020 to August 2021, 124 of 2,100 patients who underwent elective transfemoral TAVR were selected for SDD. The average age was 78.9 ± 7.8 years, the median Society of Thoracic Surgeons score was 2.4 (IQR: 1.4-4.2), and 32.3% (n = 40) had preexisting PPMs. There were no major vascular complications, strokes, or deaths during the index admission. One patient (0.8%) required PPM implantation for complete heart block and was discharged the same day. No patient required a PPM between discharge home and 30-day follow-up. The composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new PPM at 30 days occurred in 5.7% patients (n = 6 of 106).ConclusionsSDD post-TAVR is safe and feasible in selected patients at low risk for adverse clinical events postdischarge. This strategy may have a potential role in highly selected patients even when the COVID-19 pandemic abates.  相似文献   

12.
Transcatheter aortic valve replacement (TAVR) is approved for all patient risk profiles and is an option for all patients irrespective of age. However, patients enrolled in the low- and intermediate-risk trials were in their 70s, and those in the high-risk trials were in their 80s. TAVR has never been systematically tested in young (<65 years), low-risk patients. Unanswered questions remain, including the safety and effectiveness of TAVR in patients with bicuspid aortic valves; future coronary access; durability of transcatheter heart valves; technical considerations for surgical transcatheter heart valve explantation; management of concomitant conditions such as aortopathy, mitral valve disease, and coronary artery disease; and the safety and feasibility of future TAVR-in-TAVR. The authors predict that balancing these questions with patients’ clear preference for less invasive treatment will become common. In this paper, the authors consider each of these questions and discuss risks and benefits of theoretical treatment strategies in the lifetime management of young patients with severe aortic stenosis.  相似文献   

13.
ObjectivesThis study sought to better understand out-of-hospital 30-day mortality following transfemoral transcatheter aortic valve replacement (TAVR) and identify factors associated with poor outcomes.BackgroundDespite improvements in outcomes with TAVR for severe aortic stenosis, out-of-hospital 30-day mortality has not been evaluated.MethodsThis study examined patients in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry undergoing TAVR for severe aortic stenosis from January 2015 to March 2018. Primary and secondary endpoints were 30-day out-of-hospital all-cause mortality and out-of-hospital cardiovascular mortality, respectively. Logistic regression models were used to assess association between pre-specified factors and endpoints.ResultsA total of 106,749 patients underwent TAVR and were eligible for analysis. Transfemoral TAVR was performed in 92.3% of patients. A total of 2,137 (2.2%) transfemoral patients died within 30 days of the procedure, and 623 (29%) patients of these patients experienced out-of-hospital 30-day mortality. Cardiovascular and pulmonary etiologies accounted for the majority of observed mortality. Multivariable regression analysis identified older age, gender, lower body surface area, lower left ventricular ejection fraction, lower hemoglobin, atrial fibrillation or flutter, severe lung disease, home oxygen use, lack of moderate-to-severe aortic insufficiency, urgent TAVR, lower Kansas City Cardiomyopathy Questionnaire score, longer hospital length of stay, and in-hospital complications as being independently associated with the primary endpoint. New onset or pre-existent atrial fibrillation or flutter was also independently associated with 30-day out-of-hospital cardiovascular mortality in the transfemoral population.ConclusionsWe identified 30-day all-cause mortality rate for TAVR of 2.2%. Approximately one-third of patients experienced out-of-hospital mortality at 30 days. Several factors were identified as being independently associated with 30-day out-of-hospital all-cause and cardiovascular mortality. Further work is needed to understand how best to improve out-of-hospital mortality following TAVR.  相似文献   

14.
ObjectivesThe aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing.BackgroundConduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI.MethodsThe primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed.ResultsA total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004).ConclusionsOptimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870)  相似文献   

15.
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