Abstract Objectives This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). Background ...Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. Methods The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. Results SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). Conclusions Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.
Despite the valuable role of intravascular ultrasound (IVUS) guidance in percutaneous coronary interventions (PCIs), its impact on clinical outcomes remains debatable. The aim of the present study ...was to compare the outcomes of PCIs guided by IVUS versus angiography in the contemporary era on inhospital outcomes in an unrestricted large, nationwide patient population. Data were obtained from the Nationwide Inpatient Sample from 2008 to 2011. Hierarchical mixed-effects logistic regression models were used for categorical dependent variables like inhospital mortality, and hierarchical mixed-effects linear regression models were used for continuous dependent variables like length of hospital stay and cost of hospitalization. A total of 401,571 PCIs were identified, of which 377,096 were angiography guided and 24,475 (weighted n = 119,102) used IVUS. In a multivariate model, significant predictors of higher mortality were increasing age, female gender, higher baseline co-morbidity burden, presence of acute myocardial infarction, shock, weekend and emergent admission, or occurrence of any complication during hospitalization. Significant predictors of reduced mortality were the use of IVUS guidance (odds ratio 0.65, 95% confidence interval 0.52 to 0.83; p <0.001) for PCI and higher hospital volumes (third and fourth quartiles). The use of IVUS was also associated with reduced inhospital mortality in subgroup of patients with acute myocardial infarction and/or shock and those with a higher co-morbidity burden (Charlson's co-morbidity index ≥2). In one of the largest studies on IVUS-guided PCIs in the drug-eluting stent era, we demonstrate that IVUS guidance is associated with reduced inhospital mortality, similar length of hospital stay, and increased cost of care and vascular complications compared with conventional angiography-guided PCIs.
Transcatheter aortic valve implantation (TAVI) is associated with a significant learning curve. There is paucity of data regarding the effect of hospital volume on outcomes after TAVI. This is a ...cross-sectional study based on Healthcare Cost and Utilization Project's Nationwide Inpatient Sample database of 2012. Subjects were identified by International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes, 35.05 (Trans-femoral/Trans-aortic Replacement of Aortic Valve) and 35.06 (Trans-apical Replacement of Aortic Valve). Annual hospital TAVI volumes were calculated using unique identification numbers and then divided into quartiles. Multivariate logistic regression models were created. The primary outcome was inhospital mortality; secondary outcome was a composite of inhospital mortality and periprocedural complications. Length of stay (LOS) and cost of hospitalization were assessed. The study included 1,481 TAVIs (weighted n = 7,405). Overall inhospital mortality rate was 5.1%, postprocedural complication rate was 43.4%, median LOS was 6 days, and median cost of hospitalization was $51,975. Inhospital mortality rates decreased with increasing hospital TAVI volume with a rate of 6.4% for lowest volume hospitals (first quartile), 5.9% (second quartile), 5.2% (third quartile), and 2.8% for the highest volume TAVI hospitals (fourth quartile). Complication rates were significantly higher in hospitals with the lowest volume quartile (48.5%) compared to hospitals in the second (44.2%), third (39.7%), and fourth (41.5%) quartiles (p <0.001). Increasing hospital volume was independently predictive of shorter LOS and lower hospitalization costs. In conclusion, higher annual hospital volumes are significantly predictive of reduced postprocedural mortality, complications, shorter LOS, and lower hospitalization costs after TAVI.
Cerebral embolization during transcatheter aortic valve implantation (TAVI) can lead to a spectrum of clinically relevant manifestations, ranging from overt stroke to mild neurologic or cognitive ...deficits and subclinical cerebral infarcts. This study sought to determine the frequency of neurologic injury, cerebral ischemic lesions, and cognitive dysfunction in subjects undergoing contemporary commercial TAVI in the United States. Neuro-TAVR is the first prospective, multicenter study to use serial systematic neurologic and cognitive assessments and diffusion-weighted magnetic resonance imaging (at 4 ± 2 days after procedure) to investigate the incidence and severity of neurologic injury after contemporary unprotected TAVI in the United States. A total of 44 consecutive patients underwent TAVI at 5 US sites. Diffusion-weighted magnetic resonance imaging lesions were detected in 94%, with a mean of 10.4 ± 15.3 lesions per subject and a median total lesion volume of 295 mm3 (interquartile range 71.6 to 799.6 mm3 ). New neurologic impairment (worsening in National Institutes of Health Stroke Scale score from baseline with new cerebral lesions) occurred in 22.6% (7 of 31) of subjects at discharge and 14.8% (4 of 27) at 30 days. In addition, cognitive decrements from baseline were identified by the Montreal Cognitive Assessment in 33% (12 of 36) of subjects at discharge and 41% (13 of 32) at 30 days. In conclusion, this contemporary cohort of US patients confirms that TAVI results in cerebral infarction in most patients and that 1 in 5 patients have measurable neurologic impairment and 1 in 3 patients have decrease in cognitive measures by Montreal Cognitive Assessment score after TAVI, reinforcing the need for methods to mitigate the risk of brain injury during TAVI.
In recent years, there has been an increased emphasis on the diagnosis and treatment of valvular heart disease and, in particular, aortic stenosis. This has been driven in part by the development of ...innovative therapeutic options and by an aging patient population. We hypothesized an increase in the number of hospitalizations and the economic burden associated with aortic valve disease (AVD). Using Nationwide Inpatient Sample from 2000 to 2012, AVD-related hospitalizations were identified using International Classification of Diseases, Ninth Revision, Clinical Modification , code 424.1, as the principal discharge diagnosis. Overall AVD hospitalizations increased by 59% from 2000 to 2012. This increase was most significant in patients >80 years and those with higher burden of co-morbidities. The most frequent coexisting conditions were hypertension, heart failure, renal failure, anemia, and diabetes. Overall inhospital mortality of patients hospitalized for AVD was 3.8%, which significantly decreased from 4.5% in 2000 to 3.5% in 2012 (p <0.001). The largest decrease in mortality was seen in the subgroup of patients who had heart failure (62% reduction), higher burden of co-morbidities (58% reduction), and who were >80 years (53% reduction). There was a substantial increase in the cost of hospitalization in the last decade from $31,909 to $38,172 (p <0.001). The total annual cost for AVD hospitalization in the United States increased from $1.3 billion in 2001 to $2.1 billion in 2011 and is expected to increase to nearly 3 billion by 2020. The last decade has witnessed a significant increase in hospitalizations for AVD in the United States. The associated decrease in inhospital mortality and increase in the cost of hospitalization have considerably increased the economic burden on the public health system.
High-risk surgical patients undergoing transcatheter aortic valve implantation (TAVI) represent an emerging population, which may benefit from short-term use of mechanical circulatory support (MCS) ...devices. The aim of this study was to determine the practice and inhospital outcomes of MCS utilization in patients undergoing TAVI. We analyzed data from Nationwide Inpatient Sample (2011 and 2012) using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes . A total of 1,794 TAVI procedures (375 hospitals in the United States) were identified of which 190 (10.6%) used an MCS device (MCS group) and 1,604 (89.4%) did not (non-MCS group). The use of MCS devices with TAVI was associated with significant increase in the inhospital mortality (14.9% vs 3.5%, p <0.01). The mean length (11.8 ± 0.8 vs 8.1 ± 0.2 days, p <0.01) and cost ($68,997 ± 3,656 vs $55,878 ± 653, p = 0.03) of hospitalization were also significantly greater in the MCS group. Ventricular fibrillation arrest, transapical access for TAVI, and cardiogenic shock were the most significant predictors of MCS use during TAVI. In the multivariate model, use of any MCS device was found to be an independent predictor of increased mortality (odds ratio 3.5, 95% confidence interval 2.6 to 4.6, p <0.0001) and complications (odds ratio 3.3, 95% confidence interval 2.8 to 3.9, p <0.0001). The propensity score–matched analysis also showed a similar result. In conclusion, the unacceptably high rates of mortality and complications coupled with a significant increase in the length and cost of hospitalization should raise concerns about utility of MCS devices during TAVI in this prohibitive surgical risk population.
Abstract The objective of this study was to compare outcomes in women following surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) utilizing a ...self-expanding prosthesis in patients with severe aortic stenosis who were at high risk for surgical AVR. Although registries and meta-analyses have suggested that TAVR is of considerable benefit in women, perhaps even more so than in men, a rigorous evaluation of TAVR with a self-expanding valve versus SAVR in women from a randomized trial has not been performed. Patients with severe aortic stenosis were randomized 1:1 to either TAVR or SAVR. Outcomes at 1 year are reported. Treatment was attempted in a total of 353 women (183 TAVR and 170 SAVR). Baseline characteristics and predicted risk of the 2 groups were comparable, although the frequency of diabetes mellitus was lower in TAVR patients (33.3% versus 45.3%; P = 0.02). TAVR-treated patients experienced a statistically significant 1-year survival advantage compared to SAVR patients (12.7% versus 21.8%; P = 0.03). The composite all-cause mortality or major stroke rate also favored TAVR (14.9% vs. 24.2%; P = 0.04). Quality of life (QoL), as measured by the Kansas City Cardiomyopathy Questionnaire summary score, for both the TAVR and SAVR groups increased significantly from baseline to 1 year. In conclusion, female TAVR patients had lower 1-year mortality and lower 1-year all-cause mortality or major stroke compared to females undergoing SAVR, with both cohorts experiencing improved QoL. Further studies specifically in women are warranted to validate these findings.
We hypothesized that the availability of a transcatheter aortic valve implantation (TAVI) program in hospitals impacts the overall management of patients with aortic valve disease and hence may also ...improve postprocedural outcomes of conventional surgical aortic valve replacement (SAVR). The aim of the present study was to compare the inhospital outcomes of SAVR in centers with versus without availability of a TAVI program in an unrestricted large nationwide patient population >50 years of age. SAVRs performed on patients aged >50 years were identified from the Nationwide Inpatient Sample (NIS) for the years 2011 and 2012 using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes. SAVR cases were divided into 2 categories: those performed at hospitals with a TAVI program (SAVR-TAVI) and those without (SAVR-non-TAVI). A total of 9,674 SAVR procedures were identified: 4,526 (46.79%) in the SAVR-TAVI group and 5,148 (53.21%) in SAVR-non-TAVI group. The mean age of the study population was 70.2 ± 0.1 years with majority (53%) of the patients aged >70 years. The mean Charlson's co-morbidity score for patients in SAVR-TAVI group was greater (greater percentage of patients were aged >80 years, had hypertension, congestive heart failure, renal failure, and peripheral arterial disease) than that of patients in SAVR-non-TAVI group (1.6 vs 1.4, p <0.001). The propensity score matching analysis showed a statistically significant lower inhospital mortality (1.25% vs 1.72%, p = 0.001) and complications rate (35.6% vs 37.3%, p = 0.004) in SAVR-TAVI group compared to SAVR-non-TAVI group. The mean length of hospital stay was similar in the 2 groups the cost of hospitalization was higher in the SAVR-TAVI group ($43,894 ± 483 vs $41,032 ± 473, p <0.0001). Having a TAVI program was a significant predictor of reduced mortality and complications rate after SAVR in multivariate analysis. In conclusion, this largest direct comparative analysis demonstrates that SAVRs performed in centers with a TAVI program are associated with significantly lower mortality and complications rates compared to those performed in centers without a TAVI program.
Use of transcatheter endovascular stenting has been increasing in the treatment of coarctation of aorta (CoA). The present study was undertaken on adults with CoA who underwent stent placement from ...2000 to 2011 to analyze the relation of hospital volumes to the outcomes of stenting in adults with CoA. It was a retrospective study based on Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) database from 2000 to 2011 and identified subjects using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure code of 747.10 (CoA). Annual hospital volume was calculated using unique hospital identifiers. Weights provided by the Nationwide Inpatient Sample were used to generate national estimates. A total of 105 (weighted 521) subjects were identified with International Classification of Diseases, Ninth Revision , code of 39.90 (Endovascular stent). Hospital volumes were divided into tertiles. We compared the highest tertile (≥3 procedures annually) with other tertiles (<3 procedure annually). The composite outcomes of the analysis were procedure-related complications, length of stay (LOS), and cost in relation to the hospital volume. No inhospital death was reported in either group. Hospitals with ≥3 procedures annually had significantly lower incidence of complications (9.5% vs 23.0%) compared to the hospitals with <3 procedures annually (p-value 0.002). Similar results were obtained after multivariate regression analysis in relation to hospital volume. Shorter LOS and lower cost were observed with annual hospital volume of ≥3 procedures. In conclusion, stenting adults for CoA is remarkably safe, and the outcomes of the procedure have improved in centers with annual hospital volume of ≥3 procedures. There is also decreasing trend of procedure-related complications, shorter LOS, and lower costs compared to centers with annual volume <3 procedures.
The use of percutaneous aortic balloon balvotomy (PABV) in high surgical risk patients has resurged because of development of less invasive endovascular therapies. We compared outcomes of concomitant ...PABV and percutaneous coronary intervention (PCI) with PABV alone during same hospitalization using nation's largest hospitalization database. We identified patients and determined time trends using the International Classification of Diseases, Ninth Revision, Clinical Modification, procedure code for valvulotomy from Nationwide Inpatient Sample database 1998 to 2010. Only patients >60 years with aortic stenosis were included. Primary outcome included in-hospital mortality, and secondary outcomes included procedural complications, length of stay (LOS), and cost of hospitalization. Total 2,127 PABV procedures were identified, with 247 in PABV + PCI group and 1,880 in the PABV group. Utilization rate of concomitant PABV + PCI during same hospitalization increased by 225% from 5.1% in 1998 to 1999 to 16.6% in 2009 to 2010 (p <0.001). Overall in-hospital mortality rate and complication rates in PABV + PCI group were similar to that of PABV group (10.3% vs 10.5% and 23.4% vs 24.7%, respectively). PABV + PCI group had similar LOS but higher hospitalization cost (median interquartile range $30,089 $21,925 to $48,267 versus $18,421 $11,482 to $32,215, p <0.001) in comparison with the PABV group. Unstable condition, occurrence of any complication, and weekend admission were the main predictors of increased LOS and cost of hospital admission. Concomitant PCI and PABV during the same hospitalization are not associated with change in in-hospital mortality, complications rate, or LOS compared with PABV alone; however, it increases the cost of hospitalization.
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