scholarly journals Outcomes of transcatheter vs. isolated surgical aortic valve replacement in mediastinal radiation-associated severe aortic stenosis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Nauffal ◽  
C Bay ◽  
P Shah ◽  
P Sobieszczyk ◽  
T Kaneko ◽  
...  

Abstract Introduction Mediastinal radiation can lead to long-term cardiac sequelae, including aortic valve disease. Surgical aortic valve replacement (SAVR) is associated with poor outcomes in this population. Transcatheter aortic valve replacement (TAVR) now provides an alternative treatment strategy that may improve outcomes. Purpose To compare 30-day outcomes after TAVR vs. isolated SAVR for radiation-associated severe symptomatic aortic stenosis using the Society of Thoracic Surgery (STS) National Adult Cardiac Surgery Database. Methods We evaluated 1,668 TAVR and 2,611 isolated SAVR patients enrolled in the STS national database from July 2011 through December 2018. A propensity score for TAVR vs. SAVR was derived using a non-parsimonious logistic regression model that included 29 pre-operative variables and was used to generate a 1:1 matched cohort (NTotal=1,560). 30-day outcomes in TAVR vs. SAVR patients were compared in the matched cohort using conditional logistic regression. We also tested for temporal trends in 30-day mortality separately for TAVR and SAVR in the matched cohort, adjusted for potential confounders, to see if outcomes varied across the study period. Results In the propensity-matched cohort, baseline demographics, comorbidities and preoperative characteristics were balanced between the TAVR and SAVR groups. The mean age was 73.3 years and 75% were females in each group. In the propensity-matched cohort, TAVR was associated with significantly reduced 30-day all-cause [OR=0.50 (0.30–0.84), p=0.01] and cardiovascular mortality as compared to SAVR [OR=0.33 (0.14–0.78), p=0.01]. Similarly, post-operative complications occurred less in the TAVR group except for stroke/transient ischemic attack (TIA) [OR=3.17 (1.27–7.93), p=0.01] and pacemaker implantation [OR=1.71 (1.21–2.44), p=0.003] which were significantly higher with TAVR (Figure 1A). While, 30-day mortality associated with both procedures improved over the course of the study, the trend was only statistically significant in the TAVR group following adjustment for potential confounders. TAVR was consistently associated with better survival than SAVR in the matched cohort across the study period (Figure 1B). Conclusion Our findings suggest that TAVR is a safe alternative to SAVR for radiation-associated severe symptomatic aortic stenosis and is associated with lower 30-day mortality and post-operative complications. The risk of stroke/TIA and pacemaker implantation is higher with TAVR and should be considered when choosing therapy. Additional prospective studies to validate our findings and evaluate long-term outcomes are needed to further guide clinical decision making in this population. Figure 1 Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Funding to support acquisition of the data from the Society of Thoracic Surgery was obtained from discretionary funds available to Dr. Anju Nohria from the Cardiovascular Medicine Division.

Author(s):  
Victor Nauffal ◽  
Camden Bay ◽  
Pinak B. Shah ◽  
Piotr S. Sobieszczyk ◽  
Tsuyoshi Kaneko ◽  
...  

Background: Surgical aortic valve replacement (SAVR) is associated with adverse outcomes in patients with radiation-associated aortic stenosis. Transcatheter aortic valve replacement (TAVR) may improve outcomes in this population. Methods: We evaluated 1668 TAVR and 2611 patients with SAVR enrolled in the Society of Thoracic Surgeons’ database between 2011 and 2018. Multiple logistic regression was used to compare 30- day outcomes between TAVR and SAVR. Propensity-matched analysis was performed to confirm results of the overall cohort. Additionally, the cohort was stratified into early (2011–2014) versus contemporary (2015–2018) TAVR eras, and 30-day outcomes for TAVR and SAVR were compared. Finally, outcomes with transfemoral TAVR versus SAVR were compared. Results: In the overall cohort, TAVR was associated with significantly reduced 30-day mortality (odds ratio [OR] TAVR/SAVR =0.60 [0.40–0.91]). Postoperative atrial fibrillation, pneumonia, pleural effusion, renal failure, and bleeding also occurred less frequently with TAVR. Stroke/transient ischemic attack (TIA; OR TAVR/SAVR , 2.03 [1.09–3.77]) and pacemaker implantation (OR TAVR/SAVR , 1.62 [1.21–2.17]) were higher with TAVR. Propensity-matched analysis yielded similar results as the overall cohort. Following stratification by era, TAVR versus SAVR was associated with reduced 30-day mortality in the contemporary but not early era (OR Early , 0.78 [0.48–1.28]; OR Contemporary , 0.31 [0.14–0.65]). Pacemaker implantation was higher with TAVR versus SAVR in both eras (OR Early , 1.60 [1.03–2.46]; OR Contemporary , 1.64 [1.10–2.45]). There was also a nonsignificant trend towards increased stroke/TIA with TAVR during both eras (OR Early , 1.39 [0.58–3.36]; OR Contemporary , 2.46 [0.99–6.10]). Finally, transfemoral TAVR (N=1369) versus SAVR revealed similar findings as the overall cohort; however, the association of TAVR with stroke/TIA was not statistically significant (OR Stroke/TIA , 1.57 [0.79–3.09]). Conclusions: TAVR provides an effective and evolving alternative to SAVR for radiation-associated severe aortic stenosis and was associated with lower 30-day mortality and postoperative complications. TAVR was associated with increased pacemaker implantation and a trend towards increased stroke/TIA. In this unique population with extensive valvular and vascular calcifications, the risk of stroke/TIA with TAVR requires careful consideration and further investigation.


2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Richard Tangel ◽  
Ankur Sethi ◽  
John Kassotis

Background: It is well known that there is a significant gender gap in both the referral and outcomes of patients eligible for cardiac surgery. The impact of transcatheter aortic valve replacement (TAVR) on the gender disparity in the management of aortic stenosis (AS) has not been well established. The aim of this study was to analyze the referrals to and outcomes of both surgical aortic valve replacement (SAVR) and TAVR for management of AS as a function of gender in a contemporary United States population. Methods: We used the National Inpatient database 2009-2015 to study the gender distribution of admissions for both SAVR and TAVR for the treatment of AS and its effect on inpatient outcomes. The survey estimation commands were used to determine weighted national estimates. Results: During the study period there were 3,443,274 (Males (M) 46.6 ± 0.1%; Females (F) 53.3 ± 0.1%) admissions for AS diagnosis, 325,264 SAVR (M 62.0 ± 0.2%; F 37.9 ± 0.2%) and 56,542 TAVR (M 52.6 ± 0.5%; F 47.3 ± 0.5%). The gender disparity was more prominent in Whites (Wh) than Non-whites (NWh) for both SAVR (Wh M 62.7 ± 0.2%, Wh F 37.2 ± 0.2%; NWh M 57.3 ± 0.5%, NWF 42.6 ± 0.5%) and TAVR (Wh M 53.1 ± 0.5%, Wh F 46.8 ± 0.5%; NWh M 47.2 ± 1.3%, NWh F 52.7 ± 1.3%). Female TAVR patients were older and more likely to have Medicare but less likely to have diabetes, chronic kidney disease (CKD), peripheral artery disease (PAD), prior coronary bypass surgery (CABG) and percutaneous coronary intervention (PCI), and chronic obstructive pulmonary disease (COPD). They also had lower Charlson comorbidity index (CCI). However, female TAVR patients had higher inpatient deaths (OR = 1.34;1.09-1.64), bleeding (OR = 1.51; 1.40-1.62) and stroke (OR = 1.47; 1.16-1.88), but a lower rate of pacemaker implantation (0.86; 0.76-0.97) and acute renal failure (ARF) (OR = 0.78; 0.71- 0.87). SAVR females were older, more likely to have Medicare, hypertension, and heart failure but less likely to have diabetes, CKD, PAD, prior CABG and PCI, and COPD. They also had lower CCI. SAVR female patients had higher inpatient deaths (OR = 1.40; 1.29-1.53), pacemaker implantation (OR =1.19; 1.11-1.28), blood transfusion (OR = 1.40; 1.35-1.45), and stroke (OR =1.19; 1.08-1.30), but lower ARF (OR = 0.80; 0.76-0.83). Conclusion: A gender disparity in the management of aortic stenosis continues to exist; however, our study showed that TAVR appears to bridge this gap. The reduction in gender disparity was most pronounced among Non-white patients. Despite having less comorbidities, outcomes after both SAVR and TAVR remain worse in women.


2020 ◽  
Vol 31 (3) ◽  
pp. 398-404
Author(s):  
Samuli J Salmi ◽  
Tuomo Nieminen ◽  
Juha Hartikainen ◽  
Fausto Biancari ◽  
Joonas Lehto ◽  
...  

Abstract OBJECTIVES We sought to study the indications, long-term occurrence, and predictors of permanent pacemaker implantation (PPI) after isolated surgical aortic valve replacement with bioprostheses. METHODS The CAREAVR study included 704 patients (385 females, 54.7%) without a preoperative PPI (mean ± standard deviation age 75 ± 7 years) undergoing isolated surgical aortic valve replacement at 4 Finnish hospitals between 2002 and 2014. Data were extracted from electronic patient records. RESULTS The follow-up was median 4.7 years (range 1 day to 12.3 years). Altogether 56 patients received PPI postoperatively, with the median 507 days from the operation (range 6 days to 10.0 years). The PPI indications were atrioventricular block (31 patients, 55%) and sick sinus syndrome (21 patients, 37.5%). For 4 patients, the PPI indication remained unknown. A competing risks regression analysis (Fine–Gray method), adjusted with age, sex, diabetes, coronary artery disease, preoperative atrial fibrillation (AF), left ventricular ejection fraction, New York Heart Association class, AF at discharge and urgency of operation, was used to assess risk factors for PPI. Only AF at discharge (subdistribution hazard ratio 4.34, 95% confidence interval 2.34–8.03) was a predictor for a PPI. CONCLUSIONS Though atrioventricular block is the major indication for PPI after surgical aortic valve replacement, >30% of PPIs are implanted due to sick sinus syndrome during both short-term follow-up and long-term follow-up. Postoperative AF versus sinus rhythm conveys >4-fold risk of PPI. Clinical trial registration clinicaltrials.gov Identifier: NCT02626871


2020 ◽  
Vol 31 (2) ◽  
pp. 152-157
Author(s):  
Hee Jung Kim ◽  
Ho Jin Kim ◽  
Joon Bum Kim ◽  
Sung-Ho Jung ◽  
Suk Jung Choo ◽  
...  

Abstract OBJECTIVES The issue of prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (SAVR) has been a controversial topic. We sought to evaluate the long-term clinical impacts of PPM in patients undergoing SAVR in an updated, homogeneous cohort. METHODS Using the prospective institutional database, we identified 895 adult patients (median age 66, interquartile range 58–72; 45.6% women) who underwent isolated SAVR from January 2000 to March 2016. Those with pure aortic insufficiency and concomitant other cardiac operations were excluded from this study cohort. The presence of a significant PPM was defined as an indexed effective orifice area 0.85 cm2/m2 or less. The outcome of interest was all-cause deaths. Propensity score matching was performed for adjusting bias. RESULTS Significant PPM was present in 247 patients (27.6%). During the follow-up period (mean 71.2 ± 51.04 months), 134 patients (15%) died. Survival rates at 10 and 15 years were 78.3% vs 83.8% and 71.3% vs 57.6% in the PPM and non-PPM groups (P = 0.972). Risk factor analysis indicated that developing PPM was not associated with a risk of death. After propensity score matching (1:1), developing PPM was not a risk factor for long-term death as well (P = 0.584). CONCLUSIONS Significant PPM was common after SAVR in patients with aortic stenosis. However, there was no significant difference in survival rate between those with and without PPM.


2017 ◽  
Vol 104 (4) ◽  
pp. 1259-1264 ◽  
Author(s):  
Kevin L. Greason ◽  
Brian D. Lahr ◽  
John M. Stulak ◽  
Yong-Mei Cha ◽  
Robert F. Rea ◽  
...  

2020 ◽  
Vol 9 (2) ◽  
pp. 439 ◽  
Author(s):  
Polimeni ◽  
Sorrentino ◽  
De Rosa ◽  
Spaccarotella ◽  
Mongiardo ◽  
...  

Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33–0.95; p = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42–1.07; p = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17–0.39; p < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14–0.65; p < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14–0.58; p = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31–11.99; p = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33–9.07; p = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41–1.25; p = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53–1.83; p = 0.96), and MI (RR = 0.75; 95% CI 0.43–1.29; p = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.


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