Surgical Aortic Valve Replacement Cohort Research Articles

55. Infective Endocarditis After Surgical or Transcatheter Aortic Valve Replacement

BackgroundInfective endocarditis (IE) can complicate both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) with significant morbidity and mortality despite differing pathogenesis. In the presence of limited data from direct comparison studies and recent expansion of TAVI to younger and lower- risk patients, we compared the incidence and timing of IE in TAVI versus SAVR.MethodsUsing data from the TriNetX electronic health records network, we identified (1) a cohort of patients who underwent TAVI between January 2016 and December 2020 (CPT procedure code 1021150) and (2) a propensity score-matched cohort of patients who underwent SAVR (CPT procedure codes 1035167 or 1029693, without any associated transcatheter procedure). We examined the incidence of IE (captured with ICD-10 codes I33, I38, or I39) over a 5-year follow up period and matched the cohorts for demographic data and clinically relevant background history. We used Kaplan-Meier estimates and Cox proportional hazards models to compare incidence between matched cohorts.ResultsWe identified 6,302 patients with TAVI and 6,302 matched patients with SAVR. The baseline characteristics of the cohorts were well balanced, Table 1. All standardized mean differences were < 0.05, indicating adequate matching between cohorts. The Kaplan-Meier mortality at 5 years was 38.0% in the TAVI vs. 22.0% in the SAVR cohort (log-rank P < 0.001). There were 290 cases with IE in the TAVI and 604 cases in the SAVR cohort. The corresponding 5-year event rates were 10.0% vs. 16.9% (log-rank P < 0.001), respectively, Figure 1. The risk ratio of TAVI vs. SAVR related IE over the entire 5-year period was 0.48 (95%CI 0.42 — 0.55; P < 0.001). However, the relative risk for IE was non-proportional between groups over the 5-year period, with an early pronounced incidence among SAVR relative to TAVI patients and gradual convergence of the hazard rates over time, Figure 2. Figure 1. Cumulative 5-Year Incidence (Kaplan-Meier Estimates) of Infective Endocarditis Among Matched Transcatheter Aortic Valve Implantation (TAVI) vs. Surgical Aortic Valve Replacement (SAVR) Recipients Figure 2. Risk of Infective Endocarditis in SAVR vs. TAVI Recipients Over Time ConclusionIn this comparative study, the risk for IE was lower among TAVI vs. SAVR recipients, primarily due to the higher risk of IE during the early post-SAVR period. With increasing uptake of TAVI procedures, a better understanding of the temporal occurrence and pathophysiology of IE and application of effective treatment strategies in these patients is required.Disclosures All Authors: No reported disclosures

Abstract 14430: 5-year Outcomes After Transcatheter &amp; Surgical Aortic Valve Replacement in Advanced Chronic Kidney Disease Patients

Introduction: Advanced chronic kidney disease (CKD4,5) patients are known to have increased morbidity and mortality when undergoing surgical procedures. While short term outcomes among patients undergoing transcatheter (TAVR) or surgical aortic valve replacement (SAVR) have been studied, research assessing long term outcomes are scant. Therefore, the goal was to assess 5-year outcomes for these patients undergoing TAVR or SAVR. Methods: A retrospective cohort study was done using TriNetX, a national federated real time database of 69 million records. Patient cohorts were identified if they met the criteria for CKD and underwent TAVR or SAVR up until May 2016 for 5 year follow up. A 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% confidence intervals (CI) for complications of interest. Kaplan Meir (KM) analysis was done to calculate survival probability in 5 years among the 2 cohorts. Results: In a matched sample of 355 patients in each cohort, the TAVR did not show any significant differences in mortality (RR[CI]): (1.07[0.89-1.28]) compared to the SAVR Group. However, KM analysis revealed a significantly lower 5-year survival probability compared to the SAVR group (p&lt;0.035). There were no statistically significant differences among the 2 cohorts in other assessed long-term complications such as stroke (0.67[0.42-1.05]) and new pacemaker placement (1.31[0.81-2.17]). However, redo TAVR/SAVR was higher in the TAVR cohort than the SAVR cohort (3.1[1.54-6.23]). Conclusions: 5-year mortality appears to be similar in advanced CKD patients but repeat TAVR/SAVR were much higher suggesting decreased longevity of TAVR valves in this population.

Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire

BackgroundThe Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). In this study, we...

Outcomes of trans-catheter versus surgical aortic valve replacement for patients with classic low-flow low-gradient aortic stenosis

Abstract Background Classical low-flow low-gradient aortic stenosis (cLFLG-AS) is frequently encountered within clinical practice [1], and is often associated with high mortality [2]. Whilst aortic valve replacement can improve outcomes, there is a lack of real-world data guiding the decision between trans-catheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) in this specific patient cohort. Purpose To compare outcomes between TAVI and SAVR in patients with cLFLG-AS. Methods cLFLG-AS was defined by an aortic valve area &amp;lt;1cm2, mean gradient &amp;lt;40mmHg or peak velocity &amp;lt;4m/s and left ventricular ejection fraction &amp;lt;50%. All patients who met cLFLG-AS criteria who underwent TAVI or SAVR at our tertiary referral centre between 2015 and 2020 were included. Inverse probability weighting was used to adjust for differences in baseline characteristics and the non-random assignment of treatment modalities. The primary end-point was all-cause mortality. Secondary end-points were procedure-related permanent pacemaker implantation, renal replacement therapy (RRT) and stroke. Results 322 patients were included (220 TAVI and 102 SAVR). Baseline characteristics were: male sex 70%, mean gradient 30mmHg (23–35), aortic valve area 0.8cm2 (0.6–0.9). Patients undergoing TAVI were older than the SAVR group (81.3±8.5 vs 70.6±11.1 years, p&amp;lt;0.0001) with higher Logistic Euroscore (19.3 (11.8–32.3) vs 7.1 (3.7–14.1), p&amp;lt;0.0001) (figure 1). At median follow-up of 2.7 years (1.5–4.1), 99 patients had died; 70 (31.8%) had TAVI and 29 (28.4%) had SAVR. Both unweighted and weighted Kaplan-Meier curve analysis was performed; there was similar survival between SAVR and TAVI (log rank test 0=0.27 and p=0.4 respectively) (figure 2). Adjusted hazard ratio (HR) for mortality with SAVR was 0.78 unweighted (95% CI 0.5–1.21; p=0.27) and 0.66 weighted (95% CI 0.26–1.64; p=0.37). In terms of contributory procedural factors, concomitant multiple valve intervention in the SAVR group independently affected mortality (HR 5.47, 95% CI 2.52–11.51, p&amp;lt;0.001). There was no difference in permanent pacemaker insertion or stroke across the two groups, but rates of RRT were higher in SAVR cohort (13.7% vs 0%, p&amp;lt;0.001). Conclusions Despite the TAVI cohort being both older and at higher risk, there was no observed difference in mortality between TAVI and SAVR in the mid-term. Deciding upon intervention choice can therefore be based upon criteria other than the specific presence of a classic low-flow low-gradient state. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Clinical training research fellowship from the British Heart Foundation Baseline characteristics by treatmentKaplan-Meier curves for TAVI vs SAVR

A single-center analysis of outcomes, risk factors, and new valves in Asian patients treated with early transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) continues to expand as an optimal treatment in Western countries; however, Asian countries have been slower to adopt this procedure. This research aimed to explore the outcomes and status of early TAVI performed at a single center in Asia, and provide comparative outcomes of the newly designed Chinese valves. We enrolled 175 consecutive patients who successfully underwent TAVI from September 2012 to January 2018 at Fuwai Hospital (Beijing, China). After a preliminary assessment of age, we included 109 older patients (≥69 years) who underwent surgical aortic valve replacement (SAVR) during the same period. The primary endpoint was all-cause mortality. The inverse probability of treatment weighting (IPTW) was used to reduce potential bias. Cox regression was used to identify the risk factors of a poor prognosis. The TAVI cohort had higher rates of all-cause mortality [11.4% vs. 2.4%, hazard ratio (HR): 4.79, 95% confidence interval (CI): 1.47 to 15.57, IPTW-adjusted P=0.009] and permanent pacemaker implantation (PPI; 14.6% vs. 1.6%, HR: 9.98, 95% CI: 2.71 to 36.67, IPTW-adjusted P<0.001) at 3 years than the SAVR cohort. In the multivariable Cox regression analysis based on the entire sample, liver disease was associated with all-cause mortality (HR: 5.080, 95% CI: 1.067 to 24.174, P=0.041). A smoking history was associated with an increased risk of postoperative heart failure (HF) (HR: 4.902, 95% CI: 1.265 to 18.999, P=0.022). Additionally, age (HR: 1.141, 95% CI: 1.010 to 1.288, P=0.034) and diabetes (HR: 7.301, 95% CI: 2.414 to 22.079, P<0.001) were identified as predictors of postoperative stroke. In the new valve subgroups, the 1-year composite endpoints were 38.2% (Venus A), 35.3% (TaurusOne), 34% (J-Valve), and 28% (VitaFlow) (P=0.857). Not all TAVI procedures had satisfactory outcomes compared with SAVR when initiated. At first, our center faced some challenges in delivering TAVI, and this is probably one of the reasons why the use of TAVI has developed slowly in Asia. Further investigations are needed to explore the underlying factors precluding the rapid expansion of TAVI in Asia.

Outcomes and Contemporary Trends in Surgical vs Transcatheter Aortic Valve Replacement in Patients with Chronic Obstructive Pulmonary Disease

ABSTRACT Background Chronic obstructive lung disease (COPD) is a common morbidity among patients referred for aortic valve replacement. The objective of the present study is to assess trends and outcomes of COPD patients undergoing either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for severe aortic stenosis. Methods We analyzed the National Inpatient Sample database from January 2012 to December 2017 using the International Classification of Diseases, 9th and 10th Revision Clinical Modifications to identify all patients with COPD aged ≥50 years who underwent either TAVR or SAVR for aortic stenosis. To account for potential bias, 1:1 propensity-matched analysis was performed. Logistic regression was used for predictors of mortality in the cohort. Linear regression was used for trend analysis. Results Of the total of 95,555 cases, 40,080 underwent TAVR whereas 49,985 underwent SAVR. In-hospital mortality for the propensity-matched cohorts was higher in the SAVR cohort compared to the TAVR group (4.6% vs. 2.5%; p < 0.001). Respiratory complications were also higher in the SAVR group (7.5% vs. 3.7%; p < 0.001) but were less likely to have a permanent pacemaker placement (5.3% vs. 10.8%, p < 0.001). Length of stay (11.8 days [standard deviation (SD), 8.8] vs. 6.4 days [SD, 6.8]) and cost of stay ($244,657 [SD, $183,333] vs. $229,524 [SD, $146,994]) were favorable toward TAVR as compared to SAVR. In-hospital mortality has declined over the study period in the TAVR group from 4.8% to 1.5%. Conclusion TAVR has more favorable in-hospital outcomes in patients with COPD compared to SAVR.

Clinical impact of the heart team on the outcomes of surgical aortic valve replacement among octogenarians.

The effectiveness of a multidisciplinary heart team in the management of patients with severe symptomatic aortic stenosis is unknown. This study evaluated the impact of a heart team on the outcomes of surgical aortic valve replacement in octogenarians. Between May 2007 and January 2016, 528 patients aged 80years or more were referred to our institutional heart team for a transcatheter aortic valve replacement. Among these, 101 were redirected to surgical aortic valve replacement (heart team group). These patients were compared with a surgical aortic valve replacement cohort (n=506) without prior heart team screening (non-heart team group), taken from the same time period. Propensity score matching with bootstrap analysis was performed; 76 heart team patients were matched to 76 non-heart team patients. Early and late outcomes including survival and readmission for cardiovascular causes were compared. Matched subgroups were largely comparable; congestive heart failure and echocardiographic pulmonary hypertension were more prevalent in the heart team group. In-hospital mortality was significantly lower in the matched heart team group (0% vs 6.0%, bootstrap mean difference 6.0%, 95% confidence interval, 2.2-9.8). The risk of stroke, low cardiac output state, reexploration for bleeding, pneumonia, and prolonged ventilation was also significantly lower in the heart team group. There was no significant between-group difference regarding late survival (hazard ratio, 0.86, 95% confidence interval, 0.55-1.33, P=.49) or readmission for cardiovascular reasons (hazard ratio, 0.70, 95% confidence interval, 0.41-1.20, P=.19). Preoperative multidisciplinary assessment of octogenarians by a heart team was associated with lower in-hospital mortality and adverse events after surgical aortic valve replacement.

Outcomes following self-expanding transcatheter or surgical aortic valve implantation in patients at low operative risk stratified by need for revascularization

Abstract Background Self-expanding transcatheter aortic valve implantation (TAVI) was non-inferior to surgical aortic valve replacement (SAVR) in a randomized clinical trial of patients with severe aortic stenosis at low operative risk. Randomization was stratified by the need for revascularization, but it remains unclear how this has impacted the results of TAVI and SAVR. Purpose To compare TAVI and SAVR outcomes in a prespecified analysis according to the need for revascularization. Methods A total of 1403 patients underwent attempted TAVI (n=725) or SAVR (n=678) at 87 centres worldwide. Patients were deemed at low risk of early mortality (&amp;lt;3%) confirmed by a national screening committee. Patients were stratified by site and need for revascularization based on heart team assessment. The trial used a Bayesian study design for the 2-year primary analysis and an interim analysis was performed when 850 patients had reached 1-year follow-up. Results There were 85/725 (11.7%) TAVI patients and 79/678 (11.7%) SAVR patients identified as needing revascularization. Previous CABG had occurred in 3 (1.8%) patients and previous PCI had been performed in 31 (18.9%) patients. The baseline characteristics for the TAVI and SAVR cohorts are shown in the table. In the TAVI revascularization group, 44 of 85 (51.8%) received PCI concomitant or staged with TAVI and 6 of 639 (0.9%) received PCI in the no revascularization group. In the SAVR revascularization group, 65 of 79 (82.3%) underwent concomitant CABG and 27 of the 599 (4.5%) patients in the no revascularization group had concomitant CABG. Kaplan-Meier estimates of 1-year all-cause mortality or disabling stroke at the time of the interim analysis are provided for TAVI and SAVR patients by need for revascularization (Table). Conclusions The proportion of low-risk patients needing revascularization was small in this low risk population. The complete 1-year follow-up for the entire 1403 patient cohort will be available for presentation in August. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic, plc

Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial

BackgroundIt is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD. ObjectivesThis study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry. MethodsIn the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years. ResultsCompared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. ConclusionsCompared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128)

Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis

BackgroundThere is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis.MethodsIn a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality.ResultsA total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts.ConclusionsThe Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome.Trial registrationClinicalTrials.gov Identifier: NCT03385915.

Comparison of Survival of Transfemoral Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement for Aortic Stenosis in Low-Risk Patients Without Coronary Artery Disease

Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score <3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (p = 1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (p = 0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD.

Transcatheter and Surgical Aortic Valve Replacement in Patients With Recent Acute Heart Failure

Patients with severe aortic stenosis and heart failure have poor prognosis, and their outcomes may be suboptimal even after transcatheter (TAVR) and surgical aortic valve replacement (SAVR). This is an analysis of the nationwide FinnValve registry, which included patients who underwent primary TAVR or SAVR with a bioprothesis for aortic stenosis. We evaluated the outcome of patients with acute heart failure (AHF) within 60 days prior to TAVR or SAVR. The prevalence of recent AHF was 11.4% (484 of 4241 patients) in the SAVR cohort and 11.3% (210 of 1855 patients) in the TAVR cohort. In the SAVR cohort, AHF was associated with lower 30-day survival (91.3% vs 97.0%; adjusted odds ratio 1.801, 95% confidence interval [CI] 1.125-2.882) and 5-year survival (64.0% vs 81.2%; adjusted hazard ratio 1.482, 95% CI 1.207-1.821). SAVR patients with AHF had higher risk of major bleeding, need of mechanical circulatory support, acute kidney injury, prolonged hospital stay, and composite end-point (30-day mortality, stroke and/or acute kidney injury). Patients with AHF had a trend toward lower 30-day survival (crude rates 95.2% vs 97.9%; adjusted odds ratio 2.028, 95% CI 0.908-4.529) as well as significantly lower 5-year survival (crude rates 45.3% vs 58.5%; adjusted hazard ratio 1.530, 95% CI 1.185-1.976) also after TAVR. AHF increased the risk of acute kidney injury, prolonged hospital stay, and composite end-point after TAVR. Recent AHF is associated with increased risk of mortality and morbidity after SAVR and TAVR. These findings suggest that aortic stenosis patients should be referred for invasive treatment before the development of clinically evident heart failure.

A Practical Two-Stage Frailty Assessment for Older Adults Undergoing Aortic Valve Replacement.

Despite evidence, frailty is not routinely assessed before cardiac surgery. We compared five brief frailty tests for predicting poor outcomes after aortic valve replacement and evaluated a strategy of performing comprehensive geriatric assessment (CGA) in screen-positive patients. Prospective cohort study. A single academic center. Patients undergoing surgical aortic valve replacement (SAVR) (n = 91; mean age = 77.8 y) or transcatheter aortic valve replacement (TAVR) (n = 137; mean age = 84.5 y) from February 2014 to June 2017. Brief frailty tests (Fatigue, Resistance, Ambulation, Illness, and Loss of weight [FRAIL] scale; Clinical Frailty Scale; grip strength; gait speed; and chair rise) and a deficit-accumulation frailty index based on CGA (CGA-FI) were measured at baseline. A composite of death or functional decline and severe symptoms at 6 months was assessed. The outcome occurred in 8.8% (n = 8) after SAVR and 24.8% (n = 34) after TAVR. The chair rise test showed the highest discrimination in the SAVR (C statistic = .76) and TAVR cohorts (C statistic = .63). When the chair rise test was chosen as a screening test (≥17 s for SAVR and ≥23 s for TAVR), the incidence of outcome for screen-negative patients, screen-positive patients with CGA-FI of .34 or lower, and screen-positive patients with CGA-FI higher than .34 were 1.9% (n = 1/54), 5.3% (n = 1/19), and 33.3% (n = 6/18) after SAVR, respectively, and 15.0% (n = 9/60), 14.3% (n = 3/21), and 38.3% (n = 22/56) after TAVR, respectively. Compared with routinely performing CGA, targeting CGA to screen-positive patients would result in 54 fewer CGAs, without compromising sensitivity (routine vs targeted: .75 vs .75; P = 1.00) and specificity (.84 vs .86; P = 1.00) in the SAVR cohort; and 60 fewer CGAs with lower sensitivity (.82 vs.65; P = .03) and higher specificity (.50 vs .67; P < .01) in the TAVR cohort. The chair rise test with targeted CGA may be a practical strategy to identify older patients at high risk for mortality and poor recovery after SAVR and TAVR in whom individualized care management should be considered. J Am Geriatr Soc 67:2031-2037, 2019.

Valve Hemodynamics and Clinical Outcomes After Transcatheter Aortic Valve Replacement for a Small Aortic Annulus.

The hemodynamics and outcomes in patients with a small aortic annulus (SAA) after transcatheter aortic valve replacement (TAVR) with a second-generation transcatheter heart valve remain unclear. We investigated whether TAVR with a Sapien XT (Edwards Lifesciences, Irvine, California) influences postprocedural valve hemodynamics and long-term outcome in high-risk SAA patients compared with surgical aortic valve replacement (SAVR).We retrospectively identified 94 SAA patients who underwent aortic valve replacement (TAVR = 35 and SAVR = 59). SAA was defined as an aortic annulus diameter ≤ 20 mm, measured by preprocedural transesophageal echocardiography.The mean age was 80.2 years. The mean Society of Thoracic Surgeons-Predicted Risk of Mortality was 6.8%. The post-procedural peak transvalvular velocity and mean pressure gradient were significantly lower in the TAVR cohort than in the SAVR cohort, whereas the postprocedural aortic valve area was significantly higher in the TAVR cohort. Severe prosthesis-patient mismatch (PPM) occurred less frequently after TAVR than SAVR (TAVR 2.9% versus SAVR 22.0%, P = 0.01). The two-year mortality in SAA patients was similar between the two groups.TAVR with a Sapien XT in SAA patients improved the valve hemodynamics and reduced the incidence of PPM compared with SAVR. TAVR patients had a similar 2-year mortality despite higher risk baseline characteristics. To avoid PPM and the consequent poor outcomes, TAVR can be considered an alternative option to SAVR in high surgical risk patients with SAA.

Oxidation-Reduction Potential in Patients undergoing Transcatheter or Surgical Aortic Valve Replacement.

Background Aortic valve stenosis has gained increasingly more importance due to its high prevalence in elderly people. More than two decades ago, transcatheter aortic valve replacement emerged for patients who were denied surgery, and its noninferiority has been demonstrated in numerous studies. Oxidative stress has generated great interest because of its sensitivity to cell damage and the possibility of offering early hints of clinical outcomes. The aim of the present study was to investigate whether there is a significant difference between transcatheter (TAVR) or surgical aortic valve replacement (SAVR) in terms of the changes in oxidation-reduction potential (ORP) and antioxidant capacity. Therefore, we investigated perioperative oxidative stress levels and their influence on clinical outcomes. Methods A total of 72 patients (50% TAVR versus 50% SAVR) were included in the present study. Static oxidation-reduction potential (sORP) and antioxidant capacity were measured using the RedoxSys™ Diagnostic System (Luoxis Diagnostics, USA) in serum samples drawn before and after surgery, as well as on the first postoperative day. In addition, clinical data were obtained to evaluate the clinical outcome of each case. Results TAVR patients had higher preoperative sORP levels compared to the SAVR patients and more severe comorbidities. Unlike the TAVR cohort, patients in the SAVR group showed a significant difference in sORP from the pre- to postoperative levels. Capacity demonstrated higher preoperative levels in the SAVR cohort and also a greater difference postoperatively compared to the TAVR cohort. Regression analysis revealed a significant correlation between pre- and postoperative capacity levels (r = -0.9931, p < 0.0001), providing a method of predicting postoperative capacity levels by knowing the preoperative levels. According to the multivariable analysis, both sORP and antioxidant capacity are dependent on time point, baseline value, and type of surgery, with the largest variations observed for time effect and surgery method. Conclusion A high preoperative sORP level correlated to more severe illness in the TAVR patients. As the TAVR patients did not show significant differences in their preoperative levels, we assume that there was a smaller production of oxidative agents during TAVR due to the less invasive nature of the procedure. Baseline values and development of antioxidant capacity values strengthen this hypothesis. The significant correlation of pre- and postoperative capacity levels might allow high risk patients to be detected more easily and might provide more adequate and individualized therapy preoperatively. This trial is registered with clinicaltrials.gov, identifier: NCT 02488876.

One-year outcomes of patients with severe aortic stenosis and an STS PROM of less than three percent in the SURTAVI trial

The indication for transcatheter aortic valve implantation (TAVI) has evolved from inoperable patients to patients at increased surgical risk. In low-risk patients, surgical aortic valve replacement (SAVR) remains the standard of care. The aim of this study was to explore the outcomes of TAVI and SAVR in patients with a Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score below 3% in the SURTAVI trial. In SURTAVI, patients at intermediate surgical risk based on Heart Team consensus were randomised to TAVI or SAVR. We stratified the overall patient population into quintiles based on the STS PROM score; the one-year mortality was correlated with the mean STS PROM score in each quintile. The quintiles were regrouped into three clinically relevant categories of STS score: less than 3%, 3 to <5%, and >5%. All-cause mortality or disabling stroke in each risk stratum was compared between TAVI and SAVR. Linear regressions between mean values of STS PROM in each quintile and observed all-cause mortality at one year showed great association for the global population (r2=0.92), TAVI (r2=0.89) and SAVR cohorts (r2=0.73). All-cause mortality or disabling stroke of TAVI vs. SAVR was 1.5% vs. 6.5% (p=0.04), 6.5% vs. 7.6% (p=0.52) and 13.5% vs. 11.0% (p=0.40) in the <3%, 3-5%, and ≥5% STS score strata, respectively. Among patients at intermediate surgical risk but with an STS PROM <3%, TAVI may achieve superior clinical outcomes compared to SAVR. These findings support the need for an adequately powered randomised trial to compare TAVI with SAVR in patients at low operative risk.

Comparison of Frequency of Late Gastrointestinal Bleeding With Transcatheter Versus Surgical Aortic Valve Replacement

Improvements in technology and operator experience have led to exponential growth of transcatheter aortic valve implantation (TAVI) programs. Late bleeding complications were recently highlighted after TAVI with a high impact on morbidity. The purpose of the present study was to assess the incidence and financial impact of late Gastrointestinal (GI) bleeding after TAVI, and compare with the surgical cohort. Retrospective analysis of the National Readmissions Database was performed from January 2011 to December 2014, and patients who underwent TAVI or surgical aortic valve replacement (SAVR) were identified. Incidence of readmission with a diagnosis of GI bleeding was utilized as the primary end point. Overall, 43,357 patients were identified who underwent TAVI, whereas 310,013 patients underwent SAVR. Compared with SAVR, TAVI patients were older (81 vs 68y, p < 0.001), more women (48% vs 36%, p < 0.001), and had higher Elixhauser Comorbidity Index (6 vs 5, p < 0.001). Hospital stay was shorter with TAVI (5 vs 8 days, p < 0.001), but raw in-hospital mortality rates were similar (4.2% vs 3.8%, p = 0.022). In the TAVI cohort, 3.3% of patients were rehospitalized for GI bleeding compared with 1.5% of the SAVR cohort (p < 0.001). Average time to bleeding readmission was similar between cohorts (92 vs 84 days, p = 0.049). After multivariable adjustment, TAVI remained significantly associated with readmissions for GI bleeding compared with SAVR Adjusted Odds Ratio (AOR 1.54 [1.38 to 1.71], p < 0.001). In this national cohort study, TAVI was associated with more frequent readmissions for late GI bleeding compared with SAVR. In conclusion, strategies to reduce late GI bleeding may serve as important targets for improvement in overall quality of care.

Racial Comparisons of the Outcomes of Transcatheter and Surgical Aortic Valve Implantation Using the Medicare Database

Racial disparities in the outcomes after intervention for aortic valve disease remain understudied. We stratified patients by race who underwent surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) in the Medicare database. The TAVI cohort consisted of 17,973 patients (3.9% were black and 1.0% were Hispanic). The SAVR cohort consisted of 95,078 patients, (4.8% were black and 1.3% were Hispanic). Most comorbidities were more common in blacks. After TAVI, 30-day mortality was not significantly different in races with both unadjusted and adjusted data. There were no significant racial differences in readmission rates or discharge to home after TAVI. After SAVR, black patients had worse unadjusted 30-day and 1-year mortality than whites or Hispanics (30-day mortality, 4.7% vs 6.2% vs 4.7% for whites, blacks, and Hispanics, respectively, p = 0.0001; 1-year mortality 11.7% vs 16.1% vs 12.5%, respectively, p = 0.0001); however, after adjustment, there were no differences in mortality. Black patients had higher 30-day readmission rates after SAVR (20.1% vs 25.2% vs 21.7% for whites, blacks, and Hispanics, respectively, p = 0.0001), which persisted after adjustment for comorbidities. Minorities were underrepresented in both SAVR and TAVI relative to what would be predicted by population prevalence. In conclusion, while blacks have worse outcomes in SAVR compared with whites or Hispanics, race did not impact mortality, readmission, or discharge to home in TAVI. Both blacks and Hispanics were underrepresented compared with what would be predicted by population prevalence.

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis.

Transcatheter aortic valve replacement (TAVR) has been approved in patients with high or prohibited surgical risk for surgery for treatment of severe symptomatic aortic stenosis. Prospective studies examining the benefits of TAVR in intermediate risk patients are ongoing. Other smaller studies including lower risk patients have been conducted, but further meta-analysis of these studies is required to draw more broad comparisons. A Medline search was conducted using standard methodology to search for clinical trials and observational studies including intermediate risk patients. We limited our meta-analysis to studies matching patient populations by propensity scores or randomization and examined clinical outcomes between TAVR and surgical aortic valve replacement (SAVR). Analysis of the TAVR and SAVR cohorts revealed no significant differences in the outcomes of 30-day [OR (95% CI): 0.85 (0.57, 1.26)] or 1-year mortality [OR (95% CI): 0.96 (0.75, 1.23)]. A trend towards benefit with TAVR was noted in terms of neurological events and myocardial infarction (MI) without statistical significance. A statistically significant decrease in risk of post-procedural acute renal failure in the TAVR group [OR (95% CI): 0.52 (0.27, 0.99)] was observed, but so was a significantly higher rate of pacemaker implantations for the TAVR group [OR (95% CI): 6.51 (3.23, 13.12)]. We conclude that in intermediate risk patients undergoing aortic valve replacement, the risk of mortality, neurological outcomes, and MI do not appear to be significantly different between TAVR and SAVR. However, there appears to be a significant reduction in risk of acute renal failure at the expense of an increased risk of requiring a permanent pacemaker in low and intermediate risk patients undergoing TAVR compared to SAVR.

The Midterm Impact of Transcatheter Aortic Valve Replacement on Surgical Aortic Valve Replacement in Michigan

We characterized the midterm impact of transcatheter aortic valve replacement (TAVR) on surgical aortic valve replacement (SAVR) volume, patient profiles, and outcomes in Michigan. We analyzed data obtained after SAVR (n= 15,288) and TAVR (n= 1,783) using the Michigan Society of Thoracic and Cardiovascular Surgery Quality Collaborative from 2006 to 2015. During this period, 17 of 33 hospitals developed TAVR programs. Annual SAVR volume increased by 38.1% at TAVR hospitals and by 20.4% at non-TAVR hospitals, (ptrend < 0.001). In TAVR hospitals, the Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) decreased before (4.7% ± 5.1%) and after (3.5% ± 3.6%) initiation of TAVR (p < 0.001). Rates of 30-day mortality (pre-TAVR, 3.9% vs post-TAVR, 2.7%; p < 0.001) and renal failure (pre-TAVR, 5.2% vs post-TAVR, 3.3%; p < 0.001) butnot stroke (pre-TAVR, 1.9% vs post-TAVR, 1.7%; p= 0.47) were lower after TAVR implementation. Length of stay decreased from 9.0 to 8.5 days (p < 0.001). When analyzing high-risk patients undergoing SAVR (ie, PROM >8%), neither mortality, stroke, nor renal failure was different (all p > 0.15). Despite a reduction in the STS-PROM, non-TAVR hospitals did not display changes in mortality, stroke, or renal failure for either the entire or the high-risk SAVR cohorts after initiation of TAVR in Michigan. TAVR implementation in Michigan has dramatically increased overall SAVR volume. This phenomenon has occurred with a concomitant decrease in preoperative risk profile and has improved early SAVR outcomes, particularly at TAVR hospitals, but surprisingly not in patients considered at high preoperative risk. As TAVR use increases, these issues may be further clarified and elucidated.