Higher Society Of Thoracic Surgeons Research Articles

Right-ventricular/pulmonary artery coupling predicts long-term mortality in aortic stenosis patients with different flow types

Abstract Background Right-ventricular (RV) dysfunction in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) has long been neglected. Right-ventricular to pulmonary artery coupling (RV/PAc), a parameter of RV function, can be determined by echocardiography (tricuspid annular plane systolic excursion over systolic pulmonary artery pressure). Its use for mortality prediction in contemporary AS patients warrants further evaluation, data for different flow types of AS are lacking. Purpose To assess the impact of pathological RV/PAc on long-term mortality in AS patients with different flow types. Methods All 1577 consecutive patients from our registry from 2018 to 2020 were assessed. Patients without tricuspid regurgitation (n=523) or inconclusive echocardiography images (n=111) were excluded. RV/PAc could be analysed in 862 patients. To dichotomize the cohort, a receiver operator curve (ROC) analysis for 2-year mortality was used. Primary endpoint was 2-year mortality. Patients were further analysed according to the Valve Academic Research Consortium (VARC) 3 endpoint definitions. Results By ROC analysis, 0.512 mm/mmHg was defined as a cut-off, dividing the cohort into 428 patients with physiological RV/PAc (above cut-off) and 434 patients with pathological RV/PAc. Patients with pathological RV/PAc were more often male, had more comorbidities, a lower ejection fraction (50% [40-55%] vs. 55% [53-58%], p<0.01) and a higher Society of Thoracic Surgeons (STS) score (4.0 [2.5-6.0] vs. 2.8 [2.0-4.0], p<0.01). Procedural outcomes according to VARC-3 were comparable: the composite endpoints technical failure and device failure at 30 days occurred in 3.9% and 3.5% (p=0.75) and 11.3% and 13.3% (p=0.42) in the pathological and physiological group, respectively. Clinical outcomes in terms of New York Heart Association functional class were comparable at follow-up, with an improvement by at least one class in 76.2% (pathological group) and 79.9% (physiological group, p=0.33). All-cause 2-year mortality was significantly higher in the pathological group (34.9% [30.2-39.2%] vs. 15.4% [11.9-18.8%], p<0.01, hazard ratio, HR, 2.5 [1.9-3.4], Figure 1). The result persisted when adjusted for STS score (HR 2.3 [1.7-3.1]) or in a multivariate Cox regression. Cardiovascular mortality was increased too (pathological, 23.7% [19.3-27.8%], vs. physiological, 8.5% [5.8-11.2%], HR 2.9 [2.0-4.2], p<0.01). The fraction of patients with pathological RV/PAc differed significantly across the AS flow types (high-gradient, 40.3%, classical low-flow low-gradient (LFLG), 73.9%, paradoxical LFLG, 58.9%, and normal-flow low-gradient, 36.6%, p<0.01). Mortality differences persisted in high-gradient and LFLG groups (Figure 2A-D), which was consistent after statistical adjustment. Conclusions RV dysfunction defined as low RV/PAc is a strong predictor for long-term mortality in TAVI patients, with a strong prognostic value also in LFLG AS.

Impact of COVID-19 Surge Periods on Clinical Outcomes of Transcatheter Aortic Valve Implantation

Healthcare systems adopted various strategies to minimize the impact of the COVID-19 pandemic on clinical outcomes of patients with symptomatic severe aortic stenosis referred for transcatheter aortic valve implantation (TAVI). We aimed to compare baseline characteristics and procedural and clinical outcomes of patients who underwent TAVI during COVID-19 surge periods with those of patients who underwent TAVI during the nonsurge and prepandemic periods. In the prospective Bern TAVI registry, the pandemic period was divided into surge and nonsurge periods on the basis of the mean number of occupied beds in the intensive care unit in each month and matched with 11months immediately preceding the pandemic. A total of 1,069 patients underwent TAVI between April 1, 2019 and December 31, 2021. Patients who underwent TAVI during surge periods had a higher surgical risk (Society of Thoracic Surgeons predicted risk of mortality) than that of patients who underwent TAVI during nonsurge and prepandemic periods. Diagnosis-to-procedure time (in days) was longer for patients who underwent TAVI during the surge period than during the nonsurge and prepandemic periods (95.20 ± 121.07 vs 70.99 ± 72.25 and 60.46 ± 75.43, both p <0.001). At 30days, all-cause mortality was higher in the surge than in the nonsurge group (4.9 vs 1.1%, hazard ratio 4.68, 95% confidence interval 1.55 to 14.10, p=0.006), and in the surge than in the prepandemic group (4.9 vs 1.3%, hazard ratio 3.67, 95% confidence interval 1.34 to 10.11, p=0.012). In conclusion, TAVI during COVID-19 surge periods was associated with higher Society of Thoracic Surgeons predicted risk of mortality score, delayed procedure scheduling, and increased 30-day mortality than that of TAVI during nonsurge and prepandemic periods.

The interaction of forced expiratory volume in 1 s and N-terminal pro-B-type natriuretic peptide with outcomes after transcatheter aortic valve replacement.

Low forced expiratory volume in 1 s (FEV1) and elevated N-terminal pro-B-type natriuretic peptide (NT-Pro-BNP) have been individually associated with poor outcomes after transcatheter aortic valve replacement (TAVR). We hypothesized a combination of the 2 would provide prognostic indication after TAVR. We categorized 871 patients who received TAVR from 2008 to 2018 into 4 groups according to baseline FEV1 (<60% or ≥60% predicted) and NT-Pro-BNP (<1601 or ≥1601 pg/ml): group A (n = 312, high FEV1, low NT-Pro-BNP), group B (n = 275, high FEV1, high NT-Pro-BNP), group C (n = 123 low FEV1, low NT-Pro-BNP) and group D (n = 161, low FEV1, high NT-Pro-BNP). The primary end point was survival at 1 and 5 years. Patients in group A had more severe aortic stenosis and achieved the best long-term survival at 1 [93% (95% CI: 90-96)] and 5 [45.3% (95% CI: 35.4-58)] years. Low FEV1 and high NT-Pro-BNP (group D) patients had more severe symptoms, higher Society of Thoracic Surgeons predicted risk of operative mortality, lower ejection fraction and aortic valve gradient at baseline. Patients in group D had the worst survival at 1 [76% (95% CI: 69-83)] and 5 years [13.1% (95% CI: 7-25)], hazard ratio compared to group A: 2.29 (95% CI: 1.6-3.2, P < 0.001) with 25.7% of patients in New York Heart Association class III-IV. Patients in groups B and C had intermediate outcomes. The combination of FEV1 and NT-Pro-BNP stratifies patients into 4 groups with distinct risk profiles and clinical outcomes. Patients with low FEV1 and high NT-Pro-BNP have increased comorbidities, poor functional outcomes and decreased long-term survival after TAVR.

569 IMPACT OF FRAILTY ON VERY LONG-TERM OUTCOME IN PATIENTS UNDERGOING PERCUTANEOUS TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN A HIGH-FLOW REFERRAL CENTER: A PROSPECTIVE STUDY

Abstract Background Transcatheter strategies for aortic stenosis (AS) are a therapeutic option in older patients not amenable for open heart surgery. Guidelines recommend surgical scores like the Society of Thoracic Surgeons (STS) for risk stratification. However, the long-term predictive power of these scores in older patients is limited. Purpose To assess the impact of frailty status on the very long-term mortality in patients with severe AS evaluated for transcatheter aortic valve implantation (TAVI) in a high-flow and high-volume tertiary care center. Methods Consecutive patients &amp;gt;80 years referred to TAVI from January to December 2019 at our tertiary care institution were prospectively screened for frailty through a comprehensive geriatric assessment (CGA) based on physical function and the Multidimensional Prognostic Index (MPI). The MPI is a three-level score used to stratify frailty and risk of mortality (low, intermediate, or high risk) based on eight key domains for frailty assessment (functional and cognitive status, nutrition, mobility, and risk of pressure sores, multimorbidity, polypharmacy and co-habitation). Frailty was defined by an intermediate-high MPI. Patients were also analyzed by STS score (&amp;lt;4%: low risk; 4-8%: intermediate risk; &amp;gt;8%: high risk). All patients prospectively called at 1, 2 and 3 years from TAVI. Results Overall, 134 patients were referred for TAVI (mean age: 84±4 years; &amp;gt;90 years: 12%, women 67%). Average STS score was 4.6 ± 3.0 (low risk: 49%; intermediate: 39%, high risk: 12%). Mean SPPB was 6.3±3.7 (SPPB &amp;lt;6: 32%). Ninety-five (71%) patients belonged to the MPI-low risk group, 30 (22%) to the MPI intermediate risk group and nine (7%) to the MPI high risk group. After 3 years, 17 (12.7%) patients died, and 40 (29.9%) were hospitalized: 21 (15.7%) for cardiovascular complications (N=11 for acute heart failure, N=6 for major bleeding, N=4 for stroke). Four patients (2.9%) implanted a pacemaker. One patient (0.7%) required a de-novo intervention. At Cox multivariable analysis, only frailty (MPI intermediate-high) was associated with mortality (HR 5.42, 95% C.I. 1.88-12.11, p=0.002) while a high STS score showed a trend towards higher mortality risk (HR 1.63, 95% C.I. 0.91-2.91, p=0.101). Overall, at Kaplan Meier survival analysis, patients considered fit (non-frail) were characterized by a better prognosis irrespective of STS score (&amp;lt;8 vs &amp;gt;8). Conclusions In a prospectively enrolled cohort of old TAVI candidates, frailty status was able to identify patients at higher risk of mortality irrespective of STS risk. Frailty assessment could be a useful tool, coupled with other scores, for early detection of patients at risk of disability, and potentially, for preventing the futility of the TAVI procedure.

Abstract 11119: Racial and Ethnic Disparities in Preoperative Characteristics and Outcomes Following Mitral and Tricuspid Valve Surgery

Introduction: Prior investigations assessing the impact of race and ethnicity on outcomes after mitral valve surgery have reported conflicting findings. The aim of this analysis was to examine the association of race with characteristics and outcomes for patients undergoing mitral and tricuspid valve (MV; TV) surgery using a representative statewide database. Methods: We performed retrospective analyses on 5,929 patients (2,707 female, median age 63 yrs) who underwent MV ( n =4,490, 76%), TV ( n =473, 8%), or both MV and TV ( n =966, 16%) surgery in a statewide collaborative of 10 centers from 2012-2020. The influence of race/ethnicity on preoperative characteristics, MV and TV repair rates, and postoperative outcomes was assessed for White ( n =4,208, 71%), Black ( n =1,261, 21%), Hispanic ( n =140, 2%), Asian ( n =169, 3%), and mixed/other race ( n =151, 3%) patients. Results: Black patients, compared to White patients, had a higher Society of Thoracic Surgeons predicted risk of morbidity or mortality (24.5% vs 13.1% P &lt;0.001) with a higher incidence of previous valve operations, myocardial infarction, stroke, hypertension, diabetes, and chronic lung disease. Compared to White patients, Black and Hispanic patients were less likely to undergo an elective procedure (White 71%, Black 55%, Hispanic 58%, P &lt;0.001). Degenerative MV disease was more prevalent in White patients (White 62%, Black 41%, Hispanic 43%, Asian 51%, mixed/other 45%, all P &lt;0.05) while rheumatic disease was more prevalent in non-White patients (Asian 28%, Hispanic 26%, mixed/other 25%, Black 17%, White 10%, all P &lt;0.05). Repair for degenerative MV disease was more prevalent in White vs Black patients (84% vs 74%, P &lt;0.001), but after multivariable adjustment race was no longer associated with MV repair ( P =0.073). In multivariable analyses, adverse postoperative outcome incidences were not different by race groups, including mortality. Conclusions: Patient race/ethnicity affects the burden of comorbidities at the time of presentation for operation and MV disease etiology. Strategies to improve early detection and referral for surgery and to decrease rates of rheumatic disease for racial and ethnic minority patients with MV and TV disease may enhance outcomes.

Characteristics and outcomes of normal-flow low-gradient aortic stenosis patients compared to high-gradient aortic stenosis patients undergoing TAVI

Abstract Background Guidelines recommend aortic valve replacement for aortic stenosis (AS) depending on mean pressure gradients (dPmean) and flow status. It is indicated when dPmean is ≥40 mmHg (high-gradient, HG) or when patients have low-flow low-gradient AS. Normal-flow (stroke volume index, SVi &amp;gt;35 ml/m2) low-gradient (dPmean &amp;lt;40 mmHg) (NFLG) AS is subject of scientific debate and severe AS is considered unlikely in current European guidelines. Purpose We hypothesized that NFLG patients are heterogenous, containing a subgroup similar to HG patients in terms of characteristics and outcomes. The purpose of this study was to identify and assess this subgroup by dividing NFLG patients by dPmean. Methods All patients undergoing transcatheter aortic valve implantation (TAVI) at our centre between 2013 and 2019 were analysed and categorised into groups according to dPmean, left-ventricular ejection fraction, and SVi. Among 2,326 patients analysed, 386 patients fulfilled criteria for NFLG AS (dPmean &amp;lt;40 mmHg, LV-EF ≥50%, SVi &amp;gt;35 ml/m2). They were further subdivided into two groups according to the median dPmean and were compared to 956 HG AS patients (dPmean ≥40 mmHg). Groups were compared for baseline characteristics, mortality, and outcomes according to Valve Academic Research Consortium (VARC) 3 definitions. Results Median dPmean was 33 mmHg in NFLG patients. Accordingly, they were split into two groups, with 204 patients above (higher gradient NFLG) and 182 patients below (lower gradient NFLG) this value. Characteristics of lower gradient NFLG patients differed from HG patients in many aspects while they were similar between higher gradient NFLG and HG patients. This was underscored by higher Society of Thoracic Surgeons (STS) scores in lower gradient NFLG compared to the other two groups (Table). Procedural and short-term clinical complications were similar between groups. The VARC-3 composite endpoint of technical failure occurred in 42 HG (4.4%), 12 higher gradient NFLG (5.9%), and 5 lower gradient NFLG patients (2.7%, p=0.32). The rates of the VARC-3 composite endpoint of device failure at 30 days were 108 patients (11.3%), 21 patients (10.3%), and 17 patients (9.3%), respectively (p=0.71). At follow-up, symptoms of patients from all three groups improved equally by at least one New York Heart Association class (p=0.47). Hazard ratio (HR) for 3-year mortality for all NFLG patients vs. HG patients was 1.4 [95% confidence interval, CI, 1.1–1.8]. Estimated 3-year all-cause mortality was significantly higher in lower gradient NFLG compared to HG patients, whereas mortality rate of higher gradient NFLG was similar to HG (Figure). Conclusions The data show that a large subgroup of NFLG patients has characteristics similar to those of HG patients, with similar clinical and procedural outcomes and comparable mortality rates. If severe AS was identified as the main clinical problem in this subgroup, aortic valve replacement can be justified. Funding Acknowledgement Type of funding sources: None.

Transfemoral Versus Subclavian Access for Transcatheter Aortic Valve Replacement.

Objective: This study sought to compare outcomes of transcatheter aortic valve replacement (TAVR) performed through subclavian access with those performed through transfemoral access. Methods: This was an observational study utilizing an institutional TAVR database from 2010 to 2018. All patients undergoing a TAVR via a transfemoral (TF-TAVR) or subclavian (SC-TAVR) approach were included in the study. The groups were analyzed for differences in operative mortality and postoperative outcomes. Multivariable Cox analysis was performed to identify variables associated with long-term survival after TAVR. Results: Of the 1,095 patients identified, 133 patients underwent SC-TAVR and 962 patients underwent TF-TAVR. Patients who underwent SC-TAVR were younger, more likely to have chronic lung disease and peripheral vascular disease, had higher Society of Thoracic Surgeons predicted risk of mortality scores, and were more likely to have self-expanding valves placed (P < 0.05). Operative mortality was similar between the TF-TAVR (2.7%) and SC-TAVR (3.8%) groups. There were no significant differences in stroke, length of stay, 30-day readmission, blood transfusions, acute kidney injury, need for permanent pacemaker, paravalvular leak, or major vascular complications between the groups (P > 0.05). The unadjusted Kaplan-Meier survival estimate for TF-TAVR was significantly higher than for SC-TAVR (P = 0.009, log-rank). However, on multivariable Cox analysis, subclavian access was not significantly associated with an increased hazard of death as compared with transfemoral access (P = 0.21). Conclusions: Outcomes of SC-TAVR are comparable to those of TF-TAVR. Subclavian access may be a favorable alternative approach when TF-TAVR is contraindicated.

Prevalence, Risk Factors, and Etiology of Extubation Failure in Pediatric Patients After Cardiac Surgery

AbstractIn this article, our primary objective was to investigate the prevalence and etiology of extubation failure (EF) in patients following cardiac surgery for congenital heart disease. Secondarily, we examined the association of different risk factors with EF. This was single-center retrospective study in a 27-bed cardiac intensive care unit at a quaternary children's hospital. All patients between 0 and 18 years of age who underwent congenital cardiac surgery from January 2008 to September 2019 were included. During the study period, among 8,750 surgical encounters, 257 (2.9%) failed extubation, defined as reintubation within 48 hours from extubation. EF patients were younger, smaller, more likely to have genetic syndromes, higher Society of Thoracic Surgeons and the European Association for Cardio-Thoracic Surgery (STAT) mortality scores, single-ventricle physiology, longer cardiopulmonary bypass (CPB) and cross-clamp (XC) times, longer mechanical ventilation (MV) duration, and higher mortality (p &lt;0.05). In a univariate analysis, EF patients when compared to matched controls by age, gender, and STAT score, and genetic syndrome, particularly heterotaxy, were associated with increased odds of EF (p &lt;0.05). In a multivariable logistic regression of the entire cohort, the presence of any genetic syndrome was associated with higher odds of EF (p &lt;0.05). In a subgroup of neonates, a univariate analysis was performed and multivariable analysis was attempted, but both did not achieve statistical significance. In summary, EF after congenital cardiac surgery is associated with younger age, lower weight, single-ventricle physiology, longer CPB and XC times, longer duration of MV, and genetic syndromes. Patients failing extubation have increased morbidity and mortality. Recognition of these risk factors may provide clinicians the ability to identify patients at high risk allowing for timely intervention to limit adverse outcomes.

Predictors of Permanent Pacemaker Implantation in Patients After Transcatheter Aortic Valve Replacement in a Chinese Population.

Background: Permanent pacemaker (PPM) implantation is the main complication of transcatheter aortic valve replacement (TAVR). Few studies have evaluated the requirement for PPM implantation due to ECG changes following TAVR in a Chinese population.Objective: Our study aimed to evaluate the incidence and predictors of PPM implantation in a cohort of Chinese patients with TAVR.Methods: We retrospectively evaluated 39 consecutive patients with severe native aortic stenosis referred for TAVR with a self-expandable prosthesis, the Venus A valve (Venus MedTech Inc., Hangzhou, China), from 2019 to 2021 at the Heart Center of Affiliated Zhongshan Hospital of Dalian University. Predictors of PPM implantation were identified using logistic regression.Results: In our study, the incidence of PPM implantation was 20.5%. PPM implantation occurs with higher risk in patients with negative creatinine clearance (CrCl), dyslipidemia, high Society of Thoracic Surgeons (STS) Morbimortality scores, and lead I T wave elevation. TAVR induced several cardiac electrical changes such as increased R wave and T wave changes in lead V5. The main independent predictors of PPM implantation were new-onset left bundle branch block (LBBB) (coef: 3.211, 95% CI: 0.899–7.467, p = 0.004) and lead I T wave elevation (coef: 11.081, 95% CI: 1.632–28.083, p = 0.016).Conclusion: New-onset LBBB and lead I T wave elevation were the main independent predictors of PPM implantation in patients undergoing TAVR. Clinical indications such as negative CrCl, dyslipidemia, high STS Morbimortality scores, and an increased T wave elevation before TAVR should be treated with caution to decrease the need for subsequent PPM implantation.

Predictors for the risk of permanent pacemaker implantation after transcatheter aortic valve replacement: A systematic review and meta-analysis.

Transcatheter aortic valve replacement (TAVR) is a less invasive treatment than surgery for severe aortic stenosis. However, its use is restricted by the fact that many patients eventually require permanent pacemaker implantation (PPMI). This meta-analysis was performed to identify predictors of post-TAVR PPMI. The PubMed, Embase, Web of Science, and Cochrane Library databases were systematically searched. Relevant studies that met the inclusion criteria were included in the pooling analysis after quality assessment. After pooling 67 studies on post-TAVR PPMI risk in 97,294 patients, balloon-expandable valve use was negatively correlated with PPMI risk compared with self-expandable valve (SEV) use (odds ratio [OR]: 0.44, 95% confidence interval [CI]: 0.37-0.53). Meta-regression analysis revealed that history of coronary artery bypass grafting and higher Society of Thoracic Surgeons (STS) risk score increased the risk of PPMI with SEV utilization. Patients with pre-existing cardiac conduction abnormalities in 28 pooled studies also had a higher risk of PPMI(OR: 2.33, 95% CI: 1.90-2.86). Right bundle branch block (OR: 5.2, 95% CI: 4.37-6.18) and first-degree atrioventricular block (OR: 1.97, 95% CI: 1.38-2.79) also increased PPMI risk. Although the trans-femoral approach was positively correlated with PPMI risk, the trans-apical pathway showed no statistical difference to the trans-femoral pathway. The approach did not increase PPMI risk in patients with STS scores >8. Patient-prosthesis mismatch did not influence post-TAVR PPMI risk (OR: 0.88, 95% CI: 0.67-1.16). We also analyzed implantation depth and found no difference between patients with PPMI after TAVR and those without. SEV selection, pre-existing cardiac conduction abnormality, and trans-femoral pathway selection are positively correlated with PPMI after TAVR. Pre-existing left bundle branch block, patient-prosthesis mismatch, and implantation depth did not affect the risk of PPMI after TAVR.

Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation

Ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT). However, its clinical significance has not been adequately studied. We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter indexed to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year. Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83 ± 6 vs 82 ± 6 vs 81 ± 6; P < .001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (6.3 ± 3.8 vs 5.1 ± 3.1 vs 4.9 ± 3.5; P < .001) than those in the other groups. Patients in the large SOVi group had a higher incidence of moderate or severe paravalvular regurgitation (11.9% vs 4.5% vs 3.5%; P < .001). At 1 year, a large SOVi was independently associated with an increased risk of mortality (HR: 1.62; 95% CI: 1.19-2.21; P=.002) and major or life-threatening bleeding (HR: 1.30; 95% CI: 1.02-1.65; P=.035). Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in patients undergoing TAVI.

Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation

Abstract Background Progressive dilatation of the aortic root is a common finding in patients with aortic stenosis. Although ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT), its clinical significance has not been adequately studied. Purpose We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Methods In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter index to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year. Results Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83±6 vs. 82±6 vs. 81±6; p&amp;lt;0.001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (6.3±3.8 vs. 5.1±3.1 vs. 4.9±3.5; p&amp;lt;0.001) than those in the other groups. Patients in the large SOVi group had a higher incidence of moderate or severe paravalvular regurgitation (11.9% vs. 4.5% vs. 3.5%; P&amp;lt;0.001). At 1 year, a large SOVi was independently associated with an increased risk of mortality (HR: 1.64; 95% CI: 1.21–2.23; P=0.001) and major or life-threatening bleeding (HR: 1.30; 95% CI: 1.03–1.65; P=0.029) after TAVI. Conclusions Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in AS patients undergoing TAVI. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Comparison of Transvalvular Aortic Mean Gradients Obtained by Intraprocedural Echocardiography and Invasive Measurement in Balloon and Self-Expanding Transcatheter Valves.

BackgroundConcerns about discordance between echocardiographic and invasive mean gradients after transcatheter aortic valve replacement (TAVR) with balloon‐expandable valves (BEVs) versus self‐expanding valves (SEVs) exist.Methods and ResultsIn a multicenter study, direct‐invasive and echocardiography‐derived transvalvular mean gradients obtained before and after TAVR were compared as well as post‐TAVR and discharge echocardiographic mean gradients in BEVs versus SEVs in 808 patients. Pre‐TAVR, there was good correlation (R=0.614; P<0.0001) between direct‐invasive and echocardiography‐derived mean gradients and weak correlation (R=0.138; P<0.0001) post‐TAVR. Compared with post‐TAVR echocardiographic mean gradients, both valves exhibit lower invasive and higher discharge echocardiographic mean gradients. Despite similar invasive mean gradients, a small BEV exhibits higher post‐TAVR and discharge echocardiographic mean gradients than a large BEV, whereas small and large SEVs exhibit similar post‐TAVR and discharge mean gradients. An ejection fraction <50% (P=0.028) and higher Society of Thoracic Surgeons predicted risk of mortality score (P=0.007), but not invasive or echocardiographic mean gradient ≥10 mm Hg (P=0.378 and P=0.341, respectively), nor discharge echocardiographic mean gradient ≥20 mm Hg (P=0.393), were associated with increased 2‐year mortality.ConclusionsInvasively measured and echocardiography‐derived transvalvular mean gradients correlate well in aortic stenosis but weakly post‐TAVR. Post‐TAVR, echocardiography overestimates transvalvular mean gradients compared with invasive measurements, and poor correlation suggests these modalities cannot be used interchangeably. Moreover, echocardiographic mean gradients are higher on discharge than post‐TAVR in all valves. Despite similar invasive mean gradients, a small BEV exhibits higher post‐TAVR and discharge echocardiographic mean gradients than a large BEV, whereas small and large SEVs exhibit similar post‐TAVR and discharge mean gradients. Immediately post‐TAVR, elevated echocardiographic‐derived mean gradients should be assessed with caution and compared with direct‐invasive mean gradients. A low ejection fraction and higher Society of Thoracic Surgeons score, but not elevated mean gradients, are associated with increased 2‐year mortality.

Aortic valve reintervention in patients with failing transcatheter aortic bioprostheses: A statewide experience

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement since its approval, the frequency and outcomes of aortic valve reintervention after transcatheter aortic valve replacement are poorly understood. MethodsValve reinterventions, either surgical transcatheter aortic valve explantation or repeat transcatheter aortic valve replacement, between 2012 and 2019 were queried using the Society of Thoracic Surgeons Database and the Transcatheter Valve Therapy Registry through the Michigan Statewide quality collaborative. The reintervention frequency and clinical outcomes including observed-to-expected mortality ratio using Society of Thoracic Surgeons Predicted Risk of Mortality were reviewed. ResultsAmong 9694 transcatheter aortic valve replacement recipients, a total of 87 patients (0.90%) received a reintervention, consisting of 34 transcatheter aortic valve explants and 53 repeat transcatheter aortic valve replacement procedures. The transcatheter aortic valve explant group demonstrated a higher Society of Thoracic Surgeons Predicted Risk of Mortality. Reintervention cases increased from 0 in 2012 and 2013 to 26 in 2019. The proportion of transcatheter aortic valve explants among all reinterventions increased and was 65% in 2019. Self-expandable devices had a higher reintervention rate than balloon-expandable devices secondary to a higher transcatheter aortic valve explant frequency (0.58% [23/3957] vs 0.19% [11/5737]; P = .001), whereas repeat transcatheter aortic valve replacement rates were similar (0.61% [24/3957] vs 0.51% [29/5737]; P = .51). Among patients with transcatheter aortic valve explants, contraindications to repeat transcatheter aortic valve replacement included unfavorable anatomy (75%), need for other cardiac surgery (29%), other structural issues by transcatheter aortic valve device (18%), and endocarditis (12%). For transcatheter aortic valve explant and repeat transcatheter aortic valve replacement, the 30-day mortality was 15% and 2% (P = .032) and the observed-to-expected mortality ratio was 1.8 and 0.3 (P = .018), respectively. ConclusionsAortic valve reintervention remains rare but is increasing. The clinical impact of surgical device explantation was substantial, and the proportion of transcatheter aortic valve explants was significantly higher in patients with a self-expandable device.

Five-year outcome in 18 010 patients from the German Aortic Valve Registry.

To determine the 5-year outcome in patients treated by isolated transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (sAVR)-a prospective observational cohort study. A total of 18 010 patients were included (n = 8942 TAVI and n = 9068 sAVR) in the German Aortic Valve Registry (GARY) who were treated in 2011 and 2012 at 92 sites in central Germany. Eligible patients with TAVI and sAVR were matched using propensity scores in a nearest-neighbour approach. Patients with repeat procedures or unequivocal indication for one treatment option (e.g. frailty) were excluded (n = 4785 for TAVI and n = 2 for sAVR). This led to 13 223 patients (4157 TAVI and 9066 sAVR) as an unmatched subcohort. The main outcome measure was the 5-year all-cause mortality. TAVI patients were significantly older (80.9 ± 6.1 vs 68.5 ± 11.1 years, P < 0.001), had a higher Society of Thoracic Surgeons (STS) score (6.3 ± 4.9 vs 2.6 ± 3.0, P < 0.001) and a higher 5-year all-cause mortality (49.8% vs 16.5%, P < 0.0001). There was no major difference in in-hospital stroke, in-hospital myocardial infarction, or temporary and chronic dialysis. In the propensity score-matched group (n = 3640), there were 763 deaths (41.9%) among 1820 TAVI patients compared with 552 (30.3%) among 1820 treated with sAVR during the 5-year follow-up (hazard ratio 1.51, 95% confidence interval 1.35-1.68; P < 0.0001). New pacemaker implantation was performed in 448 patients (24.6%) after TAVI and in 201 (11.0%) after sAVR (P < 0.0001). The 5-year follow-up data show that TAVI patients were significantly older and had a higher STS score than sAVR patients. After propensity score matching, TAVI with early-generation prosthesis was associated with significantly higher 5-year all-cause mortality than sAVR.

Delirium in older patients undergoing aortic valve replacement: incidence, predictors, and cognitive prognosis

BackgroundTranscatheter aortic valve replacement is increasingly performed in frail older patients who were previously ineligible for a standard surgical procedure. The objectives of this study are to determine delirium incidence, predictors, and relationship with cognitive performance at 3-month follow-up in older patients undergoing aortic valve replacement (AVR).MethodsPatients (N = 93) aged 70 years and older, undergoing transcatheter (TAVR, N = 66) or surgical (SAVR, N = 27) aortic valve replacement in an academic medical center were enrolled in this prospective cohort study. Delirium was assessed using the Confusion Assessment Method (CAM) on postoperative days 1, 2, 3, and 7. Data on patients’ socio-demographics, functional status (including instrumental activities of daily living (IADL), and surgical risk scores (including Society of Thoracic Surgeons (STS) risk score), were collected at baseline. Cognitive status was assessed with the Mini-Mental Status Exam (MMSE) and the Clock Drawing Test (CDT) at baseline and 3 months after AVR.ResultsDelirium occurred in 21 (23%) patients, within the first three postoperative days in 95% (20/21) of the cases. Delirium incidence was lower in TAVR (13/66 = 20%) than SAVR (8/27 = 30%) patients, but this difference was not statistically significant (p = .298). Patients with delirium had lower baseline cognitive performance (median MMSE score 27.0 ± 3.0 vs 28.0 ± 3.0, p = .029), lower performance in IADL (7.0 vs 8.0, p = .038), and higher STS risk scores (4.7 ± 2.7 vs 2.9 ± 2.3, p = .020). In multivariate analyses, patients with intermediate (score > 3 to ≤8) and high (score > 8) STS risk scores had 4.3 (95%CI 1.2–15.1, p = .025) and 16.5 (95%CI 2.0–138.2, p = .010), respectively, higher odds of incident delirium compared to patients with low (score ≤ 3) STS risk scores. At 3-month follow-up (N = 77), patients with delirium still had lower MMSE score (27.0 ± 8.0 vs 28.0 ± 2.0, p = .007) but this difference did not remain significant once adjusting for baseline MMSE (β-coefficient 1.11, 95%CI [− 3.03–0.80], p = .248).ConclusionsDelirium occurred in about one in five older patients undergoing AVR, almost essentially within the first three postoperative days. Beside cognitive performance, STS risk score could enhance the identification of high-risk older patients to better target preventative interventions.

Characteristics and outcomes of surgically ineligible patients with multivessel disease treated with percutaneous coronary intervention.

In this study we evaluated the clinical characteristics and outcomes of surgically ineligible patients with coronary artery disease (CAD) who underwent multivessel percutaneous coronary intervention (PCI). Patients with multivessel CAD who are surgically ineligible and undergo PCI are not well represented in large trials. Out of 1,061 consecutive patients who underwent a non-emergent PCI for unprotected left main or multivessel CAD at the University of Virginia Medical Center, 137 patients were determined to be surgically ineligible for coronary artery bypass graft (CABG) surgery by a heart team. The clinical characteristics and reasons for surgical ineligibility were collected. The coronary angiograms were reviewed and the SYNTAX score calculated. The Society of Thoracic Surgeons (STS) score was calculated. Outcomes were determined at 30 days and 1-year. The mean age of the cohort was 71 and 59% were women. Hypertension, hyperlipidemia, tobacco abuse, and diabetes were common comorbidities. The average SYNTAX score was 22. The most commonly cited reasons for surgical ineligibility were advanced age, frailty, severe lung disease, ejection fraction ≤ 30% and STS score ≥ 8%. Outcomes at 30 days were excellent and better than those predicted by STS for surgery. Frailty and STS score predicted one-year outcomes. Patients undergoing PCI for multivessel disease who are surgically ineligible have multiple risk factors and comorbidities. Frailty, lung disease, poor left ventricular function, and high STS score represent common reasons for surgical ineligibility. Frailty and the STS score better predict one-year outcomes after PCI compared to the SYNTAX score.

Hyperoxia During Cardiopulmonary Bypass Is Associated With Mortality in Infants Undergoing Cardiac Surgery.

Patients undergoing cardiac surgery using cardiopulmonary bypass have variable degrees of blood oxygen tension during surgery. Hyperoxia has been associated with adverse outcomes in critical illness. Data are not available regarding the association of hyperoxia and outcomes in infants undergoing cardiopulmonary bypass. We hypothesize that among infants undergoing cardiac surgery, hyperoxia during cardiopulmonary bypass is associated with greater odds of morbidity and mortality. Retrospective study. Single center at an academic tertiary children's hospital. All infants (< 1 yr) undergoing cardiopulmonary bypass between January 1, 2015, and December 31, 2017, excluding two patients who were initiated on extracorporeal membrane oxygenation in the operating room. None. The study included 469 infants with a median age of 97 days (interquartile range, 14-179 d), weight 4.9 kg (interquartile range, 3.4-6.4 kg), and cardiopulmonary bypass time 128 minutes (interquartile range, 91-185 min). A Pao2 of 313 mm Hg (hyperoxia) on cardiopulmonary bypass had highest sensitivity with specificity greater than 50% for association with operative mortality. Approximately, half of the population (237/469) had hyperoxia on cardiopulmonary bypass. Infants with hyperoxia were more likely to have acute kidney injury, prolonged postoperative length of stay, and mortality. They were younger, weighed less, had longer cardiopulmonary bypass times, and had higher Society of Thoracic Surgeons and the European Association for Cardio-Thoracic Surgery mortality scores. There was no difference in sex, race, preoperative creatinine, single ventricle physiology, or presence of genetic syndrome. On multivariable analysis, hyperoxia was associated with greater odds of mortality (odds ratio, 4.3; 95% CI, 1.4-13.2) but failed to identify an association with acute kidney injury or prolonged postoperative length of stay. Hyperoxia was associated with greater odds of mortality in subgroup analysis of neonatal patients. Hyperoxia occurred in a substantial portion of infants undergoing cardiopulmonary bypass for cardiac surgery. Hyperoxia during cardiopulmonary bypass was an independent risk factor for mortality and may be a modifiable risk factor. Furthermore, hyperoxia during cardiopulmonary bypass was associated with four-fold greater odds of mortality within 30 days of surgery. Hyperoxia failed to identify an association with development of acute kidney injury or prolonged postoperative length of stay when controlling for covariables. Validation of our data among other populations is necessary to better understand and elucidate potential mechanisms underlying the association between excess oxygen delivery during cardiopulmonary bypass and outcome.

Incremental prognostic value of tricuspid annular dilatation over the STS score

Abstract Background Transcatheter aortic valve replacement (TAVR) is the treatment of choice in most patients with severe aortic stenosis. The Society of Thoracic Surgeons (STS) score is a well established risk score to estimate morbidity, mortality and procedural risk of patients undergoing TAVR. However, tricuspid annular Dilatation (TAD), which is an increasingly recognized pathology associated with increased mortality, is not implemented in the STS Score. Purpose The purpose of this analysis was to investigate the incremental prognoctic value of TAD over the STS score. Methods Maximal septo-lateral diameter of the tricuspid annulus was measured in 923 patients on 3-dimensional MDCT datasets. A cut-off of 23 mm/m2 body-surface area was revealed by receiver-operating curve statistics and used to define TAD. Incremental prognostic Information was tested with c-index statistics and continuous net reclassification improvement (NRI). Patients were followed for 2 years and all-cause mortality was defined as study endpoint. Results Of 923 patients included in this analyis, TAD was found in 370 patients (40%). Patients with TAD had a significantly higher mortality (hazard ratio 2.18 with 95% CI 1.71 and 2.78, p&amp;lt;0.001). The mean STS score in the investigated patient cohort was 5.6±5.0. TAD provided incremental prognostic Information over the STS score when assessed with c-index statistics (rise from 0.63 to 0.66, p&amp;lt;0.01) or continuous NRI (0.209 with 95% CI 0.127 and 0.292, p&amp;lt;0.001). Estimated survival rates at 2 years were 88.2% (95% CI 84.5 and 92.1) in patients with a low STS score (&amp;lt;4) and no TAD and 57.5% (95% CI 51.1 and 64.7) in patients with a high STS score (&amp;gt;4) and TAD. Estimated survival rates in patients with a low STS score and TAD and patients with a high STS score and no TAD were similiar (75.8% with 95% CI 68.9 and 83.5 and 74.8% with 95% CI 69.2 and 80.7, respectively). Kaplan-Meier curves are shown in Figure 1. Conclusion TAD is a common entity in patients undergoing TAVR for severe aortic stenosis. It is associated with significantly higher mortality and provides incremental prognostic Information over the STS score. Funding Acknowledgement Type of funding source: None

Five-Year Outcome in 18,010 Patients from the German Aortic Valve Registry

Background: The 5-year outcome in patients undergoing isolated transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (sAVR) was evaluated from the German Aortic Valve Registry (GARY). Methods: Allocation to TAVI or sAVR was performed after a heart team decision. Eligible patients with TAVI and sAVR were matched using propensity scores in a nearest-neighbour approach. Findings: A total of 18,010 patients treated in 2011 and 2012 were included (n=8,942 TAVI and n=9,068 sAVR). Patients with repeat procedures or unequivocal indication for one treatment option (e.g. frailty, etc.) were excluded (n=4,785 for TAVI and n=2 for sAVR). This led to 13,223 patients (4,157 TAVI and 9,066 sAVR) as an unmatched subcohort. TAVI patients were significantly older (80·9±6·1 versus 68·5±11·1 years, p<0·001), had a higher Society of Thoracic Surgeons (STS) score (6·3±4·9 versus 2·6±3·0, p<0·001) and a higher 5-year all-cause mortality (49·8% versus 16·5%, p<0·0001). There was no major difference in-hospital stroke, in-hospital myocardial infarction, or temporary and chronic dialysis.In the propensity score-matched group (n=3,640), there were 763 deaths (41·9%) among 1,820 TAVI patients compared with 552 (30·3%) among 1,820 treated with sAVR during the 5-year follow-up (HR 1·51 (95% CI 1·35-1·68; p<0·0001). New pacemaker implantation was performed in 448 patients (24·6%) after TAVI and in 201 (11·0%) after sAVR (p<·0001). Interpretation: The 5-year follow-up data show, that TAVI patients were significantly older and had a higher STS score than sAVR patients. After propensity score matching TAVI with early generation prothesis was associated with significantly higher 5-year all-cause mortality than sAVR. Funding Statement: The registry receives funding of unrestricted grants from medical device companies (Edwards Lifesciences, Medtronic, Abbott, Boston Scientific), from the German Center for Cardiovascular Research (DZHK), the German Heart Foundation, the German Ministry of Health and donations from the Dr. Rolf M. Schwiete Foundation. Funding Statement: The registry receives funding of unrestricted grants from medical device companies (Edwards Lifesciences, Medtronic, Abbott, Boston Scientific), from the German Center for Cardiovascular Research (DZHK), the German Heart Foundation, the German Ministry of Health and donations from the Dr. Rolf M. Schwiete Foundation. Declaration of Interests: Sabine Bleiziffer received proctor and speaker fees from Medtronic. All other authors have no competing interests to declare. Ethics Approval Statement: The study complies with the Declaration of Helsinki. Subjects included in the registry gave informed consent and an ethics body at participating institutions approved the use of patient data for research purposes.