SAVR In Patients Research Articles

Hyperspectral Imaging for Microcirculatory Assessment of Patients undergoing Transcatheter and Surgical Aortic Valve Replacement-a Prospective Observational Pilot Study.

This prospective, observational study evaluated Hyperspectral Imaging (HSI) to assess the effects of cardiac surgery and cardiopulmonary bypass (CPB) on microcirculation. 40 Patients with severe aortic stenosis were enrolled. 20 patients underwent transapical/transaxillary/transaortic aortic valve replacement (TAVR), 20 underwent an open surgical approach with CPB (SAVR). HSI was used to determine tissue oxygenation (StO2 and NIR), hemoglobin (THI) and water content (TWI) at the palm before/after surgery (T1/T2), and on the third postoperative day (T3). TAVR patients showed no significant changes of microcirculatory parameters during surgery. TWI significantly increased until T3. SAVR patients showed an increase of TWI and a decrease of THI, while StO2 and NIR remained unchanged at T2. In SAVR patients, StO2 and NIR correlated negatively with the duration of CPB and StO2 correlated with intraoperative urine output at T2. HSI was able to detect microcirculatory changes during cardiac surgery. CPB duration seemed to affect tissue oxygenation. Clinical trial registration: (German Clinical Trial Register): DRKS00024765.

Temporal trends of aortic valve replacement modalities by age group in the United-States 2015 - 2023

Abstract Background/Introduction Transcatheter aortic valve implantation (TAVI) has led to a paradigm shift in treating aortic stenosis (AS) across patients of all surgical-risk categories. To guide the clinical decision, the ACC/AHA guidelines recommended an age group classification; with SAVR being recommended in patients < 65 years, and TAVI being favored over SAVR in patients > 80 years. In patients between 65-80 years, both modalities are to be considered after shared decision making. The impact of those guidelines-derived age group classification on the contemporary AVR practice remains of interest and is dynamically changing. Purpose This study aims to examine the temporal trends in the modality of AVR (TAVI vs SAVR) in the U.S. among different age groups using a contemporary nationwide database. Methods We conducted a retrospective study using de-identified data from the Vizient Clinical Database, which gathers patient and hospital data from more than 1000 medical Centre. We analysed TAVI and SAVR procedures from October 1, 2015, to November 30, 2023, excluding patients under 18. We examined the national trends of TAVI vs SAVR in 3 age groups (<65, 65-80, >80 years) with AS. Trend analysis was performed using linear regression. This study was deemed exempt from the requirements of 45 CFR 46.104(d) by The Miriam Hospital Institutional Review Board given that it involved de-identified data. Results During the study period, 467,832 underwent AVR (TAVI n= 252,834, SAVR n= 214,998). The patient and hospital characteristics by age group are summarized in the Table. We observed a significant rise in TAVI adoption from 33.5% in 2015 to 59.96% in 2023. However, the pattern of temporal trends varied among different age groups. In patients > 80 years, TAVI showed a steep rise from 69.95% in 2015 to 92.96% in 2023 (p<0.002). The 65-80 years age cohort demonstrated the most pronounced growth in TAVI, rising from 26.23% in 2015 to about 60% in 2020 (p.001), after which a plateau in percentage was observed. TAVI in patients <65 years has also been increasingly adopted, rising from 7.18% in 2015 to 19.12% in 2020 (p<0.002), however, followed with a slight downtrend to 16.36% in 2023 (Figure). Conclusion In this most contemporary analysis from the U.S., we demonstrate an increase in the adoption of TAVI across all age groups over the study period, with the steepest rise observed in patients between 65-80 years of age. Since the 2020 ACC/AHA guidelines, there has been a gradual downtrend in the utilisation of TAVI in patients <65 years of age indicating a possible change in practice based on scientific societal recommendations. The stabilization in TAVI percentage in the age groups 65-80 years and > 80 years in the last few years may hint towards approaching equilibrium between TAVI and SAVR for these age groups.Proportions of AVR across age groups

Predictors of LV reverse remodeling after SAVR: insights from a prospective TTE and CMR study in patients with severe aortic stenosis

Abstract Background Left ventricular (LV) remodeling in patients with severe aortic stenosis (AS) is believed to be reversible after pressure overload relieve, as provided by both surgical (SAVR) or transcatheter aortic valve replacement. However, LV reverse remodeling (RR) is far from uniform in patients with AS and the same clinical indication for treatment. Aim To determine the prevalence and imaging predictors of LV RR after SAVR in patients with severe symptomatic AS. Methods single-center, prospective cohort study enrolling 119 patients with severe symptomatic AS (age 71±8y, 49% male; mean transaortic gradient 62±18mmHg, mean indexed aortic valve area (AVAi) 0.40±0.10 cm2/m2, mean LV ejection fraction by TTE 58±9%), with no previous history of ischemic cardiomyopathy, undergoing SAVR between 2019 and 2022. All patients underwent serial imaging assessment beyond clinical characterization (transthoracic echocardiogram – TTE, and 1.5T cardiac magnetic resonance - CMR) prior to surgery and at the 3rd to 6th month post-SAVR. Endomyocardial biopsy (EMB) for myocardial fibrosis quantification (Masson ́s Trichrome histochemistry) was performed during SAVR. LV RR was defined when in presence of at least one of the imaging criteria: > 15% reduction in LV end-diastolic indexed volume (LVEDV) by CMR; > 15% reduction in LV indexed mass (LVM) by CMR; > 15% reduction in LV geometric remodeling by CMR; >10% increase in LV ejection fraction (LVEF) either from TTE or CMR; > 50% increase in global longitudinal strain (GLS) at TTE. Clinical, imaging and histology derived data were compared in patients with post-SAVR LV RR and for each of the defined criteria. Results 107 patients (90%) met at least one criteria of LV RR. Morphological criteria were more prevalent than LV functional improvement after SAVR (Figure 1). In patients who met at least one criteria of LV RR, no differences were found between NT- proBNP, LV tissue characterization (by CMR) or myocardial fibrosis at EMB. Yet, those with LV RR had significantly smaller preoperative AVAi (0.4±0.9 vs 0.5±0.9 cm2/m2, p=0.007) and higher mean valvular gradients (62±18 vs 49±12 mmHg, p=0.017). Considering individual LV RR criteria, patients with higher NT-proBNP levels met LVEF and morphological (LVEDV and LVM) LV RR criteria (p=0.027, p=0.016 and p= 0.003, respectively). Patients with higher % of late gadolinium enhancement on pre-operative CMR [7.8 (IQR 2.5-11.3) vs. 1.6 (IQR 0-5.2)%, p=0.017] had significant GLS improvement after SAVR. Conclusion In a cohort of patients with classical severe, symptomatic AS, LV RR is common after SAVR, occurring in almost 9 out of every 10 patients. Both indexes of worse valve narrowing and pre-operative LV adaptation are associated with favorable RR after surgery. This underlines the benefits of a timely intervention even in patients with more advanced disease.

Ischemic stroke incidence in intermediate or high-risk patients undergoing transcatheter aortic valve replacement versus surgical aortic valve replacement: a comparative systematic review and meta-analysis

Background and purposeThis comparative systematic review and meta-analysis investigated the incidence of ischemic stroke in intermediate-to-high-risk patients undergoing transcatheter aortic valve replacement versus surgical aortic valve replacement.MethodsWe conducted a systematic review and meta-analysis following the PRISMA guidelines, searching PubMed, Google Scholar, Embase, Web of Science, and Cochrane CENTRAL databases from their inception to December 2023. The evaluated outcomes were primarily incidence of stroke and transient ischemic attack (TIA), along with other secondary safety end-points at 30 days and 1 year post-procedure. Odds ratios (ORs) with 95% confidence intervals (CIs) were utilized for each study, employing a random-effects model for data synthesis irrespective of heterogeneity. Statistical heterogeneity was assessed using I2 statistics. All statistical analyses were conducted using Review Manager.ResultsWe screened 8028 articles and included 8 studies consisting of 5 randomized controlled trials and 3 observational studies. The studies examining 30-day and 1-year stroke incidence found no significant difference between TAVR and SAVR patients (OR 0.83, 95% CI 0.59 to 1.17, p = 0.30, OR 0.92, 95% CI 0.64 to 1.33, p = 0.67, respectively). Both TAVR and SAVR also had a comparable risk of having a transient ischemic attack within 30 days (OR 0.93, 95% CI 0.24 to 3.63, p = 0.92, I2 52%) and 1 year (OR 1.15, 95% CI 0.72 to 1.82, p = 0.56, I2 0%) following the procedure. Regarding safety endpoints, TAVR had lower rates of all-cause mortality and acute kidney injury at 1 year post-procedure, but a higher incidence of major vascular complications at both 30 days and 1 year compared with SAVR.ConclusionThe results suggest that TAVR and SAVR have comparable outcomes for both TIA and stroke incidence at 30 days and 1 year post-procedure, but display varying safety profiles in intermediate-to-high surgical risk patients.

Registry of Transcatheter Aortic Valve Implantation (TAVI) for Patients with Severe Aortic Stenosis at Ain Shams University Hospitals

Abstract Background TAVI is now the standard of care for inoperable patients and a valid alternative to surgery for many high-risk patients (5). it has shown non-inferiority to SAVR in patients with intermediate risk for cardiac surgery, Other recent trials have assessed the safety of TAVI in low-risk patients such as the PARTNER 3, Nordic NOTION 2 and the Medtronic TAVR low risk trial. Aim The aim of this study was to evaluate the clinical and echocardiographic outcomes in patients undergoing successful TAVI at Ain Shams University Hospitals during six months follow-up after the procedure, according to the Valve Academic Research Consortium-3 (VARC-3). (9) Methods This is a retrospective & prospective cohort Study. It was conducted in cardiology department, Ain Shams University Hospitals in the period of November 2022 to May 2023.it included (151) patients who were treated with TAVI in Ain Shams University Hospitals in the period From January 2020 to October 2022 retrospectively and from November 2022 to May 2023 prospectively29 patients were missed during follow up and excluded due to incomplete data and failure of follow up, to end the study with (122) patients, fulfilling the inclusion criteria. Results Regarding death as the most objective and unbiased endpoint, our registry reported a 30-day survival rate of (97.5%), and a six-month survival rate of (96.7%). Regarding symptomatology, our registry shows high significant improvement of symptoms with 99 (81.1%) of patients were asymptomatic at follow up, p-value (<0.001), and the majority of patients with NYHA III (73%) & IV (26.2%) at baseline show high significant improvement with majority of patients at NYHA I (91.8%) & II (7.4%) at follow up with p-value (<0.001). Based on echocardiography assessment in our registry, TAVI significantly improved the patient’s hemodynamics. The mean pre- and post-procedural left ventricular ejection fraction were 59.10 ± 14.62 and 62.70 ± 11.75 respectively with p-value (<0.001), also patients with reduced EF% show significant improvement with mean pre- and post-procedural LV EF% 33.44 ± 8.42 and 42.16 ± 8.40 respectively with p-value (<0.001), The mean pre- and post-procedural pressure gradient (MPG) was 50.12 ± 14.00 and 6.13 ± 1.58 respectively with p-value (<0.001), with more than (99%) absence of moderate or severe valvular leak. Conclusions Our registry shows favourable short-term clinical outcomes in unselected TAVI patients, The study found that TAVi candidates in Egypt were younger, had a lower risk for cardiac surgery, and had lower rates of post-procedural complications and mortality than other international all-comer registries, denoting the procedure as safe and beneficial especially by accumulating experience and technical advances in devices and not only add years to patients life by reducing all-cause mortality but also add life to their years by improving quality of life.

Early extubation after elective surgical aortic valve replacement during the COVID-19 pandemic

BackgroundSurgical aortic valve replacement (SAVR) is an established therapy for severe calcific aortic stenosis. Enhanced recovery after cardiac surgery (ERACS) protocols have been shown to improve outcomes for elective cardiac procedures. The COVID-19 pandemic prompted early extubation post-elective surgeries to preserve critical care resources.Aim of this studyTo investigate the effects of extubating patients within 6 h post-elective SAVR on hospital and ICU length of stay, mortality rates, ICU readmissions, and postoperative pneumonia.Study Design and methodsThe retrospective analysis at the University Hospital Aachen, Germany, includes data from 2017 to 2022 and compares a total of 73 elective SAVR patients. Among these, 23 patients were extubated within 6 h (EXT group), while 50 patients remained intubated for over 6 h (INT group).ResultsThe INT group experienced longer postoperative ventilation, needed more vasopressor support, had a higher incidence of postoperative pneumonia, and longer ICU length of stay. No significant differences were noted in overall hospital length of stay, mortality, or ICU readmission rates between the groups.ConclusionThis study demonstrates that early extubation in high-risk, multimorbid surgical aortic valve replacement patients is safe, and is associated with a reduction of pneumonia rates, and with shorter ICU and hospital length of stays, reinforcing the benefits of ERACS protocols, especially critical during the COVID-19 pandemic to optimize intensive care use.

OR7-4 | Comparative Analysis of TAVR versus SAVR in patients with Heart Failure with Reduced Ejection Fraction: A Nationwide Observational Study

OR7-4 | Comparative Analysis of TAVR versus SAVR in patients with Heart Failure with Reduced Ejection Fraction: A Nationwide Observational Study

Transcatheter aortic valve replacement achieves similar predicted effective orifice area to surgical aortic valve replacement in bicuspid aortic stenosis

BackgroundStudies comparing transcatheter and surgical aortic valve replacement (TAVR and SAVR) for patients with trileaflet aortic stenosis (AS) have found similar or larger effective orifice area (EOA) for TAVR prostheses. To our knowledge, no studies have compared EOA in patients undergoing TAVR versus SAVR for bicuspid AS. MethodsWe retrospectively compared prosthetic valvular sizing and predicted EOA for patients with bicuspid AS undergoing TAVR or SAVR at our institution between January 1, 2016, and December 31, 2021. We excluded patients undergoing procedures for indications other than AS and those without a pre-procedural gated Chest CT. Comparisons included demographics, comorbidities, annular size, prosthetic valve size, predicted EOA and prosthesis-patient mismatch (PPM) for TAVR (N = 78) and SAVR (N = 74) cohorts. ResultsTAVR patients had smaller pre-procedural annular area (501.7 mm2 vs. 571.8 mm2, p < 0.05) and annular perimeter (80.6 mm vs. 86.5 mm, p < 0.05), but larger mean implanted prosthetic valve size (26.4 mm vs 24.2 mm, p < 0.001) compared to SAVR patients. No differences were observed in predicted EOA, predicted EOA indexed to patient body surface area (EOAi), or predicted PPM grade between TAVR and SAVR groups, including in cohorts sorted by pre-procedural annular size. ConclusionsFor bicuspid AS patients undergoing aortic valve replacement, TAVR achieves similar predicted EOA to SAVR. These data support the use of TAVR in selected patients with bicuspid AS and can inform heart team discussions.

Transcatheter versus surgical aortic valve replacement in patients with aortic stenosis: molecular pathways and correlation with clinical and echocardiographic parameters

Abstract Background Transcatheter aortic valve replacement (TAVR) has reformed the management of aortic stenosis (AS), being firstly approved in high-risk patients and becoming progressively a therapeutic alternative to surgery (surgical aortic valve replacement, SAVR) for all the risk categories. Several data pointed out the role of inflammation, oxidative stress, and pathological remodeling in AS natural history. The aim of our study is to investigate the molecular pathways involved in the AS pathophysiology and in the early response to AV replacement in patients subjected to percutaneous or surgical approach. Secondary aims are to evaluate the variation in clinical and echocardiographic parameters of left ventricular (LV) function before and after procedure. Methods We enrolled 36 consecutive patients with a diagnosis of severe AS and preserved ejection fraction (17 SAVR patients and 19 TAVR patients). Biological samples, clinical and echocardiographic evaluation were gained before (T0) and 72 hours after the procedure (T1). We performed 3 gene expression arrays on pooled cDNA from peripheral blood mononuclear cells of the 2 study groups. Results SAVR patients were significantly younger (p=0.0003) and with a lower STS score (p=0.0004). After the procedure, SAVR showed a longer ICU stay (p=0.0019) and a more frequent need of inotropes/vasopressors (p=0.006). Gene expression analysis revealed a reduction of the pro-apoptotic gene CASP3 (n=13; median, IQR: 1.01, 0..89-1.62 for T0 vs 0.68, 0.58-0.85 for T1; p=0.019) and of the transcription factor MEF2C (n=13; 1.00, 0.57-1.31 for T0 vs 0.56, 0.42-0.87 for T1; p=0.028) in TAVR patients, together with significantly increased levels of the antioxidant molecule GPX1 (n=14; 1.04, 0..71-1.34 for T0 vs 1.37, 1.23-1.85 for T1;p=0.030). In SAVR patients, our data showed increased post-procedural levels of GPX1 (n=6; 0.99, 0.49-1.23 for T0 vs 1.81, 1.27-2.00 for T1; p=0.028), and of the oxidative markers CAT (n=10; 0.40, 0.27-0.69 for T0 vs 1.17, 0.59-2.06 for T1; p=0.022,) and NOX2 (n=8; 0.41, 0.31-0.63 for T0 vs 1.04, 0.73-1.54 for T1; p=0.012) (Fig.1). TAVR patients displayed a direct correlation between the gene expression of molecules involved in apoptosis (CASP3), myocardial remodeling (GTF2I, MEF2C) and oxidative stress (MPO, CAT, TXNIP) and indexed left ventricular volumes (Fig.2A), while SAVR patients showed an inverse correlation with LVEF for GTF2I, MEF2C, CAT and MPO gene expression levels (Fig.2B). Conclusions By demonstrating 1) a significant post-procedural downregulation in the expression of genes involved in oxidative stress pathways for TAVR patients if compared with SAVR patients, and 2) a significant correlation of the basal levels of genes involved in apoptosis, myocardial remodeling, and oxidative stress with post-procedural ventricular volumes and LVEF, our study provides a biological rationale to support the percutaneous approach for AS patients, independently from their class of risk.Figure 1Figure 2

Comparison of therapeutic strategies for aortic stenosis between transcatheter and surgical aortic valve implantation: a retrospective cohort study in Japanese dialysis patients

BackgroundAlthough transcatheter aortic valve implantation (TAVI) is assumed to be a less invasive therapy in high-risk patients with aortic valve stenosis (AS), there have been limited data suggesting its beneficial effects on cardiovascular mortality in Japanese patients receiving dialysis therapy.MethodsHemodialysis patients with severe AS underwent either TAVI (n = 33) or surgical aortic valve replacement (SAVR, n = 25). We compared the postoperative outcomes and perioperative complications, including dialysis-associated parameters [e.g., intradialytic hypotension (IDH)], between TAVI and SAVR.ResultsA 30-day and 1-year mortality rate was nearly the same among the TAVI and the SAVR group. Incidence of permanent pacemaker implantation or other events, including stroke, bleeding and vascular complications, in the TAVI group were not different from those in SAVR patients during the 30-day or 1-year postoperative period. The incidence of IDH was increased following SAVR (odds ratio (OR) = 11.29 [95% CI 1.29–98.89]) but was not affected by TAVI (OR = 1.55 [95% CI 0.24–9.94]). Among the patients aged 75 or older, the incidence of IDH was particularly conspicuous in the SAVR group (OR = 15.75 [95% CI 2.30–107.93]). Because there were differences in background data (age, EuroSCORE II, and dialysis duration) between these groups, propensity score-matched analysis was conducted and showed no difference in the composite event-free probability between the TAVI and the SAVR group over one year (p = 0.816).ConclusionsTAVI offers an alternative strategy to Japanese hemodialysis patients with severe AS, with nearly the same incidence of complications as SAVR during 1-year observation.

P407 MULTIDIMENSIONAL ASSESSMENT OF THE ELDERLY PATIENT WITH SEVERE AORTIC STENOSIS: THE ROLE OF FRAILTY IN THE CHOICE OF TREATMENT (TAVI/SAVR)

Abstract Background Surgical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVI) are treatment options in patients with severe aortic stenosis. International guidelines suggest both traditional risk scores and a Comprehensive Geriatric Assessment (GCA) be determinants in treatment decision–making. The aim of the study is to identify the GCA parameters associated with the decision to perform TAVI instead of SAVR in elderly patients with severe aortic stenosis. Materials and Methods Between 2019 and 2022, 66 patients aged ≥75 years were referred to the Cardiology department of Padua Hospital for pre–operative evaluation, including CGA. The CGA consisted of functional status (Activities of Daily Living and Instrumental Activities of Daily Living Scales), cognitive impairment (Mini Mental State Examination, Montreal Cognitive Assessment), mood disorders (Geriatric Depression Scale), physical performance (Short Physical Performance Battery, 6–minute Walking Test, grip strength) and quality of life (Short–Form 36 items Health Survey). Results SAVR was proposed to 53% of patients and TAVI to 47%. The mean age was 78.9 ± 4.8 years and 47% were women. TAVI patients were older and had lower scores on both cognitive and motor performance tests than SAVR patients. The geriatric parameters associated with treatment decision–making between SAVR and TAVI were age (OR= 1.64, p &amp;lt; 0.04) and gait speed (OR= 0.09, p = 0.05). Conclusions Therapeutic decision–making in elderly patients with severe aortic stenosis is not only influenced by age, but also by a frailty index, gait speed. This could become a simple, quick and inexpensive routine test to effectively stratify patients.

Isolated surgical vs. transcatheter aortic valve replacement: a propensity score analysis

BackgroundThe debate about the optimal approach for aortic valve replacement continues. We compared the hospital and long-term outcomes (survival, aortic valve reintervention, heart failure readmissions, and stroke) between transcatheter vs. surgical (TAVR vs. SAVR) aortic valve replacement. The study included 789 patients; 293 had isolated SAVR, and 496 had isolated TAVR. Patients with concomitant procedures were excluded. Propensity score matching identified 53 matched pairs.ResultsPatients who had TAVR were significantly older (P ˂ 0.001) and had significantly higher EuroSCORE II (P ˂ 0.001), NYHA class (P ˂ 0.001), and more prevalence of diabetes mellitus (P ˂ 0.001), hypertension (P ˂ 0.001), chronic lung disease (P = 0.001), recent myocardial infarction (P = 0.002), and heart failure (P ˂ 0.001), stroke (P = 0.02), atrial fibrillation (P = 0.004), and previous percutaneous coronary interventions (P ˂ 0.001) than SAVR patients. In the matched cohort, atrial fibrillation occurred more frequently after SAVR (P = 0.01), and hospital stay was significantly longer in SAVR patients (P ˂ 0.001). There were no differences in hospital mortality between groups (P ˃ 0.99). Survival at 1, 3, and 5 years was 97%, 95%, and 94% for SAVR and 91%, 79%, and 58% for TAVR patients. Survival was lower in TAVR patients before matching (P ˂ 0.001) and after matching (P = 0.045). Freedom from the composite endpoint of stroke, aortic valve reintervention, and heart failure readmission at 1, 3, and 5 years was 98.9%, 96%, and 94% for SAVR and 94%, 86%, and 75% for TAVR. The composite endpoint was significantly higher in the TAVR group than in SVR before matching (P ˂ 0.001), while there was no difference after matching (P = 0.07). There was no significant difference in the change in ejection fraction between groups (β: −0.88 (95% CI: −2.20–0.43), P = 0.19), and the reduction of the aortic valve peak gradient was significantly higher with TAVR (β: −7.80 (95% CI: −10.70 to −4.91); P ˂ 0.001).ConclusionsTAVR could reduce postoperative atrial fibrillation and hospital stay. SAVR could have long-term survival benefits over TAVR with comparable long-term stroke, heart failure readmission, and aortic valve reinterventions between SAVR and TAVR.

Late outcomes of valve-in-valve transcatheter aortic valve implantation versus re-replacement: Meta-analysis of reconstructed time-to-event data

AimsTo evaluate all-cause mortality in ViV-TAVI versus redo SAVR in patients with failed bioprostheses. MethodsStudy-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of non-randomized studies published by September 30, 2021. ResultsTen studies met our eligibility criteria and included a total of 3345 patients (1676 patients underwent ViV-TAVI and 1669 patients underwent redo SAVR). Pooling all the studies, ViV-TAVI showed a lower risk of all-cause mortality in the first 44 days [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.49–0.93, P = 0.017], with an HR reversal after 197 days favoring redo SAVR (HR 1.53; 95% CI 1.22–1.93; P < 0.001). Pooling only the matched populations (1143 pairs), ViV-TAVI showed a lower risk of all-cause mortality in the first 55 days [hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.45–0.89, P < 0.001], with a reversal HR after 212 days favoring redo SAVR (HR 1.57; 95% CI 1.22–2.03; P < 0.001). The Cox regression model showed a statistically significant association of prosthesis-patient mismatch (PPM) with all-cause mortality during follow-up for ViV-TAVI (HR 1.03 per percentage increase in the study- and treatment arm-level proportion of PPM, 95% 1.02–1.05, P < 0.001). ConclusionViV-TAVI is associated with a strong protective effect immediately after the procedure in comparison with redo SAVR, however, this initial advantage reverses over time and redo SAVR seems to be a protective factor for all-cause mortality after 6 months. Considering that these results are the fruit of pooling data from observational studies, they should be interpreted with caution and trials are warranted.

Abstract 13481: Incidence of Post-Cardiac Injury Syndrome in Transcatheter and Surgical Aortic Valve Replacement

Introduction: Cardiac procedures and surgeries can cause injury to the pericardium and result in pericarditis, termed post-cardiotomy syndrome or post-cardiac injury syndrome (PCIS). The incidence of PCIS after transcatheter aortic valve replacement (TAVR) is unknown, and the aim of the current study is to compare the incidence of PCIS in surgical versus transcatheter aortic valve replacement (SAVR, TAVR). Methods: In a single-center retrospective cohort study of randomly selected patients who had TAVR or SAVR in 2019, the primary outcome was PCIS, defined according to ESC guidelines. Pericarditis recurrence was also defined according to ESC guidelines. Due to baseline differences in SAVR and TAVR patients, propensity score matching was performed using calipers of width equal to 0.2 of the standard deviation of the logit of the propensity score. Results: Patients undergoing TAVR (n=103) were older, had higher STS-PROM scores, and generally more co-morbidities compared to patients undergoing SAVR (n=100), with the exception of atrial fibrillation (Table). Overall, 17 patients (17%) with SAVR had PCIS compared to 1 patient (1%) with TAVR (p&lt;0.001). Ten patients (4.9%) were treated with pericarditis specific medications, of whom 7 (3.4%) received colchicine. Two patients (1.0%) developed recurrent pericarditis. In the sub-group (n=44) of propensity matched patients (Figure), 6 SAVR patients (27.3%) and no TAVR patients had PCIS. Conclusions: After TAVR, PCIS appears rare, which suggests that occult pericardial injury is uncommon. PCIS may also be less common after TAVR compared to SAVR, though larger studies are needed.

Early and mid-term outcome of patients with low-flow-low-gradient aortic stenosis treated with newer-generation transcatheter aortic valves.

Patients with non-paradoxical low-flow–low-gradient (LFLG) aortic stenosis (AS) are at increased surgical risk, and thus, they may particularly benefit from transcatheter aortic valve replacement (TAVR). However, data on this issue are still limited and based on the results with older-generation transcatheter heart valves (THVs). The aim of this study was to investigate early and mid-term outcome of TAVR with newer-generation THVs in the setting of LFLG AS. Data for the present analysis were gathered from the OBSERVANT II dataset, a national Italian observational, prospective, multicenter cohort study that enrolled 2,989 consecutive AS patients who underwent TAVR at 30 Italian centers between December 2016 and September 2018, using newer-generation THVs. Overall, 420 patients with LVEF ≤50% and mean aortic gradient <40 mmHg were included in this analysis. The primary outcomes were 1-year all-cause mortality and a combined endpoint including all-cause mortality and hospital readmission due to congestive heart failure (CHF) at 1 year. A risk-adjusted analysis was performed to compare the outcome of LFLG AS patients treated with TAVR (n = 389) with those who underwent surgical aortic valve replacement (SAVR, n = 401) from the OBSERVANT I study. Patients with LFLG AS undergoing TAVR were old (mean age, 80.8 ± 6.7 years) and with increased operative risk (mean EuroSCORE II, 11.5 ± 10.2%). VARC-3 device success was 83.3% with 7.6% of moderate/severe paravalvular leak. Thirty-day mortality was 3.1%. One-year all-cause mortality was 17.4%, and the composite endpoint was 34.8%. Chronic obstructive pulmonary disease (HR 1.78) and EuroSCORE II (HR 1.02) were independent predictors of 1-year mortality, while diabetes (HR 1.53) and class NYHA IV (HR 2.38) were independent predictors of 1-year mortality or CHF. Compared with LFLG AS treated with SAVR, TAVR patients had a higher rate of major vascular complications and permanent pacemaker, while SAVR patients underwent more frequently to blood transfusion, cardiogenic shock, AKI, and MI. However, 30-day and 1-year outcomes were similar between groups. Patients with non-paradoxical LFLG AS treated by TAVR were older and with higher surgical risk compared with SAVR patients. Notwithstanding, TAVR was safe and effective with a similar outcome to SAVR at both early and mid-term.

Tricuspid regurgitation worsening after transcatheter or surgical aortic valve replacement

Abstract Background Tricuspid regurgitation (TR) often occurs concomitantly with severe aortic stenosis. Post-operative worsening of tricuspid regurgitation has been observed after surgical and transcatheter aortic valve replacement (SAVR, TAVR) [1,2]. Purpose Pre-procedural severe tricuspid regurgitation has been shown to be a predictor of all-cause mortality in patients undergoing transcatheter aortic valve replacement (TAVR) [3,4]. However, little is known about the incidence of worsening tricuspid regurgitation after SAVR and TAVR and the impact on post-procedural outcomes. This study aims to evaluate, characterize and compare the incidence of worsening TR after TAVR and SAVR. Methods Retrospective single-center study of patients undergoing Transcatheter and Surgical Aortic Valve Replacement for severe aortic stenosis between 2014 and 2020. Incidence of tricuspid regurgitation was noted on echocardiogram at baseline and 1 year after TAVR or SAVR. This study enrolled 430 patients in the TAVR group and 237 patients in the SAVR group. The SAVR group only included patients who underwent isolated SAVR without any other valve intervention. Patients with severe TR at baseline were excluded from the study. Progression of TR severity was defined as deterioration by at least 1 grade of severity compared to baseline on echocardiography. Multivariable logistic regression analysis was performed to identify associations with worsening TR. Results Mean age of TAVR patients was higher than the SAVR patients (79±9 vs 68±12 years, p&amp;lt;0.0001). TAVR patients also had a significantly higher EuroSCORE than the SAVR patients (8.0±7 vs 3.5±4, p&amp;lt;0.0001). TAVR group was more likely to have atrial fibrillation than the SAVR group (34% vs 24%, p=0.006). Baseline right ventricular dysfunction and right ventricular enlargement were significantly higher in the TAVR group compared to the SAVR group [9% vs 4%, (p=0.009) and 10% vs 6%, (p=0.04), respectively]. Progression of TR severity occurred in 21.8% (94/430) of TAVR patients and 31.2% (74/237) of SAVR patients. Majority of these patients progressed from absent TR to mild TR [13.2% (57) in TAVR group vs 19.8% (47) in SAVR group (p=0.02)]. 6.3% (27) of patients in the TAVR group and 8.8% (21) of patients in the SAVR group had mild to moderate worsening of TR (p=0.22). 1.63% (7) in the TAVR group and 2.1% (5) in the SAVR group had progression from moderate to severe TR (p=0.65). On multivariable analysis, SAVR (Odds ratio, 2.46 [CI, 1.6–3.7]) and age (Odds ratio, 1.03 [CI, 1.03–1.05]) were associated with worsening TR severity. Conclusions In this retrospective observational study, SAVR and age were found to be associated with worsening tricuspid regurgitation. Majority of these patients progressed from absent TR to mild TR after SAVR. Further studies are necessary to determine long term outcomes of worsening tricuspid regurgitation after TAVR and SAVR. Funding Acknowledgement Type of funding sources: None.

Propensity matched comparison of TAVI and SAVR in intermediate-risk patients with severe aortic stenosis and moderate-to-severe chronic kidney disease: a subgroup analysis from the German Aortic Valve Registry

ObjectiveWe compared TAVI vs. SAVR in patients with moderate-to-severe chronic kidney disease (eGFR 15–60 ml/min/1.73 m2) for whom both procedures could possibly be considered (age ≤ 80 years, STS-score 4–8).BackgroundAccording to both ACC/AHA and ESC/EACTS recent guidelines, aortic stenosis may be treated with either transcatheter (TAVI) or surgical (SAVR) aortic valve replacement in a subgroup of patients. A shared therapeutic decision is made by a heart team based on individual factors, including chronic kidney disease (CKD).MethodsData from the large nationwide German Aortic Valve Registry were used. A propensity score method was used to select 704 TAVI and 374 SAVR matched patients. Primary endpoint was 1-year survival. Secondary endpoints were clinical complications, including pacemaker implantation, vascular complications, myocardial infarction, bleeding, and the need for new-onset dialysis.ResultsOne-year survival was similar (HR [95% CI] for TAVI 1.271 [0.795, 2.031], p = 0.316), with no divergence in Kaplan–Meier curves. In spite of post-procedural short-term survival being numerically higher for TAVI patients and 1-year survival being numerically higher for SAVR patients, such differences did not reach statistical significance (96.4% vs. 94.2%, p = 0.199, and 86.2% vs. 81.2%, p = 0.316, respectively). In weighted analyses, pacemaker implantation, vascular complications, and were significantly more common with TAVI; whereas myocardial infarction, bleeding requiring transfusion, and longer ICU-stay and overall hospitalization were higher with SAVR. Temporary dialysis was more common with SAVR (p < 0.0001); however, a probable need for chronic dialysis was rare and similar in both groups.ConclusionBoth TAVI and SAVR led to comparable and excellent results in patients with moderate-to-severe CKD in an intermediate-risk population of patients with symptomatic severe aortic stenosis for whom both therapies could possibly be considered.

Surgical vs Transcatheter Aortic Valve Replacement in Patients With a Low Ejection Fraction.

Currently, there is no preference for surgical (SAVR) vs transcatheter (TAVR) aortic valve replacement in patients with low ejection fraction (EF). The present study retrospectively compared the outcomes of SAVR vs TAVR in patients with EF ≤40% (70 SAVR and 117 TAVR patients). Study outcomes were survival and the composite endpoint of stroke, aortic valve reintervention, and heart failure readmission. The patients who had TAVR were older (median: 75 (25-75th percentiles: 69-81) vs 51 (39-66) years old; P < .001) with higher EuroSCORE II (4.95 (2.99-9.85) vs 2 (1.5-3.25); P < .001). Postoperative renal impairment was more common with SAVR (8 (12.5%) vs 4 (3.42%); P = .03), and they had longer hospital stay [9 (7-15) vs 4 (2-8) days; P < .001). There was no difference between groups in stroke, reintervention, and readmission (Sub-distributional Hazard ratio: .95 (.37-2.45); P = .92). Survival at 1 and 5 years was 95% and 91% with SAVR and 89% and 63% with TAVR. Adjusted survival was comparable between groups. EF improved significantly (β: .28 (.23-.33); P < 0.001) with no difference between groups (P = .85). In conclusion, TAVR could be as safe as SAVR in patients with low EF.

Quality of life and frailty outcomes following surgical and transcatheter aortic valve replacement

BackgroundOur objective was to report on the prospective outcomes in the areas of depression, quality of life, angina, and frailty in SAVR and TAVR patients with aortic stenosis undergoing aortic valve intervention.MethodsWe recruited 300 patients across 3 groups (TAVR, SAVR, and CABG) over 12 months. Depression, quality of life, frailty, and angina were assessed followed by propensity score matching.ResultsUsing logistical regression when all patient factors considered for all patients who had SAVR and TAVR, the only preoperative factors that impacted on 1 year mortality was hypertension and STS score. Quality of life improvements within each group over 12 months was significant (p value = 0.0001). Depression at 12 months between groups (p value = 0.0395) and within each group was significant (p value = 0.0073 for SAVR and 0.0001 for TAVR). Angina was most frequent in TAVR at 12 months in the QL (p = 0.0001), PL (p = 0.0007), and improvement was significant in the QL (SAVR p = 0.0010, TAVR p = 0.0001) and PL (SAVR p = 0.0002), TAVR p = 0.0007) domains in both groups. Frailty at 12 months improved in both groups, but was greatest in TAVR (p value = 0.00126).ConclusionsThis 12 months follow up of cardiac surgical patients has revealed significant improvement in PROMs and frailty in all groups by 3 months postoperative regardless of surgical or transcatheter approach. Outcome measures of quality of life and frailty could be utilized as a measure of outcome more regularly in patients undergoing aortic valve surgery regardless of approach.

Oral anticoagulation following bioprosthetic SAVR in patients with atrial fibrillation: what's the current status of NOACs?

Oral anticoagulation following bioprosthetic SAVR in patients with atrial fibrillation: what's the current status of NOACs?