Transcatheter Aortic Valve Replacement Group Research Articles

Impact of TAVR on patients with severe aortic stenosis and liver cirrhosis.

We sought to assess the impact of transcatheter aortic valve replacement (TAVR) on patients that have both severe aortic stenosis (SAS) and liver cirrhosis on mortality at 365 days after index event. We identified 19,210 patients that met inclusion criteria using the TriNetX database, consisting of data from 58 large healthcare organizations collected between 1 January 2010 and 24 February 2022. Of those patients, 1,283 (3.2%) had SAS with liver cirrhosis that had a TAVR, and 19,210 (96.8%) had SAS with liver cirrhosis that did not have a TAVR. We analyzed the data to compare all-cause mortality at 365 days using the TriNetX web platform. In addition, we conducted propensity score matching (PSM) to reduce the effects of confounders between the two groups. Patients with SAS and liver cirrhosis that had a TAVR were older (72.4 ± 9.7 vs. 68.0 ± 11.8, P < 0.001), and they had higher rates of heart failure (71.2 vs. 34.5%, P < 0.001), coronary artery disease (72.0 vs. 31.2%, P < 0.001), diabetes (52.5 vs. 41.2%, P < 0.001), and chronic kidney disease (43.8 vs. 30.1%, P < 0.001) compared with patients with SAS and liver cirrhosis without TAVR. PSM created two well-matched cohorts of 1,269 patients each. The TAVR group had a lower mortality rate compared with the no TAVR group (22.5 vs. 34.8%, P < 0.0001) at 365 days. This was confirmed using a log-rank test. Given these data, it appears that there is a mortality benefit associated with TAVR in patients with SAS and liver cirrhosis.NEW & NOTEWORTHY Risk calculators used to predict unfavorable surgical outcomes could flag a patient as ineligible for transcatheter aortic valve replacement (TAVR) based on the presence of liver cirrhosis. Our data analysis suggests that performing a TAVR to treat severe aortic stenosis in patients with liver cirrhosis could decrease their mortality risk as opposed to not performing a TAVR. Careful consideration should be given to this patient population to ensure the best quality of life and long-term outcome.

Mortality Outcomes in Patients With Cardiac Implantable Electronic Devices Before and After Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) carries a risk of high-grade AV block requiring cardiac implantable electronic device (CIED) implantation, which has been associated with a higher mortality rate. However, the outcomes of TAVR in patients with preexisting CIEDs are not well understood. We conducted a retrospective analysis of consecutive patients who underwent TAVR from December 2014 to December 2019 at our institution. Patients were categorized into 3 groups: preexisting CIED pre-TAVR (group 1), CIED implanted within 30days after TAVR (group 2), and no CIED implanted (group 3). Cox proportional hazard was conducted to determine the primary end point of all-cause mortality. A total of 366 patients were included, of whom 93 (25.4%), 51 (13.9%), and 222 (60.7%) comprised group 1, 2, and 3, respectively. The median follow-up time was 2.3years. The all-cause mortality rate was higher in group 1 than group 2 (hazard ratio [HR] 2.60, 95% confidence interval [CI] 1.09 to 6.18, p=0.03) and group 3 (HR 1.96, 95% CI 1.24 to 3.08, p=0.004). On the multivariate analysis, there was no statistically significant difference in mortality among the groups (group 1 vs group 2: HR 1.95, 95% CI 0.70 to 5.44, p=0.20 and group 1 vs group 3: HR 1.27, 95% CI 0.66 to 2.43, p=0.47). Preoperative hemoglobin ≤12g/100ml was an independent predictor of all-cause mortality (HR 1.75, 95% CI 1.10 to 2.80, p=0.02). Group 1 had a higher 1year congestive heart failure readmission rate (29%) than group 2 (17.6%) and group 3 (8.1%; p <0.0001). In conclusion, there was no difference in the adjusted long-term survival based on the CIED grouping. However, patients with preexisting CIEDs had higher all-cause mortality and 1-year congestive heart failure readmission rates owing to their higher co-morbidity burden, irrespective of their Society of Thoracic Surgeons score. This can be taken into account for preoperative risk stratification.

The Positive Impact of Early Frailty Levels on Mortality in Elderly Patients with Severe Aortic Stenosis Undergoing Transcatheter/Surgical Aortic Valve Replacement.

Background: Frailty is highly common in older patients (pts) undergoing transcatheter aortic valve replacement (TAVR), and it is associated with poor outcomes. The selection of patients who can benefit from this procedure is necessary and challenging. The aim of the present study is to evaluate outcomes in older severe aortic valve stenosis (AS) pts, selected by a multidisciplinary approach for surgical, clinical, and geriatric risk and referred to treatment, according to frailty levels. Methods: A total of 109 pts (83 ± 5 years; females, 68%) with AS were classified by Fried's score in pre-frail, early frail, and frail and underwent surgical aortic valve replacement SAVR/TAVR, balloon aortic valvuloplasty, or medical therapy. We evaluated geriatric, clinical, and surgical features and detected periprocedural complications. The outcome was all-cause mortality. Results: Increasing frailty was associated with the worst clinical, surgical, geriatric conditions. By using Kaplan-Meier analysis, the survival rate was higher in pre-frail and TAVR groups (p < 0.001) (median follow-up = 20 months). By using the Cox regression model, frailty (p = 0.004), heart failure (p = 0.007), EF% (p = 0.043), albumin (p = 0.018) were associated with all-cause mortality. Conclusions: According to tailored frailty management, elderly AS pts with early frailty levels seem to be the most suitable candidates for TAVR/SAVR for positive outcomes because advanced frailty would make each treatment futile or palliative.

TAVR vs balloon aortic valvotomy for severe aortic stenosis and cardiogenic shock: An insight from the National Inpatient Sample database

BackgroundSevere Aortic stenosis (AS) complicated by cardiogenic shock (CS) represents a grave clinical condition with limited treatment options. Evidence from small observation studies favors that Transcatheter Aortic Valve Replacement (TAVR) might be a feasible option in these patients in contrast to emergent Balloon Aortic Valvuloplasty (BAV) which is associated with very high short and long-term mortality. Methods11,405 hospitalizations with severe AS complicated by CS between 2016 and 2020 were identified using the National Inpatient Sample (NIS) Database, and patients were then stratified according to whether they received TAVR or BAV. Propensity-score matching was used to account for differences in the baseline characteristics. Primary and secondary outcomes were then compared between 3485 hospitalizations in direct TAVR group and with 3485 matched hospitalizations in the BAV group. The primary outcome was a composite of all-cause in-hospital death, acute cerebrovascular accident (CVA), and myocardial infarction (MI). Secondary outcomes and safety outcomes were also compared between the two groups. ResultsTAVR was associated with fewer primary outcomes events as compared to BAV {36.8 % vs 56.8 %, aOR (95%CI) = 0.38(0.30–0.47)}, due to fewer all-cause in-hospital deaths {17.8 % vs 38.9 %, aOR (95%CI) =0.34 (0.26–0.43)} and MI {12.3 % vs 32.4 %, aOR (95%CI) = 0.29 (0.22–0.39)}. TAVR was associated with higher rates of acute CVA {6.17 % vs 3.44 %, aOR (95%CI) = 1.84 (1.08–3.21)} and pacemaker implantation post procedure {11.9 % vs 6.03 %, aOR (95%CI) = 2.10 (1.41–3.18)}. ConclusionDirect TAVR in shock and severe Aortic stenosis is a better strategy than rescue Balloon aortic valvotomy.

Reoperation following transcatheter aortic valve replacement: Insights from 10 years' experience

ObjectiveUse of transcatheter aortic valve replacement (TAVR) has demonstrated dramatic growth in the past decade. This study aims to investigate implications of post-TAVR reoperation from our 10-year experience. MethodsBetween 2011 and 2022, 66 post-TAVR patients underwent a reoperation, consisting of 42 (63.6%) patients with native TAVR and 24 (36.4%) patients with valve-in-valve TAVR (VIV-TAVR) after surgical aortic valve replacement. ResultsThe aggregate proportion of patients belonging to the low-/intermediate-risk group at the time of TAVR exceeded that of the high-/extreme-risk cohort in 2021. The native TAVR group received a larger TAVR valve, whereas more frequent low-risk status at the time of TAVR than the VIV-TAVR group. Concurrent procedures were highly common during reoperation and isolated surgical aortic valve replacement represented only 18.2% of the entire cohort. The native TAVR group demonstrated significantly higher TAVR explant difficulty index score (2.0 vs 1.0 points; P < .001) and operative mortality (14.2% vs 0%; P = .079) compared with the VIV-TAVR group. The 8-year cumulative incidence of reoperation was 1.9% and 14.1% (subdistribution hazard ratio, 8.0; 95% CI, 4.1-15.9; P < .001) in the native and VIV-TAVR group, respectively. Furthermore, cumulative incidence of valve reintervention, combining reoperations and redo TAVRs, was 3.3% and 19.0% (subdistribution hazard ratio, 6.2; 95% CI, 3.6-10.9; P < .001). ConclusionsLow-/intermediate-risk patients are emerging as the predominant group necessitating reoperations. Native TAVR was associated with lower postimplant reintervention rates, albeit with higher reoperative technical difficulty and mortality. Conversely, VIV-TAVR was associated with higher reintervention, but demonstrated lower technical difficulty and mortality for reoperation.

Transcatheter Aortic Valve Replacement in Patients With Reduced Ejection Fraction and Nonsevere Aortic Stenosis.

The potential benefit of transcatheter aortic valve replacement (TAVR) in patients with nonsevere aortic stenosis (AS) and heart failure is controversial. This study aimed to assess outcomes of patients with nonsevere low-gradient AS (LGAS) and reduced left ventricular ejection fraction undergoing TAVR or medical management. Patients undergoing TAVR for LGAS and reduced left ventricular ejection fraction (<50%) were included in a multinational registry. True-severe low-gradient AS (TS-LGAS) and pseudo-severe low-gradient AS (PS-LGAS) were classified according to computed tomography-derived aortic valve calcification thresholds. A medical control group with reduced left ventricular ejection fraction and moderate AS or PS-LGAS was used (Medical-Mod). Adjusted outcomes between all groups were compared. Among patients with nonsevere AS (moderate or PS-LGAS), outcomes after TAVR and medical therapy were compared using propensity score-matching. A total of 706 LGAS patients undergoing TAVR (TS-LGAS, N=527; PS-LGAS, N=179) and 470 Medical-Mod patients were included. After adjustment, both TAVR groups showed superior survival compared with Medical-Mod patients (all P<0.001), while no difference was found between TS-LGAS and PS-LGAS TAVR patients (P=0.96). After propensity score-matching among patients with nonsevere AS, PS-LGAS TAVR patients showed superior 2-year overall (65.4%) and cardiovascular survival (80.4%) compared with Medical-Mod patients (48.8% and 58.5%, both P≤0.004). In a multivariable analysis including all patients with nonsevere AS, TAVR was an independent predictor of survival (hazard ratio, 0.39 [95% CI, 0.27-0.55]; P<0.0001). Among patients with nonsevere AS and reduced left ventricular ejection fraction, TAVR represents a major predictor of superior survival. These results reinforce the need for randomized-controlled trials comparing TAVR versus medical management in heart failure patients with nonsevere AS. URL: https://www. gov; Unique identifier: NCT04914481.

Prosthetic Valve Endocarditis After Transcatheter and Surgical Aortic Valve Replacement

BackgroundProsthetic valve endocarditis (PVE) is a devastating sequela of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). However, reoperation for post-TAVR PVE is not well described. We investigated the implications of surgically managed PVE after TAVR and SAVR. MethodsReoperations for active PVE after TAVR and SAVR from 2011 to 2021 were queried using The Society of Thoracic Surgeons (STS) database. We identified 6257 patients, consisting of 374 TAVR (6%) and 5883 SAVR recipients (94%). ResultsPost-TAVR case volume increased from 1 in 2011 to 116 in 2020. Compared with SAVR, the TAVR group was associated with older age, more frequent preexisting pacemaker, and fewer aortic root abscesses. Intraoperatively, TAVR patients received less aortic root repair (24.9% vs 34.8%; P < .001) and had shorter cardiopulmonary bypass/aortic cross-clamp times. Among all comers, the operative mortality in patients with previous was 13.6% for TAVR vs 10.8% for SAVR (P = .088). After risk adjustment, previous TAVR itself was not associated with operative mortality (odds ratio, 0.99; 95% CI, 0.72-1.38). In contrast, among 154 post-TAVR and 2232 post-SAVR patients with STS-indexed procedures (SAVR ± coronary artery bypass grafting) with available STS predicted risk of mortality, the mortality was 14.3% and 7.9% (P = .005), with corresponding observed-to-expected mortality ratio of 2.2 and 1.3, respectively. ConclusionsAortic root repair was seen less frequently after TAVR than after SAVR. Furthermore, previous TAVR was not associated with increased operative mortality. In contrast, the post-TAVR setting was associated with higher mortality regarding isolated SAVR or SAVR plus coronary artery bypass grafting.

Propensity-Matched Outcomes Comparing TAVR in Bicuspid vs Surgery in Tricuspid Aortic Valve Stenosis.

To compare 1-year outcomes in patients at low surgical risk with bicuspid aortic valve stenosis (AS) following transcatheter aortic valve replacement (TAVR) and low-risk patients with tricuspid AS following surgical aortic valve replacement (SAVR). The pivotal randomized, prospective, multicenter TAVR trials compared TAVR vs SAVR in patients with tricuspid AS. No such trials exist for bicuspid AS. The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled 150 patients from 25 sites in the United States. A screening committee confirmed bicuspid anatomy and valve classification based on computed tomography using the Sievers classification. Annular measurements guided valve sizing. These patients were propensity-matched to the SAVR patients in the randomized Evolut Low Risk Trial using 1:1 5-to-1-digit Greedy method, resulting in 144 matched pairs. For both trials, an independent clinical events committee adjudicated all serious adverse events, and the same independent core laboratory assessed all echocardiograms. The 1-year composite of death, disabling stroke, or aortic valve-related rehospitalization for bicuspid TAVR vs tricuspid SAVR was 6 (4.2%) vs 6 (4.2%) (P = .99). The effective orifice area (2.2 ± 0.7 cm2 vs 2.0 ± 0.6 cm2) was larger and the valve gradient was lower (8.7 ± 3.9 mm Hg vs 11.2 ± 4.7 mm Hg) in the TAVR group at 1 year (both P < .001). Moderate/severe aortic regurgitation was present in 1 TAVR and 2 SAVR patients (0.8% vs 1.6%; P > .99). In this select group of low-risk bicuspid patients, in the short-term follow-up, TAVR appears to have similar outcomes to those seen in comparable low-risk tricuspid patients undergoing SAVR.

The influence of metabolic syndrome in heart valve intervention. A multi-centric study.

The effect of metabolic syndrome (MetS), defined as insulin resistance along with two or more of: obesity, atherogenic dyslipidaemia and elevated blood pressure, on postoperative complications after isolated heart valve intervention remains controversial. We hypothesized that MetS may negatively influence the postoperative course in these patients. Patients from 10 cardiac units who underwent isolated valve intervention (mitral tricuspid repair/replacement (mitral valve surgery [MVS]) or surgical aortic valve replacement (SAVR), or transcatheter aortic valve replacement (TAVR) were included. MetS was defined according to the World Health Organization criteria. Primary outcome was in-hospital mortality and overall postoperative length of stay (LOS). Relevant postoperative complications were also recorded. From 2010 to 2019, 17,283 patients underwent valve intervention. The MVS, SVAR, and TAVR accounted for the 39.4%, 48.2%, and 12.3% respectively of the whole. MetS compared to no-MetS was associated to higher mortality in the MVS group (6.5% vs. 2%, p < .001), but not in the SAVR and TAVR group. In both surgical cohorts, MetS was associated with increased complications including red blood cells transfusion, renal failure, mechanical ventilation time, intensive care and overall postoperative LOS (11 (9) vs. 10 (6), p < .001 and 10 (6) versus 10 (5) days, p = .002, MVS and [SAVR]). No differences were found in the TAVR cohort, with similar mortality and complications. MetS was associated to more postoperative complications, with higher mortality in the MVS group. In the TAVR cohort, postoperative complications and mortality rate did not differ between patients with and without MetS, however LOS was longer in the MetS group.

Pearls, pitfalls, and surgical indications of the Intuity TM heart valve:A rapid deployment bioprosthesis. A systematic review of the literature.

To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature. Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement(TAVR). The incidence of paravalvular leak(PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation(Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction(MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%. This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.

Abstract 15248: Clinical Outcomes of Transcatheter Aortic Valve Replacement With and Without Percutaneous Coronary Intervention - An Updated Meta-Analysis and Systematic Review

Hypothesis: Transcatheter aortic valve replacement (TAVR) serves as a less-invasive treatment option for high-risk patients with severe aortic stenosis. Given the coexistence of obstructive coronary artery disease in patients with high-grade aortic stenosis (estimated to be 40-75%), there is inconsistent clinical data regarding potential mortality benefits of paired percutaneous coronary intervention (PCI) with TAVR procedures. Methods: We performed a literature search using PubMed, Embase, and Cochrane Library from inception through April 2022 to assess the mortality impact of preceding/concomitant PCI in patients undergoing transcatheter aortic valve replacement. The primary outcomes were 30-day all-cause mortality, 30-day cardiovascular mortality, and 6 months-1 year all-cause mortality. Secondary outcomes included 30-day myocardial infarction, stroke, major bleeding/vascular complications, and acute kidney injury. Results: 11 studies (10 retrospective cohort studies, 1 randomized control trial) involving 2791 patients were included in the meta-analysis. Compared to patients undergoing TAVR alone, the TAVR+PCI group showed no significant difference in 30-day all-cause mortality (RR 0.90, CI 0.66, 1.22, p =0.49), 30-day cardiovascular mortality (RR 0.71 CI 0.44, 1.14, p =0.16), or 6 months-1 year all-cause mortality (RR 0.94, CI 0.75, 1.18, p =0.57). Regarding secondary outcomes, 30-day myocardial infarction was higher in the TAVR+PCI group compared to the TAVR group (RR 3.09, CI 1.26, 7.57, p =0.01), while no significant differences were found in rates of 30-day stroke (RR 1.14, CI 0.56, 2.33, p =0.72), major bleeding/vascular complications (RR 1.11, CI 0.79, 1.56, p =0.55), and acute kidney injury (RR 1.07, CI 0.75, 1.54, p =0.71). Conclusion: Concomitant/preceding percutaneous coronary intervention does not confer any additional mortality benefit, and may increase the risk of 30-day myocardial infarction, in patients with high-grade aortic stenosis undergoing transcatheter aortic valve replacement. Further trials with large sample sizes are needed to confirm our findings.

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.

Comparison on the prognosis of severe aortic stenosis patients treated with transcatheter aortic valve replacement versus surgical aortic valve replacement: a systematic review and meta-analysis

Objective: To systematically review the prognosis of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis. Methods: A systematic search of PubMed, EMBASE, Scopus, Cochrane Library, China biomedical literature database, China journal full text database (CNKI), Wanfang database and VIP database from January 2012 to February 2022 was conducted for randomized controlled trial (RCT) that comparing TAVR and SAVR in the treatment of severe aortic stenosis. The primary outcomes were the incidence of all-cause mortality, stroke incidence, reoperation rate and complications (pacemaker implantation, atrial fibrillation) at 1 month and 1, 2, 5 years after operation. Jadad scale was used to evaluate the literature quality of RCTs. All statistical analyses were performed using the standard statistical procedures provided in RevMan 5.4.1. Results: A total of 17 studies including 11 712 patients were identified, including 6 007 patients treated with TAVR and 5 705 patients treated with SAVR. There were 4 high-quality studies and 13 medium-quality studies. The results of meta-analysis showed that the rate of new onset atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.28, 95%CI 0.21-0.38, P<0.001), and there was no significant difference in all-cause death, stroke, pacemaker implantation and reoperation rate (all P>0.05) at 30 days follow-up. At one year after TAVR and SAVR treatment, all-cause mortality (RR=0.85, 95%CI 0.74-0.97, P=0.01) and new onset atrial fibrillation (RR=0.28, 95%CI 0.20-0.39, P<0.001) were lower in TAVR group than SAVR group. However, the pacemaker implantation rate was higher in TAVR group than that of SAVR group (RR=1.79, 95%CI 1.11-2.89, P=0.02), while there was no significant difference in the incidence of stroke and reoperation between the two groups (P>0.05). At two years after TAVR and SAVR treatment, the pacemaker implantation rate was higher in TAVR group than that in SAVR group (RR=2.23, 95%CI 1.28-3.86, P=0.004), and the rate of new atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.46, 95%CI 0.38-0.56, P<0.001). There was no significant difference in all-cause death, stroke and reoperation rates between the two groups (P>0.05). At five years after TAVR and SAVR treatment, the pacemaker implantation rate (RR=1.89, 95%CI 1.13-3.17, P=0.02) and reoperation rate (RR=3.64, 95%CI 1.75-7.58, P=0.000 5) were higher in TAVR group than those in SAVR group, while the rate of new onset atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.45, 95%CI 0.37-0.55, P<0.001). There was no significant difference in all-cause death and stroke incidence between the two groups (all P>0.05). Conclusions: The all-cause mortality and the incidence of new onset atrial fibrillation after TAVR are lower than SAVR, and TAVR is a preferred therapy for patients with aortic stenosis.

Clinical outcomes and cumulative healthcare costs of TAVR vs. SAVR in Asia.

ObjectivesThis study compared transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in terms of short- and long-term effectiveness.MethodsThis retrospective cohort study based on nationwide National Health Insurance claims data and Cause of Death data focused on adult patients (n = 3,643) who received SAVR (79%) or TAVR (21%) between 2015 and 2019. Propensity score overlap weighting was applied to account for selection bias. Primary outcomes included all-cause mortality (ACM), hospitalization for heart failure, and a composite endpoint of major adverse cardiac events (MACE). Secondary outcomes included medical utilization, hospital stay, and total medical costs at index admission for the procedure and in various post-procedure periods. The Cox proportional-hazard model with competing risk was used to investigate survival and incidental health outcomes. Generalized estimation equation (GEE) models were used to estimate differences in the utilization of medical resources and overall costs.ResultsAfter weighting, the mean age of the patients was 77.98 ± 5.86 years in the TAVR group and 77.98 ± 2.55 years in the SAVR group. More than half of the patients were female (53.94%). The incidence of negative outcomes was lower in the TAVR group than in the SAVR group, including 1-year ACM (11.39 vs. 17.98%) and 3-year ACM (15.77 vs. 23.85%). The risk of ACM was lower in the TAVR group (HR [95% CI]: 0.61 [0.44–0.84]; P = 0.002) as was the risk of CV death (HR [95% CI]: 0.47 [0.30–0.74]; P = 0.001) or MACE (HR [95% CI]: 0.66 [0.46–0.96]; P = 0.0274). Total medical costs were significantly higher in the TAVR group than in the SAVR in the first year after the procedure ($1,271.89 ± 4,048.36 vs. $887.20 ± 978.51; P = 0.0266); however, costs were similar in the second and third years after the procedure. The cumulative total medical costs after the procedure were significantly higher in the TAVR group than in the SAVR group (adjusted difference: $420.49 ± 176.48; P = 0.0172).ConclusionIn this real-world cohort of patients with aortic stenosis, TAVR proved superior to SAVR in terms of clinical outcomes and survival with comparable medical utilization after the procedure.

A Comparison of Thirty-Day Clinical and Echocardiographic Outcomes of Patients Undergoing Transcatheter vs. Surgical Aortic Valve Replacement for Native Aortic Insufficiency

ObjectivesWe aim to compare in-hospital and 30-day outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) for native aortic insufficiency (AI). BackgroundTAVR is increasingly used off-label in patients with AI deemed high risk for SAVR. There is a paucity of data comparing TAVR and SAVR with current commercially available TAVR devices. MethodsA single-center, retrospective cohort study of patients undergoing TAVR or SAVR for native AI between 2014 and 2020 was performed. Data were obtained from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database, Transcatheter Valve Therapy (TVT) registry, and chart review. In-hospital and 30-day outcomes are reported. ResultsOf 125 total patients, 91 underwent SAVR and 34 underwent TAVR. The TAVR group had a higher STS predictive risk of mortality (PROM) (TAVR = 3.96 %, SAVR = 1.25 %, p < 0.0001). In the postoperative period, the SAVR group had higher rates of new-onset atrial fibrillation (20.9 % vs. 0 %, p < 0.001), while the TAVR group had higher rates of complete heart block requiring permanent pacemaker implantation (20.6 % vs. 2.2 %, p < 0.001). There was no difference in in-hospital or 30-day mortality, stroke, myocardial infarction, residual AI, or repeat valve intervention. ConclusionsDespite higher STS PROM and more comorbidities, patients who underwent TAVR for AI had similar in-hospital and 30-day outcomes as patients who underwent SAVR for AI. These results support TAVR in selected high-risk patients with AI, with the knowledge that pacemaker needs may be higher than patients undergoing SAVR.

Clinical Outcomes in Surgical and Transcatheter Aortic Valve Replacement: An ANZSCTS Database Review 2001-2019

Since the last formal publication reporting on the findings of the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) database on surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) in 2016, transcatheter approaches have become common practice. There has been an increase in use of TAVR following large, randomised control trials that only report on short-term outcomes in a selective cohort. This study aims to report on primary outcome measures and identify complications associated with SAVR and TAVR from a large national database. From the ANZSCTS database (2001-19), 14,097 SAVR and 1,194 TAVR patients were identified with clinical details and 30-day follow-up available. The primary endpoint was the composite of all-cause mortality and/or permanent stroke at 30 days. Secondary endpoints were post-procedure complications requiring treatment. Logistical regression followed by propensity score matching was performed. Using logistical regression when all patient factors considered for all patients who had SAVR and TAVR, the only preoperative factors that had an impact on 30-day mortality was cerebrovascular disease, respiratory disease, preoperative dialysis, angina, and hypertension. Primary outcome 30-day mortality rate was 1.83% in the SAVR group, and 1.68% in patients in the TAVR group, p=0.7001, and permanent stroke was seen in 1.07% patients in the SAVR group, and 1.26% patients in the TAVR group. Acute limb ischaemia, aortic dissection, ventricular tachycardia, bradyarrhythmia and heart block were more common following TAVR (p<0.001), while reintubation and atrial arrhythmia were more common following SAVR (p<0.001). In the real world SAVR and TAVR have been used in very different patient groups and it is difficult to compare as different baseline characteristics and complications. The two patient groups maintain similarities in primary and secondary endpoints, but differences in life threatening and life altering morbidity remains significant. Collection of SAVR and TAVR data in a combined database may help to better capture and compare these complications and institute strategies to prevent them.

Surgical aortic valve replacement provides better left ventricular mass regression than transcatheter aortic valve replacement in patients with small aortic annulus.

This study aimed to evaluate the incidence of patient-prosthesis mismatch (PPM) and degree of left ventricular (LV) mass regression after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) in patients with small aortic annulus (defined as annular diameter of ≤ 21mm). We retrospectively analyzed echocardiographic findings in total of 277 patients with aortic stenosis and small aortic annulus (63 underwent SAVR and 214 underwent TAVR) between October 2013 and March 2019. PPM was defined as an effective orifice area index (EOAI) ≤ 0.85 cm2/m2. LV mass regression was evaluated as percentage change in LV mass index (LVMI) from baseline to the 1-year follow-up. The median EOAI before discharge was slightly larger in the TAVR group than in the SAVR group (1.09 vs. 1.07 cm2/m2; P = 0.030). However, the incidence of PPM before discharge (9.4 vs. 12.7%; P = 0.438) and at the 1-year follow-up (11.7 vs. 11.1%; P = 0.901) was similar between groups. Mild or greater paravalvular leakage (PVL) after the procedure was more frequent in the TAVR group (11.7 vs. 0%; P = 0.002). Reduction in LVMI was significantly higher in the SAVR group (19.3 vs. 6.4%; P < 0.001). Multivariate analysis demonstrated that reduction in LVMI was positively associated with higher baseline transaortic pressure gradient (P < 0.001) and higher baseline LVMI (P < 0.001) and negatively associated with older age (P < 0.001) and mild or greater PVL (P < 0.001). SAVR provides better LV mass regression than TAVR with a comparable rate of PPM in patients with small aortic annulus.

Left Main Protection During Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve.

Coronary obstruction during transcatheter aortic valve replacement (TAVR) is a rare, yet life-threatening, complication. The routine use of left main (LM) protection with or without stent placement in high-risk patients remains controversial. The aim of this study was to evaluate the outcomes of LM protection during TAVR and identify anatomic factors associated with need for stent placement. We retrospectively reviewed all TAVR cases (native and valve-in-valve) performed in our institution between 2014 and 2019 and identified patients who underwent LM protection with a coronary wire, balloon, and/or stent during the procedure. We compared the pre-TAVR computed tomography aortic root characteristics, procedural data, short-, and long-term outcomes among the patients who eventually received an LM stent and those who did not. Among 1925 TAVR patients, 41 (2.1%) underwent LM protection, and 10 of them (25%) had eventually a stent placed in the LM for threatened obstruction after valve deployment. In the native TAVR group (n = 35), 8 patients underwent LM stenting. A larger TAVR prosthesis, larger annular circumference (83.8 vs 76.1​mm; P = .038), lower ratio of sinotubular junction diameter to prosthesis size (1.02 vs 1.11; P = .032), and longer left coronary cusp (15.1 vs 13.9​mm; P = .18) were associated with higher incidence of LM stenting. In the valve-in-valve TAVR group (n = 6), 5 patients had a valve-to-coronary distance of less than 4​mm, and 2 of them received an LM stent. Both stent and nonstent groups had excellent outcomes with no major adverse cardiovascular events or coronary obstruction at 30​days. After a median follow-up of 351​days, 4 patients died (9.7%) (1 in the stent and 3 in the nonstent group), without any cases of late coronary obstruction or percutaneous coronary intervention in either group. LM protection with a coronary guidewire, balloon, or stent is a safe and effective method of coronary protection during TAVR in appropriately selected high-risk patients. Annular circumference, prosthesis size, left coronary cusp length, LM ostial height, and ratio of sinotubular junction to prosthesis size are important predictors of stent deployment.

Clinical Factors and Outcomes When Real-World Heart Teams Overruled STS Risk Scores in TAVR Cases.

Objectives This study was conducted to determine why heart teams recommended transcatheter aortic valve replacement (TAVR) versus surgical AVR (SAVR) for patients at low predicted risk of mortality (PROM) and describe outcomes of these cases. Background Historically, referral to TAVR was based predominately on the Society of Thoracic Surgeons (STS) risk model's PROM >3%. In selected cases, heart teams had latitude to overrule these scores. The clinical reasons and outcomes for these cases are unclear. Methods Retrospective data were gathered for all TAVR and SAVR cases conducted by 9 hospitals between 2013 and 2017. Results Cases included TAVR patients with STS PROM >3% (n = 2,711) and ≤3% (n = 415) and SAVR with STS PROM ≤3% (n = 1,438). Leading reasons for recommending TAVR in the PROM ≤3% group were frailty (57%), hostile chest (22%), severe lung disease (16%), and morbid obesity (13%), and 44% of cases had multiple reasons. Most postoperative and 30-day outcomes were similar between TAVR groups, but the STS PROM ≤3% group had a one-day shorter length of stay (2.5 ± 3.4 vs. 3.5 ± 4.7 days; p ≤ 0.001) and higher one-year survival (91.6% vs. 86.0%, p=0.002). In patients with STS PROM ≤3%, 30-day mortality was higher for TAVR versus SAVR (2.0% vs. 0.6%; p < 0.001). Conclusions Heart teams recommended TAVR in patients with STS PROM ≤3% primarily due to frailty, hostile chest, severe lung disease, and/or morbid obesity. Similar postoperative outcomes between these patients and those with STS PROM >3% suggest that decisions to overrule STS PROM ≤3% were merited and may have reduced SAVR 30-day mortality rate.

Comparison of the levels of depression and anxiety in elderly aortic stenosis patients treated with surgical or transcatheter aortic valve replacement

ObjectiveCurrently, only a few studies have been conducted on the mental status recovery in elderly aortic stenosis (AS) patients after treatment. How transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differentially impinge on the mental status of elderly AS patients is completely unknown. The present prospective study aims to investigate this question by comparing the post-treatment levels of depression and anxiety, quality of life and frailty.MethodsA total of 120 elderly patients (age above 70) with symptomatic AS were included, where 78 of them were treated with TAVR and 42 of them were treated with SAVR. Levels of depression and anxiety, quality of life and frailty were assessed by the Chinese version of Hospital Anxiety and Depression Scale (HADS), World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD) and clinical frailty scale, respectively. Scores were recorded and compared at admission, 1 month, 4 months and 8 months after treatment.ResultsBefore treatment, both patient groups had similar baseline characteristics and all mental parameters. During the follow-up period, patients in the TAVR group demonstrated significant improvement in all assessed mental parameters to certain extent compared to the SAVR group. Specifically, frailty was significantly improved in the TAVR-treated patients at all three follow-up time points. Levels of depression and anxiety were significantly improved 8 months after treatment, although the remaining patient number is limited. Quality of life was only significantly improved 1 month after treatment.ConclusionTAVR may provide a better mental recovery outcome in elderly AS patients.