Transcatheter Aortic Valve Replacement Group Research Articles

Transcatheter Aortic Valve Replacement in Low-Surgical Risk Patients: an updated metanalysis of extended follow-up randomized controlled trials.

The long-term safety and effectiveness of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low surgical risk has not been evaluated in a pooled analysis. An electronic database search was conducted for randomized controlled trials with a maximal 5 years clinical and echocardiographic follow-up including low surgical risk patients who underwent TAVR or SAVR. We calculated odds ratio (OR) and 95% confidence intervals (CIs) using a random-effects model. Subgroups analysis was performed for permanent pacemaker implantation and paravalvular leaks. Three randomized controlled trials were included with a total of 2,611 low surgical risk patients (Society of Thoracic Surgeons score <4%). Compared with SAVR, the TAVR group had similar rates of all-cause mortality (OR 0.94,95% CI 0.65 to 1.37, p = 0.75) and disabling stroke (OR 0.84, 95% CI 0.52 to 1.36, p = 0.48). No significant differences were registered in the TAVR group in terms of major cardiovascular events (OR 0.96, 95% CI 0.67 to 1.38, p = 0.83), myocardial infarction (OR 0.69, 95% CI 0.34 to 1.40, p = 0.31), valve thrombosis (OR 3.11, 95% CI 0.29 to 33.47, p = 0.35), endocarditis (OR 0.71,95% CI 0.35 to 1.48, p = 0.36), aortic valve reintervention (OR 0.93, 95% CI 0.52 to 1.66, p = 0.80), and rehospitalization (OR 0.80, 95% CI 0.52 to 1.02, p = 0.07) compared with SAVR. However, TAVR patients had a higher risk of paravalvular leaks (OR 8.21, 95% CI 4.18 to 16.14, p <0.00001), but lower rates of new-onset atrial fibrillation (OR 0.27,95% CI 0.17 to 0.30, p <0.0001). The rates of permanent pacemaker implantation were comparable from 1 year up to a maximum of 5 years (OR 1.32, 95% CI 0.88 to 1.97, p = 0.18). Lastly, TAVR had a greater effective orifice area (0.10 cm2/m2, 95% CI 0.05 to 0.15, p = 0.0001), but similar transvalvular mean gradients (0.60, 95% CI 3.94 to 2.73, p = 0.72). In conclusion, TAVR patients had similar long-term outcomes compared with SAVR, except for an elevated risk of paravalvular leaks in the TAVR group and increased rates of atrial fibrillation in the SAVR cohort.

Transcatheter or Surgical Aortic Valve Replacement in Women With Small Annuli at Low or Intermediate Surgical Risk

There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes following AVR to understand acute valve performance and early and mid-term clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and SURTAVI intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed-tomography-measured annular perimeter of ≤ 72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary endpoint was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm2 for TAVR and 1.6 ± 0.5 cm2 for surgery, and the mean gradient was 8.0 ± 4.1 mmHg vs 12.7 ± 6.0 mmHg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of TAVR and 33.2% of surgery patients, p < 0.001. In conclusion, in women with small annuli, clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group, and fewer pacemakers in the surgical group.

Impact of the Barthel Index Score and Prognosis on Patients Undergoing Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement.

Few studies have compared the Barthel Index (BI) score and postoperative outcomes of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). We aimed to examine the relationship between the BI score and postoperative outcomes in patients who underwent TAVR and SAVR.Methods and Results: The study included patients who underwent SAVR between January 2014 and December 2022 (n=293) and patients who underwent TAVR between January 2016 and December 2022 (n=312). We examined the risk factors for long-term mortality in the 2 groups. The mean (±SD) preoperative BI score was 88.7±18.0 in the TAVR group and 95.8±12.3 in the SAVR group. The home discharge rate was significantly lower in the SAVR than TAVR group. The BI score at discharge was significantly higher in the SAVR than in TAVR group (86.2 vs. 80.2; P<0.001). Significant risk factors for long-term mortality in the TAVR group were sex (P<0.001) and preoperative hemoglobin level (P=0.008), whereas those in the SAVR group were preoperative albumin level (P=0.04) and postoperative BI score (P=0.02). The cut-off point of the postoperative BI score determined by receiver operating characteristic curve analysis was 60.0. The BI score at discharge was a significant risk factor for long-term mortality in the SAVR group, with a cut-off value of 60.0.

Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial

BackgroundSafety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR versus BAV pre TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519). MethodsClinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n=228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation). ResultsMedian follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ±6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, p=0.6). Prevalence of predicted prothesis-patient mismatch was low (n=13 [11.4%] in the direct TAVR group versus n=15 [13.2%] in BAV group) and similar between both groups (p=0.7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (p=0.4, p=0.7, p=0.3 and p=0.3 respectively). ConclusionDirect implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible. Clinical Trials Registration numberNCT05140317

Comparing Complication Rates of Transcatheter Aortic Valve Replacement to Surgical Aortic Valve Replacement

Background/Objective: Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are the two procedures used to treat severe symptomatic aortic stenosis. One of the most feared outcomes of both procedures is stroke. Conduction abnormalities and arrhythmias after TAVR are relatively common, but few studies have been done comparing the rate of these events between TAVR and SAVR. The objective of our study is to find if there are any differences between the rates of stroke, conduction abnormalities, and arrhythmias between patients that have undergone TAVR and patients that have undergone SAVR. Methods: The CRC/Sidus Real World Evidence Cardiology Dataset was used to obtain samples for this project. Patients who underwent TAVR and SAVR were identified using CPT codes. These two cohorts of patients were tracked for complications between 0 to 30 days after the procedure and between 0 days to 1 year after the procedure using ICD-10 codes. Results: Patients who underwent TAVR (n=3621) were much more likely to have conduction disorders and arrhythmias both in the 0-30 day range and 0 days-1 year range after the procedure compared to patients who underwent SAVR (n=2137). Cerebral infarction and transient cerebral ischemic attack rates were also higher in the TAVR group. Mortality rates for TAVR were lower than mortality rates for SAVR, both 30 days and 1 year after the procedure. Conclusion/Impact: TAVR has revolutionized aortic valve replacement and allowed many patients with aortic stenosis (many of whom are at high surgical risk) a minimally invasive option to improve their quality of life. Finding ways to reduce the rates of stroke, arrhythmias, and conduction abnormalities; for example, through improved devices and techniques, and improvedanti-thrombotic therapy, is extremely important as TAVR becomes more and more widely utilized.

Cardiovascular outcomes of emergent vs elective transcatheter aortic valve replacement in severe aortic stenosis: regression matched meta-analysis.

Transcatheter aortic valve replacement (TAVR) has been highly increased as the recommended option for patients with a high surgical risk. This study aims to commit a systematic review and meta-analysis to assess the outcomes in severe aortic stenosis patients following emergency transcatheter aortic valve replacement (emergent TAVR) compared to elective TAVR or eBAV followed by elective TAVR. We conducted a systematic literature search of PubMed, Embase, Cochrane CENTRAL, CINAHL, Science Direct, and Google Scholar. We included nine studies in the latest analysis that reported the desired outcomes. Outcomes were classified into primary outcomes: 30-day all-cause mortality and 30-day readmission rate, and secondary outcomes, which were further divided into (a) peri-procedural outcomes, (b) vascular outcomes, and (c) renal outcomes. Statistical analysis was performed using Stata v.17 (College State, TX) software. A total of 44,731 patients with severe aortic stenosis were included (emergent TAVR n = 4502; control n = 40045). 30-day mortality was significantly higher in the emergent TAVR group (OR: 2.62; 95% CI = 1.76-3.92; P < 0.01). Regarding post-procedural outcomes, the length of stay was significantly higher in the emergent TAVR group (Hedges's g: +4.73 days; 95% CI = +3.35 to +6.11; P < 0.01). With respect to vascular outcomes, they were similar in both groups. Regarding renal outcomes, both acute kidney injury (OR: 2.52; 95% CI = 1.59-4.00; P < 0.01) and use of renal replacement therapy (OR: 2.33; 95% CI = 1.87-2.91; P < 0.01) were significantly higher in emergent TAVR group as compared to the control group. Our study demonstrated that despite increased 30-day mortality and worse renal outcomes, the post-procedural outcomes were similar in emergent and elective TAVR groups. The increased mortality and worse renal outcomes are likely due to hemodynamic instability in the emergent group. The similarity of post-procedural outcomes is evidence of the safety of TAVR even in emergent settings.

A Meta-Analysis of Short-Term Outcomes of TAVR versus SAVR in Bicuspid Aortic Valve Stenosis and TAVR Results in Different Bicuspid Valve Anatomies

Background: To provide a comprehensive analysis of the current literature comparing the outcomes of surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis (BAS), with particular attention to BAV morphology in patients undergoing TAVR. Methods: Following PRISMA guidelines, all relevant articles with no design restrictions from PubMed, CCTR (Cochrane Controlled Trials Register), and Google Scholar were screened for inclusion. Studies were included if they reported clinical endpoints for SAVR and TAVR or, in BAS treated with TAVR, for type 1 and non-type 1 morphology. Odds ratio and Cohen’s D were considered as effect size measurements for qualitative and quantitative variables, respectively. Results: A total of eight studies comparing short-term outcomes between SAVR and TAVR and nine studies with outcomes data between type 1 and non-type 1 BAS treated with TAVR were considered for the final analysis. No statistically significant difference was found for what concerns the rates of death, stroke, and acute kidney injury between SAVR and TAVR. In comparison to patients undergoing SAVR, the incidence of PPI (permanent pacemaker implantation) was greater in the TAVR group (OR 0.35, 95% CI 0.15–0.79, p = 0.01), and the frequency of bleeding events was found to be higher among patients undergoing SAVR (OR 4.3, 95% CI 2.9–6.4, p &lt; 0.001). The probabilities of 30-day mortality, stroke, and any bleeding were not significantly affected by bicuspid valve morphology in TAVR patients. PPI or development of new conduction anomalies was found to be more frequent in type 1 anatomies (OR 0.46, 95% CI 0.30–0.70, p &lt;0.001). Mildly lower post-procedural transprothesic gradients were found in patients with type 1 morphology. Conclusions: In BAS patients, TAVR has comparable short-term outcomes rates with SAVR, but higher PPI rates and lower incidence of bleeding events. In patients undergoing TAVR, type 1 BAS is associated with lower postoperative transvalvular gradients but higher PPI rates and conduction abnormalities

Analyzing current German transcatheter and surgical aortic valve replacement practices in pure aortic regurgitation

Abstract Background In Germany, the use of transcatheter aortic valve replacement (TAVR) for treating pure aortic regurgitation is still not regular practice. Purpose Therefore, the current development of TAVR in aortic regurgitation is to be investigated. Methods In 2018–2020, 4,025 surgical aortic valve replacements (SAVR), 50 transapical, 329 balloon-expandable transfemoral, and 457 self-expanding transfemoral TAVR in pure aortic regurgitation were studied using multivariable logistic and linear regressions. Results The TAVR groups had a higher age than SAVR (76.0-77.3a vs 62.8a) and logistic EuroSCORE (17.7-19.1 vs 4.9%). Unadjusted in-hospital mortality was highest in transapical TAVR (6.0%), followed by SAVR (5.7%), and it was lowest in transfemoral TAVR, with self-expanding procedures (2.4%) showing significantly lower in-hospital mortality than balloon-expandable (5.2%; p=0.039). After risk adjustment, we saw a significant association with lower mortality rates for balloon-expandable as well as self-expanding transfemoral TAVR vs SAVR (balloon-expandable: OR=0.50, p=0.031; self-expanding: OR=0.20, p&amp;lt;0.001). In the same way, we found that other examined outcomes were significantly in favor of TAVR: stroke (balloon-expandable: OR=0.17, p&amp;lt;0.001; self-expanding: OR=0.17, p&amp;lt;0.001), major bleeding (balloon-expandable: OR=0.04, p&amp;lt;0.001; self-expanding: OR=0.03, p&amp;lt;0.001), delirium (balloon-expandable: OR=0.19, p&amp;lt;0.001; self-expanding: OR=0.16, p&amp;lt;0.001), mechanical ventilation &amp;gt;48h (balloon-expandable: OR=0.09, p&amp;lt;0.001; self-expanding: OR=0.06, p&amp;lt;0.001), and length of hospital stay (balloon-expandable: Coefficient=-6.88d, p&amp;lt;0.001; self-expanding: Coefficient=-7.22d, p&amp;lt;0.001). Conclusion Despite lower procedure volumes in TAVR vs SAVR for pure aortic regurgitation, we see lower rates of in-hospital mortality and complications, suggesting that TAVR can be used successfully in selected patients with aortic regurgitation.

Abstract 13661: In-Hospital Outcomes, Rates of Development of Complete Heart Block and Rates of Pacemaker Placement in TAVR and SAVR Cases: A 5-year Nationwide Inpatient Sample Analysis

Introduction: Complete Heart Block (CHB) is a commonly observed post-procedural complication associated with Transcatheter aortic valve replacement (TAVR) and Surgical aortic valve replacement (SAVR). Since 2016, limited data exists on In-hospital outcomes of TAVR and SAVR cases and rates of development of CHB. Methods: National Inpatient Sample 2016-2020 was used to identify and group TAVR and SAVR cases using appropriate ICD codes. Logistic regression was used to compare baseline characteristics and in-hospital outcomes. Results: 590,615 patients underwent aortic valve replacement (AVR) from 2016-2020, of which 49.6% were TAVR and 50.4% were SAVR. The most common diagnosis for AVR in both groups was nonrheumatic trileaflet aortic stenosis (AS) (86.6% in TAVR group and 53.5% in SAVR group, p&lt;0.001). In TAVR cases, development of CHB was more common (8.9%-vs-7.2%, p=0.235) along with increased need for transvenous pacing (16.6%-vs-8.7%, p=0.010) and permanent pacemaker placement (9.4%-vs-6.4%, p&lt;0.001). An upward trend in CHB occurrence and pacemaker placement (PPM) was noted in the TAVR group as shown in Image 1. TAVR group was observed to have higher rates of acute myocardial infarction (MI) (14.5%-vs-12.8%, p=0.074). SAVR group had higher rates of cardiogenic shock (8.10%-vs-2.20, p&lt;0.001) and in-hospital mortality (3.6%-vs-1.30%, p=0.02). Conclusions: Over the past few years, CHB has been more commonly observed with TAVR as compared to SAVR, necessitating increasing use for PPM placement. Despite these trends, in-hospital mortality and complications are lower with TAVR procedure.

Leadless Pacemaker Implantation, Focusing on Patients With Conduction System Disorders Post–Transcatheter Aortic Valve Replacement: A Retrospective Analysis

BackgroundImpairment of the conduction system is a common complication of transcatheter aortic valve replacement (TAVR), which is typically performed in elderly patients. A leadless pacemaker (LP) may be a suitable option in this frail population, but the available scientific data concerning the efficacy and safety of leadless pacing after TAVR are sparse. The purpose of this analysis was to evaluate the efficacy and safety of LP implantation in patients with relevant bradycardias after TAVR, compared to other indications. MethodsConsecutive patients were retrospectively enrolled. Demographics, background heart diseases, interventional parameters, and follow-up data were collected. ResultsA total of 257 consecutive patients who underwent LP implantation were included. In 26 patients, the device was implanted due to bradycardias after TAVR (TAVR group), whereas the remaining 231 patients were in the population without previous TAVR (non-TAVR group). The mean implantation duration (56 ± 22 minutes in the TAVR group vs 48 ± 20 minutes in the non-TAVR group; P = not significant [NS]) and the implantation success rate (100% in the TAVR group vs 98.7% in the non-TAVR group; P = NS) were similar in the 2 cohorts. No significant differences occurred in pacing parameters (sensing, impedance, and threshold, respectively) between the 2 groups, either at implantation or during follow-up. A total of 8 major periprocedural complications (3.1% of patients in total; 3.8% in the TAVR group vs 3.0% in the non-TAVR group; P = NS) occurred within 30 days, without significant difference between the 2 groups. ConclusionsLP implantation appears to be safe and effective in patients after TAVR, and therefore, this procedure is a suitable option for this often old and frail population.

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.

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.

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.

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

<h2>Abstract</h2><h3>Objective</h3> 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). <h3>Background</h3> The pivotal randomized, prospective, multicenter TAVR trials compared TAVR vs SAVR in patients with tricuspid AS patients. No such trials exist for bicuspid AS. <h3>Methods</h3> 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. <h3>Results</h3> 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%) (<i>P</i> = .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 <i>P</i> < .001). Moderate/severe aortic regurgitation was present in 1 TAVR and 2 SAVR patients (0.8% vs 1.6%; <i>P</i> > .99). <h3>Conclusions</h3> 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.