Assessing post-TAVR cardiac conduction abnormalities risk using an electromechanically coupled beating heart.

Transcatheter aortic valve replacement (TAVR) has rapidly displaced surgical aortic valve replacement (SAVR). However, certain post-TAVR complications persist, with cardiac conduction abnormalities (CCA) being one of the major ones. The elevated pressure exerted by the TAVR stent onto the conduction fibers situated between the aortic annulus and the His bundle, in proximity to the atrioventricular (AV) node, may disrupt the cardiac conduction leading to the emergence of CCA. In this study, an in silico framework was developed to assess the CCA risk, incorporating the effect of a dynamic beating heart and preprocedural parameters such as implantation depth and preexisting cardiac asynchrony in the new onset of post-TAVR CCA. A self-expandable TAVR device deployment was simulated inside an electromechanically coupled beating heart model in five patient scenarios, including three implantation depths and two preexisting cardiac asynchronies: (i) a right bundle branch block (RBBB) and (ii) a left bundle branch block (LBBB). Subsequently, several biomechanical parameters were analyzed to assess the post-TAVR CCA risk. The results manifested a lower cumulative contact pressure on the conduction fibers following TAVR for aortic deployment (0.018 MPa) compared to nominal condition (0.29 MPa) and ventricular deployment (0.52 MPa). Notably, the preexisting RBBB demonstrated a higher cumulative contact pressure (0.34 MPa) compared to the nominal condition and preexisting LBBB (0.25 MPa). Deeper implantation and preexisting RBBB cause higher stresses and contact pressure on the conduction fibers leading to an increased risk of post-TAVR CCA. Conversely, implantation above the MS landmark and preexisting LBBB reduces the risk.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Aortic Stenosis and Cardiogenic Shock.

BACKGROUND: Patients with aortic stenosis (AS) and cardiogenic shock (CS) are an extremely high-risk population with a poor prognosis in the absence of definitive therapy. AIMS: To compare the outcomes of transcatheter aortic valve replacement (TAVR) with surgical AVR (SAVR) in patients with AS-CS. METHODS: We queried the Nationwide Readmission Database (2016-2021) to identify patients hospitalized for AS-CS who underwent isolated TAVR or SAVR. In-hospital outcomes of TAVR vs SAVR were compared using multivariable regression and propensity-matching analyses. Ninety-day readmissions were compared using Cox proportional hazards regression model. RESULTS: Of 16,072 patients hospitalized for AS-CS, 6,381 (39.7%) underwent isolated TAVR, and 9,691 (60.3%) underwent isolated SAVR. From 2016 through 2021, the proportion of TAVR increased from 29.5% to 46.5% and the proportion of SAVR correspondingly decreased in AS-CS (ptrend<0.01). After adjustment for baseline characteristics, TAVR was associated with lower odds of stroke (adjusted odds ratio [aOR] 0.59, 95% confidence interval [CI] 0.44-0.79), acute kidney injury (aOR 0.79, 95% CI 0.68-0.92), and major bleeding (aOR 0.54, 95% CI 0.40-0.72) and higher odds of vascular complications (aOR 1.55, 95% CI 1.22-1.96) compared with SAVR. In-hospital mortality, myocardial infarction, permanent pacemaker placement, and 90-day all-cause and heart failure readmissions were similar. Length of stay was shorter and total costs and nonhome discharges were lower with TAVR. CONCLUSIONS: This nationwide observational analysis showed that TAVR is increasingly performed in patients with AS-CS and is associated with similar in-hospital mortality and 90-day readmissions, but lower in-hospital complications and resource utilization compared with SAVR.

Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR): A Randomized Controlled Trial.

BACKGROUND: Fluid overload (FO) subjects patients with severe aortic stenosis (AS) to increased risk for heart failure and death after valve replacement and can be objectively quantified using bioimpedance spectroscopy (BIS). OBJECTIVES: The authors hypothesized that in AS patients with concomitant FO, BIS-guided decongestion could improve prognosis and quality of life following transcatheter aortic valve replacement (TAVR). METHODS: This randomized, controlled trial enrolled 232 patients with severe AS scheduled for TAVR. FO was defined using a portable whole-body BIS device according to previously established cutoffs (≥1.0 L and/or ≥7%). Patients with FO (n = 111) were randomly assigned 1:1 to receive BIS-guided decongestion (n = 55) or decongestion by clinical judgment alone (n = 56) following TAVR. Patients without FO (n = 121) served as a control cohort. The primary endpoint was the composite of hospitalization for heart failure and/or all-cause death at 12 months. The secondary endpoint was the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire. RESULTS: The occurrence of the primary endpoint at 12 months was significantly lower in the BIS-guided vs the non-BIS-guided decongestion group (7/55 [12.7%, all deaths] vs 18/56 [32.1%, 9 hospitalizations for heart failure and 9 deaths]; HR: 0.36; 95% CI: 0.15-0.87; absolute risk reduction = -19.4%). Outcomes in the BIS-guided decongestion group were identical to the euvolemic control group (log-rank test, P = 0.7). BIS-guided decongestion was also associated with a higher increase in the Kansas City Cardiomyopathy Questionnaire score from baseline compared to non-BIS-guided decongestion (P = 0.001). CONCLUSIONS: In patients with severe AS and concomitant FO, quantitatively guided decongestive treatment and associated intensified management post-TAVR was associated with improved outcomes and quality of life compared to decongestion by clinical judgment alone. (Management of Fluid Overload in Patients Scheduled for Transcatheter Aortic Valve Replacement [EASE-TAVR]; NCT04556123).

Epicardial adipose tissue and muscle distribution affect outcomes in very old patients after transcatheter aortic valve replacement.

Aims: To analyse the relevance of body composition and blood markers for long-term outcomes in very old patients after transcatheter aortic valve replacement (TAVR). Methods and results: A total of 403 very old patients were characterized with regard to subcutaneous, visceral, and epicardial fat, psoas muscle area, plasma growth differentiation factor 15 (GDF-15), and leptin. Cohorts grouped by body mass index (BMI) were analysed for long-term outcomes. Patients underwent transapical and transfemoral TAVR (similar 30-day/1-year survival). Body mass index >35 kg/m2 showed increased 2- and 3-year mortality compared with BMI 25-34.9 kg/m2 but not compared with BMI <25 kg/m2. Fat areas correlated positively to BMI (epicardial: R 2 = 0.05, P < 0.01; visceral: R 2 = 0.20, P < 0.001; subcutaneous: R 2 = 0.13, P < 0.001). Increased epicardial or visceral but not subcutaneous fat area resulted in higher long-term mortality. Patients with high BMI (1781.3 mm2 ± 75.8, P < 0.05) and lean patients (1729.4 ± 52.8, P < 0.01) showed lower psoas muscle area compared with those with mildly elevated BMI (2055.2 ± 91.7). Reduced psoas muscle area and increased visceral fat and epicardial fat areas were independent predictors of long-term mortality. The levels of serum GDF-15 were the highest in BMI >40 kg/m2 (2793.5 pg/mL ± 123.2) vs. BMI <25 kg/m2 (2017.6 pg/mL ±130.8), BMI 25-30 kg/m2 (1881.8 pg/mL ±127.4), or BMI 30-35 kg/m2 (2054.2 pg/mL ±124.1, all P < 0.05). Increased GDF-15 level predicted mortality (2587 pg/mL, area under the receiver operating characteristic curve 0.94). Serum leptin level increased with BMI without predictive value for long-term mortality. Conclusion: Morbidly visceral and epicardial fat accumulation, reduction in muscle area, and GDF-15 increase are strong predictors of adverse outcomes in very old patients post-TAVR.

Transcarotid transcatheter aortic valve replacement utilizing monitored anesthesia care: a case report.

Transcatheter aortic valve replacement (TAVR) has become the standard of care for high surgical risk patients with aortic stenosis. The most common approach to TAVR is transfemoral utilizing monitored anesthesia care or general anesthesia. On occasion, transfemoral access is not possible and alternative access to TAVR is required. Herein, we describe the case of a patient undergoing a transcarotid approach to TAVR with regional anesthesia and monitored anesthesia care utilizing a multidisciplinary heart team.

Transcatheter aortic valve replacement (TAVR) involves replacement of one of the valves of the heart through a minimally invasive procedure and has become the standard of care for high surgical risk patients with a narrowed aortic heart valve. The most common approach to TAVR is through one of the femoral arteries utilizing sedation monitored anesthesia care or general anesthesia. On occasion, transfemoral access is not possible and alternative access to TAVR is required. Herein, we describe the case of a patient undergoing a TAVR using the carotid artery with regional anesthesia and monitored anesthesia care utilizing a multidisciplinary heart team.

Benchtop Flow Stasis Quantification: In Vitro Methods and In Vivo Possibilities.

PURPOSE: Neo-sinus flow stasis has ben correlated with transcatheter heart valve (THV) thrombosis severity and occurrence. Standard benchtop flow field quantification techniques require optical access or modified prosthesis models that may not reflect the true nature of the original valve. En face and fluoroscopic videodensitometry enable visualization of washout in regions otherwise unviewable. METHODS: This study compares two in vitro methods of assessing flow stasis in scenarios with insufficient optical access for traditional techniques such as particle image velocimetry (PIV). A series of seven paired experiments were conducted using a previously described laser-enhanced video densitometry (LEVD) and fluoroscopic video densitometry (FVD). Both sets of experiments were analyzed to calculate washout time as a measure of flow stasis. A novel flow stasis measure termed contrast attenuation ratio (CAR) is proposed as a viable single measure of flow stasis obtainable from only a small number of cardiac cycles of in vitro or in vivo fluoroscopic data. Retrospective fluoroscopic datasets (n = 72) were analyzed to assess the feasibility of obtaining this metric from routine clinical practice and its ability to stratify results. RESULTS: Neo-sinus flow stasis calculated from in vitro fluoroscopy was well correlated with LEVD (r2 = 0.77, p = 0.009). The newly proposed CAR metric showed good agreement with the commonly used "washout time" measure of flow stasis (r2 = 0.91, p < 0.001) while allowing for assessment with incomplete or truncated data. As a proof of concept, CAR was measured in 72 consecutive retrospective fluoroscopic datasets. CAR averaged 10.6 ± 4.6% with a range of 1.5-20.3% in these patients. CONCLUSIONS: This study demonstrates two in vitro methods that can be used to assess relative flow stasis in otherwise optically inaccessible regions surrounding cardiac or vascular implants. In addition, the fluoroscopic benchtop technique was used to validate a metric that allows for extension to routine clinical fluoroscopy. This contrast attenuation ratio (CAR) metric was found to be both accurate and clinically obtainable, and potentially offers a new method for valve thrombosis risk stratification.

A Coronary-Friendly Device Mitigating Risk of Coronary Obstruction in Transcatheter Aortic Valve Replacement.

Purpose: Transcatheter aortic valve replacement (TAVR) induced coronary artery obstruction (CAO) is a rare but devastating complication. Current preventive strategies need additional procedures and may be associated with adverse events. This study aimed to evaluate the early safety and efficacy of stand-alone TAVR using the J-Valve (Jianshi JieCheng Medical Technology Co. Ltd, Shanghai, China) in patients at potential high risk for CAO. Patients and Methods: CAO was defined as coronary ostia obstruction requiring intervention. Patients at potential high risk for CAO were identified retrospectively from 673 consecutive patients who underwent TAVR from January 2015 to July 2021 at Zhongshan Hospital, Fudan University. Procedural results and early outcomes were evaluated according to Valve Academic Research Consortium-3 definitions. Results: A total of 20 consecutive patients (age 72 ± 9 years; 85% female;) were included. The Society of Thoracic Surgeons-Predicted Risk of Mortality was 5% (interquartile range, 4 to 10%). All patients (100%) had at least 2 classical risk factors for CAO by pre-procedural computed tomography analysis, and 90% patients had native aortic valve diseases. TAVR was successful in 95% of cases, with only 1 patient requiring second device implantation. Early safety at 30 days was achieved in all cases without death. All patients were free from CAO, stroke or emergency reintervention. Post-procedural mean aortic valve gradient was 7 (interquartile range, 4, 12) mmHg, and none/trace or mild aortic regurgitation was present in all patients. Conclusion: Stand-alone TAVR using the J-Valve may mitigate the risk of TAVR-induced CAO.

Racial disparities in TAVR outcomes in patients with cancer.

Background: Advances in cancer therapies and improvement in survival of cancer patients have led to a growing number of patients with both cancer and severe aortic stenosis (AS). Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment option for this patient population. There are established racial disparities in utilization and outcomes of both cancer treatments and TAVR. However, the effect of race on TAVR outcomes in cancer patients has not been studied. Objectives: The purpose of this study was to investigate racial disparities in outcomes of TAVR in cancer patients. Methods: 343 patients with cancer who underwent TAVR at a single center over a 6-year period were included in the study. The primary endpoint was a composite of 1-year mortality, stroke, and bleeding. Secondary outcomes included individual components of the primary endpoint as well as 30-day mortality, structural complications, vascular access complications, and conduction system complications. Outcomes were compared between black and white patients by comparing incidence rates. Results: Baseline characteristics including age, sex, BMI, medical comorbidities, STS score, and echocardiographic parameters were similar between races, aside from significantly higher rates of CKD (50.0% vs. 26.6%, p = 0.005) and ESRD (18.4% vs. 4.9%, p = 0.005) in black compared to white cancer patients. There was a trend toward worse outcomes in black cancer patients with regard to a composite endpoint of 1-year mortality, stroke, and major bleeding (35.7% vs. 22.6%, p = 0.095), primarily driven by higher 1-year mortality (31.0% vs. 17.6%, p = 0.065). 30-day mortality was twice as high in black cancer patients than in white cancer patients (4.8% vs. 2.3%, p = 0.018). Conclusions: There is a trend toward worse TAVR outcomes in black cancer patients, with higher periprocedural complication rates and mortality, compared to white cancer patients. Further studies are needed to elucidate the structural, socioeconomic, and biological factors that contribute to racial differences in outcomes.

Transcatheter versus surgical valve replacement in patients with bicuspid aortic valves: an updated meta-analysis.

Patients with bicuspid aortic valves (BAV) are predisposed to the development of aortic stenosis. We performed a pairwise meta-analysis, comparing the efficacy of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in patients with BAV. Medical databases were queried to pool comparative studies of interest. Single-arm studies, conference presentations, animal studies, and studies that involved patients with tricuspid aortic morphology were excluded. Outcomes were pooled as risk ratios (RRs) with their 95% confidence intervals (CI) using the random effects model in R. There were 60,858 patients with BAV (7,565 TAVR, 53,293 SAVR) included. Compared with SAVR, TAVR was associated with a significantly lower risk of 30-day major bleeding (RR 0.29, 95%CI 0.13 to 0.63, p=0.01) but a higher risk of new permanent pacemaker placement (RR 2.17, 95%CI 1.03 to 4.58, p=0.04). No significant differences were seen with other explored outcomes, including 30-day/mid-term mortality, stroke, acute kidney injury, major vascular complications, paravalvular leak, and conduction abnormalities. In conclusion, in patients with BAV, TAVR is associated with a lower risk of 30-day major bleeding but has an increased risk for permanent pacemaker implantation when compared with SAVR. Future large-scale randomised trials comparing both the short-and long-term outcomes of SAVR and TAVR in patients with BAV are needed to assess the efficacy of each modality in a controlled population across long follow-up durations.

Thrombotic Thrombocytopenia Purpura (TTP) following emergent aortic valve replacement after a complicated TAVR procedure: a case report and review of the literature.

BACKGROUND: Thrombotic thrombocytopenic purpura (TTP) is a rare hematological disorder. The occurrence of TTP subsequent to an emergent aortic valve replacement after a TAVR procedure is exceedingly uncommon with only a few reported cases worldwide. CASE PRESENTATION: We report the case of a 70-year-old female patient diagnosed with aortic insufficiency. Following a transcatheter aortic valve replacement, she underwent emergency aortic valve replacement under cardiopulmonary bypass on the subsequent day due to heart valve displacement. The postoperative diagnosis revealed TTP and symptomatic treatment involving plasma exchange was administered. After demonstrating steady improvement, the patient was eventually discharged. CONCLUSION: Aortic valve replacement after TAVR is a high-risk procedure and increases susceptibility for developing secondary TTP. The diagnosis and treatment of secondary TPP is considerably challenging, and early diagnosis with symptomatic treatment including plasma exchange can increase patient survival.

Left Ventricular Hypertrophy Regression Following Transcatheter Aortic Replacement: A Comparison of Self-Expanding Versus Balloon-Expandable Prostheses.

There are limited reports on the impact of prosthesis-patient mismatch (PPM) on regression of left ventricular hypertrophy (LVH) following transcatheter aortic valve replacement (TAVR). We compared the relative effects of supra-annular, self-expanding (SE) versus intra-annular, balloon-expandable (BE) prostheses on TAVR LVH regression. Regression of left ventricular mass index (LVMi) was evaluated in 168 consecutive TAVR patients, including 60 treated with SE valves (Evolut series) and 108 treated with BE valves (Sapien 3). All patients had LVH determined at baseline by echocardiography and had repeat LVMi measurements at a mean follow-up time of 707±528 days. SE patients were more likely female (68.3 vs 46.3%, p=0.007), but otherwise the two cohorts did not differ with respect to baseline demographics and STS Risk Score. SE patients had a higher effective orifice area indexed to body surface area (EOAi) following TAVR (0.98±0.29 vs 0.86±0.25 cm²/m², p=0.006), with lower mean aortic valve gradients (9.9±6.5 vs 12.8±5.8 mmHg, p=0.003) and a lower prevalence of moderate/severe PPM (33.3 vs. 49.1%, p=0.049). On follow-up, changes in LVMi were similar between the SE and BE groups, with similar absolute changes in LVMi (19.2±26.8 vs. 21.9±31.7 g/m2, p=0.578) and relative LVMi decrease (14.0±19.5 vs 16.2±24.2%, p=0.547). No difference in LVMi regression was also noted comparing combined SE/BE patients with moderate/severe PPM versus those without PPM. In conclusion, despite differences in EOAi, mean aortic valve gradient, and prosthesis-patient mismatch post TAVR, the degree of LVH regression during intermediate follow-up did not differ between patients receiving supra-annular SE and intra-annular BE prostheses.

Supra-Annular Self-Expanding Versus Balloon-Expandable Valves for Valve-in-Valve Transcatheter Aortic Valve Replacement.

Self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) have not been extensively studied in valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR). We compared outcomes of supra-annular SE and BE THVs used for ViV-TAVR through a retrospective analysis of institutional data (2013 to 2023) including all patients who underwent ViV-TAVR (TAVR in previous surgical aortic valve replacement). Unmatched and propensity-matched (1:1) comparisons of clinical and echocardiographic outcomes were undertaken in SE and BE THVs along with Kaplan-Meier survival analysis. A total of 315 patients who underwent ViV-TAVR were included, of whom 73% received an SE THV. Median age was 77 years, and women comprised 42.5% of the population. Propensity-score matching (1:1) yielded 81 matched pairs. Implanted aortic valve size was comparable in the groups (23 mm [23 to 26] vs 23 mm [23 to 26], p = 0.457). At 30 days after ViV-TAVR, the SE group had a lower mean aortic valve gradient (14 mm Hg [11 to 18] vs 17.5 mm Hg [13 to 25], p = 0.007). A greater number of patients with BE THV had severe prosthesis-patient mismatch (16% vs 6.2%, p = 0.04). At 1-year follow-up, the SE THV group had a lower aortic valve gradient (14.0 mm Hg [9.6 to 19] vs 17 mm Hg [13 to 25], p = 0.04) than that of the BE THV group; 30-day mortality was 2.7%, whereas 1-year mortality was 7.5% and comparable in the groups. Survival and stroke incidence were similar in the groups up to 5 years. In conclusion, SE and BE THVs had comparable survival after ViV-TAVR. The higher residual aortic valve gradients in BE THVs are likely due to valve design and warrant long-term evaluation for potential structural valve degeneration.

Real-Time Analysis of Conduction Disturbances During TAVR With the CARA Monitor.

BACKGROUND: The occurrence of conduction disturbances (CDs) remains the most frequent complication of transcatheter aortic valve replacement (TAVR). However, little is known about the timing of electrocardiogram (ECG) changes and CDs during the TAVR procedure. OBJECTIVE: To describe ECG changes throughout the TAVR procedure using the CARA monitor. METHODS: Multicenter study including 196 prospectively enrolled patients with no CDs undergoing TAVR. All patients were monitored with the CARA system, which uses a 12-lead ECG to measure PQ and QRS intervals, QRS axis, and variations with each heartbeat at every step: baseline, wire insertion, pre-dilatation, valve deployment, post-dilatation, and end of procedure. RESULTS: PQ and QRS intervals progressively increased throughout the procedure, with a cumulative increase from 169.0±20.0ms to 186.0±31.6ms (P<0.001) for the PQ interval and from 101.3±10.5ms to 126.0±25.4ms (P<0.001) for the QRS interval, from baseline to the end of the procedure. A significant increase in the number of patients with left axis deviation was observed (8% at baseline vs 32% at end of procedure, P<0.001). A total of 161 (82.4%) patients exhibited at least one CD episode (PQ>200ms, QRS>120ms, advanced heart block) during the procedure, with most episodes occurring during pre-dilatation and valve implantation maneuvers. CONCLUSIONS: The CARA system facilitated real-time ECG monitoring, detecting subtle and progressive changes during TAVR. ECG changes occurred at each step, with most patients experiencing CDs, especially during pre-dilatation and valve implantation. The potential of ECG dynamics and timing for early detection of severe CDs should be explored in future studies.

Clinical Outcomes in Relation to Total Hospital Surgical and Transcatheter Aortic Valve Replacement Volumes.

BACKGROUND: There is a paucity of data regarding the relationship between overall hospital volumes for total aortic valve replacement (AVR; transcatheter AVR [TAVR] or surgical AVR [SAVR]) and patient outcomes. METHODS AND RESULTS: We queried the 2019 Nationwide Readmission Database for patients undergoing AVR. Based on procedural volumes of TAVR or SAVR, we classified hospitals as high (≥50th percentile) or low (<50th percentile) volume centers and categorized hospitals as high TAVR/high SAVR, high TAVR/low SAVR, high SAVR/low TAVR, and low TAVR/low SAVR. Multivariable regression models were employed. The main study outcomes were in-hospital mortality and 30-day readmission after total AVR. Our final analysis included 72 123 patients undergoing AVR at 400 hospitals across the United States. The median (interquartile range) hospital procedural volumes for total AVR, TAVR, and SAVR were 137 (86-210), 82 (50-127), and 56 (31-87) procedures, respectively. There was an inverse correlation between hospital procedural volumes of AVR, TAVR, or SAVR and in-hospital mortality after total AVR but not with 30-day readmission. Using high TAVR/high SAVR hospitals as reference, there was higher in-hospital mortality after total AVR among low TAVR/low SAVR hospitals (adjusted odds ratio [OR], 1.29 [95% CI, 1.07-1.56]) but similar in-hospital mortality among high TAVR/low SAVR hospitals and low TAVR/high SAVR volumes. There was no difference in 30-day readmission rates after total AVR among the 4 hospital categories. CONCLUSIONS: Nationwide data revealed that in-hospital mortality after total AVR (SAVR or TAVR) is inversely related to hospital total volumes of AVR. Patients with aortic stenosis have better outcomes if they are managed among experienced centers with high case volumes of both TAVR and SAVR.

Ramipril After Transcatheter Aortic Valve Implantation in Patients Without Reduced Ejection Fraction: The RASTAVI Randomized Clinical Trial.

BACKGROUND: Patients with aortic stenosis may continue to have an increased risk of heart failure, arrhythmias, and death after successful transcatheter aortic valve implantation. Renin-angiotensin system inhibitors may be beneficial in this setting. We aimed to explore whether ramipril improves the outcomes of patients with aortic stenosis after transcatheter aortic valve implantation. METHODS AND RESULTS: PROBE (Prospective Randomized Open, Blinded Endpoint) was a multicenter trial comparing ramipril with standard care (control) following successful transcatheter aortic valve implantation in patients with left ventricular ejection fraction >40%. The primary end point was the composite of cardiac mortality, heart failure readmission, and stroke at 1-year follow-up. Secondary end points included left ventricular remodeling and fibrosis. A total of 186 patients with median age 83 years (range 79-86), 58.1% women, and EuroSCORE-II 3.75% (range 3.08-4.97) were randomized to receive either ramipril (n=94) or standard treatment (n=92). There were no significant baseline, procedural, or in-hospital differences. The primary end point occurred in 10.6% in the ramipril group versus 12% in the control group (P=0.776), with no differences in cardiac mortality (ramipril 1.1% versus control group 2.2%, P=0.619) but lower rate of heart failure readmissions in the ramipril group (3.2% versus 10.9%, P=0.040). Cardiac magnetic resonance analysis demonstrated better remodeling in the ramipril compared with the control group, with greater reduction in end-systolic and end-diastolic left ventricular volumes, but nonsignificant differences were found in the percentage of myocardial fibrosis. CONCLUSIONS: Ramipril administration after transcatheter aortic valve implantation in patients with preserved left ventricular function did not meet the primary end point but was associated with a reduction in heart failure re-admissions at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03201185.

Bicuspid Aortic Valve Disease: From Pathophysiology to Treatment.

The Bicuspid Aortic Valve (BAV) is the most common congenital anomaly in adults, with a global incidence of 1.3%. Despite being well documented, BAV presents significant clinical challenges due to its phenotypic heterogeneity, diverse clinical manifestations, and variable outcomes. Pathophysiologically, BAV differs from tricuspid valves in calcification patterns and hemodynamic effects, leading to increased shear stress and aortic root dilatation, while it is influenced by genetic and hemodynamic factors. This is why therapeutically, BAV presents challenges for both surgical and transcatheter interventions, with surgical approaches being traditionally preferred, especially when aortopathy is present. However, transcatheter aortic valve implantation (TAVI) has emerged as a viable option, with studies showing comparable outcomes to surgery in selected patients, while advancements in TAVI and a better understanding of BAV's genetic and pathophysiological nuances are expanding treatment options. The choice between mechanical and bioprosthetic valves also presents considerations, particularly regarding long-term durability and the need for anticoagulation. Future research should focus on long-term registries and genetic studies to refine therapeutic strategies and improve patient outcomes. This review aims to evaluate current approaches in the surgical and interventional management of BAV, focusing on its anatomy, pathogenesis, pathophysiology, and therapeutic strategies.

Temporal Trends in Patient Characteristics and Clinical Outcomes of TAVR: Over a Decade of Practice.

Background/Objective: Transcatheter aortic valve replacement (TAVR) is indicated for severe aortic stenosis patients with a prohibitive surgical risk. However, its use has been expanding in recent years to include intermediate- and low-risk patients. Thus, registry data describing changes in patient characteristics and outcomes are needed. The aim of this study was to analyse the temporal changes in patient profiles and clinical outcomes of all-comer TAVR. Methods: Baseline characteristics and VARC-3 outcomes of 1632 consecutive patients undergoing TAVR between 2008 and 2021 were analysed. Results: The annual rate of TAVR increased from 30 procedures in 2008-2009 to 398 in 2020-2021. Over the follow-up period, patient age decreased from 85 ± 4 to 80 ± 6.8 (p < 0.001) and the STS score decreased from 5.9% to 2.8% (p < 0.001). Procedural characteristics significantly changed, representing a shift into a minimally invasive approach: adoption of local anaesthesia (none to 48%, p < 0.001) and preference of transfemoral access (74% in 2011-2012 vs. 94.5% in 2020-2021, p < 0.001). The rates of almost all procedural complications decreased, including major vascular and bleeding complications, acute kidney injury (AKI) and in-hospital heart failure. There was a striking decline in rates of complete atrioventricular block (CAVB) and the need for a permanent pacemaker (PPM). PPM rates, however, remain high (17.8%). Thirty-day and one-year mortality significantly declined to 1.8% and 8.3%, respectively. Multivariable analysis shows that AKI, bleeding and stroke are strong predictors of one-year mortality (p < 0.001). Conclusions: The TAVR procedure has changed dramatically during the last 14 years in terms of patient characteristics, procedural aspects and device maturity. These shifts have led to improved procedural safety, contributing to improved short- and long-term patient outcomes.

Outcomes of Valve-in-Valve (VIV) Transcatheter Aortic Valve Replacement (TAVR) after Surgical Aortic Valve Replacement with Sutureless Surgical Aortic Valve Prostheses Perceval™: A Systematic Review of Published Cases.

Background: Valve-in-Valve (VIV) transcatheter aortic valve replacement (TAVR) is a potential solution for malfunctioning surgical aortic valve prostheses, though limited data exist for its use in Perceval valves. Methods: searches were performed on PubMed and Scopus up to 31 July 2023, focusing on case reports and series addressing VIV replacement for degenerated Perceval bioprostheses. Results: Our analysis included 57 patients from 27 case reports and 6 case series. Most patients (68.4%) were women, with a mean age of 76 ± 4.4 years and a mean STS score of 6.1 ± 4.3%. Follow-up averaged 9.8 ± 8.9 months, the mean gradient reduction was 15 ± 5.9 mmHg at discharge and 13 ± 4.2 mmHg at follow-up. Complications occurred in 15.7% of patients, including atrioventricular block III in four patients (7%), major bleeding or vascular complications in two patients (3.5%), an annular rupture in two patients (3.5%), and mortality in two patients (3.5%). No coronary obstruction was reported. Balloon-expanding valves were used in 61.4% of patients, predominantly the Sapien model. In the self-expanding group (38.6%), no valve migration occurred, with a permanent pacemaker implantation rate of 9%, compared to 5.7% for balloon-expanding valves. Conclusions: VIV-TAVR using both balloon-expanding and self-expanding technologies is feasible after the implantation of Perceval valves; however, it should be performed by experienced operators with experience both in TAVR and VIV procedures.

Impact of Accidental High or Low Implantation Depth on Peri-Procedural Outcomes after Implantation with the Self-Expanding ACURATE neo2.

Background: Precise implantation could play a crucial role in the technical success of transcatheter aortic valve replacement (TAVR) for some prostheses. The impact of an accidental implantation depth (ID) outside the recommended range has not been assessed for the ACURATE neo2 (NEO2). Methods: Data from 1839 patients with severe native aortic stenosis treated with the NEO2 prosthesis were evaluated. We compared the results of prostheses implanted in an ID both inside and outside the recommendations. The outcome assessment followed the Valve Academic Research Consortium-3 criteria. Results: Patients were retrospectively divided into high (<3 mm; n = 412), optimal (3-7 mm; n = 1236), and low (>7 mm; n = 169) implantations. Technical success (94.7% vs. 94.7% vs. 91.7%, p = 0.296) and device success were high (90.1% vs. 89.3% vs. 84.6%, p = 0.112) without differences between groups. Rates of relevant paravalvular regurgitation (PVL; >mild or VinV due to PVL) were comparable (1.2% vs. 1.8% vs. 1.2%, p = 0.759). Even when hemodynamics were superior in the high-implantation group, with greater iEOA (1.01 cm2/m2 vs. 0.95 cm2/m2 vs. 0.92 cm2/m2, p < 0.001), spontaneous embolization or after post-dilatation was more common. Low implantation was associated with a higher rate of associated pacemaker implantation (PPI) (6.1% vs. 8.8% vs. 14.8%, p = 0.001). Conclusions: Implantation with the ACURATE neo2 showed excellent hemodynamic results, including low gradients and a small number of relevant PVL, in line with a high technical success rate that was irrespective of the ID. A favorable outcome can also be achieved in accidental low or high positions. Low implantation was associated with a higher rate of associated pacemaker implantation. Deliberately high implantation should be avoided due to the risk of embolization.