Background Aortic root rupture is a rare but lethal complication of transcatheter aortic valve replacement (TAVR). It is often the result of excessive radial forces experienced by the aorta during stent deployment. Current pre-procedural planning methods lack the predictive ability to capture interactions between the patient's native anatomical tissue and the transcatheter heart valve. Objectives This study aimed to investigate whether 3-dimensional (3D) computational modeling could be used to derive a biomarker that analyzed peak areal stretch to predict patient-specific risk for aortic root rupture. Methods In a 2-phase study, a derivation cohort (n = 26) was used to establish a peak areal stretch threshold for rupture risk, followed by a blinded validation cohort (n = 40) where modeling was performed using the federal drug administration-cleared PrecisionTAVI software. Researchers were blinded to the clinical outcomes of each case until after computational analysis had been completed. Peak areal stretch's predictive ability was compared to traditional factors such as calcium score or valve oversizing. Results A significant association was found between peak areal stretch and aortic root rupture. Rupture-positive cases had a higher mean stretch (1.956 ± 0.216) than negative cases (1.635 ± 0.284, P = .0285). A threshold of 1.6 showed strong predictive performance with an area under the curve (AUC) of 0.81, outperforming traditional metrics such as calcium score (AUC = 0.643) and valve oversizing (AUC = 0.697). Conclusion Peak areal stretch derived from computational modeling may serve as a patient-specific predictor of aortic root rupture, with potential to improve pre-TAVR planning and patient outcomes.

BACKGROUND:Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (TAVR) field have been obtained from retrospective studies. This prespecified secondary analysis of the LYTEN randomized trial (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses) aims to compare the 3-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in valve-in-valve TAVR. METHODS:Patients with a failed small (≤23 mm) surgical valve undergoing valve-in-valve TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 3-year follow-up. Study outcomes were defined according to VARC (Valve Academic Research Consortium)-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation. RESULTS:Ninety-eight patients underwent TAVR (46 BEV [SAPIEN 3/ULTRA], 52 SEV [Evolut R-PRO-PRO+]). At 3 years, patients receiving a SEV had a higher rate of intended valve performance (BEV: 27.6% versus SEV: 82.4%; P<0.001), with lower mean gradients (BEV: 20±9 versus SEV: 13±9 mm Hg; P=0.002), and larger indexed effective orifice area (BEV: 0.69±0.27 versus SEV: 0.93±0.32 cm2/m2; P=0.002). The rate of moderate aortic regurgitation was 0% in the BEV group versus 2.9% in the SEV group (P=0.582). Functional status and quality of life improved similarly in both groups. No differences were observed in the composite end point of death, stroke, or heart failure-related hospitalization (BEV: 32.6% versus SEV: 25.5%; P=0.489). Mortality was also not statistically different between groups (BEV: 23.3% versus SEV: 15.7%; P=0.375). No significant differences were observed in other adverse events. CONCLUSIONS:In patients undergoing valve-in-valve TAVR for failed small aortic bioprostheses, SEV demonstrated a superior valve hemodynamic performance at 3-year follow-up, with similar clinical outcomes and functional improvement compared with BEV. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03520101.

BackgroundTranscatheter aortic valve replacement (TAVR) has emerged as an acceptable and often preferred alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis. However, the mid- and long-term efficacy of TAVR in patients with bicuspid aortic valves (BAVs) remains unclear. This study aims to compare the mid-term outcomes of patients with BAV undergoing either procedure.MethodsWe retrospectively reviewed all patients who underwent AVR at our institution between 2011 and 2022. Of 278 patients identified, 217 underwent SAVR and 61 underwent TAVR. Propensity score matching was used to create comparable groups. Outcomes were compared using Kaplan-Meier survival analyses and chi-square tests (alpha = 0.05). Sensitivity analyses using multiple calliper widths assessed the robustness of our findings.ResultsIn both unmatched and propensity score-matched cohorts, Kaplan-Meier survival analysis demonstrated a significant survival advantage for SAVR over TAVR. TAVR patients experienced significantly higher rates of combined post-operative complications-including stroke/transient ischaemic attack, bleeding, and dialysis-and showed a trend towards increased pacemaker implantation. However, TAVR was associated with significantly shorter hospital stays. Notably, sensitivity analyses consistently favoured SAVR across all calliper widths. Similar findings were observed within the low-risk subgroup.ConclusionDespite longer hospital stays, SAVR was associated with improved mid-term survival and fewer complications compared with TAVR in patients with BAV. These differences were particularly pronounced in the low-risk cohort. Our findings support the continued consideration of SAVR for patients with BAV who are suitable surgical candidates and underscore the need for comprehensive, multicentre prospective studies.

The CT-derived aortic valve area (AVA CT) ≤ 1.2 cm² suggests severe aortic stenosis (AS) but may not account for annular or body size variations. The valve-to-annulus area ratio (VTAAR) may improve AS severity assessment. This study evaluates AVA CT ≤ 1.2 cm² and VTAAR thresholds in severe AS patients. We retrospectively analyzed consecutive patients who underwent transcatheter aortic valve replacement (TAVR) for severe symptomatic AS at a tertiary center. AVA CT was measured via mid-systolic planimetry, and VTAAR was calculated as AVA CT divided by annular area. Severe AS was determined by Structural Heart Team consensus based on transthoracic echocardiography (TTE) and supplementary imaging. Among 343 patients (mean age 79.7 ± 8.4 years, 55.4

BACKGROUND:Epicardial adipose tissue (EAT) may play a role in the pathophysiology of heart failure (HF) with preserved ejection fraction (HFpEF). OBJECTIVES:This study examined associations between increased EAT, functional status, and invasive exercise hemodynamics in a large cohort of HFpEF patients. METHODS:All patients underwent echocardiography, 6-minute walk distance (MWD) test, Kansas City Cardiomyopathy Questionnaire, and invasive hemodynamic assessment at rest and during ergometry. EAT thickness was measured alongside the right ventricle on echocardiography, expressed in mm and patients were divided according to EAT tertiles. RESULTS:In total, 566 patients were examined with mean age 72 ± 8 years, 62% women, mean EAT thickness was 6.0 ± 2.4 mm and 11.5% had EAT ≥9 mm. With increasing EAT thickness tertiles, 6-MWD and Kansas City Cardiomyopathy Questionnaire overall summary score were significantly lower (320 [247-385] vs 315 [244-383] vs 287 [210-364] meters, P = 0.001; 51 [32-67] vs 45 [32-63] vs 41, [26-56], P = 0.003; respectively), whereas the latter was independent of body mass index (P = 0.004). At rest, invasive hemodynamics were not different across EAT tertiles. At peak exercise, patients in the highest EAT thickness tertile had higher pulmonary capillary wedge pressure and pulmonary capillary wedge pressure to right atrial pressure gradient, compared to patients in the first and second EAT thickness tertiles (36 ± 8 vs 34 ± 8 mm Hg, P = 0.009; 18 ± 7 vs 16 ± 7 mm Hg, P = 0.002, respectively). CONCLUSIONS:EAT thickness was associated with impaired quality of life, lower 6-MWD, and higher left-sided filling pressures at peak exercise. Excess EAT may therefore play an important role in functional status and exercise hemodynamics in patients with HFpEF.

Background The REDUCE LAP-HF II (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II) trial found that, compared with a sham procedure, the Corvia Atrial Shunt did not improve outcomes in heart failure with preserved or mildly reduced ejection fraction. However, after 12-month follow-up, “responders” (peak-exercise pulmonary vascular resistance <1.74 WU and absence of a cardiac rhythm management device) were identified. Objectives This study sought to determine: 1) the overall efficacy and safety of the atrial shunt vs sham control after 2 years of follow-up; and 2) whether the benefits of atrial shunting are sustained in responders during longer-term follow-up or are offset by adverse effects of the shunt. Methods The study analyzed 2-year outcomes in the overall REDUCE LAP-HF II trial, as well as in responder and nonresponder subgroups. The primary endpoint was a hierarchical composite of cardiovascular death or nonfatal ischemic/embolic stroke, total heart failure events, and change in health status. Results In 621 randomized patients, there was no difference between the shunt (n = 309) and sham (n = 312) groups in the primary endpoint (win ratio: 1.01 [95% CI: 0.82-1.24]) or its individual components at 2 years. Shunt patency at 24 months was 98% in shunt-treated patients. Cardiovascular mortality and nonfatal ischemic stroke were not different between the groups; however, major adverse cardiac events were more common in those patients assigned to the shunt compared with sham (6.9% vs 2.7%; P = 0.018). More patients randomized to the shunt had an increase in right ventricular volume of ≥30% compared with the sham control (39% vs 28%, respectively; P < 0.001), but right ventricular dysfunction was uncommon and not different between the treatment groups. In responders (n = 313), the shunt was superior to sham (win ratio: 1.36 [95% CI: 1.02-1.83]; P = 0.037, with 51% fewer HF events [incidence rate ratio: 0.49 [95% CI: 0.25-0.95]; P = 0.034]). In nonresponders (n = 265), atrial shunting was inferior to sham (win ratio: 0.73 [95% CI: 0.54-0.98]). Conclusions At 2 years of follow-up in REDUCE LAP-HF II, there was no difference in efficacy between the atrial shunt and sham groups in the overall trial group. The potential clinical benefit identified in the responder group after 1 and 2 years of follow-up is currently being evaluated in the RESPONDER-HF (Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction Heart Failure) trial. (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II [REDUCE LAP-HF II]; NCT03088033)

To investigate the effect of changing systolic and diastolic blood pressures (SBP and DBP, respectively) on sinus flow and valvular and epicardial coronary flow dynamics after TAVR and SAVR. SAPIEN 3 and Magna valves were deployed in an idealized aortic root model as part of a pulse duplicating left heart flow loop simulator. Different combinations of SBP and DBP were applied to the test setup and the resulting change in total coronary flow from baseline (120/60 mmHg), effective orifice area (EOA), and left ventricular (LV) workload, with each combination, was assessed. In addition, particle image velocimetry was used to assess the Laplacian of pressure ( ∇^2P ) in the sinus, coronary and main flow velocities, the energy dissipation rate (EDR) in the sinus and the LV workload. This study shows that under an elevated SBP, there is an increase in the total coronary flow, EOA, LV workload, peak velocities downstream of the valve, ∇^2P , and EDR. With an elevated DBP, there was an increase in the total coronary flow and ∇^2P . However, EOA and LV workload decreased with an increase in DBP, and EDR increased with a decrease in DBP. Blood pressure alters the hemodynamics in the sinus and downstream flow following aortic valve replacement, potentially influencing outcomes in some patients.

BACKGROUND:A novel implantable sensor has been designed to measure the inferior vena cava (IVC) area accurately so as to allow daily monitoring of the IVC area and collapse to predict congestion in heart failure (HF). METHODS:A prospective, multicenter, single-arm, Early Feasibility Study enrolled 15 patients with HF (irrespective of ejection fraction) and with an HF event in the previous 12 months, an elevated NT-proBNP level, and receiving ≥ 40 mg of furosemide equivalent. Primary endpoints included successful deployment without procedure-related (30 days) or sensor-related complications (3 months) and successful data transmission to a secure database (3 months). Accuracy of sensor-derived IVC area, patient adherence, NYHA classification, and KCCQ were assessed from baseline to 3 months. Patient-specific signal alterations were correlated with clinical presentation to guide interventions. RESULTS:Fifteen patients underwent implantation: 66 ± 12 years; 47% female; 27% with HFpEF, NT-ProBNP levels 2569 (median, IQR: 1674-5187, ng/L; 87% NYHA class III). All patients met the primary safety and effectiveness endpoints. Sensor-derived IVC areas showed excellent agreement with concurrent computed tomography (R2 = 0.99, mean absolute error = 11.15 mm2). Median adherence to daily readings was 98% (IQR: 86%-100%) per patient-month. A significant improvement was seen in NYHA class and a nonsignificant improvement was observed in KCCQ. CONCLUSIONS:Implantation of a novel IVC sensor (FIRE1) was feasible, uncomplicated and safe. Sensor outputs aligned with clinical presentations and improvements in clinical outcomes. Future investigation to establish the IVC sensor remote management of HF is strongly warranted.

INTRODUCTION:Transcatheter aortic valve replacement (TAVR) has become a viable alternative to surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. One such high-risk group is patients with pulmonary hypertension (PH), which is known to increase surgical risk and adversely affect outcomes. This study aims to compare midterm and long-term survival in TAVR and SAVR among patients with PH. METHODS:A retrospective review of patients with PH undergoing an aortic valve replacement was conducted at a single institution. From May 2012 to June 2020, 427 patients with PH underwent a primary isolated TAVR (n = 249) or SAVR (n = 178). PH was assessed using an estimated pulmonary artery systolic pressure ≥40 mmHg. Propensity score matching was used to adjust for confounders. RESULTS:Before matching, Kaplan-Meier estimated survival was significantly lower for TAVR compared to SAVR (P < 0.01). After matching, 87 well-balanced pairs remained. Post propensity score matching, Kaplan-Meier estimated survival was still significantly lower for the TAVR group as compared to the SAVR group (P = 0.045). CONCLUSIONS:These data support the feasibility and safety of SAVR in selected patients with PH, and the presence of PH should not preclude consideration of SAVR in appropriate surgical candidates. Further multicenter research is needed to explore confounders and deepen our understanding of the long-term outcomes in this high-risk population.

AIMS:Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients. METHODS AND RESULTS:Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population. CONCLUSIONS:In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial.

Background: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies.Objectives: The authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR.Methods: Patients with a failed small (<= 23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index >= 0.25 and less than moderate AR.Results: A total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 +/- 8 mm Hg BEV vs 14 +/- 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 +/- 21.2, SEV: 81.8 +/- 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found.Conclusions: In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.

BACKGROUND:Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option. OBJECTIVES:The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF. METHODS:A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise. RESULTS:Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices. CONCLUSIONS:In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.

Coexisting hypertension and aortic stenosis are common. Some studies showed that elevated blood pressures may be associated with progression of calcific aortic valve disease (CAVD) while others showed no correlation. Flow dynamics in the sinuses of Valsalva are considered key factors in the progression of CAVD. While the relationship between hemodynamics and CAVD is not yet fully understood, it has been demonstrated that they are tightly correlated. This study aims to investigate the effect of changing systolic and diastolic blood pressures (SBP and DBP, respectively) on sinus hemodynamics in relation to potential initiation or progression of CAVD after aortic valve replacement (AVR). Evolut R, SAPIEN 3 and Magna valves were deployed in an aortic root under pulsatile conditions. Using particle image velocimetry, the hemodynamics in the sinus were assessed. The velocity, vorticity, circulation ( Γ ) and shear stress were calculated. This study shows that under elevated SBP and DBP, velocity, vorticity, and shear stress nearby the leaflets increased. Additionally, larger fluctuations of Γ and area under the curve throughout the cardiac cycle were observed. Elevated blood pressures are associated with higher velocity, vorticity, and shear stress near the leaflets which may initiate or accelerate pro-calcific changes in the prosthetic leaflets leading to bioprosthetic valve degeneration.