Native Aortic Stenosis Research Articles

Implementing a novel selection criteria and pathway for same-day discharge after TAVI

Abstract Background The expansion in indications for transcatheter aortic valve implantation (TAVI) has fuelled an increase in demand worldwide. Prolonged waiting lists and waiting list mortalities are not infrequent and often arise from limited hospital capacity and infrastructure. Approaches to address this have included procedural modifications – ‘minimalist TAVI’ and more recently the development of pathways to facilitate early discharge post-TAVI, such as same-day discharge (SDD) post-procedure. Purpose This study aims to evaluate the safety and effectiveness of a novel SDD pathway a large volume tertiary referral cardiac centre. Methods A new SDD pathway was established between March 2023 and February 2024 at a large-volume tertiary cardiac centre in UK. All patients accepted for TAVI were screened for SDD suitability based on three factors: 1) availability of adequate social support, (defined as presence of able-bodies adult individual to assist in home recovery), 2) technically suitable for transfemoral approach and 3) presence of previous pacemaker or low risk for conduction abnormalities (defined as no baseline conduction disturbances). Following TAVI, patients were deemed suitable for SDD if they were clinically stable, the procedure was technically successful and there were no procedural complications. Demographic, clinical, procedural and outcome data were collected for all patients enrolled onto the SDD pathway and reasons for non-SDD were identified. Ethical approval was obtained in accordance with local institutional policies. Results From March 2023 to February 2024, 81 out of 305 patients (26.6%) were enrolled onto the SDD pathway (median age 82 years old, 66.7% male, median STS risk score 2.34%). Indications for TAVI were severe native aortic stenosis (74/81, 91.4%), severe native aortic regurgitation (2/81, 2.5%) and severe surgical valve degeneration (5/81, 6.2%). SDD was feasible for 58/81 (71.6%) of patients, with 10/81 (12.3%) discharged the following day and 13/81 (16.0%%) requiring >24 hours hospital admission (Figure 1). Reasons for non-SDD included new conduction abnormality (10/81, 12.3%), vascular complication (6/81, 7.4%), acute stroke (3/81, 3.7%), patient preference (2/81, 2.5%) and haemodynamic instability (2/81, 2.5%). Out of the 58 SDD patients, 25/58 (43.1%) had no previous permanent pacemaker system and in these patients a balloon-expandable valve was selected for 24/25 (96.0%) of patients (Figure 2). Conclusions Patient selection based on the presence of social support at home, low risk of conduction abnormalities or previous pacemaker combined with appropriate valve selection can facilitate a safe and effective SDD post-TAVI programme.

Long-term outcomes of transapical-transcatheter aortic valve replacement.

Transapical-transcatheter aortic valve replacement is one of the main interventions indicated for patients where access via peripheral vessels is challenging. However, there have been no reports on the long-term outcomes of this intervention. Here, we report the long-term outcomes of this intervention. Among 178 patients who underwent transapical-transcatheter aortic valve replacement between October 2009 and July 2023, 173 patients who underwent this intervention for native aortic stenosis were included in this study, and early and long-term results were evaluated. The mean age was 82.4 ± 6.4years, 52.6% were women, mean body area was 1.46 ± 0.17 m2, and the Society of Thoracic Surgeons Predicted Risk of Mortality was 11.2 ± 9.9%. In-hospital mortality was observed in three patients (1.7%). Mean follow-up duration was 4.3 ± 2.8years, and the survival rates at 1-, 3-, 5-, and 8-years were 84.9%, 67.1%, 47.0%, and 22.1%, respectively. Freedom from cardiovascular mortality at 1, 3, 5, and 8-years was 92.9%, 86.1%, 75.8%, and 53.5%, respectively. The freedom from disabling stroke rates at 1, 3, 5, and 8-years were 95.0%, 92.4%, 92.4%, and 90.8%, respectively. Multivariate analysis revealed that male (Hazard Ratio 1.85, 95%Confidence Interval 1.27-2.70, p = 0.0012) and hemodialysis (Hazard Ratio 1.64, 95%Confidence Interval 1.00-2.67, p = 0.049) were significant poor prognosis factors. Long-term outcomes of transapical-transcatheter aortic valve replacement were satisfactory. Despite the variety of available approaches, the role of transapical-transcatheter aortic valve replacement, which has low vascular impact, has not been completely lost.

The novel balloon-expandable Myval transcatheter heart valve: systematic review of aortic, mitral, tricuspid and pulmonary indications

Introduction and objectivesMyval technology represents the first balloon-expandable alternative since the Edwards system became commercially available. Despite certain controversies, its use has rapidly expanded. We aimed to gather all the available literature regarding its indications and outcomes. MethodsA comprehensive search of articles published between December 2016 and May 2024 was conducted using BioMedCentral, Google Scholar, and PubMed to evaluate the main outcomes of Myval for native aortic stenosis (AS) (meta-analysis) and off-label uses (systematic review). ResultsA total of 151 studies were identified, and 74 were included in the analysis, covering aortic (n=51), mitral (n=9), tricuspid (n=6), and pulmonary (n=8) valve positions. A meta-analysis of studies on native AS demonstrated that Myval is safe and effective, with a 30-day mortality rate of 1.3%, good hemodynamic performance, low rates of pacemaker implantation (8.8%), and ≥ moderate paravalvular regurgitation (1.3%). Compared with other contemporary devices, Myval was competitive and associated with lower rates of pacemaker implantation. In a systematic review of off-label indications, Myval was also found to be safe and effective. In bicuspid AS, pure regurgitation, and aortic valve-in-valve procedures, success rates were 100%, 92%, and 100%, respectively, with pacemaker rates of 9.9%, 22.2%, and 3%, respectively. For mitral valve-in-valve/in-ring procedures, the success rate was 96.9%, while in tricuspid and pulmonary positions, small case series reported 100% success rates for both, with minimal procedural complications. ConclusionsMyval technology is safe and effective for the treatment of native valvular disease and dysfunctional prostheses or rings in all heart valve positions, although larger scale studies are warranted.

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.

Outcomes of transfemoral TAVR using two new-generation devices in patients with horizontal aorta.

Challenging anatomies and comorbidities have impact on success in transcatheter aortic valve replacement (TAVR). There is controversy whether the extent of the aortic angle (AA) has an impact on procedural outcomes. Matched comparative outcome data of new generation transcatheter heart valves (THVs) in horizontal aorta (HA) are scarce. A total of 1582 patients with severe native aortic stenosis (AS) treated with the SAPIEN3 Ultra (Ultra; n = 526) or ACURATE Neo2 (Neo2; n = 1056) THVs from January 2017 to January 2023 were analyzed. Patients with non-horizontal aortas (AA < 51.7°, n = 841) were excluded. The population was matched by 1-to-1 nearest-neighbor matching (Ultra, n = 246; Neo2, n = 246). Clinical and procedural outcome were evaluated according to VARC-3 recommendations. Technical success (93.1% vs. 94.7%, p = 0.572) was high after Ultra and Neo2. Device success (80.5% vs. 89.8%, p = 0.05) was inferior with Ultra. Neo2 reveals superior hemodynamic properties with lower rate of severe prosthesis patient mismatch (12.0% vs. 3.7%, p = 0.001) and elevated gradients ( 20 mmHg: 11.9% vs. 1.7%, p < 0.001). Ultra showed a lower rate of relevant paravalvular regurgitation ( mild paravalvular regurgitation or Valve-in-Valve due to paravalvular regurgitation: 0.0% vs. 3.7%, p = 0.004). The rate of procedural bailout maneuvers (0.8% vs. 0.4%, p = 1.000) and thirty-day all-cause mortality (1.3% vs. 2.2%, p = 0.496) was similar. Transfemoral TAVR in patients with severe aortic stenosis and HA, using the balloon expandable Sapien3 Ultra and self-expanding ACURATE Neo2 prosthesis, is feasible and safe. Therefore, valve selection between these platforms should be made irrespective of the aortic angle by a team experienced with both valves based on their specific advantages. Large, randomized trials in this sub-group of patients would be necessary to compare long term outcomes.

LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. Meril Life Sciences.

Improved Hemodynamics With Self-Expanding Compared to Balloon-Expandable Transcatheter Aortic Valve Implantation in Small Annulus Patients: A Propensity-Matched Analysis

Patients with small aortic annuli (SAA) pose a challenge in patients undergoing aortic valve replacement because of the potential for prosthesis-patient mismatch (PPM). This study aimed to compare the clinical and hemodynamic outcomes of self-expandable valve (SEV) versus balloon-expandable valve (BEV) transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and SAA. All patients who underwent TAVI for severe native aortic stenosis with a SAA between January 2018 and December 2022 were retrospectively included in the study from a single center. Propensity score matching was performed to balance the baseline characteristics. Bioprosthesis valve dysfunction was based on modified Valve Academic Research Consortium 3 criteria. A total of 1,170 TAVI procedures were performed between 2018 and 2022. After applying the exclusion criteria, 332 patients reported a SAA at computed tomography scan, and the matching created 109 balanced pairs. Echocardiographic data at discharge showed higher mean transvalvular gradients (p <0.001), higher grades of mitral regurgitation (p = 0.029), and lower ejection fraction (p <0.043) in BEVs than SEVs. At follow-up, significant differences favoring the SEV group regarding bioprosthesis valve dysfunction were observed (p = 0.002), especially in terms of severe PPM (p = 0.046) and at least moderate structural valve deterioration (p = 0.040). In conclusion, TAVI in patients with SAA using a BEV was associated with lower valve areas, higher mean pressure gradients, and PPM (including severe) than a SEV. Short- and midterm all-cause and cardiac-related mortality did not differ between the 2 groups. Future randomized studies with extended follow-ups are warranted to validate these outcomes.

ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis.

Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce. A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm2) of the native aortic valve. Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; P=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; P=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; P<0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; P<0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; P=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; P=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; P=0.817). In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.

Intraoperative Corticosteroids and Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic stenosis. However, conduction disturbances leading to pacemaker implantation remain a common complication, increasing morbidity and mortality in these patients. Hence, measures to lower its incidence should be taken, and corticosteroid therapy could be effective by reducing inflammation caused by direct mechanical trauma to the conduction system. A retrospective cohort study was conducted at the Centro Hospitalar de Vila Nova de Gaia/Espinho, analyzing the medical records of patients with native severe aortic stenosis who underwent transfemoral TAVR in 2022. The Chi-square test was used to compare the rate of pacemaker implantation in patients who received corticosteroids with patients who didn't. The statistical significance was considered for a p-value <0.05. A total of 341 patients were included in this study. Monitored anesthesia care was the preferred anesthetic technique (99.1%). Sixty-three point three percent (63.3%) of patients received corticosteroids at the beginning of the procedure. Corticosteroid administration did not significantly affect the incidence of permanent pacemaker implantation (p=0.277), vascular complications on the access site (p=0.765), or in-hospital mortality (p=0.909). Male gender, 1st-degree atrioventricular block, and right branch block were the only identified predictors of permanent pacemaker implantation after transfemoral TAVR (p=0.041 <0.001 and <0.001, respectively). Corticosteroid administration at the beginning of TAVR doesn't seem to influence the incidence of permanent pacemaker implantation, which can suggest that other factors play a more important role in the development of conduction disturbances leading to pacemaker implantation.

Hemodynamic performance of self-expandable transcatheter aortic valve replacement systems during valve deployment.

Little is known about valve hemodynamic performance during the Evolut and Neo deployment course. We aimed to evaluate transvalvular mean and peak-to-peak gradients over several intraprocedural timepoints during TAVR with Evolut PRO+ (Medtronic) and Neo (Boston Scientific) systems. This was single-center pilot sub-study from the SavvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) trial. Participants received either the Evolut PRO+ or Neo for native valve severe aortic stenosis and the SavvyWire (OpSens Medical) was used for device delivery, pacing, and continuous left ventricular and aortic pressure measurements. For the Evolut, evaluation was done for baseline, two-thirds of valve deployment (still recapturable), 90% of valve deployment (no longer recapturable), and post-deployment hemodynamics. For the Neo, analysis was done at baseline, after the first step (top-crown deployment), and at final status. Nineteen patients were included (Evolut = 15; Neo = 4). There were no statistically significant changes in peak-to-peak gradients (44 mm Hg [IQR:33-69] vs 43 mm Hg [IQR:26-62], P = .41) between baseline and two-thirds of valve deployment in the Evolut patients. There was a significant decrease in mean (40 mm Hg [IQR:32-54] vs 14 mm Hg [IQR:10-18], P less than .001) and peak-to-peak (43 mmHg [IQRS:26-62] vs 9 mm Hg [IQR:8-13], P less than .001) transvalvular gradients between two-thirds and 90% of valve deployment for Evolut. Neo patients exhibited a decrease in transvalvular gradients after top-crown deployment (42.5 mm Hg baseline vs 13 mm Hg). Transvalvular gradients did not vary between the point of "no-recapture" compared to baseline values in patients receiving the Evolut, whereas a significant reduction in transvalvular gradients was observed when the valve was deployed at 90% and fully deployed. The Neo valve was slightly obstructive after the first step of deployment.

Redo-TAVR Feasibility After SAPIEN 3 Stratified by Implant Depth and Commissural Alignment: A CT Simulation Study.

Redo-transcatheter aortic valve replacement (TAVR) can pin the index transcatheter heart valve leaflets open leading to sinus sequestration and restricting coronary access. The impact of initial implant depth and commissural alignment on redo-TAVR feasibility is unclear. We sought to determine the feasibility of redo-TAVR and coronary access after SAPIEN 3 (S3) TAVR stratified by implant depth and commissural alignment. Consecutive patients with native valve aortic stenosis were evaluated using multidetector computed tomography. S3 TAVR simulations were done at 3 implant depths, sizing per manufacturer recommendation and assuming nominal expansion in all cases. Redo-TAVR was deemed unfeasible based on valve-to-sinotubular junction distance and valve-to-sinus height <2 mm, while the neoskirt plane of the S3 transcatheter heart valve estimated coronary access feasibility. Overall, 1900 patients (mean age, 80.2±8 years; STS-PROM [Society of Thoracic Surgeons Predicted Risk of Operative Mortality], 3.4%) were included. Redo-TAVR feasibility reduced significantly at shallower initial S3 implant depths (2.3% at 80:20 versus 27.5% at 100:0, P<0.001). Larger S3 sizes reduced redo-TAVR feasibility, but only in patients with a 100:0 implant (P<0.001). Commissural alignment would render redo-TAVR feasible in all patients, assuming the utilization of leaflet modification techniques to reduce the neoskirt height. Coronary access following TAV-in-TAV was affected by both index S3 implant depth and size. This study highlights the critical impact of implant depth, commissural alignment, and transcatheter heart valve size in predicting redo-TAVR feasibility. These findings highlight the necessity for individualized preprocedural planning, considering both immediate results and long-term prospects for reintervention as TAVR is increasingly utilized in younger patients with aortic stenosis.

Commissural vs Coronary Alignment to Avoid Coronary Overlap With THV-Commissure in TAVR: A CT-Simulation Study

BackgroundCoronary alignment is proposed as an alternative to commissural alignment for reducing coronary overlap during transcatheter aortic valve replacement (TAVR). However, largescale studies are lacking. ObjectivesThis study aimed to determine the incidence of coronary overlap with commissural vs coronary alignment using computed tomography (CT) simulation in patients undergoing TAVR evaluation. MethodsIn 1,851 CT scans of native aortic stenosis patients undergoing TAVR evaluation (April 2018 to December 2022),virtual valves simulating commissural and coronary alignment were superimposed on axial aortic root images. Coronary overlap was assessed based on the angular gap between coronary artery origin and the nearest transcatheter heart valve commissure, categorized as severe (≤15°), moderate (15°-30°), mild (30°-45°), and no-overlap (45°-60°). ResultsThe overall incidence of moderate/severe and severe overlap with either coronary artery remained rare with either coronary or commissural alignment (coronary 0.52% left, 0.52% right; commissural 0.30% left, 3.27% right). Comparing techniques, coronary alignment reduced moderate/severe overlap only for the right coronary artery (0.38% vs 2.97%; P <0.0001). For the left coronary artery, both techniques showed similar moderate/severe overlap, but commissural alignment had significantly higher no-overlap rates (91.1% vs 84.9%; P < 0.0001). Fluoroscopic angle during valve deployment was strongly correlated between commissural and coronary alignment (r = 0.80; P < 0.001). ConclusionsUsing CT simulation, the incidence of coronary overlap with transcatheter heart valve-commissure is rare with commissural alignment. Coronary alignment reduced right coronary overlap, whereas commissural alignment had higher rates of no left coronary overlap. Coronary alignment should be reserved only when commissural alignment results in severe coronary overlap.

Prognostic effect of stress hyperglycemia ratio on patients with severe aortic stenosis receiving transcatheter aortic valve replacement: a prospective cohort study

BackgroundStress hyperglycemia ratio (SHR) has recently been recognized as a novel biomarker that accurately reflects acute hyperglycemia status and is associated with poor prognosis of heart failure. We evaluated the relationship between SHR and clinical outcomes in patients with severe aortic stenosis receiving transcatheter aortic valve replacement (TAVR).MethodsThere were 582 patients with severe native aortic stenosis who underwent TAVR consecutively enrolled in the study. The formula used to determine SHR was as follows: admission blood glucose (mmol/L)/(1.59×HbA1c[%]–2.59). The primary endpoint was defined as all-cause mortality, while secondary endpoints included a composite of cardiovascular mortality or readmission for heart failure, and major adverse cardiovascular events (MACE) including cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke. Multivariable Cox regression and restricted cubic spline analysis were employed to assess the relationship between SHR and endpoints, with hazard ratios (HRs) and 95% confidence intervals (CIs).ResultsDuring a median follow-up of 3.9 years, a total of 130 cases (22.3%) of all-cause mortality were recorded. Results from the restricted cubic spline analysis indicated a linear association between SHR and all endpoints (p for non-linearity > 0.05), even after adjustment for other confounding factors. Per 0.1 unit increase in SHR was associated with a 12% (adjusted HR: 1.12, 95% CI: 1.04–1.21) higher incidence of the primary endpoint, a 12% (adjusted HR: 1.12, 95% CI: 1.02–1.22) higher incidence of cardiovascular mortality or readmission for heart failure, and a 12% (adjusted HR: 1.12, 95% CI: 1.01–1.23) higher incidence of MACE. Subgroup analysis revealed that SHR had a significant interaction with diabetes mellitus with regard to the risk of all-cause mortality (p for interaction: 0.042). Kaplan-Meier survival analysis showed that there were significant differences in the incidence of all endpoints between the two groups with 0.944 as the optimal binary cutoff point of SHR (all log-rank test: p < 0.05).ConclusionsOur study indicates linear relationships of SHR with the risk of all-cause mortality, cardiovascular mortality or readmission for heart failure, and MACE in patients with severe aortic stenosis receiving TAVR after a median follow-up of 3.9 years. Patients with an SHR exceeding 0.944 had a poorer prognosis compared to those with lower SHR values.

The role of serum lipoprotein(a) levels in bioprosthetic aortic valve degeneration

Abstract Introduction Lipoprotein(a) [Lp(a)] is associated with an increased incidence of aortic stenosis. Bioprosthetic aortic valve degeneration and native aortic stenosis share similar pathological mechanisms. Evidence regarding the role of serum Lp(a) concentrations in bioprosthetic aortic valve degeneration is lacking. Purpose To evaluate the association between serum Lp(a) concentrations and bioprosthetic aortic valve degeneration. Methods In this retrospective multicenter study, consecutive patients who underwent a bioprosthetic aortic valve replacement between Jan-2010 and Dec-2020 and had a preoperatory serum Lp(a) measurement were included. A baseline transthoracic echocardiography (TTE) was performed following the aortic valve replacement and a follow-up TTE was performed at least 24 months after the baseline study to determine the presence of bioprosthetic valve degeneration. Significant degeneration was defined as: (a) an increase &amp;gt;10 mmHg in mean bioprosthetic aortic valve gradient from baseline status + a decrease in effective orifice area + a decrease in Doppler velocity index + exclusion of clinically thrombotic leaflet thickening, OR (b) new moderate or severe prosthetic aortic regurgitation (if the main component was periprosthetic, then it was not considered). Lp(a) concentrations were compared between patients with and without degeneration and regression analysis was conducted to investigate the association between bioprosthetic valve degeneration and Lp(a) levels. Results In total, 211 cases were included (mean age 74.1 ±9.4 years, 72.0% males, 29.9% transcatheter aortic valve replacements) (Figure 1). Median time between baseline and follow-up TTE was 5.0 (IQR 3.7) years. Bioprostheses degeneration was observed in 33 (15.6%) patients at follow-up. Median serum levels of Lp(a) were significantly higher in the patients affected by degeneration versus non-affected cases (50.0 vs 15.7 mg/dl, p=0.003). In the regression analysis, high Lp(a) levels (≥30 mg/dl) were associated with degeneration both in a univariate analysis (OR 4.8, 95%CI 2.2-10.9, p&amp;lt;0.001) and multivariate analysis adjusted by other risk factors for bioprostheses degeneration (age, sex, hypertension, smoking, patient prosthesis mismatch, creatinine levels, and body surface area) (OR 5.2, 95%CI 2.1-12.8, p&amp;lt;0.001). Conclusion Serum Lp(a) concentrations seem to be a risk factor for bioprosthetic aortic valve degeneration (Figure 2). There is an increasing need to accurately predict bioprosthetic aortic valve degeneration and to develop novel methods and treatments to increase their durability. Prospective studies are needed to confirm these findings and to investigate whether lowering Lp(a) could slow bioprostheses degradation.Population characteristicsLp(a) and bioprostheses degeneration

Pressure-regulated deployment for balloon-expandable TAVI is safe, effective and results in superior valve haemodynamics regardless of prosthesis size

Abstract Background A novel pressure-regulated deployment method for balloon-expandable transcatheter heart valves (THVs) has been developed(1) to improve clinical outcomes by regulating maximal annular wall tension during prosthesis expansion – to both optimise prosthesis-annulus apposition and diminish annular injury. The previous feasibility study(1) showed that THV deployment at wall tensions between 3-3.5 MPa may be associated with reduced paravalvular-leak (PVL) severity and avoidance of annular rupture. Objective To prospectively evaluate the safety and efficacy of the pressure-regulated THV deployment strategy. Methods 341 consecutive patients with severe native aortic stenosis and moderate-severe surgical risk who underwent TAVI with Sapien 3 THVs using a pressure-regulated deployment strategy were included. Target (maximal) deployment pressure was adjusted according to valve size: 5 atm for 29mm, 5.5 atm for 26mm and 6.25 atm for 23mm THVs. Key procedural and clinical outcomes were recorded and analysed using uni- and multi-variate analyses. Results The average patient age was 82.1±6.9 years and 28.2% were female (see attached table). 29.3% had moderate-severe subannular calcification and 14.5% had estimated ≥20% THV oversizing based on TAVI CT. 112 patients (32.8%) were considered at high-risk of annular rupture(2). Post-dilatation rate was 8.2% and was independently associated only with the degree of THV oversizing (OR 3.5, p=0.007, for ≤5% oversizing). On TTE prior to discharge, 85.6% had none/trivial PVL and 14.4% had mild PVL with no observed moderate/severe PVL. Mild PVL was independently associated with age (OR 1.07, p=0.02, per year) and degree of THV oversizing (OR 2.4, p=0.02, for ≤5% oversizing). Resulting THV mean gradient on TTE was 9.7±3.5mmHg overall, with similar results between 23mm (10.5±3.2mmHg) and 26/29mm valves (9.6±3.5mmHg, p=0.2). New PPM rate was 9.6% and was independently associated only with pre-existing RBBB (OR 13.5, p&amp;lt;0.001). New LBBB rate was 11.2% was independently associated only with low THV implantation depth (OR 4.3, p=0.009, for ≤60% of THV length above native aortic annulus). There were no cases of aortic/annular rupture. Conclusions The pressure-regulated strategy for balloon-expandable THV deployment is associated with an excellent safety and efficacy outcomes profile. Notably, there was no significant difference in valve haemodynamics and degree of PVL post-implantation between the smaller (23mm) and larger (26/29mm) THV sizes. These findings suggest that standardisation of THV deployment pressure to achieve target wall tension results in improved haemodynamics, particularly in small-sized valves.Main Table (Truncated)PVL and MG according to THV size

Abstract 12643: Role of Aortic Valve Replacement in Moderate Native Aortic Stenosis: A 10-year Outcomes Study

Background: Patients with moderate aortic stenosis (AS) exhibit high morbidity and mortality. Very limited evidence exists on the role of aortic valve replacement (AVR) in this patient population. Objectives: To investigate the benefit of AVR in patients with moderate AS compared to clinical surveillance on long-term survival. Methods: In a retrospective cohort study, patients aged ≥ 60 years with native tricuspid moderate AS between 2008-2016 were selected from the Cleveland Clinic echocardiographic database. Patients were classified as receiving AVR or managed with clinical surveillance. Clinical outcomes included all-cause and cardiovascular mortality, assessed by survival analyses and multivariable-adjusted Cox and competing risks regression, respectively. Results: We included 1,421 patients (mean age, 75.3 ± 5.4 years and 39.9% females) followed over a median duration of 6 years. Patients in the AVR group had lower risk of all-cause (adjusted HR = 0.51, 95% CI: [0.34, 0.77]; p = 0.001) and cardiovascular mortality (aHR = 0.50, 95% CI: [0.31, 0.80]; p = 0.004) compared to those in the clinical surveillance group irrespective of sex, receipt of other open-heart surgeries, and underlying malignancy. Conclusions: In patients with moderate AS, AVR was associated with favorable clinical outcomes and left ventricular remodeling patients. Figure 1 Incidence of all-cause mortality and cardiovascular mortality in patients with moderate AS in those who underwent AVR and clinical surveillance. Hazards ratios (HR) represent relative incidence of AVR versus clinical surveillance. HRs for all-cause mortality were calculated using Cox regression and for cardiovascular mortality using competing risks regression, with non-cardiac mortality as competing event. HRs were adjusted for age, sex, body-mass index, comorbidities, medications, and baseline echocardiographic data (AVA, MG, Vmax, and LVEF)

Role of lipoprotein(a) concentrations in bioprosthetic aortic valve degeneration

ObjectivesLipoprotein(a) (Lp(a)) is associated with an increased incidence of native aortic stenosis, which shares similar pathological mechanisms with bioprosthetic aortic valve (bAV) degeneration. However, evidence regarding the role of Lp(a)...

Association between remnant cholesterol and progression of bioprosthetic valve degeneration.

Remnant cholesterol (RC) seems associated with native aortic stenosis. Bioprosthetic valve degeneration may share similar lipid-mediated pathways with aortic stenosis. We aimed to investigate the association of RC with the progression of bioprosthetic aortic valve degeneration and ensuing clinical outcomes. We enrolled 203 patients with a median of 7.0 years (interquartile range: 5.1-9.2) after surgical aortic valve replacement. RC concentration was dichotomized by the top RC tertile (23.7 mg/dL). At 3-year follow-up, 121 patients underwent follow-up visit for the assessment of annualized change in aortic valve calcium density (AVCd). RC levels showed a curvilinear relationship with an annualized progression rate of AVCd, with increased progression rates when RC >23.7 mg/dL (P = 0.008). There were 99 deaths and 46 aortic valve re-interventions in 133 patients during a median clinical follow-up of 8.8 (8.7-9.6) years. RC >23.7 mg/dL was independently associated with mortality or re-intervention (hazard ratio: 1.98; 95% confidence interval: 1.31-2.99; P = 0.001). Elevated RC is independently associated with faster progression of bioprosthetic valve degeneration and increased risk of all-cause mortality or aortic valve re-intervention.

First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System

BackgroundThe latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited. ObjectivesThis study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience. MethodsFrom June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported. ResultsOf 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001). ConclusionsThe Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.

Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis.

Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce. The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems. Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05/2012 to 09/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations. Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299). The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes.