Outcomes in patients with aortic stenosis and severely reduced ejection fraction following surgical aortic valve replacement and transcatheter aortic valve replacement.

BACKGROUND: Patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction demonstrate improvement in left ventricular injection fraction (LVEF) after aortic valve replacement (AVR). The timing and magnitude of recovery in patients with very low LVEF (≤ 25%) in surgical or transcatheter AVR is not well studied. OBJECTIVE: Determine clinical outcomes following transcatheter aortic valve replacement (TAVR) and surgical aortic valve repair (SAVR) in the subset of patients with severely reduced EF ≤ 25%. METHODS: Single-center, retrospective study with primary endpoint of LVEF 1-week following either procedure. Secondary outcomes included 30-day mortality and delayed postprocedural LVEF. T-test was used to compare variables and linear regression was used to adjust differences among baseline variables. RESULTS: 83 patients were enrolled (TAVR = 56 and SAVR = 27). TAVR patients were older at the time of procedure (TAVR 77.29 ± 8.69 vs. SAVR 65.41 ± 10.05, p < 0.001). One week post procedure, all patients had improved LVEF after both procedures (p < 0.001). There was no significant difference in LVEF between either group (TAVR 33.5 ± 11.77 vs. SAVR 35.3 ± 13.57, p = 0.60). Average LVEF continued to rise and increased by 101% at final follow-up (41.26 ± 13.70). 30-day mortality rates in SAVR and TAVR were similar (7.4% vs. 7.1%, p = 0.91). CONCLUSION: Patients with severe AS and LVEF ≤ 25% have a significant recovery in post-procedural EF following AVR regardless of method. LVEF doubled at two years post-procedure. There was no significant difference in 30-day mortality or mean EF recovery between TAVR and SAVR. TRIAL REGISTRATION: Indiana University institutional review board granted approval for above study numbered 15,322.

Transcarotid vascular access for transcatheter aortic valve implantation: is choosing the left side always right?

BACKGROUND: The transcarotid (TC) vascular access for transcatheter aortic valve implantation (TAVI) has emerged as the first-choice alternative to the transfemoral access, in patients unsuitable for the latter. The use of both the left and right common carotid arteries (CCAs) for TC-TAVI has been described, but the optimal side is subject to debate. We conducted this pilot study to compare the level of vessel tortuosity and plaque burden from either the left CCA to the aortic annulus, or the right CCA to the aortic annulus, considering them as surrogates for technical and procedural complexity. METHODS: Consecutive patients who underwent TC-TAVI between 2018 and 2021 in our institution were included. Using three-dimensional reconstruction, pre-TAVI neck and chest computed tomography angiography exams were reviewed to assess the tortuosity index (TI), sum of angles metric, as well as plaque burden, between each CCA and the aortic annulus. RESULTS: We included 46 patients who underwent TC-TAVI. No significant difference regarding the mean TIs between the left and right sides (respectively 1.20 and 1.19, p = 0.82), the mean sum of angles (left side: 396°, right side: 384°, p = 0.27), and arterial plaque burden (arterial plaque found in 30% of left CCAs and 45% of right CCAs, p = 0.19) was found. CONCLUSIONS: We found no convincing data favoring the use of one particular access side over the other one. The choice of the CCA side in TC-TAVI should to be made on a case-by-case basis, in a multidisciplinary fashion, and may also depend on the operators' experience.

Chimney Stenting vs BASILICA for Prevention of Acute Coronary Obstruction During Transcatheter Aortic Valve Replacement.

BACKGROUND: Coronary obstruction (CO) is a potentially life-threatening complication of transcatheter aortic valve replacement (TAVR). Chimney stenting or leaflet laceration with transcatheter electrosurgery (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) are 2 techniques developed to prevent CO. OBJECTIVES: The aim of the present study was to compare periprocedural and 1-year outcomes of chimney and BASILICA in TAVR patients at high risk of CO. METHODS: This multicenter observational registry enrolled consecutive TAVR patients at high risk of CO, undergoing either preventive chimney stenting or BASILICA. Clinical success was defined as successful performance of the chimney or BASILICA technique without clinically relevant ostial CO. The primary endpoint was major adverse cardiovascular events, a composite of death, myocardial infarction, stroke, or unplanned target lesion coronary revascularization at 1 year. RESULTS: A total of 168 patients were included: 71 (42.3%) received chimney stenting, and 97 (57.7%) underwent BASILICA. Patients undergoing BASILICA had higher preprocedural risk of CO, as indicated by lower sinotubular junction height (18.2 ± 4.8 mm vs 14.8 ± 3.4 mm; P < 0.001) and diameter (28.2 ± 4.5 vs 26.8 ± 3.4; P = 0.029). Rates of periprocedural complications were similar between the 2 groups. Clinical success was 97.2% and 96.9% in chimney and BASILICA, respectively (P = 0.92). At 1-year follow-up, the cumulative incidence of major adverse cardiovascular events was 18.7% (95% CI: 11%-30.6%) in the chimney group and 19.9% (95% CI: 12.1%-31.5%) in the BASILICA group (log-rank P = 0.848), whereas chimney was associated with a numerically higher cardiovascular mortality than BASILICA (6.7% vs 1.3%; log-rank P = 0.168). CONCLUSIONS: Chimney stenting and BASILICA effectively prevent TAVR-induced acute CO. Both techniques seem to have comparable acceptable periprocedural and 1-year outcomes.

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

BACKGROUND: Coronary alignment is proposed as an alternative to commissural alignment for reducing coronary overlap during transcatheter aortic valve replacement (TAVR). However, largescale studies are lacking. OBJECTIVES: This study aimed to determine the incidence of coronary overlap with commissural vs coronary alignment using computed tomography (CT) simulation in patients undergoing TAVR evaluation. METHODS: In 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°). RESULTS: The 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). CONCLUSIONS: Using 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.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Low Muscle Mass by Preprocedural Computed Tomography Is Associated With Worse Short-Term Outcomes in Transcatheter Aortic Valve Replacement Recipients.

Low muscle mass (LMM) is associated with worse outcomes in various clinical situations. Traditional frailty markers have been used for preoperative risk stratification in patients who underwent transcatheter aortic valve replacement (TAVR). However, preoperative imaging provides an opportunity to directly quantify skeletal muscle mass to identify patients at higher risk of procedural complications. We reviewed all TAVR recipients from January to December 2018 and included subjects with preprocedural chest computed tomography. Multi-slice automated measurements of skeletal muscle mass were made from the ninth to twelfth thoracic vertebrae and normalized by height squared to obtain skeletal muscle index (cm2/m2). LMM was defined as the lowest gender-stratified skeletal muscle index tertile. Strength testing was collected during pre-TAVR evaluation. Primary outcome was a composite of perioperative complications, 1-year rehospitalization, or 1-year mortality. In our cohort, 238 patients met inclusion criteria, and 80 (33.6%) were identified to have LMM. Patients with LMM were older with lower body mass index, decreased grip strength, lower hemoglobin A1c, and higher N-terminal pro-brain natriuretic peptide. They had greater rates of the composite outcome and 2-year all-cause mortality, which remained significant on multivariable adjustment (hazard ratio 1.71, 95% confidence interval 1.05 to 2.78, p = 0.030 and hazard ratio 2.31, 95% confidence interval 1.02 to 5.24, p = 0.045, respectively) compared with patients without LMM; there was no significant difference in 5-year all-cause mortality. In conclusion, LMM was associated with an increase in the primary composite outcome and 2-year all-cause mortality in TAVR recipients. Using automatic muscle processing software on pre-TAVR computed tomography scans may serve as an additional preoperative risk stratification tool.

Trends in transcatheter aortic valve implantation practice and clinical outcomes at an Irish tertiary referral centre.

OBJECTIVE: A paucity of data exists on how transcatheter aortic valve implantation (TAVI) practice has evolved in Ireland. This study sought to analyse temporal trends in patient demographics, procedural characteristics, and clinical outcomes at an Irish tertiary referral centre. METHODS: The prospective Mater TAVI database was divided into time tertiles based on when TAVI was performed: Group A, November 2008-April 2013; Group B, April 2013-September 2017; and Group C, September 2017-February 2022. Patient and procedural characteristics and clinical outcomes were compared across groups. RESULTS: A total of 1063 (Group A, 59; Group B, 268; and Group C:, 736) patients were treated with TAVI during the study period (mean age 81.1±7.4, mean Society of Thoracic Surgeons score 5.9±5.1).Conscious sedation (Group A, 0%; Group B, 59.9%; and Group C, 90.2%, p<0.001) and femoral artery access (Group A, 76.3%; Group B, 90.7%; and Group C, 96.6%, p<0.001) were used more frequently over time. The median length of hospital stay reduced from 9 days (IQR 7, 18) in Group A to 2 days (IQR 2, 3) in Group C. In-hospital death was numerically higher in Group A compared with Group C (6.8% vs 1.9%, p=0.078). At 1-year follow-up, the rate of death and/or stroke was similar in Group A and Group C (20.3% vs 12.0%, adjusted HR 1.49, 95% CI (0.59 to 3.74)). CONCLUSION: There was exponential growth in TAVI procedural volume during the study period. A minimalist approach to TAVI emerged, and this was associated with significantly shorter procedure duration and hospital stay. Clinical outcomes at 1-year follow-up did not change significantly over time.

Comparative analysis of early postoperative results of transcatheter aortic valve implantation and surgical aortic valve replacement with a biological prosthesis.

OBJECTIVE: . Aim: The choice of aortic valve stenosis correction method is determined by a number of clinical and technical parameters. The task was to compare early postoperative outcomes in patients after correction of aortic valve stenosis using TAVI and surgical aortic valve replacement with a biological prosthesis. PATIENTS AND METHODS: Materials and Methods: This retrospective study analyzed the medical records of adult patients (18 years of age and older) who had transcatheter aortic valve implantation or surgical aortic valve replacement with a biological prosthesis at the State Institution "Heart Institute of the Ministry of Health" in the period from 2018 to 2022. RESULTS: Results: In 47 (47.5%) cases, TAVI was performed and in 52 (52.5%) cases, SAVR with a biological prosthesis was performed. Patients who underwent TAVI were significantly older (p=0.002) and had a higher EuroSCORE II operative risk score (p<0.001). In patients with TAVI, larger diameter aortic valve prostheses were significantly more often used compared with the SAVR group with biological prosthesis (27.5±2.74 vs. 22.5±1.84, p<0.001). The early postoperative period in patients with TAVI was characterized by an 11.4% (p=0.046) and 15.4% (p=0.006). The length of stay in the ICU (p=0.024), as well as the duration of hospitalization in general (p=0.005), was also significantly lower in patients with TAVI compared with patients with biological prosthesis SAVR. CONCLUSION: Conclusions: Despite the higher surgical risk of surgery according to EuroSCORE II, TAVI was characterized by a lower incidence of postoperative complications, with shorter duration of stay in ICU and hospitalization in general in comparison with patients undergoing SAVR with a biological prosthesis.

High risk of coronary artery obstruction during TAVR, how to avoid it?

BACKGROUND: Coronary artery obstruction after percutaneous aortic replacement is a complication with high short-term mortality secondary to the lack of timely treatment. There are various predictors of coronary obstruction prior to valve placement such as the distance from the ostia, the degree of calcification, the distance from the sinuses; In such a situation some measures must be taken to prevent and treat coronary obstruction. CASE PRESENTATION: An 84-year-old male, with severe aortic stenosis and high surgical risk, who was treated with TAVR. However, during the deployment of the valve he presented hemodynamic instability secondary to LMCA obstruction. The intravascular image showed obstruction of the ostium secondary to the displacement of calcium that he was successfully treated with a chimney stent technique. CONCLUSIONS: The high degree of calcification and the left ostium near the annulus are conditions for obstruction of the ostium at the time of valve release; In this context, provisional stenting prior to TAVR in patients at high risk of obstruction should be considered as a safe prevention strategy to achieve the success of the procedure.

The Effect of Aortic Angulation on Clinical Outcomes of Patients Undergoing Transcatheter Aortic Valve Replacement.

INTRODUCTION: The aim of this study was to assess the impact of aortic angulation (AA) on periprocedural and in-hospital complications as well as mortality of patients undergoing Evolut™ R valve implantation. METHODS: A retrospective study was conducted on 264 patients who underwent transfemoral-approach transcatheter aortic valve replacement with self-expandable valve at our hospital between August 2015 and August 2022. These patients underwent multislice computer tomography scans to evaluate AA. Transcatheter aortic valve replacement endpoints, device success, and clinical events were assessed according to the definitions provided by the Valve Academic Research Consortium-3. Cumulative events included paravalvular leak, permanent pacemaker implantation, new-onset stroke, and in-hospital mortality. Patients were divided into two groups, AA ≤ 48° and AA > 48°, based on the mean AA measurement (48.3±8.8) on multislice computer tomography. RESULTS: Multivariable logistic regression analysis was performed to identify predictors of cumulative events, utilizing variables with a P-value < 0.2 obtained from univariable logistic regression analysis, including AA, age, hypertension, chronic renal failure, and heart failure. AA (odds ratio [OR]: 1.73, 95% confidence interval [CI]: 0.89-3.38, P=0.104), age (OR: 1.04, 95% CI: 0.99-1.10, P=0.099), hypertension (OR: 1.66, 95% CI: 0.82-3.33, P=0.155), chronic renal failure (OR: 1.82, 95% CI: 0.92-3.61, P=0.084), and heart failure (OR: 0.57, 95% CI: 0.27-1.21, P=0.145) were not found to be significantly associated with cumulative events in the multivariable logistic regression analysis. CONCLUSION: This study demonstrated that increased AA does not have a significant impact on intraprocedural and periprocedural complications of patients with new generation self-expandable valves implanted.

Female showed favorable left ventricle hypertrophy regression during post-TAVR follow-up.

Transcatheter aortic valve replacement (TAVR) is a well-established procedure using a catheter-introduced valve prosthesis for patients with severe aortic stenosis (AS). This retrospective study investigated sex-related differences in pre- and post-TAVR clinical and hemodynamic outcomes and analyzed data of the first 100 cases at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) between December 2013 and December 2021. Baseline characteristics, procedural outcomes, mortality rates, and echocardiographic parameters were analyzed and compared between sexes. Among the 100 patients, male (46%) and female (54%) were of similar age (mean age, male 86.0 years vs. female 84.5 years) and of the same severity of AS (mean pressure gradient, male 47.5 mmHg vs. female 45.7 mmHg) at the time receiving the TAVR procedure. Women had smaller aortic valve areas calculated by continuity equation (0.8 ± 0.3 cm2 vs. 0.7 ± 0.2 cm2, p < 0.001). In addition, women had better left ventricle ejection fraction (59.6 ± 14.0% vs. men 54.7 ± 17.2%, p < 0.01). In the post-TAVR follow-up, regression of left ventricle mass and dimension was better in women than in men. None of the patient died within 30 days after the procedure, and women tended to have a more favorable survival than men (2-year mortality and overall mortality rate in 8.3 year, women 9.1% and 22.2% vs. men 22.2% and 34.8%; p = 0.6385 and 0.1277, respectively). In conclusion, the sex-based difference in post-TAVR regression of LV remodeling suggests a need for sex-based evaluation for patients with severe AS and their post TAVR follow-up.

Patient-specific computer simulation of transcatheter aortic valve replacement in patients with previous mechanical mitral prosthesis: A case series.

Transcatheter aortic valve replacement performed in patients with previously implanted mechanical mitral prosthesis represents a high risk procedure with several potential complications. We report a systematic use of a prediction model based on artificial intelligence to plan the interventional strategy in this challenging scenario.

Transcatheter Aortic Valve Implantation Wait-Time Management: Derivation and Validation of the Canadian TAVI Triage Tool (CAN3T).

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has seen indication expansion and thus exponential growth in demand over the past decade. In many jurisdictions, the growing demand has outpaced capacity, increasing wait times and preprocedural adverse events. In this study, we derived prediction models that estimate the risk of adverse events on the waitlist and developed a triage tool to identify patients who should be prioritized for TAVI. METHODS AND RESULTS: We included adult patients in Ontario, Canada referred for TAVI and followed up until one of the following events first occurred: death, TAVI procedure, removal from waitlist, or end of the observation period. We used subdistribution hazards models to find significant predictors for each of the following outcomes: (1) all-cause death while on the waitlist; (2) all-cause hospitalization while on the waitlist; (3) receipt of urgent TAVI; and (4) a composite outcome. The median predicted risk at 12 weeks was chosen as a threshold for a maximum acceptable risk while on the waitlist and incorporated in the triage tool to recommend individualized wait times. Of 13 128 patients, 586 died while on the waitlist, and 4343 had at least 1 hospitalization. A total of 6854 TAVIs were completed, of which 1135 were urgent procedures. We were able to create parsimonious models for each outcome that included clinically relevant predictors. CONCLUSIONS: The Canadian TAVI Triage Tool (CAN3T) is a triage tool to assist clinicians in the prioritization of patients who should have timely access to TAVI. We anticipate that the CAN3T will be a valuable tool as it may improve equity in access to care, reduce preventable adverse events, and improve system efficiency.

National Variability in Pacemaker Implantation Rate Following TAVR: Insights From the STS/ACC TVT Registry.

BACKGROUND: Although permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve replacement (TAVR), hospital variation and change in PPM implantation rates are ill defined. OBJECTIVES: The aim of this study was to determine hospital-level variation and temporal trends in the rate of PPM implantation following TAVR. METHODS: Using the American College of Cardiology/Society of Thoracic Surgeons TVT (Transcatheter Valve Therapy) Registry, temporal changes in variation of in-hospital and 30-day PPM implantation were determined among 184,452 TAVR procedures across 653 sites performed from 2016 to 2020. The variation in PPM implantation adjusted for valve type by annualized TAVR volume was determined, and characteristics of sites below, within, and above the 95% boundary were identified. A series of stepwise multivariable hierarchical models were then fit, and the median OR was used to measure variation in pacemaker rates among sites. RESULTS: From 2016 to 2020, the overall rate of PPM implantation was 11.3%, with wide variation across sites (range: 0%-36.4%); rates trended lower over time. Adjusted for annualized volume, there were 34 sites with PPM implantation rates above the 95th percentile CI and 28 with rates below, with wide variation among the remaining sites. After adjusting for patient-level covariates, there was variation among sites in the probability of PPM implantation (median OR: 1.39; 95% CI: 1.35-1.43, P < 0.001); although some of the variation was explained by the addition of valve type, residual variation in PPM implantation rates persisted in additional models incorporating site-level covariates (annualized volume, region, teaching status, hospital beds, etc). CONCLUSIONS: Although PPM implantation rates have decreased over time, substantial site-level variation remains even after accounting for observed patient characteristics and site-level factors. As there are numerous outlier sites both above and below the 95% confidence limit, dissemination of best practices from high-performing sites to low-performing sites and guideline-based education may be important quality improvement initiatives to reduce rates of this common complication.

Association of Bovine Arch Anatomy With Incident Stroke After Transcatheter Aortic Valve Replacement.

BACKGROUND: Acute ischemic stroke complicates 2% to 3% of transcatheter aortic valve replacements (TAVRs). This study aimed to identify the aortic anatomic correlates in patients after TAVR stroke. METHODS AND RESULTS: This is a single-center, retrospective study of patients who underwent TAVR at the Mayo Clinic between 2012 and 2022. The aortic arch morphology was determined via a manual review of the pre-TAVR computed tomography images. An "a priori" approach was used to select the covariates for the following: (1) the logistic regression model assessing the association between a bovine arch and periprocedural stroke (defined as stroke within 7 days after TAVR); and (2) the Cox proportional hazards regression model assessing the association between a bovine arch and long-term stroke after TAVR. A total of 2775 patients were included (59.6% men; 97.8% White race; mean±SD age, 79.3±8.4 years), of whom 495 (17.8%) had a bovine arch morphology. Fifty-seven patients (1.7%) experienced a periprocedural stroke. The incidence of acute stroke was significantly higher among patients with a bovine arch compared with those with a nonbovine arch (3.6% versus 1.7%; P=0.01). After adjustment, a bovine arch was independently associated with increased periprocedural strokes (adjusted odds ratio, 2.16 [95% CI, 1.22-3.83]). At a median follow-up of 2.7 years, the overall incidence of post-TAVR stroke was 6.0% and was significantly higher in patients with a bovine arch even after adjusting for potential confounders (10.5% versus 5.0%; adjusted hazard ratio, 2.11 [95% CI, 1.51-2.93]; P<0.001). CONCLUSIONS: A bovine arch anatomy is associated with a significantly higher risk of periprocedural and long-term stroke after TAVR.

Transfemoral transcatheter aortic valve replacement with VitaFlowTM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial.

BACKGROUND: Previous studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR patients lacks support from randomized trials. TRIAL DESIGN: SEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlowTM valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes. CONCLUSION: SEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only.

Effect of Neutrophil-to-Lymphocyte Ratio on Post-TAVR Mortality and Periprocedural Pulmonary Hypertension.

Aims: To evaluate the impact of neutrophil-to-lymphocyte ratio (NLR) on periprocedural pulmonary hypertension (PH) and 3-month all-cause mortality in patients with aortic stenosis (AS) who underwent transcatheter aortic valve replacement (TAVR) and to develop a nomogram for predicting the mortality for these patients. Methods and Results: 124 patients undergoing TAVR were categorized into three groups according to systolic pulmonary artery pressure (sPAP): Group I (no PH, n = 61) consisted of patients with no pre- and post-TAVR PH; Group II (improved PH, n = 35) consisted of patients with post-TAVR systolic pulmonary artery pressure (sPAP) decreased by more than 10 mmHg compared to pre-TAVR levels; and Group III (persistent PH, n = 28) consisted of patients with post-TAVR sPAP no decrease or less than 10 mmHg, or new-onset PH after the TAVR procedure. The risk of all-cause mortality within 3 months tended to be higher in Group II (11.4%) and Group III (14.3%) compared to Group I (3.3%) (P=0.057). The multinomial logistic regression analysis demonstrated a positive correlation between NLR and both improved PH (OR: 1.182, 95% CI: 1.036-1.350, P=0.013) and persistent PH (OR: 1.181, 95% CI: 1.032-1.352, P=0.016). Kaplan-Meier analysis revealed a significant association between higher NLR and increased 3-month all-cause mortality (16.1% vs. 3.1% in lower NLR group, P=0.021). The multivariable Cox regression analysis confirmed that NLR was an independent predictor for all-cause mortality within 3 months, even after adjusting for clinical confounders. A nomogram incorporating five factors (BNP, heart rate, serum total bilirubin, NLR, and comorbidity with coronary heart disease) was developed. ROC analysis was performed to discriminate the ability of the nomogram, and the AUC was 0.926 (95% CI: 0.850-1.000, P < 0.001). Conclusions: Patients with higher baseline NLR were found to be at an increased risk of periprocedural PH and all-cause mortality within 3 months after TAVR.

Sensor-guided transcatheter aortic valve replacement.

OBJECTIVES: The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population. METHODS: We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure. RESULTS: A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires. CONCLUSIONS: SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.