Reducing length of stay after transfemoral transcatheter aortic valve implantation: the FAST-TAVI II trial.

BACKGROUND AND AIMS: The length of stay (LOS) after transcatheter aortic valve implantation (TAVI) remains extremely variable whereas early discharge has been shown to be feasible and safe. The study objective was to evaluate the efficacy and safety of an intervention aimed at reducing LOS after transfemoral TAVI. METHODS: FAST-TAVI II is a prospective, multicentre, cluster, randomized, controlled study including patients with severe symptomatic aortic stenosis, who had transfemoral TAVI. The intervention consisted in a dedicated training programme to implement 10 quality of care measures to reduce LOS with an implementation phase of eight weeks. The primary endpoint was the proportion of patients discharged early within 3 days. Secondary endpoints included: LOS, 30-day mortality and 30-day incidence of readmission for cardiovascular events. RESULTS: During the study period, 969 patients were enrolled in the intervention group and 860 patients in the control group. Mean age was 81.9 ± 6.6 years and mean EuroSCORE II was 4.4 ± 4.5%. Early discharge was achieved in 563 (58.1%) patients in the intervention group vs. 364 (42.3%) patients in the control group (P < .0001). Median LOS was significantly reduced in the intervention group compared to the control group [3 (IQR: 3) vs. 4 days (IQR: 3), P < .0001]. Thirty-day mortality was low and similar in the two groups (0.5% vs. 0.9%, P = .30), as were 30-day readmissions (4.6% vs. 2.8%, P = .28). CONCLUSIONS: The intervention was simple and fast to implement, and was effective and safe to reduce LOS and increase the proportion of patients discharged early after TAVI (NCT04503655).

A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study.

BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.

Transcatheter aortic valve implantation and its impact on endothelial function in patients with aortic stenosis.

Vascular function is impaired in patients with aortic valve stenosis (AS). The impact of transcatheter aortic valve implantation (TAVI) on endothelial function is inconclusive so far. Therefore, we sought to assess the short-term influence of TAVI on endothelial dysfunction in patients with AS. We recruited 47 patients (76.6 % male, 80.04 years old) with AS scheduled for TAVI. Endothelial function was assessed by fingertip reactive hyperemia peripheral arterial tonometry (RH-PAT). Measurements were conducted one day before and three days after TAVI. Patients were grouped according to RH-PAT change after TAVI. Overall, RH-PAT measurements did not significantly improve after TAVI (Reactive Hyperemia Index: 1.5 vs 1.6, p = 0.883; logarithm of the Reactive Hyperemia Index: 0.44 vs. 0.49, p = 0.523). Interestingly, patients with no RH-PAT improvement after TAVI displayed a more severe AS and had lower blood pressure after TAVI. This might be due to a more disturbed blood flow in patients with a smaller aortic valve area and higher peak aortic valve velocity. The relationship between AS severity, endothelial dysfunction and TAVI has to be investigated in future research that apply longitudinal study designs.

Impact of stroke history on procedural cerebrovascular insult probability and long-term outcome after TAVI.

BACKGROUND: In TAVI procedural stroke is one of the most feared complications and for this reason also extensively studied. But there is a lack of data concerning the impact of previous stroke on procedural stroke and on long-term survival. The aim of this registry-based cohort study is to evaluate the prevalence of previous stroke in TAVI patients and its impact on procedural stroke risk as well as long-term outcome. METHODS: We included all patients treated with TAVI between January 2007 and December 2020 and investigated concerning previous stroke in their medical history. Among 958 patients, 55 patients had previous stroke and were included in the present analysis. RESULTS: The salient finding of the present study is that previous stroke is significantly associated with higher all-cause mortality and has established itself as a predictor for poor outcome after TAVI. This is also observed after adjusting for confounders like EuroSCORE II (European system for cardiac operative risk evaluation) and AF (atrial fibrillation) as one of the main underlying diseases for cerebrovascular insult (CVI). However, previous stroke is not associated with higher rates of procedural CVI. CONCLUSION: A history of stroke is significantly associated with higher all-cause mortality and has established itself as a predictor for poor outcome after TAVI without higher rates of procedural stroke.

Clinical impact of cerebral protection during transcatheter aortic valve implantation.

BACKGROUND: Embolization of debris can complicate transcatheter aortic valve implantation (TAVI) causing stroke. Cerebral embolism protection (CEP) devices can divert or trap debris. PURPOSE: To evaluate the efficacy of CEP during TAVI vs the standard procedure. DATA SOURCES: PubMed, SCOPUS and DOAJ 1/01/2014-04/12/2023. STUDY SELECTION: Randomized and observational studies comparing CEP versus standard TAVI, according to PRISMA. PRIMARY OUTCOME: stroke. SECONDARY OUTCOMES: death, bleeding, vascular access complications, acute kidney injury and infarct area. DATA EXTRACTION: Two investigators independently assessed study quality and extracted data. DATA SYNTHESIS: Twenty-six articles were included (540.247 patients). The primary endpoint was significantly lower (RR = 0.800 95%CI:0.682-0.940; p = 0.007) with CEP. Similarly, death rates were significantly lower with CEP (RR = 0.610 95%CI:0.482-0.771; p < 0.001). No difference was found for bleeding (RR = 1.053 95%CI:0.793-1.398; p = 0.721), vascular complications (RR = 0.937 95%CI:0.820-1.070; p = 0.334) or AKI (RR = 0.982 95%CI:0.754-1.279; p = 0.891). CONCLUSIONS: Use of CEP during TAVI is associated with improved outcomes. Future studies will identify patients who benefit most from CEP.

Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure: Rationale and design of the multicentre, prospective, observational ReTAVI registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI. METHODS: The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025. CONCLUSIONS: The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis.

Antithrombotic Therapy Following Structural Heart Disease Interventions: Current Status and Future Directions.

Interventions in structural heart disease cover many catheter-based procedures for congenital and acquired conditions including valvular diseases, septal defects, arterial or venous obstructions, and fistulas. Among the available procedures, the most common are aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure. Antithrombotic therapy for transcatheter structural heart disease interventions aims to prevent thromboembolic events and reduce the risk of short-term and long-term complications. The specific approach to antithrombotic therapy depends on the type of intervention and individual patient factors. In this review, we synopsize contemporary evidence on antithrombotic therapies for structural heart disease interventions and highlight the importance of a personalized approach. These recommendations may evolve over time as new evidence emerges and clinical guidelines are updated. Therefore, it's crucial for healthcare professionals to stay updated on the most recent guidelines and individualize therapy based on patient-specific factors and procedural considerations.

Multi-modality artificial intelligence-based transthyretin amyloid cardiomyopathy detection in patients with severe aortic stenosis.

PURPOSE: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a frequent concomitant condition in patients with severe aortic stenosis (AS), yet it often remains undetected. This study aims to comprehensively evaluate artificial intelligence-based models developed based on preprocedural and routinely collected data to detect ATTR-CM in patients with severe AS planned for transcatheter aortic valve implantation (TAVI). METHODS: In this prospective, single-center study, consecutive patients with AS were screened with [99mTc]-3,3-diphosphono-1,2-propanodicarboxylic acid ([99mTc]-DPD) for the presence of ATTR-CM. Clinical, laboratory, electrocardiogram, echocardiography, invasive measurements, 4-dimensional cardiac CT (4D-CCT) strain data, and CT-radiomic features were used for machine learning modeling of ATTR-CM detection and for outcome prediction. Feature selection and classifier algorithms were applied in single- and multi-modality classification scenarios. We split the dataset into training (70%) and testing (30%) samples. Performance was assessed using various metrics across 100 random seeds. RESULTS: Out of 263 patients with severe AS (57% males, age 83 ± 4.6years) enrolled, ATTR-CM was confirmed in 27 (10.3%). The lowest performances for detection of concomitant ATTR-CM were observed in invasive measurements and ECG data with area under the curve (AUC) < 0.68. Individual clinical, laboratory, interventional imaging, and CT-radiomics-based features showed moderate performances (AUC 0.70-0.76, sensitivity 0.79-0.82, specificity 0.63-0.72), echocardiography demonstrated good performance (AUC 0.79, sensitivity 0.80, specificity 0.78), and 4D-CT-strain showed the highest performance (AUC 0.85, sensitivity 0.90, specificity 0.74). The multi-modality model (AUC 0.84, sensitivity 0.87, specificity 0.76) did not outperform the model performance based on 4D-CT-strain only data (p-value > 0.05). The multi-modality model adequately discriminated low and high-risk individuals for all-cause mortality at a mean follow-up of 13 months. CONCLUSION: Artificial intelligence-based models using collected pre-TAVI evaluation data can effectively detect ATTR-CM in patients with severe AS, offering an alternative diagnostic strategy to scintigraphy and myocardial biopsy.

One-year initial efficacy and safety outcomes of the premounted dry-pericardium Vienna self-expandable transcatheter aortic valve system: A first-in-human VIVA feasibility study.

BACKGROUND: The dry-pericardium Vienna transcatheter aortic valve system is repositionable and retrievable, already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation. METHODS: The VIVA first-in-human feasibility study, a prospective, nonrandomized, single-center trial, evaluated the Vienna aortic valve in 10 patients with severe symptomatic aortic stenosis, who were at intermediate or high surgical risk. This study, registered at ClinicalTrials.gov (NCT04861805), focused on the safety, feasibility, clinical and hemodynamic performance of the Vienna system up to 1-year follow-up. RESULTS: The mean patient age was 79 ± 5 years, 60% male. Valve sizes used: 26 mm (10%), 29 mm (30%), 31 mm (60%). Key hemodynamic improvements were significant: mean aortic valve pressure gradient (mmHg) decreased from 48.7 to 8.1, aortic valve area (cm2) increased from 0.75 to 1.91, and maximum jet velocity through the aortic valve (m/s) decreased from 4.41 to 1.95 (p < 0.0001). No moderate/severe paravalvular leakage was observed, and computed tomography scans revealed no evidence of hypo-attenuated leaflet thickening. The study recorded one life-threatening bleeding event, two cases requiring postprocedural pacemaker implantation, and three ischemic events, with only one causing lasting neurological impairment. Importantly, there were no cases of cardiovascular mortality and only one noncardiovascular death, which was confirmed as unrelated to the device. CONCLUSIONS: The study indicates the Vienna valve as a potential option for severe symptomatic aortic stenosis, designed to streamline the procedure and potentially lower healthcare costs by reducing resource and equipment needs, also procedural errors. Further research is essential to thoroughly evaluate its safety and efficacy.

Transcatheter aortic valve implantation for severe aortic regurgitation using the J-Valve system: A midterm follow-up study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established intervention for severe aortic valve stenosis. However, its application for severe aortic regurgitation (AR) is still under evaluation. This study aims to present the 3-year follow-up outcomes of the J-Valve system in managing severe AR. AIMS: The aim of this study was to evaluate the mid-term efficacy and durability of the J-Valve system in the treatment of severe AR and to provide new information on this intervention. METHODS: In this retrospective, single-center study, we evaluated the prognostic outcomes of patients with AR, who underwent treatment with the J-Valve system at Nanjing Drum Tower Hospital. Consecutive patients who were treated with the J-Valve were included in the analysis. The study focused on the echocardiographic follow-up to assess the effectiveness and durability of the J-Valve system in managing AR. RESULTS: From January 2018 to December 2022, 36 high-risk AR patients treated with the J-Valve system had a procedural success rate of 97.2%, with one case requiring open-heart surgery due to valve displacement. Significant improvements were observed in left ventricular diameter (from 63.50 [58.75-69.50] mm to 56.50 [53.00-60.50] mm, p < 0.001) and left atrial diameter (from 44.00 [40.00-45.25] mm to 39.00 [36.75-41.00] mm, p = 0.003) postsurgery. All patients completed the 1-year follow-up, with an overall mortality rate of 2 out of 36 (5.6%). Among the surviving patients, there was one case of III° atrioventricular block and one case of stroke, both occurring within 90 days postsurgery. After a 3-year follow-up, 15.0% of patients had mild or moderate valvular regurgitation, with no cases of moderate or severe paravalvular leak. Additionally, 89.5% of patients were classified as New York Heart Association class I or II, showing significantly enhanced cardiac function. CONCLUSION: The J-Valve system has shown positive therapeutic outcomes in treating AR, with notable effectiveness in managing the condition and significant improvements in heart failure symptoms and cardiac remodeling. However, due to the limited sample size and partial follow-up data, it is important to emphasize the need for further research with comprehensive long-term follow-up, to fully validate these results.

Impact of balloon post-dilation on valve durability and long-term clinical outcomes after self-expanding transcatheter aortic valve implantation.

BACKGROUND: Balloon post-dilation (BPD) is a widely adopted strategy to optimize acute results of TAVI, with a positive impact on both paravalvular leak and mean gradients. On the other hand, the inflation of the balloon inside prosthetic leaflets may damage them increasing the risk of structural valve deterioration (SVD). Furthermore, the impact of BPD on long-term clinical outcomes and valve hemodynamics is yet unknown. AIMS: To evaluate the impact of BPD on valve durability and long-term clinical outcomes in patients undergoing self-expanding transcatheter valve implantation (TAVI). METHODS: Echocardiographic and clinical data from the ClinicalService (a nation-based data repository and medical care project) were analyzed. Patients were divided into two groups, those who underwent BPD after TAVI and those who did not. Coprimary endpoints were all-cause death and SVD. Cumulative incidence functions for SVD were estimated. RESULTS: Among 1835 patients included in the study, 417 (22.7%) underwent BPD and 1418 (77.3%) did not undergo BPD. No statistically significant differences at 6-year follow-up were found between groups in terms of all-cause mortality (HR: 1.05, 95% CI: 0.9-1.22; p = 0.557) and SVD (2.1% vs. 1.4%, p = 0.381). In addition, BPD did not predispose to higher risk of cardiovascular death, myocardial infarction, valve thrombosis, and endocarditis at 6-year follow-up. CONCLUSIONS: BPD following TAVI with a self-expanding prosthesis does not seem to be associated with an increased risk of adverse clinical outcomes or SVD at 6-year follow-up.

Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry.

BACKGROUND: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. AIMS: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. METHODS: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. RESULTS: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. CONCLUSION: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.

Concomitant percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Patients undergoing transcatheter aortic valve implantation (TAVI) frequently have coronary artery disease requiring percutaneous coronary intervention (PCI). Usually, PCI and TAVI are performed in two separate procedures and current studies are investigating potential benefits regarding the order. However, the two interventions may also be performed simultaneously, thereby limiting the risk associated with repeated vascular access. Data evaluating benefit and harm of concomitant procedures are scarce. AIMS: Therefore, this study aimed to evaluate concomitant PCI (coPCI) in TAVI patients regarding Valve Academic Research Consortium 3 (VARC-3) endpoints and long-term mortality. METHODS: A total of 2233 consecutive TAVI patients from the EVERY-VALVE registry were analyzed according to the VARC-3 endpoint definitions. A total of 274 patients had undergone TAVI and concomitant PCI (coPCI group). They were compared to 226 TAVI patients who had received PCI within 60 days before TAVI in a stepwise approach (swPCI group) and to the remaining 1733 TAVI patients who had not undergone PCI recently (noPCI group). RESULTS: Overall median age was 81.4 years, median Society of Thoracic Surgeons score was 4.0%. Patients in the coPCI and in the swPCI group were predominantly male with reduced left-ventricular ejection fraction. Rates of VARC-3 composite endpoints technical success and 30-day device success were comparable between all three groups. Mortality rates at 3 years after TAVI were similar (coPCI, 34.2% vs. swPCI, 31.9% vs. noPCI, 34.0% p = 0.84). CONCLUSIONS: coPCI during TAVI seems comparable in a retrospective analysis. Compared to a stepwise approach, it has similar rates of composite endpoints technical success and device success as well as long-term mortality.

Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

BACKGROUND: The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. PURPOSE: We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. METHODS: Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. RESULTS: The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). CONCLUSION: Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.

Transcatheter valve-in-valve interventions after aortic root replacement: A systematic review.

Structural valve deterioration after aortic root replacement (ARR) surgery may be treated by transcatheter valve-in-valve (ViV-TAVI) intervention. However, several technical challenges and outcomes are not well described. The aim of the present review was to analyze the outcomes of ViV-TAVI in deteriorated ARR. This review included studies reporting any form of transcatheter valvular intervention in patients with a previous ARR. All forms of ARR were considered, as long as the entire root was replaced. Pubmed, ScienceDirect, SciELO, DOAJ, and Cochrane library databases were searched until September 2023. Overall, 86 patients were included from 31 articles that met our inclusion criteria out of 741 potentially eligible studies. In the entire population, the mean time from ARR to reintervention was 11.0 years (range: 0.33-22). The most frequently performed techniques/grafts for ARR was homograft (67.4%) and the main indication for intervention was aortic regurgitation (69.7%). Twenty-three articles reported no postoperative complications. Six (7.0%) patients required permanent pacemaker implantation (PPI) after the ViV-TAVI procedure, and 4 (4.7%) patients had a second ViV-TAVI implant. There were three device migrations (3.5%) and 1 stroke (1.2%). Patients with previous ARR present a high surgical risk. ViV-TAVI can be considered in selected patients, despite unique technical challenges that need to be carefully addressed according to the characteristics of the previous surgery and on computed tomography analysis.

First-in-human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve-in-valve transcatheter aortic valve replacement.

Coronary obstruction (CO) is a potential pitfall for transcatheter aortic valve replacement (TAVR), especially in valve in valve procedures into degenerated surgical or transcatheter prostheses. Bioprosthetic leaflet modification techniques that incorporate electrosurgery are evolving as the preferred strategy to mitigate the risk of CO in high CO risk settings. The UNICORN method is proposed as a more predictable leaflet modification strategy than the earlier described BASILICA approach, but its proponents have hitherto mandated the use of a balloon-expandable valve (BEV) prosthesis. Many patients have small prostheses and therein face a significant risk of patient prosthesis mismatch with BEV in this setting. This risk may be curtailed if a self-expanding valve (SEV) prosthesis could be used. Herein described is a modified approach to allow for the utilization of SEV systems in this setting.

Prognostic impact of main pulmonary artery to ascending aorta diameter ratio in patients with severe aortic stenosis underwent transcatheter aortic valve implantation.

BACKGROUND: Pulmonary hypertension (PH) and right ventricular dysfunction are poor prognostic predictors in patients underwent transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS). AIMS: The prognostic impact of the main pulmonary artery/ascending aorta diameter ratio (MPA/AOr), measured simply by computed-tomographic angiography (CTA), was investigated in this patient group. METHODS: A total of 374 retrospectively evaluated patients (mean age 78.1 ± 8.4 years, 192 [51.3%] females) who underwent TAVI for severe AS were included. MPA/AOr was measured on preprocedural CTA in all patients and the effect of this measurement on the presence of PH, in-hospital and 2-year-overall long-term mortality was investigated. RESULTS: The presence of PH was defined as a systolic pulmonary artery pressure (sPAP) >42 mmHg measured by echocardiography. According to multivariate-logistic-regression analysis, MPA/AOr (adjusted [Adj] odds ratio [OR]: 1.188, confidence interval [CI] 95% [1.002-1.410], p = 0.048), tricuspid annular plane systolic excursion (TAPSE) (adj OR:0.736, CI 95% [0.663-0.816], p < 0.001) and left atrial diameter (adj OR:1.051, CI 95% [1.007-1.098], p = 0.024) were identified as independent predictors of PH. In addition, a statistically significant correlation was found between MPA/AOr and TAPSE (r: -0.283, p < 0.001). Furthermore, MPA/AOr was found to be an independent predictor of both in-hospital (adj OR:1.434, CI 95% [1.093-1.881], p = 0.009) and 2-year long-term (adj OR:1.518, CI 95% [1.243-1.853], p < 0.001) mortality in multivariate analysis including TAPSE, STS score and sPAP. In the 2-year Kaplan-Meier survival probability analysis, an MPA/AOr >0.86 was found to have a hazard ratio of 3.697 (95% CI: 2.341-5.840), with a log-rank p < 0.001. CONCLUSION: MPA/AOr, which can be measured simply by CTA, may be useful as an indicator of the presence of PH and poor prognosis in patients planned for TAVI for severe AS.

Comparative Outcomes of Surgical and Transcatheter Aortic Valve Replacement: A Meta-analysis and Parametric Extrapolation of Clinical Trials.

INTRODUCTION: We aimed to pool randomized clinical trials (RCTs) comparing surgical aortic valve replacement (SAVR) with transcatheter aortic valve replacement (TAVR) and extrapolate pooled time-to-event data to compare long-term outcomes. METHODS: An electronic database search was performed for RCTs comparing SAVR with TAVR. The most current longest follow-up data for each RCT were included. Data were pooled using a random-effects model. Survival data were pooled for Kaplan-Meier analysis as well as parametric modeling with extrapolation. RESULTS: Seven RCTs comprising 7774 patients were included. Mean valve gradient at 5 y was comparable between SAVR [11 mmHg (3.7; 18.3)] and TAVR [8.1 mmHg (1.9; 14.3)] (P = 0.38). TAVR had a higher mean valve area at 30 d, 1 y, and 2 y [1.68 cm2 (1.22; 2.13) versus 1.8 cm2 (1.35; 2.25), P = 0.02]. SAVR had a higher freedom from any paravalvular leak at 30 d and 1 y [86% (81; 90) versus 39% (36; 41), P < 0.01]. All-cause death was lower in the SAVR group at 5 y [39% (29; 50) versus 43% (31; 57), P < 0.01]. Although no differences were seen between SAVR and TAVR in the pooled Kaplan-Meier analysis of all-cause mortality and composite of all-cause mortality or stroke, parametric modeling with extrapolation showed significant divergence for both outcomes. CONCLUSIONS: Pooled all-cause mortality as well as pooled composite of all-cause mortality or stroke indicated better survival with SAVR at 5 y. Long-term parametric extrapolation also indicated superior survival with SAVR.

The role of Matrix Metalloproteinase-2 and Galectin-3 as predictive biomarkers for all-cause mortality in patients undergoing transfemoral transcatheter aortic valve implantation.

BACKGROUND: Currently available risk scores fail to accurately predict morbidity and mortality in patients with severe symptomatic aortic stenosis who undergo transcatheter aortic valve implantation (TAVI). In this context, biomarkers like matrix metalloproteinase-2 (MMP-2) and Galectin-3 (Gal-3) may provide additional prognostic information. METHODS: Patients with severe aortic stenosis undergoing consecutive, elective, transfemoral TAVI were included. Baseline demographic data, functional status, echocardiographic findings, clinical outcomes and biomarker levels were collected and analysed. RESULTS: The study cohort consisted of 89 patients (age 80.4 ± 5.1 years, EuroScore II 7.1 ± 5.8%). During a median follow-up period of 526 d, 28 patients (31.4%) died. Among those who died, median baseline MMP-2 (alive: 221.6 [170.4; 263] pg/mL vs. deceased: 272.1 [225; 308.8] pg/mL, p < 0.001) and Gal-3 levels (alive: 19.1 [13.5; 24.6] pg/mL vs. deceased: 25 [17.6; 29.5] pg/mL, p = 0.006) were higher than in survivors. In ROC analysis, MMP-2 reached an acceptable level of discrimination to predict mortality (AUC 0.733, 95% CI [0.62; 0.83], p < 0.001), but the predictive value of Gal-3 was poor (AUC 0.677, 95% CI [0.56; 0.79], p = 0.002). Kaplan-Meier and Cox regression analyses showed that patients with MMP-2 and Gal-3 concentrations above the median at baseline had significantly impaired long-term survival (p = 0.004 and p = 0.02, respectively). CONCLUSIONS: In patients with severe aortic stenosis undergoing transfemoral TAVI, MMP-2 and to a lesser extent Gal-3, seem to have additive value in optimizing risk prediction and streamlining decision-making.

Clinical characteristics and outcomes of aortic prosthetic valve endocarditis: comparison between transcatheter and surgical bioprostheses.

PURPOSE: Most data regarding infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) comes from TAVI registries, rather than IE dedicated cohorts. The objective of our study was to compare the clinical and microbiological profile, imaging features and outcomes of patients with IE after SAVR with a biological prosthetic valve (IE-SAVR) and IE after TAVI (IE-TAVI) from 6 centres with an Endocarditis Team (ET) and broad experience in IE. METHODS: Retrospective analysis of prospectively collected data. From the time of first TAVI implantation in each centre to March 2021, all consecutive patients admitted for IE-SAVR or IE-TAVI were prospectively enrolled. Follow-up was monitored during admission and at 12 months after discharge. RESULTS: 169 patients with IE-SAVR and 41 with IE-TAVI were analysed. Early episodes were more frequent among IE-TAVI. Clinical course during hospitalization was similar in both groups, except for a higher incidence of atrioventricular block in IE-SAVR. The most frequently causative microorganisms were S. epidermidis, Enterococcus spp. and S. aureus in both groups. Periannular complications were more frequent in IE-SAVR. Cardiac surgery was performed in 53.6% of IE-SAVR and 7.3% of IE-TAVI (p=0.001), despite up to 54.8% of IE-TAVI patients had an indication. No differences were observed about death during hospitalization (32.7% vs 35.0%), and at 1-year follow-up (41.8% vs 37.5%), regardless of whether the patient underwent surgery or not. CONCLUSION: Patients with IE-TAVI had a higher incidence of early prosthetic valve IE. Compared to IE-SAVR, IE-TAVI patients underwent cardiac surgery much less frequently, despite having surgical indications. However, in-hospital and 1-year mortality rate was similar between both groups.