Valve Academic Research Consortium Research Articles

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

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. 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. A total of 2233 consecutive TAVI patients from the EVERY-VALVEregistry 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). 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). 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.

Myocardial Injury After Transcatheter Mitral Valve Replacement Versus Surgical Reoperation

This study aimed to evaluate the incidence and clinical implications of myocardial injury, as determined by cardiac biomarker increase, in patients who underwent mitral bioprosthesis dysfunction treatment with transcatheter mitral valve replacement (TMVR) versus surgical mitral valve replacement reoperation (SMVR-REDO). Between 2014 and 2023, 310 patients with mitral bioprosthesis failure were included (90 and 220 patients for TMVR and SMVR-REDO, respectively). Multivariable analysis and propensity score matching were performed to adjust for the intergroup differences in baseline characteristics. Creatinine kinase-MB (CK-MB) and cardiac troponin I (cTn) were collected at baseline and 6 to 12, 24, 48, and 72 hours after intervention. The cardiac biomarkers values were evaluated in relation to their reference values. The outcomes were determined according to the Mitral Valve Academic Research Consortium criteria. CK-MB and cTn increased above the reference level in almost all patients after SMVR-REDO and TMVR (100% vs 94%, respectively), with the peak occurring within 6 to 12 hours. SMVR-REDO was associated with a two- to threefold higher increase in cardiac biomarkers. After 30 days, the mortality rates were 13.3% in the TMVR and 16.8% in the SMVR-REDO groups. At a median follow-up of 19 months, the mortality rates were 21.1% in the TMVR and 17.7% in the SMVR-REDO groups. Left ventricular ejection fraction, estimated glomerular filtration rate, CK-MB, and cTn were predictors of mortality. In conclusion, some degree of myocardial injury occurred systematically after the treatment of mitral bioprosthetic degeneration, especially after SMVR, and higher CK-MB and cTn levels were associated with increased cumulative late mortality, regardless of the approach.

Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry.

Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.

Femoral vessel complications after transfemoral TAVR-A contemporary sonography-based assessment of 480 patients with third-generation transcatheter valves.

Postinterventional sonographic assessment of the femoral artery after transfemoral transcatheter aortic valve replacement (TF-TAVR) has the potential to identify several pathologies. We investigated the incidence and risk factors of femoral vessel complications in a modern TAVR collective using postinterventional sonography. Between September 2017 and March 2022, 480 patients underwent TF-TAVR with postinterventional femoral sonography at a single center. Clinical outcomes and adverse events were analyzed after the Valve Academic Research Consortium 3 (VARC-3) criteria. In this cohort (51.2% male; age 80 ± 7.5 years, median EuroSCORE II 3.7) 74.8% (n = 359) were implanted with a self-expandable and 25.2% (n = 121) with a balloon-expandable valve. The main access (valve-delivery) was located right in 91.4% (n = 438), and the primary closure system was Proglide in 95% (n = 456). Vascular complications (VC) were observed in 29.16% (n = 140) of patients; 23.3% (n = 112) presented with minor- and 5.8% (n = 28) with major VC. Postinterventional femoral artery stenosis on the main access was observed in 9.8% (n = 47). Multivariable logistic regression analysis revealed female sex (p = .03, odds ratio [OR] 2.32, 95% confidence interval [CI] 1.09-4.89) and the number of used endovascular closure devices (p = .014, OR 0.11, 95%CI 0.02-0.64) as predictive factors for femoral artery stenosis. The incidence of postinterventional femoral artery stenosis following TF-TAVR was higher than expected with a number of used closure devices and female sex being independent risk factors. Considering the continuous advance of TAVR in low-risk patients with preserved physical activity, emphasis should be directed at the correct diagnosis and follow-up of these complications.

Higher Edmonton Frail Scale prior to transcatheter Aortic Valve Implantation is related to longer hospital stay and mortality

BackgroundInternational guidelines for the management of valvular heart disease recommend frailty assessment prior to Transcatheter Aortic Valve Implantation (TAVI), however there is no consensus how to assess frailty. We investigated whether frailty status assessed with the Edmonton Frail Scale (EFS, range 0–17 points) relates to length of stay (LOS), short- and long-term mortality and adverse outcomes after TAVI. MethodsIn this study we included 357 patients between April 2016 till December 2018. EFS was assessed at baseline. Patients were classified into low (0–3), intermediate (4–7) or high frailty status (8‐17). LOS was defined as the number of days between admission and discharge. Mortality data were obtained up to four years after TAVI. Adverse events were defined by Valve Academic Research Consortium (VARC)-2 criteria and collected <30 days after TAVI. ResultsPatients with higher frailty status had longer median LOS (days (IQR): low 5 (3), intermediate 6 (4) and high 7 (5), p < 0.001) and higher mortality: low vs intermediate vs high at 30 days 0.5%, 2.2%, 7.0% (p = 0.050), 1 year 3.7%, 10.0%, 15.2% (p = 0.052), 2 years 9.2%, 17.8%, 31.7% (p = 0.003), 3 years 17.2%, 24.0, 47.0% (p = 0.001) and 4 years 19.6%, 30.8%, 55.6% (p < 0.001). Frail patients received more often a pacemaker (2.6%, 6.6%, 13.5%, p = 0.048). ConclusionIn clinical practice, the EFS is a useful tool to screen for frailty in TAVI patients. This tool may possibly be expanded to determine benefit versus harm-risk in these patients and whether specific pre-procedurally interventions are needed in order to reduce mortality.

Mitral valve transcatheter edge-to-edge repair with PASCAL vs MitraClip: A systematic review and meta-analysis.

Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary or inoperable primary mitral regurgitation (MR). The relatively recent approval of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences) has expanded the options of TEER devices. However, evidence comparing PASCAL with MitraClip systems is still limited. We conducted a systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies comparing PASCAL and MitraClip systems. Four observational studies and 1 randomized controlled trial, involving 1315 patients total, were eligible for inclusion. All patients exhibited symptomatic (NYHA II-IV) MR grades 3+ or 4+. Baseline characteristics were comparable across all included studies. The clinical outcomes were assessed according to the Mitral Valve Academic Research Consortium consensus. The procedural success rates for the 2 devices were comparable in terms of achieving post-procedural MR grades of less than or equal to 2+ and less than or equal to 1+. Furthermore, most patients improved their clinical status, with no significant differences between patients treated with PASCAL and those treated with MitraClip. In terms of safety, both procedures exhibited low overall mortality rates and occurrence of major adverse events (MAE), without significant difference between the 2 devices. These findings remained consistent in both short- and long-term follow-up assessments. Our study revealed similar effectiveness and safety profiles between the PASCAL and MitraClip devices in patients experiencing significant symptomatic MR.

Fluoroscopy Time as a New Predictor of Short-Term Outcomes after Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) is an almost totally cine-fluoroscopic guided procedure. The amount of radiation used during the procedure is strictly related to the fluoroscopy time (FT), that has already been demonstrated to be associated with outcomes and complexity of coronary procedures. The aim of our study is to demonstrate the relationship between FT and the short-term outcomes after TAVR defined by to the Valve Academic Research Consortium (VARC)-2 and -3 consensus documents. After splitting 1797 consecutive patients into tertiles of FT, the composite endpoint early safety (ES) was adjudicated according to VARC-2 and VARC-3 definitions, whereas the composite endpoints device success (DS) and technical success (TS) according to VARC-3 criteria. The absence of all these outcomes (VARC-2 ES amd VARC-3 TS, DS, and ES) was significantly associated with longer FT: this association was independent from both intraprocedural complications and other intraprocedural factors linked to longer FT, and still persisted after propensity score matching analysis. Notwithstanding, after receiver operating characteristic analysis, FT had adequate diagnostic accuracy in identifying the absence of only VARC-3 TS and VARC-2 ES. Longer FT is related with periprocedural and short-term outcomes after the procedure, especially in those that are more challenging. A FT duration of more than 30 min has an adequate accuracy in identifying VARC-3 technical failure (TS and DS) and absence of VARC-2 ES, selecting patients who are likely to take advantage from more careful in-hospital follow-up.

Myocardial injury after transcatheter aortic valve replacement according to VARC-3 criteria

Abstract Background Periprocedural myocardial injury (PPMI) is frequent in patients undergoing transcatheter aortic valve replacement (TAVR). PPMI after TAVR as defined by Valve Academic Research Consortium-2 (VARC-2) criteria occurs in &amp;gt;50% of the patients and had inconsistent results regarding prognostic significance. However, recent VARC-3 definition is more specific, having increased the troponin threshold from 15-times to 70-times the upper reference limit (URL) to define PPMI. This recent definition of PPMI following TAVR lacks the clinical validation. Objective To determine the incidence, predictors and clinical impact of PPMI following TAVR as defined by recent VARC-3 criteria. Methods We included 1,394 consecutive patients who underwent TAVR with a new generation transcatheter heart valve in two tertiary centers in Canada and Italy, from 2015 to 2022. Patients undergoing a trans-aortic or a trans-apical approach were excluded. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs. ≥15 times according to VARC-2 definition). Baseline, procedural and follow-up data were prospectively collected in a dedicated database. Results PPMI was diagnosed in 193 patients (14%) according to the VARC-3 criteria. Female sex and peripheral artery disease were found independent predictors of PPMI in the multivariable analysis (p&amp;lt;0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.76, 95% CI: 1.54-4.95, p=0.001 for all-cause mortality; HR: 9.54, 95%CI: 2.69 to 33.80, p&amp;lt;0.001 for cardiovascular mortality) and 1-year-follow-up (HR: 1.52, 95%CI: 1.02-2.27, p=0.037 for all-cause mortality; HR: 3.04, 95%CI: 1.68-5.50, p&amp;lt;0.001 for cardiovascular mortality). PPMI according to VARC-2 criteria had no impact on mortality (Figure 1). According to restricted cubic splines analysis, the minimal threshold at which high-sensitivity troponin elevation is significantly associated with 1-year all-cause mortality is an 82-fold increase above URL (Figure 2). Conclusions About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria and it had a negative impact on early and late survival. Baseline factors as female gender and peripheral disease increased the risk. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.Kaplan-Meier estimates of mortalityRestricted cubic splines analysis

Evidence of early bioprosthetic valve dysfunction after TAVR in aortic valve stenosis during one-year follow-up according to VARC-3

Abstract Objectives Transcatheter aortic valve replacement (TAVR) has become a frequent treatment method for severe aortic stenosis and has increased significantly in younger patients and at lower surgical risk. Therefore, long-time considerations and the performance of TAVR devices are highly interesting. The Valve Academic Research Consortium 3 endpoint definitions (VARC-3) were released recently, offering updated and clear classifications of bioprosthetic valve dysfunction (BVD). In this retrospective multicenter study, we aimed to assess the prevalence of BVD during one-year follow-up and potential differences between self-expandable (SEV) and balloon-expandable valves (BEV). Methods Underlying conditions were evaluated by univariate analysis. Normality was tested using the Shapiro-Wilk normality test. The primary clinical endpoint was defined as immediate failure in device success, secondary endpoints were defined as prevalence of BVD during one year FU and composite endpoints according to VARC-3. Results The final study cohort consisted of 1478 patients from three tertiary care centers that underwent TAVR between 01/2015 and 12/2018. Mean Follow-up (FU) was 361 ± 26 days. During this time span overall BVD was documented in one-fourth of all patients (-BVD[-]: n=1090 (73.7%); BVD[+]: n=388; 26.3%). Further discrimination into the four main categories of BVD presented following results: Structural valve deterioration (SVD) n=142 (9.6%), Non-Structural valve deterioration (NSVD) n=235 (15.9%), hypo-attenuated leaflet thickening n=18 (1.2 %), and endocarditis n=31 (2.1%). Two-thirds of all events were identified within 30-days post implantation, accounting for new-onset of BVD during time course in one-third of all documented BVD. Device success was significantly lower in the +BVD cohort (80.6% vs. 70.1%, p&amp;lt;0.01*). When comparing SEV and BEV, there were significant differences in overall BVD at 30-days post implantation (13.8% vs 18.5%, p&amp;lt;0.01*), as well as in device success (74.1% vs. 81.5%, p&amp;lt;0.01*), early safety (63.8% vs. 69.8%, p=0.014) and clinical efficacy (94.1% vs. 89.9%, p&amp;lt;0.01*). Again, discrimination into the four main categories of BVD showed differences in NSVD at 30-days post implantation (9.8% vs. 14.3%, p&amp;lt;0.01*) as well as at 1-year FU (7.6% vs 14.8%, p&amp;lt;0.01*). Conclusion In this large retrospective multicenter study, we could observe that NSVD was the BVD category most frequently detected after TAVR in tricuspid aortic valves during 1-year FU. NSVD occurred mainly within 30 days post-implantation in patients with balloon-expandable valves, being one factor that significantly diminished device success, early safety, and clinical efficacy.

Valve-in-valve transcatheter aortic valve implantation for degenerative stentless versus stented surgical bioprostheses

Abstract Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in failing stented bioprosthetic valves; stentless bioprostheses lack fluoroscopic markers and could be more challenging for transcatheter therapy. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce; thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of patients with stentless (SL) versus stented (ST) aortic bioprosthetic device failure undergoing ViV-TAVI. Methods Patients undergoing ViV-TAVI between 2007 and 2022 (53% of cases after 2015) at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety. Results Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age (SL: 77 (74; 82) vs. ST: 78 (75; 83), p=0.08), sex (male: SL 70% vs. ST 56%, p=0.08), clinically relevant baseline comorbidities and surgical risk (STS PROM SL 10.0 (4.8; 12.5) % vs. ST 9.4 (4.5; 11.3) %, p=0.62). Aortic regurgitation was the mode of failure in 33% of SL vs. 8% in ST (p&amp;lt;0.01). The rate of self-expanding TAVI prostheses was 86% and 76% in SL and ST, respectively (p=0.15). The rates of technical success (SL: 84% vs ST: 80%, p=0.55), device success (SL: 67% vs ST: 54%, p=0.11), and early safety (SL: 74% vs ST: 62%, p=0.30) were comparable between groups. There were higher rates of mild/moderate residual aortic regurgitation in SL (77.5% vs. 35%, p&amp;lt;0.01), whereas the remaining mean gradient was higher in ST (11.2 (6.0; 15.5) mmHg vs. 17.0 (11.0; 22.0) mmHg, p&amp;lt;0.01). The 30-day mortality rate (SL: 7.0% vs. ST: 2.6%, p=0.14) and Kaplan-Meier estimated 1-year mortality rates (SL: 9.3% vs. ST: 8.2%, p=0.63) were comparable between groups. Conclusion Both SL and ST ViV-TAVI have comparable short-term outcomes according to VARC-3- defined endpoints and similar low rates of 1-year all-cause mortality. However, against the background of a relevant rate of residual aortic regurgitation in SL and increased gradients in ST, long-term studies are of utmost importance to determine the clinical relevance of those factors.

Vascular closure after TAVI: assessing the safety and efficacy of a collagen-based device in a real-world population

Abstract Background Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic stenosis. However, the high rates of vascular complications (5-20%) associated with the large-bore access hinder clinical outcomes. There are several options available for access site closure, including MANTA, a dedicated collagen plug-based device that showed promising results in recent trials. Purpose We sought to evaluate the safety and efficacy of large calibre arteriotomy closure with MANTA during transfemoral TAVI in a real-world cohort. Methods We retrospectively analysed all consecutive patients who underwent transfemoral TAVI access closure with the MANTA device in our centre between March 2020 and May 2022. The primary safety endpoints were the rates of closure device failure, and access-related vascular and bleeding complications. The secondary endpoint was periprocedural all-cause mortality. All endpoints were defined according to the Valve Academic Research Consortium (VARC) 3 criteria. Results A total of 299 patients were included, mean age of 81.09 ± 6.34 years, 50.5% females, median EuroSCORE II of 3.11% [IQR 2.08–4.75]. Approximately two-thirds were under antithrombotic treatment (36.4% on oral anticoagulation and 33.0% on antiplatelet therapy). Closure device failure occurred in 8.4% cases (n=25), nevertheless only one required bailout surgical closure. Vascular complications occurred in 11.4% (n=34), most minor and related to the access site (9.0%, n=27): arterial occlusion (5.0%, n=15), haematomas (3.0%, n=9) and pseudoaneurysms (1.0%, n=3). Bleeding complications occurred in 4.3% (n=13), most VARC type 1 (3.3%, n=10). Both smaller minimal femoral artery diameter (6.6 ± 1.1 mm vs 7.7 ± 1.4mm, p&amp;lt;0.001) and bigger sheath to femoral artery diameter ratio (0.76 ± 0.15 vs 0.68 ± 0.14, p=0.02) were associated with device failure. The secondary endpoint occurred in 7 patients (2.3%), both from cardiovascular (aortic dissection, n=3; ischemic stroke; n=2) and non-cardiovascular causes (sepsis, n=2). Device failure did not prolong the index hospitalization (4.00, IQR 3.00-5.00 days vs 4.00, IQR 3.00-5.00; p=0.36). Conclusions In a large real-world cohort, MANTA was a safe and effective solution for femoral arteriotomy closure after TAVI. Device failure was infrequent, rarely associated with severe complications and did not lengthen the hospital stay.

Right-ventricular/pulmonary artery coupling predicts long-term mortality in aortic stenosis patients with different flow types

Abstract Background Right-ventricular (RV) dysfunction in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) has long been neglected. Right-ventricular to pulmonary artery coupling (RV/PAc), a parameter of RV function, can be determined by echocardiography (tricuspid annular plane systolic excursion over systolic pulmonary artery pressure). Its use for mortality prediction in contemporary AS patients warrants further evaluation, data for different flow types of AS are lacking. Purpose To assess the impact of pathological RV/PAc on long-term mortality in AS patients with different flow types. Methods All 1577 consecutive patients from our registry from 2018 to 2020 were assessed. Patients without tricuspid regurgitation (n=523) or inconclusive echocardiography images (n=111) were excluded. RV/PAc could be analysed in 862 patients. To dichotomize the cohort, a receiver operator curve (ROC) analysis for 2-year mortality was used. Primary endpoint was 2-year mortality. Patients were further analysed according to the Valve Academic Research Consortium (VARC) 3 endpoint definitions. Results By ROC analysis, 0.512 mm/mmHg was defined as a cut-off, dividing the cohort into 428 patients with physiological RV/PAc (above cut-off) and 434 patients with pathological RV/PAc. Patients with pathological RV/PAc were more often male, had more comorbidities, a lower ejection fraction (50% [40-55%] vs. 55% [53-58%], p&amp;lt;0.01) and a higher Society of Thoracic Surgeons (STS) score (4.0 [2.5-6.0] vs. 2.8 [2.0-4.0], p&amp;lt;0.01). Procedural outcomes according to VARC-3 were comparable: the composite endpoints technical failure and device failure at 30 days occurred in 3.9% and 3.5% (p=0.75) and 11.3% and 13.3% (p=0.42) in the pathological and physiological group, respectively. Clinical outcomes in terms of New York Heart Association functional class were comparable at follow-up, with an improvement by at least one class in 76.2% (pathological group) and 79.9% (physiological group, p=0.33). All-cause 2-year mortality was significantly higher in the pathological group (34.9% [30.2-39.2%] vs. 15.4% [11.9-18.8%], p&amp;lt;0.01, hazard ratio, HR, 2.5 [1.9-3.4], Figure 1). The result persisted when adjusted for STS score (HR 2.3 [1.7-3.1]) or in a multivariate Cox regression. Cardiovascular mortality was increased too (pathological, 23.7% [19.3-27.8%], vs. physiological, 8.5% [5.8-11.2%], HR 2.9 [2.0-4.2], p&amp;lt;0.01). The fraction of patients with pathological RV/PAc differed significantly across the AS flow types (high-gradient, 40.3%, classical low-flow low-gradient (LFLG), 73.9%, paradoxical LFLG, 58.9%, and normal-flow low-gradient, 36.6%, p&amp;lt;0.01). Mortality differences persisted in high-gradient and LFLG groups (Figure 2A-D), which was consistent after statistical adjustment. Conclusions RV dysfunction defined as low RV/PAc is a strong predictor for long-term mortality in TAVI patients, with a strong prognostic value also in LFLG AS.

Up to 6-year performance and clinical outcomes of balloon expandable transcatheter aortic valve according to the implantation strategy: insight from the DIRECTAVI trial

Abstract 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. Purpose To evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVI versus BAV) with the SAPIEN 3 balloon-expandable device in patients included in the DIRECTAVI trial. Methods All patients included in the DIRECTAVI trial since 2016 were offered a clinical and echocardiographic follow-up until January 2023. We applied Valve Academic Research Consortium (VARC-3) criteria to define moderate/severe hemodynamic valve deterioration (HVD) as an increase in mean gradient ≥10 mm Hg resulting with a final mean gradient ≥20 mm Hg, or new/worsening aortic regurgitation (AR) of 1 grade resulting in ≥moderate AR. Survival until moderate/severe HVD between the 2 groups was the primary end-point and overall survival between direct TAVI and BAV were compared using logrank tests. Major clinical outcomes at latest follow-up were also assessed using Chi² or Fisher’s tests. Results Among 250 patients included in DIRECTAVI, 228 patients were followed-up during 4.5 ± 1.1 years. Mean age at follow-up was 87 ± 6.7 years. Incidence rates of moderate/severe HVD were similar in the 2 groups (1.45 versus 1.97 per 100 person-years, p=0.6) (Figure). Incidence rates for death were similar between groups (9.19 and 7.34 events per 100 persons-years for BAV and direct TAVI, respectively, p=0.4). No clinically significant differences in outcomes were observed at the latest follow-up, including major stroke (4.4% for BAV versus 2.6% for direct TAVI, p=0.7), hospitalizations for heart failure (15.8% for BAV group and 11.4% for direct TAVI group, p=0.3), permanent pacemaker implantation (37.7% for BAV and 31.6% for direct TAVI, p=0.3). Moderate/severe patient-prosthesis mismatch was also similar between groups (p=0.6). Conclusion Compared to systematic BAV, direct implantation of the SAPIEN 3 device was not associated with an increased risk of moderate/severe valve deterioration or adverse clinical events up to 6-year follow-up. These results encourage wide use of this simplified strategy with balloon-expandable devices, when possible.Survival without valve deterioration

Bioprosthetic aortic valve degeneration evaluated by 18F-fluoride PET-TC

Abstract Background Implantation of bioprosthetic aortic valves (BPHV) is increasing owing to the aging population and the emergence of transcatheter aortic valve implantation. Along with the increase in life expectancy, BPHV degeneration is therefore becoming an increasing problem. 18F-fluoride positron emission tomography (PET) has emerged as a method that could identify early subclinical BPHV degeneration. Purpose We aimed to compare early PET parameters of fluorid uptake with echocardiographic hemodynamic parameters at three years after the implantation of a bioprosthetic aortic valve. Methods Sub-analysis of the ANTIPRO clinical trial. Patients undergoing aortic valve replacement (AVR) for porcine bioprosthesis were recruited at two surgical centers between 01/01/2019 and 02/13/2020, and were randomized in two groups (acetylsalicylic acid (ASA) vs ASA and oral anticoagulation for 3 months). Clinical and echocardiographic controls were performed one year and three years after AVR. Bioprosthetic valve deterioration (BVD) was defined according to the Valve Academic Research Consortium 3. 43 subjects were randomly selected from the whole cohort to undergo 18F-sodium fluoride PET with CT angiography (PET-CT) at follow-up. 18F-fluoride uptake in the valve (SUVavV) and right atrium (SUVavA) was measured, creating the SUVavV/SUVavA ratio or target-to-background ratio (TBR). PET findings were categorized as "high uptake" if TBR &amp;gt; 1.3 and "low uptake" if TBR ≤1.3. TBR was compared with the mean and maximum gradients at three years. Survival between high and low uptake groups was calculated using Kaplan-Meier and compared with log-rank test. The project was approved by the national ethics committee and patients consented the procedure. Results 18F-sodium fluoride PET-CT was performed on 43 subjects, with a mean time of 22.7±8.4 months after AVR. The echocardiogram at three years was performed in a mean time of 39.9±3.0 months after AVR. Mean time between PET-CT and echocardiogram was 17.2±9.9 months. The mean TBR was 1.25±0.30. Low uptake was found in 27 patients (62.8%) and high uptake in 15 patients (34.9%). Uptake could not be quantified in one patient due to technical problems. Baseline characteristics were similar between both groups (Table 1). Mean gradient at three years was 19.6±10.3 and peak gradient 33.7±16.7. Mean gradient was similar between the high uptake and low uptake groups (17.5±11.7 vs 21.6±9.3 p=0.296). Peak gradient was also similar between the high uptake and low uptake groups (30.6±18.5 vs 36.3±15.6 p=0.362). Five patients experienced BVD, of which 4 had low uptake and 1 had high uptake (p=0.523). Survival analysis did not demonstrate statistically different survival rates between the high uptake and low uptake groups (Figure 1). Conclusion Fluorid uptake with early PET after AVR was not associated with trans-prosthetic gradients nor BVD after a mean of 17 months from the PET scan.Table 1:Baseline characteristicsFigure 1:Kaplan-Meier survival curve

Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Atrial Functional Mitral Regurgitation from the GIOTTO Registry

Atrial functional mitral regurgitation (aFMR) has a peculiar pathophysiology that may have distinctive outcomes. We investigated the impact of transcatheter edge-to-edge repair in aFMR compared with other FMR etiologies. The GIOTTO (GIse registry Of Transcatheter treatment of MR) is a multicenter, prospective study enrolling patients with symptomatic MR treated with MitraClip up to 2020. We categorized patients with FMR as aFMR, ischemic FMR (iFMR), and nonischemic ventricular FMR (niFMR). The clinical end points were defined according to the Mitral Valve Academic Research Consortium. Of 1,153 patients, 6% had aFMR, 47% iFMR, and 47% niFMR. Patients with aFMR were older, mostly women, and had a higher atrial fibrillation rate. They had better left ventricular ejection fraction and smaller left ventricular volumes, with no difference in mitral effective regurgitant orifice area. The acute device and procedural success rates were similar among the groups. At the longest available follow-up (median 478days, interquartile range 91 to 741 days), the rate of MR ≥2+ was similar among the groups. Patients with aFMR had a lower rate of cardiovascular death and heart failure than patients with iFMR (hazard ratio [HR] 0.43, p = 0.02) and niFMR (HR 0.45, p = 0.03). The aFMR etiology remained independently associated with the composite outcome, together with postprocedural MR ≤1+ (HR 0.63, p <0.01) and peripheral arteriopathy (HR 1.82, p = 0.003). The results of this GIOTTO subanalysis suggested that aFMR is less prevalent and associated with better outcomes compared with other causes of FMR treated by transcatheter edge-to-edge repair. Postprocedural MR >1+, peripheral vasculopathy, non-aFMR were independent predictors of worse outcomes.

Early safety and mid-term clinical outcomes of technology transfer of transcatheter aortic valve implantation in patients with severe aortic valve stenosis in Vietnam: a single-center experience of 90 patients

This study investigated the early safety and mid-term outcomes of stepwise implementation of transcatheter aortic valve implantation (TAVI) in Vietnamese patients with severe aortic stenosis (AS) at a single center, following the process of technical transfer. From 2017 to 2022, 90 patients with symptomatic severe AS underwent TAVI at a tertiary hospital in Vietnam. The first 30 cases received support for technology transfer from international proctors. One-year outcomes were evaluated using the Valve Academic Research Consortium-2 (VARC-2) criteria. Forty patients (45.5%) had bicuspid aortic valve (BAV). The Medtronic Evolut R/Pro self-expanding valve system was used in 98.9% of all cases, with a 29-mm valve being the most common. Device success was achieved in 95.6% of cases, whereas one procedural death occurred. At one year, four deaths (5.3%) occurred and all were in the BAV group. Other complications included stroke (2.8%), hospital readmission due to the valve or worsening heart failure (2.8%), permanent pacemaker implantation (9.9%), and moderate paravalvular leak (3.0%). The left ventricular ejection fraction and mean transvalvular gradient significantly improved after TAVI. There were no significant differences in procedural success and mortality when the proctor support period and the subsequent solo operator period were compared. TAVI procedure is safe for treating severe AS in Vietnamese patients, despite the high prevalence of BAV. The procedural complication rate was low, with promising outcomes at one year. These results also highlight the effectiveness of the TAVI technical transfer model in Vietnam. No funding was provided for this study.

Single femoral artery access is safe and feasible during transcatheter aortic valve replacement: a propensity score matched analysis.

Transcatheter aortic valve replacement (TAVR) potentially may be significantly simplified by using the single artery access (SA) technique, which does not require a secondary artery access. Nevertheless, the safety and efficacy of this technique remains unclear. Our goal was to determine if single artery access TAVR (without upgrading the sheath size) is a feasible, minimally invasive procedure. Patients with symptomatic severe aortic stenosis who underwent TAVR via the femoral artery were consecutively enrolled in this study. Eligible individuals were divided into 2 groups: the SA group and the dual artery access (DA) group. The primary end point was device success (defined by the valve academic research consortium 3, VARC 3). A 6-month follow-up and propensity score matching analyses were performed. After propensity score matching analysis, a total of 130 patients were included: 65 in the SA group and 65 in the DA group. The SA procedure achieved similar device success (95.4% vs. 87.7%; P = 0.115) compared with the DA procedure. The SA procedure shortened the operating time (102 min vs. 125 min; P = 0.001) but did not increase the x-ray time or dose. Both a 20 Fr and a 22 Fr sheath (without upgrading the sheath size) could be used for the SA procedure. There was no major vascular complication occurred in both groups. The incidence of minor main vascular and access complications in the SA group was comparable to those of the DA procedure (0.0% vs. 3.1%; P = 0.156). The SA access procedure is a promising minimally invasive TAVR technique with a low incidence of vascular complications and a high incidence of device success. It is safe and possibly applicable in all TAVR procedures.

Determinants of device success after transcatheter aortic valve replacement in patients with type-0 bicuspid aortic stenosis.

Clinical evidence of transcatheter aortic valve replacement in patients with type-0 bicuspid aortic valve was relatively scarce. Our goal was to explore determinants of device success after transcatheter aortic valve replacement in patients with type-0 bicuspid aortic valve morphology. In this retrospective multicenter analysis, we included 59 patients with symptomatic severe aortic stenosis with type-0 bicuspid aortic valve morphology who underwent transcatheter aortic valve replacement. Type-0 bicuspid aortic valve was identified with multidetector computed tomography scans. The technical success rate was 89.8%, and the device success rate was 81.4%. Patients were divided into a device success group and a device failure group according to Valve Academic Research Consortium- 3 criteria. When we compared the two groups, we found that the ellipticity index of the aortic root and the presence of bulky calcifications at the commissure were statistically different (ellipticity index 35.7 ± 1.7 vs. 29.7 ± 1.1, p = 0.018; bulky calcification at the commissure, 54.5% vs. 4.5%, p < 0.001). Further multivariate logistic analysis showed that bulky calcification at the commissure had a negative correlation with device success (odds ratio 0.030, 95% confidence interval 0.003-0.285, p = 0.002). Yet there was no statistical correlation between the ellipticity index and device success (odds ratio 0.818, 95% confidence interval 0.667-1.003, p = 0.053). The presence of bulky calcifications at the commissure is negatively correlated with device success after transcatheter aortic valve replacement in patients with type-0 bicuspid aortic valve.

Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry

BackgroundThe CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. MethodsThis was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. ResultsWe enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). ConclusionsThe Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. ClinicalTrials.gov IdentifierNCT03752866.

Mitral valve transcatheter edge-to-edge repair with PASCAL Vs MitraClip: A aystematic teview and meta-analysis.

Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary or inoperable primary mitral regurgitation (MR). The relatively recent approval of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences) has expanded the options of TEER devices. However, evidence comparing PASCAL with MitraClip systems is still limited. We conducted a systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies comparing PASCAL and MitraClip systems. Four observational studies and 1 randomized controlled trial, involving 1315 patients total, were eligible for inclusion. All patients exhibited symptomatic (NYHA II-IV) MR grades 3+ or 4+. Baseline characteristics were comparable across all included studies. The clinical outcomes were assessed according to the Mitral Valve Academic Research Consortium consensus. The procedural success rates for the 2 devices were comparable in terms of achieving post-procedural MR grades of less than or equal to 2+ and less than or equal to 1+. Furthermore, most patients improved their clinical status, with no significant differences between patients treated with PASCAL and those treated with MitraClip. In terms of safety, both procedures exhibited low overall mortality rates and occurrence of major adverse events (MAE), without significant difference between the 2 devices. These findings remained consistent in both short- and long-term follow-up assessments. Our study revealed similar effectiveness and safety profiles between the PASCAL and MitraClip devices in patients experiencing significant symptomatic MR.