Valve Academic Research Consortium Definitions Research Articles

Single arterial access versus standard access in TAVI: results from a large multicenter registry

Abstract Background The transfemoral approach has become the gold standard primary access for transcatheter aortic valve implantation (TAVI) due to low complication rates. An additional secondary access (ScA) is used for angiographic guidance of the procedure. Recently, small, single-center studies demonstrated feasibility of single-access for transfemoral TAVI without a secondary access. However, comparative and large-scale data are missing. Purpose We assessed vascular and bleeding complications of ScA and Single access (SA) approaches in a large multicenter registry to evaluate both strategies. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 10,120 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. In 9,457 patients who qualified for analysis ScA (80.7% femoral, 19.3% radial) were performed in 8709 (92%) and SA in 748 (8%). Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Median age was 81.9[IQR 78.2, 85.1] years and 48.9% of patients were female (median logistic EuroSCORE II: 3.3% [IQR 2.1, 5.6]). Peripheral artery disease was comparable between groups (13.5 vs. 14.0%, p=0.73). While overall major access-related vascular complications did not differ significantly (6.1% vs. 4.8%, p=0.20), there was a higher incidence of minor complications for ScA compared to SA (9.0% vs. 2.8%, p<0.001). Secondary access complications amounted to 2.7% in the ScA group and were mainly characterized as bleeding (1.2%) and pseudoaneurysms (1.2%) mostly treated conservatively (1.2%), yet in some cases surgical repair was needed (0.8%). No significant difference was observed regarding type III/IV bleeding (4.1% vs. 4.3%, p=0.91), stroke rate (2.4% vs. 3.6%, p=0.05), stage III/IV acute kidney injury (2.4% vs. 2.4%, p=1.00) or all-cause 30-day mortality (5.8% and 5.7%, p=0.99) for ScA compared to SA groups. Conclusion In patients treated with transfemoral TAVI, a single access approach was associated with lower rates of minor access-related vascular complications without compromising overall outcomes, suggesting potential benefits of a minimally-invasive TAVI approach with the omission of additional vascular access.

Procedural and clinical outcomes according to ultrasound-guided access in TAVI: a propensity-matched comparative sub-analysis from the PULSE registry

Abstract Background Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce the incidence of these events, particularly in large-bore arterial access. However, large-scale data on this approach are limited and it has not yet fully been implemented into standard clinical practice during TAVI. Purpose We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided (FG) access from a large multicenter TAVI registry. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 9,295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. USG and FG access were performed in 1,992 (21.4%) and 7,303 (78.6%) patients, respectively. A propensity score was used to match 1,023 FG with 1,023 USG access patients in a 1:1 fashion. The primary endpoint was a composite of minor and major vascular complications at the TAVI-access site or bleeding type II-IV. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Mean age was 81.9±6.25 years and 48.0% of patients were female. Comorbidities and clinical variables were well-balanced in matched groups. The overall risk profile was comparable in USG vs. FG (mean EuroSCORE II: 3.4 [2.1, 6.4] vs. 3.6 [2.2, 5.7], p=0.54). The primary end point occurred in 12.0% in the USG and 17.7% in the FG group, p<0.001. While major large bore access-related vascular complications did not differ significantly (3.5% vs. 4.2%, p=0.49), there was a trend towards lower minor complications for USG compared to FG (5.9% vs. 7.8%, p=0.096). Large bore access-related bleeding occurred in 5.5% versus 7.8% (p=0.04) of patients. Endovascular balloon inflation was required in 0.6% and 3.3% (p<0.001) of all large-bore access vascular complications. Stroke (1.7% vs. 1.5%, p=0.86) and stage III/IV acute kidney injury (3.0% vs. 2.2%, p=0.42) were similar in both groups. Conclusion In patients treated with transfemoral TAVI, ultrasound-guidance for gaining access was associated with lower rates of access-related vascular complications or type II-IV bleeding. Endovascular treatment was required more frequently in case of a fluoroscopy-guided approach. These findings challenge the fact that most TAVI procedures were performed with fluoroscopy-guidance.

550 Robotic Totally Endoscopic Mitral Valve Surgeries Within a Comprehensive Robotic Cardiac Program

BackgroundIn 2013, we initiated a comprehensive multispectrum robotic cardiac surgery program with emphasis on the totally endoscopic approach. We reviewed the outcomes of mitral valve (MV) procedures within this context. MethodsA retrospective review of 1714 robotic endoscopic cardiac surgeries performed at our institution between September 2013 and February 2024 was conducted. Of these, outcomes of 550 consecutive heterogeneous patients undergoing robotic totally endoscopic MV operations were analyzed. Data were collected according to the Mitral Valve Academic Research Consortium definitions. ResultsThe mean age was 63 years, and 217 patients (39%) were female. The mean Society of Thoracic Surgeons risk of mortality was 2.1% (range, 0.15%-19.4%). MV repair occurred in 98% of patients with degenerative mitral regurgitation (MR). Concomitant procedures included Cox-maze cryoablation in 127 (23%) patients, tricuspid valve repair in 54 (9.8%), septal myectomy in 15 (2.7%), totally endoscopic coronary bypass in 6 (1.1%), and aortic valve replacement in 3 (0.5%). Endoaortic balloon occlusion was used in 392 patients (71%), ventricular fibrillatory arrest in 114 (21%), and transthoracic aortic clamp in 44 (8%). Observed to expected 30-day mortality was 0.6. Mean length of hospital stay was 2.8 days. MV repair 30-day surgical success was 95.9% and procedural success was 93.0%. Postoperative echocardiography revealed no or trace residual MR in 95% and mild residual MR in 5%. Five-year freedom from reoperation for recurrent MR was 95.7%. ConclusionsRobotic endoscopic MV surgery is feasible within the context of a comprehensive multispectrum robotic cardiac surgery program.

First-in-human Results of the Novel Transcatheter Mitral Valve Repair System for Severe Mitral Regurgitation

Objective: To evaluate the feasibility, safety, and effectiveness of a novel edge-to-edge mitral valve repair system (the NovoClasp system) in patients with severe mitral regurgitation. Methods: In this prospective, single-arm, first-in-human study conducted at Beijing Anzhen Hospital, data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system. The study candidates were patients exhibiting a mitral regurgitation severity of 3+ or more and were at high-risk or contraindicated for surgical intervention. Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes. Other safety and efficacy outcomes were prospectively assessed at device implantation, discharge, and 30 d, 6 months, and 12 months post-procedure. Results: Between October 1, 2021, and January 31, 2022, 11 patients were treated for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the NovoClasp system. All patients had a baseline New York Heart Association functional class of III–IV, with 7/11 exhibiting complex mitral valve disease. All patients achieved the primary endpoints of technical and device success, with a post-operative 30-d mitral regurgitation grade reduction to 2+ or lower, which was maintained at 12 months. One patient had minor bleeding and hematoma at the access site before discharge, and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge. No additional cases of death, adverse cerebral or cardiovascular events, or device-related complications was observed during the follow-up. Conclusion: This study suggested the potential feasibility and safety of the NovoClasp system, showing a promising technical and device success rate, along with a decrease in mitral regurgitation severity. A further pivotal study is needed to assess the procedural and long-term outcomes.

Baseline NT-proBNP predicts acute kidney injury following transcatheter aortic valve implantation

Background/purposeAcute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) increases morbidity and mortality. Our study aimed to investigate the role of baseline N-terminal pro B-type natriuretic peptide (NT-proBNP) as a predictor of AKI following TAVI. MethodsAll consecutive TAVI patients were included in the analysis, except patients with dialysis and those with a GFR < 15 ml/min/1.73 m2 at baseline. Rates of AKI after TAVI were assessed according to the updated valve academic research consortium definitions using AKIN classification in three stages. NT-proBNP was measured at baseline. One-year mortality rates were assessed. ResultsWe included 1973 patients treated with TAVI between January 2006 and December 2016. Median [IQR] age was 81.0 [77.0;84.0] years, the STS score was 6.2 [3.9;9.0], and the logEuroScore was 14.5 [9.0;23.0]. 30-day and one-year mortality was 5.1 % and 16.1 % for all patients, respectively. Multivariate analysis revealed that patients with NT-proBNP levels higher than two times above the upper level of normal (ULN) had an increased risk for AKI after TAVI compared to patients with NT-proBNP levels < 2× ULN (OR 1.40 [1.03–1.91]). ConclusionsRoutine assessment of baseline NT-proBNP levels might be an additional tool to identify patients at increased risk for AKI after TAVI.

Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study

Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve. The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing. Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (pnon-inferiority<0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (pnon-inferiority<0·0001). This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary. JenaValve Technology.

Vascular complications and outcomes following transcatheter aortic valve replacement in patients on chronic steroid therapy: a meta-analysis.

Chronic steroid (CS) therapy was reportedly linked to increased vascular complications following percutaneous coronary intervention. However, its association with vascular complications after transcatheter aortic valve replacement (TAVR) remained uncertain, with conflicting results being reported. The authors aimed to compare the rate of vascular complications and outcomes between patients with and without CS use after TAVR. The authors conducted a comprehensive literature search in PubMed, Embase, and Cochrane databases from their inception until 18th April 2022 for relevant studies. Endpoints were described according to Valve Academic Research Consortium-2 definitions. Effect sizes were pooled using DerSimonian and Laird random-effects model as risk ratio (RR) with 95% CI. Five studies with 6136 patients undergoing TAVR were included in the analysis. The included studies were published between 2015 and 2022. The mean ages of patients in both study groups were similar, with the CS group averaging 80 years and the nonsteroid group averaging 82 years. Notably, a higher proportion of patients in the CS group were female (56%) compared to the nonsteroid group (54%). CS use was associated with a significantly higher risk of major vascular complications (12.5 vs. 6.7%, RR 2.32, 95% CI: 1.73-3.11, P <0.001), major bleeding (16.8 vs. 13.1%, RR 1.61, 95% CI: 1.27-2.05, P <0.001), and aortic annulus rupture (2.3 vs. 0.6%, RR 4.66, 95% CI: 1.67-13.01, P <0.001). There was no significant difference in terms of minor vascular complications (RR 1.43, 95% CI: 1.00-2.04, P =0.05), in-hospital mortality (2.3 vs. 1.4%, RR 1.86, 95% CI: 0.74-4.70, P =0.19), and 30-day mortality (2.9 vs. 3.1%, RR 1.14, 95% CI: 0.53-2.46, P =0.74) between both groups. Our study showed that CS therapy is associated with increased major vascular complications, major bleeding, and annulus rupture following TAVR. Further large multicenter studies or randomized controlled trials are warranted to validate these findings.

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

Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry

BackgroundMitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. ObjectivesThis study aimed to determine whether device position and asymmetry are associated with these outcomes. MethodsPatients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. ResultsA total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). ConclusionsValve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

Incidence, Predictors, and Prognostic Impact of Bleeding Events After TAVR According to VARC-3 Criteria

BackgroundThe updated Valve Academic Research Consortium (VARC) definition for bleeding events after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. ObjectivesThe aim of this study was to determine the incidence, predictors, and clinical impact of bleeding events following TAVR as defined by recent VARC-3 criteria. MethodsA total of 2,384 consecutive patients with severe symptomatic aortic stenosis undergoing TAVR were included. Early (at index hospitalization) and late (after hospital discharge) bleeding complications were defined according to VARC-3 criteria as type 1, 2, 3, or 4. Baseline, procedural, and follow-up (24 [IQR: 12-43] months) data were prospectively collected. ResultsBleeding events occurred in 761 patients (31.9%): types 1, 2, 3, and 4 in 169 (22.2%), 399 (52.4%), 149 (19.6%), and 44 (5.8%) patients, respectively. The primary vascular access site and gastrointestinal locations were the most common bleeding sources among early and late bleeding events, respectively. Female sex, thoracotomy access, larger (14-F) sheath use, and dual antiplatelet therapy determined an increased risk of early bleeding events (P < 0.02 for all). The use of the radial artery for secondary access was associated with a significant risk reduction of early bleeding (P < 0.001). Type 2 and type 3 events were associated with an increased mortality risk at 30-day (HR: 2.94 [95% CI: 1.43-6.03; P = 0.003] and HR: 4.91 [95% CI: 2.19-11.03; P < 0.001], respectively) and 1-year (HR: 1.86 [95% CI: 1.28-2.69; P = 0.001] and HR: 2.28 [95% CI: 1.41-3.66; P = 0.001], respectively) follow-up. A similar prognostic pattern was observed when applying VARC-2 criteria but with a much lower global incidence of early bleeding events (19% vs 27%; P < 0.001). ConclusionsBleeding events after TAVR were associated with poorer short- and long-term survival. The magnitude of this correlation was proportional to bleeding severity defined according to VARC-3 criteria. Further studies on bleeding prevention following TAVR are warranted to improve procedural safety and patient prognosis.

Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement (TAVR-CMR): A Randomized, Open-Label, Non-Inferiority Trial.

Background: Computed tomography (CT) is recommended for guiding transcatheter aortic valve replacement (TAVR). However, as a sizable proportion of TAVR candidates have chronic kidney disease (CKD), the use of iodinated contrast media is a limitation. Cardiac magnetic resonance (CMR) is a promising alternative, yet randomized data comparing the effectiveness of CMR- versus CT-guided TAVR are lacking. Methods: An investigator-initiated, prospective, randomized, open-label, non-inferiority trial was conducted at two Austrian heart centers. Patients evaluated for TAVR according to the inclusion (severe symptomatic aortic stenosis) and exclusion criteria (contraindication to CMR, CT, or TAVR, a life expectancy < 1 year, CKD 4 or 5) were randomized (1:1) to undergo CMR- or CT-guiding. The primary outcome was defined according to the Valve Academic Research Consortium-2 definition of implantation success at discharge, including absence of procedural mortality, correct positioning of a single prosthetic valve, and proper prosthetic valve performance. Non-inferiority was assessed using a hybrid modified intention-to-treat (mITT)/per-protocol (PP) approach based on an absolute risk difference margin of 9%. Results: Between September 11, 2017, and December 16, 2022, 380 candidates for TAVR were randomized to CMR-guided (191 patients) or CT-guided (189 patients) TAVR planning. Of these, 138 patients (72.3%) in the CMR-guided group and 129 patients (68.3%) in the CT-guided group eventually underwent TAVR (mITT cohort). Of these 267, 19 patients had protocol deviations, resulting in a PP cohort of 248 patients (n=121 CMR-guided, n=127 CT-guided). In the mITT cohort, implantation success was achieved in 129 patients (93.5%) in the CMR group and in 117 patients (90.7%) in the CT group (between-group difference, 2.8%; 90% confidence interval [CI]: -2.7 to 8.2%; p<0.01 for non-inferiority). In the PP cohort (n=248), the between-group difference was 2.0% (90% CI: -3.8 to 7.8%; p<0.01 for non-inferiority). Conclusions: CMR-guided TAVR was non-inferior to CT-guided TAVR in terms of device implantation success. CMR can therefore be considered as an alternative for TAVR planning.

Nationwide experience with transcarotid transcatheter aortic valve implantation: Insights from the POL-CAROTID registry.

The carotid artery is an alternative access route for transcatheter aortic valve implantation (TAVI), especially useful in patients unsuitable for traditional access routes including transfemoral (TF), subclavian, transapical, and aortic. To investigate the feasibility and safety of transcarotid (TC) access for TAVI in comparison to the TF approach in a multicenter setting. A total of 41 patients, treated between December 2014 and December 2018, were retrospectively reported to the Polish Registry of Common Carotid Artery Access for TAVI (POL-CAROTID). The median follow-up time was 619 (365-944) days, and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. Clinical outcomes were compared with 41 propensity-matched TF-TAVI patients. The mean (standard deviation [SD]) patients' age was 78.0 (7.2) years, and 29 patients (70.7%) were men. Prohibitive iliofemoral anatomy and/or obesity (46.3%) and/or the presence of a stent graft in the abdominal aorta (31.7%) were the most common indications for TC-TAVI. Device success for TC-TAVI was comparable with the matched TF-TAVI group (90.2% vs. 95.3%, respectively, P = 0.396), and no periprocedural mortality was observed. Moreover, early safety was similar between the two groups (92.7% vs. 95.3%, respectively, log-rank P = 0.658) with only 1 case of non-disabling stroke during the first month after TC-TAVI. Consequently, no cerebrovascular events were observed in the mid-term, and the clinical efficacy of TC-TAVI corresponded well with TF-TAVI (90.2% vs. 92.7%, respectively, log-rank P = 0.716). A total of 4 (9.8%) deaths were noted in the TC-TAVI cohort in comparison to 3 (7.3%) in the TF-TAVI group. The results of the study indicated that the first cohort of Polish patients with implantations of second-generation transcarotid transcatheter heart valves had a similar prognosis to TF-TAVI with regard to safety and feasibility. TC access may be considered an optimal alternative for patients in whom the TF approach is precluded.

Aortic cross-clamp time correlates with mortality in the mini-mitral international registry.

Minimally invasive access has become the preferred choice in mitral and/or tricuspid valve surgery. Reported outcomes are at least similar to classic sternotomy although aortic cross-clamp times are usually longer. We analysed the largest registry of mitral and/or tricuspid valve surgery patients (mini-mitral international registry (MMIR)) for the relationship between aortic cross-clamp times, mortality and other outcomes. From 2015 to 2021, 7513 consecutive patients underwent mini-mitral and/or tricuspid valve surgery in 17 international Heart-Valve-Centres. Data were collected according to Mitral Valve Academic Research Consortium (MVARC) definitions and 6878 patients with 1 cross-clamp period were analysed. Uni- and multivariable regression analyses were used to assess outcomes in relation to aortic cross-clamp times. Median age was 65 years (57% male). Median EuroSCORE II was 1.3% (Inpatient Quality Reporting (IQR): 0.80-2.63). Minimally invasive access was either by direct vision (28%), video-assisted (41%) or totally endoscopic/robotic (31%). Femoral cannulation was used in 93%. Three quarters were repairs with 17% additional tricuspid valve surgery and 19% Atrial Fibrillation (AF)-ablation. Cardiopulmonary bypass and cross-clamp times were 135 min (IQR: 107-173) and 85 min (IQR: 64-111), respectively. Postoperative events were death (1.6%), stroke (1.2%), bleeding requiring revision (6%), low cardiac output syndrome (3.5%) and acute kidney injury (6.2%, mainly stage I). Statistical analyses identified significant associations between cross-clamp time and mortality, low cardiac output syndrome and acute kidney injury (all P < 0.001). Age, low ejection fraction and emergent surgery were risk factors, but variables of 'increased complexity' (redo, endocarditis, concomitant procedures) were not. Aortic cross-clamp time is associated with mortality as well as postoperatively impaired cardiac and renal function. Thus, implementing measures to reduce cross-clamp time may improve outcomes.

ACURATE neo2 versus SAPIEN 3 Ultra for transcatheter aortic valve implantation.

No comparative data exist with the latest generation self-expanding ACURATE neo2 (Neo2) and the balloon-expandable SAPIEN 3 Ultra (Ultra) transcatheter heart valves (THV). We aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the Neo2 and the Ultra THV. A total of 1,356 patients at 4 centres were treated either with the Neo2 (n=608) or the Ultra (n=748). The primary endpoint was device success according to the latest Valve Academic Research Consortium definitions. The association of the THV used and the primary endpoint was assessed using inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which identified 472 matched pairs. Results: After PSM, there were no relevant differences between the groups. While rates of moderate to severe paravalvular leakage (PVL) were overall low (0.6% vs 1.1%; p=0.725), elevated transvalvular gradients (≥20 mmHg) were less frequent with the Neo2 (2.4% vs 7.7%; p<0.001), which translated into a significantly higher rate of device success with the Neo2 compared with the Ultra (91.9% vs 85.0%; p<0.001). Consistently, the Neo2 was associated with higher rates of device success in the IPTW analysis (odds ratio [OR] 1.961, 95% confidence interval [CI]: 1.269-3.031; p=0.002). Rates of mild PVL were significantly lower with the Ultra compared with the Neo2 (20.0% vs 32.8%; p<0.001). Clinical events at 30 days were comparable between the 2 groups. Short-term outcomes after TAVI using the Neo2 or Ultra THV were excellent and, overall, comparable. However, transvalvular gradients were lower with the Neo2, which translated into higher rates of device success. Rates of mild PVL were significantly lower with the Ultra THV.

1050 ULTRASOUND GUIDED CANNULATION OF FEMORAL ARTERY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT

Abstract Background Vascular access complications are a significant source of morbidity and mortality after transcatheter aortic valve replacement (TAVR). Ultrasound-guided cannulation (UGC) of central veins or arteries is a widely used approach for patients undergoing invasive procedures. Whether UGC significantly decreases the risk of vascular access complications also for large-bore access procedures, such as TAVR, lacks evidence Objectives in this study, we aimed to evaluate the benefits of routine use of UGC in patients undergoing TAVR. Methods Data were retrospectively collected from two high-volume TAVR centers from September 2009 to March 2022. UGC was performed using a two-dimensional ultrasound short-axis views, while manual palpation, fluoroscopy, or contralateral angiography were used for the other patients. The odds ratio (OR) for vascular complications was calculated using a multivariate logistic regression model including as dependent variables all relevant baseline and procedural characteristics (forward stepwise selection process). Vascular complications were adjudicated according to the Valve Academic Research Consortium definitions 3. Results Out of 874 patients included in the study, UGC access was performed in 177 subjects. Overall mean age was 80.2±5.8 years old, 60% of patients were females, 35.5% had diabetes, 61.4% had dyslipidemia, and 27.8% had chronic kidney disease, with a mean left ventricular ejection fraction of 52.7±9.7%. Looking at the procedural variables Euroscore II was 5.8±5.4, second and third valves generation have been used in 85% of the cases, while suture-based closure devices in 84% of subjects. After adjustment for clinical and procedural variables, routinely use of UGC was associated with a lower rate of total [Odds Ratio (OR): 0.38; 95% confidence interval (CI) 0.15% to 0.95%)] and major vascular complications [Odds Ratio (OR): 0.21; 95% confidence interval (CI) 0.05% to 0.75%)], while no differences were observed for minor vascular complications. Conclusions Routinely use of UGC significantly decreases the risk of vascular complications in patients undergoing TAVR. However, a dedicated randomized clinical trial assessing the safety and efficacy of this approach is warranted to confirm our results in this high-risk population.

1019 SAFETY OF PLUG-BASED AND SUTURE-BASED VASCULAR CLOSURE DEVICES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: A MULTICENTER OBSERVATIONAL STUDY

Abstract Background Transcatheter aortic valve replacement (TAVR), is the treatment of choice for most patients with aortic stenosis. Transfemoral access remains the most widely used peripheral vascular approach for TAVR and dedicated plug-based or suture-based vascular closure devices are available to achieve femoral hemostasis. However, the comparative safety of such strategies is controversial in patients undergoing transfemoral TAVR. Objectives in this study, we aimed to evaluate the rates of vascular access complications according to the use of plug-based or suture-based vascular closure in patients undergoing TAVR. Methods Data were retrospectively collected from two high-volume TAVR centers from September 2009 to March 2022. Patients were categorized according to the use of plug-based or suture-based vascular closure devices. The plug-based platform used was MANTA (Teleflex), while the suture-based devices were the Perclose ProGlide™ or the Prostar™ Systems (Abbott Vascular). Baseline demographic, clinical, and echocardiographic variables were compared between these groups using an independent-sample Student's t-test for continuous variables, presented as mean±SD, and the chi-square test for categorical or binary variables, presented as number and percentage, as appropriate. The odds ratio (OR) for vascular complications was calculated using a multivariate logistic regression model including as dependent variables all relevant baseline and procedural characteristics. The closure device variable was included in the multivariate model using the Prostar™ XL device group as reference. Vascular complications were adjudicated according to the Valve Academic Research Consortium definitions 3. Results Out of 874 patients, hemostasis was achieved with Prostar™ XL PVS in 120 (13.7%) patients, with Perclose ProGlide™ in 525 (60.1%), and with MANTA 229 (26.2%). No differences in age and common cardiovascular risk factors were observed between the group except for the prevalence of peripheral arterial disease (30.6% vs. 17.0%, p&amp;lt;0.0001) and dyslipidemia (58.9% vs. 68.6%, p=0.01) as well as for the echo and procedural variables except for the Euroscore II that was lower in the plug-based group (6.0±5.6 vs. 5.1±4.68), and for the higher use of new generation devices (79.1% vs. 98.3%, p&amp;lt;0.0001). After adjustment for common cardiovascular risk factors and procedural features, no differences were observed for total vascular complications [OR: 0.68 (95% confidence interval (CI): 0.33 to 1.38) and OR: 0.60 (95% CI: 0.33 to 1.53), for Perclose ProGlide™ and MANTA groups, respectively]. Likewise, no substantial differences were observed for major and minor vascular complications. Conclusions Both suture-based and plug-based devices have comparable outcomes with regard to the risk of vascular complications. Further randomized clinical trials are warranted to confirm this observation in high-risk sub-group patients with for example heavily calcified access or obesity.

Abstract 14335: Vascular Complications and Outcomes Following Transcatheter Aortic Valve Replacement in Patients on Chronic Steroids Therapy. A Meta-Analysis

Introduction: Chronic steroids therapy was reportedly linked to increased vascular complications (VC) following invasive vascular procedures. However, its association with VC after transcatheter aortic valve replacement (TAVR) remained uncertain, with conflicting results being reported. We aimed to compare the rate of vascular complications and outcomes between patients with and without chronic steroid use after TAVR. Methods: We conducted a comprehensive literature search in PubMed, Embase and Cochrane databases for relevant studies. Endpoints were described according to Valve Academic Research Consortium-2 definitions and were assessed within 30 days of TAVR. Effect sizes were pooled using the DerSimonian and Laird random-effects model as risk ratio (RR) with 95% confidence intervals (CI). Results: 5 studies with 6136 patients undergoing TAVR (328 steroids, 5808 non-steroids) were included in the analysis. Patients on chronic steroids were younger (mean age 80.2 vs 82.3 years) and were more likely to be female (56% vs 54%). Patients on chronic steroids had a higher risk of major vascular complications (RR 2.32, 95% CI 1.73-3.11, p&lt;0.001), major bleeding (RR 1.61, 95% CI 1.27-2.05, p&lt;0.001) and aortic annulus rupture (RR 4.66, 95% CI 1.67-13.01, p&lt;0.001). There was no significant difference in terms of minor vascular complications (RR 1.43, 95% CI 1.00-2.04, p=0.05), in-hospital mortality (RR 1.86, 95% CI 0.74-4.70, p=0.19) and 30-day mortality (RR 1.14, 95% CI 0.53-2.46, p=0.74) between both groups. Conclusion: Chronic steroid therapy is associated with increased rate of major VCs, major bleeding and aortic annulus rupture following TAVR. Further randomized controlled trials were encouraged to confirm these findings.

Contemporary Outcome Trends in Transcatheter Aortic Valve-in-Valve Implantation Versus Redo Aortic Valve Replacement

As valve-in-valve (ViV) transcatheter aortic valve implantation is still an evolving method, we evaluated the development of early and midterm outcomes after ViV and conventional redo-surgical aortic valve replacement (SAVR) over the past 2 decades. In-hospital databases were retrospectively screened for patients ≥60 years treated for failing bioprosthetic aortic valves at our center. Clinical and follow-up characteristics were compared between patients who underwent ViV or redo-SAVR according to valve academic research consortium-2 (VARC-2) definitions. The comparison of outcome parameters was adjusted for baseline differences between groups. Between June 2002 and April 2020, 209 patients with ViV and 65 redo-SAVR patients met inclusion criteria. No significant differences were found in 30 days (ViV 3.8%, SAVR 3.1%, p=0.778) or 6-month mortality (ViV 14.0%, SAVR 7.5%, p=0.283). As patients with ViV less frequently experienced acute kidney injury (stage II or III) and life-threatening bleeding, they more frequently reached the 30-day VARC-2 combined safety end point (79.2% vs 61.5%, odds ratio [OR] 2.540, p=0.023). Patients with ViV less frequently reached clinical efficacy (68.3% vs 84.6%, OR 0.408, p=0.041) and device success (79.9% vs 92.3%, OR 0.311, p=0.040) end points, because of higher frequency of postprocedural transvalvular gradients >20 mm Hg. However, over the past decade, VARC-2 clinical efficacy and device success rates continuously increased in ViV cases. In conclusion, ViV and SAVR were associated with similar acute mortality and different beneficial and adverse outcome profiles in this single-center cohort. Results after ViV procedures have continuously improved over the past years.

Transapical-transcatheter aortic valve implantation using the Edwards SAPIEN 3 valve.

Scarcely any data has been published on the mid-term effect of transapical-transcatheter aortic valve implantation (TA-TAVI) using the Edwards SAPIEN 3 valve (S3; Edwards Lifesciences Corp., Irvine, CA, USA). We present mid-term clinical and echocardiographic outcomes after TA-TAVI utilizing S3. Between 02/2014-06/2017, 122 elderly patients with severe aortic stenosis underwent TA-TAVI utilizing S3 at our institution. We conducted clinical and echocardiographic follow-up. The mean follow-up was 15 months. All end-point-related outcomes were adjudicated according to Valve Academic Research Consortium-2 definitions. The STS-score of the entire cohort was 6.26±4.6. More than one-third of the patients exhibited severe peripheral artery disease. The 30-d all-cause mortality, all-stroke rate, and myocardial infarction of the entire cohort were 4.1%, 1.6%, and 0.8% respectively. Median survival time of the entire cohort was 35 months. The cumulative mid-term myocardial infarction and stroke rate was 2.6% and 3.5%, respectively. The postoperative moderate/severe paravalvular leakage occurred in 1.6% of cases. At discharge, one-year and two-year postprocedure peak/mean gradients were 16.6±8.3/ 9±5.1 mmHg, 18±6.9/ 10±4.5 mmHg, and 22.2±5.4/ 12.8±4.6 mmHg, respectively. The rate of new pacemaker cases was 14.1%. Acute kidney injury network 2/3 appears, as an independent predictor of mortality. We observed very promising early and mid-term clinical outcomes with a high degree of device success and good hemodynamic performance after TA-TAVI using the S3 in the intermediate risk patient profile.

Risk of Bleeding after Transcatheter Aortic Valve Replacement: impact of Preoperative Antithrombotic Regimens.

Bleeding after transcatheter aortic valve replacement (TAVR) has a negative impact on the outcome of the procedure. Risk factors for bleeding vary widely in the literature, and the impact of preoperative antithrombotic agents has not been fully established. The objectives of our study were to assess bleeding after TAVR as defined by the Valve Academic Research Consortium-2 (VARC-2), identify its risk factors, and correlate with antithrombotic treatment in addition to its effect on procedural mortality. The study included 374 patients who underwent TAVR from 2009 to 2018. We grouped the patients into four groups according to the VARC-2 definition of bleeding. Group 1 included patients without bleeding (n=265), group 2 with minor bleeding (n=22), group 3 with major bleeding (n=61), and group 4 with life-threatening bleeding (n=26). The median age was 78 (25th-75th percentiles: 71-82), and 226 (60.4%) were male. The median EuroSCORE was 3.4 (2-6.3), and there was no difference among groups (P=0.886). The TAVR approach was transfemoral (90.9%), transapical (5.6%), and trans-subclavian (1.9%). Results: Predictors of bleeding were stroke (OR: 2.465; P=0.024) and kidney failure (OR: 2.060; P=0.046). Preoperative single and dual antiplatelet therapy did not increase the risk of bleeding (P=0.163 and 0.1, respectively). Thirty-day mortality occurred in 14 patients (3.7%), and was significantly higher in patients with life-threatening bleeding (n=8 [30.8%]; P<0.001). Conclusion: Bleeding after TAVR is common and can be predicted based on preprocedural comorbidities. Preprocedural antithrombotic therapy did not affect bleeding after TAVR in our population.