143 Incidence, predictors, and clinical impact of transient left bundle branch block in patients undergoing transcatheter aortic valve implantation

Aims This study aims to evaluate the incidence and prognostic impact of transient left bundle branch block (LBBB) in patients undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable or self-expanding valves. Clinical, echocardiographic and electrocardiographic predictors of transient LBBB were also investigated. Methods and results 197 patients treated with TAVI at Federico II University hospital, Naples, Italy were enrolled. Electrocardiograms (ECGs) were obtained before and after TAVI procedure, at discharge and at 30-day follow-up. ECGs were anonymously digitalized and analysed by five cardiologists. Transient LBBB was defined as LBBB regressed within 30 days after procedure. All ECGs for each patient were analysed by the same cardiologist. The primary endpoint of the study was all-cause mortality and permanent pacemaker implantation (PPI) at 1-month after TAVI. Secondary endpoints included cerebrovascular accidents, acute myocardial infarction, vascular complications, acute kidney injury, endocarditis, and re-hospitalization for all causes. Out of 197 patients enrolled, 54 (27.4%) developed transient LBBB. Among patients with transient LBBB, 70.4% were female. Mean age was higher in transient LBBB group compared with control group (81.0 ± 6.4 years, vs. 78. 6 ± 6.5 years; P = 0.022). From logistic analysis, peak transvalvular gradient (OR: 1.01, 95% CI: 0.93–1.00; P < 0.034) and left ventricular ejection fraction (LVEF) (OR: 0.96, 95% CI: 0.93–0.99, P < 0.012) were identified as predictive factors of transient LBBB. No differences between the two studied groups were observed in primary and secondary endpoints (all-cause mortality: 1.9% vs. 0.7%; P = 0.46; PPI: 9.6% vs. 12%; P = 0.80). Conclusions Peak transvalvular gradient and LVEF predict onset of transient LBBB, a common conduction disturbance after TAVI. Onset of transient LBBB does not correlate with worse clinical outcomes at 30 days.

High Post-Procedural Transvalvular Gradient or Delayed Mean Gradient Increase after Transcatheter Aortic Valve Implantation: Incidence, Prognosis and Associated Variables. The FRANCE-2 Registry

Mean Gradient (MG) elevation can be detected immediately after transcatheter aortic valve implantation (TAVI) or secondarily during follow-up. Comparisons and interactions between these two parameters and their impact on outcomes have not previously been investigated. This study aimed to identify incidence, influence on prognosis, and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (6 to 12 months after TAVI, DMGI) in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. The registry includes all consecutive symptomatic patients with severe aortic stenosis who have undergone TAVI. Three groups were analyzed: (1) PPMG < 20 mmHg without DMGI > 10 mmHg (control); (2) PPMG < 20 mmHg with DMGI > 10 mmHg (Group 1); and (3) PPMG ≥ 20 mmHg (Group 2). From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. Controls comprised 2078 patients. In Group 1(n = 131 patients), DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-years mortality than in controls (32.6% vs. 40.1%, p = 0.27). In Group 2 (n = 144 patients), PPMG was at least 20 mmHg in 6.1% and was associated with higher 4-year mortality (48.7% versus 40.1%, p = 0.005). A total of two-thirds of the patients with PPMG ≥ 20 mmHg had MG < 20 mmHg at 1 year, with mortality similar to the controls (39.2% vs. 40.1%, p = 0.73). Patients with PPMG > 20 mmHg 1 year post-TAVI had higher 4-years mortality than the general population of the registry, unlike patients with MG normalization.

Can Moderate Patient Prosthesis Mismatch Be Tolerated in a Selected Group of Patients with Aortic Valve Replacement?

Introduction: In this study, we aimed to determine the incidence of patient prosthesis mismatch (PPM) and its effects on ejection fraction (EF), gradients, and late survival. Methods: 200 patients who underwent isolated mechanical AVR between March 2013 and May 2016 were retrospectively evaluated based on patient records. Results: 200 patients were included in the study. No PPM was detected in 42 (21%) patients, moderate PPM in 122 (61%), and severe PPM in 36 (18%) patients. A significant decrease was found in all groups in terms of mean valve gradients and LVMI (preoperative LVMI compared with postoperative LVMI at the 12th month) (P < .001). A 30% decrease in mean LVMI in the no PPM and moderate PPM groups and a 20% decrease in the severe PPM group were detected at the 6th month. Conclusion: In our postoperative data, we found that EF was preserved, the transvalvular gradient reduced, and LVMI decreased. There was no difference in mortality rates between the control (no PPM) group and the moderate PPM group. Taking into account our patient groups, we can say that no-to-moderate PPM has no major effect on left ventricular remodeling in patients with preserved left ventricular functions.

The Usefulness of [18F]F-Fluorodeoxyglucose and [18F]F-Sodium Fluoride Positron Emission Tomography Imaging in the Assessment of Early-Stage Aortic Valve Degeneration after Transcatheter Aortic Valve Implantation (TAVI)—Protocol Description and Preliminary Results

Transcatheter aortic valve implantation (TAVI) is now a well-established treatment for severe aortic stenosis. As the number of procedures and indications increase, the age of patients decreases. However, their durability and factors accelerating the process of degeneration are not well-known. The aim of the study was to verify the possibility of using [18F]F-sodium fluoride ([18F]F-NaF) and [18F]F-fluorodeoxyglucose ([18F]F-FDG) positron emission tomography/computed tomography (PET/CT) in assessing the intensity of TAVI valve degenerative processes. In 73 TAVI patients, transthoracic echocardiography (TTE) at initial (before TAVI), baseline (after TAVI), and during follow-up, as well as transesophageal echocardiography (TEE) and PET/CT, were performed using [18F]F-NaF and [18F]F-FDG at the six-month follow-up (FU) visit as a part of a two-year FU period. The morphology of TAVI valve leaflets were assessed in TEE, transvalvular gradients and effective orifice area (EOA) in TTE. Calcium scores and PET tracer activity were counted. We assessed the relationship between [18F]F-NaF and [18F]F-FDG PET/CT uptake at the 6 = month FU with selected indices e.g.,: transvalvular gradient, valve type, EOA and insufficiency grade at following time points after the TAVI procedure. We present the preliminary PET/CT ([18F]F-NaF, [18F]F-FDG) results at the six-month follow-up period as are part of an ongoing study, which will last two years FU. We enrolled 73 TAVI patients with the mean age of 82.49 ± 7.11 years. A significant decrease in transvalvular gradient and increase of effective orifice area and left ventricle ejection fraction were observed. At six months, FU valve thrombosis was diagnosed in four patients, while 7.6% of patients refused planned controls due to the COVID-19 pandemic. We noticed significant correlations between valve types, EOA and transaortic valve gradients, as well as [18F]F-NaF and [18F]F-FDG uptake in PET/CT. PET/CT imaging with the use of [18F]F-FDG and [18F]F-NaF is intended to be feasible, and it practically allows the standardized uptake value (SUV) to differentiate the area containing the TAVI leaflets from the SUV directly adjacent to the ring calcifications and the calcified native leaflets. This could become the seed for future detection and evaluation capabilities regarding the progression of even early degenerative lesions to the TAVI valve, expressed as local leaflet inflammation and microcalcifications.

Left Atrial Mechanical Function Predicts Postoperative AF in Patients with Rheumatic Mitral Valve Disease Who Underwent Mitral Valve Surgery

Objective: Postoperative atrial fibrillation (PoAF) is a common complication after surgical mitral valve replacement. Late PoAF is independently associated with long-term mortality. This study aimed to test the utility of preoperative left atrial mechanical function as a predictor of early and late PoAF in clinical practice. Methods: Patients (N = 150) with a rheumatic mitral valve who underwent mitral valve replacement with or without tricuspid valvuloplasty and who were in stable sinus rhythm were included. Baseline characteristics and transthoracic echocardiographic assessment information on the day before surgery were collected. Em, Em´, and Ei´ indicate early diastolic peak velocity of the mitral valve, early diastolic velocity at the lateral wall of the mitral annulus, and early diastolic velocity at the interventricular septal annulus, respectively. Results: Early PoAF was present in 59 of 150 patients (39.3%), and 32 of 150 patients (21.3%) developed late PoAF within 1 year after surgery. Among all of the variables examined, age, diabetes, early mitral filling velocity (Mitral E), left atrial mechanical function (Mitral A), Em/Em´, Em/Ei´, and mitral transvalvular gradient showed a significant correlation with PoAF. Only age, Mitral A, and mitral transvalvular gradient showed strong, significant correlations with the occurrence of late PoAF. In a multivariate analysis, predictors of late PoAF recurrence included early PoAF and Mitral A. Conclusion: Routine evaluation of Mitral A is feasible and useful to predict early and late PoAF in patients with a rheumatic mitral valve undergoing surgical mitral valve replacement.

Abstract 14342: Redo Surgical Aortic Valve Replacement versus Valve in Valve Transcatheter Aortic Valve Replacement

Introduction: There has been a recent trend towards the increased use of biologic valves at the time of surgical aortic valve replacement (SAVR) with an understanding there may be a potential need for future valve intervention. In this study, we compared the clinical outcomes of Redo-SAVR with valve-in-valve transcatheter aortic valve replacement (VIVTAVR) in patients with a prior history of SAVR. Methods: From 2012 to 2019, 263 patients underwent isolated aortic valve reintervention after prior SAVR: VIV-TAVR (n=187) or redo-SAVR (n=86). Multivariable analysis was performed to identify risk factors mortality and aortic reintervention. Sub-analyses were performed to compare VIV-TAVR patients to Redo-SAVR patients undergoing biologic valve explant and implant (Biologic) as well as VIV-TAVR and Redo-SAVR patients matched by STS Predicted Risk of Mortality (STS PROM). Results: Operative mortality for the Redo-SAVR and VIV-TAVR was 1.2% (1) and 1.6% (3) respectively (p=0.92). Redo-SAVR patients had an increased stroke rate (7.0% vs 1.1%, p=0.02) and longer postoperative length of stay (7 vs 2 days, p<0.0001). VIV-TAVR patients had a higher rate of ≥1+ paravalvular leak (PVL) (21.4% versus 3%, p=0.0002) and a lesser reduction in transvalvular gradient (-21.9 ± 17.6mmHg vs -30.3 ± 20.7mmHg, p=0.0038). The difference in PVL was maintained during the Biologic Sub-analysis (p=0.0034). In the STS PROM Sub-analysis, early mortality was the same for each group (1.2%), and the differences in PVL (p=0.0002) and in transvalvular gradient reduction (p=0.005) were maintained. Preoperative renal failure (p=0.006) and cerebrovascular disease (p=0.04) were risk factors for mortality and prior myocardial infarction (p=0.04) was a risk factor for aortic reoperation for VIV-TAVR. No risk factors were identified for Redo-SAVR. Conclusions: Aortic valve reintervention following prior SAVR is associated with outstanding clinical outcomes. Both Redo-SAVR and VIV-TAVR can be performed with lower than expected predicted mortality. Redo-SAVR was associated with increased morbidity compared to VIV-TAVR, but improved valve function and hemodynamics. Differences in long term valve durability and patient survival between these two therapies are yet to be determined.

Prognosis and clinical outcomes after TAVI, regarding the extravalvular cardiac damage defined by echocardiography prior the procedural

Background Recent studies have shown that the extent of extravalvular (extra-aortic valve) cardiac damage in patients with severe aortic stenosis (AS) have important prognostic implications for clinical outcomes after aortic valve replacement (AVR). Aims The aim of the present study is to evaluate the prognostic impact of a defined staging classification (“Généreux Staging Classification”) (GSC) characterizing the extent of extravalvular cardiac damage in patients with severe AS undergoing percutaneous transcatheter aortic valve implantation (TAVI). Methods A total of 102 consecutive patients, admitted in our institution between 2011–2017, with severe AS (echo-defined by peak aortic velocity, mean transvalvular gradient or aortic valve area) and symptoms related to AS (dyspnea, heart failure, angina or syncope) undergoing TAVI, were included. These patients were pooled and classified according to the presence or absence of cardiac damage as detected by echocardiography prior to TAVI, regarding the GSC: no extravalvular cardiac damage (Stage 0), left ventricular damage (Stage 1), left atrial or mitral valve damage (Stage 2), pulmonary vasculature or tricuspid valve damage (Stage 3), or right ventricular damage (Stage 4). Two-year outcomes were compared using Kaplan– Meier techniques and multivariable Cox proportional hazards models were used to identify 2-year predictors of mortality. Results Out of 102 patients, 57 were male (55.9%). Mean age was 83.46±4.23 years. 2 patients (2.1%) were classified as Stage 0; 20 patients (20.3%) as Stage 1; 55 patients (54.2%) as Stage 2; 22 (21.6%) as Stage 3; and 3 patients (2.9%) as Stage 4. Two-year mortality was 0.0% in Stage 0, 5.0% in Stage 1, 5.5% in Stage 2, and 44.0% in Stages 3–4. After multivariable and univariate analysis, stage of cardiac damage was independently associated as predictor for all-cause mortality at 2-years, after TAVI (HR 2.8 [1.3±6.2], p&lt;0.01). There were not another identificable predictors of 2-years death (age, sex, hypertension [78.5% of total patients], dislipemia [64.7%], diabetes [30.3%], smoking [78.5%], O2-chronic obstructive pulmonary disease [27.5% of total patients], renal insufficiency [78.5%], previous coronary artery disease [37.3%], peak aortic velocity, mean transvalvular gradient, and aortic valve area). Conclusions Given the strong association demonstrated in this study between advanced staging of cardiac damage and worse clinical outcomes after TAVI in short-middle term survival, consideration of the GSC in patients with severe AS in future recommendations for risk stratification might be useful. Two-year all-cause death in TAVI by GSC. Funding Acknowledgement Type of funding source: None

High post-procedural transvalvular gradient or delayed gradient increase after transcatheter aortic valve implantation: the FRANCE-2 registry

Background Mean gradient (MG) elevation can be detected immediately post-procedure or secondarily during follow-up. Comparison between these two parameters and impact on outcomes has not previously been investigated. Objectives The study aimed to identify incidence, influence on prognosis and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (DMGI), in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. Methods The registry includes all consecutive symptomatic patients with severe aortic stenosis. Three groups were analyzed: 1) PPMG &lt;20mmHg without DMGI &gt;10 mmHg (control); 2) PPMG &lt;20mmHg with DMGI &gt;10 mmHg (group 1); 3) PPMG ≥20 mmHg (group 2). Results From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. The control group comprised 2078 patients; the group 1, 131 patients; and the group 2, 144 patients. DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-year mortality than in control group (32.6% vs. 40.1%, p=0.27, respectively). PPMG was at least 20 mmHg in 6.1%, and was associated with higher 4-year mortality than in control group (48.7% versus 40.1%, p=0.005, respectively) (Figure 1). Two-thirds of patients with initial PPMG ≥20 mmHg had finally a MG &lt;20 mmHg at 1 year, with mortality similar to controls (39.2% vs. 40.1%, p=0.73). Conclusions Patients with PPMG &gt;20 mmHg 1 year post-TAVI had higher 4-year mortality than the general population of the registry, unlike patients with MG normalization at 1 year. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): French National Society of Cardiology

Procedural and clinical outcomes of type 0 versus type 1 bicuspid aortic valve stenosis treated with transcatheter valve replacement: insights from the BEAT international collaborative registry

Background Transcatheter aortic valve replacement (TAVR) is an established therapy for symptomatic severe aortic stenosis. Bicuspid aortic valves (BAV) were generally excluded from randomized trials due to anatomic features that may challenge TAVR (valve morphology, annulus geometry and size and severe calcifications). Nevertheless real-world registries have shown that a consistent number of BAV has been treated with TAVR. Whether BAV phenotype may affect acute or long-term outcomes following TAVR still remains unclear. Purpose Evaluate the impact of BAV phenotype on procedural and clinical outcomes after TAVR with new generation valves. Methods Patients included in the BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry were classified according to the BAV phenotype. Procedural and clinical outcomes of type 0 (2 cusps, 1 commissure, no raphe) vs type 1 (1 raphe) BAV are here reported. Primary endpoint was post-procedural device success, according to Valve Academic Research Consortium–2 (VARC-2) criteria. Secondary endpoints included procedural complications, rate of permanent pacemaker (PM) implantation and assessment of clinical outcomes at 30-day and 1-year follow-up. Results BAV 0 phenotype was present in 25 (7.1%) cases, and BAV 1 in 218 (61.8%). 3 (0.9%) patients with BAV 2 phenotype and 105 (29.8%) patients in whom BAV phenotype was undeterminable were excluded. Baseline characteristics of the two populations were well balanced. Mean STS score tended to be lower in type 0 vs type 1 BAV (3.35% ±1.8 vs 4.5% ± 3.0, p=0.062). Mean transvalvular gradient, aortic valve area (AVA), and left ventricular ejection fraction didn't differ between groups. According to CT findings moderate-severe aortic valve calcifications were less frequently present in type 0 vs type 1 (52% vs 71.1%, p=0.01). TAVR was performed under conscious sedation in most patients (89.7%), no differences were noted in terms of valve type, valve size, pre and postdilation between groups. There was no significant difference in any peri-procedural complication including pericardial tamponade, second valve implantation, valve embolization, annular rupture, aortic dissection, coronary occlusion, conversion to open surgery, and need of PM between groups however VARC-2 success tended to be lower in type 0 BAV versus type 1 (72% vs 86.7%; p=0.07). A higher rate of mean transvalvular gradient&gt;20 mmHg was observed in the type 0 vs type 1 groups (respectively 24% vs 6%, p=0.007), while no differences were reported in the rate of moderate-severe aortic regurgitation. At 30-day and 1-year follow-up we did not find differences in clinical outcomes. Conclusions Our study confirms the feasibility of TAVR in both type 0 and type 1 BAV, however despite a lower rate of moderate-severe calcifications, a trend toward a lower VARC device success and a higher rate of mean transvalvular gradient &gt;20 mmHg was observed in type 0 vs type 1 BAV. Funding Acknowledgement Type of funding source: None