Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis

Objective: To highlight the main target points covered by clinical studies on the Perceval sutureless valve for surgical aortic valve replacement (SAVR) and raise a point of discussion for further expansion of its use when compared with stented bioprostheses (SB) and transcatheter aortic valve replacement (TAVR).Methods: We reviewed clinical trials and retrospective studies published up to date and compared the outcomes in terms of mortality, myocardial infarction (MI) stroke, paravalvular leak (PVL), permanent pacemaker implantation (PPI), bleeding and long-term outcomes.Results: Clinical studies showed that 30-day mortality ranged from 0–4% for Perceval and 2.9–7% for TAVR. The incidence of PVL (Perceval 1.9–19.4 vs. TAVR 9–53.5%), PPI (Perceval 2–11.2 vs. TAVR 4.9–25.5%), stroke (Perceval 0 vs. TAVR 0–2.8%), MI (Perceval 0 vs. TAVR 0–3.5%), were all higher in the TAVR group. Compared to other SB, mortality ranged from 0–6.4% for Perceval and 0–5.9% for SB. The incidence of PVR (Perceval 1–19.4 vs. SB 0–1%), PPI (Perceval 2–10.7 vs. SB 1.8–8.5%), stroke (Perceval 0–3.7 vs. SB 1.8–7.3%) and MI (Perceval 0–7.8 vs. SB 0–4.3%) were comparable among the groups. In patients with a bicuspid aortic valve, mortality rate was (0–4%) and PVL incidence was (0–2.3%). However, there was a high incidence of PPI (0–20%), and stroke (0–8%). Long-term survival ranged between 96.7–98.6%.Conclusions: The Perceval bioprosthesis has proved to be a reliable prosthesis for surgical aortic valve replacement due to its implantation speed, the reduced cardiopulmonary bypass time, the reduced aortic cross-clamp time and the shorter intensive care unit and hospital length of stay.

Is Porcine Small Intestinal Submucosal Extracellular Matrix (ECM) a Suitable Material for Right Ventricular Outflow Tract Reconstruction in Association With Pulmonary Valve Replacement?

Pulmonary valve replacement (PVR) with right ventricular outflow tract (RVOT) reconstruction is a common congenital cardiac operation. Porcine submucosal intestinal-derived extracellular matrix (ECM) patches have been used for RVOT reconstruction. We present 2 adult patients with Tetralogy of Fallot who underwent PVR with RVOT reconstruction utilizing ECM. Both cases required reoperation due to patch dehiscence causing a large paravalvular leak. One patient also had a pseudoaneurysm associated with ECM dehiscence. There may be a propensity for ECM dehiscence in this application and, based on these cases, we recommend avoidance of ECM in RVOT reconstruction with PVR. PVR patients repaired with ECM should be monitored for this complication.

Challenging Cases of Aortic Prosthesis Dysfunction, the Importance of Multimodality Imaging, a Case Series

ECG-gated multidetector computed tomography (MDCT) is a promising complementary technique for evaluation of cardiac native and prosthetic structures. MDCT is able to provide a broader coverage with faster scan acquisition times that yield higher spatial and temporal resolution for cardiac structures whose quality may be affected by artifacts on ultrasound. We report a case series about the most challenging complications occurring after prosthetic aortic valve implantation in four patients: pannus, paravalvular leak, prosthesis’ misfolding and subaortic membrane reformation. In all the cases, enhanced MDCT using a retrospective protocol provided accurate 3D morphoanatomic information about cardiac and extracardiac structures, improving and speeding up the correct diagnosis and treatment planning. Integrated imaging, in particular with MDCT, is now the present, and it will increasingly be the future in the assessment of cardiac structural pathology.

467 Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method

Aims Transcatheter Aortic Valve Replacement (TAVR) in patients with bicuspid aortic valve (BAV) still represents a challenge due to the peculiar anatomy and the lack of consensus for the optimal CT scan sizing method for prosthesis selection. Recent evidences have shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, known as the LIRA (Level of Implantation at the RAphe) plane. Furthermore, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level (LIRA-method) was shown to be safe and effective in 20 consecutive BAV patients with severe aortic stenosis. The purpose of this study was to confirm the safety and the efficacy of the LIRA method in a larger study population. Methods and results the LIRA plane method was applied to all consecutive patients with raphe-type BAV disease between November 2018 to September 2021 in our centre. We prospectively sized TAVI prosthesis according to the manufacture recommendations on the basis of baseline CT scan perimeters at the LIRA plane. Post-procedural device success, defined according to Valve Academic Research Consortium-2 (VARC-2) criteria, was evaluated in the overall cohort. Forty-four patients were identified as having a raphe-type BAV disease at pre-TAVI CT scans. Mean patient age was 80 ± 6.2 years and 74% were males; median Society of Thoracic Surgeons (STS) predicted risk of mortality score was 4.3 (3.0–6.5). Three different BAV anatomies (36 patients with BAV type 1 with calcific raphe, 5 patients with BAV type 1 with fibrotic raphe, and 3 patients with BAV type 2) were implanted with different types of TAVI prostheses (6 Acurate Neo 2,16 Acurate Neo, 21 Core Valve Evolut R/Pro , 1 Lotus) sized prospectively according to the LIRA plane method. In all patients, there was a significant discrepancy between LIRA and virtual basal ring (VBR) measurements with LIRA plane perimeter smaller than VBR perimeter (mean perimeter LIRA 73.1 ± 8.3 mm vs. mean perimeter VBR 81.5 ± 6.6 mm; P < 0.001). The prostheses were sized according to the manufacture recommendations on the basis of the LIRA plane perimeter (diameter prosthesis implanted/diameter prosthesis according to LIRA plane = 1) (DPI/DP LIRA = 1) and significantly downsized according to the VBR perimeter (DPI/DP VBR 0.89; P < 0.001). The median prosthesis size was 25 mm (23–27). Pre-dilatation was frequently performed (86%) with a median balloon size of 20 mm (18–22), whereas post-dilatation was applied in 27% of the cases with a median balloon size of 23 mm (20–26). The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, residual trivial/mild paravalvular leak with no cases of moderate-severe regurgitation and low transprosthetic gradient (residual mean gradient of 8.3 ± 3.5 mmHg) with no cases of mean gradient >20 mmHg pre-discharge. The rate of new pacemaker implantation was 9%. Conclusions Supra-annular sizing according to the LIRA plane method confirmed to be safe with a high device success in a larger study population. The application of the LIRA plane method might optimize TAVI prosthesis sizing in patients with raphe-type BAV disease.

746 Assessment of intracardiac fluid-dynamics of patients with aortic stenosis

Aims Recent technological developments enabled visualization of intracardiac flow patterns. This study aims to evaluate intracardiac flow dynamics of patients with aortic stenosis (AS). Methods and results Sixty-one patients with severe AS and 38 healthy sex- and BSA-matched controls (CTRL) were prospectively included. Standard echocardiographic assessment was performed in all patients. Fluid dynamics were evaluated using the HyperDoppler software to measure vortex area (VA), vortex length (VL), and vortex depth (VD). The assessment of VA, VL, and VD was feasible and reliable, as the inter-rater variability (ICCs) were very good for VA (0.878, P = 0.033), VL (0.960, P = 0.004), and VD (0.905, P = 0.021). Mean VA, VL, and VD (P = 0.033, P = 0.026, and P > 0.001, respectively) were significantly larger in AS patients compared with CTRL. A significant difference in the delta values of VA and VL, reflecting their change from before to after TAVI, was observed in patients with and without significant paravalvular leak. Conclusions The newly developed quantitative indices of flow dynamics, namely VA, VL, and VD, were significantly increased in the LV of patients with severe AS compared to controls and their measurement was feasible and reliable in a clinical setting.

464 Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry

Aims In patients with severe aortic stenosis, trans-prosthetic haemodynamics after transcatheter aortic valve implantation (TAVI) tend to be more favourable than after surgical aortic valve replacement, especially after self-expandable valve (SEV) implantation. The relative performance of TAVI according to leaflet position, that is supra-annular and intra-annular valves (SAV and IAV, respectively), has not been investigated thoroughly. Moreover, prosthesis-patient mismatch (PPM) is more common in patients with small aortic annuli, even though its clinical impact after TAVI is debated. Compare haemodynamics and clinical outcomes of transcatheter SAV and IAV in patients with small annuli. Methods TAVI SMALL 2 is an international retrospective registry of 1378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transfemoral transcatheter SEV (Evolut R/Pro, n = 750, Acurate Neo, n = 170 and Portico n = 172) and balloon-expandable valves (BEV, Sapien 3, n = 286) in 16 high-volume centres. Analyses were performed according to mechanism of valve release, that is SEV (n = 1092) vs. BEV (n = 286), and according to leaflet position, that is SAV (Evolut R/Pro and Acurate Neo, n = 920) vs. IAV (Sapien 3 and Portico, n = 458). Primary endpoints were pre-discharge mean aortic gradient and incidence of severe PPM. Secondary endpoint was incidence of all-cause mortality. Results Pre-discharge mean aortic gradient was lower both after SAV vs. IAV (7.8 ± 3.9 vs. 12.0 ± 5.1, P <0.001) and SEV vs. BEV implantation (8.0 ± 4.1 vs. 13.6 ± 4.7, P<0.001). IAV implantation was more often complicated by severe PPM when compared to SAV implantation (8.8% vs. 3.6%, P = 0.007), and severe PPM was more common after BEV than after SEV implantation (8.7% vs. 4.6%, P = 0.041). At a median follow-up of 377 days (interquartile range 168–700 days), all-cause mortality occurred in 11.9% of patients after IAV and 9.4% after SAV implantation (P = 0.172), and in 12.3% and 9.8% of BEV and SEV groups, respectively (P = 0.218). Results were confirmed at Kaplan-Meier analysis (log-rank P = 0.748 and 0.687 for SAV vs. IAV and SEV vs. BEV, respectively, Figure 1). Pre-discharge more than mild paravalvular leak (PVL) was more common with SEV than BEV (11.6% vs. 2.6%, P <0.001), while incidence of more than moderate PVL was higher both after SAV vs. IAV (1.5% vs. 0.2%, P = 0.043) and SEV vs. BEV implantation (1.4% vs. 0%, P = 0.052). New permanent pacemaker implantation was higher after SEV than BEV (13.5% vs. 8.1%, P = 0.013). Conclusions In this high-numerosity registry of patients with small aortic annuli, TAVI with SAV and SEV yielded a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. All-cause mortality did not differ between groups.