SAPIEN Valve Research Articles

Clinical assessment of patient outcomes post percutaneous pulmonary valve implantation: Insights from a single tertiary centre

Background: Percutaneous pulmonary valve implantation (PPVI) has emerged as a promising treatment for congenital right ventricular outflow tract (RVOT) dysfunction and restoring conduit graft viability. Methods: This is a single-centre retrospective study of 41 patients (18 men, 23 women; mean age 26.1±10.2 years) who underwent PPVI between December 2007 and November 2014 and were evaluated for right ventricular pressures and exercise tolerance. Results: PPVI significantly reduced mean baseline RVOT gradients across different pathologies: stenosis (45 vs 18.4 mmHg), regurgitation (19.2 vs 7.6 mmHg), and mixed disease (32.5 vs 12 mmHg). Furthermore, mean right ventricular (RV) systolic pressures decreased from 61.6±2.3 to 41.9±2 mmHg (p<0.001), while RV diastolic pressures decreased by about 60% from 14.3±1.1 to 8.6±1.4 mmHg (p<0.001). Echocardiography revealed significant improvements in pulmonary and tricuspid valve velocities (p for trend<0.01). Additionally, there was a consistent reduction in the main pulmonary artery maximum pressure gradient measured pre-procedure. No significant changes were observed in PR, QRS, or QTc interval duration on follow-up electrocardiograms. Similarly, no changes were noted in cardiopulmonary exercise test performance during follow-up. Conclusion: The study highlights the effectiveness of PPVI using Medtronic Melody and Edwards SAPIEN valves in patients with various pulmonary diseases. Immediate improvements in right ventricular pressures and functional outcomes suggest that PPVI is a valuable treatment option for individuals with RVOT dysfunction. Multi-centre collaborations are crucial for further elucidating the long-term effects of PPVI on cardiac function, exercise tolerance, and quality of life in RVOT dysfunction.

Impact of SAPIEN3 Ultra RESILIA on improvement of valve performance: Insights from the multicenter registry: a propensity-score matched analysis

Abstract Backgrounds: Transcatheter aortic valve implantation (TAVI) is now a cornerstone treatment for symptomatic severe aortic stenosis across all risk profiles, including low-risk and younger patients. As such, the performance and durability of transcatheter heart valves (THVs) are paramount. SAPIEN3 Ultra RESILIA (S3 UR) is expected to improve hemodynamics compared with SAPIEN3 (S3) due to the use of RESILIA bovine pericardial tissue and modified sawing maneuvers for each of three leaflets in 20 and 23mm valves. Aim The aim of study was to evaluate the hemodynamic improvement with S3 UR compared to S3 who underwent TAVI. Methods In a multicenter TAVI registry, we identified 1,931 patients who received a balloon-expandable valve over the past three years. We focused on post-procedural effective orifice area (EOA), post-procedural indexed EOA (EOAi), incidence of prosthesis-patient mismatch (PPM), paravalvular leakage (PVL) and post-procedural mean pressure gradient (mean PG) as our primary endpoints. We preformed propensity score matching analysis using a 1:1 ratio. Parameters including aortic stenosis severity, % oversizing and post dilatation were incorporated into the matching model. Results Of patients, mean age was 84 years old and 37.9% were male. EOAi was significantly larger in S3 UR group than in the S3 group for both cohorts [overall cohort: 1.21 (1.02 – 1.36) vs. 1.08 (0.93 – 1.26), P = 0.001; propensity matched cohort: 1.21 (1.01 – 1.35) vs. 1.11 (0.91 – 1.27), p = 0.042, respectively] (Figure 1). Similarly, the degree of PVL was significantly less in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, mild PVL was identified in 6.5% vs. 14.7%, and moderate PVL was present in 0.0% vs. 1.6% (p = 0.028). Peak PG and mean PG were significantly lower in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, peak PG was 17.7 (14.3 – 24.5) vs. 23.2 (18.2 – 29.2) (p = 0.001) and mean PG was 9.0 (7.1 – 12.5) vs. 11.5 (8.9 -14.8) (p = 0.005), respectively. The incidence of PVL ≥ mild, mean PG ≥ 20 mmHg, moderate PPM and severe PPM were tend to be lower in S3 UR group than in the S3 group for both cohorts (Figure 2). Conclusion The S3 UR valve exhibits significant hemodynamic improvements compared to the S3 valve, underscoring its potential for improved clinical outcomes in TAVI patients.

Transcatheter pulmonary valve replacement after arterial switch operation.

Patients with d-transposition of the great arteries (d-TGA) who have undergone an arterial switch operation (ASO) can develop right ventricular outflow tract (RVOT) dysfunction with pulmonary regurgitation (PR) or stenosis. In these patients, treatment may include transcatheter pulmonary valve replacement (TPVR). Coronary compression is a contraindication occurring in 5% of typical TPVR cases. After ASO, there are various anatomical considerations that can confound TPVR, including potential coronary artery compression. Our goal is to understand feasibility of TPVR in patients following ASO. This was a retrospective multicenter cohort study of patients with RVOT dysfunction after ASO who underwent cardiac catheterization with intention to perform TPVR from 2008 to 2020. Across nine centers, 33 patients met inclusion criteria. TPVR was successful in 22 patients (66%), 19 receiving a Melody valve and 3 a SAPIEN valve. RVOT stenosis in isolation or with PR dictated need for TPVR in nearly all patients. One serious adverse event occurred with valve embolization. After TPVR, the RVOT peak gradient decreased from 43 to 9 mm Hg (p < 0.001); PR was trivial/none in all but one patient, in whom it was mild. Coronary compression prohibiting TPVR occurred in eight patients (24%) and two patients (6%) had severe aortic regurgitation from aortic root deformation precluding TPVR. Seven patients underwent RVOT reintervention with a median of 5.3 years post-TPVR. TPVR in patients with d-TGA after ASO is feasible, but in this cohort, coronary compression or aortic root distortion precluded TPVR in one-third of patients. The rate of RVOT reintervention after TPVR was higher in this cohort of ASO patients that in prior studies.

Current status of transcatheter intervention for complex right ventricular outflow tract abnormalities.

Various transcatheter interventions for the right ventricular outflow tract (RVOT) have been introduced and developed in recent decades. Transcatheter pulmonary valve perforation was first introduced in the 1990s. Radiofrequency wire perforation has been the approach of choice for membranous pulmonary atresia in newborns, with high success rates, although complication rates remain relatively common. Stenting of the RVOT is a novel palliative treatment that may improve hemodynamics in neonatal patients with reduced pulmonary blood flow and RVOT obstruction. Whether this option is superior to other surgical palliative strategies or early primary repair of tetralogy of Fallot remains unclear. Transcatheter pulmonary valve replacement has been one of the biggest innovations in the last two decades. With the success of the Melody and SAPIEN valves, this technique has evolved into the gold standard therapy for RVOT abnormalities with excellent procedural safety and efficacy. Challenges remain in managing the wide heterogeneity of postoperative lesions seen in RVOT, and various technical modifications, such as pre-stenting, valve ring modification, or development of self-expanding systems, have been made. Recent large studies have revealed outcomes comparable to those of surgery, with less morbidity. Further experience and multicenter studies and registries to compare the outcomes of various strategies are necessary, with the ultimate goal of a single-step, minimally invasive approach offering the best longer-term anatomical and physiological results.

Cardiac Reverse Remodeling and Changes in Heart Failure Indices After Transcatheter Tricuspid Valve Replacement in Adults With Congenital Heart Disease.

There are limited data about changes in cardiac function (cardiac reverse remodeling) and heart failure indices after transcatheter tricuspid valve-in-valve replacement (TT-VIVR). The purpose of this study was to evaluate cardiac reverse remodeling and temporal changes in heart failure indices after TT-VIVR in adults with congenital heart disease. Retrospective cohort study of adults with congenital heart disease that underwent TT-VIVR and had >6 months of follow-up (January 1, 2011, to April 30, 2023). Echocardiographic indices of cardiac remodeling and heart failure indices (New York Heart Association class, NT-proBNP (N-terminal pro-brain natriuretic peptide), glomerular filtration rate, and model for end-stage liver disease excluding international normalized ratio score) were assessed preintervention and at 1-, 3-, and 5-year postintervention. Of 39 patients (age 39 [32-46] years), 14 (36%) and 25 (64%) received Melody valve and Sapien valve prosthesis, respectively. At 1-year post-TT-VIVR, there was a temporal improvement in right atrial reservoir strain (17±8% versus 22±8%, P<0.001), right atrial volume (81 [59-108] versus 63 [48-82] mL/m2, P<0.001), right atrial pressure (12±4% versus 6±4%, P<0.001), and right ventricular global longitudinal strain (-15±7% versus -20±7%, P<0.001). Similarly, there was a temporal improvement in NT-proBNP, glomerular filtration rate, model for end-stage liver disease excluding international normalized ratio score, and New York Heart Association class. The temporal improvements in heart failure indices and valve function were maintained at 3- and 5-year post-TT-VIVR. Considering the significant mortality risk associated with reoperations for tricuspid valve replacement, these data suggest favorable outcomes after TT-VIVR, and support TT-VIVR as a viable alternative to surgical tricuspid valve replacement, especially in high-risk patients.

Abstract 17910: Is Implantation of a Larger Edwards Sapien Transcatheter Pulmonary Valve Associated With Early Valve Failure? A Different Type of Patient-Prosthesis Mismatch

Introduction: Transcatheter pulmonary valve replacement (TPVR) is an alternative option to address failing native and bioprosthetic pulmonary valves (BPV). TPVR has expanded to implantation in native right ventricular outflow tracts (nRVOT) and progressively smaller patients. We aim to define the relationship between valve-to-patient size ratio and early development of pulmonary insufficiency (PI). Methods: This single-center retrospective cohort study identified patients who underwent TPVR with a Sapien valve between 2014 and 2021. We collected demographic, anatomic, and pre- and post-TPVR echo data. Echo data were collected at four post-TPVR time points: prior to discharge, short-term (1-9 months), mid-term (9-18 months), and most recent study. The primary outcome was development of moderate or severe PI by mid-term follow-up. Valve size-to-body surface area (BSA) ratio was evaluated for correlation with the development of moderate or severe PI. Results: The cohort consisted of 187 patients; 79 (42.2%) underwent TPVR within the nRVOT (Table). Compared to patients with TPVR in a conduit or BPV, patients with a nRVOT were younger, had lower weight, and lower BSA. Moderate or severe PI post-TPVR was more common in patients in the nRVOT group (P-value &lt; 0.001), occurring in 9 (11.5%) by mid-term follow-up, compared to 2 (1.9%) in a conduit or BPV. In the subset of patients with TPVR within the nRVOT, the development of moderate or severe PI was associated with a larger valve size-BSA ratio (OR=1.13, 95% CI: 1.03, 1.26, P-value=0.012). Conclusions: Development of moderate or severe PI following TPVR with a Sapien valve was rare in this cohort. Patients receiving a Sapien TPVR within the nRVOT with a large valve size-to-BSA ratio were more likely to develop early PI. The increased risk of early valve failure in these patients should inform counseling regarding expected longevity of the valve and may guide valve choice as more transcatheter valve options become available.

Abstract 15800: Evaluating the Correlation Between Right Ventricular Outflow Tract Dimensions and Arrhythmia Risk Following Self-Expanding Transcatheter Pulmonary Valve Replacement

Introduction: The introduction of self-expanding valves has allowed for an expanded range of patients who can be treated with transcutaneous pulmonary valve replacement (TPVR). Though major complications are rare, ventricular tachycardia has been reported following self-expanding valve placement prompting investigation of potential risk factors. Hypothesis: Significant variation in valve dimensions within the right ventricular outflow tract (RVOT) throughout the cardiac cycle is postulated as a cause for increased arrhythmia risk. We hypothesized that greater dynamic variation of the valve in the RVOT correlates to higher ventricular arrythmia risk. Methods: A single center review was performed of patients who underwent TPVR with either Harmony TPV or Alterra Pre-stent with subsequent placement of 29mm Sapien valve between 2019 and 2023. Using post-procedural 3D rotational angiography, minimum (systole) and maximum (diastole) diameters (mm), perimeter (mm) and cross-sectional area (mm 2 ) of the valve frame were measured in two locations: closest to the branch pulmonary artery bifurcation and the RV cavity. Results: Twenty-eight patients were included (14 Harmony TPV, 14 Alterra). Higher frequency of ventricular arrythmia was seen in patients with congenital pulmonary stenosis ( p =0.004). Higher ventricular arrythmia rate was associated with larger diastolic diameter (34.1 vs 33.2mm, p =0.04), mean perimeter (118.3 vs 108.6mm, p =0.03) and area (1124.5 vs 926.2mm 2 , p =0.03) of the valve frame closest to the RV cavity. Conclusions: Increased movement of the valve frame close to the RV cavity may correlate with a higher ventricular arrythmia risk due to increased contact with the native RVOT throughout the cardiac cycle. Future studies should focus on more accurate, mathematical methodology to better understand whether the complex interaction between self-expanding valves and the native RVOT is a determinant for post-procedural ventricular arrythmia.

Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study.

Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging. A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5. With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 (P<0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 (P<0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P<0.001), and the highest at Evolut node 5 (61% versus 32%; P<0.001). Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

Feasibility of Redo-Transcatheter Aortic Valve Replacement in Sapien Valves Based on In Vivo Computed Tomography Assessment.

Our aim was to assess the feasibility of repeat transcatheter aortic valve (TAV) replacement for degenerated Sapien3 (S3) prostheses by simulating subsequent implantation of S3 or Evolut, using in vivo computed tomography-based sizing and the impact on coronary and patient-prosthesis mismatch risks. Computed tomography scans from 356 patients with prior S3 TAV replacement implantation were analyzed. The in vivo sizing for second TAV based on averaged area of 3 levels of outflow, mid (narrowest) and inflow, was compared with in vitro recommendations, that is, same size as index S3 for second S3 and 1 size larger for Evolut. Risks of coronary obstruction and patient-prosthesis mismatch were determined by valve-to-aorta distance and estimated effective orifice area, respectively. Overall, the majority of patients (n=328; 92.1%) had underexpanded index S3 with an expansion area of 94% (91%-97%), leading to significant differences in size selection of the second TAV between in vivo and in vitro sizing strategies. Expansion area <89% served as a threshold, resulting in 1 size smaller than the in vitro recommendations were selected in 45 patients (13%) for S3-in-S3 and 13 (4%) for Evolut-in-S3, while the remaining patients followed in vitro recommendations (P<0.01, in vivo versus in vitro sizing). Overall, 57% of total patients for S3-in-S3 simulation and 60% for Evolut-in-S3 were considered low risk for coronary complications. Deep index S3 implantation (odds ratio, 0.76 [interquartile range, 0.67-0.87]; P<0.001) and selecting Evolut as the second TAV (11% risk reduction in intermediate- or high-risk patients) reduced coronary risk. Estimated moderate or severe patient-prosthesis mismatch risk was 21% for S3-in-S3 and 1% for Evolut-in-S3, assuming optimal expansion of the second TAV. Redo-TAV replacement with S3-in-S3 and Evolut-in-S3 could be feasible with low risk to coronaries in ≈60% of patients, while the remaining 40% will be at intermediate or high risk. The feasibility of redo-TAV replacement is influenced by sizing strategy, type of second TAV, native annular anatomy, and implant depth.

Infective Endocarditis Risk with Melody versus Sapien Valves Following Transcatheter Pulmonary Valve Implantation: A Systematic Review and Meta-Analysis of Prospective Cohort Studies.

Transcatheter pulmonary valve implantation (TPVI) is an effective non-surgical treatment method for patients with right ventricle outflow tract dysfunction. The Medtronic Melody and the Edwards Sapien are the two valves approved for use in TPVI. Since TPVI patients are typically younger, even a modest annual incidence of infective endocarditis (IE) is significant. Several previous studies have shown a growing risk of IE after TPVI. There is uncertainty regarding the overall incidence of IE and differences in the risk of IE between the valves. A systematic search was conducted in the MEDLINE, EMBASE, PubMed, and Cochrane databases from inception to 1 January 2023 using the search terms 'pulmonary valve implantation', 'TPVI', or 'PPVI'. The primary outcome was the pooled incidence of IE following TPVI in Melody and Sapien valves and the difference in incidence between Sapien and Melody valves. Fixed effect and random effect models were used depending on the valve. Meta-regression with random effects was conducted to test the difference in the incidence of IE between the two valves. A total of 22 studies (including 10 Melody valve studies, 8 Sapien valve studies, and 4 studies that included both valves (572 patients that used the Sapien valve and 1395 patients that used the Melody valve)) were used for the final analysis. Zero IE incidence following TPVI was reported by eight studies (66.7%) that utilized Sapien valves compared to two studies (14.3%) that utilized Melody valves. The pooled incidence of IE following TPVI with Sapien valves was 2.1% (95% CI: 0.9% to 5.13%) compared to 8.5% (95% CI: 4.8% to 15.2%) following TPVI with Melody valves. Results of meta-regression indicated that the Sapien valve had a 79.6% (95% CI: 24.2% to 94.4%, p = 0.019; R2 = 34.4) lower risk of IE incidence compared to the Melody valve. The risk of IE following TPVI differs significantly. A prudent valve choice in favor of Sapien valves to lower the risk of post-TPVI endocarditis may be beneficial.

Extrapolation of CT aortic annulus derived diameter/CT aortic annulus area from 2D echocardiography aortic annulus diameter in TAVR: not a reliable tool

Abstract Funding Acknowledgements Type of funding sources: None. Background Computed tomography (CT) aortic annulus area, CT area derived diameter and two-dimensional echocardiography (2D ECHO) diameters are used for valvular sizing in transcutaneous aortic valve replacement (TAVR). According to our previous study, 2D ECHO annulus diameter was smaller in comparison to CT derived diameter (22.6±2.9 vs 25.0±5.5mm, p = 0.013), but both CT aortic annulus area derived diameter/CT aortic annulus and 2D ECHO diameter predicted correct valve size selection with the same accuracy of 79–80%. However, CT requires radiation and iodine contrast administration, which might be the limitation in patients with chronic kidney disease or history of iodine allergy. Purpose To determine if 2D ECHO diameter can be used for reliable estimation of CT area derived diameter/CT aortic annulus area. Methods 139 consecutive patients with favourable outcome of Sapien XT/Sapien S3 TAVR (no more than mild aortic regurgitation, only one valve implanted) were included in the study. 2D ECHO diameter was measured from mid oesophageal three-chamber view (110–135°) just below the anatomical aortic valve annulus. CT aortic annulus was obtained as double oblique plane by manual multiplanar reconstruction of CT dataset, defined by three lowest attachment points of valvular leaflets. Aortic annulus area was measured by manual tracking of lumen contours, area derived diameter as 2*√(area/π). Linear regression analysis between pre-implant CT area derived diameter and 2D ECHO diameter was performed; extrapolated CT annulus area diameter and CT aortic annulus area [π*(d/2)2] were calculated from 2D ECHO diameter. Concordance of valve size selection based on extrapolated CT area derived diameter vs original CT area derived diameter and extrapolated CT aortic annulus area vs original CT aortic annulus area was determined on patients where CT aortic annulus area/annulus derived diameter were falling outside the overlap of the manufacturer recommended ranges for neighbouring valve sizes. Results Significant relationship between CT aera derived diameter and 2D ECHO diameter was found (r=0.720, p&amp;lt;0.001, Fig 1,2). Extrapolated CT area derived diameter would have led to inappropriate size selection in 33/100 more cases (undersizing in 16%, oversizing in 17%), similar to extrapolated aortic annulus area, where both undersizing and oversizing was observed in 18/106 (17%) more cases in comparison to original CT based parameters. Conclusion Extrapolation of CT aortic annulus area/area derived diameter from 2D ECHO diameter is not a reliable tool in valvular sizing for balloon expandable Sapien valve. In patients with chronic kidney disease or history of iodine allergy, three-dimensional (3D) ECHO aortic annulus assessment remains the only viable alternative tool.

P13 THE PHANTOM OF TRICUSPID PROSTHESIS: CASE REPORT OF A PECULIAR TRANSCATHETER TRICUSPID VALVE–IN–VALVE IMPLANTATION

Abstract Background Transcatheter tricuspid valve–in–valve replacement for patients with degenerative tricuspid surgical bioprosthesis disease has emerged in recent years as a new treatment possibility in patients that required tricuspid valve replacement at young age and in circumstances where redo tricuspid valve replacement is not feasible because of the remarkable morbidity and mortality. Case presentation. A 76 year–old Caucasian male was referred to our center for worsening dyspnoea and fatigue. He had a pacemaker implanted for third degree atrio–ventricular block in 1996. After massive endocarditis affecting the tricuspid valve and the pacemaker right ventricular lead, the patient underwent surgical tricuspid valve replacement with a 32 mm Liotta BioImplant L.P.B., right ventricular lead extraction and concomitant epicardial pacemaker reimplantation. Transthoracic echocardiogram at hospital admission denoted a degenerative stenosis of the tricuspid prosthesis with a trans–valvular mean gradient of 8 mmHg associated with right atrial and inferior vena cava dilatation. Given the high surgical risk due to comorbidities (systemic arterial hypertension, paroxysmal atrial fibrillation in DOAC, grade II obesity, smoking history and chronic lymphoproliferative leukemia) the patient was deemed not suitable for a re–do surgical tricuspid valve replacement and was offered a percutaneous replacement. Preprocedural planning with computed tomography allowed accurate reconstruction of the tricuspidal prosthetic annulus and correct sizing of Edwards SAPIEN valve, the most used in valve–in–valve procedures. The degenerated prosthesis was not visible at fluoroscopy meaning no fluoroscopic landmarks available to provide an anatomic view for valve deployment. Therefore, a combination of balloon valvuloplasty and right atrium angiographies before the valve–in–valve deployment were critical to provide the correct valve position and yield the procedure effective and safe. Hemodynamic gradient post–TVIV was absent and no paravalvular leaks were observed. Clinical and echocardiographic improvement were confirmed after the procedure and at 1 year–follow up. Conclusion Tricuspid valve–in–valve replacement can be technically feasible and a safer alternative to re–do surgical valve replacement, also in radiolucent bioprosthesis. In our case the successful procedural outcome not only relied on meticulous planning before the procedure, but also on specific intra–procedural adjustments.

Pacing-Related Differences After SAPIEN-3 TAVI: Clinical and Echocardiographic Correlates

Data regarding the impact of pacing on outcomes after transcatheter aortic valve implantation (TAVI) is evolving especially with regards to pre-existing permanent pacemaker (PPM). We examined the impact of new and previous PPM on the clinical and hemodynamic outcomes after SAPIEN-3 TAVI. We included all consecutive patients who underwent transfemoral TAVI using SAPIEN-3 valve from 2015 to 2018 at our institution. Among 1,028 patients, 10.2% required a new PPM within 30days, whereas 14% had a pre-existing PPM. The presence of either previous or new PPM had no impact on the 3-year mortality (log-rank p=0.6) or 1-year major adverse cardiac and cerebrovascular events (log-rank p=0.65). New PPM was associated with lower left ventricular (LV) ejection fraction (LVEF) at both 30days (54.4 ± 11.3% vs 58.4 ± 10.1%, p=0.001) and 1year (54.2 ± 12% vs 59.1 ± 9.9%, p=0.009) than no PPM. Similarly, previous PPM was associated with worse LVEF at 30days (53.6 ± 12.3%, p <0.001) and 1year (55.5 ± 12.1%, p=0.006) than no PPM. Interestingly, new PPM was associated with lower 1-year mean gradient (11.4 ± 3.8 vs 12.6 ± 5.6mm Hg, p=0.04) and peak gradient (21.3 ± 6.5 vs 24.1 ± 10.4mm Hg, p=0.01), despite no baseline differences. Previous PPM was also associated with lower 1-year mean gradient (10.3 ± 4.4mm Hg, p=0.001) and peak gradient (19.4 ± 8mm Hg, p <0.001) and higher Doppler velocity index (0.51 ± 0.12 vs 0.47 ± 0.13, p=0.039). Moreover, 1-year LV end-systolic volume index was higher with new (23.2 ± 16.1 vs 20 ± 10.8ml/m2, p=0.038) and previous PPM (24.5 ± 19.7, p=0.038) than no PPM. Previous PPM was associated with higher moderate-to-severe tricuspid regurgitation (35.3% vs 17.7%, p <0.001). There were no differences regarding the rest of the studied echocardiographic outcomes at 1year. In conclusion, new and previous PPM did not affect 3-year mortality or 1-year major adverse cardiac and cerebrovascular events; however, they were associated with worse LVEF, higher 1-year LV end-systolic volume index, and lower mean and peak gradients on follow-up than no PPM.

Simultaneous Stenting With Edwards SAPIEN Transcatheter Pulmonary Valve Replacement.

Prestenting of the landing zone for transcatheter pulmonary valve replacement (TPVR) with a balloon-expandable valve can dilate a stenotic right ventricular outflow tract (RVOT), prevent paravalvar leak (PVL), and protect against conduit tear. Simultaneous stenting (SS) with the Melody valve has been described, but to our knowledge, SS with a SAPIEN valve has not been reported. We report our experience with this novel technique. A retrospective chart review of patients who underwent TPVR at Rady Children's hospital and UCSD Medical Center was performed. Patients were included if they had underwent SAPIEN TPVR with SS. Rationale for stent choice was a bare metal stent to relieve long-segment stenosis and covered stents to prevent PVL or to protect against conduit tear. A total of 17 cases were identified. The majority of RVOTs were transannular patches (n = 9, 56%), with a minimum diameter of 19.6 ± 5.2 mm, and the most common valve placed was an Edwards SAPIEN 26.0 mm (n = 10, 59%). All SAPIEN valves placed were of the S3 generation. The procedure was successful in all patients, with no conduit tears. Minor complications occurred in 3 patients (17.6%). Simultaneous stent deployment with a SAPIEN TPVR is an alternative 1-step technique for patients who require prestenting. SS simplifies the procedure, has low complication rates, and offers the benefits of a longer landing zone and decreased PVL.

Ethnic Disparities and Outcomes of Edwards Sapien Transcatheter Aortic Valve Implantation in Kuwait

Introduction: Clinical outcomes after transcatheter aortic valve implantation (TAVI) have not been reported in the Gulf region. This study aims to identify baseline characteristics of patients undergoing TAVI, based on nationality, and analyze their overall outcomes at a single center in Kuwait. Methods: A retrospective study of 61 patients with severe aortic stenosis undergoing TAVI between 2018 and 2021 in Sabah Al Ahmad Cardiac Centre in Kuwait. Clinical and baseline demographics data along with preprocedural computed tomography (CT) and echocardiography were reviewed. Postprocedural outcomes, including conduction disturbances and inhospital mortality rates, were analyzed. Patients were analyzed according to Kuwaiti and non-Kuwaiti citizens' status. Results: The mean age of Kuwaiti patients was 72.2 ± 9.2, whereas the mean age of non-Kuwaiti citizens was 78.8 ± 5.5. No significant differences were observed between Kuwaiti and non-Kuwaiti in electrocardiogram (ECG) and CT parameters (P &gt; 0.05). A statistically significant difference among Kuwaiti and non-Kuwaiti patients was observed only laboratory parameters, white blood cell (WBC) count, international normalized ratio (INR), and C-reactive protein (CRP). The mean value of WBC count (WBC), INR, and CRP was higher among non-Kuwaiti patients when compared to Kuwaiti patients (P &lt; 0.05). Inhospital mortality was low 1/61 (1.6%). Conclusion: Cumulative inhospital mortality in TAVI was 1.6%. TAVI experience in Kuwait with Edwards SAPIEN valve is comparable to international cohorts. No significant differences in procedural outcomes, including conduction disturbance and mortality, were observed between the two subgroups.

SAPIEN valve infective endocarditis after transcatheter pulmonary valve replacement: A multicenter international observational cohort

SAPIEN valve infective endocarditis after transcatheter pulmonary valve replacement: A multicenter international observational cohort

254 DIFFERENT DEGREES OF DEGENERATION OF TRANSCATHETER VALVES IMPLANTED IN THE AORTIC POSITION OR EMBOLIZED DISTALLY: A CASE REPORT

Abstract While transcatheter aortic valve replacement (TAVR) gradually emerges as first line therapy for aortic disease in most surgical risk groups, structural prosthetic degeneration remains an issue that may must be considered when planning procedures in younger patients. We present the case of a 74 years old female who underwent a valve-in-valve TAVR following degeneration of a previously implanted TAVR which had initially been complicated by distal embolization of two prosthetic valves. The patient initially underwent TAVR in 2010 for severe aortic regurgitation and a porcelain aorta. The procedure was complicated by distal embolization of two prosthetic valves; firstly a 26 mm Sapien valve migrated to the pre-renal abdominal aorta. This was followed by the embolization of a 29 mm CoreValve to the descending thoracic aorta. Finally, on the third attempt, a 29 mm CoreValve was successfully implanted without complication. The patient remained clinically stable until February 2022 when she developed progressively worsening effort angina and dyspnea. Echocardiographic evaluation demonstrated prosthetic aortic valve degeneration with cusp fibrosis and calcification, with severe aortic regurgitation. Interestingly, neither of the embolized prosthetic valves showed signs of deterioration on CT imaging. The valve that had migrated to the abdominal aorta did not show any significant increase in gradient or regurgitation on Doppler evaluation. After careful evaluation and Heart Team discussion, a transfemoral valve-in-valve (ViV) procedure was performed uneventfully with a 23 mm Sapien Ultra implant, that resulted in complete abolition of regurgitation with mild prosthesis-patient mismatch (mean gradient 15 mmHg, EOA 0.8 cm2/m2). Post-procedural CT imaging confirmed a satisfactory result with no signs of dislocation of the previous valve prostheses (Figure 3). The patient was safely discharged on day 4 post-op on oral anticoagulation (due to a history of atrial fibrillation), and was asymptomatic at 30-day follow-up. This case report describes a challenging but successful ViV TAVR implantation.

Conduction disorders after transcatheter aortic valve implantation: A comparison between SAPIEN 3 and SAPIEN 3 Ultra balloon-expandable valves.

Conduction disorders (CD) are the most common complications after Transcatheter Aortic Valve Implantation (TAVI). The last generation of Edwards balloon expandable valves, the SAPIEN 3 Ultra (S3U), is provided with an external sealing skirt that aims to further reduce paravalvular leakage (PVL) compared to SAPIEN 3 (S3) and could potentially lead to higher CD rate. We sought to investigate the rate of new-onset CD in patients undergoing TAVI with the S3 or S3U valve. We included 582 consecutive patients undergoing TAVI in a single high-volume Center. Patients with previously implanted pacemaker and Valve in valve procedures were excluded. CD rate was evaluated early after implantation and at discharge. No significant difference in the overall CD rate was found between S3 and S3U patients both immediately after the procedure (S3 45.5% vs. S3U 41.8%, p = 0.575) and at discharge (S3 30.4% vs. S3U 35.6%, p = 0.348) with low rate of permanent pacemaker implantation (S3 6.3% vs. S3U 5.5%, p = 0.749). No significant differences were found also in patients with pre-existing atrial fibrillation (S3 8.2% vs. S3U 5%, p = 0.648). A significantly lower rate of PVL was found with S3U compared to S3 (S3 42% vs. S3U 26%, p = 0.007). According to the manufacturer's guidelines we confirmed that S3U were implanted in a significantly higher position compared to S3 (S3 4.89 ± 1.57 mm vs. S3U 4.47 ± 1.36 mm, p = 0.001). No significant difference in the rate of CD, including the need for PPM implantation, was found in patients undergoing TAVI with the S3 compared to S3U. Moreover, S3U significantly reduced the PVL rate.

Long-term outcomes of transcatheter pulmonary valve implantation with melody and SAPIEN valves

BackgroundTranscatheter pulmonary valve implantation (TPVI) is effective for treating right ventricle outflow tract (RVOT) dysfunction. Factors associated with long-term valve durability remain to be investigated. MethodsConsecutive patients successfully treated by TPVI with Melody valves (n = 32) and SAPIEN valves (n = 182) between 2008 and 2020 at a single tertiary centre were included prospectively and monitored. ResultsThe 214 patients had a median age of 28 years (range, 10–81). The RVOT was a patched native pulmonary artery in 96 (44.8%) patients. Median follow-up was 2.8 years (range, 3 months–11.4 years). Secondary pulmonary valve replacement (sPVR) was performed in 23 cases (10.7%), due to stenosis (n = 22, 95.7%) or severe regurgitation (n = 1, 4.3%), yielding an incidence of 7.6/100 patient-years with melody valves and 1.3/100 patient-years with SAPIEN valves (P = 0.06). The 5- and 10-year sPVR-freedom rates were 78.1% and 50.4% with Melody vs. 94.3% and 82.2% with SAPIEN, respectively (P = 0.06). The incidence of infective endocarditis (IE) was 5.5/100 patient-years with Melody and 0.2/100 patient-years with SAPIEN (P < 0.0001). Factors associated with sPVR by univariate analysis were RV obstruction before TPVI (P = 0.04), transpulmonary maximal velocity > 2.7 m/s after TPVI (p = 0.0005), valve diameter ≤ 22 mm (P < 0.003), IE (P < 0.0001), and age < 25 years at TPVI (P = 0.04). By multivariate analysis adjusted for IE occurrence, transpulmonary maximal velocity remained associated with sPVR. ConclusionsTPVI is effective for treating RVOT dysfunction. Incidence of sPVR is higher in patients with residual RV obstruction or IE. IE add a substantial risk of TPVI graft failure and is mainly linked to the Melody valve. Social media abstractTranscatheter pulmonary valve implantation is effective for treating right ventricular outflow tract dysfunction in patients with congenital heart diseases. Incidence of secondary valve replacement is higher in patients with residual obstruction or infective endocarditis.

Comparison of outcomes of trans-subclavian versus trans-apical approaches in transcatheter aortic valve implantation

BackgroundMany patients are unsuitable for conventional femoral transcatheter aortic valve implantation (TAVI) but there is limited evidence as to which alternative approach has the best outcomes. We compared clinical outcomes in patients undergoing trans-subclavian (TS) or trans-apical (TA) TAVI.MethodsThis was a national retrospective observational study of patients undergoing surgical TAVI in Scotland between January 2013 and March 2020. The pre-operative patient characteristics, intraoperative details and post-operative outcomes were compared between TS and TA cohorts using data from the National Institute of Cardiovascular Outcomes Research (NICOR) registry.ResultsAmong 1055 patients who underwent TAVI, TS or TA access was used in 50 (4.7%) and 90 (8.5%) patients respectively. Self-expanding Medtronic Evolut R valves were used in 84% of TS procedures, while balloon-expandable Edwards SAPIEN valves were used in all TA procedures. The TS group had a lower mean logistic EuroSCORE than the TA group (27.31 ± 19.44% vs 34.92 ± 19.61% p = 0.029). The TS approach was associated with a higher incidence of moderate postprocedural aortic regurgitation (12.5% vs 2.4%, p = 0.025). There was no significant difference in 30-day, 1-year or overall all-cause mortality.ConclusionsBoth trans-subclavian and trans-apical access are viable approaches for patients requiring non-transfemoral TAVI. Differences in peri-procedural indices reflect the disparate patient populations and factors governing prosthesis choice, and short- and long-term mortality was similar.