Predictors and 5-Year Clinical Outcomes of Pacemaker After TAVR: Analysis From the PARTNER 2 SAPIEN 3 Registries.

BACKGROUND: Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV). OBJECTIVES: The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV. METHODS: The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR. RESULTS: Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02). CONCLUSIONS: PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth.

Sex differences in the outcomes after transcatheter aortic valve replacement with newer generation devices: A meta-analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a reasonable therapeutic approach among patients with symptomatic severe aortic stenosis irrespective of surgical risk. Data regarding sex-specific differences in the outcomes with newer generation valves are limited. METHODS: Electronic databases were searched for studies assessing sex differences in the outcomes of patients undergoing TAVR with newer generation valves (SAPIEN 3 or Evolut). Random effects model was constructed for summary estimates. RESULTS: Four observational studies with 4522 patients (44.8% women) were included in the meta-analysis. Women were older and had a lower prevalence of coronary artery disease and mean EuroScore. Women had a higher incidence of short-term mortality (up to 30 days) (risk ratio [RR]: 1.60, 95% confidence interval [CI]: 1.14-2.25), but no difference in 1-year mortality (RR: 0.92, 95% CI: 0.72-1.17). There was no significant difference in the incidence of major bleeding (RR: 1.16, 95% CI: 0.86-1.57), permanent pacemaker (PPM) (RR: 0.80, 95% CI: 0.62-1.04), or disabling stroke (RR: 1.16, 95% CI: 0.54-2.45). CONCLUSION: In this meta-analysis, we found that women undergoing TAVR with newer-generation devices were older but had a lower prevalence of comorbidities. Women had a higher incidence of short-term mortality but no difference in the 1-year mortality, bleeding, PPM, or stroke compared with men. Future studies are required to confirm these findings.

Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

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

BACKGROUND: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: This study aimed to determine whether device position and asymmetry are associated with these outcomes. METHODS: Patients 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. RESULTS: A 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). CONCLUSIONS: Valve 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.

Comparison of Paravalvular Leak in SAPIEN 3 and EVOLUT PRO Valves in Transcatheter Aortic Valve Replacement: A Multicenter Registry.

Paravalvular leak (PVL), conduction disturbances, and vascular complications remain the most common complications after TAVR. To address these adverse outcomes, the third generation of transcatheter heart valves has been developed. The last generation prosthesis provides an outer pericardial wrap for enhanced sealing and PVL prevention. This study aimed to compare the incidence and severity of PVL and 1-year survival after TAVR using SAPIEN 3 with those using EVOLUT PRO. An observational retrospective analysis was conducted in 1,481 patients who underwent TAVR for symptomatic severe aortic stenosis in 6 different European centers. The primary end point was to assess the frequency and severity of PVL at 30 days after TAVR. The secondary end point was to compare 1-year survival using EVOLUT PRO with that using SAPIEN 3. SAPIEN 3 transcatheter heart valve was implanted in 78.3% of study participants (n = 1,160) whereas EVOLUT PRO was implanted in 21.7% (n = 321). PVL is more commonly observed in patients treated with EVOLUT PRO at prehospital discharge (55.1% vs 37.3%) and at 1-month (51% vs 41.4%) and 1-year (51.3% vs 39.3%) follow-up. This difference mainly concerns low-grade (mild/trace) PVL. The frequency of high-degree (moderate/severe) PVL was almost similar in both groups throughout the study period (5.3% vs 5.8% before hospital discharge, 4% vs 3.1% at 1 month, and 3.2% vs 4.9% at 1 year). No significant difference in survival over 1 year has been observed (hazard ratio 0.73 [0.33 to 1.63], p = 0.442) (Graphical abstract). In conclusion, the detection rate of PVL after TAVR with third-generation heart valves remains high, and there are no major differences between the devices regarding the frequency of significant (moderate/severe) PVL and survival.

The first clinical data of the SAPIEN 3 aortic valve in the treatment of aortic stenosis in China.

Background: Data on outcomes following transcatheter aortic valve replacement with SAPIEN 3 in China is limited as it was approved by the National Medical Products since 2020. The present study was designed to collect clinical data on the SAPIEN 3 aortic valve in Chinese patients with bicuspid aortic valve and tricuspid aortic valve stenosis. Methods: We analyzed the patient characteristics, procedural features and procedural outcomes of the first 438 patients (223 for bicuspid aortic valve and 215 tricuspid aortic valve) from 21 provinces in 74 sites treated with the SAPIEN 3 valve system for transcatheter aortic valve replacement between September 2020 and May 2022. Results: Procedural mortality was 0.7%. 5 cases during the operation were converted to surgery. Among 438 cases, permanent pacemaker implantation was performed in a total of 12 cases (2.7%). The patient had severe leaflet calcification of the aortic valve, with moderate and severe calcification reaching 39.7% and 35.2% respectively. The size of the implanted valves was predominantly 26 mm and 23 mm, reaching 42.5% and 39.5% respectively. The incidence of moderate or severe perivalvular leak in the postoperative period was 0.5%, with a predominance of 90/10 and 80/20 valve deployment height. There was a significant difference in the deployment height of the valve between bicuspid aortic valve and tricuspid aortic valve, with the bicuspid aortic valve having a more deployment height of 90/10. Annulus size in bicuspid aortic valve group was significantly larger than tricuspid aortic valve group. Valve sizing for oversized, within size, and undersized were different between bicuspid aortic valve and tricuspid aortic valve. Conclusions: Procedural success rates were high, with similar and good results for bicuspid aortic valve and tricuspid aortic valve, low perivalvular leak for both valve types, and low permanent pacemaker implantation rates for both valve types. Annulus size, valve sizing and coronary artery height were significantly different in the BAV and TAV group.

Meta-analysis of short- and long-term clinical outcomes of the self-expanding Evolut R/pro valve versus the balloon-expandable Sapien 3 valve for transcatheter aortic valve implantation.

BACKGROUND: The Evolut R/Pro and the Sapien 3 are the most commonly valve systems used today for transcatheter aortic valve implantation (TAVI). However, there is a still uncertainty regarding the efficacy and safety comparison of these two valves. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies comparing the Evolut R/Pro versus the Sapien 3. The primary outcome was all-cause mortality (short and long-term). The secondary outcomes were stroke, bleeding, permanent pacemaker implantation (PPI), acute kidney injury (AKI), major vascular complication, device success, moderate- severe aortic regurgitation (AR), and pressure gradients. RESULTS: Twenty-one publications totaling 35,248 patients were included in the analysis. Evolut R/Pro was associated with higher risk of short-term all-cause mortality (OR = 1.31;95% CI 1.15-1.49, p < 0.001) and a trend of higher long-term mortality (OR = 1.07;95% CI 1.00-1.16, p = 0.06). The Evolut R/Pro was associated with higher risk of PPI and AR and lower risk for bleeding, major vascular complication, and pressure gradients. There was no significant difference between the groups regarding the risk of stroke, AKI and device success. CONCLUSIONS: The Evolut R/Pro valve system compared to the Sapien 3 is associated with higher risk of short-term mortality, significant AR and PPI while providing the advantage of lower risk of bleeding, major vascular complication, and lower residual transvalvular gradients.

One-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement with SAPIEN 3 Ultra versus SAPIEN 3.

BACKGROUND: The newest-generation balloon-expandable valve, SAPIEN 3 Ultra (S3U), is expected to function well with the enhanced sealing skirt compared with SAPIEN 3 (S3). However, current literature on the comparison between these two valves is limited to short-term follow-ups. Therefore, we aimed to evaluate the 1-year outcomes and echocardiographic changes of S3U compared with S3. METHODS: We retrospectively identified patients who underwent transfemoral-transcatheter aortic valve replacement with S3U or S3 (20/23/26 mm) at our institution in 2018-2020. Outcomes were 1-year clinical events and echocardiographic parameters, and were compared between S3U and S3 after adjustment with inverse probability of treatment weighting. RESULTS: The S3U and S3 groups included 297 (25.7%) and 858 (74.3%) patients, respectively. There were no significant differences between the two groups in clinical events (death 5.8% vs. 5.5%, hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.81-1.90; death or heart failure hospitalization 10.3% vs. 10.1%, HR 1.04, 95% CI 0.67-1.62). The S3U group had a lower prevalence of mild paravalvular leakage (PVL) (13.7% vs. 22.3%, p = 0.044), with similar moderate PVL (0.7% vs. 1.2%, p > 0.99). No significant differences were observed in aortic valve mean gradient and Doppler velocity index at 1 year. However, the S3U group had a larger increase in mean gradient from implantation to 1 year (median +4.70 vs. +1.63 mmHg, p < 0.001). CONCLUSIONS: S3U and S3 carried similarly favorable clinical event risks. Nonetheless, S3U was associated with less frequent mild PVL but a larger increase in transprosthetic gradient. Further studies are needed to determine the prognostic impact of these hemodynamic differences.

Comparison of clinical outcomes between use of overexpanding an undersized versus nominal-sized SAPIEN 3 ultra transcatheter heart valve in patients with borderline annulus area.

BACKGROUND: For patients with borderline annulus areas that fall between two valve sizes, overinflating a smaller balloon-expandable transcatheter heart valve (THV) may be preferable to nominal sizing of a larger THV. OBJECTIVES: To evaluate the outcomes of nominal preparation versus over-expanding an under-sized SAPIEN 3 Ultra (S3U) transcatheter heart valve (OE-THV) in cases with borderline annuli. METHODS: 958 patients that underwent TAVR with the S3U at four high-volume TAVR centers between January 2017 and December 2020 were retrospectively reviewed. 336 patients were identified as borderline annuli size, of which 146 (44%) received OE-THVs and 190 (56%) received nominal-sized THVs. The primary composite endpoint included: in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery. RESULTS: Baseline characteristics were similar except for a larger percentage of females in the OE-THV (53.42% vs. 42.11%, p = 0.04). TAVR with OE-THV resulted a reduction in the primary composite endpoint (13.69% vs. 22.63%, p = 0.04). On subgroup analysis, there was no difference between 20 mm OE-THV versus 23 mm nominal or 23 mm OE-THV versus 26 mm nominal, but there was a reduction in the primary composite endpoint in patients with larger annuli that received a 26 mm OE-THV compared to the 29 mm nominally sized THV (9.7% vs. 27.4%, p = 0.02). At 1 month and 1 year follow-up, there was no significant difference in mortality, PVL rates, NYHA class, and/or KCCQ score. CONCLUSION: Overinflating a smaller-sized S3U THV may be a safer option in comparison to nominal sizing in patients with borderline annular area.

Transcatheter mitral valve replacement in native mitral valve with severe mitral annular calcification: Skirting the Sapien 3 to reduce the risk of paravalvular leaks.

Background: Mitral annular calcification (MAC) may represent a significant challenge for heart surgeons with an extremely high perioperative risk during mitral valve (MV) surgery. The risk is further increased when patients fail to be eligible for any percutaneous treatment, particularly because circumferential calcifications involving the anterior leaflet suggest a critical obstruction of the left ventricular outflow tract (LVOT). Objectives: The objective of this study was to evaluate residual mitral regurgitation (MR) after surgical mitral valve replacement using a Sapien 3 Ultra (Edwards Lifesciences, CA, USA) transcatheter aortic valve implantation (TAVI) prosthesis, reinforced with a pericardial skirt, in high-risk selected patients with severe MAC. Methods: Since 2020, five high-risk patients (mean age 70 years; 63-76; four women) with severe mitral disease in the context of severe MAC (computed tomography-based mean MAC Score 8.2 ± 1.1) were operated on after we adopted this novel technique. The operations were performed under general anesthesia, using a transapical TAVI delivery system to position the Sapien 3 in the mitral position under direct vision. To reinforce and avoid paravalvular leakages, a pericardial skirt was previously sewn around the prosthesis, securing it to the annulus and perivalvular atrial surface. Results: Sapien 3 Ultra implantation was successful without residual MR in all five patients (mild paravalvular leak in one case). Four patients had a 29-mm valve implanted, while one had a 26-mm valve implanted. Predilatation of the native annulus was never performed. Perfusion and clamping times were 134 ± 53 mins and 108 ± 43 mins, respectively. The presence of the pericardial skirt reduced the risk of leakage between the prosthesis and the rigid calcium surface, with final mean and maximal gradients of the TAVI prosthesis of 4.1 and 10.8 mmHg, respectively. There were no left ventricular outflow tract obstructions (mean LVOT gradient of 8 ± 1 mmHg). All patients were discharged, and neither mortality nor prosthetic dysfunction, nor residual mitral regurgitation was recorded. During follow-up, the last patient treated (MAC Score 10, severe calcification of the mitro-aortic junction) returned to our attention with a significant recurrent jet originating from the anterolateral commissure, currently medically treated, given the prohibitive redo risk. Conclusion: Direct open surgical implantation of the Sapien 3 valve can be safely done in patients with severe MAC in dedicated centers. Reinforcing the TAVI prosthesis by sewing a pericardial skirt led to satisfactory perioperative and early postoperative results, reducing paravalvular leakages. Complex anatomies have a CERTAIN risk of recurrence.

Early Acurate Neo transcatheter heart valve degeneration in a haemodialysis patient successfully managed with Sapien 3 Ultra: a case report.

Background: Aortic valve disease is the most prevalent valvular abnormality in the developed world and carries a high risk of morbidity and mortality. Transcatheter aortic valve replacement (TAVR) is favoured over open-heart surgery in high-risk patient categories and is increasingly used in lower-risk groups. End stage kidney disease (ESKD) is associated with premature calcific degeneration of bioprosthetic heart valves. Redo-TAVR requires meticulous pre-procedural planning to avoid the important risks of sinus sequestration and impaired coronary access. Transcatheter aortic valve replacement with the Acurate Neo transcatheter heart valve (THV) has been clinically available for a short time only and there are limited reports describing redo-TAVR in the Acurate Neo. Case summary: We present a case of early, rapid onset, structural valve degeneration in a Acurate Neo, supra-annular, self-expanding THV in a dialysis patient. The patient presented with chest pain and breathlessness 4 years after TAVR with a Acurate Neo for severe stenosis of a bicuspid aortic valve. Echocardiogram now showed severe stenosis of the THV and computed tomography revealed severe THV leaflet calcification but no pannus or leaflet thrombus. After careful pre-procedural planning a S3 Ultra balloon-expandable valve was selected and positioned relatively high to pin the first THV leaflets in a fully open position without compromising coronary artery flow or coronary access. Discussion: End stage kidney disease may cause rapid, calcific degeneration of TAVR valves leading to presentation with severe aortic stenosis. Redo-TAVR in the Acurate Neo THV with a Sapien 3 Ultra is feasible with careful pre-procedural planning to mitigate the risks of sinus sequestration and impaired coronary access.

Transcatheter Mitral Valve Interventions for Mitral Regurgitation: A Review of Mitral Annuloplasty, Valve Replacement, and Chordal Repair Devices.

Significant mitral regurgitation (MR) is the most common valvular disease in the United States in patients older than 75. However, many patients with severe MR are at a high risk for surgical repair due to other significant comorbidities. Over the past decade, many transcatheter mitral valve devices have been studied that address the different mechanisms of MR, but only a few have received a Conformité Européene (CE) mark or United States Food and Drug Administration (FDA) approval. The Carillon, Cardioband, and Mitralign all received CE marking for percutaneous mitral annuloplasty, while the Tendyne and SAPIEN 3 received a CE mark and FDA approval, respectively, for transcatheter mitral valve replacement. Finally, the NeoChord DS 1000 received a CE mark for transcatheter chordal repair. Each of these devices is reviewed in detail, including device indications, performance in clinical trials, anesthetic management, intraprocedural imaging guidance, and postprocedural complications. Although percutaneous devices will appear and disappear from use, understanding the procedural considerations remains highly relevant, as these key principles will apply to the next generation of transcatheter valve interventions.

The effect of stent and decalcification on mitral annular motion after aortic valve replacement.

OBJECTIVE: The purpose of this study was to evaluate the changes in mitral annular motion after surgery in patients with aortic stenosis. METHODS: Patients receiving Edwards (Edwards) valves were included in the study. Echocardiographic findings were compared among the three treatments postoperatively, at discharge, and at 1 year after the surgery. Mitral annular motion was evaluated by e prime, using tissue doppler imaging. RESULTS: There were 111 patients receiving Inspiris, 30 patients receiving Intuity and 241 patients receiving Sapien 3. The patients receiving Sapien 3 were significantly older, (Inspiris: 71 ± 6.7 years vs. Intuity: 75 ± 5.2 years vs. Sapien 3: 84 ± 5.1 years, p < .001), and prevalence of hemodialysis were significantly higher in patients receiving Intuity (Inspiris: 11.7% vs. Intuity: 46.7% vs. Sapien 3: 0.0%, p < .001). There was a significant improvement in mean pressure gradient in all groups (Inspiris: 55 ± 21.2-13 ± 5.2 mmHg, p < .001; Intuity: 48 ± 17.6-12 ± 4.9 mmHg, p < .001, Sapien 3: 55 ± 16.6-14 ± 5.2 mmHg, p < .001). Decalcification was associated with increase in e prime after surgery (no decalcification: 0.10 ± 1.280 cm/s vs. decalcification: 0.68 ± 1.405 cm/s, p < .001) Further, existence of stent was associated with less increase in e prime after surgery (no stent: 0.83 ± 1.210 cm/s vs. stent: 0.10 ± 1.356; p < .001). Multivariate analysis showed that existence of stent but not decalcification of the aortic valve was independently associated with changes in e prime after surgery (ß: -.4679, 95% confidence interval: -0.93389 to -0.00200, p = .049). CONCLUSIONS: Although improvement in pressure gradient was achieved in all treatments, existence of stent inhibited mitral annular motion after surgery.

Hemodynamics of self-expanding versus balloon-expandable transcatheter heart valves in relation to native aortic annulus anatomy.

OBJECTIVES: This study aimed to compare hemodynamic characteristics of different self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THV) in relation to native aortic annulus anatomy. BACKGROUND: A patient centered THV selection becomes increasingly important as indications for transcatheter aortic valve replacement (TAVR) are extended towards lower risk populations. METHODS: Hemodynamic parameters including mean gradient (MG), effective orifice area (EOA), Doppler velocity index (DVI), degree of paravalvular regurgitation (PVR) and patient-prosthesis mismatch (PPM) were compared by valve type, label size and in relation to quintiles of native aortic annulus area. RESULTS: 2609 patients were treated at 3 centers in Germany with SAPIEN 3 (n = 1146), ACURATE Neo (n = 649), Evolut R (n = 546) or Evolut Pro (n = 268) THV. SE THVs provided superior hemodynamics in terms of larger EOA, higher DVI and lower MG compared to BE THV, especially in patients with small aortic annuli. Severe PPM was less frequent in SE treated patients. The rate of PVR ≥ moderate was comparable for SE and BE devices in smaller annular dimensions, but remarkably lower for BE TAVR in large aortic annular dimensions (> 547.64 mm2) (2% BE THV vs. > 10% for SE THV; p < 0.001). CONCLUSIONS: Patients with small aortic annular dimensions may benefit hemodynamically from SE THV. With increasing annulus size, BE THV may have advantages since PVR ≥ moderate occurs less frequently.

Mid-term impact of underfilling and overfilling of the SAPIEN 3 balloon-expandable transcatheter aortic valve implantation on mortality and valve function.

At present, underfilling or overfilling the volume of the balloon-expandable transcatheter heart valve (THV) is generally utilized in transcatheter aortic valve implantation (TAVI). However, no research has assessed the clinical impact of filling volume variations of the current-generation SAPIEN 3 THV. We analyzed the clinical data of 331 patients who underwent TAVI with SAPIEN 3 at our institution. Post-procedural echocardiographic and multidetector computed tomography (MDCT) scan data and 3-year prognoses according to each filling volume were assessed. The procedural outcomes and 3-year mortality rates were comparable among the underfilling, nominal filling, and overfilling groups. For all THV sizes, the THV area evaluated on post-procedural MDCT scan increased stepwise along with an elevated filling volume, thereby covering a wide range of native annulus area. Compared with patients in the nominal filling and overfilling groups, those with 23-mm THVs in the underfilling group had a smaller effective orifice area (EOA) (1.38 [IQR: 1.18-1.56] vs. 1.57 [IQR: 1.41-1.84] vs. 1.58 [IQR: 1.45-1.71] cm2, P = 0.02) and a higher mean transvalvular gradient (13.6 [IQR: 11.0-15.7] vs. 12.1 [IQR: 9.0-14.9] vs. 12.0 [IQR: 8.1-14.8] cm2, P = 0.04). In conclusion, by adjusting the filling volume of SAPIEN 3 using THV with limited sizes, continuously distributed native annulus areas were covered. The underfilling implantation technique had a minimal negative effect on the valve function of 23-mm THVs only. In the entire cohort, the filling volume variations did not affect the mid-term prognosis negatively.

The use of balloon-expandable Sapien-3 valve in redo aortic valve replacement and the potential risk of left main stem occlusion.

Redo aortic valve surgery for the failure of a previously implanted valve is always challenging. In case of small-sized implanted valves, the use of a balloon-expanding Sapien-3 valve can enhance the final effective orifice area, avoid annulus enlargement complex techniques, and can reduce operative time and morbidities. We describe a case where after explanting a failed 19 mm St. Jude mechanical aortic valve and further deployment of a 23 mm Sapien-3 valve, the left coronary ostia was obstructed by the skirt of the transcatheter prosthesis. After careful removal of a little part of the skirt, we were able to restore the coronary flow and the patient had a favorable outcome.

Outcomes and feasibility of redo-TAVR after Sapien 3 Ultra TAVR in extremely-undersized versus nominally-sized annuli.

OBJECTIVES: To compare outcomes in Sapien 3 Ultra (S3U) transcatheter aortic valve replacement (TAVR) with extreme annular undersizing (EAU) versus nominal annular sizing (NAS). BACKGROUND: The Edwards S3U valve has reduced paravalvular leak (PVL) in TAVR but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future redo-TAVR but risk compromising hemodynamics. METHODS: From December 2019 to July 2021, 366 patients with native aortic stenosis underwent S3U TAVR. Patients with EAU (annular areas >430 mm2 for 23 mm or >546 mm2 for 26 mm) were compared to NAS (338-430 mm2 for 23 mm or 430-546 mm2 for 26 mm). In-hospital and 30-day outcomes, and redo-TAVR feasibility were determined. RESULTS: There were 79 (21.6%) EAU patients, with more bicuspid (p = 0.0014) and ≥moderate annular/left ventricular outflow tract calcification (p < 0.001). The EAU group had less annular oversizing than NAS group (23 mm: -8.2 ± 2.6% vs. 4.0 ± 7.0%, p < 0.001; 26 mm: -8.9 ± 2.2% vs. 6.7 ± 6.9%, p < 0.001), more balloon overfilling (71.3% vs. 11.6%, p < 0.001), and postdilatation (15.0% vs. 5.8%, p = 0.016). No differences were found in in-hospital or 30-day mortality and stroke (p > 0.05). Mild PVL (13.4% EAU vs. 11.5% NAS, p = 0.56) and mean gradients (23 mm: 13.0 ± 4.5 vs. 14.1 ± 5.4 mmHg, p = 0.40; 26 mm: 11.4 ± 4.1 vs. 11.5 ± 3.9 mmHg, p = 1.0) were similar at 30 days. Had the EAU group undergone NAS with the larger Sapien 3/S3U, by computed tomography analysis simulating 80:20 or 90:10 target implant depth, 33.3%-60.9% (vs. 4.3%-23.2%) would not be feasible for redo-TAVR due to high risk of coronary obstruction. CONCLUSIONS: In this first report of EAU with S3U TAVR, similar excellent short-term outcomes can be achieved compared to NAS, and may preserve future redo-TAVR option.