Comparing Clinical Outcomes of Patients With a Small Versus Large Annulus After Newer-Generation Balloon-Expandable Transcatheter Aortic Valve Replacement.

Self-Expanding Versus Balloon-Expandable Valve: Are We at the Cusp of Delivering a Perfect Transcatheter Aortic Valve?

Recommendations for Transesophageal Echocardiographic Screening in Transcatheter Aortic Valve Replacement: Insights for the Cardiothoracic Anesthesiologist

Outcomes of Patients With a Small and Large Aortic Annulus Following Balloon-Expandable Transcatheter Aortic Valve Replacement Across Flow-Gradient Patterns

Bioprosthetic Valve Performance After Transcatheter Aortic Valve Replacement With Self-Expanding Versus Balloon-Expandable Valves in Large Versus Small Aortic Valve Annuli: Insights From the CHOICE Trial and the CHOICE-Extend Registry

Requiem for Routine Self-Expanding TAVR Valves? A Commentary on the Comparative Analysis of Evolut PRO Versus Sapien Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation Registry (OPERA-TAVI)

Senile calcific aortic stenosis (AS) is the most common acquired valvular heart disease with an increasing prevalence attributable to an aging population. Survival is poor in patients with severe or critical AS, chiefly after the onset of symptomology that primarily includes angina, dyspnea, or syncope. On the onset of symptoms, mortality occurs at very high rates during the ensuing 2 to 3 years.1 Until recently, surgical aortic valve replacement represented the sole therapy that definitive reduced mortality and morbidity in patients with severe symptomatic AS, with medical therapy generally ineffective of these patients. Given the advanced age commonly associated with severe AS, a high proportion of these patients are denied surgical intervention because of multiple comorbidities and excessively high surgical risk.2 Recently, transcatheter aortic valve replacement (TAVR) has emerged as a novel disruptive technology that serves an alternative therapy to surgical AVR and has been shown to be an effective therapy in nonoperable and high-risk patients with severe symptomatic AS.3,4 TAVR was first described in humans by Cribier et al in 20025 by a transvenous approach delivered in an antegrade fashion. This technique requires a transseptal puncture and passage of the aortic stent valve across the mitral valve to the aortic position. Subsequently, array of alternative transvascular approaches have arisen, including transfemoral, transaortic, trans-subclavian, and aortic methods. Of these, the retrograde transarterial approach through the femoral artery, developed by Webb et al,6 has been the commonly used approach, with >60 000 such procedures performed worldwide to date. To date, the global experience with TAVR as documented in both single and multicenter registries as well as through multicenter trials have shown good clinical outcomes with improvement in hemodynamic and clinical status, establishing TAVR to be a feasible alternative therapy to traditional surgical aortic valve …

Late Clinical Outcomes of Balloon-Expandable Valves in SmallAnnuli: Results From the PARTNER Trials.

BackgroundSelf‐expanding valves (SEVs) have demonstrated superior hemodynamic performance and comparable clinical outcomes to balloon‐expandable valves (BEVs) at 1 year in patients with a small aortic annulus. However, long‐term data are limited. This study aimed to evaluate 5‐year echocardiographic and clinical outcomes of SEVs versus BEVs in patients with small aortic annulus underwent transcatheter aortic valve replacement.MethodsWe analyzed RESOLVE registry patients who underwent transcatheter aortic valve replacement at Cedars‐Sinai between 2015 and 2020. Patients with a small aortic annulus (<430 mm2 by computed tomography) were included and followed for up to 5 years. The primary outcome was a composite of all‐cause mortality, stroke, or heart failure hospitalization. Secondary outcomes included myocardial infarction, pacemaker implantation, aortic valve reintervention, and structural bioprosthetic valve dysfunction.ResultsAmong 1392 transcatheter aortic valve replacement recipients, 423 (78 SEVs, 345 BEVs) met the small annulus criteria. SEVs were associated with lower transvalvular gradients and larger indexed effective orifice area at discharge and 1 year (P<0.001). Moderate‐to‐severe paravalvular leak was more frequent with SEVs at 30 days (7.7% versus 1.5%, P<0.001), as was permanent pacemaker implantation (17.9% versus 6.1%, P<0.001). At 5 years, the primary outcome did not differ significantly (hazard ratio, 1.21; 95% CI, 0.81–1.82; P<0.33). All‐cause mortality, stroke, heart failure hospitalization, structural bioprosthetic valve dysfunction, and reintervention rates were similar between groups.ConclusionAlthough SEVs provide better hemodynamic performance in patients with severe aortic stenosis and small annuli, this advantage did not translate into improved survival or reduced cardiovascular events at 5 years.

Choice of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Impacts Hemodynamics Differently According to Aortic Annular Size

Balloon-Expandable Valve Performance Beyond 10 Years After Transcatheter Aortic Valve Implantation.

Failed bioprosthetic valve approaches: Transcatheter aortic valve replacement approach

Transcatheter Aortic Valve-in-Valve-in-Valve Implantation for a Failed Xenograft

Evidence regarding the long-term outcomes and durability of balloon-expandable transcatheter heart valves (BE-THVs) after transcatheter aortic valve implantation (TAVI) is still scarce. This study evaluates these outcomes and further examines their association with the annular size in patients. A total of 2,699 patients who had undergone TAVI with a BE-THV at least 5 years prior to our study were analysed. A small aortic annulus (SAA) was defined as an area ≤430 mm2; any larger annuli were labelled large aortic annuli (LAA). The primary endpoints were the incidence of all-cause mortality and bioprosthetic valve failure (BVF) between the SAA and LAA groups. As a subanalysis, the primary endpoints were examined in relation to postprocedural mean pressure gradient (mPG) ≥20 mmHg, severe prosthesis-patient mismatch (PPM), and sex differences, comparing SAA and LAA each time. Overall, 66.4% (n=1,793) of patients were categorised into the SAA group. At 7 years after TAVI, the cumulative all-cause mortality showed differences between the SAA and LAA groups (55.2% vs 58.6%), while BVF assessed by Gray's test was similar between the groups (3.3% vs 2.7%). The Cox multivariable analysis revealed no association between SAA and worse prognosis (hazard ratio 1.07, 95% confidence interval: 0.85-1.36; p=0.56). There were no significant differences in mortality or BVF regarding an mPG ≥20 mmHg, severe PPM, or sex between the SAA and LAA groups (allp>0.05). Annular size differences were not found to influence long-term outcomes or valve durability following TAVI with a BE-THV, suggesting that other factors warrant further investigation.

Clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is currently in the focus of clinical research. Patients with small aortic annulus are at higher risk to display PPM. Data on incidence and clinical consequences of PPM after TAVR with either balloon-expandable (BEV) or self-expanding (SEV) transcatheter heart valves in small aortic annulus are sparse. Patients with small aortic annulus (perimeter < 72 mm or aortic annulus area < 400 mm2) who underwent BEV or SEV with contemporary transcatheter heart valve types were identified from the institutional TAVR database. Propensity score matching was applied for imbalanced baseline characteristics between patients undergoing BEV or SEV. Echocardiography and clinical follow-up beyond 3 years was reported following VARC-3 recommendations. Primary endpoint was the incidence of pre-discharge PPM and its association with 3-year mortality. From a total of 507 patients with small aortic annulus, 192 matched patient pairs with SEV or BEV were identified. Mean age was 81 ± 7 (SEV) vs. 81 ± 6 (BEV) years (p = 0.5), aortic annulus perimeter was 69 ± 3 vs.69 ± 3 mm, (p = 0.8), annulus area was 357 ± 27 vs.357 ± 27 mm2 (p = 0.8), and EuroScore II was 5.8 ± 6.6 vs.5.7 ± 7.2 (p = 0.9). SEV resulted in less moderate (20% vs. 31%, p < 0.001) and severe pre-discharge PPM (9% vs.18%, p < 0.001) compared to BEV. At discharge (7 ± 4 vs. 12 ± 9 mmHg, p = 0.003) and at 1-year follow-up (7 ± 5 vs.13 ± 3 mmHg, p < 0.001), SEV displayed lower mean gradients compared to BEV. Estimated survival after SEV was 85% (95% confidence interval (CI): 80%-90%) at 1 year, 80% (95% CI: 75%-86%) at 2 years, and 71% (95% CI: 65%-78%) at 3 years; estimated survival after BEV was 87% (95% CI: 82%-92%) at 1 year, 81% (95% CI: 75%-86%) at 2 years, and 72% (95% CI: 66%-79%) at 3 years, with no significant difference among the groups (p = 0.9) Body surface area (OR: 1.35, p < 0.001), implantation of BEV (odds ratio (OR): 3.32, p < 0.001), and the absence of postdilatation (OR: 2.16, p < 0.001) were independent risk factors for any PPM. At 3 years, patients without PPM had a higher 3-year survival compared with patients with ≥moderate PPM (77% vs. 67%, p = 0.03). BEV implantation in patients with small annulus was associated with a twofold higher incidence of pre-discharge severe PPM compared to SEV implantation. Survival at 3 years after TAVR was similar after BEV and SEV. However, patients with the absence of pre-discharge PPM had a higher 3-year survival compared to patients with ≥moderate PPM.

SAPIEN3 Ultra RESILIA versus NAVITOR valve system in patients with a small aortic annulus: Insights from the OCEAN-TAVI Registry.