When Pushing the Access "Easy Button" Gets Complicated: Troubleshooting Transcarotid TAVR Access Issues.
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Two studies this morning sharpen the durability-and-selection tension that has defined the low-risk expansion debate. The Bern cohort (N=1,032, Sapien S3/Ultra, single-center, non-randomized) found that 43% of implants met at least one criterion for suboptimal deployment — noncoaxial (23%), too deep (25%), or underexpanded (5%). Suboptimal implantation tripled the 30-day modified safety endpoint (43.3% vs 19.9%) and quadrupled 5-year stage 2 bioprosthetic valve failure (subHR 4.40). [NOTABLE] This is the strongest procedural-quality-to-durability link published to date and undercuts the assumption that "TAVR is TAVR" across centers. ACC/AHA 2020 still recommends SAVR for patients <65 (Class I) and ESC 2025 raised that floor to <70; the Bern data give both guidelines cover — if 4-in-10 low-risk implants aren't optimal, the case for delaying to age 70 is stronger, not weaker.
The 52-study bicuspid meta-analysis confirms BAV TAVR carries higher paravalvular leak (RR 1.44), aortic root injury (RR 1.83), and 30-day stroke (RR 1.27) versus tricuspid anatomy, though 1-year mortality is lower — a selection artifact, not a valve win. Compared with SAVR in BAV, TAVR had 7-fold higher PVL (RR 7.08) with no early mortality advantage. Both ACC/AHA 2020 and ESC 2025 keep BAV TAVR at Class IIb; nothing here challenges that. A 385-patient OCEAN-TAVI analysis of extremely small annuli (<314 mm²) found broadly similar outcomes across balloon-expandable, supra-annular self-expanding, and intra-annular self-expanding platforms, with a numeric PVL signal favoring BEV (15.8% vs 27%). A 172-patient anatomy-tailored commissural alignment technique for Evolut FX cut moderate/severe misalignment from 30% to 14% — a low-cost tweak with real implications for future valve-in-valve access.
JACC Advances flagged rising middle-aged AS mortality and widening rural disparities in the TAVR era — access, not technology, is the story in that population.
BACKGROUND: The conventional commissural alignment for a supra-annular self-expanding valve positions the delivery catheter flush port at the 3 o'clock orientation, with confirmation of the "Hat" marker on the outer curve at the descending aorta during transcatheter aortic valve replacement. However, tailoring the "Hat" marker position according to native valve anatomy may further optimize commissural alignment. OBJECTIVES: This study evaluated the effectiveness of a novel anatomy-tailored method compared with the conventional technique. METHODS: We analyzed 172 consecutive patients who underwent transcatheter aortic valve replacement with supra-annular self-expanding valve (Evolut FX) and postprocedural contrast-enhanced computed tomography between March 2023 and February 2025. In the anatomy-tailored approach, a single additional step was incorporated into the conventional method: the "Hat" marker was repositioned to the center back in the cusp-overlap view at the descending aorta. The aim was to align the "Hat" marker to the center-front position during valve deployment. Commissural misalignment (CMA) was evaluated according to the ALIGN-TAVR (Alignment of Transcatheter Aortic-Valve Neo-Commissures) Consortium criteria. RESULTS: The mean age was 84.5 ± 5.1 years, with 54.7% (94 of 172) male patients. Of 172 patients, 67 underwent the conventional method and 105 the anatomy-tailored method. The anatomy-tailored method yielded smaller CMA angles (14.5° [IQR: 9.8-24.1] vs 20.3° [IQR: 11.0-30.6], P = 0.031) and fewer cases of moderate/severe (>30°) CMA (14.3% [15 of 105] vs 29.9% [20 of 67], P = 0.013). Coronary overlap ≤20° (either or both) was also reduced (12.4% [13 of 105] vs 28.4% [19 of 67], P = 0.009). CONCLUSIONS: The novel and easy anatomy-tailored alignment technique improved commissural alignment compared with the conventional method. Enhanced commissural alignment was associated with better coronary alignment.
BACKGROUND: Patients with extremely small aortic annuli are at increased risk of residual gradients and prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). Comparative data on contemporary valve platforms in this subset remain limited. OBJECTIVES: The authors aimed to compare early clinical and hemodynamic outcomes among balloon-expandable valves (BEVs), supra-annular self-expanding valves (SA-SEVs), and intra-annular self-expanding valves (IA-SEVs) in patients with severe aortic stenosis and extremely small annuli. METHODS: Patients with annular area <314 mm2 from the OCEAN-TAVI registry were analyzed using multinomial propensity score overlap weighting. Primary outcomes were severe PPM, mean transvalvular pressure gradient ≥20 mm Hg, and paravalvular leakage (PVL) ≥mild. RESULTS: Among 385 patients, 125, 136, and 124 underwent BEV, SA-SEV, and IA-SEV implantation, respectively. Effective sample sizes after overlap weighting were 92.4, 93.6, and 85.4, with a median follow-up of 358 days. Adjusted probabilities of severe PPM were similarly low (1.6%, 2.0%, and 2.7%; P = 0.85). mean transvalvular pressure gradient ≥20 mm Hg occurred in 4.5%, 8.3%, and 2.3%, respectively (P = 0.19). PVL ≥mild was numerically more frequent with SEV than BEV (15.8%, 27.3%, and 27.0%; P = 0.09), with adjusted odds ratios versus BEV of 1.92 (95% CI: 0.96-3.84) for SA-SEV and 1.83 (95% CI: 0.91-3.70) for IA-SEV. Major complications and 1-year mortality were similar among groups. CONCLUSIONS: Contemporary TAVR platforms showed broadly similar early outcomes, although PVL ≥mild was numerically more frequent with self-expanding valves.
BACKGROUND: The expansion of transcatheter aortic valve replacement (TAVR) to younger patients with longer life expectancy requires procedural optimization to enhance long-term valve durability. OBJECTIVES: To evaluate the relationship between fluoroscopic determinants of optimal transcatheter heart valve (THV) implantation-coaxiality, implantation depth, and expansion-and clinical and valve-related outcomes. METHODS: In this cohort study, consecutive patients undergoing transfemoral TAVR with balloon-expandable prostheses (Sapien S3, Sapien S3 Ultra) between February 2014 and June 2022 were included. THV coaxiality, implantation depth, and expansion were assessed in the 3-cusp view following deployment using standardized protocols. Suboptimal implantation was defined as ≥1 unfavorable determinants (coaxiality ≥4.8°, depth ≥6 mm, or underexpansion ≥20%). Outcomes included the modified early safety endpoint, moderate or severe hemodynamic valve deterioration, and stage 2 bioprosthetic valve failure. RESULTS: Among 1,032 patients (mean age 81 ± 6 years, 35.1% female), suboptimal THV implantation occurred in 443 (42.9%) patients and was driven by noncoaxial deployment (n = 240, 23.3%), excessive implantation depth (n = 261, 25.3%), and underexpansion (n = 54, 5.2%). Suboptimal implantation was associated with a higher likelihood of the modified early safety endpoint at 30 days (43.3% vs 19.9%; adjusted odds ratio: 3.05; 95% CI: 2.30-4.04) and stage 2 bioprosthetic valve failure at 5 years (subHR: 4.40; 95% CI: 1.25-13.59). Patients with ≥2 determinants demonstrated higher rates of hemodynamic valve deterioration at 5 years (subHR: 3.48; 95% CI: 1.24-9.80). CONCLUSIONS: Optimal THV implantation was associated with improved early procedural safety and long-term THV durability in balloon-expandable TAVR. Systematic fluoroscopic assessment of optimized valve implantation may enhance patient outcomes.
Terkelsen CJ, Freeman P, Dahl JS, et al. SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial. Lancet 2025; 405: 1362–72—In figure 2 of this Article, the position of the –1·2 label on the x axis, the border between the light and dark blue shading, and the corresponding lower one-sided 95% CI error bar have been corrected to reflect the risk difference of –1·2% and the one-sided lower 95% CI of –4·7.
Cardiovascular Business's lead this week is that surgery bests TAVR in young patients — an editorial framing that lines up with the Bern durability data and with both current guidelines. The specifics matter: ACC/AHA 2020 favors SAVR at <65 (Class I), ESC 2025 pushed the SAVR-preferred zone to <70. In BAV specifically, today's meta-analysis found no mortality advantage for TAVR vs SAVR at 30 days and 7-fold higher PVL — SAVR remains the default answer for young BAV patients with aortopathy. The COMPARE-TAVI 1 Lancet correction tightens the reported Sapien 3 vs Myval risk difference (–1.2%, one-sided lower 95% CI –4.7) — a data-integrity nudge, not a signal shift.
BACKGROUND: Device embolization (DE) is a rare but potentially life-threatening complication of left atrial appendage occlusion (LAAO). As landmark trials broaden the eligible population for LAAO, operator preparedness for DE management becomes increasingly critical. CASE SUMMARY: We present 4 cases of LAAO DE managed with distinct retrieval strategies: 1) open surgical retrieval with concurrent AtriClip ligation for an endothelialized left atrial device; 2) sequential transseptal then retrograde arterial snaring for intraprocedural migration to the abdominal aorta; 3) transseptal retrieval using a dedicated ONO system with cerebral embolic protection for partial left atrial dislodgment; and 4) retrograde large-bore arterial retrieval for delayed aortic embolization. CONCLUSIONS: Percutaneous retrieval is feasible in most cases when tailored to embolization location. Surgical backup remains indispensable. Prevention requires rigorous preprocedural imaging, accurate sizing, and routine postimplant surveillance. TAKE HOME MESSAGE: LAAO embolization has high mortality, accurate device sizing as well as follow up imaging in paramount.
BACKGROUND: Comparative outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) stenosis remain uncertain. OBJECTIVES: The authors synthesized evidence comparing: 1) TAVR outcomes in BAV vs tricuspid aortic valve (TAV) stenosis; and 2) TAVR vs surgical aortic valve replacement (SAVR) among patients with BAV stenosis. METHODS: MEDLINE, Scopus, and Cochrane CENTRAL were searched through January 31, 2026 (CRD420261304542). Random-effects models pooled risk ratios (RRs) with 95% CIs. Exploratory meta-regression assessed study-level modifiers and temporal trends in 1-year mortality. RESULTS: Fifty-two studies were included. In 39 studies comparing TAVR in BAV vs TAV, BAV was associated with higher paravalvular leak (RR: 1.44; 95% CI: 1.18-1.77; P < 0.001), aortic root injury (RR: 1.83; 95% CI: 1.10-3.04; P = 0.020), 30-day stroke (RR: 1.27; 95% CI: 1.02-1.59; P = 0.035), and 30-day mortality (RR: 1.25; 95% CI: 1.00-1.55; P = 0.047), but lower 1-year mortality (RR: 0.84; 95% CI: 0.75-0.94; P = 0.002). The Society of Thoracic Surgeons score-but not BAV anatomy-predicted 1-year mortality (RR: 1.31; 95% CI: 1.08-1.59; P = 0.006). BAV outcomes improved in recent studies (RR per year, 0.93; 95% CI: 0.87-1.00; P = 0.048). In 13 studies comparing TAVR vs SAVR in BAV, TAVR had higher paravalvular leak (RR: 7.08; 95% CI: 2.28-21.98; P < 0.001) and lower major bleeding (RR: 0.27; 95% CI: 0.17-0.44; P < 0.001) but similar 30-day stroke (P = 0.288) and mortality (P = 0.452). CONCLUSIONS: TAVR for BAV stenosis was associated with procedural risk than TAVR for TAV stenosis but lower 1-year mortality. Compared with SAVR, TAVR showed procedural trade-offs without early mortality differences.
BACKGROUND: Implementation of guideline-supported Multidisciplinary Heart Teams (MHT) for the management of complex cardiovascular disease has not been described in a public safety-net hospital setting. In May 2023, an MHT was established at Los Angeles General Medical Center to deliver comprehensive cardiovascular care to an underserved population in a resource-constrained setting. METHODS: We conducted a retrospective review of all cases discussed by a comprehensive MHT at Los Angeles General Medical Center from May 24, 2023 through January 21, 2026. The MHT convenes weekly in a hybrid format, using a privacy-compliant centralized platform for longitudinal care coordination. Referral pathways extend to affiliated safety-net clinics and hospitals. RESULTS: During the study period, the MHT discussed 494 patients, including 369 (74.7%) with any valvular disease, 78 (15.8%) with complex coronary disease, 29 (5.9%) with congenital heart disease, and 33 (6.7%) with endocarditis. The patient cohort reflected a high prevalence of health care disparities, with 93.9% reporting a race or ethnicity other than non-Hispanic White, a high proportion with publicly funded (69.0% Medicaid) or uninsured (3.6%) status, and frequent substance use disorders (28.1%). The MHT generated consensus recommendations including cardiac surgery (99 [20.0%]), transcatheter intervention (122 [24.7%]), complex percutaneous coronary intervention (30 [6.1%]), and medical management (149 [30.2%]). In-hospital mortality was low among patients who underwent surgical or percutaneous procedure (9 [3.6%]). Programmatic growth included development of a transcatheter valve repair program and increased complexity of cardiac surgical case volume. CONCLUSIONS: Establishment of an MHT in a resource-constrained public safety-net hospital was feasible and sustainable. Our model may serve as a blueprint to deliver guideline-concordant cardiovascular therapies to underserved populations.
BACKGROUND: Functional mitral regurgitation (FMR), resulting from left ventricular dysfunction or left atrial dilation, is associated with heart failure and increased mortality. Mitral transcatheter edge-to-edge repair is an established treatment for patients with severe symptomatic FMR who are at high surgical risk. However, comparative data on the 2 most commonly used mitral transcatheter edge-to-edge repair systems, MitraClip G4 and PASCAL, remain limited. This study compared the safety and efficacy of both devices in patients with FMR. METHODS: Consecutive patients with severe symptomatic FMR who underwent mitral transcatheter edge-to-edge repair using MitraClip G4 or PASCAL between 2021 and 2023 at a single center were included. Coprimary end points were 1-year survival and freedom from heart failure hospitalization. Secondary end points included MR reduction and New York Heart Association functional class. Propensity score matching was performed to adjust for baseline differences. RESULTS: The study included 319 patients, of whom 150 (47.0%) were treated with MitraClip G4 and 169 (53.0%) with PASCAL. After propensity score matching, 116 matched pairs were analyzed. Procedural success, defined as MR grade ≤2, was achieved in 98.1% of the MitraClip G4 group and 97.3% of the PASCAL group (P=0.61). At 1 year, no significant differences were observed between groups regarding residual MR (P=0.83), New York Heart Association class (P=0.41), or freedom from heart failure hospitalization (P=0.41). Estimated 1-year survival was 86.7% for MitraClip G4 and 87.8% for PASCAL (P=0.84). CONCLUSIONS: In patients with FMR, MitraClip G4 and PASCAL demonstrated similarly high procedural success, durable MR reduction, and comparable clinical outcomes at 1 year.
MitraClip G4 vs PASCAL is a coin flip in functional MR. The Leipzig propensity-matched cohort (116 pairs, single-center, non-randomized) found identical procedural success (98.1% vs 97.3%), 1-year survival (86.7% vs 87.8%), and freedom from HF rehospitalization. Operators can pick on anatomy and cost, not outcomes. This sits comfortably against ESC 2025's Class I recommendation for TEER in ventricular SMR meeting COAPT criteria — the ACC/AHA 2020 Class IIa lags behind. A separate 293-patient M-TEER cohort found women present older, more symptomatic, and with worse baseline 6-minute walk — but 6-month mortality (17% vs 22%) and HF rehospitalization tracked identically. Referral timing, not device response, is the sex-gap driver.
On the surgical side, guideline direction still favors mitral repair over TEER for primary MR — ESC 2025 upgraded early asymptomatic PMR surgery to Class I when 3+ risk factors are present (AF, SPAP >50, LA dilation, ≥moderate TR). Today's data are entirely secondary MR; the surgical comparator remains unchallenged in primary disease. A Bayesian meta-analysis of TEER for secondary MR in HF was published in JACC Advances — abstract unavailable, but it will land in the same COAPT/RESHAPE-HF2/MITRA-FR triangulation ESC used to justify its Class I upgrade.
BACKGROUND: Whether differences in outcomes exist between men and women after transcatheter edge-to-edge repair is currently unknown. OBJECTIVES: This study investigated sex-based differences in outcomes after mitral transcatheter edge-to-edge repair (M-TEER) for severe mitral regurgitation (MR). METHODS: Patients undergoing M-TEER were included from May 2014 to October 2025. The prognostic impact of sex was investigated with regard to the primary endpoint all-cause mortality at 6 months. The secondary endpoints comprised the reduction of MR, rehospitalization for heart failure (HF) and functional capacity as assessed by the 6-minute walk test. RESULTS: Of the 293 patients enrolled in the study, 119 (40.6%) were women. Compared with men, women had a similar severity of MR independent of its etiology. The prevalence of coronary artery disease (81% vs 65%; P = 0.002), and the proportion of functional MR (47% vs 37%) were higher in males. The risk of all-cause mortality at 6 months did not significantly differ in males and females (22% vs 17%; P = 0.301; adjusted OR = 0.929; 95% CI: 0.474-1.822; P = 0.830), paralleled by comparable rates of HF-related rehospitalization (10% vs 13%; P = 0.576; adjusted OR = 1.151; 95% CI: 0.520-2.548; P = 0.729). By contrast, women demonstrated a significantly lower functional capacity at baseline (P = 0.001). Interestingly, at 6 months mean improvement of functional capacity was similar between male and female patients (P = 0.778). CONCLUSIONS: Women undergoing M-TEER presented at a more advanced age and with higher symptom burden than men, potentially reflecting sex-specific clinical trajectories and differing MR etiologies. However, midterm outcomes, including all-cause mortality and HF rehospitalization, were comparable between sexes.
HighLife Receives CE Mark Approval for Clarity Valve, the Next-Generation Valve for the HighLife TMVR System BioSpace
BACKGROUND: Transcatheter edge-to-edge repair (TEER) and replacement (TTVR) have emerged as new modalities to treat patients with symptomatic significant tricuspid regurgitation. This study aimed to compare invasive hemodynamic and right ventricular (RV) changes and symptom improvement over 1 year. METHODS: Patients who underwent TEER/TTVR at Mayo Clinic (Rochester, MN, 2017-2024) were included. Hemodynamic profiles were described before and immediately after intervention, in addition to RV enlargement/dysfunction ≥moderate at 30 days and change in symptoms over time. RESULTS: Of 100 patients included (50 per group, median age 81 versus 80 years and female 62% versus 42%, in TTVR and TEER, respectively), all had ≥ moderate-severe symptomatic tricuspid regurgitation. Post intervention, mean right atrial pressure decreased in TEER (16 to 14 mm Hg, P<0.001), V wave decreased in both groups (to 16 mm Hg, P<0.001). RV enlargement was less prevalent in both cohorts at 30 days (60%-40% in TEER, P=0.01, and 72 to 58% in TTVR, P=0.07), yet prevalence of RV dysfunction decreased only in TEER (26 to 15%, P=0.17) as opposed to TTVR (31 to 44%, P=0.13). TTVR resulted in a higher stroke volume index and more complete tricuspid regurgitation elimination at 30 days. Both groups resulted in similar improvements in New York Heart Association class, with overall similar survival. CONCLUSIONS: TEER was associated with a greater reduction in right atrial pressure and more favorable RV remodeling at 30 days, as opposed to TTVR, which achieved more complete and sustained elimination of tricuspid regurgitation with higher forward stroke volume.
The Mayo Clinic 100-patient invasive-hemodynamics study (50 TEER vs 50 TTVR, single-center, non-randomized, 2017-2024) is the most granular head-to-head on transcatheter TR modality choice to date. [NOTABLE] TEER reduced mean RA pressure (16→14 mm Hg) and V wave, with RV enlargement falling from 60% to 40% and RV dysfunction trending down (26%→15%). TTVR eliminated TR more completely and delivered higher forward stroke volume, but RV dysfunction actually rose (31%→44%). The signal: TEER unloads the RV; TTVR volume-loads it while curing regurgitation. NYHA improvement and survival tracked similarly. This will not settle the repair-vs-replace question — TRISCEND II already showed TTVR wins on symptoms — but it tells the Heart Team that patients with borderline RV function may fare better with TEER than with the "definitive" replacement.
ESC 2025 gives transcatheter TV treatment Class IIa (LOE A) for high-risk symptomatic severe TR with preserved RV function, based on TRILUMINATE Pivotal, Tri.Fr, and TRISCEND II. ACC/AHA 2020 gives no recommendation because the trials hadn't read out. The Mayo data support the ESC framing but add a modality-selection nuance the guidelines don't yet capture.
Two regulatory events dominate: FDA announced a recall of all Impella heart pump controllers after 3 deaths — Abiomed/J&J franchise territory, adjacent to but not squarely inside structural heart, though the same interventional labs are affected. Separately, the FDA issued an Early Alert on Medtronic's Bravo CF esophageal pH capsule delivery device, with 184 serious injuries reported. Not a cardiac device, but a second Medtronic quality event landing the week before earnings.
FDA announces recall of all Impella heart pump controllers after 3 deaths Cardiovascular Business
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Tracked enrollment and outcomes ... full record on ClinicalTrials.gov.
Tracked enrollment and outcomes ... full record on ClinicalTrials.gov.
Tracked enrollment and outcomes ... full record on ClinicalTrials.gov.
Tracked enrollment and outcomes ... full record on ClinicalTrials.gov.
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