SGLT2-inhibitors in diabetic patients with severe aortic stenosis and cardiac damage undergoing transcatheter aortic valve implantation (TAVI).

A substantial number of patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) experience adverse events after TAVI, with health care expenditure. We aimed to investigate cardiac remodeling and long-term outcomes in diabetic patients with severe AS, left ventricular ejection fraction (LVEF) < 50%, and extra-valvular cardiac damage (EVCD) undergoing TAVI treated with sodium-glucose cotransporter-2 inhibitors (SGLT2i) versus other glucose-lowering strategies (no-SGLT2i users). Multicenter international registry of consecutive diabetic patients with severe AS, LVEF < 50%, and EVCD undergoing TAVI. Based on glucose-lowering therapy at hospital discharge, patients were stratified in SGLT2i versus no-SGLT2i users. The primary endpoint was a composite of all-cause death and heart failure (HF)-hospitalization (major adverse cardiovascular events, MACE) at 2-year follow-up. Secondary outcomes included all-cause death, cardiovascular death, and HF hospitalization. The study population included 311 patients, among which 24% were SGLT2i users. Within 1-year after TAVI, SGLT2i users experienced a higher rate of LV recovery (p = 0.032), especially those with baseline LVEF ≤ 30% (p = 0.026), despite the lower baseline LVEF. Patients not treated with SGLT2i were more likely to progress to a worse EVCD stage over time (p = 0.018). At 2-year follow-up, SGLT2i use was associated with a lower rate of MACE, all-cause death, and HF hospitalization (p < 0.01 for all). After adjusting for confounding factors, the use of SGLT2i emerged as an independent predictor of reduced MACE (HR = 0.45; 95% CI 0.17-0.75; p = 0.007), all-cause death (HR = 0.51; 95% CI 0.25-0.98; p = 0.042) and HF-hospitalization (HR = 0.40; 95% CI 0.27-0.62; p = 0.004). In diabetic patients with severe AS, LVEF < 50%, and EVCD undergoing TAVI, the use of SGLT2i was associated with a more favorable cardiac remodeling and a reduced risk of MACE at 2-year follow-up.

Paolisso P ，Belmonte M ，Gallinoro E ，Scarsini R ，Bergamaschi L ，Portolan L ，Armillotta M ，Esposito G ，Moscarella E ，Benfari G ，Montalto C ，Shumkova M ，de Oliveira EK ，Angeli F ，Orzalkiewicz M ，Fabroni M ，Baydaroglu N ，Munafò AR ，D'Atri DO ，Casenghi M ，Scisciola L ，Barbieri M ，Marfella R ，Gragnano F ，Conte E ，Pellegrini D ，Ielasi A ，Andreini D ，Penicka M ，Oreglia JA ，Calabrò P ，Bartorelli A ，Pizzi C ，Palmerini T ，Vanderheyden M ，Saia F ，Ribichini F ，Barbato E ... -  《Cardiovascular Diabetology》

Impact of Baseline Left Ventricular Ejection Fraction on Midterm Outcomes in Women Undergoing Transcatheter Aortic Valve Implantation: Insight from the WIN-TAVI Registry.

Limited evidence exists concerning the prognostic impact of baseline left ventricular ejection fraction (LVEF) on outcomes among women undergoing transcatheter aortic valve implantation (TAVI), which we aimed to investigate in the present analysis. Patients from the Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized according to baseline LVEF into 3 groups: reduced (LVEF ≤40%), mildly reduced (LVEF between 41% and 49%), and preserved (LVEF ≥50%) LVEF. The primary (Valve Academic Research Consortium 2 [VARC-2]) efficacy point was defined as a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure, or valve-related dysfunction at 1 year. The primary (VARC-2) safety end point included all-cause mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 to 3 acute kidney injury, coronary artery obstruction requiring intervention, or valve-related dysfunction requiring repeated procedures. A Cox regression model was performed using the preserved LVEF group as the reference. Among the 944 patients included, 764 (80.9%) exhibited preserved, 80 (8.5%) had mildly reduced, and 100 (10.6%) had reduced LVEF. The 1-year incidence of VARC-2 efficacy end point was numerically higher in patients with reduced LVEF, albeit not resulting in a significant risk difference. Notably, reduced LVEF was associated with a higher risk of the 1-year VARC-2 safety end point, still significant after adjustment (28.0% vs 19.6%, Hazard Ratio 1.78, 95% Confidence Interval 1.12- 2.82, p = 0.014). These differences were primarily driven by trends toward increased rates of all-cause mortality, cardiovascular mortality, and major vascular complications. Clinical outcomes were similar between patients with mildly reduced and preserved LVEF. In conclusion, when performed in women with reduced LVEF, TAVI was associated with a worse (VARC-2) safety profile at 1-year follow-up. In contrast, patients with mildly reduced LVEF appeared to align more closely with outcomes observed in the preserved LVEF group than with the reduced LVEF group.

Di Muro FM ，Vogel B ，Sartori S ，Tchetche D ，Feng Y ，Petronio AS ，Mehilli J ，Bay B ，Gitto M ，Lefevre T ，Presbitero P ，Capranzano P ，Oliva A ，Iadanza A ，Sardella G ，Van Mieghem N ，Meliga E ，Leone PP ，Dumonteil N ，Fraccaro C ，Trabattoni D ，Mikhail G ，Ferrer-Gracia MC ，Naber C ，Sharma SK ，Watanabe Y ，Morice MC ，Dangas G ，Chieffo A ，Mehran R ... -  《-》

Transcatheter aortic valve implantation for combined aortic and mitral stenoses: Insights from the OCEAN-TAVI Registry.

Mitral stenosis (MS) occasionally coexists with aortic stenosis (AS). Limited data are available regarding the functional class and clinical outcomes of patients who undergo transcatheter aortic valve implantation (TAVI) for combined AS and MS. This study compared the clinical outcomes in patients with and without MS who underwent TAVI for severe AS and assessed the impact of mitral annulus calcification (MAC) severity, transmitral gradient (TMG) and mitral valve area (MVA) on outcomes in patients with combined AS and MS. We investigated patients in the OCEAN-TAVI registry who underwent TAVI. MS was defined as an MVA ≤ 1.5 cm2 or TMG ≥ 5 mmHg. The composite of all-cause death and admission for heart failure was compared between patients with and without MS. The impact of MAC, TMG and MVA on outcomes was assessed in patients with combined AS and MS. We identified 106 patients with MS (MAC 84%; TMG 6.4 ± 2.6 mmHg; MVA 1.10 ± 0.31 cm2) and 6570 without MS as controls. The MS group was older (85 ± 5 vs. 84 ± 5 years, P = 0.033), more of women (85 vs. 67%, P < 0.01), and had a higher risk of surgery (the Society of Thoracic Surgeons Mortality Score 8.7 ± 5.1 vs. 7.6 ± 5.9, P = 0.047) than the controls. In the MS group, the New York Heart Association Functional Class was 3 or 4 in 56% of the patients at baseline and 6% at 1 year after TAVI. Thirty-day mortality (2.8% vs. 1.3%, P = 0.18) and early composite outcomes (17% vs. 15%, P = 0.56) were comparable between patients with and without MS. During a median follow-up of 2.1 years, the presence of MS was associated with a higher incidence of adverse events compared with controls (adjusted hazard ratio [HR] 1.84; 95% confidence interval [CI] 1.34-2.51, P < 0.01), even on propensity score matched analysis (adjusted HR 1.91; 95% CI 1.14-3.22, P < 0.01). Moderate or severe MAC contributed to increased risk of adverse events in patients with MS (adjusted HR 2.89; 95% CI 1.20-6.99, P = 0.018), but TMG and MVA did not. In patients undergoing TAVI for severe AS, those with moderate or severe MS experienced worse outcomes after TAVI compared with those without MS. Patients with combined AS and MS sustained symptom improvement at 1-year post-TAVI. MAC severity was a useful predictor of adverse events compared with MS haemodynamics such as TMG and MVA in patients with combined AS and MS.

Kato N ，Tabata M ，Noguchi M ，Ito J ，Obunai K ，Watanabe H ，Yashima F ，Shirai S ，Tada N ，Naganuma T ，Yamawaki M ，Yamanaka F ，Ueno H ，Ohno Y ，Izumo M ，Nishina H ，Asami M ，Watanabe Y ，Yamamoto M ，Otsuka T ，Hayashida K ，OCEAN‐TAVI investigators ... -  《ESC Heart Failure》

Long-term prognostic value of the H(2)FPEF score in patients undergoing transcatheter aortic valve implantation.

A considerable proportion of candidates for transcatheter aortic valve implantation (TAVI) have underlying heart failure (HF) with preserved ejection fraction (HFpEF), which can be challenging for diagnosis because significant valvular heart disease should be excluded before diagnosing HFpEF. This study investigated the long-term prognostic value of the pre-procedural H2FPEF score in patients with preserved ejection fraction (EF) undergoing TAVI. Patients who underwent TAVI between October 2013 and May 2017 were enrolled from the Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation Japanese multicentre registry. After excluding 914 patients, 1674 patients with preserved EF ≥ 50% (median age: 85 years, 72% female) were selected for calculation of the H2FPEF score and were dichotomized into two groups: the low H2FPEF score [0-5 points; n = 1399 (83.6%)] group and the high H2FPEF score [6-9 points; n = 275 (16.4%)] group. Patients with high H2FPEF scores were associated with a higher prevalence of New York Heart Association Functional Class III/IV (59.3% vs. 43.7%, P < 0.001), diabetes (24.4% vs. 18.5%, P = 0.03), and paradoxical low-flow, low-gradient aortic stenosis (15.9% vs. 6.2%, P < 0.001). These patients showed worse prognoses than those with low H2FPEF scores regarding the cumulative 2 year all-cause mortality (26.3% vs. 15.5%, log-rank P < 0.001), cardiovascular mortality (10.5% vs. 5.4%, log-rank P < 0.001), HF hospitalization (16.2% vs. 6.7%, log-rank P < 0.001), and the composite endpoint of cardiovascular mortality and HF hospitalization (23.8% vs. 10.8%, log-rank P < 0.001). After adjustment for several confounders, the high H2FPEF scores were independently associated with increased risk for all-cause mortality [adjusted hazard ratio (HR), 1.48; 95% confidence interval (CI), 1.09-2.00; P = 0.011] and for the composite endpoint of cardiovascular mortality and HF hospitalization (adjusted HR, 1.95; 95% CI, 1.38-2.74; P < 0.001). Subgroup analysis confirmed the excess risk of high H2FPEF scores relative to low H2FPEF scores for the composite endpoint of cardiovascular mortality and HF hospitalization increased with a lower Society of Thoracic Surgeons (STS) score (STS score <8%: adjusted HR, 2.40; 95% CI, 1.50-3.85; P < 0.001; STS score ≥8%: adjusted HR, 1.34; 95% CI, 0.79-2.28; P = 0.28; Pinteraction = 0.030). The H2FPEF score is useful for predicting long-term adverse outcomes after TAVI, including all-cause mortality, cardiovascular mortality, and HF hospitalization for patients with preserved EF. More aggressive interventions targeting HFpEF in addition to the TAVI procedure might be relevant in patients with high H2FPEF scores, particularly in those with a lower surgical risk.

Ishizu K ，Shirai S ，Isotani A ，Hayashi M ，Tabata H ，Ohno N ，Kakumoto S ，Ando K ，Yashima F ，Tada N ，Yamawaki M ，Naganuma T ，Yamanaka F ，Ueno H ，Tabata M ，Mizutani K ，Takagi K ，Watanabe Y ，Yamamoto M ，Hayashida K ，OCEAN‐TAVI Investigators ... -  《ESC Heart Failure》

Impact of prior hospitalization for heart failure on clinical outcomes of patients after transcatheter aortic valve implantation with new-generation devices: Insights from the LAPLACE-TAVI registry.

A history of hospitalization for heart failure (HHF) before transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement is associated with the prognosis of patients with severe aortic stenosis (AS). However, the impact of prior HHF on clinical outcomes after contemporary TAVI using new-generation transcatheter heart valves (THVs) has not been thoroughly investigated. Using data from the aLliAnce for exPloring cLinical prospects of AortiC valvE disease (LAPLACE)-TAVI registry, we investigated 2,752 patients who underwent TAVI with new-generation THVs with a median follow-up of 627 days. The primary outcomes were all-cause mortality and heart failure readmission after TAVI. Patients with a history of HHF (n = 809) showed a higher 30-day mortality than patients without prior HHF (n = 1,943). A Kaplan-Meier analysis revealed that the prior HHF group showed a higher incidence of the primary outcome than the non-prior HHF group (27.4% vs. 16.4%, log-rank p = 0.001). In a Cox regression analysis, prior HHF was significantly associated with the risk of the primary outcome, even after adjusting for covariates (hazard ratio, 1.344; 95% confidence interval, 1.103-1.638; p = 0.003). A subanalysis showed that the prior HHF group with ejection fraction (EF) ≥ 50% had a higher risk of the primary outcome than the non-prior HHF group, whereas the prior HHF group with EF < 50% had the worst outcome. A history of prior HHF is associated with worse outcomes in patients with severe AS, both in those with preserved EF and those with reduced EF, even after TAVI using new-generation devices.

Fukutomi M ，Onishi T ，Ando T ，Higuchi R ，Hagiya K ，Saji M ，Takamisawa I ，Iguchi N ，Takayama M ，Shimizu A ，Shimizu J ，Doi S ，Okazaki S ，Sato K ，Tamura H ，Yokoyama H ，Takanashi S ，Tobaru T ... -  《-》