Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial.

BACKGROUND: Safety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR vs BAV pre-TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519). METHODS: Clinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n = 228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation). RESULTS: Median follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ± 6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, P = 0.6). Prevalence of predicted prothesis-patient mismatch was low (n = 13 [11.4%] in the direct TAVR group vs n = 15 [13.2%] in BAV group) and similar between both groups (P = .7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (P = .4, P = .7, P = .3, and P = .3 respectively). CONCLUSION: Direct implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible. CLINICAL TRIALS REGISTRATION NUMBER: NCT05140317.

Evaluation of the safety and efficacy of the Axiostat® dressing device to achieve radial artery access hemostasis: The R3A study.

BACKGROUND: Radial access is the default approach in interventional cardiology. The Axiostat® surgical hemostatic dressing, using chitosan as its active component, has demonstrated potential in accelerating blood clotting. This study aims to assess the efficacy and the safety of the Axiostat® dressing in achieving hemostasis in patients undergoing transradial coronary angioplasty (TRCA). METHODS: This prospective, single-center observational study, conducted in 2022, enrolled consecutive patients undergoing TRCA, with a target of 150 participants. The primary outcome was the success rate of radial artery hemostasis at 120 min, without bleeding necessitating immediate re-compression. The secondary outcome included Axiostat® performance at 24 h and 30 days Postprocedure. RESULTS: The study was terminated prematurely for ethical and patient safety reasons, after inclusion of 41 consecutive TRCA patients due to an unexpectedly high radial artery thrombosis rate (19.5%, n = 8/41) observed 24 h Postprocedure. The success rate of radial hemostasis with the Axiostat® dressing was 78.0%. Procedural details and patient characteristics were comparable between successful Axiostat® removal and device failure cases. CONCLUSION: The use of the Axiostat® dressing to achieve hemostasis after TRCA is effective but is associated with an unexpectedly high incidence of radial thrombosis. Our results should encourage caution in the future evaluation and use of this device for radial artery compression following TRCA.

Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

BACKGROUND: The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. PURPOSE: We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. METHODS: Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. RESULTS: The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). CONCLUSION: Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.

Identification of Low- versus High-Risk Acute Coronary Syndrome for a Selective ECG Monitoring Strategy.

BACKGROUND: While admission of patients with acute coronary syndromes (ACS) in cardiology intensive care unit (CICU) is usual, in-hospital major outcomes in lower risk patients may be evaluated after early coronary angiography according to the European guidelines. METHODS: Consecutive ACS patients were prospectively included after coronary angiography evaluation within 24 h and percutaneous coronary intervention (PCI), when required. Patients were classified as high- or low-risk according to hemodynamics, rhythmic state, ischemic and bleeding risks. Major in-hospital outcomes were assessed. RESULTS: From January to June 2021, 277 patients were enrolled (62.8% with ST-segment elevation myocardial infarction (STEMI) (n = 174); 37.2% with non-NSTEMI (NSTEMI) (n = 103). PCI was required for 260 patients (93.9%). Seventy-four patients (26.7%) were classified as low-risk (n = 47 NSTEMI; n= 27 STEMI) and 203 patients (73.3%) as high-risk of events. All patients were monitored in CICU. While 38 patients (18.7%) from the high-risk group reached the primary endpoint, mainly related to rhythmic or conduction disorder (n = 24, 11.8%) or unstable hemodynamics (n = 17; 8.4%), only 1 patient (1.3%) in the low-risk group had one major outcome (no fatal bleeding); p < 0.01. The negative predictive value of our patient stratification for the absence of major in-hospital outcome was 100% (CI95%: 100-100%) for STEMI and 97.9% [CI95%: 93.2-100%] for NSTEMI patients. CONCLUSIONS: Stratification of ACS patients after early coronary angiography and most of the time PCI, identify a population with very low risk of in-hospital events (1/4 of all ACS and 1/2 of NSTEMI) who may probably not require ECG monitoring and/or CICU admission. (NCT04378504).

[Monocentric experience of the RenalGuard® system to limit post-contrast acute kidney injury in patients at high-risk undergoing interventional coronary procedures]. / Expérience monocentrique du système RenalGuard® pour limiter l'insuffisance rénale aiguë post-contraste après une procédure coronaire interventionnelle chez des patients à haut risque.

BACKGROUND: Despite an often favorable risk/benefit ratio, patients with severe chronic kidney disease are sometimes declined for interventional coronary procedures, due to the risk of acute kidney injury post-contrast (AKI-PC). A large preventive supply of intravenous fluid may be problematic in this population. The RenalGuard® system allows hyperhydration by maintaining a stable volemia through an enhanced diuresis. METHODS AND RESULTS: This work reports the evaluation of the RenalGuard® system in 25 consecutive patients with chronic kidney disease (glomerular filtration rate < 40 mL/min/1.73 m²) requiring an interventional coronary procedure (coronary angiography and/or percutaneous coronary intervention) and at high risk of IRA-PC. An increase in serum creatinine ≥ 26.5 µmol/L at 48-72 hours (AKI-PC definition) was observed in 4 patients (16%). The mean glomerular filtration rate was 26 ± 8 mL/min/1.73 m² at 48-72 hours versus 25 ± 8 mL/min/1.73 m² at baseline. No patient presented with an increase in serum creatinine ≥ 1.5 from baseline, stage 2 or 3 AKI, or acute pulmonary edema. No renal replacement therapy was necessary. One death unrelated to AKI-PC occurred during hospital stay. CONCLUSIONS: This single-center observational study suggests that the RenalGuard® system, allowing diuresis-adjusted hyperhydration, is safe and useful for patients at high risk of AKI-PC after an interventional coronary procedure.

Case report: takotsubo cardiomyopathy after transcatheter aortic valve-in-valve replacement.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a first-line therapeutic option in patients with severe, symptomatic aortic stenosis at increased surgical risk. Despite its success, the TAVI procedure has been associated with acute life-threatening complications as myocardial infarction secondary to periprocedural coronary occlusion, annular rupture, or vascular injury. CASE SUMMARY: A 79-year-old woman with a dysfunctional bioprosthetic valve following previous surgical valve replacement was hospitalized in our institution to perform a Valve-in-Valve Transcatheter Aortic Valve Replacement (ViV TAVR). Shortly after the implantation of an Evolut R valve (without complication), left ventricle dysfunction with apical akinesia and basal hyperkinesia was identified during bedside transthoracic echocardiography, in spite of a good prosthesis implantation and function. A concomitant Troponin elevation was noted, and the day-after resting electrocardiogram showed a lateral T-wave inversion. Coronary computed tomography angiography showed no coronary stenosis or occlusion, cardiac magnetic resonance imaging showed no necrosis or fibrosis, and no argument for myocarditis. The patient remained asymptomatic during her hospital stay, and the aforementioned anomalies spontaneously regressed after an in-hospital 2-week surveillance. In the presence of these transient anomalies and after ruling out myocardial infarction and myocarditis, post-procedural stress cardiomyopathy (takotsubo) was diagnosed. DISCUSSION: Post-TAVR stress-related cardiomyopathy seems to be an extremely rare entity. To our knowledge, this is the first case of a takotsubo cardiomyopathy after ViV TAVR. Though the association between the two seems likely to be causal, no clear physiopathological explanation can be formulated.