OBJECTIVES: This study sought to determine the percentage of patients potentially eligible for implantation of the Sentinel™ Cerebral Protection System (Sentinel-CPS) during transcatheter aortic valve implantation (TAVI) and to identify the reasons for treatment exclusion. METHODS: We retrospectively performed an analysis of pre-TAVI multislice computed tomography (MSCT) aortograms and data review of all patients undergoing a TAVI procedure in 2017 (n = 317). MSCT evaluation included the assessment of aortic arch anatomy and the vascular dimensions of the brachiocephalic and left common carotid artery. Data analysis focused on comorbid conditions, precluding 6-Fr sheath radial access and filter deployment due to history of previous artery interventions. RESULTS: MSCT and data analysis showed Sentinel-CPS compatibility in 61.5% of patients (n = 195). Sentinel-CPS would have been contraindicated in 38.5% (n = 122) due to one or more of the following: (i) measured diameters of the filter-landing zones 15 mm in the brachiocephalic artery and 10 mm in the left common carotid artery (n = 116; 88 with carotid dimensions too small); (ii) significant subclavian artery stenosis (n = 4) or an aberrant subclavian artery (n = 3) precluding Sentinel-CPS implantation and (iii) clinical characteristics including hypersensitivity to nickel–titanium (n = 1), radial artery occlusion (n = 1) or previous left common carotid artery interventions (n = 5). CONCLUSIONS: MSCT and clinical data supported Sentinel-CPS compatibility in 61.5% of patients. The most common reason for treatment exclusion was inappropriate diameter within the target landing zone of the left carotid artery. Future device development should address this limitation.

Background The dual-filter Sentinel™ Cerebral Protection System (Sentinel-CPS) is increasingly used during transcatheter aortic valve replacement (TAVR). However, complex vascular anatomy may challenge Sentinel-CPS deployment. Aim of the study We sought to investigate the impact of anatomic features of the aortic arch and the supra-aortic arteries on technical device failure of Sentinel-CPS application. Methods Analysis of the multislice computed tomography pre-TAVR aortograms of all patients undergoing TAVR with Sentinel-CPS between 2016 and 2020 (n = 92) was performed. We investigated the impact of aortic arch anatomy, configuration, and the angles of the supra-aortic arteries, including the determination of vascular tortuosity index on device failure of Sentinel-CPS application. Results The Sentinel-CPS was applied successfully in 83 patients (90.2%). Device failure in nine patients (9.8%) was due to the infeasibility to perform correct deployment of both filters (n = 7) and to obtain peripheral radial access (n = 2). Patients with a failure of Sentinel-CPS application had a higher right subclavian tortuosity index (217 [92–324] vs. 150 [42–252], p = .046), a higher brachiocephalic tortuosity index (27 [5–51] vs. 10 [0–102], p = 0.033) and a larger angulation of the brachiocephalic artery (59° [22–80] vs. 39° [7–104], p = .014) compared with patients with successful application. A brachiocephalic angle more than 59° was predictive for device failure. No differences in aortic arch anatomy or common carotid artery tortuosity were detected between the groups. Conclusions Brachiocephalic tortuosity was found to be associated with failure of Sentinel-CPS application. Filter-based usage should be avoided in TAVR patients with a brachiocephalic angle more than 59°.

Background: The novel Navitor intra-annular self-expandable transcatheter aortic valve prosthesis is designed to improve coronary access, reduce paravalvular leaks, and enhance hemodynamic performance. Comparative data with the established Evolut platform (R, Pro, FX) are still lacking. This study aimed to evaluate the short-term clinical outcomes of Navitor (NAV) versus Evolut transcatheter heart valves. Methods: We conducted a single-center analysis of patients undergoing transfemoral TAVR between January 2015 and May 2024. A propensity score matching protocol including 18 baseline variables was used to balance baseline characteristics. Clinical outcomes were assessed using VARC-3 criteria. Results: Of 1067 TAVR patients, 210 were analyzed after matching—70 with the Nav valve and 140 with the Evolut valve. Baseline characteristics were comparable between groups, with a mean age of 80.9 ± 6.5 years in the NAV group and 80.7 ± 6.7 years in the Evolut group (p = 0.9). Both groups had an intermediate STS predicted risk of mortality, 3.9 ± 3.4% for NAV and 3.9 ± 3.2% for Evolut (p = 1.0). The effective aortic annulus diameter was comparable between the NAV (23.9 ± 1.5 mm) and Evolut group (23.9 ± 2.4 mm, p = 0.8). Hemodynamic performance at discharge was similar, with mean gradients of 7.5 ± 2.8 mmHg (NAV) vs. 7.4 ± 3.7 mmHg (Evolut, p = 0.9). Valve orifice areas and paravalvular leak rates showed no difference between the groups. Device success rates at discharge were good for both THVs: 89.3% for Evolut and 91.4% for NAV (p = 0.8). Disabling stroke occurred less frequently in the NAV group (0.0% vs. 7.1%, p = 0.033), while other early safety outcomes and 30-day mortalities were similar. Conclusions: The Navitor valve offers comparable hemodynamic performance, paravalvular leak rates, and procedural success to the Evolut platform. While early safety outcomes were largely similar, the Navitor valve was associated with a lower 30-day disabling stroke rate.

Background: Wild-type transthyretin amyloid cardiomyopathy (wtATTR-CM) is characterized by heart failure, conduction abnormalities and arrhythmias. The incidence of ventricular arrhythmias, particularly ventricular tachycardias (VTs), in wtATTR-CM is unclear. With the development of targeted therapies and improved overall prognosis, there is an unmet need to identify patients at high risk for VTs who might benefit from ICD therapy. Methods: Between 2017 and 2022, 72 patients diagnosed with wtATTR-CM were prospectively evaluated for the presence of ventricular arrhythmias using a Holter ECG. VTs were defined as >3 consecutive beats with a heart rate > 100 beats per minute originating from a ventricle. Results: The incidence of VTs was 44% (n = 32/72) in unselected wtATTR-CM patients. Patients with VT showed significantly more severe left ventricular (LV) hypertrophy (septum diameter 21 ± 2.6 vs. 19 ± 3.0 mm, p = 0.006), reduced LV ejection fraction (47 ± 8 vs. 52 ± 8%, p = 0.014) and larger left atria (32 ± 7 vs. 28 ± 6 mm², p = 0.020), but no differences in cardiac markers such as NTproBNP and troponin. In a multivariable model, LV hypertrophy (LV mass indexed, OR = 1.02 [1.00–1.03], p = 0.031), LV end-diastolic diameter (OR = 0.85 [0.74–0.98], p = 0.021) and LV end-systolic diameter (OR = 1.19 [1.03–1.349], p = 0.092) were predictive for VT occurrence with an area under the receiver operating characteristic of 0.76 [0.65–0.87]. Conclusions: The incidence of ventricular arrhythmia in wtATTR-CM is high and is associated with an advanced stage of left ventricular disease. Further studies are needed evaluating the role of VTs in predicting sudden cardiac death and the benefit of ICD therapy in wtATTR-CM.

Objectives: The optimal surgical approach for the treatment of functional mitral regurgitation (FMR) remains controversial. Current guidelines suggest that the surgical approach has to be tailored to the individual patient. The aim of the present study was to clarify further aspects of this tailored treatment. Methods: From 01/2006 to 12/2015, 390 patients underwent mitral valve (MV) surgery for FMR (ischemic n = 241, non-ischemic n = 149) at our institution. A regression analysis was used to determine the effect of MV repair or replacement on survival. The patients were analyzed according to the etiology of the MR (ischemic or non-ischemic), different age groups (75 years), LV function, and LV dimensions, as well as the underlying heart rhythm. Results: The overall survival rates for the repair group at 1, 5, and 8 years were 86.1 ± 1.9%, 70.6 ± 2.6%, and 55.1 ± 3.1%, respectively. For the same intervals, the survival rates in patients who underwent MV replacement were 75.9 ± 4.5%, 58.6 ± 5.4%, and 40.9 ± 6.4%, respectively (p = 0.003). Patients younger than 65 years, with an ischemic etiology of FMR, poor ejection fraction ( 60mm), and presence of atrial fibrillation had significantly higher mortality rates after MV replacement (HR, 3.0; CI, 1.3–6.9; p = 0.007). Patients between 65 and 75 years of age had a higher risk of death when undergoing mitral valve replacement (HR, 1.7; CI, 1.0–2.8; p = 0.04). In patients older than 75 years, the surgical approach (MV repair or replacement) had no effect on postoperative survival (HR, 0.8; CI, 0.4–1.3; p = 0.003). Conclusions: Our data demonstrate that, in patients younger than 65 years, the treatment of choice for FMR should be MV repair. This advantage was even more evident in patients with an ischemic origin of MR, a poor ejection fraction, a severe LV dilatation, and atrial fibrillation.

Purpose The Sentinel Cerebral Protection System (Sentinel‐CPS) is increasingly used in transcatheter aortic valve replacement (TAVR). However, the impact of inserting the Sentinel‐CPS inside the brain‐supplying arteries on cerebral perfusion and oxygenation is unknown. Methods Twenty patients undergoing transfemoral TAVR with (n = 10) and without (n = 10) cerebral embolic protection using the Sentinel‐CPS were prospectively observed. All patients received conscious sedation and cerebral oxygen saturation (rSO₂) was continuously measured with near‐infrared spectroscopy (NIRS). The cumulative perioperative cerebral desaturation was calculated for each patient by multiplying rSO₂ below an individualized desaturation threshold by time. In addition, rSO₂ values at the time of Sentinel‐CPS insertion, filter positioning, and device retraction were analyzed. Results There was no significant difference in cumulative cerebral desaturation in patients with Sentinel‐CPS (median [IQR]) (0 [0/81] s%) and without (median [IQR]) (0 [0/23] s%), p = .762. A total of 6 patients (33.3%) experienced a perioperative decrease in rSO₂ below the individualized desaturation threshold (n = 3 with Sentinel‐CPS, n = 3 without Sentinel‐CPS; p = 1.000). Cerebral desaturation was detected during valve deployment (n = 5) and after postdilatation (n = 1). No desaturation events occurred during Sentinel‐CPS insertion, filter positioning, or retraction. Conclusion Our pilot study revealed no difference in cumulative perioperative cerebral desaturation between TAVR with and without Sentinel‐CPS. Catheter‐ and filter‐based manipulations in the brain‐supplying arteries for Sentinel‐CPS application were not associated with a decrease of cerebral perfusion and oxygenation.