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.

Two-in-one: A case report of a touchy TAVI procedure with a new valve.

Implantation of a second transcatheter heart valve (THV) into a primary THV is a bail-out situation, but may be necessary. An 85-year-old woman was referred with severe symptomatic aortic stenosis (AS). Echocardiography showed a moderately calcified AS. Computed tomography resulted in an average annular diameter of 22.3 mm and an area of 371 mm2 , leading to M-sized ACURATE NEO implantation. Deployment of the upper valve part was uneventful. During lower valve part deployment, the valve dived into the left ventricle outflow tract with the stabilization arches above the annular plane. With the SAFARI guidewire in place, a second M-sized ACURATE NEO was implanted higher inside the first displaced valve. Deployment was straightforward, with no aortic leak, no mitral regurgitation and the patient had normal hemodynamic parameters. Follow-up was uneventful. Positioning a second ACURATE NEO into a failing primary ACURATE NEO is feasible and safe, with favorable short and longer-term outcome.

A four-leaf clover: A case report of quadricuspid aortic valve stenosis.

BACKGROUND: We present the case of a patient with severe quadricuspid aortic valve (QAV) stenosis who underwent treatment with transcatheter aortic valve implantation (TAVI). CASE SUMMARY: An 87-year-old woman was referred to our department with severe aortic stenosis. Computed tomography angiography revealed a QAV with four separate equal-sized leaflets, similar in appearance to a four-leaf clover. The patient underwent successful implantation of a 23 mm Edwards Sapien 3 transcatheter valve via left transfemoral access. The valve positioning across the aortic annulus was fluoroscopically challenging due to difficulty visualizing all four cusps in only one two-dimensional view and to the position of the left main coronary artery, which was very low. The immediate result of the TAVI was good, with no aortic regurgitation and no coronary damage. Follow-up to 6 months was free of event. CONCLUSION: This case demonstrates that QAV stenosis can be treated using TAVI with good clinical outcomes.

Optimizing pacemaker longevity with pacing mode and settings programming: results from a pacemaker multicenter registry.

BACKGROUND: This study aimed to describe the influence on dual-chamber devices' expected longevity of devices' settings. METHODS: Data from patients implanted with dual chamber devices (Symphony™, SORIN CRM SAS, Clamart, France) from 2003 to 2006 were collected in registries. Programmer files were retrieved: device-estimated longevity, assessed through algorithm prediction, was analyzed according to device settings. RESULTS: One thousand sixty-eight recipients of dual chamber pacemaker in sinus rhythm (75.3±11.1 years, 54.5% male, ventricular block 30%, brady-tachy syndrome 21%, and sinus node dysfunction 49%) were followed up to 14.2±12.1 months (ranging from first quartile Q1: 2.9 months to fourth quartile Q4: 49.3 months) after implantation. DDD with automatic mode conversion and minimized ventricular pacing (SafeR) modes were programmed in 34.3%, 2.9%, and 62.8% of the patients, respectively. The mean total longevity estimated by the device was 134.1±31.5 months (11.2±2.6 years). Significant increase in longevity was observed in devices undergoing at least one reprogramming (134.4±31.4 months) versus device presenting no reprogramming (103.4±32.3 months, P=0.0005). The parameters associated with the major increase in mean longevity were the mode (mean longevity increase of +23.9 months in SafeR as compared to DDD mode, P<0.0001) and the atrial (A) and ventricular (V) amplitudes (mean longevity increase of +29.6 and +26.9 months for a decrease of less than 1V in A and V outputs respectively, P<0.0001). CONCLUSION: This study provides information on dual chamber pacemakers' longevity and highlights the impact of devices' reprogramming on expected longevities.