Safety and Efficacy of Mini-Invasive Left Atrial Appendage Closure: A Propensity-Score Analysis.

BACKGROUND: Left atrial appendage closure (LAAC) for prevention of stroke is validated in patients with nonvalvular atrial fibrillation (NVAF) contraindicated to oral anticoagulation. General anaesthesia (GA) is often used for procedural guidance by transesophageal echocardiography (TEE); however, its use may be challenging in some patients. The aim of the study was to evaluate the safety and the midterm efficacy of a mini-invasive LAAC strategy using micro-TEE under procedural sedation. METHODS: Comparison by propensity score of 2 cohorts of consecutive patients who underwent LAAC: standard TEE-guided LAAC (3-dimensional [3D] TEE under GA) and mini-invasive LAAC strategy (micro-TEE under procedural sedation). The primary endpoint was a composite of embolic or bleeding events, significant per procedural complication, and cardiovascular deaths within 3 months after LAAC. RESULTS: In total, 432 patients were included (78.7 ± 8 years old, 32.4% of women, CHA2DS2VASC score: 4.9 ± 1.1); 127 patients underwent mini-invasive LAAC strategy and were compared with 305 patients standard TEE-guided LAAC. The mini-invasive strategy was achieved in 122 of 127 (96.1%) planned patients. The primary endpoint occurred in 11.2% of patients from the mini-invasive LAAC strategy group and in 10.3% of patients from the standard TEE group (absolute difference = 0.9% [-6.4; 4.5], hazard ratio = 1.11 [0.56; 2.19], P = 0.76). Procedural times, fluoroscopy duration, and hospital stays were shorter in the mini-invasive LAAC strategy group (P < 0.001). CONCLUSIONS: The mini-invasive LAAC strategy is safe and effective compared with the standard TEE-guided LAAC strategy. A mini-invasive LAAC strategy may also be an important tool to help physicians to treat more patients as LAAC indications evolve in the future.

Transfemoral versus trans-subclavian access in transcatheter aortic valve implantation using self-expandable valve: A propensity-matched comparison.

BACKGROUND: Transcatheter aortic valve implantation is unfeasible for 10-15% of patients using the conventional transfemoral approach. Other alternative approaches, such as the subclavian approach, have emerged, with no clear recommendation indicating the superiority of one technique over another. AIM: To compare the 1-month mortality and postprocedural outcomes of patients undergoing transcatheter aortic valve implantation using a self-expandable valve via transfemoral and subclavian access. METHODS: This was a retrospective single-centre study including 1496 patients who underwent transcatheter aortic valve implantation between January 2016 and December 2020 at Clermont-Ferrand University Hospital, France. Propensity score matching was used to compare transfemoral and subclavian access. RESULTS: After building two propensity score-matched groups of 221 patients each with either access route (total n=442), baseline characteristics were similar. The procedure duration was significantly longer in the subclavian access group (53 [45-64] versus 60 [51-72] minutes; P<0.001), but with a lower amount of contrast agent (138 [118-165] versus 123 [105-150] mL; P<0.001), fluoroscopy time (11.2 [9-14] versus 9.9 [7-12] minutes; P<0.001) and radiation dose (397 [264-620] versus 321 [217-485] mGy; P<0.001). No significant difference was observed concerning 1-month mortality (odds ratio 1.62, 95% confidence interval 0.52-5.03; P=0.39) or periprocedural complications. Follow-up at 1 year confirmed no difference in longer-term mortality (hazard ratio 0.78, 95% confidence interval 0.52-5.03; P=0.43). CONCLUSIONS: The subclavian approach provides similar results to the transfemoral approach in terms of mortality, efficacy and safety; it is a reasonable and effective alternative when the reference transfemoral approach is impossible or seems complex.

Remote management of worsening heart failure to avoid hospitalization in a real-world setting.

AIMS: From a patient and health system perspective, managing worsening heart failure (WHF) as an outpatient has become a priority. Remote management allows early detection of WHF, enabling timely intervention with the aim of preventing hospitalization. The objective of the study was to evaluate the feasibility and safety of remotely managing WHF events using a multiparametric platform. METHODS AND RESULTS: All patients enrolled in the heart failure remote management programme of the Bordeaux University Hospital Telemedicine Center between 1 January and 31 December 2021 were included in the study. Follow-up data were collected until 1 March 2022. Inclusion criteria were chronic heart failure (HF) with New York Heart Association ≥II symptoms and an elevated B-type natriuretic peptide (BNP > 100 pg/mL or N-terminal-pro-BNP > 1000 pg/mL). Patient assessments were performed remotely and included measurements of body weight, blood pressure, heart rate, symptoms, biochemical parameters, and data from cardiac implantable electronic devices when available. In total, 161 patients (71 ± 11 years old, 79% male) were followed for a mean of 291 ± 66 days with a mean adherence to the remote monitoring system of 80 ± 20%. Over this period, 52 (32.3%) patients had 105 WHF events, of which 66 (63%) were successfully managed remotely, the remaining requiring hospitalization. Freedom from WHF events and hospitalization at 300 days were 66% and 85%, respectively (P < 0.001 for the difference). Increased level of BNP was associated with an increased risk of WHF event [hazard ratio (HR) per unit increase in BNP: 1.001; 95% confidence interval (CI) 1-1.002; P = 0.001] and hospitalization (HR 1.002; 95% CI 1.002-1.003; P = 0.002). A decrease in the level of glomerular filtration rate was associated with an increased risk of hospitalization (HR per unit decrease in estimated glomerular filtration rate: 0.946; 95% CI 0.906-0.989; P = 0.014). WHF event recurrence and (re)hospitalization rates at 1-month were similar among patients managed remotely (18% and 12%, respectively) and those requiring hospitalization (21% and 10%, respectively). Iatrogenic complications occurred more often during hospitalization than remote management (26% vs. 3%, P < 0.001). CONCLUSIONS: Our study suggests that remote management of WHF events based on a multiparametric approach led by a telemedical centre is feasible and safe. Adopting such a strategy for patients with chronic HF could reduce HF-related hospitalizations with expected benefits for patients, care providers, and health care systems.

Leaflet disruption of ViV-TAVI after bioprosthetic valve fracture leading to severe aortic regurgitation: a case report.

Background: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as an alternative for the treatment of degenerated bioprosthetic valves (BPVs) for high surgical risk patients. However, this procedure often results in patient-prosthesis mismatch. BPV fracture is a novel technique to address this problem. From now, complications following BPV fracture are few. Case summary: We present the case of a 84-year-old female with history of first surgical aortic BPV replacement with a Mitroflow Sorin 23 mm due to severe aotic stenosis in 2009. In 2017, a second intervention due to bioprosthetic aortic valve stenosis valve was performed with valve-in-valve TAVI with CoreValve Evolut R 23 mm. In 2021, she was admitted with severe heart failure due to TAVI degeneration with severe stenosis in the bioprothesis. After heart team discussions, the patient was deemed inoperable for new heart surgery and considered as a candidate for BPV fracture as last possible alternative. After BPV fracture was performed, the patient suffered acute hypotension. Urgent transoesophageal echocardiography and angiogram demonstrated severe acute intra-TAVI aortic insufficiency because of probable disruption of the CoreValve leaflets. The patient was successfully treated with a ViV 23 mm SAPIEN three Edwards valve with a resolution of the aortic insufficiency and improvement of her haemodynamics. The patient remains asymptomatic after 6 months, with improvement in clinical status. Discussion: This case demonstrates a disruption of the transcatheter heart valve leaflets causing severe aortic regurgitation as one of the complication of BPV fracture. To our knowledge, this is the first report of a TAVI in a patient who was already operated with ViV-TAVI. Although case series described few complications with improvement in clinical status, the procedure should be established with appropriate planning and careful technique.

Handgrip strength to screen early-onset sarcopenia in heart failure.

BACKGROUND & AIMS: Sarcopenia in heart failure (HF) is associated with severe outcomes, increased mortality, and high healthcare cost burden. Systematic muscle screening in patients with chronic HF would improve quality and appropriateness of care. Here we tested handgrip strength (HGS) as a screening tool for sarcopenia in patients with chronic HF, using the EWGSOP 2010 and 2019 reference-standard definitions of sarcopenia. METHODS: HF inpatients, aged 65 years old or above, were prospectively included between November 2014 and September 2018, and relevant sociodemographic, anthropometric and HF characterization data was collected. The accuracy of HGS as a screening test for sarcopenia was assessed by gender using area under the receiver operating characteristic (ROC) curves (AUC). RESULTS: The population consisted of 118 older patients (age: 78.9 yrs; BMI: 26.6 kg/m2) with a mean HGS of 16.1 kg (SD 4.6) in women and 26.5 kg (SD 6.7) in men. Factors associated with HGS were age (p = 0.005), Instrumental Activity of Daily Living (p = 0.001), and heart rate (p = 0.034). Screening was positive (patients confirmed as sarcopenic by the HGS test) with cut-off values of 18 kg for women and 27 kg for men, with ROC analysis giving a sensitivity of 85.7% in women and 88.2% in men. CONCLUSIONS: HGS can be used as a valid tool to screen for sarcopenia in older (≥65 yrs) patients with chronic HF. CLINICAL TRIAL REGISTRATION: NCT03153774.

Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact.

BACKGROUND & AIMS: Sarcopenia is a multifactorial syndrome resulting in a decrease in both muscle mass and function. Little is known about the prevalence and prognostic impact of sarcopenia in patients with acutely decompensated chronic heart failure (ADHF). We aimed to evaluate the prevalence (main endpoint) and impact of sarcopenia on ADHF patients. METHODS: 140 ADHF patients were enrolled between November 2014 and September 2018 in a multicenter prospective longitudinal study. A similar, independent multi-departmental cross-sectional study in 165 ADHF patients was used for external validation of prevalence data. All subjects were assessed on the European Working Group on Sarcopenia criteria. RESULTS: Ninety-one patients (65%) had sarcopenia (vs. 53.6% in the external replication regional cohort). Patients with sarcopenia were older and more likely to have eGFR <60 ml/min/1.73 m2 (p < 0.001 and p = 0.002). Sarcopenia was associated with impaired functional status [lower 6 min walking test (220 ± 108 vs. 279 ± 170, p = 0.03) and 4 m gait speed (0.56 ± 0.24 vs. 0.80 ± 0.37, p < 0.001)] and autonomy [Instrumental activities of daily living: 6.7 ± 1.4 vs. 7.3 ± 1.2, p = 0.005]. Over up to 4 years' follow-up, 30 cardiovascular (CV) deaths and 42 non-CV deaths occurred. In a multivariable analysis, sarcopenia was associated with time to first non-CV hospitalization (hazard ratio 1.93; 95% confidence interval 1.14-3.24; p = 0.014) but not with any other hospitalization, any mortality endpoint, or a composite endpoint of CV death and HF hospitalization. CONCLUSIONS: The prevalence of sarcopenia in ADHF patients is high and associated with greater risk of non-CV hospitalizations, highlighting the importance of identifying and managing the condition in a multidisciplinary approach. CLINICAL TRIAL REGISTRATION: NCT03153774.