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.

Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol.

Inflammatory processes are deeply involved in ischemia-reperfusion injuries (IRI) and ventricular remodelling (VR) after a ST-segment elevation myocardial infarction (STEMI). They are associated with clinical adverse events (heart failure and cardiovascular death) adding damage to the myocardium after reperfusion. Moreover, acute myocardial infarction (AMI) induces a local sympathetic denervation leading to electrical instability and arrythmia. Colchicine, a well-known alkaloid with direct anti-inflammatory effects, was shown to reduce the myocardial necrosis size and limit the VR. In a recent proof of concept study, colchicine appears to prevent sympathetic denervation in a mice model of ischemia/reperfusion, but not in the necrosis or in the border zone areas. The Colchicine to Prevent Sympathetic Denervation after an AMI study (COLD-MI) is an ongoing, confirmative, prospective, monocentre, randomized, open-label trial. The COLD-MI trial aims to evaluate the intensity of sympathetic denervation after AMI and its potential modulation due to low dose colchicine. Sympathetic denervation will be noninvasively evaluated using single-photon emission computed tomography (SPECT). After a first episode of STEMI (Initial TIMI flow ≤ 1) and primary percutaneous coronary intervention (PPCI), patients will be randomized (n = 56) in a 1:1 ratio to either receive colchicine or not for 30 days. The primary end point will be the percentage of myocardial denervation measured by 123I-metaiodobenzylguanidine (123I-MIBG) SPECT at a 6-month follow-up. The main secondary end points will be basic ECG parameters (QRS duration, corrected QT) and HRV parameters from a 24 hour-recording Holter at 1- and 6-months follow-up. Results from this study will contribute to a better understanding of the cardioprotective effect of colchicine after AMI. The present study describes the rationale, design, and methods of the trial.

Association between arterial stiffness and Loa loa microfilaremia in a rural area of the Republic of Congo: A population-based cross-sectional study (the MorLo project).

BACKGROUND: Loa loa filariasis (loiasis) is still considered a relatively benign disease. However, recent epidemiologic data suggest increased mortality and morbidity in L. loa infected individuals. We aimed to examine whether the density of L. loa microfilariae (mfs) in the blood is associated with cardiovascular disease. METHODOLOGY: Using a point-of-care device (pOpmètre), we conducted a cross-sectional study to assess arterial stiffness and peripheral arterial disease (PAD) in 991 individuals living in a loiasis-endemic rural area in the Republic of the Congo. Microfilaremic individuals were matched for age, sex and village of residence with 2 amicrofilaremic subjects. We analyzed markers of arterial stiffness (Pulse-Wave Velocity, PWV), PAD (Ankle-Brachial Index, ABI) and cardiovascular health (Pulse Pressure, PP). The analysis considered parasitological results (L. loa microfilarial density [MFD], soil-transmitted helminths infection, asymptomatic malaria and onchocerciasis), sociodemographic characteristics and known cardiovascular risk factors (body mass index, smoking status, creatininemia, blood pressure). PRINCIPAL FINDINGS: Among the individuals included in the analysis, 192/982 (19.5%) and 137/976 (14.0%) had a PWV or an ABI considered out of range, respectively. Out of range PWV was associated with younger age, high mean arterial pressure and high L. loa MFD. Compared to amicrofilaremic subjects, those with more than 10,000 mfs/mL were 2.17 times more likely to have an out of range PWV (p = 0.00). Factors significantly associated with PAD were older age, low pulse rate, low body mass index, smoking, and L. loa microfilaremia. Factors significantly associated with an elevation of PP were older age, female sex, high average blood pressure, low pulse rate and L. loa microfilaremia. CONCLUSION: A potential link between high L. loa microfilaremia and cardiovascular health deterioration is suggested. Further studies are required to confirm and explore this association.

Tricuspid annular plane systolic excursion over systolic pulmonary artery pressure prognostic value for in-hospital adverse events in patients hospitalized for acute coronary syndrome.

AIMS: Although several studies have shown that the right ventricular to pulmonary artery (RV-PA) coupling, assessed by the ratio between tricuspid annular plane systolic excursion and systolic pulmonary artery pressure (TAPSE/sPAP) using echocardiography, is strongly associated with cardiovascular events, its prognostic value is not established in acute coronary syndrome (ACS). We aimed to assess the in-hospital prognostic value of TAPSE/sPAP among patients hospitalized for ACS in a retrospective analysis from the prospective ADDICT-ICCU study. METHODS AND RESULTS: A total of 481 consecutive patients hospitalized in intensive cardiac care unit [mean age 65 ± 13 years, 73% of male, 46% ST-elevation myocardial infarction (STEMI)] for ACS [either STEMI or non-STEMI (NSTEMI)] with TAPSE/sPAP available were included in this prospective French multicentric study (39 centres). The primary outcome was in-hospital major adverse cardiovascular events (MACEs) defined as all-cause death, resuscitated cardiac arrest, or cardiogenic shock and occurred in 33 (7%) patients. Receiver operating characteristic curve analysis identified 0.55 mm/mmHg as the best TAPSE/sPAP cut-off to predict in-hospital MACEs. TAPSE/sPAP <0.55 was associated with in-hospital MACEs, even after adjustment with comorbidities [odds ratio (OR): 19.1, 95% confidence interval (CI) 7.78-54.8], clinical severity including left ventricular ejection fraction (OR: 14.4, 95% CI 5.70-41.7), and propensity-matched population analysis (OR: 22.8, 95% CI 7.83-97.2, all P < 0.001). After adjustment, TAPSE/sPAP <0.55 showed the best improvement in model discrimination and reclassification above traditional prognosticators (C-statistic improvement: 0.16; global χ2 improvement: 52.8; likelihood ratio test P < 0.001) with similar results for both STEMI and NSTEMI subgroups. CONCLUSION: A low RV-PA coupling defined as TAPSE/sPAP ratio <0.55 was independently associated with in-hospital MACEs and provided incremental prognostic value over traditional prognosticators in patients hospitalized for ACS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05063097.

Wearable Cardioverter Defibrillator Shortens the Lengths of Stay in Patients with Left Ventricular Dysfunction after Myocardial Infarction: A Single-Centre Real-World Experience.

The wearable cardioverter defibrillator (WCD) has been proven to be effective in preventing sudden cardiac death (SCD) in patients soon after acute myocardial infarction (AMI) and left ventricular ejection fraction (LVEF) ≤35%. The aim of this study was to assess whether a WCD may shorten the length of an initial hospital stay (total length, days in the intensive care unit (ICU) and in the acute cardiac care unit (ACCU)) among these patients. This was a single-centre, retrospective observational study of patients referred for the management of SCD risk post-AMI and LVEF ≤35%, in a tertiary care hospital. The clinical characteristics and length of index hospitalization of the group of patients discharged, with or without WCD, were compared. A propensity score analysis was performed, then weighted regression models were conducted. A total of 101 patients in the WCD group and 29 in the control group were enrolled in the analysis. In the weighted regression models, WCD significantly reduced the days spent in ACCU (p < 0.001). WCD patients had significantly fewer days spent in ACCU (5.5 ± 2.6 vs. 8.4 ± 12.8 days, p < 0.001) and shorter hospitalizations (10.2 ± 5.7 vs. 13.4 ± 17.6 days, p = 0.005), compared with the control group. It was concluded that the WCD appears to reduce the total length of hospitalization and lengths of stay in ACCU for patients post-AMI and with left ventricular dysfunction.

His-bundle pacing and atrioventricular nodal ablation for noncontrolled atrial arrhythmia: A technical challenge with major clinical benefits.

BACKGROUND: His-bundle pacing (HBP) is an appealing alternative to right ventricular pacing in patients referred for permanent ventricular pacing and atrioventricular nodal ablation (AVNA) because it preserves physiological ventricular activation. Only limited data regarding HBP combined with AVNA are available in the literature. OBJECTIVE: The purpose of this study was to provide further evidence on the feasibility and efficacy of this therapeutic approach in patients with uncontrolled atrial arrhythmia. METHODS: We prospectively included all patients who had undergone AVNA after HBP in 3 different hospitals between 2017 and 2022. RESULTS: AVNA following HBP lead implantation was performed in 75 patients. Complete atrioventricular (AV) block was obtained in 58 patients (77%), and significant modulation of AV nodal conduction (heart rate <60 bpm) was obtained in 12 patients (16%). AVNA failure was observed in 5 patients (7%). Recording of an atrial signal by the HBP lead was more frequently observed in patients with AVNA modulation/failure than in patients with complete AV block (11/17 vs 5/58; P <.001). No lead dislodgment occurred during the AVNA procedures. Acute His-bundle (HB) capture threshold increase >1 V occurred in 11 patients (15%), with return to baseline value on day 1 in 9 patients. New York Heart Association functional class and left ventricular ejection fraction significantly improved from baseline to last follow-up (3.0 ± 0.7 vs 1.6 ± 0.5; P <.001; and 47% ± 14% vs 60% ± 9%; P <.0001, respectively). CONCLUSION: AVNA combined with HBP for noncontrolled atrial arrhythmia was feasible and clinically efficient. Implanting the HB lead on the ventricular aspect of the tricuspid annulus avoiding atrial signal recording can facilitate AVNA.

Association between blood Loa loa microfilarial density and proteinuria levels in a rural area of the Republic of Congo (the MorLo project): a population-based cross-sectional study.

BACKGROUND: Case reports have hypothesised that proteinuria, sometimes with glomerulopathy or nephrotic syndromes, might be associated with loiasis. To our knowledge, no study has been done to assess this association. We aimed to investigate the association between Loa loa microfilariae burden and proteinuria. METHODS: We did a cross-sectional study between May 16, 2022, and June 11, 2022, to assess the relationship between Loa loa microfilaraemia densities and proteinuria in a rural area of the Republic of Congo. We included all consenting adults living in the target area at study commencement who had L loa microfilarial densities greater than 500 microfilariae per mL during previous screening for a clinical trial in 2019. This study is part of the MorLo project, and used the project's study population of individuals aged 18 years or older who were living near Sibiti. For each microfilaraemic individual, two individuals without L loa microfilarial densities matched on age, sex, and place of residence were included. The association between proteinuria (assessed by dipstick) and L loa microfilarial densities, age, and sex was assessed using an unconstrained ordinal regression model since the parallel-lines assumption was violated for microfilarial densities. FINDINGS: 991 participants were included, of whom 342 (35%) were L loa microfilaraemic. The prevalence of microfilaraemia was 38% (122 of 325) among individuals with trace proteinuria (<300 mg/24 h), 51% (45 of 89) among individuals with light proteinuria (300 mg to 1 g/24 h), and 71% (15 of 21) among individuals with high proteinuria (>1 g/24 h). Individuals with high proteinuria had significantly higher L loa microfilarial densities (p<0·0001): mean microfilariae per mL were 1595 (SD 4960) among individuals with no proteinuria, 2691 (7982) for those with trace proteinuria, 3833 (9878) for those with light proteinuria, and 13 541 (20 118) for those with high proteinuria. Individuals with 5000-14 999 microfilariae per mL and individuals with 15 000 microfilariae per mL or greater were, respectively, 5·39 and 20·49 times more likely to have a high proteinuria than individuals with no microfilaraemia. INTERPRETATION: The risk of proteinuria increases with L loa microfilaraemia. Further studies are needed to identify renal disorders (eg, tubulopathies, glomerulopathies, or nephrotic syndromes) responsible for loiasis-related proteinuria. FUNDING: European Research Council, MorLo project. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.