Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation.

BACKGROUND: Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited. AIMS: We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function. METHODS: In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI). RESULTS: Our analysis included 10,872 patients; baseline EF was ≤30% in 914 (8.4%) patients and >30% in 9,958 (91.6%) patients. The LV recovered in 544 (59.5%) patients, including 244 (26.7%) patients whose LV function normalised completely (EF >50%). Three-year mortality for patients without severe LV dysfunction at baseline was 29.4%. Compared to this, no LV recovery was associated with a significant increase in mortality (adjusted hazard ratio 1.32; p<0.001). Patients with similar LV function post-TAVI had similar rates of 3-year mortality, regardless of their baseline LV function. Three variables were associated with a higher likelihood of LV recovery following TAVI: no previous myocardial infarction (MI), estimated glomerular filtration rate >60 mL/min, and mean aortic valve gradient (mAVG) (expressed either as a continuous variable or as a binary variable using the standard low-flow, low-gradient aortic stenosis [AS] definition). CONCLUSIONS: LV recovery following TAVI and the extent of this recovery are major determinants of midterm mortality in patients with severe AS and severe LV dysfunction undergoing TAVI. Patients with no previous MI and those with an mAVG >40 mmHg show the best results following TAVI, which are at least equivalent to those for patients without severe LV dysfunction. (ClinicalTrials.gov: NCT04031274).

Mitral transcatheter edge-to-edge repair: patient selection, current devices, and clinical outcomes.

INTRODUCTION: Over the last two decades, mitral transcatheter edge-to-edge repair (M-TEER) has become a safe and effective therapy for severe mitral regurgitation in patients deemed at high surgical risk. AREAS COVERED: This review aims to encompass the most relevant and updated evidence in the field of M-TEER from its inception, focusing on clinical and anatomical features for proper patient and device selection. EXPERT OPINION: Growing operator experience and device iterations have resulted in improved clinical outcomes and an expansion of the therapy to patients with complex anatomies and clinical scenarios. Future investigations are warranted to determine the best management options and the most suitable device for every patient with MR.

Redo transcatheter aortic valve replacement in degenerated transcatheter bioprosthesis (TAV-in-TAV).

INTRODUCTION: With the expanding indications of transcatheter aortic valve replacement (TAVR) to younger and low-risk patients, the life expectancy of patients currently undergoing TAVR will likely outlive the durability of transcatheter bioprosthesis. Consequently, the number of failed transcatheter bioprosthesis requiring surgical valve explant or redo TAVR is expected to increase. AREAS COVERED: The aim of this review is to provide an updated overview of redo TAVR for treating degenerated transcatheter bioprosthesis, focusing on pre-procedural planning, potential challenges of coronary reaccess during TAVR-in-TAVR and main outcomes of TAVR explant and redo TAVR. EXPERT OPINION: Patient-tailored device selection and individualized implantation height should be carefully assessed during the index TAVR procedure (weighting between pacemaker avoidance and the potential risk of coronary occlusion in future TAVR-in-TAVR). Future prospective studies comparing safety and clinical outcomes between redo TAVR vs TAVR explant are eagerly awaited.

Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR.

BACKGROUND: In patients undergoing percutaneous coronary intervention (PCI) in the work-up pre-transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown. OBJECTIVES: This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR. METHODS: This was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria. RESULTS: LBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020). CONCLUSIONS: In TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients.

Impact of Baseline Anemia in Patients Undergoing Transcatheter Aortic Valve Replacement: A Prognostic Systematic Review and Meta-Analysis.

Transcatheter aortic valve replacement (TAVR) is currently the treatment of choice for patients aged ≥75 years with severe aortic stenosis. Preoperative anemia is present in a large proportion of patients and may increase the risk of post-procedural complications. The purpose of this prognostic systematic review was to analyze the impact of baseline anemia on short- and mid-term outcomes following TAVR. A computerized search was performed on PubMed and Web of Science databases for studies published between January 2013 and December 2022. Primary outcomes were 30-day need for transfusion, acute renal failure, 30-day and mid-term mortality, and readmission during the first year post-TAVR. Data were analyzed via random effects model using inverse variance method with 95% confidence intervals. Eleven observational studies met our eligibility criteria and included a total of 12,588 patients. The prevalence of baseline anemia ranged between 39% and 72%, with no relevant sex differences. Patients with preprocedural anemia received more blood transfusions [OR: 2.95 (2.13-4.09)]), and exhibited increased rates of acute kidney injury [OR:1.74 (1.45-2.10)], short-term mortality [OR: 1.47 (1.07-2.01], and mid-term [OR: 1.89 (1.58-2.25)] mortality following TAVR compared with those without anemia. Baseline anemia determined an increased risk for blood transfusion, acute kidney injury, and short/mid-term mortality among TAVR recipients.

Impact of Device Implant Depth After Left Atrial Appendage Occlusion.

BACKGROUND: Device-related thrombus (DRT) remains one of the main concerns after left atrial appendage occlusion (LAAO). Several risk factors have been proposed, but most cannot be modulated. A modifiable factor such as device implantation depth is a potential target to adjust the risk for DRT. OBJECTIVES: The aim of this study was to assess the impact of LAAO device implantation depth as a predisposing factor for DRT. METHODS: The study included patients who underwent successful LAAO at 9 centers in Europe and Canada. Patients were classified into 2 groups: proximal device implantation (covered pulmonary ridge [PR] in the lobe and disc cohort or <5 mm from the PR in the single-lobe cohort) and distal device implantation (uncovered PR in the disc and lobe cohort and ≥5 mm in the single-lobe cohort). RESULTS: A total of 1,317 patients were included. Among these, proximal and distal device implantation was achieved in 732 (55%) and 585 (45%) patients, respectively. No differences in procedural outcomes were observed between the groups. At follow-up, patients with proximal implantation had a lower incidence of DRT (2.3%) than those with distal implantation (12.2%) (P < 0.001). Deeper device implantation and a larger uncovered left atrial appendage area were associated with a higher incidence of DRT (P < 0.001), regardless of device type. In multivariable analysis, distal implant (HR: 5.92; 95% CI: 3.39-10.36) and no or single antiplatelet therapy (HR: 1.62; 95% CI: 0.99-2.62) emerged as independent predictors of DRT. CONCLUSIONS: LAAO device implantation depth is an independent risk factor for DRT. Deeper device implantation and larger uncovered left atrial appendage areas were associated with a higher incidence of DRT.

Global Longitudinal Strain Predicts Outcomes in Patients with Reduced Left Ventricular Function Undergoing Transcatheter Edge-to-Edge Mitral Repair.

BACKGROUND: The timing and selection of optimal candidates for mitral transcatheter edge-to-edge valve repair remains to be fully determined, especially in cases with severely depressed left ventricular ejection fraction (LVEF). The objective of this study is to evaluate the prognostic value of myocardial strain (LVGLS) in this setting. METHODS: Retrospectively, 172 consecutive patients with LVEF ≤40% and severe MR treated with MitraClip were included. Four groups were generated according to the LVEF (<30% or ≥30%) and median LVGLS. The primary end-point was cardiovascular mortality. RESULTS: Procedural success was high (96.5%) and complications were rare. At one-year follow-up, 82.5% of patients maintained MR grade ≤2, 79.2% were at a NYHA class ≤II and a reduction of 80% in heart failure admissions was observed in all groups. Interestingly, among patients with a more depressed LVEF, LVGLS was found to be an independent predictor for cardiovascular mortality (HR: 3.3; 95% CI: 1.1-10, p = 0.023). CONCLUSIONS: Mitral valve repair with MitraClip is safe and it improves the mid-term functional class of patients regardless of LVEF. LVGLS can help in the selection of optimal candidates and timing for this procedure, as well as in the recognition of those patients with worse prognoses.

Transcatheter aortic valve implantation in patients with extra-small aortic annuli.

BACKGROUND: A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI). Data regarding TAVI in patients with extra-SAA are scarce. AIMS: The aim of this study was to analyse the safety and efficacy of TAVI in patients with extra-SAA. METHODS: A multicentre registry study including patients with extra-SAA (defined as an aortic annulus area <280 mm2 and/or perimeter <60 mm) undergoing TAVI was established. Primary efficacy and safety endpoints were defined as device success and early safety at 30 days, respectively, using the Valve Academic Research Consortium-3 criteria, and were analysed according to valve type: self-expanding (SEV) versus balloon-expandable (BEV). RESULTS: A total of 150 patients were included, of which 139 (92.7%) were women, and 110 (73.3%) received an SEV. Intraprocedural technical success was 91.3%, with a higher rate in patients receiving an SEV (96.4% vs 77.5% with BEV; p=0.001). Overall, 30-day device success was 81.3%, (85.5% with SEV vs 70.0% with BEV; p=0.032). The primary safety endpoint occurred in 72.0% of patients (with no difference between groups; p=0.118). Severe PPM occurred in 12% (9.0% with SEV and 24.0% with BEV; p=0.039), with no impact on all-cause mortality, cardiovascular mortality, or heart failure readmission at 2-year follow-up. CONCLUSIONS: TAVI is a safe and feasible treatment in patients with extra-SAA with a high rate of technical success. The use of SEV was associated with a lower rate of intraprocedural complications, higher device success at 30 days and better haemodynamic outcomes compared to BEV.

2-year outcomes of MitraClip as a bridge to heart transplantation: The international MitraBridge registry.

BACKGROUND: In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years. METHODS: By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation. RESULTS: Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement. CONCLUSIONS: After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases.

Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. AIMS: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. METHODS: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. RESULTS: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). CONCLUSION: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.

Percutaneous paravalvular leak closure after transcatheter aortic valve implantation: the international PLUGinTAVI Registry.

BACKGROUND: Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce. AIMS: This study aims to present a large multicentre international experience of percutaneous post-TAVI PVL closure. METHODS: All patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included. RESULTS: Overall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and a significant reduction in the rate of hospitalisation for heart failure (from 40% to 6%). CONCLUSIONS: Percutaneous PVL closure is a feasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.

Left Atrial Appendage Occlusion Strengths and Weaknesses of the Lobe-Only Occluder Concept in Theory and in Practice.

Left atrial appendage closure aims to eliminate the stasis component of Virchow triad by eliminating a cul-de-sac that favors thrombosis, particularly when atrial contractility becomes inefficient, such as in atrial fibrillation. Left atrial appendage closure devices have a common objective of sealing the appendage completely, with device stability and avoidance of device thrombosis. Two main device designs have been used to perform left atrial appendage closure: those that use a pacifier design (lobe + disk) and those that use a plug (single lobe) design. This review highlights the potential features and benefits of the single-lobe devices.

Cusp-overlap technique during TAVI using the self-expanding Portico FlexNav system.

INTRODUCTION AND OBJECTIVES: The cusp overlap technique (COT) has been proposed to reduce conduction disturbances (CD) after transcatheter aortic valve implantation (TAVI) with self-expanding supra-annular devices, but there are scarce data on COT with intra-annular valves. The aim of this study was to determine whether the use of the COT during Portico implantation results in higher valve implantation and lower rates of CD. METHODS: We included 85 patients undergoing TAVI with the Portico FlexNav system: 43 retrospective patients using the standard 3-cusp view and 42 prospective patients with the COT. Primary endpoints were implantation depth and new-onset CD (composite outcome of new-onset left bundle branch block and new permanent pacemaker implantation). RESULTS: COT resulted in a higher implantation depth (noncoronary cusp: 4.9±3.9 vs 7.4±3.0; P=.005) and lower new-onset CD (31.0% vs 58.1%; P=.012), with a tendency toward a lower need for permanent pacemaker implantation (14.3% vs 30.2%, P=.078; 7.7% vs 31.0%; P=.011 in patients without pre-existing right bundle branch block). Transvalvular aortic gradients were slightly lower with COT (8.7±3.7 vs 11.0±6.1; P=.044). There were no differences in technical success or major procedure-related complications. On multivariate analysis, COT use was associated with a lower risk of new-onset CD. CONCLUSIONS: Use of the COT during Portico implantation is feasible and facilitates a higher valve implant, which in turn may help to reduce rates of new-onset CD.

Intracardiac Echocardiography to Guide Watchman FLX Implantation: The ICE LAA Study.

BACKGROUND: Intracardiac echocardiography (ICE) is increasingly used to guide left atrial appendage closure (LAAC). OBJECTIVES: The aim of this study was to investigate the efficacy and safety of ICE-guided LAAC with the Watchman FLX device. METHODS: The ICE LAA (I Can See Left Atrial Appendage) study was a prospective, multicenter study with independent adjudication of echocardiographic data by a core laboratory and clinical events by a clinical events committee. Patients with atrial fibrillation with CHA2DS2-VASc scores ≥2 and clinical indications for LAAC were eligible. Preplanning with either cardiac computed tomography or transesophageal echocardiography (TEE) within 7 days prior to LAAC was mandatory. Intraprocedural ICE was carried out from the left atrium. The primary outcome was the rate of significant peridevice leaks (>5 mm) at 45-day TEE. RESULTS: A total of 100 patients were enrolled. The mean age was 76 ± 8 years, the mean CHA2DS2-VASc score was 4.0 ± 1.5, and the mean HAS-BLED score was 2.5 ± 0.9. The incidence of the primary outcome of significant peridevice leak (>5 mm) was 0%; all patients evaluated by TEE at 45 days had effective LAAC. All patients received Watchman FLX devices, and technical success was 100%. The number of devices per case was 1.0 ± 0.1. ICE successfully guided the assessment of device release criteria, including device compression (19.2% ± 7.1%; recommended range: 10%-30%). No subject required conversion to TEE. Procedural complications were 4 access-site bleeds. There was no stroke, transient ischemic attack, systemic embolization, pericardial effusion, device embolization, or device-related thrombus during the procedure or 45-day follow-up. CONCLUSIONS: ICE can be used to successfully guide LAAC with the Watchman FLX, with excellent procedural success, a high rate of effective LAAC, and minimal periprocedural complications. (I Can See Left Atrial Appendage [ICELAA] Clinical Study; NCT04196335).

Domain expert evaluation of advanced visual computing solutions and 3D printing for the planning of the left atrial appendage occluder interventions.

Advanced visual computing solutions and three-dimensional (3D) printing are moving from engineering to clinical pipelines for training, planning, and guidance of complex interventions. 3D imaging and rendering, virtual reality (VR), and in-silico simulations, as well as 3D printing technologies provide complementary information to better understand the structure and function of the organs, thereby improving and personalizing clinical decisions. In this study, we evaluated several advanced visual computing solutions, such as web-based 3D imaging visualization, VR, and computational fluid simulations, together with 3D printing, for the planning of the left atrial appendage occluder (LAAO) device implantations. Six cardiologists tested different technologies in pre-operative data of five patients to identify the usability, limitations, and requirements for the clinical translation of each technology through a qualitative questionnaire. The obtained results demonstrate the potential impact of advanced visual computing solutions and 3D printing to improve the planning of LAAO interventions as well as the need for their integration into a single workflow to be used in a clinical environment.

Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation.

INTRODUCTION AND OBJECTIVES: The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. METHODS: Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. RESULTS: We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). CONCLUSIONS: Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.

Cardiac amyloidosis and left atrial appendage closure. The CAMYLAAC study.

INTRODUCTION AND OBJECTIVES: Transthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA. METHODS: Comparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis of CA. RESULTS: We studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA2DS2-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P=.283), hemorrhagic stroke (2.5% and 0.8% in the control group; P=.284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P <.001) but this difference was unrelated to hemorrhagic complications or ischemic stroke. CONCLUSIONS: LAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile.

Cambios en la selección e impacto potencial de los inhibidores de neprilisina y del receptor de la angiotensina en los pacientes sometidos a reparación mitral percutánea borde a borde / Temporal trend and potential impact of angiotensin receptor neprilysin inhibitors on transcatheter edge-to-edge mitral valve repair

Introducción y objetivos: En insuficiencia cardiaca persistente con insuficiencia mitral (IM) secundaria se debe considerar la reparación transcatéter borde-a-borde (TEER) de la válvula mitral. Los inhibidores de neprilisina (ARNIs) demostraron mejorar el pronóstico en insuficiencia cardiaca. Nuestro objetivo fue evaluar el impacto de los ARNIs en la selección y resultados. Métodos: La población del registro nacional de TEER (marzo/2012-enero/2021) se dividió en 2 grupos: a) TEER pre-ARNI (n=450) y b) TEER una vez que los ARNIs se recomendaron en guías europeas (n=639), teniendo en cuenta si se prescribieron (n=52) o no (n=587). Resultados: Un total de 1.089 pacientes consecutivos se sometieron a TEER para el tratamiento de la IM. Presentaron menor tamaño ventricular izquierdo (100 frente a 82mL, p=0,025) y mejor función (35 frente a 38%, p=0,011) en la era ARNI. A los 2 años, la mortalidad (10,6 frente a 17,3%, p <0,001) y los ingresos por insuficiencia cardiaca (16,6 frente a 27,8%, p <0,001) fueron menores, pero no la recurrencia de IM. En la era ARNI, la mortalidad fue comparable independientemente de la prescripción de ARNIs, pero tuvieron menor tasa de muerte+re-hospitalización a 2 años (OR=0,369, IC95%, 0,137-0,992, p=0,048), mejor NYHA y menor recurrencia de IM (1,9 frente al 14,3%, p=0,011). Conclusiones: Se observó una mejor selección y resultados en candidatos a TEER en la era ARNI y su prescripción se asoció a una reducción significativa de eventos globales, mejor NYHA y menor recurrencia de la IM.(AU)

Introduction and objectives: Transcatheter edge-to-edge repair (TEER) should be considered in patients with heart failure and secondary mitral regurgitation (MR). Angiotensin receptor-neprilysin inhibitors (ARNIs) have been demonstrated to improve prognosis in heart failure. We aimed to evaluate the impact ARNIs on patient selection and outcomes. Methods: The population of the Spanish TEER prospective registry (March 2012 to January 2021) was divided into 2 groups: a) TEER before the ARNI era (n=450) and b) TEER after the recommendation of ARNIs by European Guidelines (n=639), with further analysis according to intake (n=52) or not (n=587) of ARNIs. Results: A total of 1089 consecutive patients underwent TEER for secondary MR. In the ARNI era, there was a reduction in left ventricle dilation (82mL vs 100mL, P=.025), and better function (35% vs 38%, P=.011). At 2 years of follow-up, mortality (10.6% vs 17.3%, P <.001) and heart failure readmissions (16.6% vs 27.8%, P <.001) were lower in the ARNI era, but not recurrent MR. In the ARNI era, 1- and 2-year mortality were similar irrespective of ARNI intake but patients on ARNIs had a lower risk of readmission+mortality at 2 years (OR, 0.369; 95%CI, 0.137-0.992; P=.048), better NYHA class, and lower recurrence of MR III-IV (1.9% vs 14.3%, P=.011). Conclusions: Better patient selection for TEER has been achieved in the last few years with a parallel improvement in outcomes. The use of ARNIs was associated with a significant reduction in overall events, better NYHA class, and lower MR recurrence.(AU)

Prognostic Impact of Nutritional Status After Transcatheter Edge-to-Edge Mitral Valve Repair: The MIVNUT Registry.

Background Malnutrition is associated with poor prognosis in several cardiovascular diseases. However, its prognostic impact in patients undergoing transcatheter edge-to-edge mitral valve repair (TEER) is not well known. This study sought to assess the prevalence, clinical associations, and prognostic consequences of malnutrition in patients undergoing TEER. Methods and Results A total of 892 patients undergoing TEER from the international MIVNUT (Mitral Valve Repair and Nutritional Status) registry were studied. Malnutrition status was assessed with the Controlling Nutritional Status score. The association of nutritional status with mortality was analyzed with multivariable Cox regression models, whereas the association with heart failure admission was assessed by Fine-Gray models, with death as a competing risk. According to the Controlling Nutritional Status score, 74.4% of patients with TEER had any degree of malnutrition at the time of TEER (75.1% in patients with body mass index <25 kg/m2, 72.1% in those with body mass index ≥25 kg/m2). However, only 20% had moderate-severe malnutrition. TEER was successful in most of patients (94.2%). During a median follow-up of 1.6 years (interquartile range, 0.6-3.0), 267 (29.9%) patients died and 256 patients (28.7%) were admitted for heart failure after TEER. Compared with normal nutritional status moderate-severe malnutrition resulted a strong predictor of mortality (adjusted hazard ratio [HR], 2.1 [95% CI, 1.1-2.4]; P<0.001) and heart failure admission (adjusted subdistribution HR, 1.6 [95% CI, 1.1-2.4]; P=0.015). Conclusions Malnutrition is common among patients submitted to TEER, and moderate-severe malnutrition is strongly associated with increased mortality and heart failure readmission. Assessment of nutritional status in these patients may help to improve risk stratification.

Incidence and Predictors of Early Death in Patients Undergoing Percutaneous Left Atrial Appendage Closure.

BACKGROUND: Left atrial appendage closure (LAAC) aims to prevent ischemic events in patients with atrial fibrillation. As a preventive procedure, early death after LAAC could render the procedure futile. OBJECTIVES: The authors sought to evaluate the incidence and factors associated with early death in LAAC recipients. METHODS: This was a multicenter study including consecutive patients undergoing LAAC in a 10-year period (2009-2019). Death was considered early when occurring in the first year after LAAC. RESULTS: A total of 807 patients (mean age 76 ± 8 years, mean CHA2DS2-VASc score 4.5 ± 1.5) were included. Early death occurred in 125 patients (15.5%). In the multivariable analysis, factors associated with early death after LAAC were older age HR: 1.03; 95% CI: 1.01-1.06 per year; P = 0.01), lower body mass index (HR: 0.92; 95% CI: 0.88-0.97 per 1 kg/m2 increase; P < 0.001), diabetes (HR: 1.71; 95% CI: 1.19-2.47; P = 0.002), prior heart failure (HR: 1.74; 95% CI: 1.20-2.53; P = 0.001), and lower estimated glomerular filtration rate (HR: 1.09; 95% CI: 1.05-1.13 per 5 mL/min/1.73 m2 decrease; P < 0.001). There was a stepwise increase in risk of early death within the first year of LAAC with the combination of different risk factors (up to 48.9% in the presence of >3 risk factors). CONCLUSIONS: In this multicenter international registry, close to 1 in 6 patients died within the first year of LAAC. Older age, low body mass index, impaired estimated glomerular filtration rate, prior diabetes, and prior heart failure are independently associated with an increased risk. The risk of early death appeared to be prohibitive (∼50%) in the presence of >3 of these risk factors.