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BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60â min; P < .001) and intervention times (85 vs. 95â min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.
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Estenosis de la Válvula Aórtica , Benchmarking , Tiempo de Internación , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/cirugía , Masculino , Femenino , Anciano de 80 o más Años , Tiempo de Internación/estadística & datos numéricos , Anciano , Vías Clínicas , Europa (Continente)/epidemiología , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Seguridad del PacienteRESUMEN
BACKGROUND: Device-related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted. METHODS AND RESULTS: This sub-analysis from the EUROC-DRT-registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p = .06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p = .01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p = .40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p = .24). Women were followed-up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p = .51). Kaplan-Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%-Confidence interval [95%-CI]: .68-4.37, p = .25) and no differences in stroke (HR: .83, 95%-CI: .30-2.32, p = .72) within 2 years after LAAC. CONCLUSION: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective.
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Apéndice Atrial , Fibrilación Atrial , Sistema de Registros , Trombosis , Humanos , Femenino , Masculino , Apéndice Atrial/cirugía , Anciano , Trombosis/etiología , Fibrilación Atrial/cirugía , Factores Sexuales , Anticoagulantes/uso terapéutico , Factores de Riesgo , Complicaciones Posoperatorias , Dispositivo Oclusor Septal , Resultado del Tratamiento , Ecocardiografía Transesofágica/métodos , Europa (Continente)/epidemiología , Cierre del Apéndice Auricular IzquierdoRESUMEN
AIMS: We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous monitoring for up to 2 years. Arrhythmic events were adjudicated in a central core lab. 1836 new arrhythmic events (tachyarrhythmias: 1655 and bradyarrhythmias: 181) occurred at 2 years. Of these, 283 (15%) occurred beyond 1 year (tachyarrhythmias 212, bradyarrhythmias 71) in 33 (36%) patients, without differences between valve type. Most late (>1 year) arrhythmic events were asymptomatic (94%) and led to a treatment change in 17 (19%) patients. A total of 71 late bradyarrhythmias [high-degree atrioventricular block (HAVB): 3, severe bradycardia: 68] were detected in 17 (21%) patients. At 2 years, 18 (17%) patients had received a permanent pacemaker (PPM) or implantable cardiac-defibrillator. PPM implantation due to HAVB predominated in the early phase post-TAVR, with only 1 HAVB event requiring PPM implantation after 1 year. CONCLUSION: Patients with new-onset LBBB post-TAVR exhibited a very high burden of arrhythmic events within the 2 years post-procedure. While new tachyarrhythmic events were homogeneously distributed over time, the vast majority of new HAVB episodes leading to PPM implantation occurred early after the procedure. These results should help to guide the management of this challenging group of patients. (clinicaltrials.gov: NCT02153307).
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Estenosis de la Válvula Aórtica , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Bloqueo de Rama/diagnóstico , Bloqueo de Rama/epidemiología , Bloqueo de Rama/etiología , Humanos , Estudios Prospectivos , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Gastrointestinal bleeding (GIB) is associated with a high recurrence rate and a prior GIB episode is common in real-world left atrial appendage closure (LAAC) recipients. The present study sought to evaluate the clinical characteristics and outcomes of patients with prior GIB undergoing LAAC, and to determine the factors associated with and clinical impact of GIB recurrence. METHODS: Multicenter study including 277 consecutive patients who underwent percutaneous LAAC and had prior GIB. All-cause death, all bleeding, GIB recurrence, and clinical ischemic stroke were recorded. RESULTS: After a median follow-up of 17 (interquartile range: 6-37) months post-LAAC, the rates of death, bleeding, GIB recurrence, and ischemic stroke were 14.0 per 100 person-year (PY), 29.3 per 100 PY, 17.7 per 100 PY, and 1.1 per 100 PY, respectively. GIB recurrence occurred within 3 months post-LAAC in 55.8% of patients. A previous lower GIB (vs. upper or unclassified) (HR: 1.76; 95% CI: 1.09-2.82; p = .020) and eGFR < 45 mL/min (HR: 1.70; 95% CI:1.04-2.67; p = .033) determined an increased risk of GIB recurrence. By multivariable analysis, eGFR < 45 mL/min (HR: 2.72; 95% CI: 1.70-4.34; p < .001), GIB recurrence following LAAC (HR: 2.15; 95% CI: 1.33-3.46; p = .002), diabetes mellitus (HR: 1.77; 95% CI: 1.10-2.84; p = .018), and age (HR: 1.06; 95% CI: 1.03-1.10; p < .001) were associated with an increased mortality. CONCLUSIONS: Patients with prior GIB undergoing LAAC exhibited a relatively low rate of GIB recurrence, and prior lower GIB and moderate-to-severe chronic kidney disease determined an increased risk. GIB recurrence was associated with an increased mortality.
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Apéndice Atrial/cirugía , Fibrilación Atrial/complicaciones , Fibrilación Atrial/cirugía , Hemorragia Gastrointestinal/complicaciones , Hemorragia Gastrointestinal/epidemiología , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Incidencia , Masculino , Recurrencia , Resultado del TratamientoRESUMEN
BACKGROUND: Although there have been several reports documenting complications related with transesophageal echocardiography (TEE) manipulation following cardiac surgery, there is a paucity of data regarding the safety of TEE used to guide catheter-based interventions. The aim of this study was to determine the prevalence, types and risk factors of complications associated with procedures requiring active TEE guidance. METHODS: This study included 1249 consecutive patients undergoing either transcatheter aortic valve implantation (TAVI), Mitraclip, left atrial appendage occlusion (LAAO) or paravalvular leak closure (PVLC). Patients were divided into 2 cohorts based on the degree of probe manipulation required to guide the procedure and the risk of developing a TEE-related complication: low-risk (TAVI, nâ¯=â¯1037) and high-risk (Mitraclip, LAAO and PVLC, nâ¯=â¯212). Patients were further analyzed according to the occurrence of major and minor TEE-related complications. RESULTS: The overall incidence of TEE-related complications was 0.9% in the TAVI group and 6.1% in the rest of the cohort (Pâ¯<â¯.001). Patients in the high-risk cohort had also a higher incidence of major-complications (2.8% vs 0.6%, Pâ¯=â¯.008), and factors associated with an increased risk were being underweight, having a prior history of gastrointestinal bleeding and the use of chronic steroids/immunosuppressive medications. Procedural time under TEE-manipulation was longer in patients exhibiting complications and was an independent predictor of major complications (ORâ¯=â¯1.13, 95% CI 1.01-1.25, for each 10 minutes increments in imaging time). Patients with major complications undergoing Mitraclip had the longest median time under TEE-manipulation (297 minutes) and a risk of developing a major-complication that was 10.64 times higher than the rest of the cohort (95% CI 3.30-34.29, Pâ¯<â¯.001). CONCLUSION: The prevalence of TEE-related complications associated with interventional procedures is higher than previously reported. Undergoing a prolonged procedure, particularly in the setting of Mitraclip, was the main factor linked to TEE-related complications.
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Cateterismo Cardíaco/métodos , Trastornos de Deglución/epidemiología , Ecocardiografía Transesofágica/efectos adversos , Esófago/lesiones , Hemorragia Gastrointestinal/epidemiología , Complicaciones Posoperatorias/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Apéndice Atrial/cirugía , Transfusión Sanguínea , Perforación del Esófago/epidemiología , Perforación del Esófago/etiología , Femenino , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/terapia , Humanos , Laceraciones/epidemiología , Laceraciones/etiología , Masculino , Válvula Mitral/cirugía , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Cirugía Asistida por Computador , Factores de TiempoRESUMEN
OBJECTIVES: To report on the feasibility and technical differences between coronary procedures performed before and after TAVR with the balloon-expandable Edwards-SAPIEN or the SAPIEN XT valves. BACKGROUND: Coronary artery disease (CAD) and aortic stenosis often coexist. Transcatheter aortic valve replacement (TAVR) is emerging as a treatment for younger and lower surgical risk patients who might not present with clinically evident CAD before TAVR. The demand for performing post-TAVR coronary angiograms (CAs) and percutaneous coronary interventions (PCIs) will thus increase, posing new technical challenges. METHODS: Over 1000 TAVRs were performed at the Quebec Heart and Lung Institute, of which 616 with the abovementioned valves. Of these, 28 patients had an analyzable pre- and post-TAVR CAs and 13 patients had pre- and post-TAVR PCIs performed. Procedural characteristics were gathered from all coronary procedures and subsequently compared amongst the same type of procedure performed at these two distinct time periods. RESULTS: Neither CAs-nor PCIs-performed after valve implantation revealed significant differences regarding arterial access site, catheter diameter, number of diagnostic or guiding catheters used, procedural duration, fluoroscopy time, or achievement of selective coronary injection. Lesion location and classification, as well as the preference of using a drug-eluting stent, remained unchanged. During post-TAVR CA, the amount of contrast delivered and the radiation dose area product were significantly lower compared with pre-TAVR CA values. CONCLUSIONS: Performance of CA and PCI after TAVR with a balloon-expandable valve appears unaffected by its presence.
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Valvuloplastia con Balón , Angiografía Coronaria , Intervención Coronaria Percutánea , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Válvula Aórtica/cirugía , Medios de Contraste/administración & dosificación , Estudios de Factibilidad , Femenino , Prótesis Valvulares Cardíacas , Humanos , Masculino , Dosis de RadiaciónRESUMEN
OBJECTIVES: To assess the clinical characteristics, management, and outcomes of patients diagnosed with infective endocarditis (IE) after edge-to-edge mitral valve repair with the MitraClip device. BACKGROUND: Transcatheter edge-to-edge mitral valve repair has emerged as an alternative to surgery in high-risk patients. However, few data exist on IE following transcatheter mitral procedures. METHODS: Four electronic databases (PubMed, Google Scholar, Embase, and Cochrane Library) were searched for original published studies on IE after edge-to-edge transcatheter mitral valve repair from 2003 to 2017. RESULTS: A total of 10 publications describing 12 patients with definitive IE (median age 76 years, 55% men) were found. The mean logistic EuroSCORE/EuroSCORE II were 41% and 45%, respectively. The IE episode occurred early (within 12 months post-procedure) in nine patients (75%; within the first month in five patients). Staphylococcus aureus was the most frequent (60%) causal microorganism, and severe mitral regurgitation was present in all cases but one. Surgical mitral valve replacement (SMVR) was performed in most (67%) patients, and the mortality associated with the IE episode was high (42%). CONCLUSIONS: IE following transcatheter edge-to-edge mitral valve repair is a rare but life-threatening complication, usually necessitating SMVR despite the high-risk profile of the patients. These results highlight the importance of adequate preventive measures and a prompt diagnosis and treatment of this serious complication.
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Endocarditis Bacteriana/microbiología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas/efectos adversos , Válvula Mitral/cirugía , Infecciones Relacionadas con Prótesis/microbiología , Anciano , Anciano de 80 o más Años , Remoción de Dispositivos , Endocarditis Bacteriana/mortalidad , Endocarditis Bacteriana/fisiopatología , Endocarditis Bacteriana/cirugía , Femenino , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Válvula Mitral/microbiología , Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/microbiología , Insuficiencia de la Válvula Mitral/fisiopatología , Diseño de Prótesis , Infecciones Relacionadas con Prótesis/mortalidad , Infecciones Relacionadas con Prótesis/fisiopatología , Infecciones Relacionadas con Prótesis/cirugía , Reoperación , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Selección de Paciente , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
Importance: Optimal antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is not well established as no randomized evaluation has been performed to date. Objective: To compare the efficacy and safety of low-dose direct oral anticoagulation (low-dose DOAC) vs dual antiplatelet therapy (DAPT) for 3 months after LAAO. Design, Setting, and Participants: The ADALA (Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion) study was an investigator-initiated, multicenter, prospective, open-label, randomized clinical trial enrolling participants from June 12, 2019, to August 28, 2022 from 3 European sites. Patients who underwent successful LAAO were randomly assigned 1:1 to low-dose DOAC vs DAPT for 3 months after LAAO. The study was prematurely terminated when only 60% of the estimated sample size had been included due to lower recruitment rate than anticipated due to the COVID-19 pandemic. Interventions: The low-dose DOAC group received apixaban, 2.5 mg every 12 hours, and the DAPT group received aspirin, 100 mg per day, plus clopidogrel, 75 mg per day, for the first 3 months after LAAO. Main Outcomes and Measures: The primary end point was a composite of safety (major bleeding) and efficacy (thromboembolic events including stroke, systemic embolism, and device-related thrombosis [DRT]) within the first 3 months after successful LAAO. Secondary end points included individual components of the primary outcome and all-bleeding events. Results: A total of 90 patients (mean [SD] age, 76.6 [8.1] years; 60 male [66.7%]; mean [SD] CHADS-VASc score, 4.0 [1.5]) were included in the analysis (44 and 46 patients in the low-dose DOAC and DAPT groups, respectively). A total of 53 patients (58.8%) presented with previous major bleeding events (60 gastrointestinal [66.7%] and 16 intracranial [17.8%]). At 3 months, low-dose DOAC was associated with a reduction of the primary end point compared with DAPT (2 [4.5%] vs 10 [21.7%]; hazard ratio, 0.19; 95% CI, 0.04-0.88; P = .02). Patients in the low-dose DOAC group exhibited a lower rate of DRT (0% vs 6 [8.7%]; P = .04) and tended to have a lower incidence of major bleeding events (2 [4.6%] vs 6 [13.0%]; P = .17), with no differences in thromboembolic events such as stroke and systemic embolism between groups (none in the overall population). Conclusions and Relevance: This was a small, randomized clinical trial comparing different antithrombotic strategies after LAAO. Results show that use of low-dose DOAC for 3 months after LAAO was associated with a better balance between efficacy and safety compared with DAPT. However, the results of the study should be interpreted with caution due to the limited sample size and will need to be confirmed in future larger randomized trials. Trial Registration: ClinicalTrials.gov Identifier: NCT05632445.
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Many lesions in patients undergoing percutaneous coronary intervention (PCI) exhibit significant calcification. Several techniques have been developed to improve outcomes in this setting. However, their impact on coronary microcirculation remains unknown. The aim of this study is to evaluate the influence of plaque modification techniques on coronary microcirculation across patients with severely calcified coronary artery disease. In this multicenter retrospective study, consecutive patients undergoing PCI with either Rotablation (RA) or Shockwave-intravascular-lithotripsy (IVL) were included. Primary endpoint was the impairment of coronary microvascular resistances assessed by Δ angiography-derived index of microvascular resistance (ΔIMRangio) which was defined as the difference in IMRangio value post- and pre-PCI. Secondary endpoints included the development of peri procedural PCI complications (flow-limiting coronary dissection, slow-flow/no reflow during PCI, coronary perforation, branch occlusion, failed PCI, stroke and shock developed during PCI) and 12-month follow-up adverse events. 162 patients were included in the analysis. Almost 80% of patients were male and the left descending anterior artery was the most common treated vessel. Both RA and IVL led to an increase in ΔIMRangio (22.3 and 10.3; p = 0.038, respectively). A significantly higher rate of PCI complications was observed in patients with ΔIMRangio above the median of the cohort (21.0% vs. 6.2%; p = 0.006). PCI with RA was independently associated with higher ΔIMRangio values (OR 2.01, 95% CI: 1.01-4.03; p = 0.048). Plaque modification with IVL and RA during PCI increases microvascular resistance. Evaluating the microcirculatory status in this setting might help to predict clinical and procedural outcomes and to optimize clinical results.
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BACKGROUND: Patients treated with left atrial appendage occlusion (LAAO) are at high bleeding risk. Intensive antithrombotic treatment is recommended after the procedure to prevent device-related thrombosis. OBJECTIVES: This study sought to evaluate the incidence, consequences, and predictors of early nonprocedural bleeding after LAAO. METHODS: This was a multicenter study including 1,649 patients undergoing LAAO in 9 centers. Early nonprocedural bleeding was defined as bleeding unrelated to the procedure occurring within 3 months after device implantation. The severity of bleeding was defined by the Valve Academic Research Consortium-2 classification. A sensitivity analysis was performed at 45 days. RESULTS: A total of 121 (7.3%) patients experienced early nonprocedural bleeding events, and 69 (57.0%) were classified as major bleeding (4.2% of patients). Independent predictors of early nonprocedural bleeding were dual antiplatelet therapy (DAPT) at discharge (adjusted HR [aHR]: 1.61; 95% CI: 1.12-2.33; P = 0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P < 0.001), and multiple locations of prior bleeding (aHR: 2.33; 95% CI: 1.34-4.05; P < 0.001). DAPT at discharge was predictive of both all and major nonprocedural bleeding at 3 months and 45 days. After a median follow-up of 2.3 years (Q1-Q3: 1.1-4.1 years), early nonprocedural bleeding was independently associated with an increased risk of all-cause death (aHR: 1.53; 95% CI: 1.15-2.06; P < 0.001). This heightened mortality risk was similar at 45 days. CONCLUSIONS: Early nonprocedural bleeding after LAAO occurred in â¼7% of patients within 3 months, with more than one-half being classified as major bleeding. Regardless of severity, early nonprocedural bleeding was associated with increased mortality. DAPT at discharge determined an increased risk of early nonprocedural bleeding after LAAO. These results emphasize the importance of bleeding risk for determining antithrombotic strategies after LAAO.
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Apéndice Atrial , Fibrilación Atrial , Cateterismo Cardíaco , Hemorragia , Inhibidores de Agregación Plaquetaria , Humanos , Apéndice Atrial/fisiopatología , Apéndice Atrial/diagnóstico por imagen , Masculino , Femenino , Anciano , Factores de Riesgo , Factores de Tiempo , Fibrilación Atrial/mortalidad , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/complicaciones , Resultado del Tratamiento , Medición de Riesgo , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Hemorragia/etiología , Incidencia , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Terapia Antiplaquetaria Doble/efectos adversos , Estados Unidos/epidemiología , Persona de Mediana Edad , Fibrinolíticos/efectos adversos , Fibrinolíticos/administración & dosificación , Estudios Retrospectivos , Europa (Continente) , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificaciónRESUMEN
INTRODUCTION AND OBJECTIVES: Percutaneous left atrial appendage closure (LAAC) has emerged as a nonpharmacological alternative for thromboembolic event prevention in patients with nonvalvular atrial fibrillation. However, there are few data on readmissions after LACC. The aim of this study was to determine the rate of early (≤ 30 days) and late (31-365 days) readmission after LAAC, and to assess the predictors and clinical impact of rehospitalization. METHODS: This multicenter study included 1419 consecutive patients who underwent LAAC. The median follow-up was 33 [17-55] months, and follow-up was complete in all but 54 (3.8%) patients. The primary endpoint was readmissions for any cause. Logistic regression and Cox regression analysis were performed to determine the predictors of readmission and its clinical impact. RESULTS: A total of 257 (18.1%) patients were readmitted within the first year after LAAC (3.2% early, 14.9% late). The most common causes of readmission were bleeding (24.5%) and heart failure (20.6%). A previous gastrointestinal bleeding event was associated with a higher risk of early readmission (OR, 2.65; 95%CI, 1.23-5.71). The factors associated with a higher risk of late readmission were a lower body mass index (HR, 0.96-95%CI, 0.93-0.99), diabetes (HR, 1.38-95%CI, 1.02-1.86), chronic kidney disease (HR, 1.60; 95%CI, 1.21-2.13), and previous heart failure (HR, 1.69; 95%CI, 1.26-2.27). Both early (HR, 2.12-95%CI, 1.22-3.70) and late (HR, 1.75; 95%CI, 1.41-2.17) readmissions were associated with a higher risk of 2-year mortality. CONCLUSIONS: Readmissions within the first year after LAAC (primary endpoint) were common (18.1%), were mainly related to bleeding and heart failure events, and were associated with the patients' comorbidity burden. Readmission after LAAC confers a higher risk of mortality during the first 2 years after the procedure.
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INTRODUCTION AND OBJECTIVES: In patients undergoing percutaneous coronary intervention (PCI) in the workup pre-transcatheter aortic valve replacement (TAVR), the clinical impact of coronary revascularization complexity remains unknown. This study sought to examine the impact of PCI complexity on clinical outcomes after TAVR in patients undergoing PCI in the preprocedural workup. METHODS: This was a multicenter study including consecutive patients scheduled for TAVR with concomitant significant coronary artery disease. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with 2 stents implanted, total stent length >60mm, or chronic total occlusion. The rates of major adverse cardiac events (MACE), including cardiovascular mortality, myocardial infarction, and coronary revascularization were evaluated. RESULTS: A total of 1550 patients were included, of which 454 (29.3%) underwent complex PCI in the pre-TAVR workup. After a median follow-up period of 2 [1-3] years after TAVR, the incidence of MACE was 9.6 events per 100 patients-years. Complex PCI significantly increased the risk of cardiac death (HR, 1.44; 95%CI, 1.01-2.07), nonperiprocedural myocardial infarction (HR, 1.52; 95%CI, 1.04-2.21), and coronary revascularization (HR, 2.46; 95%CI, 1.44-4.20). In addition, PCI complexity was identified as an independent predictor of MACE after TAVR (HR, 1.31; 95%CI, 1.01-1.71; P=.042). CONCLUSIONS: In TAVR candidates with significant coronary artery disease requiring percutaneous treatment, complex revascularization was associated with a higher risk of MACE. The degree of procedural complexity should be considered a strong determinant of prognosis in the PCI-TAVR population.
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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.
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Apéndice Atrial , Fibrilación Atrial , Trombosis , Humanos , Estudios de Seguimiento , Resultado del Tratamiento , Ecocardiografía Transesofágica , Fibrilación Atrial/cirugía , Trombosis/prevención & control , Cateterismo CardíacoRESUMEN
Background: The percutaneous treatment of heart valve diseases carried out in the hemodynamic service is constantly growing. After analyzing the mortality, readmissions, success of the procedure, and complications, several studies support this type of percutaneous procedure. The increase in these procedures has required the creation of multidisciplinary teams and new diagnostic and care circuits, such as presurgical consultations and postsurgical follow-ups. Even so, there is little evidence regarding the effect of these consultations on quality indicators. Purpose: The objective of this study is to evaluate the impact of a program of presurgical and postsurgical nurse interventions (PROCESS-VALVE) on quality indicators of the health of patients undergoing percutaneous valve procedures. Patients and Methods: The influence of presurgical and postsurgical consultations on quality indicators will be evaluated through an ambispective quasi-experimental study. Patients will be recruited at a tertiary-level hospital in Barcelona, Spain. For the control group, data will be collected retrospectively from patients who underwent percutaneous valve procedures but did not receive pre- or postsurgical consultations. The intervention group comprises those patients agreeing to participate in the study and the hemodynamic nurse valve consultation program (PROCESS-VALVE). In addition, we will assess whether a face-to-face postsurgical consultation equally improves quality indicators compared to postsurgical telephone consultation; for this, a sub-study will be carried out comparing face-to-face or telephone postsurgical follow-up by means of a randomized controlled clinical trial with simple blinding in the intervention group. Discussion: This study will generate scientific evidence regarding the impact on quality indicators of a nursing intervention via presurgical and postsurgical consultations. In addition, it will allow us to decide the most appropriate follow-up strategy for this type of patient. Trial Registration: ClinicalTrials.gov NCT05179278, registration date 01/05/2022.
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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.
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Estenosis de la Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/cirugía , Bioprótesis/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Estudios Prospectivos , Diseño de Prótesis , Resultado del Tratamiento , Implantación de Prótesis de Válvulas Cardíacas/métodos , Factores de RiesgoRESUMEN
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.
Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estudios Retrospectivos , Estudios Prospectivos , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Trastorno del Sistema de Conducción Cardíaco , Bloqueo de Rama/diagnóstico , Bloqueo de Rama/terapia , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugíaRESUMEN
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.
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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.