RESUMO
BACKGROUND: Right ventricular impairment is common among patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation (SMR). Adherence to guideline-directed medical therapy (GDMT) for heart failure is poor in these patients. OBJECTIVES: The aim of this study was to evaluate the impact of GDMT on long-term survival in this patient cohort. METHODS: Within the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) international registry, we selected patients with SMR and right ventricular impairment (tricuspid annular plane systolic excursion ≤17 mm and/or echocardiographic right ventricular-to-pulmonary artery coupling <0.40 mm/mm Hg). Titrated guideline-directed medical therapy (GDMTtit) was defined as a coprescription of 3 drug classes with at least one-half of the target dose at the latest follow-up. The primary outcome was all-cause mortality at 6 years. RESULTS: Among 1,213 patients with SMR and right ventricular impairment, 852 had complete data on medical therapy. The 123 patients who were on GDMTtit showed a significantly higher long-term survival vs the 729 patients not on GDMTtit (61.8% vs 36.0%; P < 0.00001). Propensity score-matched analysis confirmed a significant association between GDMTtit and higher survival (61.0% vs 43.1%; P = 0.018). GDMTtit was an independent predictor of all-cause mortality (HR: 0.61; 95% CI: 0.39-0.93; P = 0.02 for patients on GDMTtit vs those not on GDMTtit). Its association with better outcomes was confirmed among all subgroups analyzed. CONCLUSIONS: In patients with right ventricular impairment undergoing transcatheter edge-to-edge repair for SMR, titration of GDMT to at least one-half of the target dose is associated with a 40% lower risk of all-cause death up to 6 years and should be pursued independent of comorbidities.
Assuntos
Cateterismo Cardíaco , Fármacos Cardiovasculares , Fidelidade a Diretrizes , Insuficiência da Valva Mitral , Guias de Prática Clínica como Assunto , Sistema de Registros , Disfunção Ventricular Direita , Função Ventricular Direita , Humanos , Feminino , Masculino , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Idoso , Resultado do Tratamento , Fatores de Tempo , Disfunção Ventricular Direita/fisiopatologia , Disfunção Ventricular Direita/mortalidade , Disfunção Ventricular Direita/etiologia , Disfunção Ventricular Direita/diagnóstico por imagem , Disfunção Ventricular Direita/terapia , Fatores de Risco , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Fármacos Cardiovasculares/uso terapêutico , Fármacos Cardiovasculares/efeitos adversos , Europa (Continente) , Idoso de 80 Anos ou mais , Medição de Risco , Ecocardiografia Transesofagiana , Valva Mitral/fisiopatologia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Pessoa de Meia-Idade , Recuperação de Função FisiológicaRESUMO
BACKGROUND: Minimally invasive mitral valve repair has a favorable risk-benefit profile in patients with significant de novo mitral regurgitation. Its role in patients with prior mitral valve repair is uncertain. We aimed to appraise the outcome of patients undergoing transcatheter edge-to-edge repair (TEER) with prior transcatheter or surgical mitral valve repair (SMVR). METHODS AND RESULTS: We queried the Italian multicenter registry on TEER with MitraClip, distinguishing naïve patients from those with prior TEER or (SMVR). Inhospital and long-term clinical/echocardiographic outcomes were appraised. The primary outcome was the occurrence of death or rehospitalization for heart failure. A total of 2238 patients were included, with 2169 (96.9%) who were naïve to any mitral intervention, 29 (1.3%) with prior TEER, and 40 (1.8%) with prior SMVR. Several significant differences were found in baseline clinical and imaging features. Respectively, device success was obtained in 2120 (97.7%), 28 (96.6%), and 38 (95.0%, P=0.261) patients; procedural success in 2080 (95.9%), 25 (86.2%), and 38 (95.0%; P=0.047); and inhospital death in 61 (2.8%), 1 (3.5%), and no (P=0.558) patients. Clinical follow-up after a mean of 14 months showed similar rates of death, cardiac death, rehospitalization, rehospitalization for heart failure, and their composite (all P>0.05). Propensity score-adjusted analysis confirmed unadjusted analysis, with lower procedural success for the prior TEER group (odds ratio, 0.28 [95% CI, 0.09-0.81]; P=0.019) but similar odds ratios and hazard ratios for all other outcomes in the naïve, TEER, and SMVR groups (all P>0.05). CONCLUSIONS: In carefully selected patients, TEER can be performed using the MitraClip device even after prior TEER or SMVR.
Assuntos
Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Valva Mitral , Sistema de Registros , Humanos , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Masculino , Feminino , Idoso , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , Valva Mitral/cirurgia , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Itália/epidemiologia , Idoso de 80 Anos ou mais , Readmissão do Paciente/estatística & dados numéricos , Falha de Tratamento , Próteses Valvulares Cardíacas , Anuloplastia da Valva Mitral/instrumentação , Anuloplastia da Valva Mitral/efeitos adversos , Resultado do Tratamento , Fatores de Tempo , Fatores de Risco , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/cirurgiaRESUMO
BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.
Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Valva Aórtica , Doença da Válvula Aórtica Bicúspide , Próteses Valvulares Cardíacas , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter , Humanos , Masculino , Feminino , Fatores de Risco , Idoso , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/mortalidade , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valva Aórtica/anormalidades , Resultado do Tratamento , Idoso de 80 Anos ou mais , Incidência , Fatores de Tempo , Doença da Válvula Aórtica Bicúspide/cirurgia , Doença da Válvula Aórtica Bicúspide/diagnóstico por imagem , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/cirurgia , Doenças das Valvas Cardíacas/fisiopatologia , Europa (Continente) , Medição de Risco , Desenho de Prótese , Razão de Chances , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/diagnóstico , Estudos RetrospectivosRESUMO
AIMS: This study aims to assess the applicability of the mitral regurgitation (MR) proportionality concept in patients with atrial functional mitral regurgitation (aFMR) treated with transcatheter edge-to-edge repair (M-TEER). We hypothesized that patients with disproportionate MR (higher MR relative to left ventricular size) would exhibit different outcomes compared to those with proportionate MR, despite undergoing M-TEER. METHODS AND RESULTS: We retrospectively analysed 98 patients with aFMR from the EuroSMR registry who underwent M-TEER between 2008 and 2019. Patients met criteria for aFMR (normal indexed left ventricular end-diastolic volume [LVEDV], preserved left ventricular ejection fraction [LVEF] ≥ 50% without regional wall motion abnormalities, and structurally normal mitral valves). We excluded patients with missing effective regurgitant orifice area (EROA) or LVEDV data. The primary endpoint was 2-year mortality, with an EROA/LVEDV ratio employed to differentiate disproportionate from proportionate MR. Procedural success and baseline characteristics were analysed, and multivariate Cox proportional hazards models were used to identify mortality predictors. The mean patient age was 79 ± 7.3 years, with 68.8% female, and 79% had a history of atrial fibrillation. The mean EROA was 0.27 ± 0.14 cm2, and LVEDV was 95.6 ± 33.7 mL. Disproportionate MR was identified with an EROA/LVEDV ratio >0.339 cm2/100 mL. While procedural success was similar in both groups, disproportionate MR was associated with a numerically higher estimate of systolic pulmonary artery pressures (sPAP) and rates of NYHA ≥III and TR ≥ 3+. Disproportionate MR had a significant association with increased 2-year mortality (P < 0.001). The EROA/LVEDV ratio and tricuspid annular plane systolic excursion (TAPSE) were independent predictors of 2-year mortality (EROA/LVEDV: HR: 1.35, P = 0.010; TAPSE: HR: 0.85, P = 0.020). CONCLUSIONS: This analysis introduces the MR proportionality concept in aFMR patients and its potential prognostic value. Paradoxically, disproportionate MR in aFMR was linked to a 1.35-fold increase in 2-year mortality post-M-TEER, emphasizing the importance of accurate preprocedural FMR characterization. Our findings in patients with disproportionate MR indicate that a high degree of aFMR with high regurgitant volumes may lead to aggravated symptoms, which is a known contributor to increased mortality following M-TEER. These results underline the need for further research into the pathophysiology of aFMR to inform potential preventative and therapeutic strategies, ensuring optimal patient outcomes.
Assuntos
Cateterismo Cardíaco , Átrios do Coração , Insuficiência da Valva Mitral , Valva Mitral , Humanos , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico , Feminino , Masculino , Estudos Retrospectivos , Idoso , Cateterismo Cardíaco/métodos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Valva Mitral/fisiopatologia , Átrios do Coração/fisiopatologia , Átrios do Coração/diagnóstico por imagem , Taxa de Sobrevida/tendências , Seguimentos , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia , Sistema de Registros , Ecocardiografia Transesofagiana/métodosRESUMO
The treatment of coronary artery disease (CAD) in patients with severe aortic valve stenosis (AVS) eligible for transcatheter aortic valve implantation (TAVI) is not supported by clinical evidence, and the role of physiology over anatomy as well as the timing of coronary intervention are not defined. FAITAVI (ClinicalTrials.gov: NCT03360591) is a nationwide prospective, open-label, multicentre, randomised controlled study comparing the angiography-guided versus the physiology-guided coronary revascularisation strategy in patients with combined significant CAD and severe AVS undergoing TAVI. Significant CAD will be defined as coronary stenosis ≥50%, as assessed by visual estimation in vessels ≥2.5 mm. Physiology will be tested by fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). The study will be conducted at 15 sites in Italy. In the angiography arm, percutaneous coronary intervention (PCI) will be performed either before TAVI, during the TAVI procedure - before or after the valve implantation - or within 1 month±5 days of the valve implantation, left to the operator's decision. In the physiology arm, FFR and iFR will be performed before TAVI, and PCI will be indicated for FFR ≤0.80, otherwise the intervention will be deferred. In case of borderline values (0.81-0.85), FFR and iFR will be repeated after TAVI, with PCI performed when needed. With a sample size of 320 patients, the study is powered to evaluate the primary endpoint (a composite of death, myocardial infarction, stroke, major bleeding, or ischaemia-driven target vessel revascularisation). TAVI indication, strategy and medical treatment will be the same in both groups. After discharge, patients will be contacted at 1, 6, 12 and 24 months after the procedure to assess their general clinical status, and at 12 months for the occurrence of events included in the primary and secondary endpoints. FAITAVI is the first randomised clinical trial to investigate "optimal" percutaneous coronary intervention associated with TAVI in patients with severe AVS and CAD.
Assuntos
Estenose da Valva Aórtica , Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Humanos , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Estudos Prospectivos , Resultado do Tratamento , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).
Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Bioprótese , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Bioprótese/efeitos adversos , Insuficiência Cardíaca , Estimativa de Kaplan-Meier , Complicações Pós-Operatórias/etiologia , Desenho de Prótese , Falha de Prótese , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
BACKGROUND: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. OBJECTIVES: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. METHODS: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. RESULTS: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year. CONCLUSIONS: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335).
Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Masculino , Humanos , Idoso , Feminino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Cateterismo Cardíaco/métodos , Sistema de RegistrosRESUMO
BACKGROUND: Similar to procedures requiring general anesthesia, current guidelines recommend fasting for 6 hours for solids and for 2 hours for liquids prior to coronary angiography, but without data supporting such recommendation. The CORO-NF study aimed at assessing whether a shorter fasting period prior to elective coronary angiography associates with improved patient satisfaction without more complications compared with the standard fasting approach. METHODS: We conducted a single-center, randomized, prospective, pragmatic study in 2 sequential phases: a "conventional protocol phase," continuing the usual practice (F Group); and an "experimental phase" (NF Group), reducing minimum fasting duration to 2 hours. Patients received a questionnaire to express a satisfaction score ranging from 1 (maximum complain/no approval) to 5 (minimum or no complain/full approval). All patients admitted acutely were enrolled in a control A Group registry. Fasting time and every major complication and periprocedural complications were analyzed. RESULTS: Fasting time was 821 ± 357 minutes in the F Group and 230 ± 146 minutes in the NF Group (P < .001). The satisfaction score was higher in the NF Group (4.2 ± 0.7 vs 2.9 ± 1.2, P < .001), even at multivariable analysis considering fasting time (P < .001). No intraprocedural food ingestion-related adverse events occurred in either of the 2 experimental groups, as well as in the parallel A Group, with no excess of peri- and postprocedural complications in the NF Group. CONCLUSIONS: The significantly higher satisfaction scores among patients undergoing a shorter-than-recommended fasting period prior to coronary angiography, not counterbalanced by decreased safety, underscores the potential benefits of revising the traditional 6-hour fasting protocols.
Assuntos
Angiografia Coronária , Jejum , Satisfação do Paciente , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Angiografia Coronária/métodos , Jejum/efeitos adversos , Cuidados Pré-Operatórios/métodos , Estudos Prospectivos , Fatores de TempoRESUMO
BACKGROUND AND AIMS: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing transcatheter aortic valve intervention (TAVI). METHODS: We followed the European Society of Cardiology (ESC) methodology for the development of QIs. Key domains were identified by constructing a conceptual framework for the delivery of TAVI care. A list of candidate QIs were developed by conducting a systematic review of the literature. A modified Delphi method was then used to select the final set of QIs. Finally, we mapped the QIs to the EuroHeart Data Standards for TAVI to ascertain the extent to which the EuroHeart TAVI registry captures information to calculate the QIs. RESULTS: We formed an international group of experts in quality improvement and TAVI, including representatives from the European Association of Percutaneous Cardiovascular Interventions, the European Association of Cardiovascular Imaging and the Association of Cardiovascular Nursing & Allied Professions. In total, 27 QIs were selected across eight domains of TAVI care, comprising 22 main (81%) and five secondary (19%) QIs. Of these, 19/27 (70%) are now being utilised in the EuroHeart TAVI registry. CONCLUSION: We present the 2023 ESC QIs for TAVI, developed using a standard methodology and in collaboration with ESC Associations. The EuroHeart TAVI registry allows calculation of the majority of the QIs, which may be used for benchmarking care and quality improvement initiatives.
RESUMO
BACKGROUND: The risks of prefrail and frail women undergoing transcatheter aortic valve replacement (TAVR) have not been fully examined. The aim of the analysis was to assess the prognostic impact of prefrailty and frailty in women undergoing TAVR. METHODS: Women at intermediate or high surgical risk with severe aortic stenosis undergoing TAVR from the prospective multicentre WIN-TAVI (Women's International Transcatheter Aortic Valve Implantation) registry were stratified based on the number of Fried frailty criteria (weight loss, exhaustion, low physical activity, slow gait, weakness) met: nonfrail (no criteria), prefrail (1 or 2 criteria), or frail (3 or more criteria). The primary outcome at 1 year was the Valve Academic Research Consortium 2 (VARC-2) efficacy end point, a composite of mortality, stroke, myocardial infarction, hospitalisation for valve-related symptoms or heart failure, and valve-related dysfunction; secondary outcomes included the composite of VARC-2 life-threatening or major bleeding. RESULTS: Out of 1019 women, 297 (29.1%) met at least 1 frailty criterion: 264 (25.9%) had prefrailty and 33 (3.2%) frailty. The 1-year risk of the primary outcome was significantly higher in prefrail and frail (20.2%) than in nonfrail (14.9%) women (adjusted hazard ratio [aHR] 1.51, 95% confidence interval [CI] 1.07-2.12). The risk of VARC-2 life-threatening or major bleeding was higher in prefrail or frail (19.9%) than in nonfrail (10.0%) women (aHR 2.06, 95% CI 1.42-2.97). These risks were consistently increased in the prefrail and frail groups assessed separately. CONCLUSIONS: In women undergoing TAVR, the presence of prefrailty or frailty conferred an increased risk of the VARC-2 efficacy end point and of VARC-2 life-threatening or major bleeding.
Assuntos
Estenose da Valva Aórtica , Fragilidade , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Masculino , Substituição da Valva Aórtica Transcateter/efeitos adversos , Fragilidade/complicações , Fragilidade/epidemiologia , Fragilidade/diagnóstico , Prognóstico , Fatores de Risco , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Medição de Risco , Estudos Prospectivos , Resultado do Tratamento , Hemorragia/etiologia , Sistema de Registros , Valva Aórtica/cirurgiaRESUMO
Given the expanding indications toward younger patients at lower surgical risk, transcatheter aortic valve replacement (TAVR) simplification and streamlining are gaining increasing importance. Patients who underwent TAVR from the year 2015 to 2020 were prospectively enrolled. The patients were divided in time tertiles according to the date of intervention. Data on preprocedural planning, including coronary computed tomography angiography (CCTA), procedures, and outcomes, were compared between the time tertiles. A total of 771 consecutive patients from a single institution were enrolled. We observed a trend toward the use of a fully percutaneous versus surgical approach for the index access, left radial artery versus contralateral femoral artery for the secondary access, and left ventricular pacing on the stiff guidewire versus right ventricular pacing. Immediate device success significantly increased, whereas the length of hospital stay decreased. Overall, approximately 60% of the total study population underwent CCTA instead of coronary angiography, with no adverse events. One-year survival rates significantly improved over time. A simplified TAVR approach was associated with better survival, whereas low baseline functional capacity, preexisting coronary artery disease, renal impairment, periprocedural blood transfusions, and paravalvular leak were related to worse outcomes. In conclusion, our study showed a constant tendency to procedure streamlining and improve procedural success and 1-year outcomes. A strategy based on CCTA allows sparing safely almost half of the preoperative invasive coronary angiography.
Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Valva Aórtica/cirurgia , Resultado do Tratamento , Fatores de Risco , Angiografia Coronária , Estudos RetrospectivosRESUMO
BACKGROUND: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation. AIMS: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting. METHODS: Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography). RESULTS: The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL). CONCLUSIONS: The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248).
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Desenho de Prótese , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
BACKGROUND: In the context of primary mitral regurgitation (PMR), the selection of patients for transcatheter edge-to-edge repair (TEER) does not include a systematic assessment of PMR-associated cardiac remodelling. AIMS: We aimed to investigate the epidemiology and prognostic significance of different phenotypes of extra-mitral valve (MV) cardiac involvement in a large series of patients with PMR referred for TEER. METHODS: The study included 654 patients from the multicentre Italian GIOTTO registry, stratified into groups according to extra-mitral valve (MV) cardiac involvement. The primary endpoint was all-cause death at 2-year follow-up. RESULTS: Patients with no cardiac involvement (NI; n=58), left heart involvement (LHI; n=343) and right heart involvement (RHI; n=253) were analysed. Acute technical success was achieved in 98% of patients. Kaplan-Meier curve analysis revealed significantly worse survival in patients with LHI and RHI (p=0.041). On multivariate Cox regression analysis, extra-MV cardiac involvement, haemoglobin level and technical success were independent predictors of the primary endpoint occurrence. CONCLUSIONS: Grading cardiac involvement may help refine risk stratification, since at least 1 group of extra-MV cardiac involvement represents in itself a negative predictor of midterm outcome.
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Estimativa de Kaplan-Meier , Análise Multivariada , Pacientes , Resultado do Tratamento , Cateterismo CardíacoRESUMO
BACKGROUND: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: This study aimed to determine whether device position and asymmetry are associated with these outcomes. METHODS: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. RESULTS: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). CONCLUSIONS: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.
Assuntos
Fibrilação Atrial , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Constrição Patológica/etiologia , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Hemodinâmica , Sistema de Registros , Desenho de PróteseRESUMO
BACKGROUND: Limited data are available on transcatheter heart valves (THVs) durability in bicuspid aortic valve (BAV) stenosis. AIMS: To evaluate evaluating 4-year clinical and echocardiographic outcomes of patients with BAV undergoing transcatheter aortic valve implantation (TAVI). METHODS: The bicuSpid TAvi duraBILITY (STABILITY) registry is an Italian multicentre registry including all consecutive patients with BAV and severe aortic stenosis (AS), treated by means of TAVI between January 2011 and December 2017. Outcomes of interest were all-cause death at 4-year, over time changes in echocardiographic measurements, and THV durability according to the valve aortic research consortium (VARC)-3 update definitions. RESULTS: Study population included 109 patients (50% females; mean age 78 ± 7.5 years) with a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.1 ± 4.3%. Median follow-up (FU) duration was 4.1 years [interquartile range: 2.8-5.1]. The overall cumulative incidence of all-cause death by Kaplan-Meier estimates at 4 years was 32%. Compared to baseline, a significant decrease in transprosthetic mean gradient was obtained after TAVI (54 ± 16 vs. 10 ± 5 mmHg; p < 0.001), whereas a significant increase was observed at 4-year (13 ± 6.4 mmHg, p = 0.03). Cumulative incidence of hemodynamic valve dysfunction (HVD) was 4%. Six patients met HVD criteria: three moderate and three severe HVD. All three cases of severe HVD were clinically relevant (bioprosthetic valve failure [BVF]) with two patients receiving a reintervention (TAVI in TAVI), and one patient experiencing a valve-related death due to endocarditis. CONCLUSIONS: The STABILITY registry suggests that in patients with severe AS and BAV undergoing TAVI, postprocedural clinical benefits might last, over time, up to 4-year FU. The low rates of severe HVD and BVF may support the hypothesis of good THV durability also in BAV recipient.
Assuntos
Estenose da Valva Aórtica , Doença da Válvula Aórtica Bicúspide , Doenças das Valvas Cardíacas , Próteses Valvulares Cardíacas , Estenose da Valva Mitral , Substituição da Valva Aórtica Transcateter , Feminino , Humanos , Idoso , Idoso de 80 Anos ou mais , Masculino , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Constrição Patológica , Resultado do Tratamento , Doenças das Valvas Cardíacas/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Sistema de RegistrosRESUMO
BACKGROUND: Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL). OBJECTIVES: Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA. METHODS: We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes. RESULTS: Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort. CONCLUSION: In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Desenho de Prótese , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Resultado do Tratamento , Sistema de RegistrosRESUMO
Symptoms of aortic stenosis (AS) are not proportional to its severity and patients with very severe AS (VSAS) remain asymptomatic for a long time. The appropriate time for intervention in patients with VSAS and the effects of transcatheter aortic valve implantation (TAVI) on left ventricular hypertrophy (LVH) remain debated. Our aim was to compare the procedural and 30-day outcomes of TAVI between patients with VSAS and patients with severe AS (SAS) and the changes in LVH. We selected patients with an aortic peak velocity ≥5 m/s (VSAS) and those with aortic peak velocity 4 to 5 m/s (SAS) treated with TAVI. Patients with reduced left ventricular ejection fraction (<45%) were excluded. The primary end point was the incidence of all-cause death at 30 days. The secondary end points included the 30-day incidence of cardiac death, cardiac rehospitalization, and stroke/transient ischemic attack and the changes in LVH from baseline to 30 days. A total of 102 patients in the VSAS group and 535 in the SAS group were included. Patients in the VSAS group had a thicker septal wall (p <0.001) and a higher Agaston score (p <0.001) and calcium volume (p = 0.007). No differences were observed regarding the primary and secondary clinical end points. However, patients with VSAS showed a significantly greater improvement in concentric LVH, although the prevalence of concentric LVH remained higher than in patients with SAS. TAVI in patients with VSAS showed similar procedural and clinical outcomes to patients with SAS and experienced a more pronounced improvement in the prevalence of concentric LVH.
Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Volume Sistólico , Função Ventricular Esquerda , Hipertrofia Ventricular Esquerda , Estenose da Valva Aórtica/cirurgiaRESUMO
Despite the growing experience with MitraClip in the broad spectrum of mitral regurgitation (MR), limited data are available regarding the independent prognostic role on survival of different mitral regurgitation etiology subtypes. We sought to evaluate the impact of flail leaflet etiology in a large series of patients with primary MR (PMR) who underwent MitraClip treatment. The study included 588 patients with significant PMR from the multicenter GIOTTO (Italian Society of Interventional Cardiology [GIse] registry Of Transcatheter treatment of mitral valve regurgitaTiOn), stratified into 2 groups according to MR etiology: flail+ (n = 300) and flail- (n = 288). The primary end point was a composite of cardiac death and first rehospitalization for heart failure (HF). To account for the baseline differences, patients were propensity score-matched 1:1. Flail leaflet etiology was present in about a half of the patients. Acute technical success was achieved in 98% of the overall cohort, with no significant differences between the study groups (p = 0.789). At the 2-year Kaplan-Meier analysis, the primary end point occurred in 13% of flail+ patients compared with 23% in flail- (p = 0.009). The flail+ group presented lower rates of both cardiac death and rehospitalization for HF, whereas a similar overall death rate was observed between the groups. A multivariate Cox regression analysis identified flail leaflet etiology as an independent predictor of favorable outcome in terms of the primary end point (hazard ratio 0.141, 95% confidence interval 0.049 to 0.401, p <0.001). After propensity score matching, flail+ patients had confirmed lower rates of cardiac mortality and rehospitalization for HF but similar rates of overall death. In conclusion, flail leaflet-related etiology was common in patients with PMR who underwent MitraClip treatment and was an independent predictor of midterm favorable clinical outcomes.
Assuntos
Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Prognóstico , Resultado do Tratamento , Modelos de Riscos Proporcionais , Insuficiência Cardíaca/complicações , Morte , Implante de Prótese de Valva Cardíaca/efeitos adversos , Cateterismo Cardíaco/efeitos adversosRESUMO
BACKGROUND: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR). AIMS: This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry. METHODS: The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality. RESULTS: A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality. CONCLUSIONS: In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.
Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Masculino , Idoso , Feminino , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Cateterismo Cardíaco/métodos , Resultado do Tratamento , Fatores de Risco , Sistema de RegistrosRESUMO
BACKGROUND: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited. AIMS: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry. METHODS: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria. RESULTS: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm2, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies. CONCLUSIONS: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.