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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.
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BACKGROUND: In the last recent years a new percutaneous procedure, the MitraClip, has been validated for the treatment of mitral regurgitation. MitraClip procedure is a promising alternative for patients unsuitable for surgery as it reduces the risk of death related to surgery ensuring a similar result. Few data are present in literature about the variation of hemodynamic parameters and ventricular coupling after Mitraclip implantation. METHODS: Hemodynamic data of 18 patients enrolled for MitraClip procedure were retrospectively reviewed and analyzed. Echocardiographic measurements were obtained the day before the procedure (T0) and 21 ± 3 days after the procedure (T1), including evaluation of Ejection Fraction, mitral valve regurgitation severity and mechanism, forward Stroke Volume, left atrial volume, estimated systolic pulmonary pressure, non invasive echocardiographic estimation of single beat ventricular elastance (Es(sb)), arterial elastance (Ea) measured as systolic pressure ⢠0.9/ Stroke Volume, ventricular arterial coupling (Ea/Es(sb) ratio). Data were expressed as median and interquartile range. Measures obtained before and after the procedure were compared using Wilcoxon non parametric test for paired samples. RESULTS: Mitraclip procedure was effective in reducing regurgitation. We observed an amelioration of echocardiographic parameters with a reduction of estimated systolic pulmonary pressure (45 to 37,5 p = 0,0002) and left atrial volume (110 to 93 p = 0,0001). Despite a few cases decreasing in ejection fraction (37 to 35 p = 0,035), the maintained ventricular arterial coupling after the procedure (P = 0,67) was associated with an increasing in forward stroke volume (60,3 to 78 p = 0,05). CONCLUSION: MitraClip is effective in reducing mitral valve regurgitation and determines an amelioration of hemodynamic parameters with preservation of ventricular arterial coupling.
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Cateterismo Cardíaco/métodos , Ecocardiografia/métodos , Próteses Valvulares Cardíacas , Ventrículos do Coração/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Função Ventricular Esquerda/fisiologia , Idoso , Fenômenos Biomecânicos , Feminino , Ventrículos do Coração/diagnóstico por imagem , Humanos , Masculino , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/cirurgia , Período Pré-Operatório , Estudos Prospectivos , Desenho de Prótese , Reprodutibilidade dos Testes , Volume SistólicoRESUMO
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.
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Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Volume Sistólico , Função Ventricular Esquerda , Hipertrofia Ventricular Esquerda , Estenose da Valva Aórtica/cirurgiaRESUMO
BACKGROUND: Guideline-directed medical therapy (GDMT) optimization is mandatory before transcatheter edge-to-edge mitral valve repair (M-TEER) in patients with secondary mitral regurgitation (SMR) and heart failure (HF) with reduced ejection fraction (HFrEF). However, the effect of M-TEER on GDMT is unknown. OBJECTIVES: The authors sought to evaluate frequency, prognostic implications and predictors of GDMT uptitration after M-TEER in patients with SMR and HFrEF. METHODS: This is a retrospective analysis of prospectively collected data from the EuroSMR Registry. The primary events were all-cause death and the composite of all-cause death or HF hospitalization. RESULTS: Among the 1,641 EuroSMR patients, 810 had full datasets regarding GDMT and were included in this study. GDMT uptitration occurred in 307 patients (38%) after M-TEER. Proportion of patients receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists was 78%, 89%, and 62% before M-TEER and 84%, 91%, and 66% 6 months after M-TEER (all P < 0.001). Patients with GDMT uptitration had a lower risk of all-cause death (adjusted HR: 0.62; 95% CI: 0.41-0.93; P = 0.020) and of all-cause death or HF hospitalization (adjusted HR: 0.54; 95% CI: 0.38-0.76; P < 0.001) compared with those without. Degree of MR reduction between baseline and 6-month follow-up was an independent predictor of GDMT uptitration after M-TEER (adjusted OR: 1.71; 95% CI: 1.08-2.71; P = 0.022). CONCLUSIONS: GDMT uptitration after M-TEER occurred in a considerable proportion of patients with SMR and HFrEF and is independently associated with lower rates for mortality and HF hospitalizations. A greater decrease in MR was associated with increased likelihood for GDMT uptitration.
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Insuficiência Cardíaca , Insuficiência da Valva Mitral , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Volume Sistólico , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/complicaçõesRESUMO
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become an accepted treatment for patients with severe aortic stenosis (AS). Predicting which patients are at risk for adverse clinical outcomes after TAVI remains difficult, especially in women. AIM: To identify predictors of adverse events in the WIN-TAVI cohort. METHODS: The WIN-TAVI study is an observational registry of 1019 women undergoing TAVI for severe symptomatic AS. Follow-up was 1 year. The primary outcome was defined according to VARC-2: a composite of mortality, stroke, myocardial infarction or hospitalization for valve-related symptoms or heart failure. The secondary outcome was a composite of cardiovascular mortality or hospitalization for valve-related symptoms or heart failure. RESULTS: We included 1019 women with severe AS (mean age of 82.5 ± 6.3 years). At 1 year, 16.4% of the patients experienced the primary endpoint and 12.6% the secondary endpoint. The use of oral anticoagulants (OAC) was the strongest independent predictor of the primary outcome (adjusted hazard ratio [aHR] 1.51, 95% confidence interval [CI] 1.079-2.106, p = 0.016). Independent predictors of the secondary endpoint were age (aHR 1.04 per year, 95% CI 1.01-1.074, p = 0.016) and use of OAC (aHR: 1.79, 95% CI 1.24-2.60, p = 0.002). OAC use was not associated with higher bleeding risk. CONCLUSION: Pre-procedural use of OAC was the strongest predictor of adverse outcomes during 1-year follow-up, likely reflecting a combination of high-risk factors and comorbidities, but was not related to increased bleeding risk.
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Estenose da Valva Aórtica , Insuficiência Cardíaca , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/cirurgia , Anticoagulantes/efeitos adversos , Resultado do Tratamento , Fatores de Risco , Insuficiência Cardíaca/etiologiaRESUMO
BACKGROUND: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. METHODS: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. RESULTS: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P=0.98). CONCLUSIONS: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT).
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Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Feminino , Humanos , Masculino , Cateterismo Cardíaco/efeitos adversos , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/terapia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Pontuação de Propensão , Resultado do TratamentoRESUMO
AIMS: Local instead of general anesthesia has become the standard approach in many centers for transfemoral transcatheter aortic valve replacement (TAVR). New generation devices and an increase in operator skills had led to a drastic reduction in periprocedural complications, bringing in the adoption of a minimalist approach. In our study, we aimed to compare patients treated with TAVR under local anesthesia with or without the presence of an anesthesiologist on site (AOS). METHODS: We compare procedural aspects and results of patients treated with TAVR with an AOS against patients treated with TAVR with an anesthesiologist on call (AOC). From January 2019 to December 2020, all consecutive patients undergoing transfemoral TAVR with either the self-expandable Evolut (Medtronic, MN, USA) or balloon-expandable SAPIEN 3 (Edwards Lifesciences, CA, USA) were collected. RESULTS: Of 332 patients collected, 96 (29%) were treated with TAVR with AOS, while 236 (71%) were treated with TAVR with AOC. No differences in procedural time, fluoroscopy time and amount of contrast medium were observed. No procedural death and conversion to open-chest surgery was reported. The rate of stroke/transient ischemic attacks and major vascular complications was similar in the two groups. No patients in both groups required conversion to general anesthesia. Two patients (0.8%) in the AOC group required urgent intervention of the anesthesiologist. In the AOC group, there was a greater use of morphine (55.9% vs. 33.3%, P â=â0.008), but with a lower dose for each patient (2.0 vs. 2.8âmg, P â=â0.006). On the other hand, there was a lower use of other painkiller drugs (3.4% vs. 20.8%, P â=â0.001). No difference in inotropic drugs use was observed. CONCLUSION: In patients at low or intermediate risk undergoing transfemoral TAVR, a safe procedure can be performed under local anesthesia without the presence of an anesthesiologist in the catheterization laboratory.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Anestesiologistas , Desenho de Prótese , Resultado do Tratamento , Fluoroscopia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgiaRESUMO
AIMS: The aim of this study was to minimize the procedure, and reduce the length of hospital stay (LoS) is the future objective for transcatheter aortic valve replacement (TAVI).Aims of the study are to identify procedural and electrocardiographical predictors of fast-track discharge in patients who underwent TAVI. METHODS: Patients treated with TAVI included in the One Hospital ClinicalService project were categorized according to the LoS. 'Fast-Track' population, with a postprocedural LoS less than or equal to 3âdays, was compared with the 'Slow-Track' population with a postprocedural LoS greater than 3âdays. RESULTS: One thousand five hundred and one patients were collected. Despite single baseline characteristics being almost similar between the two groups, Slow-Track group showed a higher surgical risk (Pâ<â0.001). Patients in the Slow-Track group were more frequently treated with general anaesthesia (Pâ=â0.002) and less frequently predilated (Pâ<â0.001) and received a lower amount of contrast media. No difference between Slow-Track and Fast-Track patients was observed at 30 days in death and in cardiovascular rehospitalization.In the multivariable analysis, STS score of at least 4% [odds ratio (OR): 1.64; Pâ=â0.01], general anaesthesia (OR: 2.80; Pâ=â0.03), predilation (OR: 0.45; Pâ<â001), NYHA 3-4 at baseline (OR: 1.65; Pâ=â0.01), AVB I/LBBB/RBBB onset (OR: 2.41; Pâ<â0.001) and in-hospital new PM (OR: 2.63; Pâ<â0.001) were independently associated with a higher probability of Slow-Track. CONCLUSION: Fast-Track patients were safely discharged home showing no difference in clinical outcomes after discharge up to 30âdays compared with the Slow-Track group. The STS score, general anaesthesia, NYHA 3--4 at baseline, in-hospital onset of conduction disturbances and new PM implantation after TAVI turned out to be predictors of Slow-Track.
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Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Eletrocardiografia , Fluoroscopia , Humanos , Alta do Paciente , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodosRESUMO
BACKGROUND: Transcatheter mitral valve repair (TMVR) with MitraClip™ (Abbott Laboratories; Abbott Park, IL, USA) is an established treatment for mitral regurgitation (MR). More than one MitraClip™ may be implanted if a single one does not reduce MR adequately. We aimed to appraise the outlook of patients undergoing implantation of one, two or multiple MitraClip™ for TMVR. METHODS: Exploiting the ongoing prospective GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation (GIOTTO) Study dataset, we compared patients, procedural details and outcomes distinguishing those receiving one, two or multiple MitraClip™. The primary endpoint was the composite of 1-year cardiac death or rehospitalization for heart failure. Additional endpoints included all cause death, surgical mitral repair, and functional class. Multivariable adjusted Cox proportional hazard analysis was used for confirmatory purposes. RESULTS: As many as 1824 patients were included: 718 (39.4%) treated with a single MitraClip™, and 940 (51.5%) receiving two MitraClip™, and 166 (9.1%) receiving three or more. Significant differences were found for baseline features, including age, female gender, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, atrial fibrillation, permanent pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and prior mitral valve repair (all P<0.05). Several imaging features were also different, including left ventricular dimensions, MR severity and proportionality, mitral valve area, flail leaflet, and pulmonary vein flow (all P<0.05). Among procedural features, significant differences were found for anesthesia type, MitraClip™ type, fluoroscopy, device, and operating room times, postprocedural mitral gradient, residual MR, smoke-like effect, device success partial detachment and surgical conversion (all P<0.05). In-hospital death occurred more frequently in patients receiving multiple MitraClip™, and the same applied severe residual MR (all P<0.05). Mid-term follow-up (15±13 months) showed significant differences in the risk of death, cardiac death, rehospitalization for heart failure, and their composites, mainly, but not solely, associated with multiple MitraClip™ (all P<0.05). Adjusted analysis confirmed the significantly increased risk of composite adverse events when comparing the multiple vs. single MitraClip™ groups (P=0.014 for death and rehospitalization, P=0.013 for cardiac death or rehospitalization). CONCLUSIONS: Implantation of one or two MitraClip™ is associated with favorable clinical outcomes. Conversely, bail-out implantation of three or more MitraClip™ may portend a worse long-term prognosis.
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Mortalidade Hospitalar , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/cirurgia , Estudos Prospectivos , Resultado do TratamentoRESUMO
Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.
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Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Feminino , Humanos , Masculino , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: A systemic coagulation dysfunction has been associated with COVID-19. In this case report, we describe a COVID-19-positive patient with multisite arterial thrombosis, presenting with acute limb ischaemia and concomitant ST-elevation myocardial infarction and oligo-symptomatic lung disease. CASE SUMMARY: An 83-year-old lady with history of hypertension and chronic kidney disease presented to the Emergency Department with acute-onset left leg pain, pulselessness, and partial loss of motor function. Acute limb ischaemia was diagnosed. At the same time, a routine ECG showed ST-segment elevation, diagnostic for inferior myocardial infarction. On admission, a nasopharyngeal swab was performed to assess the presence of SARS-CoV-2, as per hospital protocol during the current COVID-19 pandemic. A total-body CT angiography was performed to investigate the cause of acute limb ischaemia and to rule out aortic dissection; the examination showed a total occlusion of the left common iliac artery and a non-obstructive thrombosis of a subsegmental pulmonary artery branch in the right basal lobe. Lung CT scan confirmed a typical pattern of interstitial COVID-19 pneumonia. Coronary angiography showed a thrombotic occlusion of the proximal segment of the right coronary artery. Percutaneous coronary intervention was performed, with manual thrombectomy, followed by deployment of two stents. The patient was subsequently transferred to the operating room, where a Fogarty thrombectomy was performed. The patient was then admitted to the COVID area of our hospital. Seven hours later, the swab returned positive for COVID-19. DISCUSSION: COVID-19 can have an atypical presentation with thrombosis at multiple sites.
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BACKGROUND: The evaluation of aortic valve calcium burden is important when planning for transcatheter aortic valve implantation (TAVI). Although a robust golden standard methodology is available for calcium evaluation on noncontrast-enhanced (NCE) computed tomographic (CT) series, a standard reference for calcium assessment on contrast-enhanced CT series is currently lacking. METHODS: Two hundred and forty-four preprocedural CT scans from patients who had received TAVI were analysed. We correlated the aortic calcium volumes obtained on CE series at three thresholds [450, 850, and 'probeâ+â100' Hounsfield Units (HU)] with the Agatston score obtained on NCE scans. A subgroup analysis was performed taking into account the contrast enhancement of the left ventricular outflow tract (LVOT), with a prespecified cut-off of 300âHU. RESULTS: The overall population analysis showed higher correlation with the Agatston score using the 850âHU threshold (râ=â0.45, Pâ<â0.0001); no correlation was found with the 450âHU threshold, whilst the 'probeâ+â100'âHU threshold showed a weaker correlation (râ=â0.30, Pâ<â0.0001). In patients with LVOT enhancement less than 300âHU, 450âHU showed the highest accuracy in calcium identification (râ=â0.70, Pâ<â0.0001), whereas in patients with LVOT enhancement of at least 300âHU, the most accurate threshold was 850âHU (râ=â0.46, Pâ<â0.0001). CONCLUSION: The thresholds for correct calcium identification using the automatic 3Mensio software depend on the contrast enhancement of aortic and cardiac structures, which can be estimated by measuring the HU in the LVOT. In patients with LVOT HU of less than 300, the correct threshold to be set in the software is 450âHU, whereas in patients with LVOT HU of at least 300 the correct threshold is 850âHU.
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Estenose da Valva Aórtica , Valva Aórtica/patologia , Calcinose/diagnóstico por imagem , Cálcio/análise , Tomografia Computadorizada por Raios X/métodos , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Confiabilidade dos Dados , Feminino , Humanos , Aumento da Imagem/métodos , Masculino , Tamanho do Órgão , Avaliação de Resultados em Cuidados de Saúde , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/estatística & dados numéricosRESUMO
Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI.
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Estenose da Valva Aórtica/cirurgia , Índice de Massa Corporal , Hemorragia Pós-Operatória/etiologia , Sistema de Registros , Medição de Risco/métodos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Doenças Vasculares/etiologia , Idoso de 80 Anos ou mais , Feminino , Humanos , Incidência , Itália/epidemiologia , Masculino , Hemorragia Pós-Operatória/epidemiologia , Pontuação de Propensão , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Doenças Vasculares/epidemiologiaRESUMO
AIM: To assess the outcome of nonagenarians patients receiving transcatheter aortic valve replacement (TAVR). METHODS: We aimed to stratify the overall population from an Italian, multicenter, observational project including a total of 3792 consecutive patients who underwent TAVR with CoreValve and Evolut R/PRO devices between April 2009 and October 2018, into four groups according to their age class (≥90 vs. 80-89 years vs. 70-79 vs. <70 years) and to compare outcomes up to 4 years after TAVR. RESULTS: At 4 years, survival estimates showed no difference in terms of overall survival [Kaplan-Meier estimates (KM est.) 49.9 vs. 58.1% vs. 57.0 vs. 69.3%; Plogrankâ=â0.28] among the four groups. After 2 years from the procedure, landmark analysis showed an age-based difference in overall survival (KM est. 63.8 vs. 75.0% vs. 75.1 vs. 88.7%; Plogrankâ=â0.025) but no difference in terms of survival from cardiovascular death (KM est. 87.8 vs. 87.4% vs. 86.1 vs. 96.1%; Plogrankâ=â0.43). Finally, age itself was not correlated with overall mortality at 4 years (hazard ratio 1.06, 95% confidence interval 0.86-1.30, Pâ=â0.591). CONCLUSION: TAVR with self-expanding CoreValve and Evolut prostheses was demonstrated to have good long-term outcomes, regardless of the patient's age. At 4 years, no difference in overall mortality was reported among age-based groups, while a higher overall mortality was reported in nonagenarians after 2 years from the procedure. TAVR showed good long-term outcomes even in nonagenarian patients, and it could be the therapy of choice for selected elderly patients.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Nonagenários/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Substituição da Valva Aórtica Transcateter/métodos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Incidência , Itália/epidemiologia , Masculino , Estudos Prospectivos , Desenho de Prótese , Medição de Risco , Taxa de Sobrevida/tendências , Fatores de TempoRESUMO
OBJECTIVES: The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system. BACKGROUND: The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device. METHODS: A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported. RESULTS: Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients. CONCLUSIONS: Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Europa (Continente) , Humanos , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: No indication are available for transcatheter aortic valve implantation (TAVI) sizing in bicuspid aortic valve (BAV). Aim of the study is to develop and validate a Multi-Slice Computed Tomography (MSCT)-based algorithm for transcatheter heart valve (THV) sizing in patients with stenotic BAV under evaluation for TAVI. METHODS: A two steps method was applied: 1)evaluation of a cohort of 19 consecutive patients with type I BAV stenosis undergoing TAVI through pre and post-procedural MSCT, and development of an algorithm for THV sizing; 2)validation of the algorithm on a new cohort of 21 patients. RESULTS: In the first cohort, a high correlation was found between the raphe-level area measured at pre-procedural MSCT and the smallest THV area measured at post-procedural MSCT (p < 0.001). Moreover, reduced THV expansion was observed among patients with higher calcium burden (p = 0.048). Then, a new algorithm for TAVI sizing in BAV was develop (CASPER: Calcium Algorithm Sizing for bicusPid Evaluation with Raphe). This algorithm is based on the reassessment of the perimeter/area derived annulus diameter, according to three main anatomical features: 1) the ratio between raphe length and annulus diameter; 2)calcium burden; 3)calcium distribution in relation to the raphe. The algorithm was then validated in a new cohort of 21 patients, achieving 100% of procedural success and excellent TAVI performance. CONCLUSION: MSCT assessment of raphe length, calcium burden and its distribution is of crucial relevance in the pre-procedural evaluation of patients with BAV. These anatomical features can be combined in a new and simple algorithm for TAVI sizing.
Assuntos
Algoritmos , Estenose da Valva Aórtica/diagnóstico por imagem , Valva Aórtica/anormalidades , Diagnóstico por Computador , Doenças das Valvas Cardíacas/diagnóstico por imagem , Próteses Valvulares Cardíacas , Tomografia Computadorizada Multidetectores , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Doença da Válvula Aórtica Bicúspide , Feminino , Doenças das Valvas Cardíacas/fisiopatologia , Doenças das Valvas Cardíacas/cirurgia , Humanos , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Reprodutibilidade dos Testes , Resultado do TratamentoRESUMO
Background Transcatheter aortic valve replacement (TAVR) requires large-bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large-scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1-year follow-up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65-0.99]; P=0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58-0.98]; P=0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow-up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72-1.10]; P=0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P=0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short-term, driven by lower bleeding complications. Registration Information URL: cliniâcaltrâials.gov; Unique identifier: NCT02713932.
Assuntos
Estenose da Valva Aórtica/cirurgia , Técnicas Hemostáticas/instrumentação , Hemorragia Pós-Operatória/prevenção & controle , Substituição da Valva Aórtica Transcateter/instrumentação , Dispositivos de Oclusão Vascular , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Estudos de Coortes , Feminino , Humanos , Tempo de Internação , Masculino , Hemorragia Pós-Operatória/epidemiologia , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy. METHODS: Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission. RESULTS: Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (Pâ=â0.01) more extensive coronary disease (Pâ=â0.02), more advanced Killip class at presentation (Pâ=â0.003), use at admission of statins (Pâ=â0.004) and diuretics at discharge (Pâ<â0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), Pâ=â0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI))â=â1.89 (0.93-3.87), Pâ=â0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), Pâ=â0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabetic patients [HR (95% CI) 2.02 (1.14-3.6), Pâ=â0.02; adjusted HR (95% CI)â=â2.1 (1.01-4.3), Pâ=â0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome. CONCLUSION: Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.
Assuntos
Síndrome Coronariana Aguda/terapia , Diabetes Mellitus/epidemiologia , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/mortalidade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Trombose Coronária/epidemiologia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidade , Feminino , Nível de Saúde , Hemorragia/epidemiologia , Humanos , Itália/epidemiologia , Masculino , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Recidiva , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Stents , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Expanding indications to transcatheter aortic valve implantation (TAVI) warrant meticolous vascular management and minimization of access site complications. Two leading vascular closure devices (VCD) are currently used for TAVI, ProGlide vs. Prostar, but their comparative effectiveness and safety are debated. We aimed at comparing acute and 1-month outcomes of patients undergoing TAVI using as VCD either ProGlide (Perclose) or Prostar (XL). METHODS: The prospective RISPEVA database was queried for baseline, procedural, and outcome details of patients undergoing TAVI and in whom either ProGlide or Prostar had been used as VCD. Outcomes of interest were death, vascular complication, and bleeding, distinguishing specific subtypes. Outcomes were adjudicated according to current Valve Academic Research Consortium definitions. RESULTS: A total of 1987 subjects were included, 913 (46.0%) receiving ProGlide, and 1074 receiving Prostar (54.0%). Several baseline and procedural differences were evident, including surgical risk, concomitant coronary artery disease, sheath size, use of predilation, and chosen TAVI device (all P<0.05). Periprocedurally, despite similar rates of device success (P=0.262), Prostar was associated with a lower risk of vascular stenosis (P=0.005), but a higher rate of device malfunction (P=0.028). Unadjusted analysis for 1-month outcomes suggested higher rates of major adverse events, any bleeding, major bleeding, and renal failure in patients receiving Prostar (all P<0.05). However, propensity score-adjusted analysis did not confirm any significant differences, suggesting that confounding factors mostly drove unadjusted differences. CONCLUSIONS: Use of ProGlide and Prostar as VCD of choice for TAVI appears similarly safe and effective, despite some potential benefits associated with ProGlide. Further randomized trials are warranted to confirm or disprove these findings.