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Background: Studies assessing outcomes of transcatheter aortic valve replacement (TAVR) in patients with severe aortic valve stenosis (AS) with hemodynamic subtypes have demonstrated mixed results with respect to outcomes and periprocedural complications. This study aimed to assess the outcomes of TAVR in patients across various hemodynamic subtypes of severe AS. Methods: PubMed, Embase, and Cochrane databases were searched through September 2023 to identify all observational studies comparing outcomes of TAVR in patients with paradoxical low flow low gradient (pLFLG), classic LFLG, and high gradient AS (HGAS). The primary outcome was major adverse cardiovascular events (MACE). The secondary outcomes were components of MACE (mortality, myocardial infarction [MI], stroke). A bivariate, influential, and frequentist network meta-analysis model was used to obtain the net odds ratio (OR) with a 95% CI. Results: A total of 21 studies comprising 17,298 (8742 experimental and 8556 HGAS) patients were included in the quantitative analysis. TAVR was associated with a significant reduction in the mean aortic gradient, and an increase in the mean aortic valve area irrespective of the AS type. Compared with HGAS, TAVR in classic LFLG had a significantly higher (OR, 1.68; 95% CI, 1.04-2.72), while pLFLG (OR, 0.98; 95% CI, 0.72-1.35) had a statistically similar incidence of MACE at a median follow-up of 1-year. TAVR in LFLG also had a significantly higher need for surgery (OR, 3.57; 95% CI, 1.24-10.32), and a greater risk of periprocedural (OR, 2.00; 95% CI, 1.17-3.41), 1-month (OR, 1.69; 95% CI, 1.08-2.64), and 12-month (OR, 1.41; 95% CI, 1.05-1.88) mortality compared with HGAS. The incidence of MI, major bleeding, vascular complications, paravalvular leak, pacemaker implantation, and rehospitalizations was not significantly different between all other types of AS (HGAS vs LFLG, pLFLG). Conclusions: TAVR is an effective strategy in severe AS irrespective of the hemodynamic subtypes. Relatively, pLFLG did not have significantly different risk of periprocedural complications compared with HGAS, while classical LFLG AS had higher risk of MACE, primarily driven by the greater mortality risk.
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BACKGROUND AND AIMS: Catheter ablation is superior to pharmacological therapy in controlling atrial fibrillation (AF). There are few data on the long-term outcome of AF ablation in octogenarian patients. This analysis aims to evaluate the outcome of AF ablation in octogenarians vs. younger patients. METHODS: In this retrospective study in 13 centres in the UK, France, and Switzerland, the long-term outcomes of 473 consecutive octogenarian patients undergoing ablation for AF were compared to 473 matched younger controls (median age 81.3 [80.0, 83.0] vs. 64.4 [56.5, 70.7] years, 54.3% vs. 35.1% females; p-value for both < 0.001). The primary endpoint was the recurrence of atrial arrhythmia after a blanking period of 90 days within 365 days of follow-up. RESULTS: Acute ablation success as defined as isolation of all pulmonary veins was achieved in 97% of octogenarians. Octogenarians experienced more procedural complications (11.4% vs 7.0%, p = 0.018). The median follow-up time was 281 [106, 365] days vs. 354 [220, 365] days for octogenarians vs. non-octogenarians (p < 0.001). Among octogenarians, 27.7% (131 patients) experienced a recurrence of atrial arrhythmia, in contrast to 23.5% (111 patients) in the younger group (odds ratio 1.49; 95% confidence interval 1.16-1.92; p = 0.002). In a multivariable regression model including gender, previous AF ablation, vascular disease, chronic kidney disease, CHA2DS2-VASc score, left atrial dilatation, and indwelling cardiac implantable electronic device, age above 80 remained an independent predictor of recurrence of arrhythmia. CONCLUSION: Ablation for AF is effective in octogenarians, but is associated with slightly higher procedural complication rate and recurrence of atrial arrhythmia than in younger patients.
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BACKGROUND: This study aimed to investigate the association between index trial participation status and 30-day unplanned readmission rates, causes, and outcomes in acute coronary syndrome (ACS) patients. METHODS: The National Readmission Database was analysed for all index hospitalizations with a principal diagnosis of ACS between October 2015 to November 2019, stratified by index trial participation status (International Classification of Diseases - 10th edition code: Z00.6). The 30-day unplanned readmission rates, causes and outcomes were analysed, including the assessment of factors associated with readmission. Multivariable regression analyses were reported as adjusted odds ratios (aOR) with 95 % confidence intervals (95 % CI). All analyses were weighted and utilized hierarchical multi-level organization. RESULTS: A total of 2,066,328 cases with a principal diagnosis of ACS were included in the study, of which there were 4061 trial participants (0.2 %) and 189,240 (9.2 %) cases experienced unplanned 30-day readmission. Rates of unplanned 30-day readmission were similar between trial participants and non-participants (9.8 % vs. 9.2 %, p = 0.16). Consistently, after multivariable adjustment, there was no significant association between trial participation and unplanned 30-day readmissions (aOR 0.96, 95 % CI 0.86-1.07, p = 0.45). Compared with trial participants, the majority of readmissions in non-participants were related to cardiovascular conditions (55.2 % vs. 46.7 %, p = 0.005, respectively). There was no significant difference in all-cause mortality (5.5 % vs. 4.6 %, p = 0.368, respectively), but trial participants were more likely to develop major bleeding (3.5 % vs. 2.1 %, p = 0.044), ischemic stroke (4.0 % vs. 2.1 %, p = 0.008) and haemorrhagic stroke (2.0 % vs. 0.6 %, p < 0.001) at readmissions. CONCLUSION: Overall rates of unplanned 30-day readmissions after ACS are similar between trial participants and non-participants, but non-participation in trials was associated with a higher likelihood of cardiovascular readmission.
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BACKGROUND: Neutrophil to lymphocyte ratio (NLR) has been considered a prognostic biomarker of mortality and other major cardiac events. This study investigates NLR's efficacy in predicting in-hospital and long-term outcomes in patients with ST-segment elevated myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). METHODS: Electronic databases (PUBMED, Cochrane CENTRAL, ERIC, Embase, Ovid, and Google Scholar) were searched till June 2022 to identify studies having STEMI patients who underwent PCI. Risk ratios and mean differences (MDs), along with their corresponding 95% confidence intervals (Cis) and standard deviations (SDs), were pooled using a random-effect model. This meta-analysis has been registered on Prospero (ID: CRD42022344072). RESULTS: A total of 35 studies with 28,756 patients were included. Pooled estimates revealed an increased incidence of primary outcomes; in-hospital all-cause mortality (RRâ =â 3.52; 95% CIâ =â 2.93-4.24), long-term all-cause mortality (HRâ =â 1.07; 95% CIâ =â 1.00-1.14), (RRâ =â 3.32; 95% CIâ =â 2.57-4.30); in-hospital cardiovascular mortality (RRâ =â 2.66; 95% CIâ =â 2.04-3.48), long-term cardiovascular mortality (RRâ =â 6.67; 95% CIâ =â 4.06-10.95); in-hospital major adverse cardiovascular events (MACE) (RRâ =â 1.31; 95% CIâ =â 1.17-1.46), long-term MACE (RRâ =â 2.92; 95% CIâ =â 2.16-3.94); length of hospital stay (WMDâ =â 0.60 days; 95% CIâ =â 0.40-0.79) in patients with high NLR compared to those with a low NLR. CONCLUSION: NLR might be a valuable tool for prognostication (in-hospital) and stratification of patients with STEMI who underwent PCI.
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Linfócitos , Neutrófilos , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/sangue , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Prognóstico , Biomarcadores/sangue , Contagem de Linfócitos , Mortalidade HospitalarRESUMO
BACKGROUND: The Organ Procurement and Transplantation Network (OPTN) implemented modifications in 2018 to the adult heart transplant allocation system to better stratify the most medically urgent transplant candidates. We evaluated the impact of these changes on patients supported by a durable left ventricular assist device (LVAD) with chronic kidney disease (CKD). OBJECTIVE: To evaluate the impact of the OPTN policy change on patients supported by durable left ventricular assist devices (LVAD) with chronic kidney disease (CKD). METHODS: We performed an analysis of patients from the United Network of Organ Sharing Database supported by durable LVAD listed for a heart transplant (HT) between October 17, 2016 and September 30, 2021. Patients were divided into two groups: pre- and postpolicy, depending on whether they were listed on or prior to October 17, 2018. Patients who were on dialysis prior to surgery or discharge were excluded from the analysis. Patients with simultaneous heart and kidney transplants were excluded. Patients who were listed for transplant prepolicy change but transplanted postpolicy change were excluded. This cohort was then subdivided into degrees of CKD based on estimated glomerular filtration rate (eGFR), which resulted in 678 patients (23.7%) in Stage 1 (GFR ≥89.499) (Prepolicy: 345, Postpolicy: 333), 1233 (43.1%) in Stage 2 (89.499 > GFR ≥ 59.499) (Prepolicy: 618, Postpolicy: 615), 613 (21.4%) in Stage 3a (59.499 > GFR ≥ 44.499) (Prepolicy: 291, Postpolicy: 322), 294 (10.3%) in Stage 3b (44.499 > GFR ≥ 29.499) (Prepolicy: 143, Postpolicy: 151), 36 (1.3%) in Stage 4 (29.499 > GFR ≥ 15) (Prepolicy: 21, Postpolicy: 15), and 9 (0.3%) in Stage 5 (15 > GFR) (Prepolicy: 4, Postpolicy: 5). The primary outcome was 1-year and 2-year post-HT survival. RESULTS: There were 2863 patients who met the study criteria (1422 prepolicy, 1441 postpolicy). Overall survival, regardless of CKD stage, was lower following the policy change (p < 0.01). There was a similar risk of primary graft failure (PGF) in the pre- and postpolicy period (1.8% vs. 1.2%, p = 0.26). 1-year overall survival was 93% (91, 94) and 89% (87, 91) in the pre- and postpolicy periods, respectively. 2-year overall survival was 89% (88, 91) and 85% (82, 87) in the pre- and postpolicy periods, respectively. For CKD Stages 1, 2, 3a, 3b, 4, and 5, 1 -year survival was 93% (91, 95), 92% (90,93), 89% (86, 91), 89% (86, 93), 80% (68, 94), and 100% (100, 100), respectively. For CKD Stages 1, 2, 3a, 3b, 4, and 5, 2-year survival was 91% (88, 93), 88% (86, 90), 84% (81, 88), 84% (80, 89), 73% (59, 90), and 100% (100, 100), respectively. Patients with CKD 1 and 2 had better survival compared to those with CKD 3 (p < 0.01) and CKD 4 and 5 (p = 0.03) in the pre- and postpolicy periods. Patients with CKD 3 did not have a survival advantage over those with CKD 4 and 5 (p = 0.25). On cox regression analysis, advancing degrees of CKD were associated with an increased risk of mortality. CONCLUSIONS: Patients with LVAD support had decreased overall survival after the OPTN policy change. Patients with more advanced CKD had lower survival than patients without advanced CKD, though they were not impacted by the OPTN policy change.
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INTRODUCTION: The relationships between baseline tissue local impedance (LI), contact force (CF), atrial fibrosis, and atrial rhythm are uninvestigated in a clinical setting. We compared the relationship of LI and CF between atrial fibrillation (AF) and sinus rhythm (SR) accounting for the effects of atrial fibrosis as assessed by bipolar voltage and LI. METHODS: Patients undergoing persistent AF ablation were recruited. LI was recorded referenced to patient blood pool (LIr) and concurrent to changes in CF, with data collected at the same locations in AF and SR. RESULTS: Twenty patients were recruited. 109 locations were sampled obtaining 1903 data points (SR: 966, AF: 937). CF correlated strongly with LI (repeated measures correlation = 0.64). The relationship between CF and LIr was logarithmic. Rhythm and CF had a significant main (both p < .0005) and interaction effect (p = .022) on tissue LI: AF demonstrated higher LIr values than SR for similar CF. Bipolar voltage had no effect on the relationship of CF to LIr in either rhythm. Assessing fibrosis using LIr showed an interaction effect with CF for LIr in SR and AF, (SR: p < .0005, AF: p = .01), with increased fibrosis showing lesser change in LIr per gram of CF. CONCLUSIONS: CF and rhythm significantly affect the measured LIr of LA myocardium. Optimal catheter-tissue coupling may be better achieved with higher levels of CF and in AF rather than SR. Atrial fibrosis, as assessed by LIr but not bipolar voltage, affected the CF-LI relationship.
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Potenciais de Ação , Fibrilação Atrial , Função do Átrio Esquerdo , Ablação por Cateter , Fibrose , Átrios do Coração , Frequência Cardíaca , Humanos , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Masculino , Feminino , Pessoa de Meia-Idade , Átrios do Coração/fisiopatologia , Idoso , Fatores de Tempo , Técnicas Eletrofisiológicas Cardíacas , Impedância Elétrica , Valor Preditivo dos Testes , Resultado do Tratamento , Remodelamento AtrialRESUMO
BACKGROUND: Peri-procedural complications associated with cardiac implantable electronic devices are not uncommon. European Society of Cardiology guidelines recommend device checks of all devices within 72 h of implant. European Heart Rhythm Association expert practical guide on Cardiac implantable electronic devices (CIEDs) recommend that a chest x-ray (CXR) should be performed within 24 h to rule out pneumothorax and document lead positions. First, the rate of peri-procedural complications associated with CIED implants at our center, as well as patient and/or procedural-related factors that are associated with higher rates of complications, is analyzed. Second, the yield of the guideline-recommended measures in the early detection of peri-procedural complications is examined. MATERIALS AND METHODS: Consecutive de novo transvenous device implants at our center in 2019 were retrospectively analyzed. Patients' demographics, types and indications for device therapy, procedural reports, device checks, and CXRs were obtained from the hospital electronic records. RESULTS: A total of 578 patients (Age 74 ± 16 years, 68% male) were included. All patients had routine post-procedure CXRs and device checks. There were 16 (2.8%) complications; 7 (1.2%) pneumothoraxes, 6 (1%) pericardial effusions, and 3 (0.5%) lead displacements. Procedure time correlated significantly with complications; in uncomplicated cases it was 99 ± 43 min versus 127 ± 50 min in procedures associated with complications (p = .02). CONCLUSIONS: Routine post CIED implantation CXRs can detect early peri-procedural complications, while repeat post mobilization device checks has low yield of detection of complications. The only statistically significant predictor of peri-procedural complications is the duration of the procedure; longer procedures were associated with higher rates of complications.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Feminino , Desfibriladores Implantáveis/efeitos adversos , Estudos Retrospectivos , Coração , Reino Unido , Marca-Passo Artificial/efeitos adversosRESUMO
BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) has emerged as a non-pharmacologic alternative to oral anticoagulation in reducing stroke risk in AF patients. However, patients with mitral valve disease (MVD), who are expected to have a significantly greater risk of left atrium (LA) thrombus formation and embolic stroke were excluded from randomized trials examining percutaneous LAAO. To address this gap, we present a national registry analysis of the use of LAAO among patients with MVD. METHODS: Using the National Readmissions Database, we performed a retrospective review of all hospitalizations for LAAO identified between September 2015 and November 2019. Of these, patients with ICD-10 codes for MVD were identified. Propensity matched (PSM) analysis was used to compare patients with MVD with a matched sample of patients undergoing LAAO with non-valvular AF. Outcomes examined included all-cause mortality, stroke, major bleeding, pericardial effusion (PE), and tamponade. RESULTS: 51,540 patients who underwent LAAO without a history of MVD and 3777 with a history of MVD were identified. Crude analysis demonstrated the odds of mortality, PE, and cardiac tamponade during index hospitalization to be higher in the MVD group. The length of stay and cost of index hospitalization were also slightly greater for the MVD group. A sample of 7649 patients (MVD: 3777 MVD and no MVD: 3872) were selected for PSM analysis with similar comorbidities across the two groups. In the PSM comparison, MVD was associated with higher risk of PE. The MVD group had a slightly higher rate of readmissions the association with PE remained at 30-day readmission (OR: 2.099 [1.360-3.238], p-value: <0.001). CONCLUSION: To our knowledge, this is the first study examining the use of LAAO among MVD patients. Our findings suggest that patients with MVD who underwent LAAO had a higher risk of post-procedural PE without an increase in mortality, stroke, or major bleeding. These results provide a rationale for considering LAAO as part of the stroke prevention strategy among patients with valvular AF.
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Apêndice Atrial , Fibrilação Atrial , Cateterismo Cardíaco , Bases de Dados Factuais , Valva Mitral , Readmissão do Paciente , Sistema de Registros , Acidente Vascular Cerebral , Humanos , Apêndice Atrial/fisiopatologia , Masculino , Feminino , Estudos Retrospectivos , Idoso , Fatores de Risco , Resultado do Tratamento , Valva Mitral/fisiopatologia , Valva Mitral/cirurgia , Valva Mitral/diagnóstico por imagem , Estados Unidos/epidemiologia , Pessoa de Meia-Idade , Fatores de Tempo , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Medição de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/mortalidade , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Fibrilação Atrial/terapia , Fibrilação Atrial/complicações , Idoso de 80 Anos ou mais , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/cirurgia , Doenças das Valvas Cardíacas/complicações , Doenças das Valvas Cardíacas/fisiopatologia , Doenças das Valvas Cardíacas/diagnóstico por imagem , Custos HospitalaresRESUMO
Transcatheter edge-to-edge repair (TEER) has emerged as a widely accepted procedure for tricuspid regurgitation (TR) as gauged by echocardiographic parameters and clinical outcomes. Our study aims to assess TR severity and other echocardiographic outcomes in patients undergoing TEER with TriClip, MitraClip, and PASCAL devices. A literature search of 5 databases was performed until 1st June 2023. Randomized controlled trials (RCTs) or observational studies with moderate to severe (grade III-V) TR patients undergoing isolated TEER were considered eligible. Echocardiographic, and quality of life determining outcomes such as improvement in TR severity grade ≥3, New York Heart Association (NYHA) class ≥3, procedural success, 6-minute walking distance (6MWD), and adverse outcomes were analyzed. Grade assessment was performed and studies were assessed for risk of bias and publication bias. We included 15 studies (14 observational and 1 RCT) in our paper. Analysis revealed a substantial reduction in TR volume (P < 0.00001), TR grading (P < 0.00001), tricuspid annular diameter (P < 0.00001), proximal isovelocity surface area radius (P < 0.00001), effective regurgitant orifice area (P < 0.00001), and improvement in NYHA class (P < 0.00001) at 30 days from baseline, postprocedurally. A significant increase in 6MWD at 1 year (Pâ¯=â¯0.001) was also recorded. No significant differences in left ventricular ejection fraction (Pâ¯=â¯0.87), fractional area change (Pâ¯=â¯0.37), or tricuspid annular plane systolic excursion (Pâ¯=â¯0.76) were observed. TEER procedural success was 97%. TEER produced a significant reduction in TR grade and volume, NYHA class, 6MWD, and showed prominent procedural success. Large scale RCTs comparing the TEER devices are needed to strengthen the present findings.
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/etiologia , Resultado do Tratamento , Implante de Prótese de Valva Cardíaca/efeitos adversos , Cateterismo Cardíaco/efeitos adversos , EcocardiografiaRESUMO
Transcatheter aortic valve implantation (TAVI) has increasingly been utilized in patients with aortic insufficiency (AI) with insufficient data on its safety. The Nationwide Readmissions Database (NRD) was queried to identify patients undergoing TAVI for AI. Net clinical events (composite of in-hospital mortality, stroke, major bleeding) and procedural complications were assessed using a propensity-score matched (PSM) analysis to calculate adjusted odds ratios (OR). A total of 185,703 (AI 3873, aortic stenosis [AS] 181,830) patients were included in the analysis. Due to a significant difference in the baseline characteristics, a matched sample of 7929 patients (AI 3873, AS 4056) was selected. At index admission, the adjusted odds of in-hospital NACE (aOR 2.0, 95% CI 1.59-2.51), mortality (aOR 3.06, 95% CI 2.38-5.47), major bleeding (aOR 1.53, 95% CI 1.13-2.06) and valvular complications (aOR 9.48, 95% CI 6.73-13.38) were significantly higher in patients undergoing TAVI for AI compared with those undergoing TAVI for AS. However, there was no significant difference in the incidence of NACE, mortality, stroke, major bleeding, and need for permanent pacemaker implantation at 30- and 180-days follow-up. TAVI in AI was associated with a higher risk of periprocedural NACE, mortality, and major bleeding. The risk of these complications attenuated at 30- and 180-day readmission.
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Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Readmissão do Paciente , Fatores de Risco , Estenose da Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/cirurgia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Hemorragia/etiologia , Valva Aórtica/cirurgia , Resultado do Tratamento , Implante de Prótese de Valva Cardíaca/efeitos adversosRESUMO
Transcatheter aortic valve implantation (TAVI) is accepted as an alternative to surgery, but data on combined percutaneous coronary interventions (PCI) and TAVI during the same in-hospital stay are still lacking. Using the national inpatient sample (NIS) database, we identified all TAVI encounters and compared in-hospital outcomes of patients who had TAVI only to patients who had TAVI and PCI. We used multivariable logistic regression analysis to calculate the adjusted odds ratio (aOR). Of 291,810 patient encounters with TAVI, 13,114 (4.5%) had combined PCI during the same index admission. The average age was 79.61 ± 8.61 years in the TAVI-only vs 80.25 ± 8.73 years in the combined TAVI-PCI group. Combined TAVI and PCI was associated with higher in-hospital mortality (4.5% vs 1.8%, aOR: 2.3), stroke (4.7% vs 2.9%, aOR: 1.4), net adverse events (NAE) (20.2% vs 5.7%, aOR: 3.6), major bleeding (40.1% vs 24.3%, aOR: 1.8), vascular complications (10.6% vs 2.5%, aOR: 3.9), acute kidney injury (AKI) (23.3% vs 11.7%, aOR: 2.1), hemodialysis (HD) (4.2% vs 2.4%, aOR: 1.4), postoperative cardiogenic shock (1.2% vs 0.4%, aOR: 2.8), need for mechanical circulatory support (6.9% vs 1%, aOR: 7); p-value < 0.001 for all. The utilization of permanent pacemakers was similar between the groups (9.8% vs 9.2%, aOR: 1; pâ¯=â¯0.6). Combining TAVI and PCI during the same index admission is associated with worse outcomes. The decision to do PCI for patients undergoing TAVI should be individualized and tailored based on the patient's clinical conditions.
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Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Humanos , Idoso , Idoso de 80 Anos ou mais , Substituição da Valva Aórtica Transcateter/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Pacientes Internados , Estenose da Valva Aórtica/cirurgia , Hospitais , Valva Aórtica/cirurgia , Resultado do Tratamento , Fatores de RiscoRESUMO
Background: The use of transcatheter aortic valve implantation (TAVI) in patients with aortic valve disease excluded from clinical trials has increased with no large-scale data on its safety. Objectives: The purpose of this study was to assess the trend of utilization and adjusted outcomes of TAVI in clinical trials excluded (CTE) vs clinical trials included TAVI (CTI-TAVI) patients. Methods: We used the National Readmission Database (2015-2019) to identify 15 CTE-TAVI conditions. A propensity score-matched analysis was used to calculate the adjusted odds ratio (aOR) of net adverse clinical events (composite of mortality, stroke, and major bleeding) in patients undergoing CTE-TAVI vs CTI-TAVI. Results: Among the 223,238 patients undergoing TAVI, CTE-TAVI was used in 41,408 patients (18.5%). The yearly trend showed a steep increase in CTE-TAVI utilization (P = 0.026). At index admission, the adjusted odds of net adverse clinical events (aOR: 1.83, 95% CI: 1.73-1.95) and its components, including mortality (aOR: 2.94, 95% CI: 2.66-3.24), stroke (aOR: 1.20, 95% CI: 1.07-1.34), and major bleeding (aOR: 1.49, 95% CI: 1.36-1.63) were significantly higher in CTE-TAVI compared with CTI-TAVI. Among the individual contraindications to clinical trial enrollment in the CTE-TAVI, patients with bicuspid aortic valve, leukopenia, and peptic ulcer disease appeared to have similar outcomes compared with CTI-TAVI, while patients with end-stage renal disease, bioprosthetic aortic valves, and coagulopathy had a higher readmission rate at 30 and 180 days. Conclusions: CTE-TAVI utilization has increased significantly over the 4-year study period. Patients undergoing CTE-TAVI have a higher likelihood of mortality, stroke, and bleeding than those undergoing CTI-TAVI.
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Background: Atrial fibrillation (AF) is highly prevalent among cancer patients. The role of traditional risk stratification scores in the context of different cancer types in these patients remains unknown. Objectives: The purpose of this study was to determine the discriminative accuracy of the CHA2DS2VASc score for ischemic stroke using receiver operating characteristic and area under the curve. Methods: The National Readmission Database (2015-2019) was used to identify all AF patients stratified by the cancer diagnosis, type, and CHA2DS2VASc category (low; moderate; high risk). Outcomes at 30-day readmission were compared between cancer and noncancer groups using hierarchical multivariable logistic regression to calculate adjusted odds ratios (aORs) and 95% CIs. Results: A total of 6,996,088 AF patients were identified at index admission. Of these, 4,242,630 (642,237 cancer, 3,600,393 noncancer) were readmitted at 30 days. Cancer patients (92.1%) had a higher proportion of high CHA2DS2VASc scores compared with their noncancer counterparts (89.8%, P < 0.001). The 30-day readmission rate and incidence of major bleeding in cancer patients were significantly higher compared with their corresponding noncancer group across all CHA2DS2VASc categories. Among the different cancer types, hematological and lung cancer had a high propensity for major bleeding. The odds of ischemic stroke were lower in the cancer group across high (1.9% vs 2.4%; aOR: 0.78; 95% CI: 0.76-0.79; P < 0.0001), moderate (0.8% vs 1.3%; aOR: 0.57; 95% CI: 0.50-0.64; P < 0.0001), and low (0.4% vs 0.9%; aOR: 0.46; 95% CI: 0.34-0.62; P < 0.0001) risk category relative to the noncancer group irrespective of type of cancer. CHA2DS2VASc category had a statistically significant discriminatory accuracy for ischemic stroke in both cancer and noncancer patients. Conclusions: Cancer patients with AF are at a higher risk of readmission and major bleeding. The risk of ischemic stroke during readmission appears to be lower than noncancer patients. These findings may have implications for anticoagulant therapy in cancer patients.
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Background: Patients with severe aortic stenosis and cancer are often denied surgical aortic valve replacement (SAVR) due to a prohibitive risk of perioperative mortality. Objectives: The purpose of this study was to determine the safety of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and cancer. Methods: The Nationwide Inpatient Sample database (2002-2018) was used to study the outcomes of TAVI vs SAVR in patients with active or prior history of prostate, lung, colorectal, breast, and renal cancer. A propensity score-matched analysis to calculate adjusted odds ratios (aORs) for major adverse cardiovascular events (MACEs) and its components. Results: A total of 1,505,995 crude population and a subset of 345,413 noncancer and 33,565 cancer patients were selected on propensity score-matched analysis. The yearly trend showed a steep increase in the utilization of TAVI. Compared with SAVR, TAVI had a lower risk of in-hospital mortality in prostate cancer, while there was no difference among other cancer types. Patients with lung (aOR: 0.65; 95% CI: 0.43-0.97) and prostate cancer (aOR: 0.79; 95% CI: 0.66-0.96) had lower, while colorectal cancer (aOR: 1.43; 95% CI: 1.08-1.90) had higher odds of MACE with TAVI. The incidence of major bleeding was lower with TAVI (except for lung cancer), while the risk of stroke was similar (except for colorectal cancer) between TAVI and SAVR. Conclusions: TAVI in patients with prostate, breast, lung, and renal cancer appears to be a reasonable alternative to SAVR with lower or similar risks of mortality and MACE.
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Background: Randomized controlled trials (RCT) of ultrafiltration (UF) have demonstrated conflicting results regarding its efficacy and safety. Objective: We reviewed 10 years of data for adjustable UF during heart failure hospitalizations in a real world cohort. Methods: We performed a retrospective, single center analysis of 335 consecutive patients treated with adjustable rate UF using the CHF Solutions Aquadex Flex Flo System from 2009 to 2019. Results: Compared to previous RCTs investigating UF, our cohort was older, with worse renal impairment and more antecedent HF hospitalizations in the year preceding therapy. Mean fluid removal with UF was 14.6 l. Mean weight loss with UF was 15.6 lbs (range 0.2-57 lbs) and was sustained at 1-2 week follow-up. Mean creatinine change upon stopping UF, at discharge and follow-up (mean 30 days) was +0.11 mg/dl, +0.07 mg/dl and +0.11 mg/dl, respectively. HF rehospitalizations at 30 days, 90 days and 1 year were 12.4 %, 14.9 % and 27.3 % respectively. On average patients had 1.74 fewer hospitalizations for HF in the year following UF when compared to 12 months preceding UF. Major bleeding defined as requiring discontinuation of anticoagulation occurred in 3.6 % of patients. Conclusions: Compared with previous UF trials, our study demonstrates that UF compares favorably for HF rehospitalizations, renal function response, and weight/volume loss. Importantly, our real world experience allowed for the adjustment of UF rate during therapy and we believe this is a major contributor to our favorable outcomes. In clinical practice, UF can be a safe and effective strategy for decongestion.