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1.
Artigo em Inglês | MEDLINE | ID: mdl-33007406

RESUMO

OBJECTIVE: To examine the learning curves of atrial fibrillation (AF) ablation comparing the cryoballoon (CB) and radiofrequency (RF) catheters. METHODS: We performed a retrospective data analysis from the initiation of AF ablation program in our center. For CB ablation, a second generation 28 mm balloon was utilized and for RF ablation. RESULTS: A total of 100 consecutive patients (50 in each group) have been enrolled in the study (male 74%, mean age 58.9 ± 10 years, paroxysmal AF 85%). The mean procedure time was shorter for CB (116.6 ± 39.8 min) than RF group (191.8 ± 101.1 min) (p < 0.001). There was no difference in the mean fluoroscopy time, 24.2 ± 10.6 min in RF and 22.4 ± 11.7 min in CB group, (p = 0.422). Seven major complications occurred during the study; 5 in RF group (10%) and 2 in CB group (4%) (p = 0.436). After the mean follow up of 14.5 ± 2.4 months, 15 patients in RF group (30%) and 11 in CB group (26%) experienced AF recurrences (P = 0.300). CONCLUSION: When starting a new AF ablation program, our results suggest that CB significantly shortens procedure while fluoroscopy time and clinical outcomes are comparable to RF ablation.

2.
J Am Heart Assoc ; 9(19): e017235, 2020 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-32981423

RESUMO

Background It is still unknown whether traditional risk factors may have a sex-specific impact on coronary artery disease (CAD) burden. Methods and Results We identified 14 793 patients who underwent coronary angiography for acute coronary syndromes in the ISACS-TC (International Survey of Acute Coronary Syndromes in Transitional Countries; Clini​calTr​ials.gov, NCT01218776) registry from 2010 to 2019. The main outcome measure was the association between traditional risk factors and severity of CAD and its relationship with 30-day mortality. Relative risk (RR) ratios and 95% CIs were calculated from the ratio of the absolute risks of women versus men using inverse probability of weighting. Estimates were compared by test of interaction on the log scale. Severity of CAD was categorized as obstructive (≥50% stenosis) versus nonobstructive CAD. The RR ratio for obstructive CAD in women versus men among people without diabetes mellitus was 0.49 (95% CI, 0.41-0.60) and among those with diabetes mellitus was 0.89 (95% CI, 0.62-1.29), with an interaction by diabetes mellitus status of P =0.002. Exposure to smoking shifted the RR ratios from 0.50 (95% CI, 0.41-0.61) in nonsmokers to 0.75 (95% CI, 0.54-1.03) in current smokers, with an interaction by smoking status of P=0.018. There were no significant sex-related interactions with hypercholesterolemia and hypertension. Women with obstructive CAD had higher 30-day mortality rates than men (RR, 1.75; 95% CI, 1.48-2.07). No sex differences in mortality were observed in patients with nonobstructive CAD. Conclusions Obstructive CAD in women signifies a higher risk for mortality compared with men. Current smoking and diabetes mellitus disproportionally increase the risk of obstructive CAD in women. Achieving the goal of improving cardiovascular health in women still requires intensive efforts toward further implementation of lifestyle and treatment interventions. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT01218776.

3.
Artigo em Inglês | MEDLINE | ID: mdl-32939602

RESUMO

Cryoballoon (CB) is an established technology for atrial fibrillation (AF) ablation and is usually performed using solely fluoroscopy. We aimed to study the feasibility of three-dimensional rotational angiography (3DRA) as intra-procedural imaging in CB ablation. Analyzed data were retrospectively collected from patients that underwent second generation CB ablation from February 2015 to August 2017. We studied 68 consecutive patients that received 3DRA (3DRA group). Sixty-six patients who received conventional X-ray imaging served as a control group. 3DRA was performed via an introducer placed in the left atrium. Angiographic images were segmented and fused with live fluoroscopy to guide the ablation. We have analyzed 134 CB patients (73.8% male, 56.9 ± 11.4 years). Paroxysmal AF was present in 77.6% of patients. 3DRA was successfully performed in all 3DRA group patients. The mean procedure time was significantly shorter in the control group (82.4 ± 26.3 min) than in the 3DRA group (121.1 ± 21.4 min) (p < 0.0001). Total radiation dose (419.3 ± 317.9 vs 998.3 ± 673 mGy, p < 0.0001) and contrast administration (83.2 ± 22.3 mL vs 191.6 ± 33.4 mL, p < 0.0001) were significantly lower in control group. There was no significant difference in 2-year success rate, 35.2% of patients had AF recurrence in the 3DRA group and 30.3% in the control group (p = 0.584). Major complications occurred in 2.9% and 1.5% of patients in 3DRA group and control group, respectively (p = 1.000). 3DRA is a feasible method of intra-procedural imaging to guide CB ablation. However, it prolongs procedure time, increases radiation dose and contrast administration with no significant effect on procedure outcomes and complication rates.

4.
Int J Cardiol ; 2020 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-32950592

RESUMO

BACKGROUND: Geographic variations in management and outcomes of individuals supported by continuous-flow left ventricular assist devices (CF-LVAD) between the United States (US) and Europe (EU) is largely unknown. METHODS: We created a retrospective, multinational registry of 524 patients who received a CF-LVAD (either HVAD or Heartmate II) between January 2008 and April 2017. Follow up spanned from date of CF-LVAD implant to post-HTx period with a median follow up of 44.8 months. RESULTS: The cohort included 299 (57.1%) EU and 225 (42.9%) US patients. Although the US cohort was significantly older with a higher prevalence of comorbidities, survival was similar between the cohorts (US 63.1%, EU 68.4% at 5 years, unadjusted log-rank test p = 0.43).Multivariate analyses suggested that older age, higher body mass index, elevated creatinine, use of temporary mechanical circulatory support prior CF-LVAD, and implantation of HVAD were associated with increased mortality. Among CF-LVAD patients undergoing HTx, the median time on CF-LVAD support was shorter in the US, meanwhile US donors were younger. Finally, the pattern of adverse events (stroke, gastrointestinal bleedings, late right ventricular failure, and driveline infection) during support differed significantly between US and EU. CONCLUSIONS: Although waitlisted patients in the US on CF-LVAD have higher risk comorbid conditions, the overall outcome is similar in US and EU. Geographic variations with regards to donor characteristics, duration of CF-LVAD support prior to transplant, and adverse events on support can explain the disparity in the utilization of mechanical bridge to transplant strategy between US and EU.

6.
Artigo em Inglês | MEDLINE | ID: mdl-32778365

RESUMO

BACKGROUND: The therapeutic success in patients with congenital heart disease (CHD) leads to a growing number of adults with CHD (adult CHD [ACHD]) who develop end-stage heart failure. We aimed to determine patient characteristics and outcomes of ACHD listed for heart transplantation. METHODS: Using data from all the patients with ACHD in 20 transplant centers in the Eurotransplant region from 1999 to 2015, we analyzed patient characteristics, waiting list, and post-transplantation outcomes. RESULTS: A total of 204 patients with ACHD were listed during the study period. The median age was 38 years, and 62.3% of the patients were listed in high urgency (HU), and 37.7% of the patients were in transplantable (T)-listing status. A total of 23.5% of the patients died or were delisted owing to clinical worsening, and 75% of the patients underwent transplantation. Median waiting time for patients with HU-listing status was 4.18 months and with T-listing status 9.07 months. There was no difference in crude mortality or delisting between patients who were HU status listed and T status listed (p = 0.65). In multivariable regression analysis, markers for respiratory failure (mechanical ventilation, hazard ratio [HR]: 1.41, 95% CI: 1.11-1.81, p = 0.006) and arrhythmias (anti-arrhythmic medication, HR: 1.42, 95% CI: 1.01-2.01, p = 0.044) were associated with a higher risk of death or delisting. In the overall cohort, post-transplantation mortality was 26.8% after 1 year and 33.4% after 5 years. CONCLUSIONS: Listed patients are at high risk of death without differences in the urgency of listing. Respiratory failure requiring invasive ventilation and possibly arrhythmias requiring anti-arrhythmic medication indicate worse outcomes on waiting list.

7.
Hypertension ; 76(3): 819-826, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32654558

RESUMO

The usefulness of ß-blockers has been questioned for patients who have hypertension without a prior manifestation of coronary heart disease or heart failure. In addition, sex-based differences in the efficacy of ß-blockers for prevention of heart failure during acute myocardial ischemia have never been evaluated. We explored whether the effect of ß-blocker therapy varied according to the sex among patients with hypertension who have no prior history of cardiovascular disease. Data were drawn from the ISACS (International Survey of Acute Coronary Syndromes)-Archives. The study population consisted of 13 764 patients presenting with acute coronary syndromes. There were 2590 patients in whom hypertension was treated previously with ß-blocker (954 women and 1636 men). Primary outcome measure was the incidence of heart failure according to Killip class classification. Subsidiary analyses were conducted to estimate the association between heart failure and all-cause mortality at 30 days. Outcome rates were assessed using the inverse probability of treatment weighting and logistic regression models. Estimates were compared by test of interaction on the log scale. Among patients taking ß-blockers before admission, there was an absolute difference of 4.6% between women and men in the rate of heart failure (Killip ≥2) at hospital presentation (21.3% versus 16.7%; relative risk ratio, 1.35 [95% CI, 1.10-1.65]). On the opposite, the rate of heart failure was approximately similar among women and men who did not receive ß-blockers (17.2% versus 16.1%; relative risk ratio, 1.09 [95% CI, 0.97-1.21]). The test of interaction identified a significant (P=0.034) association between sex and ß-blocker therapy. Heart failure was predictive of mortality at 30-day either in women (odds ratio, 7.54 [95% CI, 5.78-9.83]) or men (odds ratio, 9.62 [95% CI, 7.67-12.07]). In conclusion, ß-blockers use may be an acute precipitant of heart failure in new-onset coronary heart disease among women, but not men. Heart failure increases the risk of death. Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT04008173.

8.
J Hypertens ; 38(11): 2122-2140, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32723980

RESUMO

OBJECTIVE: We aim to synthesize effects of repeated administration (≥3 days) of inorganic nitrate on blood pressure and arterial stiffness measures. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials with at least 3 days treatment of inorganic nitrate on blood pressure and arterial stiffness in individuals with or without elevated cardiovascular disease risk. MEDLINE, EMBASE and the Cochrane Library were searched through 2 July 2019. Two independent reviewers extracted relevant study data. Data were pooled using the generic inverse variance method with random-effects model, and expressed as mean differences with 95% confidence intervals. Certainty in the evidence was assessed using GRADE. RESULTS: Forty-seven trials were included (n = 1101). Administration of inorganic nitrate significantly lowered SBP [mean difference: -2.91 mmHg, 95% confidence interval (95% CI): -3.92 to -1.89, I = 76%], DBP (mean difference: -1.45 mmHg, 95% CI: -2.22 to -0.68, I = 78%], central SBP (mean difference: -1.56 mmHg, 95% CI: -2.62 to -0.50, I = 30%) and central DBP (mean difference: -1.99 mmHg, 95% CI: -2.37 to -1.60, I = 0%). There was no effect on 24-h blood pressure, augmentation index or pulse wave velocity. Certainty in the evidence was graded moderate for central blood pressure, pulse wave velocity and low for peripheral blood pressure, 24-h blood pressure and augmentation index. CONCLUSION: Repeated administration (≥3 days) of inorganic nitrate lower peripheral and central blood pressure. Results appear to be driven by beneficial effects in healthy and hypertensive individuals. More studies are required to increase certainty in the evidence.

9.
Artigo em Inglês | MEDLINE | ID: mdl-32591926

RESUMO

BACKGROUND: We aimed to analyze the rate of visualization of real-time (RT) recordings and dual fascicle electrograms in our first series of patients treated with the fourth-generation cryoballoon (CB) device. METHODS: All consecutive patients who underwent CB ablation using the fourth-generation technology were included in the analysis. In all procedures, we used a 28-mm CB placed via a single transseptal puncture guided by intracardiac ultrasound. A 20-mm octapolar intraluminal circular catheter was used for intracardiac recordings. A single 180-s freeze strategy was employed. RESULTS: A total of 129 patients (72.9% male, mean age 60.1 ± 10.9 years) were enrolled in the study. RT recordings were detected in 445 (86.2%) pulmonary veins (PVs). Specifically, RT recordings were visualized in 115 left superior PVs (89.2%), 107 left inferior PVs (82.9%), 118 right superior PVs (91.4%), and 105 right inferior PVs (81.3%). Dual fascicle electrograms could be observed only in patients in sinus rhythm, in 23 of 396 PVs (5.8%). They were most commonly observed in the left superior PV (8.1%), somewhat less in both inferior veins (6.1%), while this phenomenon was least frequent in the right superior PV (3.0%). CONCLUSIONS: By using the fourth-generation CB, we report a specific pattern of isolation represented by a sequential isolation of two apparently distinct PV fascicles during a single CB freeze delivery. This phenomenon occurred in 5.8% of PV ablations. Of note, the rate of visualization of RT isolation with this novel CB was very high and could be documented in 86.2% of PVs.

10.
Transplant Proc ; 2020 Jun 19.
Artigo em Inglês | MEDLINE | ID: mdl-32571710

RESUMO

BACKGROUND: Unlike lymphodepletion, a decrease in platelet count following induction immunosuppressive therapy with polyclonal rabbit antithymocyte globulin (rATG) is deemed as an adverse event. However, this phenomenon may represent a particular rATG antirejection mechanism. METHODS: This retrospective single-center study included 156 patients who received a heart transplant (HTx) between 2010 and 2018. All patients received rATG induction therapy for 5 days. Absolute lymphocyte count (ALC) and platelet counts were assessed on days 0, 7, and 14 following HTx. The primary outcome of the study was the first occurrence of acute cellular rejection (ACR) defined as grade ≥ 1B within 24 months after HTx. RESULTS: Both ALC and platelet counts decreased rapidly after induction. During the 24-month follow-up period, 17% of patients had ACR. Patients with ACR had significantly higher platelet count on day 7 (145 vs 104, P < .001) and higher ALC on day 14 (162 vs 130, P = .035) than those without rejection. Patients in the highest platelet count quartile showed more ACR (50% in quartile 4 vs 0% in quartile 1, P = .006) as well as a higher cumulative total rejection score. Univariate analysis showed that ACR was associated with platelet count on day 7, recipient age, and pretransplant cytomegalovirus IgG serology. In multivariable regression analysis, platelet count on day 7 was the most accurate predictor of ACR. CONCLUSIONS: Lower platelet count after induction with rATG is associated with less ACR. This suggests platelet involvement in antirejection mechanisms of rATG and a possible rationale for targeting platelets in future immunosuppressive strategies.

11.
Artigo em Inglês | MEDLINE | ID: mdl-32445011

RESUMO

PURPOSE: We aimed to demonstrate the feasibility of figure of eight (FoE) suture for groin access closure in cryoballoon (CB) ablation and its impact on the lab workflow. METHODS: We retrospectively analyzed all patients who underwent CB ablation in our institution from June 2018. From June 2019, we have been consistently using FoE suture for hemostasis (FoE+ group), and before that conventional manual compression was utilized (FoE- group). Ablations were performed under uninterrupted oral anticoagulant strategy. Both femoral veins were punctured, and a single introducer was placed in each vein. In the FoE- group, after ablation, protamine was administered, and manual compression was applied. In the FoE+ group, the suture was placed in both groins without protamine administration and manual compression. All patients were in decubitus position until the next morning. RESULTS: A total of 190 consecutive patients (73.2% male, 59.7 ± 11.0 years old) were evaluated, 90 being in the FoE+ group. There was no difference in the mean procedure duration between two groups (72.7 ± 23.1 min vs 73.7 ± 27.1 min, p = 0.784). However, the total lab time was significantly longer in FoE- group (132.9 ± 35.3 min vs 109.9 ± 32.6 min, p < 0.0001). There was no difference in complication rates. No major vascular complications were found in our cohort. CONCLUSIONS: Utilization of FoE sutures for hemostasis seems to be a safe and effective after cryoballoon ablation. It abolishes the need for protamine administration which can cause serious adverse events. As manual compression is unrequired, EP lab workflow improves due to significantly shortened total lab time per patient.

12.
Croat Med J ; 61(2): 126-138, 2020 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-32378379

RESUMO

Mitochondria are involved in crucial homeostatic processes in the cell: the production of adenosine triphosphate and reactive oxygen species, and the release of pro-apoptotic molecules. Thus, cell survival depends on the maintenance of proper mitochondrial function by mitochondrial quality control. The most important mitochondrial quality control mechanisms are mitochondrial unfolded protein response, mitophagy, biogenesis, and fusion-fission dynamics. This review deals with mitochondrial quality control in heart diseases, especially myocardial infarction and heart failure. Some previous studies have demonstrated that the activation of mitochondrial quality control mechanisms may be beneficial for the heart, while others have shown that it may lead to heart damage. Our aim was to describe the mechanisms by which mitochondrial quality control contributes to heart protection or damage and to provide evidence that may resolve the seemingly contradictory results from the previous studies.


Assuntos
Cardiopatias/metabolismo , Mitocôndrias/metabolismo , Mitofagia/fisiologia , Resposta a Proteínas não Dobradas/fisiologia , Envelhecimento/fisiologia , Humanos
13.
Int J Clin Pharmacol Ther ; 58(8): 454-456, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32324131

RESUMO

OBJECTIVE: Piperacillin/tazobactam (TZP ) is commonly used against multi-resistant nosocomial Pseudomonas infections. While TZP-induced thrombocytopenia is a well-known and easily diagnosed complication, we herein present an unusual case of spontaneous TZP-induced bleeding caused by platelet dysfunction. CASE SUMMARY: A 73-year-old-man experienced severe pulmonary hemorrhage and bloody diarrhea during the treatment with TZP for Pseudomonas aeruginosa ventilator-associated pneumonia. While both platelet count and coagulation tests were normal, platelet functional test revealed severely impaired ADP-dependent platelet aggregation. CONCLUSION: Platelet dysfunction is a little-known mechanism of TZP-induced bleeding. This is the second reported case of TZP-related bleeding that has been attributed to platelet dysfunction, and the first case report that has not been associated with surgery. While thrombocytopenia is easily recognized, this form of TZP-induced bleeding can be detected only by platelet functional tests.

14.
Eur J Heart Fail ; 22(5): 763-774, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32187429

RESUMO

Heart failure (HF) is the major contributor to cardiovascular morbidity and mortality. Given its rising prevalence, the costs of HF care can be expected to increase. Multidisciplinary management of HF can improve quality of care and survival. However, specialized HF programmes are not widely available in most European countries. These circumstances underlie the suggestion of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) for the development of quality of care centres (QCCs). These are defined as health care institutions that provide multidisciplinary HF management at all levels of care (primary, secondary and tertiary), are accredited by the HFA/ESC and are implemented into existing health care systems. Their major goals are to unify and improve the quality of HF care, and to promote collaboration in education and research activities. Three types of QCC are suggested: community QCCs (primary care facilities able to provide non-invasive assessment and optimal therapy); specialized QCCs (district hospitals with intensive care units, able to provide cardiac catheterization and device implantation services), and advanced QCCs (national reference centres able to deliver advanced and innovative HF care and research). QCC accreditation will require compliance with general and specific HFA/ESC accreditation standards. General requirements include confirmation of the centre's existence, commitment to QCC implementation, and collaboration with other QCCs. Specific requirements include validation of the centre's level of care, service portfolio, facilities and equipment, management, human resources, process measures, quality indicators and outcome measures. Audit and recertification at 4-6-year intervals are also required. The implementation of QCCs will evolve gradually, following a pilot phase in selected countries. The present document summarizes the definition, major goals, development, classification and crucial aspects of the accreditation process of the HFA/ESC QCC Programme.

15.
Eur J Prev Cardiol ; : 2047487320908698, 2020 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-32195597

RESUMO

BACKGROUND: European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) V in primary care was carried out by the European Society of Cardiology EURObservational Research Programme in 2016-2018. The main objective was to determine whether the 2016 Joint European Societies' guidelines on cardiovascular disease prevention in people at high cardiovascular risk have been implemented in clinical practice. METHODS: The method used was a cross-sectional survey in 78 centres from 16 European countries. Patients without a history of atherosclerotic cardiovascular disease either started on blood pressure and/or lipid and/or glucose lowering treatments were identified and interviewed ≥ 6 months after the start of medication. RESULTS: A total of 3562 medical records were reviewed and 2759 patients (57.6% women; mean age 59.0 ± 11.6 years) interviewed (interview rate 70.0%). The risk factor control was poor with 18.1% of patients being smokers, 43.5% obese (body mass index ≥30 kg/m2) and 63.8% centrally obese (waist circumference ≥88 cm for women, ≥102 cm for men). Of patients on blood pressure lowering medication 47.0% reached the target of <140/90 mm Hg (<140/85 mm Hg in people with diabetes). Among treated dyslipidaemic patients only 46.9% attained low density lipoprotein-cholesterol target of <2.6 mmol/l. Among people treated for type 2 diabetes mellitus, 65.2% achieved the HbA1c target of <7.0%. CONCLUSION: The primary care arm of the EUROASPIRE V survey revealed that large proportions of people at high cardiovascular disease risk have unhealthy lifestyles and inadequate control of blood pressure, lipids and diabetes. Thus, the potential to reduce the risk of future cardiovascular disease throughout Europe by improved preventive cardiology programmes is substantial.

16.
J Cardiovasc Pharmacol ; 75(2): 174-179, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32023226

RESUMO

Clopidogrel is still widely used in acute coronary syndrome despite the development of more potent P2Y12 inhibitors. Previously, we conducted a trial that evaluated serial clopidogrel dose adjustment based on platelet function testing in acute coronary syndrome patients with initial high on-treatment platelet reactivity (HTPR). In this substudy, we performed post hoc analysis of the effect of ABCB1 genetic variants C3435T and G2677T/A on platelet inhibition and outcomes. There were no differences in the proportion of HTPR patients among C3435T carriers and noncarriers in both interventional and control group. G2677T carriers expressed significantly higher proportion of HTPR pattern throughout 12-month follow-up in the control group with no difference in the interventional group. There was no difference in ischemic outcomes between C3435T and G2677T carriers and noncarriers in both groups of patients. The results indicate that ABCB1 genotyping is not useful to guide clopidogrel therapy tailoring to improve high-risk patient management.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Plaquetas/efeitos dos fármacos , Clopidogrel/administração & dosagem , Absorção Gastrointestinal/genética , Variantes Farmacogenômicos , Inibidores da Agregação de Plaquetas/administração & dosagem , Agregação Plaquetária/efeitos dos fármacos , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Receptores Purinérgicos P2Y12/efeitos dos fármacos , Subfamília B de Transportador de Cassetes de Ligação de ATP/genética , Subfamília B de Transportador de Cassetes de Ligação de ATP/metabolismo , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/diagnóstico , Idoso , Plaquetas/metabolismo , Clopidogrel/metabolismo , Monitoramento de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/metabolismo , Antagonistas do Receptor Purinérgico P2Y/metabolismo , Ensaios Clínicos Controlados Aleatórios como Assunto , Receptores Purinérgicos P2Y12/sangue , Resultado do Tratamento
17.
J Am Coll Cardiol ; 75(3): 245-254, 2020 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-31726194

RESUMO

BACKGROUND: The period shortly after hospitalization for heart failure (HF) represents a high-risk window for recurrent clinical events, including rehospitalization or death. OBJECTIVES: This study sought to determine whether the efficacy and safety of sacubitril/valsartan varies in relation to the proximity to hospitalization for HF among patients with HF with preserved ejection fraction (HFpEF). METHODS: In this post hoc analysis of PARAGON-HF (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] with ARB [Angiotensin Receptor Blocker] Global Outcomes in HFpEF), we assessed the risk of clinical events and response to sacubitril/valsartan in relation to time from last HF hospitalization among patients with HFpEF (≥45%). The primary outcome was composite total HF hospitalizations and cardiovascular death, analyzed by using a semiparametric proportional rates method, stratified by geographic region. RESULTS: Of 4,796 validly randomized patients in PARAGON-HF, 622 (13%) were screened during hospitalization or within 30 days of prior hospitalization, 555 (12%) within 31 to 90 days, 435 (9%) within 91 to 180 days, and 694 (14%) after 180 days; 2,490 (52%) were never previously hospitalized. Over a median follow-up of 35 months, risk of total HF hospitalizations and cardiovascular death was inversely and nonlinearly associated with timing from prior HF hospitalization (p < 0.001). There was a gradient in relative risk reduction in primary events with sacubitril/valsartan from patients hospitalized within 30 days (rate ratio: 0.73; 95% confidence interval: 0.53 to 0.99) to patients never hospitalized (rate ratio: 1.00; 95% confidence interval: 0.80 to 1.24; trend in relative risk reduction: pinteraction = 0.15). With valsartan alone, the rate of total primary events was 26.7 (≤30 days), 24.2 (31 to 90 days), 20.7 (91 to 180 days), 15.7 (>180 days), and 7.9 (not previously hospitalized) per 100 patient-years. Compared with valsartan, absolute risk reductions with sacubitril/valsartan were more prominent in patients enrolled early after hospitalization: 6.4% (≤30 days), 4.6% (31 to 90 days), and 3.4% (91 to 180 days), whereas no risk reduction was observed in patients screened >180 days or who were never hospitalized (trend in absolute risk reduction: pinteraction = 0.050). CONCLUSIONS: Recent hospitalization for HFpEF identifies patients at high risk for near-term clinical progression. In the PARAGON-HF trial, the relative and absolute benefits of sacubitril/valsartan compared with valsartan in HFpEF appear to be amplified when initiated in the high-risk window after hospitalization and warrant prospective validation. (PARAGON-HF; NCT01920711).

19.
Eur J Heart Fail ; 21(12): 1651-1658, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31883356

RESUMO

AIMS: Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial (ClinicalTrials.gov NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF. METHODS: AFFIRM-AHF is a multicentre, randomised (1:1), double-blind, placebo-controlled trial which recruited 1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100 ng/mL or 100-299 ng/mL if transferrin saturation <20%. Eligible patients were randomised (1:1) to either i.v. FCM or placebo and received the first dose of study treatment just prior to discharge for the index hospitalisation. Patients will be followed for 52 weeks. The primary outcome is the composite of recurrent HF hospitalisations and CV mortality. The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes. CONCLUSION: The AFFIRM-AHF trial will evaluate, compared to placebo, the effect of i.v. FCM on morbidity and mortality in iron-deficient patients hospitalised for AHF.

20.
J Am Coll Cardiol ; 74(19): 2379-2389, 2019 11 12.
Artigo em Inglês | MEDLINE | ID: mdl-31699278

RESUMO

BACKGROUND: ST-segment elevation myocardial infarction (STEMI) complicated by symptoms of acute de novo heart failure is associated with excess mortality. Whether development of heart failure and its outcomes differ by sex is unknown. OBJECTIVES: This study sought to examine the relationships among sex, acute heart failure, and related outcomes after STEMI in patients with no prior history of heart failure recorded at baseline. METHODS: Patients were recruited from a network of hospitals in the ISACS-TC (International Survey of Acute Coronary Syndromes in Transitional Countries) registry (NCT01218776). Main outcome measures were incidence of Killip class ≥II at hospital presentation and risk-adjusted 30-day mortality rates were estimated using inverse probability of weighting and logistic regression models. RESULTS: This study included 10,443 patients (3,112 women). After covariate adjustment and matching for age, cardiovascular risk factors, comorbidities, disease severity, and delay to hospital presentation, the incidence of de novo heart failure at hospital presentation was significantly higher for women than for men (25.1% vs. 20.0%, odds ratio [OR]: 1.34; 95% confidence interval [CI]: 1.21 to 1.48). Women with de novo heart failure had higher 30-day mortality than did their male counterparts (25.1% vs. 20.6%; OR: 1.29; 95% CI: 1.05 to 1.58). The sex-related difference in mortality rates was still apparent in patients with de novo heart failure undergoing reperfusion therapy after hospital presentation (21.3% vs. 15.7%; OR: 1.45; 95% CI: 1.07 to 1.96). CONCLUSIONS: Women are at higher risk to develop de novo heart failure after STEMI and women with de novo heart failure have worse survival than do their male counterparts. Therefore, de novo heart failure is a key feature to explain mortality gap after STEMI among women and men.

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