RESUMO
Quality of life and patient satisfaction after ministernotomy have never been compared to conventional full sternotomy in randomized trials. The QUALITY-AVR trial is a single-blind, single-center, independent, randomized clinical trial comparing ministernotomy to full sternotomy in patients with isolated severe aortic stenosis scheduled for elective aortic valve replacement. One hundred patients were randomized in a 1:1 computational fashion. The primary endpoint was a difference between intervention groups of ≥0.10 points in change from baseline quality of life Questionnaire EuroQOL-index, measured at 1, 6, or 12 months. Secondary endpoints were differences in change from other baseline EuroQOL-index utilities, cardiac surgery-specific satisfaction questionnaire (SATISCORE), a combined safety endpoint of 4 major adverse complications at 1 month (all-cause mortality, acute myocardial infarction, neurologic events, and acute renal failure), bleeding through drains within the first 24 hours, intubation time, and other minor endpoints. Clinical follow-up was scheduled at baseline, 1, 6, and 12 months after randomization. Change from baseline mean difference EQ-5D-index was +0.20 points (95% confidence interval 0.10-0.30, P < 0.001) and median difference +0.14 (95% confidence interval 0.06-0.22, P < 0.001), favoring the ministernotomy group at 1 month. Patient satisfaction was also better at 1 month (Satiscore 83 ± 9 vs 77 ± 13 points; P = 0.010). The ministernotomy group had significantly less bleeding in the first 24 hours (299 ± 140 vs 509 ± 251 mL, P = 0.001). Ministernotomy provides a faster recovery with improved quality of life and satisfaction at 1 month compared to full sternotomy.
Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Qualidade de Vida , Método Simples-Cego , Esternotomia/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: During the last decade, the use of ministernotomy in cardiac surgery has increased. Quality of life and patient satisfaction after ministernotomy have never been compared to conventional full sternotomy in randomised trials. The aim of the study is to determine if this minimally invasive approach improves quality of life, satisfaction and clinical morbimortality outcomes. METHODS/DESIGN: The QUALITY-AVR trial is a single-blind, single-centre, independent, and pragmatic randomised clinical trial comparing ministernotomy ("J" shaped upper hemisternotomy toward right 4th intercostal space) to full sternotomy in patients with isolated severe aortic stenosis scheduled for elective aortic valve replacement. One hundred patients will be randomised in a 1:1 computational fashion. Sample size was determined for the primary end point with alpha error of 0.05 and with power of 90% in detecting differences between intervention groups of ≥ 0.10 points in change from baseline quality of life Questionnaire EuroQOL-index (EQ-5D-5 L®), measured at 1, 6 or 12 months. Secondary endpoints are: the differences in change from other baseline EQ-5D-5 L® utilities (visual analogue scale, Health Index and Severity Index), cardiac surgery specific satisfaction questionnaire (SATISCORE®), a combined safety endpoint of four major adverse complications at 1 month (all-cause mortality, acute myocardial infarction, neurologic events and acute renal failure), bleeding through drains within the first 24 h, intubation time, postoperative hospital and intensive care unit length of stay, transfusion needs during the first 72 h and 1-year survival rates. Clinical follow up is scheduled at baseline, 1, 6, and 12 months after randomization. All clinical outcomes are recorded following the Valve Academic Research Consortium 2 criteria. DISCUSSION: The QUALITY-AVR trial aims to test the hypothesis that ministernotomy improves quality of life, satisfaction and clinical outcomes in patients referred for isolated aortic valve replacement. Statistically significant differences favouring ministernotomy could modify the surgical "gold standard" for aortic stenosis surgery, and subsequently the need to change the control group in transcatheter aortic valve implantation trials. Recruitment started on 18 March 2016. In November 2017, 75 patients were enrolled. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02726087 . Registered on 13 March 2016.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Satisfação do Paciente , Qualidade de Vida , Esternotomia/métodos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Complicações Pós-Operatórias/etiologia , Ensaios Clínicos Pragmáticos como Assunto , Índice de Gravidade de Doença , Método Simples-Cego , Espanha , Esternotomia/efeitos adversos , Inquéritos e Questionários , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Bicuspid aortic valve (BAV) is the most frequent congenital cardiac disease. It is associated to a higher risk of cardiovascular complications, including infective endocarditis (IE). METHODS: Retrospective, observational and single centre study that included all patients with IE diagnosed between 1996 and 2014. An analysis was made of the epidemiological, clinical, microbiological and echocardiographic data, complications during hospital admission, need for surgery, in-hospital mortality, and 1-year follow-up. Cases with endocarditis on prosthetic valves or other locations were excluded, as well as those for which the aortic valve morphology had not been accurately defined. A comparative statistical analysis was performed between BAV and tricuspid (TAV). RESULTS: Of a total of 328 cases with IE, 118 (35.67%) were on aortic valve, with 18 (16.22%) of them being BAV. The BAV cases were younger than TAV (51±19.06 vs. 60.83±15.73 years, P=.021) and they had less comorbidity (Charlson 0.67±0.77 vs. 1.44±1.64, P=.03).). There was a higher tendency of Staphylococcal origin (38.9 vs. 21.5%, P=.137), and 55.6% showed peri-valvular complications (TAV 16.1%, P=.001), in particular, abscesses (38.9 vs.16.1%, P=.047). BAV was the only predictive factor of peri-valvular complications (OR 7.87, 95% CI; 2.38-26.64, P=.001). Patients with BAV had more surgery during their admission (83.3 vs. 44.1%, P=.004), had less in-hospital mortality, with no statistical significance (5.6 vs. 25.8%, P=.069), and 1-year survival was significantly superior (93.8 vs 69.3%, P=.048). CONCLUSIONS: Patients with IE on BAV are young, with low comorbidity. They frequently present with peri-valvular complications and they often require early surgery. Compared to TAV cases, in-hospital mortality is lower and 1-year survival is significantly higher.
Assuntos
Valva Aórtica/anormalidades , Endocardite/epidemiologia , Doenças das Valvas Cardíacas/epidemiologia , Injúria Renal Aguda/epidemiologia , Adulto , Idoso , Antibacterianos/uso terapêutico , Valva Aórtica/diagnóstico por imagem , Doença da Válvula Aórtica Bicúspide , Encefalopatias/epidemiologia , Terapia Combinada , Comorbidade , Suscetibilidade a Doenças , Endocardite/diagnóstico por imagem , Endocardite/tratamento farmacológico , Endocardite/cirurgia , Feminino , Insuficiência Cardíaca/epidemiologia , Doenças das Valvas Cardíacas/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Estudos Retrospectivos , Choque Séptico/epidemiologiaRESUMO
We aimed to evaluate the frequency of hypoglycemia and its impact on the length of stay and all-cause in-hospital mortality in hospitalized patients with diabetes. We used data from the Basic Minimum Data Set of the Spanish National Health System. Hypoglycemia was defined as having an ICD-9-CM code 250.8, 251.0, 251.1, and 251.2, and categorized as primary if it was the main cause of admission and secondary if it occurred during the hospital stay. The association between hypoglycemia and the study outcomes was evaluated in two cohorts - with and without secondary hypoglycemia - matched by propensity scores and using multivariate models. Among the 5,447,725 discharges with a diagnosis of diabetes recorded from January 1997 to December 2010, there were 92,591 (1.7%) discharges with primary hypoglycemia and 154,510 (2.8%) with secondary hypoglycemia. The prevalence of secondary hypoglycemia increased from 1.1% in 1997 to a peak of 3.8% in 2007, while the prevalence of primary hypoglycemia remained fairly stable. Primary hypoglycemia was associated with reduced in-hospital mortality (Odds ratio [OR] 0.06; 95% Confidence interval [CI], 0.03-0.10) and a significant decrease in time to discharge (Hazard ratio [HR] 2.53; 95% CI, 2.30-2.76), while secondary hypoglycemia was associated with an increased likelihood of in-hospital mortality (OR 1.12; 95% CI, 1.09-1.15) and a significant increase in time to discharge (HR 0.80; 95% CI, 0.79-0.80). In conclusion, the prevalence of secondary hypoglycemia is increasing in patients with diabetes and is associated with an increased likelihood of in-hospital mortality and a longer hospital stay.