Quantitative flow ratio-Meta-analysis and systematic review.

INTRODUCTION: Despite of the wide evidence of use fractional flow reserve (FFR), isolated angiography evaluation is still the main tool to indicate percutaneous coronary intervention. Quantitative flow ratio (QFR) is a new functional index to assess functional significance. Recently, few studies have showed the capacity of QFR to predict significance stenosis. The aim of this research has been to describe the evidence of QFR in this clinical setting, to analyze the global diagnosis accuracy of QFR versus FFR and to compare the difference in feasibility between retrospective and prospective analysis. METHODS AND RESULTS: Systematic review of literature was performed. Eligible studies for the meta-analysis were considered those directly evaluating de QFR versus FFR. Pooled values of diagnosis test and summary receiver operator curve were calculated. Main causes of not-perform QFR analysis according to study design were also evaluated. Sixteen studies were included. Good correlation and agreement were showed. Global sensibility, specificity, PPV, and NPV were 0.84, 0.89, 0.80, and 0.92, respectively. Then, 18% of evaluated vessels could not be analyzed. Significant differences were found in the percentage of discarded vessels and the cause of nonperformed analysis between retrospective or prospective analysis. CONCLUSIONS: Excellent correlation and agreement between QFR and FFR was demonstrated. QFR assessment could be improved by its prospective analysis with a dedicated protocol.

Long-term results after reconstruction of a new annulus in heavily calcified mitral annulus.

BACKGROUND AND AIM OF THE STUDY: In 2009 our group described a new surgical technique for patients with severe mitral valve calcification undergoing mitral valve surgery. This technique creates a new mitral annulus with plication of the mitral leaflet and the atrial wall. Our objective is to report the long-term results of the experience at our institution. MATERIALS, METHODS, AND RESULTS: From 2007 to 2016, a total of 18 patients (mean age 70.5 ± 7.8 years) underwent mitral valve replacement at our institution with this technique. One patient died on the second postoperative day. Clinical and echocardiographic in-hospital and long-term follow-up (55.5 ± 40.4 months) were performed on all the remaining 17 patients. Functional improvement was achieved in all patients. Two patients died 6 and 8 years after surgery (cancer and hemorrhagic stroke). No prosthetic dysfunction, periprosthetic leak, or annular dehiscence were detected in the long-term echocardiographic examinations. CONCLUSIONS: The reconstruction of the mitral annulus by using our technique in patients with severe calcification of the mitral annulus has low long-term mortality, good functional results, and a lack of prosthetic complications.

Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial.

Aims: We aimed to determine whether treatment with sildenafil improves outcomes of patients with persistent pulmonary hypertension (PH) after correction of valvular heart disease (VHD). Methods and results: The sildenafil for improving outcomes after valvular correction (SIOVAC) study was a multricentric, randomized, parallel, and placebo-controlled trial that enrolled stable adults with mean pulmonary artery pressure ≥ 30 mmHg who had undergone a successful valve replacement or repair procedure at least 1 year before inclusion. We assigned 200 patients to receive sildenafil (40 mg three times daily, n = 104) or placebo (n = 96) for 6 months. The primary endpoint was the composite clinical score combining death, hospital admission for heart failure (HF), change in functional class, and patient global self-assessment. Only 27 patients receiving sildenafil improved their composite clinical score, as compared with 44 patients receiving placebo; in contrast 33 patients in the sildenafil group worsened their composite score, as compared with 14 in the placebo group [odds ratio 0.39; 95% confidence interval (CI) 0.22-0.67; P < 0.001]. The Kaplan-Meier estimates for survival without admission due to HF were 0.76 and 0.86 in the sildenafil and placebo groups, respectively (hazard ratio 2.0, 95% CI = 1.0-4.0; log-rank P = 0.044). Changes in 6-min walk test distance, natriuretic peptides, and Doppler-derived systolic pulmonary pressure were similar in both groups. Conclusion: Treatment with sildenafil in patients with persistent PH after successfully corrected VHD is associated to worse clinical outcomes than placebo. Off-label usage of sildenafil for treating this source of left heart disease PH should be avoided. The trial is registered with ClinicalTrials.gov, number NCT00862043.

Streptococcus bovis endocarditis: Update from a multicenter registry.

BACKGROUND: Infective endocarditis (IE) due to Streptococcus bovis has been classically associated with elderly patients, frequently involving >1 valve, with large vegetations and high embolic risk, which make it a high-risk group. Our aim is to analyze the current clinical profile and prognosis of S bovis IE episodes, in comparison to those episodes caused by viridans group streptococci and enterococci. METHODS: We analyzed 1242 consecutive episodes of IE prospectively recruited on an ongoing multipurpose database, of which 294 were streptococcal left-sided IE and comprised our study group. They were classified into 3 groups: group I (n = 47), episodes of IE due to S bovis; group II (n = 134), episodes due to viridans group streptococci; and group III (n = 113), those episodes due to enterococci. RESULTS: The incidence of enterococci IE has significantly increased in the last 2 decades (6.4% [1996-2004] vs 11.1% [2005-2013]; P = .005), whereas the incidence of IE due to S bovis and viridans streptococci have remained stable (4% and 10%, respectively). Gender distribution was similar in the 3 groups. Patients with S bovis and enterococci IE were older than those from group II. Nosocomial acquisition was more frequent in group III. Concerning comorbidity, diabetes mellitus (36.7% vs 9.2% vs 26.8%; P < .001) was more common in groups I and III. Chronic renal failure was more prevalent in patients from group III (4.2% vs 1.5% vs 19%; P < .001). Prosthetic valve IE was more frequent in enterococcal IE. Infection upon normal native valves was more frequent in S bovis IE. Colorectal tumors were found in 69% of patients from this group. Vegetation detection was similar in the 3 groups. However, vegetation size was smaller in S bovis IE. During hospitalization, in-hospital complications and in-hospital mortality were higher in enterococci episodes. CONCLUSIONS: S bovis IE accounts for 3.8% of all IE episodes in our cohort; it is associated with a high prevalence of colonic tumors, with predominance of benign lesions, and affects patients without preexisting valve disease. It is related to small vegetations and a low rate of in-hospital complications, including systemic embolisms. In-hospital mortality is similar to that of viridans group streptococci.

Contemporary epidemiology and prognosis of septic shock in infective endocarditis.

AIMS: The prognosis of patients with infective endocarditis (IE) remains poor despite the great advances in the last decades. One of the factors closely related to mortality is the development of septic shock (SS). The aim of our study was to describe the profile of patients with IE complicated with SS, and to identify prognostic factors of new-onset SS during hospitalization. METHODS AND RESULTS: We conducted a prospective study including 894 episodes of IE diagnosed at three tertiary centres. A backward logistic regression analysis was undertaken to determine prognostic factors associated with SS development. Multivariable analysis identified the following as predictive of SS development: diabetes mellitus [odds ratio (OR) 2.06; confidence interval (CI) 1.16-3.68], Staphylococcus aureus infection (OR: 2.97; CI: 1.72-5.15), acute renal insufficiency (OR: 3.22; CI: 1.28-8.07), supraventricular tachycardia (OR: 3.29; CI: 1.14-9.44), vegetation size ≥15 mm (OR: 1.21; CI: 0.65-2.25), and signs of persistent infection (OR: 9.8; CI: 5.48-17.52). Risk of SS development could be stratified when combining the first five variables: one variable present: 3.8% (CI: 2-7%); two variables present: 6.3% (CI: 3.2-12.1%); three variables present: 14.6% (CI: 6.8-27.6%); four variables present: 29.1% (CI: 11.7-56.1%); and five variables present: 45.4% (95% CI: 17.5-76.6%). When adding signs of persistent infection, the risk dramatically increased, reaching 85.7% (95% CI: 61.2-95.9%) of risk. CONCLUSIONS: In patients with IE, the presence of diabetes, acute renal insufficiency, Staphylococcus aureus infection, supraventricular tachycardia, vegetation size ≥15 mm, and signs of persistent infection are associated with the development of SS.

Prognostic role of persistent positive blood cultures after initiation of antibiotic therapy in left-sided infective endocarditis.

AIM: Persistent infection is not a scientific evidence-based definition. The guidelines of infective endocarditis (IE) establish a cut-off point of 7-10 days, which is arbitrary and probably too long. Our hypothesis is that persistent positive blood cultures after 48-72 h from the initiation of antibiotic therapy are associated with a worse prognosis in patients with left-sided IE. METHODS AND RESULTS: We repeated blood cultures after 48-72 h of the initiation of the antibiotic treatment in 407 patients with left-sided IE of a total of 692 episodes consecutively diagnosed from 1996 to 2011. We have compared the profile of patients whose blood cultures became negative and those with persistent positive blood cultures. We performed a multivariate logistic regression model to determine the prognostic implication of persistent positive blood cultures. Of 256 patients with positive blood cultures at admission, 89 (35%) had persistent positive cultures after 48-72 h from the initiation of the antibiotic treatment. Persistent positive blood cultures (OR: 2.1; 95% CI: 1.2-3.6), age (OR: 1.026; 95% CI: 1.007-1.046), Staphylococcus aureus infection (OR: 3.3; 95% CI: 1.6-6.6), heart failure (OR: 2.8; 95% CI: 1.6-4.7), and renal failure (OR: 2.9; 95% CI: 1.8-4.9) were found to be independently associated with higher in-hospital mortality. CONCLUSIONS: The presence of persistent positive blood cultures is an independent risk factor for in-hospital mortality which doubles the risk of death of patients with left-sided IE. It should be taken into account in the risk stratification of these patients.

Valvulitis: a new echocardiographic criterion for the diagnosis of bioprosthetic aortic valve infective endocarditis.

INTRODUCTION AND OBJECTIVES: Diffuse homogeneous hypoechoic leaflet thickening, with a wavy leaflet motion documented by transesophageal echocardiography (TEE), has been described in some cases of prosthetic valve endocarditis (PVE) involving aortic bioprosthesis (AoBio-PVE). This echocardiographic finding has been termed valvulitis. We aimed to estimate the prevalence of valvulitis, precisely describe its echocardiographic characteristics, and determine their clinical significance in patients with AoBio-PVE. METHODS: From 2011 to 2022, 388 consecutive patients with infective endocarditis (IE) admitted to a tertiary care hospital were prospectively included in a multipurpose database. For this study, all patients with AoBio-PVE (n=86) were selected, and their TEE images were thoroughly evaluated by 3 independent cardiologists to identify all cases of valvulitis. RESULTS: The prevalence of isolated valvulitis was 12.8%, and 20.9% of patients had valvulitis accompanied by other classic echocardiographic findings of IE. A total of 9 out of 11 patients with isolated valvulitis had significant valve stenosis, whereas significant aortic valve regurgitation was documented in only 1 patient. Compared with the other patients with AoBio-PVE, cardiac surgery was less frequently performed in patients with isolated valvulitis (27.3% vs 62.7%, P=.017). In 4 out of 5 patients with valve stenosis who did not undergo surgery but underwent follow-up TEE, valve gradients significantly improved with appropriate antibiotic therapy. CONCLUSIONS: Valvulitis can be the only echocardiographic finding in infected AoBio and needs to be identified by imaging specialists for early diagnosis. However, this entity is a diagnostic challenge and additional imaging techniques might be required to confirm the diagnosis. Larger series are needed.

3D Virtual modelling, 3D printing and extended reality for planning of implant procedure of short-term and long-term mechanical circulatory support devices and heart transplantation.

Introduction: The use of three-dimensional (3D) reconstruction and printing technology, together with extended reality applied to advanced heart failure adult patients with complex anatomy, is rapidly spreading in clinical practice. We report practical experience with application to acute and chronic heart failure: planning and performing mechanical circulatory device insertion or heart transplantation. Methods: From November 2019 until February 2022, 53 3D virtual biomodels were produced for intervention planning (using Virtual/Augmented Reality and/or 3D printing), following a specific segmentation and preprocessing workflow for biomodelling, in patients with advanced heart failure due to structural heart disease or cardiomyopathies. Four of those patients were complex cases requiring mechanical circulatory support implant procedures in our center. Results: One short-term and three long-term ventricular assist device system were successfully clinically implanted after application of this technique. In other two cases with extremely high procedural risk, visualized after application of this multimodality imaging, heart transplantation was elected. Conclusion: 3D printing based planning and virtual procedure simulation, are of great importance to select appropriate candidates for mechanical circulatory support in case of complex patient anatomy and may help to diminish periprocedural complications. Extended reality represents a perspective tool in planification of complex surgical procedures or ventricular assist device insertion in this setting.

Age-dependent profile of left-sided infective endocarditis: a 3-center experience.

BACKGROUND: The influence of age on the main epidemiological, clinical, echocardiographic, microbiological, and prognostic features of patients with infective endocarditis remains unknown. We present the series with the largest numbers and range of ages of subjects to date that analyzes the influence of age on the main characteristics of patients with isolated left-sided infective endocarditis. Furthermore, this series is the first one in which patients have been distributed according to age quartile. METHODS AND RESULTS: A total of 600 episodes of left-sided endocarditis consecutively diagnosed in 3 tertiary centers were stratified into age-specific quartiles and 107 variables compared between the different groups. With increasing age, the percentage of women, previous heart disease, predisposing disease (diabetes mellitus and cancer), and infection by enterococci and Streptococcus bovis also increased. Valvular insufficiency and perforation and Staphylococcus aureus infection were more common in younger patients. The therapeutic approach differed depending on patient age because of the growing proportion of older patients who only received medical treatment. Clinical course and hospital prognosis were worse in the older patients because of increased surgical mortality among them. CONCLUSIONS: Increasing age is associated with less valvular impairment (insufficiency and perforation), a more favorable microbiological profile, and increased surgical mortality among adults with left-sided infective endocarditis.

Challenges in cannulation of left ventricular apex for temporary circulatory support: a case report.

Apical cannulation of a left ventricle for temporary support is still challenging, especially in case of prolonged support due to donor organ shortage. Traditional cannulation techniques with the cannula being directly inserted into the left ventricle cavity are technically easy, but prone to hemorrhage during circulatory support, unsafe for a prolonged support (over than 30 days) and limits the possibility to ambulate patient due to risk for cannula dislocation and related life-threatening bleeding. We describe a case of temporary left ventricular assist device placement in a 59-year-old male patient being on veno-arterial extracorporeal membrane oxygenation support secondary to acute myocardial infarction. We present a very simple technique to secure insertion of an apical left ventricular cannula using patch of soft Teflon felt. Handmade created apical soft Teflon cuff is than fixed using twelve 4/0 prolene sutures supported with pledgets. This gives better fixation to apical myocardium (especially in case of fragile tissue after acute infarction) and secure intracavitary length of inflow cannula in a controlled mode, thus better than purse-string sutures only. Using anti-adhesive membrane, further dissection during heart transplant procedure was uneventful. This technique allowed safe circulatory support and patient ambulation in the ward during 85 days until heart transplantation.

Atrial fibrillation in patients with SARS-CoV-2 infection.

INTRODUCTION AND OBJECTIVE: the SARS-CoV-2 infection ranges from asymptomatic to critical forms and several prognostic factors have been described. Atrial fibrillation (AF) is common in acute situations where it is linked with more complications and mortality. We aimed to evaluate the prognostic information of AF in this population. METHODS: retrospective analysis of a cohort of 517 patients consecutively admitted in a tertiary hospital due to SARS-CoV-2 infection. We divided the patients in two groups according the development of AF and compared the main features of both groups. An univariable and multivariable analysis of mortality were also performed. RESULTS: among 517 patients with SARS-CoV-2 infection admitted in a tertiary center, 54 (10.4%) developed AF. These patients are older (81.6 vs 66.5 years old, p<0.001) and present more hypertension (74% vs 47%, p<0.001), cardiomyopathy (9% vs 1%, p=0.002), previous heart failure admission (9% vs 0.4%, p<0.001), previous episodes of AF (83% vs 1%, p<0.001) and bigger left atrium (47.8 vs 39.9mm, p<0.001). AF COVID-19 patients present more acute respiratory failure (72% vs 40%, p<0.001) and higher in-hospital mortality (50% vs 22%, p<0.001). Predictors of AF development are age and previous AF. AF is not an independent predictor of in-hospital mortality. Predictors are age, creatinine>1.5mg/dL at admission, LDH>250UI/L at admission and acute respiratory failure. CONCLUSION: Atrial fibrillation appears in 10% of hospitalized patients with SARS-CoV-2 infection. These patients present more comorbidities and two-fold increase in hospital mortality. Atrial fibrillation is not an independent prognostic factor.

Infective endocarditis in patients with aortic grafts.

BACKGROUND: Infective endocarditis (IE) in patients with a valve-tube ascending aortic graft (AAG) is a rare entity with a challenging diagnosis and treatment. This study describes the clinical features, diagnosis and outcome of these patients. METHODS: Between 1996 and 2019, 1654 episodes of IE were recruited in 3 centres, of which 37 patients (2.2%) had prosthetic aortic valve and AAG-IE (21 composite valve graft, 16 supracoronary graft) and conformed our study group. RESULTS: Patients with aortic grafts were predominantly male (91.9%) and the mean age was 67.7 years. Staphylococci were the most frequently isolated microorganisms (32%). Viridans group streptococci were only isolated in patients with composite valve graft. TEE was positive in 89.2%. PET/CT was positive in all 15 patients in whom it was performed. Surgical treatment was performed in 62.2% of patients. In-hospital mortality was 16.2%. Heart failure and the type of infected graft (supracoronary aortic graft) were associated with mortality. Mortality among operated patients was 21.7%. Interestingly, 14 patients received antibiotic therapy alone, and only one died. Mortality was lower among patients with a composite valve graft compared to those with a supracoronary graft (4.8% vs 31.3%; p = 0.03). CONCLUSIONS: In patients with AAG and prosthetic aortic valve IE, mortality is not higher than in other patients with prosthetic IE. Multimodality imaging plays an important role in the diagnosis and management of these patients. Heart failure and the type of surgery were risk factors associated with in-hospital mortality. Although surgical treatment is usually recommended, a conservative management might be a valid alternative treatment in selected patients.

Atrial fibrillation in patients with SARS-CoV-2 infection.

INTRODUCTION AND OBJECTIVE: the SARS-CoV-2 infection ranges from asymptomatic to critical forms and several prognostic factors have been described. Atrial fibrillation (AF) is common in acute situations where it is linked with more complications and mortality. We aimed to evaluate the prognostic information of AF in this population. METHODS: retrospective analysis of a cohort of 517 patients consecutively admitted in a tertiary hospital due to SARS-CoV-2 infection. We divided the patients in two groups according the development of AF and compared the main features of both groups. An univariable and multivariable analysis of mortality were also performed. RESULTS: among 517 patients with SARS-CoV-2 infection admitted in a tertiary center, 54 (10.4%) developed AF. These patients are older (81.6 vs 66.5 years old, p < 0.001) and present more hypertension (74% vs 47%, p < 0.001), cardiomyopathy (9% vs 1%, p = 0.002), previous heart failure admission (9% vs 0.4%, p < 0.001), previous episodes of AF (83% vs 1%, p < 0.001) and bigger left atrium (47.8 vs 39.9 mm, p < 0.001). AF COVID-19 patients present more acute respiratory failure (72% vs 40%, p < 0.001) and higher in-hospital mortality (50% vs 22%, p < 0.001). Predictors of AF development are age and previous AF. AF is not an independent predictor of in-hospital mortality. Predictors are age, creatinine > 1.5 mg/dL at admission, LDH > 250 UI/L at admission and acute respiratory failure. CONCLUSION: Atrial fibrillation appears in 10% of hospitalized patients with SARS-CoV-2 infection. These patients present more comorbidities and two-fold increase in hospital mortality. Atrial fibrillation is not an independent prognostic factor.

INTRODUCCIÓN Y OBJETIVO: La infección por SARS-CoV-2 presenta un amplio espectro clínico, y varios factores pronósticos han sido descritos. La fibrilación auricular (FA) es frecuente en situaciones agudas, donde se ha relacionado con aumento de complicaciones y mortalidad. Nuestro objetivo ha sido evaluar el impacto pronóstico de la FA en esta población. MÉTODOS: Análisis retrospectivo de una cohorte de 517 pacientes con infección SARS-CoV-2 consecutivamente ingresados en un hospital terciario. Dividimos a los pacientes en dos grupos de acuerdo al desarrollo de FA durante el ingreso y comparamos las características de los grupos. Realizamos análisis univariado y multivariado de mortalidad. RESULTADOS: De los 517 pacientes, 54 (10,4%) desarrollaron FA. Estos pacientes son mayores (81,6 vs. 66,5 años, p < 0,001) y presentan más hipertensión (74% vs. 47%, p < 0,001), miocardiopatía (9% vs. 1%, p = 0,002), ingreso previo por insuficiencia cardiaca (9% vs. 0,4%, p < 0,001), historia de FA (83% vs. 1%, p < 0,001) y mayor aurícula izquierda (47,8 vs. 39,9 mm, p < 0,001). Los pacientes con FA presentan más fallo respiratorio agudo (72% vs. 40%, p < 0,001) y mayor mortalidad hospitalaria (50% vs. 22%, p < 0,001). Los predictores de FA son la edad y la historia de FA previa. La FA no es un predictor independiente de mortalidad hospitalaria. Los predictores son: edad, creatinina > 1,5 mg/dL al ingreso, LDH > 250 U/L al ingreso y el fallo respiratorio agudo. CONCLUSIÓN: La FA aparece en el 10% de los pacientes hospitalizados por SARS-CoV-2. Estos presentan mayor comorbilidad y el doble de mortalidad hospitalaria, pero la FA no es un factor pronóstico independiente.

The 'wait for symptoms' strategy in asymptomatic severe aortic stenosis.

Calcific aortic stenosis is a prevalent and worrisome healthcare problem. The therapeutic approach in asymptomatic aortic stenosis is not well established. We argue that the natural history of this disease is based on old incomplete studies with many limitations. Likewise, studies suggesting that replacement, either surgical or percutaneous, improves prognosis in asymptomatic patients with severe aortic stenosis have important drawbacks and do not support this strategy as the treatment of choice. Despite the lack of evidence, some groups recommend early valve replacement in patients with severe asymptomatic aortic stenosis. There are five ongoing randomised trials which will shed light on this topic. Our conclusion is that unless a randomised study changes the evidence, valve replacement cannot be recommended in asymptomatic patients with severe aortic stenosis.

Cyclooxygenase-2 induced by zymosan in human monocyte-derived dendritic cells shows high stability, and its expression is enhanced by atorvastatin.

Cyclooxygenase (COX)-2 is a central enzyme of arachidonic acid metabolism, and its modulation by statins may explain some of the myocardial protective effects of these drugs. Dendritic cells (DCs) play a central role in microbial defense and in atherogenesis, and COX-2 expression in DCs is important for their migration to lymph nodes and antibody response, thus explaining why prostaglandin E(2) is a main component of the cocktails used to prepare DCs for clinical applications. On this basis, we addressed the effect of atorvastatin (ATV) on the release of arachidonic acid and on the expression of COX-2 in human monocyte-derived DCs. Although ATV on its own lacked any effect on COX-2 protein induction expression, it enhanced the release of arachidonic acid, the expression of COX-2 protein, and the production of prostaglandin E(2) induced by the fungal wall extract zymosan, and to a lower extent the effect of peptidoglycan. The effect on COX-2 protein was observed mainly 24 h after stimulation by zymosan and was not reverted by mevalonate, thus pointing to an effect unrelated to cholesterol metabolism. It is noteworthy that COX-2 protein showed a great stability, with a t((1/2)) of approximately 12 h, which was enhanced in the presence of ATV. In view of the important role played by COX-2 on DC function, these data indicate that ATV, by enhancing COX-2 stability, may increase DC function after infectious bouts and also counteract some of the risks associated with sustained inhibition of COX-2.

"A contemporary description of staphylococcus aureus prosthetic valve endocarditis. Differences according to the time elapsed from surgery".

Staphylococcus aureus prosthetic valve endocarditis (SAPVE) has a poor prognosis. There are no large series that accurately describe this entity.This is a retrospective observational study on a prospective cohort from 3 Spanish reference hospitals for cardiac surgery, including 78 definitive episodes of left SAPVE between 1996 and 2016.Fifty percent had a Charlson Index score >5; 53% were health care-related. Twenty percent did not present fever. Complications at diagnosis included: severe heart failure (HF, 29%), septic shock (SS, 17.9%), central nervous system abnormalities (19%), septic metastasis (4%). Hemorrhagic stroke was not higher in anticoagulated patients. Twenty-seven percent were methicilin-resistant SA (MRSA). Fifteen of 31 had positive valve culture; it was related to surgery within first 24 hours. At diagnosis, 69% had vegetation (>10 mm in 75%), 21.8% perianular extension, and 20% prosthetic dehiscence. Forty-eight percent had persistent bacteremia, related to nonsurgical treatment. Perianular extension progressed in 18%. Surgery was performed in 35 episodes (12 with stroke). Eleven uncomplicated episodes were managed with medical therapy, 8 survived. In-hospital mortality was 55%, higher in episodes with hemorrhagic stroke (77.8% vs 52.2%, odds ratio 3.2 [0.62-16.55]). Early SAPVE was nosocomial (92%), presented as severe HF (54%), patients were diagnosed and operated on early, 38% died. In intermediate SAPVE (9 weeks-1 year) diagnosis was delayed (24%), patients presented with constitutional syndrome (18%), renal failure (41%), and underwent surgery >72 hours after indication; 53% died. Late SAPVE (>1 year) was related with health care, diagnosis delay, and 60% of deceases.Left SAPVE frequently affected patients with comorbidity and health care contact. Complications at diagnosis and absence of fever were frequent. Presence of MRSA was high. Positive valve culture was related to early surgery. Paravalvular extension was frequent; vegetations were large, but its absence at diagnosis was common. Some uncomplicated SAPVE episodes were safety treated with medical therapy. Surgery was feasible in patients with stroke. Mortality was high. There were differences in some clinical characteristics and in evolution according to the time elapsed from valve replacement. Prognosis was better in early SAPVE.

Rationale, design, and methods for the early surgery in infective endocarditis study (ENDOVAL 1): a multicenter, prospective, randomized trial comparing the state-of-the-art therapeutic strategy versus early surgery strategy in infective endocarditis.

BACKGROUND: The prognosis of infective endocarditis is poor and has remained steady over the last 4 decades. Several nonrandomized studies suggest that early surgery could improve prognosis. METHODS: ENDOVAL 1 is a multicenter, prospective, randomized study designed to compare the state-of-the-art therapeutic strategy (advised by the international societies in their guidelines) with the early-surgery strategy in high-risk patients with infective endocarditis. Patients with infective endocarditis without indication for surgery will be included if they meet at least one of the following: (1) early-onset prosthetic endocarditis; (2) Staphylococcus aureus endocarditis; (3) periannular complications; (4) new-onset conduction abnormalities; (5) new-onset severe valvular dysfunction. A total of 216 patients will be randomized to either of the 2 strategies. Stratification will be done within 3 days of admission. In the early surgery arm, the surgical procedure will be performed within 48 hours of randomization. The only event to be considered will be death within 30 days. The study will be extended to 1 year. In the follow-up substudy, death and a new episode of endocarditis will be regarded as events. CONCLUSION: ENDOVAL 1, the first randomized study on endocarditis, will provide crucial information regarding the putative benefit of early surgery over the state-of-the-art therapeutic approach in high-risk patients with infective endocarditis.