Neurological outcomes of transcatheter aortic valve implantation with or without cerebral embolic protection devices: A meta-analysis.

INTRODUCTION: Cerebral embolic protection devices (CEPDs) are designed to prevent embolization of debris during transcatheter aortic valve implantation (TAVI). Current evidence from randomized clinical trials (RCTs) and observational studies is controversial. AIMS: The purpose of this meta-analysis was to study the influence of CEPDs on stroke, silent ischemic lesions and neurocognitive function. METHODS: A systematic search was conducted including RCTs or adjusted observational studies comparing TAVI with or without CEPDs. Pooled odds ratios, risk ratios or standardized mean differences with 95% confidence intervals were calculated using the inverse of variance method. Risk of bias sensitivity analyses and meta regression for CEPD type were also conducted. RESULTS: Five RCTs and five adjusted observational studies were included (n= 159,865). Mean age of the patients was 81.1 (SD 1.04) years in CEPDs and 81 (SD 1.86) in non-CEPD. The overall quality of evidence using the GRADE system for each endpoint was low to very low, mainly due to serious risk of bias, inconsistency and imprecision. Random effects meta-analysis detected no significant differences between CEPD and non-CEPD (OR= 0.74; 95% CI 0.51-1.07; P= 0.105; I2= 82.1%) for 30-day stroke. This finding was consistent in meta regression for CEPD type and subgroup analyses by study type and CEPD type. No significant differences between groups were observed in cerebral DW-MRI assessment and neurocognitive function evaluation. CONCLUSION: In the present meta- analysis of five RCTs and five adjusted observational studies, the use of a CEPD during TAVI was not associated with a significant benefit on 30- day stroke, total lesion volume per patient, number of ischemic lesions per patient and neurocognitive function assessments.

Thoracic Stent Grafting through Transapical Approach for Type III Endoleak due to Prosthetic Disconnection.

Thoracic endovascular aortic repair is a well-established treatment of descending thoracic aneurysms, and increasingly complex endovascular procedures including aortic arch and ascending aorta are being performed. However, follow-up complications may be expected, which will enhance the need for alternative approaches such as transapical, in case of complex anatomies and reinterventions. We report the case of a man with prior history of ischemic cardiopathy and multiple endovascular aortic interventions with proximal landing in zone 1 and distal landing proximal to celiac trunk. During the follow-up, the patient developed a 9-cm proximal thoracic aneurysm due to type III endoleak secondary to proximal prosthetic disconnection. Because of severe aortic elongation, inadequate usual vessel accesses (transfemoral/subclavian), and proximity to aortic arch, transapical approach was thought to be the best option in this case. The stent graft was correctly deployed without complications, and the postoperative imaging revealed an excellent result.

Off-Pump to On-Pump Emergency Conversion: Incidence, Risk Factors, and Impact on Short- and Long-Term Results.

BACKGROUND AND AIM OF THE STUDY: Emergency conversion to on-pump during off-pump coronary artery bypass surgery (CABG) increases morbidity and mortality. We analyze its risk factors and impact on short- and long-term outcomes. METHODS: All patients undergoing isolated CABG between 2006 and 2012 were included. Postoperative and midterm mortality and the combined event (death, myocardial infarction, cerebrovascular accident, and repeat revascularization) were compared between patients with and without conversion. Multivariate analysis and propensity score matching were performed. RESULTS: A total of 1268 patients were operated off pump and 37 patients required an emergency conversion. Postoperative death and combined event were more frequent among patients who were converted (31.6% vs. 3.31%, p < 0.001 and 43.2% vs. 11.5%, p < 0.001, respectively). Conversion was an independent predictor of both events (OR = 6.22, 95%CI: 2.01 to 19.3 and OR = 5.06, 95%CI: 2.41 to 10.61, respectively). Mean follow-up was 32.5 months. At four years, survival and freedom from the combined event was poorer for conversion (75% vs. 88%, p < 0.001 and 50% vs. 79%, p < 0.001, respectively). Conversion was an independent predictor for late mortality (HR = 2.4, 95%CI: 1.1 to 5.22) and the risk of combined event (HR = 2.97, 95%CI: 1.79 to 4.91). A 3:1 propensity score matching analysis was performed: conversion increased both perioperative and four-year mortality (12.6% vs. 4.5%, p < 0.001 and 25% vs. 12%, p = 0.007); and early and late incidence of the combined event (43.2% vs. 11.7%, p < 0.001 and 53% vs. 24%, p = 0.001). Preoperative atrial fibrillation and previous percutaneous coronary intervention were independent predictors of conversion. CONCLUSIONS: Emergency conversion from off- to on-pump CABG dramatically worsens early and late outcomes. Previous percutaneous coronary intervention and atrial fibrillation increase the risk of conversion.

Advanced considerations in survival analysis.

Investigation of survival during the follow-up period is common in cardiovascular research and has intrinsic issues that require precise knowledge, such as survival or censoring. Besides, as the follow-up period lengthens and events other than mortality are studied, the analysis becomes more complex, so Kaplan-Meier analyses or Cox models are not always sufficient. In this primer, we provide the reader with detailed information on the interpretation of the most common survival analyses and delve into methods to analyse competing risks or alternatives to the conventional methods when the proportional hazards assumption is not met.

Prognostic impact of shock in patients with type A acute aortic syndrome. Results of a nationwide multicenter study.

OBJECTIVE: To evaluate the clinical characteristics, imaging findings, treatment, and prognosis of patients with type A acute aortic syndrome (AAS-A) presenting with shock. To assess the impact of surgery on this patient population. METHODS: The study included 521 patients with A-AAS enrolled in the Spanish Registry of Acute Aortic Syndrome (RESA-III) from January 2018 to December 2019. The RESA-III is a prospective, multicenter registry that contains AAS data from 30 tertiary-care hospitals. Patients were classified into two groups according to their clinical presentation, with or without shock. Shock was defined as persistent systolic blood pressure <80 mmHg despite adequate volume resuscitation. RESULTS: 97 (18.6%) patients with A-AAS presented with shock. Clinical presentation with syncope was much more common in the Shock group (45.4% vs 10.1%, p = 0.001). Patients in the Shock group had more complications at diagnosis and before surgery: cardiac tamponade (36.2% vs 9%, p < 0.001), acute renal failure (28.9% vs 18.2%, p = 0.018), and need for orotracheal intubation (40% vs 9.1%, p < 0.001). There were no significant differences in aortic regurgitation (51.6% vs 46.7%, p = 0.396) between groups. In-hospital mortality was higher among patients with shock (48.5% vs 27.4%, p < 0.001). Surgery was associated with a significant mortality reduction both in patients with and without shock. Surgery had an independent protective effect on mortality (OR 0.03, 95% CI (0.00-0.32)). CONCLUSION: Patients with AAS-A admitted with shock have a heavily increased risk of mortality. Syncope and pericardial effusion at diagnosis are strongly associated with shock. Surgery was independently associated with a mortality reduction in patients with AAS-A and shock.

Ultrafast track versus conventional fast track in patients undergoing cardiac surgery: a propensity score-matched analysis.

OBJECTIVES: We aimed at comparing the risk of major adverse events and length of stay between patients undergoing ultrafast track and conventional fast track. METHODS: Retrospective cohort study adjusted by propensity score matching, including patients operated on between March 2020 and December 2022 of any of the following: coronary, valve surgery or ascending aorta surgery. Patients were divided into 2 groups: ultrafast track: extubation in the operating room and fast track: extubation attempted in the first 6 postoperative hours. The primary objective was to compare the risk of the combined event death, lung respiratory outcomes (reintubation, mechanical ventilation longer than 24 h or pneumonia), or acute renal failure. RESULTS: A total of 1126 patients were included. A total of 579 (51.4%) were extubated in the operating room. A total of 331 pairs were available after matching by propensity score. The risk of the primary outcome was 11.8% (n = 39) in the fast-track group and 6.3% (n = 21) in the ultrafast-track group (P = 0.013), mostly driven by lung adverse events (6.9% vs 2.4%, P = 0.011) while no significant differences were detected in the risk of death (2.4% vs 1.8%, P = 0.77) or acute renal failure (8% vs 6.3%, P = 0.56). The risk of myocardial infarction was higher in the fast-track group (2.7% vs 0%, P = 0.039). The median length of stay in the postoperative intensive care unit was longer in the fast-track group [24.7 h (interquartile range 21.5; 62.9) vs 23.5 h (interquartile range 22; 46), P = 0.015]. CONCLUSIONS: In patients undergoing cardiac surgery, extubation in the operating room is associated to a lower risk of postoperative complications (mostly driven by lung adverse events) and length of stay in intensive care unit as compared to fast track.

5-Year haemodynamic performance of three aortic bioprostheses. A randomized clinical trial.

OBJECTIVES: The Carpentier Perimount (CP) Magna Ease, the Crown Phospholipid Reduction Treatment (PRT) and the Trifecta bovine pericardial valves have been widely used worldwide. The primary end point of this study was to compare the haemodynamic performance quantified by in vivo echocardiograms of these 3 aortic prostheses. METHODS: The "BEST-VALVE" (comparison of 3 contemporary cardiac bioprostheses: mid-term valve haemodynamic performance) was a single-centre randomized clinical trial to compare the haemodynamic and clinical outcomes of the aforementioned bioprostheses. The 5-year results are assessed in this manuscript. RESULTS: A total of 154 patients were included. The CP Magna Ease (n = 48, 31.2%), Crown PRT (n = 51, 32.1%) and Trifecta (n = 55, 35.7%) valves were compared. Significant differences were observed among the 3 bioprostheses 5 years after the procedure. The following haemodynamic differences were found between the CP Magna Ease and the Crown PRT bioprostheses [mean aortic gradient: 12.3 mmHg (interquartile range {IQR} 7.8-17.5) for the CP Magna Ease vs 15 mmHg (IQR 10.8-31.9) for the Crown PRT, P < 0.001] and between the CP Magna Ease and the Trifecta prostheses [mean aortic gradient: 12.3 mmHg (IQR 7.8-17.5) for the CP Magna Ease vs 14.7 mmHg (IQR 8.2-55) for the Trifecta, P < 0.001], with a better haemodynamic performance of the CP Magna Ease. The cumulative incidence of severe structural valve degeneration was 9.5% in the Trifecta group at 6 years of follow-up. The 1-, 3- and 5-year survival from all-cause mortality was 91.5%, 83.5% and 74.8%, respectively (log rank P = 0.440). Survival from the composite event at the 1-, 3- and 5-year follow-up was 92.8%, 74.6% and 59%, respectively (log rank P = 0.299). CONCLUSIONS: We detected significant differences between the 3 bioprostheses; the CP Magna Ease had the best haemodynamic performance at the 5-year follow-up.

Co-Management Reduces Mortality in Post-Sternotomy Mediastinitis.

Background: Post-sternotomy mediastinitis (PSM) is one of the most feared complications of cardiac surgery. The impact of a multidisciplinary management approach on this pathology is yet unknown. Patients and Methods: A multidisciplinary approach based on a co-management model (CMM) of care was initiated in January 2018 because of the incorporation of a hospitalist unit on a cardiac surgery department. An observational retrospective cohort study was designed to evaluate the impact of the CMM of care compared to the standard model (SM) of care in patients diagnosed with PSM. Our primary and secondary outcomes were survival time and treatment failure rate (two or more surgical procedures needed to solve PSM or PSM-related death), respectively. Data related to patient death date were collected from the Spanish National Death Index. A multivariable Cox regression model was created using those variables believed to be clinically relevant. Results: Ninety-one patients developed PSM from January 2010 to June 2020. Regarding the pre-operative clinical status, surgical procedure, and PSM severity, both groups had similar baseline characteristics. Patients were followed for a mean of 27.54 ± 30.5 months. A total of 60.3% of the SM group and 11.1% of the CMM group (p < 0.001) died. Treatment failure occurred in 53 patients (72.6%) in the SM group versus 7 (38.6%) in the CMM group (p = 0.007). The CMM independently reduced overall mortality (hazard ratio [HR], 0.11; 95% confidence interval [CI]. 0.01-0.83) and treatment failure rate (HR, 0.01; 95% CI, 0.001-0.183). Gram-positive bacterial infection (HR, 3.73; 95% CI, .6-8.3), and complete osteosynthesis material removal (HR, 0.47; 95% CI, 0.24-0.91) also influenced mortality in our model. Conclusions: A co-management care model reduced overall mortality in patients diagnosed with post-sternotomy mediastinitis.

Combined off-pump mitral repair and thoracoscopic maze surgery.

A 67-year-old man with severe mitral regurgitation and paroxysmal atrial fibrillation was admitted to our institution for surgical repair. The procedure was carried out off-pump. We first performed a totally thoracoscopic maze box lesion set with epicardial transmural radiofrequency, and clipped the left atrial appendage. The mitral valve prolapse was repaired by implanting three transapical neochordae. Six months later, the patient was in sinus rhythm with minimal residual mitral regurgitation on echocardiography. This novel approach is less invasive than the standard surgical correction and should ensure a faster recovery with similar safety and efficacy in selected cases.

One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial.

BACKGROUND: We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna EaseTM, Crown PRTTM, and TrifectaTM). METHODS: The sample used in this study comes from the "BEST-VALVE" clinical trial, which is a phase IV single-blinded randomized clinical trial with the three above-mentioned prostheses. RESULTS: 154 patients were included. Carpentier Perimount Magna EaseTM (n = 48, 31.2%), Crown PRTTM (n = 51, 32.1%) and TrifectaTM (n = 55, 35.7%). One year after the surgery, the mean aortic gradient and the peak aortic velocity was 17.5 (IQR 11.3-26) and 227.1 (IQR 202.0-268.8) for Carpentier Perimount Magna EaseTM, 21.4 (IQR 14.5-26.7) and 237.8 (IQR 195.9-261.9) for Crown PRTTM, and 13 (IQR 9.6-17.8) and 209.7 (IQR 176.5-241.4) for TrifectaTM, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of TrifectaTM as compared to Crown PRTTM. Among patients with nominal prosthesis sizes ≤ 21, the mean and peak aortic gradient was higher for Crown PRTTM compared with TrifectaTM, and in patients with an aortic annulus measured with metric Hegar dilators less than or equal to 22 mm. CONCLUSIONS: One year after surgery, the three prostheses presented a different hemodynamic performance, being TrifectaTM superior to Crown PRTTM.

Variablity of Mechanical or Tissue Valve Implantation in Patients Undergoing Surgical Aortic Valve Replacement in Spain: National Retrospective Analysis from 2007 to 2018.

BACKGROUND: There is no robust evidence regarding the types of valves implanted among patients undergoing surgical aortic valve replacement (SAVR) in Spain. METHODS: All cases of patients undergoing SAVR ± coronary artery bypass grafting from January 2007 to December 2018 in the public Spanish National Health System were included. We analyzed the trends of SAVR volume, risk profile and type of implanted valve across time and place. Using multivariable logistic regression, we identified factors associated with biological SAVR. RESULTS: In total, 62,870 episodes of SAVR in 15 Spanish territories were included. In 35,693 (56.8%), a tissue valve was implanted. The annual volume of procedures increased from 107.3/million (2007) to 128.6 (2017). In 2018, it fell to 108.5. Age increased and Charlson's comorbity index worsened throughout the study period. Tissue valve implantation increased in most regions. After adjusting for other covariates, we observed a high variability in aortic valve implantation across different regions, with differences of as much as 20-fold in the use of tissue valves. CONCLUSIONS: Between 2007 and 2018, we detected a significant increase in the use of bioprostheses in patients undergoing SAVR in Spain, and a great variability in the types of valve between the Spanish territories, which was not explained by the different risk profiles of patients.

Isolated aortic valve replacement in Spain: national trends in risks, valve types, and mortality from 1998 to 2017.

INTRODUCTION AND OBJECTIVES: To help to illustrate the trends in isolated surgical aortic valve replacement (SAVR) in Spain, we performed a national-level analysis to investigate the changes from 1998 to 2017 in a) SAVR volume, b) patients' risk profiles, c) in-hospital mortality, and d) types of aortic valve prostheses. METHODS: We included all episodes of patients undergoing isolated SAVR from January 1998 to December 2017 recorded in the Minimum Basic Data Set (Ministry of Health, Consumer Affairs, and Social Welfare, Spain). The study duration was divided into four 5-year periods. We analyzed the trends in SAVR volume, comorbidity prevalence, and in-hospital mortality. Through multivariate logistic regression, we identified factors associated with mortality and type of prosthesis. The risk-adjusted mortality rate was compared over the study period. RESULTS: In total, 73 668 patients underwent an isolated SAVR from 1998 to 2017. The annual volume of procedures increased from 16 363 between 1998 and 2002 to 22 685 between 2013 and 2017. The prevalence of all investigated comorbidities increased, except for history of previous myocardial infarction and unplanned admission. The Charlson comorbidity index worsened from 1998-2002 (2.3; SD, 1.4) to 2013-2017 (3.6; SD, 1.7) (P <.001). In-hospital mortality decreased from 7.2% to 3.3% (P <.001) while the risk-adjusted mortality index improved from 1.3 to 0.7. The proportion of bioprostheses increased from 20.7% (1998-2002) to 59.6% (2013-2017) (P <.001). CONCLUSIONS: We detected an increase in the annual SAVR volume in Spain, with more patients receiving bioprostheses. Despite an increased risk profile of the patients, in-hospital mortality substantially reduced.

Retrospective cohort analysis of Spanish national trends of coronary artery bypass grafting and percutaneous coronary intervention from 1998 to 2017.

INTRODUCTION: Spain is one of the countries with the lowest rates of revascularisation and highest ratio of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG). OBJECTIVES: To investigate the changes and trends in the two revascularisation procedures between 1998 and 2017 in Spain. DESIGN: Retrospective cohort study. Analysis of in-hospital outcomes. SETTING: Minimum basic data set from the Spanish National Department of Health: mandatory database collecting information of patients who are attended in the Spanish public National Health System. PARTICIPANTS: 603 976 patients who underwent isolated CABG or PCI in the Spanish National Health System. The study period was divided in four 5-year intervals. Patients with acute myocardial infarction on admission were excluded. PRIMARY AND SECONDARY OUTCOMES: We investigated the volume of procedures nationwide, the changes of the risk profile of patients and in-hospital mortality of both techniques. RESULTS: We observed a 2.2-fold increase in the rate of any type of myocardial revascularisation per million inhabitants-year: 357 (1998) to 776 (2017). 93 682 (15.5%) had a coronary surgery. PCI to CABG ratio rose from 2.2 (1998-2002) to 8.1 (2013-2017). Charlson's index increased by 0.8 for CABG and 1 for PCI. The median annual volume of PCI/hospital augmented from 136 to 232, while the volume of CABG was reduced from 137 to 74. In the two decades, we detected a significant reduction of CABG in-hospital mortality (6.5% vs 2.6%, p<0.001) and a small increase in PCI (1.2% vs 1.5%, p<0.001). Risk adjusted mortality rate was reduced for both CABG (1.51 vs 0.48, p<0.001), and PCI (1.42 vs 1.05, p<0.001). CONCLUSION: We detected a significant increase in the volume of revascularisations (particularly PCI) in Spain. Risk-adjusted in-hospital mortality was significantly reduced.

Impact of postoperative acute kidney failure in long-term survival after heart valve surgery.

OBJECTIVES: We investigated the impact of acute kidney failure after a heart valve procedure among patients with or without chronic kidney disease (CKD). METHODS: All patients who had undergone a surgical valve procedure between 2005 and 2017 at our institution were divided into 2 groups depending on whether they had previous history of CKD (estimated glomerular filtration rate <60 ml/min/1.73 m2) or not. Homogeneous groups were obtained by propensity score matching. Long-term mortality was compared between the 2 groups and according to the occurrence of postoperative acute kidney failure. Level of significance was set at P-value <0.008 for multiple comparison tests. RESULTS: From the 3907 patients included to this study, 1476 (37.78%) had previous history of CKD. After adjusting for propensity score 1:1, patients with preoperative impaired renal function were at a higher risk of acute kidney failure (26.83% vs 10.16%, P < 0.001) and postoperative mortality (8.48% vs 5.17%, P = 0.001). In the follow-up, they had a poorer survival at 1, 5 and 10 years as compared to patients with normal renal function (88% vs 91.95%, 78.29% vs 81.11% and 56.13% vs 66.29%, respectively; P < 0.001). Patients without postoperative kidney failure had similar survival whether they had preoperative CKD or not [hazard ratio (HR) 1.16, 99.2% confidence interval (CI) 0.87-2.52; P = 0.142]. As compared to patients with postoperative preserved renal function, those with postoperative kidney failure had a higher long-term mortality either if they had previous kidney disease or not [(HR 2.18, 99.2% CI 1.75-2.72; P < 0.001) and (HR 1.48, 99.2% CI 1.33-1.65; P < 0.001), respectively]. Preoperative CKD was the strongest predictor of acute kidney failure (odds ratio 4.45; 95% CI 3.59-5.53; P < 0.001). CONCLUSIONS: Patients with CKD are at higher risk of postoperative adverse events and have poorer long-term outcomes. Postoperative acute kidney failure increases long-term mortality.

Early surgery for acute-onset infective endocarditis.

OBJECTIVES: Acute onset of infective endocarditis has been previously linked to the development of septic shock and a worse prognosis. The purpose of this study was to analyse the clinical features and in-hospital evolution of patients with acute-onset endocarditis as well as the potential role of early surgery in the treatment of these patients. METHODS: From 1996 to 2014, 1053 consecutive patients with left-sided endocarditis were prospectively included. Patients were classified into 2 groups according to the clinical presentation: patients with acute-onset endocarditis (n = 491) and patients with non-acute endocarditis (n = 562). Acute-onset endocarditis was considered when the time between the appearance of symptoms and diagnosis was <15 days. RESULTS: At admission, acute renal failure, septic shock and cerebral embolism predominated among patients with acute-onset endocarditis. Staphylococcus aureus was more frequently isolated in patients with an acute onset (27.7% vs 7.8% P < 0.001). During hospitalization, patients with acute onset developed systemic embolism and septic shock more frequently. Death was much more common in this group (42.7 vs 30.1%, P < 0.001). Paravalvular complications, nosocomial infection, heart failure, S. aureus and septic shock were predictors of mortality. Acute-onset presentation of endocarditis was strongly associated with increased mortality. Among patients with acute-onset endocarditis, early surgery, performed within the first 2 days after diagnosis, was associated with a 64% of reduction in mortality. CONCLUSIONS: Patients with endocarditis and acute onset of symptoms are at high risk of septic in-hospital complications and mortality. Early surgery, performed within the first 2 days after diagnosis, plays a central role in the treatment of these patients.

Evolution and prognosis of intramural aortic hematoma. Insights from a midterm cohort study.

BACKGROUND: Although several hypotheses have been proposed, the true origin and pathogenesis of aortic intramural hematoma (IMH) remain unclear. Evolution of patients with aortic IMH is highly variable. Progression to classic aortic dissection, aneurysm or to complete resolution have been described. Our purpose was to assess in-hospital and mid-term evolution of patients with aortic IMH. METHODS: From 2000 to 2015, 40 patients with aortic IMH were prospectively and consecutively recruited in a tertiary care referral center. Aortic IMH was defined as the presence of a circular or crescent-shaped thickening of the aortic wall (≥5mm) in the absence of detectable blood flow inside, within the context of acute aortic syndrome. RESULTS: Twenty three patients (57.5%) had type A, and 17 (42.5%) type B IMH. Up to 34.7% of patients with type A and 47.1% with type B IMH showed intimal tears in the imaging test at admission. In-hospital mortality was higher in the type A IMH group. All-cause mortality after discharge was 20%, without significant differences among groups. Out of hospital death was related to the aortic pathology in just one patient. At follow-up, radiological persistence of IMH was observed in 35.7% of patients with type A and 60% of those with type B IMH. CONCLUSIONS: IMH related mortality takes place primarily during the acute phase of the disease. Clinical evolution after discharge is favorable, either in cases of reabsorption or persistence of the IMH. Imaging test findings rekindle the debate on the true training mechanism of the aortic IMH.