Trends, characteristics, in-hospital outcomes and mortality in surgical mitral valve replacement among patients with and without COPD in Spain (2001-2015).
ABSTRACT: PURPOSE:We examined trends, characteristics and in-hospital outcomes in mechanical and bioprosthetic surgical mitral valve replacement (SMVR) among patients with and without chronic obstructive pulmonary disease (COPD) in Spain from 2001 to 2015. We also identified factors associated with in-hospital mortality (IHM) in both groups of patients according to the implanted valve type. METHODS:We analyzed data from the Spanish National Hospital Discharge Database for patients aged 40 years or over. We selected admissions of patients whose medical procedures included SMVR. We grouped hospitalizations by COPD status. RESULTS:Over 43,024 patients identified, 83.63% underwent mechanical mitral valve replacement and 16.37% bioprosthetic valve (6.71% and 7.78% with COPD, respectively). The incidence of SMVR decreased for mechanical valves and increased for bioprosthetic valves over time in both groups of patients. The incidence of SMVR admissions was lower among COPD patients than in those without COPD, both for mechanical and bioprosthetic valves. IHM decreased significantly over time, regardless of the type of valve, in both groups of patients. COPD was associated with a significant increase in IHM, but only among patients who underwent bioprosthetic SMVR (OR 1.32, 95% CI 1.01-1.73). CONCLUSIONS:The incidence of mechanical SMVR decreased while that of bioprosthetic SMVR increased over time in both groups of patients. COPD patients were less surgically operated than non-COPD patients for both valve types. In COPD patients, bioprosthetic SMVR was proportionally more used than mechanical SMVR. Mortality decreased over time for both valve types in patients with and without COPD. COPD increased in-hospital mortality among patients undergoing a biological SMVR.
Project description:BACKGROUND:The main aims of this study were to examine the incidence and in-hospital outcomes of mechanical and bioprosthetic surgical mitral valve replacement (SMVR) among patients with and without T2DM. METHODS:We performed a retrospective study using the Spanish National Hospital Discharge Database from 2001 to 2015. We included patients with SMVR codified in their discharge report. We grouped admissions by diabetes status. Propensity score matching (PSM) was used to compare outcomes of isolated SMVR. RESULTS:We identified 42,937 patients (16.41% with T2DM). Incidence rates of mechanical and bioprosthetic SMVR were higher among T2DM patients than among non-T2DM patients. In both groups of patients, the use of bioprosthetic SMVR increased over time. The use of mechanical valves remained stable among T2DM patients. In T2DM and non-T2DM patients with mechanical SMVR, in hospital mortality (IHM) and MACCE decreased significantly (p?<?0.001) from 2001 to 2015. T2DM patients had an overall 11.37% IHM, compared with 10.76% among non-T2DM patients (p?=?0.176). Regarding MACCE figures were 14.72% vs. 14.22% (p?=?0.320) after mechanical SMVR. Total crude IHM were 14.29% for T2DM patients and 15.13% for those without T2DM with bioprosthetic SMVR (p?=?0.165) and 18.22 vs. 19.64%, for a MACCE (p?=?0.185). Using PSM we found that the IHM and the MACCE of isolated SMVR did not differ significantly between patients with or without T2DM beside the type of valve replacement. Among T2DM patients, those who received bioprosthetic valves had higher IHM (14.29% vs. 11.37%; p?=?0.003) and a higher rate of MACCE (18.22% vs. 14.72%; p?=?0.001) than T2DM patients with mechanical SMVR. CONCLUSIONS:In Spain from 2001 to 2015, the incidence rates of hospitalization to undergo mechanical or bioprosthetic SMVR were higher among the population suffering T2DM than among the non-T2DM population. In both groups of patients the use of bioprosthetic SMVR increased over time and the use of mechanical valves remained stable in T2DM. T2DM patients have IHM and MACCE after mechanical and bioprosthetic SMVR which are not significantly different to those found among non-diabetic patients. Among T2DM patients, the crude IHM was significantly higher in those who received a bioprosthetic SMVR than those with mechanical SMVR.
Project description:OBJECTIVE:The aims of this study were to examine the incidence and in-hospital outcomes of surgical aortic valve replacement (SAVR) and to identify factors associated with in-hospital mortality (IHM) among patients according to the type of implanted valve used in SAVR. METHODS:We performed a retrospective study using the Spanish National Hospital Discharge Database, 2001-2015. We included patients who had SAVR listed as a procedure in their discharge report. RESULTS:We identified 86,578 patients who underwent SAVR (52.78% mechanical and 47.22% bioprosthetic). Incidence of SAVR coding increased significantly from 11.95 cases per 100,000 inhabitants in 2001 to 17.92 in 2015 (P<0.001). Age and comorbidities increased over time (P<0.001). There was a significant increase in the frequency of concomitant coronary artery bypass grafting (CABG) and in the use of pacemaker implantation. The use of mechanical SAVR decreased and the use of bioprosthetic valves increased over time. IHM decreased over time (from 8.13% in 2001-05 to 5.39% in 2011-15). Patients who underwent mechanical SAVR had higher IHM than those who underwent bioprosthetic SAVR (7.44% vs. 6%; P<0.05). Higher IHM rates were associated with advanced age, female sex, comorbidities, concomitant CABG, and the use of mechanical SAVR (OR 1.67; 95% CI 1.57-1.77). CONCLUSION:The number of SAVRs performed in Spain has increased since 2001. The use of mechanical SAVR has decreased and the use of bioprosthetic valves has increased over time. IHM has decreased over time for both types of valves and despite a concomitant increase in age and comorbidities of patients during the same period.
Project description:Background. ?Atypical mycobacteria, or nontuberculous mycobacteria (NTM), have been barely reported as infective endocarditis (IE) agents. Methods. ?From January 2010 to December 2013, cardiac valve samples sent to our laboratory as cases of blood culture-negative suspected IE were analyzed by 16S rDNA polymerase chain reaction (PCR). When positive for NTM, hsp PCR allowed species identification. Demographic, clinical, echocardiographic, histopathological, and Ziehl-Neelsen staining data were then collected. Results. ?Over the study period, 6 of 370 cardiac valves (belonging to 5 patients in 3 hospitals) were positive for Mycobacterium chelonae (n = 5) and Mycobacterium lentiflavum (n = 1) exclusively on bioprosthetic material. The 5 patients presented to the hospital for heart failure without fever 7.1-18.9 months (median 13.1 months) after biological prosthetic valve implantation. Echocardiography revealed paravalvular regurgitation due to prosthesis dehiscence in all patients. Histopathological examination of the explanted material revealed inflammatory infiltrates in all specimens, 3 of which were associated with giant cells. Gram staining and conventional cultures remained negative, whereas Ziehl-Neelsen staining showed acid-fast bacilli in all patients. Allergic etiology was ruled out by antiporcine immunoglobulin E dosages. These 5 cases occurred exclusively on porcine bioprosthetic material, revealing a statistically significant association between bioprosthetic valves and NTM IE (P < .001). Conclusions. ?The body of evidence confirmed the diagnosis of prosthetic IE. The statistically significant association between bioprosthetic valves and NTM IE encourages systematic Ziehl-Neelsen staining of explanted bioprosthetic valves in case of early bioprosthesis dysfunction, even without an obvious sign of IE. In addition, we strongly question the cardiac bioprosthesis conditioning process after animal sacrifice.
Project description:The choice of prosthetic heart valve type is largely dependent upon patient's age at implantation and on what, in his eyes, seems more pertinent: avoidance of complications associated with anticoagulation of mechanical valves or structural valve deterioration of bioprosthetic valves. Long lasting and new promising concepts such as transcatheter aortic valve implantation are promoting the use of bioprosthesis even in younger patients. However, it is up to the individual patient to decide.
Project description:Bioprosthetic valves for tricuspid valve replacement (TVR) have become increasingly popular in recent years, but mechanical valves remain valuable, particularly for the patients who want to avoid reoperation for bioprostheses malfunction. The aim of this study was to review our 10-year experience in adult patients who underwent TVR with the St. Jude Medical (SJM) valve. From 2005 to 2015, 265 TVRs with SJM valves were performed at our institution. The mean age at operation was 44.1?±?9.7 years, and 207 cases (78.1%) were female. The mean follow-up was 4.9?±?2.7 years. Preoperative atrial fibrillation was present in 199 cases (75.1%) and ascites in 26 (9.8%). Of all cases, 88.7% were characterized as New York Heart Association class III or IV. The hospital mortality was 6.4%. There were 9 deaths (3.8%) during late follow-up. The overall survival rates were 89.2%?±?2.2% at 5 years and 86.6%?±?2.9% at 10 years. The linearized rates of valve thrombosis and bleeding events were 0.8%/patient-year and 1.5%/patient-year, respectively. Three cases (1.3%) were reoperated due to prosthetic valve thrombosis. There was no reoperation for sperivalvular leakage and structural failure. The freedom from reoperation was 98.6%?±?0.8% at 5 years and 98.6%?±?0.8% at 10 years. The SJM valve in the tricuspid position is a reliable mechanical prosthesis with a low rate of valve thrombosis and reoperation. It is a reasonable choice for the patients who require mechanical valve replacement in the tricuspid position.
Project description:BACKGROUND:Bioprosthetic aortic valve degeneration is increasingly common, often unheralded, and can have catastrophic consequences. OBJECTIVES:The authors sought to assess whether 18F-fluoride positron emission tomography (PET)-computed tomography (CT) can detect bioprosthetic aortic valve degeneration and predict valve dysfunction. METHODS:Explanted degenerate bioprosthetic valves were examined ex vivo. Patients with bioprosthetic aortic valves were recruited into 2 cohorts with and without prosthetic valve dysfunction and underwent in vivo contrast-enhanced CT angiography, 18F-fluoride PET, and serial echocardiography during 2 years of follow-up. RESULTS:All ex vivo, degenerate bioprosthetic valves displayed 18F-fluoride PET uptake that colocalized with tissue degeneration on histology. In 71 patients without known bioprosthesis dysfunction, 14 had abnormal leaflet pathology on CT, and 24 demonstrated 18F-fluoride PET uptake (target-to-background ratio 1.55 [interquartile range (IQR): 1.44 to 1.88]). Patients with increased 18F-fluoride uptake exhibited more rapid deterioration in valve function compared with those without (annualized change in peak transvalvular velocity 0.30 [IQR: 0.13 to 0.61] vs. 0.01 [IQR: -0.05 to 0.16] ms-1/year; p < 0.001). Indeed 18F-fluoride uptake correlated with deterioration in all the conventional echocardiographic measures of valve function assessed (e.g., change in peak velocity, r = 0.72; p < 0.001). Each of the 10 patients who developed new overt bioprosthesis dysfunction during follow-up had evidence of 18F-fluoride uptake at baseline (target-to-background ratio 1.89 [IQR: 1.46 to 2.59]). On multivariable analysis, 18F-fluoride uptake was the only independent predictor of future bioprosthetic dysfunction. CONCLUSIONS:18F-fluoride PET-CT identifies subclinical bioprosthetic valve degeneration, providing powerful prediction of subsequent valvular dysfunction and highlighting patients at risk of valve failure. This technique holds major promise in the diagnosis of valvular degeneration and the surveillance of patients with bioprosthetic valves. (18F-Fluoride Assessment of Aortic Bioprosthesis Durability and Outcome [18F-FAABULOUS]; NCT02304276).
Project description:(1) Background: We examine trends (2001-2015) in the use of non-invasive ventilation (NIV) and invasive mechanical ventilation (IMV) among patients hospitalized for acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). (2) Methods: Observational retrospective epidemiological study, using the Spanish National Hospital Discharge Database. (3) Results: We included 1,431,935 hospitalizations (aged ?40 years) with an AE-COPD. NIV use increased significantly, from 1.82% in 2001-2003 to 8.52% in 2013-2015, while IMV utilization decreased significantly, from 1.39% in 2001-2003 to 0.67% in 2013-2015. The use of NIV + invasive mechanical ventilation (IMV) rose significantly over time (from 0.17% to 0.42%). Despite the worsening of clinical profile of patients, length of stay decreased significantly over time in all types of ventilation. Patients who received only IMV had the highest in-hospital mortality (IHM) (32.63%). IHM decreased significantly in patients with NIV + IMV, but it remained stable in those receiving isolated NIV and isolated IMV. Factors associated with use of any type of ventilatory support included female sex, lower age, and higher comorbidity. (4) Conclusions: We found an increase in NIV use and a decline in IMV utilization to treat AE-COPD among hospitalized patients. The IHM decreased significantly over time in patients who received NIV + IMV, but it remained stable in patients who received NIV or IMV in isolation.
Project description:Diseased aortic valves often require replacement, with over 30% of the current aortic valve surgeries performed in patients who will outlive a bioprosthetic valve. While many promising tissue-engineered valves have been created in the lab using the cell-seeded polymeric scaffold paradigm, none have been successfully tested long-term in the aortic position of a pre-clinical model. The high pressure gradients and dynamic flow across the aortic valve leaflets require engineering a tissue that has the strength and compliance to withstand high mechanical demand without compromising normal hemodynamics. A long-term preclinical evaluation of an off-the-shelf tissue-engineered aortic valve in the sheep model is presented here. The valves were made from a tube of decellularized cell-produced matrix mounted on a frame. The engineered matrix is primarily composed of collagen, with strength and organization comparable to native valve leaflets. In vitro testing showed excellent hemodynamic performance with low regurgitation, low systolic pressure gradient, and large orifice area. The implanted valves showed large-scale leaflet motion and maintained effective orifice area throughout the duration of the 6-month implant, with no calcification. After 24 weeks implantation (over 17 million cycles), the valves showed no change in tensile mechanical properties. In addition, histology and DNA quantitation showed repopulation of the engineered matrix with interstitial-like cells and endothelialization. New extracellular matrix deposition, including elastin, further demonstrates positive tissue remodeling in addition to recellularization and valve function. Long-term implantation in the sheep model resulted in functionality, matrix remodeling, and recellularization, unprecedented results for a tissue-engineered aortic valve.
Project description:Glutaraldehyde-fixed bovine pericardium is currently the most popular biomaterial utilized in the creation of bioprosthetic heart valves. However, recent studies indicate that glutaraldehyde fixation results in calcification and structural valve deterioration, limiting the longevity of bioprosthetic heart valves. Additionally, glutaraldehyde fixation renders the tissue incompatible with constructive recipient cellular repopulation, remodeling and growth. Use of unfixed xenogeneic biomaterials devoid of antigenic burden has potential to overcome the limitations of current glutaraldehyde-fixed biomaterials. Heart valves undergo billion cycles of opening and closing throughout the patient's lifetime. Therefore, understanding the response of unfixed tissues to cyclic loading is crucial to these in a heart valve leaflet configuration. In this manuscript we quantify the effect of cyclic deformation on cycle dependent strain, structural, compositional and mechanical properties of fixed and unfixed tissues. Glutaraldehyde-fixed bovine pericardium underwent marked cyclic dependent strain, resulting from significant changes in structure, composition and mechanical function of the material. Conversely, unfixed bovine pericardium underwent minimal strain and maintained its structure, composition and mechanical integrity. This manuscript demonstrates that unfixed bovine pericardium can withstand cyclic deformations equivalent to 6 months of in vivo heart valve leaflet performance.
Project description:BACKGROUND:There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR. METHODS:The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5?years to assess clinical outcomes of patients younger than 60?years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20-22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery. The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5?years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life. DISCUSSION:INDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60?years. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018).