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BACKGROUND: Equipoise exists between the use of leaflet resection and preservation for surgical repair of mitral regurgitation caused by prolapse. We therefore performed a randomized, controlled trial comparing these 2 techniques, particularly in regard to functional mitral stenosis. METHODS: One hundred four patients with degenerative mitral regurgitation surgically amenable to either leaflet resection or preservation were randomized at 7 specialized cardiac surgical centers. Exclusion criteria included anterior leaflet or commissural prolapse, as well as a mixed cause for mitral valve disease. Using previous data, we determined that a sample size of 88 subjects would provide 90% power to detect a 5-mm Hg difference in mean mitral valve gradient at peak exercise, assuming an SD of 6.7 mm with a 2-sided test with α=5% and 10% patient attrition. The primary end point was the mean mitral gradient at peak exercise 12 months after repair. RESULTS: Patient age, proportion who were female, and Society of Thoracic Surgeons risk score were 63.9±10.4 years, 19%, and 1.4±2.8% for those who were assigned to leaflet resection (n=54), and 66.3±10.8 years, 16%, and 1.9±2.6% for those who underwent leaflet preservation (n=50). There were no perioperative deaths or conversions to replacement. At 12 months, moderate mitral regurgitation was observed in 3 subjects in the leaflet resection group and 2 in the leaflet preservation group. The mean transmitral gradient at 12 months during peak exercise was 9.1±5.2 mm Hg after leaflet resection and 8.3±3.3 mm Hg after leaflet preservation (P=0.43). The participants had similar resting peak (8.3±4.4 mm Hg versus 8.4±2.6 mm Hg; P=0.96) and mean resting (3.2±1.9 mm Hg versus 3.1±1.1 mm Hg; P=0.67) mitral gradients after leaflet resection and leaflet preservation, respectively. The 6-minute walking distance was 451±147 m for those in the leaflet resection versus 481±95 m for the leaflet preservation group (P=0.27). CONCLUSIONS: In this adequately powered randomized trial, repair of mitral prolapse with either leaflet resection or leaflet preservation was associated with similar transmitral gradients at peak exercise at 12 months postoperatively. These data do not support the hypothesis that a strategy of leaflet resection (versus preservation) is associated with a risk of functional mitral stenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT02552771.
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral/cirurgia , Prolapso da Valva Mitral/cirurgia , Estenose da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Few studies have measured frailty as a potential reason for foregoing transcatheter aortic valve replacement (TAVR) in older adults with severe aortic stenosis (AS). This study sought to determine the impact of frailty and other clinician-cited reasons on restricted mean survival time (RMST). METHODS: An analysis of the McGill Frailty Registry was conducted between 2014 and 2018 at the McGill University Health Center Structural Valve Clinic. Consecutive nonsurgical patients referred for TAVR were included. In those that underwent balloon aortic valvuloplasty or medical management, the primary clinician-cited reason for foregoing TAVR was codified. Vital status was ascertained at 1 year and analysed using RMST and Kaplan-Meier analyses. RESULTS: The study consisted of 373 patients with a mean age of 82.4 years, of which 233 underwent TAVR and 140 did not. Patients who did not undergo TAVR were more likely to be nonagenarians, with left ventricular dysfunction, chronic kidney disease, dementia, disability, depression, malnutrition, and frailty. The primary clinician-cited reason was: comorbidity in 34%, frailty in 23%, procedural feasibility and risks in 16%, and mild or unrelated symptoms in 27%. Compared to the TAVR group, 1-year RMST was reduced by 2.0 months in the medical management group (95% CI 1.2, 2.7) and by 1.1 months in the valvuloplasty group (95% CI -0.2, 2.5). CONCLUSIONS: Patients with severe AS referred for TAVR may never undergo the procedure on the basis of comorbidity, frailty, procedural issues, and symptoms. The best treatment decision is one that follows from multi-disciplinary assessment encompassing frailty.
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Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Idoso Fragilizado , Fragilidade/diagnóstico , Avaliação Geriátrica , Substituição da Valva Aórtica Transcateter , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Tomada de Decisão Clínica , Comorbidade , Feminino , Fragilidade/mortalidade , Estado Funcional , Humanos , Masculino , Seleção de Pacientes , Valor Preditivo dos Testes , Quebeque , Encaminhamento e Consulta , Sistema de Registros , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidadeRESUMO
AKI after cardiac surgery is associated with mortality, prolonged hospital length of stay, use of dialysis, and subsequent CKD. We evaluated the effects of THR-184, a bone morphogenetic protein-7 agonist, in patients at high risk for AKI after cardiac surgery. We conducted a randomized, double-blind, placebo-controlled, multidose comparison of the safety and efficacy of perioperative THR-184 using a two-stage seamless adaptive design in 452 patients between 18 and 85 years of age who were scheduled for nonemergent cardiac surgery requiring cardiopulmonary bypass and had recognized risk factors for AKI. The primary efficacy end point was the proportion of patients who developed AKI according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. The proportion of patients who developed AKI within 7 days of surgery was similar in THR-184 treatment groups and placebo groups (range, 74%-79%; P=0.43). Prespecified secondary end point analysis did not show significant differences in the severity of AKI stage (P=0.53) or the total duration of AKI (P=0.44). A composite of death, dialysis, or sustained impaired renal function by day 30 after surgery did not differ between groups (range, 11%-20%; P=0.46). Safety-related outcomes were similar across all treatment groups. In conclusion, compared with placebo, administration of perioperative THR-184 through a range of dose exposures failed to reduce the incidence, severity, or duration of AKI after cardiac surgery in high-risk patients.
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Injúria Renal Aguda/etiologia , Injúria Renal Aguda/prevenção & controle , Proteína Morfogenética Óssea 7/agonistas , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Oligopeptídeos/administração & dosagem , Injúria Renal Aguda/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Oligopeptídeos/farmacologia , Período Perioperatório , Índice de Gravidade de Doença , Falha de TratamentoRESUMO
INTRODUCTION: Few bioprosthetic valved conduits for aortic root surgery are commercially available. Long-term Warfarin therapy (mechanical), potential root calcification (xeno- or homograft valves), and the need for additional ascending aorta grafts are concerns associated with currently used valved conduits. A simplified, self-assembled bioroot conduit comprising currently available materials that facilitates future intervention and exhibits advantages of a bioprosthesis was used. METHODS: From November 2015 to January 2017, 17 consecutive patients underwent urgent or elective aortic root surgery. A bioroot conduit, constructed using 28 or 30 mm of sinus of Valsalva Gelweave tube graft and a 3 to 5 mm smaller bioprosthetic Trifecta valve sewn into the sinus of Valsalva base, was preconstructed in the operating room before sternotomy. The size of the valved conduit was based on the distal ascending aorta or proximal arch and not aortic annular dimension. The bioroot was sutured to the native aortic annulus at the level of the bottom skirt of the Valsalva graft without contacting the sewing cuff of the bioprosthetic valve. RESULTS: All patients survived the operation and were discharged home without long-term anticoagulation therapy. The mean age was 65 ± 12 years, and 13 patients were male. The cardiopulmonary bypass duration was 169 ± 84 minutes, and the cross-clamp (XC) duration was 110 ± 32 minutes. The operation was elective in 12 patients, urgent/emergent in five, and redo in three. CONCLUSION: A simplified self-assembled bioroot Bentall conduit is appropriate for aortic root reconstruction. Use of a patient-tailored valved conduit will not prolong the cardiac ischemic time and will facilitate future valve replacement.
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Aorta/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese Vascular/métodos , Implante de Prótese de Valva Cardíaca/métodos , Seio Aórtico/cirurgia , Adulto , Idoso , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
OBJECTIVE: The mechanisms underlying the pathogenesis of aortic valve calcification remain unclear. With accumulating evidence demonstrating that valve calcification recapitulates bone development, the crucial roles of noncanonical Wnt ligands WNT5a, WNT5b, and WNT11 in osteogenesis make them critical targets in the study of aortic valve calcification. APPROACH AND RESULTS: Using immunohistochemistry, real-time qPCR, Western blotting, and tissue culture, we examined the tissue distribution of WNT5a, WNT5b, and WNT11 in noncalcified and calcified aortic valves and their effects on human aortic valve interstitial cells (HAVICs). Only focal strong immunostaining for WNT5a was seen in and around areas of calcification. Abundant immunostaining for WNT5b and WNT11 was seen in inflammatory cells, fibrosis, and activated myofibroblasts in areas of calcified foci. There was significant correlation between WNT5b and WNT11 overall staining and presence of calcification, lipid score, fibrosis, and microvessels (P<0.05). Real-time qPCR and Western blotting revealed abundant expression of both Wnts in stenotic aortic valves, particularly in bicuspid valves. Incubation of HAVICs from noncalcified valves with the 3 noncanonical Wnts significantly increased cell apoptosis and calcification (P<0.05). Treatment of HAVICs with the mitogen-activated protein kinase-38ß and GSK3ß inhibitors significantly reduced their mineralization (P<0.01). Raman spectroscopy identified the inorganic phosphate deposits as hydroxyapatite and showed a significant increase in hydroxyapatite deposition in HAVICs in response to WNT5a and WNT11 (P<0.05). Similar crystallinity was seen in the deposits found in HAVICs treated with Wnts and in calcified human aortic valves. CONCLUSIONS: These findings suggest a potential role for noncanonical Wnt signaling in the pathogenesis of aortic valve calcification.
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Estenose da Valva Aórtica/metabolismo , Valva Aórtica/metabolismo , Valva Aórtica/patologia , Calcinose/metabolismo , Osteogênese , Proteínas Wnt/metabolismo , Via de Sinalização Wnt , Proteína Wnt-5a/metabolismo , Idoso , Idoso de 80 Anos ou mais , Fosfatase Alcalina/metabolismo , Estenose da Valva Aórtica/genética , Estenose da Valva Aórtica/patologia , Apoptose , Calcinose/genética , Calcinose/patologia , Células Cultivadas , Durapatita/metabolismo , Feminino , Fibrose , Regulação da Expressão Gênica , Glicogênio Sintase Quinase 3 beta/metabolismo , Humanos , Imuno-Histoquímica , Masculino , Pessoa de Meia-Idade , Proteínas Quinases Ativadas por Mitógeno/metabolismo , Osteogênese/genética , Fosforilação , Análise Espectral Raman , Proteínas Wnt/genética , Proteína Wnt-5a/genéticaRESUMO
BACKGROUND: Prolonged controlled mechanical ventilation (CMV) in humans and experimental animals results in diaphragm fibre atrophy and injury. In animals, prolonged CMV also triggers significant declines in diaphragm myofibril contractility. In humans, the impact of prolonged CMV on myofibril contractility remains unknown. The objective of this study was to evaluate the effects of prolonged CMV on active and passive human diaphragm myofibrillar force generation and myofilament protein levels. METHODS AND RESULTS: Diaphragm biopsies were obtained from 13 subjects undergoing cardiac surgery (control group) and 12 brain-dead organ donors (CMV group). Subjects in each group had been mechanically ventilated for 2-4 and 12-74â h, respectively. Specific force generation of diaphragm myofibrils was measured with atomic force cantilevers. Rates of force development (Kact), force redevelopment after a shortening protocol (Ktr) and relaxation (Krel) in fully activated myofibrils (pCa(2+)=4.5) were calculated to assess myosin cross-bridge kinetics. Myofilament protein levels were measured with immunoblotting and specific antibodies. Prolonged CMV significantly decreased active and passive diaphragm myofibrillar force generation, Kact, Ktr and Krel. Myosin heavy chain (slow), troponin-C, troponin-I, troponin-T, tropomyosin and titin protein levels significantly decreased in response to prolonged CMV, but no effects on α-actin, α-actinin or nebulin levels were observed. CONCLUSIONS: Prolonged CMV in humans triggers significant decreases in active and passive diaphragm myofibrillar force generation. This response is mediated, in part, by impaired myosin cross-bridge kinetics and decreased myofibrillar protein levels.
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Diafragma/metabolismo , Diafragma/fisiopatologia , Cardiopatias , Contração Muscular , Miofibrilas/metabolismo , Respiração Artificial/efeitos adversos , Actinina/metabolismo , Actinas/metabolismo , Adulto , Idoso , Idoso de 80 Anos ou mais , Biópsia , Estudos de Casos e Controles , Conectina/metabolismo , Diafragma/patologia , Feminino , Cardiopatias/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Proteínas Musculares/metabolismo , Atrofia Muscular/metabolismo , Miofibrilas/patologia , Cadeias Pesadas de Miosina/metabolismo , Fatores de Risco , Fatores de Tempo , Doadores de Tecidos , Tropomiosina/metabolismo , Troponina C/metabolismo , Troponina I/metabolismo , Troponina T/metabolismoRESUMO
AIMS: A comprehensive description of transcatheter heart valve (THV) failure has not been performed. We undertook a systematic review to investigate the aetiology, diagnosis, management, and outcomes of THV failure. METHODS AND RESULTS: The systematic review was performed in accordance with the PRISMA guidelines using EMBASE, MEDLINE, and Scopus. Between December 2002 and March 2014, 70 publications reported 87 individual cases of transcatheter aortic valve implantation (TAVI) failure. Similar to surgical bioprosthetic heart valve failure, we observed cases of prosthetic valve endocarditis (PVE) (n = 34), structural valve failure (n = 13), and THV thrombosis (n = 15). The microbiological profile of THV PVE was similar to surgical PVE, though one-quarter had satellite mitral valve endocarditis, and surgical intervention was required in 40% (75% survival). Structural valve failure occurred most frequently due to leaflet calcification and was predominantly treated by redo-THV (60%). Transcatheter heart valve thrombosis occurred at a mean 9 ± 7 months post-implantation and was successfully treated by prolonged anticoagulation in three-quarters of cases. Two novel causes of THV failure were identified: late THV embolization (n = 18); and THV compression (n = 7) following cardiopulmonary resuscitation (CPR). These failure modes have not been reported in the surgical literature. Potential risk factors for late THV embolization include low prosthesis implantation, THV undersizing/underexpansion, bicuspid, and non-calcified anatomy. Transcatheter heart valve embolization mandated surgery in 80% of patients. Transcatheter heart valve compression was noted at post-mortem in most cases. CONCLUSION: Transcatheter heart valves are susceptible to failure modes typical to those of surgical bioprostheses and unique to their specific design. Transcatheter heart valve compression and late embolization represent complications previously unreported in the surgical literature.
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Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Falha de Prótese/efeitos adversos , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Anti-Infecciosos/uso terapêutico , Embolia/etiologia , Endocardite/tratamento farmacológico , Endocardite/etiologia , Endocardite/prevenção & controle , Feminino , Oclusão de Enxerto Vascular/etiologia , Infecções por Bactérias Gram-Positivas/diagnóstico , Infecções por Bactérias Gram-Positivas/tratamento farmacológico , Histoplasmose/diagnóstico , Histoplasmose/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de RiscoRESUMO
Objective: Ischemic mitral regurgitation (MR) is generally associated with very poor outcomes and disappointing results, despite a seemingly perfect initial repair and optimal revascularization. We previously published our intermediate-term results of posterior leaflet augmentation without follow-up extending beyond 4 years. Our objective is to assess long-term durability of the repair, survival, and the causes of late mortality. Methods: Ninety-one patients with severe (4+) Carpentier Type IIIb ischemic MR underwent repair in a single center between 2003 and 2022 by method of posterior leaflet extension using a patch of bovine pericardium and a true-sized remodeling annuloplasty ring, with or without surgical revascularization. Serial echocardiography was performed over the years to ascertain valve competence and degree of ventricular remodeling, in addition to telephone follow-up and chart reviews. Results: The average age of patients was 67 ± 9.6 years. Mean follow-up was 8 ± 5 years with some extending to almost 20 years. One-, 5-, and 10-year freedom from recurrent significant MR, characterized as moderate or severe MR, was 98.6%, 85.5%, and 71.3%, respectively. Thirty-day mortality was 6.5%. One-, 5-, and 10-year survival was 85.5%, 64.4%, and 43.3%, respectively. Of all the mortalities, only 17.5% were proven to be directly cardiac related. Conclusions: The suggested repair technique offers satisfactory long-term outcomes with minimal residual regurgitation in surviving patients when used in context of ischemic MR. Despite durable repair, we have discovered that poor long-term survival is not directly related to cardiovascular causes.
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Background: This study sought to compare characteristics and outcomes of patients who underwent surgical aortic valve replacement (SAVR) after being referred to a heart team (HT), to those of patients referred directly for SAVR. Methods: An analysis of patients who underwent SAVR from 2015 to 2020 was conducted. Patients were categorized into 3 groups, as follows: (i) H-HT: patients referred to the HT from 2015 to 2017 (historical cohort); (ii) C-HT: patients referred to the HT from 2018 to 2020 (contemporary cohort); and (iii) No-HT: patients referred directly to cardiac surgery from 2018 to 2020. Two subanalyses were performed: H-HT vs C-HT patients, and C-HT vs No-HT patients. The primary outcome was a composite of in-hospital mortality, prolonged intubation, reoperation, sternal wound infection, and stroke. Results: This study consisted of 288 patients, distributed as follows: H-HT (n = 45); C-HT (n = 51); and No-HT (n = 192). The mean ages of H-HT, C-HT, and No-HT patients was 76.3 ± 6.9 years, 73.3 ± 7.6 years, and 69.6 ± 9.7 years, respectively (P = 0.0001). H-HT, C-HT, and No-HT patients had average Society of Thoracic Surgeons scores of 4.8 ± 2.2, 3.2 ± 1.6, and 4.2 ± 2 (P = 0.002), respectively. The composite outcome rate was more than 5 times higher among H-HT patients compared to that among the C-HT patients (20.0 vs 3.9%, P = 0.02), and was numerically higher in No-HT compared to C-HT patients (13.0 vs 3.9%, P = 0.07). Conclusions: Referral to an HT appears to be primarily driven by higher chronological age rather than overall risk profile. Patients assessed by the HT prior to undergoing SAVR have a low incidence of complications, comparable to that among patients referred directly to cardiac surgery.
Contexte: Cette étude visait à comparer les caractéristiques et le devenir de patients ayant subi une chirurgie de remplacement valvulaire aortique après avoir été orientés vers une équipe de cardiologie (EC) à ceux de patients orientés directement en chirurgie cardiaque pour une chirurgie de remplacement valvulaire aortique. Méthodologie: Une analyse portant sur les patients ayant subi une chirurgie de remplacement valvulaire aortique de 2015 à 2020 a été effectuée. Les patients ont été divisés en trois groupes, à savoir : i) CH-POEC : patients orientés vers une EC de 2015 à 2017 (cohorte historique); ii) CC-POEC : patients orientés vers une EC de 2018 à 2020 (cohorte contemporaine); iii) PODC : patients orientés directement en chirurgie cardiaque de 2018 à 2020. Deux sous-analyses ont été effectuées : CH-POEC vs CC-POEC, et CC-POEC vs PODC. Le paramètre d'évaluation principal était composite. Il comprenait la mortalité hospitalière, l'intubation prolongée, la réopération, l'infection de la plaie sternale et l'accident vasculaire cérébral. Résultats: L'étude regroupait 288 patients, répartis comme suit : CH-POEC, n = 45; CC-POEC, n = 51; PODC, n = 192. L'âge moyen dans les groupes CH-POEC, CC-POEC et PODC était respectivement de 76,3 ± 6,9 ans, 73,3 ± 7,6 ans et 69,6 ± 9,7 ans (P = 0,0001). Les groupes CH-POEC, CC-POEC et PODC présentaient des indices STS (Society of Thoracic Surgeons) moyens de 4,8 ± 2,2, 3,2 ± 1,6 et 4,2 ± 2 (P = 0,002), respectivement. Le taux composite d'événements au sein du groupe CH-POEC était plus de cinq fois supérieur à celui noté dans le groupe CC-POEC (20,0 vs 3,9 %, P = 0,02). Il était aussi plus élevé au sein du groupe PODC comparativement au groupe CC-POEC (13,0 vs 3,9 %, P = 0,07). Conclusions: Le principal motif d'orientation vers une EC semble être un âge chronologique avancé plutôt que le profil de risque global. Chez les patients qui sont évalués par une EC avant de subir une chirurgie de remplacement valvulaire aortique, l'incidence de complications est faible et comparable à celle observée chez les patients orientés directement en chirurgie cardiaque.
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OBJECTIVE: Intraoperative predictors of functional mitral valve (MV) stenosis after surgical repair of mitral regurgitation (MR) caused by prolapse remain poorly characterised. This study evaluated the effect of annuloplasty size on postoperative MV haemodynamics during exercise and evaluated predictors of MV hemodynamics. METHODS: 104 patients were randomly assigned to leaflet resection or preservation for surgical repair of MR in the Canadian Mitral Research Alliance CardioLink-2 study. In this post hoc analysis, we compared MV haemodynamics between the two surgical groups and examined the relationship between annuloplasty size and MV haemodynamics 1 year after repair in the combined groups. Echocardiograms were performed at baseline and intraoperatively. Exercise transthoracic echocardiography was performed 1 year postoperatively. Multivariable linear regression analysis was used to identify predictors of exercise MV gradients at follow-up. RESULTS: Mean age of participants was 65±10 years, and 83% were male. Median annuloplasty size was 34 (IQR 32-36). Dividing by the median, 48 (46%) had annuloplasty size of <34 mm and 56 (54%) had ≥34 mm. Mean and peak exercise gradients at 1 year were 11±5 mm Hg and 22±9 mm Hg in <34, and 6±3 mm Hg and 14±5 mm Hg in ≥34 (p<0.001). Rate of residual MR was similar in both groups. In multivariable analyses, annuloplasty size of ≥34 mm was associated with lower mean and peak exercise gradients at 12 months, after adjustment for repair type, age, sex, heart rate and body surface area (ß -4.1, 95% CI -6 to -3, p<0.001, and ß -7 95% CI -10 to -4, p<0.001, respectively). Intraoperative mean and peak MV gradients by transesophageal echocardiography independently predicted mean and peak resting and exercise gradients at follow-up (p<0.001). Similar results were obtained in both leaflet resection and preservation. CONCLUSION: Annuloplasty size of ≥34 mm is associated with a 4 and 7 mm Hg reduction in mean and peak exercise MV gradients, respectively, 1 year post MV repair regardless of the repair strategy used. Intraoperative TEE MV gradients predict exercise MV gradients 1 year post repair. TRIAL REGISTRATION NUMBER: NCT02552771.
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Anuloplastia da Valva Mitral , Insuficiência da Valva Mitral , Estenose da Valva Mitral , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Anuloplastia da Valva Mitral/efeitos adversos , Anuloplastia da Valva Mitral/métodos , Canadá , Hemodinâmica , Estenose da Valva Mitral/complicações , Resultado do TratamentoRESUMO
BACKGROUND: Predischarge elevated mean mitral gradients (>5 mm Hg) may occur after repair for degenerative mitral regurgitation. We sought to identify risk factors associated with elevated gradients and to evaluate its impact on functional outcomes at 12 months in this subanalysis of the Canadian Mitral Research Alliance CardioLink-2 trial. METHODS: One hundred four patients with degenerative mitral regurgitation undergoing mitral repair were randomized to either a leaflet resection or preservation strategy. Logistic regression was used to identify risk factors associated with an elevated gradient. Functional outcomes at 12 months were compared between participants with and without elevated gradients. RESULTS: Elevated gradients was identified in 15 participants (14.4%), which was not significantly different based on allocation to each repair strategy (P = .10). Patients with elevated gradients were more likely to be women (odds ratio [OR], 4.28; 95% confidence interval [CI], 1.29-14.19; P = .02) and to have a lower preoperative hemoglobin level (OR, 0.93; 95% CI, 0.89-0.98; P = .01) and smaller intercommissural diameter (OR, 0.86; 95% CI, 0.76-0.97; P = .02) and mitral annuloplasty size (OR, 0.71; 95% CI, 0.57-0.87; P = .001). The ratio of intercommissural diameter-to-annuloplasty size was similar between those with and without elevated gradients (both 0.8 ± 0.1, P = .69). At 12 months those with elevated gradients had a worse New York Heart Association functional status (P = .0001), lower peak oxygen saturation in exercise test (P = .01), smaller body weight-walk distance product (P = .02), and higher Borg scale (P = .01) in the 6-minute walk test. CONCLUSIONS: Female gender, smaller mitral anatomy sizes, and lower preoperative hemoglobin levels were associated with postoperative elevated mitral gradients, which was in turn were associated with reduced functional status. Further research is warranted to investigate these potential risk factors.
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Implante de Prótese de Valva Cardíaca , Anuloplastia da Valva Mitral , Insuficiência da Valva Mitral , Humanos , Feminino , Masculino , Insuficiência da Valva Mitral/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Canadá/epidemiologia , Anuloplastia da Valva Mitral/efeitos adversos , Fatores de Risco , Hemoglobinas , Resultado do TratamentoRESUMO
INTRODUCTION: Acute kidney injury (AKI) is a common complication after cardiac surgery (CS) and is associated with adverse short-term and long-term outcomes. Alpha-1-microglobulin (A1M) is a circulating glycoprotein with antioxidant, heme binding and mitochondrial-protective mechanisms. RMC-035 is a modified, more soluble, variant of A1M and has been proposed as a novel targeted therapeutic protein to prevent CS-associated AKI (CS-AKI). RMC-035 was considered safe and generally well tolerated when evaluated in four clinical phase 1 studies. METHODS AND ANALYSIS: This is a phase 2, randomised, double-blind, adaptive design, parallel group clinical study that evaluates RMC-035 compared with placebo in approximately 268 cardiac surgical patients at high risk for CS-AKI. RMC-035 is administered as an intravenous infusion. In total, five doses will be given. Dosing is based on presurgery estimated glomerular filtration rate (eGFR), and will be either 1.3 or 0.65 mg/kg.The primary study objective is to evaluate whether RMC-035 reduces the incidence of postoperative AKI, and key secondary objectives are to evaluate whether RMC-035 improves postoperative renal function compared with placebo. A blinded interim analysis with potential sample size reassessment is planned once 134 randomised subjects have completed dosing. An independent data monitoring committee will evaluate safety and efficacy data at prespecified intervals throughout the trial. The study is a global multicentre study at approximately 30 sites. ETHICS AND DISSEMINATION: The trial was approved by the joint ethics committee of the physician chamber Westfalen-Lippe and the University of Münster (code '2021-778 f-A') and subsequently approved by the responsible ethics committees/relevant institutional review boards for the participating sites. The study is conducted in accordance with Good Clinical Practice, the Declaration of Helsinki and other applicable regulations. Results of this study will be published in a peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: NCT05126303.
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Injúria Renal Aguda , COVID-19 , Procedimentos Cirúrgicos Cardíacos , Humanos , SARS-CoV-2 , Método Duplo-Cego , Injúria Renal Aguda/etiologia , Injúria Renal Aguda/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ensaios Clínicos Fase II como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: Gastrointestinal (GI) complications of cardiovascular surgery, particularly bleeding, occur frequently. OBJECTIVE: To determine factors that predict upper GI bleeding (UGIB) after cardiac surgery to improve prognostication and, thus, outcomes. METHODS: The present case-control study reviewed institutional records spanning 2002 to 2005 for consecutive patients who developed in-hospital UGIB following cardiovascular surgery. Each case was matched to two to three controls for age, sex and date of hospital admission. Demographics, pharmacotherapy (including use of in-hospital acid suppression), endoscopic findings and outcomes were recorded. After adjustment for possible confounders, including Parsonnet score and demographic parameters, conditional logistic regression analysis identified independent significant predictors of the subsequent development of UGIB. RESULTS: The study population consisted of 131 cases (mean [± SD] age 68.8±10.2 years, 69.5% male, mean Parsonnet score 24.6±14.2) and 387 matched controls (mean age 68.8±10.8 years, 70.0% male, mean Parsonnet score 20.9±14.2). UGIB events occurred a mean of 10.3±7.7 days after cardiac surgery. Duration of mechanical ventilation (OR 3.01 [95% CI 1.44 to 6.28]), elevation of international normalized ratio (OR 1.91 [95% CI 1.31 to 2.78]) and occurrence of Clostridium difficile colitis before bleeding (OR 3.15 [95% CI 1.19 to 8.36]) were independent risk factors. Use of histamine type 2 receptor antagonists (H2RAs) (OR 0.65 [95% CI 0.38 to 1.12]) or proton pump inhibitors (PPIs) (OR 0.60 [95% CI 0.27 to 1.32]) demonstrated trends toward protecting against UGIB after cardiac surgery. CONCLUSIONS: GI bleeding events occurred approximately 10 days after cardiac surgery in patients with a complicated postoperative course. Significant predictors of subsequent bleeding included increased duration of mechanical ventilation and elevation of international normalized ratio; routine acid suppression with PPIs should be considered in such patients. C difficile colitis also significantly predicted UGIB, and H2RAs should be considered for acid suppression. Neither H2RAs nor PPIs were effective in preventing UGIB, although the small number of patients limits definitive conclusions regarding the role of acid suppression.
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Procedimentos Cirúrgicos Cardíacos , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/prevenção & controle , Hemorragia Pós-Operatória/etiologia , Hemorragia Pós-Operatória/prevenção & controle , Idoso , Estudos de Casos e Controles , Distribuição de Qui-Quadrado , Feminino , Gastroscopia , Humanos , Modelos Logísticos , Masculino , Fatores de Risco , Resultado do TratamentoRESUMO
AIM: The aim of this study was to determine the midterm functional quality of life in octogenarians after open valvular surgery. METHODS: One hundred and eighty-five consecutive patients above age 80 had valvular surgery with or without coronary artery bypass grafting (CABG). Using the Karnofsky Performance score and Barthel Index, patients were evaluated for functional autonomy, living disposition, and leisure activity by a single telephone interview. Subgroup analysis was performed on the 49 cases of isolated aortic valve replacement (AVR). RESULTS: Mean age of octogenarians undergoing valvular surgery was 82.7 years (range 80 to 92 years). Actuarial survival at one and three years was 71% and 59%, respectively, for the entire group, compared to 84% and 71%, respectively, for isolated AVRs. After a mean follow-up of 38 months there were 110 survivors (59.5%). Among survivors, 66% were autonomous, 26% semiautonomous, and 8% deemed dependent. Seventy-two percent were living at home, 19% in a residence, and 9% in a supervised nursing facility. Over 90% of patients pursued leisure activities in the social, cognitive, and physical domains. CONCLUSIONS: Valvular surgery in high-risk octogenarians, can be performed with acceptable mortality rates, and provide patients with functional autonomy and an excellent quality of life.
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Atividades Cotidianas , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/reabilitação , Qualidade de Vida , Fatores Etários , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/reabilitação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Vida Independente , Entrevistas como Assunto , Atividades de Lazer , Masculino , Readmissão do Paciente/estatística & dados numéricos , Autonomia Pessoal , Instituições Residenciais , Estudos Retrospectivos , Risco , Resultado do TratamentoRESUMO
AIMS: High-risk cardiac surgery is commonly complicated by low cardiac output syndrome (LCOS), which is associated with high mortality. There are limited data derived from multi-centre studies with adjudicated endpoints describing factors associated with LCOS and its downstream clinical outcomes. METHODS AND RESULTS: The Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial evaluated prophylactic levosimendan vs. placebo in patients with a reduced ejection fraction undergoing coronary artery bypass grafting (CABG) and/or valve surgery. We conducted a pre-specified analysis on LCOS, which was characterized by a four-part definition. We constructed a multivariable logistical regression model to evaluate risk factors associated with LCOS and performed Cox proportional hazards modelling to determine the association of LCOS with 90-day mortality. A total of 186 (22%) of 849 patients in the LEVO-CTS trial developed LCOS. The factors most associated with a higher adjusted risk of LCOS were pre-operative ejection fraction [odds ratio (OR) 1.26; 95% confidence interval (CI): 1.08-1.46 per 5% decrease] and age (OR 1.13; 95% CI: 1.04-1.24 per 5-year increase), whereas isolated CABG surgery (OR 0.44, 95% CI: 0.31-0.64) and levosimendan use (OR 0.65; 95% CI: 0.46-0.92) were associated with a lower risk of LCOS. Patients with LCOS had worse outcomes, including renal replacement therapy at 30-day (10 vs. 1%) and 90-day mortality (16 vs. 3%, adjusted hazard ratio of 5.04, 95% CI: 2.66-9.55). CONCLUSION: Low cardiac output syndrome is associated with a high risk of post-operative mortality in high-risk cardiac surgery.
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Procedimentos Cirúrgicos Cardíacos , Piridazinas , Disfunção Ventricular Esquerda , Humanos , Baixo Débito Cardíaco/epidemiologia , Baixo Débito Cardíaco/etiologia , Baixo Débito Cardíaco/tratamento farmacológico , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Cardiotônicos/uso terapêutico , Hidrazonas , Complicações Pós-Operatórias/etiologia , Piridazinas/uso terapêutico , Simendana/efeitos adversos , Disfunção Ventricular Esquerda/etiologiaRESUMO
Background The Essential Frailty Toolset (EFT) was shown to be easy to use and predictive of adverse events in patients undergoing aortic valve replacement procedures. The objective of this study was to evaluate the EFT in patients undergoing coronary artery bypass grafting procedures. Methods and Results The McGill Frailty Registry prospectively included patients ≥60 years of age undergoing urgent or elective isolated coronary artery bypass grafting between 2011 and 2018 at 2 hospitals. The preoperative EFT was scored 0 to 5 points as a function of timed chair rises, Mini-Mental Status Examination, serum albumin, and hemoglobin. The primary outcome was all-cause mortality assessed by Cox proportional hazards regression. The cohort consisted of 500 patients with a mean age of 71.4 ± 6.4 years, of which 27% presented with acute coronary syndromes requiring urgent surgery. The mean EFT was 1.3 ± 1.1 points, 132 (26%) were nonfrail, 298 (60%) were prefrail, and 70 (14%) were frail. Over a median follow-up of 4.0 years, 78 deaths were observed. In nonfrail, prefrail, and frail patients, survival at 1 year was 98%, 95%, and 91%, and at 5 years was 89%, 83%, and 63% (P<0.001). After adjustment, each incremental EFT point was associated with a hazard ratio of 1.28 (95% CI, 1.05-1.56) and frail patients had a 3-fold increase in all-cause mortality. Conclusions The EFT is a pragmatic and highly prognostic tool to assess frailty and guide decisions for coronary artery bypass grafting in older adults. Furthermore, the EFT may be actionable through targeted interventions such as cardiac rehabilitation and nutritional optimization.
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Ponte de Artéria Coronária , Doença das Coronárias , Fragilidade , Risco Ajustado/métodos , Idoso , Comorbidade , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/métodos , Doença das Coronárias/epidemiologia , Doença das Coronárias/cirurgia , Procedimentos Cirúrgicos Eletivos/métodos , Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Serviços Médicos de Emergência/métodos , Serviços Médicos de Emergência/estatística & dados numéricos , Feminino , Fragilidade/diagnóstico , Fragilidade/mortalidade , Fragilidade/fisiopatologia , Fragilidade/psicologia , Estado Funcional , Avaliação Geriátrica/métodos , Hemoglobinas/análise , Humanos , Masculino , Testes de Estado Mental e Demência , Mortalidade , Prognóstico , Albumina Sérica/análiseRESUMO
BACKGROUND: Management of severe ischemic mitral regurgitation remains difficult with disappointing early and intermediate-term surgical results of valve repair. METHODS AND RESULTS: Forty-four patients with severe (4+) Carpentier type IIIb ischemic mitral regurgitation underwent mitral valve repair, with or without surgical revascularization, by posterior leaflet extension with a patch of bovine pericardium and a remodeling annuloplasty. Serial echocardiography was performed preoperatively, intraoperatively, and postoperatively to assess mitral valve competence. The postoperative functional status of patients was assessed. The average Parsonnet score was 38+/-13. Thirty-day mortality was 11%, and late mortality was 14%. Mean follow-up was 38 months. The actuarial freedom from moderate or severe recurrent mitral regurgitation was 90% at 2 years, whereas 90% of patients were in New York Heart Association class I at 2 years. CONCLUSIONS: Posterior leaflet extension with annuloplasty of the mitral valve for severe type IIIb ischemic regurgitation is a safe, effective method that provides good early and intermediate-term competence of the mitral valve and therefore good functional status.
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Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Infarto do Miocárdio/complicações , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Bioprótese , Ecocardiografia Doppler em Cores , Feminino , Seguimentos , Humanos , Anastomose de Artéria Torácica Interna-Coronária , Masculino , Pessoa de Meia-Idade , Valva Mitral/ultraestrutura , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/etiologia , Infarto do Miocárdio/cirurgia , Complicações Pós-Operatórias/mortalidade , Próteses e Implantes , Estudos Retrospectivos , Técnicas de Sutura , Resultado do Tratamento , Valva Tricúspide/cirurgia , Função Ventricular EsquerdaRESUMO
PURPOSE: Combined heart and liver transplant is a rare procedure to treat end-stage cardiac and liver disease. First performed during cardiopulmonary bypass and anticoagulation, subsequent concerns about increased bleeding changed the strategy to performing liver implantation following separation from cardiopulmonary bypass. Considering the overall decrease in transfusion requirements during liver transplant and the potential benefits to the transplanted heart to remain on cardiopulmonary bypass during liver implantation, we revised the strategy for combined heart and liver transplant. We report the clinical course of four consecutive patients who underwent this procedure in our institution. CLINICAL FEATURES: Patient 1 was a 53-yr-old male with familial hypertrophic cardiomyopathy and congestive cirrhosis. Patient 2 was a 57-yr-old male with hypertrophic restrictive cardiomyopathy and congestive cirrhosis. Patient 3 was a 48-yr-old male with dilated cardiomyopathy and hepatitis B cirrhosis. Patient 4 was a 57-yr-old male with ischemic cardiomyopathy and congestive cirrhosis. Each patient underwent combined heart and liver transplant, with liver implantation performed during cardiopulmonary bypass and anticoagulation. Estimated blood loss ranged from 1,000 to 3,000 mL. Intraoperative transfusion included 2-5 U of packed red blood cells, 4-12 U of fresh frozen plasma, 0-20 U of cryoprecipitate, and 5-23 U of platelets. All patients remain well 25-38 months after surgery. CONCLUSION: Combined heart and liver transplant during cardiopulmonary bypass is a viable strategy that may confer benefit to this unique type of patient.
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Ponte Cardiopulmonar/métodos , Insuficiência Cardíaca/cirurgia , Transplante de Coração/métodos , Falência Hepática/cirurgia , Transplante de Fígado/métodos , Gasometria , Terapia Combinada , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
Mitral regurgitation (MR) is a known complication of transcatheter aortic valve replacement (TAVR). We report a case of a 90-year-old man with severe symptomatic aortic stenosis who underwent elective TAVR. The procedure was complicated by severe functional MR from left ventricular stunning and dilatation caused by hypotension throughout the procedure. An Impella CP (Abiomed, Inc, Danvers, MA) was inserted to unload the left ventricle and decrease its size with subsequent improvement in MR severity, which was sustained after Impella CP removal. In conclusion, we present the first case of successful management of post-TAVR severe functional MR with an Impella CP.