Phase II Multicenter Clinical Trial of Pulmonary Metastasectomy and Isolated Lung Perfusion with Melphalan in Patients with Resectable Lung Metastases

IntroductionThe 5-year overall survival rate of patients undergoing complete surgical resection of pulmonary metastases (PM) from colorectal cancer (CRC) and sarcoma remains low (20–50%). Local recurrence rate is high (48–66%). Isolated lung perfusion (ILuP) allows the delivery of high-dose locoregional chemotherapy with minimal systemic leakage to improve local control.MethodsFrom 2006 to 2011, 50 patients, 28 male, median age 57 years (15–76), with PM from CRC (n = 30) or sarcoma (n = 20) were included in a phase II clinical trial conducted in four cardiothoracic surgical centers. In total, 62 ILuP procedures were performed, 12 bilaterally, with 45 mg of melphalan at 37°C, followed by resection of all palpable PM. Survival was calculated according to the Kaplan–Meier method.ResultsOperative mortality was 0%, and 90-day morbidity was mainly respiratory (grade 3: 42%, grade 4: 2%). After a median follow-up of 24 months (3–63 mo), 18 patients died, two without recurrence. Thirty patients had recurrent disease. Median time to local pulmonary progression was not reached. The 3-year overall survival and disease-free survival were 57% ± 9% and 36% ± 8%, respectively. Lung function data showed a decrease in forced expiratory volume in 1 second and diffusing capacity of the alveolocapillary membrane of 21.6% and 25.8% after 1 month, and 10.4% and 11.3% after 12 months, compared with preoperative values.ConclusionCompared with historical series of PM resection without ILuP, favorable results are obtained in terms of local control without long-term adverse effects. These data support the further investigation of ILuP as additional treatment in patients with resectable PM from CRC or sarcoma

Tricuspid annuloplasty prevents right ventricular dilatation and progression of tricuspid regurgitation in patients with tricuspid annular dilatation undergoing mitral valve repair

Objectives: We hypothesize that concomitant tricuspid annuloplasty in patients with tricuspid annular dilatation who undergo mitral valve repair could prevent progression of tricuspid regurgitation and right ventricular remodeling. Methods: In 2002, 80 patients underwent mitral valve repair. Concomitant tricuspid annuloplasty was performed in 13 patients with grade 3 or 4 tricuspid regurgitation. In 2004, 102 patients underwent mitral valve repair. Concomitant tricuspid annuloplasty was performed in 21 patients with grade 3 or 4 tricuspid regurgitation and in 43 patients with an echocardiographically determined tricuspid annular diameter of 40 mm or greater. Patients underwent transthoracic echocardiographic analysis preoperatively and at the 2-year follow-up. Results: In the 2002 cohort right ventricular dimensions did not decrease (right ventricular long axis, 69 ± 7 vs 70 ± 8 mm; right ventricular short axis, 29 ± 7 vs 30 ± 7 mm); tricuspid regurgitation grade and gradient remained unchanged. In the 2004 cohort right ventricular reverse remodeling was observed (right ventricular long axis, 71 ± 6 vs 69 ± 9 mm; right ventricular short axis, 29 ± 5 vs 27 ± 5 mm; P < .0001); tricuspid regurgitation diminished (1.6 ± 1.0 vs 0.9 ± 0.6, P < .0001), and transtricuspid gradient decreased (28 ± 13 vs 23 ± 15 mm Hg, P = .021). Subanalysis of the 2002 cohort showed that in 23 patients without grade 3 or 4 tricuspid regurgitation but baseline tricuspid annular dilatation, the degree of tricuspid regurgitation was worse at the 2-year follow-up. Moreover, this caused right ventricular dilatation. Subanalysis of the 2004 cohort demonstrated reverse right ventricular remodeling and decreased tricuspid regurgitation in 43 patients with preoperative tricuspid annular dilatation who underwent tricuspid annuloplasty. Conclusions: Concomitant tricuspid annuloplasty during mitral valve repair should be considered in patients with tricuspid annular dilatation despite the absence of important tricuspid regurgitation at baseline because this improves echocardiographic outcome

Preoperative left ventricular dimensions predict reverse remodeling following restrictive mitral annuloplasty in ischemic mitral regurgitation

Objective: Ischemic mitral regurgitation can be treated with a restrictive mitral annuloplasty, with or without coronary revascularization. In this study, the extent of reverse remodeling of the left ventricle following this strategy is assessed, as well as the factors that influence it. Methods: Eighty-seven consecutive patients with ischemic mitral regurgitation and a mean ejection fraction of 32±10% underwent restrictive mitral annuloplasty (downsizing by two ring sizes, median ring size 26), with additional coronary revascularization in 75 patients. All underwent transthoracic echocardiography 18 months after surgery to assess residual mitral regurgitation, mitral valve gradient and left ventricular end-systolic and end-diastolic dimensions. Univariate and multivariate analysis was performed to identify predictors for reverse remodeling, defined as a 10% reduction in left ventricular dimension. Receiver-operating characteristic analysis was used to identify cut-off values for preoperative left ventricular dimensions in predicting reverse remodeling. Results: Early mortality was 8.0% (seven patients, three non-cardiac), late mortality was 7.5% (six patients, four non-cardiac). There were two reoperations (redo annuloplasty), and four readmissions for heart failure. At 29 months follow-up, NYHA class improved from 3.0±0.9 to 1.3±0.5 (P<0.01). Mitral regurgitation grade decreased from 3.1±0.5 to 0.6±0.6 at 18 months, left ventricular end-systolic dimension decreased from 52±8 to 44±11 mm (P<0.01), and end-diastolic dimension from 64±8 to 58±10 mm (P<0.01). Multivariate analysis identified preoperative left ventricular end-diastolic dimension as the single best factor in predicting occurrence of reverse remodeling. For end-systolic dimension, 51 mm was the optimal cut-off value to predict reverse remodeling (specificity and sensitivity 81%, area under curve 0.85); for end-diastolic dimension, the cut-off value was 65 mm (specificity and sensitivity 89%, area under curve 0.92). Conclusions: Stringent restrictive mitral annuloplasty with or without revascularization provides excellent clinical results with acceptable mortality. At 18 months follow-up, there is no significant residual mitral regurgitation. Reverse remodeling occurs in the majority of patients, but is limited by preoperative left ventricular dimensions. In patients with a left ventricular end-diastolic dimension exceeding 65 mm, additional surgical procedures are necessary to try and obtain reverse remodeling in this subgroup

Twenty-year experience with stentless biological aortic valve and root replacement: Informing patients of risks and benefits

OBJECTIVES: The aim of this study was to provide predictive data on the performance of the Freestyle stentless bioprosthesis that can be used to support and improve the shared decision-making process of prosthetic valve choice for aortic valve replacement. METHODS: Between 1993 and 2014, 604 patients received the Freestyle stentless bioprosthesis (143 subcoronary, 58 root inclusion and 403 full-root replacement). Perioperative data were collected retrospectively, and follow-up data were collected prospectively from 2015. Follow-up was 96% complete (median 4.3 years), with 114 (19%) patients having a follow-up period exceeding 10 years. A competing risks regression model was developed to predict the probability of mortality, structural valve deterioration (SVD) and reoperation for other causes than SVD. RESULTS: The median age of patients was 64 years, 91 (15%) patients had undergone previous aortic valve replacement and 351 (58%) underwent concomitant procedures. The 15-year probability of SVD, reoperation for other causes and death were 16.9%, 8.1% and 47.7%, respectively. Linearized occurrence rates for prosthesis endocarditis, thromboembolic events and bleeding were 0.5%, 0.9% and 0.1% per patient-year, respectively. The constructed predictive model, including age, renal function and implantation technique as significant covariates, had good to fair predictive performance up to 19 years. CONCLUSIONS: The Freestyle stentless bioprosthesis is an efficient prosthesis for aortic valve replacement or root replacement, with low incidences of SVD and valve-related events at long-term follow-up. The predictive model designed in this study can be used to fully inform patients about their expected individual trajectory after implantation of this prosthesis. This improves the shared decision-making process between patients and clinicians