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Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve)
Grossi, Eugene A; Patel, Nirav; Woo, Y Joseph; Goldberg, Judith D; Schwartz, Charles F; Subramanian, Valavanur; Feldman, Ted; Bourge, Robert; Baumgartner, Norbert; Genco, Christopher; Goldman, Scott; Zenati, Marco; Wolfe, J Alan; Mishra, Yugal K; Trehan, Naresh; Mittal, Sanjay; Shang, Shulian; Mortier, Todd J; Schweich, Cyril J Jr
OBJECTIVES: We sought to determine whether patients with functional mitral regurgitation (FMR) would benefit from ventricular reshaping by the Coapsys device (Myocor, Inc., Maple Grove, Minnesota). BACKGROUND: FMR occurs when ventricular remodeling impairs valve function. Coapsys is a ventricular shape change device placed without cardiopulmonary bypass to reduce FMR. It compresses the mitral annulus and reshapes the ventricle. We hypothesized that Coapsys for FMR would improve clinical outcomes compared with standard therapies. METHODS: RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) was a randomized, prospective, multicenter study of patients with FMR and coronary disease with core laboratory analysis. After enrollment, patients were stratified to the standard indicated surgery: either coronary artery bypass graft alone or coronary artery bypass graft with mitral valve repair. In each stratum, randomization was to either control (indicated surgery) or treatment (coronary artery bypass graft with Coapsys ventricular reshaping). RESULTS: The study was terminated when the sponsor failed to secure ongoing funding; 165 patients were randomized. Control and Coapsys both produced decreases in left ventricular (LV) end-diastolic dimension and MR at 2 years (p < 0.001); Coapsys provided a greater decrease in LV end-diastolic dimension (p = 0.021). Control had lower MR grades during follow-up (p = 0.01). Coapsys showed a survival advantage compared with control at 2 years (87% vs. 77%) (hazard ratio: 0.421; 95% confidence interval: 0.200 to 0.886; stratified log-rank test; p = 0.038). Complication-free survival (including death, stroke, myocardial infarction, and valve reoperation) was significantly greater with Coapsys at 2 years (85% vs. 71%) (hazard ratio: 0.372; 95% confidence interval: 0.185 to 0.749; adjusted log-rank test; p = 0.019). CONCLUSIONS: Analysis of RESTOR-MV indicates that patients with FMR requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and a significant decrease in major adverse outcomes. This trial validates the concept of the ventricular reshaping strategy in this subset of patients with heart failure. (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve [RESTOR-MV]; NCT00120276)
PMID: 21126639
ISSN: 1558-3597
CID: 115277
Reoperative valve surgery in the elderly: predictors of risk and long-term survival
Balsam, Leora B; Grossi, Eugene A; Greenhouse, David G; Ursomanno, Patricia; Deanda, Abelardo; Ribakove, Greg H; Culliford, Alfred T; Galloway, Aubrey C
BACKGROUND: Elderly patients requiring reoperative cardiac surgery for valve disease are considered high risk for immediate outcomes, but little is known about their long-term survival. It is often conjectured that medical therapy provides equivalent late survival in this population, which may dissuade both patient and surgeon from considering reoperation. We analyzed a cohort of such patients undergoing reoperative valve surgery to determine their long-term survival. METHODS: From 1992 through 2007, 363 patients aged 75 years or more underwent reoperative isolated valve surgery; 211 (58%) had aortic valve replacement and 152 (42%) had mitral valve surgery. Mean age was 80.5 years. Hospital outcomes were prospectively recorded. Survival from all-cause death was determined from the Social Security Death Index. RESULTS: Hospital mortality was 13.8% (12.8% for aortic and 15.1% for mitral valve operations; p = 0.52). Multivariable predictors of hospital death were New York Heart Association functional class III or IV heart failure (odds ratio = 3.19, p = 0.012), dialysis (odds ratio = 15.63, p = 0.003), and more than one reoperation (odds ratio = 2.59, p = 0.058). At 5 years, overall survival was 62% +/- 3% for all patients (66% +/- 4% for aortic and 56% +/- 4% for mitral valve patients). For aortic valve patients aged 80 years or more, 5-year survival was 60% +/- 0.6%. Life expectancy table analysis predicted a 5-year survival of 57% for an age-matched and sex-matched comparison group. CONCLUSIONS: Reoperative surgery for elderly patients with isolated aortic or mitral valve pathology is associated with excellent long-term survival, particularly when treating aortic valve disease. While in-hospital mortality is higher among the elderly than among younger patients, specific predictors of poor outcome can be identified preoperatively to risk stratify these patients
PMID: 20868814
ISSN: 1552-6259
CID: 113664
Invited commentary [Comment]
Grossi, Eugene A; Galloway, Aubrey C
PMID: 20732498
ISSN: 1552-6259
CID: 111979
Extended cardiac resection for obstructing pseudotumor due to ormond disease [Case Report]
Solomon, Brian; Grossi, Eugene A; Monteith, Duane; Donnino, Robert M; Srichai, Barbara; Dellis, Sophie L; Galloway, Aubrey C
A 60-year-old man presented with symptoms from an intracardiac mass. His medical history included retroperitoneal fibrosis (Ormond disease). Magnetic resonance imaging revealed an obstructing bilobular mass in the right atrium, located at the caval junction and extending intramurally into the atria, septum, and right ventricle. En bloc resection of the right atrium, interatrial septum, dome of the left atrium, vena cava, anterior tricuspid annulus, right coronary artery, and partial right ventriculectomy was completed with right ventricular repair, tricuspid valve replacement, and left and right atrial replacement with bovine pericardium. This lesion was a myofibroblastic tumor with the same histologic features as his retroperitoneal fibrosis
PMID: 20667367
ISSN: 1552-6259
CID: 111587
Analysis of the mitral coaptation zone in normal and functional regurgitant valves
Gogoladze, George; Dellis, Sophia L; Donnino, Robert; Ribakove, Greg; Greenhouse, David G; Galloway, Aubrey; Grossi, Eugene
BACKGROUND: Functional mitral regurgitation (FMR) is associated with leaflet displacement and tethering. Little is known about regional coaptation zones, including variations in coaptation length (CL) and contributions of anterior and posterior leaflets. Regional coaptation zones were analyzed in patients with normal mitral valves and with FMR. METHODS: Cardiac surgery patients underwent a three-dimensional transesophageal echocardiography. Four-dimensional volumetric datasets were acquired with Doppler interrogation. Offline analysis was performed. Orthogonal views were extracted in diastole and systole. Leaflet dimensions and coaptation distance and depth were examined for posterior and apical displacement of the coaptation zones. RESULTS: Twenty patients were analyzed (10 normal and 10 with 2 to 4+ FMR). Anterior leaflet CL was greater than posterior leaflet CL: 2.2+/-0.6 mm versus 0.9+/-0.3 mm in region 1, 3.2+/-0.7 mm versus 1.2+/-0.6 mm in region 2, and 1.8+/-0.4 mm versus 0.6+/-0.3 mm in region 3 (p<0.001). The FMR was associated with shorter leaflet CLs, with a mean anterior CL of 1.7+/-0.4 mm versus 3.1+/-0.4 mm (p=0.04), and a mean posterior CL of 0.7+/-0.3 mm versus 1.1+/-0.3 mm (p=0.03). The biggest difference in CLs was in A2-P2. Coaptation distance and depth were higher in the FMR group: 21.7+/-1.0 mm versus 17.9+/-1.0 mm (p=0.01), and 8.6+/-0.7 mm versus 5.0+/-0.7 mm (p<0.01). CONCLUSIONS: Mitral valve leaflet CL is asymmetric in normal valves, with anterior dominance. Functional mitral regurgitation is associated with a relocated coaptation zone, regional changes, and diminished coaptation. These data suggest an 'anterior leaflet reserve.' Posterior movement of the coaptation line compensates for annular dilation and presumed left ventricular enlargement in order to maintain competency until inadequate anterior leaflet CL occurs
PMID: 20338324
ISSN: 1552-6259
CID: 108926
Retrograde arterial perfusion, not incision location, significantly increases the risk of stroke in reoperative mitral valve procedures
Crooke, Gregory A; Schwartz, Charles F; Ribakove, Gregory H; Ursomanno, Patricia; Gogoladze, George; Culliford, Alfred T; Galloway, Aubrey C; Grossi, Eugene A
BACKGROUND: A recent report suggested that a thoracotomy approach for reoperative mitral valve (MV) procedures was associated with an equivalent mortality and an unacceptable risk of stroke. We assessed these outcomes in a single institution's experience. METHODS: From 1992 through 2007, 905 patients underwent reoperative MV procedures. The approach was a median sternotomy in 612 (67.6%), right anterior thoracotomy in 242 (26.7%), and left posterior thoracotomy in 51 (5.6%). Concomitant procedures in 411 patients (67.6%) included aortic procedures in 189, tricuspid procedures in 170, and coronary artery bypass grafting in 90. Hypothermic fibrillation was used in 65 patients. Logistic analysis was used to analyze risk factors and outcomes. RESULTS: Overall mortality was 12.7% (115 of 905), 6.7% (25 of 371) for first time isolated MV reoperations, and 10.1% (50 of 494) for all isolated MV operations. Overall incidence of stroke was 3.8% (34 of 905); 10.9% (9 of 82) with retrograde arterial perfusion and 3.0% (25 of 824) with central aortic cannulation (p < 0.001). For isolated MV reoperations, the incidence of stroke was 4.3% (21 of 494): 2.9% (7 of 241) for antegrade perfusion and 5.5% (14 of 253) for retrograde perfusion (p = 0.15). Risk factors for death were age (p < 0.001), renal failure (p < 0.01), tricuspid valve disease (p < 0.001), chronic obstructive pulmonary disease (odds ratio [OR], 2.9; 95% confidence interval [CI], 1.8 to 4.9; p < 0.001), emergency procedure (OR, 2.9; 95% CI, 1.2 to 6.9; p = 0.02), and ejection fraction less than 0.30 (OR, 1.9; 95% CI, 1.1 to 3.3, p = 0.018). Risk factors for stroke were retrograde perfusion (OR, 4.4; 95% CI, 1.8 to 10.3; p < 0.01) and ejection fraction below 0.30 (OR, 2.1; 95% CI, 0.9 to 5.0; p = 0.09). CONCLUSIONS: The incidence of stroke in reoperative MV operations is associated with perfusion strategies, not with the incisional approach. Reoperative sternotomy and minithoracotomy with central cannulation are both useful for reoperative MV procedures and are associated with low stroke rates
PMID: 20172117
ISSN: 0003-4975
CID: 107778
Ten-year results of folding plasty in mitral valve repair
Schwartz, Charles F; Grossi, Eugene A; Ribakove, Greg H; Ursomanno, Patricia; Mirabella, Meg; Crooke, Gregory A; Galloway, Aubrey C
BACKGROUND: Folding plasty (FP) for posterior mitral leaflet repair (PLR) is a technique that reduces the height of the repaired leaflet, closes the gap created by leaflet resection by rotation of residual leaflet, and reduces the need for localized annular plication. This report reviews late outcomes with FP repair. METHODS: From January 1994 to August 2006, 1,402 mitral valve repairs were performed for degenerative disease: 1,012 had PLR and 531 had FP technique. RESULTS: Overall hospital mortality was 2.4% (33 of 1,402 patients) and 1.3% (14 of 1,103 patients) for isolated mitral repair. For those patients with PLR, mortality for all procedures was 1.5% (15 of 1,012 patients) and 1.2% (11 of 891 patients) for isolated PLR repairs. Mortality was 0.9% (5 of 531 patients) for FP. In the last 5 years FP was used in 64.4% of PLR, compared with 35.6% of PLR in the prior era (p < 0.001). The 10-year actuarial freedom from mitral reoperation was 89%; 10-year freedom from reoperation or recurrent severe mitral insufficiency was 86% with FP and 87% without (p = 0.76). The 5-year freedom from reoperation or recurrent severe insufficiency was 89% when an annuloplasty device was used and 62% when not used (p < 0.001). CONCLUSIONS: Repair of posterior leaflet prolapse with FP is straightforward and durable. In our experience, FP is currently used for two thirds of PLR. These data also confirm that valve repair for degenerative disease should include an annuloplasty device for optimal late results
PMID: 20103326
ISSN: 1552-6259
CID: 106376
A decade of minimally invasive mitral repair: long-term outcomes
Galloway, Aubrey C; Schwartz, Charles F; Ribakove, Greg H; Crooke, Gregory A; Gogoladze, George; Ursomanno, Patricia; Mirabella, Margaret; Culliford, Alfred T; Grossi, Eugene A
BACKGROUND: Short-term results with minimally invasive approaches for mitral valve repair in degenerative disease have been encouraging, with potential for diminishing blood loss and hospital length of stay. Little is known, however, about the long-term efficacy of this approach. This report analyzes a single institution's results over 12 years with minimally invasive mitral repair. METHODS: Since 1986, 3,057 patients have undergone mitral valve repair; 1,601 patients had degenerative disease and are the subject of this report. Minimally invasive mitral repair was done in 1071 patients with a right anterior minithoracotomy and direct vision. Clinical and echocardiographic variables were entered prospectively into a database. RESULTS: Hospital mortality was 2.2% for all patients (36 of 1601); 1.3% for isolated minimally invasive (9 of 712) and 1.3% (3 of 223) for isolated sternotomy mitral valve repair; and 3.6% (24 of 666) for valve repair plus a concomitant cardiac procedure. For isolated valve repair, 8-year freedom from reoperation was 91% +/- 2% for sternotomy and 95% +/- 1% for minimally invasive (p = 0.24), and 8-year freedom from reoperation or severe recurrent insufficiency was 90% +/- 2% for sternotomy and 93% +/- 1% for minimally invasive (p = 0.30). Eight-year freedom from all valve-related complications was 86% +/- 3% for sternotomy and 90% +/- 2% for minimally invasive (p = 0.14). CONCLUSIONS: These data indicate that long-term outcomes after minimally invasive mitral repair are excellent and equivalent to results achieved with sternotomy. In view of previously published advantages of short-term morbidity, minimally invasive approaches to mitral valve surgery deserve expanded use
PMID: 19766803
ISSN: 1552-6259
CID: 102502
Correlation between plasma osteopontin levels and aortic valve calcification: potential insights into the pathogenesis of aortic valve calcification and stenosis
Yu, Pey-Jen; Skolnick, Adam; Ferrari, Giovanni; Heretis, Katherine; Mignatti, Paolo; Pintucci, Giuseppe; Rosenzweig, Barry; Diaz-Cartelle, Juan; Kronzon, Itzhak; Perk, Gila; Pass, Harvey I; Galloway, Aubrey C; Grossi, Eugene A; Grau, Juan B
OBJECTIVE: The inflammatory process of aortic stenosis involves the differentiation of aortic valve myofibroblasts into osteoblasts. Osteopontin, a proinflammatory glycoprotein, both stimulates differentiation of myofibroblasts and regulates the deposition of calcium by osteoblasts. Osteopontin levels are increased in patients with such conditions as end-stage renal disease, ectopic calcification, and autoimmune disease. We hypothesized that increased plasma osteopontin levels might be associated with the presence of aortic valve calcification and stenosis. METHODS: Venous blood from volunteers older than 65 years undergoing routine echocardiographic analysis or aortic valve surgery for aortic stenosis was collected. Plasma osteopontin levels were measured by means of enzyme-linked immunosorbent assay. The presence of aortic stenosis was defined as an aortic valve area of less than 2.0 cm(2). Aortic valve calcification was assessed by using a validated echocardiographic grading system (1, none; 2, mild; 3, moderate; 4, severe). Comparisons were performed with nonpaired t tests. RESULTS: Aortic stenosis was present in 23 patients (mean age, 78 years) and was absent in 7 patients (mean age, 72 years). Aortic valve calcification scores were 3.5 +/- 0.6 and 1.3 +/- 0.5 in patients with and without aortic stenosis, respectively (P < .001). Patients with no or mild aortic valve calcification had lower osteopontin levels compared with patients with moderate or severe aortic valve calcification (406.1 +/- 165.8 vs 629.5 +/- 227.5 ng/mL, P = .01). Similarly, patients with aortic stenosis had higher osteopontin levels compared with patients without aortic stenosis (652.2 +/- 218.7 vs 379.7 +/- 159.9 ng/mL, P < .01). CONCLUSION: Increased levels of plasma osteopontin are associated with the presence of aortic valve calcification and stenosis. These findings suggest that osteopontin might play a functional role in the pathogenesis of calcific aortic stenosis
PMID: 19577079
ISSN: 1097-685x
CID: 100629
Invited commentary [Comment]
Grossi, Eugene A
PMID: 19231376
ISSN: 1552-6259
CID: 96503