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Early Structural Deterioration of a Sutureless Bioprosthetic Aortic Valve [Case Report]

Cinelli, Michael; Schwartz, Leonard; Spagnola, Jonathan; Gulkarov, Iosif; Rosell, Frank; Lackey, Adam; Imam, Mohammed; Schwartz, Charles
Sutureless bioprosthetic valves such as the Sorin Perceval S valve (SPV) have been used in patients with aortic stenosis that require surgical aortic valve replacement (SAVR). These prostheses have been marketed on the basis of their rapid implantation techniques with avoidance of sutures and reduced aortic cross-clamp times. We report a case of an early failure of a SPV nearly 4 years after implantation in a 58-year-old woman who was low-risk. While the patient's symptoms initially improved with SAVR with a sutureless bioprosthetic valve, they progressively worsened as the valve degraded, and the leaflets became increasingly calcified and stenotic ultimately, requiring reoperative SAVR with a St. Jude mechanical valve. This case raises the issue of the lack of much-needed data describing the long-term durability and hemodynamic performance of these valves, particularly in a low-risk patient with excellent functional status. We hope to shed further insight into the lack of long-term studies on patients with SPV to assess their longevity and long-term effectiveness, as well as elucidation of possible prevention and monitoring of these potential complications. The use of newer generation prostheses, although attractive for their ease of implantation, potentially carries higher long-term risk due to shorter durability leading to reintervention to address valve deterioration. This is especially true in low-risk patients who are young and active. Cardiology and cardiothoracic surgery societies need to develop a universal registry with follow-up of all valves in order to track and study the durability of these valves, and to evaluate for incidence of known and potential complications.
PMCID:7092772
PMID: 32256918
ISSN: 1923-2829
CID: 5328772

Percutaneous embolization of patent intercostal artery causing persistent type II endoleak and sac enlargement of thoracoabdominal aneurysm 2 years after hybrid repair

Mussa, Firas F; Maldonado, Thomas S; Schwartz, Charles F
PMID: 22818123
ISSN: 0022-5223
CID: 178222

Regional changes in coaptation geometry after reduction annuloplasty for functional mitral regurgitation

Greenhouse, David G; Dellis, Sophia L; Schwartz, Charles F; Loulmet, Didier F; Yaffee, David W; Galloway, Aubrey C; Grossi, Eugene A
BACKGROUND: While it is known that band annuloplasty for functional mitral regurgitation (FMR) improves leaflet coaptation, the effect on regional coaptation geometry has not previously been well defined. We used three-dimensional transesophageal echocardiography (3D-TEE) to analyze the regional effects of semirigid band annuloplasty on annular geometry and leaflet coaptation zones of patients with FMR. METHODS: Sixteen patients with severe FMR underwent a semirigid band annuloplasty. Intraoperative full volume 3D-TEE datasets were acquired pre valve and post valve repair. Offline analysis assessed annular dimensions and regional coaptation zone geometry. The regions were defined as R1 (A1-P1), R2 (A2-P2), and R3 (A3-P3); coaptation distance, coaptation depth, and coaptation length were measured in each region. Differences were analyzed with repeated measures within a general linear model. RESULTS: Band annuloplasty decreased mitral regurgitation grade from 3.7 to 0.1 (scale 0 to 4). Annular septolateral dimension (p < 0.01) and coaptation distance (p < 0.01) decreased significantly in all regions. Likewise, anterior and posterior leaflet coaptation lengths increased in all regions (p < 0.01 and p = 0.05, respectively), with region 2 showing the greatest increase (p = 0.01). Changes in coaptation depth were not significant. CONCLUSIONS: Semirigid band annuloplasty for FMR produces significant regional remodeling of leaflet coaptation zones, with region 2 showing the greatest increase in leaflet coaptation length. This regional analysis of annular geometry and leaflet coaptation creates a framework to better understand the mechanisms of surgical success or failure of annuloplasty for FMR.
PMID: 22542067
ISSN: 0003-4975
CID: 167798

Evolution of operative techniques and perfusion strategies for minimally invasive mitral valve repair [Editorial]

Grossi, Eugene A; Loulmet, Didier F; Schwartz, Charles F; Ursomanno, Patricia; Zias, Elias A; Dellis, Sophia L; Galloway, Aubrey C
OBJECTIVE: Perfusion strategies and operative techniques for minimally invasive mitral valve repair have evolved over time. During the past decade, our institution's approach has progressed from a port access platform with femoral perfusion to predominantly a central aortic cannulation through a right anterior minithoracotomy incision. We analyzed this institutional experience to evaluate the impact of approach on patient outcomes. METHODS: Between 1995 and 2007, 1282 patients (mean age, 59.3 years; range, 18-99 years) underwent first-time, isolated mitral valve repair using a minimally invasive technique. Patient demographics included peripheral vascular disease (3.2%), chronic obstructive pulmonary disease (8.3%), atherosclerotic aorta (6.5%), cerebrovascular disease (4.3%), and ejection fraction less than 30% (4.3%). Retrograde perfusion was performed in 394 (30.7%) of all patients and endoaortic balloon occlusion in 373 (29.1%); the operative technique was a right anterior minithoracotomy in 1264 (98.6%) and left posterior minithoracotomy in 18 (1.4%). The etiology of mitral disease was degenerative in 73.2%, functional in 20.6%, and rheumatic in 2.4%. Data were collected prospectively using the New York State Cardiac Surgery Report System and a customized minimally invasive surgery data form. Logistic analysis was used to evaluate risk factors and outcomes; operative experience was divided into tertiles. RESULTS: Overall hospital mortality was 2.0% (25/1282). Mortality was 1.1% (10/939) for patients with degenerative etiology and 0.4% (3/693) for patients younger than 70 years of age with degenerative valve disease. Risk factors for death were advanced age (P = .007), functional etiology (P = .010; odds ratio [OR] = 3.3), chronic obstructive pulmonary disease (P = .013; OR = 3.4), peripheral vascular disease (P = .014; OR = 4.2), and atherosclerotic aorta (P = .03; OR = 2.8). Logistic risk factors for neurologic events were advanced age (P = .02), retrograde perfusion (P = .001; OR = 3.8), and emergency procedure (P = .01; OR = 66.6). Interaction modeling revealed that the only significant risk factor for neurologic event was the use of retrograde perfusion in high-risk patients with aortic disease (P = .04; OR = 8.5). Analysis of successive tertiles during this 12-year experience revealed a significant decrease in the use of retrograde arterial perfusion (89.6%, 10.4%, and 0.0%; P < .001) and endoaortic balloon occlusion (89.3%, 10.7%, and 0%; P < .001). The overall frequency of postoperative neurologic events was 2.3% (30/1282) and decreased from 4.7% in the first tertile to 1.2% in the second and third tertiles (P < .001). CONCLUSIONS: Central aortic cannulation through a right anterior minithoracotomy for mitral valve repair allows excellent outcomes in patients with a broad spectrum of comorbidities and has become our preferred approach for most patients undergoing mitral valve repair. Retrograde arterial perfusion is associated with an increased risk of stroke in patients with severe peripheral vascular disease and should be reserved for select patients without significant atherosclerosis.
PMID: 22285326
ISSN: 0022-5223
CID: 162028

Minimally invasive valve surgery with antegrade perfusion strategy is not associated with increased neurologic complications

Grossi, Eugene A; Loulmet, Didier F; Schwartz, Charles F; Solomon, Brian; Dellis, Sophia L; Culliford, Alfred T; Zias, Elias; Galloway, Aubrey C
BACKGROUND: A Society of Thoracic Surgeons' publication recently associated 'minimally invasive' approaches with increased neurologic complications; this proposed association was questionable due to imprecise definitions. To critically reevaluate this issue, we reviewed a large minimally invasive valve experience with robust definitions. METHODS: From November 1995 to January 2007, 3,180 isolated, non-reoperative valve operations were performed; 1,452 (45.7%) were aortic replacements and 1,728 (54.3%) were mitral valve procedures. Surgical approach was standard sternotomy (28%) or minimally invasive technique (72%). Antegrade arterial perfusion was used in 2,646 (83.2%) patients and retrograde perfusion in 534 (16.8%). Aortic clamping was direct in 83.4%, with endoclamp in 16.4% and no clamp in 0.2%. Patients were prospectively followed in a proprietary database and the New York State Cardiac Surgery Reporting System (mandatory, government audited). A neurologic event was defined as a permanent deficit, a transient deficit greater than 24 hours, or a new lesion on cerebral imaging. RESULTS: Hospital mortality for aortic valve replacement was 4.0% (sternotomy [5.1%] versus minimally invasive [3.4%] p = 0.13); for mitral procedures it was 2.4% (sternotomy [4.8%] versus minimally invasive [1.8%] p = 0.001). Multivariate analysis revealed that age, female gender, renal disease, ejection fraction less than 0.30, chronic obstructive pulmonary disease, and emergent operation were risk factors for mortality. Stroke occurred in 71 patients (2.2%) (sternotomy [2.1%] versus minimally invasive [2.3%] p = 0.82). Multivariate analysis of neurologic events revealed that cerebrovascular disease, emergency procedure, no-clamp, and retrograde perfusion were risk factors. In patients 50 years old or younger (n = 662), retrograde perfusion had no significant impact on neurologic events (1.6% vs 1.1%, p = 0.57). CONCLUSIONS: A minimally invasive approach with antegrade perfusion does not result in increased neurologic complications. Retrograde perfusion, however, is associated with increased neurologic risk in older patients
PMID: 21958781
ISSN: 1552-6259
CID: 138113

Outcomes of coronary artery bypass grafting and reduction annuloplasty for functional ischemic mitral regurgitation: A prospective multicenter study (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve)

Grossi, Eugene A; Woo, Y Joseph; Patel, Nirav; Goldberg, Judith D; Schwartz, Charles F; Subramanian, Valavanur A; Genco, Christopher; Goldman, Scott M; Zenati, Marco A; Wolfe, J Alan; Mishra, Yugal K; Trehan, Naresh
OBJECTIVE: Functional ischemic mitral regurgitation is a complication of ventricular remodeling; standard therapy is reduction annuloplasty and coronary artery bypass grafting. Unfortunately, outcomes are retrospective and contradictory. We report a multicenter study that documents the outcomes of reduction annuloplasty for functional ischemic mitral regurgitation. METHODS: Twenty-one centers randomized 75 patients to the coronary artery bypass grafting + reduction annuloplasty subgroup that was the control arm of the Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve trial. Entry criteria included patients requiring revascularization, patients with severe or symptomatic moderate functional ischemic mitral regurgitation, an ejection fraction 25% or greater, a left ventricular end-diastolic dimension 7.0 cm or less, and more than 30 days since acute myocardial infarction. All echocardiograms were independently scored by a core laboratory. Reduction annuloplasty was achieved by device annuloplasty. Two patients underwent immediate intraoperative conversion to a valve replacement because reduction annuloplasty was unable to correct mitral regurgitation; as-treated results are presented. RESULTS: Thirty-day mortality was 4.1% (3/73). Patients received an average of 2.8 bypass grafts. Mean follow-up was 24.6 months. Mitral regurgitation was reduced from 2.6 +/- 0.8 preoperatively to 0.3 +/- 0.6 at 2 years. Freedom from death or valve reoperation was 78% +/- 5% at 2 years. There was significant improvement in ejection fraction and New York Heart Association class with reduction of left ventricular end-diastolic dimension. Cox regression analyses suggested that increasing age (P = .001; hazard ratio, 1.16 per year; 95% confidence interval, 1.06-1.26) and renal disease (P = .018; hazard ratio, 3.48; 95% confidence interval, 1.25-9.72) were associated with decreased survival. CONCLUSIONS: Coronary artery bypass grafting + reduction annuloplasty for functional ischemic mitral regurgitation predictably reduces mitral regurgitation and relieves symptoms. This treatment of moderate to severe mitral regurgitation is associated with improved indices of ventricular function, improved New York Heart Association class, and excellent freedom from recurrent mitral insufficiency. Although long-term prognosis remains guarded, this multicenter study delineates the intermediate-term benefits of such an approach
PMID: 21168015
ISSN: 1097-685x
CID: 116214

Ventricular Reshaping For Repair of Functional Mitral Regurgitation has Persistent Survival Advantage Over Traditional Annuloplasty Repair: A Single Center Analysis [Meeting Abstract]

Grossi, Eugene; Schwartz, Charles; Dellis, Sophia; Ursomanno, Patricia; Balsam, Leora; Culliford, Alfred, III; Zias, Elias; Loulmet, Didier; Schweich, CJ; Mortier, Todd; Galloway, Aubrey
ISI:000299738704353
ISSN: 0009-7322
CID: 1797492

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

Female Patients Undergoing TEVAR May Have an Increased Risk of Postoperative Spinal Cord Ischemia

Shah, Tejas R; Maldonado, Thomas; Bauer, Stephen; Cayne, Neal S; Schwartz, Charles F; Mussa, Firas; Adelman, Mark A; Rockman, Caron
Background: There is a paucity of literature regarding thoracic endovascular aneurysm repair (TEVAR) in women. We report our institutional experience with TEVAR. Methods: Retrospective chart review was performed from 2004 to 2008. TEVAR was performed in 59 patients; 29 (49%) were female. Results: Mean age was 73.5 years. Mean thoracic aortic aneurysm (TAA) diameter was larger for women (5.9 cm vs 4.7 cm). A trend toward an increase in paraplegia was noted in women, 10.3% vs 4.8%. This may be related to increase in length of aortic coverage in women, 18.2 cm vs 15.2 cm (P < .05). Conclusion: TEVAR in women is safe and effective. The length of aortic coverage is greater in women, which may be related to larger aneurysms and more diffuse disease. This may be associated with a concerning increase in postoperative paraplegia. Women undergoing TEVAR should be considered for prophylactic maneuvers to prevent spinal cord ischemia (SCI), including minimizing length of coverage
PMID: 20519281
ISSN: 1938-9116
CID: 110870

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