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Keith A Horvath,
Michael A Acker,
Helena Chang,
Emilia Bagiella,
Peter K Smith,
Alexander Iribarne,
Irving L Kron,
Pamela Lackner, Michael Argenziano,
Deborah D Ascheim,
Annetine C Gelijns,
Robert E Michler,
Danielle Van Patten,
John D Puskas,
Karen O'Sullivan,
Dorothy Kliniewski,
Neal O Jeffries,
Patrick T O'Gara,
Alan J Moskowitz,
Eugene Blackstone
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ABSTRACT: Cardiac surgery is the largest consumer of blood products in medicine; although believed life saving, transfusion carries substantial adverse risks. This study characterizes the relationship between transfusion and risk of major infection after cardiac surgery. In all, 5,158 adults were prospectively enrolled to assess infections after cardiac surgery. The most common procedures were isolated coronary artery bypass graft surgery (31%) and isolated valve surgery (30%); 19% were reoperations. Infections were adjudicated by independent infectious disease experts. Multivariable Cox modeling was used to assess the independent effect of blood and platelet transfusions on major infections within 60 ± 5 days of surgery. Red blood cells (RBC) and platelets were transfused in 48% and 31% of patients, respectively. Each RBC unit transfused was associated with a 29% increase in crude risk of major infection (p < 0.001). Among RBC recipients, the most common infections were pneumonia (3.6%) and bloodstream infections (2%). Risk factors for infection included postoperative RBC units transfused, longer duration of surgery, and transplant or ventricular assist device implantation, in addition to chronic obstructive pulmonary disease, heart failure, and elevated preoperative creatinine. Platelet transfusion decreased the risk of infection (p = 0.02). Greater attention to management practices that limit RBC use, including cell salvage, small priming volumes, vacuum-assisted venous return with rapid autologous priming, and ultrafiltration, and preoperative and intraoperative measures to elevate hematocrit could potentially reduce occurrence of major postoperative infections.
The Annals of thoracic surgery 05/2013; · 3.74 Impact Factor
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ABSTRACT: Some have suggested the superiority of biatrial versus left atrial lesions. We sought to analyze our experience.
We retrospectively reviewed 305 consecutive patients from 2007 to 2011. Rhythm success was defined as freedom from atrial fibrillation (AF) or flutter determined by 12-lead electrocardiograms at 3-month intervals. Lesions sets were pulmonary vein isolation (PVI), left-extended (PVI + mitral valve annulus [MV] lesion ± left atrial appendage lesion [LAA]) or biatrial-extended (right atrial ablation + PVI + MV ± LAA).
The success rates of PVI, left-extended, and biatrial-extended lesions were as follows: at 3 months, 56.7%, 74.7%, and 79.4% (P = .003); at 6 months, 56.9%, 72.9%, and 74.6% (P = .02); at 9 months, 54.6%, 72.5%, and 83.3% (P < .001); and at 12 months, 52.6%, 76.1%, and 80.0% (P < .001). Biatrial lesions had a higher rate of pacemaker placement than did left atrial lesions (16.5% vs 7.5%; P = .02). When we grouped patients by left lesion (PVI, PVI + MV, PVI + MV + LAA) irrespective of right atrial ablation, success was as follows: 3 months, 57.9%, 71.1%, and 87.8% (P < .01); 6 months, 58.1%, 71.6%, and 77.6% (P = .03); 9 months, 55.9%, 71.3%, and 89.6% (P < .01); and 12 months, 54.1%, 74.7%, and 83.7% (P < .01).
PVI is associated with lower rhythm success than an extended left atrial lesion set. The addition of a right atrial lesion to an extended left atrial lesion set does not improve efficacy, but it does increase the rate of pacemaker placement for sinus dysfunction. Adding an LAA lesion may confer additional efficacy when added to a lesion set that includes PVI + MV.
The Journal of thoracic and cardiovascular surgery 02/2013; 145(2):356-63. · 3.41 Impact Factor
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ABSTRACT: BACKGROUND: The aim of the study is to design a specific Intensive Care Unit length-of-stay risk model based on the preoperative factors and surgeries utilizing modeling strategies for time-to-event data in a prospective observational clinical study. METHODS: From January 2004 to April 2011 data on 3861 consecutive heart surgery patients were prospectively collected. ICU length of stay was analyzed as a time-to-event variable in a competing risk framework with death as competing risk. RESULTS: The median ICU-LOS was one day. All factors considered but gender was included in the multivariable modeling. In the final model, factors that mostly affected time-to-discharge from ICU were critical preoperative state (Relative Risk 0.41; 95% Confidence Interval: 0.29-0.58), emergency (0.41; 0.32-0.53), poor left ventricular dysfunction (0.50; 0.44-0.57) and serum creatinine>200μmol/L (0.54; 0.46-0.65). Most of the predictors had a time-dependent effect that decreased in the first fifteen days and was constant thereafter. After the plateau, the risk profile was changed as most of the factors were no longer significant, Conversely, the time-to-ICU death model included only two variables, critical perioperative state and serum creatinine>200μmol/L, with a constant RR of 9.1 and 3.37 respectively. CONCLUSIONS: ICU-LOS can be predicted by preoperative data and type of surgeries. The derived ICU-LOS prediction model is dynamic and most predictors have an effect that decreases with time. The algorithm can preoperatively predict ICU-LOS curves and could have a major role in the decision making-behavior of clinicians, resources' allocation and maximization of care for high-risk patients.
International journal of cardiology 10/2012; · 7.08 Impact Factor
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The Annals of thoracic surgery 08/2012; 94(2):692-3; author reply 693-4. · 3.74 Impact Factor
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ABSTRACT: The authors sought to evaluate the association between the time interval from contrast administration to cardiac surgery and postoperative acute kidney injury (AKI).
A retrospective observational study over a 1-year period.
A US academic medical institution.
Six hundred forty-four adult patients undergoing nonemergent cardiac surgery.
No interventions were performed as part of the study.
AKI was defined as an increase in serum creatinine by ≥0.3 mg/dL or ≥50% above baseline within the first 2 postoperative days or the commencement of renal replacement therapy within the same period. Using a contrast-to-surgery time interval >7 days as the baseline, multivariable logistic regression analysis determined the association between a contrast-to-surgery time interval ≤1 day or 2 to 7 days and postoperative AKI adjusting for potential confounding variables. The incidence of AKI within the study cohort was 21.9%. After adjusting for other covariates, there was no association between the contrast-to-surgery time and AKI (odds ratio [OR] ≤1 day = 0.93; 95% confidence interval [CI], 0.52-1.66; p = 0.81; OR = 2-7 days = 1.28; 95% CI, 0.78-2.11; p = 0.34).
In an appropriately selected population, cardiac surgery can be performed within 1 day of cardiovascular catheterization and contrast administration without an increase in the incidence of postoperative AKI. Recommendations to delay cardiac surgery for a specified period after contrast administration to reduce the risk of postoperative AKI are premature. Additional evidence is required before making recommendations on optimal surgical timing after contrast exposure.
Journal of cardiothoracic and vascular anesthesia 04/2012; 26(5):804-12. · 1.06 Impact Factor
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ABSTRACT: BackgroundOver the past decade, minimally invasive cardiac surgery (MICS) has emerged as an accepted approach for the management of
cardiac disease that requires a surgical solution. We report the results of an 8-year, single-institution experience with
MICS.
MethodsBetween January 1, 2000 and December 31, 2007, a total of 910 patients underwent MICS. Major cases included aortic valve procedures
(71, 7.8%), coronary artery bypass grafting (96, 10.5%), atrioseptal defect repair (103, 11.3%), and mitral valve procedures
(507, 55.7%). Major outcomes of interest included the complication and mortality rates.
ResultsThe mean age of the patients was 57±15years; the mean ejection fraction was 55%±11%; and the mean body mass index was
26.1±4.9. Overall, 782 cases (85.9%) were performed through a mini-thoracotomy. Most of the cases were accomplished through
central cannulation (765, 84.0%), and venous drainage was most commonly performed in a bicaval fashion (percutaneous superior
vena cava and percutaneous inferior vena cava). The mean aortic cross-clamp and cardiopulmonary bypass (CPB) times were 58.1±44.9
and 101.9±66.8min, respectively. Conversion to full sternotomy occurred in 10 patients, and the median length of stay in
hospital was 6days. The overall complication rate was 8.8%, and the 30-day mortality rate was 2.9%. In the multivariate logistic
regression analysis, risk factors associated with in-hospital complications included age, CPB time, arterial cannulation location,
conversion from off-CPB to on-CPB, hepatic insufficiency, and diabetes. In the multivariate hazards regression analysis, risk
factors associated with mortality included postoperative stroke, renal failure, and sternal wound infection; CPB time; and
previous surgery.
ConclusionsIn our experience, minimally invasive approaches are effective and reproducible for a variety of cardiac operations, with
acceptable operating time durations, morbidity, and mortality.
World Journal of Surgery 04/2012; 34(4):611-615. · 2.36 Impact Factor
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Howard C Herrmann,
Zachary M Gertz,
Frank E Silvestry,
Susan E Wiegers,
Y Joseph Woo,
James Hermiller,
Douglas Segar,
David Heimansohn,
William Gray,
Shunichi Homma, Michael Argenziano,
Andrew Wang,
James Jollis,
Mark B Lampert,
John Alexander,
Laura Mauri,
Elyse Foster,
Donald Glower,
Ted Feldman
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ABSTRACT: The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population.
The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair.
The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses.
Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF.
Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.
Journal of the American College of Cardiology 04/2012; 59(14):1312-9. · 14.16 Impact Factor
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ABSTRACT: This study assessed comparative effectiveness of minimally invasive versus traditional sternotomy mitral valve surgery in elderly patients.
From January 1, 2000, to December 31, 2008, 1005 patients underwent isolated mitral valve surgery at our institution. Patients ≥ 75-years-old were included in analysis (sternotomy, n = 105; minimally invasive, n = 70). Clinical outcomes included bypass and crossclamp time, length of hospitalization, morbidity, and mortality. To assess resource use, total hospital costs and discharge location were analyzed. Three standardized inpatient functional status outcomes were also assessed.
The minimally invasive approach was associated with a 9.2-minute longer crossclamp time (P = .037) and a 25.2-minute longer bypass time (P < .001). Minimally invasive surgery was associated with a 3.1-day shorter hospitalization (P = .033). There were no significant differences in rate of major postoperative complications (P = .085) or long-term survival (P = .60). Minimally invasive approach was associated with a $6721 lower median cost of hospitalization (P = .007) and more common discharge to home, routinely or with a health aide, rather than to rehabilitation (P = .021). Minimally invasive patients achieved faster rates of independent ambulation (P = .039) and independent sit-to-stand activity (P = .003), although there were no differences in time to independent stair climbing (P = .31).
Among elderly patients, minimally invasive mitral valve surgery is associated with slightly longer crossclamp and bypass times but with equivalent morbidity and mortality and shorter hospitalization, decreased resource use, and improved postoperative functional status.
The Journal of thoracic and cardiovascular surgery 04/2012; 143(4 Suppl):S86-90. · 3.41 Impact Factor
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Donald Glower,
Gorav Ailawadi, Michael Argenziano,
Michael Mack,
Alfredo Trento,
Andrew Wang,
D Scott Lim,
William Gray,
Paul Grayburn,
John Dent,
Linda Gillam,
Barathi Sethuraman,
Ted Feldman,
Elyse Foster,
Laura Mauri,
Irving Kron
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ABSTRACT: The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement.
Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group.
The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37 patients (P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure.
These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.
The Journal of thoracic and cardiovascular surgery 04/2012; 143(4 Suppl):S60-3. · 3.41 Impact Factor
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ABSTRACT: For minimally invasive cardiac surgery (MICS) procedures requiring cardiopulmonary bypass (CPB), cannulation techniques vary and seem to be important determinants of technical difficulty and clinical outcomes. Over 10 years of MICS, we have modified our techniques substantially, and the present report outlines the evolution of our current cannulation platform.
From October 2000 to November 2010, 1087 minimally invasive cardiac procedures were performed at our institution; of these, 165 were done without CPB and were excluded. Methods of arterial and venous cannulation and aortic occlusion were retrospectively reviewed. Outcomes of interest included CPB and aortic cross-clamp time, as well as rates of in-hospital stroke, myocardial infarction, and short- and long-term mortality.
The mean age of the study population was 57 ± 15 years, with 50% being men. The MICS procedures included mitral valve surgery, atrial septal defect repair, atrial fibrillation ablation, and cardiac tumor resections. Over the study period, peripheral arterial cannulation was replaced by central aortic cannulation, which was used in 33% of patients in 2000-2001 and 93% in 2008-2010. Venous cannulation strategies also evolved over time, from percutaneous neck and femoral (78% of cases from 2000-2005), to direct superior vena cava and percutaneous femoral (67% in 2006-2007), to percutaneous dual-stage femoral (51% in 2008-2010). Aortic occlusion was achieved by endoaortic balloon in 33% of cases in 2000-2001 but, by 2002, was replaced by transaxillary clamp occlusion and direct antegrade/retrograde cardioplegia. In the post-endoballoon era, CPB and cross-clamp times have remained consistent. Overall, there were nine strokes (<1.0%), no myocardial infarctions, and 18 deaths (2.0%) within 30 days of surgery, and the incidence of these outcomes has not changed over time.
Over 10 years, our cannulation strategy for MICS has evolved to favor central aortic over femoral arterial cannulation, percutaneous femoral dual-stage bicaval venous drainage over percutaneous neck access, and transaxillary clamping over endoaortic balloon occlusion of the aorta. In our experience, this approach has resulted in low complication rates and a reliable platform for a variety of MICS procedures.
Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery 01/2012; 7(1):9-14.
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ABSTRACT: Bradyarrhythmia requiring pacemaker placement is a relatively common complication after surgical ablation for atrial fibrillation (AF). We report our experience with surgical ablation procedures using various energy modalities and lesion sets in an attempt to identify the risk factors associated with postoperative pacemaker requirement.
Intraoperative data were collected prospectively, and preoperative and postoperative data were collected retrospectively. Energy modality and lesion sets used were dependent on availability on the date of the procedure and surgeon preference.
From October 1999 to October 2009, 701 patients underwent surgical ablation for AF at our institution. Forty-five patients (7.6%) required early postoperative pacemaker placement. There were no significant differences in baseline characteristics or associated procedures between patients who required pacemaker placement and those who did not. Ninety-day mortality was greater in patients requiring pacemaker placement (15.6% versus 6.6%; p = 0.025). In multivariable analysis, a pacemaker requirement was more likely with the use of microwave energy (odds ratio [OR] 2.87; confidence interval [CI], 1.41 to 5.84; p = 0.004) and a right atrial lesion set (OR, 2.82; CI, 1.07 to 7.45; p = 0.036).
In conclusion, over our 10-year experience with surgical AF ablations, the incidence of pacemaker requirement was much lower than that reported in series of classic "cut and sew" Maze procedures, even among patients undergoing full biatrial ablations. Although biatrial ablation is currently our favored approach to patients with long-standing or persistent AF, right atrial lesion sets increase the risk of this complication and should be used judiciously.
The Annals of thoracic surgery 12/2011; 92(6):2085-9. · 3.74 Impact Factor
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Paul A Kurlansky, Michael Argenziano,
Robert Dunton,
Robert Lancey,
Edward Nast,
Allan Stewart,
Timothy Williams,
Alex Zapolanski,
Helena Chang,
Judy Tingley,
Craig R Smith
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ABSTRACT: The present study examined the relationship between hospital and surgeon coronary artery bypass grafting procedural volume, mortality, morbidity, and National Quality Forum care processes in a university-based community hospital quality improvement program.
The study population consisted of 2218 consecutive patients undergoing isolated coronary artery bypass grafting from 2007 to 2009 in a university-based quality improvement program that emphasizes involvement of all surgeons in the academic quality endeavor. The endpoints included operative mortality, major morbidity, and National Quality Forum-endorsed process measures as defined by the Society of Thoracic Surgeons. The procedural volume was analyzed as a categorical and continuous variable using general estimating equations, which accounted for clustering effects and which were adjusted for Society of Thoracic Surgeons risk scores and the propensity for operation in a low- versus high-volume program.
The annual program volume ranged from 67 to 292 (median, 136; interquartile range, 88-224) and surgeon volume from 1 to 124 (median, 58; interquartile range, 30-89). The mortality rate among the hospitals was 0.47% to 2.23% (0.8% overall), and the observed/expected mortality ranged from 0 to 1.20 (0.41 overall). When comparing low-volume (<200 cases/year) and high-volume centers, no difference was found in the mortality (odds ratio [OR], 1.08; 95% confidence interval [CI], 0.46-2.54, P = .85), morbidity (OR, 1.34; 95% CI, 0.73-2.43), or any of the medication process measures. No difference was found in mortality (OR, 1.59; 95% CI, 0.81-3.13; P = .18), morbidity (OR, 1.20; 95% CI, 0.86-1.66; P = .28), or medication failure (OR, 0.57, 95% CI, 0.3-1.10; P = .10) between the high- and low-volume surgeons (<87). After adjustment for both the Society of Thoracic Surgeons risk score and the propensity score, no association was found for either hospital or surgeon volume with mortality or morbidity. However, a lack of compliance with National Quality Forum measures was highly predictive of morbidity (OR, 1.51; 95% CI, 1.18-1.93; P = .001), regardless of volume, even after adjustment for predicted risk.
In the setting of a university-based community hospital quality improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. The surgical outcomes were not associated with program or surgeon volume, but were directly correlated with the focus on quality as manifested by compliance with evidence-based quality standards. Meaningful university affiliation might represent a new quality paradigm for cardiac surgery in the community hospital setting.
The Journal of thoracic and cardiovascular surgery 11/2011; 143(2):287-93. · 3.41 Impact Factor
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Louis P Perrault,
Alan J Moskowitz,
Irving L Kron,
Michael A Acker,
Marissa A Miller,
Keith A Horvath,
Vinod H Thourani, Michael Argenziano,
David A D'Alessandro,
Eugene H Blackstone,
Claudia S Moy,
Joseph P Mathew,
Judy Hung,
Timothy J Gardner,
Michael K Parides
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ABSTRACT: Ischemic mitral regurgitation, a complication of myocardial infarction and coronary artery disease more generally, is associated with a high mortality rate and is estimated to affect 2.8 million Americans. With 1-year mortality rates as high as 40%, recent practice guidelines of professional societies recommend repair or replacement, but there remains a lack of conclusive evidence supporting either intervention. The choice between therapeutic options is characterized by the trade-off between reduced operative morbidity and mortality with repair versus a better long-term correction of mitral insufficiency with replacement. The long-term benefits of repair versus replacement remain unknown, which has led to significant variation in surgical practice.
This article describes the design of a prospective randomized clinical trial to evaluate the safety and effectiveness of mitral valve repair and replacement in patients with severe ischemic mitral regurgitation. This trial is being conducted as part of the Cardiothoracic Surgical Trials Network. This article addresses challenges in selecting a feasible primary end point, characterizing the target population (including the degree of mitral regurgitation) and analytical challenges in this high mortality disease.
The article concludes by discussing the importance of information on functional status, survival, neurocognition, quality of life, and cardiac physiology in therapeutic decision making.
The Journal of thoracic and cardiovascular surgery 11/2011; 143(6):1396-403. · 3.41 Impact Factor
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ABSTRACT: The aim of this study was to compare the cost and effectiveness of a minimally invasive (MI) versus traditional sternotomy (ST) approach for mitral valve surgery (MVS).
From January 1, 2003, to December 31, 2008, a total of 847 patients underwent isolated MVS at our institution. Propensity matching on 22 clinical variables was carried out to generate a study cohort of 434 patients (217 matched pairs). Direct and indirect costs from the hospital perspective were retrospectively obtained from our finance department. Total hospital costs were further stratified into 13 standardized institutional billing categories. In addition, data on morbidity, mortality, discharge location, hospital readmissions within 1 year, and freedom from reoperation were obtained.
Compared with ST, MIMVS was associated with a $9054 ± $3302 lower mean total hospital cost (P = .006), driven largely by a reduction in direct (P = .003) versus indirect costs (P = .06). Among the 13 billing categories, MIMVS was associated with a significant reduction in costs of cardiac imaging (P = .004), laboratory tests (P = .005), boarding and nursing (P = .001), and radiology (P = .002). More patients in the ST group required intubation for more than 72 hours (P = .019); however, there were no differences in morbidity or long-term survival (P = .334). A higher proportion of MI patients were discharged home with no nursing services (P = .018), and a higher proportion of ST patients required readmission within 1 year (P = .023). There were no differences in freedom from reoperation between groups (P = .574).
With equivalent efficacy across a range of measures and lower costs compared with ST, MIMVS represents a cost-saving strategy for MVS.
The Journal of thoracic and cardiovascular surgery 06/2011; 142(6):1507-14. · 3.41 Impact Factor
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A Marc Gillinov, Michael Argenziano,
Eugene H Blackstone,
Alexander Iribarne,
Joseph J DeRose,
Gorav Ailawadi,
Mark J Russo,
Deborah D Ascheim,
Michael K Parides,
Evelio Rodriguez,
Denis Bouchard,
Wendy C Taddei-Peters,
Nancy L Geller,
Michael A Acker,
Annetine C Gelijns
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ABSTRACT: Since the introduction of the cut-and-sew Cox maze procedure for atrial fibrillation, there has been substantial innovation in techniques for ablation. Use of alternative energy sources for ablation simplified the procedure and has resulted in dramatic increase in the number of patients with atrial fibrillation treated by surgical ablation. Despite its increasingly widespread adoption, there is lack of rigorous clinical evidence to establish this procedure as an effective clinical therapy.
This article describes a comparative effectiveness randomized trial, supported by the Cardiothoracic Surgical Clinical Trials Network, of surgical ablation with left atrial appendage closure versus left atrial appendage closure alone in patients with persistent and long-standing persistent atrial fibrillation undergoing mitral valve surgery. Nested within this trial is a further randomized comparison of 2 different lesions sets: pulmonary vein isolation and the full maze lesion set.
This article addresses trial design challenges, including how best to characterize the target population, operationalize freedom from atrial fibrillation as a primary end point, account for the impact of antiarrhythmic drugs, and measure and analyze secondary end points, such as postoperative atrial fibrillation load.
This article concludes by discussing how insights that emerge from this trial may affect surgical practice and guide future research in this area.
The Journal of thoracic and cardiovascular surgery 05/2011; 142(2):257-64.e2. · 3.41 Impact Factor
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ABSTRACT: Over the past decade, minimally invasive cardiothoracic surgery (MICS) has grown in popularity. This growth has been driven, in part, by a desire to translate many of the observed benefits of minimal access surgery, such as decreased pain and reduced surgical trauma, to the cardiac surgical arena. Initial enthusiasm for MICS was tempered by concerns over reduced surgical exposure in highly complex operations and the potential for prolonged operative times and patient safety. With innovations in perfusion techniques, refinement of transthoracic echocardiography and the development of specialized surgical instruments and robotic technology, cardiac surgery was provided with the necessary tools to progress to less invasive approaches. However, much of the early literature on MICS focused on technical reports or small case series. The safety and feasibility of MICS have been demonstrated, yet questions remain regarding the relative efficacy of MICS over traditional sternotomy approaches. Recently, there has been a growth in the body of published literature on MICS long-term outcomes, with most reports suggesting that major cardiac operations that have traditionally been performed through a median sternotomy can be performed through a variety of minimally invasive approaches with equivalent safety and durability. In this article, we examine the technological advancements that have made MICS possible and provide an update on the major areas of cardiac surgery where MICS has demonstrated the most growth, with consideration of current and future directions.
Future Cardiology 05/2011; 7(3):333-46.
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ABSTRACT: Early invasive strategy, defined as early coronary angiography and subsequent revascularization, when appropriate, is recommended by current guidelines for the management of patients with moderate- to high-risk acute coronary syndromes. We sought to compare the outcomes of patients with acute coronary syndromes undergoing surgical revascularization with an on-pump versus off-pump approach.
Among a total of 13,819 patients with moderate- to high-risk acute coronary syndromes enrolled in the Acute Catheterization and Urgent Intervention Triage Strategy trial, 1375 patients were triaged to isolated coronary artery bypass grafting. One thousand one hundred fifty-four patients underwent operations with cardiopulmonary bypass (the coronary artery bypass grafting group), and 221 patients underwent off-pump coronary artery bypass grafting (the off-pump coronary artery bypass grafting group). Propensity score matching (1:3) was applied to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 880 matched patients with acute coronary syndromes (220 managed with off-pump coronary artery bypass grafting and 660 managed with coronary artery bypass grafting).
At 30 days, patients undergoing off-pump coronary artery bypass grafting had fewer events of bleeding (43.7% vs 56.3%, P = .0005) and myocardial infarction (7.3% vs 12.1%, P = .055) but higher rates of reintervention (3.7% vs 1.2%, P = .02). At 1 year, there was no difference between groups in death, total myocardial infarctions, reinterventions, strokes, or major adverse cardiac events, but there was a lower rate of non-Q-wave myocardial infarctions in the off-pump coronary artery bypass grafting group (4.6% vs 9.2%, P = .03).
In this large-scale study evaluating the outcomes of patients with acute coronary syndromes, off-pump coronary artery bypass grafting was associated with lower rates of bleeding and non-Q-wave myocardial infarction but more reinterventions early after the procedure. At 1 year, there was no major outcome difference between the 2 surgical strategies.
The Journal of thoracic and cardiovascular surgery 04/2011; 142(2):e33-9. · 3.41 Impact Factor
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Elena Ladich,
Mary Beth Michaels,
Russell M Jones,
Elizabeth McDermott,
Leslie Coleman,
Jan Komtebedde,
Donald Glower, Michael Argenziano,
Ted Feldman,
Masataka Nakano,
Renu Virmani
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ABSTRACT: The safety and effectiveness of the MitraClip device (Abbott Vascular, Menlo Park, CA) is being evaluated in the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) clinical studies. The healing response after device implantation has not previously been characterized in humans.
A total of 67 explanted devices (implantation duration, 1 to 1878 days) from 50 patients were submitted for histological evaluation. Explants were analyzed in 4 implantation intervals: acute (≤30 days; n=7), subacute (31 to 90 days; n=23), chronic (91 to 300 days; n=18), and long term (>300 days; n=19). The acute healing response consisted of platelet/fibrin deposition. The subacute response exhibited granulation tissue with early fibrous encapsulation (pannus). The chronic response was characterized by various degrees of tissue bridging between the device arms. The long-term healing response demonstrated collagen-rich matrix (by type I collagen), incorporating the device components with complete encapsulation by organized, fibrous growth. In long-term devices with minimal surgical disruption, a fibrous tissue bridge (mean area, 7.39±4.3 mm(2)) was observed over and between the device arms, resulting in atrial tissue continuity between the 2 valve leaflets. Devices demonstrated no evidence of endocarditis, mechanical wear, component fracture, or corrosion up to the time of explantation (median, 119 days; first and third quartiles, 42 and 365 days).
In all patients, device mechanical integrity was maintained up to the time of explantation. Four phases of physiological healing were observed: platelet and fibrin deposition, inflammation, granulation tissue, and finally, fibrous encapsulation. Long-term device fibrous encapsulation with extension over adjacent mitral leaflets and tissue bridge formation adds structural stability. Clinical Trial Registration- URL: http://clinicaltrials.gov/show/NCT00209274. Unique identifiers: NCT00209339 and NCT00209274.
Circulation 03/2011; 123(13):1418-27. · 14.74 Impact Factor
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Artificial Organs 01/2011; 35(1):96-7; author reply 97-8. · 2.00 Impact Factor
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[show abstract]
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ABSTRACT: Over the past decade, minimally invasive (MI) mitral valve surgery has grown in popularity. The purpose of this study was to compare both short- and long-term outcomes of mitral valve repair and replacement performed through a MI versus traditional sternotomy (ST) incision using a propensity analysis approach to account for differences in baseline risk.
From January 2000 to December 2008, a total of 1,121 isolated mitral valve operations were performed at our institution (548 ST, 573 MI). Data were retrospectively collected on all patients, and a logistic regression model was created to predict selection to a MI versus ST approach. Propensity scores were then generated based on the regression model and matched pairs created using 1:1 nearest neighbor matching. There were 382 matched pairs in the analysis for a total sample size of 764, or 68.2% of the original cohort. Major outcomes of interest included cardiopulmonary bypass time, cross-clamp time, hospital length of stay, major in-hospital complications, and both short- and long-term survival.
Cardiopulmonary bypass time was 117.1 ± 2.0 minutes in the ST group and 139.7 ± 2.6 minutes in the MI group (p < 0.0001), and cross-clamp time was 79.6 ± 1.5 minutes in the ST group and 83.7 ± 1.9 in the MI group (p = 0.106). The average hospital length of stay was 9.81 ± 0.61 days among ST patients and 7.76 ± 0.37 days among MI patients (p = 0.0043). There was no significant difference in the frequency of major in-hospital complications between groups. The mean duration of survival follow-up was 4.2 ± 2.4 years. There was no significant difference in mortality at 30 days (p = 0.622) or 1 year (p = 0.599). In addition, there was no significant difference in long-term survival between groups (p = 0.569).
Although minimally invasive mitral valve surgery required a slightly longer cardiopulmonary bypass time, there was no difference in cross-clamp time, morbidity, or mortality, and hospital length of stay was significantly shorter when compared with matched sternotomy control patients.
The Annals of thoracic surgery 11/2010; 90(5):1471-7; discussion 1477-8. · 3.74 Impact Factor
