Eric R. Skipper

Effect of body mass index on outcomes after cardiac surgery: is there an obesity paradox?

BACKGROUNDnNumerous studies have documented an obesity paradox in which overweight and obese people with cardiovascular disease have a better prognosis compared with patients with normal body mass index (BMI). This study sought to quantify the effect of BMI on clinical outcomes after cardiac surgery and investigate the obesity paradox.nnnMETHODSnA concurrent cohort study of 2,440 consecutive patients undergoing cardiac surgery (coronary artery bypass grafting [CABG], valve, or CABG and valve surgery) from January 2004 to December 2008 was carried out. The patients were divided into three groups on the basis of BMI: normal weight (BMI 18.5 to 24.9; n=556; 23%), overweight (BMI 25.0 to 29.9; n=965; 39%), and obese (BMI≥30; n=919; 38%). Multivariable analyses and propensity score matching were used to compare the early and late clinical outcomes among the different BMI groups.nnnRESULTSnOverweight patients had a lower operative mortality (odds ratio, 0.4; 95% confidence interval, 0.2 to 0.9; p=0.031) compared with normal BMI patients. Obese patients had a comparable risk for operative mortality (odds ratio, 0.8; 95% confidence interval, 0.4 to 1.6; p=0.47) compared with normal-weight patients. Actuarial 5-year survival was better for the overweight (hazard ratio, 0.5; 95% confidence interval, 0.4 to 0.8; p=0.002) and comparable for the obese (hazard ratio, 0.9; 95% confidence interval, 0.5 to 1.4; p=0.49) groups compared with the normal-weight patients.nnnCONCLUSIONSnOverweight patients have better early hospital outcomes and improved survival after cardiac surgery compared with normal BMI patients, supporting the obesity paradox.

Surgical Revision After Percutaneous Mitral Repair With the MitraClip Device

BACKGROUNDnPercutaneous mitral repair with the MitraClip device (Evalve, Menlo Park, CA) has been reported. Preserving conventional surgical options in the event of percutaneous treatment failure is important. We describe surgical treatment at varying intervals after the MitraClip procedure in 32 patients.nnnMETHODSnOne hundred seven patients with moderate-to-severe or severe mitral regurgitation who were either symptomatic (91%) or, if asymptomatic (9%), had evidence of left ventricular dysfunction were enrolled as part of the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) phase I registry study or as roll-in subjects in the EVEREST II study. Thirty-two of the 107 patients (30%) underwent surgery after an attempted MitraClip procedure.nnnRESULTSnOf the 32 patients undergoing post-clip mitral valve surgery, 23 patients (72%) had one or more clips implanted and 9 patients (28%) received no clip implant. The indications for mitral valve surgery in the 23 patients with a clip included partial clip detachment (n = 10), residual or recurrent mitral regurgitation greater than 2+ (n = 9), and other (atrial septal defect [n = 2], device malfunction [n = 1], and incorrectly diagnosed mitral stenosis [n = 1]). Twenty-seven of 31 patients (87%) underwent the surgical procedure planned before surgery (planned procedure unknown in 1 patient). Four of 25 patients (16%) with planned repair underwent mitral valve replacement.nnnCONCLUSIONSnStandard surgical options were preserved in patients who had surgery after percutaneous repair with the MitraClip device. Successful repair was feasible in the majority of patients after the MitraClip procedure, with repair performed as late as 18 months after clip implantation.

Quality improvement program decreases mortality after cardiac surgery.

OBJECTIVEnThis study investigated the effects of a quality improvement program and goal-oriented, multidisciplinary protocols on mortality after cardiac surgery.nnnMETHODSnPatients were divided into two groups: those undergoing surgery (coronary artery bypass grafting, isolated valve surgery, or coronary artery bypass grafting and valve surgery) after establishment of the multidisciplinary quality improvement program (January 2005-December 2006, n = 922) and those undergoing surgery before institution of the program (January 2002-December 2003, n = 1289). Logistic regression and propensity score analysis were used to adjust for imbalances in patients preoperative characteristics.nnnRESULTSnOperative mortality was lower in the quality improvement group (2.6% vs 5.0%, P < .01). Unadjusted odds ratio was 0.5 (95% confidence interval 0.3-0.8, P < .01); propensity score-adjusted odds ratio was 0.6 (95% confidence interval 0.4-0.99, P = .04). In multivariable analysis, diabetes (P < .01), chronic renal insufficiency (P = .05), previous cardiovascular operation (P = .04), congestive heart failure (P < .01), unstable angina (P < .01), age older than 75 years (P < .01), prolonged pump time (P < .01), and prolonged operation (P = .05) emerged as independent predictors of higher mortality after cardiac surgery, whereas quality improvement program (P < .01) and male sex (P = .03) were associated with lower mortality. Mortality decline was less pronounced in patients with than without diabetes (P = .04).nnnCONCLUSIONnApplication of goal-directed, multidisciplinary protocols and a quality improvement program were associated with lower mortality after cardiac surgery. This decline was less prominent in patients with diabetes, and focused quality improvement protocols may be required for this subset of patients.

Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure

Background In an early analysis of this trial, use of a magnetically levitated centrifugal continuous‐flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical‐bearing axial continuous‐flow pump, at 6 months in patients with advanced heart failure. Methods In a randomized noninferiority and superiority trial, we compared the centrifugal‐flow pump with the axial‐flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal‐flow pump group minus axial‐flow pump group) was ‐10 percentage points. Results Of 366 patients, 190 were assigned to the centrifugal‐flow pump group and 176 to the axial‐flow pump group. In the intention‐to‐treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal‐flow pump group, as compared with 106 (60.2%) in the axial‐flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal‐flow pump group than in the axial‐flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal‐flow pump group than in the axial‐flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02). Conclusions In patients with advanced heart failure, a fully magnetically levitated centrifugal‐flow pump was superior to a mechanical‐bearing axial‐flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.)

Aprotinin in cardiac surgery patients: is the risk worth the benefit?

BACKGROUNDnAprotinin is the only Food and Drug Administration-approved agent to reduce haemorrhage related to cardiac surgery and its safety and efficacy has been extensively studied. Our study sought to compare the efficacy, early and late mortality and major morbidity associated with aprotinin compared with e-aminocaproic acid (EACA) in cardiac surgery operations.nnnMETHODSnBetween January 2002 and December 2006, 2101 patients underwent coronary artery bypass grafting (CABG), valve surgery or CABG and valve surgery in our institution with the use of aprotinin (1898 patients) or EACA (203 patients). Logistic regression and propensity score analysis were used to adjust for imbalances in the patients preoperative characteristics. The propensity score-adjusted sample included 570 patients who received aprotinin and 114 who received EACA (1-5 matching).nnnRESULTSnOperative mortality was higher in the aprotinin group in univariate (aprotinin 4.3% vs EACA 1%, p=0.023) but not propensity score-adjusted multivariate analysis (4% vs 0.9%, p=0.16). In propensity score-adjusted analysis, aprotinin was also associated with a lower rate of blood transfusion (38.8% vs 50%, p=0.04), a lower rate of haemorrhage-related re-exploration (3.7% vs 7.9%, p=0.04) and a higher risk of in-hospital cardiac arrest (3.7% vs 0%, p=0.03) and a marginally but not statistically significantly higher risk of acute renal failure (6.8% vs 2.6%, p=0.09). In Cox proportional hazards regression analysis, the risk of late death was higher in the aprotinin compared to EACA group (hazard ratio=4.33, 95% confidence interval (CI)=1.60-11.67, p=0.004).nnnCONCLUSIONnAprotinin decreases the rate of postoperative blood transfusion and haemorrhage-related re-exploration, but increases the risk of in-hospital cardiac arrest and late mortality after cardiac surgery when compared to EACA. Cumulative evidence suggests that the risk associated with aprotinin may not be worth the haemostatic benefit.

Is advanced age a contraindication for emergent repair of acute type A aortic dissection

With the general increase in human lifespan, cardiac surgeons are faced with treating an increasing number of elderly patients. The aim of our study was to investigate whether advanced age poses an increased risk for major morbidity and mortality with repair of acute type A aortic dissection. Between 2000 and 2008, 119 patients underwent emergency operation for acute type A aortic dissection at two institutions; 90 were younger than 70 years of age and 29 patients were 70 years or older. Major morbidity, operative and 5-year actuarial survival were compared between groups. The operative mortality rates were comparable between the two groups (18.9% in patients <70 years vs. 24.1% for patients >or=70 years, P=0.6). There was no difference in the rates of reoperation for bleeding (<70 years 31.7% vs. 14.3% for >or=70 years, P=0.09), stroke (18.9% for those <70 years vs. 20.7% for those >or=70 years, P=0.79), acute renal failure (22.2% for those <70 years vs. 17.2% for those >or=70 years, P=0.79) or prolonged ventilation (34.4% for those <70 years vs. 24.1% for those >or=70 years, P=0.36) between the two groups. Actuarial 5-year survival rates were 77% for patients <70 years vs. 59% for patients >or=70 years (P=0.07). The mortality for patients who presented with hemodynamic instability was markedly higher (10 out of 14 patients, 71.4%) compared with the mortality of those who presented with stable hemodynamics (21 out of 88 patients, 23.9%, P<0.001), regardless of age group. No significant differences in operative mortality, major morbidity and actuarial 5-year survival were observed between patients >or=70 years and younger patients although there was a trend toward a lower actuarial 5-year survival in older patients. Surgery for type A acute aortic dissection in patients 70 years or older can be performed with acceptable outcomes. Hemodynamic instability portends a poor prognosis, regardless of age.

Concomitant surgical treatment of dental and valvular heart diseases

BACKGROUNDnInvasive dental procedures are often indicated before cardiac valve surgery. The purpose of this case-control study was to determine the risks and benefits of concomitant dental and thoracic surgery.nnnMETHODSnCritically ill cardiac inpatients requiring cardiac valve surgery were referred by the Department of Thoracic and Cardiovascular Surgery to our Oral Medicine consult service. Those requiring dental extractions were considered for dental treatment during the same general anesthetic as the cardiac surgery. These study patients were compared with control patients who had extractions before valve surgery in a different setting. There was no attempt to analyze the impact of this practice on the development of infective endocarditis. All patients received broad-spectrum antibiotics during dental surgery.nnnRESULTSnTwenty-one patients had concomitant oral and cardiac valve surgery. Seventeen patients were in the control group. There were no statistically significant differences between cases and controls in demographics, length of stay, nature of the dental surgery, mean number of teeth removed, oral bleeding, or postoperative infections. One patient in the control group developed prosthetic valve endocarditis versus none in the concomitant surgery group.nnnCONCLUSIONSnThis case-control study suggests that concomitant surgical procedures for dental and valvular heart disease can be accomplished without clinically significant oral complications. Given the risk from poor oral health following cardiac valve surgery, this approach should be considered for patients who would benefit by avoiding a second general anesthetic and/or a delay in cardiac surgery, and by having their oral surgery performed in the safest environment.

Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial

BACKGROUNDnPrimary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices.nnnMETHODSnCox proportional hazard models were used to analyze patients enrolled in the as-treated cohort (n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success.nnnRESULTSnBaseline characteristics were well balanced among HM3 (n = 151) and HMII (n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed.nnnCONCLUSIONSnThis analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned.

Must Surgeons Tell Mitral Valve Repair Candidates About a New Percutaneous Repair Device That Is Only Available Elsewhere

Robert M. Sade, MD nOne of the persistent problems in achieving informed consent for surgical patients is the question of what should be covered in the disclosure component of the consent process. Certainly, one need not tell patients about every conceivable complication or about every possible alternative therapy that might be available for their specific illnesses. So what must be included? In particular, what alternative therapies should be described or must be described to patients? The problem has become a bit more complicated in recent years as the competitive aspects of cardiothoracic surgical practice have become more prominent and as some new technologies have been used as much for marketing surgical programs as for addressing patients’ needs. n nThis issue was explored at the annual Ethics Forum session of the Southern Thoracic Surgical Association meeting in 2010. A case was built around an actual new device that was still investigational at the time of the meeting, but set in the future (November 2011) at a time when Food and Drug Administration (FDA) approval is presumed to have occurred. n n n nCase nRichard Bishop, 60 years of age, has been known to have mitral insufficiency for 5 years, has recently developed shortness of breath, and his cardiologist at Lourdes Heart Center has found left ventricular dysfunction: ejection fraction 50%, end-systolic diameter 52 mm. He has referred Mr Bishop to his long-time colleague, Dr John Crowne, a cardiothoracic surgeon who has had excellent results with open mitral valve repair for more than 15 years. n nA competing institution, St. Bernadette Medical Center, on the other side of town recently participated in a multicenter trial of a new device, the Evalve MitraClip, which is deployed percutaneously for mitral valve repair. It was approved for clinical use by the FDA 3 months ago, in August 2011. St. Bernadette has been using the device with considerable success for 3 years. Published studies indicate that the device is 98% successful in reducing moderately severe (3+) or severe (4+) regurgitation to mild or none at 30 days after than procedure [1], but there is no information about long-term durability. Many heart centers want to use MitraClip and are training personnel in the technique, but only the original investigating institutions are up and running with experience in use of the device, so Lourdes Heart Center does not yet have clinical access to it. n nDuring his initial discussion with Mr Bishop, Dr Crowne realizes that no one in the cardiology department has mentioned the MitraClip to the patient, so he does not know what the patient’s preferences might be. He has read the limited number of published papers about the device and knows that its early success rate is excellent, no long-term results are available, and the FDA believes it is safe enough for clinical use. He wonders whether he is ethically obligated to tell the patient about the MitraClip and to offer referral to St. Bernadette as a treatment alternative.