Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial.

Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of ≥2% for mitral repair (or Society of Thoracic Surgeons replacement score of ≥4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870; NCT04198870.

Ablation of atrial fibrillation during coronary artery bypass grafting: Late outcomes in a Medicare population.

BACKGROUND: This study compares outcomes of patients with preoperative atrial fibrillation undergoing coronary artery bypass grafting (CABG) with or without concomitant atrial fibrillation ablation in a nationally representative Medicare cohort. OBJECTIVES: This study examined early and late outcomes in CABG patients with a preoperative history of atrial fibrillation to determine the correlation between surgical atrial fibrillation ablation to mortality and stroke or systemic embolization. METHODS: In the Medicare-linked Society of Thoracic Surgeons database, 361,138 patients underwent isolated CABG from 2006 to 2013; 34,600 (9.6%) had preoperative atrial fibrillation; 10,541 (30.5%) were treated with surgical ablation (ablation group), and 23,059 were not (no ablation group). Propensity score matching was performed using a hierarchical mixed model. Long-term survival was summarized using Kaplan-Meier curves and Cox regression models with robust variance estimation. The stroke or systemic embolization incidence was modeled using the Fine-Gray model. Median follow-up was 4 years. RESULTS: Long-term mortality in propensity score-matched CABG patients (mean age 74 years; Society of Thoracic Surgeons risk score, 2.25) receiving ablation versus no ablation was similar (log-rank P = .30). Stroke or systemic embolization occurred in 2.2% versus 2.1% at 30 days and 9.9% versus 12.0% at 5 years (Gray P = .0091). Landmark analysis from 2 to 5 years showed lower mortality (hazard ratio, 0.89; 95% confidence interval 0.82-0.97; P = .0358) and lower risk of stroke or systemic embolization (hazard ratio, 0.73; 95% confidence interval, 0.61-0.87; P = .0006) in the ablation group. CONCLUSIONS: Concomitant ablation in CABG patients with preoperative atrial fibrillation is associated with lower stroke or systemic embolization and mortality in patients who survive more than 2 years.

Prevalence of atrial fibrillation before cardiac surgery and factors associated with concomitant ablation.

OBJECTIVE: Surgical ablation for atrial fibrillation concomitant with cardiac surgery is now a Class I recommendation for selected patients. Understanding how the revised recommendations will affect appropriate use of surgical ablation is challenging because the reported prevalence of preoperative atrial fibrillation depends on the definition used. The objective was to determine the prevalence of atrial fibrillation in the 3 years before cardiac surgery and the rate of concomitant surgical ablation. METHODS: Patients with and without a diagnosis of atrial fibrillation in the 3 years before surgical coronary artery bypass, aortic valve replacement, or mitral valve replacement/repair were identified in the 2014 Medicare Standard Analytical File. RESULTS: Patients had prior atrial fibrillation in 28.4% of 79,134 cardiac surgeries. Prior atrial fibrillation was associated with risk factors for increased cardiac surgical morbidity/mortality, including recent heart failure, renal failure, and lung disease. Black patients were less likely to have prior atrial fibrillation but more likely to have had infrequent care for it. Isolated coronary artery bypass had the lowest prevalence but highest absolute number of prior atrial fibrillation cases. Concomitant surgical ablation was performed in 22.1% of patients with prior atrial fibrillation. Patients with mitral valve surgery were 3-fold more likely to receive surgical ablation. Women were less likely to have prior atrial fibrillation but less likely to have surgical ablation when they did. CONCLUSIONS: Medicare beneficiaries had a substantially higher prevalence of atrial fibrillation diagnoses in the 3 years before cardiac surgery than previously published rates of preoperative atrial fibrillation. Concomitant surgical ablation was performed in less than one-quarter of patients with atrial fibrillation undergoing cardiac surgery for other indications.

Novel Multiphase Assessment for Predicting Left Ventricular Outflow Tract Obstruction Before Transcatheter Mitral Valve Replacement.

OBJECTIVES: This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo-left ventricular outflow tract (LVOT). BACKGROUND: Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk. METHODS: Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach. RESULTS: Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates. CONCLUSIONS: Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment.

Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.

BACKGROUND: Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated SMR with surgery is not well established in this population, and medical management remains the preferred approach in most patients. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial was designed to determine whether transcatheter mitral valve (MV) repair with the MitraClip device is safe and effective in patients with symptomatic HF and clinically significant SMR. STUDY DESIGN: The COAPT trial is a prospective, randomized, parallel-controlled, open-label multicenter study of the MitraClip device for the treatment of moderate-to-severe (3+) or severe (4+) SMR (as verified by an independent echocardiographic core laboratory) in patients with New York Heart Association class II-IVa HF despite treatment with maximally tolerated guideline-directed medical therapy (GDMT) who have been determined by the site's local heart team as not appropriate for MV surgery. A total of 614 eligible subjects were randomized in a 1:1 ratio to MV repair with the MitraClip plus GDMT versus GDMT alone. The primary effectiveness end point is recurrent HF hospitalizations through 24 months, analyzed when the last subject completes 12-month follow-up, powered to demonstrate superiority of MitraClip therapy. The primary safety end point is a composite of device-related complications at 12 months compared to a performance goal. Follow-up is ongoing, and the principal results are expected in late 2018. CONCLUSIONS: HF patients with clinically significant SMR who continue to be symptomatic despite optimal GDMT have limited treatment options and a poor prognosis. The randomized COAPT trial was designed to determine the safety and effectiveness of transcatheter MV repair with the MitraClip in symptomatic HF patients with moderate-to-severe or severe SMR.

Concomitant atrial fibrillation surgery for people undergoing cardiac surgery.

BACKGROUND: People with atrial fibrillation (AF) often undergo cardiac surgery for other underlying reasons and are frequently offered concomitant AF surgery to reduce the frequency of short- and long-term AF and improve short- and long-term outcomes. OBJECTIVES: To assess the effects of concomitant AF surgery among people with AF who are undergoing cardiac surgery on short-term and long-term (12 months or greater) health-related outcomes, health-related quality of life, and costs. SEARCH METHODS: Starting from the year when the first "maze" AF surgery was reported (1987), we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (March 2016), MEDLINE Ovid (March 2016), Embase Ovid (March 2016), Web of Science (March 2016), the Database of Abstracts of Reviews of Effects (DARE, April 2015), and Health Technology Assessment Database (HTA, March 2016). We searched trial registers in April 2016. We used no language restrictions. SELECTION CRITERIA: We included randomised controlled trials evaluating the effect of any concomitant AF surgery compared with no AF surgery among adults with preoperative AF, regardless of symptoms, who were undergoing cardiac surgery for another indication. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data. We evaluated the risk of bias using the Cochrane 'Risk of bias' tool. We included outcome data on all-cause and cardiovascular-specific mortality, freedom from atrial fibrillation, flutter, or tachycardia off antiarrhythmic medications, as measured by patient electrocardiographic monitoring greater than three months after the procedure, procedural safety, 30-day rehospitalisation, need for post-discharge direct current cardioversion, health-related quality of life, and direct costs. We calculated risk ratios (RR) for dichotomous data with 95% confidence intervals (CI) using a fixed-effect model when heterogeneity was low (I² ≤ 50%) and random-effects model when heterogeneity was high (I² > 50%). We evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to create a 'Summary of findings' table. MAIN RESULTS: We found 34 reports of 22 trials (1899 participants) with five additional ongoing studies and three studies awaiting classification. All included studies were assessed as having high risk of bias across at least one domain. The effect of concomitant AF surgery on all-cause mortality was uncertain when compared with no concomitant AF surgery (7.0% versus 6.6%, RR 1.14, 95% CI 0.81 to 1.59, I² = 0%, 20 trials, 1829 participants, low-quality evidence), but the intervention increased freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off antiarrhythmic medications > three months (51.0% versus 24.1%, RR 2.04, 95% CI 1.63 to 2.55, I² = 0%, eight trials, 649 participants, moderate-quality evidence). The effect of concomitant AF surgery on 30-day mortality was uncertain (2.3% versus 3.1%, RR 1.25 95% CI 0.71 to 2.20, I² = 0%, 18 trials, 1566 participants, low-quality evidence), but the intervention increased the risk of permanent pacemaker implantation (6.0% versus 4.1%, RR 1.69, 95% CI 1.12 to 2.54, I² = 0%, 18 trials, 1726 participants, moderate-quality evidence). Investigator-defined adverse events, including but limited to, need for surgical re-exploration or mediastinitis, were not routinely reported but were not different between the two groups (other adverse events: 24.8% versus 23.6%, RR 1.07, 95% CI 0.85 to 1.34, I² = 45%, nine trials, 858 participants), but the quality of this evidence was very low. AUTHORS' CONCLUSIONS: For patients with AF undergoing cardiac surgery, there is moderate-quality evidence that concomitant AF surgery approximately doubles the risk of freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off anti-arrhythmic drugs while increasing the risk of permanent pacemaker implantation. The effects on mortality are uncertain. Future, high-quality and adequately powered trials will likely affect the confidence on the effect estimates of AF surgery on clinical outcomes.

Gender differences in outcomes after surgical ablation of atrial fibrillation.

BACKGROUND: Gender disparities have been established in patients who have atrial fibrillation (AF), and in their outcomes after medical treatment for AF. This study evaluated differences in outcome by gender in patients who underwent surgical treatment for AF. METHODS: From April 2004 to December 2012, a total of 936 patients had surgical treatment for AF. Outcomes were analyzed by gender using propensity score-matching methods. RESULTS: Of the 936 subjects, 571 (61%) were men; women were older (aged 68.6 ± 11.3 vs 66.9 ± 11.9 years; P = .033), had more heart failure (44% vs 37%; P = .024), more mitral valve surgery (72% vs 50%; P < .001) and more tricuspid valve surgery (41% vs 18%; P < .001). Men underwent more coronary artery bypass surgery (37% vs 19%; P < .001) and aortic valve surgery (38% vs 31%; P = .029). Women had higher late stroke rate per 10 person-years (0.15 vs 0.07; P = .035), fewer catheter ablations (6.0% vs 9.8%; P = .017), and a trend toward fewer cardioversions for recurrent AF (15.7% vs 19.2%; P = .20). After propensity-score matching, late stroke rates per 10 person-years trended higher in women (0.12 vs 0.04; P = .13). No significant gender differences were found in overall survival (5-year survival: 78.8% in men, and 81.0% in women; P = .40) or freedom from AF without antiarrhythmic drugs at last follow-up (71.8% in men vs 73.6% in women, P = .59). CONCLUSIONS: Women sought surgery treatment at older ages and with more heart failure. No gender-based differences were found in stroke, overall survival, or procedure success, after propensity-score matching.

Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.

OBJECTIVES: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement. METHODS: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients. RESULTS: Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement. CONCLUSIONS: PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites.

Relation of body mass index to late survival after valvular heart surgery.

Limited data have suggested that an "obesity paradox" exists for mortality and cardiovascular outcomes in patients undergoing coronary artery bypass grafting. Much less is known about the role of the preoperative body mass index (BMI) in patients undergoing valve surgery. We evaluated 2,640 consecutive patients who underwent valve surgery between April 2004 and March 2011. The patients were classified by the World Health Organization standards as "underweight" (BMI 11.5 to 18.4 kg/m(2), n = 61), "normal weight" (BMI 18.5 to 24.9 kg/m(2), n = 865), "overweight" (BMI 25 to 29.9 kg/m(2), n = 1,020), and "obese" (BMI 30 to 60.5 kg/m(2), n = 694). Mortality was ascertained using the Social Security Death Index. Hazard ratios (HRs), adjusted for known preoperative risk factors, were obtained using Cox regression models. The mean follow-up was 31.9 ± 20.5 months. The long-term mortality rate was 1.21, 0.52, 0.32, and 0.44 per 10 years of person-time for underweight, normal, overweight, and obese patients, respectively. Compared to the normal BMI category, overweight patients (adjusted HR 0.60, 95% confidence interval 0.46 to 0.79, p <0.001) and obese patients (adjusted HR 0.67, 95% confidence interval 0.50 to 0.91, p = 0.009) were at a lower hazard of long-term all-cause mortality. Underweight patients remained at a greater adjusted risk of long-term mortality than normal weight patients (adjusted HR 1.69, 95% confidence interval 1.01 to 2.85, p = 0.048). Similar patterns of mortality outcomes were noted in the subset of patients undergoing isolated valve surgery. In conclusion, overweight and obese patients had greater survival after valve surgery than patients with a normal BMI. Very lean patients undergoing valve surgery are at a greater hazard for mortality and might require more rigorous preoperative candidate screening and closer postoperative monitoring.

Midterm benefits of preoperative statin therapy in patients undergoing isolated valve surgery.

BACKGROUND: Recent data have suggested that statins are associated with reduced early mortality and cardiovascular events after valvular heart surgery. The midterm effects of preoperative statin therapy in the setting of valvular heart surgery are presently unclear. METHODS: All patients (n=2,120) who underwent a valvular procedure between April 2004 and April 2010 were identified. Patients undergoing concomitant coronary artery bypass graft surgery were excluded. Two patient groups were studied: those who received preoperative statin therapy (n=663; 31.3%) and those who did not (n=1,457; 68.7%). Propensity score matching resulted in 381 matched pairs, thus addressing baseline risk imbalances. Thirty-day mortality, readmission rates, postoperative complications, and length of stay were analyzed. Late survival was ascertained by the Social Security Death Index. RESULTS: In the matched group, 30-day mortality was 1.3% (5 of 381) for statin-treated patients versus 4.2% (16 of 381) for statin-untreated patients (p=0.03). After a mean follow-up of 33±23 months, statin therapy was associated with significantly reduced mortality (hazard ratio 0.63, 95% confidence interval: 0.43 to 0.93, p=0.019), independent of known cardiac risk factors. Weighted log rank tests revealed that the mortality difference between the two cohorts occurred early after surgery (p=0.015). Statin users were less likely to be readmitted to the intensive care unit (3.4% versus 8.1%, p=0.01). There were no other significant differences between the two groups in terms of postoperative complications and length of stay. CONCLUSIONS: Preoperative statin administration is associated with early reductions in mortality among patients undergoing isolated valvular heart surgery, leading to improved late survival. Future prospective analyses are warranted to optimize statin therapy in this patient population.

Perioperative statin therapy reduces mortality in normolipidemic patients undergoing cardiac surgery.

OBJECTIVE: Statins might have pleiotropic effects, independent of their ability to reduce lipid levels. Recent data have suggested that statins improve early survival and cardiovascular outcomes after coronary artery bypass graft surgery. The effectiveness of statin therapy in normolipidemic cardiac surgery patients is as yet unclear. METHODS: We evaluated 3056 consecutive patients who had undergone cardiac surgery between April 2004 and April 2009. Perioperative statin therapy was defined as continued treatment both before (≥ 6 months) and after the index surgery (included as a discharge medication). Hyperlipidemia (HL) was defined as a total cholesterol level greater than 200 mg/dL within 6 months before surgery. Four groups were analyzed: (1) statin-untreated normolipidemic (NL-, n = 1052); (2) statin-treated normolipidemic (NL+, n = 206); (3) statin-untreated hyperlipidemic (HL-, n = 638); and (4) statin-treated hyperlipidemic (HL+, n = 1160) patients. Adjusted hazard ratios accounted for the known preoperative cardiac risk factors. Mortality was ascertained by retrospective database review and the Social Security Death Index. RESULTS: The mean follow-up was 2.2 years. The crude rate of 30-day mortality was 3.0% (32/1052), 0% (0/206), 8.0% (51/638), and 0.7% (8/1160) for the NL-, NL+, HL-, and HL+ groups, respectively. The overall all-cause crude mortality rate was 9.6% (101/1052), 3.9% (8/206), 17.2% (110/638), and 6.5% (75/1160) for the NL-, NL+, HL-, and HL+ groups, respectively. Statin therapy for NL patients undergoing cardiac surgery independently reduced the overall all-cause mortality (adjusted hazard ratio, 0.34; 95% confidence interval, 0.16-0.71; P = .004). CONCLUSIONS: Perioperative statin therapy was associated with reduced mid-term mortality for patients undergoing cardiac surgery, irrespective of their baseline lipid status. This clinical evidence suggests that the beneficial effects of statins might extend beyond their lipid-lowering ability.

Reduction of surgical mortality and morbidity in diabetic patients undergoing cardiac surgery with a combined intravenous and subcutaneous insulin glucose management strategy.

OBJECTIVE: To determine if glucose management in postcardiothoracic surgery patients with a combined intravenous (IV) and subcutaneous (SC) insulin regimen reduces mortality and morbidity in patients with diabetes and stress-induced hyperglycemia. RESEARCH DESIGN AND METHODS: Retrospective review of 614 consecutive patients who underwent cardiothoracic (CT) surgery in 2005 was performed to evaluate the incidence and treatment of postoperative hyperglycemia and operative morbidity and mortality. Hyperglycemic patients (glucose >6.05 mmol/l) were treated with IV insulin in the intensive care unit (ICU) followed by SC insulin (outside ICU). Subgroup analysis was performed on 159 coronary artery bypass grafting (CABG)-only patients. RESULTS: Among all CT surgeries, patients with a preoperative diagnosis of diabetes had higher rates of postoperative mortality (7.3 vs. 3.3%; P = 0.03) and pulmonary complications (19.5 vs. 11.6%; P = 0.02) but had similar rates of infections and cardiac, renal, and neurological complications on univariate analysis. However, on multivariate analysis, a preoperative diagnosis of diabetes was not a significant factor in postoperative mortality or pulmonary complications. In CABG-only patients, no significant differences were seen in outcomes between diabetic and nondiabetic patients. Independent of diabetic status, glucose > or =11 mmol/l on ICU admission was predictive of higher rates of mortality and renal, pulmonary, and cardiac postoperative complications. CONCLUSIONS: A combination of IV insulin (in the ICU) and SC insulin (outside the ICU), a less costly and less nursing-intensive therapy than 3 days of IV insulin postoperatively, results in a reduction of the increased surgical morbidity and mortality in diabetic patients after CT surgery.

The impact of left ventricular reconstruction on survival in patients with ischemic cardiomyopathy.

OBJECTIVE: Left ventricular reconstruction (LVR) is performed to improve the morphologic structure and function of the heart in patients with heart failure. This procedure has been performed at the Cleveland Clinic Foundation since 1997. We assessed mortality, functional status, and predictors of outcome in these patients. METHODS: Data were extracted from multiple prospectively acquired datasets on demographic, clinical, and operative details of 220 consecutive patients who underwent LVR between July 1997 and July 2003, where the indication for surgery was heart failure (of whom 66% had New York Heart Association (NYHA) functional class III or IV symptoms). Mortality, functional status, and postoperative complications were ascertained by reference to the clinical record, social security death index, and by phone contact. Mean preoperative left ventricular ejection fraction (LVEF) was 21.5+/-7.3% and mean left ventricular end-diastolic diameter was 6.4+/-1.0 cm. The mean age was 61.4+/-9.0 years and 80% were male. The majority (86%) of patients underwent concomitant coronary artery bypass grafting and 49% underwent mitral valve surgery. RESULTS: Thirty-day mortality was 1% and survival at 1, 3, and 5 years was 92%, 90%, and 80%, respectively. Of the survivors for whom data on NYHA functional class were available, 85% were in NYHA functional class I or II. Mortality was predicted by reduced preoperative ejection fraction <20% (unadjusted hazard ratio 1.53, p = 0.02), body mass index < or = 24 kg/m2 (unadjusted hazard ratio 1.69, p = 0.01), QRS duration > or = 130 ms (unadjusted hazard ratio 1.66, p = 0.01) and the requirement for renal replacement therapy postoperatively (unadjusted hazard ratio 3.85, p < 0.01). Mean LVEF improved to 24.7+/-8.86% (p < 0.01) and left ventricular volumes were also significantly reduced. CONCLUSIONS: In selected patients with heart failure, LVR, in conjunction with revascularization and valve surgery, is associated with excellent survival, improved symptoms, and improved LVEF and left ventricular dimensions.

Annular geometry and motion in human ischemic mitral regurgitation: novel assessment with three-dimensional echocardiography and computer reconstruction.

BACKGROUND: Annular geometry and motion in functional ischemic mitral regurgitation are incompletely understood. Three-dimensional echocardiography demonstrates saddle-shaped annular geometry, but standard methodology does not enable quantification of annular motion. Therefore, a novel technique using three-dimensional echocardiography and computer software was used to characterize alterations in mitral annular geometry and motion in patients with ischemic mitral regurgitation. METHODS: We developed a computer program to reconstruct the mitral annulus based on spatial coordinates from three-dimensional echocardiography. Data were obtained at end-diastole and end-systole in 7 patients with ischemic mitral regurgitation and 5 normal control subjects. Mitral annular motion was quantified by calculating the displacement area of the annulus between end-diastole and end-systole. RESULTS: Comparison of ischemic mitral regurgitation and control patients revealed differences in annular geometry and motion at end-diastole. Annular perimeter was greater in ischemic mitral regurgitation patients (10.7 +/- 0.7 cm versus 8.6 +/- 0.2 cm in control group; p < 0.03), with increased intertrigonal distance in ischemic mitral regurgitation patients (2.8 +/- 0.3 cm versus 2.1 +/- 0.1 cm; p < 0.06). These changes resulted in increased annular orifice area in ischemic mitral regurgitation patients (9.1 +/- 1.2 cm2 versus 5.7 +/- 0.3 cm2; p < 0.03). Ischemic mitral regurgitation patients had altered annular motion, with reduced movement of the posterior annulus (5.4 +/- 0.7 cm2 versus 8.7 +/- 1.1 cm2; p < 0.03). CONCLUSIONS: Computer analysis of data obtained from three-dimensional echocardiography demonstrates altered annular geometry and motion in patients with ischemic mitral regurgitation. Patients with ischemic mitral regurgitation have annular dilatation, with an increase in anterior and posterior annular perimeters; this is accompanied by an increase in the intertrigonal distance and restriction of annular motion.

Echocardiographic assessment of regional ventricular function after device-based change of left ventricular shape.

We assessed the effects of implantation of Myosplint (Myocor, Maple Grove, Minn), a device that changes left ventricular (LV) cross-sectional shape from circular to bilobar, on regional LV function. A total of 10 open-chest dogs with tachycardia-induced cardiomyopathy were studied before and after Myosplint implantation. LV cross-sectional epicardial echocardiography at the papillary muscle level was performed along with acquisition of hemodynamic data. LV normalized thickening, fractional thickening, end-diastolic thickness, and end-diastolic curvatures were calculated for 10 LV segments. Myosplint implantation did not affect LV hemodynamics, but decreased average end-diastolic curvature (P <.0001) and increased its segmental heterogeneity (P <.0001). There was no change in average fractional thickening, whereas normalized thickening increased (P =.05). In contrast, segmental heterogeneity of both normalized and fractional thickening increased (P =.02 and P =.01, respectively). Structural modeling confirmed that Myosplint implantation increases regional stress heterogeneity and curvature heterogeneity. LV cross-sectional shape markedly affects regional LV performance.

Noninvasive assessment of cardiac mechanics and clinical outcome after partial left ventriculectomy.

BACKGROUND: Partial left ventriculectomy (PLV) was developed as a therapy for end-stage heart failure, but results were variable with few a priori predictors of outcome. Little is known about its effects on myocardial mechanics and their relation to clinical outcome. METHODS: Twenty-four dilated cardiomyopathy patients underwent cardiac magnetic resonance imaging (MRI) before PLV, and 3 and 12 months after surgery. Left ventricular (LV) circumferential shortening and wall stress were computed at three short-axis levels. Exploratory outcome analysis grouped patients according to the timing of adverse cardiac events postsurgery. RESULTS: LV mass and volume were decreased at each postsurgical time point (all p < 0.01). At 3 months, regional wall stress was reduced at all short-axis levels; but by 12 months stress was reduced from baseline only at the apex. Circumferential shortening was increased significantly at both postsurgical time points at each level. On average, septal shortening was negative (stretching) before surgery, but increased significantly, and was positive, postsurgery. Exploratory outcome analysis found that negative values of basal septum circumferential shortening before surgery increased the probability of event-free survival beyond 6 months. CONCLUSIONS: Regional heterogeneity of LV myocardial function, associated with dilated cardiomyopathy, was diminished after PLV but was also related to patient outcome. MRI with tissue tagging is useful for assessing the efficacy of surgical therapies for congestive heart failure.

Does off-pump coronary surgery reduce morbidity and mortality?

OBJECTIVE: To compare hospital outcomes of on-pump and off-pump coronary artery bypass surgery. METHODS: From 1997 to 2000, primary coronary artery bypass grafting was performed in 481 patients off pump and in 3231 patients on pump. Hospital outcomes were compared between propensity-matched pairs of 406 on-pump and 406 off-pump patients. The 2 groups were similar in age (P =.9), left ventricular function (P =.7), extent of coronary artery disease (P =.5), carotid artery disease (P =.4), and chronic obstructive pulmonary disease (P =.5). However, off-pump patients had more previous strokes (P =.05) and peripheral vascular disease (P =.02); on-pump patients had a higher preoperative New York Heart Association class (P =.01). RESULTS: In the matched pairs the mean number of bypass grafts was 2.8 +/- 1.0 in off-pump patients and 3.5 +/- 1.1 in on-pump patients (P <.001). Fewer grafts were performed to the circumflex (P <.001) and right coronary (P =.006) artery systems in the off-pump patients. Postoperative mortality, stroke, myocardial infarction, and reoperation for bleeding were similar in the 2 groups. There was more encephalopathy (P =.02), sternal wound infection (P =.04), red blood cell use (P =.002), and renal failure requiring dialysis (P =.03) in the on-pump patients. CONCLUSIONS: Both off- and on-pump procedures produced excellent early clinical results with low mortality. An advantage of an off-pump operation was less postoperative morbidity; however, less complete revascularization introduced uncertainty about late results. A disadvantage of on-pump bypass was higher morbidity that seemed attributable to cardiopulmonary bypass.