The Need for Consistent Predictors of Success for Surgical Ablation of Atrial Fibrillation: A Call to Action.

OBJECTIVE: As with any medical therapy, identification of consistent and reliable outcome predictors is essential to understanding the efficacy of surgical ablation for atrial fibrillation. We originally intended to conduct a meta-analysis on atrial fibrillation surgical ablation to identify clinical factors that are most often associated with success. However, these studies are greatly heterogeneous. We conducted a systematic review to identify trends in outcome predictors and to provide recommendations for more uniform data analysis and reporting. METHODS: Relevant studies published between January 2005 and September 2013 were identified. To minimize heterogeneity, data were extracted only from multivariate analyses of outcome predictors. The initial approach for meta-analytic analyses was abandoned for a systematic review approach. RESULTS: From 604 initial citations, 19 studies with 5200 patients were included in the review. Systematic review of multivariable atrial fibrillation recurrence rates after surgical ablation revealed that studies were statistically heterogeneous, but atrial fibrillation recurrence after surgical ablation in mid-term follow-up was most often predicted by left atrium size, duration of atrial fibrillation, fine-wave atrial fibrillation, age of patient, and atrial fibrillation type. CONCLUSIONS: The innate heterogeneity of published data precludes a meta-analysis for predictors of surgical ablation success. Of the few published studies that allow comparison, the most consistent predictors of failure were enlarged left atrium and long atrial fibrillation duration. These results underscore the need for consistent and reliable outcome predictors. We strongly recommend the development of a standardized system of measurement for consistent clinical parameters that can be used in outcome analyses for surgical ablation of atrial fibrillation.

The impact of a multidisciplinary blood conservation protocol on patient outcomes and cost after cardiac surgery.

OBJECTIVE: Although associations between transfusion and inferior outcomes have been documented, there is a lack of blood transfusion standardization in cardiac surgery. At the Inova Heart and Vascular Institute, a multidisciplinary, criterion-driven algorithm for transfusion management was implemented. We examined the effect of our blood conservation protocol on transfusion rates and outcomes after cardiac surgery and on stability of transfusion over time. METHODS: Patients undergoing first-time cardiac surgery from 2006 (full year before protocol) were compared with those in 2009 (after protocol) and propensity score matched to improve balance. Data were prospectively collected. Stability of transfusion incidence also was compared (2005-2006 vs 2008-2014). RESULTS: After matching, 890 patients from each year were included. Use of blood products decreased from 54% in 2006 to 25% in 2009 (P < .001). Patients in 2009 had a lower incidence of postoperative renal failure (2.6% vs 4%, P = .04), reoperations for bleeding (2% vs 4%, P = .004), and readmissions at less than 30 days (6% vs 12%, P < .001). No differences were found for operative mortality, deep sternal wound infection, or permanent strokes. Patients in 2009 had greater improvement in physical (P = .001) and mental (P = .02) quality of life than patients in 2006. Reduction of blood products led to significant cost savings for packed erythrocytes (P < .001) and platelets (P < .001). After protocol implementation, transfusion incidence remained 30% or less, with less than 28% in most years. CONCLUSIONS: A multidisciplinary blood conservation program can significantly control blood transfusion rates, improve outcomes, and be sustained over time. Efforts are needed to implement evidence-based protocols to standardize and decrease blood use in cardiac surgery to improve outcomes and reduce cost.

Left-Sided Surgical Ablation for Patients With Atrial Fibrillation Who Are Undergoing Concomitant Cardiac Surgical Procedures.

BACKGROUND: Growing evidence indicates the effectiveness of surgical ablation confined to the left atrium, especially with short duration of atrial fibrillation (AF) and smaller left atrial (LA) size. This study examined rhythm status and predictors of failure in this group of patients. METHODS: Of 800 patients who underwent concomitant surgical ablation (2005 to 2015), 110 had LA-only ablation. Rhythm status was defined according to Heart Rhythm Society guidelines: sinus rhythm (SR) without class I/III antiarrhythmic drugs (AADs). Multivariate analyses examined predictors for SR without AADs. Predictors of failure were also stratified as age 75 years or older, LA size 5 cm or larger, AF duration 5 years or more, and nonparoxysmal AF type for secondary analyses. RESULTS: Mean age was 70.7 ± 9.4 years, mean EuroSCORE II (European System for Cardiac Operative Risk Evaluation) was 4.7 ± 4.3%, mean LA size was 4.4 ± 0.8 cm, median (interquartile range) AF duration was 3.5 months (range, 0.4 to 21 months), 26% of patients were female, 59% had coronary artery bypass graft procedures, 36% had aortic valve procedures, and 25% had mitral valve procedures. SR without AADs at 6, 12, and 24 months was 82% (79 of 96), 87% (78 of 90), and 79% (61 of 77), respectively. The only independent predictor of SR without AADs at 6 months was smaller LA size (odds ratio, 0.35; p = 0.014). Return to SR without AADs at 6, 12, and 24 months was as follows: 92%, 93%, and 91%, respectively, for patients with no traditional predictors of failure (n = 32); 88%, 90%, and 77%, respectively, for one predictor (n = 47); and 66%, 76%, and 70% for two or more predictors (n = 31). CONCLUSIONS: LA-only ablation yielded acceptable success rates, primarily in patients with shorter AF duration and smaller LA. However, success was reduced in patients with traditional predictors of failure. Well-designed studies with standardized lesion sets and ablation tools are required to determine whether full Cox maze yields better outcomes in patients with more advanced AF.

Health-Related Quality of Life After Minimally Invasive Cardiac Surgery.

OBJECTIVE: Factors influencing health-related quality of life (HRQL) after minimally invasive cardiac surgery have not been well described. We examined the trajectory of HRQL after minimally invasive cardiac surgery and the role of perioperative factors and rhythm on HRQL changes. METHODS: Patients underwent minimally invasive surgical ablation for atrial fibrillation and/or valve surgery (n = 235). Health-related quality of life (SF-12) and clinical status were assessed preoperatively and postoperatively. RESULTS: Physical summary HRQL (F = 36.2, P < 0.001) and mental summary HRQL (F = 3.2, P = 0.047) improved significantly by 12 months after surgery. Improvement on HRQL peaked at 6 months and plateaued between 6 and 12 months. Physical HRQL was similar to age-based normal values before surgery (P = 0.66) and surpassed norms by 6 months after surgery (P < 0.001). Younger age (r = -0.15, P = 0.02) and lower EuroSCORE II (r = -0.19, P = 0.003) correlated with greater HRQL improvements by 6 months. Only lower EuroSCORE II (r = -0.14, P = 0.04) correlated with greater HRQL improvement by 12 months. Length of stay and major morbidity were not related to HRQL improvement. In surgical ablation patients, restoration of stable sinus rhythm throughout the first 12 months was associated with greater physical HRQL improvement by 6 months compared with patients who had atrial arrhythmia recurrences (change, 5.0 vs. -1.0, P = 0.02). CONCLUSIONS: Health-related quality of life improved significantly after minimally invasive cardiac surgery. These improvements were influenced by age, operative risk, symptoms, and rhythm status. Even patients with HRQL in a normal range before surgery can experience improved HRQL after surgery. Minimally invasive cardiac surgery can offer decreased postoperative complications and also improved HRQL.

Comparison of EuroSCORE II, Original EuroSCORE, and The Society of Thoracic Surgeons Risk Score in Cardiac Surgery Patients.

BACKGROUND: The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was developed to reflect a more current dataset and evidence-based improvements in cardiac surgery. In the United States, The Society of Thoracic Surgeons (STS) risk score is more accepted owing to relatively high predictive value despite less user friendliness and inapplicability to some cardiac surgeries. We compared the precision of EuroSCORE II with EuroSCORE I and the STS risk score for operative mortality. METHODS: Data were collected prospectively for all cardiac surgery patients at a single center since 2001 (N = 11,788). A secondary analysis for patients with cardiac surgery not accommodated by the STS model compared only EuroSCORE II and I (N = 5,880). Receiver-operating characteristic analyses were performed for operative mortality to determine the discriminative ability for each score. RESULTS: Observed operative mortality was 1.8%. Mean predicted mortality for STS risk score, EuroSCORE II, and EuroSCORE I was 2.7%, 3.3%, and 7.8%, respectively. The discriminative ability for operative mortality by area under the curve for EuroSCORE II, EuroSCORE I, and STS risk score was 0.844, 0.819, and 0.846, respectively. In secondary analyses comparing EuroSCORE II with EuroSCORE I, risk scores were correlated (rs = 0.83, p < 0.001). However, for operative mortality (observed, 4%), EuroSCORE II had better absolute prediction and discriminative ability (expected, 5.8%; area under the curve 0.754) than EuroSCORE I (expected, 12.5%; area under the curve 0.688). CONCLUSIONS: EuroSCORE II had better predictive discrimination for operative mortality than EuroSCORE I, which greatly overestimated this risk. EuroSCORE II fared well compared with the STS risk score. The inclusive nature of EuroSCORE II for numerous procedures provides more flexibility than the STS score for complex procedures. EuroSCORE II should be considered for calculating risk score for complex cardiac surgical patients.

The Effects of Frailty in Patients Undergoing Elective Cardiac Surgery.

BACKGROUND: The Society of Thoracic Surgeons (STS) recommends using gait speed as a marker of frailty to identify cardiac surgery patients at risk for adverse outcomes. However, a single marker of frailty may not provide consistently reliable risk information. We evaluated the impact of frailty and gait speed on patient outcomes after elective cardiac surgery. METHODS: This was a prospective study of 167 older (≥65 years) coronary artery bypass grafting (CABG) and/or valve surgery patients. Patients were assessed using Cardiovascular Health Study (CHS) Frailty Index criteria: weight loss, exhaustion, physical activity, gait speed, and grip strength. RESULTS: Frailty was identified in 39 patients (23%) using CHS criteria. Frail patients had longer median intensive care unit stays (54 vs. 28 h, p = 0.003), longer median length of stay (8 vs. 5 days, p < 0.001), and greater likelihood of STS-defined complications (54% vs. 32%, p = 0.011) and discharge to an intermediate-care facility (45% vs. 12%, p < 0.001) but were not different from nonfrail patients on major outcome, operative mortality, or readmissions. After multivariate adjustment, frail and nonfrail patients were similar on perioperative outcomes. Absolute gait speed and slow gait speed using a cutoff were not related to incidence of STS-defined complications or major outcome in multivariate analyses. However, higher body mass index was correlated with slower gait speed (rs = 0.30, p < 0.001). CONCLUSIONS: The CHS index did not identify "frail" patients at increased risk for adverse outcomes. No relationship was found between gait speed and outcome. There is a need for alternative multidimensional measures to assess frailty in cardiac surgical patients. doi: 10.1111/jocs.12699 (J Card Surg 2016;31:187-194).

Development of the Cardiac Surgery Patient Expectations Questionnaire (C-SPEQ).

PURPOSE: Some variability in recovery and outcomes after cardiac surgery may be influenced by psychosocial aspects not routinely captured. Preliminary evidence suggests patient expectations impact health status, but there is no specific measure of expectations for cardiac surgery. The purpose of this study was to adapt an expectations scale to cardiac surgery and assess the psychometric properties of the scale. METHODS: Before surgery, 93 patients awaiting non-emergent cardiac surgery completed questionnaires, including the adapted Cardiac Surgery Patient Expectations Questionnaire (C-SPEQ). At 1 year after surgery, 68 patients completed questionnaires. RESULTS: Mean C-SPEQ score was 39.4 ± 9.02, and scores were normally distributed (Cronbach's alpha = 0.86). Higher score indicated negative expectations. Higher presurgery C-SPEQ score was correlated with greater depression (r = 0.32, p = 0.01) and perceived stress (r = 0.36, p = 0.003), but not state anxiety (r = 0.18, p = 0.14), at one-year post-surgery. Higher C-SPEQ was associated with longer recovery time (B = 0.14, p = 0.006) and lower physical HRQL after surgery (B = -0.31, p = 0.005). Higher C-SPEQ was not related to greater odds for perioperative complications (OR 1.01, p = 0.68) or readmissions <30 days (OR 1.05, p = 0.31). C-SPEQ score was not related to survival. CONCLUSIONS: Adaptation of an expectations questionnaire to cardiac surgery patients was successful with acceptable reliability and validity. Negative expectations had a detrimental impact on recovery and HRQL following cardiac surgery but were not related to clinical outcomes. Although focus is mainly on improving clinical outcomes, there are opportunities to improve non-clinical aspects of the patient experience. Presurgical education might better prepare patients, reduce negative expectations, and improve psychosocial outcomes after cardiac surgery.

The Effect of Initiation of a Transcatheter Aortic Valve Replacement Program in the Treatment of Severe Aortic Stenosis.

We assessed the effect of a transcatheter aortic valve replacement (TAVR) program and Heart Team concept on our approach to severe isolated symptomatic aortic stenosis (AS) with regard to surgical practice, patient selection, perioperative outcomes, 1-year survival, and AVR volume. TAVR program began in August 2011. Patients having isolated surgical AVR between January 2008 and August 2011, when the program began (n = 282, 42 months), were compared with those after the program began until February 2015 (n = 344, surgical AVR and n = 126, TAVR, 42 months). Isolated surgical AVR accounted for 21% of all valve procedures (isolated and concomitant) before and after the TAVR program. However, the volume of all isolated AVR (surgical and transcatheter) increased to 27% of all valve procedures (isolated and concomitant) after the TAVR program implementation. Mean Society Of Thoracic Surgeons (STS)-predicted mortality risk was similar among patients who had surgical AVR pre-TAVR and post-TAVR implementation (2.3% vs 2.1%, P = 0.227), but addition of patients who had TAVR (STS risk = 7.1%) increased STS-predicted risk for all isolated AVR (surgical and transcatheter) procedures (2.3% vs 3.4%, P < 0.001). A similar trend was found for age, including a slight decrease in octogenarians for surgical AVR post-TAVR (18% vs 13%, P = 0.084). Operative mortality for isolated surgical AVR was similar in pre-TAVR and post-TAVR (2.1% vs 1.8%, P = 0.798), as were observed/expected (O/E) ratios (0.91 vs 0.82). For all isolated AVR, O/E ratio was 0.91 pre-TAVR and 0.82 post-TAVR (n = 470), including O/E = 0.79 for patients who had TAVR. No changes were found in proportion of isolated surgical AVR cases or patient risk and outcomes after introduction of TAVR program and Heart Team. However, volume of patients with severe AS treated increased significantly post-TAVR. Our results reflect growing awareness of TAVR availability and accompanying increases in patients referred to our Heart Team for AS treatment.

Amiodarone after surgical ablation for atrial fibrillation: Is it really necessary? A prospective randomized controlled trial.

OBJECTIVE: Prophylactic antiarrhythmic drug (AAD) treatment is a well-established practice after catheter ablation for atrial fibrillation (AF), but it is controversial after surgical ablation. This prospective randomized controlled trial examined whether amiodarone after surgical ablation reduced atrial arrhythmia recurrence within the first 3 months after surgery. METHODS: Ninety patients were randomized to receive (n = 45) or not receive (n = 45) amiodarone after surgical ablation. Rhythm status was ascertained via clinical follow-up and 72-hour continuous monitoring at 6 and 12 weeks, using Heart Rhythm Society guidelines. Primary outcome was defined as atrial arrhythmia recurrence, cardioversion, ablation, or crossover from no-amiodarone to amiodarone as a result of atrial arrhythmia during follow-up. An intention-to-treat approach was used. RESULTS: The 2 study groups were similar in traditional predictors for failure, including left atrium size (5.0 vs 5.1 cm, P = .734), median AF duration (23 vs 20 months, P = .513), and long-standing persistent AF (44% vs 33%, P = .280). The primary outcome occurred in 52% of the no-amiodarone group (23 of 44) and 19% of the amiodarone group (8 of 43; P = .001). Cumulative freedom from primary outcome was greater in the amiodarone group (81.4% vs 47.7%, P < .001). Amiodarone was discontinued in 18 patients randomized to amiodarone for side effects, bradycardia, or noncompliance. CONCLUSIONS: Prophylactic amiodarone reduced early atrial arrhythmia recurrence. These results are consistent with catheter AF ablation findings and should inform recommendations for prophylactic class I/III AAD after surgical AF ablation, regardless of discharge rhythm status. As previously recommended, monitoring for side effects and amiodarone discontinuation by 3 months, for patients in sinus rhythm, is warranted. CLINICAL TRIAL REGISTRATION: NCT01416935.

New Approach to Exclude the Left Atrial Appendage During Minimally Invasive Cryothermic Surgical Ablation.

OBJECTIVE: Atrial fibrillation (AF) is associated with an increased risk for embolic stroke originating from the left atrial appendage (LAA). A recently introduced LAA epicardial clip occluder, the AtriClip PRO, can be applied through midsternotomy or small thoracotomy. We assessed the safety and efficacy of a new surgical approach to apply the AtriClip PRO and exclude the LAA through right minithoracotomy and transverse sinus. METHODS: The AtriClip PRO was applied in 24 patients with the new approach. Intraoperative transesophageal echocardiography was used to exclude LAA thrombi at baseline and evaluate LAA perfusion and residual neck postoperatively. RESULTS: Mean (SD) age was 64.5 (8.6) years; 95% of the patients had nonparoxysmal AF with median AF duration of 39 months (interquartile range, 9.3-85.3 months), and mean (SD) left atrium diameter was 4.5 (0.7) cm (range, 3.1-5.7 cm). In one attempt, the clip was not deployed because of severe adhesions in the transverse sinus area. The procedural success rate was 95%. Nine minimally invasive mitral valve repairs were combined with surgical ablation; the rest were isolated right minithoracotomy Cox maze procedures. There was no remaining LAA neck in 71% of the patients. Perioperative outcomes were acceptable, and median length of stay was 5.5 days. CONCLUSIONS: The development of a reliable approach to LAA management during minimally invasive surgical ablation through right minithoracotomy has been challenging. This new approach is safe and effective and should offer a superior and consistent early and long-term solution compared with the current approach of endocardial stitch closure.

Operative risk and preoperative hematocrit in bypass graft surgery: Role of gender and blood transfusion.

BACKGROUND: The association between lower preoperative hematocrit (Hct) and risk for morbidity/mortality after cardiac surgery is well established. We examined whether the impact of low preoperative Hct on outcome is modified by blood transfusion and operative risk in women and men undergoing nonemergent CABG surgery. METHODS: Patients having nonemergent, first-time, isolated CABG were included (N=2757). Logistic regressions assessed effect of hematocrit on major perioperative morbidity/mortality separately by males (n=2232) and females (n=525). RESULTS: Mean age was 63.2±10.1years, preoperative hematocrit was 38.9±4.8%, and STS risk score was 1.3±1.8%. Blood transfusion was more likely in female patients (26% vs. 12%, P<0.001). Multivariate analyses revealed that lower body mass index and lower preoperative hematocrit predicted transfusion in males and females, whereas older age (OR=1.03, P=0.017) also predicted transfusion in females. Major morbidity was also more likely in female patients (12% vs. 7%, P<0.001). In multivariate analyses, blood transfusion was the only predictive factor for major morbidity in females (OR=4.56, P<0.001). In males, higher body mass index (OR=1.07, P<0.001), lower hematocrit (OR=0.94, P=0.017), interaction of STS score with hematocrit (OR=1.02, P=0.045), and blood transfusion (OR=9.22, P<0.001) were significant predictors for major morbidity. CONCLUSIONS: This study showed females were more likely to have blood transfusion and major morbidities after nonemergent CABG. Traditional factors that have been found to predict outcomes, such as hematocrit and STS risk, were related only to major morbidity in male patients. However, blood transfusion negatively impacted major outcome after nonemergent CABG surgery across all STS risk levels in both genders.

Potential Impact of Modifiable Clinical Variables on Length of Stay After First-Time Cardiac Surgery.

BACKGROUND: Recent financial challenges highlight the importance of accurate prediction of length of hospital stay (LOS). We assessed reliability of The Society of Thoracic Surgeons (STS) risk prediction for extended and shorter LOS and examined whether modifiable clinical variables are associated with LOS in first-time cardiac surgery patients. METHODS: Isolated aortic valve, mitral valve, and coronary artery bypass graft surgery patients since 2008 were included (n = 3,472). Multivariate regression was used to evaluate nonmodifiable and potentially modifiable (preoperative hematocrit, hemoglobin A1c, body mass index, current smoker, major perioperative morbidity, and blood product transfusion) predictors of LOS in days. RESULTS: Mean age was 63.9 ± 11.2 years, 76% were males, and mean STS mortality risk was 1.9% ± 3.2%. Median (interquartile range) LOS was 4 (3 to 6) days. Predicted STS risk was 6.2% ± 7.1% for extended LOS (>14 days) and 48.3% ± 20.2% for short LOS (<6 days). Extended LOS was observed in 5.2% of patients (observed versus expected, 0.84; p = 0.019). Observed short LOS was better than predicted (67.8%; observed versus expected, 1.40; p < 0.001). Inclusion of modifiable variables in the LOS prediction model was significant (p < 0.001). Significant modifiable predictors were lower hematocrit, higher hemoglobin A1c, major morbidity, and transfusion. Longer predicted LOS from the model correlated with longer actual LOS (rs = 0.63; p < 0.001). Applying the prediction equation from the model to a hypothetical average patient, predicted LOS was 4.6 days. CONCLUSIONS: The STS risk model was reliably predictive of short and extended LOS but did not allow prediction of exact LOS in days. Accounting for potentially modifiable clinical variables, such as low hematocrit and blood transfusion, especially in elective patients, should lead to shorter LOS, higher satisfaction, and reduced financial burden.

Should asymptomatic patients discharged with lower hemoglobin expect worse outcomes after valve surgery?

OBJECTIVE: Blood transfusion in cardiac surgery patients is associated with increased morbidity and cost. The decision to transfuse patients after surgery varies but is often based on low hemoglobin (Hgb) levels, regardless of symptom status. This study examined whether asymptomatic patients discharged with lower Hgb levels had increased risk for perioperative complications and 1-year mortality. METHODS: Between 2008 and mid-2014, a total of 1107 valve-only procedures were performed. Patients discharged alive with complete data (N = 1044) were divided into 2 groups with discharge Hgb levels of ≤8 g/dL (n = 153) or >8 g/dL (n = 891). Propensity score matching was conducted between Hgb groups, resulting in 152 patient pairs. RESULTS: In multivariate analyses, discharge Hgb level did not predict 30-day mortality (odds ratio [OR] = 1.01, P = .991), 1-year survival (hazard ratio [HR] = 0.87, P = .34), or readmission <30 days (OR = 0.92, P = .31). Furthermore, after propensity score matching, no differences were found between groups with Hgb levels ≤8 versus >8 g/dL in 30-day mortality (0% vs 0.7%, P > .99) or readmissions (14% vs 16%, P = .52). Cumulative 1-year survival was similar between matched groups with discharge Hgb level of ≤8 versus >8 g/dL (89.3% vs 91.4%, P = .67). Matched groups with Hgb level ≤8 versus >8 g/dL had similar physical (28% vs 18% increase; P = .27) and mental (7% vs 6% increase; P = .94) health-related quality of life (HRQL) improvements at 6 months. CONCLUSIONS: Asymptomatic patients discharged with lower Hgb levels did not manifest inferior outcomes, including perioperative morbidity/mortality, readmission <30 days, HRQL, and 1-year survival. The practice of blood transfusion to correct lower Hgb levels in asymptomatic patients should be eliminated, as it may be associated with increased morbidity without apparent clinical benefits after valve surgery.

Impact of Atrial Fibrillation Duration on the Success of First-Time Concomitant Cox Maze Procedures.

BACKGROUND: Atrial fibrillation (AF) duration is one of the most consistent predictors of Cox maze (CM) procedure failure. We examined the impact of AF duration on CM success in patients having first-time concomitant surgery. METHODS: First-time concomitant CM was performed in 505 patients. Freedom from atrial arrhythmia (AA) and class I/III antiarrhythmic drug (AAD) data were collected prospectively. Patients with longer AF duration (≥ 5 years; n = 113) were compared with shorter duration (<5 years; n = 392) in primary analyses. The AF duration was examined as a continuous variable in regression analyses. RESULTS: Patients with longer AF duration were older (68.4 vs 65.1 years, p = 0.002) and in long-standing persistent AF (80% vs 36%, p < 0.001). Freedom from AA and AA off AAD was lower in longer duration patients at 1 year (80% vs 94%, p < 0.001; 74 vs 87%, p = 0.005) and 2 years (69 vs 90%, p < 0.001; 61 vs 81%, p = 0.001). Freedom from stroke or transient ischemic attack (TIA) was similar (96.1% vs 95.4%, p = 0.65). Adjusting for clinical and AF-associated factors, each 1-year increase in AF duration had 13% greater odds for failure at 1 year (odds ratio [OR], 1.13, p = 0.004) and 20% greater odds at 2 years (OR, 1.20, p < 0.001). Cryothermia as sole energy source attenuated the negative impact of AF duration on 1-year success. CONCLUSIONS: Longer AF duration significantly impacted CM success and may result from extensive tissue remodeling. Patients with longer AF duration can expect reasonable success rates, especially when on AAD, and low stroke rates during follow-up. Cryoablation may reduce AF duration impact on success compared with combined bipolar radiofrequency and cryothermia.

Effect of patient age on blood product transfusion after cardiac surgery.

OBJECTIVE: Blood product transfusion after cardiac surgery is associated with increased morbidity and mortality. Transfusion thresholds are often lower for the elderly, despite the lack of clinical evidence for this practice. This study examined the role of age as a predictor for blood transfusion. METHODS: A total of 1898 patients were identified who had nonemergent cardiac surgery, between January 2007 and August 2013, without intra-aortic balloon pumps or reoperations, and with short (<24 hours) intensive care unit stays (age ≥75 years; n = 239). Patients age ≥75 years were propensity-score matched to those age <75 years to balance covariates, resulting in 222 patients per group. Analyses of the matched sample examined age as a continuous variable, scaled in 5-year increments. RESULTS: After matching, covariates were balanced between older and younger patients. Older age significantly predicted postoperative (odds ratio = 1.39, P = .028), but not intraoperative (odds ratio = 0.96, P = .559), blood transfusion. Older age predicted longer length of stay (B = 0.21, P < .001), even after adjustment for blood product transfusion (B = 0.20, P < .001). As expected, older age was a significant predictor for poorer survival, even with multivariate adjustment (hazard ratio = 1.34, P = .042). CONCLUSIONS: In patients with a routine postoperative course, older age was associated with more postoperative blood transfusion. Older age was also predictive of longer length of stay and poorer survival, even after accounting for clinical factors. Continued study into effects of transfusion, particularly in the elderly, should be directed toward hospital transfusion protocols to optimize perioperative care.

Minimally invasive mitral valve surgery without aortic cross-clamping and with femoral cannulation is not associated with increased risk of stroke compared with traditional mitral valve surgery: a propensity score-matched analysis.

OBJECTIVES: Open-heart surgery with fibrillatory arrest has been reported to be associated with an increased risk of stroke. We examined whether minimally invasive mitral valve surgery with fibrillatory arrest conferred a higher risk of stroke/transient ischaemic attack (TIA) and other major complications compared with median sternotomy and cardioplegic arrest. METHODS: Data were collected prospectively for 387 patients who had mitral valve surgery; 239 had a minimally invasive surgical approach and 148 had median sternotomy. All minimally invasive surgeries were performed by surgeons who were experienced in minimally invasive techniques. The effect of operative approach on risk of stroke/TIA and major morbidity was examined. After propensity score matching (PSM) was conducted between the two groups, 76 patients remained in each group. RESULTS: Before matching, the incidence of stroke/TIA did not differ between patients who had minimally invasive surgery (0.5%, n = 1) and those who had median sternotomy (1.4%, n = 2; P = 0.56). Patients who had minimally invasive surgery had a lower incidence of other major morbidity (0.8%, n = 2) than patients who had median sternotomy (6.1%, n = 9; P = 0.004). After adjustment for age and Society of Thoracic Surgeons predicted risk, there was no effect of operative approach on the odds for stroke/TIA (odds ratio [OR] = 0.41, P = 0.49) or other major morbidity (OR = 0.40, P = 0.31). After PSM, patients were balanced on preoperative characteristics. No patient in either matched group experienced permanent stroke/TIA, and major morbidity did not differ between the two groups (minimally invasive, 1.3%, n = 1; median sternotomy, 1.3%, n = 1; P > 0.99). CONCLUSIONS: A minimally invasive approach for mitral valve surgery on a fibrillating heart was not associated with a greater incidence of stroke/TIA than was median sternotomy. When performed by highly experienced surgeons, the minimally invasive approach with fibrillatory arrest did not increase the risk of perioperative stroke.

A systematic review of minimally invasive surgical treatment for atrial fibrillation: a comparison of the Cox-Maze procedure, beating-heart epicardial ablation, and the hybrid procedure on safety and efficacy.

There is a growing trend to perform off-bypass surgical ablation for atrial fibrillation (AF) because it is perceived to be safer and more effective than the Cox-Maze procedure with cardiopulmonary bypass (CPB) support. In this systematic review, we compared three minimally invasive stand-alone surgical ablation procedures for AF: the endocardial Cox-Maze procedure, epicardial surgical ablation and a hybrid epicardial surgical and catheter-based endocardial ablation procedure (hybrid procedure). Relevant studies were identified in MEDLINE and the Cochrane Database of Systematic Reviews according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. From 565 initial studies, 37 were included in this review. The total number of patients across all studies was 1877 (range 10-139). Two studies reported on endocardial Cox-Maze procedures (n = 145), 26 reported on epicardial surgical ablation (n = 1382) and 9 reported on hybrid surgical ablation (n = 350). For minimally invasive Cox-Maze, epicardial and hybrid groups, operative mortality rates were 0, 0.5 and 0.9%, perioperative permanent pacemaker insertion rates were 3.5, 2.7 and 1.5%, incidence of conversion to median sternotomy was 0, 2.4 and 2.5%, and reoperation for bleeding was 1.0, 1.5 and 2.2%, with mean length of stay (days) of 5.4, 6.0 and 4.6, respectively. At 12 months, rates of sinus rhythm restoration were 93, 80 and 70%, and sinus restoration without anti-arrhythmic medications was 87, 72 and 71%, for Cox-Maze, epicardial and hybrid procedures, respectively. Of the three procedures, the minimally invasive Cox-Maze procedure with CPB support was most effective for the treatment of stand-alone AF and had important safety advantages in conversion to sternotomy and major bleeding. The minimally invasive Cox-Maze procedure with CPB support also demonstrated the potential for a higher success rate 12 months following the procedure.

Association of operative risk with the outcome of concomitant Cox Maze procedure: a comparison of results across risk groups.

OBJECTIVES: Cardiac surgery patients with atrial fibrillation face increased risks for perioperative morbidity and decreased survival, yet only 39% of patients presenting with atrial fibrillation undergo concomitant surgical ablation. This low percentage may relate to the perception of lower yield for surgical ablation, especially in patients with complex clinical presentations. In this study, we compared outcomes after a concomitant Cox maze III/IV procedure in patients with high, intermediate, and low predicted operative risk. METHODS: Outcome data were prospectively captured after surgery. The additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) was greater than 6 for high-risk patients (n = 145), 3 or less for low-risk patients (n = 76), and greater than 3 and 6 or less for intermediate-risk patients (n = 149). RESULTS: No differences were found for perioperative morbidities, including operative mortality (high vs low risk, 2% vs 1%, P = 1.00; high vs intermediate risk, 2% vs 0.7%, P = .37). Median length of stay was longer in high-risk patients versus low-risk patients (8 vs 5 days, P < .001) and intermediate-risk patients (8 vs 6 days, P < .001). Return to sinus rhythm was comparable for high-risk versus low- and intermediate-risk patients at 6, 12, and 24 months. Physical health-related quality of life scores improved similarly for all groups at 12 months. No difference in long-term survival was found (log rank = 0.40; P = .82). CONCLUSIONS: The Cox maze III/IV procedure can be performed safely and effectively in patients with higher operative risk, who fare well when compared with lower-risk patients. The Cox maze III/IV procedure should be considered carefully in patients with a significant history of atrial fibrillation.

A more specific anticoagulation regimen is required for patients after the cox-maze procedure.

BACKGROUND: Long-term management of oral anticoagulation (OAC) after ablation for atrial fibrillation (AF) is an ongoing challenge. Heart Rhythm Society (HRS) guidelines provide no specific recommendations for OAC after surgical ablation. The purpose of this study was to determine the necessity of OAC protocols after surgical ablation. METHODS: Patients (N = 691) who underwent the Cox-Maze procedure with left atrial appendage (LAA) management were followed prospectively. All patients were discharged on OAC unless contraindicated. Cardiac rhythm, bleeding, and embolic stroke or transient ischemic attack (TIA), or both, were verified during follow-up. RESULTS: Over a mean follow-up of 47.3 ± 30.3 months, stroke/TIA was reported in 14 patients (5.1 cases per 1,000 person-years) and major bleeding events were found in 46 patients (16.9 cases per 1,000 person-years). Patients with major bleeding events had higher median CHADS2 (Congestive Heart Failure, Hypertension, Age, Diabetes, Stroke/Transient Ischemic Attack) scores (2 [range, 1-3] versus 1 [range, 1-2]; p = 0.012), but no association was found between incidence of stroke/TIA and median CHADS2 score (1 [range, 0-2.25] versus 1 [range, 1-2]; p = 0.377). Patients with CHADS2 scores of 2 or greater had the same rates of stroke/TIA (p = 0.787) but a higher incidence of major bleeding (p = 0.009) as did patients with CHADS2 scores less than 2. Adjusting for OAC discontinuation and stable sinus rhythm, patients with CHADS2 scores of 2 or greater did not have higher stroke/TIA risk (hazard ratio [HR], 0.84; p = 0.759). CONCLUSIONS: Our results indicate that the decision to discontinue OAC after the Cox-Maze procedure should not be based solely on CHADS2 scores; rather, rhythm status, echocardiographic findings, and patient risk for bleeding should be considered. These findings underscore the need for an OAC protocol for patients who have undergone the Cox-Maze procedure with appropriate LAA management.

Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.

High-throughput 'omics' technologies that generate molecular profiles for biospecimens have been extensively used in preclinical studies to reveal molecular subtypes and elucidate the biological mechanisms of disease, and in retrospective studies on clinical specimens to develop mathematical models to predict clinical endpoints. Nevertheless, the translation of these technologies into clinical tests that are useful for guiding management decisions for patients has been relatively slow. It can be difficult to determine when the body of evidence for an omics-based test is sufficiently comprehensive and reliable to support claims that it is ready for clinical use, or even that it is ready for definitive evaluation in a clinical trial in which it may be used to direct patient therapy. Reasons for this difficulty include the exploratory and retrospective nature of many of these studies, the complexity of these assays and their application to clinical specimens, and the many potential pitfalls inherent in the development of mathematical predictor models from the very high-dimensional data generated by these omics technologies. Here we present a checklist of criteria to consider when evaluating the body of evidence supporting the clinical use of a predictor to guide patient therapy. Included are issues pertaining to specimen and assay requirements, the soundness of the process for developing predictor models, expectations regarding clinical study design and conduct, and attention to regulatory, ethical, and legal issues. The proposed checklist should serve as a useful guide to investigators preparing proposals for studies involving the use of omics-based tests. The US National Cancer Institute plans to refer to these guidelines for review of proposals for studies involving omics tests, and it is hoped that other sponsors will adopt the checklist as well.