Increasing Adoption of Left Atrial Appendage Occlusion in Isolated Coronary Artery Bypass Grafting.

BACKGROUND: Recent randomized trial data showed fewer strokes with left atrial appendage occlusion (LAAO) following cardiac surgery in patients with atrial fibrillation. We developed a quality initiative to increase LAAO adoption. METHODS: Among 11,099 patients undergoing isolated CABG between January 2019-March 2021 at 33 hospitals in Michigan, those with atrial fibrillation undergoing first-time, on-pump CABG were eligible (n=1,241). A goal LAAO rate of 75% was selected as a quality improvement target through a statewide collaborative. An interrupted time series analysis evaluated the change in LAAO rate before (January-December 2019) versus after (January 2020-March 2021) implementation. RESULTS: Implementation of the quality metric improved LAAO rate from 61% (357/581) before to 79% (520/660) after implementation (p<0.001). Compared to patients not undergoing concomitant LAAO, LAAO patients (71%, 877/1,241) were older, more frequently male, and had a lower STS-PROM (2.9±3.5% vs. 3.7±5.7%, p=0.003), while other baseline characteristics including CHA2DS2-VASc scores were similar. Mean bypass and cross-clamp times were 7 and 6 minutes longer, respectively, in the LAAO group among those who did not undergo concomitant ablation. Operative mortality, major morbidity, blood product administration, and thromboembolic events were similar between groups. Interrupted time series analysis showed a significant increase in LAAO rate after implementation (p=0.009). CONCLUSIONS: LAAO in patients with atrial fibrillation undergoing isolated CABG did not add operative risk versus isolated CABG without LAAO. A statewide quality improvement initiative was successful in increasing the rate of concomitant LAAO and could be further evaluated as a potential quality metric in cardiac surgery.

Lessons learned from the EACTS-MSTCVS quality fellowship: a call to action for continuous improvement of cardiothoracic surgery outcomes in Europe.

The Michigan Society of Thoracic and Cardiovascular Surgeons (MSTCVS), a pioneer in initiating and nurturing quality improvement strategies in statewide cardiothoracic surgery, has been running the Quality Collaborative (MSTCVS-QC) program since 2001. This initiative has significantly grown over the years, facilitating at least 4 in-person meetings annually. It actively engages cardiac and general thoracic surgeons, data managers and researchers from all 32 non-federally funded cardiothoracic surgery sites across Michigan. Broadening its influence on joint learning and clinical outcomes, the MSTCVS-QC formed a strategic partnership with Blue Cross Blue Shield of Michigan, the state's largest private insurer, to further promote its initiatives. The MSTCVS-QC, operating from a dedicated QC centre employs an STS-associated database with additional aspects for data collection and analysis. The QC centre also organizes audits, facilitates collaborative meetings, disseminates surgical outcomes and champions the development and implementation of quality improvement initiatives related to cardiothoracic surgery in Michigan. Recognizing the MSTCVS-QC's successful efforts in advancing quality improvement, the European Association for Cardiothoracic Surgery (EACTS) introduced a fellowship program in 2018, facilitated through the EACTS Francis Fontan Fund (FFF). This program allows early-career academic physicians to spend 4-6 months with the MSTCVS-QC team in Ann Arbor. This article chronicles the evolution and functionality of the MSTCVS-QC, enriched by the experiences of the inaugural 4 EACTS/FFF fellows. Our objective is to emphasize the critical importance of fostering a culture of quality improvement and patient safety in the field of cardiothoracic surgery with open discussion of audited, high-quality data points. This principle, while implemented locally, has implications and value extending far beyond Europe, resonating globally.

Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

The Effect of Direct Oral Anticoagulants on Outcomes After Urgent or Emergent Cardiac Surgery.

OBJECTIVE: To determine the safety of performing urgent or emergent cardiac surgery within 5 days of a patient taking a direct oral anticoagulant (DOAC). DESIGN: A multicenter retrospective registry study. SETTING: Thirty-three hospitals in a quality collaborative from 2017 to 2019. PARTICIPANTS: Patients were included if they underwent urgent or emergent coronary artery bypass grafting (CABG). Patients were excluded if they received any anticoagulant or antiplatelet agent besides DOACs, heparin, or aspirin. INTERVENTIONS: Patients were stratified based upon the receipt of a DOAC within 5 days of their surgery. Patient cohorts included DOAC within 2 days, DOAC within 3-to-5 days, and no anticoagulation. Data were unavailable on the specific DOAC agent taken prior to admission. MEASUREMENTS AND MAIN RESULTS: There were 7,201 patients included, with 94 on DOACs. Intraoperative blood transfusion was required in 23.9% of patients on no anticoagulant, 26.2% on a DOAC within 3-to-5 days of surgery (odds ratio [OR] 0.98; 95% CI 0.46-2.11), and 30.3% on a DOAC within 2 days (OR 0.99; 95% CI 0.37-2.67). Five or more intraoperative blood products were required in 4.4% on no anticoagulant, 1.7% on DOAC within 3-to-5 days (OR 0.33; 95% CI 0.04-2.71), and 6.1% on DOAC within 2 days (OR 0.47; 95% CI 0.06-4.05). No difference in mortality was observed among the 3 groups (2.9% v 3.3% v 3.0%; p = 0.67). CONCLUSIONS: For urgent or emergent CABGs, no significant differences in minor bleeding, major bleeding, or mortality were observed in patients taking a DOAC within 5 days of surgery. This study was hypothesis-generating for performing urgent or emergent surgery sooner than 5 days after holding DOACs.

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Quality Improvement: Arterial Grafting Redux, 2010:2019.

BACKGROUND: The evidence base favoring utilization of multiple arterial conduits in coronary artery bypass grafting has strengthened in recent years. Nevertheless, utilization of arterial conduits in the US lags behind that of many European peers. We describe a statewide collaborative based approach to improving utilization. METHODS: Four metrics of arterial revascularization were devised. These were displayed and discussed at quarterly statewide quality collaborative meetings from January 2016 onwards, integrated with an educational program regarding attendant benefits. We undertook retrospective review of isolated coronary artery bypass grafting statewide from 2012-2019 to assess impact. RESULTS: A total of 38,523 cases met inclusion/exclusion criteria. Statewide incidence of multiple arterial grafting increased from 7.4% at baseline to 21.7% in 2019 (P < .001), implementation across hospitals varied widely, ranging from 67.6% to 0.0%. Utilization of total arterial revascularization increased 1.9% to 4.4% (P < .001) between time frames. Utilization of both radial artery and bilateral internal thoracic artery conduit increased significantly from 5.3% to 13.2% (P < .001) and 2.1% to 8.5% (P < .001), respectively; radial artery utilization was significantly higher than bilateral internal thoracic artery for each year (P < .001 for all comparisons). CONCLUSIONS: Our statewide quality improvement initiative improved rates of utilization of multiple arterial grafting by all metrics. Barriers to current utilization were identified to guide future quality improvement efforts. This reproducible approach is readily transferable to improve quality of care in other domains and geographical areas.

Effect of sex on nadir hematocrit and rates of acute kidney injury in coronary artery bypass.

OBJECTIVE: Findings from a large multicenter experience showed that sex influenced the relationship between low nadir hematocrit and increased risk of acute kidney injury after cardiac surgery. We explored whether sex-related differences persisted among patients undergoing isolated coronary artery bypass grafting. METHODS: We undertook a prospective, observational study of 17,363 patients without dialysis (13,137 male: 75.7%; 4226 female: 24.3%) undergoing isolated coronary artery bypass grafting between 2011 and 2016 across 41 institutions in the Perfusion Measures and Outcomes registry. Odds ratios between nadir hematocrit and stage 2 or 3 acute kidney injury were calculated, and the interaction of sex with nadir hematocrit was tested. The multivariable, generalized, linear mixed-effect model adjusted for preoperative and intraoperative factors and institution. RESULTS: Median nadir hematocrit was 22% among women and 27% among men (P < .001). Women were administered a greater median net prime volume indexed to body surface area (407 vs 363 mL/m2) and more red blood cell transfusions (55.5% vs 24.3%; both P < .001). Acute kidney injury was higher among women (6.0% vs 4.3%, P < .001). There was no effect of sex on the relationship between nadir hematocrit and acute kidney injury (P = .67). Low nadir hematocrit was inversely associated with acute kidney injury (adjusted odds ratios per 1-unit increase in nadir hematocrit 0.96; 95% confidence interval, 0.93-0.98); this effect was similar across sexes and independent of red blood cell transfusions. CONCLUSIONS: We found no sex-related differences in the effect of nadir hematocrit on acute kidney injury after isolated coronary artery bypass grafting. However, the strong inverse relationship between anemia and acute kidney injury across sexes suggests the importance of reducing exposure to low nadir hematocrit.

Transcatheter Versus Surgical Aortic Valve Replacement Episode Payments and Relationship to Case Volume.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has increased in volume as an alternative to surgical aortic valve replacement (SAVR). Comparisons of total episode expenditures, although largely ignored thus far, will be key to the value proposition for payers. METHODS: We evaluated 6,359 Blue Cross Blue Shield of Michigan and Medicare fee-for-service beneficiaries undergoing TAVR (17 hospitals, n = 1,655) or SAVR (33 hospitals, n = 4,704) in Michigan between 2012 and 2016. Payments through 90 post-discharge days between TAVR and SAVR were price-standardized and risk-adjusted. Centers were divided into terciles of procedural volume separately for TAVR and SAVR, and payments were compared between lowest and highest terciles. RESULTS: Payments (± SD) were higher for TAVR than SAVR ($69,388 ± $22,259 versus $66,683 ± $27,377, p < 0.001), while mean hospital length of stay was shorter for TAVR (6.2 ± 5.6 versus 10.2 + 7.5 days, p < 0.001). Index hospitalization payments were $4,374 higher for TAVR (p < 0.001), whereas readmission and post-acute care payments were $1,150 (p = 0.001) and $739 (p = 0.004) lower, respectively, and professional payments were similar. For SAVR, high-volume centers had lower episode payments (difference: 5.0%, $3,255; p = 0.01) and shorter length of stay (10.0 ± 7.5 versus 11.1 ± 7.9 days, p = 0.002) than low volume centers. In contrast, we found no volume-payment relationship among TAVR centers. CONCLUSIONS: Episode payments were higher for TAVR, despite shorter length of stay. Although not a driver for TAVR, center SAVR volume was inversely associated with payments. These data will be increasingly important to address value-based reimbursement in valve replacement surgery.

Aortic Valve Replacement in the Moderately Elevated Risk Patient: A Population-Based Analysis of Outcomes.

BACKGROUND: As transcatheter aortic valve replacement (TAVR) therapy transitions from inoperable or high-risk patients to those considered moderate risk, a contemporary evaluation of AVR in this latter group is warranted. METHODS: Using the Michigan Cardiothoracic Surgical Quality Collaborative Database, we analyzed outcomes and identified predictors of a composite end point (30-day death, stroke, and dialysis) for 2,979 patients (2007 to 2015) undergoing AVR (n = 1,196) or AVR and coronary artery bypass grafting (n = 1,783) with a preoperative The Society of Thoracic Surgeons predicted risk of mortality (PROM) of 4% to 8% (mean, 5.5%; interquartile range, 4.5% to 6.3%). RESULTS: The 30-day mortality was 3.9%. Independent predictors of death included stage 4 chronic kidney disease and the presence of pulmonary hypertension (both p < 0.05), but not year of procedure, despite a significant trend in decreased PROM during the study period (p = 0.003). Morbidity included stroke in 2.3%, and renal failure, defined as Acute Kidney Injury Network stage 1 to 3, in 43.7%, although only 5.4% required dialysis. Prolonged ventilator support was required by 21.0%. After a mean length of stay of 10 days (interquartile range 6 to 11 days), 36.4% were discharged to extended care facilities. Independent predictors of the composite outcome included the Society of Thoracic Surgeons PROM (p < 0.001 for trend) and pulmonary hypertension (p < 0.001). Compared with those presenting with pure aortic stenosis, mixed aortic stenosis and aortic insufficiency was independently protective of the composite outcome (odds ratio, 0.58; p < 0.001), whereas pure aortic insufficiency was not (odds ratio, 0.87; p = 0.58). The composite end point frequency was not significantly different in the 17 hospitals developing TAVR programs (TAVR 9.6% vs non-TAVR 9.6%, p = 0.98). CONCLUSIONS: This population-based contemporary assessment suggests moderate-risk patients undergoing AVR experience favorable outcomes. Although increasing PROM is important in preoperative evaluation of risk, preexisting pulmonary hypertension and indication for operation are among other factors that should be considered as TAVR expands into this group of patients.

Nadir Hematocrit on Bypass and Rates of Acute Kidney Injury: Does Sex Matter?

BACKGROUND: Reports have associated nadir hematocrit (Hct) on cardiopulmonary bypass with the occurrence of renal dysfunction. Recent literature has suggested that women, although more often exposed to lower nadir Hct, have a lower risk of postoperative renal dysfunction. We assessed whether this relationship held across a large multicenter registry. METHODS: We undertook a prospective, observational study of 15,221 nondialysis-dependent patients (10,376 male, 68.2%; 4,845 female, 31.8%) undergoing cardiac surgery between 2010 and 2014 across 26 institutions in Michigan. We calculated crude and adjusted OR between nadir Hct during cardiopulmonary bypass and stage 2 or 3 acute kidney injury (AKI), and tested the interaction of sex and nadir Hct. The predicted probability of AKI was plotted separately for men and women. RESULTS: Nadir Hct less than 21% occurred among 16.6% of patients, although less commonly among men (9.5%) than women (31.9%; p < 0.001). Acute kidney injury occurred among 2.7% of patients, with small absolute differences between men and women (2.6% versus 3.0%, p = 0.20). There was a significant interaction between sex and nadir Hct (p = 0.009). The effect of nadir Hct on AKI was stronger among male patients (adjusted odds ratio per 1 unit decrease in nadir Hct 1.10, 95% confidence interval: 1.05 to 1.13) than female patients (adjusted odds ratio 1.01, 95% CI: 0.96, 1.06). CONCLUSIONS: Lower nadir Hct was associated with an increased risk of AKI, and the effect appears to be stronger among men than women. Understanding of the mechanism underlying this association remains uncertain, although these results suggest the need to limit exposure to lower nadir Hct, especially for male patients.

Orthotic and brace use in the athlete with degenerative joint disease with angular deformity.

Over the past several decades, research has shown the successful use of simple wedges, custom orthotics, and unloader braces in the treatment of athletes with DJD/angular deformity. This article reviews the use of these simple biomechanical devices in the treatment of these individuals.