Patient Characteristics and Outcomes Associated with Sentinel Protection Device Use in Patients with Aortic Valve Disease Undergoing TAVR in a "Real-World" Setting.

Background: Transcatheter aortic valve replacement (TAVR) has become the dominant treatment for aortic valve disease. While TAVR safety has improved over time, concern remains over the occurrence of cerebrovascular accidents (CVA) secondary to device placement, which is associated with increased morbidity and mortality. The Sentinel Cerebral Protection System (CPS) was developed to reduce the risk of embolic strokes associated with debris produced during TAVR. Studies evaluating Sentinel CPS efficacy have produced conflicting results, and there is little understanding of which patients are selected for device placement in "real-world" settings. With no existing guidelines on device use, the purpose of this study was to describe and compare the characteristics of patients who receive CPS with those who do not in a "real-world" setting of consecutive TAVR patients and evaluate its impact on postoperative complications, namely stroke. Methods: This was a single-center, retrospective study of all patients undergoing TAVR between July 1, 2019, and December 31, 2020. Patient demographics, baseline, and perioperative characteristics were collected prospectively using the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and our institution's TAVR database for analysis. Postoperative outcomes were assessed using primary endpoints of in-hospital/30-day stroke and the composite of death, stroke, and bleeding/vascular events at one-year. To adjust for baseline differences, a propensity score was developed including all factors that were different between groups, and Multivariate Cox Regression analysis was used to control for these differences. Patient follow-up was 97% complete at 12 months with 100% echocardiographic follow-up. Results: A total of 242 consecutive patients (57.9% male) were analyzed, with a mean age of 79.9 ± 9 years. Of these patients, 134 (55.4%) received the Sentinel CPS and 108 (44.6%) did not. Sentinel CPS patients were more likely to be male, not on dialysis, without prior CVA or pacemaker, had less severe chronic lung disease, and were lower operative risk compared to concurrent non-CPS patients. CPS patients were also found to have higher hemoglobin and albumin levels, lower creatinine, and were less likely to be on immunosuppressant therapy. The incidence of in-hospital/30-day stroke after TAVR did not differ between CPS and non-CPS patients (0.0% vs. 1.9%; p = 0.198). Unadjusted analyses at one-year showed a lower occurrence of the composite endpoint in CPS patients compared non-CPS patients (8.3% vs. 17.0%; p = 0.034). After adjustment, the hazard ratio (Adj HR) for the CPS group was no longer significantly associated with a lower composite endpoint (Adj HR = 0.609, 95% CI 0.244-1.523; p = 0.289). Both unadjusted (p = 0.233) and adjusted (p = 0.132) analyses showed no difference in the incidence of stroke at one-year. Conclusions: Our study demonstrates that in a "real-world" setting, the Sentinel CPS device is more likely to be used in healthier and less complex patients. In analyses adjusted for illness severity and patient complexity, CPS use did not have a significant effect on the incidence of in-hospital/30-day stroke or the composite endpoint of death, stroke, and bleeding/vascular events at one-year.

Implementing a protocol to optimize blood use in a cardiac surgery service: results of a pre-post analysis and the impact of high-volume blood users.

BACKGROUND: Blood transfusions are a common and costly intervention for cardiac surgery patients. Evidence suggests that a more restrictive transfusion strategy may reduce costs and transfusion-related complications without increasing perioperative morbidity and mortality. STUDY DESIGN AND METHODS: A transfusion-limiting protocol was developed and implemented in a cardiovascular surgery unit. Over a 5-year period, data were collected on patient characteristics, procedures, utilization of blood products, morbidity, and mortality, and these were compared before and after the protocol was implemented. RESULTS: After the protocol was put in place, fewer patients required transfusions (38.2% vs. 45.5%, p = 0.004), with the greatest reduction observed in postoperative blood use (29.1% vs. 37.2%, p = 0.001). In-hospital morbidity and mortality did not increase. When patients who received transfusions were stratified by procedure, the protocol was most effective in reducing transfusions for patients undergoing isolated coronary artery bypass grafting (CABG; 4.09 units vs. 2.51 units, p = 0.009) and CABG plus valve surgery (10.32 units vs. 4.77 units, p = 0.014). A small group of patients were disproportionate recipients of transfusions, with approximately 6% of all patients receiving approximately half of the blood products. CONCLUSION: A protocol to limit transfusions decreased the proportion of cardiothoracic surgery patients who received blood products. A very small group of patients received a large number of transfusions, and within that group the observed mortality was significantly higher than in the general patient population. Current protocols cannot possibly account for these patients, and this should be considered when analyzing the performance of protocols designed to reduce unnecessary transfusions.

Effects of a protocol-based management of type A aortic dissections.

BACKGROUND: Ascending aortic dissections (AADs) require prompt diagnosis and surgical treatment. We present the results of implementing a multidisciplinary aortic dissection protocol on the outcomes of AAD treatment at a nonteaching hospital. METHODS: From January 2002-December 2013, 54 patients with the diagnosis of AAD were treated at our institution. Thirty-seven (68.5%) were male with a mean age of 62.3 y. Cardiogenic shock was present in 25.9% of patients. An AAD protocol, focused on educating physicians on presenting signs and symptoms, adequate triaging, and the need for immediate surgical intervention, was implemented, alongside the standardization of surgical treatment. We divided the cohort into two eras, based on AAD program's implementation in 2006, to better assess the impact of this protocol. RESULTS: Patients from the early era had significantly longer time from Emergency Department to the operating room, more postoperative occurrence of prolonged ventilation, and a longer postoperative hospital stay at 8.7 ± 8 versus 3.1 ± 2.6 h (P = 0.002), 63% versus 18% (P = 0.002), and 63% versus 18% (P = 0.002), respectively. The overall mortality for the cohort was 9.3%, decreasing from 12.5% before 2006 to 7.9% after 2006. CONCLUSIONS: The implementation of a multidisciplinary aortic dissection protocol has resulted in faster diagnosis and transport of AAD cases from the emergency room to the operating room, improving outcomes. Our data support the concept that nonteaching institutions can deliver excellent care to patients with acute aortic emergencies.

Comparative genome-wide transcriptional analysis of human left and right internal mammary arteries.

In coronary artery bypass grafting (CABG), the combined use of left and right internal mammary arteries (LIMA and RIMA) - collectively known as bilateral IMAs (BIMAs) provides a survival advantage over the use of LIMA alone. However, gene expression in RIMA has never been compared to that in LIMA. Here we report a genome-wide transcriptional analysis of BIMA to investigate the expression profiles of these conduits in patients undergoing CABG. As expected, in comparing the BIMAs to the aorta, we found differences in pathways and processes associated with atherosclerosis, inflammation, and cell signaling - pathways which provide biological support for the observation that BIMA grafts deliver long-term benefits to the patients and protect against continued atherosclerosis. These data support the widespread use of BIMAs as the preferred conduits in CABG.

Blood transfusion in cardiac surgery does increase the risk of 5-year mortality: results from a contemporary series of 1714 propensity-matched patients.

BACKGROUND: Studies have found that cardiac surgery patients receiving blood transfusions are at risk for increased mortality during the first year after surgery, but risk appears to decrease after the first year. This study compared 5-year mortality in a propensity-matched cohort of cardiac surgery patients. STUDY DESIGN AND METHODS: Between July 1, 2004, and June 30, 2011, 3516 patients had cardiac surgery with 1920 (54.6%) requiring blood transfusion. Propensity matching based on 22 baseline characteristics yielded two balanced groups (blood transfusion group [BTG] and nontransfused control group [NCG]) of 857 patients (1714 in total). The type and number of blood products were compared in the BTG. RESULTS: Operative mortality was higher in BTG versus NCG (2.3% vs. 0.4%; p < 0.0001). Kaplan-Meier analysis of 5-year survival demonstrated no difference between groups in the first 2 years (BTG 96.3% and 93.0% vs. NCG 96.4% and 93.9%, respectively). There was a significant divergence during Years 3 to 5 (BTG 82.0% vs. NCG 89.3% at 5 years; p < 0.007). Five-year survival was significantly lower in patients who received at least 2 units of blood (79.6% vs. 88.0%; p < 0.0001). In multivariate Cox regression analyses, transfusion was independently associated with increased risk for 5-year mortality. Patients receiving cryoprecipitate products had a twofold mortality risk increase (adjusted hazard ratio, 2.106; p = 0.002). CONCLUSION: Blood transfusion, specifically cryoprecipitates, was independently associated with increased 5-year mortality. Transfusion during cardiac surgery should be limited to patients who are in critical need of blood products.

Mutational analysis clopidogrel resistance and platelet function in patients scheduled for coronary artery bypass grafting.

Clopidogrel is an oral antiplatelet pro-drug prescribed to 40 million patients worldwide who are at risk for thrombotic events or receiving percutaneous coronary intervention (PCI). However about a fifth of patients treated with clopidogrel do not respond adequately to the drug. From a cohort of 105 patients on whom we had functional data on clopidogrel response, we used ultra-high throughput sequencing to assay mutations in CYP2C19 and ABCB1, the two genes genetically linked to respond. Testing for mutations in CYP2C19, as recommended by the FDA, only correctly predicted if a patient would respond to clopidogrel 52.4% of the time. Similarly, testing of the ABCB1 gene only correctly foretold response in 51 (48.6%) patients. These results are clinically relevant and suggest that until additional genetic factors are discovered that predict response more completely, functional assays are more appropriate for clinical use.

Antiplatelet therapy, cardiac surgery, and the risk of bleeding: the surgeon's perspective.

Antiplatelet therapy is widely accepted in the contemporary management of patients with coronary syndromes. Effective platelet inhibition can cause an increased risk of bleeding, which is more evident when patients are referred to surgical coronary revascularization. The cardiac surgeon should be familiar with all new antiplatelet drugs. In this article we compile the latest information about antiplatelet therapy and its impact on cardiac surgery.

Unexpected durability of a Björk-Shiley first-generation aortic valve after 40 years of implantation.

The case is reported of a patient who underwent aortic valve replacement (AVR) in 1969 and received a (first-generation) Björk-Shiley Delrin valve. Forty years later, the patient presented to the authors' hospital in congestive heart failure and with echocardiographic evidence of severe stenosis and mild aortic regurgitation. The patient underwent a redo sternotomy and AVR with a bioprosthesis. On gross examination, the explanted 40-year-old mechanical valve appeared intact.

Spontaneous rupture of a nonaneurismatic ascending thoracic aorta.

Spontaneous rupture of the ascending thoracic aorta without any history of aneurysm, trauma, infection, dissection, or previous surgery is a very rare and potentially lethal event. We report a case of spontaneous rupture of the ascending aorta treated successfully. While the etiology is still unclear, diagnosis with bedside transesophageal echocardiography prompted emergent surgical intervention.

Cardiogenic shock due to partial occlusion of the left coronary ostium in infective endocarditis: a case report.

The case is presented of chronic aortic valve endocarditis in a previously asymptomatic 54-year-old male. The main initial clinical manifestation was cardiogenic shock, but further examination revealed the presence of a large mobile mass attached to a bicuspid aortic valve, partially occluding the left coronary ostium. The patient underwent emergency surgery to excise the vegetative mass and preserve the aortic valve. The postoperative outcome was satisfactory.

Acute mitral regurgitation requiring urgent surgery because of chordae ruptures after extreme physical exercise: case report.

Chordae rupture is the most common cause of severe acute mitral insufficiency. Many different mechanisms can cause an acute chordal rupture: degenerative mitral valve disease, infective endocarditis, myocardial infarction, or a posttraumatic event. We present 2 cases of acute mitral regurgitation requiring urgent surgery due to a posterior leaflet chorda rupture after extreme physical exercise.

Bilateral internal mammary artery Y construct with multiple sequential grafting improves survival compared to bilateral internal mammary artery with additional vein grafts: 10-year experience at 2 different institutions†.

OBJECTIVES: Utilization of bilateral internal mammary arteries (BIMAs) has been shown to improve long-term outcomes in patients undergoing coronary artery bypass grafting. To achieve complete revascularization, BIMAs may be used as either sole conduits for revascularization through a Y-graft configuration (BIMA-Y) or deployed with additional grafts used in conjunction with BIMAs. The purpose of this study was to compare the long-term outcomes of two institutions that predominantly used either the BIMA-Y configuration or BIMA plus additional grafts to achieve optimal revascularization. METHODS: From 1 January 2000 to 31 December 2010, 436 patients were revascularized using a non-sequential BIMA grafting at one institution (Group A), with veins being used for additional targets. At the second institution (Group B), 771 patients were revascularized using a BIMA-Y graft for all distal targets. Kaplan­Meier analysis was used to compare unadjusted survival between the groups. Cox proportional hazards regression modelling was used to provide an adjusted comparison of survival between the groups. RESULTS: There was no statistically significant difference between the average number of anastomotic sites used in Group A and Group B (A = 4.0 ± 0.7 vs B = 4.0 ± 0.7; P = 0.24). Group A did not have a significantly greater in-hospital mortality (0.7% vs 1.0% P = 0.39), stroke (0.5% vs 0.8% P = 0.40), deep sternal wound infection (0.0% vs 0.6% P = 0.11) or reoperation for bleeding (1.6% vs 0.6% P = 0.10) than Group B. Cox proportional hazards analyses demonstrated that at 14 years, Group B had a significantly improved survival compared to Group A (Group B = 88% vs Group A = 81%) with an overall reduction in mortality (adjusted hazard ratio 0.780, 95% confidence interval 0.448­0.849; P = 0.043). CONCLUSION: Utilization of the BIMA-Y configuration was associated with improved survival when compared to BIMA grafting with additional vein grafts. Further studies are necessary to evaluate the efficacy of BIMA-Y grafting against other means of providing complete arterial revascularization.

Homograft subclavian interposition graft to left main coronary artery ostium in aortic root replacement.

Performing a reoperative root replacement in cases of prosthetic valve endocarditis (PVE) can often be challenging due to significant inflammation and scarring. During these cases, surgeons may decide to utilize an interpositional graft when mobilization of the coronary ostia becomes too hazardous. The authors describe their experience performing a reoperative root replacement on a patient with PVE. In this case, the authors utilize a segment of the homograft left subclavian artery as an interpositional graft to provide an infection-resistant bioprosthetic graft that maintains coronary anatomy.

The effects of using a radial artery in patients already receiving bilateral internal mammary arteries during coronary bypass grafting: 30-day outcomes and 14-year survival in a propensity-matched cohort.

OBJECTIVES: Recent studies have demonstrated the superiority of bilateral internal mammary arteries (BIMAs) as conduit material for coronary artery bypass grafting (CABG) surgery. However, there is limited research on the effects of other graft conduits used in patients who require additional bypasses. The goal of this study was to evaluate the impact of the radial artery (RA) when used in conjunction with the BIMAs. METHODS: From the beginning of 2000 to the end of 2013, 4370 patients underwent CABG for three or more vessels at our institution. There were 568 and 183 patients who received BIMA + saphenous vein graft (SVG) and BIMA + radial ± SVG, respectively. Propensity matching was used to create a balanced cohort from these patients, which resulted in two groups of 183 patients. Thirty-day outcomes and long-term survival were compared between the two groups. Long-term follow-up was generated using the Social Security Death Index. RESULTS: There were no significant differences in preoperative characteristics. For 30-day outcomes, the BIMA + radial ± SVG group had more postoperative atrial fibrillation (24.6 vs 12.0%; P = 0.001) and a longer median postoperative length of stay (6 vs 5 days; interquartile range = 2; P = 0.016) than BIMA + SVG patients. There was no significant difference in long-term survival between the two groups over the 14-year period. However, before year 10, the BIMA + SVG group had a trend towards higher survival, whereas on follow-up after 10 years, there was a trend that favoured the BIMA + radial ± SVG patients. Cox regression analysis using a time-dependent covariate demonstrated that when the groups were split at 10 years, there was a statistically significant improvement in survival of the BIMA + radial ± SVG group [adjusted hazard ratio 0.254 95% confidence interval (CI) 0.062-0.977; P = 0.048] over BIMA + SVG patients between 10 and 14 years. CONCLUSIONS: Overall, there were no statistically significant differences in survival between the BIMA + SVG and BIMA + radial ± SVG groups over the 14 years. However, further analysis demonstrated that while the BIMA + radial ± SVG group had a trend towards decreased survival before 10 years, use of the RA in conjunction with BIMAs was associated with significantly increased survival in the later years. A larger cohort of patients with longer follow-up is needed to assess the outcomes of CABG using BIMA + radial ± SVG.

Influence of body size on outcomes of off-pump coronary artery bypass surgery.

OBJECTIVE: Patients of small physical stature may be more likely selected for an on-pump coronary artery surgery (ONCAB) rather than an off-pump procedure (OPCAB). Small patients who do have OPCAB may do poorly. Our hospital demographics afford a unique opportunity to examine a group of small patients. METHODS: Information was available over the past 4 years on 1015 patients who had isolated CABG and a calculable body surface area. Sixty-one patients had a body surface area of less than 1.5 m2 (SMALL). The 954 remaining patients were classed as larger (LARGER). Patients were compared with respect to preoperative risk factors, operative procedures, and postoperative results. RESULTS: Among SMALL patients, 59% were Asian, 89% female, averaged slightly older, had higher STS risk scores, lower hematocrits, more severe NYHA class ratings, and less elective surgical status (P < .05) than LARGER patients. Fifty-one percent of SMALL patients had OPCAB, 44.3% received blood, 90% had an event-free course, and 4.9% died postop (versus 1.2%, P < .05). OPCAB mortality was lower than ONCAB for both SMALL and nonsmall (P < .05). Blood use was greater for SMALL than for LARGER (44% versus 20%, P < .05) but less for SMALL OPCAB than SMALL ONCAB (27% versus 62%, P < .05). No differences were noted in postop MI, CVA, or length of stay, but 30-day readmission was lower for SMALL patients (5.0% versus 7.4%). CONCLUSIONS: Patients with small physical stature can be safely operated upon using off-pump techniques with good revascularization and postop results, despite apparently higher preop STS risk scores.

Impact of pump status and conduit choice in coronary artery bypass: A 15-year follow-up study in 1412 propensity-matched patients.

OBJECTIVE: Previous studies have demonstrated that bilateral internal mammary artery (BIMA) grafts lead to superior outcomes compared with single internal mammary artery grafts. This study examines whether cardiopulmonary bypass affects conduit-dependent outcomes of coronary artery bypass grafting (CABG) surgery. METHODS: From 1994 to 2013, a total of 6666 patients underwent isolated CABG surgery at our institution. Of these procedures, 3548 (53.2%) were performed off pump. A BIMA-saphenous vein graft (SVG) was used in 1544, and 5122 had left internal mammary artery-SVGs. These 2 conduit groups differed significantly in baseline characteristics. Propensity matching based on 22 preoperative variables and using a nearest-neighbor matching algorithm was used to make balanced cohorts, resulting in 2 groups of 1006. To account for the influence of pump status on conduit selection, a second propensity score was developed for pump use. These cases were matched to create 4 patient cohorts of 353 patients each (a total of 1412), balanced for both conduit use and pump status. Late mortality was determined using the Social Security Death Index. RESULTS: No difference was found in survival between patients receiving BIMA-SVGs on or off pump (78.9% vs 79.1%). BIMA-SVGs outperformed the left internal mammary artery-SVGs regardless of whether the procedure was performed off pump (73.9%) or on pump (69.9%). CONCLUSIONS: This study demonstrates that the use of cardiopulmonary bypass does not significantly affect the long-term outcomes in these patients as long as full revascularization is achieved. In addition, these results are consistent with prior research showing that the use of BIMAs produces better outcomes than use of a single internal mammary artery when performing CABG.

Intracardiac juvenile xanthogranuloma with presentation in adulthood.

Juvenile xanthogranuloma is the most frequent type of non-Langerhans cell histiocytosis. It most commonly presents in infancy and early childhood; manifesting as cutaneous lesions on the head, neck, and trunk that suddenly appear and usually undergo spontaneous regression. Extracutaneous involvement, although rare, may occur along with the cutaneous form or in isolation. It most frequently involves the eye, deep subcutaneous tissues, lung, and liver. Involvement of the heart is exceptionally rare, with only seven reports found in the English literature, all affecting infants. We present the first report of an intracardiac juvenile xanthogranuloma in an adult.

Perioperative predictors of midterm survival after aortic valve replacement.

BACKGROUND: Elderly patients with aortic stenosis are under-referred for aortic valve replacement surgery. This study investigated the perioperative factors associated with midterm outcomes in a consecutive series of patients undergoing aortic valve replacement with or without coronary artery bypass graft surgery. METHODS: From 2006 to 2010, 509 patients having aortic valve replacement or aortic valve replacement with coronary artery bypass were grouped according to age (<80 years and ≥80 years) and procedure (aortic valve replacement ± coronary artery bypass). Patient survival was followed up for 5 years (mean 2.6 years). Midterm survival was evaluated using Kaplan-Meier and Cox proportional hazards regression model statistics. RESULTS AND CONCLUSIONS: 5-year survival among octogenarians was 59.2% with an observed 30-day mortality of 1% for aortic valve replacement and 3% for aortic valve replacement with coronary artery bypass. Kaplan-Meier survival analysis showed that age ≥80 years, New York Heart Association functional class III/IV, and left ventricular ejection fraction <35% were significantly associated with increased midterm mortality. Cox regression modeling demonstrated that age ≥80 years was the only significant independent factor associated with midterm mortality; older patients had a 3-fold increase in mortality (adjusted hazard ratio = 3.231, 95% confidence interval: 1.764-5.920, p < 0.0001). While hospital and 30-day mortality were not statistically different between age groups, age ≥80 years was the most powerful predictor of midterm death. These results support early aortic valve replacement with or without coronary artery bypass in aortic stenosis management.

Balancing the benefits and risks of blood transfusions in patients undergoing cardiac surgery: a propensity-matched analysis.

OBJECTIVES: Prior studies have found that cardiac surgery patients receiving blood transfusions are at risk for increased mortality and morbidity following surgery. It is not clear whether this increased risk occurs across all haematocrit (HCT) levels. The goal of this study was to compare operative mortality in propensity-matched cardiac surgery patients based on stratification of the preoperative HCT levels. METHODS: Between 1 August 2004 and 30 June 2011, 3516 patients had cardiac surgery. One thousand nine hundred and twenty-two (54.5%) required blood transfusion during or after surgery. A propensity score for transfusion was developed based on 22 baseline variables. One thousand seven hundred and fourteen patients were matched: 857 in the transfusion group (TG) and 857 in the non-transfused control group (CG). Univariate analyses demonstrated that, after propensity matching, the groups did not differ on any baseline factors included in the propensity model. Operative mortality was defined as death within 30 days of surgery. Preoperative HCT was stratified into four groups: <36, 36-39, 40-42 and ≥ 43. RESULTS: For HCT <36%, 30-day mortality was higher in the TG than that in the CG (3.0 vs 0.0%). For HCT 36-39, operative mortality was similar between TG (1.1%, N = 180) and CG (0.8%, N = 361; P = 0.748). For HCT 40-42, operative mortality was significantly higher in the TG compared with that in the CG (1.9 vs 0%, N = 108 and 218, respectively; P = 0.044). For HCT of ≥ 43, there was a trend towards higher operative mortality in the TG vs the CG (2.0 vs 0%, N = 102 and 152, respectively; P = 0.083). Other surgical complications followed the same pattern with higher rates found in the transfused group at higher presurgery HCT levels. HCT at discharge for the eight groups were similar, with an average of 29.1 ± 1.1% (P = 0.117). CONCLUSIONS: Our study indicates that a broad application of blood products shows no discernible benefits. Furthermore, patients who receive blood at all HCT levels may be placed at an increased risk of operative mortality and/or other surgical complications. Paradoxically, even though patients with low HCTs theoretically should benefit the most, transfusion was still associated with a higher complication and mortality rate in these patients. Our results indicate that blood transfusion should be used judiciously in cardiac surgery patients.