Predicting risk of tracheostomy after cardiac surgery: a decade of insights from nearly 10,000 patients.

Objective: Studies have shown that requiring tracheostomy following cardiac surgery has significant implications on outcomes. This study proposes a risk stratification model to predict the likelihood of requiring a tracheostomy after cardiac surgery. Methods: Patients who underwent cardiac surgery between January 2010 and December 2019 were analyzed. Kaplan-Meier analysis and log-rank test were used to estimate and compare survival between cohorts. A prediction model for the need for postoperative tracheostomy was developed with logistic regression combined with undersampling analysis. Results: A total of 9849 patients underwent cardiac surgery, and 176 (1.8%) required postoperative tracheostomy. Tracheostomy patients were older (mean age 68.4 ± 12.3 vs 65.9 ± 11.2 years; P < 0.01) and more likely female (43.8% vs 28.5%; P < 0.01). Predictors for requiring tracheostomy included hypertension (odds ratio [OR] 1.91; P = 0.05), New York Heart Association III/IV (OR 2.68; P < 0.001), chronic lung disease (OR 3.27; P < 0.001), and history of prior myocardial infarction (OR 3.32; P < 0.001). Three-year Kaplan-Meier survival was worse in patients who received tracheostomy (log-rank P < 0.001). Conclusions: A risk prediction model for requiring tracheostomy after cardiac surgery is proposed in this study. A history of New York Heart Association III/IV, chronic lung disease, and myocardial infarction as well as undergoing valve surgeries were associated with increased risk of requiring a tracheostomy.

Outcomes of the Ross procedure in patients older versus younger than 50 years old.

OBJECTIVES: The Ross procedure is traditionally considered for young adult patients with aortic valve disease. This study compares long-term outcomes of patients undergoing the Ross procedure who are ≥50 and <50-years old. METHODS: Data were collected from 225 patients undergoing Ross procedure at a single centre from 1994 to 2019. Patients were categorized into younger (<50-years old; n = 156) and older (≥50-years old; n = 69) cohorts. Baseline demographics clinical outcomes were compared. RESULTS: The mean age was 36 ± 8.1 and 55 ± 4.2 years in the younger and older cohort, respectively. Both groups were predominantly male (58.5% vs 69.6%; P = 0.59). The younger group had a higher rate of aortic insufficiency (51% vs 26.1%; P < 0.01), and bicuspid aortic valve (81.4% vs 58.0%; P < 0.01). Aortic stenosis was more prevalent in the older cohort (25.6% vs 58.0%; P < 0.01). Operative mortality was acceptable in both groups (1.3% vs 4.3%; P = 0.15). Survival up to 10 years was not statistically different between 2 groups (96.2% vs 91.3% P = 0.16), whereas survival up to 15 years for younger patients was significantly higher (94.9% vs 85.5%; P = 0.03). After non-cardiac related deaths were excluded, survival up to 15 years (98.7% vs 91.3%; P = 0.02) was significantly lower than younger patients. In both groups, survival after the Ross procedure was similar to the age- and sex-matched US population. CONCLUSIONS: Survival up to 10 years after Ross procedure were similar, but up to 15 years was significantly higher in younger patients. The Ross procedure restored patients from both groups to expected survival. Our results suggest that at experienced centres, the Ross procedure is a safe and reasonable option for patients who are 50 years and older.

Race, neighborhood disadvantage, and survival of Medicare beneficiaries after aortic valve replacement and concomitant coronary artery bypass grafting.

BACKGROUND: Race, neighborhood disadvantage, and the interaction between these 2 social determinants of health remain poorly understood with regards to survival after aortic valve replacement with concomitant coronary artery bypass grafting (AVR+CABG). METHODS: Weighted Kaplan-Meier survival analyses and Cox proportional hazards modeling were used to evaluate the association between race, neighborhood disadvantage, and long-term survival in 205,408 Medicare beneficiaries undergoing AVR+CABG from 1999 to 2015. Neighborhood disadvantage was measured using the Area Deprivation Index, a broadly validated ranking of socioeconomic contextual disadvantage. RESULTS: Self-identified race was 93.9% White and 3.2% Black. Residents of the most disadvantaged quintile of neighborhoods included 12.6% of all White beneficiaries and 40.0% of all Black beneficiaries. Black beneficiaries and residents of the most disadvantaged quintile of neighborhoods had more comorbidities compared with White beneficiaries and residents of the least disadvantaged quintile of neighborhoods, respectively. Increasing neighborhood disadvantage linearly increased the hazard for mortality for Medicare beneficiaries of White but not Black race. Residents of the most and least disadvantaged neighborhood quintiles had weighted median overall survival of 93.0 and 82.1 months, respectively, a significant difference (P < .001 by Cox test for equality of survival curves). Black and White beneficiaries had weighted median overall survival of 93.4 and 90.6 months, respectively, a nonsignificant difference (P = .29 by Cox test for equality of survival curves). A statistically significant interaction between race and neighborhood disadvantage was noted (likelihood ratio test P = .0215) and had implications on whether Black race was associated with survival. CONCLUSIONS: Increasing neighborhood disadvantage was linearly associated with worse survival after combined AVR+CABG in White but not Black Medicare beneficiaries; race, however, was not independently associated with postoperative survival.

Vein Graft Use and Long-Term Survival Following Coronary Bypass Grafting.

BACKGROUND: Although placement of at least 1 arterial graft during coronary artery bypass grafting (CABG) has a proven survival benefit, it is unknown what degree of revascularization with saphenous vein grafting (SVG) is associated with improved survival. OBJECTIVES: The authors sought to determine whether undergoing surgery performed by a surgeon who is liberal with vein graft utilization is associated with improved survival in patients undergoing single arterial graft CABG (SAG-CABG). METHODS: This was a retrospective, observational study of SAG-CABG performed in Medicare beneficiaries from 2001 to 2015. Surgeons were stratified by number of SVG utilized per SAG-CABG into conservative (≥1 SD below mean), average (within 1 SD of mean), and liberal (≥1 SD above mean). Long-term survival was estimated using Kaplan-Meier analysis and compared among surgeon groups before and after augmented inverse-probability weighting. RESULTS: There were 1,028,264 Medicare beneficiaries undergoing SAG-CABG from 2001 to 2015 (mean age 72.0 ± 7.9 years, 68.3% male). Over time, 1-vein and 2-vein SAG-CABG utilization increased, whereas 3-vein and ≥4-vein SAG-CABG utilization decreased (P < 0.001). Surgeons who were conservative vein graft users performed a mean 1.7 ± 0.2 vein grafts per SAG-CABG, whereas those who were liberal vein graft users performed a mean 2.9 ± 0.2 vein grafts per SAG-CABG. Weighted analysis demonstrated no difference in median survival among patients undergoing SAG-CABG by liberal vs conservative vein graft users (adjusted median survival difference 27 days). CONCLUSIONS: Among Medicare beneficiaries undergoing SAG-CABG, there is no association between surgeon proclivity for vein graft utilization and long-term survival, suggesting that a conservative approach to vein graft utilization is reasonable.

Surgical treatment of infective endocarditis at comprehensive versus primary valve centers.

BACKGROUND: A recent expert consensus statement proposed designation of comprehensive and primary valve centers, with a recommendation that comprehensive centers house surgical skill and resources to treat patients with infective endocarditis (IE). We sought to compare outcomes of patients who underwent valve surgery for IE at comprehensive versus primary valve centers within a large health care system. METHODS: We reviewed 513 consecutive patients who underwent IE surgery at 8 hospitals (2 comprehensive and 6 primary valve centers) from 2014 to 2020. Outcomes from comprehensive and primary valve centers were compared after propensity score matching on the basis of patient characteristics, valve involvement, valve type, and IE treatment status. Multivariate logistic regression was used to identify risk factors for operative mortality. RESULTS: Propensity score matching generated comparable groups with similar mean Society of Thoracic Surgeons/Gaca IE risk scores among comprehensive and primary valve center cohorts. Comprehensive valve centers were more likely to perform the Bentall procedure (60.4% vs 21.7%; P < .01) when aortic root abscess was present and mitral valve repair (50.4% vs 26.3%; P < .01) in cases of mitral valve involvement. Operative mortality was significantly lower at comprehensive valve centers (6.2% vs 13.0%; P = .04), and multivariate logistic regression suggested that surgery at comprehensive valve centers was protective against operative mortality (odds ratio, 0.39; 95% confidence interval, 0.17-0.88; P = .02). Similar findings were present in a sensitivity analysis limited to patients with active IE only. CONCLUSIONS: An increased risk for operative mortality was associated with surgery performed at primary valve centers compared with comprehensive valve centers. Referral or transfer of patients with IE and surgical indications to comprehensive valve centers should be considered.

Surgical implantation of balloon-expandable heart valves for the treatment of mitral annular calcification.

OBJECTIVES: The treatment of mitral valve disease in the presence of mitral annular calcification (MAC) is associated with an increased risk of cardiovascular and all-cause mortality. Various surgical and transcatheter techniques for the treatment of mitral disease with severe MAC have been described. However, these procedures are associated with high risk of operative morbidity and mortality. We describe our experience with open surgical implantation of a balloon-expandable valve (BEV) in patients with severe MAC as an alternative approach. METHODS: BEV implantation was performed with direct vision through the left atrium via a median sternotomy or minimally invasive approach. The midportion of the anterior leaflet is excised, and a ventricular septal myectomy performed if there is high risk for left ventricular outflow tract obstruction. The primary outcome was technical success according to the Mitral Valve Academic Research Consortium criteria; secondary outcomes were 30-day and 1-year mortality. RESULTS: From October 2015 through October 2020, 51 patients at 2 institutions underwent BEV-in-MAC (mean age, 73.9 ± 8.8 years; 60.8% [31/51] were female; mean Society of Thoracic Surgeons predicted risk of mortality: 6.8% ± 4.8%). Technical success was 94.1% (48/51). Thirty-day and 1-year mortality were 13.7% (7/51) and 33.3% (15/45), and for stroke 3.9% (2/51) and 4.4% (2/45), respectively. CONCLUSIONS: Surgical implantation of a BEV in the mitral position offers a treatment option for patients with mitral valve disease complicated by severe MAC who are at increased risk for conventional surgical approaches and at risk for left ventricular outflow tract obstruction with transcatheter approaches.

Structural valve degeneration of bioprosthetic aortic valves: A network meta-analysis.

OBJECTIVE: To compare the rate of structural valve degeneration (SVD) following surgical aortic valve replacement associated with the Trifecta (TF) valve (St Jude Medical) versus other bioprosthetic valves. METHODS: A systematic literature search was conducted for studies comparing durability of the TF prosthesis to other valve types, including Perimount (Edwards Lifesciences), Carpentier-Edwards Perimount Magna Ease (ME) (Edwards Lifesciences), and Mitroflow (LivaNova USA) after surgical aortic valve replacement. Random effect pairwise and network meta-analyses were performed to compare the incident rate ratio of the composite primary outcome of SVD or reintervention due to SVD. RESULTS: Ten studies with 31,029 patients were included, of whom 6832 received TF, 19,023 received Perimount, 3514 received ME, and 713 received Mitroflow. When compared with TF, ME was associated with lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.92; P = .04). Similarly, at network meta-analysis, when compared with TF, only ME was associated with significantly lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.97). ME (incident rate ratio, 0.18; 95% CI, 0.07-0.47) and PM (incident rate ratio, 0.34; 95% CI, 0.12-0.98) were associated with significantly lower rate of all-cause reintervention when compared with TF. No differences in the other secondary outcomes were found. CONCLUSIONS: The TF valve is associated with significantly higher rates of SVD or reintervention for SVD than the ME valve, but not the Mitroflow valve. The TF valve was also associated with higher rates of all-cause reintervention than ME and Perimount valves. The underlying mechanism(s) of these findings warrant further investigation.

Outcomes of redo operations after the Ross procedure.

BACKGROUND: The Ross procedure is not commonly performed, owing to the procedural complexity and the risk of autograft and/or homograft reoperation. This study examined outcomes of patients undergoing Ross reinterventions at a dedicated Ross center. METHODS: We retrospectively reviewed 225 consecutive patients who underwent a Ross procedure between 1994 and 2019. Index and redo operation characteristics and outcomes were compared between patients with and those without redo operations. Multivariate analysis was used to identify independent predictors of Ross-related reinterventions. Survival was estimated with Kaplan-Meier analysis. RESULTS: Sixty-six patients (29.3%) required redo Ross surgery, 41 patients (18.2%) underwent autograft reoperation only, 8 patients (3.6%) had a homograft reintervention, and 17 patients (7.6%) had both autograft and homograft reoperations (12 as a combined procedure and 5 as sequential procedures). The mean time to reintervention was 11 ± 6 years for autograft reoperations and 12 ± 7 years for homograft reoperations. Patients who underwent Ross-related reinterventions were younger (mean, 38 ± 11 years vs 43 ± 11 years; P < .01) and had a higher rate of New York Heart Association class III/IV (56% vs 38%; P = .02) at the index Ross procedure. Most patients undergoing autograft reintervention had aortic insufficiency and/or aneurysm (98.2%; 57 of 58). The primary reason for homograft reintervention was pulmonary stenosis (92%; 23 of 25). The operative mortality of Ross reintervention was 1.5% (1 of 66). Survival at 15 years was similar in patients who required a redo operation and those who did not (91.2% vs 93.9%; P = .23). CONCLUSIONS: Ross reinterventions can be performed safely and maintain patients at the normal life expectancy restored by the index Ross procedure up to 15 years at experienced centers.

Contemporary Outcomes of Isolated Tricuspid Valve Surgery.

INTRODUCTION: Isolated tricuspid valve (TV) surgery is uncommonly performed and has historically been associated with excessive operative mortality. We previously reported improved short-term outcomes at our center. Understanding contemporary outcomes of isolated TV surgery beyond the perioperative period is essential to properly benchmark outcomes of newer transcatheter interventions. METHODS: Patients who underwent isolated TV surgery from 2007 to 2021 at a single institution were retrospectively reviewed. Survival was estimated using the Kaplan-Meier method and multivariable Cox proportional hazards regression modeling identified independent risk factors for all-cause mortality. RESULTS: Among 173 patients undergoing isolated TV surgery, 103 (60%) underwent TV repair and 70 (40%) underwent TV replacement. Mean age was 60.3 ± 18.9 y and 55 (32%) were male. The most common etiology of TV disease was functional (46%). In-hospital mortality was 4.1% (7/173), with no difference between TV repair and replacement (P = 0.06). Overall survival at 1 y and 5 y was 78.3% (111/142) and 64.5% (53/82), respectively. After median (interquartile range) follow-up of 2.0 (0.6-4.4) y, patients undergoing TV repair experienced a higher unadjusted survival as compared to those undergoing TV replacement (log-rank P = 0.02). However, after adjusting for covariates, TV replacement was not an independent predictor of all-cause mortality (hazard ratio 1.40; 95% confidence interval, 0.71-2.76; P = 0.33). CONCLUSIONS: Isolated TV surgery can be performed with lower operative mortality than historically reported. Establishing survival benchmarks from TV surgery is important in the era of developing transcatheter interventions.

Development of a non-transplant left ventricular assist device program.

INTRODUCTION: Although the established long-term benefit of left ventricular assist device (LVAD) therapy has led to its proliferation as destination therapy (DT), few studies have evaluated LVAD outcomes at nontransplant centers. We undertook this study to better evaluate our experience in building a nontransplant, DT LVAD program. METHODS: We conducted a retrospective review of all LVADs implanted from 2010 to 2021. Patient, operative, and outcome data were extracted from the electronic medical record. Secular trends were evaluated by organizing the data into eras of implant. Survival was assessed using the Kaplan-Meier method. Multivariable Cox proportional hazards regression models further evaluated outcomes. RESULTS: From 2010 to 2021, 100 primary LVAD implants were performed. Annual volume grew from 1 to 30 implants per year. The average age of our cohort was 65.7 years, most patients (80%) were male, 51% had an ischemic etiology, and 65 (65%) were INTERMACS profile 1 or 2. Our 1- and 2-year survival were 82% and 79%, respectively. Multivariable analysis of 1-year mortality demonstrated that decreasing renal function and increased cardiopulmonary bypass (CPB) time were associated with increased mortality while preoperative hemoglobin was protective. When stratified by era of implant, our most recent patients were more likely to be INTERMACS profile 1 or 2; had shorter CPB and aortic cross clamp times; required fewer reoperations for bleeding; and suffered less right ventricular failure requiring mechanical support. CONCLUSIONS: A single, nontransplant LVAD center can experience significant growth in volume in a high-acuity cohort while maintaining acceptable outcomes and quality of care.

Outcomes of aortic root enlargement during isolated aortic valve replacement.

OBJECTIVES: Aortic root enlargement (ARE) lowers the risk of patient prosthesis mismatch after surgical aortic valve replacement (SAVR) in patients with small annular size. Whether ARE is associated with increased operative mortality is controversial. This study compares the early and intermediate outcomes in patients undergoing SAVR with and without ARE. METHODS: All patients undergoing isolated SAVR with and without ARE from 2015 to 2020 were analyzed. Propensity-matching was used to adjust for possible confounding variables. Kaplan-Meier analysis and log-rank test were used to estimate and compare overall outcomes and survival in the study cohorts. RESULTS: Among 868 isolated SAVRs, ARE was performed in 54 (6.2%) patients. Before matching, mean age was similar but female sex (67.4% vs. 29.6%; SD: -0.82) and previous AVR (18.9% vs. 3.9%; SD: -0.48) were more common in patients undergoing SAVR + ARE versus SAVR alone. A bovine pericardial patch was used for 81.5% (44 of 54) of ARE, with a Dacron patch in the rest. After propensity matching, the average cardiopulmonary bypass (138.2 ± 34.9 vs. 102.9 ± 33.0 min; p < 0.01) and cross-clamp times (113.8 ± 26.7 vs. 83.0 ± 28.4 min; p < 0.01) were longer in the SAVR + ARE group. There were no significant differences in postoperative stroke, new-onset dialysis, pacemaker placement, reoperation for bleeding, length of hospital stay, or 30-day readmission. Thirty-day mortality (0% vs. 0.6%, p = 1.0) and 5-year survival (96.3% vs. 95.7%, p = 0.86) were also similar. CONCLUSIONS: ARE during surgical AVR can be safely performed without an increase in complications with excellent early and intermediate-term survival.

Long-Term Survival After On-Pump and Off-Pump Coronary Artery Bypass Grafting.

BACKGROUND: Off-pump coronary artery bypass grafting (CABG) may be associated with increased hazard for long-term mortality as compared with on-pump CABG. We sought to evaluate risk-adjusted long-term survival after off-pump and on-pump CABG, particularly among high-volume and low-volume CABG surgeons. METHODS: We evaluated 1,235,089 isolated CABGs (off pump = 209,085; on pump = 1,026,004) performed in Medicare beneficiaries from 2001 to 2015. Long-term hazard for mortality after off-pump versus on-pump CABG was compared with Kaplan-Meier and log-rank analysis among all CABG surgeons as well as among high-volume and low-volume CABG surgeons, before and after inverse probability of treatment weighting to adjust for confounding. RESULTS: Among all surgeons, off-pump CABG was associated with a statistically significant hazard for mortality as compared with on-pump CABG before and after inverse probability of treatment weighting (median survival: off pump 9.8 years vs on pump 10.2 years; difference in median survival -134 days; log-rank P < .001). Cox regression analysis confirmed an interaction between surgeon volume and long-term mortality. The hazard for mortality associated with off-pump CABG was decreased among high-volume surgeons (difference in median survival -84 days; log-rank P < .001) and increased among low-volume surgeons (difference in median survival -240 days; long-rank P < .001). CONCLUSIONS: Off-pump CABG was associated with a significant, but clinically modest, increased hazard for mortality as compared with on-pump CABG. The hazard was reduced when off-pump CABG was performed by high-volume CABG surgeons.

Long-term outcomes of the Ross procedure in adults.

BACKGROUND: The optimal aortic valve replacement for young and middle-aged adults remains elusive. Although several high-volume international centers and surgeons have demonstrated excellent long-term results with the pulmonary autograft (Ross procedure) in adult patients, current guidelines from the United States do not favor this technique. We evaluated long-term clinical and echocardiographic outcomes of adult patients undergoing the Ross procedure at our center. METHODS: A retrospective review of 225 consecutive adult patients undergoing the Ross procedure was completed. Kaplan-Meier analysis was performed to evaluate overall survival, which was then compared to an age- and sex-matched general population with the log-rank test. Accounting for death as a competing hazard, the cumulative incidence of reintervention and autograft or homograft dysfunction were estimated over the long-term. RESULTS: Mean age was 42±11 years, and 62 (28%) patients were at least 50 years old. A bicuspid aortic valve was present in 179 (80%) patients. The most common indications for surgery were aortic insufficiency (n=94, 43%), aortic stenosis (n=81, 36%), and mixed etiology (n=46, 21%). In-hospital mortality was 0.9%. Overall survival (with 95% confidence intervals) at 1-, 10- and 20-year was 97.8% (95.9-99.7%), 94.2% (91.0-97.4%), and 81.3% (74.8-88.3%), respectively. Overall survival approximated that of the general population (log-rank P=0.32). The cumulative incidence (with 95% confidence intervals) of any autograft or homograft reintervention at 10-, 15-, and 20-year was 16% (12-20%), 28% (21-35%), and 45% (36-54%), respectively. CONCLUSIONS: The Ross procedure restores a normal life expectancy to young and middle-aged adults with severe aortic valve disease. The need for reintervention increases steadily during the second decade after the Ross procedure, but less than half of patients require any reintervention for up to 20-year.

Minimally invasive mitral valve surgery after previous sternotomy: A propensity-matched analysis.

BACKGROUND: Although the incidence of mitral valve (MV) surgery after previous open-heart surgery is increasing, there is no consensus regarding the optimal surgical approach. Reoperative MV surgery is most commonly performed via sternotomy (ST). We sought to determine whether minimally-invasive (MIS) reoperative MV surgery is safe and feasible. METHODS: All patients with a history of ST undergoing MV surgery with or without concomitant tricuspid or atrial fibrillation surgery at a single institution from 2007 to 2018 were retrospectively reviewed. ST and MIS approaches were compared using propensity-matched analysis. The coprimary endpoints were operative mortality and 1-year survival, and secondary endpoints were operative complications and length of stay. RESULTS: A total of 305 isolated MV reoperations were performed: 199 (65%) MIS and 106 (35%) ST. MIS patients were older than ST patients (71 [63, 76.5] vs. 66 [56, 72] years, p < .01), more likely to have undergone prior coronary artery bypass grafting (57% vs. 27%, p < .01), and less likely to have had prior valve surgery (55% vs. 78%, p < .01). In unmatched comparisons, operative mortality was significantly lower among MIS patients (3.0% vs. 8.5%, p = .04), but 1-year mortality was similar (14.4% vs. 15.6%, p = .8). After propensity matching, 88 pairs had excellent balance across baseline characteristics. Mortality was similar among MIS and ST patients at 30 days (3.4% vs. 8%, p = .19) and 1 year (15.9% vs. 16.5%, p = .9). RBC and fresh frozen plasma transfusions were significantly lower in the MIS group (p < .01). CONCLUSIONS: A minimally invasive approach is a safe alternative in patients with prior ST undergoing MV surgery.

Misclassification of Mitral Valve Disease and Rate of Surgical Repair in The Society of Thoracic Surgeons Database.

BACKGROUND: Surgical repair of primary mitral regurgitation (MR) is considered an indicator of quality performance. Therefore, accurate data reporting is critical for quality assessment. During an institutional quality review, MR etiology could not be determined in 40% of operations in The Society of Thoracic Surgeons database entries, and therefore our true repair rate could not be reliably ascertained. Therefore, we reviewed all source documents and echocardiograms to assess our true disease etiology and repair rate. METHODS: Source records and echocardiograms of all operations performed in a single health care system for a 1-year period were reviewed by an experienced mitral valve surgeon, an echocardiographic core laboratory, and a data manager. Disease etiology and operation were compared with data previously entered in the database by post hoc chart abstraction. RESULTS: In all, 314 isolated mitral valve operations were performed. The MR was originally classified as primary, 163 (52%); secondary, 22 (7%); rheumatic, 37 (12%); endocarditis, 24 (8%); other, 33 (10%); and unknown, 35 (11%). Reported repair rate for primary MR was 142 of 163 (87.1%). After review, etiology was determined to be primary, 177 (56%); secondary, 33 (11%); rheumatic, 61 (20%); endocarditis, 25 (8%); and others, 18 (5%)-resulting in a change of classification in 99 of 314 patients (31.5%) and a true repair rate for primary MR of 165 of 177 (93.2%). CONCLUSIONS: Source document and imaging review of mitral valve surgery revealed significant discordance with post hoc chart abstraction methods. A more detailed data entry methodology is necessary to accurately report the true disease etiology and repair rates for primary MR.

Outcomes of Isolated Tricuspid Valve Surgery Have Improved in the Modern Era.

BACKGROUND: Surgery for isolated tricuspid valve (TV) disease remains relatively infrequent because of significant patient comorbidities and poor surgical outcomes. This study reviewed the experience with isolated TV surgery in the current era to determine whether outcomes have improved. METHODS: From 2007 through 2017, 685 TV operations were performed in a single institution, of which 95 (13.9%) operations were isolated TV surgery. Patients were analyzed for disease origin, risk factors, operative mortality and morbidity, and long-term survival. RESULTS: A total of 95 patients underwent isolated TV surgery, an average of 9 patients per year increasing from an average of 5 per year to 15 per year during the study period. Surgery was reoperative in 41% (38 of 95) of patients, including 11.6% (11 of 95) with prior coronary artery bypass grafting and 29.4% (28 of 95) with prior valve surgery (9 TV, 11 mitral, 2 aortic, 5 mitral and aortic, and 1 mitral and TV). Repair was performed in 71.6% (68 of 95) of patients, and replacement was performed in 28.4% (27 of 95). Operative mortality was 3.2% (3 of 95), with no mortality in the most recent 73 patients over the last 6 years. Stroke occurred in 2.1% (2 of 95) of patients, acute kidney injury requiring dialysis in 5.3% (5 of 95), and the need for new permanent pacemaker in 16.8% (16 of 95). CONCLUSIONS: In the current era with careful patient selection and periprocedural management, isolated TV surgery can be performed with lower morbidity and mortality than has traditionally been reported with good long-term survival. These outcomes can also serve as a benchmark for catheter-based TV intervention outcomes.

TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve.

BACKGROUND: The TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) trial (NCT01700439) evaluated the performance of the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis. METHODS: TRANSFORM was a prospective, nonrandomized, multicenter (n = 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon-expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve. Primary and effectiveness endpoints were evaluated at 1 year. RESULTS: Between 2012 and 2015, 839 patients underwent RDAVR. Mean age was 73.5 ± 8.3 years. Full sternotomy (FS) was used in 59% and minimally invasive surgical incisions in 41%. Technical success rate was 95%. For isolated RDAVR, mean crossclamp and cardiopulmonary bypass times for FS were 49.3 ± 26.9 minutes and 69.2 ± 34.7 minutes, respectively, and for minimally invasive surgical 63.1 ± 25.4 minutes and 84.6 ± 33.5 minutes, respectively. These times were favorable compared with Society of Thoracic Surgeons database comparators for FS: 76.3 minutes and 104.2 minutes, respectively, and for minimally invasive surgical, 82.9 minutes and 111.4 minutes, respectively (P < .001). At 30 days, all-cause mortality was 0.8%; valve explant, 0.1%; thromboembolism, 3.5%; and major bleeding, 1.3%. In patients with isolated aortic valve replacement, the rate of permanent pacemaker implantation was 11.9%. At 1 year, mean effective orifice area was 1.7 cm2; mean gradient, 10.3 mm Hg; and moderate and severe paravalvular leak, 1.2% and 0.4%, respectively. CONCLUSIONS: INTUITY RDAVR performed effectively in this North American trial. It may lead to a relative reduction in aortic crossclamp time and cardiopulmonary bypass time and has excellent hemodynamic performance. Pacemaker implantation rate observed was somewhat greater than European trials and requires further investigation.