Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial.

Background: The use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory-adjudicated data are scarce, however. Here we report final 7-year data on RDV use. Methods: TRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory-adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention, all-cause valve explantation, and all-cause mortality. Secondary endpoints included hemodynamic performance assessed by echocardiography. The mean duration of follow-up was 5.0 ± 2.0 years. Results: The mean patient age was 73.3 ± 8.2 years. Isolated AVR was performed in 62.1% of the patients, and AVR with concomitant procedures was performed in 37.9%. Freedom from all-cause mortality at 7 years was 76.0% for isolated AVR and 68.2% for concomitant AVR. Freedom from SVD, all-cause reintervention, and valve explantation at 7 years was 97.5%, 95.7%, and 97.8%, respectively. The mean gradient and effective orifice area at 7 years were 11.1 ± 5.3 mm Hg and 1.6 ± 0.3 cm2, respectively. Paravalvular leak at 7 years was none/trace in 88.6% and mild in 11.4%. In patients undergoing isolated AVR, the cumulative probability of pacemaker implantation was 13.9% at 30 days, 15.5% at 1 year, and 21.8% at 7 years. Conclusions: AVR for aortic stenosis using an RDV is associated with low rates of late adverse events. This surgical pericardial tissue platform provides excellent and stable hemodynamic performance through 7 years.

Influence of surgical volume on outcomes in low-risk patients undergoing isolated surgical aortic valve replacement.

BACKGROUND: Intermediate- and high-risk patients undergoing isolated surgical aortic valve replacement have superior outcomes at higher-volume compared with lower-volume hospitals. This study examines the impact of hospital volume on outcomes in low-risk patients undergoing aortic valve replacement. METHODS: Using data from our 29 North Texas hospital collaborative, we examined 2066 low-risk cases (Society of Thoracic Surgeons Predicted Risk of Mortality of ≤3%) undergoing aortic valve replacement surgery between January 1, 2012, and December 31, 2017. Cases from 3 high-volume hospitals (≥200 aortic valve replacement cases total) and 26 low-volume hospitals (<200 cases total) were examined. RESULTS: Some 53.5% of the cases were at high-volume hospitals. No statistical differences were seen in the Predicted Risk of Mortality or pertinent demographics between the high-volume and low-volume hospitals. Significant differences in outcomes were seen between the 2 groups in operative mortality (2.28% vs 1.19%, P = .007), renal failure (2.14% vs 1.00%, P = .003), and readmission within 30 days (9.72% vs 6.25%, P < .001) when comparing low-volume with high-volume hospitals. In patients undergoing aortic valve replacement, undergoing the procedure in a low-volume hospital was an independent predictor for operative mortality (odds ratio, 1.95; 95% confidence interval, 1.20-3.20; P = .008) and renal failure (odds ratio, 2.25; 95% confidence interval, 1.33-3.81; P = .003). CONCLUSIONS: Operative mortality in low-risk patients undergoing aortic valve replacement is higher in low-volume compared with high-volume hospitals. The probability of a major complication, such as renal failure, is also greater in low-volume hospitals. The relationship between volume and outcomes in low-risk patients will require more research to understand the causes and design appropriate interventions.

Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.

BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients.

BACKGROUND: The introduction of transcatheter aortic valve replacement mandates attention to outcomes after surgical aortic valve replacement (SAVR) in low-risk, intermediate-risk, and very high-risk patients. METHODS: The study population included 141,905 patients who underwent isolated primary SAVR from 2002 to 2010. Patients were risk-stratified by Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) <4% (group 1, n = 113,377), 4% to 8% (group 2, n = 19,769), and >8% (group 3, n = 8,759). The majority of patients were considered at low risk (80%), and only 6.2% were categorized as being at high risk. Outcomes were analyzed based on two time periods: 2002 to 2006 (n = 63,754) and 2007 to 2010 (n = 78,151). RESULTS: The mean age was 65 years in group 1, 77 in group 2, and 77 in group 3 (p < 0.0001). The median STS PROM for the entire population was 1.84: 1.46% in group 1, 5.24% in group 2, and 11.2% in group 3 (p < 0.0001). Compared with PROM, in-hospital mean mortality was lower than expected in all patients (2.5% vs 2.95%) and when analyzed within risk groups was as follows: group 1 (1.4% vs 1.7%), group 2 (5.1% vs 5.5%), and group 3 (11.8% vs 13.7%) (p < 0.0001). In the most recent surgical era, operative mortality was significantly reduced in group 2 (5.4% vs 6.4%, p = 0.002) and group 3 (11.9% vs 14.4%, p = 0.0004) but not in group 1. CONCLUSIONS: Nearly 80% of patients undergoing SAVR have outcomes that are superior to those by the predicted risk models. In the most recent era, early results have further improved in medium-risk and high-risk patients. This large real-world assessment serves as a benchmark for patients with aortic valve stenosis as therapeutic options are further evaluated.

Clinical implications of new-onset left bundle branch block after transcatheter aortic valve replacement: analysis of the PARTNER experience.

AIMS: Cardiac conduction disturbances, including a left bundle branch block (LBBB), occur frequently following transcatheter aortic valve replacement (TAVR) and may be associated with adverse clinical events. This analysis examines the incidence and implications of new onset, persistent LBBB in patients undergoing TAVR with a balloon-expandable valve. METHODS AND RESULTS: Patients undergoing TAVR in the Placement of Aortic Transcatheter Valves (PARTNER) trial and continued access registries with baseline and discharge/7-day electrocardiograms were included. Prior permanent pacemaker implantation (PPI) and baseline intraventricular conduction abnormalities were exclusion criteria. Predictors of new LBBB were identified and outcomes compared between patients with and without new LBBB. New LBBB occurred in 121 of 1151 (10.5%) patients and persisted in more than half at 6 months to 1 year. The only predictor of new LBBB was prior coronary artery bypass grafting. New LBBB was not associated with significant differences in 1-year mortality, cardiovascular mortality, repeat hospitalization, stroke, or myocardial infarction. However, it was associated with increased PPI during hospitalization (8.3 vs 2.8%, P = 0.005) and from discharge to 1 year (4.7 vs. 1.5%, P = 0.01). The ejection fraction failed to improve after TAVR in patients with new LBBB and remained lower at 6 months to 1 year (52.8 vs. 58.1%, P < 0.001). CONCLUSION: Persistent, new-onset LBBB occurred in 10.5% of patients without intraventricular baseline conduction who underwent TAVR in the PARTNER experience. New LBBB was not associated with death, repeat hospitalization, stroke, or myocardial infarction at 1 year, but was associated with a higher rate of PPI and failure of left ventricular ejection fraction to improve.

Transapical aortic valve replacement for severe aortic stenosis: results from the nonrandomized continued access cohort of the PARTNER trial.

BACKGROUND: Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. METHODS: In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. RESULTS: Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. CONCLUSIONS: Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.

Pulmonary function tests overestimate chronic pulmonary disease in patients with severe aortic stenosis.

BACKGROUND: Pulmonary dysfunction is an important risk factor for postoperative complications after cardiac surgery, and severe chronic obstructive pulmonary disease (COPD) is considered a relative contraindication to aortic valve replacement. Pulmonary function tests may mistakenly diagnose patients as having COPD, when in fact they have pulmonary dysfunction due to heart failure that potentially will improve with valve replacement. METHODS: Between January 2009 and July 2011, 214 consecutive patients underwent pulmonary function testing as part of their preoperative screening. Based on the testing, 143 patients were identified as having COPD (52 mild, 42 moderate, and 49 severe), according to The Society of Thoracic Surgery definition. A total of 71 patients had follow-up tests performed at 6 to 12 months postprocedure. RESULTS: A recent smoking history was present in 55 of 214 (25.7%) patients. Aortic valve replacement was performed in 13.6% (29 of 214) of patients by a conventional surgical approach, in 39.3% (84 of 214) by a transfemoral approach, and in 47.2% (101 of 214) by a transapical approach. Mortality was not significantly different in patients with COPD (12 of 71, 16.9%) compared with patients without COPD (37 of 143, 25.9%), p = 0.141. Logistic regression analyses failed to identify preoperative COPD severity category (p = 0.332) as a predictor for mortality. Comparison of pre- and postprocedure tests revealed that 42% (30 of 71) of patients with COPD showed improvement of one COPD severity category or more, including 40% (12 of 30) of patients in the mild group, 43% (9 of 21) of patients in the moderate group, and 45% (9 of 20) of patients in the severe category. CONCLUSIONS: Abnormal pulmonary function improves in a significant number of patients with severe aortic stenosis after valve replacement.

Long-term fate of patients discharged to extended care facilities after cardiovascular surgery.

BACKGROUND: The Society of Thoracic Surgeons predictive algorithms can be used to help patients understand the risks in having a surgical procedure. However, elderly patients are frequently more concerned about the quality of their remaining life and whether they will return home. Currently, we have no predictors of which patients are likely to return to independent living after surgery. We followed patients discharged home or to an extended care facility to determine which patients were most likely to return home and be alive at one year. METHODS: This single-hospital, retrospective study followed 590 cardiac surgery patients (January 2008 to December 2009) for at least 1 year after discharge. Follow-up data were collected by contacting facilities, patients, and families, and Social Security Death Index searches. RESULTS: At hospital discharge, 84.4% went home, 3.7% to rehab, 7.5% to skilled nursing facilities (SNF), and 4.4% to a long-term acute care facility (LTAC). Predictors for facility discharge include increasing age, female, dialysis, emergent status, procedures other than CAB, preoperative stroke, and moderate to severe tricuspid insufficiency. The most significant predictors of dying or still being in a facility at 1 year include being on dialysis, right heart failure, and having chronic lung disease. Considering perioperative complications, requiring prolonged ventilation decreases the odds of being home and alive at 1 year by 67%: one-year survival at home, 95.4%; rehabilitation, 63.6%; SNF, 52.3%; and LTAC, 30.8%. CONCLUSIONS: Many patients discharged to extended care do not return to their previous lifestyle; only 30.8% of those requiring care in a LTAC facility are alive at home at 1 year.

Aortic valve and ascending aorta guidelines for management and quality measures: executive summary.

The Society of Thoracic Surgeons Clinical Practice Guidelines are intended to assist physicians and other health care providers in clinical decision making by describing a range of generally acceptable approaches for the diagnosis, management, or prevention of specific diseases or conditions. These guidelines should not be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the same results. Moreover, these guidelines are subject to change over time, without notice. The ultimate judgment regarding the care of a particular patient must be made by the physician in light of the individual circumstances presented by the patient.

Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known. METHODS: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed. RESULTS: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation. CONCLUSIONS: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Two-year outcomes after transcatheter or surgical aortic-valve replacement.

BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Influence of surgeon volume on outcomes with aortic valve replacement.

BACKGROUND: A volume-outcome association has been shown for cardiovascular procedures such as coronary artery bypass grafting. The association of a volume-outcome relationship for aortic valve replacement procedures, however, has not been clearly defined. We evaluated the influence of surgeon volume on operative outcomes with isolated aortic valve replacement and aortic valve replacement with concomitant coronary artery bypass grafting. METHODS: One thousand six hundred thirty-five patients were identified as having either isolated aortic valve replacement or aortic valve replacement plus coronary artery bypass grafting between January 1, 2000, and December 31, 2009. Patients were divided into three equal terciles using their Society of Thoracic Surgery Predicted Risk of Mortality scores. Data were retrieved on 14 surgeons with complete data records in our Society of Thoracic Surgery database covering a minimum 5-year period (mean, 8.9 ± 1.5 years; median, 10 years). RESULTS: Clinically significant increases are seen in operative mortality, permanent stroke, renal failure, prolonged ventilation, and hospital and intensive care unit lengths of stay in the high-risk compared with low-risk groups. The low-risk patient group has the smallest observed to expected ratio, less than 50%, whereas in the high-risk group the ratio is greater than 1. Odds ratios demonstrate that as surgeon volume increases, outcomes improve correspondingly (ie, odds ratio <1). In low-risk patients, five of ten major complications demonstrated improved outcomes with increased surgeon volume; in medium and high-risk groups eight of ten were improved. CONCLUSIONS: Surgeon volumes have a significant influence on operative outcomes in high-risk patients undergoing aortic valve replacement or aortic valve replacement with coronary artery bypass grafting.

Does body mass index affect outcomes for aortic valve replacement surgery for aortic stenosis?

BACKGROUND: Obesity is a worldwide healthcare concern, and its association with several chronic diseases is well documented. However, the effect obesity may have on the acute care delivery is not well understood, and in cardiac surgery, reports are conflicting. The purpose of this study is to evaluate the effect of obesity in an isolated aortic valve replacement population. The hypothesis is that increasing body mass index (BMI) will portend worse long-term outcomes and greater short-term resource utilization secondary to perioperative complications but will not affect perioperative mortality. METHODS: Data were collected on 1,066 patients undergoing isolated AVR between January 2000 and December 2010. All definitions follow The Society of Thoracic Surgeons guidelines. Body mass indexes were calculated and used both as a continuous independent variable and to categorize patients into three BMI groups. Long-term mortality follow-up was by Social Security Death Index search. Standard bivariate and multivariate comparisons were performed with hierarchical models used for odds ratios. RESULTS: When controlling for standard covariates that negatively impact outcome (sex, age, renal failure needing dialysis, diabetes mellitus, and current smoker), BMI was not predictive for either operative mortality or a composite morbidity-mortality outcome. When divided into three equal-sized groups, there was again no statistical difference among groups for mortality or for the composite variable. Separate analyses for females and males yielded the same lack of correlation. Long-term follow-up out to 12 years shows that the low BMI group has statistically worse survival than the moderate or high BMI groups. CONCLUSIONS: Increasing BMI has no independent association with worsened outcomes in the short or long term, and overweight patients have a survival benefit after surgery. Patients who are at the lower end of the BMI scale, however, are at increased risk for poor long-term survival.

Preoperative beta-blocker usage: is it really worthy of being a quality indicator?

BACKGROUND: Since 2007, the use of preoperative ß-blockers has been used as a quality standard for patients undergoing coronary artery bypass graft surgery. Recent studies have called into question of the benefit of empiric preoperative ß-blocker use. METHODS: Data were extracted from our Society of Thoracic Surgeons certified database for patients undergoing isolated coronary artery bypass graft surgery from 2000 to 2008. We compared the outcomes for patients who received preoperative ß-blockers with those of patients who did not. RESULTS: The study group had 12,855 patients, of whom 7,967 (62.0%) were treated preoperatively with ß-blockers. Using propensity matching, we selected two matched groups of 4,474 patients with preoperative ß-blocker use and 4,474 not using preoperative ß-blockers. In the unmatched cohort, only deep sternal infection (0.3% versus 0.5% without ß-blockers; p=0.032), pneumonia (1.9% versus 2.4% without ß-blockers; p=0.039), and intraoperative blood usage (37.2% versus 34.1% without ß-blockers; p<0.001) reached statistically significant difference. In the matched groups, there was no difference between adverse event rates in patients treated with ß-blockers and those who were not. The number of patients requiring intraoperative blood product use was significantly higher among ß-blocker-treated patients (p=0.004). Calculating the adjusted odds ratios showed that in the matched groups, the preoperative use of ß-blockers was not an independent predictor of mortality. CONCLUSIONS: A rational for preoperative ß-blockade exists. However, as with any medical intervention, its application should be tailored to specific clinical scenarios. With no differences in mortality or morbidity, our findings do not support preoperative ß-blockade as a useful quality indicator for coronary artery bypass graft surgery.

Fungal endocarditis after transfemoral aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) was introduced in 2006 as an alternative for surgical aortic valve replacement (SAVR) as treatment for patients with aortic stenosis. Endocarditis after TAVI has been anecdotally reported, but concerns aroused because SAVR is often needed to explant the endocarditic valve in a high risk patient previously deemed not to be a surgical candidate. We report a case of a patient who underwent TAVI because he was too high risk to undergo SAVR. Several months later, he developed an intermittent self-limiting fever of unknown origin which eventually was diagnosed as endocarditis. The valve was surgically removed, and pathology showed an infection caused by Histoplasma capsulatum. The patient recovered fully and remains in good condition.

Outcomes of surgical aortic valve replacement in high-risk patients: a multiinstitutional study.

BACKGROUND: The introduction of transcatheter aortic valves has focused attention on outcomes after open aortic valve replacement (AVR) in very high-risk patients. This study analyzes the short-term and midterm outcomes of AVR in this patient cohort in the current surgical era. METHODS: A retrospective review was performed on 159 patients who underwent isolated, primary AVR with a STS PROM (Society of Thoracic Surgeons predicted risk of mortality) of 10% or greater from January 2002 to December 2007 at four US academic institutions. Patients with previous valve operations were excluded. A multivariable model was constructed to determine predictors of in-hospital mortality. Estimates of the cumulative event rate mortality were calculated by the Kaplan-Meier method. RESULTS: The mean age of all patients was 76.1±11.2 years, most were men (92 of 159, 57.9%), and mean STS PROM was 16.3%±7.3%. Significant preoperative factors included the following: peripheral vascular disease, 33.3% (53 of 159); stroke, 23.3% (37 of 159); renal failure, 50.3% (80 of 159); New York Heart Association class III-IV heart failure, 78.0% (124 of 159); and previous coronary artery bypass grafting, 39.0% (62 of 159). Mean ejection fraction was 0.461±0.153 and median implanted valve size was 23 mm. Postoperative complications included the following: stroke, 4.4% (7 of 159); heart block, 5.0% (8 of 159); multisystem organ failure, 6.9% (11 of 159); pneumonia, 7.5% (12 of 159); and dialysis, 8.2% (13 of 159). Postoperative length of stay was 12.6±11.0 days and in-hospital mortality was 16.4% (26 of 159). One-, three-, and 5-year survival was 70.9%, 56.8%, and 47.4%, respectively. CONCLUSIONS: In the current era, high-risk surgical patients undergoing open AVR have respectable short and mid-term survival. These results should serve as a benchmark for evaluating outcomes of transcatheter aortic valve implantation.