Characteristics of Clinical Trial Sites for Novel Transcatheter Mitral and Tricuspid Valvular Therapies.

Importance: Racial and ethnic minority and socioeconomically disadvantaged patients have been underrepresented in randomized clinical trials. Efforts have focused on enhancing inclusion of minority groups at sites participating at clinical trials; however, there may be differences in the patient populations of the sites that participate in clinical trials. Objective: To identify any differences in the racial, ethnic, and socioeconomic composition of patient populations among candidate sites in the US that did vs did not participate in trials for novel transcatheter therapies. Design, Setting, and Participants: This cross-sectional analysis used Medicare Provider Claims from 2019 for patients admitted to hospitals in the US. All clinical trials for transcatheter mitral and tricuspid valve therapies and the hospitals participating in each of the trials were identified using ClinicalTrials.gov. Hospitals with active cardiac surgical programs that did not participate in the trials were also identified. Data analysis was performed between July 2021 and July 2022. Exposures: Multivariable linear regression models were used to identify differences in racial, ethnic, and socioeconomic characteristics among patients undergoing cardiac surgery or transcatheter aortic valve replacement at trial vs nontrial hospitals. Main Outcome and Measures: The main outcome of the study was participation in a clinical trial for novel transcatheter mitral or tricuspid valve therapies. Results: A total of 1050 hospitals with cardiac surgery programs were identified, of which 121 (11.5%) participated in trials for transcatheter mitral or tricuspid therapies. Patients treated in trial hospitals had a higher median zip code-based household income (difference of $5261; 95% CI, $2986-$7537), a lower Distressed Communities Index score (difference of 5.37; 95% CI, 2.59-8.15), and no significant difference in the proportion of patients dual eligible for Medicaid (difference of 0.86; 95% CI, -2.38 to 0.66). After adjusting for each of the socioeconomic indicators separately, there was less than 1% difference in the proportion of Black and Hispanic patients cared for at hospitals participating vs not participating in clinical trials. Conclusions and Relevance: In this cohort study among candidate hospitals for clinical trials for transcatheter mitral or tricuspid valve therapies, trial hospitals took care of a more socioeconomically advantaged population than nontrial hospitals, with a similar proportion of Black and Hispanic patients. These data suggest that site selection efforts may improve enrollment of socioeconomically disadvantaged patients but may not improve the enrollment of Black and Hispanic patients.

Coronary Endarterectomy: Analysis of The Society of Thoracic Surgeons Adult Cardiac Surgery Database.

BACKGROUND: Coronary endarterectomy (CE) is an uncommon and often unplanned technique used to approach difficult targets during coronary artery bypass grafting (CABG). We evaluated the outcomes of CABG with CE (CE-CABG) using The Society of Thoracic Surgeons Adult Cardiac Surgery Database. METHODS: All isolated, first-time, elective or urgent CABG cases from July 2011 to September 2019 in the Adult Cardiac Surgery Database were retrospectively reviewed. Because of a higher risk profile in the patients undergoing CE-CABG, we performed propensity score matching. Primary outcomes included operative mortality and postoperative myocardial infarction. For patients ≥65 years, long-term mortality and rehospitalization were evaluated using linked data from Centers for Medicare and Medicaid Services. RESULTS: Of the total 1 111 792 patients included, 32 164 (2.9%) had CE-CABG and 1 079 628 (97.1%) underwent CABG alone. The majority of CE-CABG involved a single-vessel endarterectomy (86.9%; n = 27 945); the left anterior descending was most common (40.9%; n = 13 161). Compared with propensity score-matched CABG, CE-CABG had increased operative mortality (3.2% vs 1.7%; P < .0001; odds ratio, 1.81; 95% CI, 1.63-2.01) and postoperative myocardial infarction (6.8% vs 3.9%; P < .0001; odds ratio, 1.80; 95% CI, 1.68-1.93). CE-CABG had higher risk of mortality in the first year and rehospitalization for myocardial infarction in the first 3 years but was comparable to CABG alone thereafter. Subgroup analysis showed no difference between CE-CABG of the left anterior descending compared with CE-CABG of other coronary arteries. CONCLUSIONS: This analysis demonstrates that CE-CABG has acceptable long-term outcomes and serves as a benchmark for what can be expected when this rare procedure is used.

Racial, Ethnic, and Socioeconomic Disparities in Access to Transcatheter Aortic Valve Replacement Within Major Metropolitan Areas.

Importance: Despite the benefits of high-technology therapeutics, inequitable access to these technologies may generate disparities in care. Objective: To examine the association between zip code-level racial, ethnic, and socioeconomic composition and rates of transcatheter aortic valve replacement (TAVR) among Medicare patients living within large metropolitan areas with TAVR programs. Design, Setting, and Participants: This multicenter, nationwide cross-sectional analysis of Medicare claims data between January 1, 2012, and December 31, 2018, included beneficiaries of fee-for-service Medicare who were 66 years or older living in the 25 largest metropolitan core-based statistical areas. Exposure: Receipt of TAVR. Main Outcomes and Measures: The association between zip code-level racial, ethnic, and socioeconomic composition and rates of TAVR per 100 000 Medicare beneficiaries. Results: Within the studied metropolitan areas, there were 7590 individual zip codes. The mean (SD) age of Medicare beneficiaries within these areas was 71.4 (2.0) years, a mean (SD) of 47.6% (5.8%) of beneficiaries were men, and a mean (SD) of 4.0% (7.0%) were Asian, 11.1% (18.9%) were Black, 8.0% (12.9%) were Hispanic, and 73.8% (24.9%) were White. The mean number of TAVRs per 100 000 Medicare beneficiaries by zip code was 249 (IQR, 0-429). For each $1000 decrease in median household income, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 0.2% (95% CI, 0.1%-0.4%) lower (P = .002). For each 1% increase in the proportion of patients who were dually eligible for Medicaid services, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 2.1% (95% CI, 1.3%-2.9%) lower (P < .001). For each 1-unit increase in the Distressed Communities Index score, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 0.4% (95% CI, 0.2%-0.5%) lower (P < .001). Rates of TAVR were lower in zip codes with higher proportions of patients of Black race and Hispanic ethnicity, despite adjusting for socioeconomic markers, age, and clinical comorbidities. Conclusions and Relevance: Within major metropolitan areas in the US with TAVR programs, zip codes with higher proportions of Black and Hispanic patients and those with greater socioeconomic disadvantages had lower rates of TAVR, adjusting for age and clinical comorbidities. Whether this reflects a different burden of symptomatic aortic stenosis by race and socioeconomic status or disparities in use of TAVR requires further study.

Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement.

[Figure: see text].

Geographically Derived Socioeconomic Factors to Improve Risk Prediction in Patients Having Aortic Valve Replacement.

Socioeconomic status (SES) has been associated with adverse outcomes after cardiac surgery, but is not included in commonly applied risk adjustment models. This study evaluates whether inclusion of SES improves aortic valve replacement (AVR) risk prediction models, as this is the most common elective operation performed at our institution during the study period. All patients who underwent AVR at a single institution from 2005 to 2015 were evaluated. SES measures included unemployment, poverty, household income, home value, educational attainment, housing density, and a validated SES index score. The risk scores for mortality, complications, and increased length of stay were generated using models published by the Society for Thoracic Surgeons. Univariate models were fitted for each SES covariate and multivariable models for mortality, any complication, and prolonged length of stay (PLOS). A total of 1,386 patients underwent AVR with a 2.7% mortality, 15.1% complication rate, and 9.7% PLOS. In univariate models, higher education was associated with decreased mortality (odds ratio [OR] 0.96, p = 0.04) and complications (OR 0.97, p <0.01). Poverty was associated with increased length of stay (OR 1.02, p = 0.02). In the multivariable models, the inclusion of SES covariates increased the area under the curve for mortality (0.735 to 0.750, p = 0.14), for any complications (0.663 to 0.680, p <0.01), and for PLOS (0.749 to 0.751, p = 0.12). The inclusion of census-tract-level socioeconomic factors into the the Society of Thoracic Surgeons risk predication models is new and shows potential to improve risk prediction for outcomes after cardiac surgery. With the possibility of reimbursement and institutional ranking based on these outcomes, this study represents an improvement in risk prediction model.

Long-term outcome of surgical cryoablation for refractory ventricular tachycardia in patients with non-ischemic cardiomyopathy.

Aims: Limited data exist on the long-term outcome of patients (pts) with non-ischemic cardiomyopathy (NICM) and ventricular tachycardia (VT) refractory to conventional therapies undergoing surgical ablation (SA). We aimed to investigate the long-term survival and VT recurrence in NICM pts with VT refractory to radiofrequency catheter ablation (RFCA) who underwent SA. Methods and results: Consecutive pts with NICM and VT refractory to RFCA who underwent SA were included. VT substrate was characterized in the electrophysiology lab and targeted by RFCA. During SA, previous RFCA lesions/scars were identified and targeted with cryoablation (CA; 3 min/lesion; target -150 °C). Follow-up comprised office visits, ICD interrogations and the social security death index. Twenty consecutive patients with NICM who underwent SA (age 53 ± 16 years, 18 males, LVEF 41 ± 20%; dilated CM = 9, arrhythmogenic right ventricular CM = 3, hypertrophic CM = 2, valvular CM = 4, and mixed CM = 2) were studied. Percutaneous mapping/ablation in the electrophysiology lab was performed in 18 and 2 pts had primary SA. During surgery, 4.9 ± 4.0 CA lesions/pt were delivered to the endocardium (2) and epicardium (11) or both (7). VT-free survival was 72.5% at 1 year and over 43 ± 31 months (mos) (range 1-83mos), there was only one arrhythmia-related death. There was a significant reduction in ICD shocks in the 3-mos preceding SA vs. the entire follow-up period (6.6 ± 4.9 vs. 2.3 ± 4.3 shocks/pt, P = 0.001). Conclusion: In select pts with NICM and VT refractory to RFCA, SA guided by pre-operative electrophysiological mapping and ablation may be a therapeutic option.

Outcomes, readmissions, and costs in transfemoral and alterative access transcatheter aortic valve replacement in the US Medicare population.

OBJECTIVE: To comprehensively evaluate and compare utilization, outcomes, and especially costs of transfemoral (TF), transapical (TA), and transaortic (TAO) transcatheter aortic valve replacement (TAVR). METHODS: All Medicare fee-for-service patients undergoing TF (n = 4065), TA (n = 691), or TAO (n = 274) TAVR between January 1, 2011, and November 30, 2012, were identified using Health Care Procedure Classification Codes present on Medicare claims. Hospital charges from Medicare claims were converted to costs using hospital-specific Medicare cost-to-charge ratios. RESULTS: TA and TAO patients were similar in age, race, and common comorbidities. Compared with TF patients, TA and TAO patients were more likely to be female and to have peripheral vascular disease, chronic lung disease, and renal failure. Thirty-day mortality rates were higher among TA and TAO patients than among TF patients (TA, 9.6%; TAO, 8.0%; TF, 5.0%; P < .001). Adjusted mortality beyond 1 year did not differ by access. TA patients were more likely to require cardiopulmonary bypass (CPB). Increased adjusted mortality was associated with CPB (hazard ratio, 2.13; P < .01) and increased 30-day cost ($62,000 [interquartile range (IQR)], $45,100-$86,400 versus $48,800 [IQR, $38,100-$62,900]; P < .01). Cost at 30 days was lowest for TF ($48,600) compared with TA ($49,800; P < .01) and TAO ($53,200; P = .03). CONCLUSIONS: For patients ineligible to receive TF TAVR, TAO and TA approaches offer similar clinical outcomes at similar cost with acceptable operative and 1-year survival, except for higher rates of CPB use in TA patients. CPB was associated with worse survival and increased costs.

Cost and contribution margin of transcatheter versus surgical aortic valve replacement.

OBJECTIVE: To compare the cost of and payments for transcatheter aortic valve replacement (TAVR), a novel and expensive technology, and surgical aortic valve replacement (SAVR). METHODS: Medicare claims provided hospital charges, payments, and outcomes between January and December 2012. Hospital costs and charges were estimated using hospital-specific cost-to-charge ratios. Costs and payments were examined in propensity score- matched TAVR and SAVR patients. RESULTS: Medicare spent $215,770,200 nationally on 4083 patients who underwent TAVR in 2012. Hospital costs were higher for TAVR patients (median, $50,200; interquartile range [IQR], $39,800-$64,300) than for propensity-matched SAVR patients ($45,500; IQR, $34,500-$63,300; P < .01), owing largely to higher estimated medical supply costs, including the implanted valve prosthesis. Postprocedure hospital length of stay (LOS) length was shorter for TAVR patients (median, 5 days [IQR, 4-8 days] vs 7 days [IQR, 5-9 days]; P < .01), as was total intensive care unit (ICU) LOS (median, 2 days [IQR, 0-5 days] vs 3 days [IQR, 1-6 days]; P < .01). Medicare payments were lower for TAVR hospitalizations (median, $49,500; IQR, $36,900-$64,600) than for SAVR (median, $50,400; IQR, $37,400-$65,800; P < .01). The median of the differences between payments and costs (contribution margin) was -$3380 for TAVR hospitalizations and $2390 for SAVR hospitalizations (P < .01). CONCLUSIONS: TAVR accounted for $215 million in Medicare payments in its first year of clinical use. Among SAVR Medicare patients at a similar risk level, TAVR was associated with higher hospital costs despite shorter ICU LOS and hospital LOS. Overall and/or medical device cost reductions are needed for TAVR to have a net neutral financial impact on hospitals.

Minimally invasive mitral valve surgery is associated with equivalent cost and shorter hospital stay when compared with traditional sternotomy.

OBJECTIVE: Mitral valve surgery is increasingly performed through minimally invasive approaches. There are limited data regarding the cost of minimally invasive mitral valve surgery. Moreover, there are no data on the specific costs associated with mitral valve surgery. We undertook this study to compare the costs (total and subcomponent) of minimally invasive mitral valve surgery relative to traditional sternotomy. METHODS: All isolated mitral valve repairs performed in our health system from March 2012 through September 2013 were analyzed. To ensure like sets of patients, only those patients who underwent isolated mitral valve repairs with preoperative Society of Thoracic Surgeons scores of less than 4 were included in this study. A total of 159 patients were identified (sternotomy, 68; mini, 91). Total incurred direct cost was obtained from hospital financial records. RESULTS: Analysis demonstrated no difference in total cost (operative and postoperative) of mitral valve repair between mini and sternotomy ($25,515 ± $7598 vs $26,049 ± $11,737; P = .74). Operative costs were higher for the mini cohort, whereas postoperative costs were significantly lower. Postoperative intensive care unit and total hospital stays were both significantly shorter for the mini cohort. There were no differences in postoperative complications or survival between groups. CONCLUSIONS: Minimally invasive mitral valve surgery can be performed with overall equivalent cost and shorter hospital stay relative to traditional sternotomy. There is greater operative cost associated with minimally invasive mitral valve surgery that is offset by shorter intensive care unit and hospital stays.

Transcatheter mitral valve replacement: design implications, potential pitfalls and outcomes assessment.

Transcatheter mitral valve replacement (TMVR) is an emerging new treatment option in patients with advanced mitral valve disease deemed a high or prohibitive risk for surgery. Designing an ideal TMVR device requires a detailed understanding of different mitral valve pathologies and the complex, dynamic anatomy and physiology of the mitral apparatus. This review aims to critically evaluate design implications in TMVR in the context of mitral valve disease, imaging prerequisites, procedural approaches, potential complications, and outcomes assessment.

Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.

OBJECTIVES: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement. METHODS: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients. RESULTS: Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement. CONCLUSIONS: PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites.

Transcatheter and Surgical Aortic Valve Replacement in Dialysis Patients: A Propensity-Matched Comparison.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) clinical trials in North America excluded patients on dialysis and, consequently, the outcomes of TAVR in dialysis-dependent patients remain unknown. METHODS: All Medicare fee-for-service patients undergoing TAVR (n = 5,005) or surgical aortic valve replacement (SAVR) (n = 32,634) between January 1, 2011, and November 30, 2012, were identified using procedural codes collected by the Centers for Medicare & Medicaid Services. Dialysis status and comorbidities were identified using diagnosis codes present on arrival for TAVR hospitalization. Patients supported on dialysis who underwent TAVR (n = 224) were compared with non-dialysis patients who underwent TAVR as well as a propensity-matched group of contemporaneous dialysis patients who underwent SAVR (n = 194 pairs). RESULTS: The TAVR patients on dialysis were younger than non-dialysis TAVR patients (79.2 years vs 84.1 years; p < 0.01) but had higher prevalence of comorbidities. Dialysis TAVR patients had increased mortality at 30 days (13% vs 6%, p < 0.01) and significantly worse survival by Kaplan-Meier analysis. Multivariable regression found dialysis to be independently associated with worse survival (hazard ratio, 1.73; 95% confidence interval, 1.33% to 2.25%, p < 0.01) in TAVR patients. Propensity-matched dialysis SAVR and dialysis TAVR patients had no significant differences in demographic or risk factors. Matched dialysis TAVR patients had shorter length of stay (6 interquartile range, 4 to 10] vs 10 [IQR 7 to 18] days; p < 0.01) and comparable survival. CONCLUSIONS: TAVR in dialysis patients is associated with decreased survival compared with non-dialysis patients; however, it is comparable with SAVR in high risk dialysis patients based on a propensity-matched comparison.

Rationale, development, implementation, and initial results of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR).

BACKGROUND: The care pathway for patients undergoing transcatheter aortic valve replacement (TAVR), particularly in the US, was initially based on open surgical techniques and often includes general anesthesia, transesophageal echocardiographic monitoring, and cardiothoracic intensive care unit (ICU) stays. Whether a subgroup of patients could benefit from early extubation, fewer days in the ICU, and early ambulation in terms of both cost and effectiveness is unknown. METHODS AND RESULTS: A fast track (FT) protocol was initiated at two institutions in our health system with specific inclusion criteria. Patients with complications or morbidity post procedure deemed ineligible to continue on the FT pathway were designated as deviations. Baseline characteristics, success and deviations, subsequent course, and direct costs were compared for FT eligible and ineligible patients over a 6-month study period. Among 99 patients undergoing Transfemoral TAVR, 39 (39%) met FT inclusion criteria. The mean age of eligible and ineligible patients was similar at 85 years, but by design, eligible patients had fewer co-morbid conditions. Successful completion of the FT protocol was achieved in 28 patients (72%). Patients on the FT had shorter ICU stays (28 ± 103 vs 45 ± 46 hours, P < 0.0001) and post-operative length of stay (4.3 ± 4.4 vs 7.2 ± 5.3 days, P < 0.0001), and incurred lower direct costs ($44,923 ± $14,187 vs $56, 339 ± 17,808, P < 0.0001). CONCLUSIONS: It is feasible to identify a large percentage of suitable patients preprocedure who are eligible for a FT postprocedure care pathway. There was no evidence for compromise of care and successful completion of the pathway was associated with shorter length of stay and fewer direct costs.

Graft selection for aortic root replacement in complex active endocarditis: does it matter?

BACKGROUND: Endocarditis affecting the aortic valve, with abscess formation and root destruction, remains a challenge to treat. Aortic root homografts have been advocated because of a perceived lower risk of infective complications than with other root replacement grafts. However, the theoretical advantage of homografts has not been re-evaluated in the modern era. This report is based on an examination of our results for all aortic root replacements in complex, active endocarditis affecting the aortic valve. METHODS: From 2000 to 2010, 134 patients (70.9% male; mean age 58.3±14.8 years) at our institution underwent aortic root replacement for active endocarditis. Ninety of the patients (67.2%) had a previously implanted prosthetic aortic valve. Our findings for these patients included one or more of the following: abscess (n=110, 82.1%), valve vegetation (n=98, 73.1%), and pseudoaneurysm or rupture or both (n=62, 46.3%). We retrospectively reviewed data for the patients from hospital records and the social security data base. RESULTS: A mechanical composite graft (MC) was used in 43 of the patients (32.1%), a non-homograft biologic valve conduit (BC) in 55 patients (41.0%), and a homograft (HG) valve in 36 patients (26.9%). There was no significant difference among the groups in the incidence of major complications or in-hospital mortality. During a mean follow-up of 32.1±29.4 months, the rates of readmission, reinfection, and reoperation were similar for the three groups. The mean 5-year survival in the study was 58±9% for the MC group, 62±7% for the BC group, and 58 ± 9% for the HG group, respectively (p=0.48). CONCLUSIONS: Aortic root replacement in the presence of complex active infection is associated with significant morbidity and mortality. We report that the rates of major complications and late mortality were similar among MC, BC, and HG groups in our study.

The progression of a transcatheter aortic valve program: a decision analysis of more than 680 patient referrals.

BACKGROUND: A ground-breaking, US Food and Drug Administration clinical trial for the treatment of critical aortic stenosis commenced at our institution in November 2007 with our first transcatheter aortic valve repair (TAVR). This novel procedure created a new treatment option for high-risk patients with aortic stenosis. Although the pivotal trial completed enrollment in 2009, continued access was implemented by the Food and Drug Administration in response to an unprecedented demand for this new procedure by patients and physicians. This is an overview of one site's management strategy for patient referrals. METHODS: Patients underwent evaluation with a comprehensive assessment in a multidisciplinary transcatheter aortic valve clinic. All screened patients were classified as either traditional open surgical candidates or nonsurgical candidates. Major exclusions for open procedures included low Society of Thoracic Surgeons score, coronary artery disease, and other valvular disease. Major exclusions of nonsurgical candidates resulted from physician discretion or multiple comorbidities such as renal failure, significant liver or lung disease, and progressive cancer. A third group of patients was excluded because of inadequate femoral access. RESULTS: From November 2007 to November 2010, 681 patients were referred for evaluation, including 578 screened patients and 103 patients whose evaluation was pending. During the screening process, 82 patients died (12%). Among 343 patients who did not qualify for enrollment (50%), 108 received open surgical intervention and 235 were nonsurgical candidates; 35 of these patients underwent balloon aortic valvuloplasty. A total of 153 patients were enrolled in the TAVR trial. CONCLUSIONS: With the availability of a novel treatment option for aortic stenosis in high-risk patients, institutions offering these alternative methods will be forced to reevaluate patient management. A careful strategy that includes multidisciplinary evaluation is crucial in order to have a successful transcatheter aortic valve program.

Observational study of mortality risk stratification by ischemic presentation in patients with acute type A aortic dissection: the Penn classification.

BACKGROUND: Acute type A aortic dissection is a surgical emergency, with an operative mortality as high as 25%. Ischemia is a known predictor of mortality. We tested the efficacy of a classification system--the Penn classification, which is based on ischemic pattern at clinical presentation--to stratify operative mortality risk and identify high-risk groups of patients for further intervention and study. METHODS: In this prospective observational study, patients underwent a standard aortic dissection repair protocol at the University of Pennsylvania, Philadelphia, PA, from 1993 to 2004. Patients were classified as having no ischemia, branch vessel malperfusion with localized organ ischemia, generalized ischemia with circulatory collapse, with or without cardiac involvement, or a combination of localized and generalized ischemia. RESULTS: The cohort comprised 221 patients. The mean age was 61.6 (+/- 14.8) years and 66.5% were male. At presentation 57.9% of patients had no ischemia, 17.6% had localized ischemia, 15.4% had generalized ischemia, and 9.0% had both localized and generalized ischemia. Overall, 28 (12.7%) patients died during the perioperative period. All-cause mortality differed significantly between groups (no ischemia 3.1%, localized ischemia 25.6%, generalized ischemia 17.6%, combined ischemia 40.0%), yielding an overall 8.3-fold difference for no compared with any ischemia (3.1% versus 25.8%, P = 0.0001). Ischemic presentations together accounted for 85.7% of all deaths. CONCLUSION: The Penn classification of acute type A aortic dissection enabled stratification of patients by operative mortality risk. The system requires further validation, but might facilitate new ways to analyze mortality data for this disorder.