Papers by Lorraine Cornwell
Annals of Surgery, Jun 2, 2021
Objective: The aim of this study was to determine the sex representation among principal investig... more Objective: The aim of this study was to determine the sex representation among principal investigators (PIs) in US cardiac surgery clinical trials. Summary Background Data: Being a principal investigator in a US clinical trial confers national recognition among peers. Sex representation among principal investigators (PIs) in US cardiac surgery clinical trials has not been evaluated. Methods: We evaluated 124 US cardiac surgery trials registered on Clin-icalTrials.gov from 2014 to 2019. Sixty trials included PIs (n = 266) from 128 institutions that had a combined total of 1040 adult cardiac surgeons. We examined sex representation among junior-level (instructor or assistant professor) and senior-level (associate, full, or Emeritus professor) PIs by calculating the participation-to-prevalence ratio (PPR), whereby a PPR range of 0.8 to 1.2 reflects equitable representation. Results: The pool representation percentage was 6.1% (63/1040) for women and 93.9% (977/1040) for men. A total of 266 PI positions were assigned to adult cardiac surgeons: 6 (9.5%; PPR = 0.37) from the female pool and 260 (26.6%; PPR = 1.04) from the male pool (P = 0.004). The percentage of PIs with studies funded by industry was 9.5% ofthe female pool (PPR = 0.39) and 25.0% of the male pool (PPR = 1.04) (P = 0.009). No National Institutes of Health-funded or other funded trials had female PIs. An overall trend was observed toward disproportionally more men than women among PIs, especially at the senior level (P = 0.027). Conclusions: Equitable opportunities for PI positions are available for junior-level but not senior-level cardiothoracic surgeons. These results suggest a need for active engagement and promotion of equal opportunities in cardiac surgery.
Texas Heart Institute Journal, Jul 1, 2022
The United States Food and Drug Administration restricts the use of implantable cardiac pressure ... more The United States Food and Drug Administration restricts the use of implantable cardiac pressure monitors to patients with New York Heart Association (NYHA) class III heart failure (HF). We investigated whether single-pressure monitoring could predict survival in HF patients as part of a model constructed using data from the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial.We validated survival models in 204 patients, using all-cause 180-day mortality. Two levels of model complexity were tested: 1) a simplified 1-pressure model based on pulmonary artery mean pressure ([PAM]1P) (information obtainable from an implanted intracardiac monitor alone), and 2) a pair of 5-variable risk score models based on right atrial pressure (RAP) + pulmonary capillary wedge pressure (PCWP) ([RAP+PCWP]5V) and on RAP + PAM ([RAP+PAM]5V). The more complex models used 5 dichotomous variables: a congestion index above a certain threshold value, baseline systolic blood pressure of <100 mmHg, baseline blood urea nitrogen level of ≥ 34 mg/dL, need for cardiopulmonary resuscitation or mechanical ventilation, and posttreatment NYHA class IV status. The congestion index was defined as posttreatment RAP+PCWP or posttreatment RAP+PAM, with congestion thresholds of 34 and 42 mmHg, respectively (median pulmonary catheter indwelling time, 1.9 d).The 5-variable models predicted survival with areas under the curve of 0.868 for the (RAP+PCWP)5V model and 0.827 for the (RAP+PAM)5V model, whereas the 1-pressure model predicted survival with an area under the curve of 0.718. We conclude that decongestion as determined by hemodynamic assessment predicts survival in HF patients and that it may be the final pathway for treatment benefit despite improvements in pharmacologic intervention since the ESCAPE trial.
Circulation, Nov 14, 2017
Introduction: Aortic arch surgery is a high-risk procedure for patients who have previously under... more Introduction: Aortic arch surgery is a high-risk procedure for patients who have previously undergone coronary artery bypass grafting (CABG). The aim of our study was to assess the risk and determi...
The Journal of Thoracic and Cardiovascular Surgery, 2022
Objectives: To evaluate the association between low left ventricular ejection fraction (LVEF), co... more Objectives: To evaluate the association between low left ventricular ejection fraction (LVEF), complication rescue, and long-term survival after isolated coronary artery bypass grafting. Methods: National cohort study of patients who underwent isolated coronary artery bypass grafting (2000-2016) using Veterans Affairs Surgical Quality Improvement Program data. Left ventricular ejection fraction was categorized as 35% (n ¼ 55,877), 25%-34% (n ¼ 3893), or<25% (n ¼ 1707). Patients were also categorized as having had no complications, 1 complication, or more than 1 complication. The association between LVEF, complication rescue, and risk of death was evaluated with multivariable Cox regression. Results: Among 61,477 patients, 6586 (10.7%) had a perioperative complication and 2056 (3.3%) had multiple complications. Relative to LVEF 35%, decreasing ejection fraction was associated with greater odds of complications (25%-34%, odds ratio, 1.30 [1.18-1.42]; <25%, odds ratio, 1.65 [1.43-1.92]). There was a doseresponse relationship between decreasing LVEF and overall risk of death (35% [ref]; 25%-35%, hazard ratio, 1.46 [1.37-1.55]; <25%, hazard ratio, 1.68 [1.58-1.79]). Among patients who were rescued from complications, there were decreases in 10-year survival, regardless of LVEF. Among those rescued after multiple complications, LVEF was no longer associated with risk of death. Conclusions: While decreasing LVEF is associated with post-coronary artery bypass grafting complications, patients rescued from complications have worse long-term survival, regardless of left ventricular function. Prevention and timely treatment of complications should remain a focus of quality improvement initiatives, and future work is needed to mitigate their long-term detrimental impact on survival.
The Annals of Thoracic Surgery, Dec 1, 2018
The Journal of Thoracic and Cardiovascular Surgery, Jul 1, 2020
Objective: The frozen elephant trunk technique's safety regarding spinal cord ischemia has been q... more Objective: The frozen elephant trunk technique's safety regarding spinal cord ischemia has been questioned. We used a meta-analysis to determine the rates of adverse neurologic events and mortality. Methods: We searched PubMed/Medline, Embase, Scopus, and Cochrane databases (inception to April 2018) to identify studies of neurologic events after the frozen elephant trunk procedure. Separate meta-analyses were conducted with random-effects models to assess frozen elephant trunk associations with spinal cord ischemia, stroke, operative mortality, and all adverse events combined. Subgroup analyses compared outcomes in patients with acute versus nonacute type A dissection and aneurysm and with different extents of coverage. Results: Thirty-five studies (total N ¼ 3154) met inclusion criteria. The pooled rates of the outcomes of interest were 4.7% (95% confidence interval, 3.5-6.2) for spinal cord ischemia, 7.6% (95% confidence interval, 5.0-11.5) for stroke, and 8.8% (95% confidence interval, 7.0-10.9) for operative mortality. The spinal cord ischemia event rate was higher with stent length 15 cm or greater or coverage to T8 or beyond than with stent length of 10 cm (11.6% vs 2.5%, P<.001). Adverse event rates in patients with acute type A aortic dissection versus nonacute dissection or aneurysm were as follows: mortality 9.2% versus 7.6% (P ¼ .46), stroke 9.3% versus 6.6% (P ¼ .51), and overall adverse events 22.0% versus 16.5% (P ¼ .41). Conclusions: As the frozen elephant trunk procedure becomes more popular, accurate data regarding outcomes are vital. We associated the frozen elephant trunk technique with (nonsignificantly) more adverse events overall in acute type A dissection cases. Stent length of 10 cm was associated with significantly less risk of spinal cord ischemia. Using a stent 15 cm or greater or coverage extending to T8 or farther should be avoided.
The Journal of Thoracic and Cardiovascular Surgery, Jul 1, 2020
Although surgeons use the "eyeball test" to advise patients about surgical risk, nutritional indi... more Although surgeons use the "eyeball test" to advise patients about surgical risk, nutritional indices such as the PNI may help quantify risks beyond the VAS-QIP, performance status, and frailty scoring.
Texas Heart Institute Journal, 2021
Del Nido cardioplegic solution (DNC), used chiefly in pediatric patients, rapidly induces prolong... more Del Nido cardioplegic solution (DNC), used chiefly in pediatric patients, rapidly induces prolonged cardiac arrest during cardiac surgery. To determine whether surgical outcomes after coronary artery bypass grafting in a United States military veteran population differed when DNC was used instead of our standard Plegisol cardioplegia, we retrospectively reviewed 155 consecutive operations performed from July 2016 through June 2017. Del Nido cardioplegia was used to induce cardiac arrest in 70 patients, and Plegisol in 85. Compared with the Plegisol group, the DNC group had a shorter mean cardiopulmonary bypass time (96.8 vs 117 min; P <0.01) and aortic cross-clamp time (63.9 vs 71.7 min; P=0.02). On multiple linear regression, DNC use and number of bypasses performed were predictors of cardiopulmonary bypass time. The groups were similar in median number of bypasses performed, median time to extubation, intensive care unit stay, and total postoperative stay; however, the DNC group had a shorter mean operating room time (285.8 vs 364.5 min; P <0.01). Del Nido cardioplegia, number of bypasses, cardiopulmonary bypass time, and red blood cell transfusion were predictors of operating room time. Outcomes in the groups were similar for 30-and 180-day death, stroke, renal failure, ventilation time >48 hours, atrial fibrillation, tracheostomy, reintubation, and mechanical circulatory support. We conclude that single-dose DNC is safe, effective, and cost-effective for achieving cardiac arrest in U.S. veteran populations.
The Annals of Thoracic Surgery, Jul 1, 2022
BACKGROUND Recruiting and promoting women and racial/ethnic minorities could help enhance diversi... more BACKGROUND Recruiting and promoting women and racial/ethnic minorities could help enhance diversity and inclusion in the academic cardiothoracic (CT) surgery workforce. However, the demographics of trainees and faculty at US training programs have not yet been studied. METHODS Traditional, integrated (I-6), and fast-track (4+3) programs listed in the Accreditation Council for Graduate Medical Education (ACGME) public database were analyzed. Demographics of trainees and surgeons, including gender, race/ethnicity, subspecialty, and academic appointment (if applicable), were obtained from ACGME Data Resource Books, institutional websites, and public profiles. Chi-square and Cochran-Armitage trend tests were performed. RESULTS In July 2020, 78 institutions had at least one CT surgery training program; 40 (51%) had only a traditional program, 20 (26%) traditional and I-6, 6 (8%) all three types of program, and 4 (5%) only I-6. The proportion of female trainees increased significantly from 2011 to 2019 (19% vs 24%, p<0.001), with female I-6 trainees outnumbering female traditional trainees since 2018. Significant increases by race/ethnicity were observed overall and by program type, notably for Asians and Hispanics in I-6 programs and Blacks in traditional programs. Finally, of the 1,175 CT surgeons identified, 633 (54%) were adult cardiac surgeons, 360 (37%) assistant professors, 116 (10%) women, and 33 (3%) Black. CONCLUSIONS The demographic landscape of CT surgery trainees and faculty across multiple training pathways reflects increasing representation by gender and race/ethnicity. However, we must continue to work toward equitable representation in the workforce to benefit the diverse patients we treat.
The Journal of Thoracic and Cardiovascular Surgery, Feb 1, 2015
Objectives: To determine the preoperative and perioperative risk factors that significantly predi... more Objectives: To determine the preoperative and perioperative risk factors that significantly predict adverse outcomes after total arch replacement in patients with previous proximal aortic surgery and to analyze patient survival. Methods: We performed univariate analysis and logistic regression on data extracted from a prospectively maintained database for 119 patients who had undergone total arch operations during a 7.5-year period. All patients had undergone previous proximal aortic surgery. The adverse outcome was defined as a single composite endpoint comprising operative mortality, permanent neurologic deficit, and renal failure necessitating permanent hemodialysis. Results: The incidence of the composite endpoint was 13.5% (16 of 119 patients). The univariate predictors were preoperative pulmonary disease (P ¼ .010), cardiac ischemia time (P ¼ .032), and cardiopulmonary bypass (CPB) time (P ¼ .073). On multivariate analysis, the following were predictors of the composite endpoint: preoperative pulmonary disease (P ¼ .036), CPB time (P ¼ .039), concomitant coronary artery bypass (P ¼ .0057), previous aortic valve replacement (P ¼ .027), and previous thoracoabdominal aortic aneurysm surgery (P ¼ .057). Multivariate analysis showed that the CPB time predicted mortality (P ¼ .0044), and previous thoracoabdominal aortic aneurysm surgery predicted stroke (P ¼ .034). The overall survival was 85.3% during a median follow-up of 4.76 years (95% confidence interval, 4.2-5.1). Conclusions: Aortic arch reoperations, although technically demanding, can produce acceptable results. Preoperative pulmonary disease, CPB time, and concomitant coronary artery bypass predicted an adverse outcome. The CPB time predicted mortality, and previous thoracoabdominal aortic surgery predicted stroke.
Texas Heart Institute Journal, Oct 1, 2016
Little is known about the frequency and clinical implications of postoperative atrial fibrillatio... more Little is known about the frequency and clinical implications of postoperative atrial fibrillation in military veterans who undergo coronary artery bypass grafting (CABG). We examined long-term survival data, clinical outcomes, and associated risk factors in this population. We retrospectively reviewed baseline, intraoperative, and postoperative data from 1,248 consecutive patients with similar baseline risk profiles who underwent primary isolated CABG at a Veterans Affairs hospital from October 2006 through March 2013. Multivariable logistic regression identified predictors of postoperative atrial fibrillation. Kaplan-Meier analysis was used to evaluate long-term survival (the primary outcome measure), morbidity, and length of hospital stay. Postoperative atrial fibrillation occurred in 215 patients (17.2%). Independent predictors of this sequela were age ≥65 years (odds ratios [95% confidence intervals], 1.7 [1.3-2.4] for patients of age 65-75 yr and 2.6 [1.4-4.8] for patients >75 yr) and body mass index ≥30 kg/m 2 (2.0 [1.2-3.2]). Length of stay was longer for patients with postoperative atrial fibrillation than for those without (12.7 ± 6.6 vs 10.3 ± 8.9 d; P ≤0.0001), and the respective 30-day mortality rate was higher (1.9% vs 0.4%; P=0.014). Seven-year survival rates did not differ significantly. Older and obese patients are particularly at risk of postoperative atrial fibrillation after CABG. Patients who develop the sequela have longer hospital stays than, but similar longterm survival rates to, patients who do not.
The Annals of Thoracic Surgery, Sep 1, 2021
BACKGROUND The current representation of females and racial and ethnic minorities in cardiovascul... more BACKGROUND The current representation of females and racial and ethnic minorities in cardiovascular trials is unclear. We evaluated these groups' inclusion in US cardiovascular trials. METHODS Using publicly available data from ClinicalTrials.gov, we evaluated cardiovascular trials pertaining to coronary artery bypass grafting (CABG), heart valve disease, aortic aneurysm, ventricular assist devices, and heart transplant. This yielded 178 US trials (159 completed, 19 active but not recruiting) started between September 1998 and May 2017, with 237,132 participants. To examine females' and racial and ethnic minorities' representation in these trials, we calculated participation-to-prevalence ratios (PPR). Values of 0.8-1.2 reflect similar representation. RESULTS All 178 trials reported sex distribution, whereas only 76 trials (42.7%) reported racial distribution and 52 trials (29.2%) reported ethnic (Hispanic vs non-Hispanic) distribution. Among all trials, participants were 28.3% female, 11.2% Hispanic/Latino, 4.0% African American, 10.4% Asian, and 2.3% Other. The CABG PPR for females was 0.64, Hispanics 0.72, African Americans 0.28, and Asians 3.20. Between 2008-2012 and 2013-2017, the CABG PPR decreased for females (0.67→0.50) and African Americans (0.37→0.17) but increased for Hispanics (0.38→1.32) and Asians (3.51→4.57). CONCLUSIONS Participation in cardiovascular trials by females and minorities (except Asians) remains low. Given that inherent differences among the abovementioned groups could affect outcomes, balance is clearly needed. The engagement of our surgical leadership, community, and industry to address these disparities is vitally important.
The Annals of Thoracic Surgery, Jun 1, 2023
BACKGROUND The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic va... more BACKGROUND The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement (AVR) using a bioprosthesis with novel RESILIA tissue. RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve. METHODS Patients underwent clinically indicated surgical AVR with a bovine pericardial bioprosthesis, model 11000A in a prospective, multinational, multicenter (n = 27), Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported. RESULTS Between January 2013 and March 2016, 689 patients received the study valve. Mean age was 66.9±11.6 years, STS PROM was 2.0±1.8%, and 23.8%, 49.9%, and 24.4% were NYHA Functional Class I, II, and III at baseline, respectively. Through December 11, 2020, follow-up duration was 4.3±1.4 years, and the completeness of follow up over the observational period was 95.5%. Early (<30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause re-intervention were 89.2%, 100%, and 98.7%, respectively. At 5 years, effective orifice area was 1.6±0.5 cm2, mean gradient was 11.5±6.0 mmHg, 97.8% of patients were Class I/II, and 97.8% and 96.3% of patients had none/trace paravalvular and transvalvular regurgitation, respectively. CONCLUSIONS The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration.
NEJM evidence, Feb 22, 2022
The Journal of Thoracic and Cardiovascular Surgery, Nov 1, 2022
The Journal of Thoracic and Cardiovascular Surgery, Oct 1, 2022
The Annals of Thoracic Surgery, Nov 1, 2021
BACKGROUND With a multimodal treatment strategy, cytoreductive surgery extends survival in malign... more BACKGROUND With a multimodal treatment strategy, cytoreductive surgery extends survival in malignant pleural mesothelioma. Improving the accuracy of staging can refine patient selection. Our objective was to determine whether diagnostic laparoscopy (DL) improves staging for patients with malignant pleural mesothelioma with routine use of positron emission tomography. METHODS We performed a retrospective review of our prospectively maintained database from February 2014 until May 2019. Inclusion criteria were patients who had disease in the chest that was deemed potentially resectable by radiographic criteria and who underwent DL as part of staging evaluation prior to surgery. RESULTS 187 patients (71% male, 80% epithelial) underwent DL during staging. 76% proceeded to surgery. 22% were unresectable at exploratory thoracotomy and 78% underwent resection (Pleurectomy and decortication, 68%; extrapleural pneumonectomy, 32%). 89% had a position-emission tomography-computed tomographic scan (PET-CT) and 11% had a pre-operative CT without PET. DL revealed peritoneal disease in 17%. Among patients with pathologically proven disease at DL, 77% had negative PET-CT imaging. Based upon the pathologic findings at DL, the sensitivity, specificity, positive predictive value, and negative predictive value of PET-CT were 23%, 78%, 17%, and 83%, respectively. The accuracy of PET-CT was 68%. CONCLUSIONS PET-CT has low sensitivity and diagnostic accuracy to identify peritoneal disease in malignant pleural mesothelioma. DL as part of pre-operative staging defines an important subset of patients with bicavitary disease. We recommend DL as a component of staging prior to surgery.
JACC: Cardiovascular Interventions
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Papers by Lorraine Cornwell