Computational risk model for predicting 2-year malignancy of pulmonary nodules using demographic and radiographic characteristics.

OBJECTIVES: To determine whether discriminatory performance of a computational risk model in classifying pulmonary lesion malignancy using demographic, radiographic, and clinical characteristics is superior to the opinion of experienced providers. We hypothesized that computational risk models would outperform providers. METHODS: Outcome of malignancy was obtained from selected patients enrolled in the NAVIGATE trial (NCT02410837). Five predictive risk models were developed using an 80:20 train-test split: univariable logistic regression model based solely on provider opinion, multivariable logistic regression model, random forest classifier, extreme gradient boosting model, and artificial neural network. Area under the receiver operating characteristic curve achieved during testing of the predictive models was compared to that of prebiopsy provider opinion baseline using the DeLong test with 10,000 bootstrapped iterations. RESULTS: The cohort included 984 patients, 735 (74.7%) of which were diagnosed with malignancy. Factors associated with malignancy from multivariable logistic regression included age, history of cancer, largest lesion size, lung zone, and positron-emission tomography positivity. Testing area under the receiver operating characteristic curve were 0.830 for provider opinion baseline, 0.770 for provider opinion univariable logistic regression, 0.659 for multivariable logistic regression model, 0.743 for random forest classifier, 0.740 for extreme gradient boosting, and 0.679 for artificial neural network. Provider opinion baseline was determined to be the best predictive classification system. CONCLUSIONS: Computational models predicting malignancy of pulmonary lesions using clinical, demographic, and radiographic characteristics are inferior to provider opinion. This study questions the ability of these models to provide additional insight into patient care. Expert clinician evaluation of pulmonary lesion malignancy is paramount.

Endoscopic vs Open Vein Harvest in Drug-Eluting Stents or Bypass Surgery for Left Main Disease Trial.

BACKGROUND: We investigated outcomes of coronary artery bypass grafting (CABG) with endoscopic vein harvest (EVH) vs open vein harvest (OVH) within the Evaluation of XIENCE Versus CABG (EXCEL) trial. METHODS: All patients in EXCEL randomized to CABG were included in this study. For this analysis, the primary end points were ischemia-driven revascularization (IDR) and graft stenosis or occlusion at 5 years. Additional end points were as follows: a composite of death from any cause, stroke, or myocardial infarction; bleeding; blood product transfusion; major arrhythmia; and infection requiring antibiotics. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: Of the 957 patients randomized to CABG, 686 (71.7%) received at least 1 venous graft with 257 (37.5%) patients in the EVH group and 429 (62.5%) patients in the OVH group. At 5 years, IDR was higher (11.5% vs 6.7%; P = .047) in the EVH group. At 5 years, rates of graft stenosis or occlusion (9.7% vs 5.4%; P = .054) and the primary end point (17.4% vs 20.9%; P = .27) were similar. In-hospital bleeding (11.3% vs 13.8%; P = .35), in-hospital blood product transfusion (12.8% vs 13.1%; P = .94), and infection requiring antibiotics within 1 month (13.6% vs 16.8%; P = .27) were similar between EVH and OVH patients. Major arrhythmia in the hospital (19.8% vs 13.5%; P = .03) and within 1 month (21.8% vs 15.4%; P = .03) was higher in EVH patients. CONCLUSIONS: IDR at 5 years was higher in the EVH group. EVH and OVH patients had similar rates of graft stenosis or occlusion and the composite of death, stroke, or myocardial infarction at 5 years.

Age disparities in triple-negative breast cancer treatment and outcomes: An NCDB analysis.

BACKGROUND: Race, access to care, and molecular features result in outcome disparities in triple-negative breast cancer (TNBC). We sought to determine the role of age in TNBC disparity by hypothesizing that younger patients receive more comprehensive treatment, resulting in survival differences. METHODS: The National Cancer Database was used to identify women with unilateral TNBC treated from 2005 through 2017. Patients were stratified by age (≤40, 41-70, >70); demographics, clinical characteristics, and treatment factors were compared. Logistic regression determined factors associated with treatment received. Survival outcomes were analyzed using a stratified log-rank test. RESULTS: Of the 168,715 patients, 16,287 (9.6%) were ≤40 years. Patients ≤40 were significantly more likely to present at higher clinical stage (P < .001) and receive neoadjuvant chemotherapy (NAC, P < .001). Bilateral mastectomy was the most common surgery for patients ≤40 (37%), whereas partial mastectomy was most often used in patients 41 to 70 years old (48%) and those >70 (49%) (P < .001). Patients ≤40 years were significantly more likely to undergo both NAC and mastectomy than those >40 (odds ratio 1.5, both P < .05) despite a greater in-breast tumor response in the youngest patients. Patients treated with mastectomy and axillary lymph node dissection had inferior survival outcomes compared to those treated with partial mastectomy and sentinel lymph node biopsy across all 3 age groups (P < .001). CONCLUSION: The clinical characteristics of TNBC differ significantly at the extremes of age, likely driving treatment decisions. Although patients ≤40 present with a more advanced disease and appropriately receive NAC, they also undergo more extensive surgery that does not yield a survival benefit. Further research is needed to determine if age disparity is due to oncologic factors or patient and provider preferences.

Conventional Computed Tomographic Calcium Scoring vs full chest CTCS for lung cancer screening: a cost-effectiveness analysis.

BACKGROUND: Conventional CTCS images the mid/lower chest for coronary artery disease (CAD). Because many CAD patients are also at risk for lung malignancy, CTCS often discovers incidental pulmonary nodules (IPN). CTCS excludes the upper chest, where malignancy is common. Full-chest CTCS (FCT) may be a cost-effective screening tool for IPN. METHODS: A decision tree was created to compare a FCT to CTCS in a hypothetical patient cohort with suspected CAD. (Figure) The design compares the effects of missed cancers on CTCS with the cost of working up non-malignant nodules on FCT. The model was informed by results of the National Lung Screening Trial and literature review, including the rate of malignancy among patients receiving CTCS and the rate of malignancy in upper vs lower portions of the lung. The analysis outcomes are Quality-Adjusted Life Year (QALY) and incremental cost-effectiveness ratio (ICER), which is generally considered beneficial when <$50,000/QALY. RESULTS: Literature review suggests that rate of IPNs in the upper portion of the lung varied from 47 to 76%. Our model assumed that IPNs occur in upper and lower portions of the lung with equal frequency. The model also assumes an equal malignancy potential in upper lung IPNs despite data that malignancy occurs 61-66% in upper lung fields. In the base case analysis, a FCT will lead to an increase of 0.03 QALYs comparing to conventional CTCS (14.54 vs 14.51 QALY, respectively), which translates into an QALY increase of 16 days. The associated incremental cost for FCT is $278 ($1027 vs $748, FCT vs CTCS respectively. The incremental cost-effectiveness ratio (ICER) is $10,289/QALY, suggesting significant benefit. Sensitivity analysis shows this benefit increases proportional to the rate of malignancy in upper lung fields. CONCLUSION: Conventional CTCS may be a missed opportunity to screen for upper lung field cancers in high risk patients. The ICER of FCT is better than screening for breast cancer screening (mammograms $80 k/QALY) and colon cancer (colonoscopy $6 k/QALY). Prospective studies are appropriate to define protocols for FCT.

"Double-Stick" Transsubclavian Transcatheter Aortic Valve Replacement With Use of a Balloon Expandable Valve: A Less Invasive Option for Alternative Access.

Access options for transcatheter aortic valve replacement (TAVR) currently include transfemoral, transaortic, transapical, transsubclavian, and other approaches. Transsubclavian access for balloon expandable valves is gaining popularity when transfemoral access is not suitable, given its peripheral access compared with central access. With the transsubclavian approach, second femoral or radial artery access is necessary for pigtail catheter placement. We describe a "double-stick" transsubclavian technique that eliminates secondary arterial access. With this technique, the transsubclavian approach can still be used in patients with advanced femoral disease, and it allows for rapid ambulation in most patients.

Value of robotically assisted surgery for mitral valve disease.

IMPORTANCE: The value of robotically assisted surgery for mitral valve disease is questioned because the high cost of care associated with robotic technology may outweigh its clinical benefits. OBJECTIVE: To investigate conditions under which benefits of robotically assisted surgery mitigate high technology costs. DESIGN, SETTING, AND PARTICIPANTS: Clinical cohort study at a large multispecialty academic medical center comparing costs of robotically assisted surgery with 3 contemporaneous conventional surgical approaches for degenerative mitral valve disease. From January 1, 2006, through December 31, 2010, a total of 1290 patients with a mean (SD) age of 57 (11) years underwent mitral valve repair for regurgitation from posterior leaflet prolapse. Robotically assisted surgery was performed in 473 patients, complete sternotomy in 227, partial sternotomy in 349, and anterolateral thoracotomy in 241. Comparisons were based on intent to treat, with 3 propensity-matched groups formed based on demographics, symptoms, cardiac and noncardiac comorbidities, valve pathophysiologic disorders, and echocardiographic measurements: robotic vs sternotomy (198 pairs) vs partial sternotomy (293 pairs) vs thoracotomy (224 pairs). INTERVENTIONS: Mitral valve repair. MAIN OUTCOMES AND MEASURES: Cost of care (expressed as robotic capital investment, maintenance of equipment, and direct technical hospital costs) and benefit of care (based on differences in recovery time). RESULTS: Cost of care (median [15th and 85th percentiles]) for robotically assisted surgery exceeded that of alternative approaches by 26.8% (-5.3% and 67.9%), 32.1% (-6.1% and 69.6%), and 20.7% (-2.4% and 48.4%) for complete sternotomy, partial sternotomy, and anterolateral thoracotomy, respectively. Higher operative costs were partially offset by lower postoperative costs and earlier return to work: a median (15th and 85th percentiles) of 35 (19 and 63) days for robotically assisted surgery, 49 (21 and 109) days for complete sternotomy, 56 (30 and 119) days for partial sternotomy, and 42 (18 and 90) days for anterolateral thoracotomy. Resulting net differences (median [15th and 85th percentiles]) in the cost of robotic surgery vs the 3 alternatives were 15.6% (-14.7% and 55.1%), 15.7% (-19.4% and 51.2%), and 14.8% (-7.4% and 43.6%), respectively. Beyond a volume threshold of 55 to 100 robotically assisted operations per year, distribution of the cost of this technology broadly overlapped those of conventional approaches. CONCLUSIONS AND RELEVANCE: In exchange for higher procedural costs, robotically assisted surgery for mitral valve repair offers the clinical benefit of least-invasive surgery, lowest postoperative cost, and fastest return to work. The value of robotically assisted surgery that is similar to that of conventional approaches can be realized only in high-volume centers.

One heart in 3 patients.

In this report, we present a successful reuse of a transplanted heart under complex clinical conditions. Our patient was the second recipient, a 63-year-old man with end-stage heart failure due to amyloid-induced cardiomyopathy. After an uneventful postoperative course, he was diagnosed with acute myelogenous leukemia 6 months after transplantation and died 10 months after transplantation. This outcome was determined by a malignancy in an immunosuppressed patient. Reuse of a transplanted heart in carefully selected patients is a possible alternative in an era of donor organ shortage.

Mechanical circulatory support after heart transplantation.

OBJECTIVE: Mechanical circulatory support (MCS) may be used for severe graft failure after heart transplantation, but the degree to which it is lifesaving is uncertain. METHODS: Between June 1990 and December 2009, 53 patients after 1417 heart transplants (3.7%) required post-transplant MCS for acute rejection (n=17), biventricular failure (n=16), right ventricular failure (n=16), left ventricular failure (n=1), or respiratory failure (n=3). Although support was occasionally instituted remotely post-transplant (5>1 year), in 39 (73%) instances it was required within 1 week. Initial mode of support was extracorporeal membrane oxygenation in 43 patients (81%), biventricular assist device in 4 (7.5%), and right ventricular assist device in 6 (11%). RESULTS: Risk of requiring respiratory support was highest in those with restrictive cardiomyopathy as indication for transplant, women, and those with elevated pulmonary pressure or renal failure. Complications of support, which increased progressively with its duration, included stroke in two patients (3.8%), infection in two (3.8%), and reoperation for bleeding (seven instances) in four (7.0%). Nineteen patients (36%) recovered and were removed from support, five (9.4%) underwent retransplantation (four after biventricular failure and one after acute rejection), and 29 died while on support (55%). Overall survival after initiating support was 94%, 83%, 66%, and 43% at 1, 3, 7, and 30 days, respectively. Patients requiring support for biventricular failure had better survival than those having acute rejection or other indications (P=0.03). Survival after retransplantation or removal from support following recovery was 88% at 1 year and 61% at 10 years. CONCLUSION: Severe refractory heart failure after transplantation is a rare catastrophic event for which MCS offers the possibility of recovery or bridge to retransplantation, particularly for patients with biventricular failure in the absence of rejection. Early retransplantation should be considered in patients who show no evidence of graft recovery on MCS.

Severe mitral regurgitation in an adult patient with cor triatriatum.

A 52-year-old female patient who presented with a history of increasing shortness of breath and fatigue was diagnosed with a combination of cor triatriatum and myxomatous mitral valve disease. Transesophageal echocardiography revealed cor triatriatum and severe mitral regurgitation (MR) due to myxomatous degeneration. The patient underwent a successful removal of the left atrial membrane and repair of the mitral valve. This combination of cor triatriatum and myxomatous mitral valve disease is exceedingly rare; in the present patient the symptoms caused by MR led to the discovery of a left atrial membrane.

Quantitative electrocardiography for predicting postoperative atrial fibrillation after cardiac surgery.

BACKGROUND: Atrial fibrillation (AF) after cardiac surgery is a common marker of poor outcomes. Quantitative electrocardiographic (ECG) measurements may be valuable predictors of postoperative AF. METHODS: We evaluated clinical and ECG predictors of postoperative AF in 13,356 patients who underwent cardiac surgery in sinus rhythm. RESULTS: A total of 4724 patients (35%) developed postoperative AF. P-wave amplitude in leads aVR and V(1) were the strongest ECG predictors. A less negative P-wave amplitude in lead aVR was associated with increased risk for postoperative AF (odds ratio, 1.46; 95% confidence interval, 1.32-1.61), as was a more positive or a more negative P-wave amplitude in lead V(1) (odds ratio, 1.25; 95% confidence interval, 1.16-1.36) after adjusting for clinical and procedural predictors of postoperative AF. Reclassification analysis showed a 7% discrimination improvement (P < .0001). CONCLUSIONS: P-wave amplitude in lead aVR and lead V(1) are powerful predictors of postoperative AF and, in combination with other clinical predictors, can guide application of prophylactic interventions.

Robotic repair of posterior mitral valve prolapse versus conventional approaches: potential realized.

OBJECTIVE: Robotic mitral valve repair is the least invasive approach to mitral valve repair, yet there are few data comparing its outcomes with those of conventional approaches. Therefore, we compared outcomes of robotic mitral valve repair with those of complete sternotomy, partial sternotomy, and right mini-anterolateral thoracotomy. METHODS: From January 2006 to January 2009, 759 patients with degenerative mitral valve disease and posterior leaflet prolapse underwent primary isolated mitral valve surgery by complete sternotomy (n = 114), partial sternotomy (n = 270), right mini-anterolateral thoracotomy (n = 114), or a robotic approach (n = 261). Outcomes were compared on an intent-to-treat basis using propensity-score matching. RESULTS: Mitral valve repair was achieved in all patients except 1 patient in the complete sternotomy group. In matched groups, median cardiopulmonary bypass time was 42 minutes longer for robotic than complete sternotomy, 39 minutes longer than partial sternotomy, and 11 minutes longer than right mini-anterolateral thoracotomy (P < .0001); median myocardial ischemic time was 26 minutes longer than complete sternotomy and partial sternotomy, and 16 minutes longer than right mini-anterolateral thoracotomy (P < .0001). Quality of mitral valve repair was similar among matched groups (P = .6, .2, and .1, respectively). There were no in-hospital deaths. Neurologic, pulmonary, and renal complications were similar among groups (P > .1). The robotic group had the lowest occurrences of atrial fibrillation and pleural effusion, contributing to the shortest hospital stay (median 4.2 days), 1.0, 1.6, and 0.9 days shorter than for complete sternotomy, partial sternotomy, and right mini-anterolateral thoracotomy (all P < .001), respectively. CONCLUSIONS: Robotic repair of posterior mitral valve leaflet prolapse is as safe and effective as conventional approaches. Technical complexity and longer operative times for robotic repair are compensated for by lesser invasiveness and shorter hospital stay.

Endoscopic robotically-assisted mitral valve repair.

Robotic surgical instrumentation allows minimally invasive mitral valve repair through an endoscopic approach, eliminating the need for a thoracotomy. Robotic instruments are inserted through port-like incisions in the right hemithorax, while cardiopulmonary bypass is established via cannulation of the femoral vessels. We describe triangular resection, a simple and reproducible robotically-assisted technique for repair of posterior leaflet prolapse. The repair is completed with insertion of an annuloplasty ring.