Redefining "low risk": Outcomes of surgical aortic valve replacement in low-risk patients in the transcatheter aortic valve replacement era.

OBJECTIVES: Guidelines suggest aortic valve replacement (AVR) for low-risk asymptomatic patients. Indications for transcatheter AVR now include low-risk patients, making it imperative to understand state-of-the-art surgical AVR (SAVR) in this population. Therefore, we compared SAVR outcomes in low-risk patients with those expected from Society of Thoracic Surgeons (STS) models and assessed their intermediate-term survival. METHODS: From January 2005 to January 2017, 3493 isolated SAVRs were performed in 3474 patients with STS predicted risk of mortality <4%. Observed operative mortality and composite major morbidity or mortality were compared with STS-expected outcomes according to calendar year of surgery. Logistic regression analysis was used to identify risk factors for these outcomes. Patients were followed for time-related mortality. RESULTS: With 15 observed operative deaths (0.43%) compared with 55 expected (1.6%), the observed:expected ratio was 0.27 for mortality (95% confidence interval [CI], 0.14-0.42), stroke 0.65 (95% CI, 0.41-0.89), and reoperation 0.50 (95% CI, 0.42-0.60). Major morbidity or mortality steadily declined, with probabilities of 8.6%, 6.7%, and 5.2% in 2006, 2011, and 2016, respectively, while STS-expected risk remained at approximately 12%. Mitral valve regurgitation, ventricular hypertrophy, pulmonary, renal, and hepatic failure, coronary artery disease, and earlier surgery date were residual risk factors. Survival was 98%, 91%, and 82% at 1, 5, and 9 years, respectively, superior to that predicted for the US age-race-sex-matched population. CONCLUSIONS: STS risk models overestimate contemporary SAVR risk at a high-volume center, supporting efforts to create a more agile quality assessment program. SAVR in low-risk patients provides durable survival benefit, supporting early surgery and providing a benchmark for transcatheter AVR.

Post-cardiopulmonary bypass longitudinal strain provides higher prognostic ability than baseline strain or change in strain.

Context: Global longitudinal strain (GLS) measured by speckle-tracking echocardiography demonstrates excellent prognostic ability in predicting major adverse cardiac events after cardiac surgery. However, the optimal timing of intraoperative GLS measurement that provides the best prognostic value is unclear. Aim: Our goal was to evaluate whether GLS measured prior to cardiopulmonary bypass (pre-CPB GLS), following CPB (post-CPB GLS), or change in GLS provides the strongest association with postoperative complications. Setting and Design: Post hoc analysis of prospectively collected data from a clinical trial (NCT01187329). 72 patients with aortic stenosis undergoing elective AVR ± coronary artery bypass grafting between January 2011 and August 2013. Material and Methods: Myocardial deformation analysis from standardized transesophageal echocardiographic examinations were performed after anesthetic induction and chest closure. We evaluated the association between pre-CPB GLS, post-CPB GLS, and change in GLS (percent change from pre-CPB baseline) with postoperative atrial fibrillation and hospitalization >7 days. The association of post-CPB GLS with duration of mechanical ventilation, N-terminal pro-BNP (NT-proBNP) and troponin T were also assessed. Statistical Analysis: Multivariable logistic regression. Results: Risk-adjusted odds (OR[97.5%CI] of prolonged hospitalization increased an estimated 27% (1.27[1.01 to 1.59];Padj =0.035) per 1% decrease in absolute post-CPB GLS. Mean[98.3%CI] NT-proBNP increased 98.4[20 to 177]pg/mL; Padj =0.008), per 1% decrease in post-CPB GLS. Pre-CPB GLS or change in GLS were not associated with any outcomes. Conclusions: Post-CPB GLS provides the best prognostic value in predicting postoperative outcomes. Measuring post-CPB GLS may improve risk stratification and assist in future study design and patient outcome research.

Health-Related Quality of Life After Extensive Aortic Replacement.

To assess and compare patient-reported long-term health-related quality of life (HRQoL) after combined proximal aortic (arch ± ascending, root) and distal aortic (descending thoracic ± abdominal) replacement using open vs multimodal/endovascular (hybrid) approaches. From 2010 to 2016, 146 adults underwent single- or multi-stage aortic arch plus descending thoracic aorta replacement, 31 open and 115 hybrid. The 2 surgical approach groups had similar preoperative characteristics and extent of surgery. Cross-sectional follow-up revealed 49 deaths (7 open, 42 hybrid). Of the 97 survivors, 72 (74%) responded to the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 survey (18 open, 54 hybrid) a median 6.2 years (15th, 85th percentiles: 3.1, 7.9) after their last aortic surgery. Predictors of HRQoL scores were identified by random forest regression. Overall physical HRQoL T-score was lower than that of population norms (46 vs 50, P < 0.0001); mental HRQoL T-score was similar (50 vs 50, P > 0.9). Neither T-score was significantly different according to surgical approach (P ≥ 0.3). Greater number of postoperative complications and history of chronic obstructive pulmonary disease were the most important predictors of lower physical HRQoL, and prior myocardial infarction was the most important predictor of lower mental HRQoL. Although extensive aortic replacement had a small long-term effect on patient-reported physical HRQoL, both physical and mental HRQoL can be preserved in survivors with both surgical approaches. Surgeons should recommend the approach they believe will yield the best long-term survival, but lifelong follow-up is crucial, and patients should understand that they may require multiple operations.

Outcomes and role of peripheral revascularization in type A aortic dissection presenting with acute lower extremity ischemia.

OBJECTIVE: Limited data exists on management and outcomes of patients presenting with type A aortic dissection (TAAD) and acute lower extremity ischemia (ALI). The role of limb-related revascularization and optimal treatment strategy remains undefined. The objective of this study was to analyze dissection characteristics, treatment modalities, and outcomes of patients undergoing proximal aortic repair for TAAD with ALI. METHODS: Consecutive patients who underwent proximal aortic repair for TAAD were identified from a prospectively maintained database. Clinical data, imaging, operative details, and outcomes of patients with TAAD and ALI were retrospectively analyzed. Kaplan-Meier methodology was used to estimate overall and amputation-free survival. Log-rank tests were used to compare overall curves. Predictors of revascularization and in-hospital mortality were determined using multivariable logistic regression analysis. RESULTS: From 2010 to 2018, 463 patients with TAAD underwent proximal aortic repair. A total of 81 patients (17%) presented with ALI; 48% (39/81) with isolated ALI, and 52% (42/81) with ALI and renovisceral malperfusion. Thirty percent (24/81) required revascularization in addition to proximal aortic repair. Revascularization strategies involved endovascular (46%; 11/24), open (33%; 8/24), and hybrid (21%; 5/24) interventions. The major amputation rate was 4% (3/81), and in-hospital mortality was 21% (17/81). Amputation-free survival was significantly lower in patients requiring revascularization compared with those who did not (log-rank P = .023). Overall survival did not significantly differ between the two groups (log-rank P = .095). Overall survival was significantly lower in patients with concomitant ALI and renovisceral malperfusion compared with those with isolated ALI (log-rank P = .0017). Distal extent of dissection flap into zone 11 (odds ratio [OR], 5.65; 95% confidence interval [CI], 1.58-20.2; P = .008) and partial/complete thrombosis of any iliac artery (OR, 3.94; 95% CI, 1.23-12.6; P = .021) were associated with increased risk of requiring an additional revascularization procedure. True lumen collapse at level of renovisceral aorta (OR, 8.84; 95% CI, 1.74-44.9; P = .0086) was associated with increased risk of in-hospital mortality. CONCLUSIONS: ALI resolves after proximal aortic repair of TAAD in most cases. Distal extent of aortic dissection into zone 11 and iliac thrombosis are risk factors for additional peripheral revascularization. True lumen collapse at the renovisceral aorta and TAAD with concomitant ALI and renovisceral malperfusion portends a poor prognosis. A multi-disciplinary team approach to manage these patients who present with ascending aortic dissection and distal malperfusion may improve outcomes in this complex population.

From Court to Couch: Exercise and Quality of Life after Acute Type A Aortic Dissection.

BACKGROUND: Acute Type A aortic dissection can be physically and mentally stressful with little known about survivors' postrepair activity levels, exercise habits, and quality of life (QOL). This study was aimed to describe pre- and postdissection changes regarding exercise, understand physician recommendations, quantify use of cardiac rehabilitation, and assess QOL in dissection survivors. METHODS: A total of 295 acute Type A aortic dissection survivors were surveyed about exercise, cardiac rehabilitation, QOL, sexual activity, and posttraumatic stress disorder (PTSD) with 137 (46%) respondents. RESULTS: Respondents were less likely to participate in competitive athletics after than before dissection (1/131 [0.76%] vs. 26/131 [20%], p [McNemar test] < 0.0001) or lift heavy objects (11/111 [9.9%] vs. 41/111 [37%], p < 0.0001). Forty-eight of 132 respondents (36%) did not participate in cardiac rehabilitation. Compared with general population norms, respondents reported lower median QOL physical component scores (40 [26, 51; 15th, 85th percentile], p < 0.0001); these were lower in respondents who did not exercise (Hodges-Lehmann [HL; 95% confidence interval (CI)]: -6.8 [-11, -2.4], p = 0.002), limited sexual activity (-8.0 [-13, -4.3], p = 0.0002), or screened positive for PTSD (-10 [-14, -5.3], p = 0.0002). Median mental component scores were similar to general population norms (HL [95% CI]: 55 [34, 61], p = 0.24) but were lower among respondents who did not exercise (-4.2 [-7.8, -1.0], p = 0.01), limited sexual activity (-5.5 [-10, -1.8], p = 0.003), or screened positive for PTSD (-16 [-22, -10], p < 0.0001). CONCLUSION: Physicians should prescribe cardiac rehabilitation, encourage appropriate exercise, promote resumption of sexual activity, and identify and treat PTSD after surgery for acute Type A aortic dissection.

Renal injury after open versus laparoscopic non-cardiac surgery: a retrospective cohort analysis.

BACKGROUND: Laparoscopic surgical approaches enhance recovery, reduce postoperative pain, and shorten hospital length-of-stay. Nevertheless, increased intra-abdominal pressure is associated with decreased renal blood flow, renal hypoxia and acute kidney injury. When combined with Trendelenburg positioning, renal function may further deteriorate. We tested the primary hypothesis that the combination of laparoscopic surgical approach and Trendelenburg position is associated with larger reductions in estimated Glomerular Filtration Rate (eGFR) within the initial 48 postoperative hours compared to open surgery without Trendelenburg positioning. Secondarily, we tested, if laparoscopic procedures are associated with greater incidence of postoperative acute kidney injury. METHODS: Adults who had laparoscopic colorectal surgery in Trendelenburg position at the Cleveland Clinic Main Campus from 2009 to 2016 were propensity-matched to patients who had comparable open procedures. Patients with pre-existing renal impairment were excluded. RESULTS: Among 7,357 eligible patients, 1,846 laparoscopic cases with Trendelenburg were matched to 1,846 open cases. No association was found between laparoscopic approach and postoperative eGFR. A significant protective effect of the laparoscopic procedure on the odds of having AKI was found. Patients who had laparoscopic surgeries were an estimated 0.70 (95% CI 0.55, 0.90, pHolm-adj = 0.006) times as likely to have AKI as open surgical patients. CONCLUSION: Despite compelling potential mechanisms, laparoscopic approach with Trendelenburg position in adult colorectal surgeries did not worsen postoperative eGFR, and actually reduced postoperative acute kidney injury. Given the other advantages of laparoscopic surgery, the approach should not be avoided for concerns about renal injury.

From Tear to Fear: Posttraumatic Stress Disorder in Patients With Acute Type A Aortic Dissection.

Background Acute type A aortic dissection presents with abrupt onset of pain that requires emergency surgery. However, minimal research exists on posttraumatic stress disorder (PTSD) in survivors. We aimed to quantify the prevalence and describe characteristics of PTSD in patients following dissection. Methods and Results A total of 295 adult survivors of surgical dissection with an email on file were administered a cross-sectional online survey about their dissection experience; 137 returned questionnaires, and 129 (94%) responded to the 4-item Primary Care PTSD portion of the survey that was part of a larger lifestyle survey designed to study survivors of aortic dissection and surgery. In addition to the PTSD screening, it inquired about current sexual activity, exercise habits, and employment within the preceding 30 days. At a median of 6.8 years (quartile 1=2.6, quartile 3=8.9 years) after dissection, 23% of patients (30/129) screened positive for PTSD, with 44% (57/129) stating that within the past month they felt constantly on guard or watchful or were easily startled. Of those who screened positive and matched to their electronic medical record (n=27), only 2 (7.4%) had been tested and clinically diagnosed with PTSD. Patients who screened positive for PTSD were more likely to report limited current sexual activity than those who did not (odds ratio, 5.3; 95% CI, 1.9-15 [P=0.0006]). Conclusions PTSD is an important mental health consideration in aortic dissection survivors. Physicians should screen these patients for PTSD at follow-up visits to identify those who test positive and refer them for further testing and treatment, such as trauma-focused psychotherapy or medication.

Association between higher BMI and postoperative pain and opioid consumption in pediatric inpatients - A retrospective cohort study.

BACKGROUND: Childhood and adolescent obesity increased in recent decades, and caregivers face an increasing number of obese pediatric surgical patients. Some clinical and pharmacogenetic data suggest that obese patients have altered pain sensitivity and analgesic requirements. OBJECTIVE: To test the primary hypothesis that increased BMI in pediatric patients is associated with increased pain during the initial 48 postoperative hours. Secondarily, we tested whether BMI is associated with increased opioid consumption during the same period. DESIGN: Retrospective single-center cohort study. SETTING: Pediatric surgical wards in a tertiary medical center. PATIENTS: A total of 808 opioid naïve patients aged 8 to 18 years having elective non-cardiac surgery with hospital stay of at least 48 h in the Cleveland Clinic between 2010 and 2015. INTERVENTIONS: None. MEASUREMENTS: Using U.S. Centers for Disease Control definitions for childhood weight classifications, we retrospectively evaluated the association between body mass index (BMI) percentile and time-weighted average pain scores and opioid consumption. We used multivariable linear regression to test for an association with postoperative pain scores, and multivariable gamma regression to test for an association with postoperative opioid consumption (in mg morphine equivalents Kg-1). RESULTS: BMI was not associated with postoperative pain after general, orthopedic, or neuro-spinal surgeries. Pain increased by 0.07 [98.75% CI: (0.01, 0.13), Padj < 0.05] points per 5 percentile increase in BMI after neuro-cranial surgery. Higher BMI was associated with a decrease in postoperative opioid consumption (mean change [95% CI] -2.12% [-3.12%, -1.10%] in morphine equivalents Kg-1 per 5 percentile increase in BMI, P < 0.001). CONCLUSION: We found no clinically important increase in pain scores or opioid consumption in association with higher BMI in patients 8 to 18 years of age recovering from elective non-cardiac surgery.

Low Tidal Volumes Are Associated With Slightly Improved Oxygenation in Patients Having Cardiac Surgery: A Cohort Analysis.

BACKGROUND: Mechanical ventilation with low tidal volumes appears to provide benefit in patients having noncardiac surgery; however, whether it is beneficial in patients having cardiac surgery is unclear. METHODS: We retrospectively examined patients having elective cardiac surgery requiring cardiopulmonary bypass through a median sternotomy approach who received mechanical ventilation with a single lumen endotracheal tube from January 2010 to mid-August 2016. Time-weighted average tidal volume (milliliter per kilogram predicted body weight [PBW]) during the duration of surgery excluding cardiopulmonary bypass was analyzed. The association between tidal volumes and postoperative oxygenation (measured by arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen ratio [PaO2/FIO2]), impaired oxygenation (PaO2/FIO2 <300), and clinical outcomes were examined. RESULTS: Of 9359 cardiac surgical patients, larger tidal volumes were associated with slightly worse postoperative oxygenation. Postoperative PaO2/FIO2 decreased an estimated 1.05% per 1 mL/kg PBW increase in tidal volume (97.5% confidence interval [CI], -1.74 to -0.37; PBon = .0005). An increase in intraoperative tidal volumes was also associated with increased odds of impaired oxygenation (odds ratio [OR; 97.5% CI]: 1.08 [1.02-1.14] per 1 mL/kg PBW increase in tidal volume; PBon = .0029), slightly longer intubation time (5% per 1 mL/kg increase in tidal volume (hazard ratio [98.33% CI], 0.95 [0.93-0.98] per 1 mL/kg PBW; PBon < .0001), and increased mortality (OR [98.33% CI], 1.34 [1.06-1.70] per 1 mL/kg PBW increase in tidal volume; PHolm = .0144). An increase in intraoperative tidal volumes was also associated with acute postoperative respiratory failure (OR [98.33% CI], 1.16 [1.03-1.32] per 1 mL/kg PBW increase in tidal volume; PHolm = .0146), but not other pulmonary complications. CONCLUSIONS: Lower time-weighted average intraoperative tidal volumes were associated with a very modest improvement in postoperative oxygenation in patients having cardiac surgery.

Preoperative Vitamin D Concentration and Cardiac, Renal, and Infectious Morbidity after Noncardiac Surgery.

BACKGROUND: Low 25-hydroxyvitamin D is associated with cardiovascular, renal, and infectious risks. Postsurgical patients are susceptible to similar complications, but whether vitamin D deficiency contributes to postoperative complications remains unclear. We tested whether low preoperative vitamin D is associated with cardiovascular events within 30 days after noncardiac surgery. METHODS: We evaluated a subset of patients enrolled in the biobank substudy of the Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) study, who were at least 45 yr with at least an overnight hospitalization. Blood was collected preoperatively, and 25-hydroxyvitamin D was measured in stored samples. The primary outcome was the composite of cardiovascular events (death, myocardial injury, nonfatal cardiac arrest, stroke, congestive heart failure) within 30 postoperative days. Secondary outcomes were kidney injury and infectious complications. RESULTS: A total of 3,851 participants were eligible for analysis. Preoperative 25-hydroxyvitamin D concentration was 70 ± 30 nmol/l, and 62% of patients were vitamin D deficient. Overall, 26 (0.7%) patients died, 41 (1.1%) had congestive heart failure or nonfatal cardiac arrest, 540 (14%) had myocardial injury, and 15 (0.4%) had strokes. Preoperative vitamin D concentration was not associated with the primary outcome (average relative effect odds ratio [95% CI]: 0.93 [0.85, 1.01] per 10 nmol/l increase in preoperative vitamin D, P = 0.095). However, it was associated with postoperative infection (average relative effect odds ratio [95% CI]: 0.94 [0.90, 0.98] per 10 nmol/l increase in preoperative vitamin D, P adjusted value = 0.005) and kidney function (estimated mean change in postoperative estimated glomerular filtration rate [95% CI]: 0.29 [0.11, 0.48] ml min 1.73 m per 10 nmol/l increase in preoperative vitamin D, P adjusted value = 0.004). CONCLUSIONS: Preoperative vitamin D was not associated with a composite of postoperative 30-day cardiac outcomes. However, there was a significant association between vitamin D deficiency and a composite of infectious complications and decreased kidney function. While renal effects were not clinically meaningful, the effect of vitamin D supplementation on infectious complications requires further study.

National Trends in Prostate Biopsy and Radical Prostatectomy Volumes Following the US Preventive Services Task Force Guidelines Against Prostate-Specific Antigen Screening.

Importance: Studies demonstrate that use of prostate-specific antigen screening decreased significantly following the US Preventive Services Task Force (USPSTF) recommendation against prostate-specific antigen screening in 2012. Objective: To determine downstream effects on practice patterns in prostate cancer diagnosis and treatment following the 2012 USPSTF recommendation. Design, Setting, and Participants: Procedural volumes of certifying and recertifying urologists from 2009 through 2016 were evaluated for variation in prostate biopsy and radical prostatectomy (RP) volume. Trends were confirmed using the New York Statewide Planning and Research Cooperative System and Nationwide Inpatient Sample. The study included a representative sample of urologists across practice settings and nationally representative sample of all RP discharges. We obtained operative case logs from the American Board of Urology and identified urologists performing at least 1 prostate biopsy (n = 5173) or RP (n = 3748), respectively. Exposures: The 2012 USPSTF recommendation against routine population-wide prostate-specific antigen screening. Main Outcomes and Measures: Change in median biopsy and RP volume per urologist and national procedural volume. Results: Following the USPSTF recommendation, median biopsy volume per urologist decreased from 29 to 21 (interquartile range [IQR}, 12-34; P < .001). After adjusting for physician and practice characteristics, biopsy volume decreased by 28.7% following 2012 (parameter estimate, -0.25; SE, 0.03; P < .001). Similarly, following the USPSTF recommendation, median RP volume per urologist decreased from 7 (IQR, 3-15) to 6 (IQR, 2-12) (P < .001), and in adjusted analyses, RP volume decreased 16.2% (parameter estimate, -0.15; SE, 0.05; P = .003). Conclusions and Relevance: Following the 2012 USPSTF recommendation, prostate biopsy and RP volumes decreased significantly. A panoramic vantage point is needed to evaluate the long-term consequences of the 2012 USPSTF recommendation.

Admixture mapping of lung cancer in 1812 African-Americans.

Lung cancer continues to be the leading cause of cancer death in the USA and the best example of a cancer with undisputed evidence of environmental risk. However, a genetic contribution to lung cancer has also been demonstrated by studies of familial aggregation, family-based linkage, candidate gene studies and most recently genome-wide association studies (GWAS). The African-American population has been underrepresented in these genetic studies and has patterns of cigarette use and linkage disequilibrium that differ from patterns in other populations. Therefore, studies in African-Americans can provide complementary data to localize lung cancer susceptibility genes and explore smoking dependence-related genes. We used admixture mapping to further characterize genetic risk of lung cancer in a series of 837 African-American lung cancer cases and 975 African-American controls genotyped at 1344 ancestry informative single-nucleotide polymorphisms. Both case-only and case-control analyses were conducted using ADMIXMAP adjusted for age, sex, pack-years of smoking, family history of lung cancer, history of emphysema and study site. In case-only analyses, excess European ancestry was observed over a wide region on chromosome 1 with the largest excess seen at rs6587361 for non-small-cell lung cancer (NSCLC) (Z-score = -4.33; P = 1.5 × 10⁻5) and for women with NSCLC (Z-score = -4.82; P = 1.4 × 10⁻6). Excess African ancestry was also observed on chromosome 3q with a peak Z-score of 3.33 (P = 0.0009) at rs181696 among ever smokers with NSCLC. These results add to the findings from the GWAS in Caucasian populations and suggest novel regions of interest.