Longitudinal Examination of Swallowing Safety and Vocal Fold Mobility in Cardiac Surgical Patients.

BACKGROUND: Aspiration and vocal fold mobility impairment (VFMI) are frequently reported in adults after cardiac surgery (CS) and impede recovery. Preoperative and postoperative laryngoscopic evaluations have not been undertaken, masking the incidence and evolution of dysphagia and VFMI in CS patients. We therefore sought to determine frequency of unsafe swallowing and VFMI before and after CS. METHODS: Thirty-five adults undergoing elective CS enrolled. Participants underwent fiberoptic endoscopic evaluations of swallowing and VFMI before and after surgical procedure. Trained raters performed duplicate, blinded ratings with the validated Penetration-Aspiration Scale, and a laryngologist performed blinded ratings of VFMI. Descriptive, Wilcoxon signed rank, and McNemar tests were performed. RESULTS: Preoperative swallowing safety profiles were 60% safe, 34% penetration, and 6% aspiration. Postoperative swallowing safety profiles were 14% safe, 63% penetration, and 23% aspiration. Significant differences in preoperative to postoperative swallowing outcomes were noted for Penetration-Aspiration Scale scores (P < .0001), unsafe swallowing (40% vs 86%; χ2 = 12.8; P = .0003), and aspiration (6% vs 23%; χ2 =6; P = .01). No differences in VFMI were noted preoperatively to postoperatively (partial VFMI, 9% vs 23%; P > .05). CONCLUSIONS: A 4-fold increase in aspiration was observed in CS patients. No cases of vocal fold paralysis were observed across time points. These data highlight the utility of instrumental laryngoscopic evaluations during the acute postoperative phase.

Evaluation of the efficacy and safety of amustaline/glutathione pathogen-reduced RBCs in complex cardiac surgery: the Red Cell Pathogen Inactivation (ReCePI) study-protocol for a phase 3, randomized, controlled trial.

BACKGROUND: Red blood cell (RBC) transfusion is a critical supportive therapy in cardiovascular surgery (CVS). Donor selection and testing have reduced the risk of transfusion-transmitted infections; however, risks remain from bacteria, emerging viruses, pathogens for which testing is not performed and from residual donor leukocytes. Amustaline (S-303)/glutathione (GSH) treatment pathogen reduction technology is designed to inactivate a broad spectrum of infectious agents and leukocytes in RBC concentrates. The ReCePI study is a Phase 3 clinical trial designed to evaluate the efficacy and safety of pathogen-reduced RBCs transfused for acute anemia in CVS compared to conventional RBCs, and to assess the clinical significance of treatment-emergent RBC antibodies. METHODS: ReCePI is a prospective, multicenter, randomized, double-blinded, active-controlled, parallel-design, non-inferiority study. Eligible subjects will be randomized up to 7 days before surgery to receive either leukoreduced Test (pathogen reduced) or Control (conventional) RBCs from surgery up to day 7 post-surgery. The primary efficacy endpoint is the proportion of patients transfused with at least one study transfusion with an acute kidney injury (AKI) diagnosis defined as any increased serum creatinine (sCr) level ≥ 0.3 mg/dL (or 26.5 µmol/L) from pre-surgery baseline within 48 ± 4 h of the end of surgery. The primary safety endpoints are the proportion of patients with any treatment-emergent adverse events (TEAEs) related to study RBC transfusion through 28 days, and the proportion of patients with treatment-emergent antibodies with confirmed specificity to pathogen-reduced RBCs through 75 days after the last study transfusion. With ≥ 292 evaluable, transfused patients (> 146 per arm), the study has 80% power to demonstrate non-inferiority, defined as a Test group AKI incidence increase of no more than 50% of the Control group rate, assuming a Control incidence of 30%. DISCUSSION: RBCs are transfused to prevent tissue hypoxia caused by surgery-induced bleeding and anemia. AKI is a sensitive indicator of renal hypoxia and a novel endpoint for assessing RBC efficacy. The ReCePI study is intended to demonstrate the non-inferiority of pathogen-reduced RBCs to conventional RBCs in the support of renal tissue oxygenation due to acute anemia and to characterize the incidence of treatment-related antibodies to RBCs.

A highly penetrant ACTA2 mutation of thoracic aortic disease.

BACKGROUND: The role of ACTA2 mutations in Familial Aortic Disease has been increasingly recognized. We describe a highly penetrant variant (R118Q) in a family with aortic disease. CASE REPORT: A patient presented to us for elective repair of an ascending aortic aneurysm with a family history of his mother expiring after aortic dissection. Genetic testing revealed he was a heterozygous carrier of the ACTA2 missense mutation R118Q. Subsequently, all living family members were tested for this variant and a full medical history was obtained to compile a family tree for the variant and penetrance of an aortic event (defined as lifetime occurrence of aortic surgery / dissection). In total 9 family members were identified and underwent genetic testing with 7/9 showing presence of the ACTA2 R118Q mutation or an aortic event. All patients over the age of 50 (n = 4) had an aortic event. Those events occurred at ages 54, 55, 60, and 62 (mean event at 57.8 ± 3.9 years). Three family members with the variant under the age of 40 have not had an aortic event and most are undergoing regular aortic surveillance via CT scan. CONCLUSIONS: Existing studies of known ACTA2 mutations describe a 76% aortic event rate by 85 years old. The R118Q missense mutation is a less common ACTA2 variant, estimated to be found in about 5% of patients with known mutations. Prior studies have predicted the R118Q mutation to have a slightly decreased risk of aortic events compared to other ACTA2 mutations. In this family, however, we demonstrate 100% penetrance of aortic disease above age 50. In today's era of excellent outcomes in elective aortic surgery, our team aggressively offers elective repair. We advocate for strict aortic surveillance for patients with this variant and would consider elective aortic replacement at 4.5 cm, or at an even smaller diameter in patients with a strong family history of dissection who are identified with this mutation.

Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis.

OBJECTIVE: As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue. METHODS: This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. RESULTS: Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm2 (n = 153), and 9.4 ± 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% [152 out of 157]) or trivial/trace (2.5% [4 out of 157]) paravalvular regurgitation and none (84.7% [133 out of 157]) or trivial/trace (11.5% [18 out of 157]) transvalvular regurgitation were observed. CONCLUSIONS: We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses.

Preoperative respiratory strength training is feasible and safe and improves pulmonary physiologic capacity in individuals undergoing cardiovascular surgery.

Objective: To determine the safety, feasibility, and physiologic impact of a preoperative respiratory strength training (RST) program in individuals undergoing elective cardiac surgery (CS). Methods: Twenty-five adults undergoing an elective CS at an academic hospital setting enrolled and completed RST 5 days/week (50 repetitions, 50% training load, ≥3 weeks) at home via telehealth in this open-label prospective cohort study. RST adherence, telehealth attendance, and adverse events were tracked. Pre- and post-RST outcomes of maximum expiratory pressure (MEP), maximum inspiratory pressure (MIP), voluntary cough spirometry, and patient-reported dyspnea were collected. Descriptive analyses and Wilcoxon signed rank-tests were performed. Results: Two participants (9%) did not complete the prescribed RST program. No significant RST-related adverse events occurred. Treatment adherence for all enrolled participants was 90%, and telehealth attendance was 99%. Of the CS patients who completed the prescribed program (n = 23; 91%), treatment adherence and telehealth attendance were excellent (98% and 100%, respectively). Significant increases in primary outcomes were observed: MEP mean change, +15.4 (95% confidence interval [CI], +3.4 to +27.3, P < .007); MIP mean change, +14.9 (95% CI, +9.4 to +20.4, P < .0001). No statistically significant differences in voluntary cough or perceived dyspnea outcomes were observed (P > .05). Conclusions: These preliminary data demonstrate that a preoperative RST program is safe and feasible and can improve short-term respiratory physiologic capacity (MEP and MIP) in CS patients. Future research is warranted to validate the current findings in a larger cohort of CS patients and to determine whether RST improves postoperative extubation outcomes, airway clearance capacity, and aspiration following cardiac surgery.

Intraoperative Hemi-Diaphragm Electrical Stimulation Demonstrates Attenuated Mitochondrial Function without Change in Oxidative Stress in Cardiothoracic Surgery Patients.

Mechanical ventilation during cardiothoracic surgery is life-saving but can lead to ventilator-induced diaphragm dysfunction (VIDD) and prolong ventilator weaning and hospital length of stay. Intraoperative phrenic nerve stimulation may preserve diaphragm force production to offset VIDD; we also investigated changes in mitochondrial function after stimulation. During cardiothoracic surgeries (n = 21), supramaximal, unilateral phrenic nerve stimulation was performed every 30 min for 1 min. Diaphragm biopsies were collected after the last stimulation and analyzed for mitochondrial respiration in permeabilized fibers and protein expression and enzymatic activity of biomarkers of oxidative stress and mitophagy. Patients received, on average, 6.2 ± 1.9 stimulation bouts. Stimulated hemidiaphragms showed lower leak respiration, maximum electron transport system (ETS) capacities, oxidative phosphorylation (OXPHOS), and spare capacity compared with unstimulated sides. There were no significant differences between mitochondrial enzyme activities and oxidative stress and mitophagy protein expression levels. Intraoperative phrenic nerve electrical stimulation led to an acute decrease of mitochondrial respiration in the stimulated hemidiaphragm, without differences in biomarkers of mitophagy or oxidative stress. Future studies warrant investigating optimal stimulation doses and testing post-operative chronic stimulation effects on weaning from the ventilator and rehabilitation outcomes.

Dysphagia after cardiac surgery: Prevalence, risk factors, and associated outcomes.

OBJECTIVES: The study objectives were to determine the prevalence of swallowing impairment in adults after cardiac surgery and examine associated risk factors and health-related outcomes. METHODS: A prospective single-center study was conducted in postoperative adult cardiac surgery patients with no history of dysphagia. A standardized fiberoptic endoscopic evaluation of swallowing was performed within 72 hours of extubation. Blinded raters completed validated outcomes of swallowing safety and efficiency. Demographic, surgical, and postoperative health-related outcomes were collected. Univariate and multivariable regression analyses were performed with odds ratios (OR) and 95% confidence intervals (CIs). RESULTS: In 182 patients examined, imaging confirmed inefficient swallowing (residue) in 52% of patients and unsafe swallowing in 94% (65% penetrators, 29% aspirators). Silent aspiration was observed in 53% of aspirators, and 32% did not clear aspirate material. Independent risk factors for aspiration included New York Heart Association III and IV (OR, 2.9; CI, 1.2-7.0); reoperation (OR, 2.0; CI, 0.7-5.5); transesophageal echocardiogram images greater than 110 (OR, 2.6; CI, 1.1-6.3); intubation greater than 27 hours (OR, 2.1; CI, 0.8-5.3); and endotracheal tube size 8.0 or greater (OR, 3.1; CI, 1.1-8.6). Patients with 3 or 4 identified risk factors had a 16.4 (CI, 3.2-148.4) and 22.4 (CI, 3.7-244.7) increased odds of aspiration, respectively. Compared with nonaspirators, aspirators waited an additional 85 hours to resume oral intake, incurred $49,372 increased costs, and experienced a 43% longer hospital stay (P < .05). Aspiration was associated with pneumonia (OR, 2.6; CI, 1.1-6.5), reintubation (OR, 5.7; CI, 2.1-14.0), and death (OR, 2.8; CI, 1.2-9.0). CONCLUSIONS: Tracheal aspiration was prevalent, covert, and associated with increased morbidity and mortality.

Application of deep hypothermic circulatory arrest in open left chest aortic aneurysm repair.

OBJECTIVES: Deep hypothermic circulatory arrest (DHCA) is often required for patients undergoing repair of descending thoracic aortic aneurysm (DTAA) or thoracoabdominal aortic aneurysm via left thoracotomy when proximal crossclamping is not feasible or when aneurysmal disease extends into the transverse aortic arch. Historical literature suggests higher complications rates due to the technical complexity of this approach; we examined outcomes with this approach at our center. METHODS: Between January 2008 and May 2018, 84 patients with DTAA or Crawford extent I thoracoabdominal aortic aneurysm underwent open repair. DHCA was employed in 46 of 84 (55%) patients, of which 33 (72%) required repair of distal arch and DTAA, and 13 (28%) required repair of the distal arch and extent I thoracoabdominal aortic aneurysm. Patients who underwent DHCA had more chronic dissections than those in the non-DHCA group (70% vs 34%; P ≤ .05). RESULTS: Major adverse outcomes for the DHCA group versus non-DHCA group were as follows: early mortality 3 out of 46 (7%) versus 4 out of 38 (11%) (P = .70), stroke 3 out of 46 (7%) versus 1 out of 38 (3%) (P = .62), permanent spinal cord deficit 2 out of 46 (4%) versus 3 out of 38 (8%) (P = .65), permanent renal failure necessitating dialysis 1 out of 46 (2%) versus 2 out of 38 (5%) (P = .59). Freedom from major adverse outcomes was 38 out of 46 (83%) versus 31 out of 38 (82%) for DHCA versus non-DHCA (P = 1). CONCLUSIONS: DHCA can be employed via left thoracotomy for combined arch and DTAA or extent I thoracoabdominal aortic aneurysm open repair.

Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue.

BACKGROUND: The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences). METHODS: Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US 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 patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the 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 reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm2, mean gradient was 11.5 ± 6.0 mm Hg, 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.

Rescue therapy for symptomatic spinal cord ischemia after thoracic endovascular aortic repair.

OBJECTIVE: Spinal cord ischemia (SCI) after thoracic endovascular aortic repair (TEVAR) can cause permanent neurologic deficits and poor long-term survival. Targeted treatment of new SCI symptoms after TEVAR (rescue therapy [RT]) might improve/resolve neurologic symptoms but few data characterize the association of specific interventions with SCI outcomes. We evaluated the effectiveness of post-TEVAR RT at our tertiary aortic center. METHODS: Our institutional TEVAR database was reviewed for SCI incidence and details of RT. This included cerebrospinal fluid drainage (CSFD), medical therapy, and optimization of spinal cord oxygen delivery. SCI outcomes were categorized at discharge as paralysis/paraparesis and temporary/permanent. RESULTS: Nine hundred forty-three TEVAR procedures were performed in 869 patients from 2011 to 2020. Post-TEVAR SCI occurred in 7.8% (n = 74) with permanent paraplegia in 1.5%. Older patient age, chronic obstructive pulmonary disease, and previous abdominal aortic surgery were predictive of SCI. Half (n = 37) of SCI episodes resulted in only temporary paralysis/paraparesis. Rescue postoperative cerebrospinal fluid drains were implanted in 3.7% (n = 35) of procedures and was predicted by higher American Society of Anesthesiologists class, lower serum hemoglobin level, elevated international normalized ratio, bilateral iliac artery occlusion, nonelective procedures, and penetrating atherosclerotic ulcer/intramural hematoma indication. The most commonly used RTs were emergent placement of or increased drainage from an existing cerebrospinal fluid drain (87.8%), induced/permissive hypertension (77.0%), corticosteroid bolus (36.5%), and naloxone infusion (33.8%). Neurologic improvement occurred in 68.9% (n = 51/74). New/increased drainage was associated with improved SCI outcome. CONCLUSIONS: Permanent paraplegia from post-TEVAR SCI is rare (1.5%). Older patients with comorbidities carry greater post-TEVAR SCI risk. SCI symptoms improved/resolved with CSFD and multimodal RT in 68.9% of patients, but no intervention was independently associated with improvement. TEVAR centers should have robust protocols for timely and safe CSFD placement to augment RT strategies for SCI.

Outcomes of acute type A aortic dissection during the COVID-19 pandemic: An analysis of the Society of Thoracic Surgeons Database.

PURPOSE: There have been reported reductions of hospital presentation for acute cardiovascular conditions such as myocardial infarction and acute type A aortic dissection (ATAAD) in the United States during the COVID-19 pandemic. This study examined presentation patterns and outcomes of ATAAD in North America immediately before, and during, the COVID-19 pandemic. METHODS: The Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD) was queried to identify patients presenting with ATAAD in the 12 months pre-pandemic (March 2019-February 2020), and during the early pandemic (March through June 2020). Demographics and operative characteristics were compared using χ² test and Wilcoxon Rank-sum test. The median annual case volume designated low-volume centers versus high-volume centers (>10 cases per month). Step-wise variable selection was used to create a risk set used for adjustment of all multivariable models. RESULTS: There were 5480 patients identified: 4346 pre-pandemic and 1134 during pandemic. There was significantly lower volume of median cases per month during the COVID-19 pandemic period (286 interquartile range [IQR]: 256-306 vs. 372 IQR: 291-433,p = .0152). In historically low-volume centers (<10 cases per year), there was no difference in volume between the two periods (142 IQR: 133-166 vs. 177 IQR: 139-209, p = NS). In high-volume centers, there was a decline during the pandemic (140 IQR: 123-148 vs. 212 IQR: 148-224, p = .0052). There was no difference in overall hospital-to-hospital transfers during the two time periods (54% of cases pre-pandemic, 55% during). Patient demographics, operative characteristics, malperfusion rates, and cardiac risk factors were similar between the two time periods. There was no difference in unadjusted operative mortality (19.01% pre-pandemic vs. 18.83% during, p = .9) nor major morbidity (52.42% pre-pandemic vs. 51.24% during, p = .5). Risk-adjusted multivariable models showed no difference in either operative mortality nor major morbidity between time periods. CONCLUSIONS: For patients presenting to the hospital with ATAAD during the first surge of the pandemic, operative outcomes were similar to pre-pandemic despite a 30% reduction in volume. Out-of-hospital mortality from ATAAD during the pandemic remains unknown. Further understanding these findings will inform management of ATAAD during future pandemics.

Cardiac Rehabilitation Referral After Transcatheter Aortic Valve Replacement.

Cardiac rehabilitation following transcatheter aortic valve replacement (TAVR) is associated with improved outcomes; however, it remains relatively underutilized in this patient population. As part of a quality improvement initiative, we sought to increase the rate of cardiac rehabilitation referral after TAVR at our institution. We designed and implemented a multidisciplinary program that included education of cardiothoracic surgery providers discharging post-TAVR patients on the benefits of cardiac rehabilitation with participation of cardiac rehabilitation personnel during discharge rounds with the surgical team. The study period was defined as 12 months prior to and 6 months following the implementation of the education program. Overall referral rates increased from 5% to 56% ( P < 0.0001), and referrals placed before hospital discharge increased from 0.8% to 53% ( P < 0.0001) over the study period. In conclusion, a combination of education regarding the benefits of cardiac rehabilitation and cardiac rehabilitation personnel participation in discharge rounds significantly increased referral to cardiac rehabilitation after TAVR.