Durability of annuloplasty in patients with atrial functional mitral regurgitation associated with atrial fibrillation.

OBJECTIVE: To determine the durability of mitral valve repair (MVr) with complete ring or flexible band annuloplasty in patients with atrial functional mitral regurgitation (AFMR) due to atrial fibrillation (AF) and identify risk factors associated with postoperative recurrence of mitral regurgitation. METHODS: Between January 1, 2000, and January 1, 2023, 194 adults with a history of AF underwent MVr with annuloplasty alone for moderate/severe AFMR. Exclusion criteria were prior cardiac surgery, additional repair techniques, ejection fraction <45%, ischemic heart disease, aortic valve disease, mitral annular calcification, and concomitant procedures other than surgical ablation or tricuspid repair/replacement. The durability of annuloplasty was assessed using longitudinal analysis of postoperative echocardiographic data. RESULTS: Complete ring annuloplasty was performed in 126 of 194 patients (65%); partial ring (posterior band) in the other 68 (35%). Concomitantly, 124 of the 194 patients underwent tricuspid valve surgery, and 173 (89%) had a procedure for AF, including biatrial Cox-Maze III/IV lesion set in 152 (88%) and pulmonary vein isolation in 21 (12%). All patients were discharged with no/trace MR. Freedom from moderate/severe MR after repair with annuloplasty alone was 89% at 10 years, and no significant differences were noted between complete and partial ring annuloplasty (early, P = .41; late, P = .92). Forty-eight percent of patients developed AF at 3 months or longer after surgery, and the presence of postoperative AF was not associated with a greater likelihood of recurrence of MR (P = .15). Freedom from mitral reintervention was 96% at 10 years. CONCLUSIONS: In appropriate patients with AFMR, the long-term durability of annuloplasty is excellent with complete ring and posterior band annuloplasty techniques.

Early and late experience of the modified aortic reimplantation operation.

OBJECTIVE: Valve-sparing aortic root replacement for proximal aortic dilation with aortic regurgitation is associated with excellent outcomes. Modified aortic reimplantation entails reducing the anulus size to the expected size for sex and body surface area and creating neosinuses to preserve the aortic valve. We present our mid- and late-term outcomes with the modified technique, including a single-surgeon's experience over the past 2 decades. METHODS: From January 2002 to January 2024, 528 patients underwent modified aortic reimplantation for aortic aneurysm or dilation; 491 were included in this study. End points included time-related mortality and postoperative morbidities, including aortic valve reintervention and longitudinal aortic regurgitation grade. RESULTS: There were no operative deaths. Survival at 30 days, 1 year, and 15 years were 100%, 99.6%, and 87%, respectively. Postoperative stroke occurred in 4 patients (0.81%) and reoperation for bleeding in 7 (1.4%). Moderate or severe aortic valve regurgitation was seen in 6.2% and 10% of patients at 1 and 10 years, respectively. Aortic valve mean gradients were 7.0 and 7.5 mm Hg at 1 and 10 years, respectively. Freedom from reintervention on the aortic valve was 99.9%, 99%, and 95% at 30 days, 1 year, and 15 years, respectively. CONCLUSIONS: Modified aortic reimplantation technique is a reliable and reproducible technique with excellent mid- and long-term outcomes in survival and freedom from reintervention. The results advocate for modified reimplantation in patients with enlarged aortic roots, especially in younger patients with connective tissue disorder.

American Association for Thoracic Surgery Quality Gateway: A Surgeon Case Study of Its Application in Adult Cardiac Surgery for Quality Assurance.

OBJECTIVE: To demonstrate applying American Association for Thoracic Surgery Quality Gateway (AQG) outcomes models to a Surgeon Case Study of quality assurance in adult cardiac surgery. METHODS: The case study includes 6,989 cardiac and thoracic aorta operations performed in adults at Cleveland Clinic by one surgeon from 2001 to 2023. AQG models were used to predict expected probabilities for operative mortality and major morbidity, and to compare hospital outcomes, surgery type, risk profile, and individual risk-factor levels using virtual (digital) twin causal inference. These models were based on postoperative procedural outcomes after 52,792 cardiac operations performed in 19 hospitals of 3 high-performing hospital systems with overall hospital mortality of 2.0%, analyzed by advanced machine learning for rare events. RESULTS: For individual surgeons, their patients, hospitals, and hospital systems, the Surgeon Case Study demonstrated that AQG provides expected outcomes across the entire spectrum of cardiac surgery, from single-component primary operations to complex multi-component reoperations. Actionable opportunities for quality improvement based on virtual twins is illustrated for patients, surgeons, hospitals, risk profile groups, operations, and risk factors vis-à-vis other hospitals. CONCLUSIONS: Using minimal data collection and models developed using advanced machine learning, this case study shows that probabilities can be generated for operative mortality and major morbidity after virtually all adult cardiac operations. It demonstrates the utility of 21st century causal inference (virtual [digital] twin) tools for assessing quality for surgeons asking "How am I doing?" their patients asking "What are my chances?" and the profession asking "How can we get better?"

Automating surgical procedure extraction for society of surgeons adult cardiac surgery registry using pretrained language models.

Objective: Surgical registries play a crucial role in clinical knowledge discovery, hospital quality assurance, and quality improvement. However, maintaining a surgical registry requires significant monetary and human resources given the wide gamut of information abstracted from medical records ranging from patient co-morbidities to procedural details to post-operative outcomes. Although natural language processing (NLP) methods such as pretrained language models (PLMs) have promised automation of this process, there are yet substantial barriers to implementation. In particular, constant shifts in both underlying data and required registry content are hurdles to the application of NLP technologies. Materials and Methods: In our work, we evaluate the application of PLMs for automating the population of the Society of Thoracic Surgeons (STSs) adult cardiac surgery registry (ACS) procedural elements, for which we term Cardiovascular Surgery Bidirectional Encoder Representations from Transformers (CS-BERT). CS-BERT was validated across multiple satellite sites and versions of the STS-ACS registry. Results: CS-BERT performed well (F1 score of 0.8417 ± 0.1838) in common cardiac surgery procedures compared to models based on diagnosis codes (F1 score of 0.6130 ± 0.0010). The model also generalized well to satellite sites and across different versions of the STS-ACS registry. Discussion and Conclusions: This study provides evidence that PLMs can be used to extract the more common cardiac surgery procedure variables in the STS-ACS registry, potentially reducing need for expensive human annotation and wide scale dissemination. Further research is needed for rare procedural variables which suffer from both lack of data and variable documentation quality.

Development of American Association for Thoracic Surgery Quality Gateway outcome models, analytics, and visualizations for quality assurance.

OBJECTIVE: The study objective was to develop comprehensive quality assurance models for procedural outcomes after adult cardiac surgery. METHODS: Based on 52,792 cardiac operations in adults performed in 19 hospitals of 3 high-performing hospital systems, models were developed for operative mortality (n = 1271), stroke (n = 895), deep sternal wound infection (n = 122), prolonged intubation (6182), renal failure (1265), prolonged postoperative stay (n = 5418), and reoperations (n = 1693). Random forest quantile classification, a method tailored for challenges of rare events, and model-free variable priority screening were used to identify predictors of events. RESULTS: A small set of preoperative variables was sufficient to model procedural outcomes for virtually all cardiac operations, including older age; advanced symptoms; left ventricular, pulmonary, renal, and hepatic dysfunction; lower albumin; higher acuity; and greater complexity of the planned operation. Geometric mean performance ranged from .63 to .76. Calibration covered large areas of probability. Continuous risk factors provided high information content, and their association with outcomes was visualized with partial plots. These risk factors differed in strength and configuration among hospitals, as did their risk-adjusted outcomes according to patient risk as determined by counterfactual causal inference within a framework of virtual (digital) twins. CONCLUSIONS: By using a small set of variables and contemporary machine-learning methods, comprehensive models for procedural operative mortality and major morbidity after adult cardiac surgery were developed based on data from 3 exemplary hospital systems. They provide surgeons, their patients, and hospital systems with 21st century tools for assessing their risks compared with these advanced hospital systems and improving cardiac surgery quality.

Evolution of serious and life-threatening COVID-19 pneumonia as the SARS-CoV-2 pandemic progressed: an observational study of mortality to 60 days after admission to a 15-hospital US health system.

OBJECTIVE: In order to predict at hospital admission the prognosis of patients with serious and life-threatening COVID-19 pneumonia, we sought to understand the clinical characteristics of hospitalised patients at admission as the SARS-CoV-2 pandemic progressed, document their changing response to the virus and its variants over time, and identify factors most importantly associated with mortality after hospital admission. DESIGN: Observational study using a prospective hospital systemwide COVID-19 database. SETTING: 15-hospital US health system. PARTICIPANTS: 26 872 patients admitted with COVID-19 to our Northeast Ohio and Florida hospitals from 1 March 2020 to 1 June 2022. MAIN OUTCOME MEASURES: 60-day mortality (highest risk period) after hospital admission analysed by random survival forests machine learning using demographics, medical history, and COVID-19 vaccination status, and viral variant, symptoms, and routine laboratory test results obtained at hospital admission. RESULTS: Hospital mortality fell from 11% in March 2020 to 3.7% in March 2022, a 66% decrease (p<0.0001); 60-day mortality fell from 17% in May 2020 to 4.7% in May 2022, a 72% decrease (p<0.0001). Advanced age was the strongest predictor of 60-day mortality, followed by admission laboratory test results. Risk-adjusted 60-day mortality had all patients been admitted in March 2020 was 15% (CI 3.0% to 28%), and had they all been admitted in May 2022, 12% (CI 2.2% to 23%), a 20% decrease (p<0.0001). Dissociation between observed and predicted decrease in mortality was related to temporal change in admission patient profile, particularly in laboratory test results, but not vaccination status or viral variant. CONCLUSIONS: Hospital mortality from COVID-19 decreased substantially as the pandemic evolved but persisted after hospital discharge, eclipsing hospital mortality by 50% or more. However, after accounting for the many, even subtle, changes across the pandemic in patients' demographics, medical history and particularly admission laboratory results, a patient admitted early in the pandemic and predicted to be at high risk would remain at high risk of mortality if admitted tomorrow.

Long-term outcome of bicuspid aortic valve repair using figure-of-8 hitch-up stitches.

Objective: To maximize successful repair of bicuspid aortic valves by adding figure-of-8 hitch-up stitches at commissures. Methods: From 2000 to 2022, bicuspid aortic valve repair was performed on 1112 patients at Cleveland Clinic, with 367 patients receiving figure-of-8 hitch-up stitches along with classical techniques, including Cabrol suture, cusp plication, raphe resection, and valve-sparing root replacement. Operative outcomes, repair durability, and survival were assessed in the figure-of-8 hitch-up stitches cohort, and outcomes were compared among 195 balancing-score-matched patient pairs who underwent bicuspid aortic valve repair with and without figure-of-8 hitch-up stitches. Results: Patients who underwent bicuspid aortic valve repair with figure-of-8 stitches had an operative mortality of 0.3% (1 of 367) and in-hospital reoperation for aortic valve dysfunction of 1.1% (4 of 367). At 10 years, prevalence of severe aortic regurgitation was 8.6%, mean gradient 24 mm Hg, freedom from aortic valve reoperation 75%, and survival 98%. In matched cohorts, operative mortality was similar (0.51% vs 0%; P > .9) as were morbidities, including in-hospital reoperation due to aortic valve dysfunction (1.0% vs 1.5%; P > .9). Comparable long-term outcomes were observed at 10 years (prevalence of severe aortic regurgitation of 8.7% vs 5.0% [P = .11], mean gradient 18 vs 17 mm Hg [P = .40]; freedom from aortic valve reoperation 80% vs 81% [P = .73]; and survival 99.5% vs 94.6% [P = .18]). Conclusions: Figure-of-8 hitch-up stitch is a safe bicuspid aortic valve repair technique. It increases the likelihood of a successful repair without increasing risk of cusp tear and achieves satisfactory long-term survival and durability when added to classical repair techniques.

Efficacy and safety of a transaortic approach to midventricular and apical septal myectomy.

OBJECTIVE: The study objective was to evaluate the safety and efficacy of a transaortic approach to midventricular and apical septal myectomy in patients with hypertrophic cardiomyopathy with left ventricular outflow tract or midventricular obstruction. METHODS: From January 2018 to August 2023, 940 patients underwent transaortic septal myectomy at the Cleveland Clinic, of whom 682 (73%) had midventricular or apical resection. Patients who underwent isolated basal myectomies were excluded. Templated operative reports designated septal regions resected as basal (opposition to mitral valve up to the leaflet tips), midventricular (leaflet tips to just beyond the papillary muscle heads), and apical (apical third of the ventricle). Myocardial resection specimen weights, intraventricular gradients, and clinical outcomes were assessed. RESULTS: Of the 682 patients, 582 (85%) had basal plus midventricular resection and 78 (11%) had basal, midventricular, and apical resection. Mean preoperative intraventricular gradient was 102 ± 41 mm Hg. Median resection weight was 10 g (15th, 85th percentiles: 7, 15), and mean postoperative intraventricular gradient was 16 ± 10 mm Hg, with 625 (96%) patients achieving gradients 36 mm Hg or less. There were no iatrogenic mitral or aortic valve injuries. Permanent pacemaker placement was required in 38 patients (5.6%), of whom 8 (1.2%) had normal preoperative conduction. Operative mortality occurred in 1 patient (0.1%) after an intraoperative ventricular septal defect. CONCLUSIONS: Most patients undergoing septal myectomy for relief of obstruction required resection beyond the basal septum. With specialized instrumentation, detailed imaging and knowledge of variable septal anatomy, resecting midventricular and apical septal muscle can be safely and effectively achieved through a transaortic approach.

Contemporary experience with the Commando procedure for anterior mitral anular calcification.

Objective: Anterior mitral anular calcification, particularly in radiation heart disease, and previous valve replacement with destroyed intervalvular fibrosa are challenging for prosthesis sizing and placement. The Commando procedure with intervalvular fibrosa reconstruction permits double-valve replacement in these challenging conditions. We referenced outcomes after Commando procedures to standard double-valve replacements. Methods: From January 2011 to January 2022, 129 Commando procedures and 1191 aortic and mitral double-valve replacements were performed at the Cleveland Clinic, excluding endocarditis. Reasons for the Commando were severe calcification after radiation (n = 67), without radiation (n = 43), and others (n = 19). Commando procedures were referenced to a subset of double-valve replacements using balancing-score methods (109 pairs). Results: Between balanced groups, Commando versus double-valve replacement had higher total calcium scores (median 6140 vs 2680 HU, P = .03). Hospital outcomes were similar, including operative mortality (12/11% vs 8/7.3%, P = .35) and reoperation for bleeding (9/8.3% vs 5/4.6%, P = .28). Survival and freedom from reoperation at 5 years were 54% versus 67% (P = .33) and 87% versus 100% (P = .04), respectively. Higher calcium score was associated with lower survival after double-valve replacement but not after the Commando. The Commando procedure had lower aortic valve mean gradients at 4 years (9.4 vs 11 mm Hg, P = .04). After Commando procedures for calcification, 5-year survival was 60% and 59% with and without radiation, respectively (P = .47). Conclusions: The Commando procedure with reconstruction of the intervalvular fibrosa destroyed by mitral anular calcification, radiation, or previous surgery demonstrates acceptable outcomes similar to standard double-valve replacement. More experience and long-term outcomes are required to refine patient selection for and application of the Commando approach.

Identifying and mitigating risk of postcardiotomy cardiogenic shock in patients with ischemic and nonischemic cardiomyopathy.

OBJECTIVES: To identify preoperative predictors of postcardiotomy cardiogenic shock in patients with ischemic and nonischemic cardiomyopathy and evaluate trajectory of postoperative ventricular function. METHODS: From January 2017 to January 2020, 238 patients with ejection fraction <30% (206/238) or 30% to 34% with at least moderately severe mitral regurgitation (32/238) underwent conventional cardiac surgery at Cleveland Clinic, 125 with ischemic and 113 with nonischemic cardiomyopathy. Preoperative ejection fraction was 25 ± 4.5%. The primary outcome was postcardiotomy cardiogenic shock, defined as need for microaxial temporary left ventricular assist device, extracorporeal membrane oxygenation, or vasoactive-inotropic score >25. RandomForestSRC was used to identify its predictors. RESULTS: Postcardiotomy cardiogenic shock occurred in 27% (65/238). Pulmonary artery pulsatility index <3.5 and pulmonary capillary wedge pressure >19 mm Hg were the most important factors predictive of postcardiotomy cardiogenic shock in ischemic cardiomyopathy. Cardiac index <2.2 L·min-1 m-2 and pulmonary capillary wedge pressure >21 mm Hg were the most important predictive factors in nonischemic cardiomyopathy. Operative mortality was 1.7%. Ejection fraction at 12 months after surgery increased to 39% (confidence interval, 35-40%) in the ischemic group and 37% (confidence interval, 35-38%) in the nonischemic cardiomyopathy group. CONCLUSIONS: Predictors of postcardiotomy cardiogenic shock were different in ischemic and nonischemic cardiomyopathy. Right heart dysfunction, indicated by low pulmonary artery pulsatility index, was the most important predictor in ischemic cardiomyopathy, whereas greater degree of cardiac decompensation was the most important in nonischemic cardiomyopathy. Therefore, preoperative right heart catheterization will help identify patients with low ejection fraction who are at greater risk of postcardiotomy cardiogenic shock.

Clinical T2 N0 M0 Esophageal Cancer: Identifying Predictive Factors of Upstaging.

BACKGROUND: Inaccuracy of clinical staging renders management of clinical T2 N0 M0 (cT2 N0 M0) esophageal cancer difficult. When an underlying advanced-stage disease is understaged to cT2 N0 M0, patients miss the opportunity to gain the potential benefits of neoadjuvant therapy. This study aimed to identify preoperative factors that predict underlying advanced-stage esophageal cancer. METHODS: From 2000 to 2020, 1579 patients with esophageal cancer underwent esophagectomy. Sixty patients who underwent upfront surgery for cT2 N0 M0 esophageal cancer were included in this study. The median age was 62.5 years, and 78% (n = 47) of these patients were male. Radiologic, clinical, and endoscopic factors were evaluated as preoperative markers. The Fisher exact and the Wilcoxon rank sum tests were used for categoric and continuous variables, respectively. Random forest classification was used to identify preoperative factors for predicting upstaging and downstaging. RESULTS: Of the 60 patients, 8 (13%) were found to have pathologic T2 N0 M0 esophageal cancer. Sixteen (27%) patients had cancer that was pathologically downstaged, and 36 (60%) had upstaged disease. Seven (19%) patients had upstaged cancer on the basis of the pathologic T stage, 14 (39%) had upstaging on the basis of the pathologic N stage, and 15 (42%) had upstaging on the basis of both T and N stages. Dysphagia (P = .003) and tumor maximum standardized uptake value (P = .048) were predictors of upstaging, with a combined predictive value of up to 75%. CONCLUSIONS: The presence of dysphagia and of high maximum standardized uptake value (≥5) of the tumor is predictive of more advanced underlying disease for patients with cT2 N0 M0 esophageal cancer, and these patients should be considered for neoadjuvant therapy.

Infective Endocarditis in Patients Addicted to Injected Opioid Drugs.

BACKGROUND: Persons who inject drugs and require surgery for infective endocarditis have 2 potentially lethal diseases. Current postoperative rehabilitation efforts seem ineffective in preventing loss to follow-up, injection drug use relapse (relapse), and death. OBJECTIVES: The purpose of this study was to characterize drug use, psychosocial issues, surgical outcome, and postoperative addiction management, as well as loss to follow-up, relapse, and mortality and their risk factors. METHODS: From January 2010 to June 2020, 227 persons who inject drugs, age 36 ± 9.9 years, underwent surgery for infective endocarditis at a quaternary hospital having special interest in developing addiction management programs. Postsurgery loss to follow-up, relapse, and death were assessed as competing risks and risk factors identified parametrically and by machine learning. CIs are 68% (±1 SE). RESULTS: Heroin was the most self-reported drug injected (n = 183 [81%]). Psychosocial issues included homelessness (n = 56 [25%]), justice system involvement (n = 150 [66%]), depression (n = 118 [52%]), anxiety (n = 104 [46%]), and post-traumatic stress disorder (n = 33 [15%]). Four (1.8%) died in-hospital. Medication for opioid use disorder prescribed at discharge increased from 0% in 2010 to 100% in 2020. At 1 and 5 years, conditional probabilities of loss to follow-up were 16% (68% CI: 13%-22%) and 59% (68% CI: 44%-65%), relapse 32% (68% CI: 28%-34%) and 79% (68% CI: 74%-83%), and mortality 21% (68% CI: 18%-23%) and 68% (68% CI: 62%-72%). Younger age, heroin use, and lower education level were predictors of relapse. CONCLUSIONS: Infective endocarditis surgery can be performed with low mortality in persons who inject drugs, but addiction is far more lethal. Risk of loss to follow-up and relapse require more effective addiction strategies without which this major loss to society will continue.

The Ozaki Procedure: Standardized Protocol Adoption of a Complex Innovative Procedure.

Background: The Ozaki procedure using autologous pericardium is an interesting but complex alternative for aortic valve replacement. We present a standardized approach to minimize the learning curve and confirm reproducibility. Methods: After careful preparation, from May 2015 to February 2021, an Ozaki procedure was performed on 46 patients age 51 ± 14 years. Seven had unicuspid (15%), 29 bicuspid (63%), and 10 tricuspid (22%) aortic valves, and 2 patients had endocarditis. Endpoints were operative learning curves, perioperative outcomes, intermediate-term valve hemodynamics, reintervention, health-related quality of life (MacNew Heart Disease Health-Related Quality of Life questionnaire), and mortality. Results: Cardiopulmonary bypass and aortic clamp times decreased from 145 to 125 â€‹minutes and 120 to 100 â€‹minutes, respectively, over the first 20 cases, reflecting the learning curve. There was no major perioperative morbidity or mortality. Median postoperative stay was 6.9 days. Aortic regurgitation was mild or less in all but 2 patients who developed moderate aortic regurgitation. Mean aortic valve gradient was 7.9 mmHg postoperatively, 9.2 mmHg by 6 months, and constant thereafter. Left ventricular ejection fraction was 58% preoperatively, 60% at 6 months, and remained stable thereafter. One patient developed infective endocarditis 7 months postoperatively, failed medical management, and underwent valve replacement at 14 months. Two-year survival was 96%, with 1 noncardiac death at 16 months. Health-related quality of life in mental, physical, and emotional domains was better than matched norms, global 6.2 vs. 5.0 (p < 0.0001). Conclusions: Using a well-prepared standardized approach, the Ozaki procedure is reproducible with a short learning curve, excellent hemodynamic performance, and good quality of life.

Thoracoabdominal Esophagectomy: Then and Now.

BACKGROUND: Open approaches for esophagectomy are often still useful; of these, left thoracoabdominal esophagectomy (TAE) is poorly understood and often criticized. Hence, we examined TAE's worldwide utilization, survival, and present-day use and outcomes at our institution compared with contemporary national averages. METHODS: The Worldwide Esophageal Cancer Collaboration database includes 8854 patients who underwent esophagectomy for cancer between 2005 and 2014, a period when TAE was our center's most common approach. Two propensity score-matched models were constructed: worldwide TAE vs worldwide non-TAE (751 matched pairs); and our high-volume center TAE vs worldwide non-TAE (273 matched pairs). All-cause mortality was compared between matched groups. Institutional TAE data from 2017 to 2021 were assessed for present-day use and outcomes. RESULTS: Worldwide, propensity score-matched patients undergoing TAE had a median of 20 lymph nodes resected vs 17 after non-TAE (P < .0001). Five-year survival was 34% for worldwide TAE vs 42% for worldwide non-TAE groups (P = .04). Three-year matched survival was 52% for high-volume TAE compared with 54% for worldwide non-TAE groups (P = .1). From 2017 to 2021 at our institution, 90 (26%) of 346 esophagectomies were performed by TAE. Pneumonia developed in 5 patients (5.6%), with 88 patients (98%) alive at 30 days, comparable to contemporary averages of The Society of Thoracic Surgeons. CONCLUSIONS: When it is performed as the primary approach in high volumes, TAE can have comparable outcomes to non-TAE with low morbidity. At present, we find that TAE is most useful in patients with truncal obesity, prior abdominal operations, and locally advanced cardia tumors with potential for variable extent of resection.

Paraconduit hernia following esophagectomy: Is it safe to watch and wait?

OBJECTIVES: We hypothesized that emergency complications related to asymptomatic paraconduit hernias may occur less often than generally believed. Therefore, we assessed the occurrence and timing of paraconduit hernia diagnosis after esophagectomy, as well as outcomes of these asymptomatic patients managed with a watch-and-wait approach. METHODS: From 2006 to 2021, 1214 patients underwent esophagectomy with reconstruction at the Cleveland Clinic. Among these patients, computed tomography scans were reviewed to identify paraconduit hernias. Medical records were reviewed for timing of hernia diagnosis, hernia characteristics, and patient symptoms, complications, and management. During this period, patients with asymptomatic paraconduit hernias were typically managed nonoperatively. RESULTS: Paraconduit hernias were identified in 37 patients. Of these, 31 (84%) had a pre-esophagectomy hiatal hernia. Twenty-one hernias (57%) contained colon, 7 hernias (19%) contained pancreas, and 9 hernias (24%) contained multiple organs. Estimated prevalence of paraconduit hernia was 3.3% at 3 years and 7.7% at 10 years. Seven patients (19%) had symptoms, 4 of whom were repaired electively, with 2 currently awaiting repairs. No patient with a paraconduit hernia experienced an acute complication that required emergency intervention. CONCLUSIONS: The risk of paraconduit hernia increases with time, suggesting that long-term symptom surveillance is reasonable. Emergency complications as a result of asymptomatic paraconduit hernias are rare. A small number of patients will experience hernia-related symptoms, sometimes years after hernia diagnosis. Our findings suggest that observation of asymptomatic paraconduit hernias (watch and wait) may be considered, with repair considered electively in patients with persistent symptoms.

The Value of Fundoplication in the Treatment of Type I Achalasia.

BACKGROUND: Type I achalasia comprises 20% of achalasia and has nearly absent esophageal motor activity. Concerns that fundoplication decreases the effectiveness of Heller myotomy in these patients has increased adoption of peroral endoscopic myotomy (POEM). Hence, we compared outcomes after Heller myotomy with Dor fundoplication vs POEM. METHODS: From 2005 to 2020, 150 patients with type I achalasia underwent primary surgical myotomy (117 Heller myotomy, 33 POEM). Patient demographics, prior treatments, timed barium esophagrams, Eckardt scores, and reinterventions were assessed between the 2 groups. Median follow-up was 5 years for Heller myotomy and 2.5 years for POEM. RESULTS: The Heller myotomy group was younger, had fewer comorbidities, and lower body mass index vs POEM. Risk-adjusted models demonstrated clinical success (Eckardt ≤3) in 83% of Heller myotomies and 87% of POEMs at 3 years; longitudinal complete timed barium esophagram emptying and reintervention were also similar. An abnormal pH test result was documented in 10% (6 of 60) after Heller myotomy and in 45% (10 of 22) after POEM (P < .001). CONCLUSIONS: Despite nearly absent esophageal contractility, Heller myotomy with Dor fundoplication and POEM result in similar long-term symptom relief, esophageal emptying, and occurrence of reintervention in patients with type I achalasia. There is decreased esophageal acid exposure with the addition of a fundoplication, without compromised esophageal drainage, allaying fears of a detrimental effect of a fundoplication. Hence, choice of procedure may be personalized based on patient characteristics and esophageal morphology and not solely on manometric subtype.

Development and validation of a universal esophageal patient-reported outcome measure: The Cleveland Clinic Esophageal Questionnaire (CEQ).

OBJECTIVE: Currently, there is no validated patient-reported outcome measure (PROM) applicable to all esophageal diseases. Our objective was to create a psychometrically robust, validated universal esophageal PROM that can also objectively assess patients' quality of life (QoL). METHODS: The pilot PROM constructed based on expert opinions, literature review, and previous unpublished institutional research had 27 items covering 8 domains. It was completed by 30 patients in the outpatient clinic followed by a structured debriefing interview, which allowed for refining the PROM. The final PROM: Cleveland Clinic Esophageal Questionnaire (CEQ) included 34 items across 6 domains (Dysphagia, Eating, Pain, Reflux & Regurgitation, Dyspepsia, Dumping), each accompanied by a corresponding QoL component. Further psychometric assessment of the PROM was conducted by evaluating (1) acceptability, (2) construct validity, (3) reliability, and (4) responsiveness. RESULTS: Five hundred forty-six unique patients (median 63.7 years [54.3-71.7], 53% male [287], 86% White) completed CEQ at >90% completion within 5 minutes. Construct validity was demonstrated by differentiating scores across esophageal cancer (n = 146), achalasia (n = 170), hiatal hernia (n = 160), and other diagnoses (n = 70). Internal reliability (Cronbach alpha 0.83-0.89), and test-retest reliability (intraclass correlation coefficients 0.63-0.85) were strong. Responsiveness was demonstrated through CEQ domains improving for 53 patients who underwent surgery for achalasia or hiatal hernia (Cohen d 0.86-2.59). CONCLUSIONS: We have constructed a psychometrically robust, universal esophageal PROM that allows concise, consistent, objective quantification of symptoms and their effect on the patient. The CEQ is valuable in prognostication and tracking of longitudinal outcomes in both benign and malignant esophageal diseases.

Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis.

BACKGROUND: This study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves. METHODS: Of 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area. RESULTS: Patients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P < .001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts. CONCLUSIONS: Among patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients.