Midterm Outcomes: A Comprehensive Approach to Surgery for Hypertrophic Obstructive Cardiomyopathy.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction in obstructive hypertrophic cardiomyopathy (HCM) is caused by a constellation of abnormalities. This study reviewed outcomes of a comprehensive approach to correct these abnormalities during surgery. METHODS: This was a single-institution study of patients with HCM who underwent septal myectomy from 2016 to 2023. Their New York Heart Association functional classification and most recent echocardiogram that estimated LVOT gradient and mitral valve function were tracked. RESULTS: The study included 103 patients with a mean age of 54 years (interquartile range, 40-67 years) and common comorbidities: hypertension (50%) and atrial fibrillation (25%). On average, the preprocedure resting echocardiogram showed an LVOT gradient of 36.4 mm Hg and moderate or severe mitral regurgitation in 50.5% of patients. All patients underwent septal myectomy, and associated abnormalities contributing to LVOT obstruction were addressed. Elongation of the anterior leaflet of the mitral valve was typically treated with papillary muscle realignment (72%). Aberrant papillary muscle heads and elongated secondary chordae tendineae contributing to systolic anterior motion were resected (66%). Myocardial bands, including apicoseptal bands contributing to LVOT obstruction, were resected (68%). With an average follow-up of 4 years, 91% of patients were considered to be in New York Heart Association functional class I or II. Long-term echocardiographic follow-up showed a mean peak LVOT gradient of 11 mm Hg (interquartile range, 4-13 mm Hg). Only 1 patient had more than mild mitral regurgitation. CONCLUSIONS: A comprehensive surgical approach to HCM that addresses the entire constellation of abnormalities associated with HCM, including mitral valve anterior leaflet elongation, aberrant or displaced mitral valve subvalvular apparatus, and myocardial bands, leads to outstanding midterm outcomes.

Out with the old: Single center experience with transvenous extraction of leads older than 15 years.

BACKGROUND: Lead dwell time is the single strongest predictor of failure and complications in transvenous lead extraction. OBJECTIVES: To report the success rate and complications of transvenous lead extractions with implant dwell time of at least 15 years. METHODS: Procedural and patient data were prospectively collected into a database. The excimer laser was the primary method for lead extraction with the use of mechanical rotational sheaths and femoral snares at operator discretion. RESULTS: A total of 442 patients between 2011 and 2020 underwent lead extraction (705 leads) primarily for infection or device failure at our high-volume center. Forty-one patients with 71 leads > 15 years old were included in this cohort. Mean patient age was 53.5 ± 18.5 years, 67.5% were male. Mean lead dwell time was 19.6 ± 4.4 years. Thirty-six of 41 (88%) patients had successful extraction of all leads compared to 96% in the remaining 401 patients, p value.004. Of the five patients without fully successful extractions two of these patients had abandoned leads (three total) that were clinically significant. There were two (4.9%) major complications in the very old lead group and six (1.5%) in the other group. In the very old lead group, one patient experienced right atrial appendage perforation requiring surgical repair and recovered well. One patient experienced new complete heart block requiring 2 min of CPR but did well thereafter. There was no procedure-related mortality. CONCLUSIONS: Despite challenges posed by older leads, very old leads can be safely and effectively extracted with low complication rates.

Impact of fixation mechanism and helix retraction status on right ventricular lead extraction.

Background: The impact of lead fixation mechanism on extractability is poorly characterized. Objective: We aimed to compare the technical difficulty of transvenous lead extraction (TLE) of active vs passive fixation right ventricular (RV) leads. Methods: A total of 408 patients who underwent RV TLE by a single expert electrophysiologist at Oregon Health & Science University between October 2011 and June 2022 were identified and retrospectively analyzed; 331 (81%) had active fixation RV leads and 77 (19%) had passive fixation RV leads. The active fixation cohort was further stratified into those with successfully retracted helices (n = 181) and failed helix retraction (n = 109). A numerical system (0-9) devised using 6 procedural criteria quantified a technical extraction score (TES) for each RV TLE. The TES was compared between groups. Results: Helix retraction was successful in ≥55% of active fixation TLEs. The mean TES for active-helix retracted, active-helix non-retracted, and passive fixation groups was 1.8, 3.5, and 3.7, respectively. The TES of the active-helix retracted group was significantly lower than those of the active-helix non-retracted group (adjusted P < .01) and the passive fixation group (adjusted P < .01). There was no significant difference in TES between the passive fixation and active-helix non-retracted groups in multivariate analysis (P = .18). The TLE success rate of the entire cohort was >97%, with a major complication rate of 0.5%. Conclusion: TLE of active fixation leads where helical retraction is achieved presents fewer technical challenges than does passive fixation RV lead extraction; however, if the helix cannot be retracted, active and passive TLE procedures present similar technical challenges.

Simulating for Quality: A Centralized Quality Improvement and Patient Safety Simulation Curriculum for Residents and Fellows.

PROBLEM: Requirements for experiential education in quality improvement and patient safety (QI/PS) in graduate medical education (GME) have recently expanded. Major challenges to meeting these requirements include a lack of faculty with the needed expertise, paucity of standardized curricular models allowing for skill demonstration, and inconsistent access to data for iterative improvement. APPROACH: In October 2017, the authors began development of a centralized QI/PS flipped-classroom simulation-based medical education (SBME) curriculum for GME trainees across multiple disciplines at Oregon Health & Science University (OHSU). The curriculum development team included OHSU and Veterans Affairs faculty with experience in QI/PS and SBME, as well as house officers. The curriculum consisted of a preassessment and prework readings and videos (sent 3 weeks before the simulation day) and an 8-hour simulation day, with introductory activities, 4 linked simulation sessions, and concluding activities. The 4 linked sessions followed the same medication error from disclosure and reporting to root cause analysis, iterative implementation of an action plan, and consolidation of lessons learned into routine operations with Lean huddles. OUTCOMES: In academic year 2018-2019, 71 residents and fellows of various postgraduate years from 23 training programs enrolled in 2 pilot sessions. Learners reacted favorably to the simulation curriculum. Learner attitudes, confidence, knowledge, and skills significantly increased across all QI/PS domains studied. NEXT STEPS: This approach focuses a small cadre of educators toward the creation of a centralized resource that, owing to its experiential SBME foundation, can accommodate many learners with data-driven practice-based learning and improvement cycles in a shorter time frame than traditional QI initiatives. Next steps include the addition of a control group, assessment of the sustainability of learner outcomes, translation of learning to behavior change and improvements in patient and health system outcomes, and adapting the materials to include learners from different professions and levels.

Septal Myectomy for Obstructive Hypertrophic Cardiomyopathy in the Elderly.

BACKGROUND: Hypertrophic obstructive cardiomyopathy is a genetic disorder treated with septal reduction therapy, either alcohol septal ablation or septal myectomy (SM). Historically older patients have been presumed to be poor candidates for SM and thus referred directly for alcohol septal ablation in some centers. We reviewed our experience with SM in older patients. METHODS: We identified 100 patients at our institution who underwent SM for hypertrophic obstructive cardiomyopathy from 2015 to 2020. Demographic and clinical characteristics and outcomes of patients 65 years or older were compared with patients younger than 65. RESULTS: Sixty-five patients were in the <65 group and 35 patients in the ≥65 group. Both groups had similar preoperative peak stress left ventricular outflow tract gradients (129 mm Hg vs 110 mm Hg, P < .001). Most patients in both groups had moderate to severe mitral regurgitation on preoperative stress echocardiography. The elderly group was more likely to have coronary artery bypass graft as a concomitant procedure (37% vs 8%, P < .001). Only 1 death occurred in the series secondary to a pulmonary embolism. At the 30-day follow-up on stress echocardiography, peak stress gradients were normal in both groups (21 and 20 mm Hg, respectively; P < .001), and 88% of all patients had trace to mild mitral regurgitation. CONCLUSIONS: Properly selected older patients can safely undergo SM with excellent outcomes similar to younger patients. Relief of left ventricular outflow tract obstruction and correction of mitral regurgitation are reliably achieved in both groups. Advanced age should not be a strict criteria for selecting septal reduction therapy approach.

Factor VIII inhibitor bypass activity (FEIBA) for the reduction of transfusion in cardiac surgery: a randomized, double-blind, placebo-controlled, pilot trial.

BACKGROUND: Uncontrolled bleeding after cardiac surgery can be life-threatening. Factor eight inhibitor bypassing activity (FEIBA) is a prothrombin complex concentrate empirically used as rescue therapy for correction of refractory bleeding diathesis post-cardiopulmonary bypass (CPB). FEIBA used as rescue therapy for bleeding diathesis after CPB has been associated with a low incidence of complications and a reduction in transfusion requirement and re-exploration. The feasibility and efficacy of early administration of FEIBA after the termination of CPB have not been studied in a prospective randomized trial. METHODS: We designed a small randomized, double-blinded, placebo-controlled pilot trial to determine the feasibility of a larger trial testing the hypothesis that FEIBA decreases transfusion requirements after CPB. The study was designed to evaluate the feasibility of a larger pivotal trial to determine the effectiveness of FEIBA in reducing the total volume of blood products transfused perioperatively, and its safety profile. Study participants were adult patients undergoing elective major aortic cardiovascular surgery at a tertiary referral hospital, who were equally randomized to receive a single dose of either FEIBA or matched placebo intraoperatively at the end of CPB. RESULTS: Twenty patients were screened and 12 were randomized and included in the analysis. Protocol adherence was high, and all patients received the study drug per intention-to-treat except one patient. There were no protocol deviations or events of unblinding, and adverse events were not different between groups. Patients in the FEIBA group were older and more likely to be female and had higher BMI, lower hematocrit, and longer hypothermic circulatory arrest. There were no differences in post-randomization blood product transfusions (difference FEIBA vs. placebo -899 mL; 95% CI -5206 to 3409) or in the administration of open-label FEIBA. CONCLUSIONS: This pilot trial confirmed the adequacy of the trial design that involved the early, blinded administration of FEIBA, by demonstrating excellent protocol adherence. We conclude that a larger trial establishing the effectiveness of early prothrombin complex concentrate administration to reduce the use of blood products in the setting of high-risk cardiac surgery is feasible. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02577614 . Registered 16 October 2015.

The role of estrogen, immune function and aging in heart transplant outcomes.

BACKGROUND: Aging and loss of estrogen suppress immune function, potentially improving survival after orthotopic heart transplant (OHT). The effect of female aging on OHT outcomes is unknown. METHODS: Between 1995 and 2015, 41,299 adult OHT recipients (24.3% women) were studied using a retrospective multi-institutional cohort. Patients were stratified by age and gender into premenopausal (18-39 years), perimenopausal (40-49 years), and postmenopausal (≥50 years) groups. Kaplan-Meier survival analyses and risk-adjusted models examined gender differences across groups at one, five, and ten years. RESULTS: Kaplan-Meier survival was equivalent for postmenopausal women and men, and lower for premenopausal women than men at all time points (p ≤ 0.05). Postmenopausal women had higher risk-adjusted five-year survival than premenopausal women (AOR 1.61, 95% CI 1.15-2.25, p = 0.006). CONCLUSIONS: Premenopausal women have lower unadjusted survival than men after OHT. Post-menopausal women have significantly better five-year survival than pre-menopausal women. Menopause may contribute to improved survival after OHT.