The high-risk features among patients undergoing mitral valve operation for ischemic mitral regurgitation: The 3-strike score.

Objective: Ischemic mitral regurgitation is prevalent and associated with high surgical risk. With the less-invasive option of transcatheter edge-to-edge repair, the optimal patient selection for mitral valve operation for ischemic mitral regurgitation remains unclear. We sought to identify high-risk features in this group to guide patient selection. Methods: Using the Cardiothoracic Surgery Trial Network's severe ischemic mitral regurgitation trial data, we identified patient and echocardiographic characteristics associated with an increased risk of 2-year mortality using the support vector classifier and Cox proportional hazards model. We identified 6 high-risk features associated with 2-year survival. Patients were categorized into 3 groups, each having 1 or less, 2, or 3 or more of the 6 identified high-risk features. Results: Among the 251 patients, the median age was 69 (Q1 62, Q3 75) years, and 96 (38%) were female. Two-year mortality was 21% (n = 53). We identified 6 high-risk preoperative features: age 75 years or more (n = 69, 28%), prior sternotomy (n = 49, 20%), renal insufficiency (n = 69, 28%), gastrointestinal bleeding (n = 15, 6%), left ventricular ejection fraction less than 40% (n = 131, 52%), and ventricular end-systolic volume index less than 50 mL/m2 (n = 93, 37%). In patients who had 1 or less, 2, and 3 or more high-risk features, 90-day mortality was 4.2% (n = 5), 9.9% (n = 4), and 20.0% (n = 10), respectively (P = .006), and 2-year mortality was 10% (n = 12), 22% (n = 18), and 46% (n = 23) (P < .001), respectively. Conclusions: We developed the 3-strike score by identifying high-risk preoperative features for mitral valve surgery for ischemic mitral regurgitation. Patients having 3 or more of such high-risk features should undergo careful evaluation for surgical candidacy given the high early and late mortality after mitral valve operations.

Implementing Formal Mitral Heart Team Improves Multidisciplinary Evaluation Rate and Survival of Patients With Severe Primary Mitral Regurgitation.

BACKGROUND: Multidisciplinary heart team (HT) evaluation is recommended for patients with severe primary mitral regurgitation to optimize treatment decisions. However, its impact on patient outcomes remains unknown. We evaluated the impact of implementing mitral HT on patient survival. METHODS AND RESULTS: We conducted a retrospective cohort study of patients with new diagnoses of severe primary mitral regurgitation in a large healthcare network echocardiogram database between 2016 and 2020. We compared the incidence of multidisciplinary evaluation by structural cardiology and cardiac surgery services and 2-year survival before and after mitral HT implementation. The 1:1 propensity-score matching between pre- and post-mitral HT used Society of Thoracic Surgeons Predicted Risk of Mortality for mitral repair, age, sex, race, heart failure symptoms, inpatient setting, history of MI, and dementia as covariates. Logistic regression identified variables associated with the likelihood of undergoing multidisciplinary evaluation. Among 70 510 echocardiograms performed, 391 patients had severe primary mitral regurgitation (median age, 77 years; 46% women). Multidisciplinary evaluation increased from 29% to 89% (P<0.001), and intervention increased from 24% to 75% following mitral HT implementation (P<0.001). Among 180 propensity-score matched patients, mortality was lower post-mitral HT at 2 years (19% versus 32%, P=0.04). The multivariable model showed that mitral HT implementation and heart failure symptoms were associated with higher odds of undergoing multidisciplinary evaluation (OR [odds ratio], 18.7 and 2.72, respectively), whereas female sex and older age were associated with lower odds (OR, 0.39 and 0.93, respectively). CONCLUSIONS: Implementation of mitral HT was associated with drastic improvement in multidisciplinary evaluation for patients with severe primary mitral regurgitation. This coincided with higher proportions of patients undergoing mechanical correction of MR and improved overall patient survival.

Racial/Ethnic Disparities in Aortic Valve Replacement Among Medicare Beneficiaries in the United States, 2012-2019.

PURPOSE: There are concerns that transcatheter or surgical aortic valve replacement (TAVR/SAVR) procedures are preferentially available to White patients. Our objective was to examine differences in utilization of aortic valve replacement and outcomes by race/ethnicity in the US for patients with aortic stenosis. METHODS: We performed a serial cross-sectional cohort study of 299,976 Medicare beneficiaries hospitalized with principal diagnosis of aortic stenosis between 2012 and 2019 stratified by self-reported race/ethnicity (Black, Hispanic, Asian, Native American, and White). Outcomes included aortic valve replacement rates within 6 months of index hospitalization and associated procedural outcomes, including 30-day readmission, 30-day and 1-year mortality. RESULTS: Within 6 months of an index admission for aortic stenosis, 86.8% (122,457 SAVR; 138,026 TAVR) patients underwent aortic valve replacement. Overall, compared with White people, Black (HR 0.87 [0.85-0.89]), Hispanic (0.92 [0.88-0.96]), and Asian (0.95 [0.91-0.99]) people were less likely to receive aortic valve replacement. Among patients who were admitted emergently/urgently, White patients (41.1%, 95% CI, 40.7-41.4) had a significantly higher aortic valve replacement rate compared with Black (29.6%, 95% CI, 28.3-30.9), Hispanic (36.6%, 95% CI, 34.0-39.3), and Asian patients (35.4%, 95% CI, 32.3-38.9). Aortic valve replacement rates increased annually for all race/ethnicities. There were no significant differences in 30-day or 1-year mortality by race/ethnicity. CONCLUSIONS: Aortic valve replacement rates within 6 months of aortic stenosis admission are lower for Black, Hispanic, and Asian people compared to White people. These race-related differences in aortic stenosis treatment reflect complex issues in diagnosis and management, warranting a comprehensive reassessment of the entire care spectrum for disadvantaged populations.

Robotic Mitral Valve Repair for Degenerative Mitral Regurgitation.

BACKGROUND: Contemporary national utilization and comparative safety data of robotic mitral valve repair for degenerative mitral regurgitation compared with nonrobotic approaches are lacking. The study aimed to characterize national trends of utilization and outcomes of robotic mitral repair of degenerative mitral regurgitation compared with sternotomy and thoracotomy approaches. METHODS: Patients undergoing intended mitral repair of degenerative mitral regurgitation in The Society of Thoracic Surgeons Adult Cardiac Surgery Database between 2015 and 2021 were examined. Mitral repair was performed in 61,322 patients. Descriptive analyses characterized center-level volumes and outcomes. Propensity score matching separately identified 5540 pairs of robotic vs thoracotomy approaches and 6962 pairs of robotic vs sternotomy approaches. Outcomes were operative mortality, composite mortality and major morbidity, postoperative length of stay, and conversion to mitral replacement. RESULTS: Through the 7-year study period, 116 surgeons across 103 hospitals performed mitral repair robotically. The proportion of robotic cases increased from 10.9% (949 of 8712) in 2015 to 14.6% (1274 of 8730) in 2021. In both robotic-thoracotomy and robotic-sternotomy matched pairs, mortality and morbidity were not significantly different, whereas the robotic approach had lower conversion (1.2% vs 3.1% for robotic-thoracotomy and 1.0% vs 3.7% for robotic-sternotomy), shorter length of stay, and fewer 30-day readmissions. Mortality and morbidity were lower at higher-volume centers, crossing the national mean mortality and morbidity at a cumulative robotic mitral repair case of 40. CONCLUSIONS: Robotic mitral repair is a safe and effective approach and is associated with comparable mortality and morbidity, a lower conversion rate, a shorter length of stay, and fewer 30-day readmissions than thoracotomy or sternotomy approaches.

Endoscopic Aortic Valve Replacement: Initial Outcomes of Isolated and Concomitant Surgery.

BACKGROUND: The applicability of totally endoscopic surgical aortic valve replacement (AVR) in multivalve operations is unknown. This study describes an approach and perioperative outcomes of totally endoscopic isolated and concomitant AVR using various valve types. METHODS: A total of 216 patients (114 male; mean age, 71.3 ± 11.3 years) underwent totally endoscopic AVR from May 2017 to October 2022 in a tertiary care center. The 3-port technique was used: a 3- to 4-cm main port without rib spreading, a 10-mm 3-dimensional endoscopic port, and a 5-mm left-hand port with femoral cannulations. Sutures were hand tied with a knot pusher. Descriptive analyses compared perioperative outcomes between patients with or without concomitant procedures. RESULTS: Of 216 patients, concomitant surgery was performed in 33 (15.2%) patients. Of the 33, 21 (63.6%) had a concomitant mitral procedure. A stented bioprosthesis was implanted in 165 (76.3%) patients, a mechanical valve in 22 (10.2%) patients, and a rapid deployment or sutureless valve in 29 (13.4%) patients. Median operation time and aortic cross-clamp time were 175 minutes (interquartile range; 150-194 minutes) and 78 minutes (interquartile range; 67-92 minutes) for isolated AVR, respectively. Thirty-day mortality occurred in 1 patient (0.5%). Two patients (0.9%) had conversion to sternotomy. Major neurologic events occurred in 3 patients (1.4%). The major adverse event rate was similar between patients with or without concomitant procedures. CONCLUSIONS: Endoscopic AVR can safely address concomitant valve diseases.

Association of adherence to individual components of Society of Thoracic Surgeons cardiac surgery antibiotic guidelines and postoperative infections.

OBJECTIVES: The study objectives were to measure the association among the 4 components of Society of Thoracic Surgeons antibiotic guidelines and postoperative complications in a cohort of patients undergoing valve or coronary artery bypass grafting requiring cardiopulmonary bypass. METHODS: In this retrospective observational study, adult patients undergoing coronary revascularization or valvular surgery who received a Surgical Care Improvement Project-compliant antibiotic from January 1, 2016, to April 1, 2021, at a single, tertiary care hospital were included. The primary exposures were adherence to the 4 individual components of Society of Thoracic Surgeons antibiotic best practice guidelines. The association of each component and a combined metric was tested in its association with the primary outcome of postoperative infection as determined by Society of Thoracic Surgeons data abstractors, controlling for several known confounders. RESULTS: Of the 2829 included patients, 1084 (38.3%) received care that was nonadherent to at least 1 aspect of Society of Thoracic Surgeons antibiotic guidelines. The incidence of nonadherence to the 4 individual components was 223 (7.9%) for timing of first dose, 639 (22.6%) for antibiotic choice, 164 (5.8%) for weight-based dose adjustment, and 192 (6.8%) for intraoperative redosing. In adjusted analyses, failure to adhere to first dose timing guidelines was directly associated with Society of Thoracic Surgeons-adjudicated postoperative infection (odds ratio, 1.9; 95% confidence interval, 1.1-3.3; P = .02). Failure of weight-adjusted dosing was associated with both postoperative sepsis (odds ratio, 6.9; 95% confidence interval, 2.5-8.5; P < .01) and 30-day mortality (odds ratio, 4.3; 95% confidence interval, 1.7-11.4; P < .01). No other significant associations among the 4 Society of Thoracic Surgeons metrics individually or as a combination were observed with postoperative infection, sepsis, or 30-day mortality. CONCLUSIONS: Nonadherence to Society of Thoracic Surgeons antibiotic best practices is common. Failure of antibiotic timing and weight-adjusted dosing is associated with odds of postoperative infection, sepsis, and mortality after cardiac surgery.

Reclassification of moderate aortic stenosis based on data-driven phenotyping of hemodynamic progression.

The management and follow-up of moderate aortic stenosis (AS) lacks consensus as the progression patterns are not well understood. This study aimed to identify the hemodynamic progression of AS, and associated risk factors and outcomes. We included patients with moderate AS with at least three transthoracic echocardiography (TTE) studies performed between 2010 and 2021. Latent class trajectory modeling was used to classify AS groups with distinctive hemodynamic trajectories, which were determined by serial systolic mean pressure gradient (MPG) measurements. Outcomes were defined as all-cause mortality and aortic valve replacement (AVR). A total of 686 patients with 3093 TTE studies were included in the analysis. Latent class model identified two distinct AS trajectory groups based on their MPG: a slow progression group (44.6%) and a rapid progression group (55.4%). Initial MPG was significantly higher in the rapid progression group (28.2 ± 5.6 mmHg vs. 22.9 ± 2.8 mmHg, P < 0.001). The prevalence of atrial fibrillation was higher in the slow progression group; there was no significant between-group difference in the prevalence of other comorbidities. The rapid progression group had a significantly higher AVR rate (HR 3.4 [2.4-4.8], P < 0.001); there was no between-group difference in mortality (HR 0.7 [0.5-1.0]; P = 0.079). Leveraging longitudinal echocardiographic data, we identified two distinct groups of patients with moderate AS: slow and rapid progression. A higher initial MPG (≥ 24 mmHg) was associated with more rapid progression of AS and higher rates of AVR, thus indicating the predictive value of MPG in management of the disease.

Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation and bioprosthetic valves: A meta-analysis.

BACKGROUND: The optimal anticoagulation strategy for patients with bioprosthetic valves and atrial fibrillation remains uncertain. We conducted a meta-analysis using updated evidence comparing direct anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with bioprosthetic valves and atrial fibrillation. METHODS: Medline and Embase were searched through March 2021 to identify randomized controlled trials (RCTs) and observational studies investigating the outcomes of DOAC therapy and VKA therapy in patients with bioprosthetic valves and atrial fibrillation. The outcomes of interest were all-cause death, major bleeding, and stroke or systemic embolism. RESULTS: Our analysis included 4 RCTs and 6 observational studies enrolling a total of 6405 patients with bioprosthetic valves and atrial fibrillation assigned to a DOAC group (n = 2142) or a VKA group (n = 4263). Pooled analysis demonstrated the similar rates of all-cause death (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.77-1.05; P = .18; I2 = 0%) in the DOAC and VKA groups. However, the rate of major bleeding was significantly lower in the DOAC group (HR, 0.66; 95% CI, 0.48-0.89; P = .006; I2 = 0%), whereas the rate of stroke or systemic embolism was similar in the 2 groups (HR, 0.72; 95% CI, 0.44-1.17; P = .18; I2 = 39%). CONCLUSIONS: DOAC might decrease the risk of major bleeding without increasing the risk of stroke or systemic embolism or all-cause death compared with VKA in patients with bioprosthetic valves and atrial fibrillation.

Impact of secondary mitral regurgitation on survival in atrial and ventricular dysfunction.

BACKGROUND: Natural history of atrial and ventricular secondary mitral regurgitation (SMR) is poorly understood. We compared the impact of the degree of SMR on survival between atrial and ventricular dysfunction. METHODS: We conducted a retrospective cohort study of patients who underwent echocardiography in a healthcare network between 2013-2018. We compared the survival of patients with atrial and ventricular dysfunction, using propensity scores developed from differences in patient demographics and comorbidities within SMR severity strata (none, mild, moderate or severe). We fitted Cox proportional hazards models to estimate the risk-adjusted hazards of death across different severities of SMR between patients with atrial and ventricular dysfunction. RESULTS: Of 11,987 patients included (median age 69 years [IQR 58-80]; 46% women), 6,254 (52%) had isolated atrial dysfunction, and 5,733 (48%) had ventricular dysfunction. 3,522 patients were matched from each arm using coarsened exact matching. Hazard of death in atrial dysfunction without SMR was comparable to ventricular dysfunction without SMR (HR 1.1, 95% CI 0.9-1.3). Using ventricular dysfunction without SMR as reference, hazards of death remained higher in ventricular dysfunction than in atrial dysfunction across increasing severities of SMR: mild SMR (HR 2.1, 95% CI 1.8-2.4 in ventricular dysfunction versus HR 1.7, 95%CI 1.5-2.0 in atrial dysfunction) and moderate/severe SMR (HR 2.8, 95%CI 2.4-3.4 versus HR 2.4, 95%CI 2.0-2.9). CONCLUSIONS: SMR across all severities were associated with better survival in atrial dysfunction than in ventricular dysfunction, though the magnitude of the diminishing survival were similar between atrial and ventricular dysfunction in increasing severity of SMRs.

Midterm results after seamless patch mitral reconstruction.

Objectives: Some pathologies, including infective endocarditis or sclerotic changes of the mitral leaflet, make the conventional mitral valve repair challenging. Our previously described technique for reconstruction with a seamless pericardial patch makes the repair feasible in some of such difficult pathologies. However, the extent of mitral leaflet segments that could be safely repaired using this technique remains unknown. We investigated the association between the midterm outcome and the extent of mitral leaflet segments replaced by a pericardial patch. Methods: From January 2009 to January 2022, patients who underwent mitral valve repair with the seamless 1-patch reconstruction technique were included. The glutaraldehyde-treated pericardium was trimmed and anchored at the papillary muscle. The edge was sewn to the leaflet and the annulus. Results: A total of 49 patients (aged 60 ± 15 years) underwent mitral valve repair with this technique. The totally endoscopic approach was used in 27 patients (55%). No patient's repair was converted to valve replacement. No operative mortality or disabling stroke was observed during the early postoperative period. In the midterm follow-up, redo surgery was required in 9 patients (18%). Freedom from mitral valve reintervention rates at 1, 5, and 10 years were 84%, 82%, and 82% for all patients, respectively. Freedom from reoperation at 5 years was 100%, 92%, and 46% for commissural lesion, 1- to 2-segment involvement, and 3-segment involvement, respectively. There was a significant difference among the 3 groups with regard to mitral valve reoperation rate (P = .002). Conclusions: Mitral valve seamless patch reconstruction provides excellent midterm results if applied to commissural lesions or lesions involving up to 2 segments.

Characterization of multi-domain postoperative recovery trajectories after cardiac surgery using a digital platform.

Understanding postoperative recovery is critical for guiding efforts to improve post-acute phase care. How recovery evolves during the first 30 days after cardiac surgery is not well-understood. A digital platform may enable granular quantification of recovery by frequently capturing patient-reported outcome measures (PROM) that can be clinically implemented to support recovery. We conduct a prospective cohort study using a digital platform to measure recovery after cardiac surgery using a PROM sent every 3 days for 30 days after surgery to characterize recovery in multiple domains (e.g., pain, sleep, activities of daily living, anxiety) and to identify factors related to the patient's perception of overall recovery. We enroll patients who underwent cardiac surgery at a tertiary center between January 2019 and March 2020 and automatically deliver PROMs and reminders electronically. Of the 10 surveys delivered per patient, 8 (IQR 6-10) are completed. Patients who experienced postoperative complications more commonly belong to the worst overall recovery trajectory. Of the 12 domains modeled, only the worst anxiety trajectory is associated with the worse overall recovery trajectory membership, suggesting that even when patients struggle in the recovery of other domains, the patient may still feel progress in their recovery. We demonstrate that using a digital platform, automated PROM data collection, and characterization of multi-domain recovery trajectories is feasible and likely implementable in clinical practice. Overall recovery may be impacted by complications, while slow progress in constituent domains may still allow for the perception of overall recovery progression.

Intraoperative Finding of Anomalous Circumflex Artery Origin in the Dissected Right Coronary Ostium.

Anomalous origin of the left circumflex artery is a rare anatomical variant that may present a unique challenge in emergent aortic surgery.

Variability in surveillance practice for patients with diagnosis of bicuspid aortic valve syndrome.

In patients with bicuspid aortic valves, guidelines call for regular follow-up to monitor disease progression and guide intervention. We aimed to evaluate how closely these recommendations are followed at a tertiary care center. Among 48,504 patients who received echocardiograms (2013-2018) at a tertiary care center, 245 patients were identified to have bicuspid aortic valve. Bivariate analyses compared characteristics between patients who did and did not receive follow-up by a cardiovascular specialist. During a median follow-up of 3.5 ± 2.2 years (mean age 55.2 ± 15.6 years, 30.2% female), 72.7% of patients had at least one visit with a cardiovascular specialist after diagnosis of bicuspid aortic valve. These patients had a higher proportion of surveillance by echocardiogram (78.7% vs. 34.3%, p < .0001), CT or MRI (41.0% vs. 3.0%, p < .0001), and were more likely to undergo surgery. Patients with moderate-severe valvular or aortic pathology were not more likely to be followed by a specialist or receive follow-up echocardiograms. Follow-up care for patients with bicuspid aortic valve was highly variable, and surveillance imaging was sparse despite guidelines. There is an urgent need for mechanisms to monitor this population with increased risk of progressive valvulopathy and aortopathy.

Two hundred robotic mitral valve repair procedures for degenerative mitral regurgitation: the Yale experience.

Background: Robotic surgery has gained popularity over the past two decades due to the benefits related to smaller surgical incisions, enhanced technical dexterity and better intraoperative visualization. We present the Yale experience of the first two hundred totally endoscopic, robotic-assisted mitral valve repair procedures for the treatment of degenerative mitral regurgitation. Methods: We performed a retrospective cohort study of patients undergoing totally endoscopic, robotic-assisted isolated or concomitant mitral valve repair for degenerative mitral regurgitation at Yale-New Haven Hospital from October 2018 to April 2022. Mitral valve repair procedures for rheumatic or secondary functional mitral regurgitation and planned robotic-assisted mitral valve replacement cases were excluded. Results: Two hundred consecutive procedures were performed. The median age was 65 years (interquartile range, 58-73 years). Six patients (3.0%) had a history of mediastinal radiation, four patients (2.0%) had previous cardiac surgery, and one patient (0.5%) had cardiac dextroversion. Median cardiopulmonary bypass and aortic cross-clamp times were 122 and 79 minutes, respectively. Femoral vessel cannulation was performed percutaneously in 57 (28.5%) patients with no major access-site related complication. Aortic cross-clamping was performed with the endoaortic balloon occlusion device in 151 (75.5%) patients. No conversions to sternotomy occurred. Satisfactory repair was achieved in 100% of cases, with 184 (92.0%) and 16 (8.0%) of patients having trace/none or mild residual mitral regurgitation, respectively. Forty-two patients (21.0%) underwent concomitant Cox-maze procedure and 25 patients (12.5%) underwent concomitant tricuspid valve repair. Thirty-day mortality rate was 0.5%, with an observed-to-expected ratio of 0.53. Two patients (1.0%) underwent re-exploration for bleeding, one had early postoperative stroke (0.5%), five developed pneumothorax (2.5%) and two required dialysis for acute renal failure (1.0%). The median length of hospital stay was four days. Conclusions: Excellent short-term outcomes can be achieved in experienced centers for the treatment of degenerative mitral regurgitation with a totally endoscopic, robotic-assisted approach.

Risk factors and mortality associated with permanent pacemaker after surgical or transcatheter aortic valve replacement: Early versus late implantation.

INTRODUCTION: Inflation of transcatheter aortic valve replacement (TAVR) procedures compared to surgical aortic valve replacement (SAVR) has increased the number of patients requiring a postprocedure permanent pacemaker (PPM). We investigate the impact of PPM on mid-term mortality comparing SAVR versus TAVR procedures and risk factors for early and late (>14 days) need of PPM. METHODS: We conducted a retrospective, single-center evaluation of 903 patients that underwent either SAVR or TAVR procedures at the Yale New Haven Hospital from 2012 to 2017. Patients were stratified into PPM and non-PPM groups. We performed Kaplan-Meier and Cox proportional hazard analysis to characterize mid-term mortality. Further subgroup analysis was performed to identify risk factors for early and late PPM implantation in the TAVR cohort. RESULTS: There was no correlation between PPM implantation and mid-term mortality in both SAVR (hazard ratio [HR] = 0.69; confidence interval [CI] = 0.21-2.30; p = .56) and TAVR (HR = 0.70; CI = 0.42-1.17; p = .18) patients. The presence of the right bundle branch block (Odds ratio = 24.07; 95% CI = 2.34-247.64, p = .007) was associated with higher odds of early PPM requirement after TAVR procedures. CONCLUSION: PPM placement after SAVR or TAVR procedures is not associated with increased mid-term mortality. In-depth characterization of risk factors for early and late PPM implantation will require further analysis in the growing TAVR patient population.

Mortality and 30-Day Readmission Rates After Inpatient Leadless Pacemaker Implantation: Insights From a Nationwide Readmissions Database.

BACKGROUND: This study aimed to provide real-world data on the rates, trends, and predictors of in-hospital complications and 30-day readmission following leadless pacemaker (LP) implantation. METHODS: We analysed leadless and conventional pacemaker implantations with the use of the all-payer, nationally representative Nationwide Readmissions Database from 2017 to 2019. The national trends of in-hospital mortality, in-hospital complications, and 30-day readmission rates after pacemaker implantation were analysed. Mixed-effects multivariable logistic regression analysis was performed to identify factors associated with in-hospital death and 30-day readmission in LP patients. RESULTS: A total of 137,732 admissions (age 78 years, IQR 70-85 years, 5986 LP implantations) were analysed. The in-hospital mortality, overall in-hospital complication, and 30-day readmission rates after LP implantations were 5.0%, 16%, and 16%, respectively. In LP recipients, the national estimate of in-hospital mortality declined from 10.9% in the second quarter of 2017 to 4.3% in the fourth quarter of 2019 (P < 0.001). Furthermore, the national estimate of overall complications declined from 20.6% in the second quarter of 2017 to 13.0% in the fourth quarter of 2019 (P < 0.001). In LP recipients, female sex, history of chronic kidney disease, heart failure, and malnutrition were factors associated with in-hospital death. CONCLUSIONS: Analysis of the nationally representative claims database from the United States showed in-hospital mortality and complication rates (for LP implantation performed during hospitalisation) of 5.0% and 16%, respectively. Although these rates showed a decreasing trend over time, ongoing surveillance is needed for the safety of LP implantation.