Influence of Procedural Volume on the Outcome of Gastric Endoscopic Submucosal Dissection: A Nationwide Population-Based Study Using Administrative Data.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is a well-established treatment modality for gastric neoplasms. We aimed to investigate the effect of procedural volume on the outcome of ESD for gastric cancer or adenoma. METHODS: In this population-based cohort study, patients who underwent ESD for gastric cancer or adenoma from November 2011 to December 2017 were identified using the Korean National Health Insurance Service database. Operational definitions to identify the target population and post-procedural complications were created using diagnosis and procedure codes and were validated using hospital medical record data. Outcomes included hemorrhage, perforation, pneumonia, 30-day mortality, a composite outcome comprising all of these adverse outcomes, and additional resection. Hospital volume was categorized into 3 groups based on the results of the threshold analysis: high-, medium-, low-volume centers (HVCs, MVCs, and LVCs, respectively). Inverse probability of treatment weighting analysis was applied to enhance comparability across the volume groups. RESULTS: There were 94,246 procedures performed in 88,687 patients during the study period. There were 5886 composite events including 4925 hemorrhage, 447 perforation, and 703 pneumonia cases. There were significant differences in ESD-related adverse outcomes among the 3 hospital volume categories, showing that HVCs and MVCs were associated with a lower risk of a composite outcome than LVCs (inverse probability of treatment-weighted odds ratio [OR], 0.651; 95% CI, 0.521-0.814; inverse probability of treatment-weighted OR, 0.641; 95% CI, 0.534-0.769). Similar tendencies were also shown for hemorrhage, perforation, and pneumonia; however, these were not evident for additional resection. CONCLUSIONS: Procedural volume was closely associated with clinical outcome in patients undergoing ESD for gastric cancer or adenoma.

Annual hospital procedural volume and outcome in extracorporeal membrane oxygenation for respiratory failure.

BACKGROUND: The hospital mortality of patients suffering from pulmonary failure requiring venovenous extracorporeal membrane oxygenation (V-V ECMO) or extracorporeal carbon dioxide removal (ECCO2 R) is high. It is unclear whether outcome correlates with a hospital's annual procedural volume. METHODS: Data on all V-V ECMO and ECCO2 R cases treated from 2007 to 2019 were retrieved from the German Institute for Medical Documentation and Information. Comorbidities and outcomes were assessed by DRG, OPS, and ICD codes. The study population was divided into 5 groups depending on annual hospital V-V ECMO and ECCO2 R volumes (<10 cases; 10-19 cases; 20-29 cases; 30-49 cases; ≥50 cases). Primary outcome was hospital mortality. RESULTS: A total of 25 096 V-V ECMO and 3607 ECCO2 R cases were analyzed. V-V ECMO hospitals increased from 89 in 2007 to 214 in 2019. Hospitals handling <10 cases annually increased especially (64 in 2007 to 149 in 2019). V-V ECMO cases rose from 807 in 2007 to 2597 in 2019. Over 50% of cases were treated in hospitals handling ≥30 cases annually. Hospital mortality was independent of the annual hospital procedural volume (55.3%; 61.3%; 59.8%; 60.2%; 56.3%, respectively, p = 0.287). We detected no differences when comparing hospitals handling <30 cases to those with ≥30 annually (p = 0.659). The numbers of ECCO2 R hospitals and cases has dropped since 2011 (287 in 2007 to 48 in 2019). No correlation between annual hospital procedural volume and hospital mortality was identified (p = 0.914). CONCLUSION: The number of hospitals treating patients requiring V-V ECMO and V-V ECMO cases rose from 2007 to 2019, while ECCO2 R hospitals and their case numbers decreased. We detected no correlation between annual hospital V-V ECMO or ECCO2 R volume and hospital mortality.

Impact of the COVID-19 pandemic on interventional cardiology fellowship training in the New York metropolitan area: A perspective from the United States epicenter.

BACKGROUND: The healthcare burden posed by the coronavirus disease 2019 (COVID-19) pandemic in the New York Metropolitan area has necessitated the postponement of elective procedures resulting in a marked reduction in cardiac catheterization laboratory (CCL) volumes with a potential to impact interventional cardiology (IC) fellowship training. METHODS: We conducted a web-based survey sent electronically to 21 Accreditation Council for Graduate Medical Education accredited IC fellowship program directors (PDs) and their respective fellows. RESULTS: Fourteen programs (67%) responded to the survey and all acknowledged a significant decrease in CCL procedural volumes. More than half of the PDs reported part of their CCL being converted to inpatient units and IC fellows being redeployed to COVID-19 related duties. More than two-thirds of PDs believed that the COVID-19 pandemic would have a moderate (57%) or severe (14%) adverse impact on IC fellowship training, and 21% of the PDs expected their current fellows' average percutaneous coronary intervention (PCI) volume to be below 250. Of 25 IC fellow respondents, 95% expressed concern that the pandemic would have a moderate (72%) or severe (24%) adverse impact on their fellowship training, and nearly one-fourth of fellows reported performing fewer than 250 PCIs as of March 1st. Finally, roughly one-third of PDs and IC fellows felt that there should be consideration of an extension of fellowship training or a period of early career mentorship after fellowship. CONCLUSIONS: The COVID-19 pandemic has caused a significant reduction in CCL procedural volumes that is impacting IC fellowship training in the NY metropolitan area. These results should inform professional societies and accreditation bodies to offer tailored opportunities for remediation of affected trainees.

Relationship between procedural volume and complication rates for catheter ablation of atrial fibrillation: a systematic review and meta-analysis.

AIMS: There are conflicting data as to the impact of procedural volume on outcomes with specific reference to the incidence of major complications after catheter ablation for atrial fibrillation. Questions regarding minimum volume requirements and whether these should be per centre or per operator remain unclear. Studies have reported divergent results. We performed a systematic review and meta-analysis of studies reporting the relationship between either operator or hospital atrial fibrillation (AF) ablation volumes and incidence of complications. METHODS AND RESULTS: Databases were searched for studies describing the relationship between operator or hospital AF ablation volumes and incidence of complications which were published prior to 12 June 2020. Of 1593 articles identified, 14 (315 120 patients) were included in the meta-analysis. Almost two-thirds of the procedures were performed in low-volume centres. Both hospital volume of ≥50 and ≥100 procedures/year were associated with a significantly lower incidence of complications compared to <50/year (4.2% vs. 5.5%, OR = 0.58, 95% CI 0.50-0.66, P < 0.001) or <100/year (5.5% vs. 6.2%, OR = 0.62, 95% CI 0.53-0.73, P < 0.001), respectively. Hospitals performing ≥50 procedures/year demonstrated significantly lower mortality compared with those performing <50 procedures/year (0.16% vs. 0.55%, OR = 0.33, 95% CI 0.26-0.43, P < 0.001). A similar relationship existed between proceduralist volume of <50/year and incidence of complications [3.75% vs. 12.73%, P < 0.001; OR = 0.27 (0.23-0.32)]. CONCLUSION: There is an inverse relationship between both hospital and proceduralist AF ablation volume and the incidence of complications. Implementation of minimum hospital and operator AF ablation volume standards should be considered in the context of a broader strategy to identify AF ablation Centers of Excellence.

Mitral valve repair rates in degenerative mitral valve disease correlate with surgeon and hospital procedural volume.

STUDY AIM: To determine the relationship between surgeon and hospital procedural volume, and mitral valve repair rates and 30-day mortality for degenerative mitral regurgitation (MR), in Australian cardiac surgical centers. METHODS: A total of 4420 patients who underwent elective surgery for degenerative MR between January 2008 and December 2017 in the Australian and New Zealand Society of Cardiac and Thoracic Surgeons Database were retrospectively included. Univariate and multivariate regression analyses examined surgeon and hospital procedural volumes for associations with repair rate and mortality. RESULTS: Repair rates varied widely by caseload; from 62.57% to 79.53% for lowest to highest volume surgeons; and from 54.56% to 77.54% for lowest to highest volume hospitals. Compared to surgeons performing ≤5 procedures/annum, surgeons performing 10.1-20/annum were more likely to repair the valve (odds ratio [OR] 2.40, 95% confidence interval [CI] 1.09-5.28, p = .03), particularly if performing more than 20/annum (OR 2.88, 95% CI 1.09-7.60, p = .03). Compared to hospitals performing ≤10/annum, those performing any number of procedures more than 10 demonstrated an increased likelihood of repair (caseload 10.1-20/year OR 1.96, 95% CI 1.25-3.07, p = .003) though odds did not increase above this threshold. Low incidence of 30-day mortality (63 of 4414, 1.43%) limited analysis of contributing variables; procedural volume did not confer a survival benefit. CONCLUSIONS: Surgeon and hospital caseload were significantly associated with repair rates of degenerative MR. A threshold minimum of 10 procedures annually for surgeons and hospitals should be utilized to maximize repair rates, and ideally of 20 for surgeons. Mortality was low and may not be significantly impacted by procedural volume.

Association of revisions or conversions after sleeve gastrectomy with annual bariatric center procedural volume in the state of New York.

INTRODUCTION: Although bariatric center procedural volume has been associated with early perioperative safety, data on the effect of such volume and long-term outcomes after sleeve gastrectomy (SG) are limited. This study aims to examine the relationship between annual bariatric center SG volume and the incidence of revisions or conversions (RC) after SG. METHODS: The New York Statewide Planning and Research Cooperative System database was used to identify all patients who underwent SG between 2006 and 2012. Subsequent RC events were captured up to 2016. Bariatric centers having annual SG volume less than 45, between 45 and 65, and greater than 65 were defined as low (LV), medium (MV), and high volume (HV), respectively. Multivariable Cox proportional hazard regression analysis was performed to compare the risk of having RC among centers with different yearly sleeve volumes. RESULTS: We identified 8389 patients who underwent SG. The overall estimated cumulative incidence of RC was 0.5% (95% CI 0.3-0.6%) at 1 year, 6.2% (95% CI 5.4-7.0%) at 5 years, and 15.3% (95% CI 12.6-18.0%) at 8 years after SG. The estimated cumulative incidence of RC for LV, MV, and HV at 8 years after SG was 16.7% (95% CI 11.1-22.3%), 15.5% (95% CI 11.2-19.8%), and 13.7% (95% CI 9.4-17.9%), respectively. HV centers have lower risk of RC compared to LV (hazard ratio 0.65; 95% CI 0.48-0.88) and MV (hazard ratio 0.75; 95% CI 0.57-0.98). LV and MV centers have comparable risk of RC (hazard ratio 1.15; 95% CI 0.87-1.51). Patients having the initial SG performed in LV were the least likely to have RC in the same institution (46.1% of LV, 13.2% of MV and 22.3% of HV; p < 0.0001). CONCLUSION: Patients undergoing SG at LV centers experience the highest risk of subsequent RC. This effect persists after adjusting for patient-level factors. These data underline the relationship between volume threshold and long-term effect.

The impact of hospital volume on patient safety indicators following post-mastectomy breast reconstruction in the US.

INTRODUCTION: Despite the growing spotlight on value-based care and patient safety, little is known about the influence of patient-, reconstruction-, and facility-level factors on safety events following breast reconstruction. The purpose of this study is to characterize postoperative complications in light of hospital-level risk factors. METHODS: Using the National Inpatient Sample, all patients who underwent free flap and prosthetic breast reconstruction from 2012 to 2014 were identified. Predictor variables included patient demographic and clinical characteristics, type and timing of reconstruction, annual hospital reconstructive volume, hospital bed size, hospital setting (rural vs. urban), and length of stay. Patient safety indicators (PSIs) were based on the Agency for Healthcare Research and Quality's designation of preventable hospital complications: venous thromboembolism, bleeding, wound complications, pneumonia, and sepsis. Logistic models were used to analyze outcomes. RESULTS: The sample included 103,301 women, of which 27,695 (26.8%) underwent free flap reconstruction. 3.6% of patients experienced ≥ 1 PSI, most commonly wound PSI (4.9% and 2.5% for free flap and prosthetic reconstruction, respectively). Significant predictors of PSIs included rural setting (p < 0.01) and Elixhauser score ≥ 4 (p < 0.01) for the free flap group, and delayed reconstruction (p < 0.01) for the prosthetic group. Annual reconstructive facility volume was not associated with increased odds of PSIs in either prosthetic or free flap reconstruction (p > 0.05). CONCLUSION: PSIs were associated with rural hospitals and greater comorbidities for patients undergoing reconstruction with free flaps. Annual reconstructive facility volume was not associated with adverse inpatient outcomes with either method of reconstruction.

Clinical Outcomes in Relation to Total Hospital Surgical and Transcatheter Aortic Valve Replacement Volumes.

BACKGROUND: There is a paucity of data regarding the relationship between overall hospital volumes for total aortic valve replacement (AVR; transcatheter AVR [TAVR] or surgical AVR [SAVR]) and patient outcomes. METHODS AND RESULTS: We queried the 2019 Nationwide Readmission Database for patients undergoing AVR. Based on procedural volumes of TAVR or SAVR, we classified hospitals as high (≥50th percentile) or low (<50th percentile) volume centers and categorized hospitals as high TAVR/high SAVR, high TAVR/low SAVR, high SAVR/low TAVR, and low TAVR/low SAVR. Multivariable regression models were employed. The main study outcomes were in-hospital mortality and 30-day readmission after total AVR. Our final analysis included 72 123 patients undergoing AVR at 400 hospitals across the United States. The median (interquartile range) hospital procedural volumes for total AVR, TAVR, and SAVR were 137 (86-210), 82 (50-127), and 56 (31-87) procedures, respectively. There was an inverse correlation between hospital procedural volumes of AVR, TAVR, or SAVR and in-hospital mortality after total AVR but not with 30-day readmission. Using high TAVR/high SAVR hospitals as reference, there was higher in-hospital mortality after total AVR among low TAVR/low SAVR hospitals (adjusted odds ratio [OR], 1.29 [95% CI, 1.07-1.56]) but similar in-hospital mortality among high TAVR/low SAVR hospitals and low TAVR/high SAVR volumes. There was no difference in 30-day readmission rates after total AVR among the 4 hospital categories. CONCLUSIONS: Nationwide data revealed that in-hospital mortality after total AVR (SAVR or TAVR) is inversely related to hospital total volumes of AVR. Patients with aortic stenosis have better outcomes if they are managed among experienced centers with high case volumes of both TAVR and SAVR.

Pulmonary Valve Replacement in Tetralogy of Fallot: Procedural Volume and Durability of Bioprosthetic Pulmonary Valves.

BACKGROUND: Robust data on changes in pulmonary valve replacement (PVR) procedural volume and predictors of bioprosthetic pulmonary valve (BPV) durability in patients with tetralogy of Fallot (TOF) are scarce. OBJECTIVES: This study sought to assess temporal trends in PVR procedural volume and BPV durability in a nationwide, retrospective TOF cohort. METHODS: Data were obtained from patient records. Robust linear regression was used to assess temporal trends in PVR procedural volume. Piecewise exponential additive mixed models were used to estimate BPV durability, defined as the time from implantation to redo PVR with death as a competing risk, and to assess risk factors for reduced durability. RESULTS: In total, 546 PVR were performed in 384 patients from 1976 to 2021. The annual number of PVR increased from 0.4 to 6.0 per million population (P < 0.001). In the last decade, the transcatheter PVR volume increased by 20% annually (P < 0.001), whereas the surgical PVR volume did not change significantly. The median BPV durability was 17 years (Q1: 10-Q3: 10 years-not applicable). There was no significant difference in the durability of different BPV after adjustment for confounders. Age at PVR (HR: 0.78 per 10 years from <1 year; 95% CI: 0.63-0.96; P = 0.02) and true inner valve diameter (9-17 mm vs 18-22 mm HR: 0.40; 95% CI: 0.22-0.73; P = 0.003 and 18-22 mm vs 23-30 mm HR: 0.59; 95% CI: 0.25-1.39; P = 0.23) were associated with reduced BPV durability in multivariate models. CONCLUSIONS: The PVR procedural volume has increased over time, with a greater increment in transcatheter than surgical PVR during the last decade. Younger patient age at PVR and a smaller true inner valve diameter predicted reduced BPV durability.

Procedural volume and outcomes with atrial fibrillation ablation: A report from the NCDR AFib Ablation Registry.

BACKGROUND: The association of hospital and physician procedure volume with outcome has not been well evaluated for atrial fibrillation (AF) ablation in contemporary practice. OBJECTIVE: This study aimed to determine the association between hospital and physician AF ablation volume and procedural success (isolation of all pulmonary veins) and major adverse events (MAEs). METHODS: Procedures reported to the National Cardiovascular Data Registry AFib Ablation Registry between July 2019 and June 2022 were included. Hospital and physician procedural volumes were annualized and stratified into quartiles to compare outcomes. Three-level hierarchical (patient, hospital, and physician) models were used to assess the procedural volume-outcome relationship. RESULTS: A total of 70,296 first-time AF ablations at 186 US hospitals were included. Overall, procedural success and MAE rates were 98.5% and 1.0%, respectively. With hospital volume (Q4) as a reference, the likelihood of procedural success was lower for Q1 (odds ratio [OR], 0.44; 95% CI, 0.29-0.68), Q2 (OR, 0.50; 95% CI, 0.33-0.75), and Q3 (OR, 0.60; 95% CI, 0.40-0.89); the results were similarly significant for physician volume. With MAE for hospitals, there was an inverse procedural volume relationship for Q1 (OR, 1.78; 95% CI, 1.26-2.52) but not for Q2 (OR, 1.06; 95% CI, 0.77-1.46) or Q3 (OR, 1.19; 95% CI, 0.89-1.58) and similarly for physicians in Q1 and Q2 but not in Q3. An adjusted MAE ≤1% was predicted by an annual volume of approximately 190 for hospitals and 60 for physicians. CONCLUSION: In this national cohort, hospital and physician AF ablation procedural volumes were directly related to acute procedural success and inversely related to rates of MAE.

Cardiac Reoperation or Transcatheter Mitral Valve Replacement for Patients With Failed Mitral Prostheses.

BACKGROUND: Evidence is limited regarding patient outcomes comparing redo surgical mitral valve replacement (redo SMVR) vs transcatheter mitral valve replacement (TMVR) for failed prostheses. OBJECTIVES: The goal of this study was to compare the outcomes of redo SMVR vs TMVR in patients with failed prostheses, as well as evaluate the association between case volume and outcomes. METHODS: Medicare beneficiaries aged ≥65 years who underwent redo SMVR or TMVR for failed mitral prostheses between 2016 and 2020 were included. The primary endpoint was mid-term (up to 3 years) major adverse cardiovascular events (MACE), including all-cause death, heart failure rehospitalization, stroke, or reintervention. Propensity score-matched analysis was used. RESULTS: A total of 4,293 patients were included (redo SMVR: 64%; TMVR: 36%). TMVR recipients were older, with a higher comorbidity burden. In matched cohort (n = 1,317 in each group), mid-term risk of MACE was similar (adjusted HR: 0.92; 95% CI: 0.80-1.04; P = 0.2). However, landmark analysis revealed a lower risk of MACE with TMVR in the first 6 months (adjusted HR: 0.75; 95% CI: 0.63-0.88; P < 0.001) albeit with a higher risk beyond 6 months (adjusted HR: 1.28; 95% CI: 1.04-1.58; P = 0.02). Increasing procedural volume was associated with decreased risk of mid-term MACE after redo SMVR (P = 0.001) but not after TMVR (P = 0.3). CONCLUSIONS: In this large cohort of Medicare beneficiaries with failed mitral prostheses, outcomes were similar between redo SMVR and TMVR at 3 years, with TMVR showing a lower initial risk but a higher risk of MACE after 6 months. These findings highlight the importance of striking a balance between surgical risk, anticipated longevity, and hospital expertise when selecting interventions.

Quantifying the Impact of COVID-19 on Hand and Wrist Surgery Procedural Volume: A National Analysis of 381,046 Cases.

Purpose: To quantify and describe the impact of the COVID-19 pandemic on procedural volume trends in hand and wrist surgery from 2020 to early 2022 at multiple centers. Methods: In this retrospective comparative study, a real-time, national, federated research database was used to identify patients of interest from 56 health care organizations across the United States. Patients were queried from March 1, 2018, to February 28, 2022. Current Procedural Terminology codes were chosen using the Accreditation Council for Graduate Medical Education's hand fellowship procedure requirements. Results: Common hand and wrist surgeries exhibited substantial fluctuations in procedural volume per health care organization during the COVID-19 pandemic. Time periods with considerable procedural volume decreases corresponded with surges in increased COVID-19 caseloads and emergence of COVID-19 variants. Periods of procedural volume increase occurred in the summer of 2020 and immediately following distribution of the COVID-19 vaccine to the public. Fixation of metacarpal fracture, fixation of phalangeal fracture, tendon transfer, flexor tendon repair, and extensor tendon repair consistently showed decreased volumes over the study period. In contrast, ulnar nerve decompression was the only procedure to experience a statistically significant increase in volume over an entire year (2021, +19.2%, P < .001), as compared to before the pandemic. Conclusions: Major milestones of the COVID-19 pandemic correlated with fluctuations in the number of hand and wrist procedures performed across the United States. Future studies should seek to evaluate the impact of patient backlogs and individual procedure fluctuations on financial impacts, patient outcomes, and orthopedic trainee experience. Type of study/level of evidence: Economic/Decision Analysis IV.

Effect of procedural volume on the outcomes of congenital heart surgery in Japan.

OBJECTIVES: The present study developed a new risk model for congenital heart surgery in Japan and determined the relationship between hospital procedural volume and mortality using the developed model. METHODS: We analyzed 47,164 operations performed between 2013 and 2018 registered in the Japan Cardiovascular Surgery Database-Congenital and created a new risk model to predict the 90-day/in-hospital mortality using the Japanese congenital heart surgery mortality categories and patient characteristics. The observed/expected ratios of mortality were compared among 4 groups based on annual hospital procedural volume (group A [5539 procedures performed in 90 hospitals]: ≤50, group B [9322 procedures in 24 hospitals]: 51-100, group C [13,331 procedures in 21 hospitals]: 101-150, group D [18,972 procedures in 15 hospitals]: ≥151). RESULTS: The overall mortality rate was 2.64%. The new risk model using the surgical mortality category, age-weight categories, urgency, and preoperative mechanical ventilation and inotropic use achieved a c-index of 0.81. The observed/expected ratios based on the new risk model were 1.37 (95% confidence interval, 1.18-1.58), 1.21 (1.08-1.33), 1.04 (0.94-1.14), and 0.78 (0.71-0.86) in groups A, B, C, and D, respectively. In the per-procedure analysis, the observed/expected ratios of the Rastelli, coarctation complex repair, and arterial switch procedures in group A were all more than 3.0. CONCLUSIONS: The risk-adjusted mortality rate for low-volume hospitals was high for not only high-risk but also medium-risk procedures. Although the overall mortality rate for congenital heart surgeries is low in Japan, the observed volume-mortality relationship suggests potential for improvement in surgical outcomes.

The Bigger the Better? Center Volume Dependent Effects on Procedural and Functional Outcome in Established Endovascular Stroke Centers.

Background: Mechanical thrombectomy (MT) rates for the treatment of acute ischaemic stroke due to large vessel occlusion are steadily increasing, but are delivered in heterogenic settings. We aim to investigate effects of procedural load in centers with established MT-structures by comparing high- vs. low-volume centers with regard to procedural characteristics and functional outcomes. Methods: Data from 5,379 patients enrolled in the German Stroke Registry Endovascular Treatment (GSR-ET) between June 2015 and December 2019 were compared between three groups: high volume: ≥180 MTs/year, 2,342 patients; medium volume: 135-179 MTs/year, 2,202 patients; low volume: <135 MTs/year, 835 patients. Univariate analysis and multiple linear and logistic regression analyses were performed to identify differences between high- and low-volume centers. Results: We identified high- vs. low-volume centers to be an independent predictor of shorter intra-hospital (admission to groin puncture: 60 vs. 82 min, ß = -26.458; p < 0.001) and procedural times (groin puncture to flow restoration: 36 vs. 46.5 min; ß = -12.452; p < 0.001) after adjusting for clinically relevant factors. Moreover, high-volume centers predicted a shorter duration of hospital stay (8 vs. 9 days; ß = -2.901; p < 0.001) and favorable medical facility at discharge [transfer to neurorehabilitation facility/home vs. hospital/nursing home/in-house fatality, odds ratio (OR) 1.340, p = 0.002]. Differences for functional outcome at 90-day follow-up were observed only on univariate level in the subgroup of primarily to MT center admitted patients (mRS 0-2 38.5 vs. 32.8%, p = 0.028), but did not persist in multivariate analyses. Conclusion: Differences in efficiency measured by procedural times call for analysis and optimization of in-house procedural workflows at regularly used but comparatively low procedural volume MT centers.

Centre procedural volume and adverse in-hospital outcomes in patients undergoing percutaneous transvenous edge-to-edge mitral valve repair using MitraClip® in Germany.

AIMS: The number of transcatheter mitral valve repair (TMVr) procedures has increased substantially during the last years. A better understanding of the relationship between hospital volume of transcatheter transvenous mitral valve repairs using MitraClip® and patient outcomes may provide information for future policy decisions to improve patient management. METHODS AND RESULTS: We analysed patient characteristics and in-hospital outcomes for all TMVr procedures using MitraClip® performed in Germany from 2011 to 2017. Hospitals were stratified according to centre volumes and patients were compared for baseline characteristics and adverse in-hospital events. Overall, 24 709 inpatients were treated during the observational period. Patients treated in centres with a volume of ≤10 procedures annually developed more often pulmonary embolism (odds ratio 2.22, 95% confidence interval 1.19-4.13; P = 0.012) compared to those treated in centres with a volume of >10 procedures annually, whereas no association of centre volume (≤10 or >10) was found with in-hospital mortality (P = 0.728). Although patients treated in centres with an annual volume >25 TMVr procedures had higher numbers of comorbidities compared to those treated in centres with an annual volume of ≤25 TMVr procedures, in-hospital mortality did not differ (3.6% vs. 3.5%, P = 0.485). Similarly, when centre volumes were stratified for ≤50 vs. >50 procedural volumes, no association with in-hospital mortality was recorded (P = 0.792). A lower rate of mitral valve surgery after MitraClip® was observed over time, particularly in high-volume centres. CONCLUSION: Annual numbers of MitraClip® implantations increased from 2011 to 2017 in Germany, whereas in-hospital mortality remained stable. Although patients treated in high-volume centres had a more unfavourable risk profile, in-hospital mortality was comparable to that of low-volume centres.

Impact of Hospital Procedural Volume on Outcomes After Endovascular Revascularization for Critical Limb Ischemia.

OBJECTIVES: The aim of this study was to evaluate the interaction between hospital endovascular lower extremity revascularization (eLER) volume and outcomes after eLER for critical limb ischemia (CLI). BACKGROUND: There is a paucity of data on the relationship between hospital procedural volume and outcomes of eLER for CLI. METHODS: The authors queried the Nationwide Readmission Database (2013-2015) for hospitalized patients who underwent eLER for CLI. Hospitals were divided into tertiles according to annual eLER volume: low volume (<100 eLER procedures), moderate volume (100-550 eLER procedures), and high volume (>550 eLER procedures). Stepwise multivariable regression models were used. The main outcomes were in-hospital mortality and 30-day readmission with major adverse limb events, defined as the composite of amputation, acute limb ischemia, or repeat revascularization. RESULTS: Among 145,785 hospitalizations for eLER for CLI, 5,199 (3.6%) were at low-volume eLER hospitals, 27,857 (19.1%) at moderate-volume eLER hospitals, and 112,728 (77.3%) at high-volume eLER hospitals. On multivariable analysis, there was no difference with regard to in-hospital mortality among moderate-volume hospitals (adjusted odds ratio [OR]: 0.78; 95% CI: 0.60-1.01) and high-volume hospitals (adjusted OR: 0.84; 95% CI: 0.64-1.05) compared with low-volume hospitals. There was lower risk of in-hospital major amputation (adjusted OR: 0.82; 95% CI: 0.70-0.96) and minor amputation at high- versus low-volume hospitals. The length of hospital stay was shorter and discharges to nursing facilities were fewer among moderate- and high-volume hospitals compared with low-volume hospitals. Compared with low-volume hospitals, eLER for CLI at high-volume hospitals had a lower risk for 30-day readmission with major adverse limb events (adjusted OR: 0.83; 95% CI: 0.70-0.99), while there was no difference among moderate-volume hospitals (adjusted OR: 0.92; 95% CI: 0.77-1.10). CONCLUSIONS: This nationwide observational analysis suggests that annual eLER volume does not influence in-hospital mortality after eLER for CLI. However, high eLER volume (>550 eLER procedures) was associated with better rates of limb preservation after eLER for CLI.

Summary of the 2018 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) for transcatheter aortic valve replacement.

Medicare coverage for transcatheter aortic valve replacement (TAVR) in the United States (US) is governed by the 2012 National Coverage Determination (NCD 20.32), which enshrined minimum numbers of TAVR, surgical aortic valve replacement, and percutaneous coronary intervention that centers must perform to begin or maintain TAVR programs. In July 2018, the Centers for Medicare and Medicaid Services (CMS) convened a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to review the evidence for setting minimum procedure volume requirements and to evaluate the impact of such requirements on access to care. In this paper, we summarize the MEDCAC panel deliberations, the evidence presented to the panel, and how the panel members voted. CMS is expected to publish a draft decision in March 2019 that may reshape the TAVR landscape in the US for years to come.

The association of insurance status and race with the procedural volume of traumatic brain injury patients.

INTRODUCTION: The influence of non-medical factors on the volume of procedures undergone by TBI patients remains an issue of debate. We investigated the association of lack of insurance and African-American race with the procedural volume of TBI patients. METHODS: We performed a retrospective cohort study involving TBI patients, who were registered in the National Trauma Data Bank (NTDB) between 2009 and 2011. Multivariable logistic regression with mixed effects to control for clustering at the hospital level was used to investigate the association of insurance status and race with high volume of procedures for TBI patients. RESULTS: Of the 392,292 TBI patients, who were registered in NTDB and met the inclusion criteria, 9850 (3.8%) underwent high procedural volume, defined as 2 or more procedures during hospitalization (2 standard deviations over the mean). Multivariable logistic regression analysis demonstrated an association of uninsured patients with decreased possibility of high procedural volume (OR, 0.68; 95% CI, 0.63-0.73). This persisted after using a mixed effects model to control for clustering at the hospital level (OR, 0.66; 95% CI, 0.61-0.71). In stratified samples, uninsured patients demonstrated similar associations even for GCS below 8 (OR, 0.69; 95% CI, 0.64-0.75), or ISS above 15 (OR, 0.74; 95% CI, 0.69-0.79). Multivariable logistic regression analysis did not demonstrate an association of African Americans with procedural volume (OR, 0.93; 95% CI, 0.86-1.02). CONCLUSIONS: During the hospitalization of TBI patients, lack of insurance was associated with lower procedural volume. When controlling for insurance status, we did not observe any race associated disparities in procedural volume.

Operative volume and outcomes of cerebrovascular neurosurgery in children.

OBJECTIVE The impact of procedural volume on the outcomes of cerebrovascular surgery in children has not been determined. In this study, the authors investigated the association of operative volume on the outcomes of cerebrovascular neurosurgery in pediatric patients. METHODS The authors performed a cohort study of all pediatric patients who underwent a cerebrovascular procedure between 2003 and 2012 and were registered in the Kids' Inpatient Database (KID). To control for confounding, the authors used multivariable regression models, propensity-score conditioning, and mixed-effects analysis to account for clustering at the hospital level. RESULTS During the study period, 1875 pediatric patients in the KID underwent cerebrovascular neurosurgery and met the inclusion criteria for the study; 204 patients (10.9%) underwent aneurysm clipping, 446 (23.8%) underwent coil insertion for an aneurysm, 827 (44.1%) underwent craniotomy for arteriovenous malformation resection, and 398 (21.2%) underwent bypass surgery for moyamoya disease. Mixed-effects multivariable regression analysis revealed that higher procedural volume was associated with fewer inpatient deaths (OR 0.58; 95% CI 0.40-0.85), a lower rate of discharges to a facility (OR 0.87; 95% CI 0.82-0.92), and shorter length of stay (adjusted difference -0.22; 95% CI -0.32 to -0.12). The results in propensity-adjusted multivariable models were robust. CONCLUSIONS In a national all-payer cohort of pediatric patients who underwent a cerebrovascular procedure, the authors found that higher procedural volume was associated with fewer deaths, a lower rate of discharges to a facility, and decreased lengths of stay. Regionalization initiatives should include directing children with such rare pathologies to a center of excellence.