Geographic variability and operator trends of transcatheter edge-to-edge repair in the United States.

BACKGROUNDS: Transcatheter edge-to-edge repair (TEER) devices are used for primary mitral regurgitation (MR) and secondary MR. Despite the growing use of TEER devices, there have not been many studies on operator experience or procedure volumes by state. AIMS: We aimed to investigate nationwide operator volume trends and geographic variation in access to TEER. METHODS: The United States Center for Medicare and Medicaid Services (CMS) National Medicare Provider Utilization and Payment Database (MPUPD) was analyzed between 2015 and 2020 for initial TEER procedures. RESULTS: Procedure volume and total operators increased yearly from 2015 to 2019 but declined in 2020. Mean annual procedure volume per operator varied significantly by state, between 0 in multiple states and 35 in North Dakota. In 2019, 994 unique operators were identified, with 295 operators documented performing 10 or more procedures (29.68%). Operators performing 10 or more TEER procedures provided 68.46% of all operations in 2019, averaging 20.94 procedures per operator. CONCLUSIONS: TEER procedures are becoming increasingly common as more operators are being trained. However, significant variability exists in the procedural volume per operator.

Annual operator volume among patients treated using percutaneous coronary interventions with rotational atherectomy and procedural outcomes: Analysis based on a large national registry.

BACKGROUND: Low operator and institutional volume are associated with poorer procedural and long-term clinical outcomes in the general population of patients treated with percutaneous coronary interventions (PCI). AIM: To assess the relationship between operator experience and procedural outcomes of patients treated with PCI and rotational atherectomy (RA). METHODS: Data for conducting the current analysis were obtained from the national registry of percutaneous coronary interventions (ORPKI) maintained in cooperation with the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The study covers data from January 2014 to December 2020. RESULTS: During the investigated period, there were 162 active CathLabs, at which 747,033 PCI procedures were performed by 851 operators (377 RA operators [44.3%]). Of those, 5188 were PCI with RA procedures; average 30 ± 61 per site/7 years (Me: 3; Q1-Q3: 0-31); 6 ± 18 per operator/7 years (Me: 0; Q1-Q3: 0-3). Considering the number of RA procedures annually performed by individual operators during the analyzed 7 years, the first quartile totaled (Q1: < =2.57), the second (Q2: < =5.57), and the third (Q3: < =11.57), while the fourth quartile was (Q4: > 11.57). The maximum number of procedures was 39.86 annually per operator. We demonstrated, through a nonlinear relationship with annualized operator volume and risk-adjusted, that operators performing more PCI with RA per year (fourth quartile) have a lower number of the overall periprocedural complications (p = 0.019). CONCLUSIONS: High-volume RA operators are related to lower overall periprocedural complication occurrence in patients treated with RA in comparison to low-volume operators.

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.

Trends in proportions of hospitals and operators not meeting minimum percutaneous coronary intervention volume standards in Taiwan, 2001-2013.

OBJECTIVE: To examine trends in proportions of hospitals and operators not meeting the minimum percutaneous coronary intervention (PCI) volume standards in Taiwan during 2001-2013. BACKGROUND: The 2013 Clinical Competence Statement recommends that operators perform a minimum of ≥50 PCIs annually (averaged over a 2-year period) in hospitals conducting ≥200 PCIs annually. METHODS: Taiwan National Health Insurance claims data from 2001 to 2013 are used to determine the annual numbers of PCIs performed by each hospital and operator. RESULTS: The percentage of hospitals conducting annual PCI volumes of <200 decreased from 57% (26/46) in 2001 to 39% (29/74) in 2007 and 33% (33/91) in 2013; the percentage of operators conducting PCI volumes <50 annually remained relatively constant at 60% (146/243) in 2001, 60% (270/452) in 2007, and 58% (354/611) in 2013; and the percentage of operators conducting low volumes (<50) in low-volume hospitals (<200) decreased from 24% (57/243) in 2001 to 15% (66/452) in 2007 and 12% (76/611) in 2013. CONCLUSIONS: Approximately one-third of hospitals and three-fifths of operators in Taiwan failed to meet minimum PCI volume standards. Further research examining patient outcomes from PCIs performed by low-volume hospitals and operators is recommended.

Selection Criteria in the Era of Perfect Competition for Drug-Eluting Stents in Association With Operator Volumes: An Operator-Volume Analysis of the Selection DES Study.

Background: This study aimed to explore the factors influencing the drug-eluting stent (DES) selection criteria of cardiologists in association with percutaneous coronary intervention (PCI) volumes and to determine whether they value further DES improvements and modifications. Methods: The survey was conducted on a group of cardiologist operators from April 10 to 30, 2023. Results: The analysis included 126 operators who answered the questions. Of these, low-, intermediate-, and high-volume operators accounted for 49 (38.9%), 47 (37.3%), and 30 (23.8%), respectively. Overall, Xience™ everolimus-eluting stent (CoCr-EES) was most frequently used, with > 70% of cardiologists using it in > 20% of their PCI practice. The percentage of selection by low-, intermediate-, and high-volume operators among the DESs used demonstrated no difference, except for dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo® stent (DTS). Logistic regression analysis revealed that low-volume operators are less likely to be affected in terms of company/sales representative (odds ratio (OR): 0.402, P = 0.031) and bending lesions (OR: 0.339, P = 0.037) for selecting DES. Low-volume operators less frequently selected Resolute Onyx™ zotarolimus-eluting stents (OR: 0.689, P = 0.043) and DTS (Drug-Eluting Stents) (OR: 0.361, P = 0.006) for PCI. Conclusions: The current study results indicate that patient background, DES performance, and product specifications were not criteria for DES selection in cardiologists with different PCI volumes in routine PCI.

Association of Annual Operator Volume With the Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention.

OBJECTIVES: There are limited data on the association of operator volume with the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We analyzed the association between operator volume and procedural outcomes of 7035 CTO-PCIs performed between 2012 and February 2021 at 30 centers. RESULTS: The study population was divided into 3 groups based on annual operator CTO-PCI volume: low-volume operators (LVO: <30 cases/year; 39.7% of the cases); medium-volume operators (MVO: 30-60 cases/year; 25.7% of the cases); and high-volume operators (HVO: >60 cases/ year; 34.6% of the cases). Mean patient age was 64.4 ± 10 years and 82% were men. Cases performed by HVOs were more complex, with higher J-CTO score compared with cases performed by MVOs and LVOs (2.72 ± 1.27 vs 2.39 ± 1.19 vs 2.12 ± 1.27, respectively; P<.001). Moderate/severe proximal vessel tortuosity (35% vs 23% vs 20%; P<.001) and proximal cap ambiguity (44% vs 34% vs 32%; P<.001) was also more common in the HVO group. Cases performed by HVOs had higher technical success rates (87.9% vs 86.9% vs 82.6%; P<.001), but also higher rates of periprocedural major cardiac adverse events compared with MVOs and LVOs (3.08% vs 2.71% vs 1.50%; P<.01). On multivariable analyses, HVOs and MVOs were associated with higher technical success. CONCLUSIONS: In a contemporary, multicenter registry, 40% of CTO-PCI cases are performed by LVOs performing <30 cases per year. Cases performed by HVOs were associated with higher technical and procedural success, but also higher periprocedural major complication rates, potentially due to higher lesion complexity.

Operator Volumes and In-Hospital Outcomes: An Analysis of 7,740 Rotational Atherectomy Procedures From the BCIS National Database.

OBJECTIVES: The aims of this study were to use a national percutaneous coronary intervention (PCI) registry to study temporal changes in procedure volumes of PCI using rotational atherectomy (ROTA-PCI), the patient and procedural factors associated with differing quartiles of operator ROTA-PCI volume, and the relationship between operator ROTA-PCI volumes and in-hospital patient outcomes. BACKGROUND: Whether higher operator volume is associated with improved outcomes after ROTA-PCI is poorly defined. METHODS: Data from the British Cardiovascular Intervention Society national PCI database were analyzed for all ROTA-PCI procedures performed in the United Kingdom between 2013 and 2016. Individual logistic regressions were performed to quantify the independent association between annual operator ROTA-PCI volume and in-hospital outcomes. RESULTS: In total, 7,740 ROTA-PCI procedures were performed, with a negatively skewed distribution and an annualized operator volume median of 2.5 procedures/year (range 0.25 to 55.25). Higher volume operators undertook more complex procedures in patients with greater comorbid burdens than lower volume operators. A significant inverse association was observed between operator ROTA-PCI volume and in-hospital mortality (odds ratio [OR]: 0.986/case; 95% confidence interval [CI]: 0.975 to 0.996; p = 0.007) and major adverse cardiac and cerebral events (OR: 0.983/case; 95% CI: 0.975 to 0.993; p < 0.001). Additionally, lower rates of emergency cardiac surgery (OR: 0.964/case; 95% CI: 0.939 to 0.991; p = 0.008), arterial complications (OR: 0.975/case; 95% CI: 0.975 to 0.982; p < 0.001) and in-hospital major bleeding (OR: 0.985/case; 95% CI: 0.977 to 0.993; p < 0.001) were associated with higher ROTA-PCI operator volume. Sensitivity analyses in several subgroups demonstrated a consistency of improved outcomes as annual ROTA-PCI volume increased. An annual volume of <4 ROTA-PCI procedures/year was observed to be associated with increased major adverse cardiac and cerebral events, with 239 of 432 operators (55%) not exceeding this threshold. CONCLUSIONS: In-hospital adverse outcomes occurred less frequently as ROTA-PCI operator volume increased. These data suggest that operator volume is an important factor determining outcome after ROTA-PCI.

Influence of operator volume on early outcomes of septal myectomy for isolated hypertrophic obstructive cardiomyopathy.

BACKGROUND: Guidelines on the diagnosis and management of hypertrophic cardiomyopathy (HCM) recommend that septal myectomy be performed by experienced operators. However, the impact of operator volume on surgical treatment outcomes for isolated HCM has been poorly investigated. METHODS: From 2002 to 2014, 435 consecutive patients with isolated HCM undergoing myectomy at the Fuwai Hospital were retrospectively enrolled. All 29 surgeons were divided into beginner surgeons (operator volume ≤20) and experienced surgeons (operator volume >20) according to the guidelines for the diagnosis and treatment of HCM. Propensity score matching of patients in the two groups was performed. RESULTS: Baseline differences included advanced New York Heart Association classification and older age in the experienced surgeon group. After matching, in the beginner surgeon group (107 cases), residual obstruction (18.7% vs. 0.9%, P<0.001) was more common, and the postoperative left ventricular outflow tract pressure gradient (20.7±15.1 vs. 14.3±7.4 mmHg, P<0.001) was higher than that of the experienced surgeon group. In the experienced surgeon group (107 cases), the incidence of mitral valve replacement (1.9% vs. 11.2%, P<0.001) and permanent pacemaker implantation (1.9% vs. 3.7%, P<0.001) was significantly lower than that in the beginner surgeon group. However, there was no difference in procedural mortality (1.9% vs. 1.9%) between the two groups. CONCLUSIONS: Operator volume is an important factor in achieving better obstruction obliteration after septal myectomy in patients with isolated HCM.

Impact of operator experience and volume on outcomes after complete repair for tetralogy of Fallot.

OBJECTIVES: The aim of this study was to assess the impact of individual operator experience on outcomes after complete repair for tetralogy of Fallot. METHODS: This is a retrospective cohort study. Consecutive patients who underwent TOF repair at a single institution were included and compared according to whether the primary operator was an experienced, high-volume operator (defined as an operator who performed at least 20 surgical procedures for congenital heart disease defined as complex by the Risk Adjustment for Congenital Heart Surgery classification per year for at least 3 consecutive years). The primary outcome was defined as a composite of death, or reintervention, or significant annular peak gradient, or significant pulmonary regurgitation. Multivariable logistic regression and Cox proportional-hazards model analyses were used to assess the relationships between operator experience and outcomes. RESULTS: From January 2012 to December 2017, a total of 1760 patients with primary diagnosis of TOF underwent TOF repair by 37 operators. Of these, 5 operators (13.5%) were considered experienced, and 32 (86.5%) were considered less experienced. Complete follow-up data were available for 1728 complete repair for TOF patients with a median follow-up duration of 49 months; in 611 patients (35.4%), the surgery was performed by experienced operators, and in 1117 patients (64.6%), the surgery was performed by less experienced operators. Adjusted risks for the primary outcome and significant pulmonary regurgitation were lower for patients who were treated by experienced operators, both at discharge [adjusted odds ratio 0.67, 95% confidence interval (CI) 0.50-0.90; adjusted odds ratio 0.54, 95% CI 0.37-0.78, respectively] and at follow-up (adjusted hazard ratio 0.82, 95% CI 0.68-0.97; adjusted hazard ratio 0.70, 95% CI 0.56-0.87, respectively). The trend for the primary outcome during follow-up remained unchanged, even in most subgroups. CONCLUSIONS: Increased surgeon experience is associated with improved risk-adjusted outcomes. These results have potentially important implications for individual training, quality improvement and hospital programmes in the context of complete repair for TOF. REGISTRATION NUMBER: http://www.chictr.org.cn number, ChiCTR2000033234.

Effect of Operator Volume on In-Hospital Outcomes Following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction: Based on the 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry.

BACKGROUND AND OBJECTIVES: The relationship between operator volume and outcomes of percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) has not been fully investigated. We aimed to investigate the relationship between operator PCI volume and in-hospital outcomes after primary PCI for STEMI. METHODS: Among the total of 44,967 consecutive cases of PCI enrolled in the Korean nationwide, retrospective registry (K-PCI registry), 8,282 patients treated with PCI for STEMI by 373 operators were analyzed. PCI volumes above the 75th percentile (>30 cases/year), between the 75th and 25th percentile (10-30 cases/year), and below the 25th percentile (<10 cases/year) were defined as high, moderate, and low-volume operators, respectively. In-hospital outcomes including mortality, non-fatal myocardial infarction (MI), stent thrombosis, stroke, and urgent repeat PCI were analyzed. RESULTS: The average number of primary PCI cases performed by 373 operators was 22.2 in a year. In-hospital mortality after PCI for STEMI was 571 cases (6.9%). In-hospital outcomes by operator volume showed no significant differences in the death rate, cardiac death, non-fatal MI, and stent thrombosis. However, the rate of urgent repeat PCI tended to be lower in the high-volume operator (0.6%) than in the moderate-(0.7%)/low-(1.5%) volume operator groups (p=0.095). The adjusted odds ratios for adverse in-hospital outcomes were similar in the 3 groups. Multivariate analysis also showed that operator volume was not a predictor for adverse in-hospital outcomes. CONCLUSIONS: In-hospital outcomes after primary PCI for STEMI were not associated with operator volume in the K-PCI registry.

Higher Annual Operator Volume Is Associated With Better Reperfusion Rates in Stroke Patients Treated by Mechanical Thrombectomy: The ETIS Registry.

OBJECTIVES: The aim of this study was to determine whether individual operator characteristics have an impact on reperfusion and procedural complication rates. BACKGROUND: Mechanical thrombectomy (MT) is a Level IA treatment in acute ischemic stroke (AIS) patients. The operator's effect has been found to be an independent predictor for clinical outcome and technical performance in interventional cardiology. METHODS: From the ETIS (Endovascular Treatment in Ischemic Stroke) study, a prospective, multicenter, observational real-world MT registry, the authors included all AIS patients consecutively treated by MT between January 2012 and March 2017 in 3 high-volume comprehensive stroke centers by 19 operators. We assessed the effect of individual operator characteristics on successful reperfusion, defined as modified Thrombolysis In Cerebral Infarction 2b/3 at the end of MT, and procedural complications using multivariable hierarchical logistic regression models. RESULTS: A total of 1,541 patients with anterior and posterior AIS were enrolled (mean age 67 years; median NIHSS 16). There was a significant operator effect on successful reperfusion, with an intraclass correlation coefficient of 0.036 (p = 0.046), but not on complications (intraclass correlation coefficient = 0). There was a dose-response relationship between annual operator volume and successful reperfusion rate (p = 0.003) with an adjusted odds ratio for successful reperfusion equal to 2.52 (95% confidence interval: 1.37 to 4.64) for patients treated by an operator with an annual volume ≥40 MT/year compared with those treated by an operator with <14 MT/year (first tertile). Nevertheless, this result did not translate to better clinical outcomes. CONCLUSIONS: Our data suggest that operator volume of MT/year has a positive impact on successful reperfusion in AIS patients, but not on clinical outcomes nor on complication rates. Further studies are warranted to investigate threshold procedure numbers associated with better outcomes.

Percutaneous cardiological intervention and cardiac surgery: patient-centered care. Position statement of the Spanish Society of Cardiology.

The percutaneous treatment of coronary artery disease and some structural cardiovascular diseases has undergone spectacular changes. More and more patients with different types of heart disease are being treated by percutaneous or transcatheter interventions, with no such increase in patients undergoing cardiac surgery. This situation has led to different types of approach, requiring an objective analysis that includes all the factors possibly influencing these changes. This document assesses the 2 scenarios where this problem is most evident: coronary revascularization and the treatment of aortic stenosis. The document analyzes the situation of coronary revascularization in Spain, and the causes that may explain the differences between the number of patients who currently undergo percutaneous revascularization and those who undergo coronary surgery. In contrast, treatment of aortic stenosis through transcatheter aortic valve implantation will lead to a foreseeable reduction in the number of candidates for surgical replacement. Several international scientific societies have published the requirements on training and experience and the necessary operator and center volumes to implement a transcatheter aortic valve implantation program, conditions that the Spanish Society of Cardiology, adopting a patient-centered approach, considers absolutely essential. Given that the 2 forms of intervention (percutaneous and surgical) are complementary, multidisciplinary patient assessment (Heart Team) remains crucial to offer the best treatment option. In this scenario of diverse approaches, a key figure is the clinical cardiologist. Finally, the changes currently occurring in the treatment of structural heart disease will, in future, lead to the performance of procedures requiring the participation of professionals from both specialties. This approach will require a redesign of current training programs.

Volume-outcome relationship for peripheral endovascular interventions: a review of existing literature.

The incidence and prevalence of peripheral vascular disease has been increasing. When coexistent with coronary artery disease (CAD), it has shown to predict higher mortality along with poorer quality-of-life consequently leading to a marked increase in healthcare costs. Broadly, there has been an increase in utilization of endovascular techniques in the management of peripheral vascular diseases. An inverse relation between volume and outcomes has been noted in these procedures. Additionally, improved resource utilization has also been noted with higher hospital and operator volumes. This has led to proposals to regionalize these procedures to high volume hospitals. There have also been calls to introduce the idea of having a set threshold of procedures for providers. This review presents an overview of published literature on the volume-outcome relationship affecting the outcomes of peripheral endovascular procedures.