Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD.

Background: Anatomy is critical in risk stratification and therapeutic decision making in coronary disease. The relationship between anatomy and outcomes is not well described in PAD. We sought to develop an angiographic core lab within the VOYAGER-PAD trial. The current report describes the methods of creating this core lab, its study population, and baseline anatomic variables. Methods: Patients undergoing lower-extremity revascularization for symptomatic PAD were randomized in VOYAGER-PAD. The median follow up was 2.25 years. Events were adjudicated by a blinded Clinical Endpoint Committee. Angiograms were collected from study participants; those with available angiograms formed this core lab cohort. Angiograms were scored for anatomic and flow characteristics by trained reviewers blinded to treatment. Ten percent of angiograms were evaluated independently by two reviewers; inter-rater agreement was assessed. Clinical characteristics and the treatment effect of rivaroxaban were compared between the core lab cohort and noncore lab participants. Anatomic data by segment were analyzed. Results: Of 6564 participants randomized in VOYAGER-PAD, catheter-based angiograms from 1666 patients were obtained for this core lab. Anatomic and flow characteristics were collected across 16 anatomic segments by 15 reviewers. Concordance between reviewers for anatomic and flow variables across segments was 90.5% (24,417/26,968). Clinical characteristics were similar between patients in the core lab and those not included. The effect of rivaroxaban on the primary efficacy and safety outcomes was also similar. Conclusions: The VOYAGER-PAD angiographic core lab provides an opportunity to correlate PAD anatomy with independently adjudicated outcomes and provide insights into therapy for PAD. (ClinicalTrials.gov Identifier: NCT02504216).

Contemporary Management Before Chronic Total Occlusion Percutaneous Coronary Interventions: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

BACKGROUND: Guidelines recommend maximal antianginal medical therapy before attempted coronary artery chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The degree to which this occurs in contemporary practice is unknown. We aimed to characterize the frequency and variability of preprocedural use of antianginal therapy and stress testing within 3 months before PCI of CTO (CTO PCI) across a nationally integrated health care system. METHODS: We identified patients who underwent attempted CTO PCI from January 2012 to September 2018 within the Veterans Affairs Healthcare System. Patients were categorized by management before CTO PCI: presence of ≥2 antianginals, stress testing, and ≥2 antianginals and stress testing within 3 months of PCI attempt. Multivariable logistic regression and inverse propensity weighting were used for adjustment before trimming, with median odds ratios calculated for variability estimates. RESULTS: Among 4250 patients undergoing attempted CTO PCI, 40% received ≥2 antianginal medications and 24% underwent preprocedural stress testing. The odds of antianginal therapy with more than one medication before CTO PCI did not change over the years of the study (odds ratio [OR], 1.0 [95% CI, 0.97-1.04]), whereas the odds of undergoing preprocedural stress testing decreased (OR, 0.97 [95% CI, 0.93-0.99]), and the odds of antianginal therapy with ≥2 antianginals and stress testing did not change (OR, 0.98 [95% CI, 0.93-1.04]). Median odds ratios (MOR) showed substantial variability in antianginal therapy across hospital sites (MOR, 1.3 [95% CI, 1.26-1.42]) and operators (MOR, 1.35 [95% CI, 1.26-1.63]). Similarly, preprocedural stress testing varied significantly by site (MOR, 1.68 [95% CI, 1.58-1.81]) and operator (MOR, 1.80 [95% CI, 1.56-2.38]). CONCLUSIONS: Just under half of patients received guideline-recommended management before CTO PCI, with significant site and operator variability. These findings suggest an opportunity to reduce variability in management before CTO PCI.

Mechanical Complications of Transcatheter Aortic Valve Replacement.

Mechanical complications after transcatheter aortic valve replacement are fortunately rare with the current generation of devices. Unfortunately, life-threatening complications will occur and it is the responsibility of operators to be familiar with strategies to prevent and manage these challenging scenarios. Because these cases will not occur often, it is important for us to highlight and talk about those that do occur, to learn best practices in how to manage and prevent them going forward. We can learn much from each other's good crash landings.

Transcatheter Closure of Left Ventricle to Coronary Sinus Fistula Post-MVR and Septal Myectomy.

This paper describes the case of a patient who developed refractory heart failure due to a fistula from the left ventricle to the coronary sinus that was unintentionally created after a surgical myectomy and mitral valve replacement. Advanced image guidance with a pre-procedure 3-dimensional physical model and intraprocedure echocardiography fusion facilitated transcatheter plugging of the shunt with symptom resolution. (Level of Difficulty: Advanced.).

Dissemination of Transcatheter Aortic Valve Replacement in the United States.

BACKGROUND: Societal guidelines and payor coverage decisions for transcatheter aortic valve replacement (TAVR) attempt to strike a balance between providing access and maintaining quality. The extent to which dissemination of TAVR has achieved these ideals remains unknown. OBJECTIVES: This study sought to define patterns of TAVR dissemination in the United States and their influence on outcomes. METHODS: Using data from the TVT (Transcatheter Valvular Therapy) registry, this study identified TAVR sites from 2011 to 2018 and calculated drive-times from existing to new sites. In a contemporary cohort, this study compared site and patient characteristics by annual case volume and density of sites per million Medicare beneficiaries. Using hierarchical regression and Cox methods, this study determined the association between case volumes, site density, and changes in volume and density with patient risk profiles and outcomes. RESULTS: TAVR sites participating in the TVT registry increased from 198 to 556 from 2011 to 2018. Median drive-time from existing to new sites decreased from 403 minutes (interquartile range: 211-587 minutes) to 26 minutes (interquartile range: 17-48 minutes). In a contemporary cohort, higher site density was associated with lower procedural risk as well as with an increased hazard of 30-day risk-adjusted mortality (P = 0.017). Similarly, longitudinal increases in site density over time were associated with a higher hazard of 30-day (P = 0.011) and 1-year (P = 0.013) mortality. CONCLUSIONS: TAVR has expanded significantly over time, but with regional clustering of sites. Although procedural risk is lower at higher density sites, these sites demonstrate an increased hazard of mortality. These findings suggest that the expansion of TAVR services in the United States may have had unintended consequences on procedural quality.

Temporal Trends and Site Variation in High-Risk Coronary Intervention and the Use of Mechanical Circulatory Support: Insights From the Veterans Affairs Clinical Assessment Reporting and Tracking (CART) Program.

Background Patients undergoing percutaneous coronary intervention (PCI) are older with greater medical comorbidities and anatomical complexity than ever before, resulting in an increased frequency of nonemergent high-risk PCI (HR-PCI). We thus sought to evaluate the temporal trends in performance of HR-PCI and utilization of mechanical circulatory support in the largest integrated healthcare system in the United States. Methods and Results A cohort of high-risk adult patients that underwent nonemergent PCI in the Veterans Affairs Healthcare System between January 2008 and June 2018 were identified by objective clinical, hemodynamic, and anatomic criteria. Temporal trends in the performance of HR-PCI, utilization of mechanical circulatory support, and site-level variation were assessed. Of 111 548 patients assessed during the study period, 554 met 3 high-risk criteria whereas 4414 met at least 2 criteria for HR-PCI. There was a significant linear increase in the proportion of interventions that met 3 (P<0.001) or at least 2 (P<0.001) high-risk criteria over time, with rates approaching 1.9% and 11.2% in the last full calendar year analyzed. A minority of patients who met all high-risk criteria received PCI with mechanical support (15.7%) without a significant increase over time (P=0.193). However, there was significant site-level variation in the probability of performing HR-PCI (4.0-fold higher likelihood) and utilizing mechanical circulatory support (1.9-fold higher likelihood) between high and low utilization sites. Conclusions The proportion of cases categorized as HR-PCI has increased over time, with significant site-level variation in performance. The majority of HR-PCI cases did not utilize mechanical support, highlighting a discrepancy between current recommendations and clinical practice in an integrated healthcare system.

Association of Coronary Anatomical Complexity With Clinical Outcomes After Percutaneous or Surgical Revascularization in the Veterans Affairs Clinical Assessment Reporting and Tracking Program.

Importance: Anatomical scoring systems for coronary artery disease, such as the SYNTAX (Synergy Between Percutaneous Coronary Intervention [PCI] With Taxus and Cardiac Surgery) score, are well established tools for understanding patient risk. However, they are cumbersome to compute manually for large data sets, limiting their use across broad and varied cohorts. Objective: To adapt an anatomical scoring system for use with registry data, allowing facile and automatic calculation of scores and association with clinical outcomes among patients undergoing percutaneous or surgical revascularization. Design, Setting, and Participants: This cross-sectional observational cohort study involved procedures performed in all cardiac catheterization laboratories in the largest integrated health care system in the United States, the Veterans Affairs (VA) Healthcare System. Patients undergoing coronary angiography in the VA Healthcare System followed by percutaneous or surgical revascularization within 90 days were observed and data were analyzed from January 1, 2010, through September 30, 2017. Main Outcomes and Measures: An anatomical scoring system for coronary artery disease complexity before revascularization was simplified and adapted to data from the VA Clinical Assessment, Reporting, and Tracking Program. The adjusted association between quantified anatomical complexity and major adverse cardiovascular and cerebrovascular events (MACCEs), including death, myocardial infarction, stroke, and repeat revascularization, was assessed for patients undergoing percutaneous or surgical revascularization. Results: A total of 50 226 patients (49 359 men [98.3%]; mean [SD] age, 66 [9] years) underwent revascularization during the study period, with 34 322 undergoing PCI and 15 904 undergoing coronary artery bypass grafting (CABG). After adjustment, the highest tertile of anatomical complexity was associated with increased hazard of MACCEs (adjusted hazard ratio [HR], 2.12; 95% CI, 2.01-2.23). In contrast, the highest tertile of anatomical complexity among patients undergoing CABG was not independently associated with overall MACCEs (adjusted HR, 1.04; 95% CI, 0.92-1.17), and only repeat revascularization was associated with increasing complexity (adjusted HR, 1.34; 95% CI, 1.06-1.70) in this subgroup. Conclusions and Relevance: These findings suggest that an automatically computed score assessing anatomical complexity can be used to assess longitudinal risk for patients undergoing revascularization. This simplified scoring system appears to be an alternative tool for understanding longitudinal risk across large data sets.

Causes of Mortality After Percutaneous Coronary Intervention.

Background Public reporting of percutaneous coronary intervention (PCI) often uses periprocedural (30 days) mortality as a surrogate for procedural quality, though it is unclear how often death is attributable to the PCI. The cause of death among patients who died within 30 days of PCI in a national healthcare system was thus evaluated. Methods and Results We identified all patients who died within 30 days of PCI in the Veterans Affairs (VA) Healthcare System from October 2005 to September 2016. Causes of death were classified through a detailed chart review using definitions from the Academic Research Consortium. Of 115 191 patients undergoing PCI during the study period, 1674 patients died within 30 days of PCI (1.5%). A detailed chart review demonstrated that the majority of patients had an undifferentiated death not definitively attributable to a single cause (981, 59%), whereas a minority had a death directly attributable to a cardiovascular cause (467, 28%). The majority of cardiovascular deaths were unrelated to the interventional procedure (335, 72%). Cardiovascular deaths were more likely to occur in the inpatient setting (95%) compared with noncardiac (89%) or undifferentiated deaths (49%, P<0.001). Conclusions A minority of deaths occurring after percutaneous revascularization were definitively due to cardiac causes, with an even smaller proportion related to the PCI. With such a small proportion of deaths directly attributable to the PCI, these data suggest that 30-day mortality may be an inappropriate metric to assess procedural quality.

Contemporary use of intra-aortic balloon pumps during percutaneous coronary intervention: insights from the Veterans Affairs Clinical Assessment, Reporting, and Tracking program.

BACKGROUND: Intra-aortic balloon pumps (IABP) support nonemergent and emergent percutaneous coronary intervention (PCI). Recent studies have not showed a routine benefit to this practice. We sought to evaluate the temporal trends in balloon pump utilization and site-level variation within a large integrated healthcare system. PATIENTS AND METHODS: We identified all patients that underwent PCI in the Veterans Affairs Healthcare System between 1 January 2008 and 31 December 2015. Procedural information was ascertained from the medical record and stratified by the concomitant use of an IABP. Site-specific variation was determined with mixed logistic regression models and reported as a median odds ratio. RESULTS: There were 88 851 interventions performed on 71 529 patients across 71 hospitals with 1289 (1.5%) of these utilizing an IABP. Patients that underwent an intervention with this device had more medical comorbidities, as reflected by an increase in the median National Cardiovascular Data Registry CathPCI mortality score (34 vs. 15, P<0.001). The overall utilization of balloon pumps was constant throughout the study period (P=0.446). However, there was a significant decline (P=0.027) in its use during emergent cases with a significant increase (P=0.009) during nonemergent cases. Furthermore, there was site variation in use independent of patient or procedural characteristics (median odds ratio: 1.82, 95% confidence interval: 1.58-2.16). CONCLUSION: In the largest integrated healthcare system in the USA, there was a significant decline in IABP use among emergent cases and a significant increase during nonemergent cases. Residual site variation suggests an opportunity to standardize a procedural approach consistent with currently available data.