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Background: Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown. Methods: All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients’ baseline health status accounted for variability in outcomes, the proportion of variability ( R 2 ) explained by sequentially adding these variables to the model was quantified. Results: Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46–1.69). The greatest contribution to the variability in health status outcomes was from patients’ baseline KCCQ-OS score ( R 2 =25%) with Conclusions: There is moderate variation across sites in their patients’ achievement of health status benefits from TMVr, with patient’s baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr.

Background: In inoperable patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) reduced mortality and hospitalization as compared with medical therapy. However, hospitalization rates after TAVR remain high, given the age and comorbidities of patients undergoing TAVR. Studies have thus far focused on rehospitalization after TAVR and have not examined the decline in hospitalizations achieved with TAVR. We sought to compare hospitalization rates in the 3 months before and after TAVR and further examine these changes in patients with and without LV dysfunction. Methods: We used the 2014 Nationwide Readmission Database (NRD) to identify patients who underwent TAVR between April and September, to allow for assessment of hospitalizations 3 months before and after TAVR. We compared hospitalization rates before and after TAVR using McNemar tests and also examined rates among patients with heart failure with reduced ejection fraction (HFrEF) and those without HFrEF. Results: Among 10416 who underwent TAVR between 4/1/14-9/30/14, mean age was 81.1 ± 8.4 years, 45.4% were men, mean number of chronic condition was 9.6 ± 3.1, and 40.6% had HFrEF. The rate of all-cause hospitalization in the 3 months before TAVR was 34.1%, which decreased to 25.5% in the 3 months after TAVR (p Conclusion: Although patients who are treated with TAVR have high rates of rehospitalization after the procedures, TAVR is associated with a reduction in all-cause hospitalization, which appears to be even more pronounced among patients with HFrEF. Further investigation is needed to better understand the patient factors associated with response to TAVR, in terms of hospitalization

Background: Drug-eluting stents reduce the risk of restenosis in patients undergoing percutaneous coronary intervention, but their use necessitates prolonged dual antiplatelet therapy, which increases costs and bleeding risk, and which may delay elective surgeries. While >80% of patients in the United States receive drug-eluting stents, less than a third report that their physicians discussed options with them. Methods and Results: An individualized shared decision-making (SDM) tool for stent selection was designed and implemented at 2 US hospitals. In the postimplementation phase, all patients received the SDM tool before their procedure, with or without decision coaching from a trained nurse. All patients were interviewed with respect to their knowledge of stents, their participation in SDM, and their stent preference. Between May 2014 and December 2016, 332 patients not receiving the SDM tool, 113 receiving the SDM tool with coaching, and 136 receiving the tool without coaching were interviewed. Patients receiving the SDM tool + coaching, as compared with usual care, demonstrated higher knowledge scores (mean difference +1.8; P P P Conclusions: An SDM tool for stent selection was associated with improvements in patient knowledge and SDM only when accompanied by decision coaching. However, the SDM tool (with or without coaching) had no impact on stent selection or concordance between patients’ stent preference and stent received, suggesting that physician-level barriers to SDM may exist. Clinical Trial Information URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02046902.

Introduction: Acute Kidney Injury (AKI) is common, morbid, costly, increases patients’ mortality risk, and may be mitigated by limiting contrast use. Our objective was to examine variation in CI-AKI across physicians and the proportion of this variation explained by differences in contrast, after adjusting for patient characteristics. Methods: Using the NCDR CathPCI Registry data (2009-12, N=1346932 PCIs), we defined CI-AKI by Acute Kidney Injury Network criteria and used hierarchical regression to identify a) variation in CI-AKI rates by physicians performing > 50 PCI/yr, b) variation in their contrast use and c) variation in CI-AKI rates explained by variation in contrast use, after adjustment for patient and hospital characteristics. Results: Among >1.3M PCIs, CI-AKI occurred in 94,584 (7%). We observed a large variation in AKI rates across individual physicians, from 0% to 30% (unadjusted) (Fig1) and an adjusted 43% excess likelihood of AKI for identical patients presenting to 2 random NCDR physicians. We also observed large variation in physicians’ mean contrast volume, ranging from 79 - 487 ml with an intraclass correlation coefficient of 0.23, implying a 23% variation in contrast volume across physicians’, after adjustment. Variation in contrast volume (per 75 ml) explained an excess 14.3% increased variation in AKI rate. Conclusions: AKI rates vary greatly among physicians, largely due to variation in their contrast use. Our study underscores an important opportunity to reduce AKI by reducing the variation in contrast volumes across physicians.

Introduction: TIMI Major and Minor bleeding, reflecting large bleeds of >5 and >3g/dl, respectively, are routinely tracked as outcomes of PCI. Lesser degrees of bleeding, called ‘nuisance’ bleeding (NB), can occur as a result of chronic dual antiplatelet therapy (DAPT). NB has never been reported in clinical trials of PCI or DAPT. The frequency of patient-reported NB after PCI and its association with patients’ quality of life (QOL) is therefore unknown. Methods: We assessed the incidence of NB in a 9-center prospective PCI registry, the PRISM study, at 1 and 6 months after the index PCI. NB was defined by patients who responded positively, via telephone interviews, to the following question: ‘Since leaving the hospital after your heart procedure have you had easy bleeding?” QOL was assessed with the EuroQOL-5D visual analogue scale (EQ5D VAS) score (range 0-100, higher = better). Hierarchical linear regression models was used to assess the association of NB at 6 months with QOL (EQ5D VAS) at 6 months, after adjustment for socio-demographic and clinical factors (age, gender, race, insurance status, warfarin use, atrial fibrillation and baseline EQ5D VAS score). Results: Among 2,630 patients enrolled in the PRISM trial, NB occurred in 1085 (41.25%) at 6 months. Compliance with DAPT was 98.6% at 1 month and 93.3% at 6 months, precluding an assessment of its association with NB. NB was associated with a significant decrement in QOL, even after adjusting for baseline EQ5D-VAS score and other confounders (EQ5D VAS estimate -1.41, 95%CI -2.79 to -0.03, P-value 0.045, Figure) Conclusions: In this multicenter study of PCI, we found NB to be very common and to be independently associated with worse QOL. These results suggest that NB should be quantified in future outcomes studies and interventions to minimize its occurrence should be explored.

Introduction: Transradial percutaneous coronary intervention (TRI) is associated with reduced bleeding rates and length of stay (LOS), compared to transfemoral PCI (TFI). However, TRI requires specialized guide catheters, access equipment and costs attributable to a ‘learning curve’ in the US. The cost-effectiveness of transradial vs. transfemoral PCI in contemporary real-world US practice is unknown. Methods: We developed a decision-analytic model (Figure) of costs and bleeding events of transradial vs. transfemoral PCI using inputs from a hospital system, and direct PCI costs from each hospital’s respective cost accounting system. Independent costs of radial PCI, urgent vs. elective PCI indication and bleeding complications were identified by a linear regression model and used as model inputs. The efficacy measure was major bleeding as defined by the NCDR. Results: Cost and clinical data were derived from the 2,972 consecutive PCI procedures (TRI N=559) performed in 6/2009-3/2011. TRI was associated with a shorter LOS (1.4 ± 1.4 days) vs. TFI (1.9 ± 2.3 days), P< 0.001. Although procedural day costs were similar in the 2 groups - $12,949 ± 3932 for TRI vs. 13,104 ± 3325 for TFI, post-procedural day costs were lower in the TRI groups ($1524 ± 4108 vs. TFI group $ 2798 ± 9076), primarily from a reduced LOS. Hence, total costs were lower with TRI ($14,468 ± 5442) vs. TFI ($15,608 ± 6920), PCost data from 4 additional high volume centers will be included prior to the AHA QCOR presentation. Conclusions: This is the first decision-analytic modeling study which shows TRI is an economically dominant strategy with lesser costs and a trend towards greater efficacy (less bleeding), when compared against TFI. Cost savings resulting from TRI are large and exceed $800/patient undergoing PCI. Apart from the known advantages of patient convenience and reduced bleeding complications, increased adoption of TRI may result in significant cost-savings to hospitals and ultimately the U.S. healthcare system.

Purpose: The consent form and process are highly variable from hospital to hospital, as well as from physician to physician. We created an evidence-driven, web-based tool, PREDICT (Patient Refined Expectations for Deciding Invasive Cardiac Treatments) which redesigns the procedure consent for patients undergoing percutaneous coronary intervention (PCI). We prospectively evaluated the challenges and successes of implementing such an evidence-based information technology (IT) decision support. Methods: We conducted qualitative, in-depth interviews with clinicians at 5 U.S. hospitals within 6 weeks of implementation of the new PREDICT individualized consent form. PCI volumes at each hospital ranged from 60 to 120 per month thus allowing for a sufficient number of consent forms to be generated and evaluated. Collected data was content analyzed, categorizing response as either supporting or impeding the implementation. Results: We interviewed 61 clinicians (minimum of 8 per site; 50 registered nurses, 6 care technicians, and 5 nursing managers). The majority described the new consent form process as a positive experience, commenting that patients benefited from the individualized information. Additionally, facilitators and barriers were identified (see Table). Conclusions: This implementation study identified tasks to ease implementation (facilitators) as well as anticipating and strategizing to diminish impedance (barriers) to the integration of an improved PCI consent form and process. The need for a strong, visible clinical champion was identified as a strong influencer in both categories.

BACKGROUND Despite widespread acceptance of drug eluting stents (DES), concerns about cost and safety contributed to lower DES use by late 2006, particularly in off-label scenarios such as acute MI. The population-level impact of this trend on health status is unknown. METHODS We evaluated Seattle Angina Questionnaire (SAQ) scores among patients (pts) undergoing in-hospital PCI in TRIUMPH, a 24-center registry of acute MI. For each 3-month period of enrollment, we calculated the frequency of DES use and the mean 6-month Angina Frequency (SAQ-AF) score for pts treated that quarter. We then constructed a linear regression model to evaluate whether DES use, or time periods of high vs. low DES use, were independently associated with 6-month SAQ-AF scores. RESULTS Among 1744 MI pts undergoing PCI with complete health status assessments, 1033 were treated with DES (59%). DES use decreased significantly in late 2006, but overall 6-month angina burden remained stable ( Figure ). After adjusting for multiple clinical factors, SAQ-AF scores exhibited a borderline association with DES use (ß-coefficient 1.86 ± 1.0, p=0.06). When dichotomizing pts into years with high (2005-06) and low (2007-08) DES use, there was no relationship between high vs. low DES use on SAQ-AF in the multivariable model (ß=0.01 ± 1.0, p=0.99). CONCLUSION More selective use of DES after 2006 has not impacted population-level angina control at 6 months among MI pts treated with PCI. This suggests that clinicians were able to reduce DES use through better selection of those pts most likely to benefit from DES therapy, but further research is needed to better understand the processes of care associated with these findings.