Reversing the "Risk-Treatment Paradox" of Bleeding in Patients Undergoing Percutaneous Coronary Intervention: Risk-Concordant Use of Bleeding Avoidance Strategies Is Associated With Reduced Bleeding and Lower Costs.

Background Bleeding is a common, morbid, and costly complication of percutaneous coronary intervention. While bleeding avoidance strategies ( BAS ) are effective, they are used paradoxically less in patients at high risk of bleeding. Whether a patient-centered approach to specifically increase the risk-concordant use of BAS and, thus, reverse the risk-treatment paradox is associated with reduced bleeding and costs is unknown. Methods and Results We implemented an intervention to reverse the bleeding risk-treatment paradox at Barnes-Jewish Hospital, St. Louis, MO, and examined: (1) the temporal trends in BAS use and (2) the association of risk-concordant BAS use with bleeding and hospital costs of percutaneous coronary intervention. Among 3519 percutaneous coronary interventions, there was a significantly increasing trend ( P=0.002) in risk-concordant use of BAS . The bleeding incidence was 2% in the risk-concordant group versus 9% in the risk-discordant group (absolute risk difference, 7%; number needed to treat, 14). Risk-concordant BAS use was associated with a 67% (95% confidence interval, 52-78%; P<0.001) reduction in the risk of bleeding and a $4738 (95% confidence interval, 3353-6122; P<0.001) reduction in per-patient percutaneous coronary intervention hospitalization costs (21.6% cost-savings). Conclusions In this study, patient-centered care directly aimed to make treatment-related decisions based on predicted risk of bleeding, led to more risk-concordant use of BAS and reversal of the risk-treatment paradox. This, in turn, was associated with a reduction in bleeding and hospitalization costs. Larger multicentered studies are needed to corroborate these results. As clinical medicine moves toward personalization, both patients and hospitals can benefit from a simple practice change that encourages objectivity and mitigates variability in care.

Racial Comparisons of the Outcomes of Transcatheter and Surgical Aortic Valve Implantation Using the Medicare Database.

Racial disparities in the outcomes after intervention for aortic valve disease remain understudied. We stratified patients by race who underwent surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) in the Medicare database. The TAVI cohort consisted of 17,973 patients (3.9% were black and 1.0% were Hispanic). The SAVR cohort consisted of 95,078 patients, (4.8% were black and 1.3% were Hispanic). Most comorbidities were more common in blacks. After TAVI, 30-day mortality was not significantly different in races with both unadjusted and adjusted data. There were no significant racial differences in readmission rates or discharge to home after TAVI. After SAVR, black patients had worse unadjusted 30-day and 1-year mortality than whites or Hispanics (30-day mortality, 4.7% vs 6.2% vs 4.7% for whites, blacks, and Hispanics, respectively, p = 0.0001; 1-year mortality 11.7% vs 16.1% vs 12.5%, respectively, p = 0.0001); however, after adjustment, there were no differences in mortality. Black patients had higher 30-day readmission rates after SAVR (20.1% vs 25.2% vs 21.7% for whites, blacks, and Hispanics, respectively, p = 0.0001), which persisted after adjustment for comorbidities. Minorities were underrepresented in both SAVR and TAVI relative to what would be predicted by population prevalence. In conclusion, while blacks have worse outcomes in SAVR compared with whites or Hispanics, race did not impact mortality, readmission, or discharge to home in TAVI. Both blacks and Hispanics were underrepresented compared with what would be predicted by population prevalence.

Novel Patient-Centered Approach to Facilitate Same-Day Discharge in Patients Undergoing Elective Percutaneous Coronary Intervention.

BACKGROUND: Same-day discharge (SDD) after elective percutaneous coronary intervention is safe, less costly, and preferred by patients, but it is usually performed in low-risk patients, if at all. To increase the appropriate use of SDD in more complex patients, we implemented a "patient-centered" protocol based on risk of complications at Barnes-Jewish Hospital. METHODS AND RESULTS: Our objectives were as follows: (1) to evaluate time trends in SDD; (2) to compare (a) mortality, bleeding, and acute kidney injury, (b) patient satisfaction, and (c) hospital costs by SDD versus no SDD (NSDD); and (3) to compare SDD eligibility by our patient-centered approach versus Society for Cardiovascular Angiography and Interventions guidelines. Our patient-centered approach was based on prospectively identifying personalized bleeding, mortality, and acute kidney injury risks, with a personalized safe contrast limit and mitigating those risks. We analyzed Barnes-Jewish Hospital's National Cardiovascular Data Registry CathPCI Registry data from July 1, 2009 to September 30, 2015 (N=1752). SDD increased rapidly from 0% to 77% (P<0.001), independent of radial access. Although SDD patients were comparable to NSDD patients, SDD was not associated with adverse outcomes (0% mortality, 0% bleeds, and 0.4% acute kidney injury). Patient satisfaction was high with SDD. Propensity score-adjusted costs were $7331 lower/SDD patient (P<0.001), saving an estimated $1.8 million annually. Only 16 patients (6.95%) met the eligibility for SDD by Society for Cardiovascular Angiography and Interventions guidelines, implying our patient-centered approach markedly increased SDD eligibility. CONCLUSIONS: With a patient-centered approach, SDD rapidly increased and was safe in 75% of patients undergoing elective percutaneous coronary intervention, despite patient complexity. Patient satisfaction was high, and hospital costs were lower. Patient-centered decision making to facilitate SDD is an important opportunity to improve the value of percutaneous coronary intervention.

Outcomes of Early Mitral Valve Reoperation in the Medicare Population.

BACKGROUND: Surgical series on mitral valve reoperation are limited by small numbers and lack of national representation. Large-scale outcomes of reoperation for mitral valve surgery remain uncertain. METHODS: This is a descriptive analysis of 1,627 Medicare beneficiaries who underwent mitral valve reoperation within a 3-year follow-up period after an initial mitral operation (repair or replacement) that took place between 2000 and 2006. The primary outcomes were hospital mortality and long-term survival. RESULTS: The 1,627 patients included in the study comprise 1.6% of patients who underwent operation between 2000 and 2006. The initial surgery was repair in 49.9%, bioprosthetic replacement in 22.0%, and mechanical replacement in 28.1%. Re-repair was performed in 15.4%. Hospital mortality was 12.0% and was similar for repair and bioprosthetic or mechanical replacement. Reoperative mortality was similar for men and women and for patients aged 75 years or less versus more than 75 years; and was significantly higher for nonelective than for elective operations (15.6% versus 5.5%, p = 0.0001), for patients with endocarditis than without endocarditis (21.4% versus 11.0%, p = 0.0001), and for patients with heart failure than without heart failure (14.2% versus 9.9%, p = 0.0080). Cumulative long-term survival rates were 58.6% at 5 years. CONCLUSIONS: The incidence of mitral valve reoperation within 3 years after initial repair or replacement is low but carries high surgical risk, which is significantly increased by certain preoperative characteristics, such as urgent status, endocarditis, and heart failure.

Transcatheter Aortic Valve Replacement Outcomes in Nonagenarians Stratified by Transfemoral and Transapical Approach.

BACKGROUND: Survival and other outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) in the Medicare population are unclear. METHODS: Patients aged 65 years and older who underwent TAVR from November 2011 through 2013 were considered for inclusion. RESULTS: The study consisted of 18,283 patients and 19.3% were aged 90 years or older. Compared with patients younger than 90 years, patients 90 years or older were less likely to have a number of comorbidities, including previous myocardial infarction (17.5% versus 21.8%), previous coronary artery bypass grafting (20.0% versus 35.0%), and chronic obstructive pulmonary disease (25.4% versus 39.0%) among others. The 30-day and 1-year mortality rates were 8.4% versus 5.9% (p = 0.0001) and 25.4% versus 21.5% (p = 0.0001) in the older and younger groups, respectively (odds ratio [OR] 1.47, 95% confidence interval [CI]: 1.28 to 1.70, p = 0.0001). Patients 90 years and older were more likely to undergo pacemaker insertion (11.1% versus 8.3%, p = 0.0001). Among nonagenarians, compared with the transapical group, patients undergoing transfemoral TAVR had lower 30-day (7.2% versus 13.6%, p = 0.0001) and 1-year (23.8% versus 31.6%, p = 0.0001) mortality rates, were more likely to be discharged home (54.4% versus 34.1%, p = 0.0001), and had lower 30-day readmission rates (23.8% versus 31.8%, p = 0.0001). After adjustment for patient characteristics, transapical TAVR was an independent predictor of 30-day mortality rate (OR 1.94, 95% CI: 1.48 to 2.56, p = 0.0001) and readmission (OR 1.46, 95% CI: 1.19 to 1.80, p = 0.0003). CONCLUSIONS: In patients undergoing TAVR, although 30-day and 1-year mortality rates were slightly worse for nonagenarians than their younger counterparts, long-term survival was still encouraging, with 75% of nonagenarians living to 1 year. Transapical TAVR was associated with worse outcomes in nonagenarians.

Learning Alternative Access Approaches for Transcatheter Aortic Valve Replacement: Implications for New Transcatheter Aortic Valve Replacement Centers.

BACKGROUND: Smaller transcatheter aortic valve replacement (TAVR) delivery systems have increased the number of patients eligible for transfemoral procedures while decreasing the need for transaortic (TAo) or transapical (TA) access. As a result, newer TAVR centers are likely to have less exposure to these alternative access techniques, making it harder to achieve proficiency. The purpose of this study was to evaluate the learning curve for TAVR approaches and compare perioperative outcomes. METHODS: From January 2008 to December 2014, 400 patients underwent TAVR (transfemoral, n = 179; TA, n = 120; and TAo, n = 101)). Learning curves were constructed using metrics of contrast utilization, procedural, and fluoroscopy times. Outcomes during the learning curve were compared with after proficiency was achieved. RESULTS: Depending on the metric, learning curves for all three routes differed slightly but all demonstrated proficiency by the 50th case. There were no significant differences in procedural times whereas improvements in contrast use were most notable for TA (69 ± 40 mL versus 50 ± 23 mL, p = 0.002). For both TA and TAo, fewer patients received transfusions once proficiency was reached (62% versus 34%, p = 0.003, and 42% versus 14%, p = 0.002, respectively). No differences in 30-day or 1-year mortality were seen before or after proficiency was reached for any approach. CONCLUSIONS: The learning curves for TA and TAo are distinct but technical proficiency begins to develop by 25 cases and becomes complete by 50 cases for both approaches. Given the relatively low volume of alternative access, achieving technical proficiency may take significant time. However, technical proficiency had no effect on 30-day or 1-year mortality for any access approach.

Risk model for estimating the 1-year risk of deferred lesion intervention following deferred revascularization after fractional flow reserve assessment.

AIMS: Although lesions deferred revascularization following fractional flow reserve (FFR) assessment have a low risk of adverse cardiac events, variability in risk for deferred lesion intervention (DLI) has not been previously evaluated. The aim of this study was to develop a prediction model to estimate 1-year risk of DLI for coronary lesions where revascularization was not performed following FFR assessment. METHODS AND RESULTS: A prediction model for DLI was developed from a cohort of 721 patients with 882 coronary lesions where revascularization was deferred based on FFR between 10/2002 and 7/2010. Deferred lesion intervention was defined as any revascularization of a lesion previously deferred following FFR. The final DLI model was developed using stepwise Cox regression and validated using bootstrapping techniques. An algorithm was constructed to predict the 1-year risk of DLI. During a mean (±SD) follow-up period of 4.0 ± 2.3 years, 18% of lesions deferred after FFR underwent DLI; the 1-year incidence of DLI was 5.3%, while the predicted risk of DLI varied from 1 to 40%. The final Cox model included the FFR value, age, current or former smoking, history of coronary artery disease (CAD) or prior percutaneous coronary intervention, multi-vessel CAD, and serum creatinine. The c statistic for the DLI prediction model was 0.66 (95% confidence interval, CI: 0.61-0.70). CONCLUSION: Patients deferred revascularization based on FFR have variation in their risk for DLI. A clinical prediction model consisting of five clinical variables and the FFR value can help predict the risk of DLI in the first year following FFR assessment.

The Society for Cardiovascular Angiography and Interventions Structural Heart Disease Early Career Task Force survey results: endorsed by the Society for Cardiovascular Angiography and Interventions.

Over the last decade, structural heart disease interventions have emerged as a new field in interventional cardiology. Currently, the Accreditation Council for Graduate Medical Education accredited interventional cardiology fellowship programs in the United States provide high-quality and well established training curriculum in coronary and peripheral interventions, but training in structural interventions remains in its infancy. The current survey seeks to collect relevant information and assess the opinion of interventional cardiology program directors in ACGME-accredited institutions that are actively involved in structural interventional training. Our study describes the actual number of structural procedures performed by interventional cardiology fellows in ACGME-accredited programs, the form of the structural training today and the suggestions from program directors who are actively trying to integrate structural training in the interventional cardiology fellowship programs.