Outcomes of urgent/emergent transcatheter mitral valve repair (MitraClip): A single center experience.

OBJECTIVES: To describe the outcomes of urgent/emergent transcatheter edge-to-edge mitral valve repair (TMVr) and compare the clinical, echocardiographic, and procedural characteristics of survivors and nonsurvivors. BACKGROUND: TMVr is a treatment strategy for select patients with severe primary or secondary mitral regurgitation. However, knowledge regarding outcomes for urgent/emergent TMVr is limited. METHODS: All urgent or emergent TMVr procedures using MitraClip performed at the University of Washington Medical Center between January 2018 and March 2019 were identified and clinical, echocardiographic, hemodynamic, procedural, and outcomes data were obtained by chart review. Outcomes included all-cause mortality, hospital mortality, procedural success, periprocedural complications, and hospital readmission. RESULTS: Of the 20 patients who underwent urgent/emergent TMVr, eight were treated for cardiogenic shock (CS), four for acute decompensated heart failure (ADHF) with hypoxemic respiratory failure requiring mechanical ventilation, and eight for ADHF with failure of inpatient medical therapy. Mechanical circulatory support (MCS) was used in six patients; preceding TMVr in three patients and immediately post-TMVr in three patients. Overall, 30-day mortality and hospital readmission rates were 21 and 13%, respectively. Over a median 153 days (IQR 20-491) of follow-up, 10 patients (50%) died. Preprocedure CS, new or ongoing MCS post-TMVr, refractory respiratory failure post-TMVr, and acute kidney injury post-TMVr were associated with mortality. CONCLUSIONS: In a single-center retrospective analysis, urgent/emergent TMVr in high-risk patients with ADHF or CS was associated with high short-term mortality and periprocedural complications. Prospective studies are warranted to inform patient selection and periprocedural management for urgent/emergent TMVr.

Eligibility for Low-Dose Rivaroxaban Based on the COMPASS Trial: Insights from the Veterans Affairs Healthcare System.

INTRODUCTION: Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population. METHODS: The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student's t tests were used to compare patients eligible versus ineligible patients. RESULTS: From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p < 0.001 for all comparisons). A median of 38.7% (IQR 4.6%) of total ASCVD patients per facility were rivaroxaban eligible. Estimated annual VA pharmacy budgetary impact would range from $0.47 billion to $1.88 billion for 25% to 100% treatment penetration. Annual facility level pharmaceutical budgetary impact would be a median of $12.3 million (IQR $8.0-$16.3 million) for treatment of all eligible patients. Among eligible patients, age greater than 65 years was the most common risk enrichment factor (86.9%). Prevalence of eligible patients with multiple enrichment factors varied from 34.2% (one factor) to 6.2% (four or more). CONCLUSION: Over one third of patients with stable ASCVD may qualify for low-dose rivaroxaban within the VA. Additional studies are needed to understand eligibility in other populations and a formal cost-effectiveness analysis is warranted.

Uncommon but devastating: Stroke after percutaneous coronary intervention.

Stroke occurs infrequently following percutaneous coronary intervention (PCI) with 30-day and 1-year cumulative incidence of 0.4 and 1.5%, respectively. Patient comorbidities, acute presentations, and complex coronary lesions are more prevalent among patients who sustain a stroke. The occurrence of stroke is associated with higher short-term and overall mortality compared with bleeding or myocardial infarction.

Initial report of safety and procedure duration of robotic-assisted chronic total occlusion coronary intervention.

BACKGROUND: No previous reports have examined the impact of robotic-assisted (RA) chronic total occlusion (CTO) PCI on procedural duration or safety compared to totally manual CTO PCI. METHODS: Among 95 patients who underwent successful PCI of a single CTO lesion at two centers, 49 (52%) were performed RA and were performed 46 (48%) totally manually. Cockpit time was the time the primary operator entered to robotic cockpit until the procedure was complete. "Theoretical" cockpit time in the control group was time the primary operator would have entered the cockpit after lesion crossing until the procedure was complete. Major adverse events (MAEs) were the composite of death, myocardial infarction, clinical perforation, significant vessel dissection, arrhythmia, acute thrombosis, and stroke. RESULTS: The lesion characteristics, procedural time, and contrast dose were similar. All procedures except for one (2%) selected for robotic completion after lesion crossing were completed successfully. The frequency of MAE was similar between groups and there were no in-hospital deaths. The cockpit time was 8 min longer in RA CTO PCI than the theoretical cockpit time in totally manual CTO PCI (40.6 ± 12.7 vs. 32.1 ± 17.8, p < .01). CONCLUSION: RA CTO PCI was not associated with excess adverse events compared with totally manual CTO PCI and resulted in an average 41 min cockpit time equaling to 48% of procedure time without radiation exposure or requirement for the primary operator to wear a lead apron. Understanding the relationship between cockpit time and reductions in radiation exposure and lead apron-related orthopedic complications for operators requires future study.

Management of Out-of-Hospital Cardiac Arrest Complicating Acute Coronary Syndromes.

PURPOSE OF THE REVIEW: Out-of-hospital cardiac arrest (OHCA) complicating acute coronary syndromes (ACS) continues to carry a high rate of morbidity and mortality despite significant advances in EMS and interventional cardiology services. In this review, we discuss an evidence-based approach to the initial care and management of patients with OHCA complicating ACS from the pre-hospital response and initial resuscitation strategy, to advanced therapies such as coronary angiography, targeted-temperature management, neuro-prognostication, and care of the post-arrest patient. RECENT FINDINGS: Early recognition of cardiac arrest and prompt initiation of bystander CPR are the most important factors associated with improved survival. A comprehensive and coordinated approach to in-hospital management, including PCI, targeted temperature management, critical care, and hemodynamic support represents a significant critical link in the chain of survival. OHCA complicated by ACS continues to be one of the most challenging disease states facing healthcare practitioners and maintains a high mortality rate despite substantial advancements in healthcare delivery. A comprehensive approach to in-hospital management and further exploration of novel interventions, including ECMO, may yield opportunities to optimize care and improve outcomes for cardiac arrest patients.

SAMe-TT2R2 predicts quality of anticoagulation in patients with acute venous thromboembolism: The MAQI2 experience.

A high SAMe-TT2R2 score predicted poor warfarin control and adverse events among atrial fibrillation patients. However, the SAMe-TT2R2 score has not been well validated in venous thromboembolism (VTE) patients. A cohort of 1943 warfarin-treated patients with acute VTE was analyzed to correlate the SAMe-TT2R2 score with time in therapeutic range (TTR) and clinical adverse events. A TTR <60% was more frequent among patients with a high (>2) versus low (0-1) SAMe-TT2R2 score (63.4% vs 52.3%, p<0.0001). A high SAMe-TT2R2 score (>2) correlated with increased overall adverse events (7.9 vs 4.5 overall adverse events/100 patient years, p=0.002), driven primarily by increased recurrent VTE rates (4.2 vs 1.5 recurrent VTE/100 patient years, p=0.0003). The SAMe-TT2R2 score had a modest predictive ability for international normalized ratio (INR) quality and adverse clinical events among warfarin-treated VTE patients. The utility of the SAMe-TT2R2 score to guide clinical decision-making remains to be investigated.

Government Regulation and Percutaneous Coronary Intervention Volume, Access and Outcomes: Insights From the Washington State Cardiac Care Outcomes Assessment Program.

Background It is unclear how to geographically distribute percutaneous coronary intervention (PCI) programs to optimize patient outcomes. The Washington State Certificate of Need program seeks to balance hospital volume and patient access through regulation of elective PCI. Methods and Results We performed a retrospective cohort study of all non-Veterans Affairs hospitals with PCI programs in Washington State from 2009 to 2018. Hospitals were classified as having (1) full PCI services and surgical backup (legacy hospitals, n=17); (2) full services without surgical backup (new certificate of need [CON] hospitals, n=9); or (3) only nonelective PCI without surgical backup (myocardial infarction [MI] access hospitals, n=9). Annual median hospital-level volumes were highest at legacy hospitals (605, interquartile range, 466-780), followed by new CON, (243, interquartile range, 146-287) and MI access, (61, interquartile range, 23-145). Compared with MI access hospitals, risk-adjusted mortality for nonelective patients was lower for legacy (odds ratio [OR], 0.59 [95% CI, 0.48-0.72]) and new-CON hospitals (OR, 0.55 [95% CI, 0.45-0.65]). Legacy hospitals provided access within 60 minutes for 90% of the population; addition of new CON and MI access hospitals resulted in only an additional 1.5% of the population having access within 60 minutes. Conclusions Many PCI programs in Washington State do not meet minimum volume standards despite regulation designed to consolidate elective PCI procedures. This CON strategy has resulted in a tiered system that includes low-volume centers treating high-risk patients with poor outcomes, without significant increase in geographic access. CON policies should re-evaluate the number and distribution of PCI programs.

Potential Impact of the 2019 ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease Recommendations on the Inappropriate Routine Use of Aspirin and Aspirin Use Without a Recommended Indication for Primary Prevention of Cardiovascular Disease in Cardiology Practices: Insights From the NCDR PINNACLE Registry.

BACKGROUND: Aspirin is recommended in patients with atherosclerotic cardiovascular disease for secondary prevention. In patients without atherosclerotic cardiovascular disease and not at high 10-year risk, there is no evidence aspirin reduces adverse cardiovascular events and it could increase bleeding. The 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease state that aspirin may be considered for primary prevention (class IIb) in patients 40 to 70 years that are at higher risk of atherosclerotic cardiovascular disease and that routine use of aspirin should be avoided (class III:Harm) for patients >70 years. We examined the frequency of patients on aspirin for primary prevention that would have been considered unindicated or potentially harmful per the recent guideline where aspirin discontinuation may be beneficial. METHODS: To assess the potential impact, within the National Cardiovascular Disease Registry Practice Innovation and Clinical Excellence Registry, we assessed 855 366 patients from 400 practices with encounters between January 1, 2018 and March 31, 2019, that were receiving aspirin for primary prevention. We defined inappropriate use as the use of aspirin in patients <40 or >70 years and use without a recommended indication as use of aspirin in patients 40 to 70 years with low, borderline, or intermediate 10-year atherosclerotic cardiovascular disease risk. Frequency of inappropriate use and use without a recommended indication were calculated and practice-level variation was evaluated using the median rate ratio. RESULTS: Inappropriate use occurred in 27.6% (193 674/701 975) and use without a recommended indication in 26.0% (31 810/122 507) with significant practice-level variation in inappropriate use (predicted median practice-level rate 33.5%, interquartile range, 24.1% to 40.8%; median rate ratio, 1.71 [95% CI, 1.67-1.76]). CONCLUSIONS: Immediately before the 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease, over one-fourth of patients in this national registry were receiving aspirin for primary prevention inappropriately or without a recommended indication with significant practice-level variation. These findings help to determine the potential impact of guideline recommendations on contemporary use of aspirin for primary prevention.

Temporal Trends in Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting: Insights From the Washington Cardiac Care Outcomes Assessment Program.

Background Patient selection and outcomes for percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) have changed over the past decade. However, there is limited information on outcomes for both revascularization strategies in the same population. The study evaluated temporal changes in risk profile, procedural characteristics, and clinical outcomes for PCI- and CABG-treated patients. Methods and Results We analyzed all PCI and isolated CABG between 2005 and 2017 in nonfederal hospitals in Washington State. Descriptive analysis was performed to evaluate temporal changes in risk profile and, risk-adjusted in-hospital mortality. Over the study period, 178 474 PCI and 36 592 CABG procedures were performed. PCI and CABG volume decreased by 2.9% and 22.6%, respectively. Compared with 2005-2009, patients receiving either form of revascularization between 2014 and 2017 had a higher prevalence of comorbidities including diabetes mellitus and hypertension and dialysis. Presentation with ST-segment-elevation myocardial infarction (17% versus 20%) and cardiogenic shock (2.4% versus 3.4%) increased for patients with PCI compared with CABG. Conversely, clinical acuity decreased for patients receiving CABG over the study period. From 2005 to 2017, mean National Cardiovascular Data Registry CathPCI mortality score increased for patients treated with PCI (20.1 versus 22.4, P<0.0001) and decreased for patients treated with CABG (18.8 versus 17.8, P<0.0001). Adjusted observed/expected in-hospital mortality ratio increased for PCI (0.98 versus 1.19, P<0.0001) but decreased for CABG (1.21 versus 0.74, P<0.0001) over the study period. Conclusions Clinical acuity increased for patients treated with PCI rather than CABG. This resulted in an increase in adjusted observed/expected mortality ratio for patients undergoing PCI and a decrease for CABG. These shifts may reflect an increased use of PCI instead of CABG for patients considered to be at high surgical risk.

Association of Body Mass Index With Risk Factor Optimization and Guideline-Directed Medical Therapy in US Veterans With Cardiovascular Disease.

BACKGROUND: Obesity is a growing epidemic that has been linked to the development of cardiovascular disease (CVD). Guideline-directed medications for secondary prevention and risk factor control are recommended for patients with all forms of CVD. The association of body mass index (BMI) with use of medications for secondary prevention and risk factor control in patients with CVD are poorly understood. METHODS AND RESULTS: We identified 1 122 567 patients with CVD receiving care in 130 Veterans Affairs facilities from October 1, 2013, to September 30, 2014. Five groups were stratified by BMI-underweight (BMI, <18.5 kg/m2), normal (BMI, 18.5-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obese (BMI, 30-39.9 kg/m2), and extremely obese (BMI, ≥40 kg/m2). A composite of 4 measures-blood pressure <140/90 mm Hg, hemoglobin A1c ≤9% in diabetic patients, statin use, and antiplatelet use-termed optimal medial therapy (OMT) was compared among groups. Multivariable logistic regression was performed with normal BMI as the referent category. Underweight patients comprised 12 623 (1.1%), normal BMI 230 471 (20.5%), overweight 413 590 (36.8%), obese 404 105 (36%), and extremely obese 61 778 (5.5%) of the cohort. Only 43.7% of the entire cohort received OMT, and this was the highest in the overweight group. Adjusted odds ratios for receiving OMT were 0.81 (95% CI, 0.77-0.85), 1.11 (95% CI, 1.10-1.13), 1.08 (95% CI, 1.06-1.09), and 0.87 (95% CI, 0.85-0.89), for patients who were underweight, overweight, obese, and extremely obese, respectively, compared with normal BMI. CONCLUSIONS: OMT was low in the entire cohort. There is an inverse U-shaped relationship between OMT and BMI with patients who are underweight and extremely obese less likely to receive OMT compared with patients with normal BMI.

Valve durability after transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure to treat severe symptomatic aortic stenosis. While the TAVI procedure can be performed safely and provide excellent 5-year results, little is known about long-term durability. TAVI valves are composed of bioprosthetic leaflets are prone to deterioration, which are categorized as structural valve deterioration (SVD) and non-SVD. SVD refers to an intrinsic pathology of the leaflets or stent structure with mechanisms that include leaflet calcification, leaflet tear, stent fracture, or stent creep. Non-SVD processes include valve thrombosis, infective endocarditis and patient prosthesis mismatch. TAVI valves degenerate by similar mechanisms as bioprosthetic surgical aortic valves. Unique mechanisms that contribute to TAVI degeneration include valve crimpling, balloon expansion, stent under-expansion and valve thrombosis. The absence of a universally accepted definition of SVD poses a challenge in estimating valve durability. Traditional surgical bioprosthetic aortic valves have demonstrated excellent durability with clinically relevant SVD of 6.6% at 10-year follow up. Long-term durability of TAVI valves, however, remain poorly defined. From meta-analysis TAVI trials, SVD was estimated at 7% at 5 years. With iterative improvements in TAVI valve construction and deployment techniques, long-term durability may improve. Until long-term outcomes are better understood, TAVI should be used with caution in younger patients.

Evaluating the role of clinical pharmacists in pre-procedural anticoagulation management.

OBJECTIVES: While physicians are typically responsible for managing perioperative warfarin, clinic pharmacists may improve pre-procedural decision-making. We assessed the impact of pharmacist-driven care for chronic warfarin-treated patients undergoing outpatient right heart catheterization (RHC). METHODS: 200 warfarin patients who underwent RHC between January 2012 and September 2015 were analyzed. Pharmacist-care (n = 79) was compared to the usual care model (n = 121). The primary outcome was a composite of (1) documentation of anticoagulation plan, (2) holding warfarin at least 5 days prior to procedure, (3) guideline-congruent low molecular weight heparin (LMWH) bridging, and (4) correct LMWH dosing if bridging deemed necessary. Chi-squared test performed to assess the role of pharmacist. A multivariable logistic regression analysis was performed to the composite endpoint, adjusted for the month of procedure. RESULTS: Compared to the usual care model, pharmacist-driven care (OR 4.69, 95% CI 1.73-12.71, p = 0.002) and date of the procedure (OR 1.06/month, 95% CI 1.01-1.10, p = 0.011) were independently associated with the primary composite outcome. Of the individual outcome components, pharmacist-driven care was only associated with documentation (96.2% vs. 67.8%, OR 9.19, 95% CI 2.19-38.62, p = 0.002). Remaining components including hold warfarin for at least 5 days, appropriate bridging and correct LMWH dosing were not significantly associated with pharmacist-care. CONCLUSIONS: Pharmacist-care is associated with better guideline-based anticoagulation management, but this was primarily driven by improved documentation. The impact of pharmacist managed peri-procedural anticoagulation on clinical outcomes remains unknown.