Effect of Pharmacist Clinic Visits on 30-Day Heart Failure Readmission Rates at a County Hospital

Purpose: This study evaluated the comparative effectiveness of different pharmacist visit types on reducing readmission rates. Method: A single-center, retrospective cohort study was conducted from January 2015 to July 2017. Patients were 18 years or older with an index heart failure (HF) exacerbation admission. Upon hospital discharge, patients were seen in clinic by a clinical pharmacy specialist (CPS) with collaborative practice agreement (CPA) (High Intensity Bundle), medication therapy management (MTM) pharmacist without CPA (Low Intensity Bundle), or no pharmacist (Standard of Care [SOC]). The primary outcome was 30-day all-cause readmission rate. Secondary outcomes included rate of 30-day HF readmissions and average number of days until readmission in those who were readmitted. Results: Totally, 98 patients were included in the final analysis (35 High Intensity Bundle, 28 Low Intensity Bundle, and 35 SOC). The primary outcome of all-cause readmissions was lower in both the pharmacist groups compared with SOC (CPS 8.6% [3/35] vs SOC 25.7% [9/35], P = 0.046 and MTM 7.1% [2/28] vs SOC 25.7% [9/35], P = 0.057). Incremental differences were seen between visit types for the secondary outcome of 30-day HF readmissions (CPS 2.9% vs MTM 7.1% vs SOC 17.1%, P = 0.039). The average number of days until readmission was longer in the CPS versus the MTM and SOC (26.7 days vs 12.5 days vs 14.1 days, respectively). Conclusion: Post-hospital discharge pharmacist visits were associated with lower 30-day all-cause readmission. In particular, clinic visits with a Higher Intensity Bundle may be more effective in reducing HF readmissions. These exploratory findings warrant further investigation.

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Abstract 14984: Post-Discharge Beta-Blockers and Early Mortality and Readmission in Older Patients With Heart Failure: An Instrumental Variable Analysis

Circulation ◽

10.1161/circ.142.suppl_3.14984 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Lauren Gilstrap ◽

Andrea Austin ◽

Barbara Gladders ◽

Amber Barnato ◽

Anna Tosteson ◽

...

Keyword(s):

Heart Failure ◽

Hospital Discharge ◽

Beta Blocker ◽

Instrumental Variable ◽

Older Patients ◽

Early Mortality ◽

Secondary Outcome ◽

Readmission Rates ◽

Instrumental Variable Analysis ◽

Variable Analysis

Introduction: The rate of growth of the older heart failure population has outpaced that of any other age group. Importantly, these older patients were underrepresented in the early beta-blocker trials and there are several reasons, including a decreased potential for mortality benefit and an increased risk of side effects, why the risk/benefit trade-off may be different in this older population. Hypothesis: The association between receipt of a beta-blocker at the time of hospital discharge and early mortality and readmissions in heart failure with reduced ejection fraction (HFrEF) patients aged ≥75 is not significantly different than among HFrEF patients <75 years old. Methods: We used 100% Medicare Parts A and B and a random 40% sample of Part D to create a cohort of beneficiaries with ≥1 hospitalization for HFrEF between 2008 and 2016 and determined beta-blocker use at hospital discharge. The primary outcome was 90-day, all-cause mortality; the secondary outcome was 90-day, all-cause readmission. To address both measured and unmeasured confounding, we used the two-stage least squared instrumental variable analysis method. Results: Among all HFrEF patients, receipt of a beta-blocker at the time of discharge was associated with a -4.34% (95% CI -6.26% to -2.42%, p<0.001) decrease in 90-day mortality and a -4.67% (95% CI -7.41% to -1.91%, p=0.001) decrease in 90-day readmission rates. Among patients >75 years old, receipt of a beta-blocker was also associated with a significant -4.74% decrease (95% CI -7.13% to -2.34%, p<0.001) in 90-day mortality and a -4.67% (95% CI -8.96% to -2.93%, p<0.00) decrease in 90-day readmissions. Conclusions: We find that patients aged ≥75 years who receive a beta-blocker at HFrEF discharge have significantly lower 90-day mortality and readmission rates. The magnitude of benefit from beta-blocker therapy after HFrEF discharge does not appear to wane with age.

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Impact of Pharmacy Student–Driven Postdischarge Telephone Calls on Heart Failure Hospital Readmission Rates: A Pilot Program

Hospital Pharmacy ◽

10.1177/0018578718769243 ◽

2018 ◽

Vol 54 (2) ◽

pp. 100-104 ◽

Cited By ~ 3

Author(s):

Roda Plakogiannis ◽

Ana Mola ◽

Shreya Sinha ◽

Abraham Stefanidis ◽

Hannah Oh ◽

...

Keyword(s):

Heart Failure ◽

Hospital Discharge ◽

Hospital Readmission ◽

Pharmacy Students ◽

Pharmacy Student ◽

Pilot Program ◽

Readmission Rates ◽

Phone Calls ◽

Hospital Readmission Rates ◽

Telephone Calls

Background: Heart failure (HF) hospitalization rates have remained high in the past 10 years. Numerous studies have shown significant improvement in HF readmission rates when pharmacists or pharmacy residents conduct postdischarge telephone calls. Objective: The purpose of this retrospective review of a pilot program was to evaluate the impact of pharmacy student–driven postdischarge phone calls on 30- and 90-day hospital readmission rates in patients recently discharged with HF. Methods: A retrospective manual chart review was conducted for all patients who received a telephone call from the pharmacy students. The primary endpoint compared historical readmissions, 30 and 90 days prior to hospital discharge, with 30 and 90 days post discharge readmissions. For the secondary endpoints, historical and postdischarge 30-day and 90-day readmission rates were compared for patients with a primary diagnosis of HF and for patients with a secondary diagnosis of HF. Descriptive statistics were calculated in the form of means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Results: Statistically significant decrease was observed for both the 30-day ( P = .006) and 90-day ( P = .007) readmission periods. Prior to the pharmacy students’ phone calls, the overall group of 131 patients had historical readmission rates of 24.43% within 30 days and 38.17% within 90 days after hospital discharge. After the postdischarge phone calls, the readmission rates decreased to 11.45%, for 30 days, and 22.90%, for 90 days. Conclusion: Postdischarge phone calls, specifically made by pharmacy students, demonstrated a positive impact on reducing HF-associated hospital readmissions, adding to the growing body of evidence of different methods of pharmacy interventions and highlighting the clinical impact pharmacy students may have in transition of care services.

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Reduction of 30-Day Hospital Readmissions after Patient-centric Telephonic Medication Therapy Management Services

Hospital Pharmacy ◽

10.1310/hpj5111-907 ◽

2016 ◽

Vol 51 (11) ◽

pp. 907-914 ◽

Cited By ~ 5

Author(s):

Daryl E. Miller ◽

Teresa E. Roane ◽

Karen D. McLin

Keyword(s):

Hospital Discharge ◽

Hospital Readmission ◽

Hospital Readmissions ◽

Medication Therapy Management ◽

Medication List ◽

Readmission Rates ◽

Therapy Management ◽

Medication Therapy ◽

Hospital Readmission Rates ◽

Significant Difference

Background Transitional care programs are a growing topic in health care systems across the country, with a focus on achieving a reduction in hospital readmissions and improving patient and medication safety. Numerous strategies have been employed and studied to determine successful approaches to patient transition from the hospital setting to the home setting. Pharmacist-mediated postdischarge telephonic outreach has demonstrated decreased hospital readmission rates in multiple hospital systems. Objective To evaluate the effectiveness of pharmacist-facilitated telephonic medication therapy management (MTM) services on reducing hospital readmissions. Methods A retrospective chart analysis ( n = 314) was performed for patients who received MTM services following hospital discharge between February 23, 2014 and July 4, 2014. The primary outcome was 30-day all-cause readmission. The secondary outcomes were identification of pharmacist interventions for and recommendations about medication-related problems and discrepancies found between the patients' reported medication list and the hospital discharge medication list. Results The data revealed no statistically significant difference in hospital readmission rates between the intervention and control groups (odds ratio, 1.04; 95% CI, 0.68–1.60). Pharmacists intervened on 189 medication-related problems via facsimile to the prescriber (35.7% of charts), contacted prescribers by phone for 23 medication-related or health-related issues, and identified 823 medication list discrepancies (78.34% of charts). Conclusion Although the provision of telephonic MTM services by pharmacists did not result in an improvement in the readmission rate during this study period, pharmacists were able to intervene on numerous medication-related problems and medication list discrepancies.

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P3518Men with heart failure have higher readmission rates: a closer review of sex and gender based analyses

European Heart Journal ◽

10.1093/eurheartj/ehz745.0382 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Hoang-Kim ◽

C Parpia ◽

C Freitas ◽

P C Austin ◽

H J Ross ◽

...

Keyword(s):

Heart Failure ◽

Sex Differences ◽

Full Text ◽

Primary Outcome ◽

Search Strategy ◽

Rater Agreement ◽

Readmission Rates ◽

Gender Based ◽

One Year

Abstract Background There has been increased attention on reducing hospital readmission rates. However, little is known about any difference in readmission rates in heart failure by sex, although evidence exists demonstrating differences in the etiology of heart failure. As a result, strategies to optimize readmission reduction programs and care strategies for women and men remain unclear. Purpose (1) To identify studies examining readmission rates according to sex, and (2) to provide a qualitative overview of possible considerations for the impact of sex or gender. Methods A scoping protocol was developed using the Arksey and O'Malley framework and the Joanna Briggs Institute methodology. Our search strategy was reviewed according to the peer-review of electronic search strategy (PRESS) checklist. Full text articles published between 2002 and 2017 and drawn from multiple databases (i.e. MEDLINE, EMBASE), grey literature (i.e. National Technical Information, Duck Duck Go), and experts were consulted for additional articles. Screening criteria were established a priori. Once an acceptable inter-rater agreement was established at 80% by two independent reviewers, articles were screened for potential eligibility. A descriptive analytical method was employed to chart primary research articles. Articles were considered relevant if the cohort consisted of adult heart failure patients who were readmitted after an index hospitalization and a sex/gender-based analysis was performed. Results The literature search yielded 5887 articles, of which 746 underwent full text assessment for eligibility. Of 164 eligible articles, 34 studies addressed the primary outcome, 103 studies considered sex differences as a secondary outcome and 25 studies included disaggregated data for sex but no subsequent interaction was reported. Good inter-rater agreement was reached: 83% for title and abstract screening; 88% for full text review; kappa: 0.69 (95% CI: 0.526–0.851). Twelve of 34 studies included for the primary outcome reported higher readmission rates for men compared to five studies reporting higher readmission rates for women. However, there were differential readmission rates that were dependent on duration of follow-up. Women were more likely to experience higher readmission rates than men when time to event was less than one year. Readmission rates for men were higher when follow-up was longer than one year. Conclusion Sex differences in readmission rates were dependent on follow up time. Most studies used composite outcomes and had short times to event, which may mask underlying effects of sex on readmission. Acknowledgement/Funding Ontario SPOR Support Unit

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Serum syndecan-1 concentration in hospitalized patients with heart failure may predict readmission-free survival

PLoS ONE ◽

10.1371/journal.pone.0260350 ◽

2021 ◽

Vol 16 (12) ◽

pp. e0260350

Author(s):

Yuichiro Kitagawa ◽

Itta Kawamura ◽

Keiko Suzuki ◽

Hideshi Okada ◽

Takuma Ishihara ◽

...

Keyword(s):

Heart Failure ◽

Primary Outcome ◽

Cox Regression ◽

Kidney Injury ◽

Endothelial Glycocalyx ◽

Secondary Outcome ◽

Regression Analyses ◽

Free Survival ◽

Patients With Heart Failure ◽

The Relationship

Syndecan-1 is found in the endothelial glycocalyx and is released into the bloodstream during stressed conditions, including severe diseases such as acute kidney injury, chronic kidney disease, and cardiovascular disease. This study investigated the prognostic value of serum syndecan-1 concentration in patients with heart failure upon admission. Serum syndecan-1 concentration was analyzed in 152 patients who were hospitalized for worsening heart failure from September 2017 to June 2018. The primary outcome of the study was readmission-free survival, defined as the time from the first admission to readmission for worsened heart failure or death from any cause, which was assessed at 30 months after discharge from the hospital. The secondary outcome of the study was survival time. Blood samples and echocardiogram data were analyzed. Univariate and multivariable time-dependent Cox regression analyses adjusted for age, creatinine levels, and use of antibiotics were conducted. The serum syndecan-1 concentration was significantly associated with readmission-free survival. Subsequently, the syndecan-1 concentration may have gradually decreased with treatment. The administration of human atrial natriuretic peptide and antibiotics may have modified the relationship between readmission-free survival and serum syndecan-1 concentration (p = 0.01 and 0.008, respectively). Serum syndecan-1 concentrations, which may indicate injury to the endothelial glycocalyx, predict readmission-free survival in patients with heart failure.

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Hemodynamic profiles by non-invasive monitoring of cardiac index and vascular tone in acute heart failure patients in the emergency department: external validation and clinical outcomes

10.1101/2021.11.18.21266430 ◽

2021 ◽

Author(s):

Nicholas Eric Harrison ◽

Sarah Meram ◽

Xiangrui Li ◽

Patrick Medado ◽

Morgan B White ◽

...

Keyword(s):

Heart Failure ◽

Emergency Department ◽

Cardiac Index ◽

Acute Heart Failure ◽

Vascular Tone ◽

Primary Outcome ◽

De Novo ◽

Risk Scores ◽

Secondary Outcome ◽

Non Invasive

Abstract Background Non-invasive finger-cuff monitors measuring cardiac index and vascular tone (SVRI) classify emergency department (ED) patients with acute heart failure (AHF) into three otherwise-indistinguishable subgroups. Our goals were to validate these hemodynamic profiles in an external cohort and assess their association with clinical outcomes. Methods AHF patients (n=257) from five EDs were prospectively enrolled in the validation cohort (VC). Cardiac index and SVRI were measured with a ClearSight finger-cuff monitor (formerly NexFin, Edwards Lifesciences) as in a previous study (derivation cohort, DC, n=127). A control cohort (CC, n=127) of ED patients with sepsis was drawn from the same study as the DC. K-means cluster analysis previously derived two-dimensional (cardiac index and SVRI) hemodynamic profiles in the DC and CC (k=3 profiles each). The VC was subgrouped de novo into three analogous profiles by unsupervised K-means consensus clustering. PERMANOVA tested whether VC profiles 1-3 differed from profiles 1-3 in the DC and CC, by multivariate group composition of cardiac index and vascular tone. Profiles in the VC were compared by a primary outcome of 90-day mortality and a 30-day ranked composite secondary outcome (death, mechanical cardiac support, intubation, new/emergent dialysis, coronary intervention/surgery) as time-to-event (survival analysis) and binary events (odds ratio, OR). Descriptive statistics were used to compare profiles by two validated risk scores for the primary outcome, and one validated score for the secondary outcome. Results The VC had median age 60 years (interquartile range {49-67}), and was 45% (n=116) female. Multivariate profile composition by cardiac index and vascular tone differed significantly between VC profiles 1-3 and CC profiles 1-3 (p=0.001, R2=0.159). A difference was not detected between profiles in the VC vs. the DC (p=0.59, R2=0.016). VC profile 3 had worse 90-day survival than profiles 1 or 2 (HR = 4.8, 95%CI 1.4-17.1). The ranked secondary outcome was more likely in profile 1 (OR = 10.0, 1.2-81.2) and profile 3 (12.8, 1.7-97.9) compared to profile 2. Diabetes prevalence and blood urea nitrogen were lower in the high-risk profile 3 (p<0.05). No significant differences between profiles were observed for other clinical variables or the 3 clinical risk scores. Conclusions Hemodynamic profiles in ED patients with AHF, by non-invasive finger-cuff monitoring of cardiac index and vascular tone, were replicated de novo in an external cohort. Profiles showed significantly different risks of clinically-important adverse patient outcomes.

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Effect of bromhexine in hospitalized patients with COVID-19

Journal of Investigative Medicine ◽

10.1136/jim-2020-001747 ◽

2021 ◽

pp. jim-2020-001747

Author(s):

Ramin Tolouian ◽

Zuber D Mulla ◽

Hamidreza Jamaati ◽

Abdolreza Babamahmoodi ◽

Majid Marjani ◽

...

Keyword(s):

Hospital Discharge ◽

Clinical Improvement ◽

Primary Outcome ◽

Adverse Drug Events ◽

Antiviral Effect ◽

Hospitalized Patients ◽

Secondary Outcome ◽

Risk Of Death ◽

Significant Difference ◽

Transmembrane Serine Protease

BackgroundBromhexine is a potent inhibitor of transmembrane serine protease 2 and appears to have an antiviral effect in controlling influenza and parainfluenza infection; however, its efficacy in COVID-19 is controversial.MethodsA group of hospitalized patients with confirmed COVID-19 pneumonia were randomized using 1:1 allocation to either standard treatment lopinavir/ritonavir and interferon beta-1a or bromhexine 8 mg four times a day in addition to standard therapy. The primary outcome was clinical improvement within 28 days, and the secondary outcome measures were time to hospital discharge, all-cause mortality, duration of mechanical ventilation, the temporal trend in 2019-nCoV reverse transcription-polymerase chain reaction positivity and the frequency of adverse drug events within 28 days from the start of medication.ResultsA total of 111 patients were enrolled in this randomized clinical trial and data from 100 patients (48 patients in the treatment arm and 52 patients in the control arm) were analyzed. There was no significant difference in the primary outcome of this study, which was clinical improvement. There was no significant difference in the average time to hospital discharge between the two arms. There were also no differences observed in the mean intensive care unit stay, frequency of intermittent mandatory ventilation, duration of supplemental oxygenation or risk of death by day 28 noted between the two arms.ConclusionBromhexine is not an effective treatment for hospitalized patients with COVID-19. The potential prevention benefits of bromhexine in asymptomatic postexposure or with mild infection managed in the community remain to be determined.

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Prognostic value of reduction in left atrial size during a follow-up of heart failure: an observational study

BMJ Open ◽

10.1136/bmjopen-2020-044409 ◽

2021 ◽

Vol 11 (2) ◽

pp. e044409

Author(s):

Masayuki Shiba ◽

Takao Kato ◽

Takeshi Morimoto ◽

Hidenori Yaku ◽

Yasutaka Inuzuka ◽

...

Keyword(s):

Heart Failure ◽

Lower Risk ◽

Left Atrial ◽

Primary Outcome ◽

Outcome Measure ◽

No Reduction ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Group Change

ObjectiveThe association between sequential changes in left atrial diameter (LAD) and prognosis in heart failure (HF) remains to be elucidated. The present study aimed to investigate the link between reduction in LAD and clinical outcomes in patients with HF.DesignA multicentre prospective cohort study.SettingThis study was nested from the Kyoto Congestive Heart Failure registry including consecutive patients admitted for acute decompensated heart failure (ADHF) in 19 hospitals throughout Japan.ParticipantsThe current study population included 673 patients with HF who underwent both baseline and 6-month follow-up echocardiography with available paired LAD data. We divided them into two groups: the reduction in the LAD group (change <0 mm) (n=398) and the no-reduction in the LAD group (change ≥0 mm) (n=275).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or hospitalisation for HF during 180 days after 6-month follow-up echocardiography. The secondary outcome measures were defined as the individual components of the primary composite outcome measure and a composite of cardiovascular death or hospitalisation for HF.ResultsThe cumulative 180-day incidence of the primary outcome measure was significantly lower in the reduction in the LAD group than in the no-reduction in the LAD group (13.3% vs 22.2%, p=0.002). Even after adjusting 15 confounders, the lower risk of reduction in LAD relative to no-reduction in LAD for the primary outcome measure remained significant (HR 0.59, 95% CI 0.36 to 0.97 p=0.04).ConclusionPatients with reduction in LAD during follow-up after ADHF hospitalisation had a lower risk for a composite endpoint of all-cause death or HF hospitalisation, suggesting that the change of LAD might be a simple and useful echocardiographic marker during follow-up.

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Evaluation of the Clinical Impact of Thromboprophylaxis in Patients With COVID-19 Following Hospital Discharge

Annals of Pharmacotherapy ◽

10.1177/10600280211064306 ◽

2022 ◽

pp. 106002802110643

Author(s):

Lindsay A. Courtney ◽

Toby C. Trujillo ◽

Joseph J. Saseen ◽

Garth Wright ◽

Surabhi Palkimas

Keyword(s):

Hospital Discharge ◽

Thromboembolic Event ◽

Primary Outcome ◽

Bleeding Event ◽

Secondary Outcome ◽

Bleeding Events ◽

Post Discharge ◽

University Of Colorado ◽

Discharge Outcomes

Background: Data are limited regarding the incidence of thromboembolism post-hospital discharge among COVID-19 patients. Guidelines addressing the role of extended thromboprophylaxis for COVID-19 patients are limited and conflicting. Objective: The purpose of this study was to evaluate the incidence of post-discharge thromboembolic and bleeding events and the role of thromboprophylaxis among COVID-19 patients. Methods: A retrospective analysis was conducted of hospitalized patients with symptomatic COVID-19 infection who were discharged from a University of Colorado Health (UCHealth) hospital between March 1, 2020, and October 31, 2020. The primary outcome was objectively confirmed thromboembolism within 35 days post-discharge. The main secondary outcome was the incidence of bleeding events within 35 days post-discharge. Outcomes were compared between those who received extended prophylaxis and those who did not. Results: A total of 1171 patients met the study criteria. A total of 13 (1.1%) of patients had a documented thromboembolic event and 10 (0.9%) patients had a documented bleeding event within 35 days post-discharge. None of the 132 patients who received extended prophylaxis had a thromboembolic event compared to 13 of 1039 who did not receive extended prophylaxis (0 and 1.3%, respectively; P = .383). The incidence of bleeding was higher among patients who received extended prophylaxis compared to those who did not (3.0% vs 0.6%, P = .019). Conclusions and Relevance: These results suggest that post-discharge extended prophylaxis may be beneficial for select COVID-19 patients, while carefully weighing the risk of bleeding. Application of our findings may assist institutions in development of thromboprophylaxis protocols for discharged COVID-19 patients.

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Abstract 12936: Impact of Mitral Regurgitation on Heart Failure Hospitalization and Mortality in Older Age Adults With a Preserved Ejection Fraction

Circulation ◽

10.1161/circ.142.suppl_3.12936 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Ginger Y Jiang ◽

Warren J Manning ◽

Lawrence Markson ◽

A. R Garan ◽

Marwa A Sabe ◽

...

Keyword(s):

Heart Failure ◽

Mitral Regurgitation ◽

Ejection Fraction ◽

Primary Outcome ◽

Secondary Outcome ◽

P Value ◽

Preserved Ejection Fraction ◽

Risk Of Death ◽

Increased Risk ◽

All Cause Mortality

Background: The effect of mitral regurgitation (MR) severity on heart failure (HF) hospitalization and mortality in individuals with a preserved ejection fraction (LVEF) and no prior HF history is uncertain. Methods: Transthoracic echocardiogram (TTE) reports from patients with an LVEF > 50% at our institution were linked to complete Medicare inpatient claims, 2003-2017. Patients with HF hospitalization within the 12 months prior to TTE were excluded. We evaluated the relationship of baseline MR severity and time to the composite of all-cause mortality or HF hospitalization using the Kaplan-Meier technique. Secondary outcomes included the individual components of all-cause mortality and HF hospitalization, adjusting for the competing risk of death with Fine-Gray methods. Results: A total of 18,315 individuals met inclusion criteria (77.6 ±7.7 years, 54.3% female). Over a median follow-up time of 6.5 (IQR 3.0 to 10.2) years, the primary endpoint occurred in 7566 individuals (50.6%) of whom 6,927 (37.8%) died and 1703 (13.9%) were admitted for HF at a median of 1.4 (IQR 0.2 to 4.3) years and 1.6 (IQR 0.2 to 4.3) years respectively ( Figure ). After multivariable adjustment, MR severity was not associated with the primary or secondary outcome at 1-, 3-, 5-, or 10-years after TTE (p > 0.05 for all). Mitral valve prolapse (MVP) was associated with decreased risk of the primary outcome at 1-year and 3-years (interaction p-value = 0.04 for both). Jet eccentricity did not impact the observed relationship (interaction p-value > 0.05). Conclusions: In this large, single institution echocardiographic study of individuals with preserved ejection fraction and no prior history of HF, MR severity was not associated with an increased risk of all-cause mortality or HF hospitalization. Presence of MVP was associated with decreased risk of the primary outcome with increasing MR severity.

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