Team-based home blood pressure monitoring for blood pressure equity a protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Home Blood Pressure Monitoring (HBPM) that includes a team with a clinical pharmacist is an evidence-based intervention that improves blood pressure (BP). Yet, strategies for promoting its adoption in primary care are lacking. We developed potentially feasible and sustainable implementation strategies to improve hypertension control and BP equity. METHODS: We assessed barriers and facilitators to HBPM and iteratively adapted implementation strategies through key informative interviews and guidance from a multistakeholder stakeholder team involving investigators, clinicians, and practice administration. RESULTS: Strategies include: 1) pro-active outreach to patients; 2) provision of BP devices; 3) deployment of automated bidirectional texting to support patients through education messages for patients to transmit their readings to the clinical team; 3) a hypertension visit note template; 4) monthly audit and feedback reports on progress to the team; and 5) training to the patients and teams. We will use a stepped wedge randomized trial to assess RE-AIM outcomes. These are defined as follows Reach: the proportion of eligible patients who agree to participate in the BP texting; Effectiveness: the proportion of eligible patients with their last BP reading <140/90 (six months); Adoption: the proportion of patients invited to the BP texting; Implementation: patients who text their BP reading ≥10 of days per month; and Maintenance: sustained BP control post-intervention (twelve months). We will also examine RE-AIM metrics stratified by race and ethnicity. CONCLUSIONS: Findings will inform the impact of strategies for the adoption of team-based HPBM and the impact of the intervention on hypertension control and equity. REGISTRATION DETAILS: www. CLINICALTRIALS: gov Identifier: NCT05488795.

Outcomes Associated with Introduction of the 5th Generation High-Sensitivity Cardiac Troponin in Patients Presenting with Cardiovascular Disorders.

BACKGROUND: The new high-sensitivity cardiac troponin T (hs-cTnT) is now widely used in the United States. OBJECTIVES: We aimed to examine outcomes associated with the introduction of the new 5th generation hs-cTnT assay among patients presenting to the emergency department (ED) with cardiovascular (CV) disorders. METHODS: The study comprised 5377 patients presenting to the ED with CV disorders between January and September 2018. Outcomes included rates of direct ED discharge, cardiac testing/procedures, and mortality. CV indications for troponin testing were categorized as rule-out acute coronary syndrome (RO-ACS) and other-CV (O-CV). RESULTS: Mean age was 62 ± 17 years, and 47% were female. Demographics and medical history did not differ significantly between the troponin groups. The use of hs-cTnT was associated with increased rates of direct discharge from the ED in the RO-ACS (48% vs. 37%; p < 0.01), but not in the O-CV (25% vs. 25%) cohort. Cardiac tests/procedures were more often performed after hs-cTnT vs. cTnT testing in both cohorts (45% vs. 41% for RO-ACS, and 33% vs. 28% for O-CV; p < 0.05 for both). Multivariate analysis demonstrated that hs-cTnT was not associated with a significant increase in postdischarge mortality in both cohorts (RO-ACS: hazard ratio = 1.47 [p = 0.13], O-CV: hazard ratio = 0.97 [p = 0.87]). CONCLUSIONS: Among patients with RO-ACS, hs-cTnT implementation resulted in increased rates of direct home discharge from the ED, without a significant increase in postdischarge mortality. Among patients presenting with O-CV indication, hs-cTnT implementation resulted in increased rates of cardiac testing procedures without an effect of ED discharge rates or long-term mortality.

Low Blood Pressure Threshold for Adverse Outcomes During Left Ventricular Assist Device Support.

It has been suggested that maintaining low mean arterial pressure (MAP) in left ventricular assist device (LVAD) recipients is associated with a reduced risk of stroke/death. However, the lower limit of the optimal MAP range has not been established. We aimed to identify this lower limit in a contemporary cohort of LVAD recipients with frequent longitudinal MAP measurements. We analyzed 86,651 MAP measurements in 309 patients with an LVAD (32% LVADs with full magnetic levitation of the impeller) at a tertiary medical center during a mean follow-up of 1.7 ± 1.1 years. Cox proportional hazards regression modeling was used to study the association of serial MAP measurements with stroke/death within 3 years after index discharge. Multivariate analysis identified MAP ≤75 mm Hg, compared with MAP >75 mm Hg, as the low MAP threshold associated with increased risk of death (hazard ratio [HR] 4.74, 95% confidence interval [CI] 2.85 to 7.87, p <0.001), stroke (HR 2.72;, 95% CI 1.39 to 5.33, p = 0.01), and stroke/death (HR 4.45, 95% CI 2.83 to 6.99, p <0.001). The risk associated with MAP ≤75 mm Hg was consistent in subgroups categorized by age, gender, race, device type, renal function, right-sided heart failure, and blood pressure medications. In conclusion, our findings suggest that maintaining MAP ≤75 mm Hg during long-term follow-up in LVAD recipients is associated with increased risk of stroke/death regardless of risk factors or medical management.

Outcomes associated with the high sensitivity cardiac troponin testing in patients presenting with non-cardiovascular disorders.

There are limited data regarding the utility of troponin testing in patients presenting with non-cardiovascular (CV) symptoms as the primary manifestation. The study population comprised 2057 patients who presented to the emergency department (ED) of a US healthcare system with non-CV symptoms as the primary manifestation between January and September 2018. We compared the effect of high-sensitivity cardiac troponin T (hs-cTnT) (n = 901) after its introduction vs. 4th generation cTnT (n = 1156) on the following outcomes measures: ED length of stay (LOS), coronary tests/procedures (angiography or stress test), and long-term mortality. Mean age was 64 ± 17 yrs., and 47% were female. Primary non-CV manifestations included pneumonia, obstructive pulmonary disease, infection, abdominal-complaint, and renal failure. Mean follow up was 9 ± 4 months. Patients' demographics and medical history were clinically similar between the two troponin groups. A second cTn test was obtained more frequently in the hs-cTnT than cTnT (84% vs. 32%; p < 0.001), possibly leading to a longer ED stay (8.1 ± 8.2 h vs 5.6 ± 3.4 h, respectively; p < 0.001). Coronary tests/procedures were performed at a significantly higher rate in the hs-cTnT than cTnT following the introduction of the hs-cTnT test (28% vs. 22%, p < 0.001). Multivariate analysis showed that following the introduction of hs-cTnT testing, there was a significant 27% lower risk of long-term mortality from ED admission through follow-up (HR = 0.73, 95%CI 0.54-0.98; p = 0.035). In conclusion, we show that in patients presenting primarily with non-CV disorders, the implementation of the hs-cTnT was associated with a higher rate of diagnostic coronary procedures/interventions, possibly leading to improved long-term survival rates.

Cost-impact analysis of baroreflex activation therapy in chronic heart failure patients in the United States.

BACKGROUND: The study evaluated the cost of baroreflex activation therapy plus guideline directed therapy (BAT + GDT) compared to GDT alone for HF patients with reduced ejection fraction and New York Heart Association Class III or II (with a recent history of III). Baroreflex activation therapy (BAT) is delivered by an implantable device that stimulates the baroreceptors through an electrode attached to the outside of the carotid artery, which rebalances the autonomic nervous system to regain cardiovascular (CV) homeostasis. The BeAT-HF trial evaluated the safety and effectiveness of BAT. METHODS: A cost impact model was developed from a U.S. health care payer or integrated delivery network perspective over a 3-year period for BAT + GDT versus GDT alone. Expected costs were calculated by utilizing 6-month data from the BeAT-HF trial and existing literature. HF hospitalization rates were extrapolated based on improvement in NT-proBNP. RESULTS: At baseline the expected cost of BAT + GDT were $29,526 per patient more than GDT alone due to BAT device and implantation costs. After 3 years, the predicted cost per patient was $9521 less expensive for BAT + GDT versus GDT alone due to lower rates of significant HF hospitalizations, CV non-HF hospitalizations, and resource intensive late-stage procedures (LVADs and heart transplants) among the BAT + GDT group. CONCLUSIONS: BAT + GDT treatment becomes less costly than GDT alone beginning between years 1 and 2 and becomes less costly cumulatively between years 2 and 3, potentially providing significant savings over time. As additional BeAT-HF trial data become available, the model can be updated to show longer term effects.

Canceling dental procedures due to elevated blood pressure: Is it appropriate?

BACKGROUND: In 1974, the American Dental Association first considered recommending that dental offices measure blood pressure (BP) routinely, and it has been further encouraged since 2006. Investigators in several dental publications have recommended cancellation of dental procedures based solely on BP greater than 180/110 millimeters of mercury for urgent oral health care and greater than 160/100 mm Hg for elective oral health care, in the absence of prior medical consultation. METHODS: The authors reviewed the evidence for cancellation of any dental or surgical procedures by using an Ovid MEDLINE search for the terms dental, elevated blood pressure, and hypertension. In addition, the authors searched resources at ebd.ada.org using the same criteria. The authors collaborated to develop recommendations in view of 2017 guidelines on this subject. RESULTS: To the authors' knowledge, there are no professionally accepted criteria or study evidence indicating a specific BP elevation at which to prohibit oral health care. Researchers of a 2015 review on management of comorbidities in ambulatory anesthesia failed to find increased morbidity from hypertension in the outpatient setting. CONCLUSIONS: To the authors' knowledge, there are no prospective study investigators that have addressed whether or when to cancel dental procedures due to office-measured elevated BP. The authors recommend using current anesthesiology guidelines based on functional status and past BP measurements to prevent unnecessary cancellations. PRACTICAL IMPLICATIONS: It is seldom necessary to cancel dental procedures on the basis of BP measured before a planned procedure for patients under a physician's care.

An Evidence-Based Review of Elevated Blood Pressure for the Inpatient.

Elevated blood pressure is common in patients who are hospitalized. There are no guidelines and few recommendations to help inpatient providers manage patients with elevated blood pressure. There are no normal reported values for blood pressure in the inpatient and recording circumstances often widely vary. Many factors may influence blood pressure such as pain, anxiety, malaise, nicotine withdrawal, or withholding home medications. This review of available literature suggests potential harm and little to no potential benefit in treating asymptomatic patients with elevated blood pressure. This review also found no evidence that asymptomatic elevated blood pressure progresses to lead to end-organ damage. However, there are clear instances of hypertensive emergency where treatment is indicated. Conscientious adjustment of an anti-hypertensive regimen should be undertaken during episode of elevated blood pressure associated with end-organ damage.

A community-wide quality improvement initiative to improve hypertension control and reduce disparities.

Initiatives to improve hypertension control within academic medical centers and closed health systems have been extensively studied, but large community-wide quality improvement (QI) initiatives have been both less common and less successful in the United States. The authors examined a community-wide QI initiative across 226 843 patients from 198 practices in nine counties across upstate New York to improve hypertension control and reduce disparities. The QI initiative focused on (a) providing population and practice-level comparative data, (b) community engagement, especially in underserved communities, and (c) practice-level quality improvement assistance, but was not designed to examine causality of specific components. Across the nine counties, hypertension control rates improved from 61.9% in 2011 to 69.5% in 2016. Improvements were greatest among whites (73.7%-81.5%) and more modest among black patients (58.8%-64.7%). The authors noted a considerable improvement in BP within the group of patients with the highest risk (defined as a BP ≥ 160/100) and a decrease in disparities within this group. The quality collaborative identified five key lessons to help guide future community initiatives: (a) anticipate a plateauing of response; (b) distinguish the needs of disparate populations and create subpopulation-specific strategies to address and reduce disparities; (c) recognize the variation across low SES practices; (d) remain open to the refinement of outcome measures; and (e) continually seek best practices and barriers to success. Overall, a large community-wide QI initiative, involving multiple different stakeholders, was associated with improvements in BP control and modest reductions in some targeted disparities.

An Exploration of Gene-Gene Interactions and Their Effects on Hypertension.

Hypertension tends to perpetuate in families and the heritability of hypertension is estimated to be around 20-60%. So far, the main proportion of this heritability has not been found by single-locus genome-wide association studies. Therefore, the current study explored gene-gene interactions that have the potential to partially fill in the missing heritability. A two-stage discovery-confirmatory analysis was carried out in the Framingham Heart Study cohorts. The first stage was an exhaustive pairwise search performed in 2320 early-onset hypertensive cases with matched normotensive controls from the offspring cohort. Then, identified gene-gene interactions were assessed in an independent set of 694 subjects from the original cohort. Four unique gene-gene interactions were found to be related to hypertension. Three detected genes were recognized by previous studies, and the other 5 loci/genes (MAN1A1, LMO3, NPAP1/SNRPN, DNAL4, and RNA5SP455/KRT8P5) were novel findings, which had no strong main effect on hypertension and could not be easily identified by single-locus genome-wide studies. Also, by including the identified gene-gene interactions, more variance was explained in hypertension. Overall, our study provides evidence that the genome-wide gene-gene interaction analysis has the possibility to identify new susceptibility genes, which can provide more insights into the genetic background of blood pressure regulation.

Device-Directed Therapy for Resistant Hypertension.

Hypertension remains a significant risk factor for an array of diseases despite advancements in pharmacotherapy. Patients with resistant hypertension who do not respond to conventional medical treatments and lifestyle modifications are especially at risk for poor health outcomes. With the increasing awareness of resistant hypertension, ever-evolving research efforts continue to focus on innovative interventions, including renal denervation, median nerve stimulation, and baroreceptor activation therapy. This article reviews the current evidence and summarizes previous clinical trials for each of these interventions.

Sustained Reduction of Blood Pressure With Baroreceptor Activation Therapy: Results of the 6-Year Open Follow-Up.

Baroreflex activation therapy is a novel technique for treating patients with resistant hypertension. Although short-term studies have demonstrated that it lowers blood pressure, long-term results have not yet been reported. The aim of the present study is to assess the long-term efficacy and safety of baroreflex activation therapy. Long-term follow-up data were analyzed from all patients who had been included in 1 of the 3 trials that focused on treatment-resistant hypertensive patients. Altogether, 383 patients were available for analysis: 143 of these had completed 5 years of follow-up and 48 patients had completed 6 years of follow-up. In the entire cohort, office systolic blood pressure fell from 179±24 mm Hg to 144±28 mm Hg (P<0.0001), whereas office diastolic pressure dropped from 103±16 mm Hg to 85±18 mm Hg (P<0.0001). Heart rate fell from 74±15 beats per minute to 71±13 beats per minute (P<0.02). The effect of baroreflex activation therapy is greater than average in patients with signs of heart failure and less than average in patients with isolated systolic hypertension. In ≈25% of patients, it was possible to reduce the number of medications from a median of 6 to a median of 3. Temporary side effects, related to either the surgical procedure or the cardiovascular instability, do occur, but they do not require specific measures and resolve over time.After a follow-up of 6 years, baroreflex activation therapy maintains its efficacy for persistent reduction of office blood pressure in patients with resistant hypertension without major safety issues.

An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems.

Baroreflex activation therapy (BAT) is a device-based therapy for patients with treatment-resistant hypertension. In a randomized, controlled trial, the first-generation system significantly reduced blood pressure (BP) versus sham. Although an open-label validation study of the second-generation system demonstrated similar BP reductions, controlled data are not presently available. Therefore, this investigation compares results of first- and second-generation BAT systems. Two cohorts of first-generation BAT system patients were generated with propensity matching to compare against the validation group of 30 second-generation subjects. The first cohort was drawn from the first-generation randomized trial sham group and the second cohort from the active therapy group. Safety and efficacy were compared for the second-generation group relative to the first generation. At 6 months, second-generation BAT outperformed first-generation sham systolic BP reduction by 20 ± 28 mm Hg (mean ± standard deviation, P = .008), while BP reduction in first- and second-generation active groups was similar. At 12 months, efficacy was comparable between all three groups after the sham group had received 6 months of therapy; 47% of second-generation patients achieved goal systolic BP of 140 mm Hg or less after 12 months, comparable to 50% of patients at goal in the first-generation group (P > .999). Implant procedure time, system/procedural safety, and pulse generator longevity improved with the second-generation system. Propensity-matched cohort analysis of the first- and second-generation BAT systems suggests similar therapeutic benefit and superior BP reduction of the second-generation system relative to sham control. Implantation procedure duration and perioperative safety were improved with the second-generation device. These findings should be validated in a prospective randomized trial.