Scott Wright, MD, Professor of Medicine, Chair of the IRB at the Mayo Clinic. In this video, he speaks about the Phase III ORION-9,10, and 11 Studies.
In summary:
This is a placebo-controlled, double-blind, randomized Phase III research in patients with ASCVD with increased LDL-C despite the maximum tolerated dose of LDL-C lowering treatments to assess the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection (s). The study will be conducted in multiple locations across the United States.
Jean Marie Ruddy, MD, Vascular surgeon with clinical interests in lower extremity venous insufficiency and atherosclerotic disease of the abdominal aorta, carotid artery, and extremity vessels at Medical University of South Carolina. Anne Kroman DO, PhD, Cardiac Electrophysiologist at Medical University of South Carolina. Ryan Tedford, MD, Dr. Peter C. Gazes Endowed Chair in Heart Failure; Professor of Medicine at Medical University of South Carolina; Chief, Heart Failure; Medical Director, Cardiac Transplantation; Director, AHFTX Fellowship Program. In this video, she and her colleagues speak about the article MUSC doctors first at academic medical center to perform ‘game-changing’ new heart failure device procedure.
Two MUSC Health doctors are the first at an academic medical center and just the second in the world to employ a new, minimally invasive procedure to implant a heart failure therapy device – and, in an unusual turn of events, they're both women in traditionally male-dominated specialties.
Jean Marie Ruddy, M.D., a vascular surgeon, is the lead investigator at the MUSC site for the testing of this innovative implantation procedure for Barostim. Anne Kroman, D.O., Ph.D., a cardiac electrophysiologist, is the site co-principal investigator for the BATwire percutaneous implant research employing the Barostim Neo System.
Following successful trials headed by MUSC Health cardiologist Michael Zile, M.D., Barostim received breakthrough device approval from the US Food and Drug Administration in 2019. The device stimulates the nerve that regulates blood pressure with electrical impulses, causing the blood arteries to relax.
Although the gadget cannot cure heart failure, it can significantly enhance patients' quality of life. According to cardiologist Ryan Tedford, M.D., section chief of heart failure, medical director of cardiac transplantation, and professor in the College of Medicine, it's intended for patients who aren't getting enough benefit from medication but aren't sick enough for a heart pump or heart transplant.
On Thursday, his patient became the first at MUSC Health to undergo the innovative type of implantation.
To insert the electrode, the first method of implantation required a vascular surgeon to create an incision in the patient's neck. However, in a "engineering achievement," the new approach being investigated would allow the device to be implanted through a wire, according to Ruddy. Kroman explained that it is comparable to how pacemaker wires are now implanted.
Instead, the surgeons used ultrasound to locate the region of the blood vessel where the proper nerve is located, then advanced a needle into place to guide the wire through. The whole thing took around an hour and a half. Although it is believed that this will become an outpatient treatment, participants must be hospitalized overnight for the duration of the experiment.
Patients who have already had the device implanted have reported an improvement in their quality of life, according to Ruddy and Kroman. Patients are typically short of breath before the treatment, even while walking about, and may have given up cherished activities – Ruddy noted one patient who was eager to return to fishing.
According to Tedford, there are a substantial number of people who could benefit from this type of treatment, either because they aren't sick enough for more serious procedures or because they don't match the criteria for those surgeries.
Michelle M. Kittleson, MD, PhD, Director, Heart Failure Research, Director, Post Graduate Medical Education in Heart Failure and Transplantation, Professor of Medicine at Cedars-Sinai. In this video, she speaks about A Clinician's Guide to the 2022 ACC/AHA/HFSA Guideline for the Management of Heart Failure.
The American College of Cardiology/American Heart Association/Heart Failure Society of America (ACC/AHA/HFSA) 2022 Guideline for the Management of Heart Failure provides clinicians with patient-centered recommendations for preventing, diagnosing, and managing heart failure patients (HF). 1 The document, the result of nearly two years of work by the writing committee's 26 members, includes 159 pages of text (including 40 pages of references), 14 sections, 33 tables, 15 figures, and 192 recommendations—a daunting task for any clinician interested in optimizing the care of patients with HF. What is the best strategy to approach a new policy?
Andrea Natale M.D., F.A.C.C., F.H.R.S., F.E.S.C., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center at Texas Cardiac Arrhythmia. In this video, he speaks about Endocardial Scar-Homogenization With vs Without Epicardial Ablation in VT Patients With Ischemic Cardiomyopathy.
\n\n
Observation -
\n\n
Goals:
\n\n
The authors of this study compared the success of scar homogeneity with a mixed (epicarddial + endocardial) vs endocardial-only technique for ventricular tachycardia (VT) in patients with ischemic cardiomyopathy (ICM) at 5 years of follow-up.
\n\n
Origins:
\n\n
The best ablation strategy for achieving long-term success in VT patients with ICM is unknown.
\n\n
Methodology:
\n\n
Patients with ICM who underwent VT ablation at our center were divided into two groups: endocardial + epicardial scar homogenization and endocardial scar homogenization. Patients who had already undergone open heart surgery were not eligible. Despite the fact that all group 1 patients were noninducible following endocardial ablation, epicardial ablation was done. All patients received bipolar substrate mapping with conventional scar settings of >1.5 mV for normal tissue and 0.5 mV for severe scar. The procedure\'s endpoint in both groups was noninducibility of monomorphic VT. Implantable device interrogations were performed on patients every 4 months for 5 years.
\n\n
Outcomes:
\n\n
The study included 361 participants (n = 70 in group 1 and n = 291 in group 2). At 5 years, 81.4 percent (n = 57/70) of group 1 patients and 66.3 percent (n = 193/291) of group 2 patients were arrhythmia-free (P = 0.01). Anti-arrhythmic medications (AAD) were used by 26 of 57 (45.6 percent) and 172 of 193 (89.1 percent) of the patients in groups 1 and 2 (log-rank P 0.001). Endo-epicarddial scar homogeneity was linked with a substantial reduction in arrhythmia recurrence after controlling for age, gender, and obstructive sleep apnea (HR: 0.48; 95 percent CI: 0.27-0.86; P = 0.02).
\n\n
Observations:
\n\n
Despite being noninducible following endocardial ablation, epicardial substrate was found in all group 1 patients in this series of patients with ICM and VT. Furthermore, when compared to endocardial ablation alone, combined endo-epicarddial scar homogeneity was linked with a much higher success rate at 5 years of follow-up and a significantly lower demand for antiarrhythmic medicines after the treatment.
Jonathan P. Piccini, MD, Associate Professor at Duke University. In this video, he speaks about the Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study.
Summarization:
Backstory -
The use of direct-acting oral anticoagulants for stroke prevention in atrial fibrillation is restricted due to bleeding concerns. Asundexian, a new oral small molecule activated coagulation factor XIa (FXIa) inhibitor, has the potential to minimize thrombosis while having no effect on haemostasis. In individuals with atrial fibrillation, we wanted to find the best dose of asundexian and compare the risk of bleeding to that of apixaban.
Techniques -
We compared asundexian 20 mg or 50 mg once daily with apixaban 5 mg twice daily in patients 45 years or older with atrial fibrillation, a CHA2DS2-VASc score of at least 2 if male or at least 3 if female, and an increased bleeding risk in this randomised, double-blind, phase 2 dose-finding study. The research was carried out at 93 sites across 14 nations, including 12 in Europe, Canada, and Japan. Using an interactive web response system, participants were randomly assigned (1:1:1) to a treatment group, with randomization stratified by whether patients were using a direct-acting oral anticoagulant prior to the study's start. A double-dummy design was used to achieve masking, with participants receiving both the assigned treatment and a placebo that mimicked the non-assigned therapy. The primary outcome was a composite of major or clinically relevant non-major bleeding based on International Society of Thrombosis and Haemostasis criteria, which was examined in all patients who received at least one dose of study medication. This study is listed on ClinicalTrials.gov as NCT04218266 and EudraCT as 2019-002365-35.
Results -
862 patients were registered between January 30, 2020, and June 21, 2021. 755 individuals were randomized to treatment at random. Because two participants (assigned to asundexian 20 mg) did not take any trial medicine, 753 patients were included in the analysis (249 received asundexian 20 mg, 254 received asundexian 50 g, and 250 received apixaban). The participants' mean age was 737 years (SD 83), 309 (41%) were women, 216 (29%) had chronic renal disease, and the mean CHA2DS2-VASc score was 39 (13%). Asundexian 20 mg inhibited FXIa activity by 81 percent at trough concentrations and 90 percent at peak concentrations; asundexian 50 mg inhibited FXIa activity by 92 percent at trough concentrations and 94 percent at peak concentrations. The incidence proportions for the primary endpoint were 050 (90 percent confidence interval 014–168) for asundexian 20 mg (three events), 016 (001–099) for asundexian 50 mg (one event), and 033 (009–097) for pooled asundexian (four occurrences) against apixaban (six events). Any adverse event occurred at the same rate in all three treatment groups: 118 (47%) with asundexian 20 mg, 120 (47%) with asundexian 50 mg, and 122 (49%) with apixaban.
Explanation -
In patients with atrial fibrillation, the FXIa inhibitor asundexian at dosages of 20 mg and 50 mg once daily led in decreased rates of bleeding compared to normal apixaban treatment, with near-complete in vivo FXIa suppression.
Anuradha Lala, MD, Associate Professor of Medicine, Cardiology, Associate Professor, Population Health Science and Policy at Icahn School of Medicine at Mount Sinai. Robert John Mentz, MD, Associate Professor of MedicineAssociate Professor in Population Health Sciences, Member in the Duke Clinical Research Institute at Duke University. In this video, she speaks about the article #WordsMatter Continued: Moving from “Candidacy” To “Benefit Derived”.
As professionals who care for patients suffering from heart failure, we are all too familiar with such phrases.
Consider yourself a patient who has been told that you are not a "candidate" for a particular therapy. Is this language likely to make you feel marginalized? Ill-fated? Denied? Such difficulties have recently come to light in relation to the need for COVID-19 vaccination prior to being listed for heart transplantation.
The definition of the candidate, according to Merriam-Webster Dictionary, covers the following:
a:
one who wants to, is nominated for, or qualifies for a position, membership, or honor
b:
one who is likely to go through or be chosen for something specific
Complex integrated decision-making, as is prevalent in clinical practice, contributes to our patients' "fate." However, this is another important proof of how much our #wordsmatter. Our goal is not to determine fate. It is not to favor one patient over another or to refuse anyone life-saving treatment. Rather, our aim and role are to serve as resource stewards while also assisting in determining the amount to which a patient will benefit from a certain therapy (based on aggregated experience and data).
So we've been debating... Why not phrase it that way if that is the intention?
Consider the following phrase in place of the preceding:
"Mr. X is unlikely to benefit from heart transplantation at this time due to active colon cancer (which would grow due to post-transplant immunosuppression)."
Or
"Ms. Y is unlikely to benefit appreciably from sustained LVAD installation at this time due to past stroke, severe peripheral vascular disease, and recurrent gastrointestinal bleeding, all of which put her at high risk of post-surgical complications and mortality."
These rephrasing issues also apply to medical therapies:
"The patient is unlikely to benefit from sacubitril/valsartan at this time due to significant symptomatic hypotension - which may worsen after medication administration."
Articulating why an individual may or may not benefit from therapy at a certain time allows us to communicate more effectively - not only with patients and their loved ones but also among physicians. Furthermore, rather than conveying judgmental feelings, this approach emphasizes nonmaleficence, in which decisions are balanced against all benefits, risks, and consequences. Circumstances change, and assessments based on the current level of expected benefit from a therapy might be evaluated at individualized intervals.
Heart failure is a disease with unacceptably high morbidity and fatality rates. Let us focus on how we relay and convey information as we attempt to enhance therapeutic outcomes. At JCF, we know that our #wordsmatter — to patients, their families, each other, and the communities we serve – whether it's changing "failure" to "function", replacing "non-compliance" with "barriers to adherence", or shifting from "candidacy" to "extent of benefit obtained."
Ibrahim Sultan, MD, Associate Professor of Cardiothoracic Surgery, Director, Center for Thoracic Aortic Disease, Surgical Director, Center for Heart Valve Disease, UPMC Heart and Vascular Institute at UPMC. In this video, he speaks about Transfusion of non–red blood cell blood products does not reduce survival following cardiac surgery.
Outline
Goals:
The evidence suggests that patients undergoing cardiac surgery who receive perioperative packed red blood cell (pRBC) transfusions have an increased risk of death. The current investigation is to determine whether there is a link between non–pRBC blood product transfusions and higher mortality.
Methodology:
Patients who underwent heart surgery between 2010 and 2018 were included in data from our center's Society of Thoracic Surgeons database. Patients requiring pRBC infusions or experiencing circulatory arrest were excluded. Propensity matching (1:1; caliper = 0.2 times the standard deviation of logit of propensity score) was used. Cox regression and Kaplan–Meier estimates were utilized. This study excluded individuals with cardiac transplants, ventricular assist devices, transcatheter aortic valves, and circulatory arrest.
Outcomes:
A total of 8042 patients met the analytic requirements. 395 patients requiring perioperative non–pRBC blood products (platelets, fresh-frozen plasma, and cryoprecipitate) were matched with 395 nontransfusion patients using propensity matching (1:1), resulting in equitable patient cohorts. The median duration of follow-up was 4.5 (3.0-6.4) years. Platelets (327 [82.8 percent]), fresh-frozen plasma (141 [35.7 percent]), and cryoprecipitate were given to patients (60 [15.2 percent ]). There was no statistically significant difference in postoperative mortality (6 [1.5%] vs 4 [1.0%]; P =.52). The transfusion group had higher rates of reoperation (20 [5.0 percent] vs 8 [2.0 percent]; P.02) and prolonged ventilation (36 [9.1 percent] vs 19 [4.8 percent]; P.02). Blood product use was strongly linked with emergent surgery (odds ratio [OR] 2.86 [1.72-4.78]; P.001), intra-aortic balloon pump (OR 3.24 [1.64-6.39]; P.001), and multivalve surgery (OR 4.34 [2.83-6.67]; P.001). Blood product transfusion (hazard ratio: 1.15 [0.89-1.48]; P =.3) was not related with an increased risk of death. There was no significant difference in long-term survival between groups.
Findings:
Those undergoing cardiac surgery who require blood products alone, without pRBC transfusion, have comparable postoperative and long-term survival to patients who do not require blood products. These findings are based on a small number of patients, and further research will help to improve the generalizability of these findings.
Prakriti Gaba, MD, Cardiology Fellow at Harvard Medical School. In this video, she speaks about the Prevention of Cardiovascular Events and Mortality With Icosapent Ethyl in Patients With Prior Myocardial Infarction.
Outline
Origins:
REDUCE-IT was a double-blind experiment in which 8,179 statin-treated individuals with reduced low-density lipoprotein cholesterol and moderately increased triglycerides were randomly assigned to icosapent ethyl (IPE) or placebo. The primary objective, including death from cardiovascular (CV) causes, was significantly reduced. It was uncertain what effect IPE has on people who had previously had a myocardial infarction (MI).
Goals:
In REDUCE-IT, we wanted to look at the effect of IPE on ischemic events in patients who had previously had a MI.
Methodology:
We conducted post-hoc analysis on patients who had previously experienced MI. CV mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina were the primary endpoints. The most important secondary outcome was CV death, MI, or stroke.
Outcomes:
A total of 3,693 patients had a previous MI. With IPE vs placebo, the primary endpoint was lowered from 26.1 percent to 20.2 percent; HR: 0.74 (95 percent CI: 0.65-0.85; P = 0.00001). The main secondary endpoint was lowered from 18.0% to 13.3%; HR: 0.71 (95 percent CI: 0.61-0.84; P = 0.00006). There was also a substantial 35% relative risk reduction in total ischemia events (P = 0.0000001), 34% reduction in MI (P = 0.00009), 30% reduction in CV death (P = 0.01), and a 20% reduction in all-cause mortality (P = 0.054), despite a modest rise in atrial fibrillation. Sudden cardiac death and cardiac arrest were also drastically reduced by 40% and 56%, respectively.
Inferences:
Patients in REDUCE-IT with a history of recent MI who were treated with IPE had large and significant relative and absolute risk reductions in ischemic events, including CV mortality. (AMR101 Study to Assess Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and Statin Use. The primary goal is to assess the effect of 4 g/day AMR101 on the occurrence of a first major cardiovascular event. NCT01492361; [REDUCE-IT])
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Michelle M. Kittleson, MD, PhD, Director, Heart Failure Research, Director, Post Graduate Medical Education in Heart Failure and Transplantation, Professor of Medicine at Cedars-Sinai. In this video, she speaks about A Clinician's Guide to the 2022 ACC/AHA/HFSA Guideline for the Management of Heart Failure.
The American College of Cardiology/American Heart Association/Heart Failure Society of America (ACC/AHA/HFSA) 2022 Guideline for the Management of Heart Failure provides clinicians with patient-centered recommendations for preventing, diagnosing, and managing heart failure patients (HF). 1 The document, the result of nearly two years of work by the writing committee's 26 members, includes 159 pages of text (including 40 pages of references), 14 sections, 33 tables, 15 figures, and 192 recommendations—a daunting task for any clinician interested in optimizing the care of patients with HF. What is the best strategy to approach a new policy?
Anuradha Lala, MD, Associate Professor of Medicine, Cardiology, Associate Professor, Population Health Science and Policy at Icahn School of Medicine at Mount Sinai. Robert John Mentz, MD, Associate Professor of MedicineAssociate Professor in Population Health Sciences, Member in the Duke Clinical Research Institute at Duke University. In this video, she speaks about the article #WordsMatter Continued: Moving from “Candidacy” To “Benefit Derived”.
As professionals who care for patients suffering from heart failure, we are all too familiar with such phrases.
Consider yourself a patient who has been told that you are not a "candidate" for a particular therapy. Is this language likely to make you feel marginalized? Ill-fated? Denied? Such difficulties have recently come to light in relation to the need for COVID-19 vaccination prior to being listed for heart transplantation.
The definition of the candidate, according to Merriam-Webster Dictionary, covers the following:
a:
one who wants to, is nominated for, or qualifies for a position, membership, or honor
b:
one who is likely to go through or be chosen for something specific
Complex integrated decision-making, as is prevalent in clinical practice, contributes to our patients' "fate." However, this is another important proof of how much our #wordsmatter. Our goal is not to determine fate. It is not to favor one patient over another or to refuse anyone life-saving treatment. Rather, our aim and role are to serve as resource stewards while also assisting in determining the amount to which a patient will benefit from a certain therapy (based on aggregated experience and data).
So we've been debating... Why not phrase it that way if that is the intention?
Consider the following phrase in place of the preceding:
"Mr. X is unlikely to benefit from heart transplantation at this time due to active colon cancer (which would grow due to post-transplant immunosuppression)."
Or
"Ms. Y is unlikely to benefit appreciably from sustained LVAD installation at this time due to past stroke, severe peripheral vascular disease, and recurrent gastrointestinal bleeding, all of which put her at high risk of post-surgical complications and mortality."
These rephrasing issues also apply to medical therapies:
"The patient is unlikely to benefit from sacubitril/valsartan at this time due to significant symptomatic hypotension - which may worsen after medication administration."
Articulating why an individual may or may not benefit from therapy at a certain time allows us to communicate more effectively - not only with patients and their loved ones but also among physicians. Furthermore, rather than conveying judgmental feelings, this approach emphasizes nonmaleficence, in which decisions are balanced against all benefits, risks, and consequences. Circumstances change, and assessments based on the current level of expected benefit from a therapy might be evaluated at individualized intervals.
Heart failure is a disease with unacceptably high morbidity and fatality rates. Let us focus on how we relay and convey information as we attempt to enhance therapeutic outcomes. At JCF, we know that our #wordsmatter — to patients, their families, each other, and the communities we serve – whether it's changing "failure" to "function", replacing "non-compliance" with "barriers to adherence", or shifting from "candidacy" to "extent of benefit obtained."
Scott Wright, MD, Professor of Medicine, Chair of the IRB at the Mayo Clinic. In this video, he speaks about the Phase III ORION-9,10, and 11 Studies.
In summary:
This is a placebo-controlled, double-blind, randomized Phase III research in patients with ASCVD with increased LDL-C despite the maximum tolerated dose of LDL-C lowering treatments to assess the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection (s). The study will be conducted in multiple locations across the United States.
Andrea Natale M.D., F.A.C.C., F.H.R.S., F.E.S.C., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center at Texas Cardiac Arrhythmia. In this video, he speaks about Endocardial Scar-Homogenization With vs Without Epicardial Ablation in VT Patients With Ischemic Cardiomyopathy.
\n\n
Observation -
\n\n
Goals:
\n\n
The authors of this study compared the success of scar homogeneity with a mixed (epicarddial + endocardial) vs endocardial-only technique for ventricular tachycardia (VT) in patients with ischemic cardiomyopathy (ICM) at 5 years of follow-up.
\n\n
Origins:
\n\n
The best ablation strategy for achieving long-term success in VT patients with ICM is unknown.
\n\n
Methodology:
\n\n
Patients with ICM who underwent VT ablation at our center were divided into two groups: endocardial + epicardial scar homogenization and endocardial scar homogenization. Patients who had already undergone open heart surgery were not eligible. Despite the fact that all group 1 patients were noninducible following endocardial ablation, epicardial ablation was done. All patients received bipolar substrate mapping with conventional scar settings of >1.5 mV for normal tissue and 0.5 mV for severe scar. The procedure\'s endpoint in both groups was noninducibility of monomorphic VT. Implantable device interrogations were performed on patients every 4 months for 5 years.
\n\n
Outcomes:
\n\n
The study included 361 participants (n = 70 in group 1 and n = 291 in group 2). At 5 years, 81.4 percent (n = 57/70) of group 1 patients and 66.3 percent (n = 193/291) of group 2 patients were arrhythmia-free (P = 0.01). Anti-arrhythmic medications (AAD) were used by 26 of 57 (45.6 percent) and 172 of 193 (89.1 percent) of the patients in groups 1 and 2 (log-rank P 0.001). Endo-epicarddial scar homogeneity was linked with a substantial reduction in arrhythmia recurrence after controlling for age, gender, and obstructive sleep apnea (HR: 0.48; 95 percent CI: 0.27-0.86; P = 0.02).
\n\n
Observations:
\n\n
Despite being noninducible following endocardial ablation, epicardial substrate was found in all group 1 patients in this series of patients with ICM and VT. Furthermore, when compared to endocardial ablation alone, combined endo-epicarddial scar homogeneity was linked with a much higher success rate at 5 years of follow-up and a significantly lower demand for antiarrhythmic medicines after the treatment.
Jonathan P. Piccini, MD, Associate Professor at Duke University. In this video, he speaks about the Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study.
Summarization:
Backstory -
The use of direct-acting oral anticoagulants for stroke prevention in atrial fibrillation is restricted due to bleeding concerns. Asundexian, a new oral small molecule activated coagulation factor XIa (FXIa) inhibitor, has the potential to minimize thrombosis while having no effect on haemostasis. In individuals with atrial fibrillation, we wanted to find the best dose of asundexian and compare the risk of bleeding to that of apixaban.
Techniques -
We compared asundexian 20 mg or 50 mg once daily with apixaban 5 mg twice daily in patients 45 years or older with atrial fibrillation, a CHA2DS2-VASc score of at least 2 if male or at least 3 if female, and an increased bleeding risk in this randomised, double-blind, phase 2 dose-finding study. The research was carried out at 93 sites across 14 nations, including 12 in Europe, Canada, and Japan. Using an interactive web response system, participants were randomly assigned (1:1:1) to a treatment group, with randomization stratified by whether patients were using a direct-acting oral anticoagulant prior to the study's start. A double-dummy design was used to achieve masking, with participants receiving both the assigned treatment and a placebo that mimicked the non-assigned therapy. The primary outcome was a composite of major or clinically relevant non-major bleeding based on International Society of Thrombosis and Haemostasis criteria, which was examined in all patients who received at least one dose of study medication. This study is listed on ClinicalTrials.gov as NCT04218266 and EudraCT as 2019-002365-35.
Results -
862 patients were registered between January 30, 2020, and June 21, 2021. 755 individuals were randomized to treatment at random. Because two participants (assigned to asundexian 20 mg) did not take any trial medicine, 753 patients were included in the analysis (249 received asundexian 20 mg, 254 received asundexian 50 g, and 250 received apixaban). The participants' mean age was 737 years (SD 83), 309 (41%) were women, 216 (29%) had chronic renal disease, and the mean CHA2DS2-VASc score was 39 (13%). Asundexian 20 mg inhibited FXIa activity by 81 percent at trough concentrations and 90 percent at peak concentrations; asundexian 50 mg inhibited FXIa activity by 92 percent at trough concentrations and 94 percent at peak concentrations. The incidence proportions for the primary endpoint were 050 (90 percent confidence interval 014–168) for asundexian 20 mg (three events), 016 (001–099) for asundexian 50 mg (one event), and 033 (009–097) for pooled asundexian (four occurrences) against apixaban (six events). Any adverse event occurred at the same rate in all three treatment groups: 118 (47%) with asundexian 20 mg, 120 (47%) with asundexian 50 mg, and 122 (49%) with apixaban.
Explanation -
In patients with atrial fibrillation, the FXIa inhibitor asundexian at dosages of 20 mg and 50 mg once daily led in decreased rates of bleeding compared to normal apixaban treatment, with near-complete in vivo FXIa suppression.
Prakriti Gaba, MD, Cardiology Fellow at Harvard Medical School. In this video, she speaks about the Prevention of Cardiovascular Events and Mortality With Icosapent Ethyl in Patients With Prior Myocardial Infarction.
Outline
Origins:
REDUCE-IT was a double-blind experiment in which 8,179 statin-treated individuals with reduced low-density lipoprotein cholesterol and moderately increased triglycerides were randomly assigned to icosapent ethyl (IPE) or placebo. The primary objective, including death from cardiovascular (CV) causes, was significantly reduced. It was uncertain what effect IPE has on people who had previously had a myocardial infarction (MI).
Goals:
In REDUCE-IT, we wanted to look at the effect of IPE on ischemic events in patients who had previously had a MI.
Methodology:
We conducted post-hoc analysis on patients who had previously experienced MI. CV mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina were the primary endpoints. The most important secondary outcome was CV death, MI, or stroke.
Outcomes:
A total of 3,693 patients had a previous MI. With IPE vs placebo, the primary endpoint was lowered from 26.1 percent to 20.2 percent; HR: 0.74 (95 percent CI: 0.65-0.85; P = 0.00001). The main secondary endpoint was lowered from 18.0% to 13.3%; HR: 0.71 (95 percent CI: 0.61-0.84; P = 0.00006). There was also a substantial 35% relative risk reduction in total ischemia events (P = 0.0000001), 34% reduction in MI (P = 0.00009), 30% reduction in CV death (P = 0.01), and a 20% reduction in all-cause mortality (P = 0.054), despite a modest rise in atrial fibrillation. Sudden cardiac death and cardiac arrest were also drastically reduced by 40% and 56%, respectively.
Inferences:
Patients in REDUCE-IT with a history of recent MI who were treated with IPE had large and significant relative and absolute risk reductions in ischemic events, including CV mortality. (AMR101 Study to Assess Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and Statin Use. The primary goal is to assess the effect of 4 g/day AMR101 on the occurrence of a first major cardiovascular event. NCT01492361; [REDUCE-IT])
Jean Marie Ruddy, MD, Vascular surgeon with clinical interests in lower extremity venous insufficiency and atherosclerotic disease of the abdominal aorta, carotid artery, and extremity vessels at Medical University of South Carolina. Anne Kroman DO, PhD, Cardiac Electrophysiologist at Medical University of South Carolina. Ryan Tedford, MD, Dr. Peter C. Gazes Endowed Chair in Heart Failure; Professor of Medicine at Medical University of South Carolina; Chief, Heart Failure; Medical Director, Cardiac Transplantation; Director, AHFTX Fellowship Program. In this video, she and her colleagues speak about the article MUSC doctors first at academic medical center to perform ‘game-changing’ new heart failure device procedure.
Two MUSC Health doctors are the first at an academic medical center and just the second in the world to employ a new, minimally invasive procedure to implant a heart failure therapy device – and, in an unusual turn of events, they're both women in traditionally male-dominated specialties.
Jean Marie Ruddy, M.D., a vascular surgeon, is the lead investigator at the MUSC site for the testing of this innovative implantation procedure for Barostim. Anne Kroman, D.O., Ph.D., a cardiac electrophysiologist, is the site co-principal investigator for the BATwire percutaneous implant research employing the Barostim Neo System.
Following successful trials headed by MUSC Health cardiologist Michael Zile, M.D., Barostim received breakthrough device approval from the US Food and Drug Administration in 2019. The device stimulates the nerve that regulates blood pressure with electrical impulses, causing the blood arteries to relax.
Although the gadget cannot cure heart failure, it can significantly enhance patients' quality of life. According to cardiologist Ryan Tedford, M.D., section chief of heart failure, medical director of cardiac transplantation, and professor in the College of Medicine, it's intended for patients who aren't getting enough benefit from medication but aren't sick enough for a heart pump or heart transplant.
On Thursday, his patient became the first at MUSC Health to undergo the innovative type of implantation.
To insert the electrode, the first method of implantation required a vascular surgeon to create an incision in the patient's neck. However, in a "engineering achievement," the new approach being investigated would allow the device to be implanted through a wire, according to Ruddy. Kroman explained that it is comparable to how pacemaker wires are now implanted.
Instead, the surgeons used ultrasound to locate the region of the blood vessel where the proper nerve is located, then advanced a needle into place to guide the wire through. The whole thing took around an hour and a half. Although it is believed that this will become an outpatient treatment, participants must be hospitalized overnight for the duration of the experiment.
Patients who have already had the device implanted have reported an improvement in their quality of life, according to Ruddy and Kroman. Patients are typically short of breath before the treatment, even while walking about, and may have given up cherished activities – Ruddy noted one patient who was eager to return to fishing.
According to Tedford, there are a substantial number of people who could benefit from this type of treatment, either because they aren't sick enough for more serious procedures or because they don't match the criteria for those surgeries.
Ibrahim Sultan, MD, Associate Professor of Cardiothoracic Surgery, Director, Center for Thoracic Aortic Disease, Surgical Director, Center for Heart Valve Disease, UPMC Heart and Vascular Institute at UPMC. In this video, he speaks about Transfusion of non–red blood cell blood products does not reduce survival following cardiac surgery.
Outline
Goals:
The evidence suggests that patients undergoing cardiac surgery who receive perioperative packed red blood cell (pRBC) transfusions have an increased risk of death. The current investigation is to determine whether there is a link between non–pRBC blood product transfusions and higher mortality.
Methodology:
Patients who underwent heart surgery between 2010 and 2018 were included in data from our center's Society of Thoracic Surgeons database. Patients requiring pRBC infusions or experiencing circulatory arrest were excluded. Propensity matching (1:1; caliper = 0.2 times the standard deviation of logit of propensity score) was used. Cox regression and Kaplan–Meier estimates were utilized. This study excluded individuals with cardiac transplants, ventricular assist devices, transcatheter aortic valves, and circulatory arrest.
Outcomes:
A total of 8042 patients met the analytic requirements. 395 patients requiring perioperative non–pRBC blood products (platelets, fresh-frozen plasma, and cryoprecipitate) were matched with 395 nontransfusion patients using propensity matching (1:1), resulting in equitable patient cohorts. The median duration of follow-up was 4.5 (3.0-6.4) years. Platelets (327 [82.8 percent]), fresh-frozen plasma (141 [35.7 percent]), and cryoprecipitate were given to patients (60 [15.2 percent ]). There was no statistically significant difference in postoperative mortality (6 [1.5%] vs 4 [1.0%]; P =.52). The transfusion group had higher rates of reoperation (20 [5.0 percent] vs 8 [2.0 percent]; P.02) and prolonged ventilation (36 [9.1 percent] vs 19 [4.8 percent]; P.02). Blood product use was strongly linked with emergent surgery (odds ratio [OR] 2.86 [1.72-4.78]; P.001), intra-aortic balloon pump (OR 3.24 [1.64-6.39]; P.001), and multivalve surgery (OR 4.34 [2.83-6.67]; P.001). Blood product transfusion (hazard ratio: 1.15 [0.89-1.48]; P =.3) was not related with an increased risk of death. There was no significant difference in long-term survival between groups.
Findings:
Those undergoing cardiac surgery who require blood products alone, without pRBC transfusion, have comparable postoperative and long-term survival to patients who do not require blood products. These findings are based on a small number of patients, and further research will help to improve the generalizability of these findings.
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Luis M. Ruilope is a professor at the Autonoma University's Department of Public Health and Preventive Medicine and the director of the Instituto de Investigación 12 de Octubre's Cardiovascular and Renal Risk, both in Madrid, Spain. His main areas of interest include hypertension and cardiovascular risk. In this video Dr. Ruilope speaks on Digital therapeutics and lifestyle.
Link to Abstract-
https://academic.oup.com/eurheartj/article/42/40/4123/6377082
Hypertension, defined as a clinic blood pressure (BP) of less than 140/90 mmHg according to the most recent European [European Society of Cardiology (ESC)/European Society of Hypertension (ESH)] guidelines1, affects nearly a third of adults worldwide, and it is still one of the leading causes of premature death. 2
The 'westernized way of life,' which is characterized not only by physical inactivity and unhealthy dietary habits, which have resulted in a true pandemic of overweight/obesity, but also by frequent disruption of circadian rhythms with poor sleep patterns and high levels of psychosocial stress, is likely to increase the prevalence of hypertension in the years ahead.
3 In contrast, 'non-westernized' populations (e.g., hunter–gatherers like the Hadza, or foragers–horticulturists like the Tsimané or Yanomani) who continue to live in ways that are similar to those that have characterized human evolution (with high levels of daily physical activity and sleep–wake cycles corresponding to natural dark–light exposure, among other things) have a very low prevalence of hypertension, with virtually no evidence of age-related 3 The ESC/ESH guidelines, on the other hand, consider an optimal lifestyle (i.e. 150–300 minutes of moderate–vigorous physical activity per week, dynamic resistance such as lifting weights two–three times per week, increased consumption of vegetables, fresh fruits, fish, nuts, and unsaturated fatty acids, sodium intake 2000 mg/day, maintaining a body mass index of 20–25 kg/m2, moderate alcohol intake, and avoiding smoking) to be the only treatment needed for people with mild 1 Indeed, prescribing antihypertensive medicines at the outset has no effect on the incidence of CVD or death in people with moderate hypertension who are at low risk, and may potentially increase the risk of adverse events (e.g. hypotension, electrolyte abnormalities, or acute kidney injury). 4
In fact, there is strong evidence that living a healthy lifestyle can help prevent or control hypertension.
3 For example, a network meta-analysis (n = 39 742 participants) indicated that exercise programs and antihypertensive medication were equally beneficial in lowering blood pressure in people with hypertension.
5 There is also strong evidence for body weight reductions back to normal values in people who are overweight or obese,6 sodium restriction in people who have been diagnosed with hypertension,7 and the Dietary Approaches to Stop Hypertension (DASH) diet in people who have pre-hypertension or hypertension.
8 Furthermore, while more study is needed, accumulating evidence supports the use of less "traditional" techniques, such as circadian entrainment and stress management strategies, notwithstanding the need for more research. 3
The molecular processes explaining the effects of lifestyle intervention against hypertension are multisystemic, in contrast to the many antihypertensive medications. Preventing obesity and insulin resistance, improving vascular health—through improved redox and inflammatory status, or a healthy pattern of vessel remodelling in those who exercise regularly (i.e. an increase in the luminal diameter of conduit and resistance arteries, as well as the capillary density of skeletal muscle tissue)—and reducing sympathetic nervous system overactivity are just a few examples (SNS). 3 Regular exercise can also help to lower blood pressure through 'non-traditional' mechanisms, such as the release of muscle-derived factors (usually, but not always, small peptides) known as'myokines,' which are produced in the exercise environment and can travel through the bloodstream to induce a variety of beneficial effects, such as reduced inflammation or vasorelaxation. 9
However, in our modern communities, one of the primary issues with lifestyle modifications is sustainability. The effects of exercise intervention to lower blood pressure in young individuals with pre-hypertension/hypertension are lost after 12 months, according to meta-analytical evidence. 10 Similarly, a recent network meta-analysis indicated that while varied diets result in considerable weight and blood pressure reductions after 6 months, there are essentially no advantages beyond 12 months. 11 How can we effectively increase Westerners' adherence to healthy lifestyle interventions? One option is to exploit the present over-reliance on cellphones and other devices as a health tool. A new notion of personalised medical follow-up (dubbed "mHealth"), along with efforts by companies like Google and Apple to make their devices into mobile health centers, might usher in a new era in medicine. Another initiative along these lines is 'Digital therapeutics,' which aims to make disease management easier by encouraging people to make lifestyle changes. Despite the fast increasing availability of mobile technology aimed at improving blood pressure management, scientific evidence of their efficacy remains scarce. 12,13
The findings of HERB-DH1, a pivotal trial investigating the efficacy and safety of Digital therapeutics (a 12-week intervention followed by a 12-week follow-up) in patients with untreated essential hypertension (baseline office and ambulatory 24 h BP 140/90 mmHg and 130/80 mmHg, respectively) are reported in this issue of the European Heart Journal by Kario et al.14. HERB mobile is a new interactive smartphone software that encourages extensive lifestyle changes (such as lowering salt intake, controlling body weight, exercising, improving sleep patterns, stress coping, and limiting alcohol use) that can lead to a considerable reduction in blood pressure. Kario et al.14 developed their trial in three steps: I a lecture and advising program, followed by (ii) lifestyle interventions and (iii) self-planning and evaluation with participants, who were then encouraged to adopt the various lifestyle alterations into their lives. The intervention group showed a significant reduction in office, home, and 24-hour BP when compared to a control group that received lifestyle recommendations without the support of the mobile app, followed by improved BP control with the addition of antihypertensive medication in the second part of the study. These results were accompanied by improvements in secondary outcomes such as bigger salt intake reductions and lower body weight.
Kario et al.14's findings are intriguing and add to the body of knowledge about how to achieve adequate goals in arterial hypertension. Aside from the necessity to replicate these findings in additional cohorts, there are a few factors to consider. One is the intervention's long-term viability, with variations in blood pressure between groups marginally reduced after 24 weeks. Adherence to interventions is a crucial challenge in this regard. In this regard, participants in the study by Kario et al. showed near ideal adherence, as evidenced by a >95 percent engagement rate with the mobile app and >90 percent completion of the trial's recommendations in steps I and (ii). Future studies should show whether adherence, as well as the BP advantages, can be sustained over time. On the other hand, in order to use the app appropriately, physicians in charge must develop an adequate contact with the patient, which may constitute a time constraint. This new methodology may, in our judgment, be led by well-trained nurses. Finally, it has to be seen whether this unique method can prevent the development of sustained hypertension in persons with pre-hypertension, which would be a huge breakthrough in the area.
To effectively apply healthy lifestyle modifications for the prevention and control of arterial hypertension, more effort is required. Digital therapies, for example, could pave the way for a new era in which new millennium technology can be employed to help us return to a more "traditional" (non-westernized) way of life (Graphical Abstract).
Luis M. Ruilope is a professor at the Autonoma University's Department of Public Health and Preventive Medicine and the director of the Instituto de Investigación 12 de Octubre's Cardiovascular and Renal Risk, both in Madrid, Spain. His main areas of interest include hypertension and cardiovascular risk. In this video Dr. Ruilope speaks on Digital therapeutics and lifestyle.
Link to Abstract-
https://academic.oup.com/eurheartj/article/42/40/4123/6377082
Hypertension, defined as a clinic blood pressure (BP) of less than 140/90 mmHg according to the most recent European [European Society of Cardiology (ESC)/European Society of Hypertension (ESH)] guidelines1, affects nearly a third of adults worldwide, and it is still one of the leading causes of premature death. 2
The 'westernized way of life,' which is characterized not only by physical inactivity and unhealthy dietary habits, which have resulted in a true pandemic of overweight/obesity, but also by frequent disruption of circadian rhythms with poor sleep patterns and high levels of psychosocial stress, is likely to increase the prevalence of hypertension in the years ahead.
3 In contrast, 'non-westernized' populations (e.g., hunter–gatherers like the Hadza, or foragers–horticulturists like the Tsimané or Yanomani) who continue to live in ways that are similar to those that have characterized human evolution (with high levels of daily physical activity and sleep–wake cycles corresponding to natural dark–light exposure, among other things) have a very low prevalence of hypertension, with virtually no evidence of age-related 3 The ESC/ESH guidelines, on the other hand, consider an optimal lifestyle (i.e. 150–300 minutes of moderate–vigorous physical activity per week, dynamic resistance such as lifting weights two–three times per week, increased consumption of vegetables, fresh fruits, fish, nuts, and unsaturated fatty acids, sodium intake 2000 mg/day, maintaining a body mass index of 20–25 kg/m2, moderate alcohol intake, and avoiding smoking) to be the only treatment needed for people with mild 1 Indeed, prescribing antihypertensive medicines at the outset has no effect on the incidence of CVD or death in people with moderate hypertension who are at low risk, and may potentially increase the risk of adverse events (e.g. hypotension, electrolyte abnormalities, or acute kidney injury). 4
In fact, there is strong evidence that living a healthy lifestyle can help prevent or control hypertension.
3 For example, a network meta-analysis (n = 39 742 participants) indicated that exercise programs and antihypertensive medication were equally beneficial in lowering blood pressure in people with hypertension.
5 There is also strong evidence for body weight reductions back to normal values in people who are overweight or obese,6 sodium restriction in people who have been diagnosed with hypertension,7 and the Dietary Approaches to Stop Hypertension (DASH) diet in people who have pre-hypertension or hypertension.
8 Furthermore, while more study is needed, accumulating evidence supports the use of less "traditional" techniques, such as circadian entrainment and stress management strategies, notwithstanding the need for more research. 3
The molecular processes explaining the effects of lifestyle intervention against hypertension are multisystemic, in contrast to the many antihypertensive medications. Preventing obesity and insulin resistance, improving vascular health—through improved redox and inflammatory status, or a healthy pattern of vessel remodelling in those who exercise regularly (i.e. an increase in the luminal diameter of conduit and resistance arteries, as well as the capillary density of skeletal muscle tissue)—and reducing sympathetic nervous system overactivity are just a few examples (SNS). 3 Regular exercise can also help to lower blood pressure through 'non-traditional' mechanisms, such as the release of muscle-derived factors (usually, but not always, small peptides) known as'myokines,' which are produced in the exercise environment and can travel through the bloodstream to induce a variety of beneficial effects, such as reduced inflammation or vasorelaxation. 9
However, in our modern communities, one of the primary issues with lifestyle modifications is sustainability. The effects of exercise intervention to lower blood pressure in young individuals with pre-hypertension/hypertension are lost after 12 months, according to meta-analytical evidence. 10 Similarly, a recent network meta-analysis indicated that while varied diets result in considerable weight and blood pressure reductions after 6 months, there are essentially no advantages beyond 12 months. 11 How can we effectively increase Westerners' adherence to healthy lifestyle interventions? One option is to exploit the present over-reliance on cellphones and other devices as a health tool. A new notion of personalised medical follow-up (dubbed "mHealth"), along with efforts by companies like Google and Apple to make their devices into mobile health centers, might usher in a new era in medicine. Another initiative along these lines is 'Digital therapeutics,' which aims to make disease management easier by encouraging people to make lifestyle changes. Despite the fast increasing availability of mobile technology aimed at improving blood pressure management, scientific evidence of their efficacy remains scarce. 12,13
The findings of HERB-DH1, a pivotal trial investigating the efficacy and safety of Digital therapeutics (a 12-week intervention followed by a 12-week follow-up) in patients with untreated essential hypertension (baseline office and ambulatory 24 h BP 140/90 mmHg and 130/80 mmHg, respectively) are reported in this issue of the European Heart Journal by Kario et al.14. HERB mobile is a new interactive smartphone software that encourages extensive lifestyle changes (such as lowering salt intake, controlling body weight, exercising, improving sleep patterns, stress coping, and limiting alcohol use) that can lead to a considerable reduction in blood pressure. Kario et al.14 developed their trial in three steps: I a lecture and advising program, followed by (ii) lifestyle interventions and (iii) self-planning and evaluation with participants, who were then encouraged to adopt the various lifestyle alterations into their lives. The intervention group showed a significant reduction in office, home, and 24-hour BP when compared to a control group that received lifestyle recommendations without the support of the mobile app, followed by improved BP control with the addition of antihypertensive medication in the second part of the study. These results were accompanied by improvements in secondary outcomes such as bigger salt intake reductions and lower body weight.
Kario et al.14's findings are intriguing and add to the body of knowledge about how to achieve adequate goals in arterial hypertension. Aside from the necessity to replicate these findings in additional cohorts, there are a few factors to consider. One is the intervention's long-term viability, with variations in blood pressure between groups marginally reduced after 24 weeks. Adherence to interventions is a crucial challenge in this regard. In this regard, participants in the study by Kario et al. showed near ideal adherence, as evidenced by a >95 percent engagement rate with the mobile app and >90 percent completion of the trial's recommendations in steps I and (ii). Future studies should show whether adherence, as well as the BP advantages, can be sustained over time. On the other hand, in order to use the app appropriately, physicians in charge must develop an adequate contact with the patient, which may constitute a time constraint. This new methodology may, in our judgment, be led by well-trained nurses. Finally, it has to be seen whether this unique method can prevent the development of sustained hypertension in persons with pre-hypertension, which would be a huge breakthrough in the area.
To effectively apply healthy lifestyle modifications for the prevention and control of arterial hypertension, more effort is required. Digital therapies, for example, could pave the way for a new era in which new millennium technology can be employed to help us return to a more "traditional" (non-westernized) way of life (Graphical Abstract).
Dr. Quyyumi is a tenured Professor of Medicine in Emory University School of Medicine's Division of Cardiology and Director of the Emory Clinical Cardiovascular Research Institute. In this video Dr. Quyyumi discusses the Effects of a Health‐Partner Intervention on Cardiovascular Risk.
Link to Abstract-
https://www.ahajournals.org/doi/10.1161/JAHA.116.004217
Background
Lifestyle changes are the first line of defense against cardiovascular disease. It's less apparent whether a healthy lifestyle can also help with cardiovascular health. Our research looked at the impact of a lifestyle intervention provided by a Health Partner on indicators of optimum cardiovascular health.
Results and Methods
At Emory University, 711 university employees (4811 years old; 66 percent women, 72 percent Caucasian/22.5 percent African Americans) participated in a program promoting healthy living (Atlanta, GA). At baseline, 6 months, 1 year, and 2 years after that, anthropometric, laboratory, and physical activity measurements were taken. The Health Partner used the results to create a customised plan aimed at achieving ideal health metrics. At the 6-month, 1-year, and 2-year follow-up visits, systolic blood pressure was lower by 3.6, 4.6, and 3.3 mm Hg (P0.001), total cholesterol was lower by 5.3, 6.5, and 6.4 mg/dL (P0.001), body mass index was lower by 0.33, 0.45, and 0.38 kg/m2 (P0.001), and the percentage of smokers was lower by 1.3 percent, 3.5 percent, and 3.5 percent The changes were more pronounced in those who had more anomalies at the start. Finally, compared to the baseline visit, the American Heart Association "Life's Simple 7" ideal cardiovascular health score increased by 0.28, 0.40, and 0.33 at 6 months, 1 year, and 2 years.
Conclusions
A personalized, goal-directed Health Partner intervention reduced the cardiometabolic risk profile and cardiovascular health measures dramatically. These effects were visible six months after enrollment and lasted for two years. More research is needed to see if the Health Partner intervention reduces long-term morbidity and mortality while remaining cost-effective. /
Dr. Quyyumi is a tenured Professor of Medicine in Emory University School of Medicine's Division of Cardiology and Director of the Emory Clinical Cardiovascular Research Institute. In this video Dr. Quyyumi discusses the Effects of a Health‐Partner Intervention on Cardiovascular Risk.
Link to Abstract-
https://www.ahajournals.org/doi/10.1161/JAHA.116.004217
Background
Lifestyle changes are the first line of defense against cardiovascular disease. It's less apparent whether a healthy lifestyle can also help with cardiovascular health. Our research looked at the impact of a lifestyle intervention provided by a Health Partner on indicators of optimum cardiovascular health.
Results and Methods
At Emory University, 711 university employees (4811 years old; 66 percent women, 72 percent Caucasian/22.5 percent African Americans) participated in a program promoting healthy living (Atlanta, GA). At baseline, 6 months, 1 year, and 2 years after that, anthropometric, laboratory, and physical activity measurements were taken. The Health Partner used the results to create a customised plan aimed at achieving ideal health metrics. At the 6-month, 1-year, and 2-year follow-up visits, systolic blood pressure was lower by 3.6, 4.6, and 3.3 mm Hg (P0.001), total cholesterol was lower by 5.3, 6.5, and 6.4 mg/dL (P0.001), body mass index was lower by 0.33, 0.45, and 0.38 kg/m2 (P0.001), and the percentage of smokers was lower by 1.3 percent, 3.5 percent, and 3.5 percent The changes were more pronounced in those who had more anomalies at the start. Finally, compared to the baseline visit, the American Heart Association "Life's Simple 7" ideal cardiovascular health score increased by 0.28, 0.40, and 0.33 at 6 months, 1 year, and 2 years.
Conclusions
A personalized, goal-directed Health Partner intervention reduced the cardiometabolic risk profile and cardiovascular health measures dramatically. These effects were visible six months after enrollment and lasted for two years. More research is needed to see if the Health Partner intervention reduces long-term morbidity and mortality while remaining cost-effective. /
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