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.
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."
Acute Coronary Syndromes
Description
Acute Coronary Syndromes
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.
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.
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.
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.
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.
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."
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."
Marco Corridore, MD, is an anesthesiologist at Nationwide Children's Hospital and The Heart Center and a clinical assistant professor of anesthesiology at Ohio State University School of Medicine. In this video Dr. Carridore discusses A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass.
Link to Abstract:
https://clinicaltrials.gov/ct2/show/study/NCT03757312?recrs=e&cond=Heart+Defects%2C+Congenital&lupd_s=01%2F01%2F2019&lupd_e=11%2F09%2F2021&draw=2
Abstract:
The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) after cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD) measured by non-invasive ultrasound. That is. ONSD is used as a correlation for ICP because it is not possible to measure ICP directly by CPB. ONSD has been shown to be effective in detecting increased ICP in intensive care units and emergency rooms and is recognized as the standard for such measurements. The main hypothesis is that changes in ICP after CPB occur without clinically identifiable signs or symptoms. These changes to the ICP will be reflected in the changes to the ONSD. If there is a significant postoperative incidence of asymptomatic cerebral edema and an increase in ICP, these results may affect postoperative hemodynamics and ventilation.
Marco Corridore, MD, is an anesthesiologist at Nationwide Children's Hospital and The Heart Center and a clinical assistant professor of anesthesiology at Ohio State University School of Medicine. In this video Dr. Carridore discusses A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass.
Link to Abstract:
https://clinicaltrials.gov/ct2/show/study/NCT03757312?recrs=e&cond=Heart+Defects%2C+Congenital&lupd_s=01%2F01%2F2019&lupd_e=11%2F09%2F2021&draw=2
Abstract:
The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) after cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD) measured by non-invasive ultrasound. That is. ONSD is used as a correlation for ICP because it is not possible to measure ICP directly by CPB. ONSD has been shown to be effective in detecting increased ICP in intensive care units and emergency rooms and is recognized as the standard for such measurements. The main hypothesis is that changes in ICP after CPB occur without clinically identifiable signs or symptoms. These changes to the ICP will be reflected in the changes to the ONSD. If there is a significant postoperative incidence of asymptomatic cerebral edema and an increase in ICP, these results may affect postoperative hemodynamics and ventilation.
Professor Ng earned a first-class honours degree in medicine from the University of Sydney before going on to study the molecular biology of early coronary artery disease for his PhD. He went on to Stanford University Medical Center to complete his fellowship program. His study has won various prizes and accolades, including the Young Investigator of the Year award from the Royal Australasian College of Physicians. In this video Professor Ng discusses Novel Pressure-Regulated Deployment Strategy for Improving the Safety and Efficacy of Balloon-Expandable Transcatheter Aortic Valves.
Link to Abstract:
https://www.jacc.org/doi/10.1016/j.jcin.2021.08.037
Abstract:
Abstract \sObjectives
The authors propose a new pressure-controlled approach for balloon-expandable transcatheter heart valve (THV) deployment, with the goal of maximizing prosthesis-annulus apposition while minimizing tissue harm.
Background
The best way to deploy balloon-expandable THV is still up for dispute. Current techniques are volume-dependent, relying on the deployment apparatus being under- or overfilled. The maximum THV diameter and balloon pressure (Laplace's law) define the annular wall tension exerted by the expanding prosthesis during deployment.
Methods
A total of 330 patients with severe native aortic stenosis who received TAVR with SAPIEN 3 THVs were included in the study. Sixty-six patients were deemed to be at high risk of annular rupture. The THVs were deployed until a predetermined balloon pressure was reached. To minimize mild or severe angiographic paravalvular regurgitation, postdilatation was used (PVR). Annular wall stress was calculated using a biomechanical model for each instance and compared to rates of postdilatation, mild or greater PVR on transthoracic echocardiography, new permanent pacemaker installation or left bundle branch block, and annular rupture.
Results
Postdilatation rate (P 0.001) and ultimate PVR (P = 0.014) were lower in patients with wall stress more than 3 MPa. Annular rupture occurred in two of three high-risk patients with wall stress greater than 3.5 MPa (3.69 and 3.84 MPa), but not in 95 high-risk patients with wall stress less than 3.5 MPa. To assure deployment within target wall stress levels of 3 to 3.5 MPa, we selected a single target deployment pressure per THV size: 6.25 atm for 23-mm THVs, 5.5 atm for 26-mm THVs, and 5 atm for 29-mm THVs. There was a 10.0 percent postdilatation rate, 12.7 percent mild PVR, and no moderate to severe PVR in patients in this target range (n = 136). There was no consistent link between balloon filling volume, related pressure, and wall stress.
Conclusions
Regardless of high-risk anatomical complexities, pressure-regulated THV deployment is a straightforward, reproducible, safe, and effective approach.
Dr. Brendan Carry is an American Board of Internal Medicine certified Cardiologist who attended Thomas Jefferson University. In this video Dr. Carry will discuss Genomic Screening for Pathogenic Transthyretin Variants Finds Evidence of Underdiagnosed Amyloid Cardiomyopathy From Health Records
Link to Abstract-
https://www.jacc.org/doi/10.1016/j.jaccao.2021.07.002
Abstract
Background
New treatments for transthyretin amyloidosis help patients live longer, but diagnosis is still difficult. Transthyretin amyloidosis is caused by pathogenic or probable pathogenic (P/LP) mutations in the transthyretin (TTR) gene, and genomic screening has been proposed to detect at-risk individuals. However, there is a lack of data on illness characteristics and penetrance to help determine the efficacy of population-based genomic screening for TTR.
Objectives
This study looked at the prevalence of P/LP variations in TTR discovered using exome sequencing, as well as the burden of disease associated with these variants based on electronic health records for people with these variants from a large (N = 134,753), mostly European-ancestry sample.
Methods
Individuals with and without P/LP TTR mutations were compared in terms of the frequency of common illness symptoms and cardiac imaging findings.
Results
We found P/LP TTR variations in 157 of 134,753 (0.12 percent) people (43 percent male, median age 52 [Q1-Q3: 37–61] years). All findings were accounted for by seven P/LP variations, the bulk of which were V122I. (p.V142I; 113, 0.08 percent ). African ancestry was found in approximately 60% (n = 91) of people with P/LP TTR mutations (all V122I). Although associated heart disease diagnoses, such as cardiomyopathy and heart failure, were considerably higher in individuals with P/LP TTR variations who were over 60 years old, amyloidosis diagnoses were rare (2 of 157 patients). Only one of the 14 percent (7 of 49) of people aged 60 or older with a P/LP TTR variation had cardiac disease and a ventricular septal thickness greater than 1.2 cm, and only one of them had amyloidosis.
Conclusions
Individuals with P/LP TTR variations discovered through genomic screening had a higher risk of heart disease after 60 years, despite the fact that amyloidosis is likely underdiagnosed without knowing the genetic variant.