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])
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."
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?
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.
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.
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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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.
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?
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])
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.
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.
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.
Trending
Justin Ezekowitz, MBBCh, MSc, Professor Department of Medicine Division of Cardiology, co-director of the Canadian VIGOUR Centre at the University of Alberta. In this video, he speaks about SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF).
Brief Synopsis:
SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic heart failure to assess the efficacy of a reduced sodium diet on a composite clinical outcome comprised of all-cause mortality, cardiovascular hospitalizations, and cardiovascular emergency department visits. The study's premise is that patients who follow a low-sodium diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those who were randomly assigned to Usual Care.
Justin Ezekowitz, MBBCh, MSc, Professor Department of Medicine Division of Cardiology, co-director of the Canadian VIGOUR Centre at the University of Alberta. In this video, he speaks about SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF).
Brief Synopsis:
SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic heart failure to assess the efficacy of a reduced sodium diet on a composite clinical outcome comprised of all-cause mortality, cardiovascular hospitalizations, and cardiovascular emergency department visits. The study's premise is that patients who follow a low-sodium diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those who were randomly assigned to Usual Care.
Professor Lars Søndergaard, Cardiologist at the Region Hovedstaden and Professor at the University of Copenhagen. In this video, he speaks about the Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes.
Observation -
Origins:
The innovative self-expanding, repositionable transcatheter heart valve (THV) device was created to treat severe, symptomatic aortic stenosis in patients who are at high surgical risk.
Goals:
The goal of this study was to report on the 1-year results of transcatheter aortic valve replacement with the novel THV system.
Methodologies:
This ongoing international, multicenter trial investigated patients with severe, symptomatic aortic stenosis who were implanted with the THV via transfemoral access and were followed up on at 30 days, one year, and annually for the next five years. The primary goal is 1-year all-cause mortality; supplementary endpoints include adjudicated clinical outcomes and echocardiographic measures.
Outcomes:
A total of 941 patients (82.4 5.9 years old; 65.7 percent female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8 percent) were enrolled and implanted at 61 sites across Europe, Australia, and Canada. Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, debilitating stroke rates, and myocardial infarction were 12.1 percent, 6.6 percent, 2.2 percent, and 2.5 percent, respectively, at one year. The mean aortic transvalvular gradient was 8.66 mm Hg, and the aortic valve area was 1.75 cm2. In 2.6 percent of individuals with no severe leakage, there was moderate or severe paravalvular leakage. At 30 days and 1 year, new pacemaker rates were 18.7 percent and 21.3 percent, respectively, among pacemaker naive patients. From baseline to one year, functional class, exercise capacity, and quality of life all increased significantly.
Findings:
Transcatheter aortic valve replacement using the new THV is related with low 1-year mortality and stroke rates in individuals at high surgical risk. At one year, hemodynamic findings are favorable, with a modest transvalvular pressure gradient and a low incidence of substantial paravalvular leakage. (5-Year Follow-up of Patients With PORTICO Valves [PORTICO-I]; NCT01802788)
Professor Lars Søndergaard, Cardiologist at the Region Hovedstaden and Professor at the University of Copenhagen. In this video, he speaks about the Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes.
Observation -
Origins:
The innovative self-expanding, repositionable transcatheter heart valve (THV) device was created to treat severe, symptomatic aortic stenosis in patients who are at high surgical risk.
Goals:
The goal of this study was to report on the 1-year results of transcatheter aortic valve replacement with the novel THV system.
Methodologies:
This ongoing international, multicenter trial investigated patients with severe, symptomatic aortic stenosis who were implanted with the THV via transfemoral access and were followed up on at 30 days, one year, and annually for the next five years. The primary goal is 1-year all-cause mortality; supplementary endpoints include adjudicated clinical outcomes and echocardiographic measures.
Outcomes:
A total of 941 patients (82.4 5.9 years old; 65.7 percent female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8 percent) were enrolled and implanted at 61 sites across Europe, Australia, and Canada. Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, debilitating stroke rates, and myocardial infarction were 12.1 percent, 6.6 percent, 2.2 percent, and 2.5 percent, respectively, at one year. The mean aortic transvalvular gradient was 8.66 mm Hg, and the aortic valve area was 1.75 cm2. In 2.6 percent of individuals with no severe leakage, there was moderate or severe paravalvular leakage. At 30 days and 1 year, new pacemaker rates were 18.7 percent and 21.3 percent, respectively, among pacemaker naive patients. From baseline to one year, functional class, exercise capacity, and quality of life all increased significantly.
Findings:
Transcatheter aortic valve replacement using the new THV is related with low 1-year mortality and stroke rates in individuals at high surgical risk. At one year, hemodynamic findings are favorable, with a modest transvalvular pressure gradient and a low incidence of substantial paravalvular leakage. (5-Year Follow-up of Patients With PORTICO Valves [PORTICO-I]; NCT01802788)
Latest Videos
Justin Ezekowitz, MBBCh, MSc, Professor Department of Medicine Division of Cardiology, co-director of the Canadian VIGOUR Centre at the University of Alberta. In this video, he speaks about SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF).
Brief Synopsis:
SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic heart failure to assess the efficacy of a reduced sodium diet on a composite clinical outcome comprised of all-cause mortality, cardiovascular hospitalizations, and cardiovascular emergency department visits. The study's premise is that patients who follow a low-sodium diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those who were randomly assigned to Usual Care.
Justin Ezekowitz, MBBCh, MSc, Professor Department of Medicine Division of Cardiology, co-director of the Canadian VIGOUR Centre at the University of Alberta. In this video, he speaks about SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF).
Brief Synopsis:
SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic heart failure to assess the efficacy of a reduced sodium diet on a composite clinical outcome comprised of all-cause mortality, cardiovascular hospitalizations, and cardiovascular emergency department visits. The study's premise is that patients who follow a low-sodium diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those who were randomly assigned to Usual Care.
Professor Lars Søndergaard, Cardiologist at the Region Hovedstaden and Professor at the University of Copenhagen. In this video, he speaks about the Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes.
Observation -
Origins:
The innovative self-expanding, repositionable transcatheter heart valve (THV) device was created to treat severe, symptomatic aortic stenosis in patients who are at high surgical risk.
Goals:
The goal of this study was to report on the 1-year results of transcatheter aortic valve replacement with the novel THV system.
Methodologies:
This ongoing international, multicenter trial investigated patients with severe, symptomatic aortic stenosis who were implanted with the THV via transfemoral access and were followed up on at 30 days, one year, and annually for the next five years. The primary goal is 1-year all-cause mortality; supplementary endpoints include adjudicated clinical outcomes and echocardiographic measures.
Outcomes:
A total of 941 patients (82.4 5.9 years old; 65.7 percent female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8 percent) were enrolled and implanted at 61 sites across Europe, Australia, and Canada. Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, debilitating stroke rates, and myocardial infarction were 12.1 percent, 6.6 percent, 2.2 percent, and 2.5 percent, respectively, at one year. The mean aortic transvalvular gradient was 8.66 mm Hg, and the aortic valve area was 1.75 cm2. In 2.6 percent of individuals with no severe leakage, there was moderate or severe paravalvular leakage. At 30 days and 1 year, new pacemaker rates were 18.7 percent and 21.3 percent, respectively, among pacemaker naive patients. From baseline to one year, functional class, exercise capacity, and quality of life all increased significantly.
Findings:
Transcatheter aortic valve replacement using the new THV is related with low 1-year mortality and stroke rates in individuals at high surgical risk. At one year, hemodynamic findings are favorable, with a modest transvalvular pressure gradient and a low incidence of substantial paravalvular leakage. (5-Year Follow-up of Patients With PORTICO Valves [PORTICO-I]; NCT01802788)
Professor Lars Søndergaard, Cardiologist at the Region Hovedstaden and Professor at the University of Copenhagen. In this video, he speaks about the Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes.
Observation -
Origins:
The innovative self-expanding, repositionable transcatheter heart valve (THV) device was created to treat severe, symptomatic aortic stenosis in patients who are at high surgical risk.
Goals:
The goal of this study was to report on the 1-year results of transcatheter aortic valve replacement with the novel THV system.
Methodologies:
This ongoing international, multicenter trial investigated patients with severe, symptomatic aortic stenosis who were implanted with the THV via transfemoral access and were followed up on at 30 days, one year, and annually for the next five years. The primary goal is 1-year all-cause mortality; supplementary endpoints include adjudicated clinical outcomes and echocardiographic measures.
Outcomes:
A total of 941 patients (82.4 5.9 years old; 65.7 percent female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8 percent) were enrolled and implanted at 61 sites across Europe, Australia, and Canada. Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, debilitating stroke rates, and myocardial infarction were 12.1 percent, 6.6 percent, 2.2 percent, and 2.5 percent, respectively, at one year. The mean aortic transvalvular gradient was 8.66 mm Hg, and the aortic valve area was 1.75 cm2. In 2.6 percent of individuals with no severe leakage, there was moderate or severe paravalvular leakage. At 30 days and 1 year, new pacemaker rates were 18.7 percent and 21.3 percent, respectively, among pacemaker naive patients. From baseline to one year, functional class, exercise capacity, and quality of life all increased significantly.
Findings:
Transcatheter aortic valve replacement using the new THV is related with low 1-year mortality and stroke rates in individuals at high surgical risk. At one year, hemodynamic findings are favorable, with a modest transvalvular pressure gradient and a low incidence of substantial paravalvular leakage. (5-Year Follow-up of Patients With PORTICO Valves [PORTICO-I]; NCT01802788)
Cardiac Injury
Marie-Sophie de Koning, MD, PhD Candidate in Cardiology at the UMCG Cardiology Research Institute. In this video, she speaks about AAC 2022 Abstract - Results from the GIPS-IV Trial.
Brief Synopsis:
The most effective treatment for ST-segment elevation myocardial infarction is now timely and successful reperfusion with primary percutaneous coronary intervention (PPCI) (STEMI). However, persistent myocardial injury caused by ischemia and subsequent reperfusion is seen in the vast majority of patients (88%) and poses a risk of heart failure development. In numerous experimental models, hydrogen sulfide (H2S) administration has been found to protect the heart from "ischemia reperfusion injury." Human data suggests that the H2S-releasing chemical sodium thiosulfate (STS) can be safely administered.
The goal of this study was to examine the efficacy and safety of STS versus placebo treatment on myocardial infarct size in STEMI patients treated with PCI.
A multicenter, double-blind, randomized controlled clinical trial was used for the study. A total of 380 patients aged 18 and up who were undergoing primary PCI for a first STEMI and deemed amenable by the investigator to be treated with STS 12.5g intravenously (i.v.) or matched placebo immediately after arrival at the catheterization laboratory (cath-lab) and a repeated dose administered 6 hours after the first dose, on top of standard treatment, were included in the study. The primary endpoint is the size of the infarct as determined by cardiac magnetic resonance imaging (CMR-imaging) four months following randomization.
Marie-Sophie de Koning, MD, PhD Candidate in Cardiology at the UMCG Cardiology Research Institute. In this video, she speaks about AAC 2022 Abstract - Results from the GIPS-IV Trial.
Brief Synopsis:
The most effective treatment for ST-segment elevation myocardial infarction is now timely and successful reperfusion with primary percutaneous coronary intervention (PPCI) (STEMI). However, persistent myocardial injury caused by ischemia and subsequent reperfusion is seen in the vast majority of patients (88%) and poses a risk of heart failure development. In numerous experimental models, hydrogen sulfide (H2S) administration has been found to protect the heart from "ischemia reperfusion injury." Human data suggests that the H2S-releasing chemical sodium thiosulfate (STS) can be safely administered.
The goal of this study was to examine the efficacy and safety of STS versus placebo treatment on myocardial infarct size in STEMI patients treated with PCI.
A multicenter, double-blind, randomized controlled clinical trial was used for the study. A total of 380 patients aged 18 and up who were undergoing primary PCI for a first STEMI and deemed amenable by the investigator to be treated with STS 12.5g intravenously (i.v.) or matched placebo immediately after arrival at the catheterization laboratory (cath-lab) and a repeated dose administered 6 hours after the first dose, on top of standard treatment, were included in the study. The primary endpoint is the size of the infarct as determined by cardiac magnetic resonance imaging (CMR-imaging) four months following randomization.
Ian A. White, MS, Ph.D., Founder, President & Chief Scientific Officer at Neobiosis speaks about the Breakthrough Paper Outlines Path to Heart Regeneration After Cardiac Injury.
Link to Article:
https://www.pubstemcell.com/epub/016010300010EPA121120.htm?fbclid=IwAR3HybxbXXEBRK4FXsfcUc-MBImTiSc1USuIg-J_8f0JLuwKL3O_oWa1qf4
Cardiovascular disorder claims the lives of over 650,000 Americans per year. (1) Those who survive a myocardial infarction are still at risk of dying because the human heart's capacity to heal itself is limited. No one has yet discovered a mechanism for regenerating a weakened human heart's cardiovascular system. But it could all improve due to a groundbreaking medical paper written by Dr. Ian White, President and Chief Scientific Officer of Neobiosis, a regenerative medicine corporation.
A mouse heart, like the hearts of other mammals, has a very brief time (1-7 days) after birth where it maintains its primordial regenerative powers. White's latest approach, however, maintains a neonatal mouse heart alive and beating in a stable environment for up to a month, extending the regenerative cycle. This gives scientists more time to figure out how various treatments or medications can help the weakened organ heal or rebuild.
The epicardium, a single layer of cells that protects the nucleus, is involved in neonatal cardiac recovery, according to White's article. In response to injury, the cells proliferate before successfully migrating to the damaged area.
The discovery has far-reaching health consequences, especially for those who have suffered heart damage as a result of COVID-19 exposure.
White is happy to share his creations with the rest of the world. He also urged colleagues to conduct their own studies using the same neonatal heart preservation process. Neobiosis is a pioneer in the field of regenerative science, as shown by the dissemination of this research.
Regenerative medicine, according to White and his colleagues at the University of Florida's Sid Martin Innovate Biotechnology Institute, carries the promise of long-term survival and wellbeing. Many concerned with the new laboratory are optimistic that their findings and affiliation with the University of Florida would lead to new health therapies, and they also urge the FDA to reconsider its position on this groundbreaking area of science.
Regenerative Therapy's Advantages
Regenerative medicine has the ability to revolutionize healthcare and combat illness. The medications focus on assisting the body in healing, regenerating, and rebuilding itself. These are some of the advantages:
* Using biochemical guidance and raw biomaterials to stimulate the body's own repair processes to functionally restore previously irreparable tissues and organs.
* Reducing inflammation to help with healing and tissue repair.
* Use alternative methods to treat trauma and illness without the use of surgery or opioids.
Cardiac Surgery
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.
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.
Professor Daniel I Sessler, Michael Cudahy Professor and Chair at the department of outcomes resesarch at Cleveland Clinic. In this video, he speaks about Aggressive intraoperative warming versus routine thermal management during non-cardiac surgery (PROTECT): a multicentre, parallel group, superiority trial.
Synopsis
Origins:
Intraoperative hypothermia of moderate severity causes myocardial damage, surgical site infections, and blood loss. It is unknown whether forceful warming to a true normothermic temperature approaching 37°C improves outcomes. We wanted to see if intensive intraoperative warming minimizes severe perioperative problems.
Methodologies:
During non-cardiac surgery, patients were randomly assigned (1:1) to either aggressive warming to a target core temperature of 37°C (aggressively warmed group) or routine thermal management to a target of 35°C (routine thermal management group) at 12 sites in China and the Cleveland Clinic in the United States. Randomization was stratified by location, with randomly sized blocks generated by a computer. Eligible patients (aged 45 years) had at least one cardiovascular risk factor, were scheduled for inpatient non-cardiac surgery lasting 2–6 hours under general anaesthesia, and had at least half of the anterior skin surface available for warming. Patients on dialysis and those with a BMI more than 30 kg/m2 were excluded. In the modified intention-to-treat population, the primary outcome was a composite of myocardial damage (troponin increase, probably of ischemic origin), non-fatal cardiac arrest, and all-cause mortality within 30 days of surgery. NCT03111875, this study is registered with ClinicalTrials.gov.
Observations:
5056 participants were enrolled between March 27, 2017 and March 16, 2021, with 5013 included in the intention-to-treat population (2507 in the aggressively warmed group and 2506 in the routine thermal management group). Patients allocated to intense warming had a mean final intraoperative core temperature of 371°C (SD 03), whereas patients assigned to regular thermal care had a mean final intraoperative core temperature of 356°C (SD 03). At least one of the primary outcome components (myocardial damage following non-cardiac surgery, cardiac arrest, or mortality) occurred in 246 (99% of 2497) of the forcefully warmed patients and in 239 (96% of 2490) of the normal thermal care patients. The calculated common impact relative risk of active versus routine thermal management was 104 (95 percent CI 087–124; p=069). There were 39 adverse events (17 of which were significant) in patients assigned to intense warming and 54 in those assigned to normal thermal care (30 of which were serious). One major adverse event in a patient who had been intensively warmed was thought to be connected to thermal management.
Observation:
The 30-day composite of main cardiovascular events did not differ substantially between participants randomly assigned to 355°C or 37°C. There was no evidence that any significant consequence differed throughout a 15°C range from extremely mild hypothermia to full normothermia. In surgical patients, maintaining a core temperature of at least 355°C appears to be sufficient.
Professor Daniel I Sessler, Michael Cudahy Professor and Chair at the department of outcomes resesarch at Cleveland Clinic. In this video, he speaks about Aggressive intraoperative warming versus routine thermal management during non-cardiac surgery (PROTECT): a multicentre, parallel group, superiority trial.
Synopsis
Origins:
Intraoperative hypothermia of moderate severity causes myocardial damage, surgical site infections, and blood loss. It is unknown whether forceful warming to a true normothermic temperature approaching 37°C improves outcomes. We wanted to see if intensive intraoperative warming minimizes severe perioperative problems.
Methodologies:
During non-cardiac surgery, patients were randomly assigned (1:1) to either aggressive warming to a target core temperature of 37°C (aggressively warmed group) or routine thermal management to a target of 35°C (routine thermal management group) at 12 sites in China and the Cleveland Clinic in the United States. Randomization was stratified by location, with randomly sized blocks generated by a computer. Eligible patients (aged 45 years) had at least one cardiovascular risk factor, were scheduled for inpatient non-cardiac surgery lasting 2–6 hours under general anaesthesia, and had at least half of the anterior skin surface available for warming. Patients on dialysis and those with a BMI more than 30 kg/m2 were excluded. In the modified intention-to-treat population, the primary outcome was a composite of myocardial damage (troponin increase, probably of ischemic origin), non-fatal cardiac arrest, and all-cause mortality within 30 days of surgery. NCT03111875, this study is registered with ClinicalTrials.gov.
Observations:
5056 participants were enrolled between March 27, 2017 and March 16, 2021, with 5013 included in the intention-to-treat population (2507 in the aggressively warmed group and 2506 in the routine thermal management group). Patients allocated to intense warming had a mean final intraoperative core temperature of 371°C (SD 03), whereas patients assigned to regular thermal care had a mean final intraoperative core temperature of 356°C (SD 03). At least one of the primary outcome components (myocardial damage following non-cardiac surgery, cardiac arrest, or mortality) occurred in 246 (99% of 2497) of the forcefully warmed patients and in 239 (96% of 2490) of the normal thermal care patients. The calculated common impact relative risk of active versus routine thermal management was 104 (95 percent CI 087–124; p=069). There were 39 adverse events (17 of which were significant) in patients assigned to intense warming and 54 in those assigned to normal thermal care (30 of which were serious). One major adverse event in a patient who had been intensively warmed was thought to be connected to thermal management.
Observation:
The 30-day composite of main cardiovascular events did not differ substantially between participants randomly assigned to 355°C or 37°C. There was no evidence that any significant consequence differed throughout a 15°C range from extremely mild hypothermia to full normothermia. In surgical patients, maintaining a core temperature of at least 355°C appears to be sufficient.