This document summarizes clinical results and registry data on Enhanced External Counterpulsation (EECP) therapy. It discusses several studies that show EECP therapy:
1) Can reduce angina and extend the time to ischemia and increase exercise tolerance in patients with symptomatic coronary artery disease.
2) Improved exercise tolerance and heart failure symptoms in patients with mild to moderate heart failure, but did not improve peak oxygen consumption 6 months after treatment.
3) Provided functional benefits for older patients (65+) with heart failure, with a higher rate of improved peak oxygen consumption compared to pharmacologic therapy alone.
1) EECP therapy is a non-invasive treatment that uses inflatable cuffs around the legs to enhance blood flow and reduce workload on the heart.
2) A study of 139 patients found that EECP therapy significantly increased exercise time and reduced chest pain episodes compared to a control group.
3) A separate study of 187 heart failure patients found that EECP therapy significantly improved exercise duration and quality of life over 6 months compared to medication therapy alone.
EECP therapy is a non-invasive treatment for angina and heart failure administered through inflatable cuffs on the legs. It is done as an outpatient in daily one-hour sessions for seven weeks, improving symptoms in about 75% of patients. The cuffs inflate in synchronization with the heart to increase blood flow and reduce workload. Over 190 studies have demonstrated its safety and effectiveness through improved endothelial function, reduced inflammation, and increased collateral circulation. Contraindications include certain arrhythmias, bleeding disorders, and severe vascular disease.
This document discusses the goals and treatment modalities for pulmonary arterial hypertension (PAH) management. The goals are to prevent disease progression in stable patients, and stabilize right-sided heart function and provide symptomatic relief in unstable patients. Treatment includes pharmacological therapies like prostanoids, endothelin receptor antagonists, phosphodiesterase type-5 inhibitors, and combinations. Non-pharmacological options discussed include balloon atrial septostomy surgery. The document provides detailed information on specific drugs, their mechanisms, studies demonstrating efficacy, dosing, and side effects.
This document provides guidelines for managing hyperglycemia in ICU patients using insulin therapy. It recommends a target blood glucose range of 100-150 mg/dL. The guidelines describe different types of insulin, including rapid, short, intermediate and long-acting varieties. It presents a protocol for intravenous insulin therapy that involves calculating initial bolus and infusion rates based on the patient's starting blood glucose level. The protocol provides guidance on adjusting the infusion rate based on hourly blood glucose monitoring and includes steps to avoid and treat hypoglycemia.
The Cardiopulmonary Exercise Test (CPET) is a non-invasive stress test that assesses how well the heart, lungs, and muscles work individually and together during exercise. It measures oxygen use, carbon dioxide production, breathing, and electrocardiogram responses. A CPET can detect various cardiac and pulmonary conditions that limit exercise capacity, such as heart failure, ischemia, and lung disorders. It involves wearing a face mask and EKG stickers while exercising on a treadmill or bike according to a protocol, with monitoring of vital signs throughout. Results provide information on functional capacity and can guide medical management and exercise prescription.
We aimed to investigate the potential effects of fi x-dose atorvastatin plus amlodipine treatment and amlodipine alone treatment for 24 weeks on blood pressure, arterial stiffness and endothelial function in patients with hypertension and hypercholesterolemia. In a single-blinded, randomized, placebo-controlled and parallel design, 60 hypertensive and hypercholesterolemic patients were allocated to receive atorvastatin 10 mg/day plus amlodipine 5 mg/day or amlodipine 5 mg/day for 24 weeks. Central blood pressure was reduced significantly greater in atorvastatin plus amlodipine group than in amlodipine group after 12 and 24 weeks’ treatment. Both amlodipine and atorvastatin plus amlodipine therapy signifi cantly improved Flow-Mediated Dilation (FMD) compared to baseline (p < 0.01), the effect of atorvastatin plus amlodipine therapy was even greater after 24 weeks(p < 0.05). Atorvastatin plus amlodipine therapy signifi cantly decreased Heart Rate-Adjusted Augmentation Index (AIx@HR75), carotid-femoral and brachial-ankle Pulse Wave Velocity (PWV) when compared with baseline in both 12 weeks and 24 weeks’ administration, while amlodipine therapy not. FMD improvement was independently correlated with change in TC (β = -0.416, P = 0.004), while arterial stiffness improvement assessed with AIx@HR75 and baPWV, was correlated with change in central SBP (β = 0.772, P < 0.001, and β = 0.420, P = 0.003, respectively) in multivariate linear stepwise model. Fixed-dose amlodipine and atorvastatin treatment for 24 weeks reduced central BP and arterial stiffness, improved endothelial function greater than amlodipine therapy. Our findings suggested decrease in TC was the independent protective factor for endothelial function improvement and decrease in central SBP was the independent protective factor for arterial stiffness reduction during the follow-up period.
Rehabilitation considerations for cardiac transplantation patientsBPT4thyearJamiaMilli
This document discusses considerations for exercise testing and training for heart transplant patients. It notes that cardiopulmonary exercise testing can help assess prognosis and timing of transplantation. Peak oxygen consumption thresholds help determine if medical management or transplantation is most appropriate. The document outlines aerobic and resistance exercise benefits after transplantation and rehabilitation protocols both inpatient and outpatient. It provides guidelines for exercise prescription post-transplant including intensity, duration and type of exercises.
This document discusses non-invasive guided goal-directed therapy (GDT) for hemodynamic monitoring and optimization. It describes using a bedside monitor to continuously and non-invasively estimate cardiac output and stroke volume based on pulse wave transit time analysis of ECG and pulse oximetry signals. The method is calibrated using intermittent non-invasive blood pressure readings. Studies show this approach can guide fluid administration and help achieve hemodynamic goals like those used in invasive GDT protocols to improve outcomes. The document provides details on set up, use, and limitations of this non-invasive GDT method for perioperative hemodynamic optimization.
1) EECP therapy is a non-invasive treatment that uses inflatable cuffs around the legs to enhance blood flow and reduce workload on the heart.
2) A study of 139 patients found that EECP therapy significantly increased exercise time and reduced chest pain episodes compared to a control group.
3) A separate study of 187 heart failure patients found that EECP therapy significantly improved exercise duration and quality of life over 6 months compared to medication therapy alone.
EECP therapy is a non-invasive treatment for angina and heart failure administered through inflatable cuffs on the legs. It is done as an outpatient in daily one-hour sessions for seven weeks, improving symptoms in about 75% of patients. The cuffs inflate in synchronization with the heart to increase blood flow and reduce workload. Over 190 studies have demonstrated its safety and effectiveness through improved endothelial function, reduced inflammation, and increased collateral circulation. Contraindications include certain arrhythmias, bleeding disorders, and severe vascular disease.
This document discusses the goals and treatment modalities for pulmonary arterial hypertension (PAH) management. The goals are to prevent disease progression in stable patients, and stabilize right-sided heart function and provide symptomatic relief in unstable patients. Treatment includes pharmacological therapies like prostanoids, endothelin receptor antagonists, phosphodiesterase type-5 inhibitors, and combinations. Non-pharmacological options discussed include balloon atrial septostomy surgery. The document provides detailed information on specific drugs, their mechanisms, studies demonstrating efficacy, dosing, and side effects.
This document provides guidelines for managing hyperglycemia in ICU patients using insulin therapy. It recommends a target blood glucose range of 100-150 mg/dL. The guidelines describe different types of insulin, including rapid, short, intermediate and long-acting varieties. It presents a protocol for intravenous insulin therapy that involves calculating initial bolus and infusion rates based on the patient's starting blood glucose level. The protocol provides guidance on adjusting the infusion rate based on hourly blood glucose monitoring and includes steps to avoid and treat hypoglycemia.
The Cardiopulmonary Exercise Test (CPET) is a non-invasive stress test that assesses how well the heart, lungs, and muscles work individually and together during exercise. It measures oxygen use, carbon dioxide production, breathing, and electrocardiogram responses. A CPET can detect various cardiac and pulmonary conditions that limit exercise capacity, such as heart failure, ischemia, and lung disorders. It involves wearing a face mask and EKG stickers while exercising on a treadmill or bike according to a protocol, with monitoring of vital signs throughout. Results provide information on functional capacity and can guide medical management and exercise prescription.
We aimed to investigate the potential effects of fi x-dose atorvastatin plus amlodipine treatment and amlodipine alone treatment for 24 weeks on blood pressure, arterial stiffness and endothelial function in patients with hypertension and hypercholesterolemia. In a single-blinded, randomized, placebo-controlled and parallel design, 60 hypertensive and hypercholesterolemic patients were allocated to receive atorvastatin 10 mg/day plus amlodipine 5 mg/day or amlodipine 5 mg/day for 24 weeks. Central blood pressure was reduced significantly greater in atorvastatin plus amlodipine group than in amlodipine group after 12 and 24 weeks’ treatment. Both amlodipine and atorvastatin plus amlodipine therapy signifi cantly improved Flow-Mediated Dilation (FMD) compared to baseline (p < 0.01), the effect of atorvastatin plus amlodipine therapy was even greater after 24 weeks(p < 0.05). Atorvastatin plus amlodipine therapy signifi cantly decreased Heart Rate-Adjusted Augmentation Index (AIx@HR75), carotid-femoral and brachial-ankle Pulse Wave Velocity (PWV) when compared with baseline in both 12 weeks and 24 weeks’ administration, while amlodipine therapy not. FMD improvement was independently correlated with change in TC (β = -0.416, P = 0.004), while arterial stiffness improvement assessed with AIx@HR75 and baPWV, was correlated with change in central SBP (β = 0.772, P < 0.001, and β = 0.420, P = 0.003, respectively) in multivariate linear stepwise model. Fixed-dose amlodipine and atorvastatin treatment for 24 weeks reduced central BP and arterial stiffness, improved endothelial function greater than amlodipine therapy. Our findings suggested decrease in TC was the independent protective factor for endothelial function improvement and decrease in central SBP was the independent protective factor for arterial stiffness reduction during the follow-up period.
Rehabilitation considerations for cardiac transplantation patientsBPT4thyearJamiaMilli
This document discusses considerations for exercise testing and training for heart transplant patients. It notes that cardiopulmonary exercise testing can help assess prognosis and timing of transplantation. Peak oxygen consumption thresholds help determine if medical management or transplantation is most appropriate. The document outlines aerobic and resistance exercise benefits after transplantation and rehabilitation protocols both inpatient and outpatient. It provides guidelines for exercise prescription post-transplant including intensity, duration and type of exercises.
This document discusses non-invasive guided goal-directed therapy (GDT) for hemodynamic monitoring and optimization. It describes using a bedside monitor to continuously and non-invasively estimate cardiac output and stroke volume based on pulse wave transit time analysis of ECG and pulse oximetry signals. The method is calibrated using intermittent non-invasive blood pressure readings. Studies show this approach can guide fluid administration and help achieve hemodynamic goals like those used in invasive GDT protocols to improve outcomes. The document provides details on set up, use, and limitations of this non-invasive GDT method for perioperative hemodynamic optimization.
American Heart AVOID study: Air Versus Oxygen In ST-elevation myocardial Infa...Emergency Live
We’ve been waiting for the AVOID study, since we mentioned it a few years ago in another post on the harm of excessive oxygen. AVOID (Air Versus Oxygen in Myocardial Infarction). Now, it’s out. As expected, it shows that unnecessary oxygen supplement worsens outcome. The surprise is just how big a difference it makes! In this study, too much oxygen increased recurrent MI fivefold!
Avoiding hyperoxemia isn’t new. Normoxemia has been a trend, but lacked hard evidence in form of an RCT, and the reflex-O2-mask in ED has been hard to fight. Right now, the full AVOID article has yet to be released, but the results have just been presented at AHA’s congress in Chicago last week. And AHA has posted a video interview with Dr. Stub, one of the investigators of the AVOID trial, on the results, as well as posted his presentation slides here. This research performed an investigator initiated multicenter randomized controlled trial to compare supplemental oxygen therapy with no oxygen therapy in normoxic patients with STEMI to determine its effect on myocardial infarct size.
ORIGINAL SOURCE: http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_469664.pdf
Intra-arrest induction of Therapeuitic Hypothermia via large-volume ice-cold...Emergency Live
This document summarizes a study conducted by the NYC Project Hypothermia Working Group to evaluate the effects of intra-arrest induction of therapeutic hypothermia via large-volume ice-cold saline infusion on survival outcomes for out-of-hospital cardiac arrest. The study found that administering large volumes of ice-cold saline during cardiac arrest resuscitation efforts improved rates of return of spontaneous circulation and survival to hospital discharge when compared to a control period without this intervention. Further research is still needed to evaluate the long-term effects and most appropriate patient populations.
This document summarizes potential applications of pressure wire measurement in the peripheral circulation and presents results from a study examining its use in below-the-knee (BTK) angioplasty. The study aimed to assess correlations between invasive and non-invasive measurements of blood pressure and flow pre-and post-BTK intervention. 31 patients with critical limb ischemia underwent angiography, pressure wire assessment of resting and hyperemic pressures, and measurements of ankle-brachial index and tissue oxygen levels. Procedural success was achieved in all patients based on angiographic and clinical improvement. Correlations were observed between invasive pressure and non-invasive flow measurements, though further studies are needed to validate results and clarify optimal vasodil
IOSR Journal of Pharmacy (IOSRPHR), www.iosrphr.org, call for paper, research...iosrphr_editor
This study investigated the effects of oral clonidine premedication on hemodynamic changes during laparoscopic cholecystectomy. 100 patients were randomly assigned to receive either oral clonidine 150 micrograms or ranitidine 150 mg 90 minutes before surgery. Heart rate, blood pressure, and the need for antihypertensive treatment were significantly lower in the clonidine group during and after surgery. Postoperative nausea, vomiting, shivering, pain, and sedation were also reduced with clonidine premedication. The results suggest that oral clonidine can provide hemodynamic stability and reduce postoperative complications for patients undergoing laparoscopic cholecystectomy.
The document summarizes evidence from multiple randomized controlled trials and systematic reviews comparing treatments for intermittent claudication in the lower extremities. It finds that supervised exercise therapy, endovascular therapy, and open surgery are superior to medical management alone in improving walking distance, pain, and claudication. Specifically, supervised exercise therapy significantly improves walking performance compared to usual care. Both endovascular and open revascularization lead to faster improvement in blood flow parameters than exercise therapy, but do not necessarily correlate with better clinical outcomes. The evidence is limited by the small number of high-quality trials.
Effectiveness of intra-articular dexmedetomidine as postoperative analgesia i...iosrphr_editor
Background And Objectives: To study the effect of inj.Ropivacaine (0.25%) 2mg/kg with and without Inj.Dexmedetomidine (1-2μg/kg) intraarticularly for postoperative analgesia in arthroscopic knee surgery.1:To Evaluate Onset, Duration and analgesic efficacy of Intraarticular Dexmedetomidine2: To monitor the safety of Dexmedetomidine and Ropivacaine.
Methods: A prospective randomized double blind study, was conducted in 50 patients undergoing elective arthroscopy of knee joint under spinal anaesthesia. At the completion of the surgery, all patients were divied into two groups;GroupP(n=25):received Inj. Ropivacaine 0.25% and GroupD(n=25):received Inj.Ropivacaine(0.25%)+Inj. Dexmedetomidine(1μg/kg) total volume 20 ml was deposited intra-articularly.Patients were monitored in the postoperative ward for the hemodynamic parameters and their Sedation score was assessed.. The efficacy of the drug was determined by improvement in VAS score, duration of analgesia and total number of rescue analgesics during 24 hr in post operative period.
Results: There was no statistically significant differences observed in heart rate except changes at 6 and 8 hr. At 6 and 8 hr in group P pulse (82.48 ± 7.49, 81.44 ± 8.78) as compared to group D (75.38 ± 6.52, 74.96 ± 5.70),because of duration of action of ropivacaine with or without dexmedetomidine.There was no statistically significant difference in blood pressure was found, except at 12 hour and 24 hour (p=0.018), because of longer duration of action of intrarticular dexmedetomidine with ropivacaine in group D.At 6 hrs patients in Group P had a mean VAS score of 3.2 as compared to VAS score values of 1.8 in Group D which is statistically significant..At 2 , 4, 6 and 8 hour VAS score in P group was 1.64, 2.44, 3.24, 2.84 respectively. As compared to group P, in group D VAS score at 2, 4, 6 and 8 hour was 0.92, 1.04, 1.79 and 2.08 respectively. So VAS score lower in group D as compared to group P at 2, 4, 6 and 8 hrs.
Based on the details provided, the results of this study appear to be applicable and helpful for guiding treatment decisions for patients similar to those enrolled in the trial - namely, patients with moderate PE who are ineligible for full-dose thrombolysis. The treatment appears feasible and significantly reduced important clinical outcomes. As with any intervention, the risks and benefits for an individual patient should be considered.
Perioperative management of patients on corticosteroidsTerry Shaneyfelt
In these annotated PowerPoints I discuss the evaluation and perioperative management of patient taking or who have taken steroids. I discuss how to determine if the adrenal axis is suppressed and how to provide supplemental glucocorticoids if needed. Remember to download these slides to see the annotations for each slide.
This document provides guidelines for intravenous insulin infusion therapy, including thresholds for when to initiate therapy based on glucose levels and target glucose ranges. It recommends starting with an insulin multiplier of 0.02 in a formula that calculates insulin units per hour based on blood glucose levels, and adjusting the multiplier up or down by 0.01 each hour to reach targets. It also provides a formula for correcting hypoglycemia with intravenous dextrose administration based on current blood glucose levels and patient weight.
This document discusses guidelines and considerations for clinical trials in hypertension. It provides information on:
1. The increasing global prevalence and costs of hypertension, with an estimated 1.6 billion hypertensive patients by 2025.
2. Guidelines for classifying and treating hypertension from organizations like JNC, WHO, and ESC/ESH. The JNC 8 guideline is evidence-based and recommends treatment thresholds, goals, and medications based on randomized controlled trials.
3. Methodological considerations for designing and conducting clinical trials to evaluate antihypertensive drugs and combinations, including study populations, measures of efficacy like blood pressure and target organ damage, safety aspects, and trial durations. Long-term safety data is important
Evaluvation of Perioperative Haemodynamic Changes in Hypertensive Patients Tr...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
This document discusses best practices for perioperative fluid management. It notes that perioperative fluid management can be complicated due to factors like fasting, bowel preps, and surgical stress that can cause fluid and electrolyte imbalances. The goals of perioperative fluid management are hemodynamic stability, adequate tissue perfusion, avoidance of fluid overload, and avoidance of acute kidney injury in order to achieve best surgical outcomes. Different fluid management strategies are discussed for the preoperative, intraoperative, and postoperative periods including restricted versus liberal or goal-directed approaches using fluid biomarkers. Enhanced Recovery After Surgery (ERAS) protocols emphasize individualized fluid plans guided by physiologic targets as part of multimodal care.
This case report describes an adolescent male with near fatal asthma who was unresponsive to conventional therapy and required rescue therapy. He presented with severe hypoxemia, hypercapnia, and acidosis. Despite aggressive management including mechanical ventilation, his condition deteriorated further with the development of barotrauma and hemodynamic instability. The introduction of extracorporeal membrane oxygenation (ECMO) dramatically improved his gas exchange and lung mechanics. ECMO allowed his lungs time to recover from inflammation while minimizing ventilator-induced injury. With ECMO support for 72 hours, the patient was successfully weaned from ventilation and made a full recovery.
This document discusses the management of diabetes in surgical patients. It covers types of diabetes, glucose homeostasis, stress response and its effects on blood sugar, risks of hyper/hypoglycemia, assessment of diabetic patients before surgery, different protocols for minor vs major surgeries, intravenous insulin protocols, and postoperative care and monitoring of blood sugar levels.
This study analyzed data from over 31,000 orthopedic trauma surgery cases to determine if the time of day of surgery affected mortality and complication rates. The results showed that surgeries performed in the afternoon or at night had significantly higher mortality rates (1.1% in morning vs 2.4% at night) and general complication rates compared to morning surgeries. Higher rates of emergencies, injury severity, and surgeon fatigue after-hours may contribute to these outcomes. While no differences were found for intra- or post-operative complication rates based on surgery time, optimizing patient safety at all times, including surgeon self-awareness, is important.
Enhanced external counterpulsation (eecp) role inMonir zaman
Enhanced external counterpulsation (EECP) involves the use of inflatable cuffs wrapped around the lower extremities that are synchronized with the cardiac cycle to improve coronary perfusion. A study investigated EECP in patients with heart failure and found it improved exercise duration but not peak oxygen consumption compared to medical therapy alone. While EECP appears safe, more research is still needed to determine its efficacy in treating heart failure.
The document describes external counterpulsation (ECP) therapy for patients with coronary artery disease. ECP involves inflation and deflation of pressure cuffs on the lower limbs synchronized with the cardiac cycle to increase blood flow to the heart. It is administered as 35 one-hour sessions over 7 weeks or twice daily sessions over 3.5 weeks. Approximately 75% of patients experience relief of angina symptoms following treatment. ECP improves cardiac output and blood flow, recruits new collaterals, and reduces inflammation and arterial stiffness through effects on endothelial function and vascular resistance.
Exercise Training Recommendation for Individual with Chronic Stable Angina an...nihal Ashraf
For patients with cardiovascular disease, exercise is a critically important intervention and should be prioritized to slow the progression of disease and prevent or reverse physical deconditioning.
This document provides information about treadmill exercise stress testing. It discusses the indications, protocols, measurements, and interpretation of treadmill stress tests. Key points include: treadmill stress testing evaluates the cardiovascular system's response to exercise; the Bruce and modified Bruce protocols are most commonly used; measurements include ECG changes, symptoms, heart rate and blood pressure response, and functional capacity; ST segment depression greater than 1mm is considered abnormal.
Title: A Study to Evaluate the Hemodynamic Effects of Swiss Ball Exercise in Post-Operative Coronary Artery Bypass Graft Patients
Introduction:
Coronary artery bypass graft (CABG) surgery is a common procedure to restore blood flow to the heart in patients with coronary artery disease.
Post-operative cardiac rehabilitation is crucial for optimizing recovery and improving overall cardiovascular health.
Swiss ball exercises have gained popularity as a rehabilitation tool due to their potential to improve balance, core stability, and functional capacity.
Objective:
To assess the hemodynamic effects of Swiss ball exercise in patients undergoing post-operative coronary artery bypass graft surgery.
Methods:
Study Design: A prospective, randomized controlled trial.
Participants: Patients who underwent coronary artery bypass graft surgery and met inclusion criteria.
Randomization: Patients will be randomly assigned to either the intervention group (Swiss ball exercise) or the control group (standard cardiac rehabilitation).
Intervention: The intervention group will perform supervised Swiss ball exercises as part of their cardiac rehabilitation program.
Control Group: The control group will receive standard cardiac rehabilitation without Swiss ball exercises.
Outcome Measures: Hemodynamic parameters, including heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance, will be measured at baseline and at specified time intervals during the study period.
Data Analysis: Statistical analysis will be performed to compare the hemodynamic parameters between the intervention and control groups.
Expected Results:
Improved Hemodynamic Parameters: It is hypothesized that the Swiss ball exercise group will exhibit improved hemodynamic parameters compared to the control group.
Increased Cardiac Output and Stroke Volume: Swiss ball exercises may enhance cardiac performance, leading to increased cardiac output and stroke volume.
Decreased Systemic Vascular Resistance: Swiss ball exercises may result in improved vascular function, leading to reduced systemic vascular resistance.
Enhanced Functional Capacity: Patients in the intervention group may experience improved functional capacity, as reflected by increased exercise tolerance and reduced exertional symptoms.
Significance:
Clinical Application: The findings of this study may provide evidence supporting the inclusion of Swiss ball exercises in post-operative cardiac rehabilitation programs for CABG patients.
Rehabilitation Guidelines: The study results may contribute to the development of guidelines for incorporating Swiss ball exercises into standard cardiac rehabilitation protocols.
Improved Patient Outcomes: If Swiss ball exercises are found to have positive hemodynamic effects, their implementation in post-operative rehabilitation
American Heart AVOID study: Air Versus Oxygen In ST-elevation myocardial Infa...Emergency Live
We’ve been waiting for the AVOID study, since we mentioned it a few years ago in another post on the harm of excessive oxygen. AVOID (Air Versus Oxygen in Myocardial Infarction). Now, it’s out. As expected, it shows that unnecessary oxygen supplement worsens outcome. The surprise is just how big a difference it makes! In this study, too much oxygen increased recurrent MI fivefold!
Avoiding hyperoxemia isn’t new. Normoxemia has been a trend, but lacked hard evidence in form of an RCT, and the reflex-O2-mask in ED has been hard to fight. Right now, the full AVOID article has yet to be released, but the results have just been presented at AHA’s congress in Chicago last week. And AHA has posted a video interview with Dr. Stub, one of the investigators of the AVOID trial, on the results, as well as posted his presentation slides here. This research performed an investigator initiated multicenter randomized controlled trial to compare supplemental oxygen therapy with no oxygen therapy in normoxic patients with STEMI to determine its effect on myocardial infarct size.
ORIGINAL SOURCE: http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_469664.pdf
Intra-arrest induction of Therapeuitic Hypothermia via large-volume ice-cold...Emergency Live
This document summarizes a study conducted by the NYC Project Hypothermia Working Group to evaluate the effects of intra-arrest induction of therapeutic hypothermia via large-volume ice-cold saline infusion on survival outcomes for out-of-hospital cardiac arrest. The study found that administering large volumes of ice-cold saline during cardiac arrest resuscitation efforts improved rates of return of spontaneous circulation and survival to hospital discharge when compared to a control period without this intervention. Further research is still needed to evaluate the long-term effects and most appropriate patient populations.
This document summarizes potential applications of pressure wire measurement in the peripheral circulation and presents results from a study examining its use in below-the-knee (BTK) angioplasty. The study aimed to assess correlations between invasive and non-invasive measurements of blood pressure and flow pre-and post-BTK intervention. 31 patients with critical limb ischemia underwent angiography, pressure wire assessment of resting and hyperemic pressures, and measurements of ankle-brachial index and tissue oxygen levels. Procedural success was achieved in all patients based on angiographic and clinical improvement. Correlations were observed between invasive pressure and non-invasive flow measurements, though further studies are needed to validate results and clarify optimal vasodil
IOSR Journal of Pharmacy (IOSRPHR), www.iosrphr.org, call for paper, research...iosrphr_editor
This study investigated the effects of oral clonidine premedication on hemodynamic changes during laparoscopic cholecystectomy. 100 patients were randomly assigned to receive either oral clonidine 150 micrograms or ranitidine 150 mg 90 minutes before surgery. Heart rate, blood pressure, and the need for antihypertensive treatment were significantly lower in the clonidine group during and after surgery. Postoperative nausea, vomiting, shivering, pain, and sedation were also reduced with clonidine premedication. The results suggest that oral clonidine can provide hemodynamic stability and reduce postoperative complications for patients undergoing laparoscopic cholecystectomy.
The document summarizes evidence from multiple randomized controlled trials and systematic reviews comparing treatments for intermittent claudication in the lower extremities. It finds that supervised exercise therapy, endovascular therapy, and open surgery are superior to medical management alone in improving walking distance, pain, and claudication. Specifically, supervised exercise therapy significantly improves walking performance compared to usual care. Both endovascular and open revascularization lead to faster improvement in blood flow parameters than exercise therapy, but do not necessarily correlate with better clinical outcomes. The evidence is limited by the small number of high-quality trials.
Effectiveness of intra-articular dexmedetomidine as postoperative analgesia i...iosrphr_editor
Background And Objectives: To study the effect of inj.Ropivacaine (0.25%) 2mg/kg with and without Inj.Dexmedetomidine (1-2μg/kg) intraarticularly for postoperative analgesia in arthroscopic knee surgery.1:To Evaluate Onset, Duration and analgesic efficacy of Intraarticular Dexmedetomidine2: To monitor the safety of Dexmedetomidine and Ropivacaine.
Methods: A prospective randomized double blind study, was conducted in 50 patients undergoing elective arthroscopy of knee joint under spinal anaesthesia. At the completion of the surgery, all patients were divied into two groups;GroupP(n=25):received Inj. Ropivacaine 0.25% and GroupD(n=25):received Inj.Ropivacaine(0.25%)+Inj. Dexmedetomidine(1μg/kg) total volume 20 ml was deposited intra-articularly.Patients were monitored in the postoperative ward for the hemodynamic parameters and their Sedation score was assessed.. The efficacy of the drug was determined by improvement in VAS score, duration of analgesia and total number of rescue analgesics during 24 hr in post operative period.
Results: There was no statistically significant differences observed in heart rate except changes at 6 and 8 hr. At 6 and 8 hr in group P pulse (82.48 ± 7.49, 81.44 ± 8.78) as compared to group D (75.38 ± 6.52, 74.96 ± 5.70),because of duration of action of ropivacaine with or without dexmedetomidine.There was no statistically significant difference in blood pressure was found, except at 12 hour and 24 hour (p=0.018), because of longer duration of action of intrarticular dexmedetomidine with ropivacaine in group D.At 6 hrs patients in Group P had a mean VAS score of 3.2 as compared to VAS score values of 1.8 in Group D which is statistically significant..At 2 , 4, 6 and 8 hour VAS score in P group was 1.64, 2.44, 3.24, 2.84 respectively. As compared to group P, in group D VAS score at 2, 4, 6 and 8 hour was 0.92, 1.04, 1.79 and 2.08 respectively. So VAS score lower in group D as compared to group P at 2, 4, 6 and 8 hrs.
Based on the details provided, the results of this study appear to be applicable and helpful for guiding treatment decisions for patients similar to those enrolled in the trial - namely, patients with moderate PE who are ineligible for full-dose thrombolysis. The treatment appears feasible and significantly reduced important clinical outcomes. As with any intervention, the risks and benefits for an individual patient should be considered.
Perioperative management of patients on corticosteroidsTerry Shaneyfelt
In these annotated PowerPoints I discuss the evaluation and perioperative management of patient taking or who have taken steroids. I discuss how to determine if the adrenal axis is suppressed and how to provide supplemental glucocorticoids if needed. Remember to download these slides to see the annotations for each slide.
This document provides guidelines for intravenous insulin infusion therapy, including thresholds for when to initiate therapy based on glucose levels and target glucose ranges. It recommends starting with an insulin multiplier of 0.02 in a formula that calculates insulin units per hour based on blood glucose levels, and adjusting the multiplier up or down by 0.01 each hour to reach targets. It also provides a formula for correcting hypoglycemia with intravenous dextrose administration based on current blood glucose levels and patient weight.
This document discusses guidelines and considerations for clinical trials in hypertension. It provides information on:
1. The increasing global prevalence and costs of hypertension, with an estimated 1.6 billion hypertensive patients by 2025.
2. Guidelines for classifying and treating hypertension from organizations like JNC, WHO, and ESC/ESH. The JNC 8 guideline is evidence-based and recommends treatment thresholds, goals, and medications based on randomized controlled trials.
3. Methodological considerations for designing and conducting clinical trials to evaluate antihypertensive drugs and combinations, including study populations, measures of efficacy like blood pressure and target organ damage, safety aspects, and trial durations. Long-term safety data is important
Evaluvation of Perioperative Haemodynamic Changes in Hypertensive Patients Tr...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
This document discusses best practices for perioperative fluid management. It notes that perioperative fluid management can be complicated due to factors like fasting, bowel preps, and surgical stress that can cause fluid and electrolyte imbalances. The goals of perioperative fluid management are hemodynamic stability, adequate tissue perfusion, avoidance of fluid overload, and avoidance of acute kidney injury in order to achieve best surgical outcomes. Different fluid management strategies are discussed for the preoperative, intraoperative, and postoperative periods including restricted versus liberal or goal-directed approaches using fluid biomarkers. Enhanced Recovery After Surgery (ERAS) protocols emphasize individualized fluid plans guided by physiologic targets as part of multimodal care.
This case report describes an adolescent male with near fatal asthma who was unresponsive to conventional therapy and required rescue therapy. He presented with severe hypoxemia, hypercapnia, and acidosis. Despite aggressive management including mechanical ventilation, his condition deteriorated further with the development of barotrauma and hemodynamic instability. The introduction of extracorporeal membrane oxygenation (ECMO) dramatically improved his gas exchange and lung mechanics. ECMO allowed his lungs time to recover from inflammation while minimizing ventilator-induced injury. With ECMO support for 72 hours, the patient was successfully weaned from ventilation and made a full recovery.
This document discusses the management of diabetes in surgical patients. It covers types of diabetes, glucose homeostasis, stress response and its effects on blood sugar, risks of hyper/hypoglycemia, assessment of diabetic patients before surgery, different protocols for minor vs major surgeries, intravenous insulin protocols, and postoperative care and monitoring of blood sugar levels.
This study analyzed data from over 31,000 orthopedic trauma surgery cases to determine if the time of day of surgery affected mortality and complication rates. The results showed that surgeries performed in the afternoon or at night had significantly higher mortality rates (1.1% in morning vs 2.4% at night) and general complication rates compared to morning surgeries. Higher rates of emergencies, injury severity, and surgeon fatigue after-hours may contribute to these outcomes. While no differences were found for intra- or post-operative complication rates based on surgery time, optimizing patient safety at all times, including surgeon self-awareness, is important.
Enhanced external counterpulsation (eecp) role inMonir zaman
Enhanced external counterpulsation (EECP) involves the use of inflatable cuffs wrapped around the lower extremities that are synchronized with the cardiac cycle to improve coronary perfusion. A study investigated EECP in patients with heart failure and found it improved exercise duration but not peak oxygen consumption compared to medical therapy alone. While EECP appears safe, more research is still needed to determine its efficacy in treating heart failure.
The document describes external counterpulsation (ECP) therapy for patients with coronary artery disease. ECP involves inflation and deflation of pressure cuffs on the lower limbs synchronized with the cardiac cycle to increase blood flow to the heart. It is administered as 35 one-hour sessions over 7 weeks or twice daily sessions over 3.5 weeks. Approximately 75% of patients experience relief of angina symptoms following treatment. ECP improves cardiac output and blood flow, recruits new collaterals, and reduces inflammation and arterial stiffness through effects on endothelial function and vascular resistance.
Exercise Training Recommendation for Individual with Chronic Stable Angina an...nihal Ashraf
For patients with cardiovascular disease, exercise is a critically important intervention and should be prioritized to slow the progression of disease and prevent or reverse physical deconditioning.
This document provides information about treadmill exercise stress testing. It discusses the indications, protocols, measurements, and interpretation of treadmill stress tests. Key points include: treadmill stress testing evaluates the cardiovascular system's response to exercise; the Bruce and modified Bruce protocols are most commonly used; measurements include ECG changes, symptoms, heart rate and blood pressure response, and functional capacity; ST segment depression greater than 1mm is considered abnormal.
Title: A Study to Evaluate the Hemodynamic Effects of Swiss Ball Exercise in Post-Operative Coronary Artery Bypass Graft Patients
Introduction:
Coronary artery bypass graft (CABG) surgery is a common procedure to restore blood flow to the heart in patients with coronary artery disease.
Post-operative cardiac rehabilitation is crucial for optimizing recovery and improving overall cardiovascular health.
Swiss ball exercises have gained popularity as a rehabilitation tool due to their potential to improve balance, core stability, and functional capacity.
Objective:
To assess the hemodynamic effects of Swiss ball exercise in patients undergoing post-operative coronary artery bypass graft surgery.
Methods:
Study Design: A prospective, randomized controlled trial.
Participants: Patients who underwent coronary artery bypass graft surgery and met inclusion criteria.
Randomization: Patients will be randomly assigned to either the intervention group (Swiss ball exercise) or the control group (standard cardiac rehabilitation).
Intervention: The intervention group will perform supervised Swiss ball exercises as part of their cardiac rehabilitation program.
Control Group: The control group will receive standard cardiac rehabilitation without Swiss ball exercises.
Outcome Measures: Hemodynamic parameters, including heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance, will be measured at baseline and at specified time intervals during the study period.
Data Analysis: Statistical analysis will be performed to compare the hemodynamic parameters between the intervention and control groups.
Expected Results:
Improved Hemodynamic Parameters: It is hypothesized that the Swiss ball exercise group will exhibit improved hemodynamic parameters compared to the control group.
Increased Cardiac Output and Stroke Volume: Swiss ball exercises may enhance cardiac performance, leading to increased cardiac output and stroke volume.
Decreased Systemic Vascular Resistance: Swiss ball exercises may result in improved vascular function, leading to reduced systemic vascular resistance.
Enhanced Functional Capacity: Patients in the intervention group may experience improved functional capacity, as reflected by increased exercise tolerance and reduced exertional symptoms.
Significance:
Clinical Application: The findings of this study may provide evidence supporting the inclusion of Swiss ball exercises in post-operative cardiac rehabilitation programs for CABG patients.
Rehabilitation Guidelines: The study results may contribute to the development of guidelines for incorporating Swiss ball exercises into standard cardiac rehabilitation protocols.
Improved Patient Outcomes: If Swiss ball exercises are found to have positive hemodynamic effects, their implementation in post-operative rehabilitation
1. The document discusses several studies that have evaluated the use of thromboelastography (TEG) or thromboelastometry (ROTEM) to guide blood product transfusion in patients undergoing cardiac surgery or with massive bleeding.
2. The studies found that TEG/ROTEM-guided transfusion protocols may reduce the use of blood products such as fresh frozen plasma, platelets, and total units transfused compared to usual care. However, the evidence is still weak to moderate and did not show significant effects on mortality or other clinical outcomes.
3. Confounding factors between studies include differences in the time points for TEG/ROTEM monitoring, transfusion triggers, and
The document provides information about enhanced external counterpulsation (EECP) therapy, a non-invasive treatment for angina and heart failure. EECP therapy involves inflating and deflating pressure cuffs around the legs in synchronization with the heart's rhythm to increase blood flow to the heart and reduce its workload. Most patients complete 35 hours of hourly treatments over 7 weeks and experience significant symptom relief for up to 3 years. EECP therapy is described as safe and effective for reducing angina and improving quality of life for patients who do not benefit from or wish to avoid invasive heart procedures.
1. Exercise testing involves monitoring a patient's physiological responses like ECG, heart rate, and blood pressure as the level of physical activity is gradually increased in a controlled setting.
2. It is used to evaluate cardiac function and exercise capacity in patients with conditions like heart disease or claudication.
3. Contraindications include recent heart attacks or procedures, unstable angina, and certain arrhythmias or heart failure. Precautions like rest and informed consent are required.
EXERCISE TOLERANCE TESTING A BREIF NOTE.pptxAjilAntony10
This document provides information on exercise stress testing, including:
1. It describes exercise stress testing as a diagnostic and prognostic tool for assessing patients with suspected or known ischemic heart disease by evaluating their heart's response to increased metabolic demands during exercise.
2. It outlines the clinical relevance of exercise stress testing for evaluating patients with chest pain or known heart disease and notes sensitivity of 78% and specificity of 70% for detecting coronary artery disease.
3. It discusses protocols, safety considerations, electrocardiographic changes monitored, and contraindications for exercise stress testing.
1) Exercise stress testing is used to detect myocardial ischemia through monitoring changes in the ECG and physiological parameters during exercise.
2) Key parameters include heart rate, blood pressure, oxygen consumption and the presence of ECG changes like ST segment depression or elevation.
3) Abnormal responses include inadequate heart rate or blood pressure increase, chest pain, significant ST changes and ventricular arrhythmias, which can indicate coronary artery disease.
3. combined exercise and inspiratory muscle training in patientsHibaAnis2
The document summarizes research on combining exercise and inspiratory muscle training for patients with heart failure. A study found that adding inspiratory muscle training to aerobic training resulted in greater improvements in respiratory muscle function, quality of life, and biomarkers compared to aerobic training alone, though no additional benefit was seen for exercise capacity. A second study found that combining aerobic training with resistance and inspiratory muscle training (the "ARIS" program) led to greater gains in lower limb and respiratory muscle strength, exercise capacity, and quality of life compared to aerobic training only. The findings suggest multi-modal exercise training provides additional benefits over aerobic training alone for patients with heart failure.
ERAS Cardiac is an evidence-based, multidisciplinary initiative to standardize perioperative care and promote faster recovery for cardiac surgery patients. It includes 22 interventions divided into pre, intra, and postoperative phases. Implementation of ERAS Cardiac protocols resulted in decreased length of stay, ICU hours, and complications, as well as increased patient satisfaction compared to conventional care. Standardizing key processes like preoperative education, intraoperative glycemic control, and multimodal analgesia through a team-based approach can successfully enhance recovery after cardiac surgery.
Exercise Training Recommendation For Individual With Left Ventricular Assisti...Javidsultandar
A left ventricular assist device, or LVAD, is a mechanical pump that is implanted inside a person's chest to help a weakened heart pump blood. Unlike a total artificial heart, the LVAD doesn't replace the heart. It just helps it do its job
Cardiac rehabilitation is a program for patients with cardiovascular diseases and conditions to help improve their heart health and quality of life through medical evaluation, exercise training, risk factor modification, and education. It consists of 3 phases - an inpatient phase focusing on recovery, an outpatient phase of 3-6 months for a structured therapy program, and a maintenance phase. The goals are to reduce risk factors, encourage healthy lifestyle changes, and help patients maintain these habits long term. Exercise is a core part of rehabilitation and is individually prescribed based on stress test results.
Enhanced Recovery After Surgery (ERAS) is a multidisciplinary approach to perioperative care designed to reduce surgical stress, accelerate recovery, and shorten hospital stays. Key elements include preoperative education and counseling, no mechanical bowel prep, carbohydrate loading before surgery, short-acting anesthesia, minimizing fluids and tubes, early feeding and mobilization, multimodal pain control to reduce opioids, and clear discharge criteria. Implementing ERAS has been shown to reduce complications by 50% and shorten hospital stays by 30% compared to traditional care pathways.
Fast Track surgery from the orthopedic point of view
How to apply FTS in orthopedics specially in Arthroplasty surgery. Evidence based practice in orthopedics
2. 22
Vasomedical EECP® is an FDA cleared, non-invasive
medical therapy for the treatment of stable and unstable
angina, congestive heart failure, acute myocardial
infarction, and cardiogenic shock.
eECP® THERAPY delivery
The EECP® Therapy system consists of three sets of
inflatable pressure cuffs wrapped around the calves and
the lower and upper thighs, including the buttocks. In
synchronization with each cardiac cycle, obtained with an
integrated 3-lead ECG, the cuffs are sequentially inflated
from the calves to the buttocks during diastole to produce
an arterial retrograde flow towards the aortic root to
increase coronary blood flow. This inflation action also
increases venous return, increasing blood volume to the
ventricles and raises cardiac ouput. The cuffs are deflated
simultaneously before the onset of systole, leaving behind
an empty vascular space, reducing systemic vascular
resistance, and significantly reducing the workload and
oxygen demand of the heart.
PATIENT SELECTION
Currently, EECP® Therapy has been approved for
national coverage by the Centers for Medicare and
Medicaid Services (CMS) under the guidelines as a non-
pharmacologic outpatient treatment for patients with
chronic stable angina symptoms including chest pain,
atypical pain, shortness of breath, fatigue, and cough.
EECP® is also commonly used for the treatment of
patients with heart failure.
What is EECP®
Therapy?
3. 3www.vasomedical.com www.eecp.com
More than 190 clinical papers have been published
in peer-reviewed medical journals demonstrating
EECP®
to be safe and effective in the treatment of
angina pectoris, chronic heart failure and other
diseases.
contraindications
EECP® Therapy should not be used for the treatment of
patients with:
Arrhythmias that interfere with the machine triggering••
mechanism
Bleeding diathesis••
Active thrombophlebitis••
Severe lower extremity vascular occlusive disease••
Presence of a documented aortic aneurysm requiring••
surgical repair
Pregnancy••
PRECAUTIONS
Patients with blood pressure higher than 180/110••
mmHg should be controlled prior to treatment with
EECP®.
Patients with a heart rate more than 120 bpm should be••
controlled prior to treatment with EECP®.
Patients at high risk of complications from increased••
venous return should be carefully chosen and monitored
during treatment with EECP®. Optimizing cardiac
afterload reduction and cardiac output may help
minimize increased cardiac filling pressures due to
increased venous return.
Patients with clinically significant valvular disease••
should be carefully chosen and monitored during
treatment with EECP®.
4. 4
CLINICAL BENEFITS
Clinical evaluation of EECP® in patients with angina
pectoris and congestive heart failure has been performed
in multi-center, single center and registry-based clinical
investigations. Results of these investigations have
demonstrated clinical benefit and safety in:
Time to•• st-depression during stress test
Peak oxygen consumption••
Exercise duration••
Angina episodes••
Nitroglycerin usage••
Quality of life••
Functional ability measures••
MECHANISMS OF ACTION
In addition, the following mechanisms of action of EECP®
have been demonstrated clearly in medical literature:
Induces higher shear stress acting on the endothelium••
due to increased blood flow velocity
Improves endothelial function by increasing nitric oxide••
and reducing endothelin-1
Promotes angiogenesis and recruits collateral••
circulation to ischemic regions
Reduces myocardial oxygen demand••
Inhibits inflammatory cytokines••
Reduces arterial stiffness••
Reduces the proliferation and migration of smooth••
muscle cells
Inhibits the process of atherosclerosis••
Evidence supporting these results are shown in the
following selected papers.
6. 6
Goal
Assess safety and efficacy of EECP•• ®
Endpoints
Exercise duration••
Time to ≥1-mm ST-segment depression••
Angina episodes••
Nitroglycerin usage ••
Study Design
A multicenter, prospective, randomized, blinded, sham-••
controlled trial conducted in 7 university hospitals with
139 angina outpatients randomized to the active EECP®
group (n=72) using 300 mmHg pressure applied to the
cuffs versus the inactive EECP® group (Control, n=67)
with up to 75 mmHg pressure to the treatment cuffs
Patients with documented angiographic stenosis••
>70% in at least one major coronary artery, history of
myocardial infarction (MI), or positive nuclear exercise
stress test for MI or ischemia
Exercise treadmill test (ETT) using a standard or a••
modified Bruce protocol at baseline and within 1 week
after completion of EECP®
treatment
35 1-hour EECP•• ®
treatment sessions were delivered
once or twice per day to both the active and the inactive
group with appropriate cuff pressure.
Arora, et al., J Am Coll Cardiol 1999;33:1833-40
MUST-EECP® (Multicenter Study
of Enhanced External Counter-
pulsation): Effect of EECP® on
Exercise Induced Myocardial
Ischemia and Angina Episodes
7. 7www.vasomedical.com www.eecp.com
Results
Significant increase in exercise time post-EECP•• ®
from baseline in the active EECP®
group (426±20 to
470±20 s, p<0.001) versus inactive (432±22 to 464±22s,
p<0.03). However, there was no statistically significant
difference between the groups in change in exercise
duration from baseline to post-EECP®
(active 42±11 vs
inactive 26±12 s, p>0.3).
EECP•• ®
significantly improved time to ≥1-mm ST-
segment depression in the active group (337±18 to
379±18 s, p<0.002) compared with the inactive group
(326±21 to 330±20 s, p<0.74). There was a significant
difference between the groups in the change in time to
exercise-induced ischemia from baseline to post-EECP®
in the active group (37±11 s) versus the inactive group
(-4 ±12 s), p=0.01.
Time to Exercise-Induced Ischemia
Mean Change from Baseline (seconds)
60
50
40
30
20
10
0
-10
p= 0.01
-4 s
37 s
EECP®
Control
8. 8
Angina episodes per day were 0.72±0.14 at baseline and••
0.57±0.38 post-EECP® in the active group and 0.77±0.14
at baseline and 0.76±0.22 post treatment in the
inactive group. The difference between the groups was
significant with -0.033±0.27 in the active and 0.15±0.27
in the inactive group, p<0.035.
Nitroglycerin usage was 0.39±0.11 and 0.56±0.17••
at baseline, 0.12±0.04 and 0.43±0.21 post-EECP® in
the active and the inactive group respectively. The
difference between the groups was not significant,
p>0.1.
Adverse events
Leg discomfort including pain and abrasion was••
reported in 11.6±22.7% in the active group, and
4.9±18.7% in the inactive group.
CONCLUSION
MUST-EECP® demonstrates that EECP® Therapy••
can reduce angina and extend the time to ischemia
and increase exercise tolerance in patients with
symptomatic CAD.
EECP®
Control
0.9
0.8
0.5
0.4
0.2
0.7
0.6
0.3
0.1
0
Baseline Post-EECP®
Angina Episodes Per Day
p<0.035
0.77 0.72 0.76 0.57
9. 9www.vasomedical.com www.eecp.com 9www.vasomedical.com www.eecp.com
PEECH (Prospective Evaluation
of Enhanced External
Counterpulsation in Congestive
Heart Failure): EECP® Improves
Exercise Tolerance in Patients
with Chronic Heart Failure
Goal
Assess the benefits of EECP® in the treatment of patients••
with mild to moderate heart failure
Endpoints
Primary:••
Percentage of subjects with ≥ 60 s increase in exercise••
duration at 6 months after EECP® treatment
or
Percentage of subjects with ≥ 1.25 ml/min/kg••
increase in peak volume of oxygen uptake (pVO2
) at 6
months after completion of EECP® Therapy
Secondary:••
Exercise duration••
Peak VO•• 2
NYHA functional classification••
Quality of life using the Minnesota Living with Heart••
Failure (MLWHF) instrument
Study Design
A prospective, randomized, controlled trial conducted••
in 29 centers with NYHA functional class II and III heart
failure patients (n=187*) having a left ventricular ejection
fraction (LVEF)≤ 35%, randomized in a 1:1 ratio to EECP®
(n=93) versus control with protocol-defined pharmacologic
therapy (PT, n=94)
Feldman, et al., J Am Coll Cardiol 2006;48:1198-205
* Intent to treat
10. 10
Exercise treadmill test (ETT) and peak oxygen uptake••
using a standard modified Naughton protocol at
baseline, 1 week after EECP® treatment completion and
at 3-month and 6-month follow-up
35 1-hour EECP® treatment sessions were delivered••
once or twice per day to the EECP® group.
Results
Exercise duration increased by ≥ 60 s in 35.4% in the••
EECP® group compared with 25.3% in the PT group at
the 6-month follow-up visit (p=0.016).
Peak VO•• 2
increase by ≥ 1.25 ml/kg/min did not differ
between the two groups (22.8% vs 24.1%).
EECP® was associated with a significant increase••
in exercise duration versus PT at 1-week follow-up
(26.4±12.2 vs -5.5±11.7 s, p<0.01), at 3-month follow-
up (34.5±13.9 vs -7.0±12.7 s, p=0.014) and at 6-month
follow-up (24.7±15.2 vs -9.9±13.2 s, p=0.013) after
treatment.
EECP®
Control
40
35
30
25
20
15
10
0
5
%OfSubjectsWhoMetThreshold
p=0.016
Exercise Duration
≥ 60s
Peak VO2
≥ 1.25ml/kg/min
p=NS
25.3 35.4 22.824.1
Exercise Duration & Peak VO2
(6-Month Follow-Up)
11. 11www.vasomedical.com www.eecp.com
EECP® significantly improved ≥ 1 NYHA functional class••
with 33.3% of patients vs 11.4% in the PT group 1 week
after completion of EECP® treatment, and 31.6% vs
12.2% at 3 month, 31.3% vs 14.3% at 6-month follow-up.
Quality of Life (QoL), assessed by a Minnesota••
Living with Heart Failure instrument, also improved
significantly in the EECP® group when compared with
the PT group at the 1-week and 3-month follow-
up. However, there was no difference in QoL at the
6-month follow-up.
50
40
30
20
10
0
-10
-20
26.4
-5.5
34.5
-7
24.7
-9.9
ChangefromBaseline(sec)
p=0.01
1 Week
p=0.01
3 Months
p=0.01
6 Months
Exercise Duration
EECP®
Control
35
30
25
20
15
10
5
0
33.311.4 31.612.2 31.314.3
%PatientsImprovedinNYHAClass
p<0.001
1 Week
p<0.02
3 Months
p<0.01
6 Months
Improvement in NYHA
EECP®
Control
12. 12
ADVERSE EVENTs
Adverse events occurred in 11.8% of the EECP® group••
versus 3.2% in the PT group.
However, the number of major adverse cardiovascular••
events (MACE) that occurred during the trial were
small and were the same in both the EECP® and the PT
groups.
CONCLUSION
EECP® Therapy improved exercise tolerance and HF••
symptoms in patients with NYHA class II and III HF, but
did not improve peak VO2
6 months after completion of
EECP® treatment.
0
-1
-2
-3
-4
-7
-8
-10
-3.4 -8.9 -2.9 -7.1 -2.9 -3.7
1 Week 3 Months 6 Months
Improvement in Quality Of LifeTotalChangesBaseline
Better
QOL
EECP®
Control
13. 13www.vasomedical.com www.eecp.com 13www.vasomedical.com www.eecp.com
Goal
Assess whether the effects of EECP® Therapy in the••
overall PEECH population could be observed in patients
65 years and older
Endpoints
Pecentage of subjects with ≥ 60 s increase in exercise••
duration at 6 months after completion of EECP® Therapy
or
Percentage of subjects with ≥ 1.25 ml/min/kg increase••
in peak volume of oxygen uptake (pVO2
) at 6 months
after completion of EECP® therapy
Study Design
A prespecified subgroup of elderly patients ≥ 65 years••
enrolled in the PEECH trial were randomized to the
EECP® group (n=41) versus the control with protocol-
defined pharmacologic therapy (PT, n=44) group
Results
In contrast to the overall population in the PEECH••
trial, the major findings of this subgroup analysis
demonstrated a significantly higher responder rate in
pVO2
in the EECP® group at the 6-month follow-up when
compared with the control PT group (29.7% vs 11.4%,
p=0.017).
Abbottsmith, et al., CHF 2006;12:307-311
EECP® Improves Exercise
Duration and Peak Oxygen
Consumption in Older Patients
with Heart Failure: A Subgroup
Analysis of the PEECH Trial
14. 14
ADVERSE EVENTS
MACE occurred in fewer subjects in the EECP® group••
relative to the PT group (29.3% vs 36.4%).
CONCLUSION
The results of this subgroup analysis indicate that••
adjunctive use of EECP® Therapy provides functional
benefit in older patients with chronic, stable systolic HF
in contrast to the overall population in the PEECH study.
The EECP® group demonstrated a significantly higher
rate of pVO2
improvement than the control group.
Exercise Duration (6-Month Follow-Up)
40
35
30
25
20
15
10
0
5
%OfSubjectsWhoMetThreshold
p=0.008
Exercise Duration ≥ 60s
25.0 35.1
Peak VO2
(6-Month Follow-Up)
Peak VO2
≥ 1.25ml/kg/min
40
35
30
25
20
15
10
0
5
%OfSubjectsWhoMetThreshold
p=0.017
11.4 29.7
EECP®
Control
EECP®
Control
15. 15www.vasomedical.com www.eecp.com 15www.vasomedical.com www.eecp.com
Goal
To test the hypothesis that EECP® treatment augments••
coronary collateral development
Endpoints
Primary:••
Coronary collateral flow index (CFI)••
Secondary:••
Coronary collateral conductance (CCC)••
Brachial artery flow-mediated dilatation (FMD) ••
Study Design
20 sessions of EECP® Therapy over 4 weeks, each••
session lasting 90 minutes, were performed in 20
chronic stable coronary artery disease patients
randomly assigned to the EECP® group (n=10) with 300
mmHg cuff inflation pressure versus the sham control
group (n=10) with 80 mmHg inflation pressure.
CFI was determined by invasive coronary••
catheterization pressure measurements and calculated
by dividing the mean distal coronary pressure during
balloon occlusion by the mean aortic pressure after
subtracting out the central venous pressure (CVP) from
both.
CCC was determined by the ratio of myocardial blood••
flow to the difference of aortic pressure to distal
coronary pressure during balloon occlusion.
FMD was determined using 2-dimensional vascular••
ultrasound imaging.
Gloekler, et. al, Heart 2010;96:202-207
Coronary Collateral Growth by
External Counterpulsation: A
Randomized Controlled Trial
16. 16
Results
CFI changed from 0.125±0.073 at baseline to••
0.174±0.104 at follow-up in the EECP® group (p=0.006),
and from 0.129±0.122 to 0.111±0.125 at follow-up in
the sham group (p=0.14). The absolute change in CFI
from baseline to follow-up amounted to 0.069±0.128 in
the EECP® group and -0.017±0.049 in the sham group
(p=0.0009).
Resting CCC obtained during vessel occlusion changed••
from 0.365±0.268 at baseline to 0.568±0.585 ml/
min/100 mmHg at follow-up in the EECP® group
(p=0.072), and from 0.229±0.212 at baseline to
0.305±0.422 ml/min/100 mmHg at follow-up in the
sham group (p=0.45).
0.2
0.16
0.1
0.18
0.12
0.14
0.06
0.08
0.04
0.02
0
EECP®
Post-EECP®
Baseline
Sham
p=0.14p=0.006
CollateralFlowIndex
Collateral Flow Index
0.125 0.174 0.129 0.111
17. 17www.vasomedical.com www.eecp.com
FMD changed from 4.3±1.5 % at baseline to 6.9±3.5 %••
at follow-up in the EECP® group (p=0.018), and from
6.0±3.0 % at baseline to 7.6±3.5 % at follow-up in the
sham group (p=0.10). The absolute change in FMD from
baseline to follow-up amounted to 1.75±2.8 % in the
EECP® group and 0.50±1.0 % in the sham group (p=0.07).
ADVERSE EVENTs
No MACE was reported.••
conclusion
EECP® Therapy appears to be effective in promoting••
collateral growth. The extent of collateral function
improvement is related to the amount of improvement
in systemic endothelial function.
18. 18
Goal
To investigate the effects of EECP® on peripheral artery••
flow-mediated dilation, endothelial functions and
clinical outcomes
Endpoints
Endothelial function: brachial artery flow-mediated••
dilatation (FMD), nitric oxide nitrate/nitrite (NOx),
6-keto-prostaglandin F1ɑ
(PGF1ɑ
) and endothelin-1
(ET-1)
Inflammatory markers: tumor necrosis••
factor- (TNF- ), high sensitivity C-reactive protein
(hs-CRP), monocyte chemoattractant protein-1 (MCP-1),
and soluble vascular cell adhesion molecule (sVCAM)
Lipid peroxidation marker: 8-isoprostane-F•• 2ɑ
(PGF2ɑ
),
and asymmetrical dimethylarginine (ADMA)
Clinical outcomes: blood pressure, exercise duration,••
peak oxygen consumption (peak VO2
), Canadian
Cardiovascular Society (CCS) functional class, angina
frequency and nitrate usage
study Design
42 consecutive patients with chronic stable angina••
were randomized in a 2:1 manner into either EECP®
treatment (n=28) with 300 mmHg cuff inflation pressure
or sham group (n=14) with 70 mmHg inflation pressure.
Braith, et al., Circulation 2010;122:1612-1620
EECP® Improves Peripheral
Artery Flow-Mediated Dilation
in Patients with Chronic Angina:
A Randomized Sham-Controlled
Study
19. 19www.vasomedical.com www.eecp.com
EECP® treatment was given in 35 hourly sessions over••
7 weeks.
FMD was determined using 2-dimensional vascular••
ultrasound imaging.
Symptom-limited exercise tests using a modified••
Naughton protocol were performed by all subjects
before and after 35 sessions of EECP®.
Results
There were significant improvements in endothelial••
function, reductions in inflammatory markers and lipid
peroxidation in the EECP® group with no significant
changes in the sham group .
Evidence of improved arterial FMD and endothelial-••
derived vasoactive agents after EECP® treatment was
paralleled by decreased angina symptoms and reduced
CCS angina classification from a mean of 3.1 to 1.2
(p<0.001).
EECP®
Sham p
FMD 51% 2% <0.05
NOx 36% 2% <0.05
6-keto-PGF1α 71% 1% <0.05
ET-1 25% 5% <0.05
TNF-ɑ 16% 12% <0.05
hs-CRP 32% 5% <0.05
MCP-1 13% 0.2% <0.05
20. 20
ADVERSE EVENTs
No MACE was reported.••
Conclusion
EECP® Therapy demonstrates in CAD patients to have••
beneficial effects: improvement in brachial & femoral
artery FMD, increases in bioavailability of nitric oxide
and PGF1ɑ
, decreases in plasma inflammatory and
oxidative stress biomarkers. These beneficial changes
were in parallel with improvements of clinical outcomes
such as a decrease in angina symptoms and an increase
in exercise tolerance.
EECP®
Sham p
sVCAM 6% 1% <0.05
8-iso-PGF2α 21% 1.3% <0.05
ADMA 28% 0.2% <0.05
Exercise
Duration
24% 3% <0.001
Peak VO2 12.3% 0.6% =0.002
CCS Class 62% 0% <0.001
Angina
Frequency
72% 6% <0.001
Nitrate Usage 81% 10% <0.01
21. 21www.vasomedical.com www.eecp.com 21www.vasomedical.com www.eecp.com
Goal
To test the hypothesis that decreases in arterial••
stiffness and aortic wave reflection are a therapeutic
target related to benefits in clinical outcomes
Endpoints
Central and peripheral pulse-wave velocity (PWV)••
Aortic wave reflection augmentation index (Alx)••
Wasted left ventricular pressure energy••
Aortic systolic tension-time index••
(AsTTI (mmHg*s*min-1))
Clinical outcomes: exercise duration, peak time to••
angina, peak oxygen consumption (peak VO2
), and
Canadian Cardiovascular Society (CCS) functional class,
angina frequency and nitrate usage
Study Design
42 consecutive patients with chronic stable angina••
were randomized in a 2:1 manner into either the EECP®
treatment group (n=28) with 300 mmHg cuff inflation
pressure or the sham group (n=14) with 70 mmHg
inflation pressure.
All data was taken at baseline within 1 week before••
EECP® treatment, then at the 17th hour and at the
completion of 35 hours.
Casey, et al., Am J Cardio. 2011;107(10):1466-1472
Effects of Enhanced External
Counterpulsation on Arterial
Stiffness and Myocardial Oxygen
Demand in Patients with Chronic
Angina Pectoris: A Randomized
Sham-Controlled study
22. 22
EECP® treatment was given in 35 hourly sessions over••
7 weeks.
Assessment of arterial wave reflection was performed••
with the SphygmoCor system recording peripheral
pressure waveforms using applanation tonometry
with a high-fidelity micromanometer. Results of the
peripheral measurements were used to generate the
corresponding aortic waveform using a generalized
transfer function.
A SphygmoCor Pulse Wave Velocity Vx system was used••
to measure PWV at 3 sets of sites sequentially: carotid-
radial, carotid-femoral and femoral-dorsalis pedis.
Central PWV was evaluated using the carotid-femoral
data and peripheral PWV using the femoral-dorsalis
pedis and carotid-radial data.
Symptom-limited exercise tests using a modified••
Naughton protocol were performed by all subjects
before and after 35 hours of EECP® treatment.
RESULTS
Carotid-femoral PWV was decreased at the 17th••
hour (10.6±0.4 m/s) and post-EECP® (10.2±0.4 m/s)
compared to baseline (11.5±0.5 m/s), both p<0.01, while
there were no changes in the sham group .
EECP®
Sham
14
13
12
12.5
11
11.5
10
10.5
9
9.5
PWV: Carotid - Femoral (m/sec)
Baseline 17th hr 35th hr
13.5
23. 23www.vasomedical.com www.eecp.com
PWV in the Carotid-radial (7.8±0.3 vs 8.3±0.3 m/s,••
p<0.01) and femoral-dorsalis pedis (8.7±0.4 vs 9.9±0.4
m/s p<0.05) were significantly decreased post-EECP®
compared to baseline, while there were no changes in
the sham group.
EECP® produced a progressive decrease in Alx of••
25.8±2.7% at the17th hour and 23.3±2.7% at the 35th
hour compared to 29.1±2.3% at baseline (p≤0.01) while
there were no changes in the sham group.
PWV: Femoral - Dorsalis Pedis
(m/sec)
EECP®
Sham
10
10.5
11
11.5
12
9.5
9
8.5
8
7.5
7
Baseline 17th hr 35th hr
PWV: Carotid - Radial
(m/sec)
EECP®
Sham
10
9.5
9
8.5
8
7.5
7
Baseline 17th hr 35th hr
EECP®
Sham
Aortic Augmentation Index (AIx%)
Baseline 17th hr 35th hr
32
34
28
30
24
26
20
22
24. 24
There was a substantial••
decrease in wasted left
ventricular pressure
energy after 35 hours
of EECP® treatment
compared to baseline
(1,598±233 vs 2,167±372
dyne/cm2/s, p<0.01).
Wasted Left Ventricular
Pressure Ew
(dynes cm2
s)
EECP®
Sham
2300
2200
2100
2000
1900
1800
1700
1600
1500
Baseline 17th hr 35th hr
EECP® treatment led to••
progressive increases in
pVO2
from 17.0±1.3 at
baseline to 18.4±1.4 after
17 hours and 19.4±1.5 ml/
kg/ min at 35 hours; while
there were no changes in
the sham group, 16.5±1.3,
17.0±1.4 and 16.6±1.4
respectively.
Peak Oxygen Uptake (ml/kg/min)
EECP®
Sham
21
20
19
18
17
16
15
Baseline 17th hr 35th hr
Total exercise duration••
also increased significantly
in the EECP® group from
586±41 at baseline to
678±52 after 17 hours
and 774±65 sec after 35
hours while there were
no changes in the sham
group.
Exercise Time (sec)
EECP®
Sham
900
850
800
750
700
650
600
550
500
Baseline 17th hr 35th hr
25. 25www.vasomedical.com www.eecp.com
Peak time to angina••
increased significantly
in the EECP® group from
406±39 at baseline to
537±48 after the 17th
hour, and 645±64 sec
after the 35th hour, while
there was no change in
the sham group (449±54,
466±52 and 471±53 sec
respectively).
Peak Time to Angina (sec)
EECP®
Sham
700
750
650
600
550
500
450
400
350
300
Baseline 17th hr 35th hr
There were also statistically significant decreases in••
the average angina episodes per day and nitroglycerin
usage per day in the EECP® group while there were no
significant changes in the sham group.
There were statistically••
significant decreases in
CCS class from 3.2±0.1 at
baseline to 2.4±0.1 after
17 hours and 1.2±0.1 after
35 hours, while there were
no changes in the sham
group (2.9±0.1, 2.9±0.1 and
2.9±0.1).
CCS Angina Class
EECP®
Sham
4
3.5
3
2.5
2
1.5
1
0.5
0
Baseline 17th hr 35th hr
Nitroglycerin Usage per day
EECP®
Sham
1.4
1.2
1
0.8
0.6
0.4
0.2
0
Baseline 17th hr 35th hr
Angina Episodes per day
EECP®
Sham
2
1.6
1.2
0.8
0.4
0
Baseline 17th hr 35th hr
26. 26
ADVERSE EVENTS
No MACE was reported.••
CONCLUSION
EECP® Therapy decreases central and peripheral••
arterial stiffness, which may explain improvements in
myocardial oxygen demand in patients with chronic
angina pectoris after treatment. These changes were
parallel to improvements in clinical outcomes including
exercise tolerance, peak oxygen consumption and
angina functional class.
27. 27www.vasomedical.com www.eecp.com 27www.vasomedical.com www.eecp.com
E. E. Buschmann, et al., Eur J Clin Invest 2009;39 (10):866-875
Art.Net.-2 Trial: Improvement
of Fractional Flow Reserve and
Collateral Flow by Treatment
with EECP®
Goal
To investigate the effect of EECP® on coronary collateral••
artery growth
Endpoints
Primary: Invasive pressure derived collateral flow index••
(CFIp) and fractional flow reserve (FFR)
Secondary: Symptom-limited bicycle ergometric test••
Canadian Cardiovascular Society (CCS) and New York••
Heart Association (NYHA) classification
Study Design
23 patients with angiographic narrowing of >70% in at••
least one coronary artery assessed by FFR<0.8 were
randomized in a 2:1 manner to 35 hours, 1 hour daily,
5 hours per week for 7 weeks active EECP® treatment
(n=16) or to the control group (n=7) with 7 weeks, 5
times per week walk-in appointment for non-therapy
related diagnostics, nutrition-counseling.
Cardiac catheterization with hemodynamic••
measurements of aortic pressure (Pa), central venous
pressure (Pv) , mean distal coronary pressure (Pd) and
coronary wedge pressure (Pw) were measured with a
balloon occlusion proximal to the coronary stenosis.
28. 28
A symptom-limited bicycle ergometric test was••
performed at baseline and at the 8th week starting with
25 or 50 Watts and continued with an increase of 25
Watts every 2 minutes.
CCS and NYHA were evaluated before the invasive••
procedure at baseline and at the 8th week.
RESULTS
CFIp defined to be the ratio of (Pw-Pv) to (Pa-Pv)••
increased from 0.08±0.01 to 0.15±0.02 (p<0.001) in the
EECP® group while there was no significant change in
the control group (0.15±0.03 to 0.14±0.02 (p=0.7).
The FFR changed from 0.68±0.03 at baseline to••
0.79±0.03 at follow-up in the EECP® group (p=0.001),
with no change in the control group from 0.68±0.06 to
0.7±0.05 (p=0.4) at follow-up.
Week 8Baseline
EECP®
0.85
0.75
0.8
0.7
0.6
0.65
Control
p=0.001p=0.4
Fractional Flow Reserve (FFR)
0.68 0.7 0.68 0.79
29. 29www.vasomedical.com www.eecp.com
A significant reduction in CCS classification was••
achieved after EECP® treatment (p=0.008) whereas in
the control group no change was observed (p=0.25).
The severity of dyspnea as measured by NYHA••
classification was reduced after EECP® (p<0.001) but
not within the control group (p=0.28) .
At the end of therapy, 81% of the EECP® group were free••
of angina pectoris compared to 56% at baseline, and in
the control group, only 14% improved after 7 weeks.
ADVERSE EVENTS
No MACE occurred during the study.••
CONCLUSION
This study provides direct functional evidence for the••
stimulation of coronary angiogenesis via EECP® in
patients with stable CAD.
30. 30
Levenson, et al., Am J Hypertension 2006;19:867-872
Cyclic GMP Release by
Acute Enhanced External
Counterpulsation: A Randomized
Sham-Controlled Study
Goal
To investigate the effect of a single 1-hour session of••
EECP® treatment on plasma and platelet cGMP
Determine whether the activation of nitric oxide••
dependent pathways modulate changes in platelet
cGMP
Endpoints
Plasma and platelet cGMP••
Inhibition of nitric oxide synthesis by Ng-monomethyl-••
L-arginine (L-NMMA) on platelet cGMP
Effect on platelet cGMP by neutralizing superoxide••
anion with superoxide dismutase (SOD) in the presence
of catalase
Inhibition of phosphodiesterase 5 by Zaprinast on••
platelet cGMP
Study Design
55 subjects, 25 asymptomatic with high cardiovascular••
risk (HCVR) and 30 with angiographically proven
coronary artery disease (CAD), were randomized to
sham EECP® treatment (n=28) with less than 75 mmHg
applied to cuff inflation with the remaining 27 subjects
enrolled in the active EECP® group with 300 mmHg
inflation pressure.
31. 31www.vasomedical.com www.eecp.com
Blood samples were collected before and after••
1 hour of active or sham EECP® treatment and
plasma and platelet cGMP levels were measured by
radioimmunoassay.
RESULts
Absolute changes in plasma cGMP doubled in CAD••
subjects undergoing active EECP® treatment compared
with sham control (p<0.01) by 235% in active EECP® CAD
patients but not in the group with HCVR.
Application of 1 hour of active EECP® treatment••
significantly increased platelet cGMP content by 19%
(p<0.01) in the overall population (CAD+HCVR) but not in
the sham group.
EECP® significantly increased platelet cGMP compared••
to their respective baseline values (by 22% for L-NMMA,
by 21% for SOD with catalase, and by 63% after inhibition
of phosphodiestarase 5, all p<0.01).
Absolute changes in plasma cGMP (nmol/l)
5
4
3
2
1
0
p<0.05
Overall HCVR
p<0.01
CAD
EECP®
Sham
32. 32
Adverse Events
No MACE was reported.••
CONCLUSION
The counterpulsation induced cGMP increase was twice••
as large in subjects receiving active EECP® treatment
versus those serving as a sham group.
EECP® increases platelet cGMP content, which suggests••
nitric oxide synthase activation. EECP® increases cGMP
production which may be the mechanism by which
EECP® exerts its clinical benefit.
Analysis of the modulation of platelet cGMP content••
suggests EECP® activates the nitric oxide-dependent
pathways.
1.2
1
0.8
0.6
0.4
0.2
0
Baseline L-NMMA SOD-cat SOD-CAT
Zaprinast
Platelets cGMP before and after
1-hr EECP (pmol/108
platelets)
EECP®
Sham
33. 33www.vasomedical.com www.eecp.com 33www.vasomedical.com www.eecp.com
Effects of EECP® on Carotid
Circulation in Patients with
Coronary Artery Disease
Levenson, et al., Cardiology 2007;108:104-110
Goal
A randomized, sham-controlled study to investigate••
whether arterial stiffness and resistance of carotid
circulation are altered by EECP® Therapy
Endpoints
The ß stiffness index••
Carotid vascular resistance••
Study Design
30 patients with stable coronary artery disease (CAD)••
demonstrated by angiographic proven stenosis greater
than 50% in at least one major coronary artery or a
documented MI treated according to medical therapy
guidelines were randomized in a 1:1 manner into either
EECP® treatment (n=15) with 300 mmHg cuff inflation
pressure or sham group (n=15) with 75 mmHg inflation
pressure.
All data was taken at baseline within 1 week prior to EECP®••
treatment, then at the 17th hour and at the completion of
35 hours, 1 hour daily for 7 weeks.
Echo-Doppler studies were performed with a high-••
resolution ultrasound imager on the right and left common
carotid arteries with a 7.5 to 12 MHz probe.
The ß stiffness index calculated by ln(Ps/Pd)/ DD, where••
Ps and Pd are the systolic and diastolic blood pressure
and DD is the ratio between carotid pulse and diastolic
diameter.
Carotid vascular resistance was calculated as the ratio••
between mean arterial blood pressure and mean blood
34. 34
flow (mmHg/ml/sec).
Results
The ß stiffness index was significantly reduced at 1 hour••
(-3.7, p<0.01), 17 hours (-3.6, p<0.001) and 35 hours (-3.3,
p<0.01) in the active EECP® group, and this decrease was
statistically different when compared with the sham
group at 1 hour and 35 hours (p<0.05 respectively).
Carotid vascular resistance was concomitantly reduced••
in the active EECP® group at 17 hours (-2.1 mmHg/ml/
sec, p<0.05), and 35 hours (-3.9 mmHg/ml/sec, p<0.01),
while there was an increase in the sham group showing
a significant difference between groups at 17 hours
(p<0.01) and 35 hours (p<0.001) respectively.
1st Hr 17th Hr 35th Hr
Change in ß Arterial Stiffness Index
EECP®
Sham
5
4
3
2
1
-1
0
-3
-2
-4
2.7
-3.7 -2.3
2.2
-3.6 -3.3
35. 35www.vasomedical.com www.eecp.com
ADVERSE EVENTS
One patient with worsening arrhythmia withdrew from••
the sham EECP® group after 17 hours. No other major
complications occurred.
CONCLUSION
EECP® exerts clear vascular relaxation effects on both••
large and small arteries of carotid circulation.
1st Hr 17th Hr 35th Hr
Change in Vascular Resistance
(mmHg/ml/sec)
EECP®
Sham
5
4
3
2
1
-1
0
-3
-2
-4
1.1 2.2
-1.3
1.8
-2.1 -3.9
36. 36
Left Ventricular Systolic
Unloading and Augmentation
of Intracoronary Pressure and
Doppler Flow during EECP®
Michaels, et al., Circulation 2002;106:1237-1242
Goal
Examine intracoronary and left ventricular••
hemodynamics in the cardiac catheterization laboratory
during EECP®
Endpoints
Diastolic and systolic pressure in the central aorta••
during EECP®
Diastolic and systolic pressure in the coronary artery••
during EECP®
Intracoronary average peak Doppler velocity during••
EECP®
Peak diastolic blood flow velocity in the coronary artery••
during EECP®
Study Design
10 outpatients referred for diagnostic cardiac••
catheterization with suspected coronary artery disease
(n=5), severe mitral regurgitation (n=3), and prior
orthotopic heart transplantation (n=2) were studied
with measurement of the central aortic pressure,
intracoronary pressure and intracoronary Doppler flow
velocity with a sensor-tipped transducer and guidewire.
results
Significant decrease in peak aortic systolic pressure by••
11% from 114±19 at baseline to 101±28 mmHg during
EECP® (p=0.02)
37. 37www.vasomedical.com www.eecp.com
Significant increase in aortic diastolic pressure by 92%••
from 71±10 at baseline to 136±22 mm Hg during EECP®
(p<0.0001)
Significant increase in intracoronary peak diastolic••
pressure by 93% from 71±10 at baseline to137±21 mm Hg
during EECP® (p<0.0001)
Significant decrease in peak systolic intracoronary••
pressure by 15% from a baseline of 116±20 to 99±26 mm
Hg during EECP® (p=0.002)
Significant increase in intracoronary average peak Doppler••
velocity by 109% from 11±5 at baseline to 23±5 cm/s
during EECP® (p=0.001)
Significant increase in intracoronary peak diastolic blood••
flow velocity by 150% from 18±7 at baseline to 45±14
cm/s during EECP® (p<0.0004)
200
150
100
50
0
IntracoronaryPressure(mmHg)
Intracoronary Diastolic Pressure
Baseline EECP®
71±10
137±21
p<0.0001
38. 38
ADVERSE EVENTS
No MACE was reported during the study.••
CONCLUSION
EECP® significantly decreases aortic systolic pressure to••
reduce the workload of the heart, resulting in decreased
myocardial oxygen demand.
EECP® significantly increases aortic and intracoronary••
diastolic pressure, thereby increasing intracoronary blood
flow, augmenting energy supply to the myocardium.
75
50
25
0
IntracoronaryDopplerVelocity(cm/s)
Intracoronary Peak Diastolic Doppler Flow
Velocity
Baseline EECP®
18±7
45±14
p<0.0004
39. 39www.vasomedical.com www.eecp.com 39www.vasomedical.com www.eecp.com
International EECP® Patient
Registry I and II (IEPR I and II)
Goal
IEPR I and II were organized to document the patterns of••
use, patient characteristics, safety and efficacy of EECP®
during the treatment period and long term follow-up for
a period of 3 years post treatment.
STUDY DESIGN
IEPR-I: 5,056 patients from Jan 1998 to July 2001 in 119••
U.S. and 21 International sites with a 3 year follow-up
IEPR-II: 2,917 consecutive patients from Jan 2002 to Oct••
2004 in 95 U.S. sites with a 2 year follow-up
IEPR data was collected by the Epidemiology Data Center••
of the University of Pittsburgh.
Entry criteria: consecutive patients gave consent and••
underwent at least 1 hour of EECP® treatment.
Data Collection
IEPR-1••
Patients’ demographics••
Medical history••
CAD status, quality of life••
CCS Classification, medication••
Angina frequency••
Adverse clinical events before EECP®, post EECP®, and••
during follow-up period
IEPR-2••
NYHA class••
Number of hospitalizations for heart failure patients••
Duke Activity Status Index••
40. 40
Responses to the Kansas Cardiomyopathy••
Questionnaire
rESULTS
(Selected results from more than 66 published papers)
Primer: Practical Approach to the Selection of
Patients for and Application of EECP®
Michaels, et al., Nat Clin Pract Cardiovascular Med 2006;3(11):623-632
At baseline, 86% of the 7,973 CAD patients were in••
Canadian Cardiovascular Society (CCS) angina class III
and IV. At the 6-month follow-up after EECP®, 25% of the
4,565 patients were in CCS class III and IV. 76% of patients
improved their CCS angina status by at least 1 class.
Enhanced External Counterpulsation in the Treatment
of Chronic Refractory Angina: A Long-term Follow-up
Outcome from the International Enhanced External
Counterpulsation Patient Registry
Loh, et al., Clin Cardiol. 2008;31,4:159-164
At 3 years follow-up, there was a reduction in CCS Class••
of at least 1 class in 78% of the patients, and by at least 2
classes in 38%. This was sustained in 74% of the patients
during follow-up.
70
60
50
40
30
20
10
0
No Angina I II III IV
Distribution of Canadian Cardiovascular Society Class
(CCS %)
Baseline
After 35 Sessions
Of EECP®
6 Months
Post-EECP®
41. 41www.vasomedical.com www.eecp.com
The frequency of angina reduced by 4-6 episodes per••
week immediately post-EECP® and this was sustained at
the 3 year follow-up.
Adverse events
During EECP® treatment, 1.5% experienced••
musculoskeletal discomfort, 2.5% skin breakdown, 2.2%
heart failure exacerbation, 4.5% unstable angina, 0.8% MI,
0.8% PCI, 0.6% CABG and 0.5% death.
Cumulative 3-year mortality was 17%, MI was 11.8%, and••
MACE was 40.8%.
Impact of EECP® on Emergency Department Visits
and Hospitalizations in Refractory Angina Patients
with Left Ventricular Dysfunction
Soran, et al., CHF 2007;13:36-40
There were 2,917 patients enrolled in IEPR-II. 450 had••
refractory angina with LV dysfunction (LVEF≤40%) and
complete data on emergency department (ED) visits
and hospitalizations 6 months before EECP® treatment.
93% were in CCS class III and IV, 50% had history of heart
failure (HF), mean LVEF was 30±8%.
After completion of EECP® treatment, angina class••
decreased by at least 1 CCS class in 72% of the patients,
19% reported no angina and 2% had an increase in
angina class. Mean angina frequency decreased by 7±14
episodes per week from 11.4±16.9 to 3.8±10.9 (p<0.001).
70
60
50
40
30
20
10
0
No Angina I II III IV
Distribution of Canadian Cardiovascular Society Class
(CCS %)
Baseline 3-Yr Post-EECP®
42. 42
The mean number of ER visits per patient decreased from••
0.9±2.0 during the 6-month period pre-EECP® to 0.2±0.7
during the 6-month period post-EECP® (p<0.001). The
mean number of hospitalizations reduced from 1.1±1.7
during the 6-month period pre-EECP® to 0.3±0.7 during
the 6-month period post-EECP® (p<0.001).
Adverse events
MACE occurring during EECP® treatment was 0.7% MI,••
0.2% CABG, 1.2% PCI, and no death for a total MACE rate
of 1.8%. Heart failure exacerbation was reported in 2.6% of
patients.
6 months after completion of EECP® treatment cumulative••
mortality was 5.3%, MI was 1.9%, and MACE was 10.6%.
CONCLUSION
EECP® used in everyday clinical practice without the••
constraint of trial inclusion and exclusion criteria
demonstrated improvement in angina class in 74% of the
treated patients and these benefits were sustained for up
to 3 years.
Similarly, EECP® reduced the number of angina episodes.••
EECP® Therapy was cost effective in reducing the number••
of emergency department visits and hospitalizations.
Pre-EECP®
Post-EECP®
Emergency Room Visits & Hospitalization
Hospitialization
1.25
0.75
1
0.5
0
0.25
ER Visit
p<0.001p<0.001
0.20.9 1.1 0.3
43. 43www.vasomedical.com www.eecp.com 43www.vasomedical.com www.eecp.com
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