The EVEREST II Randomized Clinical Trial compared the safety and efficacy of the MitraClip device to surgical repair or replacement in patients with mitral regurgitation. The study found that (1) the rate of major adverse events at 30 days was significantly lower for the MitraClip device group compared to surgery (9.6% vs 57%), (2) the clinical success rate at 12 months, defined as freedom from death, surgery, or moderate/severe mitral regurgitation, was non-inferior for the MitraClip device compared to surgery (72.4% vs 87.8%), and (3) both groups experienced improvements in left ventricular function, NYHA functional class, and quality of life
Hemodynamic monitoring measures factors that influence blood flow and pressure. It aids in diagnosing, monitoring, and managing critically ill patients by measuring things like cardiac output, fluid status, and the body's response to therapies. The document discusses the components, placement, and use of pulmonary artery catheters to obtain important hemodynamic measurements, as well as how to interpret the results and optimize cardiac output in critical care patients. Potential complications of PA catheters are also reviewed.
This presentation is all about patient prosthetic mismatch.what is PPM?.
Diameters of heart valve
Effective orifice area of different heart valves
How to avoid PPM
How to manage increased gradients across the heart valve
Surgical management of aortic arch pathology often requires complex techniques to protect vital organs like the brain during replacement or repair of the aortic arch. Conventional techniques used hypothermic circulatory arrest and surface cooling but had limitations. Newer techniques like antegrade and retrograde selective cerebral perfusion allow prolonged safe periods of cerebral protection with improved cooling and independent control of cerebral and systemic circulation, though they are more technically challenging. The optimal approach considers individual patient and anatomical factors to maximize benefits and reduce risks.
The document discusses fractional flow reserve (FFR), a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis to determine if it impedes blood flow. FFR is measured using intracoronary pressure wires during maximal hyperemia induced by intravenous adenosine. While FFR allows real-time assessment of lesion severity, it does not provide information on plaque morphology and requires an invasive procedure.
The document discusses various techniques for cannulation during cardiopulmonary bypass (CPB). Venous cannulation is typically done via the superior vena cava (SVC) and inferior vena cava (IVC) using either a bicaval, single atrial, or cavoatrial approach. Arterial cannulation is usually via the ascending aorta but can also be done through femoral, axillary, or other arteries if needed. Proper positioning and sizing of cannulas is important to maximize blood flow and minimize complications like air embolism, bleeding, or malposition. Factors such as patient anatomy, surgical plan, and vessel disease must be considered to select the optimal cannulation method.
Cardiopulmonary bypass in pediatric patients with congenital heart disease requires special considerations due to physiological differences from adults. These include smaller blood volumes, higher oxygen demands, and the presence of intracardiac and extracardiac shunting. The bypass plan must account for the specific anatomy and physiology of each patient's heart defect to ensure adequate perfusion and protection during surgery. Flow rates, temperature management, venting strategies, and cardioplegia administration may need to be modified from standard adult protocols. Close monitoring is important to detect any issues with oxygen delivery or end-organ perfusion during bypass.
This document provides information on surgical repair of the mitral valve for acquired mitral valve disease. It discusses that mitral valve repair is preferred over replacement when possible as it has lower risks and better preserves heart function. Techniques for repair include annuloplasty to reshape the valve ring, leaflet resection or suturing to address prolapse, and creation of artificial chordae to improve leaflet coaptation. The quality of repairs must be assessed using techniques like saline testing to ensure adequate valve function is restored.
Hemodynamic monitoring measures factors that influence blood flow and pressure. It aids in diagnosing, monitoring, and managing critically ill patients by measuring things like cardiac output, fluid status, and the body's response to therapies. The document discusses the components, placement, and use of pulmonary artery catheters to obtain important hemodynamic measurements, as well as how to interpret the results and optimize cardiac output in critical care patients. Potential complications of PA catheters are also reviewed.
This presentation is all about patient prosthetic mismatch.what is PPM?.
Diameters of heart valve
Effective orifice area of different heart valves
How to avoid PPM
How to manage increased gradients across the heart valve
Surgical management of aortic arch pathology often requires complex techniques to protect vital organs like the brain during replacement or repair of the aortic arch. Conventional techniques used hypothermic circulatory arrest and surface cooling but had limitations. Newer techniques like antegrade and retrograde selective cerebral perfusion allow prolonged safe periods of cerebral protection with improved cooling and independent control of cerebral and systemic circulation, though they are more technically challenging. The optimal approach considers individual patient and anatomical factors to maximize benefits and reduce risks.
The document discusses fractional flow reserve (FFR), a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis to determine if it impedes blood flow. FFR is measured using intracoronary pressure wires during maximal hyperemia induced by intravenous adenosine. While FFR allows real-time assessment of lesion severity, it does not provide information on plaque morphology and requires an invasive procedure.
The document discusses various techniques for cannulation during cardiopulmonary bypass (CPB). Venous cannulation is typically done via the superior vena cava (SVC) and inferior vena cava (IVC) using either a bicaval, single atrial, or cavoatrial approach. Arterial cannulation is usually via the ascending aorta but can also be done through femoral, axillary, or other arteries if needed. Proper positioning and sizing of cannulas is important to maximize blood flow and minimize complications like air embolism, bleeding, or malposition. Factors such as patient anatomy, surgical plan, and vessel disease must be considered to select the optimal cannulation method.
Cardiopulmonary bypass in pediatric patients with congenital heart disease requires special considerations due to physiological differences from adults. These include smaller blood volumes, higher oxygen demands, and the presence of intracardiac and extracardiac shunting. The bypass plan must account for the specific anatomy and physiology of each patient's heart defect to ensure adequate perfusion and protection during surgery. Flow rates, temperature management, venting strategies, and cardioplegia administration may need to be modified from standard adult protocols. Close monitoring is important to detect any issues with oxygen delivery or end-organ perfusion during bypass.
This document provides information on surgical repair of the mitral valve for acquired mitral valve disease. It discusses that mitral valve repair is preferred over replacement when possible as it has lower risks and better preserves heart function. Techniques for repair include annuloplasty to reshape the valve ring, leaflet resection or suturing to address prolapse, and creation of artificial chordae to improve leaflet coaptation. The quality of repairs must be assessed using techniques like saline testing to ensure adequate valve function is restored.
Immune system and inflamatory response to cpb(1)Manu Jacob
The document discusses the immune and inflammatory responses to cardiopulmonary bypass (CPB). It explains that CPB activates both the innate and acquired immune systems, inducing a complex inflammatory response known as the systemic inflammatory response syndrome (SIRS). SIRS can lead to organ dysfunction or failure in some patients. The document outlines the roles that various immune cells like neutrophils, monocytes, endothelial cells, and platelets play in mounting the inflammatory response to CPB. It also discusses how factors like contact with the CPB circuit, ischemia-reperfusion injury, and hypothermia can trigger and exacerbate this inflammatory cascade.
This document discusses proposed criteria for patient selection for transcatheter mitral valve repair using the MitraClip device. It outlines anatomical and clinical considerations for both degenerative and functional mitral regurgitation. Experience from high-volume centers indicates MitraClip can be effective for selected patients at high risk for surgery, though longer-term data is still needed, especially for functional MR. A multidisciplinary team approach is important to thoroughly evaluate each patient's suitability and discuss risks versus benefits of MitraClip versus surgery.
Heart transplantation involves replacing a failing heart with a healthy donor heart. It is considered for patients with advanced heart failure who do not get relief from medications. Key steps include evaluating the recipient and donor, matching them based on blood type and size, performing the surgery by removing the recipient's heart and suturing in the donor heart, and providing lifelong immunosuppression drugs to prevent rejection. Long term challenges after transplantation include organ rejection, infection, coronary artery disease in the transplant heart, and cancer due to immunosuppression.
- The SYNTAX trial compared outcomes of percutaneous coronary intervention (PCI) using drug-eluting stents versus coronary artery bypass grafting (CABG) for treating three-vessel or left main coronary artery disease.
- For the primary endpoint of major adverse cardiac and cerebrovascular events at 12 months, CABG was superior to PCI. However, outcomes were similar between treatments for patients with less complex disease as measured by low or intermediate SYNTAX scores.
- For patients with more complex disease and high SYNTAX scores, CABG had significantly fewer primary events than PCI at 12 months.
This study evaluated outcomes of 26 patients who underwent surgical repair of post-myocardial infarction ventricular septal defect (VSD) at Nizams Institute of Medical Sciences between 1997-2012. 20 patients underwent VSD repair with concomitant coronary artery bypass grafting, while 6 had VSD closure alone. The mean time between MI and VSD appearance was 7.2 days, and between VSD appearance and surgery was 27.2 days. Overall in-hospital mortality was 30.9% and 30-day mortality was 33%. Patients who underwent emergency surgery within 3 days of MI had 100% mortality, while those operated on after 3 weeks had 100% survival. Concomitant CABG during VSD repair was associated with lower
Microemboli during cardiac bypass procedures can reduce patient quality of life and cause strokes. Various emboli like gases, particulates, thrombi and biological material from the bypass apparatus and patient can lodge in organs. While emboli cannot be eliminated, their occurrence can be greatly reduced through measures like filters, membrane oxygenators, avoiding air, adequate anticoagulation, and flooding surgical fields with CO2. Prevention is emphasized as there is lack of effective treatment once emboli occur.
Minimally invasive cardiac surgery techniques are being adopted at NH MMI Hospital in Raipur, Chhattisgarh, India. The techniques include smaller incisions and ports compared to traditional full median sternotomy. Procedures performed so far include ASD closure, mitral valve replacement, aortic valve replacement, and minimally invasive CABG. The advantages over traditional surgery are less pain, bleeding, and faster recovery time. Special equipment and training are required but the techniques provide cosmetically appealing and less traumatic alternatives to full open cardiac surgery.
Complicationsandsafetyduringcpb 180414072601Manu Jacob
This document discusses safety during cardiopulmonary bypass (CPB). It covers several topics:
1. Bypass safety has improved considerably with better safety features and techniques, though fatal accidents occurred in 1/1800 cases and serious incidents in 1/130 procedures in 1981.
2. Organizational aspects emphasize teamwork, cooperation, coordination, and effective communication within the open-heart unit.
3. Protocols should be established for equipment, patient specifics, perfusion management, and handling accidents to maximize safety. Human error is the leading cause of accidents, followed by equipment failures. Constant updates and a focus on safety can help minimize risks.
This document summarizes the history and classification of sinus of Valsalva aneurysm (SOVA). Some key points:
- SOVA was first described in 1839 and the first successful repair was in 1956 using cardiopulmonary bypass.
- SOVAs can be congenital or acquired due to various connective tissue/inflammatory disorders.
- The majority originate from the right coronary cusp (77%) and most commonly rupture into the right ventricle (67.9%).
- The classic Sakakibara classification categorizes SOVAs arising from the right coronary cusp into three types based on location of rupture/protrusion. A modified classification exists for non-cor
1) Transthoracic and transesophageal echocardiography are important modalities for assessing atrial septal defects (ASDs). TTE can identify RV volume overload and septal flattening, while TEE precisely measures defect size and evaluates rim morphology.
2) The four main types of ASDs - ostium secundum, ostium primum, sinus venosus, and coronary sinus defects - have distinguishing echo features. Doppler can demonstrate shunt direction and magnitude.
3) Echocardiography guides percutaneous ASD closure by assessing defect and rim anatomy, device sizing, and post-procedure result. Understanding echo features is key to ensuring procedure success.
This document discusses various types of heart valve prostheses including mechanical and bioprosthetic valves. It provides details on specific valve models and discusses considerations for aortic and mitral valve replacement. Complications related to valve replacement and long-term follow-up and management are outlined. Several postoperative syndromes that can occur are also summarized.
The document discusses drug-eluting stents, focusing on the Zilver PTX stent. It provides an overview of the Zilver PTX, including its stent platform, paclitaxel drug coating, mechanism of action, intended use, sizing, and available configurations. Clinical trial results show the Zilver PTX significantly reduces restenosis and need for reintervention compared to standard care or bare metal stents at 5-year follow-up.
This document discusses coronary guidewires used in percutaneous coronary intervention (PCI). It describes the components, classifications, and appropriate uses of guidewires for different clinical scenarios. Guidewires are classified based on tip flexibility, device support, coating, and tip load. Commonly used guidewires include Balance Middleweight Universal, Choice Floppy, and BMW. Guidewire selection depends on vessel anatomy, lesion morphology, devices used, and operator experience. Special guidewires are discussed for procedures like left main PCI, bifurcation PCI, dissections, calcified lesions, and chronic total occlusions.
This document discusses heart transplantation, including indications, donor and recipient criteria. It provides a brief history of heart transplantation from early experiments to modern procedures. Key points include common indications for transplant like dilated cardiomyopathy, the importance of matching donor and recipient size and blood type, and selecting recipients without other medical issues that could impact outcomes. Contraindications and special considerations for procedures like ABO incompatible and pediatric transplants are also summarized.
History of cardiac surgery DR NIKUNJ R SHEKHADA (MBBS,MS GEN SURG ,DNB CTS SR)DR NIKUNJ SHEKHADA
The document provides a history of cardiac surgery from the 19th century to modern times. It discusses early operations on the heart and pericardium in the 19th century. It then covers the development of anesthesia, vascular surgery, cardiac catheterization, and heart-lung bypass machines, which enabled open-heart surgery. Some key events summarized are the first successful cardiac surgery without complications in 1896, the first use of external heart-lung machines in the 1950s, the first open-heart repair under direct vision in 1952, the first coronary artery bypass surgery in 1960, and the first human heart transplant in 1967. The document also discusses the early development of heart valve surgery and prosthetic heart valves.
This document discusses mechanical circulatory support devices for advanced heart failure, including intra-aortic balloon pumps (IABP) and ventricular assist devices (VADs). It describes the physiology and indications for IABP, including how it increases coronary perfusion and reduces left ventricular afterload. It also discusses VADs, describing both pulsatile and non-pulsatile devices, components, classifications based on period of use and pumping mechanism. Patient selection criteria for VADs include being refractory to medical therapy, having a life expectancy less than 2 years without support, and being ineligible for heart transplant.
The document discusses conduits used in coronary artery bypass grafting (CABG). It describes the history of CABG, beginning with Alexis Carrel's description in the early 1900s. It outlines the three eras of CABG and discusses key pioneers like Michael DeBakey and Rene Favaloro. The document then describes the different types of arterial and venous conduits used in CABG, focusing on the internal thoracic artery and radial artery. It discusses the anatomy, histology, harvesting techniques, and patency rates of different conduits.
The Ross procedure involves replacing the diseased aortic valve with the patient's own pulmonary valve, and replacing the pulmonary valve with a homograft. This avoids the need for lifelong anticoagulation. The pulmonary valve is excised and implanted into the aortic position using techniques like subcoronary implantation. A homograft is then used to replace the pulmonary valve. Long term outcomes are generally good, though there is a risk of dilation of the pulmonary autograft over time which can lead to aortic insufficiency. Careful postoperative management of blood pressure and use of NSAIDs is important.
The RESOLUTE International study evaluated the Resolute stent in a large "real-world" patient population across multiple international centers. Over 2,300 patients were enrolled with nearly complete 12-month follow-up. The primary endpoint of cardiac death and target vessel myocardial infarction at 12 months occurred in 4.1% of patients. Rates of stent thrombosis, target lesion revascularization, and other secondary endpoints were also low out to 12 months, and event rates were similar between monitored and unmonitored patients. Outcomes were also consistent across various high-risk subgroups. Results from RESOLUTE International are generally comparable to those seen in the RESOLUTE All Comers trial.
Immune system and inflamatory response to cpb(1)Manu Jacob
The document discusses the immune and inflammatory responses to cardiopulmonary bypass (CPB). It explains that CPB activates both the innate and acquired immune systems, inducing a complex inflammatory response known as the systemic inflammatory response syndrome (SIRS). SIRS can lead to organ dysfunction or failure in some patients. The document outlines the roles that various immune cells like neutrophils, monocytes, endothelial cells, and platelets play in mounting the inflammatory response to CPB. It also discusses how factors like contact with the CPB circuit, ischemia-reperfusion injury, and hypothermia can trigger and exacerbate this inflammatory cascade.
This document discusses proposed criteria for patient selection for transcatheter mitral valve repair using the MitraClip device. It outlines anatomical and clinical considerations for both degenerative and functional mitral regurgitation. Experience from high-volume centers indicates MitraClip can be effective for selected patients at high risk for surgery, though longer-term data is still needed, especially for functional MR. A multidisciplinary team approach is important to thoroughly evaluate each patient's suitability and discuss risks versus benefits of MitraClip versus surgery.
Heart transplantation involves replacing a failing heart with a healthy donor heart. It is considered for patients with advanced heart failure who do not get relief from medications. Key steps include evaluating the recipient and donor, matching them based on blood type and size, performing the surgery by removing the recipient's heart and suturing in the donor heart, and providing lifelong immunosuppression drugs to prevent rejection. Long term challenges after transplantation include organ rejection, infection, coronary artery disease in the transplant heart, and cancer due to immunosuppression.
- The SYNTAX trial compared outcomes of percutaneous coronary intervention (PCI) using drug-eluting stents versus coronary artery bypass grafting (CABG) for treating three-vessel or left main coronary artery disease.
- For the primary endpoint of major adverse cardiac and cerebrovascular events at 12 months, CABG was superior to PCI. However, outcomes were similar between treatments for patients with less complex disease as measured by low or intermediate SYNTAX scores.
- For patients with more complex disease and high SYNTAX scores, CABG had significantly fewer primary events than PCI at 12 months.
This study evaluated outcomes of 26 patients who underwent surgical repair of post-myocardial infarction ventricular septal defect (VSD) at Nizams Institute of Medical Sciences between 1997-2012. 20 patients underwent VSD repair with concomitant coronary artery bypass grafting, while 6 had VSD closure alone. The mean time between MI and VSD appearance was 7.2 days, and between VSD appearance and surgery was 27.2 days. Overall in-hospital mortality was 30.9% and 30-day mortality was 33%. Patients who underwent emergency surgery within 3 days of MI had 100% mortality, while those operated on after 3 weeks had 100% survival. Concomitant CABG during VSD repair was associated with lower
Microemboli during cardiac bypass procedures can reduce patient quality of life and cause strokes. Various emboli like gases, particulates, thrombi and biological material from the bypass apparatus and patient can lodge in organs. While emboli cannot be eliminated, their occurrence can be greatly reduced through measures like filters, membrane oxygenators, avoiding air, adequate anticoagulation, and flooding surgical fields with CO2. Prevention is emphasized as there is lack of effective treatment once emboli occur.
Minimally invasive cardiac surgery techniques are being adopted at NH MMI Hospital in Raipur, Chhattisgarh, India. The techniques include smaller incisions and ports compared to traditional full median sternotomy. Procedures performed so far include ASD closure, mitral valve replacement, aortic valve replacement, and minimally invasive CABG. The advantages over traditional surgery are less pain, bleeding, and faster recovery time. Special equipment and training are required but the techniques provide cosmetically appealing and less traumatic alternatives to full open cardiac surgery.
Complicationsandsafetyduringcpb 180414072601Manu Jacob
This document discusses safety during cardiopulmonary bypass (CPB). It covers several topics:
1. Bypass safety has improved considerably with better safety features and techniques, though fatal accidents occurred in 1/1800 cases and serious incidents in 1/130 procedures in 1981.
2. Organizational aspects emphasize teamwork, cooperation, coordination, and effective communication within the open-heart unit.
3. Protocols should be established for equipment, patient specifics, perfusion management, and handling accidents to maximize safety. Human error is the leading cause of accidents, followed by equipment failures. Constant updates and a focus on safety can help minimize risks.
This document summarizes the history and classification of sinus of Valsalva aneurysm (SOVA). Some key points:
- SOVA was first described in 1839 and the first successful repair was in 1956 using cardiopulmonary bypass.
- SOVAs can be congenital or acquired due to various connective tissue/inflammatory disorders.
- The majority originate from the right coronary cusp (77%) and most commonly rupture into the right ventricle (67.9%).
- The classic Sakakibara classification categorizes SOVAs arising from the right coronary cusp into three types based on location of rupture/protrusion. A modified classification exists for non-cor
1) Transthoracic and transesophageal echocardiography are important modalities for assessing atrial septal defects (ASDs). TTE can identify RV volume overload and septal flattening, while TEE precisely measures defect size and evaluates rim morphology.
2) The four main types of ASDs - ostium secundum, ostium primum, sinus venosus, and coronary sinus defects - have distinguishing echo features. Doppler can demonstrate shunt direction and magnitude.
3) Echocardiography guides percutaneous ASD closure by assessing defect and rim anatomy, device sizing, and post-procedure result. Understanding echo features is key to ensuring procedure success.
This document discusses various types of heart valve prostheses including mechanical and bioprosthetic valves. It provides details on specific valve models and discusses considerations for aortic and mitral valve replacement. Complications related to valve replacement and long-term follow-up and management are outlined. Several postoperative syndromes that can occur are also summarized.
The document discusses drug-eluting stents, focusing on the Zilver PTX stent. It provides an overview of the Zilver PTX, including its stent platform, paclitaxel drug coating, mechanism of action, intended use, sizing, and available configurations. Clinical trial results show the Zilver PTX significantly reduces restenosis and need for reintervention compared to standard care or bare metal stents at 5-year follow-up.
This document discusses coronary guidewires used in percutaneous coronary intervention (PCI). It describes the components, classifications, and appropriate uses of guidewires for different clinical scenarios. Guidewires are classified based on tip flexibility, device support, coating, and tip load. Commonly used guidewires include Balance Middleweight Universal, Choice Floppy, and BMW. Guidewire selection depends on vessel anatomy, lesion morphology, devices used, and operator experience. Special guidewires are discussed for procedures like left main PCI, bifurcation PCI, dissections, calcified lesions, and chronic total occlusions.
This document discusses heart transplantation, including indications, donor and recipient criteria. It provides a brief history of heart transplantation from early experiments to modern procedures. Key points include common indications for transplant like dilated cardiomyopathy, the importance of matching donor and recipient size and blood type, and selecting recipients without other medical issues that could impact outcomes. Contraindications and special considerations for procedures like ABO incompatible and pediatric transplants are also summarized.
History of cardiac surgery DR NIKUNJ R SHEKHADA (MBBS,MS GEN SURG ,DNB CTS SR)DR NIKUNJ SHEKHADA
The document provides a history of cardiac surgery from the 19th century to modern times. It discusses early operations on the heart and pericardium in the 19th century. It then covers the development of anesthesia, vascular surgery, cardiac catheterization, and heart-lung bypass machines, which enabled open-heart surgery. Some key events summarized are the first successful cardiac surgery without complications in 1896, the first use of external heart-lung machines in the 1950s, the first open-heart repair under direct vision in 1952, the first coronary artery bypass surgery in 1960, and the first human heart transplant in 1967. The document also discusses the early development of heart valve surgery and prosthetic heart valves.
This document discusses mechanical circulatory support devices for advanced heart failure, including intra-aortic balloon pumps (IABP) and ventricular assist devices (VADs). It describes the physiology and indications for IABP, including how it increases coronary perfusion and reduces left ventricular afterload. It also discusses VADs, describing both pulsatile and non-pulsatile devices, components, classifications based on period of use and pumping mechanism. Patient selection criteria for VADs include being refractory to medical therapy, having a life expectancy less than 2 years without support, and being ineligible for heart transplant.
The document discusses conduits used in coronary artery bypass grafting (CABG). It describes the history of CABG, beginning with Alexis Carrel's description in the early 1900s. It outlines the three eras of CABG and discusses key pioneers like Michael DeBakey and Rene Favaloro. The document then describes the different types of arterial and venous conduits used in CABG, focusing on the internal thoracic artery and radial artery. It discusses the anatomy, histology, harvesting techniques, and patency rates of different conduits.
The Ross procedure involves replacing the diseased aortic valve with the patient's own pulmonary valve, and replacing the pulmonary valve with a homograft. This avoids the need for lifelong anticoagulation. The pulmonary valve is excised and implanted into the aortic position using techniques like subcoronary implantation. A homograft is then used to replace the pulmonary valve. Long term outcomes are generally good, though there is a risk of dilation of the pulmonary autograft over time which can lead to aortic insufficiency. Careful postoperative management of blood pressure and use of NSAIDs is important.
The RESOLUTE International study evaluated the Resolute stent in a large "real-world" patient population across multiple international centers. Over 2,300 patients were enrolled with nearly complete 12-month follow-up. The primary endpoint of cardiac death and target vessel myocardial infarction at 12 months occurred in 4.1% of patients. Rates of stent thrombosis, target lesion revascularization, and other secondary endpoints were also low out to 12 months, and event rates were similar between monitored and unmonitored patients. Outcomes were also consistent across various high-risk subgroups. Results from RESOLUTE International are generally comparable to those seen in the RESOLUTE All Comers trial.
The document discusses results from the Phase 3 ESTABLISH 2 clinical trial comparing the efficacy and safety of tedizolid to linezolid for the treatment of acute bacterial skin and skin structure infections. The trial demonstrated that tedizolid was non-inferior to linezolid across all efficacy endpoints while exhibiting a favorable safety and tolerability profile with fewer gastrointestinal side effects. Tedizolid represents a promising new 6-day treatment option for skin infections that could provide an improved option compared to the standard 10-day linezolid regimen.
This document summarizes the results of a randomized trial comparing outcomes of PCI performed at hospitals with and without on-site cardiac surgery. It found that at 6 weeks and 9 months, rates of death, heart attack, bleeding, stroke and other complications were similar between the two hospital types. However, PCI failure and use of bare-metal stents were higher, and staged procedures and catheterization lab visits were more frequent, at hospitals without on-site surgery.
Montecucco Carlo Murizio Torino 13° Convegno Patologia Immune E Malattie Orfa...cmid
This document summarizes safety data from the LORHEN registry on anti-TNF-α treatments in rheumatoid arthritis patients. It found that 18.2% of patients discontinued treatment due to adverse events, with serious infections occurring in 6.9% of patients. Risk of discontinuation due to adverse events increased with age and higher corticosteroid doses. The risk of serious infections was highest for infliximab. The study provides valuable real-world safety data on anti-TNF-α treatments from a large observational registry.
Which Chest Pain Can Be Safely Discharged From EdRashidi Ahmad
This document discusses strategies for evaluating and safely discharging chest pain patients from the emergency department (ED). It notes that over 30% of medical admissions are for chest pain, but only 50% actually have acute coronary syndrome (ACS). The diagnostic challenges include non-specific symptoms, limitations of electrocardiograms and cardiac markers in the early stages of ACS. Risk prediction tools like the TIMI score can help determine which low-risk patients may be safely discharged. Younger patients with no cardiac risk factors and normal initial tests have a very low 0.14% risk of ACS. Stress tests and echocardiography have limitations in the ED setting but may help rule out problems in some patients. The goal is to
How Long Before the Clinical Diagnosis of Heart Failure are HF Signs and Symp...HMO Research Network
1) This study used natural language processing on medical records to identify when heart failure signs and symptoms were first documented prior to an official clinical diagnosis of heart failure.
2) On average, common symptoms like ankle edema and shortness of breath on exertion were documented over 200 days before diagnosis, while findings on physical exam like rales were noted around 133 days before.
3) In many cases, signs and symptoms of heart failure were present in medical records well before the patient received an official clinical diagnosis of heart failure, suggesting that improved use of electronic health records could enable earlier identification and treatment of heart failure.
The ACT Trial was a large, pragmatic randomized controlled trial that investigated whether acetylcysteine reduces the risk of contrast-induced nephropathy (CIN) in over 2,300 patients undergoing coronary angiography. The trial found no difference in the primary outcome of CIN or other clinical outcomes like mortality between patients receiving acetylcysteine or placebo. Subgroup and sensitivity analyses also found no benefit of acetylcysteine. An updated meta-analysis of high-quality trials, including the ACT Trial, similarly found no effect of acetylcysteine on reducing CIN risk. The results suggest acetylcysteine is not effective in preventing CIN and may inform updating clinical guidelines.
The ACT Trial was a large pragmatic randomized controlled trial that evaluated the effectiveness of acetylcysteine in preventing contrast-induced nephropathy in over 2,300 high-risk patients undergoing coronary angiography. The trial found no significant difference in the rates of contrast-induced nephropathy or other clinical outcomes like mortality between patients who received acetylcysteine or placebo. Subgroup and meta-analysis of previous trials confirmed these results. The conclusions indicate that acetylcysteine is not effective in reducing short-term renal or clinical risks in high-risk patients undergoing angiography.
Amarelli 313 Transplantation Ii Early Graft Failure After Heart Transplant Le...Cristiano Amarelli
The document discusses a study examining risk factors for early graft failure (EGF) within 24 hours of heart transplantation. The study analyzed 317 transplant recipients and identified factors significantly associated with EGF, including male sex, redo surgery, high donor inotrope use, weight mismatch over 20%, and longer ischemic time. EGF occurred in 32 patients (10.1%) and was associated with high mortality of 52.9%.
The document discusses various clinical trials comparing percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) for treating multivessel coronary artery disease and/or left main coronary artery disease. It specifically mentions the SYNTAX trial which found CABG had better outcomes than PCI at 2 years, driven by a greater need for revascularization with PCI. The document also discusses trials of second-generation drug-eluting stents like the NEVO stent which were found to be more effective and safer than first-generation stents like the Taxus stent.
1) This study compared long-term outcomes of 626 STEMI patients treated with primary PCI who were randomized to drug-eluting stents (DES, n=313) or bare-metal stents (BMS, n=313).
2) At 3 years, the rate of major adverse cardiac events (MACE), including death, MI, and target lesion revascularization (TLR), was significantly lower in the DES group compared to the BMS group (10.5% vs 16.3%, p=0.024).
3) Rates of cardiac death (4.2% vs 6.1%), MI (6.1% vs 8.9%), and TLR (3
This study evaluated 60 patients with advanced hepatocellular carcinoma treated with sorafenib using RECIST, modified RECIST (mRECIST), and Choi criteria to assess tumor response. mRECIST and Choi criteria identified more patients with objective responses compared to RECIST, including some considered non-responders by RECIST. Objective responses by mRECIST and Choi correlated with longer survival, suggesting they better capture treatment benefit compared to RECIST. The study concludes mRECIST and Choi criteria can reclassify some RECIST non-responders as true partial responders with significant survival benefit from sorafenib.
Cytori Cell Therapy aims to improve quality and length of life through innovative cell therapy. The company has treated over 4,000 patients for conditions like cardiovascular disease and soft tissue disorders. Recent clinical trials show promise for treating chronic myocardial ischemia and acute heart attack. For chronic heart failure, cell therapy may help improve heart condition, activity, and reduce mortality for "no option" patients, representing a large potential market.
This document provides a summary of 6 late-breaking sessions to attend at the Heart Rhythm Society Scientific Sessions in Boston from May 13-16, 2015. The sessions include: (1) a study on the impact of remote monitoring on clinical events and healthcare utilization; (2) a randomized global trial comparing uninterrupted rivaroxaban to vitamin K antagonists in patients undergoing catheter ablation; and (3) a study comparing cryoballoon versus open irrigated radiofrequency ablation in patients with paroxysmal atrial fibrillation. The other sessions include: (4) first-in-human experience with a miniaturized transcatheter pacing system; (5) results from the Canadian Registry of Card
This document provides details on the top 5 sessions to attend at the HIMSS.15 conference. The sessions cover topics like structured cardiology procedure reporting, connected heart health using American Heart Association resources, using BI and analytics to reduce sepsis and heart failure readmissions, how health information exchanges can support population health through New York's Million Hearts initiative, and a session on transforming data into information and driving transformation. Speakers include doctors, public health experts, and data analysts.
This document provides details on the top 5 sessions to attend at the HIMSS.15 conference. The sessions cover topics like structured cardiology procedure reporting, connected heart health using American Heart Association resources, using BI and analytics to reduce sepsis and heart failure readmissions, how health information exchanges can support population health through New York's Million Hearts initiative, and a session on transforming data into actionable information. The sessions will take place between April 13-16, 2015 and include speakers such as doctors, healthcare executives, and data analysts.
This document summarizes 7 innovative technologies that will be on display at ACC.15:
1) Medtronic's CoreValve transcatheter aortic valve replacement system provides a minimally invasive alternative to open heart surgery for replacing diseased heart valves.
2) St. Jude Medical's CardioMEMS heart failure monitoring system allows clinicians to monitor pulmonary pressures and manage treatment in patients with heart failure.
3) Toshiba's dose-tracking system measures radiation skin dose during interventional procedures to help clinicians monitor patient radiation exposure.
4) Merge Cardio provides a centralized web-based system for physicians to manage multiple aspects of patients' integrated cardiovascular records.
The document summarizes several imaging sessions at the upcoming American College of Cardiology's Annual Scientific Session & Expo on March 14-16 in San Diego. Key sessions include:
1) Results from the PROMISE trial comparing diagnostic testing for chest pain will be presented on Saturday, and costs will be discussed on Sunday.
2) A joint multimodality imaging symposium with several societies will discuss imaging high risk patients, techniques for difficult diagnoses, and radiation safety.
3) An international perspective on cardiac imaging will be provided including a discussion of using CT on Egyptian mummies to study heart disease over millennia.
If you want to avoid damaging litigation, concentrate on dialogue and details. Cardiologists who fail to maintain detailed, two-way conversations with patients and thoroughly assess diagnostic data are at risk of negligence lawsuits, a study shows.
The 2014 RSNA conference in Chicago saw over 56,000 attendees, up 5% from the previous year, with more than 2,000 additional professional registrations. Although exhibitor attendance dipped slightly by 2%, the conference floor was packed with 636 exhibits occupying over 426,000 square feet. The conference featured special exhibits celebrating RSNA's 100th anniversary and highlighting the organization's contributions to advances in medical imaging over the past century.
Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf finalTrimed Media Group
This study compared the real-world effectiveness and safety of rivaroxaban versus warfarin for stroke prevention in nonvalvular atrial fibrillation patients using claims data. The study found:
1) Rivaroxaban and warfarin had similar risks of major bleeding, stroke, systemic embolism, and venous thromboembolism.
2) Rivaroxaban was associated with a higher risk of gastrointestinal bleeding compared to warfarin.
3) Patients were less likely to discontinue rivaroxaban treatment compared to warfarin, suggesting better treatment persistence with rivaroxaban.
This document summarizes a study examining the length of stay and economic implications of treating pulmonary embolism with rivaroxaban versus low molecular weight heparin-vitamin K antagonist (LMWH-VKA) in an emergency room setting. The study found that among patients in North America from the EINSTEIN PE trial, the median length of stay was 1 day shorter for those treated with rivaroxaban (3 days) compared to LMWH-VKA (4 days). This 1 day reduction in length of stay was associated with an estimated $2040 savings per patient for the rivaroxaban cohort based on average hospital costs. The study concluded that rivaroxaban was associated with a consistent
Shorr and bria innovation at the point-of-care rethinking the doctor-patient...Trimed Media Group
The document discusses innovations in doctor-patient interactions through technology. It proposes two solutions: 1) Creating a "story" of the patient's medical history and presenting issues for doctors to review before visits to improve care. This would be generated through automated document assembly. 2) Developing an "ad hoc" user interface optimized for point-of-care use, allowing doctors to take notes digitally in various formats like ink, checkboxes and dictation to focus on patient interaction instead of formal documentation. The goal is to enhance both the patient and provider experience through disruptive technology.
Kuperman Health Information Exchange & Care CoordinationTrimed Media Group
1) Care coordination requires improved information sharing both within care teams and across settings using health information exchange (HIE). However, current electronic health records (EHRs) were not designed for care coordination and do not adequately support sharing data and coordinating care.
2) NewYork-Presbyterian Hospital is working to enhance care coordination for patients with diabetes and depression by improving EHR tools, care team workflows, and data sharing across settings using its regional HIE. Key features include standardized screening and monitoring, patient and provider education, population health analytics, and secure messaging.
3) The success of care coordination interventions is being evaluated based on clinical outcomes like HbA1c and depression measures, as well as process measures
This document discusses the need for innovation in healthcare, particularly for the elderly population and their caregivers. It introduces the InfoSAGE project, which aims to create a "living laboratory" to study how technology can improve communication, coordination and collaboration between elderly patients and their families. InfoSAGE will connect various sources of health information and services through identity and content coordination to address the challenges of aging and caregiving. The goal is to develop tools that help address problems around care coordination, respecting patient preferences and reducing caregiver burnout, as electronic health records currently do not adequately meet the needs of elderly patients and their families.
[Hongsermeier] clinical decision support services amdis finalTrimed Media Group
1) Clinical Decision Support Services (CDSS) allow externalization of clinical knowledge and decision support logic from electronic health records (EHRs) to specialized CDSS providers.
2) The Clinical Decision Support Consortium (CDSC) is working on standards for knowledge management, specification, and sharing of CDS content and services.
3) Opportunities exist for EHR vendors to leverage external CDSS as curating all needed clinical knowledge internally is challenging, and most EHR CDS cannot support advanced inferencing required for personalized medicine. Challenges include ensuring appropriate implementation and use of external CDSS within EHR workflows.
This document discusses delivering clinical knowledge and guidance directly into healthcare workflows through clinical decision support (CDS). CDS aims to provide clinicians and patients with intelligently filtered, situation-specific information to enhance patient care. The goal is to repurpose existing clinical content from various sources and deliver the most precise and useful information for each workflow and information need. Physician information needs were analyzed from query data to develop an ontology of needs. Content is curated, indexed as discrete facts, and tailored for specific situations by matching it to patient data, workflows, and information needs. Knowledge delivery aims to integrate actionable tools and options directly into clinical systems like EHRs.
The document summarizes a presentation on providing collaborative and coordinated care for patients with complex illnesses. Some key points:
- To achieve the goals of improved health outcomes, quality of care, and reduced costs ("Triple Aim"), the healthcare system needs to focus on caring for patients with complex chronic conditions who account for a large portion of costs.
- Successful models involve interdisciplinary, team-based care coordinated across care settings. CareMore, a Medicare Advantage plan, achieves better outcomes and lower costs through intensive management of frail patients using nurse practitioners, protocols, home monitoring, and an electronic health record.
- Clinical IT can support collaborative care by enabling documentation, care planning, decision support, and information
This document discusses challenges with using electronic health records (EHRs) to support clinical knowledge management (KM) and continuous learning. It outlines several investments made by Lahey Health to address these challenges, including using an external collaboration platform to manage clinical decision support (CDS) content outside of the EHR. The document argues that EHRs are not designed for collaboration or learning, and that clinical KM 3.0 approaches are needed to help health systems and users continuously self-improve.
The document is from the Intelligent Health Lab and discusses several topics:
1. The Lab's director and its affiliation with Harvard.
2. The potential for an "App Store for Health" where innovators can create and distribute apps across EMR systems, similar to app stores for smartphones.
3. The vision of a "Learning Health System" where evidence is continuously generated from patient data to improve outcomes over time.
Kibbe expect direct health information exchange in the context of state 2 mea...Trimed Media Group
This document provides an introduction to Direct exchange for those engaged in Stage 2 Meaningful Use programs. It discusses how Direct exchange relates to Stage 2 MU objectives and the role of DirectTrust in supporting Direct exchange adoption. Direct exchange allows EHR users using different vendors to securely send and receive messages and attachments. It is one way providers can meet Stage 2 MU requirements for transmitting care summaries during transitions of care and allowing patients to view, download and transmit health information. The document describes how Direct exchange works, involving Health Information Service Providers, Certificate Authorities, Registration Authorities, and X.509 certificates to enable secure exchange between organizations and individuals.
Crotty engaging patients in new ways from open notes to social mediaTrimed Media Group
The document discusses new ways to engage patients through open notes and social media. It describes initial findings from the OpenNotes project that showed patients found value in reading clinical notes. It also outlines how patients use social media to find health information and connect with others. The document argues that healthcare providers can leverage these technologies and concepts to reduce information asymmetry, educate patients, and learn from them to provide more engaging and effective care.
Crotty engaging patients in new ways from open notes to social media
Everest ii
1. Endovascular Valve Edge-to-Edge
REpair Study (EVEREST II)
Randomized Clinical Trial:
Primary Safety and Efficacy Endpoints
Ted Feldman, Laura Mauri, Elyse Foster, Don Glower
on behalf of the EVEREST I I Investigators
American College of Cardiology
March 14, 2010
Atlanta, GA
2. Catheter-Based Mitral Valve Repair
MitraClip® System
4
Investigational Device only in the US; Not available for sale in the US
3. Clinical Experience
St udy Populat ion n
EVEREST I (Feasibility) * Non-randomized 55
EVEREST II * Pre-randomization 60
EVEREST II High Risk Registry 78
EVEREST II (Pivotal) Randomized patients 279
(2:1 MitraClip to Surgery) 184 MitraClip
95 Surgery
REALISM (Continued Access) High Risk & Non High Risk 266
European Experience 472
Total 1,115
MitraClip
*Percutaneous Mitral Valve Repair Using the Edge-to-Edge Repair: Six months Results of the EVEREST Phase I Clinical trial, JACC 2005;46:2134-2140.
Percutaneous Mitral Repair with the MitraClip System: Safety and Midterm Durability in the Initial EVEREST Cohort, JACC 2009; 54:686-694.
Data as of 2/15/2010. 5
Investigational Device only in the US; Not available for sale in the US
4. EVEREST II Randomized Clinical Trial
Study Design
279 Patients enrolled at 37 sites
Significant MR (3+-4+)
Specific Anatomical Criteria
Randomized 2:1
Device Group Control Group
MitraClip System Surgical Repair or Replacement
N= 184 N= 95
Echocardiography Core Lab and Clinical Follow-Up:
Baseline, 30 days, 6 months, 1 year, 18 months, and
annually through 5 years
6
Investigational Device only in the US; Not available for sale in the US
5. EVEREST II Randomized Clinical Trial
Baseline Demographics & Co-morbidities
Device ( % ) Cont r ol ( % )
n= 184 n= 95 P
Age (mean) 67.3 years 65.7 years 0.32
Male 62.5 66.3 0.60
Congestive heart failure 90.8 77.9 < 0.01
Coronary artery disease 47.0 46.3 > 0.99
Myocardial infarction 21.9 21.3 > 0.99
Angina 31.9 22.2 0.12
Atrial fibrillation 33.7 39.3 0.42
Cerebrovascular disease 7.6 5.3 0.62
Peripheral vascular disease 6.5 11.6 0.17
Cardiomyopathy 17.9 14.7 0.61
Hypercholesterolemia 61.0 62.8 0.80
Hypertension 72.3 78.9 0.25
Moderate to severe renal disease 3.3 2.1 0.72
Diabetes 7.6 10.5 0.50
Previous cardiovascular surgery 22.3 18.9 0.54
MR Severity: 3+ to 4+ 95.7 92.6 0.48
MR Etiology: Degenerative / Functional 73 / 27 73 / 27 0.81
10
Investigational Device only in the US; Not available for sale in the US
6. EVEREST II Randomized Clinical Trial
Primary Endpoints
Pre-Specified MAEs
Death
Safety Major Stroke
Re-operation of Mitral Valve
Major Adverse Event Rate at 30 days Urgent / Emergent CV Surgery
Myocardial I nfarction
Per protocol cohort Renal Failure
Deep Wound Infection
Ventilation > 48 hrs
Superiority hypothesis New Onset Permanent Atrial Fib
Septicemia
GI Complication Requiring Surgery
All Transfusions > 2 units
Effectiveness
Clinical Success Rate
• Freedom from the combined outcome of
– Death
– MV surgery or re-operation for MV dysfunction
– MR > 2+ at 12 months
Per protocol cohort
Non-inferiority hypothesis
12
Investigational Device only in the US; Not available for sale in the US
7. EVEREST II RCT: Primary Endpoints
Per Protocol Cohort
Safety Effectiveness
Major Adverse Events Clinical Success Rate*
30 days 12 months
Device Group, n= 136 Device Group, n= 134
9.6% 72.4%
pSUP < 0.0001 pNI = 0.0012
Control Group, n= 79 Control Group, n= 74
57.0% 87.8%
Met superiorit y hypot hesis Met non - inferior it y hypot hesis
inferiorit
• Pre-specified margin = 6% • Pre-specified margin = 31%
• Observed difference = 47.4% • Observed difference = 15.4%
• 97.5% LCB = 34.4% • 95% UCB = 25.4%
* Freedom from the combined outcome of
LCB = lower confidence bound
death, MV surgery or re-operation for MV
UCB = upper confidence bound 17
dysfunction, MR > 2+ at 12 months
Investigational Device only in the US; Not available for sale in the US
8. EVEREST II RCT: Primary Safety Endpoint
Per Protocol Cohort
# Patients experiencing event
30 Day MAE, non-hierarchical Device Group Control Group
(n= 136) (n= 79)
Death 0 2 (2.5%)
Major Stroke 0 2 (2.5%)
Re-operation of Mitral Valve 0 1 (1.3%)
Urgent / Emergent CV Surgery 0 4 (5.1%)
Myocardial Infarction 0 0
Renal Failure 0 0
Deep Wound Infection 0 0
Ventilation > 48 hrs 0 4 (5.1%)
New Onset Permanent Atrial Fib 0 0
Septicemia 0 0
GI Complication Requiring Surgery 1 (0.7%) 0
All Transfusions > 2 units* 12 (8.8%) 42 (53.2%)
TOTAL % of Pat ient s w it h MAE 9.6% 57.0%
p< 0.0001*
* p< 0.0001 if include Major Bleeding only (95% CI 34.4%, 60.4%)
18
Investigational Device only in the US; Not available for sale in the US
9. EVEREST II RCT: MR Reduction
Per Protocol Cohort
Device Group Control Group
≤2+ 81.5% ≤2+ 97.0%
3+/4+ 3+/4+
3+/4+ 18.5%
n= 137 n= 119 n= 80 n= 67
21
Investigational Device only in the US; Not available for sale in the US
10. EVEREST II RCT: Left Ventricular Volume
Per Protocol Cohort
Device Group Control Group
n=118, matched data n=65, matched data
p< 0.0001 p< 0.0001
p= 0.0005 p= 0.0255
LVEDV LVESV LVEDV LVESV
Baseline 12 Months
LVEDV = left ventricular end diastolic volume
LVESV = left ventricular end systolic volume Pre-specified hypothesis for statistical analysis 23
Investigational Device only in the US; Not available for sale in the US
11. EVEREST II RCT: NYHA Functional Class
Per Protocol Cohort
Device Group Control Group
p< 0.0001 p< 0.0001
I
I
II
II
I I 87.9%
97.6% NYHA
NYHA Class I/ II
Class I / II
III II I
II II
III
IV IV
Baseline 12 months Baseline 12 months
n= 124, Matched data n= 66, Matched data
Hypothesis not pre-specified for statistical analysis 25
Investigational Device only in the US; Not available for sale in the US
12. EVEREST II RCT: Summary
Safety & effectiveness endpoints met
• Safety: MAE rate at 30 days
– MitraClip device patients: 9.6%
– MV surgery patients: 57%
• Effectiveness: Clinical Success Rate at 12 months
– MitraClip device patients: 72%
– MV Surgery patients: 88%
Clinical benefit demonstrated for MitraClip System and MV surgery
patients through 12 months
– Improved LV function
– Improved NYHA Functional Class
– Improved Quality of Life
Surgery remains an option after the MitraClip procedure
27
Investigational Device only in the US; Not available for sale in the US
13. EVEREST II RCT: Conclusion
The MitraClip procedure is an important
therapeutic option for selected patients
with significant mitral regurgitation given
the demonstrated safety, effectiveness
and clinical benefit.
28
Investigational Device only in the US; Not available for sale in the US