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Novinky sjezdu Evropské kardiologické společnosti

Novinky sjezdu Evropské kardiologické společnosti

Paříž, 27. - 31. 8. 2011

Výroční sjezd ESC se svým významem v prezentaci inovativních terapií, výsledků vědeckých prací a nových technologií blíží pomalu sjezdům amerických kardiologických společností AHA/ACC. Počet účastníků pařížského sjezdu převýšil  33 000.

Zásadní uváděné novinky v oblasti kardiologie, které mění postupy v klinické praxi:

  1. 4 nová guidelines ESC – léčba HLP, KV onemocnění a gravidita, léčba periferních arteriálních onemocnění, kapesní verze doporučení pro léčbu srdečního selhání (verze 2010)
  2. antikoagulační léčba u pacientů s fibrilací síní – po pozitivních výsledcích studií s dabigatranem a rivaroxabanem byla nově prezentována data studie ARISTOTLES , která jasně ukazují superioritu apixabanu nad warfarinem v tak závažných ukazatelích, jako je celková mortalita a redukce tromboembolických komplikací
  3. na sjezdu AESC byla nově prezentována studie RAFT, publikovaná v NEJMu koncem loňského roku, která definitivně prokazuje redukci mortality (nově) a morbidity u pacientů indikovaných k srdeční resynchronizační léčbě , NYHA II a QRS > 150 ms. Indikační třída se tak mění u těchto pacientů na IA
  4. I.IKK FNOL prezentovala 3 sděleními a 1 posterem výsledky studie pacientů s rezistentní hypertenzí, kterým byl ke standardní léčbě přidán spironolacton (25 mg) a u kterých došlo k dalšímu poklesu jak systolického tak diastolického TK (studie ASPIRANT)
  5. další významnou novinkou je efekt ivabradinu na prevenci remodelace levé komory u pacientů se srdečním selháním a dysfunkcí levé komory. V této oblasti plánuje I. IKK FNOL vlastní klinickou studii u nemocných se srdeční resynchronizační léčbou.
  6. byla diskutována otázka digoxinu a jeho potencionálního vlivu na mortalitu pacientů v kombinaci s dronedaronem v rámci předčasněn ukončené studie PALLAS.
  7. byly podány nové důkazy o vysoce účinném antioxidašním efektu hořké čokolády
  8. I. IKK FNOL prezentovala na sjezdu úspěšně 5 prezentací a 2 postery

 

Novinka v oblasti nefarmakologické léčby pacientů s pokročilým srdečním selháním:

CHAMPION Study Published in The Lancet

CardioMEMS Sensor Significantly Reduces Heart Failure Hospitalizations

ATLANTA – February 10, 2011 –The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial was published online today in The Lancet. CHAMPION demonstrated a 30% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 39% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor, compared to control patients receiving standard heart failure treatment. The CHAMPION Trial also met all of its safety and secondary efficacy endpoints.

The CHAMPION trial was a randomized, prospective, multicenter, controlled trial that enrolled 550 patients at 64 leading heart centers in the U.S. The trial was led by Dr. William Abraham at the Ohio State University Medical Center and Dr. Philip Adamson at the Oklahoma Heart Hospital. It evaluated the safety and effectiveness of CardioMEMS’ heart failure pressure measurement system in New York Heart Association Class III (NYHA Class III) heart failure patients. NYHA Class III patients represent approximately 30% of the over six million heart failure patients in the U.S. and account for nearly half of all heart failure hospitalizations.

All subjects in the CHAMPION trial had the CardioMEMS heart failure sensor permanently implanted in the pulmonary artery using a simple, catheter-based technique. All patients took daily pulmonary artery pressure readings from home that were transmitted to CardioMEMS’ secure patient database. For patients in the treatment group only, healthcare providers were provided access to the pressure readings which were used in the treatment of their heart failure condition. For control group patients, health care providers were denied access to the pressure readings and they continued to receive standard care.

“The results from the CHAMPION study are very significant and provide a valuable new tool in the battle against heart failure. Pulmonary artery pressure monitoring is the first major device breakthrough in heart failure since CRT therapy,” said William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.

Dr. Adamson, director of the Heart Failure Institute at the Oklahoma Heart Hospital, added, “The CHAMPION trial illustrates how close monitoring of patients with chronic heart failure can reduce the need for costly and dangerous hospitalization while improving quality of life. These results are the beginning of a new era of hope for patients suffering from chronic symptomatic heart failure complementing medical and device therapies. The ‘Hemodynamic Era’ is a major advancement with promise for profound long-term impact on heart failure morbidity.”

“Hospitalizations are very traumatic for heart failure patients and costly to the health care system,” said Jay Yadav, M.D., founder and CEO of CardioMEMS and a cardiologist at the Piedmont Heart Institute. “With the CardioMEMS heart failure monitoring system, frequent hemodynamic monitoring can allow doctors and nurses to more efficiently manage their patients and produce meaningful reductions in their patients’ heart failure related hospitalizations.”

In September of 2010, St. Jude Medical (NYSE: STJ) invested $60 million in CardioMEMS in exchange for a 19% equity ownership interest and an exclusive option to acquire the remaining 81% of CardioMEMS for an additional $375 million during a period that extends through the completion of certain commercialization milestones.

Caution: Investigational device limited by federal law to investigational use.

 

About CardioMEMS, Inc.

CardioMEMS is a medical device company that has developed and is commercializing proprietary wireless sensing and communication technology for the human body. Its technology platform is designed to improve the management of severe chronic cardiovascular diseases such as aneurysms, heart failure and hypertension. CardioMEMS miniature wireless sensors can be implanted using minimally invasive techniques and transmit cardiac output, blood pressure and heart rate data, which are critical to the management of patients. The sensors can be permanently implanted into the heart and blood vessels due to their small size, durability and lack of wires and batteries. Using radiofrequency (RF) energy, the sensors transmit real-time data to external electronic readers, which then communicate this information to the patient’s physician. Previous lead investors in CardioMEMS include Arcapita Ventures, Boston Millennia Partners and Foundation Medical Partners. More information about CardioMEMS is located at www.cardiomems.com.

 

Investor Contact:
Daniel H. Bauer, CardioMEMS, Inc.
678-651-2376
dbauer@cardiomems.com

Media Contact:
Jenn Harrison, Carabiner Communications
678-313-3438
jharrison@carabinerpr.com

CardioMEMS and the CardioMEMS Logo are registered trademarks of CardioMEMS, Inc.

EndoSure® Wireless AAA Pressure Measurement System

The EndoSure® Wireless AAA Pressure Measurement System is cleared by the FDA for the measuring of intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and during endovascular thoracic aortic aneurysm repair (TAA). It serves as an adjunctive tool in the detection of intraoperative leaks of the stent graft during AAA repair.

The EndoSure sensor is inserted during the minimally invasive repair via a catheter into a patient’s aneurysm sac and communicates pressure information to an external electronics module from inside the sac.

Technology Overview

The EndoSure Wireless Pressure Measurement System is composed of two components: a miniaturized, wireless implantable sensor and an external electronics module. The external electronics module wirelessly communicates with our sensors to deliver vital patient data. Our wireless sensors are powered by RF energy delivered by an external electronics module and transmit real-time data without batteries. 

CardioMEMS EndoSure
Wireless Pressure Sensor

The EndoSure sensor is designed and manufactured using microelectromechanical systems, or MEMS, technology, which enables the fabrication of millimeter-scale devices with internal features in the nanometer to micrometer range. MEMS technology allows the creation of sensors with measurement stability and energy efficiency.

The EndoSure sensor is approximately the size of a paperclip. It is a hermetically sealed circuit, encapsulated in fused silica and silicone, and is surrounded by a PTFE-coated nickel-titanium wire. Inside the fused silica is a micron scale cavity. Changes to the membrane of this cavity result in changes to the sensor's resonant frequency. These changes correlate to pressure changes. The sensor contains no batteries or internal power source, but is instead powered by RF-energy provided by a proprietary electronic antenna.

The EndoSure sensor comes pre-loaded in a one-piece 14 French delivery system that enables the physician to insert the sensor during the same procedure as the stent graft. Radiopaque markers assist the physician in delivery of the sensor by clearly defining the sensor location within the aneurysm sac between the stent graft and aortic wall. The EndoSure sensor is intended to be a permanent implant in the aneurysm sac. 

EndoSure Sensor implanted in aneurysm sac repaired using endovascular repair procedure.

The external electronics module consists of three parts: the internal signal processing electronics, or main unit, the antenna used to wirelessly communicate with the sensor, and the graphical user interface that displays the patient information. During a reading, the antenna is placed near the implant site and communicates with the sensor by way of a RF signal that is generated and processed by the main unit.

The graphical user interface allows for system operation and data entry and displays information generated from the sensor. This information includes a pressure waveform and readings, such as mean pressure, systolic pressure, diastolic pressure, heart rate and cardiac output. By comparing pressure waveforms before and after deployment of the stent graft, the EndoSure system assists the physician in confirming traditional angiographic findings of successful stent graft placement. During the endovascular repair procedure, pre-exclusion and post-exclusion pressure measurements demonstrate the difference between an aneurysm sac that is exposed to circulation and one that is excluded.

Pre-Exclusion Pressure Waveform

Post-Exclusion Pressure Waveform



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