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PainFREE R x II Investigators Директор исследования : Mark Wathen, MD

Проспективное Рандомизированное многоцентровое исследование эмпирической ЭКС по сравнению с шоковой терапией при быстрой ЖТ у пациентов с ИКД Результаты PainFREE R x II Trial. PainFREE R x II Investigators Директор исследования : Mark Wathen, MD.

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PainFREE R x II Investigators Директор исследования : Mark Wathen, MD

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  1. Проспективное Рандомизированное многоцентровое исследование эмпирической ЭКС по сравнению с шоковой терапией при быстрой ЖТ у пациентов с ИКДРезультаты PainFREE Rx II Trial PainFREE Rx II Investigators Директор исследования: Mark Wathen, MD Wathen MS, et al. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients withimplantable cardioverter defibrillators: PainFREE Rx II Trial Results. Circulation 2004;110:2591-2596.

  2. Цель PainFREE Rx II Сравнить эффективность эмпирической частой ЭКС (ATP) по сравнению с шоками при спонтанной быстрой ЖТ у пациентов с ИКД Первичная цель: • Оценить безопасность: длительность эпизодов FVT , купированные АТР были менее 6 сек Вторичная цель: • Качество жизни, эффективность ATP, акселерация, синкопе PainFREE Rx II

  3. Дизайн исследования • 634 пациента • 42 центров США • «слепое» • Включение: январь 2001 – март 2002 • Наблюдение: до апреля 2003 • Спонсор: Medtronic PainFREE Rx II

  4. Пациенты n= 634 ATP n= 313 Shock n= 321 Возраст, лет 67 67 ФВ, % 0.32 0.32 Мужчины, % 80% 77% ФК ХСН> II 53% 53% ИБС 83% 87% Перв. профилактика ВС 48% 47% PainFREE Rx II

  5. Требовалась детекция FVT внутри окна VF # интервалы детекции = 18/24 VF Fast VT Slow VT  360 ms (167 bpm) 320 ms (188 bpm) 240 ms (250 bpm) • PR Logic “ON” во всех двухкамерныхИКД • SVT limit = 320ms PainFREE Rx II

  6. Терапия FVT DFT – порог дефибрилляции PainFREE Rx II

  7. Длительность эпизодов Группа Shock Группа ATP p медиана 9.7 s 10.0 s mean±SE 10.7 ± 0.7 s 12.7 ± 0.8 s <.001 PainFREE Rx II

  8. Истинные события* (n=1342 ) “медл” ЖТ 777,58% ФЖ 134,10% FVT 431,32% (98 pts) FVT составляла 76% всех случаев в традиционной зоне ФЖ (< 320ms) ! PainFREE Rx II

  9. Распределение желудочковых аритмий в детектируемых зонах VF 10% FVT 32% VT 58% <200 200 220 240 260 280 300 320 340 360 380 400 420 440 >460 Средняя длина цикла (ms) PainFREE Rx II

  10. Группа Шока ATP** 4/147 2% Шоки 99/147 64% Спонтанное окончание 44/147 34% PainFREE Rx II

  11. Группа ATP Успех АТР 229/284 72% Неудача АТР 49/284 28% PainFREE Rx II

  12. Распределение успешности АТР в зависимости от цикла ЖТ N= 2 6 11 12 31 28 51 75 60 8 PainFREE Rx II

  13. Общая смерть ВСС 32 (10%) 1 (0.3%) 24 (7%) 2 (0.6%) NS NS Другие конечные точки PainFREE Rx II

  14. Изменение качества жизниSF-36: изменение за 12 мес Группа Шоков (n=55 pts) Группа ATP(n=43 pts) * p<0.05 * * Изменение за 12 мес по сравнению к исходному уровню * Mental Summary Vitality Social functioning Role emotional Mental health Physical function Role physical Bodily pain General health Physical Summary Физический статус Ментальный статус PainFREE Rx II

  15. Заключение • Изолированная Эмпирическая ATP купирует 72% случаев FVT. • ATP не даёт акселерации ЖТ, синкопе и повышения смертности. • Пациенты с включением ATP в сравнении с пациентами только шоковой терапии • Авторы исследования рекомендуют включать ATP в качестве предпочтительной терапии при FVT у большинства пациентов с ИКД PainFREE Rx II

  16. R Study Design Группа ATP 12 мес* Инф. согласие Измерение DFT Группа Шоков 12 мес* * наблюдение: 1, 3, 6, 9 и 12 мес шкала качества жизни исходно и через 12 мес PainFREE Rx II

  17. Критерии включения\Исключения • Включение • Имплантация ИКД • Возможность шока с запасом 10 Дж от DFT • Апикальная позиция ПЖ электрода • Исключение • ГКМП • Синдром Brugada • Синдром удлинённого интервала QT PainFREE Rx II

  18. Пациенты: исходная терапия PainFREE Rx II

  19. Детектированные эпизоды FVT * У 2 пац было 131 эпизода, у других 45 пац- 152 эпизодов PainFREE Rx II

  20. Ismaile Abdalla, Amarillo, TX Wayne Adkisson, Suffolk, VA William Bailey, Lake Charles, LA Omar Bakr, Grand Blanc, MI Bradley Banks, Covington, LA Robert Belt, Knoxville, TN Ker Boyce, Pinehurst, NC David Broudy, Seattle, WA Alfred Buxton, Providence, RI Robert Canby, Austin, TX John Corbelli, Williamsville, NY Rahul Doshi, Las Vegas, NV Dennis Glascock, Toledo, OH Eric Grubman, New Haven, CT John Haughland, St. Louis Park, MN Bruce Hook, Manchester, NH Mark Josephson, Boston, MA Michael Katcher, Salem, MA Koroush Khalighi, Easton, PA Erol Kosar, Inglewood, CA Mark Landers, Pinehurst, NC Huagi Li, Omaha, NE Participating Investigators Albert Lin, Chicago, IL Mark Link, Boston, MA Christian Machado, Southfield, MI Karen MacMurdy, Portland, OR Thomas Mattioni, Phoenix, AZ Terrence May, Roanoke, VA John McKenzie III, Glendale, CA Michael Orlov, West Roxbury, MA Peter Ott, Tucson, AZ Darren Peress, Tucson, AZ Joseph Reilly, Randallstown, MD Donald Rubenstein, Greenville, SC Lisa Schiller, St. Louis, MO Lyle Siddoway, York, PA Felix Sogade, Macon, GA Jasbir Sra, Milwaukee, WI Michael Sweeney, Boston, MA Timothy Talbert, Chattanooga, TN Gregg Taylor, Greensboro, NC Jesus Val-Mejias, Wichita, KS Kent VanWhy, Davenport, IA Kent Volosin, Cherry Hill, NJ Mark Wathen, Nashville, TN PainFREE Rx II

  21. References Wathen MS, et al. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter defibrillators: PainFREE Rx II Trial Results. Circulation 2004;110:2591-2596. PainFREE Rx II

  22. Brief Statement Indications/Contraindications Medtronic implantable cardioverter defibrillator (ICD) systems are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Contraindicated for patients with transient or reversible ventricular tachyarrhythmia or as the sole treatment of atrial arrhythmia. Warnings/Precautions For Medtronic implantable cardioverter defibrillator systems: Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should stay away from sources of magnetic and electromagnetic radiation, including MRI, diathermy, and electrosurgical units, to avoid possible underdetection, inappropriate therapy delivery, and/or electrical reset of the device. Do not place transthoracic defibrillation paddles directly over the device. Potential Complications Medtronic implantable cardioverter defibrillator systems include, but are not limited to, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and lead system complications. See the technical manual for detailed uses, indications, contraindications, warnings, precautions, and potential complications. See the warranty card or technical manual for information concerning warranties. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. PainFREE Rx II

  23. Brief Statement for Medtronic CRT-ICD Systems Indications: • Medtronic CRT-ICD devices are indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction <35% and a QRS duration >130 ms. • Medtronic CRT-ICD devices are also indicated for ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. • The Attain Leads have application as part of a Medtronic biventricular pacing system. Contraindications: • Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms. • Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy. • CRT-ICD Devices are contraindicated for patients whose ventricular tachyarrhythmias may have transient or reversible causes and for patients with incessant VT or VF. • CRT Devices are contraindicated for Dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias.Warnings and Precautions: • Patients implanted with these systems should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device. • Certain programming and device operations may not provide cardiac resynchronization. See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. PainFREE Rx II

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