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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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slide1

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.

painfree r x ii
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

slide3
Дизайн исследования
  • 634 пациента
  • 42 центров США
  • «слепое»
  • Включение: январь 2001 – март 2002
  • Наблюдение: до апреля 2003
  • Спонсор: Medtronic

PainFREE Rx II

n 634
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

fvt vf
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

slide6
Терапия FVT

DFT – порог дефибрилляции

PainFREE Rx II

slide7
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

slide8

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

slide9

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

slide10

Группа Шока

ATP**

4/147

2%

Шоки

99/147

64%

Спонтанное

окончание

44/147

34%

PainFREE Rx II

slide11
Группа ATP

Успех АТР

229/284

72%

Неудача АТР

49/284

28%

PainFREE Rx II

slide12

Распределение успешности АТР в зависимости от цикла ЖТ

N= 2 6 11 12 31 28 51 75 60 8

PainFREE Rx II

slide13

Общая смерть

ВСС

32 (10%)

1 (0.3%)

24 (7%)

2 (0.6%)

NS

NS

Другие конечные точки

PainFREE Rx II

sf 36 12
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

slide15
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

study design

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

slide17
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

slide19

Детектированные эпизоды FVT

* У 2 пац было 131 эпизода, у других 45 пац- 152 эпизодов

PainFREE Rx II

participating investigators
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

references
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

slide22
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

brief statement for medtronic crt icd systems
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