Authors' objectives: This Rapid HTA Report was developed to answer the following questions: • Policy question: what is the optimal use of the cardiac resynchronization therapy and defibrillator (CRT-D)? • Research question: what are the effects of the use of the CRT-D compared to cardiac resynchronization therapy and pacemaker (CRT-P) in patient with chronic heart failure?

Authors' recommendations: Despite the development of drug therapy, prognosis of patients with HF has not improved much. Those more likely to benefit from CRT-D insertion are those with mild to moderate heart failure. The individual patient meta-analysis by Chen et al considered the major studies comparing CRTD versus ICD and investigated these series through analysis conducted for subgroups according to NYHA class, duration of follow-up, and design of the study. The study by Chen et al shows a significant superiority of CRT-D on ICD in reducing hospitalizations for heart failure and improvement in functional class in all subgroups. Additional recent evidence shows efficacy of CRT-D in bundle branch block but not in the other conduction disturbances. At present there is no clear evidence about the effectiveness of CRT-D in patients with atrial fibrillation (AF) or for those with near normal QRS. The MADIT-CRT and RAFT studies show a higher incidence of procedural complications such as pneumothorax, device-related infections, pocket hematoma, catheter problems in the CRT-D group than in the ICD. Chen et al report the significant increase in the dislocation of catheters and dissection of the coranary sinus. Although these complications have not been fatal, they have increased the duration of hospitalization and decreased the quality of life. Our preliminary observations are not dissimilar from those made by the NICE appraisal committee in it's recent preliminary guidance document "Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure" (review TA95 e TA 120, June 2014).. Best evidence suggests that CRT-D is not dominant compared to CRT-P. The most recent studies comparing ICD with CRT-D come to different conclusions, possibly because of the less serious type of patients included in the studies.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.salute.gov.it/imgs/C_17_pagineAree_1202_listaFile_itemName_2_file.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Italy

Organisation Name: The Italian National Agency for Regional Health Services (Agenas)

Contact Address: Agenzia nazionale per i servizi sanitari regionali, Via Puglie 23, 00187 Rome, Italy

Contact Name: hta@agenas.it

Contact Email: hta@agenas.it

Copyright: Italian Ministry of Health and Agenas