Clinical Trials of Cardiac Resynchronization Therapy: Pacemakers and Defibrillators

Author(s):  
LESLIE A. SAXON ◽  
TERESA DE MARCO ◽  
KENNETH A. ELLENBOGEN
2010 ◽  
Vol 8 (3) ◽  
pp. 0-0
Author(s):  
Vytė Maneikienė ◽  
Germanas Marinskis ◽  
Audrius Aidietis ◽  
Sigita Aidietienė ◽  
Jelena Čelutkienė ◽  
...  

Vytė Maneikienė, Germanas Marinskis, Audrius Aidietis, Sigita Aidietienė, Jelena Čelutkienė, Kęstutis Ručinskas, Vytautas Sirvydis, Aleksandras Laucevičius Vilniaus universiteto Širdies ir kraujagyslių ligų klinika, Santariškių g. 2, LT-08661 VilniusEl. paštas: [email protected] Įvadas / tikslas: Širdies resinchronizavimo terapijos metodas sumažina širdies nepakankamumo simptomus, pagerina širdies sistolinę funkciją ir išgyvenamumą pacientų, sergančių toli pažengusiu širdies nepakankamumu, atspariu optimaliam medikamentiniam gydymui, ir turinčių elektrinio širdies asinchroniškumo požymį – plačius QRS kompleksus, tačiau vėlyvieji ilgo stebėjimo rezultatai dar nėra iki galo aiškūs ir plačiai tyrinėjami. Darbo tikslas – apžvelgti pagrindines šiuolaikines resinchronizacijos taikymo nuorodas, papildomų atrankos kriterijų paieškų rezultatus; pateikti Vilniaus universitetinės ligoninės Santariškių klinikų Kardiologijos ir angiologijos centro patirties apžvalgą. Ligoniai ir metodai: Analizuojami pacientų, gydytų resinchronizacine terapija nuo 2002 metų vidurio iki 2009 metų pabaigos, atvejai. Klinikinė informacija renkama iš pacientų ligos istorijų, ambulatorinio stebėjimo kortelių. Visi iki šiol gyvenantys pacientai periodiškai kviečiami nuodugniai klinikinei patikrai. Prieš ir po resinchronizacijos procedūros atliekami išplėstiniai širdies echoskopijos tyrimai įvertinant mechaninį asinchroniškumą, spiroergometrijos tyrimai, nustatomas smegenų natriurezinio peptido kiekis kraujyje. Rezultatai: Per aštuonerius metus, nuo 2002 iki 2009 metų pabaigos, implantuoti 92 resinchronizacijos prietaisai. Darbų apimtis gerokai padidėjo per pastaruosius dvejus metus. Šių pacientų, priklausančių III–IV NYHA funkcinei klasei, išgyvenamumo rodikliai yra geri (mirštamumas per 8 metus – tik 10,8 %). Daliai pacientų (4 %) biventrikuliniai stimuliatoriai tapo tiltu į sėkmingą širdies transplantaciją. Išvados: Širdies resinchronizavimo terapija saugiai ir gana veiksmingai pagerina pacientų, sergančių širdies nepakankamumu ir priklausančių III–IV NYHA funkcinei klasei, gyvenimo kokybę. Atrenkant pacientus gydyti šiuo būdu pagal šiuolaikines rekomendacijas, išlieka didelis procentas nepakankamai gerų rezultatų, nors tokios toli pažengusio širdies nepakankamumo grupės ligonių išgyvenamumas yra daug geresnis nei tikėtinas. Reikšminiai žodžiai: resinchronizacija, širdies nepakankamumas, klinikinės studijos Current clinical guidelines for cardiac resynchronization therapy: the experience of vilnius cardiology-angiology center Vytė Maneikienė, Germanas Marinskis, Audrius Aidietis, Sigita Aidietienė, Jelena Čelutkienė, Kęstutis Ručinskas, Vytautas Sirvydis, Aleksandras Laucevičius Vilnius University, Clinic of Cardiovascular Diseases, Santariškių str. 2, LT-08661 Vilnius, LithuaniaEl. paštas: [email protected] Background /objective: Cardiac resynchronisation therapy improves cardiac function and clinical outcomes for patients suffering from congestive heart failure due to systolic dysfunction associated with ventricular dyssinchrony, who are already optimized with medical therapy. The aim of the study was to present the current clinical guidelines of cardiac resynchronization therapy and the results of current clinical trials, as well as to overview the experience of the Vilnius cCardiology-aAngiology Center. Patients and Methods: We analyse patients who underwent cardiac resynchronisation therapy in 2002–2009. Their in- and outpatient histories were studied. The patients were tested before and after the procedure. eEchocardiography was performed to assess mechanical dyssinchrony, cardiopulmonary exercise testing, B-type natriuretic peptide level. Results:Between June 2002 and December 2009 92 resynchronisation devices, were implanted. Cardiac resynchronisation therapy resulted in a higher survival of patients with NYHA III–IV. For four patients, resynchronisation therapy was a bridge to successful transplantation. Conclusions: Cardiac resynchronization therapy safely improved the quality of life in patients with moderate to severe chronic heart failure (New York Heart Association class III–IV). The present criteria for patient selection have some percent age of no responders, but the survival rate in this group of patients is significantly higher than could be expected. Keywords: resynchronization, heart failure, clinical trials


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Marissa Edmiston ◽  
Ajay Vallakati ◽  
Ashish Aneja

Introduction: Late gadolinium enhancement on cardiac magnetic resonance imaging (LGE-CMR) has been shown to predict adverse cardiovascular outcomes, especially ventricular arrhythmic events. Hypothesis: A few studies, limited by small sample size, have examined the relationship between myocardial scar and cardiac resynchronization therapy (CRT) response. We performed a meta-analysis to determine whether scar identified on LGE predicts response to CRT in cardiomyopathy. Methods: We searched PubMed and Embase for clinical trials reporting CRT response based on scar determined by LGE -CMR. Primary outcome was defined as improvement in NYHA class or echocardiographic parameters (not limited to but including dP/dT, radial strain and reduction of LV end systolic volume). Random effects model was used to pool the data across the studies. Results: After screening 1876 articles, we identified 14 clinical trials that met inclusion criteria. A total of 984 patients were included in the analysis. There was no significant heterogeneity across the studies (I 2 =30%, p= 0.13). Presence of scar on LGE-CMR decreased CRT response by 39% (RR: 0.61 (95% CI 0.53 - 0.71; p<0.001). Exclusion sensitivity analysis did not change the effect size. Pooled analysis of studies reporting only ischemic cardiomyopathy revealed that any myocardial scar reduced CRT response by 38% (RR: 0.62 (0.44 - 0.86; p=0.004). Conclusions: The presence of any myocardial scar detected by LGE predicts sub-optimal response to CRT in cardiomyopathy. This shows that identification of scar using LGE- CMR can be used as an important risk stratification tool for CRT response.


2008 ◽  
Vol 17 (5) ◽  
pp. 443-452 ◽  
Author(s):  
Deborah W. Chapa ◽  
Hyeon-Joo Lee ◽  
Chi-Wen Kao ◽  
Erika Friedmann ◽  
Sue A. Thomas ◽  
...  

Use of device therapy to prevent sudden cardiac death in patients with heart failure is expanding on the basis of evidence from recent clinical trials. Three multicenter prospective clinical trials—Sudden Cardiac Death in Heart Failure (SCD-HeFT); Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION); and Cardiac Resynchronization-Heart Failure (CARE-HF)—were conducted to determine the effectiveness of devices in reducing mortality in patients with heart failure who did not have a history of ventricular arrhythmias. The 3 trials varied in the devices used, the population of patients included, and the study designs. In SCD-HeFT, implantable cardioverter defibrillators were more effective than pharmacological therapy in preventing mortality among patients with mild to moderate heart failure. In COMPANION, cardiac resynchronization therapy alone and cardiac resynchronization therapy plus an implantable cardioverter defibrillator were more effective than optimal drug treatment in reducing morbidity and all-cause mortality in patients with moderate to severe heart failure. In CARE-HF, cardiac resynchronization therapy alone was more effective than optimal drug treatment in reducing all-cause mortality in patients with moderate to severe heart failure. No direct comparison of the devices used has been done. These 3 clinical trials provide clear evidence that device therapy is beneficial for some patients with heart failure, even patients who do not have a history of ventricular arrhythmia.


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