Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial

Merkely, Béla; Kosztin, Annamária; Róka, Attila; Gellér, László; Zima, Endre; Kovács, Attila; Boros, András; Klein, Helmut U.; Wranicz, Jerzy Krzysztof; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z.; Moss, Arthur J.; Goldenberg, Ilan; Kutyifa, Valentina

doi:10.1093/europace/euw193

Cited by 29 publications

(40 citation statements)

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“…These findings warrant confirmation in prospective randomized trials, such as the ongoing BUDAPEST-CRT Upgrade Study. 21 Until these results become available, our observations need to be considered when counseling individual patients on the need for a CRT upgrade. …”

Section: Discussionmentioning

confidence: 99%

Effects of Upgrade Versus De Novo Cardiac Resynchronization Therapy on Clinical Response and Long-Term Survival

Vámos

Erath

Bári

et al. 2017

Circ: Arrhythmia and Electrophysiology

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Background— Benefits of cardiac resynchronization therapy (CRT) on morbidity and mortality in selected patients are well known. Although the number of upgrade procedures from single- or dual-chamber devices to CRT is increasing, there are only sparse data on the outcomes of upgrade procedures compared with de novo CRT. This study aimed to evaluate clinical response and survival in patients receiving de novo versus upgrade CRT defibrillator therapy. Methods and Results— Prospectively collected outcome data were compared in patients undergoing de novo or upgrade CRT defibrillator implantation at 3 implant centers in Germany and Hungary. Clinical response was defined as an improvement by at least one New York Heart Association (NYHA) functional class. CRT implantation was performed in 552 consecutive patients of whom 375 underwent a de novo and 177 an upgrade procedure. Upgrade patients were more often implanted for secondary prevention, suffered more often from atrial fibrillation, chronic kidney disease, diabetes mellitus, and dyslipidemia, and had more often a non-LBBB (left bundle branch block) wide QRS complex, and lower left ventricular ejection fraction. Upgrade procedures were associated with a lower response rate compared to the de novo group (57% versus 69%, P univariate=0.008, P multivariate=0.021). During the follow-up of 37±28 months, survival was worse after upgrade compared with de novo CRT defibrillator implantations (hazard ratio, 1.65; 95% confidence interval, 1.22–2.24; P =0.001) even after careful adjustment for important baseline variables (adjusted hazard ratio, 1.68; 95% confidence interval, 1.20–2.34; P =0.002) and after propensity-score matching (propensity-adjusted hazard ratio, 1.79; 95% confidence interval, 1.08–2.95; P =0.023). Conclusions— Both clinical response and long-term survival were less favorable in patients undergoing CRT upgrade compared to de novo implantations.

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Section: Discussionmentioning

confidence: 99%

Effects of Upgrade Versus De Novo Cardiac Resynchronization Therapy on Clinical Response and Long-Term Survival

Vámos

Erath

Bári

et al. 2017

Circ: Arrhythmia and Electrophysiology

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“…Paced patients have a different electrical substrate compared with patients with native LBBB . The deleterious effects of chronic RVP in patients with systolic heart failure may be more profound than a native LBBB . As such, mitigation of LV dysfunction because of chronic RV pacing may not confer indefinite benefit.…”

Section: Discussionmentioning

confidence: 99%

“…Such conjecture will need further studies to clarify. The currently enrolling Budapest‐CRT trial may help to clarify these results . Our study does suggest that more intense scrutiny be paid to patients upgraded to CRT‐D devices starting 2.5 years after implant.…”

Section: Discussionmentioning

confidence: 99%

Long term outcomes in patients with chronic right ventricular pacing upgraded to cardiac resynchronization therapy

Rickard

Gorodeski

Patel

et al. 2019

Cardiovasc electrophysiol

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Introduction In patients with chronic systolic heart failure and frequent right ventricular pacing (RVP), upgrade to cardiac resynchronization therapy (CRT) has become common practice despite a lack of randomized clinical trials. We aimed to evaluate long term outcomes in patients upgraded to CRT from chronic RVP compared with de novo CRT implants. Methods and results We reviewed medical charts on consecutive patients with a left ventricular ejection fraction (LVEF) ≤ 35% and a QRSd ≥ 120 ms undergoing CRT. Survival free of left ventricular assist device (LVAD) and a heart transplant was compared amongst patients on the basis of pre‐CRT QRS morphology. Improvement in LVEF was also compared across groups. A total of 1260 patients met inclusion criteria of whom 233 were upgraded from chronic RVP. Over a mean follow up 6.5 ± 4.0 years there were 821 endpoints (27 LVAD, 30 heart transplants, and 764 deaths). In a multivariate Cox regression model, upgraded patients had worse outcomes (HR 1.3(1.1‐1.7) P = .007) compared with those with native LBBB and similar outcomes to patients with non‐LBBB(HR 0.96(0.76‐1.21) P = .7). The survival curve for chronic RVP parallels native LBBB for approximately 2.5 years before dropping sharply. Patients with chronic RVP derive similar improvements in LVEF compared with those with LBBB and superior improvements compared with those with non‐LBBB. Conclusions Despite achieving similar levels of LVEF improvement, patients with systolic heart failure with chronic RVP undergoing upgrade to CRT have inferior long term outcomes compared with patients with native LBBB. Long term outcomes with CRT in patients with chronic RVP, RBBB, and IVCD are similar.

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“…a funkcionális státuszban vannak. Kontrollcsoportként a folytatott VVI/DDD-kezelés szerepel (18,19).…”

Section: úJ Lehetőségek a Szívelégtelenség Eszközös Kezelésében (Barounclassified

Implantálható aritmia detekciós és terápiás eszközök műtétei Magyarországon 2014–2016 között

Földesi¹

2017

Cardiologia Hungarica

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Összefoglalómban az eszközös kezelést igénylő brady-, illetve tachycardia miatt végzett pacemaker-és cardioverter-defibrillátor (ICD) implantációk utolsó 3 év adatait elemezve mutatnám be ezen aritmológiai részszakma jelenlegi helyzetét. A 2014-2016-os időszak adatainak elemzése alapján megállapíthatjuk, hogy a konvencionális, antibradycardia pacemakerek implantációs számai lényegében megfelelnek a korábbi évek adatainak. Az ICD-k és a szívelégtelen-ség kezelésben rendkívül fontos kardiális reszinkronizációs terápia (CRT) tekintetében, bár lassulóan, de folytatódott a korábbi években megfigyelhető növekedés. Az eszméletvesztések diagnosztizálásához segítséget nyújtó, 2013-ban bevezetett beültethető eseménymonitor-implantációk pedig a mindennapi klinikai gyakorlat részei lettek. Az elmúlt 3 évben új implantálható eszközökkel is tudtuk a betegeinken segíteni, mint a subcutan ICD, a baroreflex stimulációs eszközök, kardiális kontraktilitást moduláló speciális pacemakerek. A fentieken túl a vezeték nélküli "leadless" pacemakerek implantációja is megkezdődött. A készülékbeültetéseken túl nem szabad megfeledkeznünk az infekció vagy egyéb ok miatt (pl. elektródatörés) szükséges pacemaker/ICD-rendszerek, illetve elektródák eltávolítása céljából vég-zett beavatkozásokról sem. ThisrecentreviewtargetedtoanalysetheutilizationofimplantedpacemakersanddefibrillatorsinHungary betweentheyearsof2014-2016The implantation numbers of conventional pacemakers did not really change compared to previous years; however the procedure numbers of both implantable cardioverter defibrillator and cardiac resynchronization therapy forward increased. Beside the pacemaker and ICD implantations novel terapeutic devices entered into the practice such as the subcutan ICDs, the Baroreflex Activation Terapy devices, the Cardiac Contractility Modulation pacemakers and the leadless pacemakers. In this period not only the number of implanted devices increased but in the explantation centeres the number of lead and total pacemaker/ICD system explantations are increased too.Kulcsszavak: pacemaker, implantálható cardioverter defibrillátor, kardiális reszinkronizációs kezelés, implantációs adatok, explantáció pacemaker pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy, implantation data, lead and device explantation Keywords:A tartós bradycardiák kezelésének egyetlen hosszú tá-von is biztonságos kezelési módszere a végleges pacemaker-beültetés, amely már több mint 50 éve alkalmazott gyógyítási eszköz a klinikai gyakorlatban. Az elmúlt évti-zedek drámai fejlődése részeként egyre kisebb, de komplexebb eszközök és programozható algoritmusok kerültek be a mindennapi klinikai gyakorlatba, amelyek segítségé-vel nemcsak antibradycardia-ingerlést, hanem a betegek igényeihez állítható fiziológiás ingerlést lehet elérni (1-6).A klasszikus pacemakereken felül évtizedek óta rendelkezünk az életveszélyes kamrai tachycardiák megszünteté-sére képes implantálható defibrillátorokkal (ICD) is (7-9).

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Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial

Cited by 29 publications

References 23 publications

Effects of Upgrade Versus De Novo Cardiac Resynchronization Therapy on Clinical Response and Long-Term Survival

Effects of Upgrade Versus De Novo Cardiac Resynchronization Therapy on Clinical Response and Long-Term Survival

Long term outcomes in patients with chronic right ventricular pacing upgraded to cardiac resynchronization therapy

Implantálható aritmia detekciós és terápiás eszközök műtétei Magyarországon 2014–2016 között

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