Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation (REPACE)
Patient Selection and Long-Term Outcomes in Patients With a Pace & Ablate Strategy for Interventional Rate Control in Symptomatic Permanent Atrial Fibrillation - A Retrospective Multicenter Analysis
Atrioventricular node ablation with permanent pacing (the "pace-and-ablate" strategy) controls ventricular rate in atrial fibrillation that has not responded to drug therapy or catheter ablation. Chronic right ventricular pacing, however, can cause pacing-induced cardiomyopathy (PICM), and it is not well established which patients are at risk and should therefore receive conduction system pacing or biventricular pacing instead.
REPACE is a multicentre retrospective cohort of consecutive patients who underwent atrioventricular node ablation from January 2011 onwards at five centres in Switzerland, the United Kingdom and Poland: Liverpool Heart and Chest Hospital, Inselspital Bern, University Hospital Basel, Geneva University Hospitals and the Silesian Centre for Heart Diseases, Zabrze. More than 2,000 patients ablated up to March 2024 have been included to date; patients ablated after that date at the participating centres are being added.
The study has three aims: to validate, in an independent multicentre population, a previously published risk model for pacing-induced cardiomyopathy; to describe the procedural technique and outcomes of atrioventricular node ablation across different health systems; and to estimate the health-economic impact of the pace-and-ablate strategy.
Pacing-induced cardiomyopathy is defined as an absolute reduction in left ventricular ejection fraction of at least 10 percentage points to a value below 50%. All potential endpoints are adjudicated by a clinical events committee blinded to the classification made at the site.
調査の概要
状態
詳細な説明
Data collection. Baseline demographics, comorbidity, device and procedural data, electrocardiographic and echocardiographic measurements, follow-up events and mortality were abstracted from hospital records at each participating centre into a central electronic case report form.
Endpoint adjudication. Every potential endpoint is reviewed by two independent adjudicators blinded to the classification made at the site, with a third reviewer consulted where they disagree. Pacing-induced cardiomyopathy is assessed on every adjudicated event, independently of how that event is otherwise classified.
Analysis populations. The validation of the risk model is performed in the patients who had neither cardiac resynchronisation therapy nor conduction system pacing at baseline, because a decline in left ventricular function in an already resynchronised patient represents non-response to resynchronisation rather than pacing-induced cardiomyopathy. Patients with resynchronisation at baseline are described and contribute to the procedural and health-economic analyses. No lower limit of baseline ejection fraction is applied: since the definition requires a fall of at least 10 percentage points to a value below 50%, patients already below 50% at baseline can meet it.
Health-economic analysis. Direct costs are derived from Hospital Episode Statistics in the United Kingdom, individual procedure costs from the SwissEPnet registry for Switzerland, and diagnosis-related group and hospital costs for Switzerland and Poland, covering hospital charges, device costs and subsequent care for complications and follow-up. Cost-utility and cost-effectiveness analyses use Markov models to compare pacing strategies.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Nikola A Kozhuharov, PD Dr. med.
- 電話番号：+41 76 443 90 86
- メール：nikola.kozhuharov@insel.ch
研究場所
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Merseyside
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Liverpool、Merseyside、イギリス、L14 3PE
- 募集
- Liverpool Heart and Chest Hospital
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コンタクト：
- Dhiraj Gupta, MD, FRCP
- メール：Dhiraj.Gupta@lhch.nhs.uk
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主任研究者：
- Dhiraj Gupta, MD, FRCP
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Basel、スイス、4031
- 募集
- University Hospital Basel
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主任研究者：
- Christian Sticherling, MD
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Geneva、スイス、1205
- 募集
- Geneva University Hospitals
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主任研究者：
- Haran Burri, MD
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Canton of Bern
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Bern、Canton of Bern、スイス、3010
- 募集
- Inselspital, Universitätsspital Bern
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コンタクト：
- Nikola A Kozhuharov, PD Dr. med.
- メール：nikola.kozhuharov@insel.ch
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主任研究者：
- Nikola A Kozhuharov, PD Dr. med.
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Zabrze、ポーランド、41-800
- 募集
- Silesian Centre for Heart Diseases
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主任研究者：
- Agnieszka Babińska, MD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Consecutive adults with symptomatic atrial fibrillation refractory to drug therapy or catheter ablation who underwent atrioventricular node ablation as part of a pace-and-ablate strategy at five participating centres in Switzerland, the United Kingdom and Poland from January 2011 onwards.
Retrospective inclusion is covered by general consent to the further use of health-related data where this is on file. For deceased or uncontactable patients with no documented refusal, inclusion is covered by the exception from consent under Article 34 of the Swiss Human Research Act (Absence of informed consent), the project having been approved by the Kantonale Ethikkommission Bern. The United Kingdom site operates under IRAS 314643.
説明
Inclusion Criteria:
- Age 18 years or older at the time of atrioventricular node ablation
- Atrial fibrillation, undergoing atrioventricular node ablation with a permanent cardiac implantable electronic device already in situ or implanted as part of the pace-and-ablate strategy
- Availability of baseline echocardiographic data, including left ventricular ejection fraction
Exclusion Criteria:
* Documented refusal of the further use of health-related data
Note: cardiac resynchronisation therapy or conduction system pacing at baseline is not an eligibility exclusion. Such patients are included in the cohort and in the procedural and health-economic analyses, but are excluded from the validation of the pacing-induced cardiomyopathy risk model, in which a decline in left ventricular function would represent non-response to resynchronisation. No lower limit of baseline ejection fraction is applied.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
|---|
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Pace-and-ablate cohort
Consecutive adults with atrial fibrillation who underwent atrioventricular node ablation with a permanent cardiac implantable electronic device at the five participating centres from January 2011 onwards. Within this cohort, the patients who had neither cardiac resynchronisation therapy nor conduction system pacing at baseline form the population for the validation of the pacing-induced cardiomyopathy risk model. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of pacing-induced cardiomyopathy (PICM)
時間枠：From atrioventricular node ablation up to 10 years
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Proportion of patients who develop PICM, defined as an absolute reduction in left ventricular ejection fraction (LVEF) of at least 10 percentage points to a value below 50% on echocardiography after atrioventricular node ablation with ventricular pacing. Each potential event is adjudicated by two independent reviewers blinded to the classification made at the site, with a third reviewer consulted in case of disagreement. |
From atrioventricular node ablation up to 10 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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All-cause mortality by pacing modality
時間枠：From atrioventricular node ablation up to 5 years
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Proportion of patients who die from any cause, reported separately for right ventricular pacing, biventricular pacing and conduction system pacing. |
From atrioventricular node ablation up to 5 years
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Heart failure hospitalisation by pacing modality
時間枠：From atrioventricular node ablation up to 5 years
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Proportion of patients with at least one hospitalisation for heart failure, reported separately for right ventricular pacing, biventricular pacing and conduction system pacing. |
From atrioventricular node ablation up to 5 years
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Acute procedural success of atrioventricular node ablation
時間枠：Periprocedural (index atrioventricular node ablation)
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Proportion of procedures with complete atrioventricular block at the end of the procedure, i.e. intended loss of atrioventricular conduction with transition to ventricular pacing. |
Periprocedural (index atrioventricular node ablation)
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Use of a second ablation catheter, by type of first ablation catheter (irrigated versus non-irrigated)
時間枠：Periprocedural (index atrioventricular node ablation)
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Proportion of procedures in which a second ablation catheter was required to achieve atrioventricular block, reported separately for procedures started with an irrigated and with a non-irrigated catheter. |
Periprocedural (index atrioventricular node ablation)
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Presence of a ventricular escape rhythm after atrioventricular node ablation
時間枠：Periprocedural (index atrioventricular node ablation)
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Proportion of patients with a ventricular escape rhythm documented at the end of the atrioventricular node ablation procedure. |
Periprocedural (index atrioventricular node ablation)
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Procedure duration by use of a long sheath
時間枠：Periprocedural (index atrioventricular node ablation)
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Duration of the atrioventricular node ablation procedure in minutes, reported separately for procedures performed with and without a long sheath. |
Periprocedural (index atrioventricular node ablation)
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Cumulative direct healthcare costs per patient
時間枠：From atrioventricular node ablation up to 5 years
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Cumulative direct healthcare costs per patient in euros, covering the index procedure (hospital stay, device and consumables) and subsequent hospital care for complications and follow-up. Costs are derived from Hospital Episode Statistics (United Kingdom), the SwissEPnet registry and diagnosis-related group data (Switzerland, Poland) and converted to euros. |
From atrioventricular node ablation up to 5 years
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Incremental cost-effectiveness ratio of conduction system pacing versus right ventricular pacing
時間枠：From atrioventricular node ablation up to 5 years
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Incremental cost per quality-adjusted life-year (QALY) gained, estimated with a Markov model from the observed event rates and direct healthcare costs, overall and across strata of predicted pacing-induced cardiomyopathy risk and of procedural complexity. |
From atrioventricular node ablation up to 5 years
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Return to sinus rhythm during follow-up
時間枠：From atrioventricular node ablation up to 5 years
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Proportion of patients with documented return to sinus rhythm on electrocardiogram or device interrogation after atrioventricular node ablation. |
From atrioventricular node ablation up to 5 years
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Discrimination of the published and of an updated pacing-induced cardiomyopathy risk model (C-statistic)
時間枠：From atrioventricular node ablation up to 10 years
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C-statistic (area under the receiver operating characteristic curve) for predicting pacing-induced cardiomyopathy, reported for the previously published risk model as originally specified and for a model updated in this cohort (recalibration and re-estimation of predictor weights, with candidate additional predictors), in patients without cardiac resynchronisation therapy or conduction system pacing at baseline. |
From atrioventricular node ablation up to 10 years
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Incremental cost-effectiveness ratio of biventricular pacing versus right ventricular pacing
時間枠：From atrioventricular node ablation up to 5 years
|
Incremental cost per quality-adjusted life-year (QALY) gained, estimated with a Markov model from the observed event rates and direct healthcare costs, overall and across strata of predicted pacing-induced cardiomyopathy risk and of procedural complexity. |
From atrioventricular node ablation up to 5 years
|
協力者と研究者
協力者
捜査官
- 主任研究者：Nikola A Kozhuharov, PD Dr. med.、Insel Gruppe AG, University Hospital Bern
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2019-01151
- 2019 (米国 NIH グラント/契約)
- 4079 (その他の識別子：Insel Gruppe AG, University Hospital Bern)
- 314643 (その他の識別子：IRAS, UK Health Research Authority)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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