Pub Date : 2024-09-12DOI: 10.1016/j.jcin.2024.08.008
Kirtipal Bhatia, Soumya Gupta, Kristen Carter, Marija Petrovic, Samantha V Shetty, Devika Aggarwal, Abel Casso Dominguez, Stamatios Lerakis, Edgar Argulian
{"title":"Single-Leaflet Device Attachment After Mitral Transcatheter Edge-to-Edge Repair: Systematic Review and Meta-analysis.","authors":"Kirtipal Bhatia, Soumya Gupta, Kristen Carter, Marija Petrovic, Samantha V Shetty, Devika Aggarwal, Abel Casso Dominguez, Stamatios Lerakis, Edgar Argulian","doi":"10.1016/j.jcin.2024.08.008","DOIUrl":"https://doi.org/10.1016/j.jcin.2024.08.008","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.1016/j.jcin.2024.06.028
Santiago Garcia MD, Tsuyoshi Kaneko MD, Michael Reardon MD, Sachin Goel MD, David J. Cohen MD, MSc, João L. Cavalcante MD, Michael L. Chuang MD, Rebecca T. Hahn MD, Azeem Latib MD, Ron Waksman MD, David G. Rizik MD, Peter Fail MD, Sameer A. Gafoor MD, Dean J. Kereiakes MD
{"title":"Treatment of Aortic Regurgitation With a Novel Device","authors":"Santiago Garcia MD, Tsuyoshi Kaneko MD, Michael Reardon MD, Sachin Goel MD, David J. Cohen MD, MSc, João L. Cavalcante MD, Michael L. Chuang MD, Rebecca T. Hahn MD, Azeem Latib MD, Ron Waksman MD, David G. Rizik MD, Peter Fail MD, Sameer A. Gafoor MD, Dean J. Kereiakes MD","doi":"10.1016/j.jcin.2024.06.028","DOIUrl":"10.1016/j.jcin.2024.06.028","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.1016/j.jcin.2024.06.023
So-Min Lim MD, Jung-Min Ahn MD, Do-Yoon Kang MD, Ha Hye Jo MD, Joong Min Lee MD, Young-Sun Park MD, Duk-Woo Park MD, Seung-Jung Park MD, PhD
{"title":"Volume-Adjusted Annular Sizing of Balloon-Expandable Transcatheter Heart Valves for Severe Bicuspid Aortic Valve Stenosis","authors":"So-Min Lim MD, Jung-Min Ahn MD, Do-Yoon Kang MD, Ha Hye Jo MD, Joong Min Lee MD, Young-Sun Park MD, Duk-Woo Park MD, Seung-Jung Park MD, PhD","doi":"10.1016/j.jcin.2024.06.023","DOIUrl":"10.1016/j.jcin.2024.06.023","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142163342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.1016/j.jcin.2024.06.001
Marvin H. Eng MD , Houman Khalili MD , John Vavalle MD , Karim M. Al-Azizi MD , Tom Waggoner DO , Jefferey A. Southard MD , Kenith Fang MD , Rebecca T. Hahn MD , James Lee MD , Dee Dee Wang MD , Mackram F. Eleid MD , William W. O’Neill MD , Amr E. Abbas MD
Background
A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry–based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV).
Objectives
The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes.
Methods
Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality.
Results
In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF).
Conclusions
Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.
背景:之前胸外科医师协会/美国心脏病学会 TVT(经导管瓣膜治疗)注册中心的一项分析报告显示,小型(20 毫米)与大型(≥23 毫米)球囊扩张瓣膜(BEV)的 1 年临床疗效相似:本研究旨在描述小瓣膜与大瓣膜的 3 年中期临床疗效,以及出院超声心动图平均梯度(MG)和假体与患者不匹配(PPM)的不同定义与临床疗效之间的关系:利用与美国医疗保险和医疗补助服务中心(Centers for Medicare and Medicaid Services)链接的 TVT 注册表,对接受 20 毫米与≥23 毫米 BEV 的患者进行倾向匹配分析。结果显示,MG与3年死亡率之间的关系是通过Spline曲线和Kaplan-Meier图以及调整后的HRs确定的:共分析了 316,091 例患者;经过倾向匹配后,每组有 8,100 对患者进行了比较。与≥23毫米的BEV相比,20毫米的BEV与较高的MG有关(16.2 ± 7.2毫米汞柱 vs 11.8 ± 5.7毫米汞柱;P < 0.0001)。3 年后,20 mm 和 ≥23 mm BEV 之间的死亡率没有差异(分别为 31.5% vs 32.5%;HR:0.97;95% CI:0.90-1.05)。与 10 至 30 mm Hg 的 MG 相比,MG 更低:小人工瓣膜(20 毫米)患者与大人工瓣膜(≥23 毫米)患者的 3 年生存率相同。测量到的严重 PPM 和低 MG (
{"title":"3-Year Outcomes of Balloon-Expandable Valves","authors":"Marvin H. Eng MD , Houman Khalili MD , John Vavalle MD , Karim M. Al-Azizi MD , Tom Waggoner DO , Jefferey A. Southard MD , Kenith Fang MD , Rebecca T. Hahn MD , James Lee MD , Dee Dee Wang MD , Mackram F. Eleid MD , William W. O’Neill MD , Amr E. Abbas MD","doi":"10.1016/j.jcin.2024.06.001","DOIUrl":"10.1016/j.jcin.2024.06.001","url":null,"abstract":"<div><h3>Background</h3><p>A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry–based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV).</p></div><div><h3>Objectives</h3><p>The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes.</p></div><div><h3>Methods</h3><p>Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality.</p></div><div><h3>Results</h3><p>In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; <em>P</em> < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; <em>P</em> < 0.0001) and (33.5% vs 31.1% vs 30%; <em>P</em> < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF).</p></div><div><h3>Conclusions</h3><p>Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.</p></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1936879824008574/pdfft?md5=208ccfa7d91dfbfede1b2c638328c8f0&pid=1-s2.0-S1936879824008574-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.1016/j.jcin.2024.07.012
Jonathan X. Fang MBBS, Pedro A. Villablanca MD, Brian P. O’Neill MD, Dee Dee Wang MD, Pedro Engel Gonzalez MD, Sammi Dali MD, Gennaro Giustino MD, James C. Lee MD, William W. O’Neill MD, Tiberio M. Frisoli MD
{"title":"Mechanical Circulatory Support–Assisted Percutaneous Rescue of Ventricularly Embolized Transcatheter Heart Valve","authors":"Jonathan X. Fang MBBS, Pedro A. Villablanca MD, Brian P. O’Neill MD, Dee Dee Wang MD, Pedro Engel Gonzalez MD, Sammi Dali MD, Gennaro Giustino MD, James C. Lee MD, William W. O’Neill MD, Tiberio M. Frisoli MD","doi":"10.1016/j.jcin.2024.07.012","DOIUrl":"10.1016/j.jcin.2024.07.012","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1936879824009762/pdfft?md5=2d3ba976e503ba617c4b1c8eed921490&pid=1-s2.0-S1936879824009762-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.1016/j.jcin.2024.06.020
Jaouad Azzahhafi MD , Wout W.A. van den Broek MD , Dean R.P.P. Chan Pin Yin MD , Niels M.R. van der Sangen MD , Shabiga Sivanesan MD , Salahodin Bofarid MD , Joyce Peper MSc, PhD , Daniel M.F. Claassens MD, PhD , Paul W.A. Janssen MD, PhD , Ankie M. Harmsze PharmD, PhD , Ronald J. Walhout MD, PhD , Melvyn Tjon Joe Gin MD , Deborah M. Nicastia MD , Jorina Langerveld MD, PhD , Georgios J. Vlachojannis MD, PhD , Rutger J. van Bommel MD, PhD , Yolande Appelman MD, PhD , Ron H.N. van Schaik MSc, PhD , José P.S. Henriques MD, PhD , Wouter J. Kikkert MD, PhD , Jurriën M. ten Berg MD, PhD
Background
CYP2C19 genotype–guided de-escalation from ticagrelor or prasugrel to clopidogrel may optimize the balance between ischemic and bleeding risk in patients with acute coronary syndrome (ACS).
Objectives
This study sought to compare bleeding and ischemic event rates in genotyped patients vs standard care.
Methods
Since 2015, ACS patients in the multicenter FORCE-ACS (Future Optimal Research and Care Evaluation in Patients with Acute Coronary Syndrome) registry received standard dual antiplatelet therapy (DAPT). Since 2021, genotype-guided P2Y12 inhibitor de-escalation was recommended at a single center, switching noncarriers of the loss-of-function allele CYP2C19∗3 or CYP2C19∗2 from ticagrelor or prasugrel to clopidogrel, whereas loss-of-function carriers remained on ticagrelor or prasugrel. The primary ischemic endpoint, a composite of cardiovascular mortality, myocardial infarction, or stroke, and the primary bleeding endpoint, Bleeding Academic Research Consortium 2, 3, or 5 bleeding, were compared between a genotyped cohort and a cohort treated with standard DAPT after 1 year.
Results
Among 5,321 enrolled ACS patients, 406 underwent genotyping compared with 4,915 nongenotyped ACS patients on standard DAPT. In the genotyped cohort, 65.3% (n = 265) were noncarriers, 88.7% (n = 235) of whom were switched to clopidogrel. The primary ischemic endpoint occurred in 5.2% (n = 21) of patients in the genotyped cohort compared to 6.9% (n = 337) in the standard care cohort (adjusted HR: 0.82; 95% CI: 0.53-1.28). The primary bleeding rate was significantly lower in the genotyped cohort compared to the standard care cohort (4.7% vs 9.8%; adjusted HR: 0.47; 95% CI: 0.30-0.76).
Conclusions
The implementation of a CYP2C19 genotype–guided P2Y12 inhibitor de-escalation strategy in a real-world ACS population resulted in lower bleeding rates without an increase in ischemic events compared to a standard DAPT regimen.
{"title":"Real-World Implementation of a Genotype-Guided P2Y12 Inhibitor De-Escalation Strategy in Acute Coronary Syndrome Patients","authors":"Jaouad Azzahhafi MD , Wout W.A. van den Broek MD , Dean R.P.P. Chan Pin Yin MD , Niels M.R. van der Sangen MD , Shabiga Sivanesan MD , Salahodin Bofarid MD , Joyce Peper MSc, PhD , Daniel M.F. Claassens MD, PhD , Paul W.A. Janssen MD, PhD , Ankie M. Harmsze PharmD, PhD , Ronald J. Walhout MD, PhD , Melvyn Tjon Joe Gin MD , Deborah M. Nicastia MD , Jorina Langerveld MD, PhD , Georgios J. Vlachojannis MD, PhD , Rutger J. van Bommel MD, PhD , Yolande Appelman MD, PhD , Ron H.N. van Schaik MSc, PhD , José P.S. Henriques MD, PhD , Wouter J. Kikkert MD, PhD , Jurriën M. ten Berg MD, PhD","doi":"10.1016/j.jcin.2024.06.020","DOIUrl":"10.1016/j.jcin.2024.06.020","url":null,"abstract":"<div><h3>Background</h3><p><em>CYP2C19</em> genotype–guided de-escalation from ticagrelor or prasugrel to clopidogrel may optimize the balance between ischemic and bleeding risk in patients with acute coronary syndrome (ACS).</p></div><div><h3>Objectives</h3><p>This study sought to compare bleeding and ischemic event rates in genotyped patients vs standard care.</p></div><div><h3>Methods</h3><p>Since 2015, ACS patients in the multicenter FORCE-ACS (Future Optimal Research and Care Evaluation in Patients with Acute Coronary Syndrome) registry received standard dual antiplatelet therapy (DAPT). Since 2021, genotype-guided P2Y<sub>12</sub> inhibitor de-escalation was recommended at a single center, switching noncarriers of the loss-of-function allele <em>CYP2C19∗3</em> or <em>CYP2C19∗2</em> from ticagrelor or prasugrel to clopidogrel, whereas loss-of-function carriers remained on ticagrelor or prasugrel. The primary ischemic endpoint, a composite of cardiovascular mortality, myocardial infarction, or stroke, and the primary bleeding endpoint, Bleeding Academic Research Consortium 2, 3, or 5 bleeding, were compared between a genotyped cohort and a cohort treated with standard DAPT after 1 year.</p></div><div><h3>Results</h3><p>Among 5,321 enrolled ACS patients, 406 underwent genotyping compared with 4,915 nongenotyped ACS patients on standard DAPT. In the genotyped cohort, 65.3% (n = 265) were noncarriers, 88.7% (n = 235) of whom were switched to clopidogrel. The primary ischemic endpoint occurred in 5.2% (n = 21) of patients in the genotyped cohort compared to 6.9% (n = 337) in the standard care cohort (adjusted HR: 0.82; 95% CI: 0.53-1.28). The primary bleeding rate was significantly lower in the genotyped cohort compared to the standard care cohort (4.7% vs 9.8%; adjusted HR: 0.47; 95% CI: 0.30-0.76).</p></div><div><h3>Conclusions</h3><p>The implementation of a <em>CYP2C19</em> genotype–guided P2Y<sub>12</sub> inhibitor de-escalation strategy in a real-world ACS population resulted in lower bleeding rates without an increase in ischemic events compared to a standard DAPT regimen.</p></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1936879824009130/pdfft?md5=bdbcd0c647f8d12cb0ad346c91c990df&pid=1-s2.0-S1936879824009130-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142107528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.1016/j.jcin.2024.06.022
Kseniya Halavina MD , Matthias Koschutnik MD , Carolina Donà MD , Maximilian Autherith MD , Fabian Petric MD , Anna Röckel , Georg Spinka MD , Daryush Danesh MD , Jürgen Puchinger MD , Martin Wiesholzer MD , Katharina Mascherbauer MD , Gregor Heitzinger MD, PhD , Varius Dannenberg MD , Sophia Koschatko MD , Charlotte Jantsch MD , Max-Paul Winter MD, PhD , Georg Goliasch MD, PhD , Andreas A. Kammerlander MD, PhD , Philipp E. Bartko MD, PhD , Christian Hengstenberg MD , Christian Nitsche MD, PhD
Background
Fluid overload (FO) subjects patients with severe aortic stenosis (AS) to increased risk for heart failure and death after valve replacement and can be objectively quantified using bioimpedance spectroscopy (BIS).
Objectives
The authors hypothesized that in AS patients with concomitant FO, BIS-guided decongestion could improve prognosis and quality of life following transcatheter aortic valve replacement (TAVR).
Methods
This randomized, controlled trial enrolled 232 patients with severe AS scheduled for TAVR. FO was defined using a portable whole-body BIS device according to previously established cutoffs (≥1.0 L and/or ≥7%). Patients with FO (n = 111) were randomly assigned 1:1 to receive BIS-guided decongestion (n = 55) or decongestion by clinical judgment alone (n = 56) following TAVR. Patients without FO (n = 121) served as a control cohort. The primary endpoint was the composite of hospitalization for heart failure and/or all-cause death at 12 months. The secondary endpoint was the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire.
Results
The occurrence of the primary endpoint at 12 months was significantly lower in the BIS-guided vs the non–BIS-guided decongestion group (7/55 [12.7%, all deaths] vs 18/56 [32.1%, 9 hospitalizations for heart failure and 9 deaths]; HR: 0.36; 95% CI: 0.15-0.87; absolute risk reduction = −19.4%). Outcomes in the BIS-guided decongestion group were identical to the euvolemic control group (log-rank test, P = 0.7). BIS-guided decongestion was also associated with a higher increase in the Kansas City Cardiomyopathy Questionnaire score from baseline compared to non–BIS-guided decongestion (P = 0.001).
Conclusions
In patients with severe AS and concomitant FO, quantitatively guided decongestive treatment and associated intensified management post-TAVR was associated with improved outcomes and quality of life compared to decongestion by clinical judgment alone. (Management of Fluid Overload in Patients Scheduled for Transcatheter Aortic Valve Replacement [EASE-TAVR]; NCT04556123)
背景流体超负荷(FO)使严重主动脉瓣狭窄(AS)患者在瓣膜置换术后发生心力衰竭和死亡的风险增加,可使用生物阻抗光谱(BIS)进行客观量化。方法这项随机对照试验纳入了 232 例计划进行 TAVR 的严重 AS 患者。根据之前确定的临界值(≥1.0 L 和/或≥7%),使用便携式全身 BIS 设备对 FO 进行定义。FO患者(n = 111)按1:1的比例随机分配到TAVR后接受BIS引导下的减充血(n = 55)或仅靠临床判断的减充血(n = 56)。无 FO 的患者(n = 121)作为对照组。主要终点是12个月时因心衰住院和/或全因死亡的复合终点。结果BIS引导组与非BIS引导下解除充血组相比,12个月时主要终点的发生率显著降低(7/55 [12.7%,全部死亡] vs 18/56 [32.1%,9例心衰住院和9例死亡];HR:0.36;95% CI:0.15-0.87;绝对风险降低=-19.4%)。BIS引导下解除充血组的结果与无充血对照组相同(对数秩检验,P = 0.7)。结论 在重度 AS 并伴有 FO 的患者中,与仅通过临床判断进行减充血相比,TAVR 术后定量指导减充血治疗和相关强化管理可改善预后和生活质量。(计划接受经导管主动脉瓣置换术患者的体液超负荷管理[EASE-TAVR];NCT04556123)
{"title":"Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR)","authors":"Kseniya Halavina MD , Matthias Koschutnik MD , Carolina Donà MD , Maximilian Autherith MD , Fabian Petric MD , Anna Röckel , Georg Spinka MD , Daryush Danesh MD , Jürgen Puchinger MD , Martin Wiesholzer MD , Katharina Mascherbauer MD , Gregor Heitzinger MD, PhD , Varius Dannenberg MD , Sophia Koschatko MD , Charlotte Jantsch MD , Max-Paul Winter MD, PhD , Georg Goliasch MD, PhD , Andreas A. Kammerlander MD, PhD , Philipp E. Bartko MD, PhD , Christian Hengstenberg MD , Christian Nitsche MD, PhD","doi":"10.1016/j.jcin.2024.06.022","DOIUrl":"10.1016/j.jcin.2024.06.022","url":null,"abstract":"<div><h3>Background</h3><p>Fluid overload (FO) subjects patients with severe aortic stenosis (AS) to increased risk for heart failure and death after valve replacement and can be objectively quantified using bioimpedance spectroscopy (BIS).</p></div><div><h3>Objectives</h3><p>The authors hypothesized that in AS patients with concomitant FO, BIS-guided decongestion could improve prognosis and quality of life following transcatheter aortic valve replacement (TAVR).</p></div><div><h3>Methods</h3><p>This randomized, controlled trial enrolled 232 patients with severe AS scheduled for TAVR. FO was defined using a portable whole-body BIS device according to previously established cutoffs (≥1.0 L and/or ≥7%). Patients with FO (n = 111) were randomly assigned 1:1 to receive BIS-guided decongestion (n = 55) or decongestion by clinical judgment alone (n = 56) following TAVR. Patients without FO (n = 121) served as a control cohort. The primary endpoint was the composite of hospitalization for heart failure and/or all-cause death at 12 months. The secondary endpoint was the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire.</p></div><div><h3>Results</h3><p>The occurrence of the primary endpoint at 12 months was significantly lower in the BIS-guided vs the non–BIS-guided decongestion group (7/55 [12.7%, all deaths] vs 18/56 [32.1%, 9 hospitalizations for heart failure and 9 deaths]; HR: 0.36; 95% CI: 0.15-0.87; absolute risk reduction = −19.4%). Outcomes in the BIS-guided decongestion group were identical to the euvolemic control group (log-rank test, <em>P =</em> 0.7). BIS-guided decongestion was also associated with a higher increase in the Kansas City Cardiomyopathy Questionnaire score from baseline compared to non–BIS-guided decongestion (<em>P =</em> 0.001).</p></div><div><h3>Conclusions</h3><p>In patients with severe AS and concomitant FO, quantitatively guided decongestive treatment and associated intensified management post-TAVR was associated with improved outcomes and quality of life compared to decongestion by clinical judgment alone. (Management of Fluid Overload in Patients Scheduled for Transcatheter Aortic Valve Replacement [EASE-TAVR]; <span><span>NCT04556123</span><svg><path></path></svg></span>)</p></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1936879824009154/pdfft?md5=268eb1fc933d2f59c283ea12055e4927&pid=1-s2.0-S1936879824009154-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142163254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}