Pub Date : 2024-12-01DOI: 10.1016/j.jchf.2024.06.007
Abigail R. Benkert MD , Jeffrey E. Keenan MD , Jacob N. Schroder MD , Adam D. DeVore MD, MHS , Chetan B. Patel MD , Carmelo A. Milano MD , Oliver K. Jawitz MD, MHS
Background
Heart transplantation following donation after circulatory death (DCD HT) has short-term survival outcomes comparable to donation after brain death and has led to a significant increase in transplantation volume. The U.S. experience with the normothermic regional perfusion (NRP) DCD HT procurement method has not been evaluated.
Objectives
The aim of this study was to examine short-term outcomes associated with NRP vs direct procurement and perfusion (DPP) methods used during DCD HT in the United States.
Methods
The UNOS (United Network for Organ Sharing) registry was queried for all adult (age ≥18 years) heart recipients and corresponding donors of controlled DCD HT from January 2019-December 2023. Transplantations were stratified by NRP or DPP reperfusion methods. The primary outcome was overall survival.
Results
A total of 918 heart donors and recipients met inclusion criteria, including 622 (68%) DPP and 296 (32%) NRP transplantations. Unadjusted Kaplan-Meier survival analysis demonstrated improved short-term survival associated with NRP (log-rank P = 0.005). After adjustment, DCD HT with NRP was independently associated with improved survival (HR: 0.39 [95% CI: 0.22-0.70]; P = 0.002). A propensity-matched analysis similarly demonstrated a cumulative survival benefit to NRP (log-rank P = 0.006).
Conclusions
In this largest national series of DCD HT procurement perfusion strategies, NRP is associated with improved short-term survival as compared with DPP. This study evaluates the U.S. early experience with DCD HT, and longer-term follow-up data are needed to further assess the impact of DPP and NRP methods on post-heart transplantation outcomes.
{"title":"Early U.S. Heart Transplant Experience With Normothermic Regional Perfusion Following Donation After Circulatory Death","authors":"Abigail R. Benkert MD , Jeffrey E. Keenan MD , Jacob N. Schroder MD , Adam D. DeVore MD, MHS , Chetan B. Patel MD , Carmelo A. Milano MD , Oliver K. Jawitz MD, MHS","doi":"10.1016/j.jchf.2024.06.007","DOIUrl":"10.1016/j.jchf.2024.06.007","url":null,"abstract":"<div><h3>Background</h3><div>Heart transplantation following donation after circulatory death (DCD HT) has short-term survival outcomes comparable to donation after brain death and has led to a significant increase in transplantation volume. The U.S. experience with the normothermic regional perfusion (NRP) DCD HT procurement method has not been evaluated.</div></div><div><h3>Objectives</h3><div>The aim of this study was to examine short-term outcomes associated with NRP vs direct procurement and perfusion (DPP) methods used during DCD HT in the United States.</div></div><div><h3>Methods</h3><div>The UNOS (United Network for Organ Sharing) registry was queried for all adult (age ≥18 years) heart recipients and corresponding donors of controlled DCD HT from January 2019-December 2023. Transplantations were stratified by NRP or DPP reperfusion methods. The primary outcome was overall survival.</div></div><div><h3>Results</h3><div>A total of 918 heart donors and recipients met inclusion criteria, including 622 (68%) DPP and 296 (32%) NRP transplantations. Unadjusted Kaplan-Meier survival analysis demonstrated improved short-term survival associated with NRP (log-rank <em>P =</em> 0.005). After adjustment, DCD HT with NRP was independently associated with improved survival (HR: 0.39 [95% CI: 0.22-0.70]; <em>P =</em> 0.002). A propensity-matched analysis similarly demonstrated a cumulative survival benefit to NRP (log-rank <em>P =</em> 0.006).</div></div><div><h3>Conclusions</h3><div>In this largest national series of DCD HT procurement perfusion strategies, NRP is associated with improved short-term survival as compared with DPP. This study evaluates the U.S. early experience with DCD HT, and longer-term follow-up data are needed to further assess the impact of DPP and NRP methods on post-heart transplantation outcomes.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2073-2083"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874823","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 : 2024-12-01DOI: 10.1016/j.jchf.2024.07.022
John P. Boehmer MD , Sebastian Cremer MD , Wael S. Abo-Auda MD , Donny R. Stokes MD , Azam Hadi MD , Patrick J. McCann MD , Ashley E. Burch PhD , Diana Bonderman MD
Background
There is an unmet need for early detection of heart failure decompensation, allowing patients to be managed remotely and avoid hospitalization.
Objectives
The purpose of this study was to compare a strategy utilizing data from a wearable HF sensor for management following a HF hospitalization to usual care.
Methods
Eligible subjects were discharged from the hospital within the previous 10 days and had a HF event in the previous 6 months. The concurrent control study was divided into 2 arms; a control arm, BMAD-HF and an open-label intervention arm, BMAD-TX. The HFMS (Heart Failure Monitoring System) was worn by subjects for up to 90 days. Device data was blinded to investigators and subjects in the BMAD-HF control arm but provided proactively in the BMAD-TX intervention arm. The impact of HF management with the HFMS was evaluated by Kaplan-Meier analysis of time to first HF hospitalization.
Results
A total of 522 subjects were enrolled in the study at 93 sites. A total of 245 subjects in BMAD-HF and 249 in BMAD-TX were eligible for intention-to-treat analysis. There were 276 hospitalizations in 189 subjects at 90 days, of which 108 events were determined to be heart failure related in 82 subjects. The subjects in the arm managed using HFMS data to direct HF therapy had a 38% lower HF hospitalization rate during the 90 days following a HF hospitalization compared to subjects in the control arm (HR: 0.62; P = 0.03).
Conclusions
In patients with a recent HF hospitalization, a strategy of using HFMS data for HF management is associated with a 38% relative risk reduction in 90-day HF rehospitalization. (Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-TX]; NCT04096040; Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-HF]; NCT03476187)
{"title":"Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization","authors":"John P. Boehmer MD , Sebastian Cremer MD , Wael S. Abo-Auda MD , Donny R. Stokes MD , Azam Hadi MD , Patrick J. McCann MD , Ashley E. Burch PhD , Diana Bonderman MD","doi":"10.1016/j.jchf.2024.07.022","DOIUrl":"10.1016/j.jchf.2024.07.022","url":null,"abstract":"<div><h3>Background</h3><div>There is an unmet need for early detection of heart failure decompensation, allowing patients to be managed remotely and avoid hospitalization.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to compare a strategy utilizing data from a wearable HF sensor for management following a HF hospitalization to usual care.</div></div><div><h3>Methods</h3><div>Eligible subjects were discharged from the hospital within the previous 10 days and had a HF event in the previous 6 months. The concurrent control study was divided into 2 arms; a control arm, BMAD-HF and an open-label intervention arm, BMAD-TX. The HFMS (Heart Failure Monitoring System) was worn by subjects for up to 90 days. Device data was blinded to investigators and subjects in the BMAD-HF control arm but provided proactively in the BMAD-TX intervention arm. The impact of HF management with the HFMS was evaluated by Kaplan-Meier analysis of time to first HF hospitalization.</div></div><div><h3>Results</h3><div>A total of 522 subjects were enrolled in the study at 93 sites. A total of 245 subjects in BMAD-HF and 249 in BMAD-TX were eligible for intention-to-treat analysis. There were 276 hospitalizations in 189 subjects at 90 days, of which 108 events were determined to be heart failure related in 82 subjects. The subjects in the arm managed using HFMS data to direct HF therapy had a 38% lower HF hospitalization rate during the 90 days following a HF hospitalization compared to subjects in the control arm (HR: 0.62; <em>P =</em> 0.03).</div></div><div><h3>Conclusions</h3><div>In patients with a recent HF hospitalization, a strategy of using HFMS data for HF management is associated with a 38% relative risk reduction in 90-day HF rehospitalization. (Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-TX]; <span><span>NCT04096040</span><svg><path></path></svg></span>; Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-HF]; <span><span>NCT03476187</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2011-2022"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465734","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 : 2024-12-01DOI: 10.1016/j.jchf.2024.08.003
Andrew J.S. Coats DM, DSc , Stefan D. Anker MD, PhD , Lars H. Lund MD, PhD , Gerasimos Filippatos MD , Patrick Rossignol MD, PhD , Bertram Pitt MD , Matthew R. Weir MD , Mikhail N. Kosiborod MD , Marco Metra MD , Michael Böhm MD , Justin A. Ezekowitz MBBCh, MSc , Antoni Bayes-Genis MD, PhD , Robert J. Mentz MD , Piotr Ponikowski MD, PhD , Michele Senni MD, PhD , John G.F. Cleland MD, PhD , Assen Goudev MD, PhD , Irakli Khintibidze MD, PhD , Joann Lindenfeld MD , Bela Merkely MD, PhD , Javed Butler MD, MPH, MBA
Background
For heart failure with reduced ejection fraction (HFrEF), suboptimal use of renin-angiotensin-aldosterone system inhibitors (RAASis), including mineralocorticoid receptor antagonists (MRAs), due to hyperkalemia, may be improved by potassium binders.
Objectives
This prespecified analysis of the phase 3 DIAMOND (Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure) trial assessed the effect of patiromer in patients with HFrEF and either current or past hyperkalemia.
Methods
Patients with HFrEF and current or past (within 1 year before enrollment) hyperkalemia (serum potassium [sK+] >5.0 mmol/L) entered a single-blind, run-in phase to optimize RAASis while receiving patiromer. They were subsequently randomized, double-blind, to continue patiromer or change to placebo.
Results
Of the 1,038 patients who completed run-in, 354 (83.9%) of 422 with current hyperkalemia and 524 (85.1%) of 616 with past hyperkalemia achieved RAASi optimization and were randomized to treatment. During the double-blind phase, patiromer lowered sK+ levels compared with placebo in both the current and past hyperkalemia subgroups: difference in adjusted mean change from baseline: –0.12 (95% CI: –0.17 to –0.07) and –0.08 (95% CI: –0.12 to –0.05), respectively; Pinteraction = 0.166. Patiromer was more effective than placebo in maintaining MRA at target dose in patients with current vs past hyperkalemia (HR: 0.45 [95% CI: 0.26-0.76] vs HR: 0.85 [95% CI: 0.54-1.32]; Pinteraction = 0.031). Adverse events were similar between subgroups.
Conclusions
The use of patiromer facilitates achieving target doses of RAASis in patients with HFrEF with either current or past hyperkalemia. For those with current hyperkalemia before RAASi optimization, use of patiromer may be more beneficial in helping to maintain sK+ control and achieve MRA target dose. (Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure [DIAMOND]; NCT03888066)
{"title":"Patiromer for Heart Failure Medication Optimization in Patients With Current or Past Hyperkalemia","authors":"Andrew J.S. Coats DM, DSc , Stefan D. Anker MD, PhD , Lars H. Lund MD, PhD , Gerasimos Filippatos MD , Patrick Rossignol MD, PhD , Bertram Pitt MD , Matthew R. Weir MD , Mikhail N. Kosiborod MD , Marco Metra MD , Michael Böhm MD , Justin A. Ezekowitz MBBCh, MSc , Antoni Bayes-Genis MD, PhD , Robert J. Mentz MD , Piotr Ponikowski MD, PhD , Michele Senni MD, PhD , John G.F. Cleland MD, PhD , Assen Goudev MD, PhD , Irakli Khintibidze MD, PhD , Joann Lindenfeld MD , Bela Merkely MD, PhD , Javed Butler MD, MPH, MBA","doi":"10.1016/j.jchf.2024.08.003","DOIUrl":"10.1016/j.jchf.2024.08.003","url":null,"abstract":"<div><h3>Background</h3><div>For heart failure with reduced ejection fraction (HFrEF), suboptimal use of renin-angiotensin-aldosterone system inhibitors (RAASis), including mineralocorticoid receptor antagonists (MRAs), due to hyperkalemia, may be improved by potassium binders.</div></div><div><h3>Objectives</h3><div>This prespecified analysis of the phase 3 DIAMOND (Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure) trial assessed the effect of patiromer in patients with HFrEF and either current or past hyperkalemia.</div></div><div><h3>Methods</h3><div>Patients with HFrEF and current or past (within 1 year before enrollment) hyperkalemia (serum potassium [sK<sup>+</sup>] >5.0 mmol/L) entered a single-blind, run-in phase to optimize RAASis while receiving patiromer. They were subsequently randomized, double-blind, to continue patiromer or change to placebo.</div></div><div><h3>Results</h3><div>Of the 1,038 patients who completed run-in, 354 (83.9%) of 422 with current hyperkalemia and 524 (85.1%) of 616 with past hyperkalemia achieved RAASi optimization and were randomized to treatment. During the double-blind phase, patiromer lowered sK<sup>+</sup> levels compared with placebo in both the current and past hyperkalemia subgroups: difference in adjusted mean change from baseline: –0.12 (95% CI: –0.17 to –0.07) and –0.08 (95% CI: –0.12 to –0.05), respectively; <em>P</em><sub>interaction</sub> = 0.166. Patiromer was more effective than placebo in maintaining MRA at target dose in patients with current vs past hyperkalemia (HR: 0.45 [95% CI: 0.26-0.76] vs HR: 0.85 [95% CI: 0.54-1.32]; <em>P</em><sub>interaction</sub> = 0.031). Adverse events were similar between subgroups.</div></div><div><h3>Conclusions</h3><div>The use of patiromer facilitates achieving target doses of RAASis in patients with HFrEF with either current or past hyperkalemia. For those with current hyperkalemia before RAASi optimization, use of patiromer may be more beneficial in helping to maintain sK<sup>+</sup> control and achieve MRA target dose. (Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure [DIAMOND]; <span><span>NCT03888066</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2026-2037"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346903","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 : 2024-12-01DOI: 10.1016/j.jchf.2024.09.004
Mikhail N. Kosiborod MD , Elke Platz MD, MS , Sean Wharton MD , Carel W. le Roux MD, PhD , Martina Brueckmann MD , Samina Ajaz Hussain MD, MFPM , Anna Unseld MSc , Elena Startseva MD, MBA , Lee M. Kaplan MD, PhD , SYNCHRONIZE–CVOT Trial Committees and Investigators
Dual agonism of glucagon and glucagon-like peptide-1 (GLP-1) receptors may be more effective than GLP-1 receptor agonism alone in reducing body weight, but the cardiovascular (CV) effects are unknown. The authors describe the rationale and design of SYNCHRONIZE-CVOT, a phase 3, randomized, double-blind, parallel-group, event-driven, CV safety study of survodutide, a dual glucagon and GLP-1 receptor agonist, administered subcutaneously once weekly compared with placebo in adults with a body mass index ≥27 kg/m2 and established CV disease or chronic kidney disease, and/or at least 2 weight-related complications or risk factors for CV disease. The primary endpoint of SYNCHRONIZE-CVOT is time to first occurrence of the composite adjudicated endpoint of 5-point major adverse CV events. This global CV outcomes trial is currently enrolling, with a target recruitment of 4,935 participants. SYNCHRONIZE-CVOT is the first trial that will determine the CV safety and efficacy of survodutide in people with obesity and increased CV risk. (A Study to Test the Effect of Survodutide [BI 456906] on Cardiovascular Safety in People With Overweight or Obesity [SYNCHRONIZE–CVOT]; NCT06077864)
{"title":"Survodutide for the Treatment of Obesity","authors":"Mikhail N. Kosiborod MD , Elke Platz MD, MS , Sean Wharton MD , Carel W. le Roux MD, PhD , Martina Brueckmann MD , Samina Ajaz Hussain MD, MFPM , Anna Unseld MSc , Elena Startseva MD, MBA , Lee M. Kaplan MD, PhD , SYNCHRONIZE–CVOT Trial Committees and Investigators","doi":"10.1016/j.jchf.2024.09.004","DOIUrl":"10.1016/j.jchf.2024.09.004","url":null,"abstract":"<div><div>Dual agonism of glucagon and glucagon-like peptide-1 (GLP-1) receptors may be more effective than GLP-1 receptor agonism alone in reducing body weight, but the cardiovascular (CV) effects are unknown. The authors describe the rationale and design of SYNCHRONIZE-CVOT, a phase 3, randomized, double-blind, parallel-group, event-driven, CV safety study of survodutide, a dual glucagon and GLP-1 receptor agonist, administered subcutaneously once weekly compared with placebo in adults with a body mass index ≥27 kg/m<sup>2</sup> and established CV disease or chronic kidney disease, and/or at least 2 weight-related complications or risk factors for CV disease. The primary endpoint of SYNCHRONIZE-CVOT is time to first occurrence of the composite adjudicated endpoint of 5-point major adverse CV events. This global CV outcomes trial is currently enrolling, with a target recruitment of 4,935 participants. SYNCHRONIZE-CVOT is the first trial that will determine the CV safety and efficacy of survodutide in people with obesity and increased CV risk. (A Study to Test the Effect of Survodutide [BI 456906] on Cardiovascular Safety in People With Overweight or Obesity [SYNCHRONIZE–CVOT]; <span><span>NCT06077864</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2101-2109"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500654","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 : 2024-12-01DOI: 10.1016/j.jchf.2024.08.002
Stephen J. Greene MD , Lori D. Bash PhD, MPH , Kathryn W. Tebbs MSc , Lucy N. Hancock BSc , Sophie G. Barlow MSc , Catelyn R. Coyle PhD
{"title":"Physician-Reported Reasons for Not Initiating Guideline-Directed Medical Therapy for Heart Failure","authors":"Stephen J. Greene MD , Lori D. Bash PhD, MPH , Kathryn W. Tebbs MSc , Lucy N. Hancock BSc , Sophie G. Barlow MSc , Catelyn R. Coyle PhD","doi":"10.1016/j.jchf.2024.08.002","DOIUrl":"10.1016/j.jchf.2024.08.002","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2120-2122"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287502","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 : 2024-12-01DOI: 10.1016/j.jchf.2024.06.014
Manuel Urina-Jassir MD , Sergio Teruya MD , William S. Blaner PhD , Pierre-Jacques Brun PhD , Tatiana Prokaeva MD, PhD , Felix J. Tsai BS , Jeffery W. Kelly PhD , Mathew S. Maurer MD , Frederick L. Ruberg MD
{"title":"Differential Association of Transthyretin Stability with Variant and Wild-Type Transthyretin Amyloid Cardiomyopathy","authors":"Manuel Urina-Jassir MD , Sergio Teruya MD , William S. Blaner PhD , Pierre-Jacques Brun PhD , Tatiana Prokaeva MD, PhD , Felix J. Tsai BS , Jeffery W. Kelly PhD , Mathew S. Maurer MD , Frederick L. Ruberg MD","doi":"10.1016/j.jchf.2024.06.014","DOIUrl":"10.1016/j.jchf.2024.06.014","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2113-2115"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901788","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 : 2024-12-01DOI: 10.1016/j.jchf.2024.07.007
Olivier F. Clerc MD, MPH , Shilpa Vijayakumar MD, MPH , Sarah A.M. Cuddy MD , Giada Bianchi MD , Jocelyn Canseco Neri MS , Alexandra Taylor BS , Dominik C. Benz MD , Yesh Datar BA , Marie Foley Kijewski PhD , Andrew J. Yee MD , Frederick L. Ruberg MD , Ronglih Liao PhD , Rodney H. Falk MD , Vaishali Sanchorawala MD , Sharmila Dorbala MD, MPH
Background
In light-chain (AL) amyloidosis, whether functional status and heart failure–related quality of life (HF-QOL) correlate with cardiomyopathy severity, improve with therapy, and are associated with major adverse cardiac events (MACE) beyond validated scores is not well-known.
Objectives
The authors aimed to: 1) correlate functional status and HF-QOL with cardiomyopathy severity; 2) analyze their longitudinal changes; and 3) assess their independent associations with MACE.
Methods
This study included 106 participants with AL amyloidosis, with 81% having AL cardiomyopathy. Functional status was evaluated using the NYHA functional class, the Karnofsky scale, and the 6-minute walk distance (6MWD), and HF-QOL using the MLWHFQ (Minnesota Living with Heart Failure Questionnaire). Cardiomyopathy severity was assessed by cardiac 18F-florbetapir positron emission tomography/computed tomography, cardiac magnetic resonance, echocardiography, and serum cardiac biomarkers. MACE were defined as all-cause death, heart failure hospitalization, or cardiac transplantation.
Results
NYHA functional class, Karnofsky scale, 6MWD, and MLWHFQ were impaired substantially in participants with recently diagnosed AL cardiomyopathy (P < 0.001), and correlated with all markers of cardiomyopathy severity (P ≤ 0.010). NYHA functional class, 6MWD, and MLWHFQ improved at 12 months in participants with cardiomyopathy (P ≤ 0.013). All measures of functional status and HF-QOL were associated with MACE (P ≤ 0.017), independent of Mayo stage for 6MWD and MLWHFQ (P ≤ 0.006).
Conclusions
Functional status and HF-QOL were associated with AL cardiomyopathy severity, improved on therapy within 12 months, and were associated with MACE, independently of Mayo stage for 6MWD and MLWHFQ. They may be validated further in addition to prognostic scores and as surrogate outcomes for future studies.
{"title":"Functional Status and Quality of Life in Light-Chain Amyloidosis","authors":"Olivier F. Clerc MD, MPH , Shilpa Vijayakumar MD, MPH , Sarah A.M. Cuddy MD , Giada Bianchi MD , Jocelyn Canseco Neri MS , Alexandra Taylor BS , Dominik C. Benz MD , Yesh Datar BA , Marie Foley Kijewski PhD , Andrew J. Yee MD , Frederick L. Ruberg MD , Ronglih Liao PhD , Rodney H. Falk MD , Vaishali Sanchorawala MD , Sharmila Dorbala MD, MPH","doi":"10.1016/j.jchf.2024.07.007","DOIUrl":"10.1016/j.jchf.2024.07.007","url":null,"abstract":"<div><h3>Background</h3><div>In light-chain (AL) amyloidosis, whether functional status and heart failure–related quality of life (HF-QOL) correlate with cardiomyopathy severity, improve with therapy, and are associated with major adverse cardiac events (MACE) beyond validated scores is not well-known.</div></div><div><h3>Objectives</h3><div>The authors aimed to: 1) correlate functional status and HF-QOL with cardiomyopathy severity; 2) analyze their longitudinal changes; and 3) assess their independent associations with MACE.</div></div><div><h3>Methods</h3><div>This study included 106 participants with AL amyloidosis, with 81% having AL cardiomyopathy. Functional status was evaluated using the NYHA functional class, the Karnofsky scale, and the 6-minute walk distance (6MWD), and HF-QOL using the MLWHFQ (Minnesota Living with Heart Failure Questionnaire). Cardiomyopathy severity was assessed by cardiac <sup>18</sup>F-florbetapir positron emission tomography/computed tomography, cardiac magnetic resonance, echocardiography, and serum cardiac biomarkers. MACE were defined as all-cause death, heart failure hospitalization, or cardiac transplantation.</div></div><div><h3>Results</h3><div>NYHA functional class, Karnofsky scale, 6MWD, and MLWHFQ were impaired substantially in participants with recently diagnosed AL cardiomyopathy (<em>P <</em> 0.001), and correlated with all markers of cardiomyopathy severity (<em>P ≤</em> 0.010). NYHA functional class, 6MWD, and MLWHFQ improved at 12 months in participants with cardiomyopathy (<em>P ≤</em> 0.013). All measures of functional status and HF-QOL were associated with MACE (<em>P ≤</em> 0.017), independent of Mayo stage for 6MWD and MLWHFQ (<em>P ≤</em> 0.006).</div></div><div><h3>Conclusions</h3><div>Functional status and HF-QOL were associated with AL cardiomyopathy severity, improved on therapy within 12 months, and were associated with MACE, independently of Mayo stage for 6MWD and MLWHFQ. They may be validated further in addition to prognostic scores and as surrogate outcomes for future studies.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 1994-2006"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145664","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}
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