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Psychosocial Risk to Predict Outcomes After LVAD Implantation: A Small Step Forward in Predicting Human Behavior 预测左心室人工肾脏植入术后预后的社会心理风险:预测人类行为的一小步。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.11.002
MATTHEW CAGLIOSTRO MD, MPH, JULIE ROLDAN AGACNP-BC, DONNA MANCINI MD
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引用次数: 0
High Circulating Dipeptidyl Peptidase 3 Predicts Mortality and Need for Organ Support in Cardiogenic Shock: An Ancillary Analysis of the ACCOST-HH Trial 高循环二肽基肽酶 3 预测心源性休克患者的死亡率和器官支持需求:ACCOST-HH 试验的辅助分析。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.03.014
ADRIEN PICOD MD, MSc , HUGO NORDIN MSc , DOMINIK JARCZAK MD , TANJA ZELLER PhD , CLAIRE ODDOS MD, MSc , KARINE SANTOS PhD , OLIVER HARTMANN PhD , ANTOINE HERPAIN MD , ALEXANDRE MEBAZAA MD, PhD , STEFAN KLUGE MD, PhD , FERIEL AZIBANI PhD , MAHIR KARAKAS MD, PhD MBA

Background

Cardiogenic shock (CS) is burdened with high mortality. Efforts to improve outcome are hampered by the difficulty of individual risk stratification and the lack of targetable pathways. Previous studies demonstrated that elevated circulating dipeptidyl peptidase 3 (cDPP3) is an early predictor of short-term outcome in CS, mostly of ischemic origin. Our objective was to investigate the association between cDPP3 and short-term outcomes in a diverse population of patients with CS.

Methods and Results

cDPP3 was measured at baseline and after 72 hours in the AdreCizumab against plaCebO in SubjecTs witH cardiogenic sHock (ACCOST-HH) trial. The association of cDPP3 with 30-day mortality and need for organ support was assessed. Median cDPP3 concentration at baseline was 43.2 ng/mL (95% confidence interval [CI], 21.2–74.0 ng/mL) and 77 of the 150 patients (52%) had high cDPP3 over the predefined cutoff of 40 ng/mL. Elevated cDPP3 was associated with higher 30-day mortality (adjusted hazard ratio [aHR] = 1.7; 95% CI, 1.0–2.9), fewer days alive without cardiovascular support (aHR, 3 days [95% CI, 0–24 days] vs aHR, 21 days [95% CI, 5–26 days]; P < .0001) and a greater need for renal replacement therapy (56% vs 22%; P < .0001) and mechanical ventilation (90 vs 74%; P = .04). Patients with a sustained high cDPP3 had a poor prognosis (reference group). In contrast, patients with an initially high but decreasing cDPP3 at 72 hours had markedly lower 30-day mortality (aHR, 0.17; 95% CI, 0.084–0.34), comparable with patients with a sustained low cDPP3 (aHR, 0.23; 95% CI, 0.12–0.41). The need for organ support was markedly decreased in subpopulations with sustained low or decreasing cDPP3.

Conclusions

The present study confirms the prognostic value of cDPP3 in a contemporary population of patients with CS.
背景:心源性休克的死亡率很高。由于难以对个体进行风险分层以及缺乏有针对性的途径,改善预后的努力受到了阻碍。先前的研究表明,循环二肽基肽酶 3(cDPP3)的升高是心源性休克(主要是缺血性休克)短期预后的早期预测因子。我们的目的是在不同的心源性休克人群中研究 cDPP3 与短期预后之间的关系。方法:在 ACCOST-HH 试验中,对基线和 72 小时后的 cDPP3 进行了测量。方法:在 ACCOST-HH 试验中,分别在基线和 72 小时后测量 cDPP3,评估 cDPP3 与 30 天死亡率和器官支持需求的关系:结果:基线cDPP3浓度中位数为43.2纳克/毫升[21.2-74],150名患者中有77人(52%)的cDPP3浓度高于预先设定的40纳克/毫升。cDPP3 升高与较高的 30 天死亡率(调整后 (a) HR=1.7 [1.0-2.9])和较少的无心血管支持存活天数(3 [0-24] vs 21 天 [5-26],pConclusion)有关:本研究证实了 cDPP3 在当代心源性休克患者中的预后价值。
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引用次数: 0
Exploring The Relationship Between Caregiver Contributions To Heart Failure Self-care And Patient Self-care
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.10.015
Heba Aldossary , Elliane Irani , Mary Dolansky , Ercole Vellone
<div><h3>Introduction</h3><div>Heart failure (HF) poses a global health challenge, contributing to frequent readmissions and emergency department visits. Effective HF management requires active patient engagement in self-care, yet many patients struggle with its execution. This underscores the crucial role of caregivers in supporting patients' self-care activities. Despite the recognized importance of HF self-care and caregiver involvement, uncertainties persist regarding the impact of increased caregiver contributions to self-care on patient outcomes, emphasizing the need for further research.</div></div><div><h3>Hypothesis</h3><div>This study aims to investigate the relationship between caregivers' contributions to HF self-care and patients' self-care maintenance, monitoring, and management.</div></div><div><h3>Methods</h3><div>A secondary analysis was conducted on data from a cross-sectional study involving 277 HF dyads (277 adult HF patients18 years and older and 277 primary caregivers). Patients were classified according to the New York Heart Association (NYHA) functional classes I-IV. Convenience sampling was employed at outpatient centers between March 2017 and January 2019. Data were collected using the Self-Care of Heart Failure Index (SCHFI v.7.2) and Caregiver Contribution to Self-Care of Heart Failure Index version 2 (CC-SCHFI v.2). For data analysis, multiple regression was utilized.</div></div><div><h3>Results</h3><div>The average patient age was 68 years (range: 39-97 years), with a slight majority being male (54.9%). Conversely, caregivers were predominantly female (70.4%) with an average age of 52 years. The degree of kinship highlighted that a significant proportion of caregivers were children (46.9%), followed by spouses (28.2%). majority of HF patients had a NYHA class II (38.3%), indicating a mild level of heart failure symptoms among participants. Notably, a combined 39% of participants fell into NYHA classes 3 and 4, indicating moderate to severe heart failure symptoms and limitations in daily activities. There was a statistically significant positive association between caregiver contribution to HF self-care maintenance with patient self-care maintenance (β = 0. 245, p <.001, 95% CI [0.143, 0.348]). Caregiver contribution to HF self-care monitoring showed significant association with patient self-care monitoring (β = 0.253, p <.001, 95% CI [0.133, 0.374]). In the realm of patient self-care management, caregiver contribution to self-care management was associated with patient self-care management (β = 0.467, p < 0.001, 95% CI [0.352, 0.583]).</div></div><div><h3>Conclusion</h3><div>This study revealed a statistically significant positive association between caregiver contribution and all aspects of self-care (maintenance, monitoring, and management) in heart failure patients. Given the substantial proportion of patients with advanced stages (NYHA III & IV), further research is necessary to optimize how caregive
{"title":"Exploring The Relationship Between Caregiver Contributions To Heart Failure Self-care And Patient Self-care","authors":"Heba Aldossary ,&nbsp;Elliane Irani ,&nbsp;Mary Dolansky ,&nbsp;Ercole Vellone","doi":"10.1016/j.cardfail.2024.10.015","DOIUrl":"10.1016/j.cardfail.2024.10.015","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Heart failure (HF) poses a global health challenge, contributing to frequent readmissions and emergency department visits. Effective HF management requires active patient engagement in self-care, yet many patients struggle with its execution. This underscores the crucial role of caregivers in supporting patients' self-care activities. Despite the recognized importance of HF self-care and caregiver involvement, uncertainties persist regarding the impact of increased caregiver contributions to self-care on patient outcomes, emphasizing the need for further research.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Hypothesis&lt;/h3&gt;&lt;div&gt;This study aims to investigate the relationship between caregivers' contributions to HF self-care and patients' self-care maintenance, monitoring, and management.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;A secondary analysis was conducted on data from a cross-sectional study involving 277 HF dyads (277 adult HF patients18 years and older and 277 primary caregivers). Patients were classified according to the New York Heart Association (NYHA) functional classes I-IV. Convenience sampling was employed at outpatient centers between March 2017 and January 2019. Data were collected using the Self-Care of Heart Failure Index (SCHFI v.7.2) and Caregiver Contribution to Self-Care of Heart Failure Index version 2 (CC-SCHFI v.2). For data analysis, multiple regression was utilized.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The average patient age was 68 years (range: 39-97 years), with a slight majority being male (54.9%). Conversely, caregivers were predominantly female (70.4%) with an average age of 52 years. The degree of kinship highlighted that a significant proportion of caregivers were children (46.9%), followed by spouses (28.2%). majority of HF patients had a NYHA class II (38.3%), indicating a mild level of heart failure symptoms among participants. Notably, a combined 39% of participants fell into NYHA classes 3 and 4, indicating moderate to severe heart failure symptoms and limitations in daily activities. There was a statistically significant positive association between caregiver contribution to HF self-care maintenance with patient self-care maintenance (β = 0. 245, p &lt;.001, 95% CI [0.143, 0.348]). Caregiver contribution to HF self-care monitoring showed significant association with patient self-care monitoring (β = 0.253, p &lt;.001, 95% CI [0.133, 0.374]). In the realm of patient self-care management, caregiver contribution to self-care management was associated with patient self-care management (β = 0.467, p &lt; 0.001, 95% CI [0.352, 0.583]).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;This study revealed a statistically significant positive association between caregiver contribution and all aspects of self-care (maintenance, monitoring, and management) in heart failure patients. Given the substantial proportion of patients with advanced stages (NYHA III &amp; IV), further research is necessary to optimize how caregive","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 1","pages":"Page 183"},"PeriodicalIF":6.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143141350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Comparison Of Single Versus Dual Treatment With Stabilizers And Silencers In Transthyretin Amyloid Cardiomyopathy
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.10.019
Joban Vaishnav, Lisa Yanek, Yazan Alshawkani, Bairavi Shankar, Daniel Tsottles, Isaiah Norman, Jennifer Barranco, Mark Ranek, Kavita Sharma, Michael Polydefkis

Introduction

Treatment for transthyretin amyloid cardiomyopathy (ATTR-CM) with TTR stabilization or gene silencing depends on presence of pathogenic variant and phenotype (cardiomyopathy v neuropathy). There are limited data on efficacy of dual treatment with TTR stabilizer and silencer.

Hypothesis

We hypothesize dual treatment with stabilizers and silencers will confer no added benefit compared to single agent treatment.

Methods

Patients seen at our center with a diagnosis of ATTR-CM treated with either stabilizer (Tafamidis, Diflunisal), silencer (Patisiran, Vutisiran), or both (stabilizer and silencer) for >6 months were included. Mortality data was collected through 5 years from diagnosis. Characteristics for single v dual treatment groups were compared using chi-squared or Fisher's exact tests, or t-tests or Wilcoxon tests. Kaplan-Meier curves and Cox proportional hazard regression models were used to assess relationships with mortality.

Results

Of 183 patients, 144 (79%) were on single agent, including 132 (72%) on stabilizer, and 13 (7%) on silencer and 38 (21%) were on dual treatment with stabilizer and silencer. Patients on dual treatment were younger (70.1 [8.3] v 76.1 [9.0] yrs), more likely hereditary (79.0% v 43.9%), had higher eGFR, lower NT-proBNP, and less likely on loop diuretic (39.5 v 69.9%) at baseline, all p<0.05. There was no difference in sex, race, or NAC stage by groups at baseline (Table). K-M curves showed significantly superior survival with dual treatment (log-rank p-value 0.009, Figure). In univariate Cox analysis, dual treatment significantly reduced risk of death (HR 0.363, 95% CI 0.164-0.801, p<0.05); however, in multivariate model including age, dual treatment was no longer statistically significant (HR 0.468, 95% CI 0.21-1.07 p=0.07), though age was significantly associated with risk of death (HR 1.04, 95% CI 1.004-1.07, p=0.025).

Conclusion

In a large ATTR-CM cohort, we found that dual treatment with stabilizers and silencers was not associated with reduction in risk of death when adjusted for age. While larger scale studies are needed, given the expense of current FDA approved treatments, our findings suggest that dual treatment is unlikely to be cost effective or of incremental clinical benefit. Future studies are needed to determine optimal treatment, stabilizer or silencer, for the various phenotypes associated with ATTR-CM.
{"title":"A Comparison Of Single Versus Dual Treatment With Stabilizers And Silencers In Transthyretin Amyloid Cardiomyopathy","authors":"Joban Vaishnav,&nbsp;Lisa Yanek,&nbsp;Yazan Alshawkani,&nbsp;Bairavi Shankar,&nbsp;Daniel Tsottles,&nbsp;Isaiah Norman,&nbsp;Jennifer Barranco,&nbsp;Mark Ranek,&nbsp;Kavita Sharma,&nbsp;Michael Polydefkis","doi":"10.1016/j.cardfail.2024.10.019","DOIUrl":"10.1016/j.cardfail.2024.10.019","url":null,"abstract":"<div><h3>Introduction</h3><div>Treatment for transthyretin amyloid cardiomyopathy (ATTR-CM) with TTR stabilization or gene silencing depends on presence of pathogenic variant and phenotype (cardiomyopathy v neuropathy). There are limited data on efficacy of dual treatment with TTR stabilizer and silencer.</div></div><div><h3>Hypothesis</h3><div>We hypothesize dual treatment with stabilizers and silencers will confer no added benefit compared to single agent treatment.</div></div><div><h3>Methods</h3><div>Patients seen at our center with a diagnosis of ATTR-CM treated with either stabilizer (Tafamidis, Diflunisal), silencer (Patisiran, Vutisiran), or both (stabilizer and silencer) for &gt;6 months were included. Mortality data was collected through 5 years from diagnosis. Characteristics for single v dual treatment groups were compared using chi-squared or Fisher's exact tests, or t-tests or Wilcoxon tests. Kaplan-Meier curves and Cox proportional hazard regression models were used to assess relationships with mortality.</div></div><div><h3>Results</h3><div>Of 183 patients, 144 (79%) were on single agent, including 132 (72%) on stabilizer, and 13 (7%) on silencer and 38 (21%) were on dual treatment with stabilizer and silencer. Patients on dual treatment were younger (70.1 [8.3] v 76.1 [9.0] yrs), more likely hereditary (79.0% v 43.9%), had higher eGFR, lower NT-proBNP, and less likely on loop diuretic (39.5 v 69.9%) at baseline, all p&lt;0.05. There was no difference in sex, race, or NAC stage by groups at baseline (<strong>Table</strong>). K-M curves showed significantly superior survival with dual treatment (log-rank p-value 0.009, <strong>Figure</strong>). In univariate Cox analysis, dual treatment significantly reduced risk of death (HR 0.363, 95% CI 0.164-0.801, p&lt;0.05); however, in multivariate model including age, dual treatment was no longer statistically significant (HR 0.468, 95% CI 0.21-1.07 p=0.07), though age was significantly associated with risk of death (HR 1.04, 95% CI 1.004-1.07, p=0.025).</div></div><div><h3>Conclusion</h3><div>In a large ATTR-CM cohort, we found that dual treatment with stabilizers and silencers was not associated with reduction in risk of death when adjusted for age. While larger scale studies are needed, given the expense of current FDA approved treatments, our findings suggest that dual treatment is unlikely to be cost effective or of incremental clinical benefit. Future studies are needed to determine optimal treatment, stabilizer or silencer, for the various phenotypes associated with ATTR-CM.</div></div>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 1","pages":"Pages 184-185"},"PeriodicalIF":6.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143141357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Consistent Care By One Physician Is Associated With Fewer Cardiovascular Hospitalizations Amongst Patients With Heart Failure
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.10.040
Sahityasri Thapi , Pooja Anand Gownivaripally , Aarti Rao , Ankitha Radakrishnan , Ashwin Sawant , Birgit Vogel , Girish N Nadkarni , Roxana Mehran , Anu Lala

Introduction

Strong patient-physician relationships may optimize care in heart failure (HF). Provider consistency is thought to be important for these relationships and potentially allowing for better patient outcomes. As more practices move towards group models, the impact of care provided by a consistent physician on outcomes in HF remains unexplored.

Hypothesis

We hypothesized that care provided by a consistent physician would be linked to improved outcomes among patients with HF as measured by cardiovascular (CV) hospitalizations and mortality.

Methods

We retrospectively studied patients with HF treated in an urban health-system from 2015 to 2022. HF was identified upon meeting all 3 of the following criteria: ICD code for HF, prior CV hospitalization, and elevated natriuretic peptide (BNP >100, NTproBNP >400) in the preceding year. We also examined whether patient-physician sex concordance, defined as having consistent care for 75% of visits with a physician of the same sex was associated with outcomes. Varying frequencies were used to define consistency and sex concordance (67%, 75% and 85%) to better assess their relationship with outcomes. We conducted univariate and multivariate Poisson regression analyses on the association of consistent care with CV hospitalizations and mortality.

Results

A total of 1848 patients met inclusion criteria, with mean age 71.1 ± 14.5, 40% female, and mean follow up time of 620 days. Consistency criteria was met by 1466 (79.3%) patients. Patients without consistency were younger (p<0.001), with more kidney disease (p<0.001), diabetes (p=0.001), and obesity (p=0.002), and more clinic visits on average (9.4 vs 6.8, p<0.001). Physician consistency was associated with significantly fewer CV hospitalizations (Incidence Rate Ratio (IRR) 0.734 [95% CI, 0.688-0.783], p<0.001), after adjusting for age, sex, race, and comorbidities (Fig1). The results were similar with consistency defined as 67% (IRR 0.735 [95% CI, 0.688-0.786], p<0.001), and 85% (IRR 0.733 [95% CI, 0.690-0.778],p<0.001). There was no significant association between consistent care and mortality (p=0.875). Further, we observed that patient-physician sex concordance amongst patients with 75% consistency was also associated with fewer CV hospitalizations (IRR 0.844 [95% CI, 0.797-0.895], p<0.001) but not mortality (HR 1.08; 95%CI 0.889-1.316).

Conclusions

Among outpatients with HF, receiving care from a consistent physician was associated with fewer CV hospitalizations but not mortality, strengthened by patient-physician sex concordance. Prospective studies are needed to verify these findings and assess how they may play a role in optimizing care delivery in HF.
{"title":"Consistent Care By One Physician Is Associated With Fewer Cardiovascular Hospitalizations Amongst Patients With Heart Failure","authors":"Sahityasri Thapi ,&nbsp;Pooja Anand Gownivaripally ,&nbsp;Aarti Rao ,&nbsp;Ankitha Radakrishnan ,&nbsp;Ashwin Sawant ,&nbsp;Birgit Vogel ,&nbsp;Girish N Nadkarni ,&nbsp;Roxana Mehran ,&nbsp;Anu Lala","doi":"10.1016/j.cardfail.2024.10.040","DOIUrl":"10.1016/j.cardfail.2024.10.040","url":null,"abstract":"<div><h3>Introduction</h3><div>Strong patient-physician relationships may optimize care in heart failure (HF). Provider consistency is thought to be important for these relationships and potentially allowing for better patient outcomes. As more practices move towards group models, the impact of care provided by a consistent physician on outcomes in HF remains unexplored.</div></div><div><h3>Hypothesis</h3><div>We hypothesized that care provided by a consistent physician would be linked to improved outcomes among patients with HF as measured by cardiovascular (CV) hospitalizations and mortality.</div></div><div><h3>Methods</h3><div>We retrospectively studied patients with HF treated in an urban health-system from 2015 to 2022. HF was identified upon meeting all 3 of the following criteria: ICD code for HF, prior CV hospitalization, and elevated natriuretic peptide (BNP &gt;100, NTproBNP &gt;400) in the preceding year. We also examined whether patient-physician sex concordance, defined as having consistent care for 75% of visits with a physician of the same sex was associated with outcomes. Varying frequencies were used to define consistency and sex concordance (67%, 75% and 85%) to better assess their relationship with outcomes. We conducted univariate and multivariate Poisson regression analyses on the association of consistent care with CV hospitalizations and mortality.</div></div><div><h3>Results</h3><div>A total of 1848 patients met inclusion criteria, with mean age 71.1 ± 14.5, 40% female, and mean follow up time of 620 days. Consistency criteria was met by 1466 (79.3%) patients. Patients without consistency were younger (p&lt;0.001), with more kidney disease (p&lt;0.001), diabetes (p=0.001), and obesity (p=0.002), and more clinic visits on average (9.4 vs 6.8, p&lt;0.001). Physician consistency was associated with significantly fewer CV hospitalizations (Incidence Rate Ratio (IRR) 0.734 [95% CI, 0.688-0.783], p&lt;0.001), after adjusting for age, sex, race, and comorbidities (Fig1). The results were similar with consistency defined as 67% (IRR 0.735 [95% CI, 0.688-0.786], p&lt;0.001), and 85% (IRR 0.733 [95% CI, 0.690-0.778],p&lt;0.001). There was no significant association between consistent care and mortality (p=0.875). Further, we observed that patient-physician sex concordance amongst patients with 75% consistency was also associated with fewer CV hospitalizations (IRR 0.844 [95% CI, 0.797-0.895], p&lt;0.001) but not mortality (HR 1.08; 95%CI 0.889-1.316).</div></div><div><h3>Conclusions</h3><div>Among outpatients with HF, receiving care from a consistent physician was associated with fewer CV hospitalizations but not mortality, strengthened by patient-physician sex concordance. Prospective studies are needed to verify these findings and assess how they may play a role in optimizing care delivery in HF.</div></div>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 1","pages":"Page 194"},"PeriodicalIF":6.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143141359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparing Outcomes Of Non-Ischemic Cardiomyopathy And Ischemic Cardiomyopathy In Patients Admitted With Sepsis: A Nationwide Analysis
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.10.073
Aditya Thakkar , Soumya Gupta , Lalith Namburu , Dilpat Kumar , Venkata Vedantam

Introduction

Sepsis poses a significant threat to individuals with underlying cardiac conditions, including non-ischemic cardiomyopathy (NICM) and ischemic cardiomyopathy (ICM). This retrospective observational study compares in-hospital outcomes and complications between septic patients with NICM and ICM.

Methods

Data was obtained from the Nationwide Inpatient Sample database from January 2016 to December 2020. The study included all adult patients who had sepsis as their primary discharge diagnosis and also had a concomitant diagnosis of NICM or ICM. These two groups were then compared. The primary outcome of our study was inpatient mortality. Secondary outcomes were cardiac arrest, arrhythmias, acute respiratory failure, and acute renal failure, as well as the need for transfusions, pressors, ventilators, tracheostomy, and ECMO.

Results

The study included 117,031 patients, among whom 69.1% had NICM and 30.9% had ICM. In-hospital mortality rates were significantly different between the two groups, with NICM patients having 13% higher odds of mortality after adjusting for age, sex, race, and Charlson's Comorbidity Index (aOR [95% CI] = 1.13 [1.01-1.28], p < 0.001). Furthermore, they also had a significantly higher risk of acute renal failure(aOR: 1.03; p<0.05), and acute respiratory failure (aOR: 1.18; p<0.001). They also had a higher need for life-saving treatments like the use of mechanical ventilation (aOR: 1.23; p<0.001), pressors (aOR: 1.14; p<0.001), blood transfusions(aOR: 1.15; p<0.001) and tracheostomy (aOR: 1.55;p<0.001). However, this group had a lower risk of ventricular arrhythmias (aOR:0.88;p<0.001). There was no significant difference in the risk of cardiac arrest, need for dialysis or ECMO.

Conclusion

Our study sheds light on the distinct clinical trajectories of septic patients with non-ischemic cardiomyopathy versus ischemic cardiomyopathy. Patients with the former form of cardiomyopathy had significantly worse inpatient outcomes compared to the latter during the state of sepsis. Further research is warranted to elucidate the underlying mechanisms of this interesting finding. Doing this could potentially help us find better interventions and improve outcomes.
{"title":"Comparing Outcomes Of Non-Ischemic Cardiomyopathy And Ischemic Cardiomyopathy In Patients Admitted With Sepsis: A Nationwide Analysis","authors":"Aditya Thakkar ,&nbsp;Soumya Gupta ,&nbsp;Lalith Namburu ,&nbsp;Dilpat Kumar ,&nbsp;Venkata Vedantam","doi":"10.1016/j.cardfail.2024.10.073","DOIUrl":"10.1016/j.cardfail.2024.10.073","url":null,"abstract":"<div><h3>Introduction</h3><div>Sepsis poses a significant threat to individuals with underlying cardiac conditions, including non-ischemic cardiomyopathy (NICM) and ischemic cardiomyopathy (ICM). This retrospective observational study compares in-hospital outcomes and complications between septic patients with NICM and ICM.</div></div><div><h3>Methods</h3><div>Data was obtained from the Nationwide Inpatient Sample database from January 2016 to December 2020. The study included all adult patients who had sepsis as their primary discharge diagnosis and also had a concomitant diagnosis of NICM or ICM. These two groups were then compared. The primary outcome of our study was inpatient mortality. Secondary outcomes were cardiac arrest, arrhythmias, acute respiratory failure, and acute renal failure, as well as the need for transfusions, pressors, ventilators, tracheostomy, and ECMO.</div></div><div><h3>Results</h3><div>The study included 117,031 patients, among whom 69.1% had NICM and 30.9% had ICM. In-hospital mortality rates were significantly different between the two groups, with NICM patients having 13% higher odds of mortality after adjusting for age, sex, race, and Charlson's Comorbidity Index (aOR [95% CI] = 1.13 [1.01-1.28], p &lt; 0.001). Furthermore, they also had a significantly higher risk of acute renal failure(aOR: 1.03; p&lt;0.05), and acute respiratory failure (aOR: 1.18; p&lt;0.001). They also had a higher need for life-saving treatments like the use of mechanical ventilation (aOR: 1.23; p&lt;0.001), pressors (aOR: 1.14; p&lt;0.001), blood transfusions(aOR: 1.15; p&lt;0.001) and tracheostomy (aOR: 1.55;p&lt;0.001). However, this group had a lower risk of ventricular arrhythmias (aOR:0.88;p&lt;0.001). There was no significant difference in the risk of cardiac arrest, need for dialysis or ECMO.</div></div><div><h3>Conclusion</h3><div>Our study sheds light on the distinct clinical trajectories of septic patients with non-ischemic cardiomyopathy versus ischemic cardiomyopathy. Patients with the former form of cardiomyopathy had significantly worse inpatient outcomes compared to the latter during the state of sepsis. Further research is warranted to elucidate the underlying mechanisms of this interesting finding. Doing this could potentially help us find better interventions and improve outcomes.</div></div>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 1","pages":"Pages 208-209"},"PeriodicalIF":6.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143141404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Resetting The Rhythm: Rethinking Implantable Cardioverter Defibrillators From A Left Ventricular Non-compaction Perspective
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.10.077
Ahmad K Younis , Tala Al Natsheh , Majd Enayah , Ghina Alsawad , Karam Albdour , Nora AbuAmouneh , Ahmad Turk

Introduction

Left Ventricular Non-Compaction (LVNC) is identified as a unique cardiomyopathy, marked by excessive trabeculation in the left ventricle due to arrested myocardial embryogenesis. Its prevalence, estimated through cardiac MRI, varies from 0.014% to 1.3% in the general population, suggesting it may often go undiagnosed. Our study examines the decision-making for implantable cardioverter defibrillator (ICD) placement in LVNC patients with normal Ejection Fraction (EF), aiming to refine treatment strategies and understanding of managing LVNC with preserved systolic function.

Case

A 25-year-old woman experiencing palpitations consulted an advanced heart failure clinic, considering ICD placement. Holter monitoring revealed occasional premature ventricular contractions and a short episode of non-sustained ventricular tachycardia (NSVT). Further imaging through echocardiography and MRI showed LVNC characteristics with a compacted:non-compacted end-diastolic ratio of >2.3:1. Notably, she had a normal EF. Given she did not meet the end-systolic noncompaction criterion, ICD placement was deferred, with recommendations to pursue genetic testing for evaluation of possible pathognomonic genotypes first.

Discussion

Our case report delves into the complex decision of whether to implement an ICD in a patient with LVNC but normal EF who exhibited NSVT. This patient profile challenges conventional protocols that primarily associate arrhythmia risks predominantly with systolic dysfunction, thereby questioning the necessity and timing of ICD placement. The discussion pivots on how to balance the benefits of ICD placement against potential risks in patients with no systolic impairment but with arrhythmic episodes, emphasizing the importance of a personalized, informed approach to ICD decision-making. While calling for a reevaluation of management strategies for LVNC, our exploration adds to the growing dialogue on optimizing care for LVNC patients by ensuring decisions about ICD implantation are grounded in a comprehensive understanding of individual patient risks and benefits. Additionally, it highlights a significant gap in the literature, especially concerning ICD placement in LVNC patients with preserved EF and arrhythmias, underlining the urgent need for further research. This lack of detailed studies challenges clinicians to make informed decisions with limited evidence, emphasizing the critical need for more focused research to develop effective, nuanced management strategies for this unique patient population.
{"title":"Resetting The Rhythm: Rethinking Implantable Cardioverter Defibrillators From A Left Ventricular Non-compaction Perspective","authors":"Ahmad K Younis ,&nbsp;Tala Al Natsheh ,&nbsp;Majd Enayah ,&nbsp;Ghina Alsawad ,&nbsp;Karam Albdour ,&nbsp;Nora AbuAmouneh ,&nbsp;Ahmad Turk","doi":"10.1016/j.cardfail.2024.10.077","DOIUrl":"10.1016/j.cardfail.2024.10.077","url":null,"abstract":"<div><h3>Introduction</h3><div>Left Ventricular Non-Compaction (LVNC) is identified as a unique cardiomyopathy, marked by excessive trabeculation in the left ventricle due to arrested myocardial embryogenesis. Its prevalence, estimated through cardiac MRI, varies from 0.014% to 1.3% in the general population, suggesting it may often go undiagnosed. Our study examines the decision-making for implantable cardioverter defibrillator (ICD) placement in LVNC patients with normal Ejection Fraction (EF), aiming to refine treatment strategies and understanding of managing LVNC with preserved systolic function.</div></div><div><h3>Case</h3><div>A 25-year-old woman experiencing palpitations consulted an advanced heart failure clinic, considering ICD placement. Holter monitoring revealed occasional premature ventricular contractions and a short episode of non-sustained ventricular tachycardia (NSVT). Further imaging through echocardiography and MRI showed LVNC characteristics with a compacted:non-compacted end-diastolic ratio of &gt;2.3:1. Notably, she had a normal EF. Given she did not meet the end-systolic noncompaction criterion, ICD placement was deferred, with recommendations to pursue genetic testing for evaluation of possible pathognomonic genotypes first.</div></div><div><h3>Discussion</h3><div>Our case report delves into the complex decision of whether to implement an ICD in a patient with LVNC but normal EF who exhibited NSVT. This patient profile challenges conventional protocols that primarily associate arrhythmia risks predominantly with systolic dysfunction, thereby questioning the necessity and timing of ICD placement. The discussion pivots on how to balance the benefits of ICD placement against potential risks in patients with no systolic impairment but with arrhythmic episodes, emphasizing the importance of a personalized, informed approach to ICD decision-making. While calling for a reevaluation of management strategies for LVNC, our exploration adds to the growing dialogue on optimizing care for LVNC patients by ensuring decisions about ICD implantation are grounded in a comprehensive understanding of individual patient risks and benefits. Additionally, it highlights a significant gap in the literature, especially concerning ICD placement in LVNC patients with preserved EF and arrhythmias, underlining the urgent need for further research. This lack of detailed studies challenges clinicians to make informed decisions with limited evidence, emphasizing the critical need for more focused research to develop effective, nuanced management strategies for this unique patient population.</div></div>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 1","pages":"Page 210"},"PeriodicalIF":6.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143141549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hemodynamic Comparison And Prognostication Of V122I Versus Wild Type Transthyretin Amyloid Cardiomyopathy
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.10.036
Joban Vaishnav , Lisa R Yanek , Bairavi Shankar , Artrish Jefferson , Yazan Alshawkan , Daniel Tsottles , Serena Zampino , Godoy Lola , Vivek Jani , Mark Ranek , Michael Polydefkis , Kavita Sharma

Introduction

Transthyretin amyloid cardiomyopathy (ATTR-CM), in particular V122I disease, is a highly morbid cause of heart failure (HF). There are limited contemporary data on hemodynamic prognostication in ATTR-CM. We aimed to compare hemodynamics and evaluate prognostic significance in patients with V122I and wild type (wt) ATTR-CM.

Hypothesis

We hypothesize that patients with V122I will have more hemodynamic abnormalities and that hemodynamics will have additive prognostic value in ATTR-CM.

Methods

Patients with either V122I or wtATTR-CM who underwent RHC at our center were included. Hemodynamic abnormalities by each group and prognostic relevance by classic cut offs with endpoint of death was assessed. Characteristics for V122I or wtATTR-CM were compared using chi-squared or Fisher's exact tests, or t-tests or Wilcoxon tests. Kaplan-Meier curves and Cox proportional hazard regression models were used to assess relationships with mortality and the composite of mortality or HF hospitalization.

Results

Of 152 patients, 73 (48%) had V122I variant. V122I vs wtATTR patients were younger (72.7 [7.4] v 78.5 [7.3] yrs), more likely Black (94.5 v 17.7%), and NHYA Class III or IV (53.8 v 35.1%), all p<0.05, with no significant difference in National Amyloid Center (NAC) staging. On RHC, V122I patients were more likely to have abnormal filling pressures compared to wtATTR including mRA >8 (61.1% v 43.8%), mPAP >25 (75.0% v 54.8%), PCWP >18 (56.9% v 38.4%), all p<0.05. CI was low in the majority of patients and not different by V122I v wtATTR (CI <2.2: 82.6% v 80.3%, p=0.72, CI <1.8: 56.5% v 53.5%, p=0.72). V122I patients with abnormal mPAP, PCWP, and CI had significantly lower survival when compared to V122I patients with normal parameters and wtATTR patients with normal and abnormal parameters (Figure). Hemodynamics independently predicted risk on top of NAC stage 3 disease (p<0.05 for all parameters, Table).

Conclusion

The majority of patients with ATTR-CM have abnormal hemodynamics, with greater derangement in V122I disease. In patients with abnormal hemodynamics, V122I patients had poorer survival compared to wtATTR. Hemodynamics are independently predictive of adverse outcomes on top of classification in the most severe prognostic stage. In the era of non-invasive diagnosis for ATTR-CM, our findings highlight the ongoing role for hemodynamic investigation in patients with ATTR-CM.
{"title":"Hemodynamic Comparison And Prognostication Of V122I Versus Wild Type Transthyretin Amyloid Cardiomyopathy","authors":"Joban Vaishnav ,&nbsp;Lisa R Yanek ,&nbsp;Bairavi Shankar ,&nbsp;Artrish Jefferson ,&nbsp;Yazan Alshawkan ,&nbsp;Daniel Tsottles ,&nbsp;Serena Zampino ,&nbsp;Godoy Lola ,&nbsp;Vivek Jani ,&nbsp;Mark Ranek ,&nbsp;Michael Polydefkis ,&nbsp;Kavita Sharma","doi":"10.1016/j.cardfail.2024.10.036","DOIUrl":"10.1016/j.cardfail.2024.10.036","url":null,"abstract":"<div><h3>Introduction</h3><div>Transthyretin amyloid cardiomyopathy (ATTR-CM), in particular V122I disease, is a highly morbid cause of heart failure (HF). There are limited contemporary data on hemodynamic prognostication in ATTR-CM. We aimed to compare hemodynamics and evaluate prognostic significance in patients with V122I and wild type (wt) ATTR-CM.</div></div><div><h3>Hypothesis</h3><div>We hypothesize that patients with V122I will have more hemodynamic abnormalities and that hemodynamics will have additive prognostic value in ATTR-CM.</div></div><div><h3>Methods</h3><div>Patients with either V122I or wtATTR-CM who underwent RHC at our center were included. Hemodynamic abnormalities by each group and prognostic relevance by classic cut offs with endpoint of death was assessed. Characteristics for V122I or wtATTR-CM were compared using chi-squared or Fisher's exact tests, or t-tests or Wilcoxon tests. Kaplan-Meier curves and Cox proportional hazard regression models were used to assess relationships with mortality and the composite of mortality or HF hospitalization.</div></div><div><h3>Results</h3><div>Of 152 patients, 73 (48%) had V122I variant. V122I vs wtATTR patients were younger (72.7 [7.4] v 78.5 [7.3] yrs), more likely Black (94.5 v 17.7%), and NHYA Class III or IV (53.8 v 35.1%), all p&lt;0.05, with no significant difference in National Amyloid Center (NAC) staging. On RHC, V122I patients were more likely to have abnormal filling pressures compared to wtATTR including mRA &gt;8 (61.1% v 43.8%), mPAP &gt;25 (75.0% v 54.8%), PCWP &gt;18 (56.9% v 38.4%), all p&lt;0.05. CI was low in the majority of patients and not different by V122I v wtATTR (CI &lt;2.2: 82.6% v 80.3%, p=0.72, CI &lt;1.8: 56.5% v 53.5%, p=0.72). V122I patients with abnormal mPAP, PCWP, and CI had significantly lower survival when compared to V122I patients with normal parameters and wtATTR patients with normal and abnormal parameters (<strong>Figure</strong>). Hemodynamics independently predicted risk on top of NAC stage 3 disease (p&lt;0.05 for all parameters, <strong>Table</strong>).</div></div><div><h3>Conclusion</h3><div>The majority of patients with ATTR-CM have abnormal hemodynamics, with greater derangement in V122I disease. In patients with abnormal hemodynamics, V122I patients had poorer survival compared to wtATTR. Hemodynamics are independently predictive of adverse outcomes on top of classification in the most severe prognostic stage. In the era of non-invasive diagnosis for ATTR-CM, our findings highlight the ongoing role for hemodynamic investigation in patients with ATTR-CM.</div></div>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 1","pages":"Page 192"},"PeriodicalIF":6.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143142031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Virtual Simulation-based Continuing Medical Education Improves Management Of Patients With Infiltrative Cardiomyopathy
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.10.062
Margaret Harris, Catherine Capparelli

Introduction

The ability of virtual patient simulation (VPS) case-based interventions to improve clinical decision making for patients with infiltrative cardiomyopathy is unknown.

Methods

Two patient cases were presented using a VPS platform where learners could order tests, make diagnoses, and order treatments in a manner matching the scope and depth of actual practice. Clinical decisions were analyzed, and learners received clinical guidance (CG) based on current evidence and expert recommendations. Learners could modify their decisions post-CG. Pre-(baseline) vs. post-CG decisions were compared using McNemar's test. The intervention launched May of 2023 and data were collected through February, 2024.

Results

Overall, 714 physicians participated (399 case 1, 315 case 2). Physician specialties included cardiologists (59%), primary care physicians (PCPs) (30%), and neurologists (11%). Significant improvements were seen for appropriate patient assessment and diagnosis of transthyretin cardiomyopathy (ATTR-CM) and treatment selection in the overall learner population (Table). Despite improvements, approximately 2/3 of learners were still unable to make appropriate diagnosis of ATTR-CM or treatment selection post-CG, respectively (Table). Learners who ordered the appropriate patient assessments were more likely to tailor appropriate treatments for patients (67% post-CG vs 17% post-CG). For those who ordered appropriate treatment, 63% appropriately selected transthyretin stabilization therapy and 72% selected gene silencer therapy for case 1; 84% correctly selected transthyretin stabilization therapy for case 2.

Conclusion

Case-based infiltrative cardiomyopathy intervention employing VPS was associated with improvements in diagnosis of ATTR-CM and therapeutic decision-making among cardiologists, PCPs, and neurologists. Despite the observed improvements, gaps remain in diagnosing and selecting appropriate treatment strategies for patients with infiltrative cardiomyopathy.
{"title":"Virtual Simulation-based Continuing Medical Education Improves Management Of Patients With Infiltrative Cardiomyopathy","authors":"Margaret Harris,&nbsp;Catherine Capparelli","doi":"10.1016/j.cardfail.2024.10.062","DOIUrl":"10.1016/j.cardfail.2024.10.062","url":null,"abstract":"<div><h3>Introduction</h3><div>The ability of virtual patient simulation (VPS) case-based interventions to improve clinical decision making for patients with infiltrative cardiomyopathy is unknown.</div></div><div><h3>Methods</h3><div>Two patient cases were presented using a VPS platform where learners could order tests, make diagnoses, and order treatments in a manner matching the scope and depth of actual practice. Clinical decisions were analyzed, and learners received clinical guidance (CG) based on current evidence and expert recommendations. Learners could modify their decisions post-CG. Pre-(baseline) vs. post-CG decisions were compared using McNemar's test. The intervention launched May of 2023 and data were collected through February, 2024.</div></div><div><h3>Results</h3><div>Overall, 714 physicians participated (399 case 1, 315 case 2). Physician specialties included cardiologists (59%), primary care physicians (PCPs) (30%), and neurologists (11%). Significant improvements were seen for appropriate patient assessment and diagnosis of transthyretin cardiomyopathy (ATTR-CM) and treatment selection in the overall learner population (<strong>Table</strong>). Despite improvements, approximately 2/3 of learners were still unable to make appropriate diagnosis of ATTR-CM or treatment selection post-CG, respectively (<strong>Table</strong>). Learners who ordered the appropriate patient assessments were more likely to tailor appropriate treatments for patients (67% post-CG vs 17% post-CG). For those who ordered appropriate treatment, 63% appropriately selected transthyretin stabilization therapy and 72% selected gene silencer therapy for case 1; 84% correctly selected transthyretin stabilization therapy for case 2.</div></div><div><h3>Conclusion</h3><div>Case-based infiltrative cardiomyopathy intervention employing VPS was associated with improvements in diagnosis of ATTR-CM and therapeutic decision-making among cardiologists, PCPs, and neurologists. Despite the observed improvements, gaps remain in diagnosing and selecting appropriate treatment strategies for patients with infiltrative cardiomyopathy.</div></div>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 1","pages":"Page 204"},"PeriodicalIF":6.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143142046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating The Trends In The Reported Adverse Events Related To Impella: Insights From The US FDA MAUDE Database
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-01 DOI: 10.1016/j.cardfail.2024.10.046
Harsha Sai Sreemantula, Stanley Yong, Sai Abhishek Narra, Vartika Singh, John J Finley

Background

In recent years, there has been an increasing demand for left ventricular mechanical assist devices, and one of the commonly used such devices includes Impella. This study evaluates the trends associated with Impella based on the data reported from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE).

Methods

The MAUDE database was queried using the identifier code "OZD" from January 2020 to December 2023 to identify adverse events associated with Impella. The entries were then analyzed for Gender, Access site, type of Impella, indication, and type of complication. The percentages of Device types, Gender, Access site, Indications and Complications across various Impella models were then calculated.

Results

In our cohort of 5100 reported events, 4543 were included for analysis after excluding reports with duplicates and insufficient information. Among those, the highest reported were Impella CP (54.37%) and Impella 5.5 (36.10%) across device types, Male (58.82%) across gender, Acute Myocardial infarction/High-Risk Coronary PCI (36.94%) across indications, Femoral (15.14%) across access site and Bleeding/Hematoma (22.98%) across complications with a nonnegligible contribution from unspecified information in some. Further trends, including complications under each impella device, are in Table 1, Table 2, and Figure 1.

Conclusion

These findings highlight the need for continued surveillance and comparative analyses of different Impella models to optimize patient outcomes. Further studies into complications associated with these devices may bring about the need for specific mitigation strategies to prevent them in the future. At the same time, certain limitations exist in using such databases, such as the inability to calculate the incidences, underreporting of events and furthermore .
{"title":"Evaluating The Trends In The Reported Adverse Events Related To Impella: Insights From The US FDA MAUDE Database","authors":"Harsha Sai Sreemantula,&nbsp;Stanley Yong,&nbsp;Sai Abhishek Narra,&nbsp;Vartika Singh,&nbsp;John J Finley","doi":"10.1016/j.cardfail.2024.10.046","DOIUrl":"10.1016/j.cardfail.2024.10.046","url":null,"abstract":"<div><h3>Background</h3><div>In recent years, there has been an increasing demand for left ventricular mechanical assist devices, and one of the commonly used such devices includes Impella. This study evaluates the trends associated with Impella based on the data reported from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE).</div></div><div><h3>Methods</h3><div>The MAUDE database was queried using the identifier code \"OZD\" from January 2020 to December 2023 to identify adverse events associated with Impella. The entries were then analyzed for Gender, Access site, type of Impella, indication, and type of complication. The percentages of Device types, Gender, Access site, Indications and Complications across various Impella models were then calculated.</div></div><div><h3>Results</h3><div>In our cohort of 5100 reported events, 4543 were included for analysis after excluding reports with duplicates and insufficient information. Among those, the highest reported were Impella CP (54.37%) and Impella 5.5 (36.10%) across device types, Male (58.82%) across gender, Acute Myocardial infarction/High-Risk Coronary PCI (36.94%) across indications, Femoral (15.14%) across access site and Bleeding/Hematoma (22.98%) across complications with a nonnegligible contribution from unspecified information in some. Further trends, including complications under each impella device, are in Table 1, Table 2, and Figure 1.</div></div><div><h3>Conclusion</h3><div>These findings highlight the need for continued surveillance and comparative analyses of different Impella models to optimize patient outcomes. Further studies into complications associated with these devices may bring about the need for specific mitigation strategies to prevent them in the future. At the same time, certain limitations exist in using such databases, such as the inability to calculate the incidences, underreporting of events and furthermore .</div></div>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 1","pages":"Pages 196-197"},"PeriodicalIF":6.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143142288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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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Journal of Cardiac Failure
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