Patient acceptance: Metrics, meaning, and the “missing piece” in evaluating novel devices

Sears, Samuel F.; Force, Zachary; Khan, Saleen; Nekkanti, Rajasekhar

doi:10.1111/jce.15292

Cited by 4 publications

(4 citation statements)

References 12 publications

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“…We should also be mindful of patient factors, such as comorbid depression, that may impair decisional quality even among those who assent to clinician recommendations, as this could play a role in patient acceptance and device‐specific quality of life after ICD implantation. 46 …”

Section: Discussionmentioning

confidence: 99%

Depression and Implantable Cardioverter‐Defibrillator Implantation in Black Patients at Risk for Sudden Cardiac Death

Boursiquot,

Young,

Alhanti

et al. 2024

JAHA

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Background Black patients meeting indications for implantable cardioverter‐defibrillators (ICDs) have lower rates of implantation compared with White patients. There is little understanding of how mental health impacts the decision‐making process among Black patients considering ICDs. Our objective was to assess the association between depressive symptoms and ICD implantation among Black patients with heart failure. Methods and Results This is a secondary analysis of the VIVID (Videos to Address Racial Disparities in ICD Therapy via Innovative Designs) randomized trial, which enrolled self‐identified Black individuals with chronic systolic heart failure. Depressive symptoms were assessed by the Patient Health Questionnaire‐2 and the Mental Component Summary of the 12‐Item Short‐Form Health Survey. Decisional conflict was measured by an adapted Decisional Conflict Scale (DCS). ANCOVA was used to assess differences in Decisional Conflict Scale scores. Multivariable logistic regression was used to examine the association between depressive symptoms and ICD implantation. Among 306 participants, 60 (19.6%) reported depressed mood, and 142 (46.4%) reported anhedonia. Participants with the lowest Mental Component Summary of the 12‐Item Short‐Form Health Survey scores (poorer mental health and higher likelihood of depression) had greater decisional conflict regarding ICD implantation compared with those with the highest Mental Component Summary of the 12‐Item Short‐Form Health Survey scores (adjusted mean difference in Decisional Conflict Scale score, 3.2 [95% CI, 0.5–5.9]). By 90‐day follow‐up, 202 (66.0%) participants underwent ICD implantation. There was no association between either the Patient Health Questionnaire‐2 score or the Mental Component Summary of the 12‐Item Short‐Form Health Survey score and ICD implantation. Conclusions Depressed mood and anhedonia were prevalent among ambulatory Black patients with chronic systolic heart failure considering ICD implantation. The presence of depressive symptoms did not impact the likelihood of ICD implantation in this population.

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Section: Discussionmentioning

confidence: 99%

Depression and Implantable Cardioverter‐Defibrillator Implantation in Black Patients at Risk for Sudden Cardiac Death

Boursiquot,

Young,

Alhanti

et al. 2024

JAHA

Self Cite

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“…Medical innovation without attention to QOL and patient acceptance can create technology with limited benefits and use 11 . The current study employed both a general QOL measure (SF‐12) and a device‐specific QOL measure (FPAS) and both provided useful sensitivity to a physical health change over time and device acceptance information.…”

Section: Discussionmentioning

confidence: 99%

“…Medical innovation without attention to QOL and patient acceptance can create technology with limited benefits and use. 11 The current study employed both a general QOL measure (SF-12)…”

Section: Discussionmentioning

confidence: 99%

Patient‐reported quality of life and acceptance of the extravascular implantable cardioverter‐defibrillator: Results from pivotal study

Sears,

Harrell,

Crozier

et al. 2023

Cardiovasc electrophysiol

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IntroductionThe pivotal study of the extravascular implantable cardioverter‐defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient‐reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device.MethodsThe EV ICD Pivotal Study was a prospective, single‐arm, nonrandomized, global, premarket approval trial. Patients completed the 12‐Item Short Form Survey (SF‐12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months.ResultsFrom baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF‐12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV‐ICD or S‐ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S‐ICD and 73.0 ± 17.4, p = .004 for TV‐ICD).ConclusionThe initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6‐month follow‐up and markedly better overall acceptance of their ICD compared to a previous study with S‐ICD and TV‐ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

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“…The most significant distinction between the studies lies in the patient populations analyzed. We initially assessed device acceptance in 176 S-ICD patients and compared them with In the editorial accompanying our article, 5 Dr. Sears highlighted that patient-reported outcomes allow a comprehensive examination of the patient experience, representing the "missing piece" to full technology evaluation after safety and efficacy have been demonstrated. He also emphasized the importance of long-term follow-up, since young patients are more likely to receive these devices, and pointed out that randomized, 6,7 observational 8 trials, and metaanalyses 9 have confirmed that S-ICD is at least as effective and safe as T-ICD for preventing sudden cardiac death, with observation periods longer than 4 years.…”

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confidence: 99%

Reply to: Patient‐reported quality of life and acceptance of the extravascular implantable cardioverter‐defibrillator: Results from pivotal study

Vicentini,

Rordorf

2024

Cardiovasc electrophysiol

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Patient acceptance: Metrics, meaning, and the “missing piece” in evaluating novel devices

Cited by 4 publications

References 12 publications

Depression and Implantable Cardioverter‐Defibrillator Implantation in Black Patients at Risk for Sudden Cardiac Death

Depression and Implantable Cardioverter‐Defibrillator Implantation in Black Patients at Risk for Sudden Cardiac Death

Patient‐reported quality of life and acceptance of the extravascular implantable cardioverter‐defibrillator: Results from pivotal study

Reply to: Patient‐reported quality of life and acceptance of the extravascular implantable cardioverter‐defibrillator: Results from pivotal study

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