Remote Postdischarge Treatment of Patients With Acute Myocardial Infarction by Allied Health Care Practitioners vs Standard Care

This randomized clinical trial compares the safety and efficacy of nurse practitioner–led remote intensive management with cardiologist-led standard care for low-risk patients with acute myocardial infarction.

A cute myocardial infarction (AMI) is a leading cause of global morbidity and mortality. 16][7] Initiation and adjustment of these medications can be challenging during hospitalization, particularly among patients with borderline or low systemic blood pressure because of an emphasis on shortening length of stay and the challenges in organizing frequent face-to-face visits early after discharge. 8,9elemedicine has enabled the transition from face-toface care and is set to play a key role in the post-coronavirus disease-19 era. 10 However, there are few randomized clinical trials on the remote management of AMI after discharge.Therefore, we evaluated the safety and efficacy of postdischarge telehealth-enabled, allied health care practitioner-led remote intensive management (RIM) of AMI.

Methods
Improving Remodeling in Acute Myocardial Infarction Using Live and Asynchronous Telemedicine (IMMACULATE) was a multicenter randomized clinical trial of 6-month RIM compared with standard care (SC) among patients with recent AMI and who had a predischarge whole-blood N-terminal pro-btype natriuretic peptide (NT-pro-BNP) concentration more than 300 pg/mL (trial protocol and statistical analysis plan are available in Supplement 1; eMethods in Supplement 2).The National Healthcare Group Domain Specific Review Board approved the study for all 3 hospitals (National University Heart Centre, National Heart Centre, and Tan Tock Seng Hospital in Singapore), and all participants gave written informed consent.Patients were enrolled from July 8, 2015, to March 29, 2019.
Eligible participants were randomized 1:1 to RIM or SC.Baseline cardiac magnetic resonance imaging was performed between 5 to 10 days of the index admission and repeated at 6 months (image acquisition and analysis are available in Supplement 3).
Participants randomized to RIM transmitted twice-daily blood pressure and heart rate measurements using a Bluetoothenabled device immediately after the baseline cardiac magnetic resonance imaging (eFigure 1 in Supplement 2).Weekly consultations were conducted via telephone for 2 months and then every 2 weeks for 4 months by nurse practitioners (C.-Y Lee, J.G., C.-Y. Lo, and K.W.L.K.) who remotely adjusted ACE-I/ARBs and β-blockers according to a standardized algorithm (page 29 of the trial protocol in Supplement 1).The first measurements of serum creatinine and potassium concentration were performed at 30 days unless the nurse practitioners determined that earlier testing was required.Participants randomized to SC received regular face-to-face consultations with their cardiologists who would perform the medication adjustment.
The primary safety end point was a composite of hospitalization due to hypotension, bradycardia, hyperkalemia, or acute kidney injury.The primary efficacy end point was the indexed LV end-systolic volume (LVESV) at 6 months, adjusted for baseline LVESV.The secondary efficacy end points were LV ejection fraction and indexed LV mass at 6 months, reduction in NT-proBNP less than 20% from baseline to 6 months, difference in NT-proBNP concentration at 6 months, and β-blocker and ACE-I/ARB dose intensity at 1 month and 6 months (eMethods and eTable 1 in Supplement 2).
The mean difference in LVESV, LVEF, LV mass index, and NT-proBNP at 6 months was compared using the t test, and adjustment for the respective baseline measurements was made using the analysis of covariance test 11 (Supplement 1).Stata version 16 (StataCorp) was used.Two-sided P values were significant at .05. Analysis began March 26, 2020.

Results
Of 489 participants enrolled, 301 participants had NT-proBNP concentration more than 300 pg/mL and were randomized to RIM (149 [49.5%]  1); 130 RIM participants (87.2%) and 124 SC participants (81.6%) completed both baseline and 6-month scans and had images of sufficient quality to be included in the primary efficacy analysis.
The primary safety end point occurred in 0 RIM participants and 2 SC participants (1.4%) (Table 2).Twenty-three participants experienced 23 adverse events in the RIM group, and 19 participants experienced 22 adverse events in the SC group (eTable 2 in Supplement 2).Twenty-one participants experienced 19 serious adverse events in the RIM group, and 21 participants experienced 24 serious adverse events in the SC group (eTable 3 in Supplement 2).

Key Points
Question Is remote postdischarge treatment of low-risk patients with acute myocardial infarction by a centralized nurse clinician team under physician supervision feasible and safe?Findings In this multicenter randomized clinical trial of 301 participants, there were no significant differences in safety events, medication adjustment, or left ventricular reverse remodeling outcomes in low-risk patients with acute myocardial infarction treated for 6 months after discharge by a centralized nurse practitioner-led telehealth program compared with standard in-person care by a cardiologist.
Meaning Remote telehealth-enabled allied health care practitioner-led postdischarge management of low-risk patients with acute myocardial infarction is feasible and should be studied in higher-risk acute myocardial infarction cohorts.
Downloaded From: https://jamanetwork.com/ by a University College London User on 11/17/2022 There was no significant difference in β-blocker dose intensity at 1 and 6 months; the adjusted mean difference in β-blocker dose intensity over 6 months between RIM and SC groups was 0.12 (95% CI, −0.02 to 0.26; P = .10).There was a nonsignificant increase in ACE-I/ARB dose intensity with RIM over SC at 1 and 6 months; the adjusted mean difference in ACE-I/ARB dose intensity over 6 months was 0.19 (95% CI, −0.02 to 0.40; P = .07).

Discussion
Among patients hospitalized for AMI with predischarge NT-proBNP concentration more than 300 pg/mL, RIM, consisting of frequent remote consultation and medication adjustment led by nurse practitioners, had similarly low safety events and achieved similar dose intensities of ACE-I/ARBs and β-blockers but did not improve the indexed LVESV at 6 months compared with face-to-face cardiologist-led SC.
Other trials have tested telemedicine strategies to follow up and adjust medications in patients after hospitalization for heart failure. 12Instead, the IMMACULATE trial tested remote intensive follow-up and drug adjustment for patients in the early post-MI period.The limited window for ameliorating adverse post-MI remodeling presents itself as a unique opportunity for more cost-effective telemedicine deployment 1 in contrast with chronic heart failure, which requires potentially a Rerandomized numbers and total randomized numbers are mutually exclusive.Ten participants had to be rerandomized because of carbon 11 -labeled acetate quality control failure in a position emission tomography substudy.b A total of 136 participants successfully underwent remote intensive management after baseline cardiac magnetic resonance imaging.c A total of 13 participants did not receive remote intensive management because 7 participants withdrew before baseline cardiac magnetic resonance imaging and 6 had claustrophobia.d A total of 139 participants underwent standard care after baseline cardiac magnetic resonance imaging.e A total of 13 participants did not receive standard care because 8 participants withdrew before baseline cardiac magnetic resonance imaging and 5 had claustrophobia.f Primary analysis included participants who completed both baseline and follow-up cardiac magnetic resonance imaging scans and had images that were interpretable.
perpetual deployment of telemedicine services to prevent recurrent hospitalization over a patient's health span. 11ossible explanations for the present trial's neutral primary end point were a lower-than-expected risk of participants enrolled with relatively young age, early revascularization, and preserved LVEF.

Limitations
Our study had several limitations.First, this trial was conducted at 3 tertiary cardiac centers, and our telemedicine unit was managed by nurse practitioners with a master's degree in nursing and more than 10 years of nursing experience.As such, our findings may not be generalizable to allied health care professionals in other health care settings.Second, only 2 RIM participants were lost to follow-up compared with 9 SC participants, which could have biased the comparison of outcomes.Third, despite the reassuringly small number of adverse events attributable to RIM, these salutary safety signals need further validation in a larger trial of higher-risk patients with reduced LVEF or heart failure.

Conclusions
Among patients hospitalized for AMI with elevated NT-proBNP concentration and preserved LVEF, a 6-month postdischarge multicenter RIM program by a centralized allied health care team had an equally low number of safety events and achieved similar β-blocker and ACE-I/ARB doses but did not improve LV remodeling outcomes compared with face-toface SC by cardiologists.This feasibility study demonstrates the potential for RIM to be tested on a higher-risk AMI population with reduced LVEF or heart failure.

Table 2 .
Six-Month Effect (95% CI) of RIM vs SC on Primary and Secondary Outcomes