Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE‐HF
Background Diagnostic variables from insertable cardiac monitors may be useful in identifying patients at increased risk of heart failure (HF) events. High‐risk alerts must be coupled with interventions to improve outcomes. We aim to assess the safety of a predefined protocolized intervention pathwa...
Saved in:
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-10-01
|
| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.124.035501 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850284007835566080 |
|---|---|
| author | Rami Kahwash Michael R. Zile Prasad Chalasani Barry Bertolet Laura Gravelin Muhammad Shahzeb Khan Jennifer Wehking Brian Van Dorn Shantanu Sarkar Verla Laager Bart Gerritse Aimee Laechelt Javed Butler |
| author_facet | Rami Kahwash Michael R. Zile Prasad Chalasani Barry Bertolet Laura Gravelin Muhammad Shahzeb Khan Jennifer Wehking Brian Van Dorn Shantanu Sarkar Verla Laager Bart Gerritse Aimee Laechelt Javed Butler |
| author_sort | Rami Kahwash |
| collection | DOAJ |
| description | Background Diagnostic variables from insertable cardiac monitors may be useful in identifying patients at increased risk of heart failure (HF) events. High‐risk alerts must be coupled with interventions to improve outcomes. We aim to assess the safety of a predefined protocolized intervention pathway activated by insertable cardiac monitor high‐risk alerts. Methods and Results ALLEVIATE‐HF (Algorithm Using LINQ Sensors for Evaluation and Treatment of Heart Failure) Phase 1 was a randomized interventional study enrolling patients with New York Heart Association class II/III and a recent HF event. A HF risk score based on insertable cardiac monitor diagnostics, including impedance, respiration rate, atrial fibrillation burden, heart rate during atrial fibrillation, heart rate variability, and activity duration, was calculated. A protocolized intervention pathway was activated when high‐risk scores were detected that involved physician‐prescribed nurse‐implemented uptitration of diuretic for 4 days, unless safety rule‐out conditions were met. Interventions could be repeated if high‐risk scores persisted and did not require worsening symptoms. In total, 59 patients were randomized (mean age 68.2±11.8 years; 59.3% male); 67.8% with ejection fraction ≥50%. The mean follow‐up was 11.8±8.1 months. Overall, 146 high‐risk scores were recorded in 33 patients and 118 interventions occurred in 75 (51.4%) high‐risk alerts that did not meet safety rule‐out criteria. There were no serious adverse events and 13 adverse events related to interventions. In patients with symptoms at intervention initiation, symptoms resolved in 37 interventions (80%) and worsened in 8 (17%). In asymptomatic patients, symptoms developed in 3 interventions (7%). Conclusions A personalized medication intervention based on insertable cardiac monitor risk score can be safely instituted in patients with HF, irrespective of symptoms. Registration URL: https://www.clinicaltrials.gov; Unique Identifier: NCT04452149. |
| format | Article |
| id | doaj-art-6d06d9aaef18466ba5b5cc440685cb0f |
| institution | OA Journals |
| issn | 2047-9980 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-6d06d9aaef18466ba5b5cc440685cb0f2025-08-20T01:47:40ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802024-10-01132010.1161/JAHA.124.035501Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE‐HFRami Kahwash0Michael R. Zile1Prasad Chalasani2Barry Bertolet3Laura Gravelin4Muhammad Shahzeb Khan5Jennifer Wehking6Brian Van Dorn7Shantanu Sarkar8Verla Laager9Bart Gerritse10Aimee Laechelt11Javed Butler12The Ohio State University Columbus OH USAMedical University of South Carolina Charleston SC USAFlorida Heart Center Fort Pierce FL USACardiology Associates Research LLC North Mississippi Medical Center Tupelo MS USAMount Carmel Health System Columbus OH USADuke University Medical Center Durham NC USAMedtronic Mounds View MN USAMedtronic Mounds View MN USAMedtronic Mounds View MN USAMedtronic Mounds View MN USAMedtronic Bakken Research Center Maastricht NetherlandsMedtronic Mounds View MN USABaylor Scott and White Research Institute Dallas TX USABackground Diagnostic variables from insertable cardiac monitors may be useful in identifying patients at increased risk of heart failure (HF) events. High‐risk alerts must be coupled with interventions to improve outcomes. We aim to assess the safety of a predefined protocolized intervention pathway activated by insertable cardiac monitor high‐risk alerts. Methods and Results ALLEVIATE‐HF (Algorithm Using LINQ Sensors for Evaluation and Treatment of Heart Failure) Phase 1 was a randomized interventional study enrolling patients with New York Heart Association class II/III and a recent HF event. A HF risk score based on insertable cardiac monitor diagnostics, including impedance, respiration rate, atrial fibrillation burden, heart rate during atrial fibrillation, heart rate variability, and activity duration, was calculated. A protocolized intervention pathway was activated when high‐risk scores were detected that involved physician‐prescribed nurse‐implemented uptitration of diuretic for 4 days, unless safety rule‐out conditions were met. Interventions could be repeated if high‐risk scores persisted and did not require worsening symptoms. In total, 59 patients were randomized (mean age 68.2±11.8 years; 59.3% male); 67.8% with ejection fraction ≥50%. The mean follow‐up was 11.8±8.1 months. Overall, 146 high‐risk scores were recorded in 33 patients and 118 interventions occurred in 75 (51.4%) high‐risk alerts that did not meet safety rule‐out criteria. There were no serious adverse events and 13 adverse events related to interventions. In patients with symptoms at intervention initiation, symptoms resolved in 37 interventions (80%) and worsened in 8 (17%). In asymptomatic patients, symptoms developed in 3 interventions (7%). Conclusions A personalized medication intervention based on insertable cardiac monitor risk score can be safely instituted in patients with HF, irrespective of symptoms. Registration URL: https://www.clinicaltrials.gov; Unique Identifier: NCT04452149.https://www.ahajournals.org/doi/10.1161/JAHA.124.035501heart failureprotocolized intervention pathwayremote monitoringrisk metric |
| spellingShingle | Rami Kahwash Michael R. Zile Prasad Chalasani Barry Bertolet Laura Gravelin Muhammad Shahzeb Khan Jennifer Wehking Brian Van Dorn Shantanu Sarkar Verla Laager Bart Gerritse Aimee Laechelt Javed Butler Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE‐HF Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease heart failure protocolized intervention pathway remote monitoring risk metric |
| title | Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE‐HF |
| title_full | Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE‐HF |
| title_fullStr | Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE‐HF |
| title_full_unstemmed | Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE‐HF |
| title_short | Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE‐HF |
| title_sort | personalized intervention strategy based on a risk score generated from subcutaneous insertable cardiac monitor results from phase 1 of alleviate hf |
| topic | heart failure protocolized intervention pathway remote monitoring risk metric |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.124.035501 |
| work_keys_str_mv | AT ramikahwash personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT michaelrzile personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT prasadchalasani personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT barrybertolet personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT lauragravelin personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT muhammadshahzebkhan personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT jenniferwehking personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT brianvandorn personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT shantanusarkar personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT verlalaager personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT bartgerritse personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT aimeelaechelt personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf AT javedbutler personalizedinterventionstrategybasedonariskscoregeneratedfromsubcutaneousinsertablecardiacmonitorresultsfromphase1ofalleviatehf |