Clinical, Functional, and Quality of Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.

PURPOSE: To report 90-day results from the first interim analysis of the STRIKE-PE study, which is evaluating safety, effectiveness, and functional and quality of life (QoL) outcomes of Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System for the treatment of acute pulmonary embolism (PE). METHODS: STRIKE-PE is a prospective, international, multicenter study that will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT. Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and QoL assessments. RESULTS: The first 150 consecutive patients were treated with Lightning 12 CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 before thrombectomy to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four patients (2.7%) experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale and QoL measures, and the NYHA class distribution returned to that reported before the index PE. CONCLUSION: These interim results demonstrate a rapid reduction in RV/LV ratio, achieved with a fast thrombectomy time while maintaining safety. This is accompanied by improvements in 90-day functional and QoL outcomes.

Impact of Coronavirus Disease 2019 Pandemic on Cardiac Arrest and Emergency Care.

The incidence of both out-of-hospital and in-hospital cardiac arrest increased during the coronavirus disease 2019 (COVID-19) pandemic. Patient survival and neurologic outcome after both out-of-hospital and in-hospital cardiac arrest were reduced. Direct effects of the COVID-19 illness combined with indirect effects of the pandemic on patient's behavior and health care systems contributed to these changes. Understanding the potential factors offers the opportunity to improve future response and save lives.

Association of the COVID-19 Pandemic on Treatment Times for ST-Elevation Myocardial Infarction: Observations from the Los Angeles County Regional System.

Previous studies have documented longer treatment times and worse outcomes for patients with ST-elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI) during the COVID-19 pandemic. The objective of the present study was to evaluate the impact of the COVID-19 pandemic on treatment times and outcomes for patients with STEMI who underwent primary PCI within a regional system of care. This was a retrospective study using data from the Los Angeles County Emergency Medical Services Agency. Data on the emergency medical service activations were abstracted for patients with STEMI from March 19, 2020 to January 31, 2021, during the COVID-19 pandemic and for the same interval the previous year. All adult patients (≥18 years) with STEMI who underwent emergent coronary angiography were included. The primary end point was the first medical contact (FMC) to device time. The secondary end points included treatment time intervals, vascular complications, need for emergent coronary artery bypass surgery, length of hospital stay, and in-hospital mortality. During the study period, 3,017 patients underwent coronary angiography for STEMI, 1,893 patients pre-COVID-19 and 1,124 patients during COVID-19 (40% lower). A total of 2,334 patients (77%) underwent PCI. During the COVID-19 period, rates of PCI were significantly lower compared with the control period (75.1% vs 78.7%, p = 0.02). FMC to device time was shorter during the COVID-19 period compared with the control period (median 77.0 vs 81.0 minutes, p = 0.004). For patients with STEMI complicated by out-of-hospital cardiac arrest, FMC to device time was similar during the COVID-19 period compared with the control period (median 95.0 [33.0] vs 100.0 [40.0] minutes, p = 0.34). Vascular complications, the need for emergent bypass surgery, length of hospital stay, and in-hospital mortality were similar between the periods. In conclusion, in this large regional system of care, we found a relatively small but significant decrease in treatment times, yet overall, similar clinical outcomes for patients with STEMI who underwent primary PCI and were treated during the COVID-19 period compared with a control period. These findings suggest that mature cardiac systems of care were able to maintain efficient care despite the challenges of the COVID-19 pandemic.

The addition of evolocumab to maximal tolerated statin therapy improves walking performance in patients with peripheral arterial disease and intermittent claudication (Evol-PAD study).

OBJECTIVE: To test the hypothesis that in patients with peripheral arterial disease (PAD) and claudication, treated with maximal tolerated statin therapy, the addition of a monthly subcutaneous injection of evolocumab for 6 months improves treadmill walking performance. BACKGROUND: Lipid lowering therapy improves walking parameters in patients with PAD and claudication. Evolocumab decreases cardiac and limb adverse events in patients with PAD; however, the effect of evolocumab on walking performance is not known. METHODS: We performed a double-blind, randomized, placebo-controlled study to compare maximal walking time (MWT) and pain free walking time (PFWT) in patients with PAD and claudication treated with monthly subcutaneous injections of evolocumab 420 mg (n = 35) or placebo (n = 35). We also performed measurements of lower limb perfusion, brachial flow mediated dilatation (FMD), carotid intima media thickness (IMT), and serum biomarkers of PAD disease severity. RESULTS: After six-months of treatment with evolocumab MWT increased by 37.7 % (87.5 ± 24 s) compared to 1.4 % (-21.7 ± 22.9 s) in the placebo group, p = 0.01. PFWT increased by 55.3 % (67.3 ± 21.2 s) in the evolocumab group compared to 20.3 % (8.5 ± 20.3 s) in the placebo group, p = 0.051. There was no difference in lower extremity arterial perfusion measurements. FMD increased by 42.0 ± 73.9 % (1.01 ± 0.7 %) in the evolocumab group and decreased by 16.29 ± 20.06 % (0.99 ± 0.68 %) in the placebo group (p < 0.001). IMT decreased by 7.16 ± 4.6 % (0.06 ± 0.04 mm) in the evolocumab group and increased by 6.68 ± 4.9 % (0.05 ± 0.03 mm) in the placebo group, (p < 0.001). CONCLUSIONS: The addition of evolocumab to maximal tolerated statin therapy improves maximal walking time in patients with PAD and claudication, increases FMD, and decreases IMT. CONDENSED ABSTRACT: Peripheral arterial disease (PAD) impairs quality of life by causing lower extremity intermittent claudication, rest pain, or amputation. Evolocumab is a monthly injectable monoclonal antibody medication that reduces cholesterol. In this study, we randomly treated patients with PAD and claudication, and on background statin therapy, with evolocumab or placebo, and found that evolocumab improves walking performance on a treadmill test by increasing maximal walking time. We also found that evolocumab decreases plasma MRP-14 levels, a marker of PAD severity.

Impact of Coronavirus Disease 2019 Pandemic on Cardiac Arrest and Emergency Care.

The incidence of both out-of-hospital and in-hospital cardiac arrest increased during the coronavirus disease 2019 (COVID-19) pandemic. Patient survival and neurologic outcome after both out-of-hospital and in-hospital cardiac arrest were reduced. Direct effects of the COVID-19 illness combined with indirect effects of the pandemic on patient's behavior and health care systems contributed to these changes. Understanding the potential factors offers the opportunity to improve future response and save lives.

Attempted Cardiopulmonary Bypass Venous Cannula Extraction Catheter Extraction of a Rare Intracardiac Myoepithelioma.

Myoepithelioma of the soft tissue is a rare entity that can mimic myxoma when presenting within the heart. We present a case where cardiopulmonary bypass venous cannula extraction catheter removal of an intracardiac myoepithelioma was attempted with minimal debulking and subsequently required minimally invasive open-heart surgery with cardiopulmonary bypass. (Level of Difficulty: Advanced.).

Sustained Reduction in Pulmonary Artery Pressures and Hospitalizations During 2 Years of Ambulatory Monitoring.

BACKGROUND: Therapy guided by pulmonary artery (PA) pressure monitoring reduces PA pressures and heart failure hospitalizations (HFH) during the first year, but the durability of efficacy and safety through 2 years is not known. METHODS AND RESULTS: The CardioMEMS Post-Approval Study investigated whether benefit and safety were generalized and sustained. Enrollment at 104 centers in the United States included 1200 patients with NYHA Class III symptoms on recommended HF therapies with prior HFH. Therapy was adjusted toward PA diastolic pressure 8-20 mmHg. Intervention frequency and PA pressure reduction were most intense during first 90 days, with sustained reduction of PA diastolic pressure from baseline 24.7 mmHg to 21.0 at 1 year and 20.8 at 2 years for all patients. Patients completing two year follow-up (n = 710) showed similar 2-year reduction (23.9 to 20.8 mmHg), with reduction in PA mean pressure (33.7 to 29.4 mmHg) in patients with reduced left ventricular ejection. The HFH rate was 1.25 events/patient/year prior to sensor implant, 0.54 at 1 year, and 0.37 at 2 years, with 59% of patients free of HFH during follow-up. CONCLUSIONS: Reduction in PA pressures and hospitalizations were early and sustained during 2 years of PA pressure-guided management, with no signal of safety concerns regarding the implanted sensor.

The Correlation between COVID-19 Hospitalizations and Emergency Medical Services Responses for Time-Sensitive Emergencies during the COVID-19 Pandemic.

OBJECTIVE: COVID-19 has had significant secondary effects on health care systems, including effects on emergency medical services (EMS) responses for time-sensitive emergencies. We evaluated the correlation between COVID-19 hospitalizations and EMS responses for time-sensitive emergencies in a large EMS system. METHODS: This was a retrospective study using data from the Los Angeles County EMS Agency. We abstracted data on EMS encounters for stroke, ST-elevation myocardial infarction (STEMI), out-of-hospital cardiac arrest (OHCA), and trauma from April 5, 2020 to March 6, 2021 and for the same time period in the preceding year. We also abstracted daily hospital admissions and censuses (total and intensive care unit [ICU]) for COVID-19 patients. We designated November 29, 2020 to February 27, 2021 as the period of surge. We calculated Spearman's correlations between the weekly averages of daily hospital admissions and census and EMS responses overall and for stroke, STEMI, OHCA, and trauma. RESULTS: During the study period, there were 70,616 patients admitted for confirmed COVID-19, including 12,467 (17.7%) patients admitted to the ICU. EMS responded to 899,794 calls, including 9,944 (1.1%) responses for stroke, 3,325 (0.4%) for STEMI, 11,207 (1.2%) for OHCA, and 114,846 (12.8%) for trauma. There was a significant correlation between total hospital COVID-19 positive patient admissions and EMS responses for all time-sensitive emergencies, including a positive correlation with stroke (0.41), STEMI (0.37), OHCA (0.78), and overall EMS responses (0.37); and a negative correlation with EMS responses for trauma (-0.48). ICU COVID-19 positive patient admissions also correlated with increases in EMS responses for stroke (0.39), STEMI (0.39), and OHCA (0.81); and decreased for trauma (-0.53). Similar though slightly weaker correlations were found when evaluating inpatient census. During the period of surge, the correlation with overall EMS responses increased substantially (0.88) and was very strong with OHCA (0.95). CONCLUSION: We found significant correlation between COVID-19 hospitalizations and the frequency of EMS responses for time-sensitive emergencies in this regional EMS system. EMS systems should consider the potential effects of this and future pandemics on EMS responses and prepare to meet non-pandemic resource needs during periods of surge, particularly for time-sensitive conditions.

Ambulatory Pulmonary Artery Pressures After Transcatheter Edge-to-Edge Repair of the Mitral Valve in Patients With Heart Failure and Mitral Regurgitation.

The objective of this study was to assess ambulatory hemodynamics after transcatheter edge-to-edge repair (TEER) of the mitral valve. Pulmonary artery pressure (PAP) measurements from implanted sensors were collected through a remote monitoring database and linked to Medicare fee-for-service claims data. Among patients with linked data, those undergoing TEER were included if the ambulatory PAP monitor was implanted ≥3 months before TEER and ≥3 months of PAP data after TEER were available. The primary end point was diastolic PAP (dPAP) at 3 months after TEER compared with baseline. A total of 50 patients undergoing TEER between July 2014 and March 2020 were included, with an average age of 75 ± 8 years and 70% were men. dPAP was significantly lower at 3 months after TEER than baseline, -1.8 ± 4.8 mm Hg, p = 0.010. The cumulative reduction in dPAP (area under the curve) was significantly lower at 3 months after TEER, 113 ± 267 mm Hg-days, p = 0.004. A reduction in dPAP at 3 months after TEER was independently associated with a significantly lower risk of heart failure hospitalization (p = 0.023). TEER of the mitral valve is associated with a clinically relevant and sustained reduction in dPAP.

Impact of Coronavirus Disease 2019 Pandemic on Cardiac Arrest and Emergency Care.

The incidence of both out-of-hospital and in-hospital cardiac arrest increased during the coronavirus disease 2019 (COVID-19) pandemic. Patient survival and neurologic outcome after both out-of-hospital and in-hospital cardiac arrest were reduced. Direct effects of the COVID-19 illness combined with indirect effects of the pandemic on patient's behavior and health care systems contributed to these changes. Understanding the potential factors offers the opportunity to improve future response and save lives.

Contemporary treatment of below-the-knee peripheral arterial disease in patients with chronic limb threatening ischemia: Observations from the Vascular Quality Initiative.

OBJECTIVE: We sought to determine trends in percutaneous transluminal angioplasty (PTA) versus non-PTA interventions over time, as well as factors that influence the decision for non-PTA intervention. BACKGROUND: Although the optimal strategy for revascularization in patients with below-the-knee (BTK) chronic limb-threatening ischemia (CLTI) remains under investigation, PTA has been the preferred endovascular approach. Recently, there has been an increase in the use of non-PTA approaches for revascularization. METHODS: We performed a retrospective analysis of the Vascular Quality Initiative. Between 2011 and 2020, a total of 23,850 procedures corresponding to 33,098 arteries in 19,404 patients with CLTI were included. After application of exclusion criteria and removal of missing variables, 18,644 arteries were included in the study cohort. The primary analysis was factors associated with receiving non-PTA intervention. Secondary analysis included trends in PTA versus non-PTA intervention over time. RESULTS: Throughout the study period, the majority of interventions (72%) were PTA alone. The percentage of non-PTA interventions, on a per-artery basis, increased over the study period from 18% to 33%, p < 0.01. Advanced age, increasing TransAtlantic Inter-Society Consensus classification, and concomitant above-the-knee disease were associated with an increased likelihood for non-PTA intervention. In contrast, longer lesion length, insulin-dependent diabetes mellitus, bilateral disease, and discharge to location other than home were associated with an increased likelihood of PTA. CONCLUSIONS: We observed a significant increase in the percentage of non-PTA interventions for patients with CLTI requiring BTK interventions over the last decade, with lesion- and patient-specific characteristics associated with the type of endovascular approach.

Fulminant myocarditis secondary to murine typhus mimicking acute coronary syndrome.

Myocarditis is a disease with variable clinical presentation, ranging from an uncomplicated febrile illness to cardiogenic shock. Herein, we report a case of fulminant myocarditis secondary to murine typhus in a 52-year-old male that initially mimicked an acute coronary syndrome. Emergent coronary angiography showed angiographically normal coronary arteries. Left ventriculography showed global hypokinesis with an ejection fraction of 10%. The patient required mechanical support with an intra-aortic balloon pump and fully recovered. .

Use of the CardioHELP Device for Temporary Hemodynamic Support During High-Risk Percutaneous Coronary Intervention.

BACKGROUND: Temporary extracorporeal membrane oxygenation (ECMO) support for high-risk percutaneous coronary intervention (PCI) has been described in select patients, and data are limited on the CardioHELP device (Maquet). The objective of this study was to assess clinical outcomes in patients undergoing elective, high-risk PCI with CardioHELP support. METHODS: Fifteen consecutive patients receiving the CardioHELP device for elective, high-risk PCI treated at 2 medical centers were included. Patients with cardiogenic shock, cardiac arrest, or non-PCI indications for ECMO were excluded. Baseline demographics, angiographic variables, procedure-related variables, and in-hospital events were collected. RESULTS: Mean age was 71 ± 11 years, 73% were male, mean ejection fraction (EF) was 29 ± 13%, 10 patients (67%) had an EF <30%, and mean SYNTAX I score was 32 ± 11. Multivessel coronary artery disease was present in 14 patients (93%) and unprotected left main coronary artery disease was present in 4 patients (27%). PCI was successful in all patients. In-hospital mortality occurred in 3 patients (20%), 7 patients (47%) received a blood transfusion, and there were no major vascular complications. CONCLUSION: Temporary use of the CardioHELP device for high-risk PCI is associated with acceptable short-term outcome and may be a new option for patients with complex coronary artery disease and left ventricular dysfunction.

Emergency Medical Services Responses to Out-of-Hospital Cardiac Arrest and Suspected ST-Segment-Elevation Myocardial Infarction During the COVID-19 Pandemic in Los Angeles County.

Background Public health emergencies may significantly impact emergency medical services responses to cardiovascular emergencies. We compared emergency medical services responses to out-of-hospital cardiac arrest (OHCA) and ST-segment‒elevation myocardial infarction (STEMI) during the 2020 COVID-19 pandemic to 2018 to 2019 and evaluated the impact of California's March 19, 2020 stay-at-home order. Methods and Results We conducted a population-based cross-sectional study using Los Angeles County emergency medical services registry data for adult patients with paramedic provider impression (PI) of OHCA or STEMI from February through May in 2018 to 2020. After March 19, 2020, weekly counts for PI-OHCA were higher (173 versus 135; incidence rate ratios, 1.28; 95% CI, 1.19‒1.37; P<0.001) while PI-STEMI were lower (57 versus 65; incidence rate ratios, 0.87; 95% CI, 0.78‒0.97; P=0.02) compared with 2018 and 2019. After adjusting for seasonal variation in PI-OHCA and decreased PI-STEMI, the increase in PI-OHCA observed after March 19, 2020 remained significant (P=0.02). The proportion of PI-OHCA who received defibrillation (16% versus 23%; risk difference [RD], -6.91%; 95% CI, -9.55% to -4.26%; P<0.001) and had return of spontaneous circulation (17% versus 29%; RD, -11.98%; 95% CI, -14.76% to -9.18%; P<0.001) were lower after March 19 in 2020 compared with 2018 and 2019. There was also a significant increase in dead on arrival emergency medical services responses in 2020 compared with 2018 and 2019, starting around the time of the stay-at-home order (P<0.001). Conclusions Paramedics in Los Angeles County, CA responded to increased PI-OHCA and decreased PI-STEMI following the stay-at-home order. The increased PI-OHCA was not fully explained by the reduction in PI-STEMI. Field defibrillation and return of spontaneous circulation were lower. It is critical that public health messaging stress that emergency care should not be delayed.

Empagliflozin Effects on Pulmonary Artery Pressure in Patients With Heart Failure: Results From the EMBRACE-HF Trial.

BACKGROUND: Sodium glucose cotransporter 2 inhibitors (SGLT2 inhibitors) prevent heart failure (HF) hospitalizations in patients with type 2 diabetes and improve outcomes in those with HF and reduced ejection fraction, regardless of type 2 diabetes. Mechanisms of HF benefits remain unclear, and the effects of SGLT2 inhibitor on hemodynamics (filling pressures) are not known. The EMBRACE-HF trial (Empagliflozin Evaluation by Measuring Impact on Hemodynamics in Patients With Heart Failure) was designed to address this knowledge gap. METHODS: EMBRACE-HF is an investigator-initiated, randomized, multicenter, double-blind, placebo-controlled trial. From July 2017 to November 2019, patients with HF (regardless of ejection fraction, with or without type 2 diabetes) and previously implanted pulmonary artery (PA) pressure sensor (CardioMEMS) were randomized across 10 US centers to empagliflozin 10 mg daily or placebo and treated for 12 weeks. The primary end point was change in PA diastolic pressure (PADP) from baseline to end of treatment (average PADP weeks 8-12). Secondary end points included health status (Kansas City Cardiomyopathy Questionnaire score), natriuretic peptides, and 6-min walking distance. RESULTS: Overall, 93 patients were screened, and 65 were randomized (33 to empagliflozin, 32 to placebo). The mean age was 66 years; 63% were male; 52% had type 2 diabetes; 54% were in New York Heart Association class III/IV; mean ejection fraction was 44%; median NT-proBNP (N-terminal pro B-type natriuretic peptide) was 637 pg/mL; and mean PADP was 22 mm Hg. Empagliflozin significantly reduced PADP, with effects that began at week 1 and amplified over time; average PADP (weeks 8-12) was 1.5 mm Hg lower (95% CI, 0.2-2.8; P=0.02); and at week 12, PADP was 1.7 mm Hg lower (95% CI, 0.3-3.2; P=0.02) with empagliflozin versus placebo. Results were consistent for PA systolic and PA mean pressures. There was no difference in mean loop diuretic management (daily furosemide equivalents) between treatment groups. No significant differences between treatment groups were observed in Kansas City Cardiomyopathy Questionnaire scores, natriuretic peptide levels, and 6-min walking distance. CONCLUSIONS: In patients with HF and CardioMEMS PA pressure sensor, empagliflozin produced rapid reductions in PA pressures that were amplified over time and appeared to be independent of loop diuretic management. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03030222.

Endovascular Removal of Thrombus and Right Heart Masses Using the AngioVac System: Results of 234 Patients from the Prospective, Multicenter Registry of AngioVac Procedures in Detail (RAPID).

PURPOSE: To assess device and procedural safety and technical success associated with the use of the AngioVac System to remove vascular thrombi and cardiac masses. MATERIALS AND METHODS: The Registry of AngioVac Procedures in Detail (RAPID) study prospectively collected data for 234 patients receiving treatment with AngioVac at 21 sites between March 2016 and August 2019: 84 (35.9%) with caval thromboemboli (CTEs), 113 (48.3%) with right heart masses (RHMs), 20 (8.5%) with catheter-related thrombi (CRTs), and 4 (1.7%) with pulmonary emboli (PEs). Thirteen patients had a combination of procedures during the same admission. RESULTS: Using the AngioVac system, 70%-100% thrombus or mass removal was achieved in 73.6% of patients with CTEs, 58.5% of patients with RHMs, 60% of patients with CRTs, and 57.1% of patients with PEs. Extracorporeal bypass time was < 1 hour for 176 (75.2%) procedures. Estimated blood loss was < 250 mL for 179 procedures (76.5%). Mean hemoglobin decreased from 10.4 g/dL ± 2.9 preoperatively to 9.4 g/dL ± 2.6 postoperatively. Transfusions were administered in 59 procedures (25.2%) with 47 transfusions (78.2%) being ≤ 2 U. There were 36 procedure-related complications, including 1 death. CONCLUSIONS: The RAPID registry data demonstrate that the AngioVac System can be safely and effectively used to remove vascular thrombi and cardiac masses across a broad range of patient populations. The limited use of the device to remove pulmonary emboli in the present series precludes recommending the use of the AngioVac device for this indication.

Implementation of Targeted Temperature Management After Out-of-Hospital Cardiac Arrest: Observations From the Los Angeles County Regional System.

Background Despite the benefits of targeted temperature management (TTM) for out-of-hospital cardiac arrest), implementation within the United States remains low. The objective of this study was to evaluate the prevalence and factors associated with TTM use in a large, urban-suburban regional system of care. Methods and Results This was a retrospective analysis from the Los Angeles County regional cardiac system of care serving a population of >10 million residents. All adult patients aged ≥18 years with non-traumatic out-of-hospital cardiac arrest transported to a cardiac arrest center from April 2011 to August 2017 were included. Patients awake and alert in the emergency department and patients who died in the emergency department before consideration for TTM were excluded. The primary outcome measure was prevalence of TTM use. The secondary analysis were annual trends in TTM use over the study period and factors associated with TTM use. The study population included 8072 patients; 4154 patients (51.5%) received TTM and 3767 patients (46.7%) did not receive TTM. Median age was 67 years, 4780 patients (59.2%) were men, 4645 patients (57.5%) were non-White, and the most common arrest location was personal residence in 4841 patients (60.0%). In the adjusted analysis, younger age, male sex, an initial shockable rhythm, witnessed arrest, and receiving coronary angiography were associated with receiving TTM. Conclusions Within this regional system of care, use of TTM was higher than previously reported in the literature at just over 50%. Use of integrated systems of care may be a novel method to increase TTM use within the United States.

Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study.

BACKGROUND: Ambulatory hemodynamic monitoring with an implantable pulmonary artery (PA) sensor is approved for patients with New York Heart Association Class III heart failure (HF) and a prior HF hospitalization (HFH) within 12 months. The objective of this study was to assess the efficacy and safety of PA pressure-guided therapy in routine clinical practice with special focus on subgroups defined by sex, race, and ejection fraction. METHODS: This multi-center, prospective, open-label, observational, single-arm trial of 1200 patients across 104 centers within the United States with New York Heart Association class III HF and a prior HFH within 12 months evaluated patients undergoing PA pressure sensor implantation between September 1, 2014, and October 11, 2017. The primary efficacy outcome was the difference between rates of adjudicated HFH 1 year after compared with the 1 year before sensor implantation. Safety end points were freedom from device- or system-related complications at 2 years and freedom from pressure sensor failure at 2 years. RESULTS: Mean age for the population was 69 years, 37.7% were women, 17.2% were non-White, and 46.8% had preserved ejection fraction. During the year after sensor implantation, the mean rate of daily pressure transmission was 76±24% and PA pressures declined significantly. The rate of HFH was significantly lower at 1 year compared with the year before implantation (0.54 versus 1.25 events/patient-years, hazard ratio 0.43 [95% CI, 0.39-0.47], P<0.0001). The rate of all-cause hospitalization was also lower following sensor implantation (1.67 versus 2.28 events/patient-years, hazard ratio 0.73 [95% CI, 0.68-0.78], P<0.0001). Results were consistent across subgroups defined by ejection fraction, sex, race, cause of cardiomyopathy, presence/absence of implantable cardiac defibrillator or cardiac resynchronization therapy and ejection fraction. Freedom from device- or system-related complications was 99.6%, and freedom from pressure sensor failure was 99.9% at 1 year. CONCLUSIONS: In routine clinical practice as in clinical trials, PA pressure-guided therapy for HF was associated with lower PA pressures, lower rates of HFH and all-cause hospitalization, and low rates of adverse events across a broad range of patients with symptomatic HF and prior HFH. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02279888.