Implications of the proposed memo on the national coverage decision for durable mechanical circulatory support device therapy

2020 ◽  
Vol 44 (12) ◽  
pp. 1248-1250
Author(s):  
Francis D. Pagani
Keyword(s):  
Mechanical Circulatory Support ◽  
Circulatory Support ◽  
Device Therapy ◽  
Coverage Decision ◽  
Support Device ◽  
Mechanical Circulatory Support Device ◽  
Circulatory Support Device

scholarly journals Inhaled nitric oxide preserves ventricular function during resuscitation using a percutaneous mechanical circulatory support device in a porcine cardiac arrest model: an echocardiographic myocardial work analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Christoph Nix ◽  
Rashad Zayat ◽  
Andreas Ebeling ◽  
Andreas Goetzenich ◽  
Uma Chandrasekaran ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Cardiac Arrest ◽  
Mechanical Circulatory Support ◽  
Left Ventricular ◽  
Inhaled Nitric Oxide ◽  
Circulatory Support ◽  
Support Device ◽  
Mechanical Circulatory Support Device ◽  
Rv Function ◽  
Circulatory Support Device

Abstract Background Resuscitation using a percutaneous mechanical circulatory support device (iCPR) improves survival after cardiac arrest (CA). We hypothesized that the addition of inhaled nitric oxide (iNO) during iCPR might prove synergistic, leading to improved myocardial performance due to lowering of right ventricular (RV) afterload, left ventricular (LV) preload, and myocardial energetics. This study aimed to characterize the changes in LV and RV function and global myocardial work indices (GWI) following iCPR, both with and without iNO, using 2-D transesophageal echocardiography (TEE) and GWI evaluation as a novel non-invasive measurement. Methods In 10 pigs, iCPR was initiated following electrically-induced CA and 10 min of untreated ventricular fibrillation (VF). Pigs were randomized to either 20 ppm (20 ppm, n = 5) or 0 ppm (0 ppm, n = 5) of iNO in addition to therapeutic hypothermia for 5 h following ROSC. All animals received TEE at five pre-specified time-points and invasive hemodynamic monitoring. Results LV end-diastolic volume (LVEDV) increased significantly in both groups following CA. iCPR alone led to significant LV unloading at 5 h post-ROSC with LVEDV values reaching baseline values in both groups (20 ppm: 68.2 ± 2.7 vs. 70.8 ± 6.1 mL, p = 0.486; 0 ppm: 70.8 ± 1.3 vs. 72.3 ± 4.2 mL, p = 0.813, respectively). LV global longitudinal strain (GLS) increased in both groups following CA. LV-GLS recovered significantly better in the 20 ppm group at 5 h post-ROSC (20 ppm: − 18 ± 3% vs. 0 ppm: − 13 ± 2%, p = 0.025). LV-GWI decreased in both groups after CA with no difference between the groups. Within 0 ppm group, LV-GWI decreased significantly at 5 h post-ROSC compared to baseline (1,125 ± 214 vs. 1,835 ± 305 mmHg%, p = 0.011). RV-GWI was higher in the 20 ppm group at 3 h and 5 h post-ROSC (20 ppm: 189 ± 43 vs. 0 ppm: 108 ± 22 mmHg%, p = 0.049 and 20 ppm: 261 ± 54 vs. 0 ppm: 152 ± 42 mmHg%, p = 0.041). The blood flow calculated by the Impella controller following iCPR initiation correlated well with the pulsed-wave Doppler (PWD) derived pulmonary flow (PWD vs. controller: 1.8 ± 0.2 vs. 1.9 ± 0.2L/min, r = 0.85, p = 0.012). Conclusions iCPR after CA provided sufficient unloading and preservation of the LV systolic function by improving LV-GWI recovery. The addition of iNO to iCPR enabled better preservation of the RV-function as determined by better RV-GWI. Additionally, Impella-derived flow provided an accurate measure of total flow during iCPR.

A simulation tool for mechanical circulatory support device interaction with diseased states

2020 ◽  
Vol 23 (2) ◽  
pp. 124-132
Author(s):  
David J. Horvath ◽  
Dennis W. Horvath ◽  
Jamshid H. Karimov ◽  
Barry D. Kuban ◽  
Takuma Miyamoto ◽  
...  
Keyword(s):  
Mechanical Circulatory Support ◽  
Circulatory Support ◽  
Simulation Tool ◽  
Support Device ◽  
Mechanical Circulatory Support Device ◽  
Device Interaction ◽  
Circulatory Support Device

P1712The Impella percutaneous mechanical circulatory support device in cardiogenic shock: a single-center, real-world, observational experience

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Pazzanese ◽  
M B Ancona ◽  
L F Bertoldi ◽  
M Pagnesi ◽  
C Marini ◽  
...  
Keyword(s):  
Real World ◽  
Mechanical Circulatory Support ◽  
Independent Predictor ◽  
Left Ventricular ◽  
Circulatory Support ◽  
Single Center ◽  
All Cause Mortality ◽  
Support Device ◽  
Mechanical Circulatory Support Device ◽  
Circulatory Support Device

Abstract Background The Impella () percutaneous mechanical circulatory support device is a catheter-based, impeller-driven, axial-flow pump. It reduces left ventricular (LV) stroke work and myocardial oxygen demand while increasing systemic and coronary perfusion in the setting of cardiogenic shock (CS). Purpose The aim of the study was to evaluate clinical characteristics and outcomes of patients with CS treated with Impella at our center. Methods Our single-center, real-world, observational registry included all consecutive patients with CS treated with Impella 2.5, CP, 5.0, or RP at our center from February 2013 to June 2018. Indication for Impella implantation was CS, defined as hypotension (systolic blood pressure <90 mmHg) despite adequate filling status with signs of hypoperfusion. Results A total of 130 patients were included in the registry, mean age was 61±12 years, and 79.2% were males. A history of prior MI, chronic heart failure, and chronic kidney disease was present in 28.9%, 26.1%, and 18.3%, respectively. The etiologies of CS were the following: fulminant myocarditis in 6.1% of the patients, acute coronary syndromes in 59.2%, peri-procedural CS during ventricular tachycardia ablation in 7.7% and acute heart failure in 27%. Out-of-hospital cardiac arrest was present in 30.4% of the patients; 60.2% were in INTERMACS I class at presentation. At admission, mean arterial pressure (MAP) was 65±18 mmHg, serum lactate was 6.7±5.5 mmol/L, mean left ventricular ejection fraction 21.4±11.7%, right ventricular dysfunction was indeed present in 48.6% of the patients. Inotropic drugs support was used in 66.4% of the patients. Impella 2.5, CP, and 5.0 were implanted in 76.1%, 15.4%, and 1.5% of the patients, respectively. Impella RP was also used in 11.5% of patients.The mean duration of support was 135±167 hours. Of note, extra-corporeal membrane oxygenation (ECMO) and intra-aortic balloon pump (IABP) were implanted before Impella insertion in 42.8% and 46.7% of the patients, respectively. Escalation to ECMO, ventricular assist device, or heart transplantation was needed in 35.8% of the patients. During hospital stay, acute kidney injury occurred in 56.7% of the patients; need of renal replacement therapy (RRT) 31.7%; access site-related bleeding 14.3%; life-threatening bleeding 31.5%; acute limb ischemia 14.5%; hemolysis 33.3%. The rate of all-cause mortality at 30 day was 39.7%. Need of RRT was the only independent predictor of 30-day mortality (OR 6.56; CI 1.71–25.15; p=0.006). Conclusion Our single-center, real-world, observational experience reports acceptable clinical outcomes after Impella implantation in a particularly complex population of patients with CS (INTERMACS class I in 60.2% of patients, prior use of ECMO in 42.8% of patients). All-cause mortality at 30 days was 39.7%, and need of RRT was the only independent predictor for 30-day mortality.

scholarly journals 174. Temporizing Surgical Measures for Deep Mechanical Circulatory Support Device Infections: Case Series Report

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S110-S110
Author(s):  
Armita Kabirpour ◽  
Daniel G Tang ◽  
Oveimar De laCruz
Keyword(s):  
Heart Transplant ◽  
Mechanical Circulatory Support ◽  
Klebsiella Oxytoca ◽  
Case Series ◽  
Circulatory Support ◽  
Bridge To Transplant ◽  
Surgical Measures ◽  
Support Device ◽  
Mechanical Circulatory Support Device ◽  
Circulatory Support Device

Abstract Background Durable mechanical circulatory support device (MCSD) use continues to grow. MCSD deep-seated infections are a serious complication. Removal of the infected hardware is not always possible. Methods Single institution retrospective review of all culture-proven deep MCSD infection (pump and/or driveline) from 2009–2019. Patients were managed with intravenous (IV) and oral (PO) antibiotics; definitive surgical interventions included incision and drainage (I&D), device replacement, and heart transplant; and temporizing surgical measures were chronic chest tube (CCT) drainage for pump pocket and mediastinum and antibiotic impregnated bead implantation for driveline infection. Outcomes were analyzed. Results Total of 29 patients identified, 23 (79%) were male. Median age at device implantation was 44 years (20–68). MCSD were 18 (62%) destination therapy and 11 (38%) bridge to transplant. MCSD included 1 Heartmate I, 17 Heartmate II, 1 Heartmate III, 4 Heartware HVAD, and 6 Syncardia TAH. The median time to infection of 258 days (43–1551), affecting pump in 8 (28%), pump + driveline in 13 (44%), and driveline in 8 (28%). Microorganisms were S. aureus in 17 (60%, MRSA 11 and MSSA 6); coag-negative staphylococci in 3 (10%); Viridans streptococci in 1; Serratia marcescens in 3; P. aeruginosa in 2; Klebsiella oxytoca in 1; Mycobacterium abscessus in 1 and C. albicans in 1. Antibiotics are given to 28 patients, 23 (80%) with initial IV for a median of 6 weeks (1–14) and 5 (17%) with initial PO, for a median of 7 weeks (2–20). Nineteen patients (83%) on IV received PO antibiotics after. 17 patients (61%) remained on chronic suppression antibiotics (13 PO, 2 IV, 2 PO and IV). Twenty-six (90%) patients had I&D, 6 (21%) had device replacement and 11 (38%) had transplant. Of 21 patients with pump infection 16 (76%) had CCT drainage of pump pocket site or mediastinum for a median of 116 days (range 10–887 days). Of 21 patients with driveline infections, 6 (29%) had antibiotic impregnated bead implants. Overall survival at 90 days was 28/29 (95%) and 24/29 (83%) at 1 year. Infection-related mortality in Table 1. Conclusion Deep MCSD infection remains a challenging clinical problem. CCT drainage (for pump) and antibiotic-impregnated bead implant (for driveline) may be temporizing options for patients unable to undergo timely device replacement or heart transplant. Disclosures All authors: No reported disclosures.

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