Efficacy and safety of hydro-mechanical defragmentation in intermediate- and high-risk pulmonary embolism

Ayman K M Hassan, Heba Ahmed, Yousef Ahmed, Abd-Elazim Abo Elfadl, Amany Omar, Ayman K M Hassan, Heba Ahmed, Yousef Ahmed, Abd-Elazim Abo Elfadl, Amany Omar

Abstract

Background: Pulmonary embolism (PE) is the third most common acute cardiovascular syndrome. Percutaneous catheter directed hydro-mechanical defragmentation (HMD) is one of the recommended treatment options for PE in patients with contraindications to thrombolytic therapy or failed systemic thrombolysis (ST). We aimed to identify the safety and outcomes of catheter directed HMD in patients with high-risk PE. This nonrandomized controlled trial enrolled all patients with confirmed diagnoses of high- and intermediate-high-risk PE from October 2019 till January 2021. Fifty patients were included and divided into two groups by the PE response team according to the presence or absence of a contraindication for ST. Group B (ST) consists of 25 patients and group A (HMD) of 25 patients who cannot receive ST.

Results: The two groups were comparable regarding baseline clinical characteristics with mean age 51 ± 13 years. In group A, systolic blood pressure (BP) and oxygen saturation increased after 24 h (p = 0.002) and 48 h (p < 0.001) compared to pre-HMD procedure. Mean pulmonary artery systolic pressure (PASP) and respiratory rate (RR) decreased after 48 h and at 30 days (p < 0.001) compared to pre-HMD procedure. The increase in systolic BP and oxygen saturation were significantly higher in HMD group compared with ST group after 48 h and at 30 days (p < 0.007). The decrease in PASP and RR was significantly higher in HMD group compared to ST group after 48 h and at 30 days (p < 0.001). Mortality rate at 30 days was 20% in HMD group compared to 32% in ST group.

Conclusions: Catheter directed HMD for high-risk and intermediate-high-risk PE is safe and effective with acceptable mortality Trial registration Clinical trial ID: NCT04099186.

Keywords: Catheter-directed therapy; High risk; Hydro-mechanical defragmentation; Pulmonary embolism; Systemic thrombolysis.

Conflict of interest statement

No conflict of interest.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of the study population. All 166 patients were first diagnosed by PERT who decide the treatment strategy. HMD: hydro-mechanical defragmentation, ST = systemic thrombolysis, PERT = pulmonary embolism response team, PE: pulmonary embolism, pt. = patients, ECHO = echocardiography, SO2 = oxygen saturation
Fig. 2
Fig. 2
Pigtail catheter in different patients’ pulmonary artery. a Pigtail cath. In right main pulmonary artery (PA) with thrombus seen at tip of catheter using 20-ml contract injection. b The pigtail cath. in left main PA showing a thrombus at tip of cath. before fragmentation. Clips of patient spinal surgery is seen in both frames. c Pigtail cath. in main PA before bifurcation in another patient using right jugular vein for cath. insertion. d Pigtail cath.in left PA after successful fragmentation with residual thrombus in distal LPA but opened distal vessels
Fig. 3
Fig. 3
Rate of change in systolic blood pressure and pulmonary artery systolic pressure between study groups at admission and during follow-up
Fig. 4
Fig. 4
Rate of change in respiratory rate and oxygen saturation between study groups at admission and during follow-up

References

    1. Konstantinides SV, Meyer G, Galié N, et al. ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS) Eur Respir J. 2019 doi: 10.1183/13993003.01647-2019.
    1. Piazza G, Hohlfelder B, Jaff MR, et al. A prospective, single-arm, multicenter trial of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute massive and submassive pulmonary embolism: the SEATTLE II study. JACC Cardiovasc Interv. 2015;8(10):1382–1392. doi: 10.1016/j.jcin.2015.04.020.
    1. Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2 SUPPL.):e419S–e496S. doi: 10.1378/chest.11-2301.
    1. Kucher N, Goldhaber SZ. Management of massive pulmonary embolism. Circulation. 2005 doi: 10.1161/circulationaha.105.551374.
    1. Piazza G. Submassive pulmonary embolism. JAMA. 2013;309(2):171–180. doi: 10.1001/jama.2012.164493.
    1. Chatterjee S, Chakraborty A, Weinberg I, et al. Thrombolysis for pulmonary embolism and risk of all-cause mortality, major bleeding, and intracranial hemorrhage: a meta-analysis. JAMA. 2014;311(23):2414–2421. doi: 10.1001/jama.2014.5990.
    1. Kuo WT, Gould MK, Louie JD, Rosenberg JK, Sze DY, Hofmann LV. Catheter-directed therapy for the treatment of massive pulmonary embolism: systematic review and meta-analysis of modern techniques. J Vasc Interv Radiol. 2009;20(11):1431–1440. doi: 10.1016/j.jvir.2009.08.002.
    1. Schmitz-Rode T, Janssens U, Schild HH, Basche S, Hanrath P, Günther RW. Fragmentation of massive pulmonary embolism using a pigtail rotation catheter. Chest. 1998;114(5):1427–1436. doi: 10.1378/chest.114.5.1427.
    1. Kuo WT. Endovascular therapy for acute pulmonary embolism. J Vasc Interv Radiol. 2012;23(2):167–179.e4. doi: 10.1016/j.jvir.2011.10.012.
    1. Abou Ali AN, Saadeddin Z, Chaer RA, Avgerinos ED. Catheter directed interventions for pulmonary embolism: current status and future prospects. Expert Rev Med Devices. 2020;17(2):103–110. doi: 10.1080/17434440.2020.1714432.
    1. Avgerinos ED, Chaer RA. Catheter-directed interventions for acute pulmonary embolism. J Vasc Surg. 2015;61(2):559–565. doi: 10.1016/j.jvs.2014.10.036.
    1. Barco S, Konstantinides S. Catheter-directed thrombolysis for acute pulmonary embolism: where do we stand? Lung India. 2017;34(3):221–222. doi: 10.4103/lungindia.lungindia_115_17.
    1. Popescu BA, Andrade MJ, Badano LP, et al. European Association of Echocardiography recommendations for training, competence, and quality improvement in echocardiography. Eur J Echocardiogr. 2009 doi: 10.1093/ejechocard/jep151.
    1. Doherty JU, Kort S, Mehran R, et al. ACC/AATS/AHA/ASE/ASNC/HRS/SCAI/SCCT/SCMR/STS 2019 appropriate use criteria for multimodality imaging in the assessment of cardiac structure and function in nonvalvular heart disease. Cardiol. 2019;73:488–516. doi: 10.1016/j.echo.2019.01.008.
    1. Raskob GE, Hull RD, Carter CJ. Heparin therapy for venous thrombosis and pulmonary embolism. Blood Rev. 1988;2(4):251–258. doi: 10.1016/0268-960X(88)90014-8.
    1. Berger T, Green J, Horeczko T, et al. Shock index and early recognition of sepsis in the emergency department: pilot study. West J Emerg Med. 2013;14(2):168–174. doi: 10.5811/westjem.2012.8.11546.
    1. Wells GA, Elliott J, Kelly S, et al. Bleeding classification system definitions. Published online 2019. Accessed May 20, 2021.
    1. Engelberger RP, Kucher N. Catheter-based reperfusion treatment of pulmonary embolism. Circulation. 2011;124(19):2139–2144. doi: 10.1161/CIRCULATIONAHA.111.023689.
    1. Kuo WT, Banerjee A, Kim PS, et al. Pulmonary embolism response to fragmentation, embolectomy, and catheter thrombolysis (PERFECT) Chest. 2015;148(3):667–673. doi: 10.1378/chest.15-0119.
    1. Kucher N, Boekstegers P, Müller OJ, et al. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014;129(4):479–486. doi: 10.1161/CIRCULATIONAHA.113.005544.
    1. Chopard R, Ecarnot F, Meneveau N. Catheter-directed therapy for acute pulmonary embolism: Navigating gaps in the evidence. Eur Hear J Suppl. 2019;21(Suppl I):I23–I30. doi: 10.1093/eurheartj/suz224.
    1. Mohan B, Aslam N, Kumar Mehra A, et al. Impact of catheter fragmentation followed by local intrapulmonary thrombolysis in acute high risk pulmonary embolism as primary therapy. Indian Heart J. 2014;66(3):294–301. doi: 10.1016/j.ihj.2014.03.024.
    1. Kuo WT, Banerjee A, Kim PS, et al. Pulmonary embolism response to fragmentation, embolectomy, and catheter thrombolysis (PERFECT): initial results from a prospective multicenter registry. In: Chest. Vol 148. American College of Chest Physicians; 2015, p. 667–673. doi:10.1378/chest.15-0119
    1. Bajaj NS, Kalra R, Arora P, et al. Catheter-directed treatment for acute pulmonary embolism: systematic review and single-arm meta-analyses. Int J Cardiol. 2016;225:128–139. doi: 10.1016/j.ijcard.2016.09.036.
    1. D’Auria S, Sezer A, Thoma F, et al. Outcomes of catheter-directed thrombolysis vs. standard medical therapy in patients with acute submassive pulmonary embolism. Pulm Circ. 2020;10(1):204589401989836. doi: 10.1177/2045894019898368.
    1. Hobohm L, Schmidt FP, Gori T, et al. In-hospital outcomes of catheter-directed thrombolysis in patients with pulmonary embolism. Eur Hear Journal Acute Cardiovasc Care. 2020 doi: 10.1093/ehjacc/zuaa026.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner