Graphical abstract

Introduction
- Konstantinides SV
- Meyer G
- Becattini C
- Bueno H
- Geersing GJ
- Harjola VP
- Huisman MV
- Humbert M
- Jennings CS
- Jiménez D
- Kucher N
- Lang IM
- Lankeit M
- Lorusso R
- Mazzolai L
- Meneveau N
- Ní Áinle F
- Prandoni P
- Pruszczyk P
- Righini M
- Torbicki A
- Van Belle E
- Zamorano JL
2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS).
- Stevens SM
- Woller SC
- Baumann Kreuziger L
- Bounameaux H
- Doerschug K
- Geersing GJ
- Huisman MV
- Kearon C
- King CS
- Knighton AJ
- Lake E
- Murin S
- Vintch JRE
- Wells PS
- Moores LK.
- Piazza G
- Hohlfelder B
- Jaff MR
- Ouriel K
- Engelhardt TC
- Sterling KM
- Jones NJ
- Gurley JC
- Bhatheja R
- Kennedy RJ
- Goswami N
- Natarajan K
- Rundback J
- Sadiq IR
- Liu SK
- Bhalla N
- Raja ML
- Weinstock BS
- Cynamon J
- Elmasri FF
- Garcia MJ
- Kumar M
- Ayerdi J
- Soukas P
- Kuo W
- Liu PY
- Goldhaber SZ
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.
- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
- Avgerinos ED
- Liang NL
- El-Shazly OM
- Toma C
- Singh MJ
- Makaroun MS
- Chaer RA.
- Piazza G
- Hohlfelder B
- Jaff MR
- Ouriel K
- Engelhardt TC
- Sterling KM
- Jones NJ
- Gurley JC
- Bhatheja R
- Kennedy RJ
- Goswami N
- Natarajan K
- Rundback J
- Sadiq IR
- Liu SK
- Bhalla N
- Raja ML
- Weinstock BS
- Cynamon J
- Elmasri FF
- Garcia MJ
- Kumar M
- Ayerdi J
- Soukas P
- Kuo W
- Liu PY
- Goldhaber SZ
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.
- Avgerinos ED
- Liang NL
- El-Shazly OM
- Toma C
- Singh MJ
- Makaroun MS
- Chaer RA.
Methods
- Schulman S
- Kearon C
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.
Results
- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
- Avgerinos ED
- Liang NL
- El-Shazly OM
- Toma C
- Singh MJ
- Makaroun MS
- Chaer RA.
Sekulic I, Dzudovic B, Matijasevic J, Batranovic U, Rusovic S, Mihajlovic M, Miladinovic U, Rancic N, Subotic B, Novicic N, Gavrilovic S, Boskovic-Sekulic J, Obradovic S. Ultrasound assisted thrombolysis in intermediate-risk patients with pulmonary thromboembolism [published online August 1, 2019]. Acta Cardiol doi:10.1080/00015385.2019.1646850.

- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
- Avgerinos ED
- Liang NL
- El-Shazly OM
- Toma C
- Singh MJ
- Makaroun MS
- Chaer RA.
Sekulic I, Dzudovic B, Matijasevic J, Batranovic U, Rusovic S, Mihajlovic M, Miladinovic U, Rancic N, Subotic B, Novicic N, Gavrilovic S, Boskovic-Sekulic J, Obradovic S. Ultrasound assisted thrombolysis in intermediate-risk patients with pulmonary thromboembolism [published online August 1, 2019]. Acta Cardiol doi:10.1080/00015385.2019.1646850.
- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
- Avgerinos ED
- Liang NL
- El-Shazly OM
- Toma C
- Singh MJ
- Makaroun MS
- Chaer RA.
Sekulic I, Dzudovic B, Matijasevic J, Batranovic U, Rusovic S, Mihajlovic M, Miladinovic U, Rancic N, Subotic B, Novicic N, Gavrilovic S, Boskovic-Sekulic J, Obradovic S. Ultrasound assisted thrombolysis in intermediate-risk patients with pulmonary thromboembolism [published online August 1, 2019]. Acta Cardiol doi:10.1080/00015385.2019.1646850.
- Avgerinos ED
- Liang NL
- El-Shazly OM
- Toma C
- Singh MJ
- Makaroun MS
- Chaer RA.
Study, year | Country | Study Period | Number of patients (n) | CDT device | Thrombolytic dose protocol | Contribution | Follow-up (months) | |||
---|---|---|---|---|---|---|---|---|---|---|
Total | CDT | SA | CDT | SA | ||||||
Kucher et al, 2014 9
Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014; 129: 479-486 | Germany, Switzerland | 2010-2013 | 59 | 30 | 29 | USCDT (EkoSonic Endovascular System) | tPA 1 mg/h for 5 hours then 0.5 mg/h for 10 hours | 90-day mortality, major and minor bleeding | 3 | 3 |
Avgerinos et al, 2016 10
Improved early right ventricular function recovery but increased complications with catheter-directed interventions compared with anticoagulation alone for submassive pulmonary embolism. J Vasc Surg Venous Lymphat Disord. 2016; 4: 268-275 | USA | 2009-2014 | 128 | 64 | 64 | USCDT (EkoSonic Endovascular System) or conventional CDT (Cragg-McNamara or UniFuse) | tPA 2-4 mg bolus then 0.5-1 mg/h infusion | In-hospital, 90-day, and 1-year mortality, major and minor bleeding | 12 | 12 |
Schissler et al, 2018 15 | USA | 2011-2016 | 104 | 65 | 39 | USCDT (EkoSonic Endovascular System) | Alteplase 0-5 mg bolus then 0.5-1 mg/h infusion | 1-year mortality, major and minor bleeding, RV recovery, hospital LOS | 12 | 12 |
Sista et al, 2018 22 | USA | 2013-2014 | 79 | 25 | 54 | USCDT (Ekowave) or conventional CDT (Cragg-McNamara or UniFuse) | tPA 1 mg/h for a total dose of 18-24 mg | In-hospital mortality, major bleeding, blood transfusion | - | - |
D'Auria et al, 2020 20 | USA | 2014-2016 | 198 | 99 | 99 | USCDT or conventional CDT | tPA 1 mg/h for up to 12 hours | 30-day and 1-year mortality, blood transfusion | 24 | 24 |
Kline et al, 2020 16 | USA | 2014-2019 | 130 | 40 | 90 | USCDT (EkoSonic Endovascular System) | Alteplase 2 mg bolus then 0.75 mg/h infusion | In-hospital mortality, major and minor bleeding, blood transfusion | - | - |
Sekulic et al, 2020 17 Sekulic I, Dzudovic B, Matijasevic J, Batranovic U, Rusovic S, Mihajlovic M, Miladinovic U, Rancic N, Subotic B, Novicic N, Gavrilovic S, Boskovic-Sekulic J, Obradovic S. Ultrasound assisted thrombolysis in intermediate-risk patients with pulmonary thromboembolism [published online August 1, 2019]. Acta Cardiol doi:10.1080/00015385.2019.1646850. | Serbia, Bosnia, Herzegovina | 2012-2018 | 251 | 24 | 227 | USCDT (EkoSonic Endovascular System) | Alteplase 1-2 mg/h with a dose range of 12-50 mg | 30-day mortality, major bleeding | 1 | 1 |
Stein et al, 2020 11 | USA | 2016 | 8,170 | 1,260 | 6,910 | USCDT or conventional CDT | - | In-hospital mortality | - | - |
Bradley et al, 2021 18 | USA | 2011-2018 | 42 | 21 | 21 | Conventional CDT | tPA 0.5 or 1 mg/h infusion | In-hospital mortality, minor bleeding, blood transfusion, hospital LOS | - | - |
Omaygenc et al, 2021 21 | Turkey | 2015-2019 | 30 | 14 | 16 | USCDT (EkoSonic Endovascular System) or conventional CDT | Alteplase 5 mg bolus then 1 mg/h infusion for 24 hours | Major and minor bleeding, blood transfusion | - | - |
Zulty et al, 2021 19 | USA | 2017-2019 | 214 | 37 | 177 | Conventional CDT | - | In-hospital and 90-day mortality, major and minor bleeding | 3 | 3 |
Gorgis et al, 2022 12 | USA | 2013-2019 | 384 | 192 | 192 | USCDT (EkoSonic Endovascular System) | tPA 2 mg bolus then 0.5-1 mg/h infusion for total 24 mg | In-hospital, 30-day, 90-day, and 1-year mortality, major bleeding, RV recovery, hospital LOS | 12 | 12 |
Kucher et al, 2014 | Avgerinos et al, 2016 | Schissler et al, 2018 | Sista et al, 2018 | D'Auria et al, 2020 | Kline et al, 2020 | Sekulic et al, 2020 | Stein et al, 2020 | Bradley et al, 2021 | Omaygenc et al, 2021 | Zulty et al, 2021 | Gorgis et al, 2022 | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CDT | SA | CDT | SA | CDT | SA | CDT | SA | CDT | SA | CDT | SA | CDT | SA | CDT | SA | CDT | SA | CDT | SA | CDT | SA | CDT | SA | |
Age (years) | 64 | 62 | 58.5 | 60.1 | 53.9 | 58.4 | 62 | 64 | 58 | 59 | 58 | 66 | 59.2 | 66.3 | 60 | 60 | 55.3 | 58.3 | 57.1 | 67.1 | - | - | 58.9 | 59.8 |
Male | 37% | 59% | 47% | 52% | 48% | 39% | 60% | 46% | 47% | 58% | 50% | 41% | 67% | 52% | 52% | 48% | 67% | 52% | 57% | 38% | - | - | 48% | 50% |
DM | 20% | 14% | - | - | 20% | 10% | - | - | - | - | 18% | 19% | 8% | 23% | 17% | 17% | 19% | 24% | 29% | 56% | - | - | 25% | 30% |
HTN | 67% | 52% | 52% | 50 | 46% | 56% | - | - | - | - | - | - | - | - | - | - | 62% | 48% | 14% | 13% | - | - | 59% | 58% |
Smoking | 13% | 24% | 17% | 14% | 32% | 28% | - | - | - | - | 15% | 11% | 27% | 22% | - | - | 43% | 24% | - | - | - | - | 41% | 50% |
CAD | 7% | 3% | 11% | 16% | - | - | - | - | 10% | 13% | 5% | 9% | 8% | 15% | - | - | - | - | - | - | - | - | 7% | 9% |
CHF | 7% | 3% | 3% | 11% | 2% | 3% | 4% | 4% | 4% | 2% | - | - | 8% | 22% | 1% | 0% | - | - | - | - | - | - | 5% | 7% |
Chronic lung disease | - | - | 19% | 11% | 28% | 28% | 4% | 7% | 12% | 22% | - | - | 4% | 15% | 12% | 13% | - | - | - | - | - | - | 13% | 14% |
Renal failure | 13% | 17% | - | - | 8% | 5% | - | - | - | - | - | - | 12% | 40% | 8% | 9% | 10% | 19% | - | - | - | - | 12% | 12% |
Prior stroke | 0% | 3% | - | - | - | - | - | - | - | - | - | - | 12% | 8% | - | - | - | - | - | - | - | - | - | - |
Prior DVT/PE | - | - | 22% | 5% | 23% | 28% | - | - | 19% | 27% | 15% | 24% | - | - | - | - | - | - | - | - | - | - | 27% | 34% |
Hyper-coagulable state | - | - | 6% | 14% | - | - | - | - | 8% | 2% | - | - | - | - | - | - | 0% | 5% | - | - | - | - | 3% | 5% |
Cancer | 17% | 7% | 13% | 22% | - | - | 32% | 35% | 12% | 15% | 8% | 29% | 8% | 15% | 16% | 15% | 5% | 29% | 0% | 19% | - | - | 18% | 21% |
Contraceptives | - | - | 9% | 2% | 12% | 18% | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Recent surgery | - | - | 20% | 20% | - | - | - | - | - | - | - | - | 29% | 16% | - | - | - | - | - | - | - | - | 9% | 8% |
Obesity (BMI ≥ 30 kg/m2) | - | - | - | - | 60% | 59% | - | - | - | - | 63% | 51% | 27% | 21% | - | - | - | - | 21% | 13% | - | - | - | - |



Discussion
- Avgerinos ED
- Liang NL
- El-Shazly OM
- Toma C
- Singh MJ
- Makaroun MS
- Chaer RA.
- Piazza G
- Hohlfelder B
- Jaff MR
- Ouriel K
- Engelhardt TC
- Sterling KM
- Jones NJ
- Gurley JC
- Bhatheja R
- Kennedy RJ
- Goswami N
- Natarajan K
- Rundback J
- Sadiq IR
- Liu SK
- Bhalla N
- Raja ML
- Weinstock BS
- Cynamon J
- Elmasri FF
- Garcia MJ
- Kumar M
- Ayerdi J
- Soukas P
- Kuo W
- Liu PY
- Goldhaber SZ
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.
- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
- Tapson VF
- Sterling K
- Jones N
- Elder M
- Tripathy U
- Brower J
- Maholic RL
- Ross CB
- Natarajan K
- Fong P
- Greenspon L
- Tamaddon H
- Piracha AR
- Engelhardt T
- Katopodis J
- Marques V
- Sharp ASP
- Piazza G
- Goldhaber SZ.
- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
- Piazza G
- Hohlfelder B
- Jaff MR
- Ouriel K
- Engelhardt TC
- Sterling KM
- Jones NJ
- Gurley JC
- Bhatheja R
- Kennedy RJ
- Goswami N
- Natarajan K
- Rundback J
- Sadiq IR
- Liu SK
- Bhalla N
- Raja ML
- Weinstock BS
- Cynamon J
- Elmasri FF
- Garcia MJ
- Kumar M
- Ayerdi J
- Soukas P
- Kuo W
- Liu PY
- Goldhaber SZ
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.
- Tapson VF
- Sterling K
- Jones N
- Elder M
- Tripathy U
- Brower J
- Maholic RL
- Ross CB
- Natarajan K
- Fong P
- Greenspon L
- Tamaddon H
- Piracha AR
- Engelhardt T
- Katopodis J
- Marques V
- Sharp ASP
- Piazza G
- Goldhaber SZ.
- Piazza G
- Hohlfelder B
- Jaff MR
- Ouriel K
- Engelhardt TC
- Sterling KM
- Jones NJ
- Gurley JC
- Bhatheja R
- Kennedy RJ
- Goswami N
- Natarajan K
- Rundback J
- Sadiq IR
- Liu SK
- Bhalla N
- Raja ML
- Weinstock BS
- Cynamon J
- Elmasri FF
- Garcia MJ
- Kumar M
- Ayerdi J
- Soukas P
- Kuo W
- Liu PY
- Goldhaber SZ
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.
- Tapson VF
- Sterling K
- Jones N
- Elder M
- Tripathy U
- Brower J
- Maholic RL
- Ross CB
- Natarajan K
- Fong P
- Greenspon L
- Tamaddon H
- Piracha AR
- Engelhardt T
- Katopodis J
- Marques V
- Sharp ASP
- Piazza G
- Goldhaber SZ.
- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
- Piazza G
- Hohlfelder B
- Jaff MR
- Ouriel K
- Engelhardt TC
- Sterling KM
- Jones NJ
- Gurley JC
- Bhatheja R
- Kennedy RJ
- Goswami N
- Natarajan K
- Rundback J
- Sadiq IR
- Liu SK
- Bhalla N
- Raja ML
- Weinstock BS
- Cynamon J
- Elmasri FF
- Garcia MJ
- Kumar M
- Ayerdi J
- Soukas P
- Kuo W
- Liu PY
- Goldhaber SZ
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.
- Tapson VF
- Sterling K
- Jones N
- Elder M
- Tripathy U
- Brower J
- Maholic RL
- Ross CB
- Natarajan K
- Fong P
- Greenspon L
- Tamaddon H
- Piracha AR
- Engelhardt T
- Katopodis J
- Marques V
- Sharp ASP
- Piazza G
- Goldhaber SZ.
- Konstantinides SV
- Meyer G
- Becattini C
- Bueno H
- Geersing GJ
- Harjola VP
- Huisman MV
- Humbert M
- Jennings CS
- Jiménez D
- Kucher N
- Lang IM
- Lankeit M
- Lorusso R
- Mazzolai L
- Meneveau N
- Ní Áinle F
- Prandoni P
- Pruszczyk P
- Righini M
- Torbicki A
- Van Belle E
- Zamorano JL
2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS).
- Stevens SM
- Woller SC
- Baumann Kreuziger L
- Bounameaux H
- Doerschug K
- Geersing GJ
- Huisman MV
- Kearon C
- King CS
- Knighton AJ
- Lake E
- Murin S
- Vintch JRE
- Wells PS
- Moores LK.
- Kucher N
- Boekstegers P
- Müller OJ
- Kupatt C
- Beyer-Westendorf J
- Heitzer T
- Tebbe U
- Horstkotte J
- Müller R
- Blessing E
- Greif M
- Lange P
- Hoffmann RT
- Werth S
- Barmeyer A
- Härtel D
- Grünwald H
- Empen K
- Baumgartner I.
Disclosures
Appendix. Supplementary materials
Supplementary Table 1. The risk of bias assessment of the included studies.
Supplementary Figure 1. Funnel plots for outcomes showing symmetrical distribution of studies and no evidence of publication bias.
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Dr. Goldsweig reports support from the National Institute of General Medical Sciences, Bethesda, Maryland , 1U54GM115458 , and the University of Nebraska Medical Center for Heart and Vascular Research, Omaha, Nebraska.
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