Other relevant studies

Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5.

Table 5 additional studies identified

Case reports, case series ≤20 without unique safety/efficacy outcomes and non-systematic narrative reviews have not been included in table 5.

Article	Number of patients and follow-up	Direction of conclusions	Reason study was not included in main evidence summary
Bunwaree, S., Roffi, M., Bonvini, J.M., et al. (2013). AngioJet® rheolytic thrombectomy: a new treatment option in cases of massive pulmonary embolism. Interventional Cardiology, 5, 71-87.	N=197 Group A (massive PE) = 76 Group B (massive + submassive PE) = 121 Systematic review of Angiojet rheolytic thrombectomy. Variable follow-up. 14 studies included: 9 (Group A) massive PE only 5 (Group B) massive and submassive PE combined population	Successful procedure (including clinical success/ technical success/ procedural successs) reported in 66/76 (86.8%) in group A, 99/105 (94.3%) group B. In Group A (reported in 5 studies) systolic PAP was reduced from pre-procedure: 55 ± 9.9 to post-procedure: 37.3 ± 18.8 and mPAP was reduced from pre-procedure: 37.8 ± 5.8 to post-procedure: 33.9 ± 8.2. In group B (reported in 4 studies) systolic PAP: pre-procedure, 48.7 ± 0.4 vs post-procedure, 37.9 ± 0.8; mPAP: pre-procedure 34.3 ± 4.9 vs post-procedure, 27.3 ± 1.2. Significance not reported. There were 31/197 (15.7%) major periprocedural events including 23 (11.6%) episodes of bradyarrhythmia and 2 (1%) transient asystole, out of which 18 (9.1%) required temporary pacemaker implantation. The review reported 6 (3%) intraprocedural deaths (all in group A)- 1 prior to device activation. The in-hospital mortality rate was 29/197 (14.7%): 13/76 (17.1%) in group A and 16/121 (13.2%) in group B. After discharge, no further deaths to 30 days. Major postprocedural events in 61/197 (30.1%) patients including 6 (3.0%) episodes of haemoptysis, 13 (6.6%) major inguinal haematomas, 2 (1%) episodes of melaena, 5 (2.5%) macro-haematuria, 2 (1%) retroperitoneal bleeding, 4 (2%) cerebral haemorrhage, 23 (11.7%) impaired renal function, 3 (1.5%) multiorgan failure and 7 (3.5%) significant thrombocytopaenia.	Older systematic review referencing solely the Angiojet device. Country of origin not detailed for studies. All but 2 of the studies included fewer than 20 participants each and most were retrospective case series lacking comparator arms. Many of the studies did not report the clinical outcomes studied and in more than 40% of the patients included, thrombolysis was given which makes interpretation of the efficacy and safety of thrombectomy difficult. Three of the included studies (Bonvini, 2013; Margheri, 2008; Chechi, 2009) are also discussed separately.
Chechi T, Vecchio S, Spaziani G, Giuliani G, Giannotti F, Arcangeli C, Rubboli A, Margheri M. Rheolytic thrombectomy in patients with massive and submassive acute pulmonary embolism. Catheter Cardiovasc Interv. 2009 Mar 1;73(4):506-13. doi: 10.1002/ccd.21858. PMID: 19235240.	N=51 Angiojet Massive and submassive PE Average follow-up 35.5 ± 21.7 months	Technical success in 92.2% Statistically significant improvement in obstruction, perfusion and Miller index in all subgroups of severity (p<0.0001) and in systolic PAP (p<0.05). 4/51 major bleeding events (7.8%) 8/51 (15.7%) in-hospital mortality (6 due to persistent/refractory shock) 3 further deaths at long term follow-up unrelated to procedure/PE	Small sample, retrospective.
Cherfan P, Abou Ali AN, Zaghloul MS, Yuo TH, Phillips DP, Chaer RA, Avgerinos ED. Propofol administration during catheter-directed interventions for intermediate-risk pulmonary embolism is associated with major adverse events. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):621-626. doi: 10.1016/j.jvsv.2020.08.026. Epub 2020 Aug 26. PMID: 32858244.	N=340 Of which: 85 catheter directed thrombolysis, 229 ultrasound-assisted thrombolysis, 26 suction thrombectomy.	36 patients (10.6%) received propofol; 304 patients (89.4%) received midazolam plus fentanyl, morphine, or hydromorphone. Overall, 18 patients had ≥1 MAE (10 intubations, 11 decompensations, 2 surgical conversions, 3 deaths). Propofol group had a statistically significantly greater adverse event rate (13.8%) vs no-propofol group (4.2%; p=0.015). 16 patients experienced major bleeding or other procedure-related events (stroke in 4 (1.17%), coronary sinus perforation in 1, tricuspid valve rupture in 1, and the need for transfusion in 10 patients). Type of intervention was not a predictive factor for any outcome.	Majority of patients had catheter thrombolysis, only 26 suction thrombectomy. Reviewing effect of anaesthetic rather than intervention directly. Retropsective.
Ciampi-Dopazo JJ, Romeu-Prieto JM, Sánchez-Casado M, Romerosa B, Canabal A, Rodríguez-Blanco ML, Lanciego C. Aspiration Thrombectomy for Treatment of Acute Massive and Submassive Pulmonary Embolism: Initial Single-Center Prospective Experience. J Vasc Interv Radiol. 2018 Jan;29(1):101-106. doi: 10.1016/j.jvir.2017.08.010. Epub 2017 Nov 6. PMID: 29102272.	N=18 Indigo Aspiration System Follow-up to discharge (median hospital stay 10 days)	Technical success in 17/18 (94.4%) and clinical success in 15/18 (83.3%). Statistically significant improvement in right ventricle size (46.36 mm ± 2.2 before treatment vs 41.79 mm ± 7.4 after; p=0.041). Two patients died with massive PE and one patient died with submassive PE. Mortality= 16.7%. Of the 4 patients who received thrombolysis, 2 experienced intracranial bleeding and 1 abdominal bleeding.	Small sample, short follow-up.
Donaldson, C.W., Baker, J.N., Narayan, R.L., Provias, T.S., Rassi, A.N., Giri, J.S., Sakhuja, R., Weinberg, I., Jaff, M.R. and Rosenfield, K. (2015), Thrombectomy using suction filtration and veno-venous bypass: Single center experience with a novel device. Cathet. Cardiovasc. Intervent., 86: E81-E87	N=14, AngioVac Mean follow-up 23 days	Indications included intracardiac mass (73%), acute PE (33%), and caval thrombus (73%). Four patients (27%) were in shock at the start of the procedure. Successful evacuation of mass in 73%. Peri-procedure mortality was 0% and in-hospital mortality 13% at a mean follow-up of 23 days. No pulmonary haemorrhages, strokes or myocardial infarctions. 73% had a post procedural drop in haematocrit with 6 of these 11 requiring transfusion. Two patients required subsequent embolectomy (one open).	Small sample, short follow-up, focuses more on right heart thrombi.
Dukkipati, R., Yang, E., Adler, S. et al. Acute kidney injury caused by intravascular hemolysis after mechanical thrombectomy. Nat Rev Nephrol 5, 112–116 (2009). https://doi.org/10.1038/ncpneph1019	N=1 Case report Angiojet	43F, 8 weeks pregnant Bilateral PE treated with Angiojet system. Intraprocedural bradycardia. Post-procedural massive intravascular haemolysis and acute kidney injury. 48 hours in ICU, haemodialysis until day 21. Fetal loss on day 7. Renal function returned to normal on day 25.	Case report.
Dumantepe, M., Teymen, B., Akturk, U. and Seren, M. (2015), The Efficacy of Rotational Thrombectomy on the Mortality of Patients with Massive and Submassive Pulmonary Embolism. J Card Surg, 30: 324-332. https://doi.org/10.1111/jocs.12521	N=36 Massive and submassive PE Aspirex percutaneous aspiration device. Mean follow-up 14.3±5.8 months.	Complete thrombus clearance (≥90%) in 83.3% and near-complete (50% to 90%) clearance in 13.8%. Statistically significant decrease (56%) in mean PAP post-procedure. Major complication rate 6.3%. Two in-hospital deaths (one from refractory shock). Two patients had a significant bradycardic episode. No major bleeding events. Total 360-day survival was 88.8%.	Small sample, retrospective case series
Eid-Lidt G, Gaspar J, Sandoval J, de los Santos FD, Pulido T, González Pacheco H, Martínez-Sánchez C. Combined clot fragmentation and aspiration in patients with acute pulmonary embolism. Chest. 2008 Jul;134(1):54-60. doi: 10.1378/chest.07-2656. Epub 2008 Jan 15. PMID: 18198243.	N=18, follow-up 12.3 ± 9.4 months. Massive PE.	Statistically significant increase in systolic blood pressure post-procedure and statistically significant decrease in mean PAP (37.1 ± 8.5 mmHg vs 32.3 ± 10.5 mmHg, p = 0.0001). In-hospital major complication rate 11.1%, one death from refractory shock. One patient had intracerebral haemorrhage with minor neurologic sequelae (deemed to be secondary to local fibrinolytic therapy). Two transitory decreases in oxygen saturation during procedure (Aspirex device) without haemodynamic instability.	Small sample
Eid-Lidt G, Gaspar J, Sandoval J, et al. Persistent pulmonary hypertension and right ventricular function after percutaneous mechanical thrombectomy in severe acute pulmonary embolism. Eur Respir J 2017; 49: 1600910 [https://doi.org/10.1183/13993003.00910-2016]	N=52 Mean follow-up 40.2 ± 16.7 months. Excluded 8 for prior pulmonary artery hypertension, 8 for right ventricular hypertrophy and 5 for follow-up < 6 months. 7 patients died in hospital and were not included in analysis.	After the procedure, the shock index (1.1±0.23 vs 0.7±0.1; p=0.019), heart rate (113±14 vs post- 86±13 bpm; p=0.005) and systolic systemic arterial pressure (100±14 vs 124±13 mmHg; p=0.005) improved. No recurrence of pulmonary embolism in-hospital. Four patients were re-admitted to hospital, two patients for recurrence of severe pulmonary embolism (4.1%) and two for complicated pneumonia. Overall survival (extra-hospital phase) at 5 years was 96.2%. Improvements in right ventricular function were mainly in the first 6 months with a 24% reduction in PAP.	Small sample
Escobar GA, Burks D, Abate MR, Faramawi MF, Ali AT, Lyons LC, Moursi MM, Smeds MR. Risk of Acute Kidney Injury after Percutaneous Pharmacomechanical Thrombectomy Using AngioJet in Venous and Arterial Thrombosis. Ann Vasc Surg. 2017 Jul;42:238-245. doi: 10.1016/j.avsg.2016.12.018. Epub 2017 Apr 13. PMID: 28412100.	N=102 (n=52 Angiojet, n=50 catheter-directed thrombolysis) Follow-up 3 days	Acute kidney injury (AKI) occurred in 29% of patients treated with Angiojet vs 8% of catheter-directed thrombolysis. Odds for AKI increased by Angiojet (OR 8.2, 95% CI 1.98-34.17, p=0.004). Concomitant open surgery and drop in haematocrit also raise the odds of AKI.	Includes use of Angiojet catheter with thrombolytic drugs, includes various arterial and venous thromboses so not specific to PE.
Gayen S, Upadhyay V, Kumaran M, Bashir R, Lakhter V, Panaro J, Criner G, Dadparvar S, Rali P. Changes in Lung Perfusion in Patients Treated with Percutaneous Mechanical Thrombectomy for Intermediate-Risk Pulmonary Embolism. Am J Med. 2022 Aug;135(8):1016-1020. doi: 10.1016/j.amjmed.2022.03.028. Epub 2022 Apr 22. PMID: 35469736.	N=3 Intermediate risk PE. FlowTriever Use of imaging for perfusion tracking	Pre-procedure and post-procedure perfusion estimation: Case 1: perfusion score improved from 5/15 pre-procedure to 12/15 within 48h and 13/15 at 3 months. Case 2: 7/15 pre-procedure to 8/15 within 72h, 10.5/15 at 3 months and 12/15 at 9 months. Case 3: 6/15 pre-procedure to 7/5/15 within 72h and 9/15 at 3 months. Overall, average lung perfusion score increased from 6/15 (40%) pre-procedure to 9.17/15 (61.1%) immediately post-procedure and 11.33/15 (75.6%) at last follow-up. No PE-related readmission within 30 days or PE-related complications.	Small sample
Graif A, Patel KD, Wimmer NJ, Kimbiris G, Grilli CJ, Upparapalli D, Kaneria AR, Leung DA. Large-Bore Aspiration Thrombectomy versus Catheter-Directed Thrombolysis for Acute Pulmonary Embolism: A Propensity Score-Matched Comparison. J Vasc Interv Radiol. 2020 Dec;31(12):2052-2059. doi: 10.1016/j.jvir.2020.08.028. Epub 2020 Nov 9. PMID: 33183975.	N=52 CDT group=26 Large-bore aspiration thrombectomy (LBAT)=26 (FlowTriever for majority)	Statistically significant decrease in systolic PAP, diastolic PAP, mean PAP, HR, and Miller score in both groups. Systolic PAP: Baseline and final systolic PAP was similar between the two groups (LBAT: 54.5 mm Hg ± 12.9 vs CDT: 54.5 mm Hg ± 16.3 at baseline, P=0.8; and LBAT: 42.5 mm Hg ± 14.1 vs CDT: 42.6 mm Hg ± 12.1, P =0.8, respectively). Heart rate: reductions not statistically significantly different between the 2 groups: (LBAT: -5.4 bpm ± 19.2 vs CDT: -9.6 bpm ± 15.8, P=0.4). Miller score: CDT demonstrated a higher reduction (-10.1 ± 3.9 vs -7.5 ± 3.8, P=0.02). Complications: LBAT had 1 minor haemorrhagic complication and 2 procedure-related deaths vs CDT resulted in 1 minor and 1 major haemorrhagic complication. ICU stay: 18/26 LBAT group and 26/26 CDT, p=0.004. Similar hospital length of stay.	Small sample, retrospective, propensity matched, non-randomised.
Kumar N, Janjigian Y, Schwartz DR. Paradoxical worsening of shock after the use of a percutaneous mechanical thrombectomy device in a postpartum patient with a massive pulmonary embolism. Chest. 2007 Aug;132(2):677-9. doi: 10.1378/chest.06-1082. PMID: 17699140.	Case report, unique safety information. Angiojet	31F, onset 1h post-caesarean section. Obstructive shock due to PE. Rheolytic thrombectomy removed obstruction and restoration of PA flow. Immediately post procedure refractory shock, cor pulmonale, gross haematuria and drop in haemoglobin secondary to fragmentary haemolysis. Haemolysis and shock resolved within 24h, remaining hospital course uneventful, and the patient discharged on day 7. An outpatient echocardiogram shortly after discharge revealed normal biventricular function and PAP.	Small sample, older report.
Margheri M, Vittori G, Vecchio S, Chechi T, Falchetti E, Spaziani G, Giuliani G, Rovelli S, Consoli L, Biondi Zoccai GG. Early and long-term clinical results of AngioJet rheolytic thrombectomy in patients with acute pulmonary embolism. Am J Cardiol. 2008 Jan 15;101(2):252-8. doi: 10.1016/j.amjcard.2007.07.087. PMID: 18178417.	N=25 (8 severe haemodynamic compromise, 12 moderate, 5 mild) Angiojet Median follow-up 61 months.	Technical and procedural success 100% Statistically significant improvement in obstruction, perfusion and Miller indexes overall, and in each subgroup (all p values <0.001). Statistically significant improvement in all above seen in patients given local fibrinolysis (n=8) and in those not given local fibrinolysis (n=17, p<0.05). 4/25 (16%) in-hospital mortality (2 persistent shock, 1 cerebral haemorrhage, 1 recurrence of embolism). All others alive at long-term follow-up except 1 noncardiopulmonary cause. Temporary transvenous pacing in 3 (12%) for bradycardia. 10 major haematomas requiring transfusion (40%). 7 postprocedural worsening of renal function (28%)	Small sample, retrospective, no comparator.
Martillotti, G, Boehlen, F, Robert-Ebadi, H, Jastrow, N, Righini, M, Blondon, M. Treatment options for severe pulmonary embolism during pregnancy and the postpartum period: a systematic review. J Thromb Haemost 2017; 15: 1942– 50.	Systematic review N=7 for percutaneous thrombectomy	Maternal survival 100% Two cases went on to further treatments. Risk of fetal death 25% Risk of major bleeding 20% All reported good angiographic results without procedure-related complications. One case, a rheolytic thrombolysis complicated by severe haemolysis (paper included separately).	Different modalities used in different cases (systematic review including a number of case reports). Small sample size.
Morrow KL, Kim AH, Plato SA 2nd, Shevitz AJ, Goldstone J, Baele H, Kashyap VS. Increased risk of renal dysfunction with percutaneous mechanical thrombectomy compared with catheter-directed thrombolysis. J Vasc Surg. 2017 May;65(5):1460-1466. doi: 10.1016/j.jvs.2016.09.047. Epub 2016 Nov 19. PMID: 27876521.	N=145 Retrospective comparative review, single centre. 4 groups: Percutaneous mechanical thrombectomy (PMT) alone (n=15), PMT with tissue-plasminogen activator (tPA) pulse-spray, PMT (n=42) with catheter directed thrombolysis (CDT) (n=70), or CDT only (n=18). Follow-up to 6 months.	The overall incidence of renal dysfunction was 15%. The incidence was highest in the PMT/tPA pulse group (21%), followed by the PMT group (20%) and the PMT/CDT group (14%). CDT was not associated with renal dysfunction (0%). PMT (p=0.046), and PMT/tPA pulse (p=0.033) were associated with higher rates of renal dysfunction than the CDT controls. Renal dysfunction was higher in the arterial thrombus (21%) than venous thrombus (12%) groups. Stratified by the RIFLE (Risk, Injury, Failure, Loss, and End-stage renal disease) criteria, 13 (9%) patients progressed to the risk category, 6 (4%) progressed to the injury category, and 3 (2%) progressed to the failure category. None of the patients progressed to dialysis within the same admission period. The average length of time for creatinine values to return to baseline was 5.1 ± 5.2 days. No difference in 6-month outcomes between procedural groups.	Assesses catheter therapies in all vasculature locations with only 11 in pulmonary vasculature. Retrospective, small sample.
Mously H, Hajjari J, Chami T, Hammad T, Schilz R, Carman T, Elgudin Y, Abu-Omar Y, Pelletier MP, Shishehbor MH, Li J. Percutaneous mechanical thrombectomy and extracorporeal membranous oxygenation: A case series. Catheter Cardiovasc Interv. 2022 Aug;100(2):274-278. doi: 10.1002/ccd.30295. Epub 2022 Jun 10. PMID: 35686535.	N=9 Follow-up 90 days Large bore thrombectomy and ECMO	2/9 minimal thrombus retrieval (1 given salvage systemic thrombolysis, 1 converted to surgical embolectomy) Median ECMO duration 5 days (2.3-11.6) Median ICU stay 10 days (1.5-25.5) Median hospitalisation 16.1 days (1.5-30.9) 90 day mortality 22%	Small sample, combined treatment with ECMO. Results reporting limited.
Pelliccia F, De Luca A, Pasceri V, Tanzilli G, Speciale G, Gaudio C. Safety and Outcome of Rheolytic Thrombectomy for the Treatment of Acute Massive Pulmonary Embolism. J Invasive Cardiol. 2020 Nov;32(11):412-416. PMID: 33130592.	N=33 patients contraindicated to thrombolysis. Angiojet rheolytic thrombectomy. Follow-up 1 year	Angiographic improvement 32/33 (96%) Rapid improvement in functional class (3.3 ± 0.9 to 2.1 ± 0.7; P<0.001) Increase in oxygen saturation (71 ± 15% to 92 ± 17%; P<0.001) No deaths, no major bleeding, no renal failure. Post procedure anaemia in 4/33 (12.1%) Periprocedural side effects: Transient heart block (n=1, 3%) Hypotension (n=3, 9%) Bradycardia (n=5, 15.1%) At 1 year follow-up (n=30): PAP statistically significantly lower than baseline (65 ± 31 mm Hg vs 31 ± 19 mm Hg; P<0.001).	Small sample, no comparator.
Qureshi AM, Petit CJ, Crystal MA, Liou A, Khan A, Justino H. Efficacy and safety of catheter-based rheolytic and aspiration thrombectomy in children. Catheter Cardiovasc Interv. 2016 Jun;87(7):1273-80. doi: 10.1002/ccd.26399. Epub 2016 Feb 1. PMID: 26833887.	Included for consideration of paediatric population.Median age 1.9 months. Median follow-up 10 months. N=21 Rheolytic and aspiration thrombectomy.	Thrombectomy was performed in 50 vessels in 21 patients. Thrombectomy successful in 47/50 (94%) vessels in 18/21 (86%) patients. Additional balloon/stent therapy or tPA administration performed in 16/18 (89%) of these patients. 2 (9.5%) major complications (both with AngioJet): asystole when using activation times of >5 sec. At median follow-up 10 months: all 47 treated vessels patent and 8/18 (44%) required reintervention. Of the 4 pulmonary vessel patients, 2/4 (50%) thrombectomy successful, 3/4 Angiojet and1/4 pronto catheter.	Only 4/21 patients had PE. The rest had thrombosis in other vessels. Small sample, retrospective.
Nakazawa K, Tajima H, Murata S, Kumita S-I, Yamamoto T, And Tanaka K. Catheter fragmentation of acute massive pulmonary thromboembolism: distal embolisation and pulmonary arterial pressure elevation The British Journal of Radiology 2008 81:971, 848-854	Case series Rotating pigtail catheter N=25	Decrease in mPAP after thrombus fragmentation (34.2mmHg to 30.8mmHg, p<0.05) and after thrombolysis and thrombus aspiration (24.0 mmHg, p<0.01). Distal embolization occurred in 7/25 cases, in this group mPAP statistically significantly increased after thrombus fragmentation (34.1 to 37.9 mmHg, p<0.05) before statistically significantly decreasing after thrombolysis and aspiration (25.7mmHg, p<0.05). Statistically significant decrease in Miller Score after fragmentation (21.2 to 18.5, p<0.01) and aspiration (to 14.1, p<0.01). No recurrences observed. Continuous monitoring of mPAP can predict distal embolization and may improve safety.	Small sample All cases received local thrombolytic therapy as well.
Nezami N, Chockalingam A, Cornman-Homonoff J, Marino A, Pollak J, Mojibian H. Mechanical thrombectomy for pulmonary embolism in patients with patent foramen Ovale. CVIR Endovasc. 2020 Nov 28;3(1):89. doi: 10.1186/s42155-020-00180-9. PMID: 33247349; PMCID: PMC7695793.	Case series N=9 (3 high-risk and 6 intermediate/high risk) FlowTriever	Included for unique patient group (PFO). Technical success rate 100% Clinical success rate 77.8% Right heart-strain improved in 6/8 mPAP statistically significantly decreased (36.0 ± 15.2 vs 23.4 ± 8.4 mmHg, p<0.012) 1 patient developed middle cerebral artery embolic stoke 1 day post-procedure (unclear if related to procedure). No in-hospital mortality	Small sample, retrospective
Toma, C, Khandhar, S, Zalewski, AM, D'Auria, SJ, Tu, TM, Jaber, WA. Percutaneous thrombectomy in patients with massive and very high-risk submassive acute pulmonary embolism. Catheter Cardiovasc Interv. 2020; 96: 1465– 1470. https://doi.org/10.1002/ccd.29246	Mulit-centre case series N=34 Massive and very high-risk submassive PE. FlowTriever Mean follow-up 205 days.	Clot removal successful in 32/34 (94.1%). Procedural failure 2/34, both deteriorated during procedure and one died (2.9%). Decompensation following intubation (known profound negative haemodynamic effect in large PEs). Cardiac index improved from 2.0 ± 0.1 L/min/m2 before thrombectomy to 2.4 ± 0.1 L/min/m2 after (p = 0.01). The mPAP decreased from 33.2 ± 1.6 mmHg to 25.0 ± 1.5 mmHg (p = 0.01). Procedure. In 6 patients, cardiac index decreased post-procedure but additional vasopressors not required. At 24 hr blood pressures and heart rates statistically significantly improved. No complications directly attributable to device. No major treatment-related bleeding events. Statistically significant drop in haemoglobin was noted at 24 hr (12.2 ± 0.5 g/dL to 10.5 ± 2.2 g/dL, p = 0.007). The average length of stay was 9.8 ± 1.6 days. 33/34 (97%) survival to 205 days.	Small sample, no comparator.
Wible BC, Buckley JR, Cho KH, Bunte MC, Saucier NA, Borsa JJ. Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. J Vasc Interv Radiol. 2019 Sep;30(9):1370-1375. doi: 10.1016/j.jvir.2019.05.024. Epub 2019 Jul 30. PMID: 31375449.	N=46 (8 massive, 38 submassive). Retrospective case series. FlowTriever Follow-up 30 days post discharge.	Technical success 100% mPAP improved statistically significantly for all (33.9 ± 8.9 mm Hg before, 27.0 ± 9.0 mm Hg after; P < 0.0001) Intraprocedural reduction in mPAP in 88%. Survival to discharge 100% 2 MAEs (4.6%): haemoptysis requiring intubation, procedure-related blood loss requiring transfusion. No procedure-related deaths within 30d of discharge.	Small sample, single-centre, no comparator.

Article

Number of patients and follow-up

Direction of conclusions

Reason study was not included in main evidence summary

Akbarshakh Akhmerov, Heidi Reich, James Mirocha, Danny Ramzy; Effect of Percutaneous Suction Thromboembolectomy on Improved Right Ventricular Function. Tex Heart Inst J 1 April 2019; 46 (2): 115–119. doi: https://doi.org/10.14503/THIJ-17-6551

N=13, AngioVac, median follow-up 74 days

77% survival to hospital discharge. Pre-procedure 8 (62%) had severe right ventricular dysfunction, post procedure this was 2 (17%) (p=0.031).

3 patients had intraprocedural haemodynamic instability leading to conversion to open surgery and standard cardiopulmonary bypass. Three in-hospital deaths, unrelated to procedure.

Small sample, short follow-up

Al-Hakim R, Park J, Bansal A, Genshaft S, Moriarty JM. Early Experience with AngioVac Aspiration in the Pulmonary Arteries. J Vasc Interv Radiol. 2016 May;27(5):730-4. doi: 10.1016/j.jvir.2016.01.012. PMID: 27106647.

N=5: 4 massive PE

AngioVac

2/5 (40%) technical success (reduction in Miller Index ≥5).

4/5 deaths (80%) at mean of 7.3 days post procedure, of which 1 related to right ventricular free wall perforation.

Small sample, retrospective

Bonvini RF, Roffi M, Bounameaux H, Noble S, Müller H, Keller PF, Jolliet P, Sarasin FP, Rutschmann OT, Bendjelid K, Righini M. AngioJet rheolytic thrombectomy in patients presenting with high-risk pulmonary embolism and cardiogenic shock: a feasibility pilot study. EuroIntervention. 2013 Apr 22;8(12):1419-27. doi: 10.4244/EIJV8I12A215. PMID: 23680957.

N=10 (high risk PE and cardiogenic shock).

Angiojet

Follow-up to 3 months

In 2, IV thrombolysis given due to progressive haemodynamic deterioration following procedure.

7/10 patients died in the first 12 hours post-procedure (4 refractory right heart failure).

3/10 patients favourable outcomes and normalisation of RV function, no PE recurrence at 1 year.

Small sample, short follow-up, single centre.

Bunc M, Steblovnik K, Zorman S, Popovic P. Percutaneous mechanical thrombectomy in patients with high-risk pulmonary embolism and contraindications for thrombolytic therapy. Radiol Oncol. 2020 Feb 14;54(1):62-67. doi: 10.2478/raon-2020-0006. PMID: 32061168; PMCID: PMC7087421.

N=25

(high-risk PE)

Follow-up to hospital discharge.

56%: pigtail catheter

44%: Aspirex device

Non-significant improvements in systemic blood pressure and heart rate.

Statistically significant reduction in peak systolic tricuspid pressure gradient (57 ± 14 mm Hg vs 31 ± 3 mm Hg; p = 0.018).

Technical success in 80%

Salvage thrombolytic therapy in 8/25 (32%).

68% survival to hospital discharge.

No statistically significant difference in technical success, survival or any other parameters between subgroups receiving thrombolysis and PMT and those who only received PMT apart from transfusion requirement (50% vs 12%, p=0.04).

Major complications: 1 significant puncture site bleeding

Minor complications: 6/25 (24%)- 5 transient bradycardia during catheterisation and 1 groin haematoma.

Small sample, retrospective

Bunwaree, S., Roffi, M., Bonvini, J.M., et al. (2013). AngioJet® rheolytic thrombectomy: a new treatment option in cases of massive pulmonary embolism. Interventional Cardiology, 5, 71-87.

N=197

Group A (massive PE) = 76

Group B (massive + submassive PE) = 121

Systematic review of Angiojet rheolytic thrombectomy.

Variable follow-up.

14 studies included:

9 (Group A) massive PE only

5 (Group B) massive and submassive PE combined population

Successful procedure (including clinical success/ technical success/ procedural successs) reported in 66/76 (86.8%) in group A,

99/105 (94.3%) group B.

In Group A (reported in 5 studies) systolic PAP was reduced from pre-procedure: 55 ± 9.9 to post-procedure: 37.3 ± 18.8

and mPAP was reduced from pre-procedure: 37.8 ± 5.8 to post-procedure: 33.9 ± 8.2. In group B (reported in 4 studies) systolic PAP: pre-procedure, 48.7 ± 0.4 vs post-procedure, 37.9 ± 0.8; mPAP: pre-procedure 34.3 ± 4.9 vs post-procedure, 27.3 ± 1.2. Significance not reported.

There were 31/197 (15.7%) major periprocedural events including 23 (11.6%) episodes of bradyarrhythmia and 2 (1%) transient asystole, out of which 18 (9.1%) required temporary pacemaker implantation. The review reported 6 (3%) intraprocedural deaths (all in group A)- 1 prior to device activation. The in-hospital mortality rate was 29/197 (14.7%): 13/76 (17.1%) in group A and 16/121 (13.2%) in group B.

After discharge, no further deaths to 30 days. Major postprocedural events in 61/197 (30.1%) patients including 6 (3.0%) episodes of haemoptysis, 13 (6.6%) major inguinal haematomas, 2 (1%) episodes of melaena, 5 (2.5%) macro-haematuria, 2 (1%) retroperitoneal bleeding, 4 (2%) cerebral haemorrhage, 23 (11.7%) impaired renal function, 3 (1.5%) multiorgan failure and 7 (3.5%) significant thrombocytopaenia.

Older systematic review referencing solely the Angiojet device. Country of origin not detailed for studies. All but 2 of the studies included fewer than 20 participants each and most were retrospective case series lacking comparator arms. Many of the studies did not report the clinical outcomes studied and in more than 40% of the patients included, thrombolysis was given which makes interpretation of the efficacy and safety of thrombectomy difficult. Three of the included studies (Bonvini, 2013; Margheri, 2008; Chechi, 2009) are also discussed separately.

Chechi T, Vecchio S, Spaziani G, Giuliani G, Giannotti F, Arcangeli C, Rubboli A, Margheri M. Rheolytic thrombectomy in patients with massive and submassive acute pulmonary embolism. Catheter Cardiovasc Interv. 2009 Mar 1;73(4):506-13. doi: 10.1002/ccd.21858. PMID: 19235240.

N=51

Angiojet

Massive and submassive PE

Average follow-up 35.5 ± 21.7 months

Technical success in 92.2%

Statistically significant improvement in obstruction, perfusion and Miller index in all subgroups of severity (p<0.0001) and in systolic PAP (p<0.05).

4/51 major bleeding events (7.8%)

8/51 (15.7%) in-hospital mortality (6 due to persistent/refractory shock)

3 further deaths at long term follow-up unrelated to procedure/PE

Small sample, retrospective.

Cherfan P, Abou Ali AN, Zaghloul MS, Yuo TH, Phillips DP, Chaer RA, Avgerinos ED. Propofol administration during catheter-directed interventions for intermediate-risk pulmonary embolism is associated with major adverse events. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):621-626. doi: 10.1016/j.jvsv.2020.08.026. Epub 2020 Aug 26. PMID: 32858244.

N=340

Of which:

85 catheter directed thrombolysis, 229 ultrasound-assisted thrombolysis, 26 suction thrombectomy.

36 patients (10.6%) received propofol; 304 patients (89.4%) received midazolam plus fentanyl, morphine, or hydromorphone.

Overall, 18 patients had ≥1 MAE (10 intubations, 11 decompensations, 2 surgical conversions, 3 deaths).

Propofol group had a statistically significantly greater

adverse event rate (13.8%) vs no-propofol group (4.2%; p=0.015).

16 patients experienced major bleeding or other procedure-related events (stroke in 4 (1.17%), coronary sinus perforation in 1, tricuspid valve rupture in 1, and the need for transfusion in 10 patients).

Type of intervention was not a predictive factor for any outcome.

Majority of patients had catheter thrombolysis, only 26 suction thrombectomy.

Reviewing effect of anaesthetic rather than intervention directly.

Retropsective.

Ciampi-Dopazo JJ, Romeu-Prieto JM, Sánchez-Casado M, Romerosa B, Canabal A, Rodríguez-Blanco ML, Lanciego C. Aspiration Thrombectomy for Treatment of Acute Massive and Submassive Pulmonary Embolism: Initial Single-Center Prospective Experience. J Vasc Interv Radiol. 2018 Jan;29(1):101-106. doi: 10.1016/j.jvir.2017.08.010. Epub 2017 Nov 6. PMID: 29102272.

N=18

Indigo Aspiration System

Follow-up to discharge (median hospital stay 10 days)

Technical success in 17/18 (94.4%) and clinical success in 15/18 (83.3%).

Statistically significant improvement in right ventricle size (46.36 mm ± 2.2 before treatment vs 41.79 mm ± 7.4

after; p=0.041).

Two patients died with massive PE and one patient died with submassive PE.

Mortality= 16.7%.

Of the 4 patients who received thrombolysis, 2 experienced intracranial bleeding and 1 abdominal bleeding.

Small sample, short follow-up.

Donaldson, C.W., Baker, J.N., Narayan, R.L., Provias, T.S., Rassi, A.N., Giri, J.S., Sakhuja, R., Weinberg, I., Jaff, M.R. and Rosenfield, K. (2015), Thrombectomy using suction filtration and veno-venous bypass: Single center experience with a novel device. Cathet. Cardiovasc. Intervent., 86: E81-E87

N=14,

AngioVac

Mean follow-up 23 days

Indications included intracardiac mass

(73%), acute PE (33%), and caval thrombus (73%). Four patients (27%) were in shock at the start of the procedure. Successful evacuation of mass in 73%. Peri-procedure mortality was 0% and in-hospital mortality 13% at a mean follow-up of 23 days. No pulmonary haemorrhages,

strokes or myocardial infarctions. 73% had a post procedural drop in haematocrit with 6 of these 11 requiring transfusion. Two patients required subsequent embolectomy (one open).

Small sample, short follow-up, focuses more on right heart thrombi.

Dukkipati, R., Yang, E., Adler, S. et al. Acute kidney injury caused by intravascular hemolysis after mechanical thrombectomy. Nat Rev Nephrol 5, 112–116 (2009). https://doi.org/10.1038/ncpneph1019

N=1

Case report

Angiojet

43F, 8 weeks pregnant

Bilateral PE treated with Angiojet system.

Intraprocedural bradycardia.

Post-procedural massive intravascular haemolysis and acute kidney injury.

48 hours in ICU, haemodialysis until day 21. Fetal loss on day 7. Renal function returned to normal on day 25.

Case report.

Dumantepe, M., Teymen, B., Akturk, U. and Seren, M. (2015), The Efficacy of Rotational Thrombectomy on the Mortality of Patients with Massive and Submassive Pulmonary Embolism. J Card Surg, 30: 324-332. https://doi.org/10.1111/jocs.12521

N=36

Massive and submassive PE

Aspirex percutaneous aspiration device.

Mean follow-up 14.3±5.8 months.

Complete thrombus clearance (≥90%) in 83.3% and near-complete (50%

to 90%) clearance in 13.8%. Statistically significant decrease (56%) in mean PAP post-procedure. Major complication rate 6.3%. Two in-hospital deaths (one from refractory shock). Two patients had a significant bradycardic episode. No major bleeding events.

Total 360-day survival was 88.8%.

Small sample, retrospective case series

Eid-Lidt G, Gaspar J, Sandoval J, de los Santos FD, Pulido T, González Pacheco H, Martínez-Sánchez C. Combined clot fragmentation and aspiration in patients with acute pulmonary embolism. Chest. 2008 Jul;134(1):54-60. doi: 10.1378/chest.07-2656. Epub 2008 Jan 15. PMID: 18198243.

N=18, follow-up 12.3 ± 9.4 months.

Massive PE.

Statistically significant increase in systolic blood pressure post-procedure and statistically significant decrease in mean PAP (37.1 ± 8.5 mmHg vs 32.3 ± 10.5 mmHg, p = 0.0001).

In-hospital major complication rate 11.1%, one death from refractory shock. One patient had intracerebral haemorrhage with minor neurologic sequelae (deemed to be secondary to local fibrinolytic therapy). Two transitory decreases in oxygen saturation during procedure (Aspirex device) without haemodynamic instability.

Small sample

Eid-Lidt G, Gaspar J, Sandoval J, et al. Persistent pulmonary hypertension and right

ventricular function after percutaneous mechanical thrombectomy in severe acute pulmonary embolism.

Eur Respir J 2017; 49: 1600910 [https://doi.org/10.1183/13993003.00910-2016]

N=52

Mean follow-up 40.2 ± 16.7 months.

Excluded 8 for prior pulmonary artery hypertension, 8 for right ventricular hypertrophy and 5 for follow-up < 6 months.

7 patients died in hospital and were not included in analysis.

After the procedure, the shock index (1.1±0.23 vs 0.7±0.1; p=0.019),

heart rate (113±14 vs post- 86±13 bpm; p=0.005) and systolic systemic arterial pressure (100±14 vs 124±13 mmHg; p=0.005) improved. No recurrence of pulmonary embolism in-hospital. Four patients were re-admitted to hospital, two patients for recurrence of severe pulmonary

embolism (4.1%) and two for complicated pneumonia.

Overall survival (extra-hospital phase) at 5 years was 96.2%. Improvements in right ventricular function were mainly in the first 6 months with a 24% reduction in PAP.

Small sample

Escobar GA, Burks D, Abate MR, Faramawi MF, Ali AT, Lyons LC, Moursi MM, Smeds MR. Risk of Acute Kidney Injury after Percutaneous Pharmacomechanical Thrombectomy Using AngioJet in Venous and Arterial Thrombosis. Ann Vasc Surg. 2017 Jul;42:238-245. doi: 10.1016/j.avsg.2016.12.018. Epub 2017 Apr 13. PMID: 28412100.

N=102 (n=52 Angiojet, n=50 catheter-directed thrombolysis)

Follow-up 3 days

Acute kidney injury (AKI) occurred in 29% of patients treated with Angiojet vs 8% of catheter-directed thrombolysis. Odds for AKI increased by Angiojet (OR 8.2, 95% CI 1.98-34.17, p=0.004). Concomitant

open surgery and drop in haematocrit also raise the odds of AKI.

Includes use of Angiojet catheter with thrombolytic drugs, includes various arterial and venous thromboses so not specific to PE.

Gayen S, Upadhyay V, Kumaran M, Bashir R, Lakhter V, Panaro J, Criner G, Dadparvar S, Rali P. Changes in Lung Perfusion in Patients Treated with Percutaneous Mechanical Thrombectomy for Intermediate-Risk Pulmonary Embolism. Am J Med. 2022 Aug;135(8):1016-1020. doi: 10.1016/j.amjmed.2022.03.028. Epub 2022 Apr 22. PMID: 35469736.

N=3

Intermediate risk PE.

FlowTriever

Use of imaging for perfusion tracking

Pre-procedure and post-procedure perfusion estimation:

Case 1: perfusion score improved from 5/15 pre-procedure to 12/15 within 48h and 13/15 at 3 months.

Case 2: 7/15 pre-procedure to 8/15 within 72h, 10.5/15 at 3 months and 12/15 at 9 months.

Case 3: 6/15 pre-procedure to 7/5/15 within 72h and 9/15 at 3 months.

Overall, average lung perfusion score increased from 6/15 (40%) pre-procedure to 9.17/15

(61.1%) immediately post-procedure and 11.33/15

(75.6%) at last follow-up.

No PE-related readmission within 30 days or PE-related complications.

Small sample

Graif A, Patel KD, Wimmer NJ, Kimbiris G, Grilli CJ, Upparapalli D, Kaneria AR, Leung DA. Large-Bore Aspiration Thrombectomy versus Catheter-Directed Thrombolysis for Acute Pulmonary Embolism: A Propensity Score-Matched Comparison. J Vasc Interv Radiol. 2020 Dec;31(12):2052-2059. doi: 10.1016/j.jvir.2020.08.028. Epub 2020 Nov 9. PMID: 33183975.

N=52

CDT group=26

Large-bore aspiration thrombectomy (LBAT)=26 (FlowTriever for majority)

Statistically significant decrease in systolic PAP, diastolic PAP, mean PAP, HR, and

Miller score in both groups.

Systolic PAP: Baseline and final systolic PAP was similar between the two groups (LBAT: 54.5 mm Hg ± 12.9 vs CDT: 54.5 mm Hg ± 16.3 at baseline, P=0.8; and LBAT: 42.5 mm Hg ± 14.1 vs

CDT: 42.6 mm Hg ± 12.1, P =0.8, respectively).

Heart rate: reductions not statistically significantly different between the 2 groups: (LBAT: -5.4 bpm ± 19.2 vs CDT: -9.6 bpm ± 15.8, P=0.4).

Miller score: CDT demonstrated a higher reduction (-10.1 ± 3.9 vs -7.5 ± 3.8, P=0.02).

Complications:

LBAT had 1 minor haemorrhagic complication and 2 procedure-related deaths vs CDT resulted in 1 minor and 1 major haemorrhagic complication.

ICU stay: 18/26 LBAT group and 26/26 CDT, p=0.004. Similar hospital length of stay.

Small sample, retrospective, propensity matched, non-randomised.

Kumar N, Janjigian Y, Schwartz DR. Paradoxical worsening of shock after the use of a percutaneous mechanical thrombectomy device in a postpartum patient with a massive pulmonary embolism. Chest. 2007 Aug;132(2):677-9. doi: 10.1378/chest.06-1082. PMID: 17699140.

Case report, unique safety information.

Angiojet

31F, onset 1h post-caesarean section.

Obstructive shock due to PE. Rheolytic thrombectomy removed obstruction and restoration of PA flow. Immediately post procedure refractory shock, cor pulmonale, gross haematuria and drop in haemoglobin secondary to fragmentary haemolysis.

Haemolysis and shock resolved within 24h, remaining hospital course uneventful, and the patient discharged on day 7. An outpatient echocardiogram

shortly after discharge revealed normal biventricular function and

PAP.

Small sample, older report.

Margheri M, Vittori G, Vecchio S, Chechi T, Falchetti E, Spaziani G, Giuliani G, Rovelli S, Consoli L, Biondi Zoccai GG. Early and long-term clinical results of AngioJet rheolytic thrombectomy in patients with acute pulmonary embolism. Am J Cardiol. 2008 Jan 15;101(2):252-8. doi: 10.1016/j.amjcard.2007.07.087. PMID: 18178417.

N=25

(8 severe haemodynamic compromise, 12 moderate, 5 mild)

Angiojet

Median follow-up 61 months.

Technical and procedural success 100%

Statistically significant improvement in obstruction, perfusion and Miller indexes overall, and in each subgroup (all p values <0.001). Statistically significant improvement in all above seen in patients given local fibrinolysis (n=8) and in those not given local fibrinolysis (n=17, p<0.05).

4/25 (16%) in-hospital mortality (2 persistent shock, 1 cerebral haemorrhage, 1 recurrence of embolism). All others alive at long-term follow-up except 1 noncardiopulmonary cause.

Temporary transvenous pacing in 3 (12%) for bradycardia.

10 major haematomas requiring transfusion (40%).

7 postprocedural worsening of renal function (28%)

Small sample, retrospective, no comparator.

Martillotti, G, Boehlen, F, Robert-Ebadi, H, Jastrow, N, Righini, M, Blondon, M. Treatment options for severe pulmonary embolism during pregnancy and the postpartum period: a systematic review. J Thromb Haemost 2017; 15: 1942– 50.

Systematic review

N=7 for percutaneous thrombectomy

Maternal survival 100%

Two cases went on to further treatments.

Risk of fetal death 25%

Risk of major bleeding 20%

All reported good angiographic results without procedure-related complications.

One case, a rheolytic thrombolysis complicated by severe haemolysis (paper included separately).

Different modalities used in different cases (systematic review including a number of case reports).

Small sample size.

Morrow KL, Kim AH, Plato SA 2nd, Shevitz AJ, Goldstone J, Baele H, Kashyap VS. Increased risk of renal dysfunction with percutaneous mechanical thrombectomy compared with catheter-directed thrombolysis. J Vasc Surg. 2017 May;65(5):1460-1466. doi: 10.1016/j.jvs.2016.09.047. Epub 2016 Nov 19. PMID: 27876521.

N=145

Retrospective comparative review, single centre. 4 groups:

Percutaneous mechanical thrombectomy (PMT) alone (n=15), PMT with tissue-plasminogen activator (tPA) pulse-spray, PMT (n=42) with catheter directed thrombolysis (CDT) (n=70), or CDT only (n=18).

Follow-up to 6 months.

The overall incidence of renal dysfunction was 15%. The incidence was highest in the PMT/tPA pulse group (21%), followed by the PMT group (20%) and the PMT/CDT group (14%). CDT was not associated with renal dysfunction (0%). PMT (p=0.046), and PMT/tPA pulse (p=0.033) were associated with higher rates of renal dysfunction than the CDT controls.

Renal dysfunction was higher in the arterial thrombus (21%) than venous thrombus (12%) groups.

Stratified by the RIFLE (Risk, Injury, Failure, Loss, and End-stage renal disease) criteria, 13 (9%) patients progressed to the risk category, 6 (4%) progressed to the injury category, and 3 (2%) progressed to the failure category. None of the patients progressed to dialysis within the same admission period.

The average length of time for creatinine values to return to baseline was 5.1 ± 5.2 days.

No difference in 6-month outcomes between procedural groups.

Assesses catheter therapies in all vasculature locations with only 11 in pulmonary vasculature.

Retrospective, small sample.

Mously H, Hajjari J, Chami T, Hammad T, Schilz R, Carman T, Elgudin Y, Abu-Omar Y, Pelletier MP, Shishehbor MH, Li J. Percutaneous mechanical thrombectomy and extracorporeal membranous oxygenation: A case series. Catheter Cardiovasc Interv. 2022 Aug;100(2):274-278. doi: 10.1002/ccd.30295. Epub 2022 Jun 10. PMID: 35686535.

N=9

Follow-up 90 days

Large bore thrombectomy and ECMO

2/9 minimal thrombus retrieval (1 given salvage systemic thrombolysis, 1 converted to surgical embolectomy)

Median ECMO duration 5 days (2.3-11.6)

Median ICU stay 10 days (1.5-25.5)

Median hospitalisation 16.1 days (1.5-30.9)

90 day mortality 22%

Small sample, combined treatment with ECMO.

Results reporting limited.

Pelliccia F, De Luca A, Pasceri V, Tanzilli G, Speciale G, Gaudio C. Safety and Outcome of Rheolytic Thrombectomy for the Treatment of Acute Massive Pulmonary Embolism. J Invasive Cardiol. 2020 Nov;32(11):412-416. PMID: 33130592.

N=33 patients contraindicated to thrombolysis.

Angiojet rheolytic thrombectomy.

Follow-up 1 year

Angiographic improvement 32/33 (96%)

Rapid improvement in functional class (3.3 ± 0.9 to 2.1 ± 0.7; P<0.001)

Increase in oxygen saturation (71 ± 15% to 92 ± 17%; P<0.001)

No deaths, no major bleeding, no renal failure.

Post procedure anaemia in 4/33 (12.1%)

Periprocedural side effects:

Transient heart block (n=1, 3%)

Hypotension (n=3, 9%)

Bradycardia (n=5, 15.1%)

At 1 year follow-up (n=30): PAP statistically significantly lower than baseline (65 ± 31 mm Hg vs 31 ± 19 mm Hg; P<0.001).

Small sample, no comparator.

Qureshi AM, Petit CJ, Crystal MA, Liou A, Khan A, Justino H. Efficacy and safety of catheter-based rheolytic and aspiration thrombectomy in children. Catheter Cardiovasc Interv. 2016 Jun;87(7):1273-80. doi: 10.1002/ccd.26399. Epub 2016 Feb 1. PMID: 26833887.

Included for consideration of paediatric population.Median age 1.9 months.

Median follow-up 10 months.

N=21

Rheolytic and aspiration thrombectomy.

Thrombectomy was performed in 50 vessels in 21 patients.

Thrombectomy successful in 47/50 (94%) vessels in 18/21 (86%) patients. Additional balloon/stent therapy or tPA administration performed in 16/18 (89%) of these patients.

2 (9.5%) major complications (both with AngioJet): asystole when using activation times of >5 sec.

At median follow-up 10 months: all 47 treated vessels patent and 8/18 (44%) required reintervention.

Of the 4 pulmonary vessel patients, 2/4 (50%) thrombectomy successful, 3/4 Angiojet and1/4 pronto catheter.

Only 4/21 patients had PE. The rest had thrombosis in other vessels. Small sample, retrospective.

Nakazawa K, Tajima H, Murata S, Kumita S-I, Yamamoto T, And Tanaka K. Catheter fragmentation of acute massive pulmonary thromboembolism: distal embolisation and pulmonary arterial pressure elevation

The British Journal of Radiology 2008 81:971, 848-854

Case series

Rotating pigtail catheter

N=25

Decrease in mPAP after thrombus fragmentation (34.2mmHg to 30.8mmHg, p<0.05) and after thrombolysis and thrombus aspiration (24.0 mmHg, p<0.01).

Distal embolization occurred in 7/25 cases, in this group mPAP statistically significantly increased after thrombus fragmentation (34.1 to 37.9 mmHg, p<0.05) before statistically significantly decreasing after thrombolysis and aspiration (25.7mmHg, p<0.05).

Statistically significant decrease in Miller Score after fragmentation (21.2 to 18.5, p<0.01) and aspiration (to 14.1, p<0.01).

No recurrences observed.

Continuous monitoring of mPAP can predict distal embolization and may improve safety.

Small sample

All cases received local thrombolytic therapy as well.

Nezami N, Chockalingam A, Cornman-Homonoff J, Marino A, Pollak J, Mojibian H. Mechanical thrombectomy for pulmonary embolism in patients with patent foramen Ovale. CVIR Endovasc. 2020 Nov 28;3(1):89. doi: 10.1186/s42155-020-00180-9. PMID: 33247349; PMCID: PMC7695793.

Case series

N=9 (3 high-risk and 6 intermediate/high risk)

FlowTriever

Included for unique patient group (PFO).

Technical success rate 100%

Clinical success rate 77.8%

Right heart-strain improved in 6/8

mPAP statistically significantly decreased (36.0 ± 15.2 vs 23.4 ± 8.4 mmHg, p<0.012)

1 patient developed middle cerebral artery embolic stoke 1 day post-procedure (unclear if related to procedure).

No in-hospital mortality

Small sample, retrospective

Toma, C, Khandhar, S, Zalewski, AM, D'Auria, SJ, Tu, TM, Jaber, WA. Percutaneous thrombectomy in patients with massive and very high-risk submassive acute pulmonary embolism. Catheter Cardiovasc Interv. 2020; 96: 1465– 1470. https://doi.org/10.1002/ccd.29246

Mulit-centre case series

N=34

Massive and very high-risk submassive PE.

FlowTriever

Mean follow-up 205 days.

Clot removal successful in 32/34 (94.1%).

Procedural failure 2/34, both deteriorated during procedure and one died (2.9%). Decompensation following intubation (known profound negative haemodynamic effect in large PEs).

Cardiac index improved

from 2.0 ± 0.1 L/min/m2 before thrombectomy to 2.4 ± 0.1 L/min/m2 after (p = 0.01).

The mPAP decreased from 33.2 ± 1.6 mmHg to 25.0 ± 1.5 mmHg (p = 0.01).

Procedure.

In 6 patients, cardiac index decreased post-procedure but additional vasopressors not required.

At 24 hr blood pressures and heart rates statistically significantly improved.

No complications directly attributable to device. No major treatment-related bleeding events. Statistically significant drop in haemoglobin was noted at 24 hr (12.2 ± 0.5 g/dL to 10.5 ± 2.2 g/dL, p = 0.007). The average length of stay was 9.8 ± 1.6 days.

33/34 (97%) survival to 205 days.

Small sample, no comparator.

Wible BC, Buckley JR, Cho KH, Bunte MC, Saucier NA, Borsa JJ. Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. J Vasc Interv Radiol. 2019 Sep;30(9):1370-1375. doi: 10.1016/j.jvir.2019.05.024. Epub 2019 Jul 30. PMID: 31375449.

N=46

(8 massive, 38 submassive). Retrospective case series.

FlowTriever

Follow-up 30 days post discharge.

Technical success 100%

mPAP improved statistically significantly for all (33.9 ± 8.9 mm Hg before, 27.0 ± 9.0 mm Hg after; P < 0.0001)

Intraprocedural reduction in mPAP in 88%.

Survival to discharge 100%

2 MAEs (4.6%): haemoptysis requiring intubation, procedure-related blood loss requiring transfusion.

No procedure-related deaths within 30d of discharge.

Small sample, single-centre, no comparator.

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Interventional procedure overview of percutaneous thrombectomy for massive pulmonary embolism

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