To document the real-world experience with the use of pneumatic pulsatile mechanical circulatory support (MCS) with the PulseCath iVAC2L during high-risk percutaneous coronary interventions (HR-PCIs). Background: The use of MCS in HR-PCIs may reduce the rate of major adverse cardiovascular events (MACEs) at 90 days. The PulseCath iVAC2L is a short-term pulsatile transaortic left ventricular (LV) assist device that has been in use since 2014. The iVAC2L Registry tracks its safety and efficacy in a variety of hospitals worldwide. Methods: The iVAC2L Registry is a multicenter, observational registry that aggregates clinical data from patients treated with the iVAC2L worldwide. A total of 293 consecutive cases were retrospectively collected and analyzed. Estimated rates of in-hospital clinical endpoints were described. All-cause mortality was used as the primary endpoint and other outcomes of interest were used as secondary endpoints. The rates obtained were reported and contextualized. Results: The in-hospital rate of all-cause mortality was 1.0%, MACE was 3.1%. Severe hypotension occurred in 8.9% of patients. Major bleeding and major vascular complications occurred in 1.0% and 2.1%, respectively. Acute myocardial infarction occurred in 0.7% of patients. Cerebrovascular events occurred in 1.4% of patients. Cardiac arrest occurred in 1.7% of patients. A statistically significant improvement in blood pressure was observed with iVAC2L activation. Conclusions: The results of the present study suggest that the iVAC2L is capable of improving hemodynamics with a low rate of adverse events. However, confirmatory studies are needed to validate these findings.

Department of Cardiology International Clinical Research Center St Anne University Hospital and Masaryk University School of Medicine 656 91 Brno Czech Republic

Department of Cardiology National Institute of Medicine 02 507 Warsaw Poland

Department of Cardiology National Medical Institute of the Internal Affairs and Administration Ministry 02 005 Warsaw Poland

Department of Cardiology University Hospital in Martin 036 01 Martin Slovakia

Department of Internal Medicine University Hospital Center Zagreb 10000 Zagreb Croatia

PulseCath BV 6811 KS Arnhem The Netherlands

Thoraxcentrum Erasmus Medical Center 3015 GD Rotterdam The Netherlands

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Chieffo A., Dudek D., Hassager C., Combes A., Gramegna M., Halvorsen S., Huber K., Kunadian V., Maly J., Møller J.E., et al. Joint EAPCI/ACVC expert consensus document on percutaneous ventricular assist devices. Eur. Heart J. Acute Cardiovasc. Care. 2021;10:570–583. doi: 10.1093/ehjacc/zuab015. PubMed DOI PMC

Maini B., Naidu S.S., Mulukutla S., Kleiman N., Schreiber T., Wohns D., Dixon S., Rihal C., Dave R., O’Neill W. Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: The USpella Registry. Catheter. Cardiovasc. Interv. 2012;80:717–725. doi: 10.1002/ccd.23403. PubMed DOI

O’Neill W.W., Anderson M., Burkhoff D., Grines C.L., Kapur N.K., Lansky A.J., Mannino S., McCabe J.M., Alaswad K., Daggubati R., et al. Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices. Am. Heart J. 2022;248:139–149. doi: 10.1016/j.ahj.2022.02.006. PubMed DOI

Thohan V., Stetson S.J., Nagueh S.F., Rivas-Gotz C., Koerner M.M., Lafuente J.A., Loebe M., Noon G.P., Torre-Amione G. Cellular and hemodynamics responses of failing myocardium to CF mechanical circulatory support using the DeBakey–Noon LV assist device: A comparative analysis with pulsatile-type devices. J. Heart Lung Transplant. 2005;24:566–575. doi: 10.1016/j.healun.2004.02.017. PubMed DOI

Bastos M.B., van Wiechen M.P., Van Mieghem N.M. PulseCath iVAC2L: Next-generation pulsatile mechanical circulatory support. Future Cardiol. 2020;16:103–112. doi: 10.2217/fca-2019-0060. PubMed DOI

Cohen M.G., Matthews R., Maini B., Dixon S., Vetrovec G., Wohns D., Palacios I., Popma J., Ohman E.M., Schreiber T., et al. Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. Am. Heart J. 2015;170:872–879. doi: 10.1016/j.ahj.2015.08.009. PubMed DOI

Alaswad K., Basir M.B., Khandelwal A., Schreiber T., Lombardi W., O’Neill W. The Role of Mechanical Circulatory Support During Percutaneous Coronary Intervention in Patients Without Severely Depressed LV Function. Am. J. Cardiol. 2018;121:703–708. doi: 10.1016/j.amjcard.2017.11.045. PubMed DOI

Sef D., Kabir T., Lees N.J., Stock U. Valvular complications following the Impella device implantation. J. Card. Surg. 2021;36:1062–1066. doi: 10.1111/jocs.15303. PubMed DOI

Kapur N.K., Alkhouli M.A., DeMartini T.J., Faraz H., George Z.H., Goodwin M.J., Hernandez-Montfort J.A., Iyer V.S., Josephy N., Kalra S., et al. Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction. Circulation. 2019;139:337–346. doi: 10.1161/CIRCULATIONAHA.118.038269. PubMed DOI

O’Neill B.P., Grines C., Moses J.W., Ohman E.M., Lansky A., Popma J., Kapur N.K., Schreiber T., Mann’no S., O’Neill W.W., et al. Outcomes of bailout percutaneous ventricular assist device versus prophylactic strategy in patients undergoing nonemergent percutaneous coronary intervention. Catheter. Cardiovasc. Interv. 2021;98:E501–E512. doi: 10.1002/ccd.29758. PubMed DOI

Chieffo A., Ancona M.B., Burzotta F., Pazzanese V., Briguori C., Trani C., Piva T., De Marco F., Di Biasi M., Pagnotta P., et al. Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: The IMP-IT registry. EuroIntervention. 2020;15:e1343–e1350. doi: 10.4244/EIJ-D-19-00428. PubMed DOI

Burkhoff D., Naidu S.S. The science behind percutaneous hemodynamic support: A review and comparison of support strategies. Catheter. Cardiovasc. Interv. 2012;80:816–829. doi: 10.1002/ccd.24421. PubMed DOI

Elia E., Iannaccone M., D’Ascenzo F., Gallone G., Colombo F., Albani S., Attisani M., Rinaldi M., Boccuzzi G., Conrotto F., et al. Short term outcomes of Impella circulatory support for high-risk percutaneous coronary intervention a systematic review and meta-analysis. Catheter. Cardiovasc. Interv. 2022;99:27–36. doi: 10.1002/ccd.29757. PubMed DOI

Sjauw K.D., Konorza T., Erbel R., Danna P.L., Viecca M., Minden H.H., Butter C., Engstrøm T., Hassager C., Machado F.P., et al. Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry. J. Am. Coll. Cardiol. 2009;54:2430–2434. doi: 10.1016/j.jacc.2009.09.018. PubMed DOI

Van den Buijs D.M.F., Wilgenhof A., Knaapen P., Zivelonghi C., Meijers T., Vermeersch P., Arslan F., Verouden N., Nap A., Sjauw K., et al. Prophylactic Impella CP versus VA-ECMO in Patients Undergoing Complex High-Risk Indicated PCI. J. Interv. Cardiol. 2022;2022:8167011. doi: 10.1155/2022/8167011. PubMed DOI PMC

Griffioen A.M., Van Den Oord S.C.H., Van Wely M.H., Swart G.C., Van Wetten H.B., Danse P.W., Damman P., Van Royen N., Van Geuns R.J.M. Short-Term Outcomes of Elective High-Risk PCI with Extracorporeal Membrane Oxygenation Support: A Single-Center Registry. J. Interv. Cardiol. 2022;2022:7245384. doi: 10.1155/2022/7245384. PubMed DOI PMC

Eckman P.M., Katz J.N., El Banayosy A., Bohula E.A., Sun B., van Diepen S. Veno-Arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock: An Introduction for the Busy Clinician. Circulation. 2019;140:2019–2037. doi: 10.1161/CIRCULATIONAHA.119.034512. PubMed DOI

Fearon W.F., Nishi T., De Bruyne B., Boothroyd D.B., Barbato E., Tonino P., Jüni P., Pijls N.H.J., Hlatky M.A., FAME 2 Trial Investigators Clinical outcomes and cost-effectiveness of fractional flow reserve-guided percutaneous coronary intervention in patients with stable coronary artery disease. Circulation. 2018;137:480–487. doi: 10.1161/CIRCULATIONAHA.117.031907. PubMed DOI

Travis A.R., Giridharan G.A., Pantalos G.M., Dowling R.D., Prabhu S.D., Slaughter M.S., Sobieski M., Undar A., Farrar D.J., Koenig S.C. Vascular pulsatility in patients with a pulsatile- or continuous-flow ventricular assist device. J. Thorac. Cardiovasc. Surg. 2007;133:517–524. doi: 10.1016/j.jtcvs.2006.09.057. PubMed DOI

Undar A. Energy equivalent pressure formula is for precise quantification of different perfusion modes. Ann. Thorac. Surg. 2003;76:1777–1778. doi: 10.1016/S0003-4975(03)00668-4. PubMed DOI

Ji B., Undar A. An evaluation of the benefits of pulsatile versus nonpulsatile perfusion during cardiopulmonary bypass procedures in pediatric and adult cardiac patients. ASAIO J. 2006;52:357–361. doi: 10.1097/01.mat.0000225266.80021.9b. PubMed DOI

Orime Y., Shiono M., Nakata K.I., Hata M., Sezai A., Yamada H., Iida M., Kashiwazaki S., Nemoto M., Kinoshita J.I., et al. The role of pulsatility in end-organ microcirculation after cardiogenic shock. ASAIO J. 1996;42:M724–M729. doi: 10.1097/00002480-199609000-00083. PubMed DOI

Wollmuth J., Patel M.P., Dahle T., Bharadwaj A., Waggoner T.E., Chambers J.W., Ruiz-Rodriguez E., Mahmud E., Thompson C., Morris D.L., et al. Ejection fraction improvement following contemporary high-risk percutaneous coronary intervention: RESTORE EF study results. J. Soc. Cardiovasc. Angiogr. Interv. 2022;1:100350. doi: 10.1016/j.jscai.2022.100350. PubMed DOI PMC

Burzotta F., Russo G., Ribichini F., Piccoli A., D’Amario D., Paraggio L., Previ L., Pesarini G., Porto I., Leone A.M., et al. Long-term outcomes of extent of revascularization in complex high risk and indicated patients undergoing Impella-protected percutaneous coronary intervention: Report from the Roma-Verona registry. J. Interv. Cardiol. 2019;2019:5243913. doi: 10.1155/2019/5243913. PubMed DOI PMC

Buccheri S., Franchina G., Romano S., Puglisi S., Venuti Ge D’Arrigo P., Francaviglia B., Scalia M., Condorelli A., Barbanti M., Capranzano P., et al. Clinical outcomes following intravascular imaging-guided versus coronary angiography-guided percutaneous coronary intervention with stent implantation: A systematic review and Bayesian network meta-analysis of 31 studies and 17,882 patients. JACC Cardiovasc. Interv. 2017;10:2488–2498. doi: 10.1016/j.jcin.2017.08.051. PubMed DOI

Thel M.C., Califf R.M., Tardiff B.E., Gardner L.H., Sigmon K.N., Lincoff A.M., Topol E.J., Kitt M.M., Blankenship J.C., Tcheng J.E. Timing of and risk factors for myocardial ischemic events after percutaneous coronary intervention (IMPACT-II). Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis. Am. J. Cardiol. 2000;85:427–434. doi: 10.1016/S0002-9149(99)00767-5. PubMed DOI