Six months follow-up of protected high-risk percutaneous coronary intervention with the microaxial Impella pump: results from the German Impella registry.
Aged
Aged, 80 and over
Coronary Artery Disease
/ complications
Female
Follow-Up Studies
Germany
/ epidemiology
Heart-Assist Devices
Humans
Male
Middle Aged
Mortality
Percutaneous Coronary Intervention
/ methods
Perioperative Care
/ methods
Registries
Retrospective Studies
Risk
ST Elevation Myocardial Infarction
/ epidemiology
Stroke
/ epidemiology
Stroke Volume
Ventricular Dysfunction, Left
/ complications
Journal
Coronary artery disease
ISSN: 1473-5830
Titre abrégé: Coron Artery Dis
Pays: England
ID NLM: 9011445
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
pubmed:
29
10
2019
medline:
29
6
2021
entrez:
29
10
2019
Statut:
ppublish
Résumé
Percutaneous coronary intervention (PCI) represents an important alternative to coronary bypass surgery for the treatment of patients with complex coronary artery disease and high perioperative risk. Protected percutaneous coronary intervention applies temporary percutaneous ventricular assist devices to mitigate potential hemodynamic compromise in high-risk patients. The Impella system is currently the most commonly used device for protected percutaneous coronary intervention and showed improved hemodynamic parameters in earlier trials. This study was designed as a retrospective, observational multi-center registry conducted in ten hospitals in Germany. We included consecutive patients undergoing protected high-risk percutaneous coronary intervention with Impella support. The primary endpoint was defined as the occurrence of a major adverse cardiac event defined as all-cause mortality, ST-elevation myocardial infarction, or stroke during a postprocedural 180-day follow-up period. In total, 157 patients (80.3% male; mean age 71.8 ± 10.8 years) were included in the present study, and 180-day follow-up was complete for 149 patients (94.9%). At baseline, the patients had a median left ventricular ejection fraction of 39.0% (interquartile range, 25.0-50.0%). The median SYNergy between PCI with TAXUS and Cardiac Surgery-Score I was 33.0 (interquartile range, 24.0-40.5) and the median EuroSCORE II was 7.2% (interquartile range, 3.2-17.1%). During postprocedural follow-up, 34 patients (22.8%) suffered a major adverse cardiac event. All-cause mortality was 18.1% (27 patients). Nine patients (6.0%) sustained a ST-elevation myocardial infarction, while 4 patients (2.7%) had a stroke. Patients undergoing protected high-risk percutaneous coronary intervention with Impella support showed an acceptable 180-day clinical outcome regarding major adverse cardiac event and mortality.
Sections du résumé
BACKGROUND
Percutaneous coronary intervention (PCI) represents an important alternative to coronary bypass surgery for the treatment of patients with complex coronary artery disease and high perioperative risk. Protected percutaneous coronary intervention applies temporary percutaneous ventricular assist devices to mitigate potential hemodynamic compromise in high-risk patients. The Impella system is currently the most commonly used device for protected percutaneous coronary intervention and showed improved hemodynamic parameters in earlier trials.
METHODS
This study was designed as a retrospective, observational multi-center registry conducted in ten hospitals in Germany. We included consecutive patients undergoing protected high-risk percutaneous coronary intervention with Impella support. The primary endpoint was defined as the occurrence of a major adverse cardiac event defined as all-cause mortality, ST-elevation myocardial infarction, or stroke during a postprocedural 180-day follow-up period.
RESULTS
In total, 157 patients (80.3% male; mean age 71.8 ± 10.8 years) were included in the present study, and 180-day follow-up was complete for 149 patients (94.9%). At baseline, the patients had a median left ventricular ejection fraction of 39.0% (interquartile range, 25.0-50.0%). The median SYNergy between PCI with TAXUS and Cardiac Surgery-Score I was 33.0 (interquartile range, 24.0-40.5) and the median EuroSCORE II was 7.2% (interquartile range, 3.2-17.1%). During postprocedural follow-up, 34 patients (22.8%) suffered a major adverse cardiac event. All-cause mortality was 18.1% (27 patients). Nine patients (6.0%) sustained a ST-elevation myocardial infarction, while 4 patients (2.7%) had a stroke.
CONCLUSIONS
Patients undergoing protected high-risk percutaneous coronary intervention with Impella support showed an acceptable 180-day clinical outcome regarding major adverse cardiac event and mortality.
Identifiants
pubmed: 31658135
doi: 10.1097/MCA.0000000000000824
pii: 00019501-202005000-00007
doi:
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
237-242Références
Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, et al. Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet. 2013; 381:639–650
Herrmann J. Peri-procedural myocardial injury: 2005 update. Eur Heart J. 2005; 26:2493–2519
Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB III, et al.; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the american college of cardiology/american heart association task force on practice guidelines (ACC/AHA/SCAI writing committee to update the 2001 guidelines for percutaneous coronary intervention). J Am Coll Cardiol. 2006; 47:e1–e121
Dangas GD, Kini AS, Sharma SK, Henriques JP, Claessen BE, Dixon SR, et al. Impact of hemodynamic support with impella 2.5 versus intra-aortic balloon pump on prognostically important clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (from the PROTECT II randomized trial). Am J Cardiol. 2014; 113:222–228
Ferrari M, Kruzliak P, Spiliopoulos K. An insight into short- and long-term mechanical circulatory support systems. Clin Res Cardiol. 2015; 104:95–111
Burzotta F, Trani C, Doshi SN, Townend J, van Geuns RJ, Hunziker P, et al. Impella ventricular support in clinical practice: collaborative viewpoint from a European Expert User Group. Int J Cardiol. 2015; 201:684–691
Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, et al. A prospective feasibility trial investigating the use of the impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (the PROTECT I trial): initial U.S. experience. JACC Cardiovasc Interv. 2009; 2:91–96
Gómez-Hospital JA. Left ventricular support with impella for high risk percutaneous coronary intervention. The demonstration of the hemodynamic benefit in daily practice. Int J Cardiol. 2019; 274:254–256
Ferreiro JL, Gómez-Hospital JA, Cequier ÁR, Angiolillo DJ, Roura G, Teruel L, et al. Use of impella recover LP 2.5 in elective high risk percutaneous coronary intervention. Int J Cardiol. 2010; 145:235–237
Remmelink M, Sjauw KD, Henriques JP, de Winter RJ, Vis MM, Koch KT, et al. Effects of mechanical left ventricular unloading by impella on left ventricular dynamics in high-risk and primary percutaneous coronary intervention patients. Catheter Cardiovasc Interv. 2010; 75:187–194
Sauren LD, Accord RE, Hamzeh K, de Jong M, van der Nagel T, van der Veen FH, Maessen JG. Combined impella and intra-aortic balloon pump support to improve both ventricular unloading and coronary blood flow for myocardial recovery: an experimental study. Artif Organs. 2007; 31:839–842
Valgimigli M, Steendijk P, Sianos G, Onderwater E, Serruys PW. Left ventricular unloading and concomitant total cardiac output increase by the use of percutaneous impella recover LP 2.5 assist device during high-risk coronary intervention. Catheter Cardiovasc Interv. 2005; 65:263–267
Cohen MG, Matthews R, Maini B, Dixon S, Vetrovec G, Wohns D, 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
Russo G, Burzotta F, D’Amario D, Ribichini F, Piccoli A, Paraggio L, et al. Hemodynamics and its predictors during impella-protected PCI in high risk patients with reduced ejection fraction. Int J Cardiol. 2019; 274:221–225
Baumann S, Werner N, Ibrahim K, Westenfeld R, Al-Rashid F, Sinning JM, et al. Indication and short-term clinical outcomes of high-risk percutaneous coronary intervention with microaxial impella® pump: results from the german impella® registry. Clin Res Cardiol. 2018; 107:653–657
Becher T, Eder F, Baumann S, Loßnitzer D, Pollmann B, Behnes M, et al. Unprotected versus protected high-risk percutaneous coronary intervention with the impella 2.5 in patients with multivessel disease and severely reduced left ventricular function. Medicine (Baltimore). 2018; 97:e12665
Ait Ichou J, Larivee N, Eisenberg MJ, Suissa K, Filion KB. The effectiveness and safety of the impella ventricular assist device for high-risk percutaneous coronary interventions: a systematic review. Catheter Cardiovasc Interv. 2018; 91:1250–1260
Becher T, Baumann S, Eder F, Perschka S, Lossnitzer D, Fastner C, et al. Comparison of peri and post-procedural complications in patients undergoing revascularisation of coronary artery multivessel disease by coronary artery bypass grafting or protected percutaneous coronary intervention with the impella 2.5 device. Eur Heart J Acute Cardiovasc Care. 2019; 8:360–368
Stone GW, Sabik JF, Serruys PW, Simonton CA, Généreux P, Puskas J, et al.; EXCEL Trial Investigators. Everolimus-eluting stents or bypass surgery for left main coronary artery disease. N Engl J Med. 2016; 375:2223–2235
Mäkikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, et al.; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016; 388:2743–2752
O’Connor GT, Malenka DJ, Quinton H, Robb JF, Kellett MA Jr, Shubrooks S, et al. Multivariate prediction of in-hospital mortality after percutaneous coronary interventions in 1994-1996. Northern new england cardiovascular disease study group. J Am Coll Cardiol. 1999; 34:681–691
Werner N, Akin I, Al-Rashid F, Bauer T, Ibrahim K, Karatolios K, et al. Expertenkonsensus zum praktischen einsatz von herzkreislaufunterstützungssystemen bei hochrisiko-koronarinterventionen. Der Kardiologe. 2017; 11:460–472
Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the american college of cardiology foundation/american heart association task force on practice guidelines and the society for cardiovascular angiography and interventions. Circulation. 2011; 124:e574–e651
Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, et al.; Authors/Task Force m. 2014 ESC/EACTS guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014; 35:2541–2619
Sinning JM, Asdonk T, Erlhöfer C, Vasa-Nicotera M, Grube E, Nickenig G, Werner N. Combination of angiographic and clinical characteristics for the prediction of clinical outcomes in elderly patients undergoing multivessel PCI. Clin Res Cardiol. 2013; 102:865–873
Bonzel T, Schächinger V, Dörge H. Description of a heart team approach to coronary revascularization and its beneficial long-term effect on clinical events after PCI. Clin Res Cardiol. 2016; 105:388–400
Schrage B, Ibrahim K, Loehn T, Werner N, Sinning JM, Pappalardo F, et al. Impella support for acute myocardial infarction complicated by cardiogenic shock. Circulation. 2019; 139:1249–1258
Loehn T, O’Neill WW, Lange B, Pfluecke C, Schweigler T, Mierke J, et al. Long term survival after early unloading with Impella CP((R)) in acute myocardial infarction complicated by cardiogenic shock. Eur Heart J Acute Cardiovasc Care. 2018204887261881506310.1177/2048872618815063
doi: 10.1177/2048872618815063
Henriques JP, Claessen BE, Dangas GD, Kirtane AJ, Popma JJ, Massaro JM, et al. Performance of currently available risk models in a cohort of mechanically supported high-risk percutaneous coronary intervention–from the PROTECT II randomized trial. Int J Cardiol. 2015; 189:272–278