Procedural safety of rotational atherectomy and modified balloon angioplasty: insights from a German national registry.
Coronary artery disease
Cutting balloon
In-hospital safety
Modified balloon
Procedural safety
Real-world cohort
Rotational atherectomy
Scoring balloon
Journal
Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123
Informations de publication
Date de publication:
11 Sep 2024
11 Sep 2024
Historique:
received:
19
04
2024
accepted:
29
08
2024
medline:
11
9
2024
pubmed:
11
9
2024
entrez:
11
9
2024
Statut:
aheadofprint
Résumé
Modified balloons (MB) and rotational atherectomy (RA) are recommended tools for treatment of coronary plaques with superficial calcium. Knowledge about in-hospital safety is limited. Patients with coronary artery disease who underwent coronary angiography with RA or MB angioplasty in Germany were identified via ICD and OPS codes from 2017 to 2020. Acute coronary syndromes were excluded. Since patients were not randomized toward MB or RA, potential confounding factors were taken into account using the propensity score methods. Thereby, inverse probability weighting was applied. Ten thousand.ninety-twopatients underwent RA with an increasing trend from 1817 in 2017 toward 3166 in 2020. MBs were used in 22,378 patients also with an increasing trend from 4771 in 2017 toward 6078 in 2020. Patients receiving RA were older (74.23 ± 8.68 vs. 71.86 ± 10.02, p < 0.001), had a higher Charlson Comorbidity Index (2.07 ± 1.75 vs. 1.99 ± 1.76, p = 0.001) and more frequently left main (17.96% vs. 12.91%, p < 0.001) or three vessel disease (66.25% vs. 58.10%, p < 0.001). Adjusted procedural risk of major adverse cardiac and cerebrovascular events (MACCE) was similar in both groups, while pericardial effusion (RR 2.69; 95% CI 1.88-3.86, p < 0.001), pericardial puncture/pericardiotomy/pericardial tamponade (RR 2.66; 95% CI 1.85-3.81, p < 0.001) and bleeding (RR 1.65; 95% CI 1.12-2.43, p < 0.011) occurred more frequently in patients receiving RA. Patients treated with RA at high volume centers were hospitalized shorter (p = 0.005) and had a lower rate of acute cerebrovascular events (p < 0.001). Rate of MACCE, bleeding and pericardial puncture were not influenced by the annual RA numbers per center. MBs had a lower risk of bleeding and pericardial puncture. Patients treated at centers with high annual RA procedure numbers had a lower risk of acute cerebrovascular events and were hospitalized shorter.
Sections du résumé
BACKGROUND
BACKGROUND
Modified balloons (MB) and rotational atherectomy (RA) are recommended tools for treatment of coronary plaques with superficial calcium. Knowledge about in-hospital safety is limited.
METHODS
METHODS
Patients with coronary artery disease who underwent coronary angiography with RA or MB angioplasty in Germany were identified via ICD and OPS codes from 2017 to 2020. Acute coronary syndromes were excluded. Since patients were not randomized toward MB or RA, potential confounding factors were taken into account using the propensity score methods. Thereby, inverse probability weighting was applied.
RESULTS
RESULTS
Ten thousand.ninety-twopatients underwent RA with an increasing trend from 1817 in 2017 toward 3166 in 2020. MBs were used in 22,378 patients also with an increasing trend from 4771 in 2017 toward 6078 in 2020. Patients receiving RA were older (74.23 ± 8.68 vs. 71.86 ± 10.02, p < 0.001), had a higher Charlson Comorbidity Index (2.07 ± 1.75 vs. 1.99 ± 1.76, p = 0.001) and more frequently left main (17.96% vs. 12.91%, p < 0.001) or three vessel disease (66.25% vs. 58.10%, p < 0.001). Adjusted procedural risk of major adverse cardiac and cerebrovascular events (MACCE) was similar in both groups, while pericardial effusion (RR 2.69; 95% CI 1.88-3.86, p < 0.001), pericardial puncture/pericardiotomy/pericardial tamponade (RR 2.66; 95% CI 1.85-3.81, p < 0.001) and bleeding (RR 1.65; 95% CI 1.12-2.43, p < 0.011) occurred more frequently in patients receiving RA. Patients treated with RA at high volume centers were hospitalized shorter (p = 0.005) and had a lower rate of acute cerebrovascular events (p < 0.001). Rate of MACCE, bleeding and pericardial puncture were not influenced by the annual RA numbers per center.
CONCLUSION
CONCLUSIONS
MBs had a lower risk of bleeding and pericardial puncture. Patients treated at centers with high annual RA procedure numbers had a lower risk of acute cerebrovascular events and were hospitalized shorter.
Identifiants
pubmed: 39259363
doi: 10.1007/s00392-024-02538-8
pii: 10.1007/s00392-024-02538-8
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Kirtane AJ, Doshi D, Leon MB, Lasala JM, Ohman EM, O’Neill WW et al (2016) Treatment of higher-risk patients with an indication for revascularization: evolution within the field of contemporary percutaneous coronary intervention. Circulation 134(5):422–431
pubmed: 27482004
pmcid: 9117111
doi: 10.1161/CIRCULATIONAHA.116.022061
Généreux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L et al (2014) Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing outcomes with revascularization and stents in acute myocardial infarction) and ACUITY (Acute catheterization and urgent intervention triage strategy) TRIALS. J Am Coll Cardiol 63(18):1845–1854
pubmed: 24561145
doi: 10.1016/j.jacc.2014.01.034
Bourantas CV, Zhang YJ, Garg S, Iqbal J, Valgimigli M, Windecker S et al (2014) Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart 100(15):1158–1164
pubmed: 24846971
doi: 10.1136/heartjnl-2013-305180
De Maria GL, Scarsini R, Banning AP (2019) Management of calcific coronary artery lesions: is it time to change our interventional therapeutic approach? JACC Cardiovasc Interv 12(15):1465–1478
pubmed: 31395217
Budoff MJ, Young R, Lopez VA, Kronmal RA, Nasir K, Blumenthal RS et al (2013) Progression of coronary calcium and incident coronary heart disease events: MESA (Multi-ethnic study of atherosclerosis). J Am Coll Cardiol 61(12):1231–1239
pubmed: 23500326
pmcid: 4148074
doi: 10.1016/j.jacc.2012.12.035
Généreux P, Redfors B, Witzenbichler B, Arsenault MP, Weisz G, Stuckey TD et al (2017) Two-year outcomes after percutaneous coronary intervention of calcified lesions with drug-eluting stents. Int J Cardiol 231:61–67
pubmed: 28040289
doi: 10.1016/j.ijcard.2016.12.150
Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Généreux P (2014) Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol 63(17):1703–1714
pubmed: 24530667
doi: 10.1016/j.jacc.2014.01.017
Bamford P, Collins N, Boyle A (2022) A state-of-the-art review: the percutaneous treatment of highly calcified lesions. Heart Lung Circ 31(12):1573–1584
pubmed: 36150953
doi: 10.1016/j.hlc.2022.08.009
Barbato E, Gallinoro E, Abdel-Wahab M, Andreini D, Carrié D, Di Mario C et al (2023) Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group. Eur Heart J 44(41):4340–4356
pubmed: 37208199
doi: 10.1093/eurheartj/ehad342
Tomey MI, Kini AS, Sharma SK (2014) Current status of rotational atherectomy. JACC Cardiovasc Interv 7(4):345–353
pubmed: 24630879
doi: 10.1016/j.jcin.2013.12.196
Karvouni E, Stankovic G, Albiero R, Takagi T, Corvaja N, Vaghetti M et al (2001) Cutting balloon angioplasty for treatment of calcified coronary lesions. Catheter Cardiovasc Interv 54(4):473–481
pubmed: 11747183
doi: 10.1002/ccd.1314
Tang Z, Bai J, Su SP, Wang Y, Liu MH, Bai QC et al (2014) Cutting-balloon angioplasty before drug-eluting stent implantation for the treatment of severely calcified coronary lesions. J Geriatr Cardiol 11(1):44–49
pubmed: 24748881
pmcid: 3981983
Kurbaan AS, Kelly PA, Sigwart U (1997) Cutting balloon angioplasty and stenting for aorto-ostial lesions. Heart 77(4):350–352
pubmed: 9155615
pmcid: 484730
doi: 10.1136/hrt.77.4.350
Okura H, Hayase M, Shimodozono S, Kobayashi T, Sano K, Matsushita T et al (2002) Mechanisms of acute lumen gain following cutting balloon angioplasty in calcified and noncalcified lesions: an intravascular ultrasound study. Catheter Cardiovasc Interv 57(4):429–436
pubmed: 12455075
doi: 10.1002/ccd.10344
Song X, Adachi T, Kawase Y, Kimura T, Saito N (2022) Efficacy of the Wolverine cutting balloon on a circumferential calcified coronary lesion: Bench test using a three-dimensional printer and computer simulation with the finite element method. Cardiovasc Interv Ther 37(1):78–88
pubmed: 33389646
doi: 10.1007/s12928-020-00739-2
Jujo K, Saito K, Ishida I, Kim A, Suzuki Y, Furuki Y et al (2016) Intimal disruption affects drug-eluting cobalt-chromium stent expansion: a randomized trial comparing scoring and conventional balloon predilation. Int J Cardiol 221:23–31
pubmed: 27400292
doi: 10.1016/j.ijcard.2016.07.002
de Ribamar CJ, Mintz GS, Carlier SG, Mehran R, Teirstein P, Sano K et al (2007) Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol 100(5):812–817
doi: 10.1016/j.amjcard.2007.03.100
Abdel-Wahab M, Richardt G, Joachim Büttner H, Toelg R, Geist V, Meinertz T et al (2013) High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv 6(1):10–19
pubmed: 23266232
doi: 10.1016/j.jcin.2012.07.017
Furuichi S, Sangiorgi GM, Godino C, Airoldi F, Montorfano M, Chieffo A et al (2009) Rotational atherectomy followed by drug-eluting stent implantation in calcified coronary lesions. EuroIntervention 5(3):370–374
pubmed: 19736163
doi: 10.4244/V5I3A58
Cao CF, Ma YL, Li Q, Liu J, Zhao H, Lu MY et al (2020) Comparison of bailout and planned rotational atherectomy for severe coronary calcified lesions. BMC Cardiovasc Disord 20(1):374
pubmed: 32799806
pmcid: 7429776
doi: 10.1186/s12872-020-01645-4
Abdel-Wahab M, Toelg R, Byrne RA, Geist V, El-Mawardy M, Allali A et al (2018) High-speed rotational atherectomy versus modified balloons prior to drug-eluting stent implantation in severely calcified coronary lesions. Circ Cardiovasc Interv 11(10):e007415
pubmed: 30354632
doi: 10.1161/CIRCINTERVENTIONS.118.007415
Maier A, Kaier K, Heidt T, Westermann D, von Zur Mühlen C, Grundmann S (2023) Catheter based left atrial appendage closure in-hospital outcomes in Germany from 2016 to 2020. Clin Res Cardiol. https://doi.org/10.1007/s00392-023-02299-w
doi: 10.1007/s00392-023-02299-w
pubmed: 37982864
pmcid: 10808194
Oettinger V, Hilgendorf I, Wolf D, Rilinger J, Maier A, Zehender M et al (2024) Comparing balloon-expandable and self-expanding transfemoral transcatheter aortic valve replacement based on subgroups in Germany 2019/2020. Clin Res Cardiol 113(1):168–176
pubmed: 37982864
doi: 10.1007/s00392-023-02326-w
Glasheen WP, Cordier T, Gumpina R, Haugh G, Davis J, Renda A (2019) Charlson comorbidity index: ICD-9 update and ICD-10 translation. Am Health Drug Benefits 12(4):188–197
pubmed: 31428236
pmcid: 6684052
Shah M, Najam O, Bhindi R, De Silva K (2021) Calcium modification techniques in complex percutaneous coronary intervention. Circ Cardiovasc Interv 14(5):e009870
pubmed: 33441017
doi: 10.1161/CIRCINTERVENTIONS.120.009870
Beohar N, Kaltenbach LA, Wojdyla D, Pineda AM, Rao SV, Stone GW et al (2020) Trends in usage and clinical outcomes of coronary atherectomy: a report from the national cardiovascular data registry cathpci registry. Circ Cardiovasc Interv 13(2):e008239
pubmed: 31973557
doi: 10.1161/CIRCINTERVENTIONS.119.008239
Ayoub M, Tajti P, Ferenc M, Akin I, Behnes M, Neumann FJ et al (2023) Feasibility and outcome of the Rotapro system in treating severely calcified coronary lesions: the rotapro study. Cardiol J 30(4):526–533
pubmed: 34671968
pmcid: 10508079
doi: 10.5603/CJ.a2021.0128
Bortnick AE, Epps KC, Selzer F, Anwaruddin S, Marroquin OC, Srinivas V et al (2014) Five-year follow-up of patients treated for coronary artery disease in the face of an increasing burden of co-morbidity and disease complexity (from the NHLBI dynamic registry). Am J Cardiol 113(4):573–579
pubmed: 24388624
doi: 10.1016/j.amjcard.2013.10.039
Doost A, Rankin J, Sapontis J, Ko B, Lo S, Jaltotage B et al (2022) Contemporary evidence-based diagnosis and management of severe coronary artery calcification. Heart Lung Circ 31(6):766–778
pubmed: 35227609
doi: 10.1016/j.hlc.2022.01.011
Cockburn J, Hildick-Smith D, Cotton J, Doshi S, Hanratty C, Ludman P et al (2014) Contemporary clinical outcomes of patients treated with or without rotational coronary atherectomy–an analysis of the UK central cardiac audit database. Int J Cardiol 170(3):381–387
pubmed: 24289876
doi: 10.1016/j.ijcard.2013.11.018
Safian RD, Feldman T, Muller DW, Mason D, Schreiber T, Haik B et al (2001) Coronary angioplasty and rotablator atherectomy trial (CARAT): immediate and late results of a prospective multicenter randomized trial. Catheter Cardiovasc Interv 53(2):213–220
pubmed: 11387607
doi: 10.1002/ccd.1151
Barbato E, Carrié D, Dardas P, Fajadet J, Gaul G, Haude M et al (2015) European expert consensus on rotational atherectomy. EuroIntervention 11(1):30–36
pubmed: 25982648
doi: 10.4244/EIJV11I1A6
Bacmeister L, Breitbart P, Sobolewska K, Kaier K, Rahimi F, Löffelhardt N et al (2023) Planned versus unplanned rotational atherectomy for plaque modification in severely calcified coronary lesions. Clin Res Cardiol 112(9):1252–1262
pubmed: 36928928
pmcid: 10449691
doi: 10.1007/s00392-023-02176-6
Kawamoto H, Latib A, Ruparelia N, Boccuzzi GG, Pennacchi M, Sardella G et al (2016) Planned versus provisional rotational atherectomy for severe calcified coronary lesions: Insights From the ROTATE multi-center registry. Catheter Cardiovasc Interv 88(6):881–889
pubmed: 26775275
doi: 10.1002/ccd.26411
Allali A, Abdel-Wahab M, Sulimov DS, Jose J, Geist V, Kassner G et al (2017) Comparison of bailout and planned rotational atherectomy for heavily calcified coronary lesions: a single-center experience. J Interv Cardiol 30(2):124–133
pubmed: 27990696
doi: 10.1111/joic.12361
Angiolillo DJ, Bhatt DL, Cannon CP, Eikelboom JW, Gibson CM, Goodman SG et al (2021) Antithrombotic therapy in patients with atrial fibrillation treated with oral anticoagulation undergoing percutaneous coronary intervention: a north american perspective: 2021 update. Circulation 143(6):583–596
pubmed: 33555916
doi: 10.1161/CIRCULATIONAHA.120.050438
Kataoka H (2000) Pericardial and pleural effusions in decompensated chronic heart failure. Am Heart J 139(5):918–923
pubmed: 10783228
doi: 10.1016/S0002-8703(00)90026-7
Wallace TW, Berger JS, Wang A, Velazquez EJ, Brown DL (2009) Impact of left ventricular dysfunction on hospital mortality among patients undergoing elective percutaneous coronary intervention. Am J Cardiol 103(3):355–360
pubmed: 19166689
doi: 10.1016/j.amjcard.2008.09.088
Ye Z, Lu H, Li L (2018) Reduced left ventricular ejection fraction is a risk factor for in-hospital mortality in patients after percutaneous coronary intervention: a hospital-based survey. Biomed Res Int 2018:8753176
pubmed: 30627579
pmcid: 6304602
doi: 10.1155/2018/8753176
Isogai T, Yasunaga H, Matsui H, Tanaka H, Fushimi K (2016) Relationship between hospital volume and major cardiac complications of rotational atherectomy: a nationwide retrospective cohort study in Japan. J Cardiol 67(5):442–448
pubmed: 26271446
doi: 10.1016/j.jjcc.2015.07.008
Ishihara T, Iida O, Takahara M, Tsujimura T, Okuno S, Kurata N et al (2021) Improved crossability with novel cutting balloon versus scoring balloon in the treatment of calcified lesion. Cardiovasc Interv Ther 36(2):198–207
pubmed: 32222901
doi: 10.1007/s12928-020-00663-5
Matsukawa R, Kozai T, Tokutome M, Nakashima R, Nishimura R, Matsumoto S et al (2019) Plaque modification using a cutting balloon is more effective for stenting of heavily calcified lesion than other scoring balloons. Cardiovasc Interv Ther 34(4):325–334
pubmed: 30771163
doi: 10.1007/s12928-019-00578-w
Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S et al (2021) Intravascular lithotripsy for treatment of calcified coronary lesions: patient-level pooled analysis of the disrupt CAD studies. JACC Cardiovasc Interv 14(12):1337–1348
pubmed: 33939604
doi: 10.1016/j.jcin.2021.04.015