Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry

Maurizio Taramasso; Mara Gavazzoni; Alberto Pozzoli; Hannes Alessandrini; Azeem Latib; Adrian Attinger-Toller; Luigi Biasco; Daniel Braun; Eric Brochet; Kim A. Connelly; Sabine de Bruijn; Paolo Denti; Florian Deuschl; Rodrigo Estevez-Louriero; Neil Fam; Christian Frerker; Edwin Ho; Jean Michel Juliard; Ryan Kaple; Susheel Kodali; Felix Kreidel; Karl Heinz Kuck; Alexander Lauten; Julia Lurz; Vanessa Monivas; Michael Mehr; Tamin Nazif; Georg Nickening; Giovanni Pedrazzini; Fabien Praz; Rishi Puri; Josep Rodés-Cabau; Ulrich Schäfer; Joachim Schofer; Horst Sievert; Gilbert H.L. Tang; Ahmed A. Khattab; Holger Thiele; Matthias Unterhuber; Alec Vahanian; Ralph Stephan Von Bardeleben; John G. Webb; Marcel Weber; Stephan Windecker; Mirjam Winkel; Michel Zuber; Jörg Hausleiter; Philipp Lurz; Francesco Maisano; Martin B. Leon; Rebecca T. Hahn

doi:10.1016/j.jcin.2019.10.058

Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry

Maurizio Taramasso, Mara Gavazzoni, Alberto Pozzoli, Hannes Alessandrini, Azeem Latib, Adrian Attinger-Toller, Luigi Biasco, Daniel Braun, Eric Brochet, Kim A. Connelly, Sabine de Bruijn, Paolo Denti, Florian Deuschl, Rodrigo Estevez-Louriero, Neil Fam, Christian Frerker, Edwin Ho, Jean Michel Juliard, Ryan Kaple, Susheel KodaliFelix Kreidel, Karl Heinz Kuck, Alexander Lauten, Julia Lurz, Vanessa Monivas, Michael Mehr, Tamin Nazif, Georg Nickening, Giovanni Pedrazzini, Fabien Praz, Rishi Puri, Josep Rodés-Cabau, Ulrich Schäfer, Joachim Schofer, Horst Sievert, Gilbert H.L. Tang, Ahmed A. Khattab, Holger Thiele, Matthias Unterhuber, Alec Vahanian, Ralph Stephan Von Bardeleben, John G. Webb, Marcel Weber, Stephan Windecker, Mirjam Winkel, Michel Zuber, Jörg Hausleiter, Philipp Lurz, Francesco Maisano, Martin B. Leon, Rebecca T. Hahn

Medicine

Research output: Contribution to journal › Article › peer-review

33 Scopus citations

Abstract

Objectives: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. Background: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. Methods: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. Results: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm² vs. 0.6 ± 0.3 cm²; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). Conclusions: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

Original language	English (US)
Pages (from-to)	554-564
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	13
Issue number	5
DOIs	https://doi.org/10.1016/j.jcin.2019.10.058
State	Published - Mar 9 2020

Keywords

transcatheter tricuspid intervention
tricuspid regurgitation
tricuspid valve

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2019.10.058

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Taramasso, M., Gavazzoni, M., Pozzoli, A., Alessandrini, H., Latib, A., Attinger-Toller, A., Biasco, L., Braun, D., Brochet, E., Connelly, K. A., de Bruijn, S., Denti, P., Deuschl, F., Estevez-Louriero, R., Fam, N., Frerker, C., Ho, E., Juliard, J. M., Kaple, R., ... Hahn, R. T. (2020). Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry. JACC: Cardiovascular Interventions, 13(5), 554-564. https://doi.org/10.1016/j.jcin.2019.10.058

Taramasso, M, Gavazzoni, M, Pozzoli, A, Alessandrini, H, Latib, A, Attinger-Toller, A, Biasco, L, Braun, D, Brochet, E, Connelly, KA, de Bruijn, S, Denti, P, Deuschl, F, Estevez-Louriero, R, Fam, N, Frerker, C, Ho, E, Juliard, JM, Kaple, R, Kodali, S, Kreidel, F, Kuck, KH, Lauten, A, Lurz, J, Monivas, V, Mehr, M, Nazif, T, Nickening, G, Pedrazzini, G, Praz, F, Puri, R, Rodés-Cabau, J, Schäfer, U, Schofer, J, Sievert, H, Tang, GHL, Khattab, AA, Thiele, H, Unterhuber, M, Vahanian, A, Von Bardeleben, RS, Webb, JG, Weber, M, Windecker, S, Winkel, M, Zuber, M, Hausleiter, J, Lurz, P, Maisano, F, Leon, MB & Hahn, RT 2020, 'Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry', JACC: Cardiovascular Interventions, vol. 13, no. 5, pp. 554-564. https://doi.org/10.1016/j.jcin.2019.10.058

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title = "Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry",

abstract = "Objectives: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. Background: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. Methods: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. Results: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). Conclusions: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.",

keywords = "transcatheter tricuspid intervention, tricuspid regurgitation, tricuspid valve",

author = "Maurizio Taramasso and Mara Gavazzoni and Alberto Pozzoli and Hannes Alessandrini and Azeem Latib and Adrian Attinger-Toller and Luigi Biasco and Daniel Braun and Eric Brochet and Connelly, {Kim A.} and {de Bruijn}, Sabine and Paolo Denti and Florian Deuschl and Rodrigo Estevez-Louriero and Neil Fam and Christian Frerker and Edwin Ho and Juliard, {Jean Michel} and Ryan Kaple and Susheel Kodali and Felix Kreidel and Kuck, {Karl Heinz} and Alexander Lauten and Julia Lurz and Vanessa Monivas and Michael Mehr and Tamin Nazif and Georg Nickening and Giovanni Pedrazzini and Fabien Praz and Rishi Puri and Josep Rod{\'e}s-Cabau and Ulrich Sch{\"a}fer and Joachim Schofer and Horst Sievert and Tang, {Gilbert H.L.} and Khattab, {Ahmed A.} and Holger Thiele and Matthias Unterhuber and Alec Vahanian and {Von Bardeleben}, {Ralph Stephan} and Webb, {John G.} and Marcel Weber and Stephan Windecker and Mirjam Winkel and Michel Zuber and J{\"o}rg Hausleiter and Philipp Lurz and Francesco Maisano and Leon, {Martin B.} and Hahn, {Rebecca T.}",

note = "Publisher Copyright: {\textcopyright} 2020 American College of Cardiology Foundation",

year = "2020",

month = mar,

day = "9",

doi = "10.1016/j.jcin.2019.10.058",

language = "English (US)",

volume = "13",

pages = "554--564",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

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number = "5",

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TY - JOUR

T1 - Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads

T2 - Data From the TriValve Registry

AU - Taramasso, Maurizio

AU - Gavazzoni, Mara

AU - Pozzoli, Alberto

AU - Alessandrini, Hannes

AU - Latib, Azeem

AU - Attinger-Toller, Adrian

AU - Biasco, Luigi

AU - Braun, Daniel

AU - Brochet, Eric

AU - Connelly, Kim A.

AU - de Bruijn, Sabine

AU - Denti, Paolo

AU - Deuschl, Florian

AU - Estevez-Louriero, Rodrigo

AU - Fam, Neil

AU - Frerker, Christian

AU - Ho, Edwin

AU - Juliard, Jean Michel

AU - Kaple, Ryan

AU - Kodali, Susheel

AU - Kreidel, Felix

AU - Kuck, Karl Heinz

AU - Lauten, Alexander

AU - Lurz, Julia

AU - Monivas, Vanessa

AU - Mehr, Michael

AU - Nazif, Tamin

AU - Nickening, Georg

AU - Pedrazzini, Giovanni

AU - Praz, Fabien

AU - Puri, Rishi

AU - Rodés-Cabau, Josep

AU - Schäfer, Ulrich

AU - Schofer, Joachim

AU - Sievert, Horst

AU - Tang, Gilbert H.L.

AU - Khattab, Ahmed A.

AU - Thiele, Holger

AU - Unterhuber, Matthias

AU - Vahanian, Alec

AU - Von Bardeleben, Ralph Stephan

AU - Webb, John G.

AU - Weber, Marcel

AU - Windecker, Stephan

AU - Winkel, Mirjam

AU - Zuber, Michel

AU - Hausleiter, Jörg

AU - Lurz, Philipp

AU - Maisano, Francesco

AU - Leon, Martin B.

AU - Hahn, Rebecca T.

PY - 2020/3/9

Y1 - 2020/3/9

N2 - Objectives: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. Background: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. Methods: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. Results: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). Conclusions: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

AB - Objectives: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. Background: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. Methods: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. Results: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). Conclusions: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

KW - transcatheter tricuspid intervention

KW - tricuspid regurgitation

KW - tricuspid valve

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U2 - 10.1016/j.jcin.2019.10.058

DO - 10.1016/j.jcin.2019.10.058

M3 - Article

C2 - 31954676

AN - SCOPUS:85079899666

SN - 1936-8798

VL - 13

SP - 554

EP - 564

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 5

ER -

Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry

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