Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads

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ª 2020 THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION. PUBLISHED BY ELSEVIER. ALL RIGHTS RESERVED.

Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads Data From the TriValve Registry Maurizio Taramasso, MD, PHD,a Mara Gavazzoni, MD,a Alberto Pozzoli, MD,a Hannes Alessandrini, MD,b Azeem Latib, MD,c Adrian Attinger-Toller, MD,d Luigi Biasco, MD,e Daniel Braun, MD,f Eric Brochet, MD,g Kim A. Connelly, MD,h Sabine de Bruijn, MD,i Paolo Denti, MD,j Florian Deuschl, MD,k Rodrigo Estevez-Louriero, MD, PHD,l Neil Fam, MD,h Christian Frerker, MD,b Edwin Ho, MD,c,h Jean-Michel Juliard, MD,g Ryan Kaple, MD,m Susheel Kodali, MD,n Felix Kreidel, MD,o Karl-Heinz Kuck, MD,b Alexander Lauten, MD,p Julia Lurz, MD,q Vanessa Monivas, MD,l Michael Mehr, MD,f Tamin Nazif, MD,n Georg Nickening, MD,r Giovanni Pedrazzini, MD,e Fabien Praz, MD,s Rishi Puri, MD,t Josep Rodés-Cabau, MD,t Ulrich Schäfer, MD,k Joachim Schofer, MD,u Horst Sievert, MD,i Gilbert H.L. Tang, MD, MSC, MBA,v Ahmed A. Khattab, MD,a,w,x Holger Thiele, MD,q Matthias Unterhuber, MD,q Alec Vahanian, MD,g Ralph Stephan Von Bardeleben, MD,o John G. Webb, MD,d Marcel Weber, MD,r Stephan Windecker, MD,s Mirjam Winkel, MD,s Michel Zuber, MD,a Jörg Hausleiter, MD,f Philipp Lurz, MD, PHD,q Francesco Maisano, MD,a Martin B. Leon, MD,n Rebecca T. Hahn, MDn

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. 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 ¼ 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p ¼ 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 ¼ 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion ¼ 16.7  5.0 mm vs. 15.9  4.0 mm; p ¼ 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 ¼ 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p ¼ 0.7). At 30 days, residual TR #2þ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p ¼ 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p ¼ 0.3). Survival at 12 months was 80.7  3.0% in the no-CIED patients and 73.6  5.0% in the CIED patients (p ¼ 0.3). 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. (J Am Coll Cardiol Intv 2020;-:-–-) © 2020 the American College of Cardiology Foundation. Published by Elsevier. All rights reserved.

From the aCardiology Department, University Hospital of Zurich, University of Zurich, Zurich, Switzerland; bCardiology Department, Asklepios Klinik St. Georg, Hamburg, Germany; cCardiology Department, Montefiore Medical Center, New York, New York; d f

Cardiology Department, St. Paul Hospital, Vancouver, Canada; eCardiology Department, Cardiocentro, Lugano, Switzerland;

Cardiology Department, Klinikum der Universität München, Munich, Germany; gCardiology Department, Hôpital Bichat, Uni-

versité Paris VI, Paris, France; hCardiology Department, Toronto Heart Center, St. Michael’s Hospital, Toronto, Canada; iCardiology

ISSN 1936-8798/$36.00

https://doi.org/10.1016/j.jcin.2019.10.058

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ABBREVIATIONS AND ACRONYMS CI = confidence interval CIED = cardiac implantable electronic device

HR = hazard ratio NYHA = New York Heart

ardiac implantable electronic de-

crease in the future, owing to the aging population and

vices (CIEDs) have increased the

improved life expectancy (3–5).

quality and duration of life for mil-

The presence of an endocardial lead to provide

lions of patients, providing support of heart

pacing or defibrillation in the right side of the heart

rate, atrioventricular and interventricular

may interfere with the tricuspid valve (TV) compo-

synchrony, and prevention of sudden cardiac

nents, contributing to or being the main mechanism

death (1,2).

of tricuspid regurgitation (TR). The association be-

Yearly, more than 1 million new CIEDs

Association

RV = right ventricular TAPSE = tricuspid annular

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Feasibility of Transcatheter Tricuspid Intervention in Patients With Transvalvular Lead

tween the presence of a transvalvular lead and TR

(about 700,000 permanent pacemakers and

was first reported decades ago and has been consis-

about

cardioverter-

tently documented in case reports and small series

300,000

implantable

defibrillators) are implanted worldwide, ac-

since then (6–8), with a reported frequency of 7% to

cording to the 2009 survey of cardiac

45% (5). The presence of a CIED lead is associated

permanent

implantable

with progression of TR (4,6,9–12), poor outcomes

valve intervention

cardioverter-defibrillators, and the number

(9,13,14), and poses specific therapeutic challenges to

TV = tricuspid valve

of patients requiring CIEDs is expected to in-

transcatheter tricuspid valve intervention (TTVI)

plane systolic excursion

TR = tricuspid regurgitation TTVI = transcatheter tricuspid

pacemakers

and

Department, CardioVascular Center Frankfurt, Frankfurt am Main, Germany; jCardiac Surgery Department, San Raffaele University Hospital, Milan, Italy; kCardiology Department, University Heart Center Hamburg, Hamburg, Germany; lCardiology Department, Department of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain; chester Medical Center, Valhalla, New York;

m

Cardiology Department, West-

n

Cardiology Department, New York-Presbyterian/Columbia University Medical

Center, New York, New York; oCardiology Department, Department of Cardiology, University Medical Center Mainz, Mainz, Germany; pCardiology Department, Charité University Hospital, Berlin, Germany; qCardiology Department, Heart Center Leipzig, University Hospital Leipzig, Leipzig, Germany; rCardiology Department, Universitatsklinikum Bonn, Bonn, Germany; sCardiology Department, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; tCardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada; uCardiology Department, Albertinen Heart Center, Hamburg, Germany; v

Cardiac Surgery Department, Mount Sinai Hospital, New York, New York; wCardiology Department, Cardiance Clinic, Pfäffikon,

Switzerland; and the xCardiology Department, University of Bern, Bern, Switzerland. Dr. Taramasso has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic; and received speaker honoraria from Edwards Lifesciences. Dr. Gavazzoni has served as a consultant for Biotronik. Dr. Latib has served on the advisory board for Medtronic and Abbott Vascular; on the Speakers Bureau for Abbott Vascular; on the scientific advisory board for Millipede; and as a consultant for 4Tech, Mitralign, and Millipede. Dr. Braun has received speaker honoraria and travel support from Abbott Vascular. Dr. Brochet has received speaker fees from Abbott Vascular. Dr. Connelly has received honoraria from Abbott Industries. Dr. Denti has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and received honoraria from Abbott and Edwards. Dr. Deuschl has served as a proctor and consultant for Valtech/Edwards Lifesciences and Neovasc; received speaker honoraria from Abbott; and received unrestricted travel grants from Boston Scientific, Abbott, Edwards Lifesciences, and Neovasc. Dr. Kodali has served on the scientific advisory board for Microinterventional Devices, Dura Biotech, Thubrikar Aortic Valve, and Supira; has served as a consultant for Meril Lifesciences, Admedus, Medtronic, and Boston Scientific; has served on the steering committee for Edwards Lifesciences and Abbott Vascular; has received honoraria from Meril Lifesciences, Admedus, Abbott Vascular, and Dura Biotech; and owns equity in Dura Biotech, Thubrikar Aortic Valve, Supira, and MID. Dr. Kreidel has received speaker honoraria and consulting fees from Abbott and Edwards Lifesciences. Dr. Kuck has served as a consultant for Abbott Vascular, St. Jude Medical, Biotronik, Medtronic, Biosense Webster. Boston Scientific, Edwards Lifesciences, and Mitralign; and is cofounder of Cardiac Implants. Dr. Lauten has received research support from Abbott and Edwards Lifesciences; and has been a consultant to Abbott, Edwards Lifesciences, and TricValve. Dr. Lurz has received speaker fees from Abbott. Dr. Mehr has received a travel grant from Bristol-Myers Squibb. Dr. Nazif has served as a consultant for and received consulting honoraria from Edwards Lifesciences, Boston Scientific, Medtronic, and Biotrace Medical. Dr. Praz has been a consultant to Edwards Lifesciences. Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences. Dr. Schäfer has received lecture fees, study honoraria, travel expenses from, and has been a member of an advisory board for Abbott. Dr. Sievert has received study honoraria, travel expenses, and consulting fees from 4TECH Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr. Tang has served as a consultant, advisory board member, and faculty trainer for Abbott Structural Heart. Dr. Vahanian has served as a consultant for Abbott Vascular, Edwards Lifesciences, MitralTech, and Cardiovalve; and received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr. Webb has received research support from Edwards Lifesciences; and served as a consultant for Abbott Vascular, Edwards Lifesciences, and St. Jude Medical. Dr. Windecker has received institutional research grants from Abbott, Amgen, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, St Jude, and Terumo. Dr. Hausleiter has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Maisano has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; is cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (FMR surgical annuloplasty); and is a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr. Leon has served as

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Taramasso et al. Feasibility of Transcatheter Tricuspid Intervention in Patients With Transvalvular Lead

techniques (13–15), including the interference with device imaging or positioning.

collected. Pre-discharge and follow-up events, and echocardiographic data were collected whenever

Current options for treatment of CIED-induced

available from the respective centers. The inclusion

TR include lead extraction, surgical TV repair or

of patients in this study was approved in each center

replacement or medical therapy (4). Recent single-

by a local ethics committee or per local practice for

site studies have suggested, however, that lead

the collection of retrospective data.

extraction may not result in significant reduction in TR, particularly in patients with a dilated TV annulus (16).

The

international

TriValve

(Transcatheter

Tricuspid Valve Therapies) registry (NCT03416166) is the largest international registry to collect data of patients undergoing TTVI with the currently available devices, and was established to investigate the clinical profile and outcomes of patients undergoing TTVI (17). Outcomes from the TriValve registry have suggested that TTVI is feasible with different techniques and associated with promising early outcomes (17,18). Feasibility and efficacy of TTVI in presence of a CIED is unclear and has never been investigated on a large scale (19). The aim of the present study is to investigate the feasibility, safety, and efficacy of TTVI in patients with CIED leads among patients included in the TriValve registry.

DEFINITIONS. All the patients included in the regis-

try had severe or greater symptomatic TR according to the European or American guidelines for the management of heart valve disease and were treated according

to

local

multidisciplinary

team

deci-

sion (22,23). Grading of the severity of TR was assessed using a combination of semiquantitative and quantitative assessment, as described by the American Society of Echocardiography guidelines as well as the European Association of Echocardiography guidelines (24,25). Procedural success was defined as patient alive at the end of the procedure, with the device successfully implanted and delivery system retrieved, with a residual TR #2þ. In the absence of specific criteria and definitions for TTVI adverse outcomes, Mitral Valve Academic

METHODS

Research Consortium criteria were used instead to

DESIGN OF THE STUDY. The design of the registry

has been described previously (17). A total of 21 heart centers across Europe and North America contributed to the registry. Continued communication with involved centers (M.T.) was initiated. Data were

define adverse events (26). Follow-up data were collected for patients at 1 month and then according to the time frame elapsed from the index procedure to data lock for the present analysis.

collected with the use of a dedicated dataset. TV

STATISTICAL

therapies included in the registry were MitraClip

performed with the use of JMP software version 8.0

(Abbott Vascular, Santa Clara, California), FORMA

(SAS Institute, Cary, North Carolina). Patients were

(Edwards Lifesciences, Irvine, California), Cardio-

divided in 2 groups according to the presence of

band

(4Tech,

transtricuspid CIED lead (CIED group) or not (no-CIED

Galway, Ireland), Trialign (Edwards Lifesciences),

group). Baseline features, periprocedural results and

CAVI,

and

follow-up outcomes were compared and reported

NaviGate (NaviGate Cardiac Structures, Lake Forest,

accordingly. Results are presented as mean  SD for

California). The comprehensive descriptions of the

continuous variables that were normally distributed

different

(tested by the Shapiro-Wilk normality test), as me-

(Edwards PASCAL

Lifesciences), (Edwards

procedures

have

TriCinch

Lifesciences),

been

reported

else-

where (20,21). local investigators and during on-site data moniBaseline

anatomical,

analysis

was

dian and interquartile range for continuous variables

All inconsistencies were resolved directly with toring.

ANALYSIS. Statistical

and

and

intraprocedural

echocardiographic

clinical,

data

were

without normal distribution, and as proportions for categorical data. One-way analysis of variance and paired Student’s t-test were used to compare normally distributed

a nonpaid member of the scientific advisory board of Edwards Lifesciences; and has been a consultant to Abbott Vascular and Boston Scientific. Dr. Hahn has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3mensio. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received July 29, 2019; revised manuscript received September 30, 2019, accepted October 9, 2019.

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Feasibility of Transcatheter Tricuspid Intervention in Patients With Transvalvular Lead

RESULTS

T A B L E 1 Baseline Clinical Profile of the Study Population: Overall and Subgroups

(CIED and No-CIED Patients)

PATIENT DEMOGRAPHICS AND CLINICAL PROFILE Overall Population (N ¼ 470)

OF THE STUDY POPULATION. Between January 2015

No CIED (n ¼ 349)

CIED (n ¼ 121)

p Value

and December 2018, 470 patients with severe symp-

Age, yrs

76.0  8.6

77.7  8.6

75.0  9.0

0.073

tomatic TR underwent TTVI in 21 different centers

Female

291 (62.0)

208 (59.0)

54 (44.0)

0.013

(Europe, United States, and Canada) and were

EuroSCORE II

10.0  8.0

10.3  5.0

10.8  10.0

0.6

included in the TriValve registry.

TR etiology Functional Degenerative Mixed

428 (91.0) 19 (4.0) 16 (3.0)

315 (91.0) 15 (4.0) 15 (4.0)

113 (92.0) 4 (3.0) 1 (0.8)

0.23

 8.6 years, with a 62% prevalence of female patients.

In the overall study population, mean age was 76.0 Expected surgical risk for mortality assessed with EuroSCORE (European System for Cardiac Operative

Pure PM-induced TR

7 (1.4)

Previous left-sided valve intervention (surgical/transcatheter)

91/42

70/33

21/9

0.23

170 (36.0)

120 (35.0)

50 (40.0)

0.1

pnea: 93.0% (438 patients) were in New York Heart

Atrial fibrillation

3 (2.5)

Risk Evaluation) II was 10  8%. Most patients were severely symptomatic for dys-

100 (21.0)

61 (18.0)

39 (32.0)

0.001

Association (NYHA) functional class III to IV, 73.0%

44.2  16.0

44.2  20.0

42.0  19.0

0.3

had a previous admission owing to right ventricular

32/25

28/20

20/20

0.45

(RV) failure within the 12 months before the proced-

NYHA functional class III–IV

438 (93.0)

322 (92.3)

116 (95.9)

0.02

ure. The presence of a CIED lead through the TV was

Ascites

103 (21.9)

64 (19.0)

39 (33.0)

0.001

observed in 121 (26.0%) patients in the CIED group,

Peripheral edema

377 (80.0)

275 (75.0)

102 (84.0)

0.01

while in 349 (74.0%) patients in the no-CIED group, a

Previous admission for RV failure

346 (73.0)

240 (69.0)

106 (87.8)

0.002

lead was present. The main etiology of TR was func-

5,417  424

4,851  446

10.5  2.3

10.7  3.0

COPD eGFR, ml/min Median AST/ALT

NT pro-BNP, pg/ml Baseline hemoglobin, g/dl Medical therapy Torasemide (n ¼ 300), mg Furosemide (n ¼ 170), mg

7,920  1,079 0.04 10.9  2.3

0.56

tional in 91.0% (n ¼ 428) of the cases, degenerative in 4.0% (n ¼ 19) and mixed in 3.0% (n ¼ 16); pure pacemaker-induced TR (in which the only mechanism

30 (10–40) 80 (20–140)

31  11 80  50

19  9 120  44

0.01 0.056

Values are mean  SD, n (%), or median (interquartile range), unless otherwise indicated. ALT ¼ alanine aminotransferase; AST ¼ aspartate aminotransferase; CIED ¼ cardiac implantable electronic device; COPD ¼ chronic obstructive pulmonary disease; eGFR ¼ estimated glomerular filtration rate; EuroSCORE ¼ European System for Cardiac Operative Risk Evaluation; NT-proBNP ¼ N-terminal pro–B-type natriuretic peptide; NYHA ¼ New York Heart Association; PM ¼ pacemaker; RV ¼ right ventricular; TR ¼ tricuspid regurgitation.

determining TR was the interference or interaction of the lead with the leaflets or valve component) was observed only in 7 (1.4%) patients. As compared with patients in the no-CIED group, the patients in the CIED group were comparable in terms of age (75.0  9.0 years of age vs. 77.7  8.6 years of age; p ¼ 0.07) and predicted surgical risk (10.8  10.0 vs. 10.3  5.0; p ¼ 0.6). Prevalence of chronic obstructive lung disease was higher in the

continuous variables; Mann-Whitney and Kruskal-

CIED group (32.0% vs. 18.0%; p ¼ 0.001), while the 2

Wallis test were used for non-normally distributed

groups did not differ in terms of atrial fibrillation and

data. Chi-square and Fisher exact tests were used to

renal and liver dysfunction. Patients in the CIED

compare categorical variables. Cumulative event-free

group were more symptomatic: 95.9% (n ¼ 116) were

survival was reported using the Kaplan-Meier method

in NYHA functional class III to IV compared with

and comparisons were performed using the log-rank

92.3% (n ¼ 322) in the no-CIED group (p ¼ 0.02);

test. A p value <0.05 was considered statistically

33.0% (n ¼ 39) in the CIED group versus 19% (n ¼ 64)

significant, and all reported p values are 2-sided.

in the no-CIED group (p ¼ 0.001) presented with as-

Univariate analysis of predictors of procedural suc-

cites and 84.0% (n ¼ 102) versus 75.0% (n ¼ 275)

cess was performed with nominal logistic regression;

(p ¼ 0.01) had peripheral edema despite maximally

multivariable Cox proportional hazards regression

tolerated diuretic therapy in the CIED and no-CIED

modeling was performed to determine the indepen-

groups,

dent predictors of mortality at follow-up using pur-

frequently at least 1 admission owing to right heart

poseful selection of covariates. Variables associated

failure within the 12 months before the index pro-

respectively.

CIED

patients

had

more

at univariate analysis with death at follow-up (all

cedure (87.8% vs. 69.0%; p ¼ 0.002) and had signifi-

with a p # 0.10) and those judged to be of clinical

cantly

importance were eligible for inclusion in the multi-

natriuretic peptide at baseline (7,920  1,079 pg/ml

variable model-building process. Results are reported

vs. 4,851  446 pg/ml; p ¼ 0.04). Clinical profile of the

as hazard ratio (HR) with 95% confidence interval

overall population and of the 2 groups are summa-

(CI).

rized and compared in Table 1.

higher

levels

of

N-terminal

pro–B-type

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Feasibility of Transcatheter Tricuspid Intervention in Patients With Transvalvular Lead

ECHOCARDIOGRAPHIC

PROFILE

OF

OVERALL

POPULATION AND PATIENTS WITH AND WITHOUT

T A B L E 2 Baseline Echocardiographic Profile of the Overall Population and Subgroups

CIED LEAD. The main etiology causing TR was func-

Overall Population (N ¼ 470)

No CIED (n ¼ 349)

CIED (n ¼ 121)

p Value (No CIED vs. CIED)

LV ejection fraction, %

49.0  13.0

52.0  12.0

43.1  15.0

0.00001

LVEDD, mm

tional in both groups (92.0% vs. 91.0% in the CIED group and no-CIED groups; p ¼ 0.20). An interaction between CIED and the TV component as the sole mechanism causing TR was reported only in 2.5% of the patients of CIED group. The main location of TR jet was central in 66.0% versus 69.0% and anteroseptal in 14.0% versus 10.0% of the patients in the CIED group and no-CIED group (p ¼ 0.01). As compared with those in the no-CIED group, patients in the CIED group had significantly larger left ventricular dimensions (54.0  11.0 mm vs. 49.3  8.5 mm; p ¼ 0.0004) and lower left ventricular ejection fraction (43.1  15.0% vs. 52.0  12.0%; p ¼ 0.0001). No-CIED patients had significantly more severe TR (effective regurgitant orifice area 0.70  0.60 cm 2 vs. 0.58  0.30 cm 2; p ¼ 0.02; vena contracta

50.0  9.6

49.3  8.4

54.0  11.0

0.001

Concomitant MR $3þ

82 (29.0)

104 (30.0)

69 (57.0)

0.053

Left atrial volume, ml

106  56

102  55

114  57

0.06

TR jet location Central Anteroseptal Anteroposterior Posteroseptal Unknown

325 (69.0) 54 (11.0) 11 (2.3) 20 (4.3) 60 (12.0)

244 (69.0) 37 (10.0) 4 (0.1) 13 (3.7) 51 (14.0)

81 (66.0) 17 (14.0) 7 (5.0) 7 (5.0) 9 (7.4)

0.018 0.01 0.01 0.20 0.23

Tricuspid vena contracta, cm

1.4  0.9

1.3  0.7

1.0  0.7

0.03

Tricuspid regurgitant volume, ml

54  34

50  10

52  14

0.12

Tricuspid anteroseptal diameter, mm

47.1  9.0

45.0  2.0

46.0  4.0

0.214

0.78  0.60

0.70  0.60

0.58  0.30

0.02 0.678

Tricuspid EROA, cm2

1.3  0.7 cm vs. 1.0  0.7 cm; p ¼ 0.03), but slightly

Right atrial volume, ml

113  73

113  76

111  62

better RV function (tricuspid annular plane systolic

RVEDD, mm

38  12

38  10

37  11

0.734

excursion [TAPSE] 16.7  5.0 mm vs. 15.9  4.0 mm;

TAPSE, mm

16.2  4

15.9  4

16.7  5

0.041

p ¼ 0.04). No differences were observed in terms of

S-TDI, cm/s

annular diameter between the 2 groups (46  4 mm

Coaptation Depth, mm

vs. 45  2 mm; p ¼ 0.2), but patients in the CIED group had more pronounced tethering of the TV (coaptation

Systolic pulmonary artery pressure, mm Hg

depth 7.1  5.0 mm vs. 5.8  5.0 mm; p ¼ 0.01).

IVC diameter, cm

Baseline echocardiographic profile of the patients in the study population and differences between the 2 groups are summarized in Table 2. INTRA-

AND

PERIPROCEDURAL

10  8

9.5  8

10  7

0.47

9.9  5.4

5.8  5.0

7.1  5.0

0.013

41.0  14.8 22  10

37.0  15.0 41.0  14.0 19  10

18  10

0.0008 0.235

Values are mean  SD or n (%). EROA ¼ effective regurgitant orifice area; IVC ¼ inferior vena cava; LV ¼ left ventricular; LVEDD ¼ left ventricular end-diastolic diameter; MR ¼ mitral regurgitation; S-TDI ¼ systolic tissue Doppler index; TAPSE ¼ tricuspid annular plane systolic excursion; other abbreviations as in Table 1.

OUTCOMES. The

device mostly used in both groups was MitraClip, which was used in 87.6% (n ¼ 106 of 121) of patients in the CIED group as compared with 76.5% (n ¼ 267 of

T A B L E 3 Procedural Characteristics of the Study Population and Subgroups

349) in the no-CIED group (p ¼ 0.03). TTVI was perOverall Population (N ¼ 470)

No CIED (n ¼ 349)

CIED (n ¼ 121)

p Value (No CIED vs. CIED)

Duration of procedure, min

132  64

131  65

136  63

0.70

Concomitant other valve intervention (mitral or aortic)

155 (33.0)

101 (29.0)

55 (46.0)

0.02

0.03

formed as a concomitant procedure to other valve intervention in 33.0% of cases (MitraClip in mitral position in 154 patients and aortic PVL closure in 1 patient). The detailed distribution of the different TTVI devices used in both groups is reported in Table 3. Intraprocedural and periprocedural outcomes are summarized in Table 4. Procedural success was achieved in 80.0% of the no-CIED group and in 78.6% of the CIED group (p ¼ 0.74). Procedural time was 131  65 min and 136  63 min for the no-CIED and CIED groups, respectively (p ¼ 0.70). In-hospital mortality was 2.9% in the no-CIED group and 3.7% in the CIED group, respectively

Type of TTVI MitraClip

373 (79.0)

267 (76.0)

106 (87.0)

Trialign

18 (3.0)

18 (5.0)

0

NA

TriCinch

14 (3.0)

14 (4.0)

0

NA

CAVI

30 (6.3)

20 (6.0)

10 (8.0)

0.30

FORMA

16 (3.0)

14 (4.0)

2 (1.6)

0.25

Cardioband

12 (2.5)

11 (3.0)

1 (0.8)

0.16

NaviGate

6 (1.2)

5 (1.4)

1 (0.8)

0.20

PASCAL

1 (0.2)

0 (0)

1 (0.8)

0.17

(p ¼ 0.70). In total, 12 in-hospital deaths occurred: 3 were due to sepsis and subsequent multiorgan fail-

Values are n (%).

ure, 2 were due to respiratory insufficiency, and 7

CAVI ¼ caval valve implantation; CIED ¼ cardiac implantable electronic device; NA ¼ not appropriate; TTVI ¼ transcatheter tricuspid valve intervention.

were due to progressive RV failure. Overall, no

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improvement was observed in both groups: 66.0% of

T A B L E 4 Intraprocedural, Periprocedural, 30-Day, and Early-Term Outcomes

Overall Population (N ¼ 470)

No CIED (n ¼ 349)

the no-CIED patients and 65.0% of CIED patients were

CIED (n ¼ 121) p Value

Early-term outcomes Procedural success

374 (80.0)

In-hospital mortality

12 (2.6)

Postoperative length of stay (from procedure to discharge), days Acute kidney injury

6.5  5.0

279 (80.0) 95 (78.6) 10 (2.9)

0.74

4 (3.7)

0.50

6.0  4.0 8.0  4.0 0.175

in NYHA functional class I to II at 30 days (p ¼ 0.30), compared with 7.7% and 4.1% at baseline (p < 0.0001 for both groups) (Table 4 and Figure 1B). FOLLOW-UP. Median

follow-up was 7.00 (inter-

quartile range: 1.15 to 20.00) months. Survival at 12 months was 80.7  3.1% in the no-CIED group and

40 (8.5)

29 (8.0)

11 (9.0)

0.23

4 (4.5)

3 (0.8)

1 (0.8)

0.178

73.6  5.2% in the CIED group in the overall study

Pericardial effusion

6 (1.2)

3 (0.8)

3 (2.4)

0.32

population (p ¼ 0.30) (Figure 2A). Considering only

Low cardiac output syndrome

9 (1.9)

5 (1.4)

4 (3.3)

0.291

patients with isolated tricuspid intervention, no sig-

Atrial fibrillation (new onset)

6 (1.2)

4 (1.7)

2 (1.6)

0.30

nificant differences were observed at follow-up in

Infection

18 (3.8)

12 (5.1)

6 (4.9)

0.230

term of survival (82.9  4.2% and 82.0  8.4% at

Stroke

4 (0.8)

4 (1.1)

0 (0)

0.12

Myocardial infarction

0 (0)

0 (0)

0 (0)

—

12 months for no-CIED and CIED patients; p ¼ 0.70,

CIED dislodgment or malfunctioning

0 (0)

0 (0)

0 (0)

—

Postoperative renal replacement therapy

TR #2þ at discharge

344 (73.2)

253 (72.7) 90 (74.5)

0.80

332 (70.0) 309 (75.0) 18 (3.8)

244 (70.0) 88 (73.0) 230 (66.0) 79 (65.0) 13 (3.7) 5 (4.0)

0.60 0.30 0.512

30-day outcomes TR #2þ NYHA functional class I–II Mortality

Figure 2B). Presence of a transtricuspid CIED lead was not associated with increased mortality at follow-up (HR: 0.72; 95% CI: 0.20 to 1.40; p ¼ 0.50). Procedural success (HR: 0.22; 95% CI: 0.01 to 4.50; p ¼ 0.0009), baseline systolic pulmonary artery pressure (HR: 16.20; 95% CI: 2.00 to 135.80; p ¼ 0.0088), and presence of ascites (HR: 3.10; 95% CI: 1.50 to 16.50; p ¼ 0.01)

Values are n (%) or mean  SD.

were identified as independent predictors of mortality

Abbreviations as in Table 1.

during follow-up (Table 5). significant differences were observed in terms of periprocedural

adverse

events.

Neither

CIED

DISCUSSION

dislodgment nor malfunctioning was reported. At discharge echocardiography, TR #2þ was present in

The most important finding of this study is that TTVI

73.2% of the overall population (72.7% in the no-CIED

is feasible in the presence of a transtricuspid CIED

group and 74.5% in the CIED group; p ¼ 0.80).

lead in selected patients who are treated in experi-

At 30 days, residual TR #2þ was observed in 70.0%

enced centers. Acute procedural success, safety and

of no-CIED patients and in 73% of CIED-patients

short-term clinical outcomes are comparable to those

(p ¼ 0.6) (Figure 1A). Similar NYHA functional class

observed in patients without a transtricuspid lead.

F I G U R E 1 Tricuspid Regurgitation and NYHA Functional Class at Baseline and 30 Days

Clinical and echocardiographic outcomes: New York Heart Association (NYHA) functional class and tricuspid regurgitation (TR) at baseline and after 30 days in the 2 groups. CIED ¼ cardiac implantable electronic device.

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This finding may be related to the highly select patient population in which a device could be

F I G U R E 2 Overall Survival in the Study Population and in Isolated Tricuspid

Procedures

deployed, which excluded most patients with CIEDinduced TR. In fact, only 1.4% of patients were identified as having isolated CIED-induced TR. Although it has been suggested that lead extraction may not result in significant reduction in TR (16), in selected patients with purely CIED-induced TR, extraction and eventual repositioning of the lead could be considered as an option. The precise definition of etiology of TR in patients with CIED is usually

challenging

and

requires

advanced

echo

operators with extensive experience in the field. In fact, previous surgical series have showed that echo correlates poorly with intraoperative findings in detecting CIED-mediated TR (7), therefore the real prevalence of CIED-mediated TR in our series could be underestimated. The Central Illustration classifies the different types of CIED-related TR. EVOLVING RISK PROFILE IN PATIENTS UNDERGOING TTVI. Compared with the first report from the Tri-

Valve registry (17,18), patients enrolled in this phase of the study have a similar epidemiology, confirming the high-risk profile of patients with symptomatic severe TR who are referred for intervention. Of note, most of the patients included in the TriValve registry have been excluded from the different ongoing early feasibility trials (mainly owing to severe pulmonary hypertension,

RV

dysfunction,

and

associated

co-pathologies) and have been treated as compassionate use. Therefore, the epidemiology of the patients

in

the

TriValve

registry

are

potentially

representative of the real-world profile of patients with symptomatic severe or greater TR. Interestingly,

the

presence

of

transvalvular

Survival at follow-up: Kaplan-Meier curves showing survival of the 2 groups (cardiac

tricuspid leads increased by 13.0%. The increase in

implantable electronic device [CIED] and no CIED) (A) in the overall study population

risk profile and number of CIED patients reflects the

and (B) in isolated tricuspid valve intervention.

growing referral base for transcatheter therapies and the prior reports of improved clinical outcomes with even 1 or 2 grades of TR reduction (27,28), as well as the feasibility of device placement in the presence of a CIED (19,28–30).

The CIED group had more dilated left ventricle and lower left ventricular ejection fraction compared with the no-CIED cohort. In addition, the CIED cohort had

CLINICAL AND ECHOCARDIOGRAPHIC CORRELATES

a higher prevalence of male sex, chronic obstructive

OF CIED IN OUR COHORT. CIED was present in 25%

pulmonary disease, ascites, peripheral edema, previ-

of patients treated in this study. This prevalence is

ous admission for right heart failure, and higher dose

higher than that reported in previous analysis from

of diuretics.

TriValve registry and in previous published early use

These specific correlates should be considered a

studies with different devices; the TriRepair study

marker of more advance concomitant left-sided dis-

using the Cardioband device in which 14% of patients

ease, rather than the consequence of chronic RV

had CIED (31) and the report of compassionate use of

pacing (32). This is confirmed by the significantly

the FORMA device in which 17% of patients had a

higher proportion of patients having concomitant

CIED (28). Other early feasibility trials excluded

mitral treatment in the CIED group as compared with

pacemakers (27).

the no-CIED group.

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success as well as in-hospital survival and complica-

T A B L E 5 Univariate and Multivariate Analysis of Predictor of Survival at

tion rates were comparable, despite the different

Follow-Up (Cox Regression)

baseline characteristics of the 2 groups. Univariate HR (95% CI)

Age

Multivariate p Value

A higher rate of procedural success was achieved in

HR (95% CI)

p Value

0.22 (0.01–4.50)

0.009

this last analysis compared with previous published

5.50 (0.90–93.80)

0.20

Procedural success

0.23 (0.01–5.60)

<0.0001

CIED vs. no CIED

0.72 (0.20–1.40)

0.50

TAPSE <17 mm

0.53 (0.10–7.80)

0.09

1.7 (0.70–16.00)

0.30

sPAP

3.98 (0.79–17.80)

0.09

16.20 (2.00–135.80)

0.0088

Isolated TTVI

0.66 (0.30–15.60)

0.50

Post-procedural events were infrequent and not

LV ejection fraction

0.90 (0.10–6.00)

0.90

significantly different in the 2 groups; no device dislocation or malfunctioning were reported, sug-

Vena contracta

4.0 (0.30–22.00)

0.20

EuroSCORE II

1.50 (0.10–9.00)

0.70

NYHA III/IV

5.18 (1.80–17.50)

0.02

COPD

1.13 (0.90–8.70)

0.70

Ascites

1.77 (1.01–5.80)

0.10

Previous RV failure

data (80.0% rather than 73.0%) (17,18). This result reaffirms the importance of the learning curve in TTVI, including a better understanding of TV anatomy and disease pathophysiology and the improvement in intraprocedural imaging guidance.

gesting the safety of TTVI in patients with trans5.04 (0.80–14.10)

0.30

valvular leads.

3.10 (1.50–16.50)

0.01

significantly more used in CIED patients, but no dif-

Regarding the type of device, the MitraClip was

1.90 (0.20–9.10)

0.30

ferences were observed in terms of outcome between

NT-proBNP

2.10 (0.01–66.00)

0.70

the different devices. Procedural time was not

eGFR

0.21 (0.02–2.00)

0.20

affected by the presence of device leads.

CI ¼ confidence interval; HR ¼ hazard ratio; sPAP ¼ systolic pulmonary artery pressure; other abbreviations as in Tables 1 and 3.

CLINICAL OUTCOMES AT FOLLOW-UP. Patients with

CIED and patients without CIED had comparable 30-day outcomes in terms of TR reduction, NYHA

In addition to more advanced left heart disease,

functional class, and mortality. The presence of CIED

more severe TR with larger TR vena contracta widths,

leads did not affect the mortality at follow-up. How-

greater coaptation depth or height, and higher sys-

ever, procedural success, baseline systolic pulmonary

tolic pulmonary artery pressure compared with no-

artery pressure, and presence of ascites were inde-

CIED patients. Compared with no-CIED patients,

pendent predictors of mortality at follow-up.

CIED patients had more anteroseptal and ante-

Systolic pulmonary artery pressure is the strongest

roposterior TR jets and fewer had central jets, which

variable related to death at follow-up, and this

may result in more noncircular or crescent-shaped

finding reaffirms that patients must be treated with

defects and greater underestimation of TR severity

ongoing optimal medical therapy, allowing the

by the proximal isovelocity surface area method.

best RV pulmonary artery coupling in the peri-

Interestingly, TAPSE is slightly higher in the CIED than in the no-CIED patients, and this is not

interventional period with the lowest possible RV afterload.

completely surprising. In addition to severe TR which

The presence of ascites is independently related to

can itself lead to overestimation of RV longitudinal

worst outcomes. From a pathophysiological stand-

motion the higher RV afterload observed in CIED pa-

point, this sign is either a marker of more advance

tients further increases the overestimation. The RV

disease or an important co-factor in worsening heart

apex is more pulled toward to the left ventricle during

failure because abdominal pressure is an important

systole (“apical traction”) and this mechanism is a

factor related to worsening renal function and

“passive” traction of the TV annulus that further re-

diuretic resistance in heart failure patients (34).

duces the reliability of the TAPSE value, which is

Last but not least, procedural success is associated

merely based on the systolic excursion of the

with improved survival and this finding confirms the

tricuspid annulus (33). This finding confirms that

role of residual TR for outcomes and the need to

TAPSE is an inappropriate tool to assess RV function

obtain the best procedural results to impact the

in patients with significant TR and suggests that

prognosis of these patients.

better methods would be required and validated in this specific setting.

STUDY LIMITATIONS. The present analysis is a sub-

analysis of TriValve registry, which is a prospective

PROCEDURAL DATA. The most important finding of

nonrandomized study, without a control group.

the present study is that no differences in term of

Moreover, this is a real-world registry reporting the

feasibility, safety, and efficacy were observed be-

clinical practice in different centers and countries;

tween patients with and without a CIED. Procedural

therefore, echocardiographic and clinical outcomes

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Taramasso et al. Feasibility of Transcatheter Tricuspid Intervention in Patients With Transvalvular Lead

C ENTR AL I LL U STRA T I O N Classification of CIED-Related Tricuspid Regurgitation

Taramasso, M. et al. J Am Coll Cardiol Intv. 2020;-(-):-–-.

Classification of the different types of cardiac implantable electronic device–induced tricuspid regurgitation.

9

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Feasibility of Transcatheter Tricuspid Intervention in Patients With Transvalvular Lead

have been reported without core lab adjudication,

comparable procedural success and clinical outcomes

and the modalities of follow-up are different within

to those observed in patients without a transtricuspid

the different centers. The correct distribution of

lead.

pacemaker, defibrillator, and cardiac resynchronization therapy was not available. Importantly, the

ADDRESS FOR CORRESPONDENCE: Dr. Maurizio

CIED cohort is a highly selected patient cohort

Taramasso, University Hospital of Zurich, Cardiovas-

without

for

cular Surgery Department, Rämistrasse 100, 8091

treatment of CIED-induced TR include lead extrac-

Zurich, Switzerland. E-mail: maurizio.taramasso@

tion, surgical TV repair, or replacement or medical

usz.ch.

CIED-induced

TR.

Current

options

therapy (4). However, recent single-site studies have suggested that lead extraction may not result in

PERSPECTIVES

significant reduction in TR, particularly in patients with a dilated TV annulus (16). In these patients,

WHAT IS KNOWN? TTVIs are an emerging therapy

transcatheter solutions may still be a potential

to treat symptomatic high-risk patients with severe

treatment option. Another limitation is that most of

TR. The presence of a CIED lead through the TV poses

the patients of the CIED group were treated with

specific challenges. Feasibility and efficacy of TTVI in

MitraClip; therefore, feasibility of TTVI in CIED pa-

presence of a CIED is unclear and has never been

tients undergoing different procedures has to be

investigated on a large scale.

further investigated. Last, in the absence of standardized definitions for

WHATIS NEW? The present study showed that TTVI

procedural success, technical success, and outcomes,

is feasible with different devices in selected patients

investigator-reported results were used.

with CIED lead: acute procedural success and shortterm clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

CONCLUSIONS TTVI is feasible with different technologies in wellselected patients with CIED treated in experienced centers. Successful TTVI is associated significant

WHAT IS NEXT? Further studies to better analyze the mechanism of CIED-induced TR and feasibility of TTVI in specific anatomical subset are required.

clinical improvement at midterm follow-up with

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KEY WORDS transcatheter tricuspid

pacemaker. J Am Coll Cardiol Intv 2017;10: e147–9.

intervention, tricuspid regurgitation, tricuspid valve

11