Добавил:

Sekretar kiopkiopkiop18@yandex.ru t.me/Prokururor I Вовсе не секретарь, но почту проверяю Опубликованный материал нарушает ваши авторские права? Сообщите нам.

Вуз:

Ростовский Государственный Медицинский Университет

Предмет:

Медицина общая

Файл:

Книга_3928_Библиотеки_им_академика_М_И_Перельмана

.pdf

Скачиваний:

Добавлен:

10.10.2026

Размер:

8 Мб

Скачать

☆

<<< < Предыдущая 1 2 3 4 5 6 7 8 9 10 11 12 1314 / 1914 15 16 17 18 19 > Следующая >>>

Declaration of competing interest

The authors declared no potential conﬂicts of interest with respect

to the research, authorship, and/or publication of this article.

Funding sources

This research did not receive any speciﬁc grant from funding

agencies in the public, commercial, or not-for-proﬁt sectors.

Ethics statement and patient consent

The research reported has adhered to the relevant ethical guide-

lines, and patient consent was obtained in writing.

Supplementary material

To access the supplementary material accompanying this article,

visit the online version of the Journal of the Society for Cardio-

vascular Angiography & Interventions at 10.1016/j.jscai.2023.100

976.

References

1. Rose PS, Punjabi NM, Pearse DB. Treatment of right heart thromboemboli. Chest.

2002;121(3):806–814. https://doi.org/10.1378/chest.121.3.806

2. Athappan G, Sengodan P, Chacko P, Gandhi S. Comparative efﬁcacy of

different modalities for treatment of right heart thrombi in transit: a pooled

analysis. Vas c Med. 2015;20(2):131–1 38. https://doi.org/10.1177/1358863X155

69009

3. Steinberg ZL, Elison D, Vincent LL, Oxorn D, McCabe JM. The simpliﬁed extraction

of atrial tumor with targeted loop electricity (SEATTLE) procedure. JACC Case

Rep. 2023;10, 101758.

Figure 1.



OCOR retrieval system and extraction. The



O is a 12F stainless steel reinforced catheter (A) through which a braided nitinol retrieval basket is passed (B). The Simpliﬁed

Extraction of Atrial Tumor with Targeted Loop Electricity (SEATTLE) technique is demonstrated with a snare advanced through the



O lumen and the additional electrocautery snare

external to the nitinol basket (C). On the ﬁrst attempt, the mass was safely encased by the basket (D), and rescue forceps were used to grasp the right atrial mass (E). On the second

attempt, a 20-mm loop snare was advanced through the



O and secured around the mass (F). Gentle tension was applied, and the preloaded 27-mm cautery snare was advanced

exterior to the basket and secured around the base of the mass. Cautery was delivered as the mass is withdrawn (G).

2 A. Karunanandaa et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100976

Original Research

One-year Outcomes of XIENCE Skypoint 48-mm Drug-Eluting Stents in

Long Coronary Lesions: The SPIRIT 48 Trial

Ki E. Park, MD

, Chiung-Jen Wu, MD

, Bassem Chehab, MD

, Aziz Maksoud, MD

Barry Bertolet, MD

, Shih-Wa Ying, MSc

, Tiessa Simoes, PharmD

, Sandeep C. Pingle,

MD, PhD

, Chi-Jen Chang, MD

Division of Cardiovascular Medicine, Malcom Randall VA Medical Center, University of Florida, Gainesville, Florida;

Department of Cardiology,

Chung-Gung Memorial Hospital, Kaohsiung, Taiwan;

Department of Medicine, Ascension Via Christi Hospital, University of Kansas, Wichita, Kansas;

Department of Medicine, Cardiovascular Research Institute of Kansas, University of Kansas, Wichita, Kansas;

Cardiac Catheterization Laboratory, North

Mississippi Medical Center, Tupelo, Mississippi;

Abbott Vascular, Santa Clara, California;

Cardiovascular Division, Department of Internal Medicine, Chang

Gung Memorial Hospital, Tapei, Taiwan

ABSTRACT

Background: Diffuse coronary artery disease may need multiple overlapping stents, associated with less favorable outcomes than those of a single stent. The

availability of longer stents can circumvent the need for overlapping stents in long lesions. This prospective, single-arm, SPIRIT 48 trial evaluated the safety

and effectiveness of Abbott’s next-generation drug-eluting stent, XIENCE Skypoint 48, in patients with coronary artery disease with long de novo native

coronary lesions.

Methods: SPIRIT 48 enrolled 107 patients at 25 sites in 3 countries. Patients were required to have 1 target lesion treated with XIENCE Skypoint 48 (lesion

length of >32.0 mm and 44.0 mm). The primary end point was target lesion failure (TLF; composite of cardiac death, target vessel–related myocardial

infarction, or clinically indicated target lesion revascularization) at the 1-year compared with a prespeciﬁed performance goal of 20%, established through

historical control data. This study recently completed its 1-year follow-up.

Results: XIENCE Skypoint 48 was implanted in 105 patients with a device success rate of 97.2%. SPIRIT 48 met its primary end point, with a TLF rate of 5.7%,

and the upper bound of 95% CI at 9.5% (<performance goal of 20%). This was associated with a low rate of 5.8% (6/104 patients) for cardiac death/all

myocardial infarction at 1 year. Deﬁnite or probable device thrombosis at 1 year occurred in only 1 subject (1.0%).

Conclusions: Primary end point data obtained at the 1-year follow-up from the SPIRIT 48 trial present strong evidence supporting the deliverability, safety,

and effectiveness of XIENCE Skypoint 48 mm drug-eluting stent in treating long de novo coronary lesions.

Introduction

Increased rates of cardiac death and target lesion revascularization

(TLR) in addition to higher ﬂuoroscopy time are associated with over-

lapping multiple stent placements when compared with those of single

long stent placements.

Moreover, the use of multiple overlapping stents

can be challenging owing to longer procedure times and the need for

higher contrast volumes.

2–4

The availability and use of longer stents can

circumvent the need for multiple overlapping stents and facilitate inter-

ventional management of patients with long coronary artery lesions.

Advances in coronary drug-eluting stent technology have improved

the clinical outcomes associated with the treatment of complex

coronary artery lesions, such as long lesions. However, with only one 48-

mm length stent currently approved by the US Food and Drug

Administration (FDA), there are limited options in the United States for

single-stent coverage of long coronary artery lesions. Previous studies

have reported that the use of multiple stents can lead to increased

procedural time, ﬂuoroscopic time, contrast usage, and cost, affecting

negatively both patients and health economics.

€

aber et al

reported

that metal stent overlap in certain situations is associated with stent

fracture, malposition, restenosis, and delayed vascular healing and

increased clinical event rates.

The XIENCE Skypoint Everolimus-Eluting Coronary Stent System

(XIENCE Skypoint; Abbott) is a new iteration of the XIENCE family of

Abbreviations: CAD, coronary artery disease; DMR, all death, all MI, all revascularization; FAS, full-analysis set; MI, myocardial infarction; PCI, percutaneous coronary intervention;

PG, performance goal; TLF, target lesion failure; TV, target vessel; TVR, target vessel revascularization; ST, stent thrombosis.

Keywords: drug-eluting stents; coronary disease; percutaneous coronary intervention.

* Corresponding author: ki.park@medicine.uﬂ.edu (K.E. Park).

https://doi.org/10.1016/j.jscai.2023.101001

Received 24 March 2023; Received in revised form 17 April 2023; Accepted 18 April 2023

Available online 18 May 2023

2772-9303/Published by Elsevier Inc. on behalf of the Society for Cardiovascular Angiography and Interventions Foundation. This is an open access article under the CC BY-NC-ND

license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101001

Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/

stents, which have been the subject of extensive clinical studies for the

treatment of patients with coronary artery disease (CAD) and have

shown excellent long-term outcomes.

Overall, the safety and effec-

tiveness of the XIENCE family of stents have been well established. The

SPIRIT 48 study is a prospective, single-arm, open-label, multicenter

global (in and outside of the United States) clinical investigation to

evaluate the safety and effectiveness of the 48-mm stent length of the

XIENCE Skypoint. The study device is referred to as XIENCE Skypoint

48 investigational device or XIENCE Skypoint 48 IDE (also referred to as

Abbott Next-Generation Drug-Eluting Stent 48 mm in the study

documentation). XIENCE Skypoint 48 IDE is a balloon-expandable stent

made of L-605 cobalt chromium with a poly(n-butyl methacrylate) and

copolymer of vinylidene ﬂuoride and hexaﬂuoropropylene/everolimus

coating. The objective of the SPIRIT 48 study was to evaluate the safety

and effectiveness of XIENCE Skypoint 48 IDE in improving coronary

artery luminal diameter in patients with CAD because of de novo native

coronary artery long lesions.

Methods

The SPIRIT 48 study was a prospective, single-arm, open-label,

multicenter global study that enrolled 107 patients at 25 sites globally,

with patients registered in the United States, Taiwan, and Australia. This

clinical investigation was conducted in accordance with this Clinical

Investigation Plan, the Declaration of Helsinki, applicable Good Clinical

Practices and regulations (eg, US 21 CFR Part 50, 21 CFR Part 56, 21

CFR Part 812, and ISO14155:2011) and the appropriate local legisla-

tion(s). The conduct of the clinical investigation was approved by the

appropriate institutional review board/ethics committee of the

respective investigational site and by the applicable regulatory au-

thorities (eg, FDA). The subject registration for this study started on

June 17, 2020, and ended on September 17, 2021. The study is

registered at www.clinicaltrials.gov as NCT04282148.

The clinical outcomes from the SPIRIT 48 study were compared with

a prespeciﬁed performance goal (PG) established using historical con-

trol data from the SPIRIT PRIME Long Lesion Registry (LLR)

(NCT00916370). Patients registered in the study must have experi-

enced exactly 1 single de novo native coronary target lesion eligible to

be treated by a single XIENCE Skypoint 48 IDE stent. Planned overlap

was not allowed for the treatment of the target lesions. If a bailout stent

was necessary for the target lesion, a XIENCE family of stent with an

appropriate size (including XIENCE Skypoint 48 IDE) was allowed to be

used. A nontarget lesion, if located in a different epicardial coronary

vessel than the target lesion, was allowed to be treated by stents other

than XIENCE Skypoint 48 IDE per site’s standard of care during the

index procedure. All patients were required to be treated with only 1

XIENCE Skypoint 48 IDE. A maximum of 40% of patients with 2 treated

lesions could be registered in the study. Approximately 50% of the

patients were registered at the US sites. Each subject is/will be followed

up for a 2-year period, with all patients being scheduled for a hospital or

ofﬁce follow-up visit at 30 days, 6 months, 1 year, and 2 years.

Study design and procedure

Inclusion and exclusion criteria. The SPIRIT 48 trial included patients

aged 18 years, with evidence of myocardial ischemia (eg, unstable

angina, postinfarct angina, stable angina, or silent ischemia) suitable for

nonemergent percutaneous coronary intervention (PCI). The angio-

graphicinclusion criterion was a target lesion in the native coronary artery

with visually estimated reference vessel diameter of 2.5 mm and 4.25

mm and estimated lesion length of >32.0 mm and 44.0 mm and was

able to be covered by a single XIENCE Skypoint 48, with visually esti-

mated diameter stenosis of >50% and <100% with a thrombolysis in

myocardial infarction (MI) ﬂow grade of 1. Patients with acute MI within

48 hours of the index procedure, left ventricular ejection fraction of

<30%, or previous PCI within the target vessel (TV) during the last 12

months were excluded. Complete details on the inclusion and exclusion

criteria are provided in Supplemental Appendix A. Predilation was

mandatory, and postdilation was strongly encouraged. Patients

requiring chronic ant icoagulation were excluded from the study.

Study end points. The primary end point of the SPIRIT 48 study was

target lesion failure (TLF) deﬁ

ned as a composite of cardiac death,

TV–re

lated MI (TV-MI) (MI per Society for Cardiovascular Angiography &

Interventions [SCAI] deﬁnition),

and clinically indicated TLR at 1 year. A

diagnosis of periprocedural MI based on SCAI deﬁnition

involved

creatine kinase myoglobin band values of 10 times above the upper

reference limit (URL) or creatine kinase myoglobin band values 5 times

above the URL plus new pathologic Q-waves in 2 contiguous leads,

new persistent non–rate-related left bundle branch block or cardiac

troponin values of 70 times the URL or 35 times the URL with new

pathologic Q-waves in 2 contiguous leads, or new persistent left

bundle branch block.

Secondary end points included TLF in hospital, at 30 days, and 180

days and were descriptive without a prespeciﬁed statistical assumption.

Additional end points included acute success (device and procedural

success) and clinical end points, such as composite all death, all MI, and

all revascularization (DMR) and cardiac death/MI at 1 year. Individual

end points included any death considering cardiac, vascular, and non-

cardiovascular related; all MI (Q-wave MI and non–Q-wave MI) and TV-

MI; any revascularization, such as all target vessel revascularization

(TVR), TLR, and non-TVR; and stent thrombosis (ST; per the Academic

Research Consortium [ARC] deﬁnition: deﬁnite, probable, or possible)

and timing (acute [1 day], subacute [>1 day to 30 days], late [>30

days to 365 days], and very late [>365 days]).

Device/procedural success. Device success was deﬁned as the

achievement of a ﬁnal in-stent residual diameter stenosis of <50% (by

quantitative coronary angiography), using only study device(s) without

device malfunction. Procedural success was the achievement of ﬁnal in-

stent residual diameter stenosis of <50% (by quantitative coronary

angiography) using the assigned device and with any adjunctive device,

without the occurrence of cardiac death, TV-MI (per ARC 2 deﬁnition),

or repeat coronary revascularization of the target lesion during the

hospital stay (7 days if a subject was still in the hospital). All procedural

angiograms were evaluated using an independent core angiographic

laboratory (Beth Israel Deaconess Medical Center), and reported lesion

characteristics were based on core laboratory assessment.

Statistical methods

The full-analysis set (FAS) population is the analysis set that included

all registered patients in whom XIENCE Skypoint 48 IDE had been

successfully delivered to the treatment site and deployed. A registered

subject without a successful delivery of the XIENCE Skypoint 48 IDE

stent was retained as registered but not included in the FAS. The per-

protocol (PP) population is deﬁned as the patients in the FAS who did

not have any major protocol deviations (Supplementary Appendix A).

The primary analysis of the primary end point is based on the FAS.

All other descriptive analyses on the baseline characteristics and clinical

end points were performed on both FAS and PP groups, except for that

of the acute success end point, being analyzed based on all registered

populations with attempted study device implantation.

The primary end point for this study was TLF at a 1-year follow-up.

The Com-Nougue method

was used to test the null hypothesis at

1-sided 5% signiﬁcance level to evaluate this hypothesis for the FAS

population. A P value of <.05 was considered signiﬁcant. The

2 K.E. Park et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101001

Com-Nougue survival method, using the Kaplan-Meier estimate and

Greenwood variance, was used to construct the 1-sided 95% conﬁ-

dence limit to compare against the PG for the primary end point eval-

uated at 1 year. This time-to-event analysis method was used to

consider early termination and censoring of the COVID-confounded

follow-up information.

TLF was compared with a prespeciﬁed PG of 20%, which was based

on comparable patients assessed as part of the SPIRIT PRIME LLR (in-

ternal Abbott data) that assessed patients with 33.0-mm and 38.0-mm

XIENCE stents. The observed 1-year TLF rates were 7.7% and 12.5%

per the WHO MI deﬁnition and the protocol ARC deﬁnition, respec-

tively. A 0.4% TLF rate increase for every 1.0-mm lesion length was

estimated. Given the lesion length difference between the stents of

33.0 or 38.0 mm and the stents of 48.0 mm, the adjusted 1-year TLF rate

in SPIRIT 48 was estimated to be 10%. The PGs for SPIRIT PRIME LLR

were 19.2% and 26% per WHO MI and ARC MI deﬁnition, respectively.

Given the estimated true rate of 10% for SPIRIT 48, the PG for SPIRIT 48

was set at 20%. A sample size of 107 was calculated to have ~93%

statistical power through simulation. To avoid undue inﬂuence from a

single study site, any single site was allowed to register 20% of the

total patients. Secondary end points were summarized descriptively

with counts, percentages, and exact 95% Clopper-Pearson CIs. The

secondary end point was evaluated according to the speciﬁed de-

nominator rule: for in-hospital and 30-day follow-up, the total number of

subjects in the analysis population was used. For the 180-day follow-up

(visit window 180  14 days) and beyond, subjects who were termi-

nated before the early visit window (eg, day 166) without experiencing

any DMR events (all death, all MI regardless of MI deﬁnition, and all

revascularization) were excluded from the denominator. Subgroup an-

alyses were performed to examine the consistency of the primary end

point across age (<65 years vs 65 years), sex (female vs male), and

race (White vs non-White). In addition to the aforementioned pre-

speciﬁed analyses, an analysis to compare patients with or without

diabetes was conducted.

Results

The SPIRIT 48 study enrolled 107 patients at 25 sites (Figure 1). Of

the 107 registered subjects, the study device was successfully

implanted in 105 subjects. In the remaining 2 subjects, the study device

could not be advanced and deployed at the lesion. Although these 2

subjects were retained as registered, they were excluded from the FAS

and any end point analyses. Hence, the FAS population comprised 105

subjects. After excluding those patients with major protocol deviations,

the primary end point was assessed in 86 patients, which encompassed

the PP population. Most of the protocol deviations, 12 deviations, were

because of cardiac biomarkers being outside the study protocol.

Clinical and lesions characteristics

Baseline clinical characteristics are listed in Table 1. Patients had a

mean age of 67.3 years (range, 35-91 years), and 72.4% were male

patients, with 72.4% with stable angina and 15.2% unstable angina.

Furthermore, 91.4% of patients received a P2Y12 inhibitor, of which

69.5% received clopidogrel, 19% ticagrelor, and 2.9% prasugrel. After

the index procedure, 100% of the patients were on a P2Y12 inhibitor

and 95.2% of the patients were on aspirin. Approximately 97.1% of

patients were on dual antiplatelet therapy at discharge, 99% at 1

month, 98.1% at 6 months, and 84.8% at 1 year. Of the 105 patients,

132 lesions were treated (105 target lesions, 27 nontarget lesions).

Figure 1.

SPIRIT 48 study enrollment and follow-up. FAS, full-analysis set.

Table 1. Baseline clinical charact eristics

Patient characteristics N ¼ 105

Age, y 67.3  10.8 (105/105)

Female sex 27.6 (29/105)

Not Hispanic or Latino 97.1 (102/105)

Body mass index, kg/m

28.97  6.88

Medical history

Current/former smoker 53.3 (56/105)

Diabetes 34.3 (36/105)

Hyperlipidemia 88.6 (93/105)

Hypertension 82.9 (87/105)

Cardiac history

Previous myocardial infarction 14.6 (15/105)

Coronary artery disease 66.0 (68/105)

Previous coronary intervention 41.7 (43/103)

Lipid-lowering agents 81.9 (86/105)

β-Blockers 57.1 (60/105)

Values are mean  SD or % (n/N).

K.E. Park et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101001 3

Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/

Target lesion angiographic features and procedural characteristics are

noted in Table 2. The left anterior descending artery was the TV in

51.4% of the patients, with a mean stent diameter of 3.05  0.48 mm,

and the total study device length at the target lesion was 50.3  7.1

mm. Moderate or severe calciﬁcation was found in 47.1% of the pa-

tients. The angiographic core laboratory–adjudicated mean target

lesion length was 35.19  8.03 mm, with 12 patients having a target

lesion length of 44.0 mm. The mean postprocedural in-device per-

centage of diameter stenosis was 11.96%  7.63%, and the in-device

mean minimum lumen diameter was 2.44  0.41 mm.

Device/procedural success

Acute success included device and procedure success and was

analyzed in all registered patients (N ¼ 107) in whom XIENCE Skypoint

48 IDE implantation was attempted. For 1 subject, the angiographic

core laboratory was not able to determine the in-stent residual diameter

stenosis, and hence, this subject was excluded from analysis, leading to

complete data in 106 patients.

Device success in the SPIRIT 48 trial was 97.2%, (95% CI, 91.95-

99.41; 103/106). The 3 cases of failure included 2 patients with the

inability to deliver and deploy the study device, and 1 additional sub-

ject with failure to advance the device past the lesion, which required a

second device to be implanted. Procedure success in the SPIRIT 48 trial

was 93.4% (95% CI, 86.87-97.30), with 99/106 patients having TV-MI

per ARC 2 deﬁnition during their hospital stay. In addition, SPIRIT 48

achieved a procedural success rate of 94.3% (100/106) when TV-MI was

deﬁned per SCAI deﬁnition.

Clinical outcomes

The primary end point of TLF at 1 year in the FAS with Kaplan-Meier

estimate of the TLF rate was 5.7% (95% CI upper bound of 9.5%), which

was signiﬁcantly lower than the PG of 20% (P <.0001) (Figure 2). In

addition, in the PP population, the Kaplan-Meier estimate of the TLF

rate was 7%, with 95% CI upper bound of 11.5%, signiﬁcantly lower

than the PG of 20%. These ﬁndings are consistent with the primary end

point data obtained in the FAS population. In SPIRIT 48, 6 primary end

point events were observed, most of which were TV-MI in the ﬁrst 48

hours after the index procedure, termed as periprocedural myocardial

infarction (PPMI). Furthermore, TLF results were consistent in all pre-

speciﬁed subgroup analyses (Supplemental Figures S1-S4). Secondary

clinical outcomes at 1 year for FAS are presented in Table 3. Secondary

end points of TLF in hospital, at 30 days, and at 180 days for FAS and

Table 2. Baseline target lesion and procedural characteristics (adjudicated

by the angiographic core laboratory)

Values

Target lesion characteristics, N ¼ 105

Radial access 68.6 (72/105)

Target vessels treated

LAD 51.4 (54/105)

Circumﬂex/ramus 8.6 (9/105)

RCA 40.0 (42/105)

Mean number of total stents per target lesion 1.1

Patients with >1 stent

12.4 (13/105)

Lesion length, mm 35.19  8.03 (105/105)

Reference vessel diameter, mm 2.75  0.46 (105)

Average stent diameter, mm 3.05  0.48

Total study device length, mm 50.3  7.1

Minimum lumen diameter, mm 1.03  0.44 (105)

%diameter stenosis 62.85  13.06 (105)

Pre-TIMI ﬂow grade 3 94.3 (99/105)

Modiﬁed AHA/ACC B2/C 99.0 (104/105)

Calciﬁcation, moderate/severe 47.1 (49/104)

Procedural characteristics: 105 target lesions

and 132 lesions treated

Device success 97.2 (103/106) (91.95-99.41)

Procedural success

ARC-2 93.4 (99/106) (86.87-97.30)

SCAI 94.3 (100/106) (88.09-97.89)

Total stent length implanted, mm 50.3  7.1 (105)

Mean number of lesions treated (target

and nontarget)

1.3 (132)

Predilation 94.7, (125/132)

Postdilation 93.9, (124/132)

Postprocedural characteristics

Reference vessel diameter, mm 2.77  0.44 (104)

Minimum lumen diameter, mm

In-stent 2.4  0.41 (104)

In-segment 2.20  0.45 (104)

Acute gain, mm

In-stent 1.4  0.45 (104)

In-segment 1.17  0.43 (104)

%Diameter stenosis

In-stent 11.96  7.63 (104)

In-segment 20.92  8.89 (104)

Values are mean  SD or % (n/N).

ACC, American College of Cardiology; AHA, American Heart Association; ARC,

Academic Research Consortium; LAD, left anterior descending artery; RCA, right

coronary artery; SCAI, Society for Cardiovascular Angiography & Interventions;

TIMI, Thrombolysis in Myocardial Infarction.

Thirteen patients had unplanned bailout used owing to longer lesions and/or

geographic misses (1 with XIENCE Skypoint 48 IDE used for bailout, 11 with

XIENCESierrausedfor bailout, and 1 withXIENCESkypoint).Overall, 106 XIENCE

Skypoint 48 IDE devices were implanted in 105 target lesions (105 patients).

Figure 2.

Primary end point of target lesion failure (TLF) at 1 year. The P value was calculated

from the Z test using Kaplan-Meier survival estimate together with the Greenwood

method estimated variance, against the prespeciﬁed performance goal of 20% at 1-

sided signiﬁcance level of 5%.

Table 3. Secondary clinical end points through 1 year

Events In hospital 0-30 d 0-180 d 0-365 d

Cardiac death 0 (0/105) (0.00-3.45) 0 (0/105) (0.00-3.45) 0 (0/104) (0.00-3.48) 1 (1/104) (0.02-5.24)

All target vessel revascularization (including TLR) 0 (0/105) (0.00-3.45) 1 (1/105) (0.02-5.19) 1 (1/104) (0.02-5.24) 1 (1/104) (0.02-5.24)

All TLR 0 (0/105) (0.00-3.45) 1 (1/105) (0.02-5.19) 1 (1/104) (0.02-5.24) 1 (1/104) (0.02-5.24)

Target lesion failure (SCAI deﬁnition) 3.8 (4/105) (1.05-9.47) 4.8 (5/105) (1.56-10.76) 4.8 (5/104) (1.58-10.86) 5.8 (6/104) (2.15-12.13)

Values are mean  SD or % (n).

In-hospital deﬁned as hospitalization 7 d post- index procedure.

SCAI, Society for Cardiovascular Angiography & Interventions; TLR, target lesion revascularization.

4 K.E. Park et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101001

PP by SCAI, ARC 2, and Fourth Universal deﬁnitions are noted in

Supplemental Table S1.

The eventrates for clinical end points,those for composites (DMR and

cardiac death/MI) and ST, are summarized in Table 4. The rates of ST

were also exceedingly low with 1-year rates of deﬁniteacute/subacute ST

in eitherthe FASor PP of <2%. The 1 event of deﬁnite acute/subacute ST

observedin SPIRIT 48 occurred 10 days after the index procedure when a

patient developed MI that was treated with revascularization and medi-

cation, such as the modiﬁcation of the antiplatelet regiment from aspirin/

clopidogrel to aspirin/prasugrel after the MI. This event was adjudicated

as a deﬁnite ST and possibly related to the study device.

Discussion

SPIRIT 48 was a prospective, single-arm, open-label, multicenter

global study, which met the prespeciﬁed primary end point of the 1-

year composite outcome of TLF in patients with diffuse coronary le-

sions (Central Illustration). Diffuse CAD presents both clinical and

technical challenges because overlapping stents are often needed,

which increases the risk of restenosis, and delivery of stents can be

challenging. Reducing the number of stents needed to treat diffuse

disease can reduce the risk of restenosis and lead to more adequate

lesion coverage. Streamlining PCI with delivery of longer-length stents

may also facilitate patient workﬂow, reduce ﬂuoroscopy time and

contrast exposure, and shorten procedure times.

The rates of device and procedural successwere highwith low rates of

adverse cardiac events and ST. The results are comparable with those of

previous iterations of XIENCE everolimus-eluting stent (EES). An analysis

published by Gautier et al

in 2022 assessed the safety and efﬁcacy of the

48.0-mm XIENCE Xpedition EES in an all-comer population, with the

following results: TLF occurred (5.3%), mainly driven by TLR (4.1%); 2

cardiac deaths were noted (0.7%); patient-oriented composite end point

occurred in 30 patients (11.6%) mainly driven by repeat revascularization

(9.7%); and deﬁnite ST was observed in 2 patients (0.7%). These results

are comparable with the data from this study and consistent with other

multiplestudiesas well. Similarly, Hsiao et al

in 2022publisheddata from

2 sites in Taiwan, assessing 213 patients receiving 48.0-mm XIENCE

Expedition EES and noting a procedural success rate of 98.6%, (TVF) rate

at 1 year of 4.2%,and cardiacdeath in 3 patients.The rates of TV-MI,TVR,

and deﬁnite/probable ST were 1.4%, 3.3%, and 0.9%, respectively,

again comparable with the ﬁndings of this study.

The data obtained in this SPIRIT 48 trial are also comparable with

those reported recently by Karmpaliotis et al

in EVOLVE 48 that tested

the 48.0-mm SYNERGY stent use in long coronary lesions. The patient’s

demographic characteristics and lesion characteristics were comparable

between the 2 studies, with EVOLVE noting a TLF rate of 4.1% at 2 years.

Although EVOLVE 48 presented its 2-year follow-up data but SPIRIT 48

only its 1-year follow-up data, it is notable that, similar to EVOLVE 48, low

rates of TV-MI, cardiac death, and revascularization were noted.

The evaluation of PPMI has been controversial because of a lack of

consensus on its deﬁnition. Similar to previous studies,

all 3 deﬁnitions

for PPMI were used in the ongoing SPIRIT 48 study: SCAI, ARC-2

deﬁnition, and Fourth Universal deﬁnition. For the primary end point

analysis, PPMI deﬁned per SCAI was used, whereas a secondary anal-

ysis was performed using both ARC-2 and Fourth Universal deﬁnitions

on all end points with MI. Consistent with the current literature, in SPIRIT

48, different event rates were identiﬁed using the 3 deﬁnitions.

This study builds on the proven clinical success of the previous gen-

erationsof XIENCE stent platforms, translating this EES technology into a

longer-length option for the treatment of de novo diffuse CAD. The

availability of this platform lengthprovides an alternativeto the treatment

of diffuse disease where other long-length stent options are limited.

Study limitations

The results presented in this study represent data obtained from a

nonrandomized single-arm trial without a comparator group in a select

Table 4. Composite clinical end points at 1 year

Clinical end point (FAS) SCAI deﬁnition ARC 2

deﬁnition

Fourth universal

deﬁnition

DMR 5.8 (6/104)

(2.15-12.13)

6.7 (7/104)

(2.75-13.38)

6.7 (7/104)

(2.75-13.38)

Composite rate of

cardiac death and all

5.8 (6/104)

(2.15-12.13)

6.7 (7/104)

(2.75-13.38)

6.7 (7/104)

(2.75-13.38)

Values are mean  SD or % (n).

Stent thrombosis (ST): 1 event of deﬁnite acute/subacute ST observed in SPIRIT

48 occurred 10 days after the index procedure. In the FAS, the deﬁnite acute/

subacute ST was 1.0% (1/105), and the 1-year cumulative rate for deﬁnite ST was

1.0% (1/104). In the PP, the deﬁnite acute/subacute ST was 1.2% (1/86), and the 1-

year cumulative rate for deﬁnite ST was 1.2% (1/85).

DMR, composite of all death, all MI, and all revascularization; FAS, full-analysis

set; PP, per-protocol.

Central Illustration.

A summary of key ﬁndings from SPIRIT 48. MI, myocardial infarction; RVD, reference vessel diameter; TLF, target lesion failure.

K.E. Park et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101001 5

Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/

population of patients with diffuse CAD within a relatively narrow win-

dow of lesion length range. The use of an additional overlapping stent

was allowed only as a bailout, thus results may only be extrapolated to

the 48.0-mm use in lesions that are excessively diffuse and require a

stent of >50.0 mm. ST overall is a rare event, and thus, limited sample

size may preclude the capture of such rare events. Signiﬁcant calciﬁed

lesions that required calcium modiﬁcation and bifurcation lesions were

not included, which may limit generalizability to a growing subset of

patients with complex disease. The use of physiology and intracoronary

imaging was not mandated as part of the study.

Conclusions

The SPIRIT 48 study demonstrated the efﬁcacy and safety of

XIENCE Skypoint 48.0-mm EES for the treatment of diffuse coronary

lesions with few adverse events and successfully meeting prespeciﬁed

PGs at 1 year. These data support the excellent clinical and lesion

outcomes of the XIENCE Skypoint 48.0-mm EES when used to treat

lengthy coronary lesions.

Acknowledgments

The authorsthank Jin Wang for his guidance on the statistical analysis

and Guangda Liu and Shawn Yu for the statistical analysis support.

Declaration of competing interests

Ki Park, Chi-Jen Chang, Shih-Wa Ying, Tiessa Simoes, and Sandeep

Pingle report association with Abbott. Aziz Maksoud reports association

with Abbott, Pﬁzer, and Bristol-Myers Squibb. Chiung-Jen Wu, Bassem

Chehab, and Barry Bertolet reported no ﬁnancial interests.

Funding sources

The SPIRIT 48 trial was funded by Abbott.

Ethics statement and patient consent

The conduct of the clinical investigation was approved by the

appropriate institutional review boards/ethics committees of the

respective investigational site and by the applicable regulatory au-

thorities (eg, FDA), and appropriate patient consent was obtained per

regulatory guidelines.

Supplementary material

To access the supplementary material accompanying this article,

visit the online version of the Journal of the Society for Cardiovascular

Angiography & Interventions at 10.1016/j.jscai.2023.101001.

References

1. S

aylıkF,Çınar T, Selçuk M, Çiçek V, Hayıro



glu MI, Orhan AL. Comparison of

outcomes between single long stent and overlapping stents: a meta-analysis of

the literature. Herz. Published online January 11, 2023. https://doi.org/10.1007

/s00059-022-05152-4

2. Hoffmann R, Herrmann G, Silber S, et al. Randomized comparison of success

and adverse event rates and cost effectiveness of one long versus two short

stents for treatment of long coronary narrowings. Am J Cardiol. 2002;90(5):

460–464.

3. Jurado-Rom



an A, Abell



an-Huerta J, Requena JA, et al. Comparison of clinical

outcomes between very long stents and overlapping stents for the treatment of

diffuse coronary disease in real clinical practice. Cardiovasc Revasc Med. 2019;

20(8):681–686.

4. R

€

aber L, Jüni P, L

€

offel L, et al. Impact of stent overlap on angiographic and long-

term clinical outcome in patients undergoing drug-eluting stent implantation.

J Am Coll Cardiol. 2010;55(12):1178–1188.

5. Kufner S, Joner M, Thannheimer A, et al. Ten-year clinical outcomes from a trial of

three limus-eluting stents with different polymer coatings in patients with coronary

artery disease. Circulation. 2019;139(3):325–333.

6. Moussa ID, Klein LW, Shah B, et al. Consideration of a new deﬁnition of clinically

relevant myocardial infarction after coronary revascularization: an expert

consensus document from the Society for Cardiovas cular Angiography and

Interventions (SCAI). J Am Coll Cardiol. 2013;62(17):1563 – 1570.

7. Com-Nougue C, Rodary C, Patte C. How to establish equivalence when data are

censored: a randomized trial of treatments for B non-Hodgkin lymphoma. Stat

Med. 1993;12(14):1353–1364.

8. Gautier A, Hovasse T, Arroyo D, et al. Safety and efﬁcacy of 48 mm Xience

Xpedition everolimus-eluting stent for the treatment of long coronary lesions.

Catheter Cardiovasc Interv. 2022;100(2):179–187.

9. Hsiao FC, Tsai CT, Hsu LA, et al. Procedural and one-year clinical outcomes of long

48 mm Xience Xpedition everolimus-Eluting Stent in complex long diffuse coronary

artery lesions. J Invasive Cardiol. 2022;34(2):E80–E86.

10.

Karmpaliotis D, Stoler R, Walsh S, et al. Safety and efﬁcacy

of everolimus-eluting

bioabsorbable polymer-coated stent in patients with long coronary lesions: the

EVOLVE 48 study. Catheter Cardiovasc Interv. 2022;99(2):373–380.

11. Toth GG, Wijns W. Endpoint deﬁnitions in clinical trials: consensuses, a synonym for

dissensuses? J Am Coll Cardiol Intv. 2019;12(9):885– 889.

6 K.E. Park et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101001

Original Research

Predictors of Residual Severe Tricuspid Regurgitation After Transcatheter

Mitral Valve Repair

Craig Basman, MD

, Arber Kodra, MD

, Luigi Pirelli, MD

, Ahmad Mustafa, MD

Priti Mehla, MD

, Biana Trost, MD

, Caroline Ong, MD

, Taylor Remillard, MD

Emily Schultz, MD

, Denny Wang, BS

, Shangyi Liu, MS

, Efstathia Mihelis, PA-C

Bruce Rutkin, MD

, Elana Koss, MD

, Robert Kalimi, MD

, Gregory Maniatis, MD

Azhar Supariwala, MD

, S. Jacob Scheinerman, MD

, Chad Kliger, MD

Department of Cardiovascular and Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York;

Department of Cardiovascular and

Thoracic Surgery, Staten Island/Northwell Health, New York, NY;

Department of Cardiovascular and Thoracic Surgery, North Shore University/Northwell

Health, New York, New York;

Department of Cardiovascular and Thoracic Surgery, South Shore University/Northwell Health, New York, New York

ABSTRACT

Background: Severe tricuspid regurgitation (TR) may persist after a mitral transcatheter edge-to-edge repair (M-TEER) and is associated with worsened

clinical outcomes and survival. It is unclear which patients with concomitant mitral regurgitation (MR) and TR will have TR reduction after M-TEER. The aim of

this study was to identify the predictors of residual TR after transcatheter edge-to-edge repair (TEER).

Methods: Data were collected from the Northwell TEER registry, a prospectively maintained mandatory database including 4 high-volume transcatheter

aortic valve replacement/TEER centers. Transthoracic echocardiograms, both pre-TEER and post-TEER, were evaluated. Univariate and multivariate logistic

regression analyses were performed to identify predictors of severe TR after M-TEER. Signiﬁcant TR reduction was deﬁned as a reduction in TR grade by at

least 1þ with moderate (2þ) or less TR at 1 month.

Results: Of the 479 patients who underwent M-TEER, 107 patients with concomitant severe MR/TR were included. Successful MR reduction occurred in 89

patients (84%) and a signiﬁcant TR reduction in 45 (42%). On the univariate analysis, the only predictors of severe residual TR were right atrial area and

unsuccessful M-TEER. On the multivariate logistic regression model, the only predictor variable for patients with a reduction in TR was MR reduction of 3þ

with M-TEER.

Conclusions: In patients with concomitant severe MR and TR, TR reduction after isolated M-TEER occurs in only ~40% of patients. MR grade reduction 3þ

was the only independent predictor for TR reduction. Other clinical and echocardiographic variables (including pulmonary hypertension, right ventricular

function, tricuspid annular dilation, atrial ﬁbrillation, and presence of a cardiac implantable electrical device) were not associated with residual TR. Inability to

predict TR reduction after M-TEER highlights the importance of establishing transcatheter tricuspid valve therapies and should factor in heart-team

discussions.

Introduction

Mitral transcatheter edge-to-edge repair (M-TEER) for mitral regur-

gitation (MR) is indicated in patients with high surgical risk.

However,

currently, there is no recommendation for transcatheter treatment for

concomitant tricuspid regurgitation (TR). In the surgical population,

current valvular guidelines recommend performing concomitant

tricuspid valve (TV) surgery in patients undergoing left-sided valve

surgery who also have severe TR, mild-to-moderate TR with dilated

annulus (40 mm), or signs of right-heart failure.

However, the TV is

neglected in patients with concomitant MR and TR who undergo

M-TEER. In addition, the presence of moderate-to-severe TR after

M-TEER is associated with worsened clinical outcomes and survival.

2-4

Previous studies have shown that TR improves in <50% of patients after

transcatheter edge-to-edge repair (TEER).

5-7

Therefore, the ability to

predict which patients will have residual TR after M-TEER is crucial for

Abbreviations: AF, atrial ﬁbrillation; CIED, cardiac implantable electrical device; MR, mitral regurgitation; M-TEER, mitral transcatheter edge-to-edge repair; PASP, pulmonary artery

systolic pressure; RA, right atrial; TR, tricuspid regurgitation; TV, tricuspid valve; TTE, transthoracic echocardiogram; TEER, transcatheter edge-to-edge repair.

Keywords: transcatheter mitral valve repair; transcatheter mitral valve replacement; tricuspid regurgitation; transcatheter edge-to-edge repair.

* Corresponding author: cbasman@northwell.edu (C. Basman).

https://doi.org/10.1016/j.jscai.2023.100612

Received 12 December 2022; Received in revised form 5 February 2023; Accepted 22 February 2023

Available online 19 May 2023

CC BY license (http://creativecommons.org/licenses/by/4.0/).

Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100612

Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/

procedural selection. This study aimed to address the predictors of

residual TR after M-TEER.

Methods

For this retrospective cohort study, data were collected from the

Northwell TEER registry, a prospectively maintained mandatory data-

base including 4 high-volume transcatheter aortic valve replacement/

TEER centers. Of the included 479 consecutive patients with symp-

tomatic, moderate-to-severe/severe MR who underwent M-TEER with

the MitraClip (Abbott) between 2014 and 2020, 107 patients with

concomitant severe MR/TR were analyzed (Figure 1). All patients were

evaluated by a multidisciplinary team and deemed to be of high/pro-

hibitive surgical risk. Patients were included if they had 3þ (severe) or

more TR before TEER.

Procedure

Using the MitraClip, M-TEER was performed in a standard fashion.

All TEER procedures were performed under general anesthesia with

transesophageal echocardiography guidance.

Echocardiography

We evaluated the transthoracic echocardiogram (TTE) both pre-

TEER and post-TEER. All patients underwent TTE before intervention

and at 1-6 months of follow-up. TTE examinations were performed by

an imaging cardiologist or echocardiography technician and inter-

preted by an imaging cardiologist. Six board-certiﬁed imaging spe-

cialists (C.B., A.K., P.M., B.T., C.O., C.K.) reviewed TTEs pre-TEER and

post-TEER, who were blinded to the outcome. TR was assessed in

multiple views and graded according to a 5-grade schema: none/trivial

¼ 0þ, mild¼ 1þ, moderate ¼ 2þ, severe ¼ 3þ, massive ¼ 4þ, and

torrential ¼ 5þ.

Left ventricular ejection fraction was calculated in the 2

chamber and 4-chamber views with the Simpson biplane method.

Tricuspid annular plane systolic excursion (TAPSE) was obtained. Right

ventricular (RV) end-diastolic diameters (or tricuspid annulus diameter

[TAD]) were obtained in the 4-chamber view. Pulmonary artery systolic

pressure (PASP) was estimated from the TR jet velocity.

Clinical end points

Patients recorded regular follow-up within 1-6 months and at 1 year

after the procedure. The echocardiograms from 1- to 6-month follow-

ups were used to assess residual TR (because 1-year echocardiograms

were often not obtained). The average echocardiogram follow-up

occurred at 1.7 months (median, 1.5 months) after M-TEER. Success-

ful TR reduction was deﬁned as a reduction in TR grade by at least 1þ

with moderate (2þ) or less TR at 1 month. Data regarding clinical

outcomes were obtained from the database that included all clinical

end points and echocardiographic parameters.

Statistical analysis

Categorical variables, presented as counts and/or percentages,

were compared using the Fisher exact test. Continuous variables, pre-

sented as the mean  SD or the median (lower quartile, upper quartile),

were compared using the Student t test or the Mann-Whitney U test

because the Shapiro-Wilks test showed these variables to be not nor-

mally distributed. A P value <.05 was considered statistically signiﬁcant.

All statistical tests were 2-tailed and performed using Prism 9.2.0

(GraphPad Software). A multivariable logistic regression model was

used to estimate the predictors for severe TR after M-TEER. Clinically

important variables such as atrial ﬁbrillation (AF) or ﬂutter, degenerative

or functional MR, RV end-diastolic diameter (or TAD), MR improvement,

previous cardiac implantable electrical device (CIED) placement, RV

function, and PASP were included in the initial multivariable model

irrespective of P values from the univariate analysis. P values of <.1 in

the univariate analysis were included in the initial multivariable model.

A backward elimination procedure was applied to the initial model, and

P <.05 criteria were used for variables to stay in the model.

Results

The average age was 79.2 years with a high Society of Thoracic

Surgeons (STS) score (9.35%). Successful M-TEER (MR reduction 2þ)

occurred in 83% of patients. There was a reduction in TR in 45 patients

(42%), no change in TR in 48 patients (45%), and worsening of TR in 14

patients (13%). TR reduction of >1 grade occurred in only 15% of pa-

tients (Central Illustration).

The differences between the unsuccessful TR reduction and suc-

cessful TR reduction groups are described in Table 1. Clinical variables

such as age, female sex, body mass index, STS repair score, previous

coronary artery bypass grafting, myocardial infarction, AF, left ventricular

(LV) systolic dysfunction, hypertension, and presence of a CIED showed

no difference between the groups. On the univariate analysis, echocar-

diographic variables such as RV end-diastolic diameter (TAD), TAPSE, RV

end-diastolic area, LV end-diastolic diameter, RV function, inferior vena

cava diameter, and etiology of MR (functional vs degenerative) showed

no difference between the groups. TR etiology was most commonly

functional, with only 8.5% of patients considered to experience a

degenerative origin of TR. However, the etiology of TR did not correlate

with residual TR. Patients with unsuccessful TR reductionwere more likely

to record a larger right atrial (RA) area (30.35 cm

vs 24.26 cm

; P ¼ .002).

Among the patients who showed unsuccessful MR reduction with

M-TEER, patients were also more likely to experience unsuccessful TR

reduction (77.8% vs 22.2%; P ¼ .034).

On the multivariate logistic regression model, the effects of pre-

dictor variables for patients with a reduction in TR by 1 grade or more

were analyzed. The predictor variables chosen were the presence of

CIED, AF/atrial ﬂutter, functional MR, PASP, TAD, moderate/severe RV

dysfunction, and MR reduction (by 1, 2, or 3 grades). After the analysis,

the only signiﬁcant predictor for a reduction in TR was an MR reduction

of 3þ (Table 2).

Discussion

To date, this study is the largest study evaluating the effect of

isolated transcatheter mitral repair o n the TV in patients with

concomitant severe TR and MR. We found that severe TR not only

remains in ~60% of patients after M-TEER but also worsens in

Figure 1.

Schematics of study design. TMVr, transcatheter mitral valve repair; TR, tricuspid

regurgitation.

2 C. Basman et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100612

~13% of patients. Baseline clinical traits (such as age, presence of

CIED, and functional MR) did not correlate with residual TR. The

only clinical and/or echocardiographic variables associated with

severe residual TR on the univariate analysis were a larger RA area

and unsuccessful M-TEER. On the multivariate analysis, we did not

identify any preoperative clinical o r echocardiographic variables

that were predictive of TR red uction after M-TEER (such as CIED,

PASP, RV function, functional MR, and TAD). However, patients with

a 3þ reduction in MR were more likely to experience TR reduc-

tion than those with le ss MR reduction.

In patients who undergo M-TEER, the prevalence of severe residual

TR may be >50%.

TR is common after TEER and associated with worse

clinical outcomes and survival. Results from the TriValve (Transcatheter

Tricuspid Valve Therapies) and TRAMI (Transcatheter Mitral Valve In-

terventions) registries showed that concomitant transcatheter mitral

valve and TV repair was associated with a higher 1-year survival rate

than that with isolated TEER in patients with MR/TR.

However,

currently, transcatheter TV interventions are not approved in the United

States, and few operators have experience with transcatheter mitral

valve and TV repair. Previous studies have found that severe TR im-

proves from 20% to 50% in patients who undergo isolated TEER.

5-7

Previously found risk factors for residual TR after M-TEER include

advanced age, presence of AF, RV dysfunction, severity of TR, tricuspid

annular dilation, and unsuccessful mitral valve repair.

5,6

However, this

study did not ﬁnd the presence of AF, TAD, RV dysfunction, and/or

advanced age to be factors leading to a lack of improvement in TR.

Nonetheless, similar to previous studies, we did ﬁnd that unsuccessful

M-TEER was associated with residual TR. As expected, residual MR may

Central Illustration.

Predictors of residual severe tricuspid regurgitation after transcatheter mitral valve repair. CIED, cardiac implantable electrical device; MR, mitral regurgitation; M-TEER, mitral

transcatheter edge-to-edge repair; PASP, pulmonary arterial systolic pressure; TR, tricuspid regurgitation.

Table 1. Univariate predictors of reduction in tricuspid regurgitation after

TEER.

Variables Successful TR

reduction (n ¼ 45)

Unsuccessful TR

reduction (n ¼ 61)

Baseline characteristics

Age, y 78.58  12.08 81.88  9.20 .249

BMI, kg/m

25.25  6.01 25.94  6.41 .464

Female sex 47.92 57.63 .317

STS repair score, % 9.37  10.19 9.34  6.70 .987

CABG 13.56 16.67 .654

Previous MI 15.25 16.67 .842

Hypertension 83.33 94.92 .061

Atrial ﬁbrillation 60.42 72.88 .172

Presence of CIED 20.83 16.95 .608

Left-sided heart variables

LV systolic dysfunction 34.48 35.42 .920

LV end-diastolic

diameter, mm

47.7  9.7 53.2 .270

Functional MR 44.07 45.83 .855

Unsuccessful TEER 22.22 77.78 .034

Right-sided heart variables

RV dysfunction (moderate

or severe)

21.28 25.86 .583

TAPSE, mm 18.23  5.45 17.26  4.56 .177

PASP >50 mm Hg 54.35 38.98 .117

IVC diameter, cm 2.36  2.5 2.19  0.66 .238

TR pathology

(degenerative)

8.51 8.47 .995

RV end diastolic

diameter, mm

41.25  7.73 43.58  8.34 .267

RA end systolic area, cm

24.23  7.97 30.35  11.21 .003

RV end diastolic area, cm

19.79  5.87 21.94  6.79 .676

Values are mean  SD or %.

BMI, body mass index; CABG, coronary artery bypass grafting; CIED, cardiac

implantable electrical device; IVC, inferior vena cava; LV, left ventricle; MI,

myocardial infarction; MR, mitral regurgitation; PASP, pulmonary artery systolic

pressure; RA, right atrial; STS, Society of Thoracic Surgeons; TAPSE, tricuspid

annular plane systolic excursion; TEER, transcatheter edge-to-edge repair; TR,

tricuspid regurgitation.

Table 2. Multivariate predictors of reduction in tricuspid regurgitation after

TEER.

Clinical variable Odds ratio 95% CI P

Presence of CIED 0.4939 0.1908-1.225 .1342

Presence of atrial ﬁbrillation/ﬂutter 0.9713 0.3948-2.407 .9494

Functional MR 1.055 0.4349-2.579 .9061

MR reduction by 1þ or less 5.729 0.7016-125.3 .1506

MR reduction by 2þ 5.525 0.7973-113.8 .1394

MR reduction by 3þ 13.73 1.851-292.0 .0270

Pulmonary artery systolic pressure 1.013 0.9852-1.044 .3651

Tricuspid annular diameter 1.001 0.9424-1.064 .9682

RV function, moderate or worse 0.7304 0.2450-2.095 .5616

CIED, cardiac implantable electrical device; MR, mitral regurgitation; RV, right

ventricular.

C. Basman et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100612 3

Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/

<<< < Предыдущая 1 2 3 4 5 6 7 8 9 10 11 12 1314 / 1914 15 16 17 18 19 > Следующая >>>

Соседние файлы в папке Библиотека им академика М.И. Перельмана

#
10.10.20268 Мб0Книга_3922_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20268 Мб0Книга_3924_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20268 Мб0Книга_3925_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20268 Мб0Книга_3926_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20268 Мб0Книга_3927_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20268 Мб0Книга_3928_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20267 Мб0Книга_3929_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20267 Мб0Книга_3931_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20267 Мб0Книга_3932_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20267 Мб0Книга_3934_Библиотеки_им_академика_М_И_Перельмана.pdf
#
10.10.20267 Мб0Книга_3936_Библиотеки_им_академика_М_И_Перельмана.pdf