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114

– More patients in the

surgery group than in

the TAVI group

withdrew from the trial

– Missing data from the

KCCQ

rapid improvements

in QoL at 30days

but no differences

seen at 1year

– sAVR patients having

more extensive

procedures than isolated

AV R

– QoL in the surgical

cohort was also

sAVR led to

improvements in

health status at

5years

assessing complex

operations other than

isolated sAVR

– More reinterventions,

rehospitalizations, and

paravalvular leaks in

the TAVI cohort at

5year

– sAVR patients having

more extensive

signicantly with

M. Monteagudo-Vela et al.

procedures than isolated

AV R

– QoL in the surgical

cohort was also

assessing complex

operations other than

isolated sAVR

both TAVI and

sAVR through

2years of follow up

– Early

improvement was

greater for TAVIs

via transfemoral

access (borderline

signicance)

KCCQ 1–12months – TAVI had more

Procedures &

mean age Questionnaire Follow-up Conclusions Limitations/critics

Patients

(included/total)

(73.3yo)

2016–2017 950/1000 496 TAVI

454 sAVR (73.6

yo)

KCCQ Baseline-1-12-24-36-48-60months – Both TAVI and

5 y:

– TAVI 920

(91.0%)

2032 Data available at

Recruitment:

2011–2013

Follow up:

Up to

– sAVR 831

(81.4%)

2016–2018

Baseline-1-12-24months – QoL improved

KCCQ

EQ-5D

yo)

2011–2013 2032 1011 TAVI (81.5

SF-36

1021 sAVR

(81.7 yo)

Study Period

Table 6.2 Summary of relevant studies

RANDOMIZED TRIALS TAVI vs sAVR

Mack etal. [13]

Transcatheter

Aortic-Valve

Replacement with a

Balloon Expandable

Valve in Low-Risk

Patients

Makkar etal. [32]

Five-Year Outcomes

of Transcatheter or

Surgical Aortic- Valve

Replacement

Results From the

PARTNER 2

Randomized Clinical

Trial

Baron etal. [41]

Health Status Benets

of Transcatheter vs

Surgical Aortic Valve

Replacement in

Patients With Severe

Aortic Stenosis at

Intermediate Surgical

Risk: Results From

the PARTNER 2

Randomized Clinical

Trial

6 QOL andPROMS Following Transcatheter Aortic Valve Implantation

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

More patients declined

surgery post

randomisation

non-inferior with

TAV I

– PATNER trial was not

blinded

– Very early experience

with TA

between baseline

and 1year after

either TAVR or

sAVR

– TF was associated

with a short-term

advantage compared

with surgery

– Retrospective registry

– Attrition bias: analysis

on results from only

20% of the cohort

by surgical risk

– Improvement in

QoL at 30days that

was sustained over

– Multi-centre

– Short/early results

1year follow-up

one-month

– No mortality reported

follow-up

– TAVI procedure

helps to improve

QoL

– Adequate for

octogenarians and

nonagenarians

115

(continued)

1–12months – QoL was

KCCQ

SF-12

Procedures &

mean age Questionnaire Follow-up Conclusions Limitations/critics

yo)

401 sAVR (83.5

Patients

(included/total)

2011–2012 795/871 394 TAVI (83.2

yo)

1–6-12months – Improvement

KCCQ

EQ-5D

SF-12

Transfemoral

(83.8 yo)

2007–2009 628/699 446

182 sAVR (82.6

yo)

KCCQ Baseline-1-12months – Patients stratied

Intermediate

risk: 80 yo

Low risk: 75 yo

2011–2019 59,130/276316 High risk: 81 yo

EQ-5D-3L Baseline-1m – QoL increased in

167

Transapical: 17

84 yo

184 Transfemoral:

POL-TAVI

registry 2017

Study Period

Adams etal. [42]

Transcatheter

Aortic-Valve

Replacement with a

Self-Expanding

Prosthesis

Reynolds etal. [40]

Health-Related

Quality of Life After

Transcatheter or

Surgical Aortic Valve

Replacement in

High-Risk Patients

With Severe Aortic

Stenosis

Non-RANDOMIZED TRIALS TAVI

Carroll etal. [44]

STS-ACC TVT

Registry of

Transcatheter Aortic

Valve Replacement

Stańska etal. [37]

Improvement of

quality-of-life

following

transcatheter aortic

valve implantation in

the elderly: a

multi-centre study

based on the Polish

national TAVI registry

116

and generic health

status improved

substantially within

the rst 2weeks.–

Only minimal

further improvement

– QoL analysis was not

based on full

thereafter

survival and QoL

questionnaires but

isolated questions

compared to general

population

– <80 y worse

survival and QoL

– Mental status not

compared to the

general population

– QoL is maintained

assessed

– No mortality reported

– Signicant mean age

difference between

groups

up to 12months

post-TAVI and

sAVR but only

improves at 2year

after sAVR

– TAVI adequate in

population with

M. Monteagudo-Vela et al.

– No baseline analysis

– No improvement in

NYHA class

– High mortality

– Attrition bias (77%

9.2%

– PPM: 12.6%

– 64.7% were in

limited life

expectancy

NYHA III/IV,

drop off)

compared to 67.0%

prior to TAVI

– 22.8% were alive

at a median FU of

7year

2weeks-1-12months – Disease-specic

KCCQ

SF-12

Procedures &

mean age Questionnaire Follow-up Conclusions Limitations/critics

84 yo

Patients

(included/total)

2015–2017 358/411 Transfemoral

Baseline-12months – >80 y have similar

SF-36

(isolated

questions)

Transapical

Transaortic

Divided in 3

2013–2017 5498 Transfemoral

groups ages:

>80, 80–65, <65

Perioperative

12month

24month

MLHFQ

EQ-5D-3L

– Mobility

yo)

sAVR: 134 (69.5

2011–2013 173 TAVI: 39 (80

– Self-care

– Usual

activities

yo)

(surgical

includes mini

– Pain/

discomfort

– Anxiety/

thoracotomy,

mini sternotomy,

and sternotomy)

EQ-5D-5L 5years – In H mortality:

depression

Transfemoral:

Transapical: 35

5year

(452 TAVIs in

2006–2012 103 alive at

80.1±7.9 yo

that period)

Study Period

Table 6.2 (continued)

Lauck etal. [45]

Very Early Changes in

Quality of Life After

Transcatheter Aortic

Valve Replacement:

Results From the 3M

TAVR Trial

Zelis etal. [39]

Survival and quality

of life after

transcatheter aortic

valve implantation

relative to the general

population

Tokarek etal. [46]

Assessment of Quality

of Life in Patients

After Surgical and

Transcatheter Aortic

Valve Replacement

Murray etal. [33]

Life beyond 5Years

after TAVI: Patients’

Perceived Health

Status and Long-Term

Outcome after

Transcatheter Aortic

Valve Implantation

6 QOL andPROMS Following Transcatheter Aortic Valve Implantation

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

– Prospective

observational study

– Attrition bias (30%

drop off)

QoL, (mobility and

usual activities)

– Higher in the

transcatheter TAVI

as compared to the

transapical TAVI

group

– Small cohort

– sAVR have a better

baseline QoL

and general health

in TAVI and positive

trend in sAVR

– Small cohort.

– 30days mortality

9.5%

– 6.5month mortality:

20%

and MLHFQ

– Less improvement

in QoL if PVD

– Attrition bias (28%

drop off)

– 30days mortality

10.1%

function, bodily

– Small cohort

– Attrition bias (40%

drop off)

pain, general health,

vitality

– No changes in

mental health

– Worse role &

emotional

dimensions

117

EQ-5D-5L Baseline-12months – Improvements in

Procedures &

mean age Questionnaire Follow-up Conclusions Limitations/critics

1626 (81.1 yo)

Transapical: 662

Patients

(included/total)

2011 2288/3875 Transcatheter:

Study Period

Lange etal. [34]

Quality of Life After

Transcatheter Aortic

(80.3 yo)

Valve Replacement:

Prospective Data from

GARY (German

Aortic Valve Registry)

EQ-5D-3L 1–2–3–12months – Improved NYHA

Transapical: 15

sAVR: 15

45 Transfemoral:

June

2009–Dec

2010

Kala etal. [47]

Quality of life after

transcatheter aortic

valve implantation and

surgical replacement

in high-risk elderly

MLHFQ 6.5months – Improved NYHA

Transapical: 25

81.6±8 yo

74/74 Transfemoral:49

April

2009–April

2010

patients

Gonçalves etal. [35]

Quality of life

improvement at

SF-36 3months – Improved physical

99/164 Transfemoral:73

Nov 2007

midterm follow-up

after transcatheter

aortic valve

implantation

Krane etal. [36]

Transapical: 26

82 yo (57–94)

Dec 2008

Quality of life among

patients undergoing

transcatheter aortic

valve implantation

MLHFQ: Minnesota Living with Heart Failure Questionnaire; SF-12: Short Form 12 Health Survey Questionnaire; SF-36: Short Form 36 Health Survey Questionnaire; EQ-5D-3L:

EuroQol 3L questionnaire; EQ-5D-5L: EuroQol 5L questionnaire; KCCQ: Kansas City Cardiomyopathy Questionnaire

118

M. Monteagudo-Vela et al.

vibrant quality that was associated with the vigour of youth’ [29]. In this sense, recent studies [30] not only focus on clinical outcomes but also on health status pre- and post-procedure in order to clarify indications, decision-making process and to judge outcomes (Fig.6.2).

Our analysis has shown that TAVI, when performed via the transfemoral access, has a shortterm advantage over surgery in improving QoL within the rst month following the procedure. However, there is no difference in QoL for patients treated with either TAVI or sAVR after the rst year following the procedure. Even though improvements in QoL are sustained in sAVR treated patients up to 10years [15], this remains largely unknown for TAVI patients beyond 2 years, with only two studies reporting QoL results at 5 years; one with an attrition bias of 77% [31] and another, with higher incidences of

PREOPERATIVE FACTORS

Co-morbidities

Age, gender

Frailty

Functional health status (QoL Questionnaires)

paravalvular leaks, valve related reinterventions and rehospitalizations in the TAVI cohort [32].

Most of the studies reviewed have not stratied their patients by age groups. The questionnaires were not age-weighted, which makes it difcult to quantify and compare answers not only between studies but also between age groups in each study. This is an important factor if the published results are to be extrapolated and used to expand TAVI into younger age groups, using the recently published results on intermediate- and low-risk patients.

TAVI Registries Reporting onQoL

The majority of the studies contribute very limited data on long-term complication rates and hospital readmissions following TAVI. Most studies are reporting outcomes on the procedure survivors,

INTRAPROCEDURE FACTORS

Access complications

Bleeding

Acute Cerebrovascular Accident

Myocardial Infarction

Acute kidney injury

Perforations

POSTOPERATIVE FACTORS

Conduction disturbances

Paravalvular leaks

New AF

Recovery

Fig. 6.2 Predictors of poor quality of life in TAVI population

6 QOL andPROMS Following Transcatheter Aortic Valve Implantation

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119

with a large number of studies having well over 20% attrition rate, adding a signicant bias in their QoL analysis. As an example, the study from Murray et al. [33] published QoL data from a cohort of 452 TAVI patients with a very high attrition rate (only 22.7% of patients alive at 5-years). With such an attrition rate it is rather difcult to derive any meaningful long-term QoL conclusions from this study, especially given the fact that there was no baseline assessment of the 22.7% of patients analysed and reported upon. In the large study from the GARY registry, transfemoral TAVI was associated with more pronounced improvement of QoL when compared to transapical TAVI.However, there is a considerable selection bias in this comparison [34] and the transapical as an approach in performing TAVIs has largely fallen off favour in the current years.

The studies by Gonçalves [35] etal. and Krane [36] et al. showed an improvement of QoL in early follow-up but they both had a very high reported mortality at follow-up. Stanska et al. [37] showed improvement in QoL at the early post procedural period (1month) and concluded based on this that TAVI is an adequate treatment for octogenarians and nonagenarians.

TAVI has clearly proven useful in patients at their ninth and tenth decade of life, where sAVR is associated with higher mortality and morbidity. While younger patients have particular expectations including lower tolerance of complications and hospital stay, elderly people often express their preference for quality of life over quantity, and therefore the consequences of health status after TAVI procedure could be even more important than survival in this age group [38]. In this sense, Krane etal. highlight the importance of an improvement in QoL after TAVI, especially with regards to patients’ satisfaction and procedurerelated perception [36].

TAVI vs. General Population

In the study by Zelis etal. an age and gender subgroup was propensity matched to a similar cohort of people from the general population. Their survival and QoL were compared. They concluded

that TAVI patients aged 80 or older have a similar long-term survival and a comparable QoL as the age-matched general population cohort. However, patients under 80 had a worse survival and QoL when compared to the general population [39]. This could imply a worsening QoL with time, reecting possible issues with valve durability, other associated diseases or even medically induced, post-TAVI related problems like paravalvular leaks, pacemaker, and prosthetic valve endocarditis.

TAVI vs. sAVR Short andIntermediate Term Outcomes– Results fromRandomised Controlled Trials (Industry Supported Studies)

Reynolds etal. [40] studied the PARTNER-1 trial population and described a health status improvement between baseline and 1-year after either TAVI or sAVR, in high-risk patients with severe AS.The benet in early QoL improvement was only seen in the transfemoral access.

PARTNER-2 trial reported a signicant improvement of the health status on intermediate risk patients [12] for both TAVI and sAVR, at 2-years [41] and 5-years [32] follow up. An early (30 days) health status improvement of borderline signicance was observed with TAVI, amongst patients treated via transfemoral access [41]. QoL after TAVI however, was compared to QoL from mixed population of patients, all under the umbrella of sAVR, 10% of which had extensive cardiac procedures (sAVR with mostly concomitant CABG but also concomitant root replacement, root enlargement, and mitral valve procedures). At 5years there was no difference in QoL between TAVI and sAVR despite more reinterventions, rehospitalizations, and paravalvular leaks in the TAVI cohort.

In the PARTNER-3 trial by Mack etal. [13], patients who underwent TAVI had more rapid improvements in the NYHA class, 6-min walktest distance, and KCCQ score than those who underwent surgery. However, at 1year, the differences vanished for both NYHA class and KCCQ scores and the analysis was performed accepting

120

M. Monteagudo-Vela et al.

the fact that more patients in the surgery group than in the TAVI group withdrew from the trial and that there were missing data from the KCCQ.

Similar non-inferiority QoL improvement was reported by Adams etal., at 1 year after TAVI when compared to sAVR [42] with a large number of patients having declined surgery post randomisations.

With this review we have exposed the need for further, better-structured research into the eld of QoL after TAVI, with bigger cohorts and longer follow-ups. Further research might need to also evaluate the inuence that procedure-related complications (stroke, need for permanent pacemaker, vascular complications, residual paravalvular aortic regurgitation or mismatch and prosthesis durability) have upon QoL for patients who have TAVI as treatment of their underlying aortic valve disease.

Delivering treatment to patients with severe aortic stenosis irrespective of durability or QoL but primarily based on general service capacity, speed, and pressure in treating life threatening conditions like severe AS [37] when the health system is under stress can be an option, as we are currently experiencing with the COVID-19 pandemic. There is an ongoing debate whether TAVI

should be offered for patients who in normal, nonpandemic setting would have undergone sAVR, in order to release resources and help hospitals allocate help where needed. TAVI patients have normally shorter procedural times, limited use of intensive care beds at a period of crisis and shorter hospital stay when resources are limited [13, 43]. This can lead to improve patient satisfaction and early resolution of symptoms but unspecied and uncharted long-term consequences for the patients and the health service alike.

Conclusions

Quality of life plays a crucial role in the decisionmaking process for health-related procedures like TAVI and sAVR.TAVI can offer a faster improvement in QoL when compared to sAVR but there is no difference to the QoL at intermediate 2 and 5-year follow-up. Further research is required using standardise tools to further evaluate QoL and durability of TAVI procedures in younger populations, providing this is ethically acceptable, given the excellent and long-term outcomes currently available and supporting sAVR (Fig.6.3).

Quality of life plays a crucial role in the decision-making process for health-related procedures like TAVI and sAVR.

TAVI can offer a faster improvement in QoL when compared to sAVR but there is no difference to the QoL at intermediate 2 and 5-year follow-up.

Further studies are required using standardise tools to further evaluate QoL and durability of TAVI procedures in younger populations.

Need of better-structured research into the field of QoL after TAVI, with bigger cohorts and longer follow-ups.

Fig. 6.3 Highlighted conclusions

6 QOL andPROMS Following Transcatheter Aortic Valve Implantation

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121

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Patient-Reported Quality ofLife

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

After Stand-Alone andConcomitant Arrhythmia Surgery: ASystematic Review andMeta-Analysis

BartMaesen, ClaudiaA.J.van der Heijden, ElhamBidar, ReinVos, ThanosAthanasiou, andJosG.Maessen

Abbreviation

AF Atrial brillation AFEQT AF Effect on QualiTy-of-life

Questionnaire AFSS AF Symptom and Severity score AV Aortic valve CABG Coronary artery bypass graft C-cap Cardiff cardiac ablation prom CCS-SAF Canadian Cardiovascular Society

Severity of AF CFAE Complex fractionated atrial

Electrograms CTI Cavotricuspid isthmus CVA Cerebrovascular accident

Bart Maesen and Claudia A.J. van der Heijden contributed equally with all other contributors.

B. Maesen (*) · E. Bidar · J. G. Maessen Department of Cardiothoracic Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands

Cardiovascular Research Institute Maastricht, Maastricht, The Netherlands e-mail: b.maesen@mumc.nl; elham.bidar@mumc.nl;

j.g.maessen@mumc.nl

C. A. J. van der Heijden Department of Cardiothoracic Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands e-mail: claudia.vander.heijden@mumc.nl

EHRA European Heart Rhythm

Association EQ-5D Euroqol 5d GP Ganglionated plexi Hrqol Health related quality of life LA Left atrial LAA LA appendage LM Ligament of Marshall MFI Multidimensional fatigue inventory MV Mitral valve Prom Patient recorded outcome PVI Pulmonary vein isolation QOL Quality of life RCT Randomized controlled trial RF Radiofrequency SCV Superior caval vein SE Standard error SF-12 Short Form 12

R. Vos Department of Methodology and Statistics, Maastricht University, Maastricht, The Netherlands e-mail: rein.vos@maastrichtuniversity.nl

T. Athanasiou Department of Cardiothoracic Surgery, Imperial College London, St Mary’s Hospital, London, UK e-mail: t.athanasiou@imperial.ac.uk

https://doi.org/10.1007/978-3-031-09815-4_7

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