JACC: CARDIOVASCULAR INTERVENTIONS VOL. 12, NO.

4, 2019

ª 2019 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

PUBLISHED BY ELSEVIER

EDITORIAL COMMENT

The “Big Five” Complications After

Transcatheter Aortic Valve Replacement
Do We Still Have to Be Afraid of Them?*

Eberhard Grube, MD, Jan-Malte Sinning, MD

S ince 2002, the treatment of severe aortic valve

stenosis has been revolutionized by intro-
ducing transcatheter aortic valve replacement
(TAVR) as a complementary technique to surgical
abnormalities, such as high-degree atrioventricular
block (11) with the necessity for permanent pace-
maker implantation.
Not surprisingly, an “event-free” TAVR procedure,
aortic valve replacement (SAVR). During this time, without the occurrence of any of the “Big 5” compli-
TAVR has become the standard of care for patients cations, has the lowest morbidity and mortality.
with severe aortic stenosis at increased surgical risk Actually, the term “Big 5” was coined by big-game
(1). The year 2016 was a breakthrough for this technol- hunters in the southern parts of Africa and refers to
ogy, because this was the first time when overall the 5 most-feared animals that are dangerous to
in-hospital mortality after transvascular TAVR was encounter on foot. In a figurative sense, this means
numerically lower than after isolated SAVR in Ger- that the “sighting” (occurrence) of the “Big 5 of TAVR
many. Despite the fact that the patient cohorts were complications” (Figure 1) has to be prevented by all
completely different and SAVR patients were at a means during the procedure.
numerically lower surgical risk, as indicated by the SEE PAGE 362
German aortic valve score, similar in-hospital sur-
In this issue of JACC: Cardiovascular Inter-
vival was only found in the low-risk group, whereas
ventions, Arnold et al. (12) assessed the impact of
TAVR was superior in patients at intermediate, high,
these 5 periprocedural complications on mortality
and very high risk (2).
and quality-of-life after TAVR among 3,763 patients
Surgical risk scores cannot be translated to the
at intermediate or high surgical risk from the
typical TAVR patients and often seem to overestimate
PARTNER 2 studies. The authors used multivariable
the procedural risk (3,4). Nonetheless, we have
models that included complications and baseline
learned over the years that 5 periprocedural compli-
clinical factors to examine the independent associ-
cations may occur that impact survival after TAVR
ation of each complication with the outcomes.
more or less significantly: moderate/severe para-
Although major stroke and stage-3 AKI were associ-
valvular leakage (PVL) (5,6); major vascular and
ated with a markedly increased 1-year mortality risk
bleeding complications (7,8); disabling stroke (9);
and poorer quality-of-life among survivors, other
acute kidney injury (AKI) (10); and conduction
complications, such as moderate/severe PVL, major
or life-threatening bleeding, and conduction distur-
bances with the need for pacemaker implantation,
*Editorials published in JACC: Cardiovascular Interventions reflect the
were each associated with a more modest increase in
views of the authors and do not necessarily represent the views of JACC: mortality and decrement of quality-of-life. After
Cardiovascular Interventions or the American College of Cardiology. adjusting for baseline characteristics and patient
From the Heart Center Bonn, Department of Medicine II, University factors (the so-called “surgical risk” of the patient),
Hospital Bonn, Bonn, Germany. Dr. Grube is proctor and member of the the strongest independent predictors of short-term
scientific advisory board of Medtronic and Boston Scientific; and has
mortality and impaired quality-of-life following the
received honoraria from Medtronic and Boston Scientific. Dr. Sinning is
proctor for Medtronic; and has received speaker honoraria and research procedure continued to be major stroke, major
grants from Medtronic, Edwards Lifesciences, and Boston Scientific. bleeding events, and stage 3 AKI.

ISSN 1936-8798/$36.00 https://doi.org/10.1016/j.jcin.2018.12.019

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 12, NO. 4, 2019 Grube and Sinning 371
FEBRUARY 25, 2019:370–2 Big Five After TAVR

A debate is still ongoing whether conduction dis-

F I G U R E 1 The Big 5 Periprocedural Complications
That Significantly Impact Long-Term Outcome After
turbances, such as a new-onset left bundle branch
Transcatheter Aortic Valve Replacement block or an intermittent high-degree atrioventricular
block, pose a potential threat for the patient and may
explain sudden cardiac death during follow-up. The
common consensus is that a trade-off exists between
oversizing of the prosthesis with less PVL on one
hand and the occurrence of conduction abnormalities
on the other hand. In this large-scale analysis, Arnold
et al. (12) showed that besides the effect on length of
hospital stay and costs, this post-procedural issue had
only a small effect on survival or quality-of-life
after adjustment for other pre- and peri-procedural
characteristics.
Undisputedly, post-procedural stroke remains
the most-dreaded complication following TAVR.
Experiencing a major (disabling) stroke is more
feared than death itself by many of the elderly
patients undergoing TAVR. However, as there are 2
AKI ¼ acute kidney injury; AVB ¼ atrioventricular block; sides to every coin, we must differentiate the
PVL ¼ paravalvular leakage.
periprocedural (probably embolic) stroke risk dur-
ing the first 48 h, which accounts for only one-half
of the TAVR-related strokes, from the later risk
that may be associated with occult atrial fibrillation
In the early years of the TAVR procedure, occur-
or subclinical valve thrombosis. Fortunately, the
rence of the “Big 5” during or shortly after completion
TAVR-related stroke risk is lower than that found
of the procedure was not uncommon. Over the past
for SAVR patients, and major stroke occurs in <2%
decade, device modifications in combination with
of TAVR procedures (13,14). Ongoing trials are
increased operator experience, better patient selec-
working to address whether cerebral protection
tion, and optimized pre-procedural planning by using
during the procedure, better intraprocedural phar-
routine computed tomography sizing have led to a
macological protection, or increased use of antico-
substantial reduction in most of the procedure-
agulants after TAVR (at the same time exposing
related issues. The former “Achilles’ heel” for the
patients to a higher risk of post-procedural
procedure, PVL, has been addressed by the intro-
bleeding) will be helpful to further mitigate
duction of next-generation transcatheter heart valves
stroke risk.
that have external sealing skirts covering the peri-
The group of authors are congratulated on this
prosthetic space. These devices lead to a lower rate of
substantial analysis that brings together the pieces
PVL than their predecessors in real-world clinical
of the puzzle: occurrence of the “Big 5” complica-
practice and are at least in part repositionable to
tions seems to have a more substantial impact on
correct a suboptimal initial positioning (13,14) The
outcome and quality-of-life than the individual co-
occurrence of major vascular and bleeding complica-
morbidity burden as indicated by surgical risk
tions can also be reduced by decreasing the profile of
scores. Therefore, an “event-free” TAVR procedure
the sheaths and deployment catheters used for these
has to be the ultimate goal for the well-being of
so-called next-generation transcatheter heart valves
patients.
(13,14). Addressing these 2 issues has helped to pre-
vent hypotensive phases during the procedure and
guarantees a more stable hemodynamic situation af- ADDRESS FOR CORRESPONDENCE: Dr. Eberhard
ter the procedure, along with a lower rate of AKI after Grube, Heart Center Bonn, Department of Medicine II,
TAVR. However, 2 periprocedural issues still remain: University Hospital Bonn, Sigmund-Freud-Strasse 25,
conduction abnormalities and embolic stroke. 53105 Bonn, Germany. E-mail: grubee@aol.com.
372 Grube and Sinning JACC: CARDIOVASCULAR INTERVENTIONS VOL. 12, NO. 4, 2019

Big Five After TAVR FEBRUARY 25, 2019:370–2

REFERENCES

1. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/ 6. Sinning JM, Vasa-Nicotera M, Chin D, et al. 11. Auffret V, Puri R, Urena M, et al. Conduction
EACTS Guidelines for the management of valvular Evaluation and management of paravalvular aortic disturbances after transcatheter aortic valve
heart disease. Eur Heart J 2017;38:2739–91. regurgitation after transcatheter aortic valve replacement. Circulation 2017;136:1049–69.
replacement. J Am Coll Cardiol 2013;62:11–20.
2. Gaede L, Blumenstein J, Liebetrau C, et al. 12. Arnold SV, Zhang Y, Baron SJ, et al. Impact of
Outcome after transvascular transcatheter aortic 7. Sinning JM, Scheer AC, Adenauer V, et al. Sys- short-term complications on mortality and quality
valve implantation in 2016. Eur Heart J 2017;39: temic inflammatory response syndrome predicts of life after transcatheter aortic valve replace-
667–75. increased mortality in patients after transcatheter ment. J Am Coll Cardiol Intv 2019;12:362–9.
aortic valve implantation. Eur Heart J 2012;33:
3. Sedaghat A, Sinning JM, Vasa-Nicotera M, et al. 13. Grube E, Van Mieghem NM, Bleiziffer S, et al.
1459–68.
The revised EuroSCORE II for the prediction of Clinical outcomes with a repositionable self-
mortality in patients undergoing transcatheter 8. Généreux P, Cohen DJ, Mack M, et al. Incidence, expanding transcatheter aortic valve prosthesis:
aortic valve implantation. Clin Res Cardiol 2013; predictors, and prognostic impact of late bleeding the International FORWARD Study. J Am Coll
102:821–9. complications after transcatheter aortic valve Cardiol 2017;70:845–53.
replacement. J Am Coll Cardiol 2014;64:2605–15. 14. Thourani VH, Kodali SK, Makkar RR, et al. Ar-
4. Seiffert M, Sinning JM, Meyer A, et al.
Development of a risk score for outcome after 9. Kapadia SR, Huded CP, Kodali SK, et al. Stroke ticles Transcatheter aortic valve replacement
transcatheter aortic valve implantation. Clin Res after surgical versus transfemoral transcatheter versus surgical valve replacement in intermediate-
Cardiol 2014;103:631–40. aortic valve replacement in the PARTNER trial. risk patients: a propensity score analysis. Lancet
J Am Coll Cardiol 2018;72:2415–26. 2016;387:2218–25.
5. Sinning JM, Hammerstingl C, Vasa-Nicotera M,
et al. Aortic regurgitation index defines severity of 10. Sinning JM, Ghanem A, Steinhäuser H, et al.
peri-prosthetic regurgitation and predicts outcome Renal function as predictor of mortality in patients
in patients after transcatheter aortic valve im- after percutaneous transcatheter aortic valve im- KEY WORDS complications, event-free, TAVR,
plantation. J Am Coll Cardiol 2012;59:1134–41. plantation. J Am Coll Cardiol Intv 2010;3:1141–9. transcatheter aortic valve replacement