Transseptal Instead of Transapical Valve Implantation

JACC: CARDIOVASCULAR INTERVENTIONS

VOL. 9, NO. 11, 2016

ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

ISSN 1936-8798/$36.00

PUBLISHED BY ELSEVIER

http://dx.doi.org/10.1016/j.jcin.2016.04.006

EDITORIAL COMMENT

Transseptal Instead of Transapical Valve Implantation Making Mitral Great Again?* Danny Dvir, MD

P

atients with progressive mitral valve disease

percutaneous approach can be achieved via the atrial

are frequently considered high risk for con-

septum, with the valve inserted through either the

ventional open-heart surgery, whereas the

jugular or, more frequently, the femoral vein.

less-invasive approach of transcatheter mitral repair

Currently, transapical is by far the most common

is not as effective (1). In recent years, an alternative

approach for transcatheter valve implantation in the

approach of transcatheter bioprosthetic valve implan-

mitral position. Almost all of the contemporary

tation is increasingly performed inside native mitral

transcatheter devices dedicated to the treatment of

valves and in failed valves after cardiac surgery

native mitral valve regurgitation are designed for

(2,3). Treatment of these patients is challenging since

transapical access (4). Updated data from the VIVID

many of them are old, frail, and have cardiomyop-

(Valve-in-Valve-International-Data)

athy. Other comorbidities such as renal failure, atrial

that the transapical approach is utilized in 81%

fibrillation, and previous stroke are common as well.

of valve in valve cases and 68% in valve in ring cases.

registry shows

Unfortunately, transcatheter mitral valve implanta-

We can learn a considerable amount about trans-

tion in these patients is still associated with nonfav-

apical approach from the vast experience gained

orable clinical outcomes, especially after treating

from treating patients with aortic stenosis. Trans-

native stenotic or regurgitant mitral valves, as well

apical access was highly utilized in the first decade

as in valve-in-ring procedures (4,5). Many of these

of transcatheter aortic valve replacement but its use

challenges are related to patient characteristics and

has since decreased dramatically (6). This decline is

anatomical complexity of the mitral valve and its

directly related to a reduction in the required sheath

related structures. However, technical considerations

size, enabling safe transfemoral artery delivery and

may have an influence on clinical outcomes as well.

a paradigm shift aiming to treat high-risk patients using a less-invasive minimalist approach. In addi-

PROCEDURAL ACCESS: ALL ROADS LEAD TO ROME

tion substantial clinical data suggest that transapical approach is associated with worse clinical outcomes that cannot be explained solely by dissimilar patient

Transcatheter approach to replace the mitral valve

characteristics (7–10). Transapical approach can oc-

can be divided into surgical and fully percutaneous

casionally lead to the impairment of left ventricular

access. Surgical transcatheter access is performed via

apical function (11,12). This deterioration in ventric-

thoracotomy and includes a direct left atrial, as well

ular function, even if only transient, is obviously

as a much more common transapical approach. Fully

undesirable in patients with functional mitral regurgitation who already have cardiomyopathy at baseline. Transapical-related complications also include

*Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology. From the Department of Cardiology, St Paul’s Hospital, Vancouver,

pleural effusion, bleeding, atrial fibrillation, prolonged intubation, and others (7–10). The femoral vein is of a large caliber and almost

British Columbia, Canada. Dr. Dvir has served as a consultant for Edwards

always enables safe introduction of a large sheath.

Lifesciences, Medtronic Ltd, and St. Jude Medical.

Subsequently a valve can be delivered through the

1176

Dvir

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 11, 2016 JUNE 13, 2016:1175–7

Transseptal Mitral Valve Implantation

T A B L E 1 Characteristics That May Favor Either Transapical or Transseptal Approach in

Transcatheter Mitral Valve Implantation* Favors Transapical†

Favors Transseptal‡

associated with limited efficacy, its safety is very clear and could be associated with its less-invasive access as well. SEE PAGE 1161

Operator characteristics Extensive experience with transapical procedures

Extensive experience with transseptal mitral interventions

Patient and anatomical characteristics

In this issue of JACC: Cardiovascular Interventions, Eleid et al. (15) describe a data collection of 48 high-

Combined mitral and aortic valve implantation

Combined mitral and pulmonary/tricuspid valve implantation

risk patients, average Society of Thoracic Surgeons

Need for very precise positioning§

Aiming for a shorter hospital stay

predicted risk of mortality of 13.2%, who had trans-

Crossing the surgical valve with a transcatheter heart valve is predicted to be challengingk

Chest wall deformity or when aiming for avoiding thoracotomy¶

septal

Future transseptal procedure is planned#

Clinical need to avoid general anesthesia**

Peripheral venous system abnormality††

Apical scar or recent myocardial infarction

(Irvine, California). These implants were mainly per-

Atrial septal anatomy is challenging‡‡

Left ventricular systolic dysfunction

Thrombus in left atrial cavity or appendagekk

Chronic renal failure¶¶

valve

implantation

using

SAPIEN

formed in failed surgical bioprostheses but also inside mitral rings and in native stenotic mitral valves. The authors report acute procedural success in 88% of

Mitral valve characteristics Poor fluoroscopic markers##

mitral

devices, mostly SAPIEN XT Edwards Lifesciences

Severely calcified and bulky subvalvular apparatus

Small surgical valve***

cases. Almost one-third of patients included in this cohort were discharged home the next day, which is dramatically shorter than the average length of stay

Surgical valve with paravalvular leakage of uncertain significance†††

after transapical procedures. The evolution of the transseptal approach and simplified techniques were

Transcatheter valve characteristics Device enables retrograde implantation only

Device enables antegrade implantation only

apparent in this report, which increasingly included

Currently available retrievable devices‡‡‡

Using a longer transcatheter heart valve§§§

SAPIEN 3 devices, smaller septal predilatation,

Using a smaller and better trackable delivery system§§§

avoiding an apical rail, using potentially less traumatic stiff wires, selective omission of rapid pacing,

*These considerations are based mainly on personal clinical experience and only little on scientific data. †Left atrial approach, which includes several of the advantages and limitations of the transapical approach, was not included in this table because of relatively limited worldwide transcatheter clinical practice. ‡Intended for either transfemoral or transjugular venous access. The vast majority of transseptal cases that were performed worldwide were via the femoral vein. §Cases at need for more atrial position: high risk for left ventricular outflow tract obstruction; cases at need for more ventricular position: small surgical valve label size #25 mm, considering no long-term anticoagulation. kSuch as in cases with very small mitral valve orifice area. In general, crossing a stenotic valve retrogradely (transapical) is more challenging then crossing a valve antegradely (transseptal), however, not being able to cross with a transcatheter valve located in the left atrium may cause serious implications. ¶Such as in patients with chronic lung disease. #Including left atrial appendage closure, electrophysiological procedure. **Transesophageal echocardiogram could be performed during transseptal puncture only or puncture be guided by intracardiac echocardiography. ††Diminutive peripheral veins, active deep vein thrombosis, inferior vena cava filter, and numerous pacemaker cables in left atrium. ‡‡Including previous atrial septal defect closure. kkThrombus in the left atrial cavity or appendage could be considered a contraindication for transapical implantation as well but is more of a concern when manipulation in the left atrium is required. ¶¶Data from aortic stenosis therapy suggests that transapical is independently more associated with acute kidney injury than transfemoral access. ##Such as Epic valve (St. Jude Medical, Minneapolis, Minnesota). ***All those with label size 25 mm and those with true internal diameter #22 mm. In these cases highly accurate and more ventricular implantation could be hemodynamically advantageous. †††Paravalvular leakage of mild or uncertain significance can increase after valve in valve. Performing the procedure through the heart apex may improve the capability to deploy a closure device successfully. ‡‡‡Retrievable devices such as DirectFlow (DirectFlow Medical, Santa Rosa, California) and Lotus (Boston Scientific, Marlborough, Massachusetts) maybe considered in cases at risk for left ventricular outflow tract obstruction or device malposition. §§§Such as with SAPIEN 3 (in comparison to SAPIEN XT, Edwards Lifesciences, Irvine, California). Longer device is commonly easier to position.

and more. These learning curve changes were translated into

shorter

procedural time, less major

bleeding, and procedural success achieved in all cases in the more contemporary group of cases. Clearly, larger studies are needed to further explore the utilized approach and compare it to the alternatives. However, this important report does provide an excellent description of the techniques required for successful transseptal mitral valve implantation.

CLINICAL IMPLICATIONS Transapical and transseptal valve deliveries differ in numerous aspects. Table 1 displays anatomical and patient characteristics, in addition to device capabilities and operator skills, which may favor one approach over the other. The cardiac apex is consid-

vena cava, atrial septum and implanted in the mitral

erably closer to the mitral valve, than the peripheral

position (13,14). Although the transseptal approach is

veins, and as a result transapical implantation

still performed in a minority of these patients there is

enables better control over the implant position,

a worldwide increase in the number of transseptal

which could be of considerable value in some cases.

mitral valve implantations. Data from the VIVID

Mitral valve-in-ring and transcatheter valve implan-

registry shows a 15% utilization of the transseptal

tation in mitral annulus calcification are associated

approach for mitral valve in valve or valve in ring up

with elevated risk of left ventricular outflow tract

to 2013 but more recently this has significantly grown

obstruction. A more atrial device position in some of

to 25.4% in procedures performed from 2014 to

these cases could be advantageous and easier to

early 2016. Mitraclip, the most common transcatheter

control via the heart apex. The transseptal approach,

mitral valve repair procedure, is performed through

using currently available devices and delivery sys-

a transseptal approach. Although this procedure is

tems, is unfortunately associated with poor device

Dvir

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 11, 2016 JUNE 13, 2016:1175–7

Transseptal Mitral Valve Implantation

coaxiality to the mitral valve orifice plane and also with residual atrial septal defect that occasionally

F I G U R E 1 LVEF After Mitral Valve-in-Valve in Patients With Baseline LVEF #50%

needs to be closed. Nevertheless, the main advantage of the transseptal approach is being less invasive, eliminating the need for either thoracotomy or trauma to the left ventricle. Data from the VIVID registry

shows

an

improvement

in

myocardial

contraction in patients with left ventricular dysfunction treated by transseptal approach that was more significant than in those treated transapically (p < 0.001) (Figure 1). The clinical approach toward high-risk patients with severe mitral disease having transcatheter mitral valve implantation may change in the next few years. Certain surgeons may argue, “We do not need to make mitral valve implantation great again. Trans-

There was no difference in baseline left ventricular ejection fraction (LVEF) between

apical mitral implants have never stopped being

the transapical and transseptal groups (VIVID [Valve-in-Valve International Data] registry,

great.” I would like to challenge that claim because

mitral valve-in-valve patients with baseline LVEF#50% n ¼ 173; p ¼ 0.32). However, after

current clinical evidence, unfortunately, does not

implantation the transseptal group had a significantly higher LVEF (p ¼ 0.03; absolute

seem to favor an invasive approach in a high-risk

average difference 5.5%).

patient population (7–10). We can predict that in a couple of years with device and delivery system advancements, and with improved interventional

cardiologists, and researchers should continue to

cardiologists’ skills in operating in left atrium arena,

evaluate clinical outcomes of transcatheter mitral

there will be an increase in less-invasive transseptal

implantations, to define the optimal treatment of our

approach for mitral implantations. If this trend con-

patients.

tinues, surgical approaches for transcatheter mitral implants (transapical and direct left atrium) will

REPRINT REQUESTS AND CORRESPONDENCE: Dr.

likely be reserved for selective patient popula-

Danny Dvir, St Paul’s Hospital, 1081 Burrard Street,

tions. Most importantly, until robust clinical data

Vancouver, Canada V6Z1Y6. E-mail: danny.dvir@

becomes available, cardiac surgeons, interventional

gmail.com.

REFERENCES 1. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J 2007;28:1358–65. 2. O’Gara PT, Calhoon JH, Moon MR, Tommaso CL. Transcatheter therapies for mitral regurgitation: a professional society overview from the American College of Cardiology, the American Association for Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and the Society of Thoracic Surgeons. J Am Coll Cardiol 2014;63:840–52. 3. Herrmann HC, Maisano F. Transcatheter therapy of mitral regurgitation. Circulation 2014;130: 1712–22. 4. Mylotte D, Piazza N. Transcatheter mitral valve implantation: a brief review. EuroIntervention 2015;11:W67–70. 5. Guerrero M, Dvir D, Himbert D, et al. Transcatheter mitral valve replacement in native mitral valve disease with severe mitral annular calcification. J Am Coll Cardiol Intv 2016. In press. 6. Holmes DR Jr., Nishimura RA, Grover FL, et al. Annual outcomes with transcatheter valve therapy:

from the STS/ACC TVT registry. J Am Coll Cardiol 2015; 66:2813–23. 7. Biancari F, Rosato S, D’Errigo P, et al. Immediate and intermediate outcome after transapical versus transfemoral transcatheter aortic valve replacement. Am J Cardiol 2016; 117:245–51.

11. Gutierrez M, Rodes-Cabau J, Bagur R, et al. Electrocardiographic changes and clinical outcomes after transapical aortic valve implantation. Am Heart J 2009;158:302–8. 12. Barbash IM, Dvir D, Ben-Dor I, et al. Impact of transapical aortic valve replacement on apical wall motion. J Am Soc Echocardiogr 2013;26:255–60.

8. Gada H, Kirtane AJ, Wang K, et al. Temporal trends in quality of life outcomes after transapical transcatheter aortic valve replacement: a Placement of AoRTic TraNscathetER Valve (PARTNER) trial substudy. Circ Cardiovasc Qual Outcomes 2015;8:338–46.

13. Cullen MW, Cabalka AK, Alli OO, et al. Transvenous, antegrade Melody valve-in-valve implantation for bioprosthetic mitral and tricuspid valve dysfunction: a case series in children and adults. J Am Coll Cardiol Intv 2013;6:598–605.

9. D’Onofrio A, Salizzoni S, Agrifoglio M, et al. When does transapical aortic valve replacement become a futile procedure? An analysis from a national registry. J Thorac Cardiovasc Surg 2014;

14. Bouleti C, Fassa AA, Himbert D, et al. Transfemoral implantation of transcatheter heart valves after deterioration of mitral bioprosthesis or previous ring

148:973–9.

15. Eleid MF, Cabalka AK, Williams MR. Percutaneous transvenous transseptal transcatheter valve implantation in failed bioprosthetic mitral valves, ring annuloplasty and calcific mitral stenosis. J Am Coll Cardiol Intv 2016;9:1161–74.

10. Ghatak A, Bavishi C, Cardoso RN. Complications and mortality in patients undergoing transcatheter aortic valve replacement with Edwards SAPIEN & SAPIEN XT valves: a meta-analysis of world-wide studies and registries comparing the transapical and transfemoral accesses. J Interv Cardiol 2015;28:266–78.

annuloplasty. J Am Coll Cardiol Intv 2015;8:83–91.

KEY WORDS access, mitral valve, transapical, transseptal, valve-in-valve

1177