Review Article
This work is licensed under a Creative Commons Attribution-NonCommercial- NoDerivatives International License. ©2021 Japan Transcatheter Valve Therapies
Safety of Transcatheter Aortic Valve Replacement in Patients
with Prosthetic Mitral Valve
Junjiro Kobayashi
National Cerebral and Cardiovascular Center, Suita, Osaka, Japan
Received: December 15, 2020; Accepted: January 19, 2021
Corresponding author: Junjiro Kobayashi. National Cerebral and Cardiovascular Center, 6-1, Kishibe-shimmachi, Suita, Osaka 564-8565, Japan
Email: jkobayas@ncvc.go.jp
Transcatheter aortic valve replacement (TAVR) has become an alternative procedure for treating aortic stenosis in patients with advanced age and comorbidities. Although patients with previous surgical mitral valve replacement (MVR) are also indicated for TAVR, there might increase the risk of malposition of device, stuck of mechanical valve leaflet, or paravalvular leakage (PVL). My objective is to review the risk of TAVR in patients with prosthetic mitral valve with some experimental study. TAVR patients with prosthetic mitral valve had similar mortality and morbidity compared with TAVR without pros-thetic mitral valve. Transcatheter heart valve (THV) migration or interaction to mitral prospros-thetic valve was rare. Interference of THV with prosthetic valve was high when aorto-mitral angle was less than 90° and mitral prosthesis distance was less than 7 mm in my experimental study in vitro. Anatomically implanted bileaflet valve (oriented like anterior and posterior mitral valve) or anti-anatomically implanted single tilting disc valve (major orifice opening to the left ventricular outflow tract) is a risk of impingement and stuck with THV. Preoperative evaluation of aorto-mitral anatomy and prosthetic valve implanta-tion method by multi-modalities are important.
Keywords: valves, heart disease, surgery
Introduction
Transcatheter aortic valve replacement (TAVR) has become an alternative procedure to surgical aortic valve replacement for treating of aortic stenosis in patients with advanced age and comorbidities.1–7). However, patients
with previous surgical mitral valve repair or replacement has been excluded from TAVR clinical trials.1–6)
Several issues should be considered when TAVR is performed in a patient with preexisting mitral valve prosthesis: (1) transcatheter heart valve (THV) emboli-zation due to “watermelon seeding” phenomenon (bal-loon or device slippage during launch), (2) possibility of not fully expanding or deformity of THV by the pros-thetic mitral valve, and (3) stuck mechanical mitral valve
due to interference of proximal edge of THV with the tilting prosthetic leaflet.
THV Embolization
THV embolization is categorized in valve mispositioning in VARC 2 document.8) The definition is “The valve
pros-thesis moves during or after deployment such that it loses contact with the aortic annulus.” Valve migration is differ-ent from valve embolization. Valve migration is defined as “After initial correct positioning, the valve prosthesis moves upward or downward, within the aortic annulus from its initial position, with or without consequences.”
The incidence of THV embolization was less than 1%.9) Independent risk factors were the use of first
generation, or self-expandable valve, and the presence of a bicuspid aortic valve. Although cover index by perimeter and area was significantly higher in the embolization group, transcatheter embolization occurred in patients with both undersized and over-sized prosthesis selection. In addition, the cover index by area was low in both groups. If there is enough cal-cification in the aortic valve apparatus as outer support and proper initial positioning with appropriate sized THV is selected, THV embolization is rare. The cause of THV embolization is mainly technical failure and undersized valve selection.
This might be also true for TAVR in patients with prior mitral valve replacement (MVR). Thourani et al.10)
reported the results of TAVR after prior mitral valve sur-gery by TAVR registry. VARC-2 defined device success rate was significantly (p = 0.016) higher among patients with prior mitral valve surgery (93.4%) compared with patients without prior mitral valve surgery (90.1%). In addition, conversion rate to open heart surgery was sig-nificantly (p = 0.008) lower in patients with prior mitral valve surgery (0.1%) than in patients without prior mitral valve surgery (1.2%). Systematic review of TAVR after previous MVR in 137 patients showed only one THV migration into the left ventricle and no THV emboliza-tion.11) In Japanese Ocean TAVI registry of 3043 patients,
31 (1.0%) had previously undergone MVR prior to TAVR, and no THV embolization occurred.12) However, THV
shift occurred in nine patients (29.0%; 8 for upward and 1 for downward direction) in SAPIEN (Edwards Life-sciences, Irvine, CA, USA) THV implantation. Large-sized THV (26 or 29 mm) was a predictor of THV shift. No THV shift was observed in TAVR with CoreValve Evolut R (Medtronic Inc., Minneapolis, MN, USA) or in patients with a bioprosthetic mitral valve. Although some THV shift occurred in patients with prior MVR, THV embolization in patients with prior MVR due to “water-melon seeding” phenomenon was thought to be rare.
On the other hand, Amat-Santos et al.13) reported high
THV embolization both in patients with prior mitral valve surgery (6.7%) and without prior mitral valve surgery (3.3%; p = 0.127) in a multicenter analysis.13) They pointed
out that the risk of THV embolization was the distance from the annulus to mitral valve prosthesis <7 mm.
THV Dysfunction
THV dysfunction due to implanted mitral valve prosthe-sis is also a rare complication. Not fully expanding or
deformity of THV by the prosthetic mitral valve is the possible cause of dysfunction. In the TAVR registry, the incidence of paravalvular leakage (PVL) in TAVR with prior MVR (5.78%) was like in TAVR without prior MVR (4.91%).10) In a multicenter analysis, grade 3 or
4 PVL immediately and 6 months after TAVR was simi-lar (p = 0.999 and p = 0.495) both in patients with prior MVR (2.9% and 1.9%) and without prior MVR (4.2% and 0.9%). Mean THV pressure gradient immediately and 6 months after TAVR was slightly higher in patients with prior MVR (12.86 mmHg and 13.54 mmHg) than without prior MVR (11.23 mmHg and 10.53 mmHg) though sta-tistically not significant (p = 0.144 and p = 0.062).12)
Tanaka et al.reported that the incidence of THV stenosis was 6.5% and grade 3 or 4 PVL was 3.2% among 31 patients with prior MVR, respectively.12) In recent
pro-spective trials, grade 3 or 4 PVL has been improved to 2% to 3% simply due to newer TAVR devices.7)
Interference of TAVI Device to
Mitral Valve Prosthesis
In the systemic review of TAVR after MVR, there were three cases where THV interfered disc of mechanical mitral valve.11) These patients underwent prior MVR with
single tilting disc valve.14–16) Major orifice was opening to
the left ventricular outflow tract (anti-anatomical position), and the disc was impinged by THV or tissue of aorto-mitral curtain. Sudden hemodynamic deterioration occurred. In the first case, CoreValve caused mitral regurgitation, and was snared up to the ascending aorta with resolution of mitral valve impingement.14) The second patient died
with-out any treatment after SAPIEN XT valve implantation.15)
The third patient converted to surgical aortic valve replace-ment after SAPIEN 3 implantation, and discharged home on postoperative day 8.16) It is believed by most cardiac
surgeons that anatomical implantation (major orifice toward the posterior leaflet) of a single tilting disc valve in the mitral position favors optical hemodynamic flow with-out disturbance of left ventricular ejection.17) However, a
single tilting disc valve was implanted anti-anatomically (major orifice toward the left ventricular outflow tract) in these three cases. Major orifice facing to the left ventricular outflow and the aortic valve is a risk of interference and mitral encroachment after TAVR.
TAVR also has interference to a bileaflet mechanical mitral valve.12) There was one patient who had ATS
bileaflet valve (ATS Medical, Inc., Minneapolis, MN, USA) 29 mm in the mitral position. After a 23-mm
SAPIEN 3 was implanted by transfemoral approach, the edge of SAPIEN 3 partially occluded the opening of one leaflet of the ATS valve. The aortic annulus to the mitral prosthesis was 0.9 mm, which is a strong risk for valve interference. The aorto-mitral angle was 120° by multi-detector computed tomography (MDCT). Opening of one disk did not fully open without encroachment to the SAPIEN edge. However, the mean pressure gradient increased from 1.0 to 5.0 mmHg, and mitral regurgita-tion increased from grade 2 to 3. The patient was fol-lowed up for more than 1 year without any major adverse event. ATS valve orientation in the mitral position is generally anti-anatomical (perpendicular to the native leaflets) to avoid interference of aortic regurgitation flow18) and preserved mitral subvalvular apparatus19) like
other bileaflet valves. In this case, ATS valve was implanted in the anatomical position (bileaflets orien-tated like native anterior and posterior leaflets).
We examined the interference of THV with mechani-cal mitral valve in vitro (Fig. 1). We used St.Jude Valve 29 mm (Abbott Inc., Abbott Park, IL, USA), and Sorin Biomedics Valve 23 mm (LivaNova, Saluggia, Italy) as bileaflet valves, and Björk-Shiley Monostrut valve 25 mm (Shiley Inc., Irvine, CA, USA) as a single tilting disc valve. As THV SAPIEN 3 26 mm and Evolut PRO 29 mm were tested. Aorta-mitral angle (θ) was set at 120° and 90°. The aorto-mitral distance was set 0 mm, minimal distance (D) to interfere prosthetic disk move-ment was measured in Table 1.
When aorto-mitral angle was 120° and bileaflet mechanical valve was orientated in anti-anatomical posi-tion, the risk of impingement of THV with disc is absent even if aortic annulus is close to the mitral prosthetic
valve. On the other hand, when Björk-Shiley Monostrut valve 29 mm was positioned anti-anatomically, THV interfere with the tilting disc if implanted 8 mm deep from the aortic annulus suppose aortic annulus and pros-thetic valve is at the same level. This result is compatible with the previous report.13)
When aorto-mitral angle was 90°, the risk of interfer-ence of THV with the mechanical disk was present. St’Jude Valve has pivot guards and bileaflet is prominent only 3 mm below the housing and the risk of interference with THV is low irrespective of implant method in the mitral position. As far as THV is implanted in good posi-tion of manufacturer’s recommendaposi-tion, the risk of impingement is zero. On the contrary, if a single tilting disk valve (Björk-Shiley Monostrut valve) was implanted anti-anatomically and curved disc bileaflet valve (Sorin Biomedics Valve) was implanted anatomically, the edge of THV interferes with the disc even if recommended TAVI procedure is applied. Preoperative evaluation of aortic root anatomy and prosthetic valve implantation method by multi-modalities are very important.
Aorto-mitral angle is narrowing with age. Becker compared the aorto-mitral angle in autopsy hearts over 60 years of age and under 20 years of age.20) The angle
varied between 110 and 150° in hearts under 20 years of age. The angle varied between 100° and 135° over 60 years of age. The aorto-mitral angle narrowing was also reported after resection of strut chordae and implan-tation of rigid mitral valve prostheses.21) The aorto-mitral
angle is suspended by the tension in the strut chordae, which pull on the fibrous trigones. If this tension is released by strut chorda transection, the annuli are drawn together, narrowing aorto-mitral angle approaching 90° in elderly patients who are candidate for TAVR.22)
Poulin et al.23) reported a case who presented
biopros-thetic mitral valve perforation of Mosaic valve 29 mm six months after TAVR with SAPIEN XT 26 mm causing severe mitral regurgitation and heart failure.23) Autopsy
suggested deformation of mitral leaflet due to repeated contact with THV edge. In this case, one mitral strut is positioned in the center of anterior mitral leaflet and pro-truded into the left ventricular outflow tract just beneath the aortic annuls. Soft flexible Mosaic valve strut was pushed inward, and the mitral leaflet was directly contract with low implanted THV. Usually, two struts of a biopros-thetic valve are oriented on the fibrous trigone. Therefore, THV does not contract directly with a tissue valve.
It is recommended that the THV should be positioned more ventricularly when SAPIEN XT is used because of Fig. 1 SAPIEN 3 26 mm and St.Jude Valve 29 mm were used in
this figure. St.Jude valve was oriented as anti-anatomical position. Aorto-mitral distance was set 0 mm, and the implantation depth was the distance from the mitral cuff
Table 1 Minimal distance of THV device to interfere with prosthetic mitral valve
THV Mitral valve prosthesis Minimal interference depth (mm)
SAPIEN 3 26 mm Aorta-mitral angle 120° Aorta-mitral angle 90°
Anatomical position
St‘Jude Medical 29 mm >15 8
Sorin Biomedics 23 mm >15 3
Björk-Shiley Monostrut valve 25 mm >15 12
Anti-anatomical position
St‘Jude Medical 29 mm >15 12
Sorin Biomedics 23 mm >15 4
Björk-Shiley Monostrut valve 25 mm 8 3
Evolut PRO 29 mm
Anatomical position
St‘Jude Medical 29 mm >15 8
Sorin Biomedics 23 mm >15 3
Björk-Shiley Monostrut valve 25 mm >15 11
Anti-anatomical position
St‘Jude Medical 29 mm >15 11
Sorin Biomedics 23 mm >15 4
Björk-Shiley Monostrut valve 25 mm 7 3
Anatomical position: major orifice toward the posterior leaflet of a single tilting disc valve (Björk-Shiley Monostrut valve), Anti-anatomical position: bileaflet valve perpendicular to the native posterior leaflet (St’Jude Medical and Sorin Biomedics)
the anticipated aortic shift during deployment to prevent valve embolization.24) Newer SAPIEN 3 is designed to
be shorten with balloon inflation to decrease complete heart block. Ventricular side of the balloon shortens 5.5– 8.5 mm upward to the ascending aorta according to the device size. Impingement of the balloon with prosthetic
housing and strut must be reduced. When SAPIEN 3 29 mm is set 50% of its stent below the annulus, the ventric-ular edge of the THV valve is 7.0 mm below the aortic annulus after shortening. Therefore, there is no impinge-ment if aorto-mitral device distance is more than 7 mm (Fig. 2), which is compatible with recommendation by Amat-Santos and associates.13)
As I mentioned above, balloon expandable SAPIEN 3 device is relatively safe to avoid malposition as far as mitral valve is more than 7 mm below the aortic annulus. When aorto-mitral distance is less than 7 mm, retrievable Evolut PRO is feasible.
Other Clinical Issues
MortalityAmat-Santos et al.13) found no significant difference in
the in-hospital mortality of 5.5% for 91 patients with prior MVR compared with 7.3% for 2323 without prior MVR (p = 0.514). Thourani et al.10) also reported no
dif-ference in the hospital mortality (3.7% vs. 4.1%, p = 0.478) or 30-day mortality (4.6% vs. 5.5%, p = 0.293) among patients with and without prior mitral valve sur-gery. There was significant higher 1-year mortality among patients with prior mitral valve surgery (20% vs. Fig. 2 SAPIEN 3 29 mm was set 50% of its stent below the
annulus, the ventricular edge of the THV valve was 7.0 mm below the aortic annulus after deployment. There was no impingement if aorto-mitral device distance was more than 7 mm
17.5%, HR 1.18, p = 0.043). Mitral bioprosthesis, mechanical mitral valve, and mitral repair were not asso-ciated with mortality at 30 days or 1 year before or after adjustment. Amat-Santos et al. found no difference in the mortality of TAVR with (31.1%) and without (33.1%) prior MVR at median follow-up of 5 years (p = 0.636).
Morbidity
Patients with prior mitral valve surgery had lower rates of in-hospital stroke (1.2% vs. 2.1%, p = 0.035) and new permanent pacemaker (4.8% vs. 8.5%, p <0.001). There was no difference in rates of myocardial infarc-tion, stroke, reinterveninfarc-tion, new dialysis, and readmis-sion at 30 days or 1 year after TAVR by the STS/ACC TVT registry.10)
Conclusion
TAVR patients with prosthetic mitral valve has similar mortality and morbidity compared with TAVR without prosthetic mitral valve. Although THV migration or interaction to mitral prosthetic valve was rare, interfer-ence of THV with prosthetic valve is high when aorto- mitral angle is 90° and aortic annulus to mitral prosthesis distance is less than 7 mm. Anatomically implanted bileaflet valve (oriented like anterior and posterior mitral valve) or anti-anatomically implanted single tilting disc valve (major orifice opening to the left ventricular out-flow tract) is a risk of impingement and stuck with THV. Preoperative evaluation of aorto-mitral anatomy and prosthetic valve implantation method by multi-modali-ties are very important.
Disclosure Statement
The author has no conflicts of interest to declare.
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