Title: Minimally Invasive Valve Repair in Bi-Leaflets Prolapse
Mitral Regurgitation (Barlow’s
Disease)
Authors : Alessandro
Barbone M.D.
Ph.D.1, Alessio Basciu M.D.1,
Alessandra IaccarinoM.D. 1, Ginevra Droandi M.D.1, Giorgio Romano M.D. 1, Ines
Andriani M.D. 1, Mauro Chiarito
M.D.2, Andrea Fumero M.D.1, Enrico
Citterio M.D. 1, Giuseppe Crescenzi
M.D.3, Lucia Torracca M.D.1
Form the: UO of Cardiac Surgery1, : IRCCS Humanitas
Clinical and Research Center, Via A. Manzoni 56, 20089 Rozzano (MI);
Department of Biomedical Sciences2, Humanitas
University, Via Rita Levi Montalcini, 4, 20090 Pieve Emanuele (MI);
UO of Cardiac Anesthesia3; IRCCS Humanitas Clinical
and Research Center, Via A. Manzoni 56, 20089 Rozzano (MI)
Short Title: Minimally Invasive Mitral Repair
Word Count: 3857
Corresponding Author: Alessandro Barbone M.D. Ph.D.,
Area Medici Ovest 1,
IRCCS Humanitas Clinical and Research Center
Via A. Manzoni 56, 20089 Rozzano (Mi).
Phone: +39 02 8224 4602
Fax: +39 02 8224 4691
email:alessandro.barbone@humanitas.it
No conflict of interest or outsource of founding needs to be disclosed.
The present manuscript was presented as abstract at the:
31st EACTS Meeting – 07-11 October 2017 – Vienna,
Austria
Abstract
Background and Aim of the Study:
Barlow’s disease is characterized by an excess myxomatous degenerative
tissue, leaflets prolapse and/or billowing, chordal elongation, and
annular dilation. We reviewed our experience in Minimally Invasive
Mitral Valve Repair (MIMVR) techniques to treat this complex mitral
pathology.
Methods:
Between 1999 and 2017 a group of 125 patients was identified as Barlow’s
disease undergoing MIMVR. The diagnosis of Barlow disease was based upon
preoperative transesophageal-echocardiography (TEE) and confirmed by the
surgeon’s assessment during open-heart procedure. Operative technique
and data were retrospectively collected along with intra-hospital and
long-term follow-up.
Results:
Successful Mitral Repair was possible in 100% of cases (125 patents)
within the first cross clamp. Most patients (118 pts – 94.4%) were
treated by the Edge to Edge (Alfieri-Stich), while 2 cases (1.6%) where
corrected by neochordae implant and 2 cases (1.6%) by quadrangular
resection. 58 patients (47.1%) received a complete semi-rigid ring,
while 65 (52.9%) an incomplete flexible partial ring excluding the LAM.
Concomitant procedures were additional cleft occlusion in 10 cases
(8%), tricuspid valve repair (ring implant or remodeling) in 29 cases
(23.2%), left atrial ablation for atrial fibrillation in 4 cases
(3.2%) and atrial septal repair in 4 (3.2%). Operative mortality was
0%. Average long-term follow-up was 85 ± 62 months, with a survival
rate of 97.6%, freedom from redo mitral surgery of 98.4% and freedom
from >2+ recurrent mitral regurgitation of 94.5%. No
difference in outcome could be related to annuloplasty ring type.
Conclusions:
Mitral repair can be safely and successfully achieved though minimal
invasive approach, with optimal long-term results.
INTRODUCTION
Minimally invasive mitral valve repair (MIMVR) has been proven as a
valid alternative to full sternotomy and has become the standard of care
in many centers. Some reports in the literature have shown that MIMVR
can be safely used also in the context of complex mitral pathologies
such as bileaflet prolapse in Barlow’s disease1.
Barlow disease is characterized by excessive myxomatous leaflet tissue,
bileaflet prolapse, chordal elongation and severe annulus dilatation.
Recent histopathologic analysis have shown distinct changes in Barlow
disease and fibroelastic deficiency confirming that they should be
considered two separate entities2. Patients with
Barlow disease often require surgery in young age and the possibility to
offer a minimally invasive approach and a durable repair is particularly
attractive for this young population. Different surgical techniques have
been proposed to repair these complex valves. The objective of our study
was to describe the early and long-term results of MIMVR in a large
series of patients with Barlow disease.
MATHERIALS and METHODS
Study Population
Between 1999 and 2017 a cohort of 125 patients was identified as having
Barlow’s disease and not requiring concomitant other cardiac procedures
that could not be performed through a Minimal Invasive Surgery (MIS)
approach (e.g., coronary bypass, ascending aorta, or aortic valve
surgery). The diagnosis of Barlow disease was made during the
preoperative transesophageal echocardiography (TEE) examination and
confirmed by the surgeon’s direct assessment of the valve during open
heart procedure.
The degree of MR was classified as grade 0 (absent or trivial), 1
(mild), 2 (moderate), 3 (moderate-to-severe), and 4 (severe MR),
according to published literature3.
Baseline demographics and preoperative characteristics of the 125
patients are summarized in Table 1. Patient with previous right
thoracotomy were excluded from this approach. Male and female patients
are equally represented in the study population. Mean age was 43 ± 12
years. Mean preoperative left ventricle ejection fraction was 61.2% ±
7.4%. All patients were operated electively
Surgical Technique
MIMVR technique has been previously described4.
Shortly a small (5-7 cm in length) right anterolateral mini-thoracotomy
is performed in the 3rd or 4thintercostal space; cardiopulmonary bypass (CPB) is instituted via
femoral arterial and venous cannulation. Endoscopic vision is
facilitated by means of 0° or 30° camera along with a full HD system.
The aorta is cross clamped either by a Chitwood clamp5or by a Cignet malleable clamp (VITALITEC, 10 Cordage Park Circle, Suite
100/200 Plymouth, MA 02360 USA) through the thoracotomy, and myocardial
protection is achieved by antegrade delivery of crystalloid Custodiol
cardioplegia (2 L)6, 7. The left atrium is then open
though the interatrial groove, and a left atrial retractor is used to
expose the MV. CO2 was actively insufflated inside the
chest cavity throughout the surgical repair and intracardiac air removal
achieved by means of active ventricular and aortic root suction. Few
different surgical technique are used in our experience: ring
annuloplasty, neochordae implant (Gore-Tex; WL Gore & Associates Inc,
Flagstaff, Ariz), leaflet resection with sliding
annuloplasty8, and Edge-to-Edge (“Alfieri”)
technique9. At the end of cardiopulmonary bypass (CPB)
TEE is performed to evaluate the presence of residual MR and to measure
MV area and gradient. MV area is evaluate through a trans gastric short
axis view by a planimetric method. A complete echocardiographic
evaluation is performed once the patient gains physical autonomy,
usually on 4th post-operative day: no patients is
considered for hospital discharge with a residual mitral regurgitation
greater than 2+ (mild to moderate).
Follow-up
Clinical long-term follow-up was 100% complete and consisted of mitral
valve function evaluation accordingly to the latest echocardiographic
examination available (yearly check-up either with at our institution or
at the referring cardiologist), reoperation for MV disease or any other
cardiac reoperation, and patient survival. Follow up data were collected
by telephone contact with the patient or family members, or by contact
with the family physician. In those cases, in which MR grade was
reported to be between 2 categories, it was rounded up to the worse
grade. The average follow time after surgery was 85 ±62 months.
Statistical Analysis
Continuous variables are reported as mean ± standard deviation, and
categoric variables are reported as percentages of group totals
throughout the article. In case outliers might significantly alter
perception of the real outcome, for the sake of completeness median and
moda are also provided. The Kaplan–Meier method was used to estimate
survival rate, freedom from MV reoperation, and freedom from recurrent
MR greater than grade 2; furthermore, a Kaplan-Meier curve was arranged
accordingly the different kind of annuloplasty ring used during surgery
and results were calculate on the composite endpoint of survival +
recurrence of MR and reoperation among groups, were comparing by
Mantel-Haenszel test. Data for patients lost to follow-up were censored
at the time of the last contact. Excel program (Microsoft Corp, Redmond,
Wash) and Stata version XI (StataCorp, College Station, Tex) were used
for statistical and survival analyses.
RESULTS
Operative Technique and
Outcomes
Intraoperative data and MV repair techniques are listed in Table 2. As
previously anticipated, anterolateral mini-thoracotomy with femoral
cannulation for CPB was the surgical approach in all 125
patients4.
Repair techniques consisted of neochordae implant with the loop
technique in 2 patients. Resection of the PML and sliding plasty was
performed in other 2 patients. The Alfieri (Edge to
Edge)9 technique was applied in 118 patients (94.4%).
In 105 patients (84%) the stich was placed in the central valve area,
in 17 patients (10.4%) in paracommissural position, depending on the
mechanism of mitral insufficiency and the jet localization.
A total of 10 patients (8%) also received a concomitant cleft plication
and 1 patients the suture of leaflet perforation.
123 patients (98.4%) received a ring annuloplasty. A total of 58
patients (47.1%) received a complete semi-rigid ring (average size 36 ±
2.6 mm), while the remaining 65 patients (52.9%) received an incomplete
flexible partial ring excluding the LAM (average ring size was 33.9 ±
2.1 mm). A subgroup analysis was performed to understand if any of the
two devices offered any advantage in term of either survival or freedom
from complication; a Kaplan-Meyer projection is reporting that no
difference was recorded (Fig 4).
A group of 29 patients (23.2%) received concomitant tricuspid valve
repair: 23 by ring annuloplasty (average ring size 27 ± 3 mm), 3
patients by Kay plasty and 3 patients a De Vega repair.
Non-valvular associated procedure consisted of 4 PFO/ASD closure, and 4
left atrial ablation for atrial fibrillation treatment.
Average cardiopulmonary bypass time was 103 ± 29 min while average
cardiac arrest time was 72 ± 21 min.
In the overall experience only in 1 case was required a conversion to
full sternotomy because of inadequate mitral valve exposition (patient
with pectus excavatum ) (Table 3).
In another single case a second cross clamp and cardiac arrest was
required to allow retroflexion of the left atrial appendage that
appeared inappropriately introflexed after weaning from cardiopulmonary
bypass; the reason of this inconvenience was not clear neither the
possible clinical significance but we felt safer to reinstitute the
native cardiac anatomy by a new cross clamp and cardioplegia time.
In 3 patients Intraortic Ballon Pump (IABP) was required to facilitate
weaning from cardiopulmonary by-pass.
One patient underwent to coronary angiography immediately after surgery
due to abnormal ST elevation: angiography showed diffuse coronary spasm
treated medically with resolution of the angiographic picture and ECG
modification. The subsequent postoperative course was uneventful.
Three patients required a surgical revision for bleeding in the
immediate post-operative time and 5 suffered (4%) a Low Output Syndrome
(LOS) during the Intensive Care Unit stay. Respiratory failure requiring
prolonged mechanical ventilation occurred in 2 patients.
Overall, average ICU length of stay was 41 ± 36.2 hours (Median 30 h,
Moda 12 h) (Table 4).
A total of 19 patients (15.2%) suffered of postoperative Atrial
Fibrillation along the subsequent hospitalization throughout discharge
and overall 2 patients required permanent pacemaker before hospital
discharge. 2 patients suffered a pleuro-pericardial effusion requiring
percutaneous drainage during the first hospital admission.
Average post-operative hospital stay to discharge either home or to
rehabilitative institute was 7.6 ± 4.9 days (Median and Moda 6 days).
Successful mitral repair at discharge was obtained in 125 patients
(100%), neither any patients requiring a mitral valve replacement nor
any patients was discharged with a mitral regurgitation >
mild-moderate (grade >2). No mortality was recorded in the
perioperative period (30 days).
Follow up
Average follow up time after surgery was 85 ± 62 months (Table 4). At
follow up 3 patients were found dead: one due to neoplasia more than 130
months after surgery; one patient succumbed of sepsis after being
re-operated because of mitral valve endocarditis 39 months after initial
uneventful surgery; and 1 young (42 years old) female patient was found
dead in a park while exercising 2.4 months after surgery. Overall, at
echocardiographic control 7 patients presented >2+
recurrent mitral regurgitation (greater than moderate) at an average
follow up time of 138 ± 49.3 months; 1 patient was found with moderate
mitral stenosis, 2 case of mild mitral stenosis and 1 case of mild
stenosis associate to mild regurgitation Two patients underwent redo
mitral surgery (mitral replacement) at 40 and 186 months for recurrent
symptomatic mitral regurgitation. Kaplan-Meier for the mentioned outcome
are available at Figure 1 to 3. As shown in Figure 4, there were no
significant differences in terms of overall mortality, reoperation or
recurrence of MR (composite end-point) according to the different kind
of annuloplasty ring used during surgery.
DISCUSSION
MIMVR has become the standard of care in many centers. Data from the
literature have shown clinical advantages in terms of less bleeding and
transfusion, less surgical site infection and postoperative atrial
fibrillation, faster recovery and improved
cosmesis10-13. We have introduced this surgical
approach in the late 1990 and progressively expanded his application.
Since the beginning our experience has accounted of more than 400
patients treated with minimal invasive mitral surgery; we feel that a
significant learning curve is required for this procedure, as it is for
most complex cardiac procedure. In the first 4 years of the experience
the procedure was limited to more than ideal patients for more than
ideal procedure. After roughly 40 patients the technique appeared to be
sufficiently reproducible and under control to be available on a routine
basis. Today we can easily affirm that is the first choice for young
patients with atrioventricular valves or atrial cardiac surgical
procedure. Although we feel that this technique requires continuous
application and practice to be safe and sound not only for the surgeon,
but for the entire surgical team.
Barlow patients are usually a young population (our mean age was
43+ 11.9 years) thus highly motivated to receive a minimally
invasive procedure and obviously a durable repair. On the other hand,
they have a complex valvular disease still considered a challenging
procedure for mitral repair. Barlow disease is characterized by
proteoglycans accumulation in the spongiosa layer and intimal thickening
both contributing to leaflets thickening. Macroscopically Barlow valves
show excess tissue, leaflets thickening, chordal elongation, bileaflet
prolapse, annulus dilatation and, not rarely, annular calcification This
extensive valve remodeling and the global involvement of all valve
structures into the disease process, make the valve repair particularly
demanding. Nevertheless, a variety of surgical techniques have been
proposed to repair Barlow valves.
In the current study, neochordae implantation was used in 2 patients. In
2 other patients a quadrangular resection with sliding plasty of the
posterior leaflet was performed accordingly to Carpentier
technique8. Most of the patients (n=118: 94.4%)
received a valve repair using the edge-to edge technique. As described
by Alfieri’s group, the technique is effective in restoring mitral
competence in Barlow disease with good early and long-term
results9, 14. One hundred and five patients (84.0%)
received a central edge-to-edge while 13 (10.4%) a paracommissural
stich, depending on the valve pathology and regurgitant jet
localization.
In Barlow valves the technique of stich placement is a key point for the
surgical result. The edge-to-edge stich should be placed deep in the
body of the leaflets to decrease the height of the leaflets and move the
coaptation point within the left ventricle, below the mitral annulus
level. In patients with particularly high risk of SAM due to anatomical
reason (basal septal hypertrophy, narrow mitral-aortic angle) the
edge-to-edge stich can be placed, at level of the posterior leaflet, few
millimeters far away from the posterior mitral anulus. This surgical
trick shifts the coaptation point of the mitral valve toward the
posterior mitral annulus, moving the anterior mitral leaflet away from
the LV outflow tract and avoiding SAM. Indeed, in our study we didn’t
observed the occurrence of SAM in any of the 125 patients.
At 10 years follow up the expected survival according to the Kaplan
Meier estimates is 99.2 ± 1.6%, while at 15 years is 96.3 ± 5.8%.
Freedom from MR>2+ was 98.7% ± 2.4 % at 10 years and 77.8
± 19.2 % at 15 years: a total of 7 patients were found with a moderate
or more recurrent Mitral Regurgitation at follow up. Freedom from
reoperation was 98.8% ± 2.4% at 10 years, same rate at 15 years,
accounting for a total of 2 reoperation in the overall follow up.
In the current study all but 2 patients (characterized by particular
calcified and surgically unapproachable mitral annulus) undergoing MV
repair received an annuloplasty ring: two different type of ring were
used in our experience: either a complete semi-rigid annuloplasty ring
in 58 cases (47.1%) or incomplete flexible partial ring in 65 patients
(52.9%). The incomplete rings were used in an average smaller size
compared to the complete (33.9 ± 2.1 mm vs 36 ± 2.6 mm) but this seemed
do not affect neither the short nor the long-term outcome. Debate
between surgical philosophies on which is the most reliable device for
mitral annuloplasty has been ongoing for years 15. The
intention of restoring anatomically accurate mitral valve has driven
Carpentier’s development of a rigid prosthetic annuloplasty ring. The
ring is intended to restore the normal systolic size and shape of the
annulus, thus restoring leaflet coaptation and preventing further
deformation in time of the annulus. The ring size is based on precise
measurement of the anterior leaflet surface area, approximating the size
and shape of the mitral orifice in systole8, 16.
Although, thanks to further development of cardiac imaging technique, in
particular 3D echocardiography, was elucidated the dynamic structure of
the mitral annulus and its evolution along the cardiac cycle. Indeed, to
allow a functional restoration of the mitral valve physiology, a
flexible and incomplete annuloplasty ring sparing the anterior leaflet
was developed and implemented to maximize the mitral annular
excursions17, 18 and limit the diastolic restrain on
the leaflets.
In our series this trend was followed, favoring the complete
annuloplasty ring at the beginning of the surgical experience, moving to
a more flexible and incomplete ring once surgical data was accumulating
on this latter device. Notably in recent published revaluations of past
surgical experience, partial rings showed lower rest and exercise trans
mitral gradients, predicting a more favorable clinical outcome in terms
of echocardiographic atrial remodeling (smaller left atrial size
predicting lower atrial fibrillation rate) and functional performance
(better 6 minutes walking test of Heart Failure symptoms tolerance)
without affecting long term outcome of mitral repair19,
20.
It has to be noted how an incomplete ring sparing the LAM, further
simplifies the minimal invasive approach reducing the number of suture
required in an especially complex area to be exposed, rendering device
preferable.
Thus can be underlined how direct comparison of our finding with other
contemporary series shows reproducible results.
Munaretto and colleagues are reporting 50 cases of MIS in Barlow disease
over a 3 years timeframe, with an average follow up of 36 months with a
successful repair through either resection approach (P2 resection and
neocordae on LAM) or non-resection approach (neocordae on LPM and LAM)
apparently without differences in late outcome21. The
average cross clamp and cardiopulmonary bypass time is substantially
longer compared to what reported in our and other different
experience22, due most likely to the more complex
repair approach. This apparently is not affecting neither the short nor
the long term follow up, indeed allowing an overall shorter ICU and
hospital stay.
Borger and colleagues reported their experience with MIMVR in Barlow
Disease using different surgical techniques22. All
patients undergoing MV repair but 1 patients received a partial ring
annuloplasty with a mean ring size of 35.7±2.8 mm. Freedom from
reoperation was 96.8% at 5 years, and 93.8%at 10 years. Late
echocardiographic follow-up showed freedom from moderate-to-severe MR in
90,2% at 5 years and 88.4% at 11 years.
Our surgical results favorably compare also with large surgical series
in which mitral repair has been performed via median sternotomy and long
term follow up has been reported.
Flameng and colleagues reported a series of 348 patients with both
Barlow and fibroelastic deficiency23. Freedom from
recurrent MR (>2+) was 82.2% at 5 years and 64.9%at 10
years for the entire group, with worse outcomes for patients with
Barlow’s disease.
David and colleagues are reporting 840 MV repair in median sternotomy
with very long follow up. At 20 years, freedom from recurrent severe MR
was 90.7%, and freedom from moderate or severe MR was 69.2% for the
entire group24. Advanced mixomatous degeneration, like
Barlow disease, as long as anterior mitral prolapse, is recognized as a
predictor of valve failure.
De Bonis, from the Alfieri’s group , reports on long term follow up of
174 patients treated by edge-to-edge technique through median sternotomy
and comprising Barlow disease patients25. Freedom from
MR>3 was 83,8% at 14 years with no difference between
anterior and bileaflet mitral prolapse. Residual MR at discharge being
the only predictors of MR recurrence.
A particularly interesting reports is from Zekry and colleagues that are
proposing to treat MR in Barlow by a simple annuloplasty
ring26. In their manuscript they are claiming that
Patients with Barlow disease have enormously enlarged annulus size and
extremely excessive leaflet tissue thus placement of a mitral
annuloplasty ring remodels the MV shape and reduces annulus size. As the
annulus size decreases, leaflets get closer and are pushed down toward
the left ventricular apex. According to authors this technique not only
bears a much shorter operative time, but even a better long-term outcome
hitting a 100% freedom from recurrent MR. However, this approach
limited to a simple annuloplasty without any tissue resection or
rearrangement bares a couple of serious concerns, although it might
highly simplify MIMVR. First, excessive tissue may cause functional MV
stenosis, and second, it heightens the risk of postoperative SAM (as
proven by the occurrence of this complication in 7 over 24 patients
although apparently medically solved in most cases). Thus, in our center
we are not keen to accept this pathophysiological approach to mitral
valve repair.
The results of our study confirm that patients with Barlow disease can
be safely treated with a minimally invasive procedure. The use of the
edge to edge technique has provided very good long-term results
favorably comparing with the data available in the literature.
Both surgical experience in mitral repair and minimally invasive surgery
are mandatory to obtain good results and exposure to a large number of
procedure is the precondition to hit this goal.
Study Limitations
Our study is retrospective in nature and therefore subject to the
inherent weaknesses of a retrospective analysis. First limit is related
to the lack of comparison with a sternotomy group of patients treated
during the same period by the same surgeons. Furthermore,
echocardiographic follow up evaluation is not ideal not being performed
in our echo lab but only obtained as a report from outside institution.
Only data regarding the outcome of mitral valve repair are available and
no other information neither on LV function nor dimension or mechanism
of valve failure are available.
Conclusions
MIMVR can be safely used to treat mitral regurgitation in patients with
complex Barlow disease. Long term follow up has shown good results in
our quite large population of patients treated predominantly with
edge-to-edge technique. Surgical experience on mitral repair and
minimally invasive surgery are mandatory to obtain reproducible
long-term results.
Author Contribution to the research and Manuscript:
Alessandro Barbone M.D. Ph.D.: Concept/design, Data
analysis/interpretation, Drafting article, Statistics, Data collection
Alessio Basciu M.D.: Drafting article, Data collection
Alessandra IaccarinoM.D.: Data analysis/interpretation, Data collection,
Ginevra Droandi M.D.: Data collection
Giorgio Romano M.D.: Concept/design, Data collection
Ines Andriani M.D. Data collection
Mauro Chiarito M.D.: Data analysis/interpretation, Critical revision of
article, Statistics
Andrea Fumero M.D.: Data analysis/interpretation, Approval of article,
Enrico Citterio M.D.: Data analysis/interpretation, Critical revision of
article
Giuseppe Crescenzi M.D.: Concept/design, Data analysis/interpretation,
Critical revision of article,
Lucia Torracca M.D.: Concept/design, Data analysis/interpretation,
Drafting article
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Figure Legend
Fig 1: Kaplan Meier Estimate Survival with Population at Risk
CI: 95% Confidence Interval, MR: Mitral Regurgitation; Data Reported As
Mean ± SD
Fig 2: Kaplan Meier Estimate Survival Free of Recurrence of Mitral
Regurgitation >2+
CI: 95% Confidence Interval, MR: Mitral Regurgitation; Data Reported As
Mean ± SD
Fig 3: Kaplan Meier Estimate of Survival Free of Reoperation:
CI: 95% Confidence Interval, Data Reported As Mean ± SD
Fig 4: Kaplan Meier Estimate of survival in subgroups arranged by
annuloplasty ring type.
CI: 95% Confidence Interval, Data Reported As Mean ± SD