Volume 86, Number 3
`
`September 1983
`TheJournalof THORACIC AND
`CARDIOVASCULAR SURGERY
`
`:ty
`
`CARDIOVASC SuRG 86:323-337, 1983
`
`Honored Guest's Address
`
`valve surgery-the "French correction"
`
`Carpentier, MD., Paris, France
`
`President, I would like to begin by expressing
`Y• gratiitucle to the Association for the priviledge of
`the Honored Guest Lecture at the Sixty-third
`Meeting of The American Association for
`Surgery. What surprises me the most in this
`is my presence on this podium, since this honor
`.iSusttally reserved for more senior and __ preeminent
`thoracic surgery. I suppose that you'wanted to
`distin!~h;h a team rather than a man, so that I would
`to share this honor with my co-workers who are
`in this room: Drs. Deloche, Fabiani, Chauvaud,
`Lessana, Lapeyre, Mrs. Chauveau, Mrs.
`Menissier, Mrs. Veneziani, and with my wife, Sophie,
`who has participated in my laboratory work throughout
`the ve,us. I also would like to pay special tribute to my
`respected teacher, Professor Charles Duhost, and to
`. . mention my two colleagues, PrQfessors Blondeau and
`Claude d'~es, wh? _are unfortunately not with us
`
`Memtbers of the Association, in ili~ past 14 years, I
`• have attended the annual meeting of your Association
`· 14 times with the priviledge of having presented a paper
`10 times. All through these years, wearing a pink
`
`HOpita! BroussaiS, Paris, France.
`' Read at the Sixty-third Annual Meeting_ofThe American Association
`Thoracic Surgery, Atlanta; Ga., April 25-27, 1983
`Address for ieprints: Department of Cardiovascular Surgery, H6pital
`Broussais, 96 Rue Didot, '75674, Paris Cedex 14, Fmnce.
`
`identification badge, I observed with great admiration
`and respect the famous people wearing a white printed
`badge and seated in a carefully delineated area of
`reserved seats! Permit me to tell you how proud I am to
`enter your prestigious circle.
`Guests, you are seated outside this circle, but only
`temporarily! I address you specifically, since you repre(cid:173)
`sent the future of thoracic surgery and the future of this
`august Association.
`Members and guests, cardiac surgery has achieved
`remarkable progress in the past 10 years. Safer tech(cid:173)
`niques of anesthesia and postoperative care, improved
`extracorporeal circulation and myocardial protection,
`and sophisticated suigical techniques are new tools
`which have been instrumental in reducing hospital
`mortality and increasing the efficiency of our operations .
`New surgical tools impose neW surgical goals. Its not
`enough to save patients' lives; we must also take into
`consideration the quality of life given to the patient and
`the socioeconomic impact of our surgical actions. There
`already-have been some trends in this direction, such as
`operating for congenital malformations at an earlier
`stage- and the development of reconstructive operations
`to replace palliative techniques. Reconstructive valve
`surgery can very well be considered another example of
`this nouvelle chirurgie which justifies making it the
`subject of today's lecture.
`Since everything we do in life has some visible or
`obscure relationship to the environment in which it
`
`323
`
`orth
`it 1,
`
`ully
`
`the
`
`OE.
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`3 2 4 Carpentier
`
`N" ol VAlVES
`
`=-
`
`The Journal of ,
`Thoracic and Cardiovascular
`
`Surgery
`
`SIOPROBTH!SII
`
`Table I. lVfitral valve diseases
`
`Liiologr
`
`Rl,cllllldli<..
`1\ . .:gcncr;tti \''-'
`
`Film.1cb~tic Lh.:ficicnc_\
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`Bnctct·ial cndoca1·ditis
`Ischemic
`
`i I
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`60
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`
`Fig. 1. Mitral valve procedures per year used at the H6pital
`Brou::;sais from 1970 through 1980 (see text).
`
`develops, I would first like to say a few words about my
`place of work, its people, and its activities. H6pital
`Broussais is situated on the left bank of the Seine River
`in Paris not far from the Latin Quarter, where are
`concentrated most of the universities and reputed
`schools. It is a medium-sized hospital of 732 beds
`specializing in cardiovascular diseases. Cardiac surgery
`is located in a six story building named Clinique
`Leriche, which was built in 1960 from private funds
`raised at the- instigation of Pfofessor Fran~is de Gall(cid:173)
`dart d'Ailaines, who became the first chief of service and
`was followed by Professor Charles Dubost from 1964 to
`1982. Clinique Leriche comprises 100 beds, five operat(cid:173)
`ing rooms, ~ 16 bed intensive care unit, five full-time
`surgeons, one part -time surgeon, three senior residents,
`five residents, seven foreign residents, 12 anesthesiolo(cid:173)
`gists (who also take care of the intensive care unit),
`seven p~ut-time cardiologists, 162 nurses, one research
`laboratory, six sheep, and 200 rats.
`With these. facilities, the Clinique accommodates
`slightly more than 2,000 cardiovascular operations per
`year with an average of seven to nine operations per day.
`Valve operations represent 46% ofthe_activity, coronary
`ar(ery operations 28%, ·congenital procedures 11%, and
`major vascular. procedures 15%, with hospital mortali(cid:173)
`ties.of, respectively, 4%, 4.2%; 3.9%, and 4.1% in the
`past )rear.
`The surprisingly high proportion of valve disease is
`explained by a selective referrcil of patients from our
`cardiologists as well as by the great number of foreign
`patients,_ in particular those frOm North Mrica, Icily,
`and variOus other Mediterranean countries in which
`rheumatic fever has not been completely eradicated
`(Table I). Degenerative valve disease is being seen with
`increasing frequency in other European countries such
`
`as France and particularly in elderly patients. Bacteriaf
`endocarditis is also seen with increasing frequency.
`The broad geographic origin of our patients
`coming from areas where adequate anticoagulation ·
`not possible), the young age of many of them, and
`specific risks associated with anticoagulation stirnulate
`our interest in nonthrombogenic techniques, which
`turn led us to an eclectic use of the various types
`operations.
`Fig. 1 traces the evolution of our policy during
`past 12 years with regard to the use of mitral
`reconstruction, bioprosthetic valve replacement,
`mechanical valve replacement. As seen in Fig. 1,
`1975 and 1976 the use of these four techniques
`pended upon the preference of the individual
`Utilizing these patients, Perier 1 compared the
`four series of 100 consecutive patients at 7 to 8
`(Fig. 2).
`Our current indications for reconstructive valve
`ations vary according to the valve orifice
`mitral, tricuspid, or aortic.
`
`l\1itral valve disease and reconstruction
`
`The great pathologist Maurice Lev once
`"Mitral valve diseases are like women; the more
`study them the less you understand them!" I
`share his opinion, at least with regard to the
`true that the variety of diseases and the co1mpkxity
`the lesions which affect the mitral valve
`analysis or valve pathology difficult and conseq,ue~t
`also
`the indications for valve
`already complex situation has been further cornplica)
`by an extreme confusion in the terminology
`various aulhors and by our own early cor1tri.bution
`Between 1968 and 1978, I thought it was necesS!rr)''.1
`carefully describe the numerous mitral valve lesions
`·
`were encountered and to develop various
`adapted to these lesions. My co-worker, Dr.
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`'f <if;,,,me 86
`
`'" Journal 01
`"diovascular
`Surgery
`
`Cardiac valve surgery 3 2 5
`
`'i,~' "''"'"!"h
`I!
`
`Repair
`N•1 00
`Bioprosthesis N•100
`
`Starr
`Bjork
`
`N=100
`N•100
`
`I J
`4
`
`REPAIR
`
`BIOPROSTHESIS
`
`80-
`
`1
`
`(j)
`
`YEARS
`
`REPAIR
`
`BIOPROSTHESIS
`
`N = 100
`
`RePair
`Bloprosthesis N ~ 100
`N = 100
`Starr
`N = 100
`Bjork
`
`2
`
`3
`
`4
`
`;
`
`6
`
`;
`
`; YEARS
`
`100%-
`
`90-
`
`80-
`
`70-
`
`Repair
`N• 100
`Bioprosthesis N-100
`N•100
`N-100
`
`' Starr
`
`Bjork
`
`REPAIR
`
`BIOPROSTHESIS
`
`STARR
`
`BJORK
`
`(iJ ,m. '
`Fig. 2. Comparative evaluation of four different procedures for mitral valve surgery consecutively performed at
`the HOpital Broussais between 1974 and 1976. A, Valve-related mortality. B, Freedom from reoperation. C,
`Freedom from thromboembolism.
`
`2
`
`3
`
`4
`
`'
`5
`
`6
`
`'
`7
`
`8 YEARS
`
`TYPE I
`NORNAL LEAFLET MOTION
`
`TYPE I I
`LEAFLET PROLAPSE
`
`TYPE I I l
`RESTRICTED LEAFLET t~OTION
`
`Fig .. 3. Physiopathological classification. Diagrammatic representation. Drawings represent a mitral valve
`apparatus with the mural leaflet (left), the anterior leaflet (right), two papillary muscles, and the chordae. Dotted
`lines represent the course of- the leaflets between opening and closing positions.
`
`describe!! no less than 10 -acquired and 14
`valve lesions. The complexity of both the
`and the techniques Was , :i deterrent to their
`use. l;_his led us to approach the problem
`a different angle by disregarding the lesions and
`!COJotr:1tir1g on the function of the valve apparatus.
`''functional-approach." Surgeons· are not basi(cid:173)
`_CQJ),cemed with lesions. We Care more -"about
`Then6fore one m3.y define the aim of a valve
`om;tn•ction as restoring normal valve function rather
`
`than normal valve anatomy. This· functional approach
`has led to a significant simplification. There are only two
`functiomil anomalies: The opening and closing motions
`of each leaflet are either increased as with leaflet
`prolapse or diminished as with restricted leaflet motion
`(Fig. 3).
`Leaflet prolapse is present when the free edge of the
`leaflet overrides the plane of the orifice during systole.
`This condition must be clearly separated from the
`billowing valve described by Barlow, in which excess
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`3 2 6 Carpentier
`
`The Journal Of
`.
`Thorac1c and Cardiovascular
`
`Surgery
`
`PROLAPSED
`LEAFLET
`
`BILLOWING
`VALVE
`{BARLOW)
`
`BILLOWING VAL'IE
`PROLAPSED LEA 0 LET
`
`Fig. 4. Nosologic definition of prolapsed valve, billowing valve (Barlow), and prolapsed billowing valve (see
`text).
`
`Table II. Types of valve diseases
`
`Type
`
`Type I
`
`Type II
`
`Type III
`
`Description
`
`Normal leaflet motion
`Annular dilatation
`Leaflet perforation
`Leaflet prolapse
`Chordal rupture
`Chordal elongation
`Papillary muscle rupture
`Papillary muscle elongation
`Restricted leaflet motion
`Commissure fusion, leaflet thickening
`Chordal fusion/thickening
`
`leaflet tissue protrudes into the atrium during systole
`with the free edge of the leaflets remaining in apposition
`below the plane of the mitral valve anulus. Note that a
`prolapse may complicate the course of a billowing mitral
`valve (Fig. 4).
`The term "restricted leaflet motion" defines a condi(cid:173)
`tion \in which a leaflet does not open riormally during
`diastole. Leaflet prolapse and restricted leaflet motion
`may be associated. Each may affect one of the two
`leaflets; for example, prolapse ·Jf the anterior leaflet
`combined with restricted motion of the posterior leaf(cid:173)
`let.
`Valve analysis is simplified with the functional
`approach, since it is necessary only to determine whether
`the motion of each leaflet is normal (type I), prolapsed
`(type II). or restricted (type III). This classification is
`helpful in recognizing the lesions that produce this
`dysfunction (Table II). Thus prolapsed leaflet may
`result from chordal rupture or elongation or from
`
`papillary muscle rupture or elongation. Restricted
`let motion may result from commissural fusion,
`thickening. chordal fusion, and/or chordal thic:kertin
`Several lesions are usually associated. When the
`of the two leaflets is normal, mitral valve incompeten
`may be due to leaflet perforation or pure
`dilatation. I will follow this classification in
`the various steps of the operation and
`techniques used.
`Exposure. Adequate exposure is a
`requirement and a sine qua non condition
`operation. The patient is cooled to 22° C. "--·•h,. h,
`fibrillates, the left atrium is opened without
`clamping the aorta. The left atrial incision should
`posteriorly beneath both venae cavae. A
`retractor is used for optimal exposure of the
`Whenever necessary, the papillary muscles are
`by placing a laparotomy pad within the
`and/or by traction on the base of the papillary
`cle.
`Valve analysis. Valve analysis requires the' surgeor
`be technically and psychologically prepared to
`valve reconstruction rather than a valve m>hc<Om
`and therefore to be ready to spend a few
`carefully examine the valvular apparatus. There
`some exceptions to this rule, as I experienced some
`ago. I was invited to the Texas Heart Institute to
`lecture on valve reconstruction. After the lecture,
`ton Cooley invited me to watch him operate
`patient with mitral valve insufficiency. He
`atrium in 2 seconds, took out the valve in
`seconds, and then, with the valve in his hand, said:
`see what we can do to repair this valve, now." For
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`fhe Journal Of fc i;\i~uroe 86
`
`;ardiovascular
`Surgery
`
`Cardiac valve surgery 3 2 7
`
`::: (see
`
`5. Ring selectiOn is based on the'measurement of the
`area of the anterior leaflet (see text).
`
`surgeons such as myself, valve analysis requires
`and should be carried out step by step. First,
`is examined to determine whether a jet lesion
`which would indicate a prolapse of the
`leaflet. The anulus is evaluated for annular
`which is most common. The leaflet tissue is
`mobilized with a nerve hook to assess leaflet
`and to check for leaflet prolapse 9f restricted
`motion. Precise 'measurement of leaflet -prolapse
`be obtained by the "reference point" method ..
`traction with a nerve hook on different points
`free edge of the leaflets makes it possible to find a.
`?nprol••ps<l<i area, usually ori the mural leaflet adjacent
`anterior commissure. With this as a reference
`it is possible to measure the degree of prolapse of
`areas: the anterior half and posterior half of the
`leaflet and the middle scallop and posterior
`of the mural leaflet Precise measurement is
`by using a prolapseffieier, which has recently
`designed for tlris pirrpose.
`Te<ch•tiqtJesof repair.
`"l'"?St<~et.i'c ring annuloplasty. l'rosthetic ring annulo(cid:173)
`is one of the major steps ·of valve reconstruction
`mandatOr-y -in almost all cases of mitral valve
`
`~~~~~~~~~-~Two important characteristics separate
`
`from other types of annuloplasty. First,
`is_ based on pr~e measurement of the
`:veappat·at•us so as to restore,. an optimal orifiCe area.
`the prosthetic ring restores not only the size but
`the shape of the orifice, so that stenosis, leaflet
`·
`and resultant val;e dysfunction ~.7 avoided.
`
`Fig. 6. Annular remodeling using prosthetic rings. The pros(cid:173)
`thetic ring restores not only the size but also the shape of the
`orifice (inset).
`
`Proper ring selection is based on measuring the
`surface area of the anterior leaflet with sized obturators
`after unfurling the leaflet by means of a right-angle
`clamp passed around the major chOrdae of the leaflet
`(Fig. 5). Ring in?plantation is achieved with 2-0 Tevdek
`mattress sutures placed through the anulus I to 2 mm
`outside the junction between the leaflet and the atrium
`and then throUgh the sewing ring. Two pilot mattress
`sutures should be placed on either side of the middle of
`the attachment of the anterior leaflet. Suture placement
`is facilitated by firmly grasping the body of the leaflet
`tissue with tissue forceps. Sutures are passed thrOugh the
`prosthetic ring with care taken to match them adequate(cid:173)
`ly. The same space interval must be maintained between
`sutures of the anterior leaflet and the corresponding
`portion of the prosthetic ring. Spacing is reduced for
`sutures of the posterior leaflet and the commissures
`(Fig. 6). The ring is lowered into position and the valve
`is tested before the sutures are tied. Saline is injected
`into the ventricular cavity through the valve with a bulb
`syringe after the aortic root has been vented to prevent
`air embolism into the coronary arteries (Fig. 7). Repair
`is judged to be satisfactory if the line of leaflet closure is
`parallel to the mural part of the ring; since this indicates
`a good apposition of the leaflets (Fig. 8). An asymmetric
`line of closure means that some leaflet prolapse or
`restricted leaflet motion persists. Remaining anomalies
`can still be corrected at this time by pulling up the
`ring.
`Repair of mural leaflet prolapse. Prolapse of the
`mural leaflet, whether the result of ruptured chordae or
`elongated chordae, is treated by extensive rectangular
`resection of the prolapsed portion, annular plication in
`
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`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`3 2 8 Carpentier
`
`The Journal l
`0
`Thoracic and Cardiov
`ascular
`Surgery
`
`Fig. 7. Testing is achieved by injecting saline into the ventricular cavity.
`
`Fig. 8. Repair is judged to be satisfactory whenever the line of closure is parallel to the mural part of the ring
`(left), which indicates a good apposition of the leaflets (inset). Asymmetric line of closure (right) means a residual
`leaflet prolapse {inset) or a residual restricted leaflet motion.
`
`of
`
`the \;orresponding area, and subsequent suture of the
`free edges of the leaflets (Fig. 9). Stay sutures are placed
`around the normal chordae adjacent to the prolapsed
`portion of the leaflet. The leaflet is incised perpendicu(cid:173)
`larly to the free edge of the anulus so as to remove a
`quadrangular portion of the tissue. Leaflet continuity is
`restored by annular plication and leaflet suture with 5-0
`sutures so that the knots are tied on the ventricular side.
`A prosthetic ring is necessary to remodel the anulus, to
`reinforce the repair, and to avoid further dilatation of
`the anulus.
`Repair of anterior leaflet prolapse. Prolapse of the
`anterior leaflet requires different techniques of repair
`depending on the lesions:
`
`·
`
`CHORDAL RUPTURE OF THE ANTERIOR LEAFLET has
`considered a contraindication to valve repair. The
`gular resection of the leaflet that we used in
`beginning of our experience led to disappointing
`In the past few years, we have experimented with
`techniques which seem to offer a valuable
`LEAFLET FIXATION ON SECONDARY CHORDAE (fig.
`The free edge of the prolapsed leaflet is
`adjacent secondary chordae. This technique reomir•esOJ
`or two thick and strong secondary chordae close to
`prolapsed part of the leaflet. Two or three
`passed through the chordae and then through the
`at a corresponding level.
`TRANSPOSITION OF CHORDAE (fig. 11). Strong
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`
`
`Cardiac valve surgery 3 2 9
`
`The Jouma; of
`id Cardiovascular
`Surgery
`
`
`
`
`
`Fig. 9. Repair of"mural leaflet prolapse by extensive rectangular resection.
`
`
`
`
`igigggl
`
`10. Repair of anterior!
`
`eaflet prolapse due to chordal rupture by leaflet fixation on a secondary chorda (see
`
`
`
`text).
`0 the mural leaflet located opposite the prolapsed part
`the anterior leaflet are detached from the mural
`m
`
`the chordae to be shortened, then through the other half
`of the trench. Pulling the endsof the suture taiit buries
`the extra length of _the chordae within the papillary
`muscle, which is subsequently wrapped around the
`chordae. The length of shortening is twice the distance
`that separates the suture from theltip of the papillary
`muscle.
`'
`Repair of restricted leaflet motion. Leaflet mobiliza-
`tion is achieved by treating the four lesions which are
`responsible for restricted leaflet motion, i.e., cornmissur-
`al. fusion.
`leaflet thickening, chordai
`.
`chordal fusion.
`‘
`
`COMMISSUROTOMY. Except for cases in which the
`
`existenceof a commissural remnant indicates the correct-
`line to follow in performing eommissurotomy, the met
`frequent absence of any landmark makes it
`
`NeoChord v. Univ of‘.
`y
`.E:Xh_-i’b
`
`\FLET has bee
`tall’. The tn
`used in the
`ointing resul
`>nted witht
`e alternativ
`DAE (Fig. 1
`1s sutured
`ze requires 0
`
`__
`
`_
`_
`tenor leaflet with 5-0 mattress sutures.
`. CHORD,-\L ELONGATIONVC-)'l5 "THE ANTERIOR LEAFLET, a
`_
`__]or cause of mitral valve’ incompetence, is found in
`40% of our cases. Chordal elongation can be corrected
`repair of the chordae, which
`he excess length‘ of the chordae
`
`
`
`The papillary muscle is exposed by placing a laparotomy
`
`Dad in the pericardium. A trench is made within the
`
`terior half of the tip of the papillary muscle. A 5-0
`ture is placed through half of the trench,» then around
`
`
`
`
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`3 3 0 Carpentier
`
`The Journal of
`.
`ThoraCIC and Cardiovascular
`
`Surgery
`
`Fig. 11. Repair of anterior leaflet prolapse due to chordal rupture, by transposition of mural leaflet chordae (see
`text).
`
`Fig. 12. Repair of anterior leaflet prolapse due to chordal elongation, by a shortening plasty of the chordae.
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`The Journal Of
`Cardiovascular
`Surgery
`
`Cardiac valve surgery 3 3 I
`
`-
`
`1e (see
`
`Fig. 13. Leaflet remobilization by Commissurotomy (from left to right and clockwise). Whenever lack of
`delineation renders the identification of the commissure difficult, traction on the leaflet opposite the commissure
`creates a furrow indicating the site of the incision (see text).
`
`1!!.··, r.· ...
`)~ ~
`
`Fig. 14. teaflet mobilization by resection of secondary chordae (inset) and fenestration of marginal chordae
`.
`(dotted line).
`
`the site of the commissure. The following
`''""''·· · · \las been useful (Fig. 13): Traction opposite
`~'":;;;:~:~is applied with a nerve hook around the
`ic
`of the anterior leaflet. This creates a
`at the junction oL the aoterior and posterior
`
`leaflets. Commissurotomy is performed along this line of
`plication starting 6 mm away from the anulus and is
`directed toward the center of the orifice.
`RESECTION OF SECONDARY CHORDAE. Chordal thicken(cid:173)
`ing is the major cause of restricted leaflet motion. This
`
`ordae.
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`3 3 2 Carpentier
`
`The Journal 01
`.
`ThoraciC and Cardiovascular
`
`Surgery
`
`Fig. 15. Prosthetic ring tricuspid annuloplasty. Upper left, Anatomic study. Central numbers indicate normal
`dimensions in millimeters; peripheral numbers indicate dimensions of the distended anulus.
`
`fENf5;TRAT10N OF MARGINAL CHORDAE.
`chordae cannot be resected since they prevent
`of the leaflet. Whenever fused, they should be
`trated" by removing a triangular wedge of fibrous
`so as to mobilize the leaflet and release the sub>val'vul'
`stenosis (Fig. 14).
`
`Tricuspid valve incompetence
`The same principles of repair
`tricuspid valve incompetence.
`Valve analysis. Tricuspid valve incompetence
`nized prior to operation either clinically or by
`namic investigation is analyzed by direct vision.
`palpation has proved to be unreliable and has led
`negative conclusions under operative conditions.
`The atrium is opened parallel to the atriiov<mtricula,
`groove. Leaflet tissue is analyzed for organic
`usually leaflet thickening and commissural fusion,
`leaflet prolapse or leaflet tear or perforation.
`The anulus is measured with obturators
`with precision the degree of distension or delformatiorti
`Indications
`for valve
`repair are based on
`following criteria: (1) annular size greater than
`No. 33 obturator in women and the No. 35 obl:u"'tor
`in men; (2) organic lesions with or without
`dilatation.
`
`Fig. 16. Sizing is performed by measuring the anterior leaflet
`area using- obturatorS.
`
`involves the secondary chordae which are attached to
`the ventricular surfaoe of the base of the leaflets (Fig.
`14). They are often responsible for valve thickening.
`Removal of these thick chordae with resection of their
`thick attachment to the leaflet mobilizes the mural
`leaflet. AI; many as 10 chordae can 1)e removed, so that
`a~ few as five marginal chordae ~re left.
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`e Journal of
`rdiovascular
`Surgery
`
`Cardiac valve surgery 3 3 3
`
`rmal
`
`Fig. 17. Suturing of the prosthetic ring using mattress sutures. Interval between sutures is reduced at the
`commissures (arrow).
`
`Te•chrliq1oes of valve repair.
`,,;;;'J?emodelingofanuius. Anatomic studies by Deloche
`associates2 have shown that dilatation Of the anulus
`the various parts ·of the anulus in an irregular
`: in a descending order of magnitude, the
`'&ii~teJrOS<,ptal and anteroposterior commissures, the pos(cid:173)
`and the anterior leaflets, and to a lesser degree the
`i~ntero:;epl:al commissure and the septal leaflet (Fig. 15).
`anulus is not only dilated but also deformed, with
`anteroposterior diameter being greater than the
`7lfan•ve:rse diameter, contrary to normal. Reducing the
`size without restoring the shape of the orifice
`}):Suited in \t 15% stenosis in--order to achieve valve
`
`Fig. 18. Repair of restricted leaflet mOtion of the tricuspid
`valve b:Y triple commissurotomy and annular remodeling
`(upper right) or bicuspidization whenever the posterior leaflet
`is retracted (lower right).
`
`3. The ring is.flexible, so that stress on the multiple
`points of fixation is reduced.
`· Atrioventricular block has always been a concern in
`tricuspid valve operations. When asked how he avoided
`this complication, Varco used to reply: "I send my·wife
`
`·· ,~~~f.:t~~~:; \This has been confirmed by subsequent
`
`"'.,.
`
`from others.3
`and deformation of the tricuspid anulus
`appropriately be corrected by suitably shaped and
`prosthetic rings. This technique has the following
`i;J,~v•mtag<os over. ihe semicircular suture or the annular
`techniqu~s:
`Measured annuloplasty gives optimal orifice area.
`selection is based on measurement of the anterior
`by obturators (Fig. 16).
`The anulus is reduced selectively at the point of
`dilatation, i.e., thy· commissures rather than
`(Fig. 17).
`.
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`3 3 4 Carpentier
`
`The Journal Of
`Thoracic and Cardiovascular
`
`Surgery
`
`free
`meaS1
`Re
`Restr
`mY ~
`tissu(.:
`
`Clinij
`
`B~
`
`Fig. 20. Aortic cusp prolapse treated by triangular
`tion.
`
`valve is more precise than that of the mitral
`tricuspid valves. The cusps have less coaptive
`than the mitral and tricuspid leaflets. These "momach
`are still under investigation and the techniques
`described only for current information.
`Valve analysis. The valve is analyzed in a systenlllti
`manner. Annular dilatation is demonstrated by a
`apposition of otherwise pliable leaflets. Leaflet
`is recognized by evaluating the degree of elongation
`the free edge of one or several cusps below the level
`the anulus. Restricted leaflet motion is assessed
`mobilizing the leaflets.
`Valve repair.
`Repair of annular dilatation (Fig. 19).
`dilatation is repaired by means of a circular suture.
`circular suture is possible because of the circular
`uration of the orifice as opposed to that of the mitral
`tricuspid orifices. The circular suture is a contti"nu<>~
`vertical mattress stitch of 2-0 Tevdek suture
`passed through the anulus successively downward
`the aorta toward the ventricle and upward from
`ventricle toward the anulus.
`Repair of leaflet prolapse (Fig. 20). Leaflet
`is repaired by a triangular resection of the middle
`the distended cusp so as to restore normal length to
`
`Fig. 19. Repair of aortic annular dilatation by cirCular
`suture.
`
`to· church." We have found it even more effective to
`open the ring in the area of the bundle of His.
`Repair of organic le_siQJlS. CommissUral fusion is
`treated by a triple commissurotomy and subsequent
`remoddling of the anulus. It may he necessary to resect
`some secondary chordae to mobilize the leaflet (Fig.
`18).
`Subacute bacterial endocarditis can be treated by
`valve reconstruction provided that (!) an adequate
`antibiotic regimen has been ·undertaken for at least 15
`days prior to operation, (2) the lesions can be resected,
`and (3) sufficient leaflet tjssue remains after resection.
`
`Aortic valve disease and reconstruction
`
`Attempts at aOrtic valve repair have followed the
`same principles. Predictable results haye been difficult
`to achieve because the closing mec~a:ilism of the aortic
`
`/
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`The Journal 01
`Cardiovascular
`Surgery
`
`Cardiac valve surgery 3 3 5
`
`· free edge. The extent of this resection is calculated by
`u~f.. JlleastLr~,g the free edge of the adjacent cusps.
`·'<Repair of restricted
`leaflet motion (Fig, 21).
`-Restricted leaflet motion is corrected by commissuroto(cid:173)
`!llY and cusp shaving so as to thin out the leaflet
`tigsue.
`
`qinical experience
`:J3etween January, 1969, and September, 1982, 3,328
`'"
`repairs were performed. Excluding pure valve
`and valve repairs associated with valve replace(cid:173)
`there were 1,090 single mitral valve repairs, 331
`and tricuspid valve repairs, and 95 aortic valve
`
`........ ·:Mitr:•l valve repair. Of the 1,421 cases of mitral
`inco\npetence, 15% were of type I (nor:nalleaflet
`n.•uuv"'" 55% were of type II (prolapsed leaflet), and
`of type Ill-(restricted leaflet motion). The
`'OIIOraltive mortality was 3.6% in ·the mitral group and
`in the mitral and tricuspid group. In the past year,
`these rates were, respectively, 1.6% and 3.2%. Detailed
`long-term follow-up of over 10 years was reported in
`in THE JOURNAL Of THORACIC AND CARDIOVASCU-
`TAR SuRGERY.4 The reoperation rate was 1.6% per
`Pf1tient-year for recurrent mitral valve incompetence in
`the .group with rheumatic valve disease and 0.7% per
`P,tient-year in the degenerative disease group. The
`thromboembolic rate was 0.6% per patient-year.
`Jricuspid valve repair. Of 1,345. tricuspid valve
`~Pairs performed in ;:tSsociation with mitral yalve repair
`(331) or with mitral or aortic replacement (1,014),
`1;210 were achieved by the prosthetic ring annuloplasty
`· .ajld 135 by the semicircular suture technique (De Vega)
`fo!.-comparative evaluation. The incidence of reoperation
`was 0.6% in the prosthetic ring annuloplasty group and
`6A% in the semicircular annuloplasty group. For further
`evaluation, 30 patients (15 with functional and 15 with
`organic disease) treated by prosthetic ring annuloplasty
`were subjected to follow-up catheterization, angiograms,
`dye-dilution curves, and
`intracardiac phonocardio(cid:173)
`grams. 5 A: good result with no significant valve stenosis
`- -\Vis observed in all patients but one;- who had severe
`organic tricuspid disease.
`Aortic valve repair. From January, 1971, to Decem(cid:173)
`ber, 1982, 95 patients with aortic valve incompetence
`~~!e treated by reconstruction of the aortic valve.
`Fifteen patients had isolated aortic valve disease, and 50
`c--P""'"'lS had associated ntitral valve insufficiency treated
`either mitral valve repair (39 patients) or bioprosthet(cid:173)
`~Iq:yabre replacement (ll patients). Thirty patients had
`triple valve disease treated by triple valve reconstruction
`or·, aortic and tricuspid valve reconstruction associated
`With mitral valve replaceiilent. Hospital mortality was
`
`.-iangular
`
`19).
`;ular
`
`Fig. 21. Restricted cusp motion treated by cusp shaving.
`
`3.3% for the entire group. Reoperation was necessary
`eight times (13%) because of significant residual regur(cid:173)
`gitation. Residual moderate aortic insufficiency per(cid:173)
`sisted in 15% of the patients not requiring reoperation.
`There were no thromboembolic complications.
`From these results, we conclude that it is too early to
`recommend these techniques of aortic valve repair in the
`adult. However, they are a valuable alternative to valve
`replacement in children.
`
`Indications
`Mitral valve operations. Current indications for
`mitral valve reconstruction can be summarized as
`follows:
`All cases of noncalcified valve disease must be
`considered for valve repair.
`Indications are based upon the lesions rather than
`age, cause of the disease, and patient condition. Howev(cid:173)
`er, the you1,1ger the patient the more pressing are the
`indications for valve reconstruction.
`Rheumatic valve disease is a preeminent indication.
`The acute phase of rheumatic fever is not a contraindi(cid:173)
`cation. Repair is feasible in 50% of adults and 90% of
`children in this group.
`
`NeoChord v. Univ of Maryland
`Exhibit 1009
`
`

`
`3 3 6 Carpentier
`
`The Journal 01
`_
`ThoraCic and Cardiovascular
`
`SUigery
`
`try \\~
`treat :
`of ca
`elimi~
`
`Fig. 22. An operating station of the Touston Heart Institute in the year 2050.
`
`Degenerative valve diseases are excellent indications.
`The extreme thinness of the chordae may leave open to
`question the durability of such a ·repair. However,
`experience has shown that the moSt du~able long-term
`results were obtained in this group of patieuts. Rate of
`reoperation was 0.7% per pat