Catheterization and Cardiovascular Diagnosis 7:425-432 (1 981)
`
`Percutaneous Left Ventricular AndocrraDhv
`
`C.M. Hlbng, MB, MRCP, P.H.C. Hlbng, MB, MRCP, and
`G.A.H. Miller DM, FRCP
`
`Recurrence of penlstence of heart fallure In patlents sftw mltral and aortic valve re
`placement Is a difficult dlagnostk problem. Cllnkal evaluatlon and nonlnvaslve tests
`cannot always dlstlngukh poor kft ventricular functlon from paraprosthetic kak or
`persistent pulmonsry vascular disease. Full evaluatlon by cardlac catheterisatlon
`may then be necessary but Is dlffkult because of the lnacceulblllty of the left vent+
`cb. Under these circumstances, kft ventrlculography by direct trmuplcal punctun
`Is an alternative to crosslng the prosthesis by a catheter and may be the only way of
`obtalnlng diagnostk Infafmatlon. uk describe our exprlence of left ventrlculog
`raphy by percutaneous transapical passage of a flexlbk angbgraphlc catheter (as
`distinct from a rl~ld anglographk noodle) In 15 such patlents (on 16 occasions). Non-
`fatal complkatbns ocwmd In three patlents. The Information thus obtainad allowed a
`cllnkal dedalon to be made and dlstlngulshed the Inoperable ttom the operable group.
`Surgery was subsequently performed In seven patlonts wlth benefklal results.
`
`Key words: cardlac catheterisation, prosthetic valves, transurglcal Insettion of catheter
`
`INTRODUCTION
`
`In patients with mitral and aortic mechanical prosthetic valves, neither of the two
`conventional approaches to the left ventricle - retrograde via the aortic valve or
`transeptal and antegrade through the mitral valve - is possible without the risk of
`temporary dislocation or immobilisation of the poppet or disc by the catheter. The r e
`sulting haemodynamic disturbance caused by the catheter traversing the prosthesis
`may make measurements unrepresentative of those under normal conditions. When
`left ventricular pressure measurement is all that is required, transapical thoracic
`puncture with a fine needle (gauge 21) is a well-established technique [l]. On occa-
`sion, however, left ventriculography is required to establish the diagnosis and, in par-
`ticular, to assess left ventricular function and to demonstrate or exclude parapros-
`thetic mitral regurgitation. Transapical left ventriculography using a rigid needle is a
`well-known, if seldom-used, technique. A similar technique with a non-rigid catheter
`was described by Lurie et al in 1%2 for use in children [2]. It is the purpose of this
`
`From Brompton Hospltal, London, and Grantham Hospltal, Hong Kong.
`Address reprint requests to Dr. G.A.H. Miller, Cardiac Department, Brornpton Hospital. London, SW3,
`England.
`Received March 19, 1981; revision accepted June 3, 1981.
`
`0098~589/81/0704-0425$02.50 0 1981 Alan R. Liss, Inc.
`
`Edwards Exhibit 1013, pg. 1
`
`

`
`Wong, Wong, and Miller
`4%
`communication to report our experience of transapical left ventriculography with a
`non-rigid catheter in adults in whom entry to the left ventricle was otherwise impossi-
`ble, usually because of the presence of mitral and aortic prosthetic valves. We have
`used the technique on 16 occasions in 15 patients without fatal complications. Though
`seldom required, the technique appears to be a safe and useful addition to those cur-
`rently available in the catheterisation laboratory.
`
`PATIENTS AND METHODS
`
`Between 1%8 and 1980, 15 patients (13 at the Brompton Hospital and two at the
`Grantham Hospital, Hong Kong), ages 23 to 7l years, underwent percutaneous left
`ventricular angiography with a conventional catheter (”hble I). Ten patients had dou-
`ble prosthetic valve replacement (mitral and aortic) for rheumatic heart disease.
`Three patients had single aortic prosthetic valve replacement, one patient had calcific
`aortic valvular disease and ruptured chordae tendineae of the mitral valve, and one
`patient had congenital aortic stenosis and coarctation, patent ductus arteriosis, and
`aneurysm of the right coronary artery. The last two patients were investigated in
`Hong Kong. All patients, except the last had congestive heart failure. Three were in
`sinus rhythm and 12 in atrial fibrillation. In patients with previous valve replacement,
`clinical examination revealed signs of heart failure, and in the majority of patients a
`systolic murmur was audible. In all patients with previous valve replacement, clinical
`assessment failed to distinguish poor left ventricular function from paraprosthetic
`leak or from progressive pulmonary vascular disease as the cause of heart failure. In
`the patient with aortic and mitral valve disease, clinical examination failed to deter-
`mine the relative severity of each lesion. Chest x-ray f i i s showed cardiomegaly in all
`patients. Echocardiograms were available for nine patients. The findings are detailed
`in Tables I and 11.
`
`CATHETERISATION TECHNIQUES
`
`Patients received either no medication of diazepam 10 mg orally 30 minutes before
`cardiac catheterisation depending on their clinical state. When measurement of the
`pressure gradient across the mitral or aortic valve was required, the pulmonary artery
`“wedge” pressure was obtained with a Goodale-Lubin or Swan-Ganz catheter via the
`right antecubital or brachial vein, and aortic pressure was obtained with a “pigtail”
`catheter via the right brachial or femoral artery.
`
`Technical Details of Left Ventricular Angiography
`
`1) The position of the cardiac apex is located by palpation and a radiopaque instru-
`ment, for example, forcep or scapel, is placed against the apical impulse on the chest
`wall so that the position may be checked by fluoroscopy and modified if necessary.
`2) Following infiltration of the skin with lo/, Lignocaine, the subcutaneous tissue
`and pericardium are anaesthetised until the infiltrating needle is felt to impinge on the
`cardiac apex, a moment frequently signalled by the appearance of one or more ven-
`tricular ectopic beats.
`3) A small (2 mm) skin incision is made and a needle of 18-gauge internal bore, large
`enough to accept a 0.035 cm diameter guidewire, is advanced towards the back of the
`
`Edwards Exhibit 1013, pg. 2
`
`

`
`P Y
`
`r f
`
`Continuous
`
`SM
`
`Asymptomatic
`
`CCF
`
`SM
`SM
`EDM
`SM
`SM
`
`SM
`
`SM
`EDM
`SM
`
`SM
`DM
`SM
`
`SM
`
`None
`
`SM
`
`DM
`
`Cardiac murmurs present
`
`SM
`
`CCF
`CCF
`
`No improvement after repair
`
`CCF
`
`CCF
`
`CCF
`
`CCF
`
`CCF
`
`CCF
`
`CCF
`
`CCF
`
`CCF
`
`CCF
`
`CCF
`
`-
`-
`4yr
`10
`
`12
`1
`
`34
`
`I5
`
`4
`
`ayr
`
`13
`
`26
`
`24
`
`a
`6
`
`9
`
`-
`SE -
`SE
`SE
`BS
`BS
`Bs
`Bs
`Bs
`SE
`Bs
`Bs
`SE
`Beall
`
`Bs
`SE
`SE
`SE
`SE
`SE
`SE
`SE
`SE
`SE
`SE
`
`Presentation
`
`Prosthesis used Months postop
`
`Previous surgery
`
`SM, systolic murmur; DM, diastolic murmur; EDM, early diastolic murmur, CABG. coronary artery bypass graft.
`AVR, aortic valve replacement; MVR, mitral valve replacement; SE, Starr-Edwards; Bs, Bjork Shiley; CCF, congestive cardiac failure;
`I5
`14
`
`-
`-
`AVR
`MVR
`AVR
`AVR
`MVR
`
`Repair of dehiscmt MVR
`
`AVR
`MVR
`CABG
`AVR
`AVR
`MVR
`AVR
`MVR
`
`AVR
`AVR
`MVR
`AVR
`MVR
`AVR
`MVR
`AVR
`MVR
`AVR
`MVR
`
`23M
`62F
`
`54M
`48M
`
`53M
`
`31M
`
`59M
`
`64F
`
`44F
`
`42M
`
`59M
`
`70M
`
`56M
`
`32M
`
`13
`12
`
`11
`
`10
`
`9
`
`a
`7
`
`6
`
`5
`
`4
`
`3
`
`2
`
`39M
`
`1
`number Age, Sex
`case
`TABLE 1. Clinical Detail8 of Patients
`
`Edwards Exhibit 1013, pg. 3
`
`

`
`n
`(D a
`a co 0
`€
`a co 0
`€
`
`Antifailure treatment
`
`MVR
`MVR
`
`Antifailure treatment
`
`MVR.Dicdof
`
`Antifailure treatment
`Antifailure treatment
`Antifailure treatment
`respiratory failure
`
`MVR
`Remarks
`
`Mitral prosthesis dchkcacc
`Worn disc mitral prosthesis
`
`-
`
`Dehiscent mitral prosthesis
`
`Gross MPL
`
`-
`
`-
`-
`-
`
`Transient hypotension
`
`None
`
`Bansient hypotension
`
`None
`
`None
`None
`
`None
`None
`
`Hamothorax requiring drainage
`
`~~
`
`~
`
`Poor LV function
`
`Gross MPL
`
`Gross MPL
`
`3
`2
`1
`number Echocardiogram Catheterfindings
`CaSe
`
`Poor LV function
`
`N.A.
`
`N.A.
`
`Operative fmdings
`
`Complications
`
`TABLE II. Correlation of Echocardlographic, Catheter, and Operative Findings
`
`patent ductus artcriosis; MVR, mitral valve replacement; AVR. aortic valve replacement; APS, aortic prosthetic stenosis; N.A., not available.
`LV, left ventricle; PL, paraprosthetic kak, MPL. mitral paraprosthetic leak; APL, aortic paraprosthetic leak, MR, mitral regurgitation; PDA.
`
`~
`
`~~
`
`~~
`
`~
`
`PDA and coarctation
`Surgical correction of
`
`Antifailure treatment
`
`MVR, AVR
`
`Antifailure treatment
`Antifailure treatment
`
`MVR
`
`PDA. aortic stenosis
`Coarctation of aorta.
`Calcitic aortic valve
`Ruptured chordae
`
`-
`-
`-
`MPL
`
`Mitral prosthesis dehiscence Repair of mitral prosthesis
`
`None
`
`None
`None
`
`None
`None
`None
`
`None
`
`No improvement following repair
`
`Preduaal coarctation
`
`Aortic stenosis
`
`PDA
`
`Poor LV function
`
`Aortic stenosis
`
`Gross MR
`
`Normalcardiac
`Aortic stenosis
`Rheumatic MR.
`Poor LV function
`
`anatomy
`
`Poor LV function
`Poor LV function
`
`Gross MPL
`
`Mild APS
`
`Mild APL, gross MPL
`
`Mild MR
`
`Gross MPL, mild APL
`
`Mild MR, mild APL
`Poor LV function
`Poor LV function
`
`Gross MPL
`
`Poor LV function
`
`Gross MPL
`
`N.A.
`
`N.A.
`
`PL
`PL
`N.A.
`N.A.
`N.A.
`
`Poor LV function Poor LV function
`
`15
`
`14
`13
`
`12
`11
`
`10
`
`9
`8
`7
`6
`5
`4
`
`Edwards Exhibit 1013, pg. 4
`
`

`
`Percutaneous Left Ventricular Angiography
`429
`right shoulder until it enters the left ventricular cavity. The needle is connected to a
`pressure transducer by a length of flexible manometer tubing so that the moment of
`entry into the ventricle will be signalled by the appearance of a ventricular pressure
`trace on the oscilloscopic display. Care is taken to ensure that the pressure trace is un-
`damped, with a clear display of early and end-diastolic pressure. In case of difficulty,
`the position of the needle is checked fluoroscopically. Occasionally, the right ventri-
`cle is entered. This error can be recognised by the lower systolic pressure of the ven-
`tricular trace as compared to that of the ascending aorta. The needle should then be
`withdrawn and reintroduced more posteriorly.
`4) With the needle in the left ventricular cavity, the manometer tubing is disconnect-
`ed, and a guidewire is advanced under fluoroscopy until three to four inches of the
`guidewire is lying within the cavity of the left ventricle.
`5) A Teflon Gensini angiographic catheter, French size 6,7 or 8, is then advanced
`over the guidewire, and its position is checked fluoroscopically. The catheter is then
`used for angiography. Ideally the catheter should be as short as possible to permit a
`rapid delivery of contrast medium. Teflon Gensini angiographic catheters of French
`size 6,7 or 7.5 and only 65 cm long have been made available to us by USCI.
`
`The above described technique is nothing more than a combination of standard
`transapical puncture and standard percutaneous insertion of a catheter over a guide-
`wire. Certain details are worth emphasizing, however.
`
`1) Oral anticoagulant therapy should be adjusted to give a prothrombin ratio with-
`in the therapeutic range to reduce the risk of bleeding complications.
`2) The use of fluoroscopy to check the position of the apex and the position of the
`needle, guidewire, and catheter is a valuable aid. The true apex is frequently one in-
`tercostal space lower than that located by palpation.
`3) The needle should be advanced under pressure monitoring.
`4) All preparations for angiography, pressure recording, etc should be completed
`before the puncture is begun.
`
`MEASUREMENTS
`
`Simultaneous pulmonary artery wedge pressure, aortic pressure, and left ventricu-
`lar pressure were recorded with a fluid-filled system connected to a pressure trans-
`ducer. Cardiac output was determined by the Fick principle. Angiography was per-
`formed after haemodynamic measurements had been made.
`
`RESULTS
`
`The angiographic catheter was introduced in all 15 patients on 16 occasions without
`difficulty, and diagnostic left ventricular angiograms were obtained in all. In two in-
`stances, the exploring needle entered the right ventricle. The needle was then with-
`drawn and reintroduced into the left ventricle without sequelae. The gradient across
`the mitral or aortic valve was measured in all patients when this information was re-
`quired. In the patient with congenital aortic stenosis and preductal coarctation, as-
`cending aortic pressure was not obtainable by retrograde passage of a catheter due to
`aberrant subclavian vessels and failure to cross the coarctation from the femoral a p
`
`Edwards Exhibit 1013, pg. 5
`
`

`
`Wong, Wong, and Miller
`430
`proach. The gradient was obtained by passing the catheter antegradely across the aor-
`tic valve.
`Complications occurred in three patients. In the first patient of our series, percu-
`taneous left ventriculography was performed when his anticoagulation was poorly
`controlled with a prothrombin ratio of 3: 1; he developed an haemothorax, which re-
`quired pleural drainage and blood transfusion. lko patients developed hypotension
`following cardiac catheterisation, but both recovered spontaneously. There were no
`other complications.
`Correlation Between Catheter, Clinical, Echocardiographlc, and Surgical
`Flndings
`The presence of a heart murmur, systolic or diastolic, bore little relationship to the
`presence of a significant paraprosthetic leak ('Igble I). This is hardly surprising, as a
`severe paraprosthetic leak may be silent [3, 71 and the cardiac murmur may result
`from some other valvular lesion - for example, tricuspid regurgitation. There was
`good correlation between catheter and echocardiographic findings ('kble 11). Severe
`impairment of left ventricular function or gross paraprosthetic leak shown on echo-
`cardiogram were confirmed at cardiac catheterisation. When the paraprosthetic leak
`was mild, and when there was coexisting poor left ventricular function, the diagnosis
`was not obvious from the echocardiogram.
`
`DISCUSSION
`Heart failure following mechanical valve replacement may be due to prosthetic ob-
`struction, paraprosthetic leak, other valvular lesion, progressive pulmonary vascular
`disease, or left ventricular dysfunction. All but the last two are amenable to surgical
`correction, and hence accurate diagnosis is important in their management.
`Diagnosis of prosthetic valve dysfunction may not be apparent clinically because
`physical signs may be absent [3, 41 or atypical [5]. Noninvasive investigations that
`may be of value include absence of the opening click of the mitral prosthesis, a reduc-
`tion of A2-OC interval and excessive tilting motion of a prosthetic valve on fluoros-
`copy and echocardiography.
`Absence of the opening click of a mitral valve prosthesis has been considered a val-
`uable sign in diagnosing paraprosthetic leak [a]. It occurs, however, in normally func-
`tioning prosthetic valves, and in one study, the presence of an opening click was
`noted in the majority of patients known to have significant paraprosthetic leak [6].
`Gross reduction of A2-OC interval is present in patients with severe paraprosthetic
`leak [S], but there is a significant overlap between patients with a mild to moderate
`leak and patients with normally functioning mitral prostheses.
`Excessive tilting motion of the prosthetic valve is a sign of paraprosthetic leak, but
`there is such a wide variation between individuals that it is useful only in serial follow-
`up in the same patient.
`Echocardiographic evidence of prosthetic valve malfunction may be derived from
`abnormal valve movement. Reductions in the opening or closing rates of prosthetic
`valves are indications of prosthetic obstruction. Incorrect placement of the trans-
`ducer, however, can mimic the appearance of valve obstruction. Study of the left ven-
`tricular filling pattern is helpful in determining valve function. Gross reduction of the
`left ventricular filing rate is present in significant prosthetic obstruction of the mitral
`
`Edwards Exhibit 1013, pg. 6
`
`

`
`Percutaneous Left Ventricular Anglography
`
`431
`
`valve. Normalisation of reversed septal movement and increased peak rate of left
`ventricular dimensional increase during early diastole are signs of paraprosthetic leak
`[9]. Increased left ventricular dimension, reduced ejection fraction, and akinetic sep-
`tum and posterior left ventricular wall are signs of poor left ventricular function. The
`use of two-dimensional echowdiography permits diagnosis of generalised poor left
`ventricular function in the majority of patients. These echocardiographic features,
`together with clinical assessment, frequently give useful information and may allow
`one to recommend surgery without catheterisation. However, in case of uncertainty,
`cardiac catheterisation remains the only definitive investigation.
`Although a xenograft or homograft would readily accept a catheter passed across
`the valve, passage of an angiographic catheter across a mechanical prosthesis may
`cause important malfunction of the valve. Percutaneous left ventriculography is an
`alternative approach in patients with mitral and aortic valve replacement with
`mechanical prostheses or in patients with aortic mechanical prostheses where mitral
`regurgitation is a likely diagnosis.
`Potential hazards of percutaneous left ventriculography are similar to those of
`direct left ventricular puncture. They include haemopericardium, pneumothorax,
`haemothorax, laceration of acoronary artery, embolisation, and cardiac arrhythmias.
`Thirteen of our patients had previous valve replacement, which rendered their pericar-
`dium adherent to the epicardium and theoretically minimised the risk of cardiac tam-
`ponade. Of these l3 patients, only one had a significant bleeding problem (haemo-
`thorax), which required blood transfusion and surgical drainage. Two developed
`transient hypotension lasting 15 to 30 minutes following cardiac catheterisation and
`recovered spontaneously. The patient who developed haemothorax was the first in
`our series, and his anticoagulation was poorly controlled. We do not now perform the
`procedure until the prothrombin ratio is 2: 1 or less.
`Laceration of a coronary artery was not encountered in our series. This is not sur-
`prising as the catheter passes through the apex of the left ventricle and avoids the
`routes of major coronary arteries. Ventricular ectopic beats are frequently encoun-
`tered during introduction of the catheter, but once the catheter is in situ, the domi-
`nant rhythm resumes, and the left ventriculogram is usually free of ectopic beats.
`Baxter et al [ 111 reported 17 patients in whom a left ventriculogram was performed
`via a 19-gauge angiographic needle introduced via the transapical route. The compli-
`cation rate was 18%. Greves et a1 [U] reported transthoracic left ventricular puncture
`and angiography using an 18-gauge occluded-tip needle in 23 patients, 19 of whom
`had double valve replacement, and reported a complication rate of 21 070, with haemo-
`thorax in three and transient neurological events in two patients. Although the num-
`bers in our series are small our complication rate was certainly no higher, suggesting
`that the additional introduction of a catheter did not significantly increase the risk of
`the procedure. A flexible catheter in the left ventricular cavity has certain advantages
`over a rigid angiographic needle. A relatively larger internal diameter permits more
`rapid injection of contrast medium and better visualisation of the ventricular cavity
`and paraprosthetic regurgitation. A catheter is more manoeuverable, and gradient
`across the aortic valve can be obtained when retrograde access to the ascending aorta
`is not possible due to tortuous or aberrant vessels.
`In the first few patients of our series, a number 6 Gensini catheter, 120 cm long,
`was used. The angiograms obtained, though diagnostic, were not as good in quality
`as the conventional left ventriculogram obtained with, for example, a number 8 pig-
`
`Edwards Exhibit 1013, pg. 7
`
`

`
`Wong, Wong, and Miller
`432
`tail catheter. Subsequently, we have used number 8 Gensini catheters with no bleed-
`ing complications. A shorter catheter (65 cm) with a narrower internal bore should
`provide an equally good result.
`A definite diagnosis was obtained in all our patients. Surgery was performed in
`seven patients with symptomatic relief in six. One patient died postoperatively from
`respiratory failure. Five patients were found to have poor left ventricular function,
`and therefore surgery was not recommended.
`Percutaneous left ventriculography with a flexible angiographic catheter is a proce-
`dure that can provide information not otherwise obtainable. The technique is a prac-
`ticable alternative to the more usual approach of crossing a prosthetic valve with a cath-
`eter and should be considered when the latter approach is considered undesirable.
`
`1.
`
`2.
`
`3.
`
`7.
`
`8.
`
`4.
`5.
`6.
`
`REFERENCES
`Brock R, Milstein B, Ross DN: Percutaneousleft ventricular puncture in theassessment of aortic sten-
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`Lurie PR, Armer RM, Klatte EC: An apical technique for catheterisation of the left side of the heart
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`Morrow AG, Harrison DC, Ross J, Braunwald NS, Clark WD. The surgical management of mitral
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`Sanders C A Editorial: Prosthetic problems. N Engl J Med 281501-502, 1969.
`Sawker L: Unusual location of the mitral prosthesis murmur. N Engl J Med 281:1075, 1969.
`Aravanis C, Toutouzas P, Stavon S: Disappearances of opening sound of Starr-Edward mitral valve
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`St. John Sutton MG. Traill TA. Ghafour AS, Brown DJ. Gibson DG: Echocardiographic assessment
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`Am J Cardiol41:42-47. 1978.
`Greves J, DeMots H, Murphy E, McAnulty J, Rahimtoola SH, Kloster F: Transthoracic left ventric-
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`9.
`
`10.
`
`11.
`
`12.
`
`Edwards Exhibit 1013, pg. 8