04/17/2023
Percutaneous Treatment Strategies of Valvular Heart Disease
Dr.Nagula PraveenFinal Yr DM PG
2
Introduction Concept of treating diseased heart valves began after the coronary
angioplasty.
Initially the stenotic valves (pulmonic, aortic, mitral) by balloon
valvuloplasty.
No much change with regards to basic techniques and equipment
required over the last two decades --- balloon valvuloplasty.
The revolution(Paradigm shift) was with regards to percutaneous
repairs of mitral regurgitation (MR), aortic valve replacement, left
atrial appendage(LAA) closure for which previously only surgery was
the choice.04/17/2023
304/17/2023
1.PBMV 2.Mitral valve repair – Mitraclip, annuloplasty ring 3.Transcatheter Mitral Valve Implantation (TMVI) 4.Para Valvular Mitral Leak (PVML) 5.Balloon aortic valvuloplasty 6.Transcatheter Aortic Valve Implantation(TAVI) 7.PBPV 8.Transcatheter Pulmonary Valve Implantation 9.Tricuspid valve repair 10.Tricuspid valve replacement 11.Left atrial appendage closure
4
Mitral valve apparatus
Anatomic or functional abnormalities of any structure in mitral valve apparatus lead to MR.
04/17/2023
504/17/2023
604/17/2023
704/17/2023
15-65 mm coronary sinus length
804/17/2023
904/17/2023
Approach to a patient with Mitral Regurgitation with regards to management.
Symptoms – onset ,progression Etiology Risk factors/comorbidities – age ,hypertension,diabetes,CKD. Surgical Risk score – ATS,EuroSCORE ECG Chest X ray Echo evaluation - LA size, Mitral valve apparatus,quantifying
MR,commissural level,LV EDD,LVESD,LVEF. Favorable valve anatomy for repair. Stabilization of patients symptoms.
1004/17/2023
1104/17/2023
1204/17/2023
Carpentier’s classification
J Thorac Cardiovasc Surg. 1983 Sep;86(3):323-37. Cardiac valve surgery--the "French correction".Carpentier A.
1304/17/2023
1404/17/2023
Risk of unsuccessful repair (Primary MR)
Presence of a large central regurgitant jet. Severe annular dilatation (D>50mm) Involvement of greater than or equal to three scallops especially
AML Extensive calcifications Lack of valve tissue in rheumatic disease IE with large perforation
David TE,J Thorac Cardiovasc Surg 2005:130(5):1245-9.
1504/17/2023
Preoperative echocardiographic predictors of recurrent MR
Coaptation distance >10 mm Systolic tenting area > 2.5 cm2 Posterior leaflet angle > 45 Distal anterior mitral leaflet angle >25 End systolic interpapillary muscle distance >20 mm Posterior papillary – fibrosa distance >40 mm Systolic sphericity index >0.7 Severe LV enlargement (LVEDD >65 mm,LVESD >51mm).
Am J Cardiol.2010:106(3):395-401.
1604/17/2023
Guidelines for management of Mitral Regurgitation
ACC/AHA 2014 guidelines for management of valvular heart disease.
1704/17/2023
1804/17/2023
1904/17/2023
2004/17/2023
2104/17/2023
2204/17/2023
Ideal patient for Mitral valve repair
Impossible to precisely define the subgroups of patients who will benefit from repair.(<2000 pts).
Personalized medicine Pathology of MR to be known Symptomatic severe MR and Not candidates for surgical correction Preference of a less invasive approach without need of a CP
bypass. Comorbidities confering a high surgical risk. Life expectancy more than 1 yr. Surgical risk – assess
estimated mortality.MorbidityRisk of compromising quality of lie.
2304/17/2023
Basis for percutaneous mitral valve repair
Best studied approach is the edge to edge repair Based on the surgical repair championed by Dr.Alfieri. Coronary sinus proximity to the mitral annulus – conformational
change – decreases MR. LV reshaping – subvalvular pathology tackled – better than all in
causing reduction in septal –lateral diameter. Direct annuloplasty – annulus repair directly
2404/17/2023
Goal
To restore normal leaflet function but not necessarily normal valve anatomy.
2504/17/2023
Modalities of mitral valve repair (MVRe)
Isolated leaflet repair
Edge to edge leaflet repair – Mitraclip
Indirect annuloplasty via coronary sinus
Cardiac chamber remodelling
Transventricular (retrograde) direct annuloplasty.
Others
2604/17/2023
Alfieri Edge to Edge stitch repair
1998,Milan,Italy. Initially developed for anterior leaflet prolapse. Posterior and bileaflet prolapse. Free edge of anterior and posterior leaflets are sewn together in an
attempt to increase leaflet contact and coaptation and reduce regurgitation.
Prevents systolic anterior motion of AML following traditional MVRe techniques.
Double orifice mitral valve does not cause stenosis,even when combined with an annuloplasty ring.
Maisano F,Eur J Cardiothorac Surg 13:240-245.1998.
2704/17/2023
Results
January 1991 to Septmeber 1997. 432 patients 121 patients –edge to edge correction Anterior prolapse in 61% patients Double orifice repair(60%) others paracommissural repair. Low in hospital mortality(1.6%) Survival (92%) at 6 years. Freedom from reoperation 95%. >80% in NYHA I/II
Maisano F,Eur J Cardiothorac Surg 13:240-245.1998.
28
Mitral Clip Best studied of the options for percutaneous MVRe. 24F steerable delivery guide catheter Trans septal approach to place a v shaped clip (Mitraclip) on the
mitral leaflets – double orifice repair. Under TEE guidance. Device – guiding catheter – LA – arms of clip opened, clip aligned to
long axis of the heart. Arms of clip – perpendicular to the line of coaptation of the valve
leaflets. Clip advance to LV – retracted during systole to grasp the middle
scallops of the anterior and posterior valve lealfets in the gripper arms.
After confirmation – clip is locked into position. Process can be repeated until satisfactory. Fibrosis and scarring in the bridging segment.
2904/17/2023
Mitraclip apparatus
3004/17/2023
3104/17/2023
3204/17/2023
3304/17/2023
Methods: Anatomic Eligibility TEE evidence of FMR:
Absence of Degenerative valve disease Presence of leaflet “tethering”
Not exceeding 10mm
Sufficient leaflet tissue available for mechanical coaptation > 2mm “vertical” leaflet tissue available Protocol anatomic exclusions
Coaptation depth >11mm Coaptation length < 2mm
Absence of severe LV dysfunction Excluding LVID-s > 55mm or EF <25% Ischemic or non-ischemic etiology
<2mm
>11mm
Exclusions
3404/17/2023
EVEREST I trialEndovascular Valve Edge to Edge REpair STudy I Year 2005
Type of study Phase I ,Prospective,multicenter safety and feasibility trial
No .of patients 27
Inclusion criteria Moderate to severe MR,primary MR(93%),Ischemic MR(7%)
Exclusion criteria Rheumatic disease, severeMAC, severeLV systolic dysfunction, severe LV cavity dilation.
Primary end point Acute safety at 30 days(freedom from death,cardiac tamponade,stroke,clip detachment,septicemia,cardiac surgery for failed clip).
MACE events 15% (3 clip detachments) ,1 stroke (<34.4% required on basis of comparison with surgical data).
Successful depolyment 24 patients (89%)
Partial clip detachment 3 patients
30 day follow up 6 patients had ≥3+ MR
At 6 months follow up 13 patients (48%) MR ≤ 2+
2 years Mild MR,positive LV remodelling noticed.
JACC 46:2134-2140,2005.
3504/17/2023
EVEREST cohort follow up
Patients 79% primary MR,21% functional MR
Acute procedural success (APS) 79 patients(74%)
Priamry end point(MR < 2+,freedom from surgery,death)
66% patients
At discharge MR 77% < 2+MR
At 6 months follow up 50 of 76 patients (66%) < 2 + MR
Mitral valve surgery 32 patients (23 had clip placement)
For clip detachment 10 patients
For >2+MR 9 patients
MV replcement 4 patients
Surgical repair is feasible for upto 18 months
JACC 54(8):686-694,2009.
3604/17/2023
EVEREST trial IIRandomized Controlled trial,prospective,multicentered 2:1 randomization
Mitraclip with standard cardiac surgery
No. 279 patients(184 Mitraclip,85 surgery)
Severe MR (73% degenerative,27% functional)
Priamry end point MACE – death,stroke,MI,reoperation,transfusion
Secondary end point Noinferiority compared to surgery
Study group 178 underwent treatment
APS 137 (77%)
At 30 days 1 end point – 9.6%(study group),(57% controls)(more transfusions)
At 12 months Echo – positive LV remodelling ( LVEDD),81% <2+MR,
Symptoms – NYHA I or II – 97.6% vs 87.9%
Cross over 21%
No events in 136 patients who underwent Mitraclip placement
Importance in functional MR also
Mitraclip is noninferior to surgery 72.4% vs 87.8%
Feldman et al, ACC/AHA 2010
3704/17/2023
EVEREST high risk group cohort
Registry 78 patients vs 36 controls
Patients Symptomatic moderate to severe MR
Surgical risk >12%
Mean age >77 yrs
Previous cardiac surgery >50% in both groups
Successful treatment 96%
Improvement in MR 78% had atleast 1 grade improvement
One month mortality 7.7%(8.3% control group)
One year survival 76.4% vs 55.3% p=0.037
At one yr 74% < 2+MR
Annual rate of hospitalization for CHF Decreased by 45%
3804/17/2023
REALISM trialReal World Expanded Multicenter Study of the Mitraclip System Continued access registry High risk patients and no high risk patients
ClinicalTrials.gov Identifier:NCT01931956First received: August 27, 2013Last updated: March 5, 2014Last verified: March 2014
Ted Feldmann
3904/17/2023
June 2012. Safety and efficacy in HF patients with functional MR,at high surgical
risk. As of December 22, 2014, the total enrollment is 159 randomized of
an expected 420 (+42 roll-ins); there are 71 of 83 activated sites, with a projected date of completion in quarter one or two of 2017 (personal correspondence with Abbott Vascular, February 2015).
Primary end point Single leaflet device attachment
Device embolization
Endocarditis requiring surgery
MS requiring surgery
LVAD implantation,Heart TRx
Hospital readmission
Secondary end points Composite of all cause death,stroke,MI,MR severity,6 min walk test
4004/17/2023
RESHAPE HF
Abbott Vascular Safety and efficacy of MitraClip in patients with HF and severe
cardiomyopathy. Not yet started enrolling patients, and the projected completion date
will be determined after the first patient is enrolled.
4104/17/2023
Current status of Mitraclip
FDA approved 2013
4204/17/2023
Indirect annuloplasty via coronary sinus.
Annuloplasty,integral part of MVRe in the majority of the surgical approachs – improves mitral valve leaflet coaptation,reduces MR.
Reduction in mitral annulus diameter of ≥25%. Coronary Sinus (CS) covers about 50% mitral annulus perimeter
80% posterior inter trigonal distance. Anatomic proximity of the CS to the mitral annulus for modulating
annular size and shape. (VARIABLE) LCx crosses between the myocardium and the CS in nearly 50% -
arterial compromise. Cardiac CT, angiography,echocardiography – important for
relationship. Success depends on long term safety of instrumenting the CS.
Percutaneous Transvenous Mitral Annuloplasty system (PTMA)
Viacor,Wilmington,MA
Decrease the septal –lateral mitral annular diameter.
Composite nitinol and stainless steel construct coated with teflon and
plastic – lengths ranging from 35 mm to 85 mm.
Rigid distal element
Flexible push rod to facilitate delivery.
Straight shape of the distal portion of the device causes a
conformational change in mitral annulus.
ProcedureAccess Right internal jugular vein
Balloon tipped catheter is advanced to the ostium of the coronary sinus.
Inflation of the balloon
Coronary venogram obtained Anterior interventricular branch of the great cardiac vein
Engaging of great cardiac vein by hydrophilic wire
9F delivery catheter advanced upto the ostium of the anterior interventricular branch
Annuloplasty device is introduced into the lumen of the delivery catheter and advance to the distal portion of the guiding catheter at the ostium of the vein (anterior IVbranch)
Optimal size based on the length of the distal straight segment
Combination of rods can be used
Advantage – can be revised – number and stiffness of rods
4604/17/2023
4704/17/2023
Trial evidence Human feasibility studies Results of first 27 patients,Moderate or severe functional MR General anaesthesia. A diagnostic PTMA device placed for determining efficacy and safety. If benefit to treatment noticed – changes to permanent implant device. Diagnostic procedure was done in 19 patients Successful in decreasing the MR by atleast one grade in 13 patients (48%). Successful change to permanent implant device in 9 patients (33%). Device fracture – one patient Crossover to surgical annuloplasty – 3 patients Follow up – reduction in septal lateral dimension – modest Procedural MACE – 1pericardial effusion,1 device fracture,1 circumflex
impingement Long term efficacy need to be determined.
4904/17/2023
PTOLEMY trial
Percutaneous TransvenOus Mitral AnnuloplastY The PTOLEMY I trial evaluated the feasibility and safety of the
PTMA device in 27 symptomatic patients with moderate-severe functional mitral regurgitation. The device was successfully implanted in only 9 patients. In these patients, there was a reduction in the degree of mitral regurgitation and a reduction in the mitral annulus septal–lateral dimension (Sack et al., 2009).
PTOLEMY II trial since 2014
CARILLON Mitral Contour SystemCardiac Dimensions
Fixed length double anchor device Positioned in coronary sinus. Tension applied to anchors of the device results in tissue plication and
reduces the mitral annular diameter and MR. 9F catheter,Internal Jugular vein Nitinol annuloplasty device Distal anchor of the device is deployed b passive expansion,locked into
the fully expanded position by use of delivery catheter. Tension is placed on the delivery system bringing the proximal anchor
toward the coronary sinus ostium. Optimal reduction in annular dimension(≈25%),reduced MR on real
time echocardiography. Adjustment can be done again if needed.
5104/17/2023
AMADEUS trialDevice CARILLON XE device
No. 48 patients
Etiology Functional MR,LV systolic dysfunction
Successful implantation 30 patients
6 month follow up
Decrease in mitral annular diameter 4.2 to 3.78 cm,10%
MR reduction 23%
NYHA class 2.9 to 1.8
Quality of life score improved
6 minute walk test 307- 403 meters
18 patients
5 Coronary sinus related complications(n=3)Fluoroscopic equipment failure(n=2)
13 Retrieval of device after implantation (inadequate reduction in MR or coronary compromise.
complications 6 patients within 30 days of procedure
One multiorgan failure,3 MI,3 coronary dissection /perforation
Siminiak T.; Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial). Am J Cardiol. 104 2009:565-570
Present status
CE approval in Europe.
TITAN trial
No. 53 patients
country 8 centers in Europe
6 months interim report 68% successful implantation
15% transient coronary impingement
MACE rate 1.9%
6 month follow up Reduction in MR was 35%.
1 grade reduction in NYHA class
100 meter improvement in 6 min walk distance
Eur J Heart Fail, 14 (2012), pp. 931–938
MONARC (originally VIKING system)Edwards LifesciencesInc., Irvine,CA.
VIKING - Distal self expanding anchor,a spring like bridge segment and a proximal self expanding anchor.
Bridge segment – shape memory properties. Shortening of the device at the room temperature. MONARC – delayed release system of nitinol and biodegradable
spacers –slowly dissolve over 3-6 weeks. Shortening intended to induce a conformational change in the
coronary sinus,extending to the mitral annulus,further reducing any postprocedural MR.
5504/17/2023
5604/17/2023
Procedure Access Internal Jugular vein
Cannulation of the coronary sinus with hydrophilic wire and advanced into the distal great cardiac vein.
Measurement catheter for the proper device size.
9F delivery catheter
Left coronary injections – verify proper device positioning,distal anchor is released by retracting the outer restraining sheath.
Distal anchor of the device is intended to be on the inner curve of the coronary sinus
Slack is removed from the bridging element by placing tension on the delivery catheter
Proximal anchor is released just within the edge of the coronary sinus by further retraction of the outer restraining sheath of the delivery catheter.
Device cannot be recaptured after the anchor has been deployed.
EVOLUTION trial
Multicenter feasibility and safety study
Europe and Canada
Interim 2 year follow up of 72 patients
Inclusion criteria 2+ to 4+ functional MR
Exclusion criteria Severe LVSD(<25%),organic mitral valve disease,severe MAC,coronary sinus pacing leads.
Device implantation 59 patients (82%)
Venous tortuoisity or unfavorable size 13 patients
Safety from secondary end point 83% (6 months),81% @ 1 yr,72%@ 2 yrs.
NYHA class improvement 2.7 to 2.0(p=0.002)
At 2 yrs MR improvement was significant
Device is moderately effective
Cardiac chamber remodelling devices
Functional MR caused by dilated cardiomyopathy and ischemic MR caused by geometric alterations affect not only the mitral annulus but also the LA and the LV and their relationships to the annulus.
These alterations in paravalvular geometry are not addressed by typical ring annuloplasty.
Two rings have been engineered with this consideration in mind. 1.Coapsys iCoapsys 2.Percutaneous Septal Sinus Shortening system(PS3)
5904/17/2023
COAPSYS and iCOAPSYS PS3 System
Myocor ,Maple Grove,MN Ample Medical Inc,Foster city,CA.
Surgical placement of pericardial implants pumps off pump.
Trans atrial bridge
Epicardial surface of the heart Uses the coronary sinus and a septal closure device to place a cord across the atrium,create tension on the annulus, remodel the mitral annulus and LA.
Tethering subvalvular cord that crosses the ventricle internally.
Septal lateral annular cinching – traction between the interatrial septum and the coronary sinus at the level of the P2 mitral segment.
Cord is cinched to decrease the mitral annulus diameter and eliminate MR.
Adv – 1.ability to treat functional MR off pump2.Allow the combination of off pump bypass and MVRe.
3.Preserves normal valve dynamics
4.Addresses mitral annulus as well as the subvalvular space and abnormal left ventricular geometry.
6004/17/2023
6104/17/2023
6204/17/2023
Trial evidenceCOAPSYS
1. Clinical feasibility trial – successful implantation in 34 patients with functional MR at the time of bypass surgery.
One year follow up – 11 patients - decrease in MR (2.9 to 1.1),jet area 7.4cm2 -3.0 cm2 and NYHA class improvement(2.5-1.2) at 12 months.
2.RESTORE MV – randomized trial
CAD and ischemic MR
CABG+MVRe vs CABG+COAPSYS
19 patients received the implant
Reduction in MR is significant (P=0.0001)
165 patients have been randomized 77 pts with MVRe and 87 with COAPSYS
Funding issues – terminated prematurely
Results have not yet been published
iCOAPSYS pericardial access sheath.
VIVID trial – prematurely discontinued because of funding issues.
6304/17/2023
Trial Evidence
PERCUTANEOUS SEPTAL SINUS SHORTENING SYSTEM(PS3)
Palacios and colleagues
2 patients with functional MR
Mitral annular reduction was significant
No further testing because of financial constraints
Reduction of mitral annular diameter comparable withthat of surgical annuloplasty and greater than that of other percutaneous approaches
6404/17/2023
Trans ventricular (Retrograde)Direct Annuloplasty
Exciting area of development. Ability to apply repair directly to the annulus,where the pathological
mechanism of MR is frequently located. Eliminated the anatomic uncertainity about the LCx artery,and the
proximity of the coronary sinus to the mitral annulus Addresses the pathological mechanisms of functional MR. 1.Mitralign Direct Annuloplasty System 2.GDS AccuCinch Annuloplasty System
6504/17/2023
Mitralign Direct Annuloplasty System Based on the concept of direct suture annuloplasty. Three metal anchors connected by standard suture materials. Anchors are placed in the mitral annulus and suture cinched to
perform the annuloplasty. Retrograde ventricular access Unique translation catheter with a two pronged “bi dent” design
for device delivery. Magnetic guiding catheter placed in the coronary sinus Anchors placed from the ventricular side by imaging techniques. Positioned below the valve at the level of each posterior leaflet
scallop – deployed – connected by suture material. Plicating the annulus by cinching the suture. In clinical testing
6604/17/2023
6704/17/2023
GDS Accucinch Annuloplasty System
Same as the previous First in human study was initiated in the Europe Implantation was successful in several patients.
6804/17/2023
6904/17/2023
Other Annuloplasty devices
Application of subablative RF energy to remodel the mitral annulus
QUANTUMCOR Transventricular annulus remodelling – scarring and shrinkage of
the mitral annulus after application of RF energy directly to the annulus.
Surgical and transcatheter use. Malleable tip ,seven electrodes to deliver RF energy. Pulse generator – modulated by temperature sensors in the
electrodes –regulate the amount,duration of energy delivery. Specific locations can be applied. No human data available.
7004/17/2023
Dynaplasty ring
Micardia Adjustable annuloplasty ring Early phases of development Not yet been used in humans. Implanted surgically during conventional repair procedures. Ring responds to the electrical stimulation by RF wires placed
directly against the ring in the activation zones. Ring changes configuration – favorable shape. Reshaped intraoperatively or subsequently via transseptal approach if
MR recurs.
7104/17/2023
28 mm through 36 mm
7204/17/2023
7304/17/2023
7404/17/2023
7504/17/2023
7604/17/2023
7704/17/2023
7804/17/2023
7904/17/2023
8004/17/2023
8104/17/2023
8204/17/2023
8304/17/2023
Transcatheter Mitral Valve Implantation
Has not yet been applied clinically. Radial force cannot be applied in the mitral position. CardiAQ valve Technologies and EndoValve
8404/17/2023
8504/17/2023
CardiAQ valve
Self expanding nitinol frame 3 leaflets of bovine pericardial tissue. Does not use radial force for fixation to the annulus. Two sets of anchors grasping the mitral leaflets from LA and LV side
- used for fixation. Foreshortening of the frame creates a clamping action that anchors
the valve above and below the annulus. Chordae and papillary muscles to be preserved. Can be repositioned. Percutaneously through the femoral vein Transeptal access to LA (antegrade),transapical approach
(retrograde)
8604/17/2023
8704/17/2023
Tiara ValveNeovasc Inc,British Columbia,Canada
Self expanding bioprosthesis
Cross linked bovine pericardial tissue leaflets mounted inside a metal alloy frame.
Atrial portion – specifically fits the saddle shaped annulus
D shape – natural shape of the mitral orifice and prevent impingement of the LVOT.
Ventricular shape – covered skirt to prevent PVL
3 anchoring structures – 2 anterior – fibrous trigones at both sides of AML
1 posterior – behind PML
Retrograde dislodgement during systole is prevented by this mechanism
Can be retreivable and repositionable before deployment
Transapically
32F delivery catheterNo need of rapid pacing
8804/17/2023
8904/17/2023
9004/17/2023
9104/17/2023
Trial evidencePreclinical Development
Safety and feasiblity of the Tiara valve has been successful.
Acute and chronic animal models and human cadavaers.
Acute cases 29/36 successfully implanted
None of the valve migrated or embolized after implantation
No LVOT obstruction
No coronary artery obstruction
No transvalvular gradient
High rate of PVL in chronic models – one size only available.
White fibrotic connective tissue along the atrial and ventricular struts.
Intact leaflets at follow up without tears or perforations
HUMAN CADAVERIC MODEL – appropriate geometric positioning with full circumferential coverage of the atrial aspect of the mitral annulus and good apposition and location of the ventricular anchoring system
9204/17/2023
Tendyne valve Medtronic TMV FORTIS Valve Cardiovalve
Device Trileaflet pericardial valve
Trileaflet pericardial valve
Bovine pericardial tissue
frame Nitinol self expanding stent
Large atrial inflowShort outflow ventricular portion
Cloth covered self expanding frame
Descendant of the Lutter valve
retreivable Fully retreivable Fully retreivable
delivery transapically TransatriallyTransseptal
Transapically Transfemoral route
Secured via a tether(neochordae) near the LV apex - sits on epicardium
2 step processA.Polyester skirtB.Implantation of valve
Animal studies successful successful
First in Human French HospitalParaguay
--- St.Thomas Hospital,London
Year 2013 March 6,2014
Approval Status
TENDYNE VALVE
MEDTRONIC TMV
FORTIS VALVE
CARDIOVALVE
9304/17/2023
9404/17/2023
High life Medical TMV
Endovalve Gorman TMV Mitrassist
access Transfemoral Transatrial access
Foldable nitinol structure
Nitinol framework
Neither repair nor replacement
Locking component in LV through femoral approach
Transapical approach
Single nitinol wire –woven to complex 3D
Valve implant placed on top of the native MV
Stent valve deployed via transatrial access
Valve sparing deviceSpecially designed grippers
Arms insinuate themselves around leaflets – exposure to LVSP
Nitinol frame with pericardium.Asymmetrical bileaflet design
Groove in stent valve shape should engage with locking component
No risk of LVOT obstruction
Left thoracotomyAtriotomy30F delivery system
Conform to the native MV anatomic shape,Preserve function
Anchoring and sealing in the annular region
Permaseal technologySutureless wound closure
18 F catheter
Preclinical Animal studies successful
successful successful
9504/17/2023
Percutaneous Repair of Paravalvular leaks
All are being used off label Device Shape of device Device deployment
Amplatzer device (AGA Medical,MN,USA)
Septal occluder Round Antegrade or retrograde
Muscular VSD occluder Round Anterograde or retrograde
Duct occluder Round Only antegrade
Vascular plugs Round Either antegrade or retrograde
Amplatzer vascular plug III (AVP III) occluder
oval Either antegrade or retrograde
Vascular coils Round Either antegrade or retrograde
9604/17/2023
9704/17/2023
TEE is mandatory – identify,characterize,number,shape of PVLs. Paravalvular MR may be missed on TTE because of artifacts and
reverberations caused by MV prosthesis. Leaks have irregular shape. Color doppler flow jet outside of the sweing ring of the
implanted valve. Severity –MR jet width at its origin is measured. Vitarelli and colleague
3D TEE useful in management. Rocking valve,PVML >30% of valve circumference,active
endocarditis,intracardiac thrombus - C/I
Mild 1-2 mm
3-6 mm moderate
>6 mm severe PVL
9804/17/2023
Antegrade approach Retrograde approach Transapical access
Femoral veinIJV
Severe PVML PVML along IAS
IJV- leak close to IAS Femoral artery Ruiz and colleagues
PVML End hole diagnostic JR or JL Guide wire and support catheter
Hydrophilic 0.035 in wire JR or MP
Stiffer exchange wire replaces above once crossed
Hydrophilic wire
Delivery sheath into LV LA disc is deployed first
Proximal device is opened in the LV
LV disc is deployed later
Device pulled back to the ventricular side
Risk of injury to chordae,papillary muscles
LA disc deployed
9904/17/2023
10004/17/2023
Complications of PVML closure
complication Etiology Treatment/prevention
Pericardial effusion /tamponade
TS puncture,guidewire or catheter perforation of LA/LV
Pericardial drainageSurgery if needed.
Air embolism Large sheaths – allow air into circulation
Aspiration,flushing of catheterKeep at level below the heart – insertion or removal
Thrombus formation Foreign material - thrombus ACT 250 -300msec
Failure to cross the leak with delivery sheath
Severe friction Hydrophilic wires
Difficulty to probe the lesions Steerable sheath
Persistent ASD
10104/17/2023
Recurrence rates and mortality assosciated with each reoperation for paravalvular leakReoperation Recurrence rate Mortality
1st 8 13
2nd 20 15
3rd 42 37
10204/17/2023
Future
10304/17/2023
Conclusions
Percutaneous mitral valve repair is an exciting new field with many devices at early stages of preclinical and clinical evaluation.
Can be used as a preventive technology – alter the course of disease.
Nothing to lose standards – surgery can be done. Collegial interaction between the specialities of
cardiology,cardiothoracic surgery and imaging is needed.
10404/17/2023
Take Home Message
Percutaneous MVRe and TMVR have been proved to be feasible procedures in patients at high surgical risk.
Percutaneous MVRe – the future of management of MR. TMVR – valve in valve and valve in ring procedure. Part of preventive approach. First in Man studies of these approaches are impressive.
10504/17/2023
Thank you
Top Related