The Edwards Transcatheter Heart Valve Newsletter
`Summer 2014 I TAVI Physicians
`
`TAVItalk
`
`DESIGNING THE FUTURE OF TAVI — A Technology-Focused Edition: The SAPIEN 3 Valve
`
`Inside TAVItalk
`Addressing Critical Needs —
`A Shared Vision with Heart Teams
`Jean-Luc Lemercier
`
`Clinical Trial Update
`Thomas Walther & John Webb
`
`SAPIEN 3 Valve:
`Excellent Early Clinical Experience
`Danny Dvir
`
`SAPIEN 3 Valve: Evolution
`or Revolution?
`Thierry Lefèvre & Marie-Claude Morice
`
`Deployment Tips and Tricks
`Holger Schröfel
`
`Experience in 34 Consecutive
`Patients—An Interview with
`Dr. Achim Büttner
`
`The Hamburg Experience with
`Case Studies
`Patrick Diemert & Hendrik Treede
`
`Imaging with SAPIEN 3 Valves:
` Overall Imaging Considerations
` Philipp Kahlert
` MDCT Annular Sizing
` Jonathan Leipsic & John Webb
` 3D TOE
` Mark J Monaghan
`
`Engineers’ Corner
`Designing the Future of TAVI
`Tim Geiser
`
`ADDITIONAL PHYSICIAN
`TESTIMONIALS:
`Gerhard Schymik
`Olaf Wendler
`Thomas Walther
`Holger Schröfel
`Martyn Thomas
`Daniel Wendt, Philipp Kahlert
`Marie-Claude Morice
`Hélène Eltchaninoff
`
`(Kerckhoff Heart Center,
`Bad Nauheim, Germany)
`Philipp Kahlert (West German Heart Center,
`Essen, Germany)
`
`Addressing Critical Needs—
`A Shared Vision with Heart Teams
`
`Jean-Luc Lemercier
`Vice President, Transcatheter Heart Valves Europe
`Edwards Lifesciences
`
`TAVI’s rapid evolution has made it one of the most exciting developments in the
`treatment of valvular heart disease. As one of the leaders in this field, it is our duty to
`maintain the pace of innovation. While additional treatment options for patients remain
`important, so too do refinements that can meaningfully improve outcomes.
`
`The Edwards SAPIEN 3 valve is a case in point. Recently approved for use in Europe,
`Edwards’ most advanced transcatheter valve reflects our strategy of using innovation
`to service continual enhancement in clinical outcomes. Its design has the potential to
`reduce paravalvular leak and vascular complications.
`
`We look forward to working with you to bring the Edwards SAPIEN 3 valve to your
`clinical practice and patient care. •
`
`Clinical Trial Update
`The Edwards SAPIEN 3 Valve
`CE Mark Trial Overview
`Study design, patients, early observations
`
`Thomas Walther Kerckhoff Heart Center Cardiac Surgery Clinic,
`Bad Nauheim, Germany
`John Webb St. Paul’s Hospital, Department of Cardiology, Vancouver, BC, Canada
`
`The SAPIEN 3 CE Mark Trial is a non-randomized, prospective, multicentred
`study designed to assess the safety and device success of the Edwards
`SAPIEN 3 valve and the Edwards Commander and Edwards Certitude delivery
`systems in patients with symptomatic, severe aortic stenosis who are indicated for
`surgical aortic valve replacement (SAVR). Initial enrollment consisted of 50 high-risk
`patients. The subsequent 100 patients enrolled could have an
`
`(continued on page 2)
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`Clinical Trial Update
`(continued from page 1)
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`intermediate- or high-risk profile. Phases
`1 and 2 of the SAPIEN 3 CE Mark Trial
`have successfully completed enrollment
`(see Figure 1).
`
`One hundred and fifty patients were
`recruited in 20 sites across France,
`Germany, Italy, Spain, the UK and
`Canada. The study was initiated in
`January 2013, and patient inclusion
`for Phases 1 and 2 was finished by
`November 2013. Patients are being
`treated via a transfemoral, transapical
`or transaortic approach. Follow-up
`is scheduled at 30 days, 1 year, and
`annually thereafter up to 5 years.
`
`The SAPIEN 3 valve (see Figure 2) was
`available in sizes of 23, 26 and 29 mm.
`The SAPIEN 3 valve is inserted using the
`Edwards Commander delivery system
`(14F or 16F eSheath-compatible) or the
`Edwards Certitude delivery system (18F
`or 21F sheath-compatible).
`
`The primary endpoint of the
`SAPIEN 3 valve CE Mark Trial study
`is all-cause mortality at 30 days
`post-index procedure.
`
`Secondary endpoints are device
`success according to VARC 2 as a
`composite of no procedural mortality,
`correct positioning of a single prosthetic
`heart valve into the proper anatomical
`location and performance of the
`prosthetic heart valve (no valve-patient
`mismatch, mean aortic valve gradient
`< 20 mmHg or peak velocity < 3 m/s
`and no moderate or severe prosthetic
`valve regurgitation).
`
`Safety outcomes according to VARC 2
`are a composite safety endpoint covering
`stroke, major vascular complications,
`life-threatening bleeding, acute kidney
`injury, myocardial infarction or new
`conduction abnormalities. Clinical
`efficacy is assessed by means of a
`composite clinical efficacy endpoint
`based on need for rehospitalization
`for cardiac causes, NYHA class,
`6-minute walk test, quality of life, total
`valvular regurgitation and length of
`stay in ICU and hospital for the total
`index procedure.
`
`Hemodynamic performance is assessed
`by echo as follows: paravalvular and
`total regurgitation, effective orifice area,
`
`Figure 1.
`
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`I TAVItalk SUMMER 2014
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`The SAPIEN 3 CE Mark Trial
`
`Indictations:
`
`Symptomatic
`Severe Aortic
`Stenosis Patients
`Indicated for SAVR
`N=275
`
`Phase 1
`(n=50)
`High Surgical Risk*:
`
`STS Score > 8
`or
`EuroSCORE > 15
`
`Phase 2
`(n=100)
`Immediate** or
`High Surgical Risk*:
`
`STS Score > 4
`or
`EuroSCORE > 10
`
`Phase 3
`(n=125)
`Immediate** or
`High Surgical Risk*:
`Added 20mm valve
`
`STS Score > 4
`or
`EuroSCORE > 8
`
`Primary Endpoint:
`
`All-cause Mortality at
`30 days Post-index
`Procedure
`
`Follow Up: 30 days, 1 year, annually to 5 years
`
`*France STS > 10. EuroSCORE > 20
`**Excluding France
`
` Progress of SAPIEN 3 CE Mark Trial.
`
`mean transvalvular gradient, LV ejection
`fraction or structural valve deterioration.
`Clinical data on the initial commercial
`experience with the SAPIEN 3 valve will
`
`be captured in the SOURCE 3 Registry.
`Phase 3 of the trial is currently enrolling
`patients suitable for a 20 mm valve and
`patients of intermediate risk. •
`
`Conclusions – The SAPIEN 3 Trial
`
`• Outcomes at 30 days were excellent.
`• Transfemoral (TF) SAPIEN 3 valve implantation was associated with a very
`low mortality of 2.1%, stroke of 1.0%, and very few access-site complications.
`• TF implantation was associated with a very low mortality of 1.1% in the
`valve implant population.
`• 99.3% of valves were implanted at the intended location — due to precise
`SAPIEN 3 positioning.
`• 96.6% of patients had ≤ mild PVL. There was no severe PVL.
`• Post-implant maneuvers were rarely needed despite reduced oversizing
`- Procedural post-dilatation (3.3%), valve-in-valve implants (0%)
`• The SAPIEN 3 valve may enable treatment of intermediate-risk patients
`with aortic stenosis.
`
`For more information on the conclusion of the SAPIEN 3 Trial, please visit
`
`centers: St Paul’s Hospital in Vancouver
`and Hospital Laval in Quebec City1 and
`have now extended our analysis to 26
`patients in a study led by Dr John Webb.
`Average patient age was 79.2±9.3 years,
`88.5% were male and the average STS
`score was 6.1±3.6. Device size was
`26 mm in 88.5% and 29 mm in 11.5%
`of patients. Valve positioning was
`accurate in all cases, with no moderate
`or severe paravalvular leaks. Mean
`aortic valve gradient decreased from
`39.6±15.7 mmHg to 12.4±4.7 mmHg
`
`and mean aortic valve area increased
`from 0.67±0.16 cm2 to 1.62±0.35 cm2
`(p<0.001). Major vascular complications
`occurred in 3.8%. There were no stroke
`events. Hospital discharge was a median
`of three days after the procedure.
`Survival at 30 days was 96.2%, and
`92.3% of survivors were in NYHA
`functional class I or II.
`
`We concluded that early outcomes with
`the SAPIEN 3 valve were excellent with
`improved device positioning and reduced
`
`post-procedural regurgitation. Longer
`follow-up of a larger group of patients,
`as being evaluated in The PARTNER Trial
`and in Europe is needed to validate
`these findings. •
`
`TAVItalk Quotable
`Expect fewer complications
`
`“We saw no PV leakage with our patients and did not have to post-dilate. We expect that these early good
`results will diminish complication rates in the future.”
`
`With the SAPIEN 3 valve, PV leak can be even further prevented as the outer skirt is designed to fill in any
`remaining paravalvular space once the valve has been deployed. The immediate effect is the prevention or
`reduction of PV leakage. As a result, less post-dilatation is needed to obtain a good result.
`These theoretical considerations have been confirmed with our SAPIEN 3 valve
`implantations during the CE mark study.”
`
`Gerhard Schymik
`TAVI Team Karlsruhe, Germany
`
`TAVItalk Quotable
`
`Reduced risk
`
`SAPIEN 3 Valve:
`Excellent Early Clinical Experience
`
`Danny Dvir St Paul’s Hospital, Vancouver, BC, Canada
`(Presented at TCT 2013, San Francisco)
`
`“The new SAPIEN 3 valve design reduces the size of the device – not only for the transfemoral, but also
`transapical and transaortic routes. As a surgeon, I consider the user-friendly new design of the Edwards
`Certitude delivery system to be a huge step forward. With its smaller profile and nose cone and no need
`for a separate pusher, transapical implantation has become less traumatic and faster. Deployment of the
`SAPIEN 3 valve is easily reproducible. Most important from my point of view is that the SAPIEN 3 valve
`has new technical features to reduce paravalvular leakage. . . . There is no doubt that the SAPIEN 3 valve
`has resulted in further reduction of this risk.”
`
`The SAPIEN 3 valve with the low-profile
`Edwards Commander and Edwards
`Certitude delivery systems incorporates
`features intended to facilitate accurate
`
`positioning and improve paravalvular
`sealing. We have reported our preliminary
`clinical experience with the
`SAPIEN 3 valve in two Canadian medical
`
`Olaf Wendler
`Professor of Cardiac Surgery, King’s College London,
`King’s College Hospital, London UK
`
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`SAPIEN 3 Valve
`(continued from page 3)
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`Positive clinical experience
`
`“Our experience with the SAPIEN 3 valve was quite positive for transfemoral and transapical implantation
`when starting the study early in 2013. None of our initial 15 patients who were included in the clinical trial
`in January and February 2013 have had any clinically relevant aortic incompetence (Figure 2).”
`
`Thomas Walther, Jörg Kempfert, Helge Möllmann
`Kerckhoff Heart Center, Cardiac Surgery Clinic, Bad Nauheim, Germany
`TAVI Team
`
`Figure 2. Initial 15 patients showed no aortic regurgitation.
`
`TAVItalk Quotable
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`Significant advantage for all patients
`
`“When I saw this valve for the first time, I was a bit surprised but, after looking at it more carefully, I realized it
`is quite a clever concept — especially the new technique to diminish or really alleviate the risk for paravalvular
`leakage. We have had a very good experience in our first 22 patients. We had good screening with CT and
`echo pre-operatively and good sizing, and we really did not see any relevant paravalvular leak in any of the
`patients treated so far: this translates into a very significant advantage for all patients. Until now, PV leakage
`has been one of the major drawbacks. If we can stop that and if we have a device that allows us to implant it
`safely without risk of PV leakage (or with only minimal PV leakage), then this is a major step forward.”
`
`Thomas Walther
`Kerckhoff Heart Center, Cardiac Surgery Clinic, Bad Nauheim, Germany
`
`The SAPIEN 3 Valve: Evolution or Revolution?
`
`Thierry Lefèvre and Marie-Claude Morice
`Institut Cardiovasculaire Paris Sud (ICPS) at the Jacques Cartier Hospital, Massy, France
`
`ultra-low 14F eSheath and 18F
`Edwards Certitude Sheath can be
`positioned in both planes of the annulus
`and in a larger landing zone. This makes
`implantation more intuitive, which may
`dramatically reduce the risk of vascular
`complications and paravalvular leak. •
`
`In just a few years, TAVI has become a
`well-accepted approach for patients with
`severe aortic stenosis who are at high
`risk or denied for surgery. Today the
`30-day mortality rate in high-risk patients
`is close to 5%. However, some limitations
`remain, which are the last frontiers for
`extending indications to intermediate-
`risk patients. Two of the most critical
`needs are the risk of severe vascular
`complications with the femoral approach
`(about 10%) and significant paravalvular
`leak (8 to 20%).2
`
`The SAPIEN 3 valve is a very clear
`advance on previous designs which
`incorporates an inner and outer skirt
`made of polyethylene terephthalate
`(PET) that serves as a paravalvular
`sealing system and an active
`3-dimensional coaxial positioning
`catheter that is compatible with a 14F
`expandable sheath for the 23 and 26 mm
`valves and 16F for the 29 mm valve.
`
`The valve structure is still made of cobalt-
`chromium and the proximal struts are
`larger, with the angle between the struts
`modified to improve the profile while
`maintaining the same radial strength. The
`crimped and deployed valve is 3-4 mm
`higher than the SAPIEN XT valve, which
`
`results in a larger landing zone.
`The delivery system is very intuitive.
`The nose-cone-tipped inner balloon
`catheter on which the valve is crimped
`has radiopaque valve alignment markers
`defining the valve position and the
`working length of the balloon. A central
`radiopaque marker aids valve positioning
`at the annulus level. The outer deflectable
`flex catheter is attached to the handle,
`which incorporates a wheel for extra
`flex of the catheter tip to gain coaxiality
`with the annulus. An indicator shows the
`degree of tip flexion. Final positioning
`at the annulus level is obtained by
`rotating the fine alignment wheel which
`allows for millimetric movement of the
`SAPIEN 3 valve.
`
`We were able to include nine patients
`(mean age 87.9+6.1 years, Logarithmic.
`Euroscore 29.9+17.6) in the SAPIEN 3 CE
`Mark Trial; valve implantation using slow
`initial inflation was successful in 100% of
`cases. The outcomes from these patients
`will be presented, along with the entire
`study data, at EuroPCR 2014.
`
`Our preliminary experience is more than
`promising and hints at the SAPIEN 3 valve
`being a true revolution in the TAVI world.
`The SAPIEN 3 valve with its low-profile,
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`Deployment Tips and Tricks
`
`Holger Schröfel
`TAVI Team Karlsruhe,
`Cardiac Surgery Clinic Karlsruhe,
`Germany
`
`The TAVI Team in Karlsruhe has
`implanted more than 1.600 transcatheter
`valves since April 2008. In the summer of
`2013 we had the opportunity to test the
`newly developed SAPIEN 3 valve as part
`of the CE Mark Trial. The most obvious
`changes you will notice are the new stent
`geometry and the innovative outer skirt
`which is designed to dramatically reduce
`PV leaks. The implantation starts, as
`usual, with the positioning of the valve
`in the perpendicular oriented aortic
`root. For this, the new valve positioning
`marker (in the middle of the balloon) is
`very useful. The SAPIEN 3 valve should
`be positioned with the centre marker
`at the insertion point of the leaflets
`(Figure 3). The biggest difference in
`implanting the SAPIEN 3 valve is the
`new stent design: the stent clearly
`shortens during deployment (personal
`
`A stunning realization was the efficacy of
`the outer skirt in substantially reducing
`paravalvular regurgitation.
`
`Do you plan to use this valve in
`more patients? If yes, what type of
`patients – i.e., inoperable, severe
`aortic stenosis, others?
`In our initial series (N= 34 consecutive
`TAVI patients), the SAPIEN 3 valve was
`suitable for all anatomies and implantation
`was successful via femoral access
`in all patients. The reduced profile
`is likely to encourage access via the
`transfemoral route and reduce the need
`
`for transapical interventions. The favorable
`hemodynamics of the
`SAPIEN 3 valve with minimal pressure
`gradient and substantially reduced
`transvalvular regurgitation appears to
`improve outcomes. However, this has
`to be proven in prospective trials and
`registries before TAVI indications can
`be expanded to younger and healthier
`patients. A THV with a large inner
`diameter would enable opportunities for
`future valve-in-valve implantations which
`could be especially important in
`younger patients.
`
`
`Do you feel this valve offers more
`benefits than previous SAPIEN valves?
`More than other commercial valves? If
`yes, explain the benefits.
`Compared to the previous SAPIEN
`family of valves, a wider range of annular
`diameters up to 29.5 mm can be treated
`with the SAPIEN 3 THV. For borderline
`annular diameters, a smaller THV size
`can be considered due to the effect of
`the outer skirt in reducing paravalvular
`leakage. This could reduce the risk for
`annular ruptures where there is severe
`calcification or a small aortic root. •
`
`Figure 3. Positioning: Align the centre
`marker of the valve at the insertion
`point of the native valve leaflets as
`visualized under fluoroscopy.
`
`Figure 4: Implant result: Confirmed
`placement of the SAPIEN 3 valve
`with the external sealing ring below
`the native annulus.
`
`The Hamburg Experience
`
`•
`
`Patrick Diemert and Hendrik Treede
`Interventional Cardiology and Cardiovascular Surgery
`University Heart Center Hamburg, Hamburg, Germany
`
`Experience in 34 Consecutive Patients — an Interview with
`Dr. Achim Büttner on Behalf of the TAVI Heart Team
`University Heart Center Freiburg/Bad Krozingen
`
`In February and March 2014, the
`SAPIEN 3 Transcatheter Heart Valve
`(THV) was implanted in 34 consecutive
`TAVI patients at our centre. All had
`symptomatic severe aortic stenosis
`and were treated via femoral
`arterial access.
`
`Patient characteristics
`• Mean age was 83.8±5.0 years
`• Multidetector computed tomography
`(MDCT) estimated aortic annular area
`457±59 mm²
`• Area derived annular diameter
`24.0±1.5 mm
`• Doppler-echo mean pressure gradient
`46±15 mmHg
`• Calculated aortic valve area
`0.8±0.2 cm²
`
`
`
`5 patients received a 23 mm valve, 22
`patients received a 26 mm valve and 7
`patients received a 29 mm valve. Valve
`implantation using slow initial inflation
`was successful in all 34 cases. No
`balloon pre-dilatation was performed
`in the last 23 cases and we had no
`difficulties in crossing the native valve
`or fine-positioning the THV. Paravalvular
`leakage (PVL) was less than mild in all
`cases (no PVL in 65%, trace in 35%). No
`post-dilatations were performed.
`
`There were no major vascular
`complications (focal femoral artery stent
`implantation in two patients). The post-
`transcatheter aortic valve replacement
`MDCT showed consistently symmetrical
`and circular valves and the Doppler-echo
`mean pressure gradient at discharge was
`9.9±2.9 mmHg.
`
`
`Conclusion:
`The SAPIEN 3 valve and delivery system
`could facilitate fully percutaneous
`implantation in a broader range of
`patients with the potential to provide
`more accurate positioning and less
`paravalvular regurgitation.
`
`Was the implant procedure faster or
`more efficient than previously? If so,
`in what way?
`The design of the Edwards Commander
`delivery system is a step forward and
`makes the procedure less traumatic and
`faster to do. The reduced profile of the
`valve and the added distal flex of the
`delivery system seems to reduce the
`risk of vascular complications and eases
`positioning of the THV in the native aortic
`valve. Our initial experience showed that
`implantation of the SAPIEN 3 THV is
`feasible without balloon pre-dilatation.
`
`
`The overall goal of aortic valve
`replacement is to restore left ventricular
`function and physiologic blood flow
`through the aortic annulus and at the
`same time to protect from new risks or
`complications related to the intervention.
`During the recently finished
`SAPIEN 3 valve CE Mark Trial, our team
`at the University Heart Center Hamburg
`had the chance to treat 21 patients
`suffering from severe aortic stenosis with
`the new SAPIEN 3 valve. Here we would
`like to present two representative cases
`and share some of our insights.
`
`Case 1: 86-year-old patient,
`transapical SAPIEN 3 valve
`implantation
`This 86-year-old patient presented with
`progressive dyspnoea due to severe
`aortic stenosis. Echocardiography
`showed an aortic orifice area of 0.8
`cm2 with a gradient of 86/41 mmHg.
`Because of significant co-morbidities
`(previous pacemaker implantation for
`AV-block, pulmonary emphysema and
`an abdominal aortic aneurysm), we
`selected a transapical approach using
`the Edwards Certitude delivery system.
`As in all our TAVI patients, we performed
`a planning CT that was reconstructed
`
`prior to the procedure using a dedicated
`software program. From the CT we
`calculated a perimeter-derived aortic
`annulus diameter of 24.6 mm and an
`area-derived diameter of 24 mm. The
`reconstructed CT-image (Figure 5)
`shows a tricuspid aortic valve with heavy
`calcification distributed in a symmetric
`pattern across all three leaflets.
`
`We opted for a 26 mm SAPIEN 3 valve.
`The apex was accessed with a small
`incision (4 cm) over the fifth intercostal
`space, as calculated in the planning CT.
`We used a soft-tissue retractor without
`rib spreader to minimize trauma and
`postoperative pain. The 18F Edwards
`Certitude delivery system developed
`for transapical (TA) implantation of the
`SAPIEN 3 valve allows for significant
`downsizing from earlier TA delivery
`systems, which means that both the
`intercostal access and the sutures of the
`cardiac apex can be kept very small in
`the sense of a truly minimally invasive
`approach. We routinely perform
`TA implantations of the SAPIEN XT valve
`without pre-dilatation with good results.
`So far, the Instructions for Use
`and the clinical trial protocol of the
`SAPIEN 3 valve study demand
`
`pre-dilatation for both TA and TF delivery,
`but in our opinion, the pre-dilatation step
`can be omitted for most cases. However,
`more data will be needed on this aspect
`of the SAPIEN 3 valve. We introduced the
`26 mm SAPIEN 3 valve and positioned
`the middle marker at the insertion point
`of the leaflets, which in our experience is
`the optimal starting point for deployment
`of the SAPIEN 3 valve (Figure 5).
`The balloon was slowly inflated over a
`period of 4 seconds; during balloon
`inflation we gave a bolus of contrast.
`The “slow-deployment technique” allows
`for correction of the positioning height
`during expansion, which in our case
`was not needed. In spite of the heavy
`calcification, we achieved excellent
`stent expansion and a very good
`functional result.
`
`On transoesophageal echo and aortic
`angiography we could not detect any
`paravalvular leakage, and the gradient
`post-implantation was 9/4 mmHg with a
`calculated aortic orifice area of 2.2 cm2.
`The patient was extubated right after
`the procedure and showed no
`postoperative pain and an uneventful
`postoperative course.
`
`(continued on page 8)
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`The Hamburg Experience
`(continued from page 7)
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`Figure 5. CT view of valvular calcification pattern and positioning of the SAPIEN 3 valve before deployment under fluoroscopic view.
`
`Case 2: 81-year-old patient,
`transfemoral SAPIEN 3 valve
`implantation
`This 81-year-old lady was admitted to
`our hospital with a history of syncope
`and exertional angina. Angiography
`ruled out coronary artery disease, but
`echocardiography revealed high grade
`aortic stenosis with a gradient of 91/43
`mmHg and an effective orifice area of
`0.7 cm2. Our patient had a history of
`allergic asthma that was intermittently
`treated with steroids; otherwise the
`medical history was without significance.
`However, because the patient appeared
`frail with reduced grip-strength and
`mobility, the Heart Team selected
`transfemoral (TF) TAVI rather than
`surgical aortic valve replacement.
`Computed tomography showed a
`tricuspid aortic valve with eccentric
`calcification (Figure 6). The aortic annulus
`diameter was 20 mm on TOE and 21 mm
`by CT (perimeter-derived effective
`annulus diameter). The aorta, iliac
`and femoral vessels did not show any
`significant calcification, but the diameters
`of the common femoral arteries were quite
`narrow with only 0.6 cm on the left side
`and 0.7 cm on the right side. We decided
`on a 23 mm SAPIEN 3 valve using the
`14F expandable Edwards Commander
`delivery system. With this significantly
`
`downsized delivery system, transfemoral
`access did not present a problem in spite
`of the narrow femoral arteries.
`
`This was one of our first cases with
`the SAPIEN 3 valve, and we were
`very mindful of the asymmetric
`foreshortening of the stent during valve
`deployment. It is quite essential for the
`implanter to be aware that the lower
`stent part of the SAPIEN 3 valve will
`show a higher degree of foreshortening
`compared to the upper half of the stent.
`During our first SAPIEN 3 valve cases
`we quickly learned that you can have
`very predictable results with the
`SAPIEN 3 valve if you follow three
`important rules:
`
`1. Start with the middle positioning marker
`at the insertion point of the leaflets.
`2. Use nominal volume for deployment
`3. Perform a very slow inflation with
`a bolus of contrast to correct for
`implantation height, if necessary.
`
`In our case, we had an excellent result
`without the need for post-dilatation and
`without paravalvular leakage despite the
`eccentric calcification (see Figure 6). The
`transvalvular gradient was 9/4 mmHg,
`and the calculated aortic orifice area
`was 1.9 cm2. The patient was extubated
`
`on the OR table immediately after the
`procedure and showed an uneventful
`postoperative course. The
`SAPIEN 3 valves allow for predictable
`and precise placement which is key
`to shorter procedures and, more
`importantly, to fewer maneuvers and
`manipulations within the native valve.
`This is important as the number of
`maneuvers has been associated
`with stroke.3
`
`In summary: With the new
`SAPIEN 3 valve we have consistently
`achieved good implantation results with
`a remarkably low rate of paravalvular
`leakage. The downsizing of both TA
`and TF delivery systems is a significant
`advantage. There are some important
`changes in the implantation technique
`compared to the SAPIEN XT valve
`that implanters need to be aware of,
`especially in regard to the need for
`fewer maneuvers, the future potential
`of deploying valve without prior BAV
`and predictable deployment. However,
`if these steps are properly applied, the
`SAPIEN 3 valve implantation is very
`straightforward and reliable. •
`
`Figure 6. CT view of eccentric valvular calcification pattern and final angiography after SAPIEN 3 valve deployment.
`
`TAVItalk Quotable
`
`Shorter procedure time and easier closure
`“The low 18F profile of the Edwards Certitude delivery system allows for much easier delivery, as
`well as greatly improved flexibility for ease of coaxial positioning of the SAPIEN 3 valve across the
`annulus. The delivery system also incorporates an integrated pusher and easier-to-use handle design.
`The SAPIEN 3 valve and the Edwards Certitude delivery system have facilitated our Heart Team
`procedures by enabling shorter procedure times and easier closure.”
`
`Holger Schröfel
`TAVI Team Karlsruhe, Cardiac Surgery Clinic Karlsruhe, Germany
`
`Edwards Certitude Delivery System
`
`Edwards Commander Delivery System
`
`8
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`TAVItalk SUMMER 2014 I 9
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`Page 5 of 9
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`

`

`Adequate patient selection is the primary
`key for a predictable procedure with
`an optimal outcome and a minimized
`complication rate. Pre-interventional
`imaging is used to confirm the diagnosis
`of severe aortic stenosis and to precisely
`assess the aortic valve pathology
`including calcium distribution, the
`dimensions of the left-ventricular
`outflow tract, the aortic annulus, the
`aortic root and the distances from the
`coronary arteries to the annular plane.
`It also enables assessment of tortuosity,
`calcification and diameter of the peripheral
`access vessels (Figure 7). In addition,
`coronary artery status, left ventricular
`function and concomitant valvular heart
`disease need to be assessed.
`
`• TT and TOE evaluate the diagnosis of
`severe aortic stenosis as well as left-
`ventricular function and the presence
`of concomitant valvular heart disease.
`
`
`
` •
`
` Coronary angiography determines
`coronary artery status.
`
`• Real-time 3D TOE and MDCT
`improve accuracy of single-plane
`measurements such as the aortic
`annulus, i.e. the mid-oesophageal
`long-axis view. These technologies
`take into account the non-circularity
`of the annulus by measuring mean
`diameter, annular perimeter and area
`(Figure 8).
`
`• MDCT sizing has been studied
`intensively over recent years, and
`it has already been evaluated
`prospectively for the SAPIEN XT
`valve, demonstrating that a controlled
`oversizing of around 10% of the
`annular area leads to a significant
`reduction of relevant paravalvular
`leaks without increasing complications
`such as annular rupture. In addition
`to annular sizing, MDCT also allows
`the determination of the distance
`from the coronary arteries to the
`annulus and evaluation of the access
`vasculature. While angiography of
`the iliac and femoral arteries should
`also be performed during invasive
`coronary angiography, MDCT with 3D
`reconstruction completes the picture,
`giving relevant information on the
`degree and distribution of calcium
`which would otherwise have to be
`evaluated by intravascular ultrasound
`(Figure 7).
`
`(continued on page 12)
`
`Figure 8. Evaluation of the aortic valve anatomy and assessment of annular dimensions
`using 2D (A) as well as 3D (C, D) transoesophageal echocardiography and MDCT (B).
`
`Figure 9. Post-procedural evaluation of the result using 2D transoesophageal
`echocardiography (A), fluoroscopy/angiography (B) and real-time 3D transoesophageal
`color Doppler echocardiography with post-processing (C, D).
`
`TAVItalk SUMMER 2014 I 11
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`TAVItalk Quotable
`
`Fewer vascular complications
`“The Commander delivery system has a central fluoroscopic marker that sits under the center of the crimped
`SAPIEN 3 valve. There are three other important features of the SAPIEN 3 valve which should be remembered.
`The height of the SAPIEN 3 valve provides a large ‘landing zone’ and the height varies depending on the valve
`size. The second feature is the cell size at the top of the valve which allows easy access to the coronary arteries,
`if needed. The final feature is the shortening of the valve during deployment. This occurs two thirds of the way
`up from the ventricular side of the device and happens ‘late’ during balloon inflation and in a very predictable
`fashion. From prior studies, we know that one of the biggest concerns in TAVI has been the rate of vascular
`complications. With the significant reduction in sheath sizes, it is expected that vascular complications will also
`diminish significantly, and we look forward to new data and sub-analyses that will enable us to have further
`comparisons with earlier generation valves and delivery systems.”
`
`Martyn Thomas on behalf of the Heart Team
`Clinical Director, Guy’s and St Thomas’ Hospital, London, UK
`
`Imaging with SAPIEN 3 Valve: Overall Imaging Considerations
`
`Philipp Kahlert
`For the West German Heart Center
`Essen TAVI team
`
`Fewer than 10 years after its introduction,
`TAVI has become the new standard of
`treatment for inoperable patients with
`severe symptomatic aortic stenosis
`and a viable alternative for high-risk but
`operable patients. This breakthrough
`technology continues to evolve rapidly.
`One of the most important current
`development objectives is procedural
`safety, specifically including the
`reduction of access site complications
`and paravalvular regurgitation, both
`of which have been associated with
`increased mortality. As TAVI has
`evolved, so has the visualization of the
`cardiac and vascular anatomy during
`pre-interventional patient screening,
`peri-interventional imaging guidance
`and post-procedural evaluation of
`the implanted valve. Various imaging
`modalities such as transthoracic
`(TT) and transoesophageal 2D and
`3D echocardiography (TOE), X-ray-
`fluoroscopy and angiography as well as
`multi-detector computer tomography
`(MDCT) are now being employed for the
`various aspects of TAVI imaging.
`
`10 I TAVItalk SUMMER 2014
`
`Figure 7. Pre-interventional assessment of the peripheral vasculature using MDCT
`with 3D reconstruction (A), with post-processing by dedicated imaging software
`(3mensio Medical Imaging BV, Netherlands) (B, D) and evaluation of a plaque in the right
`common femoral artery using intravascular ultrasound during coronary and ileofemor