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CME / ABIM MOC

Advances in Transcatheter-Edge-to-Edge Repair for Degenerative Mitral Regurgitation: New Data for Novel Devices

  • Authors: Linda D. Gillam, MD, MPH​; Scott Lim, MD​; Robert Smith, MD​
  • CME / ABIM MOC Released: 9/28/2022
  • Valid for credit through: 9/28/2023
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Target Audience and Goal Statement

This activity is intended for cardiologists, primary care physicians (PCPs), surgeons, and other healthcare providers (HCPs) who provide care for patients with mitral regurgitation (MR).

The goal of this activity is for learners to be better able to improve understanding of the latest data for the use of TEER to treat DMR.

Upon completion of this activity, participants will:

  • Have increased knowledge regarding the
    • Consequences of DMR 
    • Latest clinical data for TEER to treat DMR
  • Have greater competence related to
    • Using strategies to integrate the latest data into clinical care to improve patient outcomes


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Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated. Others involved in the planning of this activity have no relevant financial relationships.

Disclosures for additional planners can be found here.


Faculty

  • Linda D. Gillam, MD, MPH​

    Chair of Cardiovascular Medicine​
    Morristown Medical Center/​Atlantic Health System​
    Professor of Medicine ​
    Sidney Kimmel Medical College ​
    Thomas Jefferson University​
    Past President of the American Society of Echocardiography​
    Morristown, New Jersey

    Disclosures

    Linda D. Gillam, MD, MPH, has the following relevant financial relationships:
    Consultant or advisor for: Bracco; Edwards Lifesciences; Phillips
    Contracted researcher for: Edwards Lifesciences; Medtronic

  • Scott Lim, MD​

    Professor of Medicine and Pediatrics​
    Director Emeritus – Advanced Cardiac Valve Center​
    University of Virginia
    Charlottesville, Virginia

    Disclosures

    Scott Lim, MD, has the following relevant financial relationships:
    Consultant or advisor for: Ancora; Phillips; Venus; WL Gore
    Research funding from: Abbott Vascular; Boston Science; Edwards Lifesciences; Medtronic

  • Robert Smith, MD​

    Chairman Cardiovascular Surgical Services​
    Baylor Scott & White​
    The Heart Hospital Plano
    Assistant Medical Director of Cardiovascular Surgery​
    Baylor Scott & White​
    Plano, Texas

    Disclosures

    Robert Smith, MD, has the following relevant financial relationships:
    Speaker or member of speakers bureau for: Artivion; Medtronic
    Research funding from: Abbott Vascular; Artivion; Edwards Lifesciences

Editors

  • Joy P. Marko, MS, APN-C, CCMEP

    Senior Medical Education Director, Medscape, LLC 

    Disclosures

    Joy P. Marko, MS, APN-C, CCMEP, has no relevant financial relationships.

  • Cheryl Leigh Perkins, MD, RPh

    Medical Education Director, Medscape, LLC 

    Disclosures

    Cheryl Leigh Perkins, MD, RPh, has no relevant financial relationships.

Compliance Reviewer

  • Leigh Schmidt, MSN, RN, CNE, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Leigh Schmidt, MSN, RN, CNE, CHCP, has no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has no relevant financial relationships.


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CME / ABIM MOC

Advances in Transcatheter-Edge-to-Edge Repair for Degenerative Mitral Regurgitation: New Data for Novel Devices

Authors: Linda D. Gillam, MD, MPH​; Scott Lim, MD​; Robert Smith, MD​Faculty and Disclosures

CME / ABIM MOC Released: 9/28/2022

Valid for credit through: 9/28/2023

processing....

Activity Transcript

SEGMENT 1

Medscape attempts to use generic names for drugs and devices whenever possible. In this program, the trade names for TEER devices are used for clarity. The use of trade names should not be viewed as an endorsement by Medscape of specific products.

Linda D. Gillam, MD, MPH: Welcome to this program on Advances in Transcatheter Edge-to-Edge Repair, TEER for short, for Degenerative Mitral Regurgitation: New Data for Novel Devices.

Joining me today will be Scott Lim and Rob Smith, and I'm Linda Gillam, the chair of cardiovascular medicine at Morristown Medical Center, professor of medicine at Thomas Jefferson University, and past president of the American Society of Echocardiography.

I'm going to lead off by giving you a landscape of treatment options for degenerative mitral regurgitation, a primer if you like. And let's start first with definitions, defining degenerative mitral regurgitation, DMR for short. Let's get down to the basics. Hopefully you all appreciate the difference between primary and secondary mitral regurgitation (MR). Simply stated, primary MR is a disease of the valve, and secondary MR is a disease of the ventricle, or as we more recently learned, of the atrium.

Now, primary mitral regurgitation can be further subdivided. The most common cause is degenerative mitral regurgitation, with other etiologies being rheumatic, mitral annular calcification, and so on. What's not widely appreciated is that we use the term degenerative in a very restricted way, referring exclusively to patients who have mitral valve prolapse or flail. So, we do not term patients who have a little bit of leaflet thickening, a little bit of calcium, as having degenerative mitral regurgitation.

In another classification system, the Carpentier classification system for mechanisms of MR, DMR falls into type 2, characterized by excessive leaflet motion. When there's continuity between the chords and the mitral leaflets, this is mitral valve prolapse. When there is disruption, this is mitral valve flail, and both prolapse and flail fall under the umbrella of DMR. So, there's also a spectrum of degenerative mitral regurgitation based on both the degree of leaflet abnormality and its spatial extent.

So on the far left, we see localized fibroelastic deficiency, typically P2. On the far right, we see widespread myxomatous changes, the so-called Barlow's valve, and this is what they look like in real time. We see here, hopefully you can readily appreciate this P2 flail with the chord sort of flopping in the breeze. It is from the surgeon's view. To be contrasted to this patient, who's got diffuse myxomatous valve disease, a Barlow's valve.

Now, very important to know the epidemiology and clinical impact of DMR. First, and perhaps most importantly, DMR is very common, and it counts for 80% of isolated mitral valve surgeries, with an overall incidence of 2% to 3% per year. Left untreated, patients with severe DMR will develop heart failure, pulmonary hypertension and/or arrhythmias, and may die. There is no direct medical therapy for DMR, except for blood pressure control for hypertensive patients, and heart failure management for those who developed left ventricular dysfunction. Now, although surgery, ideally mitral repair, may offer definitive therapy, many patients are at high risk for surgery. And in fact, in 1 series, 47% of patients with primary MR were not referred for surgery.

And yet, in those not referred for surgery, at least 1 indication for surgery was present in 74% of those unoperated patients.

Clearly, there is a need for alternatives to surgery for treating DMR. In terms of nonsurgical options, there are currently 2 Food and Drug Administration (FDA)-approved options for DMR repair, and both fall under the umbrella of transcatheter edge-to-edge repair.

The new kid on the block is the PASCAL transcatheter valve repair system. It's structure is shown on this slide. Importantly, leaflet grasping is done independently, meaning that you can stage leaflet capture and make adjustments independently, ie, without having to simultaneously grasp both the anterior and posterior leaflets. In addition, grasping is achieved with a single row of retention elements, which minimizes the likelihood of leaflet and/or chordal trauma. There's also a central spacer, which helps bridge the coaptation gap. The device is constructed out of nitinol, which allows for passive closure and allows for the device in place to move with the leaflets. Importantly, a feature of implantation is that there is the ability to elongate the delivery system, which makes it easier to manipulate in the subvalvular space that is densely occupied by chords.

Finally, there are 2 devices, the original PASCAL implant, and the smaller recent edition PASCAL Ace.

MitraClip offers 4 design options, as this device is now in its fourth iteration. We see these to the left, A, B, E, and F, NT, NTW, XT, and XTW. The Ws that are added refers to the width of the arms. NT vs XT refers to the length of the arms, so XT, as you might imply, refers to arms that are longer, and this detail is provided in the 4 images to the right.

In terms of current indications, we have the "2020 ACC/AHA Guideline for Management of Patients with Valvular Heart Disease," which establish a class 2a indication for TEER in patients who have severe symptomatic degenerative mitral regurgitation, who are at high or prohibitive surgical risk, and who have favorable mitral valve anatomy, and a patient life expectancy of at least 1 year.

In summary, degenerative mitral regurgitation is clinically important and affects many patients who need alternatives to surgical valve repair or replacement. Transcatheter edge-to-edge repair therefore fills an important clinical need. We are lucky in that we now have 2 devices that are FDA approved, new kid on the block, PASCAL and MitraClip. Thus, we have 2 very effective tools in our therapeutic toolbox. Thank you for listening to the segment, and please stay with us and carry on to the next segment.

SEGMENT 2

Medscape attempts to use generic names for drugs and devices whenever possible. In this program, the trade names for TEER devices are used for clarity. The use of trade names should not be viewed as an endorsement by Medscape of specific products.

Scott Lim, MD: Good day, and welcome to segment 2. I'm Scott Lim from the University of Virginia, and this segment is titled “Digging Deep Into New Data for Degenerative MR: Rationale and Trial Design.”

So, as you can see on this slide, transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair, which essentially is TEER started approximately at the same time, completing the first trials in about 2010, 2011. But since then, it's been rapid fire. We've had tremendous development in the TAVR space, but there's been a relative delay, a bit of a dearth of clinical trials in the mitral repair space for about 8 to 10 years. And we're now just finally trying to get caught up. And so today, we're going to look at some trials that are in this space and we're getting some data out as well as some trials that are just getting launched.

So the 4 trials we'll focus on is for the MitraClip EXPAND G4, which is a registry study. It's been completed, and just the other day presented the data. So, we can share that. The CLASP IID trial, which is a randomized trial -- it's been completed, and now it's been published. The 2 other trials that I think are quite exciting as well in this space that are both in the enrolling phase, are the REPAIR MR which is randomized MitraClip vs surgery in intermediate-risk patients and above, and the PRIMARY trial, which is transcatheter edge-to-edge repair, regardless of the device type vs surgery in low risk on up.

All these trials are focusing on the transcatheter repair space with either the MitraClip, as you can see here, or the PASCAL device. So, the MitraClip EXPAND G4 really focuses on the fourth generation of the MitraClip. It's a prospective, multicenter, single-arm [study], with a characterization it's being real world, of more than a thousand patients in the United States, Europe, Canada, and Japan. As you can see here, looking at acute as well as chronic outcome measures, not just procedural success alone, the echocardiograms are assessed at later time points by independent echo core laboratory although entry into the study was based on site reports in terms of MR severity.

The next study is a CLASP IID, which is comparing the predicate device, the MitraClip, which you saw before with the newer PASCAL device as you can see here on this screen. The PASCAL implant, like MitraClip, grabs both anterior and posterior leaflets of the mitral valve and brings them together, but where the PASCAL differs is as a central spacer, so that the leaflets are brought to the spacer rather than being pulled tighter together, edge to edge. It also is a nitinol construction and a hollow design, so the entire implant has some degree of flexibility throughout the cardiac cycle. The whole device can elongate exposing only smooth rounded edges and therefore allowing the operator to navigate with greater confidence hopefully through dense chordal structures. And lastly, it comes in 2 sizes, a standard PASCAL vs PASCAL ACE vs the 4 sizes of the MitraClip current variation, which is longer or shorter arms, wider or narrower arms.

So, the PASCAL device was studied in CLASP IID, randomized trial, the trial flow as you can see here had also an independent screening committee, an echo core laboratory that is adjudicating entry into the trial, as well as subsequent time points, events committee, and data safety monitoring board. And this is for degenerative MR, 4 or 4+ only coming in. And if the site heart team, as well as eligibility committee, felt that the patient could be randomized to book PASCAL and MitraClip, that patient then entered the randomized portion of the trial. On the other hand, if the patient was deemed suitable for PASCAL only and not MitraClip, then it went into the registry arm. Primary endpoints were non inferiority, safety, major adverse events at 30 days and effectiveness 2 plus or less at 6 months.

The next trial that is quite interesting is the REPAIR MR trial. Now, this is looking slightly farther down on the surgical risk strata where patients had to have intermediate surgical risk on up, and patients were randomized either to the MitraClip therapy or to surgical repair. The plan is over 60 sites in the United States, Canada, and Europe, enrolling up to 500 subjects.

The next trial down the risk strata is the PRIMARY trial, which was designed as a superiority trial. Again, looking at 3 or 4+ degenerative or primary MR. And patients with low intermediate or even high risk could be randomized.

Thank you very much. We’ll now be moving on to the next segment.

SEGMENT 3

Medscape attempts to use generic names for drugs and devices whenever possible. In this program, the trade names for TEER devices are used for clarity. The use of trade names should not be viewed as an endorsement by Medscape of specific products.

Scott Lim, MD: And now we're on segment 3. I'm Scott Lim. Again, I'm from the University of Virginia, and this segment is “Digging Deep Into New Data for Degenerative Mitral Regurgitation: The Results Are In!”

So, particularly for those first 2 trials we talked about, number 1 is a MitraClip EXPAND G4 registry. Over a thousand patients were enrolled and a very high success rate in terms of implanting the device, 98% of the time. There also was a relatively high though slightly lower acute procedural success rate, at 96.2%. The striking thing here is that device times, procedure times have gotten better and better as we've seen over the years and now a device time on average of 35 minutes. Also on average, 1.4 clips per patient procedure were used. If you look on the bottom right of this slide, you can see in EXPAND G4, the percentages of these newer wider clip devices vs all devices in terms of their mean inflow gradients.

Going into this at earlier stage, everyone had their question, these wider device types, could they reduce the MR without creating mitral stenosis (MS)? It appears by this data it did not increase mean gradients either at any time point in follow-up to 30 days. Adverse events rates in this large cohort of patients were relatively low. The entire field, in addition to becoming more efficient is getting better results in terms of safety. All-cause mortality was low at 1.3%. The leaflet adverse events, SLDA, or single-leaflet device attachment rate, was reasonably low at 1%.

In terms of MR reduction, the slide here shows from the EXPAND G4 registry that the first thing that jumps out is at baseline, all patients were adjudicated as having 3 or 4+ by the site, but later on rereviewed by the echo core lab, and the echo core lab found that nearly 30% had 4+, 40% had 3+ MR, but fully just over 30% of patients had 2+ or 1+ MR.

So, I think it's important when we look at these results is to view that in context. At 30 days, the acute outcome shows that 98% of these patients had 2+ or less MR and 91% down to 1+.

But then if we look at just the patients at 3 and 4+ MR you see in this slide, and this slide shows only those patients, and in those patients, 97% were able to achieve 2+ or less and 89% 1+ or less. So, compared with our earlier days of MitraClip, clearly, these results have gotten better.

Now, the next trial where we have results just came in as well is from that CLASP IID randomized study. So again, that was, this cohort is a randomized cohort, 2-to-1 randomization PASCAL device vs MitraClip. As you can see here, 117 such patients randomized to receive the PASCAL device vs 63 in the MitraClip arm.

By 30 days, there was 1 mortality in each arm. Mortality in a PASCAL arm was adjudicated as not being related to the device. Mortality in the MitraClip arm was adjudicated as being related to the device. Specifically, the operator had the device being stuck on chords below the valve, was not able to retrieve it without an unrecoverable hemodynamic collapse. By 6 months, there was an additional 5 mortalities in the PASCAL arm, and 3 more in the MitraClip arm. All 5 in the PASCAL arm, where it was adjudicated again as being not related to the device or the procedure. The 3 in the MitraClip arm, 1 of those 3 was adjudicated as being related to the device as patient developed mitral stenosis, had to have surgery, and unfortunately did not survive surgery. The other 2 mortalities there were not related to device.

In terms of the procedure, high success rate in implanting either the PASCAL device or the MitraClip device. There was 1 patient on the PASCAL side that had unsuccessful procedure. In that case, it was an inability to place the device relative to a very short, retracted posterior leaflet. Both procedure and device times were longer in the PASCAL group. All of the operators in this trial were sites chosen because they had extensive 10, 15, or more years of experience with MitraClip. But it was for many of them, it was their first time getting their hands on the PASCAL device. And it was reflected in this increased procedure and device time, which when you dive down even deeper really was related to the first case. But second and subsequent cases had similar device and procedure times as the MitraClip arm. Average number of devices implanted was no different between the 2 groups nor was length of the stay. The pie charts in the bottom show the breakdown of use of device types.

The PASCAL Ace device came in to use in the latter part of the trial, so its use was limited by that. On the MitraClip side of things, it was whatever the MitraClip was that was commercially available at that time with a majority of patients getting the latest generation, the G4.

In terms of the primary safety endpoint, it was met. With the composite major adverse event (MAE) rate at 30 days of 3.4% for PASCAL vs 4.8% for MitraClip. So statistically no different and well within a noninferiority margin that was prespecified.

Breaking down further on adverse events, as you can see, one of the key things I think is a very low adverse event rate in both arms. Again, the field has improved.

In terms of primary effectiveness endpoint of MR 2+ or less at 6 months, it was virtually the same, 96% in both groups, the absolute difference of 0.3% and well within the prespecified noninferiority margin.

Looking more specifically about MR at different time points, as you can see at baseline compared with the previous study, this showed all patients had 3 and 4+, with the majority having 4+ MR. Going out 6 months in both arms, they were about 98% 2+ or less in the PASCAL arm. One plus or less was achieved in 84%, and that appeared to be stable. In the MitraClip arm, there was some slight degradation noted that was statistically significant, such that 1+ or less was achieved and maintained in 71%.

That ends this. Now, we'll be moving on to segment 4. Thank you.

SEGMENT 4

Medscape attempts to use generic names for drugs and devices whenever possible. In this program, the trade names for TEER devices are used for clarity. The use of trade names should not be viewed as an endorsement by Medscape of specific products.

Robert Smith, MD: My name's Robert Smith. I'm chairman of cardiovascular surgical services at The Heart Hospital, Baylor Plano. I just want to thank everyone for joining us today. I'm going to be speaking to Looking Ahead: Implications for the New Data that was presented regarding mitral valve TEER therapy.

And I think one of the things that's really important here is at the completion of the Transcatheter Cardiovascular Therapeutics (TCT) 2022 Convention, we now have 2 devices that are really effective in treating degenerative mitral valve regurgitation for patients who are otherwise prohibitive risk for surgery.

And so, what this really leads to is a really excellent discussion with patients. I want to really emphasize that, and I'll go through some of the data and why that is. But we had presented a randomized control trial, which is the first randomized control trial data that we've had since 2012. And additionally, we have 2 very important registries which were presented including the CLASP IID registry and the EXPAND G4 registry.

And from these, we also get some really important information about fine tuning or tailoring the treatment of degenerative valve disease outside of the typical leaflet pathologies that we're used to. And some of the questions that come up as a result of this is, are there any real limits to TEER therapy or are there even device advantages for the different types of devices? And then lastly, as a result of these excellent findings, we have some upcoming trials to evaluate mitral valve TEER therapy vs surgery. And the question is, will there be a new day for TEER therapy?

As we look at this, the typical anatomy that we usually treat is straight down the middle of the mitral valve, and there's an excellent paper created by the Heart Valve Consortium and written by Scott Lim that kind of describes 3 basic groups of patients, 1 with very straightforward anatomy, the next with complex anatomy that we don't really have great data and outcomes to tell us what's the right thing, and then the last group is prohibitive anatomy that would keep us from that.

And in the group where we have very suitable anatomy, and looking at an echocardiogram, the midpoint of the valve where the top leaflet and the bottom leaflet come together, that's where the majority of the anatomy in this case that we usually use TEER therapy is dysfunctional. That's where we usually find most of it and really where we're centered on treating. But there's a fair number of pathologies that can occur to either side of that, that also really bear treatment options and are really important for patients, and we learned something from these trials that came out.

But when we talk about the disease that's straight down the middle, the TEER suitable group, we had the G4 registry that showed in their evaluation of patients, almost 91% of patients had very successful treatment with 1+ or less mitral regurgitation.

And what that means for patients is when we came out of the EVEREST II trial, we would have to sit down with patients and say, "You know what, there's about a 20% chance that we go in there to do this procedure to make you better and we don't do anything that's really that impressive, and we leave you with severe regurgitation. And there's about an 80% chance that maybe we get to less than moderate mitral regurgitation, but that was all we had. Now we're talking, hey, maybe in a typical scenario for a patient at a center that does a really good job of this and does a lot of it, there's a greater than 90% chance we're going to get you out of there with 1+ or less mitral regurgitation and all the associated benefits that come with that.

And this was then also echoed in the CLASP IID trial, which was a randomized control trial, comparing the MitraClip device with the PASCAL device, and while the numbers weren't quite as good in both of the groups as were reported in the G4, they were actually quite excellent, with 97% and 98% of patients with 2+ or less mitral regurgitation, far better than the EVEREST II trial data and almost 84% and 70% of patients who had less than 1+ mitral regurgitation. Again, excellent news for patients who have straightforward disease.

But the important thing here is there are a lot of tools that a plumber will use to fix your broken pipes. And in these trials, we learned about more devices, although they're of similar make, but more devices that can be used to treat and tailor potentially the way that we expect to treat a patient with degenerative valve disease.

We have both the PASCAL and the Ace device, which is the smaller narrower device, and for the MitraClip, we have the NT and the NTW, the XT and the XTW. So we have 4 devices in a category, and so all told we now have really 6 potential options for treating patients in a different of combinations.

And when we look at different mitral valve pathology, we see that there was a lot of different types of valve anatomies that were treated in both registries with very successful implant times and implant rates with very remarkable reductions in regurgitation for both groups.

And in that G4 category, we had patients who had both risk of stenosis and inadequate reduction of regurgitation based on their anatomy who come out with 75% or 97% or better 1+ or less mitral regurgitation without incurring mitral valve stenosis, which is what we'd want to avoid. And they did it with all sorts of different clips in the G4 group and both PASCAL and Ace devices in the registry.

And so what that really means is now we have reasonable data to support reasonable outcomes when treating disease that's outside of the original indications. And that's really important because it's not always straight down the middle. And in fact, we have different devices that can be used in treating this. And there's a question of whether or not some devices are better than the other, the PASCAL device can straighten up and when we have mitral valve anatomy that has a complex, dense, rich network of chords over on the outside of the valve, outside of that region, by straightening it out, it may be that that is a safer device in those regions. And then we have the MitraClips, we have varying sizes and lengths, which may do a better job of taking care of really long and excessively long leaflets and then pairing them up with shorter leaflets for different pathologies.

We don't really know how this is going to turn out, but we do know that the clinicians with gaining experience with these devices are going to do a great job, figuring it out. And so the question is the toolbox really big enough with just TEER or their continued limitations? And time will tell us that, but given these excellent results really in the end of this, it came down to, should we take a second look at TEER vs surgery?

And there are 2 design trials that are coming up, both a noninferiority trial and a superiority trial being one, is supported by industry and the other by the Cardiothoracic Surgical Trials Network (CTSN) group, which is through the National Heart, Lung, and Blood Institute (NHLBI), that will be focusing more on short-term and hopefully longer-term evaluation of whether TEER therapy vs surgery is the right thing to do at least for patients who are age 65 or older, or 75 or older, depending on the trial design. There's a lot more coming down the road, and we look forward to learning about this.

In conclusion, I'd like to really end with acknowledging that we have a much greater understanding with these reported data. We see improved outcomes in patients with TEER therapy, and these improved outcomes really importantly improved the conversations that we're able to have with patients who are currently meeting the indication for treatment with TEER therapy. Additionally, we have safely and thoroughly expanded the patho- and anatomic spectrum where TEER therapy is effective.

We're exploring those boundaries and I feel very confident that clinicians, as they gain extra experience with these devices will continue to improve upon these excellent results that were presented. And I think what's really important here is that we are reminded that we need to keep innovating and keep investigating continually and responsibly to push the frontiers of structural heart therapy. And we will see that in the upcoming trials for surgery.

In the end, I certainly would like to thank everyone who's presented and to all those who are listening, thank you for joining us in this presentation, I hope that you get a lot out of it. And really what is most important is that I'm excited that patients will be getting a lot out of what all this extra effort went into making their lives better. So, thank you very much.

This transcript has not been copyedited.

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