TAVR Update: New Insights and Perspectives from the U.S.

National STS/ACC TVT RegistryJoseph E. Bavaria, MD

STS/ACC TVT Registry Steering Committee Chairman (2017-2020)Past-President of STS (2016-17)

Roberts-Measey Professor and Vice-Chair of Cardiovascular Surgery at the University of Pennsylvania

Society of Thoracic Surgeons (STS) American College of Cardiology (ACC)

Disclosures• STS-ACC Transcatheter Valve Therapy (TVT) Registry Steering Committee

Chairman• Co-Chair of the 4-Society TAVR Institutional and Operator Writing

Committee (ACC/STS/AATS/SCAI)• Site Investigator in Transcatheter Valve Trials or Consultant

– W.L. Gore: Cardiac & Aortic Teams – Edwards Lifesciences: PARTNER family of Trials, Commence Trial– Abbott/St. Jude: Portico, Trifecta Trials– Medtronic: SURTAVI Intermediate Risk Trials

• Founders Shares and Equity holder in CardiAQ TMVR (sold to Edwards in Oct 2015 with no financial conflict presently)

Disclosures

• I love TAVR!!

History of the TVT Registry

The STS/ACC TVT RegistryTM , created by a collaboration between the Society for Thoracic Surgeons (STS) and the American College of Cardiology (ACC), monitors patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures –emerging treatments for valve disease patients.

TVT = Transcatheter Valve Therapy

Value of TVT: The Key to Sustainability

A Clinical Knowledge Machine:

Key to US Learning Health Care System

Hospital System QA/QI

Site PerformanceNational

BenchmarksAUC

A Component of Regulatory and Reimbursement

Reform

A Source of Data for Patients:

Decision-AidsPublic Reporting

Medical Device Industry Expansion of Indications Imbedding CA and PAS

StudiesRegular Comprehensive

Reports

The Need for a National Clinical Registry

TVT Registry

Stakeholders

STSHospital Systems

NHLBI

Device Companies

CMS

FDA

ACC

Patient Advocacy

Media US

News

AATS & SCAI

Multiple Stakeholders

Professional SocietiesGovernment agenciesHospital NetworksDevice IndustryUniversity Analytic CentersHealth Media

An Update of the Data Collected in the Three Modules

Transcatheter aortic valve replacement (TAVR)Transcatheter mitral valve repair (MitraClip)

Transcatheter mitral valve replacement (Valve-in-Valve)

CMS Mandated

“Science tells us what we can do;

Guidelines what we should do; &

Registries what we are actually doing.”Lukas Kappenberger MDHeart Rhythm Society Policy ConferenceWashing ton DC 2005

An Update of the Data Collected in the Three Modules

Transcatheter aortic valve replacement (TAVR)Transcatheter mitral valve repair (MitraClip)

Transcatheter mitral valve replacement (Valve-in-Valve)

CMS Mandated

TVT Registry Sites

Alaska

• Last 2 years 115 new sites

• New sites opening are most frequently in close proximity to existing sites

• Whether or not new sites meet current NCD requirements is unknown

• First Wyoming TAVR site to open in 2020

656 TAVR Sites

Thru October 16, 2019

TVT Registry Sites since new NCD

• US has 1 TAVR site for every 70,000 people over the age of 65 years. More than ANYother country

Sites Enrolled in the TVT Registry as ofOctober 16, 2019

156

252

348400

485

550598

656

0

100

200

300

400

500

600

700

2012 2013 2014 2015 2016 2017 2018 2019 YTD

Steady Growth each year

TVT National Volumes Data: Snapshot of U.S. TAVR Practice

Patterns

STS/ACC TVT Registry

4,6668,946

16,301

27,143

41,339

54,421

63,361

32,845

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

2012 2013 2014 2015 2016 2017 2018 2019YTD

TVT Registry Datamart Data as of 10/16/19

Commercial TAVR Submitted to the TVT Registry

Over 250,000 TAVR Patients are in Registry. Anticipate >70,000 in 2019

Transcatheter TherapyModules in TVT Registry

CurrentNumber of

Sites Performing Treatment

2018 Patient Volume in USA

2018 Mean Number of

Procedures per Site

TAVRNative and Valve-in-Valve 642 63,361 105

Transcatheter Mitral Valve Repair

(MitraClip)355 7,230 20

Transcatheter Mitral Valve Replacement

(Sapien Valve-in-Valve and Valve-in-Ring)

184 937 5

Transcatheter Tricuspid Valve Repair and Replacement

(2020?) TBD TBD TBD

Sept. 1, 2019

7022074048 74408 74830 73687

7022869885

28948 30772 30159 30432 2892526426

25513

18466 1861318548

18157 17733 1618215929

19146 2068021543

2200722238 22255

22322

3660 3983 4158 4234 47915365

612146668946

16106

24908

38276

51303

58657

0

10000

20000

30000

40000

50000

60000

70000

80000

2012 2013 2014 2015 2016 2017 2018Total of all SAVRS (includes Bentalls) Isolated AVR SAVR + CABG SAVR Other Bentalls TAVR

The Aortic Valve “Universe” in the USA

Linked TVT and STS Data. From the STS/ACC TVT Steering CommitteeRepresents approx. 93% and 97% of SAVR and TAVR respectively

TAVR, for the First time, in 2019 surpassed SAVR in all its forms. Surpassed Isolated AVR in 2016

TAVR Age(25th and 75th percentiles)

88 88 88 87 87 86 86

78 78 77 77 76 75 75

84 84 83 83 82 81 81

65

70

75

80

85

90

2012 2013 2014 2015 2016 2017 2018

The predominant etiology is age-related Degenerative AS. Therefore Age statistics have changed minimally with Intermediate Risk patients. But ….

TAVR Age(25th and 75th percentiles)

88 88 88 87 87 86 86

78 78 77 77 76 75 75

84 84 83 83 82 81 81

65

70

75

80

85

90

2012 2013 2014 2015 2016 2017 2018

Average age of Low Risk trials = 74 years

4,6668,946

16,301

25,824

38,988

51,270

59,630

32,845

255 499 1319 23513151 3731 2,215

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

2012 2013 2014 2015 2016 2017 2018 2019 YTDTVT Registry Datamart Data as of 10/16/19

TVT RegistryTAVR and TAVR ViV Procedures

V-in-V is an important part of TAVR: approx. = 7%

TAVR Records Heart Team Reason for Procedure

2852

6111 67044820 4593

6537

17597

26567 2620826352

498 1078

4318

8865

26537

82 254 371 9731456

0

5000

10000

15000

20000

25000

30000

2014 2015 2016 2017 2018

Extreme Risk High Risk Intermediate Risk Low Risk 58938

Expansion of TAVI into Intermediate Risk.Absolute Number of patients with extreme and high risk remains substantial

Few Low Risk in 2018 but …..

TAVRMedian LOS in Days

(25th and 75th percentiles)

10 109

8

65

44 4 43

2 21

67

6

43 2 2

0

2

4

6

8

10

12

2012 2013 2014 2015 2016 2017 2018

LOS reductions becoming less

TAVR In-Hospital Mortality Risk Score* (Median, 25th and 75th %)

6.3%

7.2%

6.1%

5.0%4.5% 4.2% 4.0%

2.9%3.3%

2.9% 2.6% 2.5% 2.3% 2.3%

4.1%4.8%

4.0%3.5% 3.3% 3.1% 3.0%

0%

1%

2%

3%

4%

5%

6%

7%

8%

2012 2013 2014 2015 2016 2017 2018

*Based on TVT Registry TAVR in-hospital mortality risk score

*Based on TVT Registry TAVR in-hospital mortality risk score

Mean TAVR risk is similar for 3-years but range has narrowed … interesting!

STS SAVR Risk Score Patients Undergoing TAVR(Median, 25th and 75th %)

11.1%10.4% 10.1% 9.7%

9.0%8.0% 8.0%

4.7% 4.5% 4.4% 4.1% 3.7% 3.3% 3.2%

7.1% 6.8% 6.7% 6.3%5.7%

5.1% 5.0%

0%

2%

4%

6%

8%

10%

12%

2012 2013 2014 2015 2016 2017 2018

Lower Risk Patients each year

TAVR Access Site

75.2%

46.4%

69.3%

86.8%92.4% 94.2%

14.3%

45.2%

19.2%

6.2%2.3%

1.5%4.7% 6.3%9.1%

3.8% 1.4% 1.0%0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%

100.0%

2012 2013 2014 2015 2016 2017 Q1

Femoral

Transapical

Transaortic

Source: STS/ACC TVT Registry Database.as of Jul 17,2017

TF Dominates: >95% in 2018: Good for Patients

Chart1

201220122012

201320132013

201420142014

201520152015

201620162016

2017 Q12017 Q12017 Q1

Femoral

Transapical

Transaortic

0.752

0.143

0.047

0.464

0.452

0.063

0.693

0.192

0.091

0.868

0.062

0.038

0.924

0.023

0.014

0.942

0.015

0.01

Sheet1

FemoralTransapicalTransaortic

201275.2%14.3%4.7%

201346.4%45.2%6.3%

201469.3%19.2%9.1%

201586.8%6.2%3.8%

201692.4%2.3%1.4%

2017 Q194.2%1.5%1.0%

Sheet1

Femoral

Transapical

Transaortic

Sheet2

Sheet3

Concurrent and 30-Day PCI with TAVR Procedure

1.34%

1.89%2.12%

1.91% 1.85%

0.62%0.45% 0.45% 0.41% 0.51%

0%

1%

1%

2%

2%

3%

2014 2015 2016 2017 2018

Concurrent with TAVR 30 Day after TAVR

Steady and Reasonable

Real World TAVR Clinical Outcomes

STS/ACC TVT Registry

TAVR: In HospitalMajor and Life-Threatening Bleed

6.0%

5.0%

4.2%3.9%

3.4%3.1% 3.1%

6.9%

6.0%

3.8%

3.0%2.3% 2.2%

1.8%

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

2012 2013 2014 2015 2016 2017 2018

Major Bleed LT/Disabling Bleed

Complications continue to decrease, however completely flat for 3 years

TAVR StrokeIn-Hospital, 30 Day, and One Year Stroke

2.2% 2.0% 2.2% 2.0% 1.9% 1.9% 1.8%

2.8% 2.7% 2.8% 2.5% 2.4% 2.5% 2.4%

3.9% 3.9%4.2% 4.3% 4.2%

3.9%

0.0%0.5%1.0%1.5%2.0%2.5%3.0%3.5%4.0%4.5%5.0%

2012 2013 2014 2015 2016 2017 2018In Hospital 30 Day One Yr CMS linked Cerebral

protection approved

Stroke Rates are Very Flat; No real change ….. VERY Important

if we’re going into Low Risk!

TAVR Stroke: In-Hospital, 30 Day, and One Year Stroke

2.2% 2.0% 2.2% 2.0% 1.9% 1.9% 1.8%

2.8% 2.7% 2.8% 2.5% 2.4% 2.5% 2.4%

3.9% 3.9%4.2% 4.3% 4.2%

3.9%

0.0%0.5%1.0%1.5%2.0%2.5%3.0%3.5%4.0%4.5%5.0%

2012 2013 2014 2015 2016 2017 2018In Hospital 30 Day One Yr CMS linked Cerebral

protection approved

Risk-adjusted stroke model completed

and results reported to all TAVR sites

quarterly.

Use of cerebral protection is now captured by TVT

Registry

TAVR - 30 Day Dialysis 2.1%

2.3%

1.9%

1.1%0.8%

0.6% 0.7%

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

2012 2013 2014 2015 2016 2017 2018 Q1

Very good. Rates are Very Flat; No real change in 3 years …..

VERY Important if we’re going into Low Risk!

TAVR MortalityIn-Hospital, 30 Day, and One Year Mortality

5.7% 5.2% 4.1%2.9% 2% 1.7% 1.5%

7.5% 7% 6%4.4%

3.2% 2.8% 2.6%

26.4%

21.8% 21.6%

18.2%

15.3% 13.9%

0%

5%

10%

15%

20%

25%

30%

2012 2013 2014 2015 2016 2017 2018In Hospital 30 Day 1yr (CMS linked data)

Steadily improving National results. 30 day mortality a bit flat recently

TAVR -All Cause Readmission (Readmitted for any reason, valve or not valve related)

19.0% 18.0% 17.9%15.4% 14.1% 13.5% 13.4%

56.5% 54.5% 54.4%51.3%

48.8% 47.2%

0%

10%

20%

30%

40%

50%

60%

2012 2013 2014 2015 2016 2017 201830 Day (Registry) 1 Yr (CMS linked)

Wow!! Not sure what to make of this?? 81 year old natural

history? CHF admissions? Poor selection nationally? …..

Terrible!! ….. And not improving over 3 years

Alive and Well At One Year After TAVR (among 1-year survivors with complete KCCQ*)

79.3% 76.4% 76.2% 76.7% 78.4%80.0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

2012 2103 2014 2015 2016 2017

1-Yr KCCQ >= 60 and no more than a 10 unit decrease in KCCQ score from baseline to 1 year

This is pretty good. No Change in 6 years BUT it’s nice that 80% SELF REPORT that they are better

TAVR Disposition

4.8% 5.8% 5.2% 5.1% 4.2% 3.2%

27.2% 30.1% 24.3%18.0%

13.3%9.5%

62.4% 58.9%66.3%

74.0%80.4%

85.0%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

2012 2013 2014 2015 2016 2017 Q1

Nursing Home

Rehab

Home

Source: STS/ACC TVT Registry Database.as of Jul 17,2017

This is Excellent!

Chart1

201220122012

201320132013

201420142014

201520152015

201620162016

2017 Q12017 Q12017 Q1

Nursing Home

Rehab

Home

0.048

0.272

0.624

0.058

0.301

0.589

0.052

0.243

0.663

0.051

0.18

0.74

0.042

0.133

0.804

0.032

0.095

0.85

Sheet1

Nursing HomeRehabHome

20124.8%27.2%62.4%

20135.8%30.1%58.9%

20145.2%24.3%66.3%

20155.1%18.0%74.0%

20164.2%13.3%80.4%

2017 Q13.2%9.5%85.0%

Sheet1

Nursing Home

Rehab

Home

Sheet2

Sheet3

TAVR Disasters:Three Major Procedure Events

1.2%1.5%

1.2%0.8%

0.5%0.5% 0.5%

3.5%

4.4%

2.5%

1.4%0.9% 0.7% 0.5%

3.4%

2.6%

1.2%0.9%

0.7%

0.8% 0.7%

0.0%0.5%1.0%1.5%2.0%2.5%3.0%3.5%4.0%4.5%5.0%

2012 2013 2014 2015 2016 2017 2018

Convert to OHS CPB Used Procedure Aborted

About 2.0% Catastrophe rate: Stable x 3 years

Location of TAVI Procedures: where are they being performed?

64% 63% 61% 58% 57%

26% 27% 27% 27% 27%

11% 10% 12%14% 15%

0%

10%

20%

30%

40%

50%

60%

70%

2014 2015 2016 2017 2018Hyrid OR Suite Hybrid Cath Lab Cath Lab

TAVRNew Pacemaker after TAVR (Excludes PPM pre TAVR)

9.1%

12.9% 13.2%

11.0%9.9% 9.4%

10.9%

14.8% 15.1%

13.1%11.9% 11.8%

0%

2%

4%

6%

8%

10%

12%

14%

16%

2013 2014 2015 2016 2017 2018In Hospital Pacemaker 30 Day Pacemaker

New (excludes PPM pre TAVR)In Hospital and 30-Day Pacemaker

9.1%

12.9% 13.2%

11.0%9.9% 9.4%

10.9%

14.8% 15.1%

13.1%11.9% 11.8%

0%

2%

4%

6%

8%

10%

12%

14%

16%

2013 2014 2015 2016 2017 2018In Hospital Pacemaker 30 Day Pacemaker

30 day = 11.8% NEW pacemakers. Important as it is well known that pacemaker in younger

patients (Low Risk?) die earlier!NO CHANGE IN 6 YEARS

Events (%)

S3HROveral

l(n=583)

S3HRTF

(n=491)

S3HRTA/TA

o(n=92)

S3iOverall(n=1076)

S3iTF

(n=951)

S3iTA/TA

o(n=125)

Major Vascular Comps. 5.0 5.3 3.3 5.6 5.9 3.2Bleeding - Life Threatening 6.3 5.5 10.9 5.4 4.4 12.9

Annular Rupture 0.3 0.2 1.1 0.2 0.2 0Myocardial Infarctions 0.5 0.4 1.1 0.3 0.3 0Coronary Obstruction 0.2 0 1.1 0.4 0.4 0Acute Kidney Injury 1.0 0.8 2.2 0.5 0.3 1.6New Permanent Pacemaker 13.0 13.2 12.0 10.1 10.4 7.2

Aortic Valve Re-intervention 1.0 0.8 2.2 0.7 0.8 0

Endocarditis 0.2 0.2 0 0.1 0.1 0

Other Clinical Events Intermediate RiskAt 30 Days (As Treated Patients)

Corroboration: TVT Data Consistent ….In the S3i TF

group, the Partner 2 “BEST GROUP” = 10.4% Pacemakers

- 1000 patients

TAVR: 2018 NYHA Data

3.4%

40%

25%

28%

60%

6.0%11.2%0.6%

0%

20%

40%

60%

80%

100%

Baseline 30 days

Class I Class II Class III Class IV

Note: 30 day NYHA excludes 25% of pts with missing NYHA

These are good results

The Big Question in the U.S. Regarding TAVR: Is There a

Significant Volume – Outcome Relationship??

National Policy Recommendations:

J Am Coll Cardiol 2019;73:427–40

United States Procedure Volume and Outcomes in Transcatheter Aortic Valve

Replacement

Sreekanth Vemulapalli, MD,1,2 John D. Carroll, MD,3 Michael J. Mack, MD,4 David Dai, PhD,2 Zhuokai Li, PhD,2 Andrzej S. Kosinski, PhD,2,5 Dharam J. Kumbhani, MD, SM,6 Carlos Ruiz, MD,7 Vinod H. Thourani, MD,8 George Hanzel, MD,9 Thomas G. Gleason, MD,10 Howard C Herrmann, MD,11 Ralph G. Brindis, MD, MPH,12 Joseph E. Bavaria, MD13

NEJM; 2019

Post-MEDCAC Meeting: Analyses on Volume-Outcome Relationship in TAVR

Sensitivity Analysis Excluding 12-Month Start-up Period at Each Hospital

United States Procedure Volume and Outcomes in Transcatheter Aortic Valve Replacement

Sreekanth Vemulapalli, MD,1,2 John D. Carroll, MD,3 Michael J. Mack, MD,4 David Dai, PhD,2 Zhuokai Li, PhD,2 Andrzej S. Kosinski, PhD,2,5Dharam J. Kumbhani, MD, SM,6 Carlos Ruiz, MD,7 Vinod H. Thourani, MD,8 George Hanzel, MD,9 Thomas G. Gleason, MD,10 Howard C Herrmann, MD,11 Ralph G. Brindis, MD, MPH,12 Joseph E. Bavaria, MD13

NEJM; 2019Approximately 27% Risk Reduction in high volume vs the lowest volume centers

30 Day Composite Major Outcomes Related to Site Annual Volume

2016-2017 Complete One-Year Data from STS-ACC TVT Registry

Site Annual TAVR Volume

Freq

uenc

y of

Maj

or C

ompl

icat

ions

% P

Is the Data any Good? Is it Reliable?

Is the Data any Good? Is it Reliable?

10% of all sites are AUDITED each year per Steering Committee Resolution!

National Audit ProgramEvaluates accuracy and reliability

• Assesses proper and complete reporting of cases• Voluntary

2018 Results (Draft Results)• Base and Follow Over Accuracy= 91.5%• Overall Follow Up Accuracy = 90.7%• 30 Day Follow Up Accuracy = 92.4%

TAVR Module Data Completeness

KCCQ and Follow-Up

DQR Submission Status

R

Y

G

A “Red” status indicates the submission (one quarter/timeframe) is not included in the benchmark statistics. Data is not displayed in the quarterly column.

A “Yellow” status indicates the submission (one quarter/timeframe) is not included in the benchmark statistics. Data is displayed in the quarterly column, but is not included in the “My Hospital R4Q” summary. The data has not passed the overall completeness assessment checks.

A “Green” status indicates the submission (one quarter/timeframe) is included in the benchmark statistics. The data has successfully passed all data assessment and completeness checks.

TVT Registry Base Submissions Green Yellow Red Status

2014-201891% 92%

97% 97% 98%

9% 8%3% 3% 2%

0%0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2015 2016 2017 2018 2019 Q1

TVT Registry Follow Up Submissions Green Yellow Red Status

2014-2018

65%

89% 93%95% 95% 95%

7% 10% 6% 3% 4% 4%

1% 1% 1% 1% 1% 1%0%10%20%30%40%50%60%70%80%90%

100%

2014 2015 2016 2017 2018 2019Q1

TAVR - 30 Day Follow Up Completed Some follow up assessment 21-75 days after TAVR

80%85% 89%

90% 91% 92% 92%

0%10%20%30%40%50%60%70%80%90%

100%

2012 2013 2014 2015 2016 2017 2018 Q1

30-day Follow up is a Standard of Care. It

is Malpractice not to know what

happened to your patient at 30 days

after a procedure!!

Comparison: STS Database 30-day mortality >98%

TAVRBaseline KCCQ Completed

24%

74%

87% 90% 91%92% 93%

0%10%20%30%40%50%60%70%80%90%

100%

2012 2013 2014 2015 2016 2017 2018

Baseline and One Year KCCQ Complete

66%

67%

70%

71%

63%

64%

65%

66%

67%

68%

69%

70%

71%

72%

2014 2015 2016 2017

Among One Year Survivors

Data Completeness Becomes Essential if Institutional and Operator Volume

Requirements are Replaced with Quality Metrics

Will Updated TAVR NCD Address This Problem of Sites Not Submitting

Complete and Accurate Data?

The NCD??

STS/ACC TVT Registry Mortality and Morbidity

Composite Risk Model for TAVRNimesh D. Desai MD PhD

On behalf of the TVT Risk Modeling Subcommittee

Death

• In-Hospital or 30-day mortality

Stroke

• In-Hospital or 30-day stroke

Bleed

• In-hospital or 30-day VARC major or longterm/disabling bleed

AKI• In-hospital sig creatinine increase or 30 day new

dialysis (AKI III)

PVL• In-hospital or 30-day moderate/severe peri-valvular

leak (PVL)

None • None of the above

TVT Risk Model: Global Rank Methodology

STS/ACC TVT Registry “New Stuff”

What new ideas, devices, knowledge, and research are “informing” the TVT??

Centera

Collecting Data on New Techniques is Becoming Very Important for the TVT Registry

1. Cerebral protection using one FDA approved device: Sentinel– to address the not “insignificant” stroke rates despite new TAVR technology and lower risk patients

2. Fracturing of sewing rings of surgically implanted prosthetic valves during V-in-V treatment for degenerated bioprosthetic valves

– To address the problem of small surgically implanted valves/ and prosthetic-patient mismatch

3. Catheter-based electrosurgery techniques to lacerate valve leaflets and reduce risks of obstruction from TAVR and TMVR implantation

– BASILICA: Technique applied to aortic leaflets of native and bioprosthetic valves to prevent coronary obstruction

– LAMPOON: technique applied to anterior leaflet of mitral valve to prevent LVOT obstruction

4. Vascular Access using the transcaval (IVC to aorta) technique for TAVR

TVT Registry Updates • Embolic protection and bioprosthetic valve

fracture is captured in the device table in v2(current version)

Cerebral Protection• Stroke is a devastating complication of

interventional procedures and surgery.• The development of “cerebral

protection” devices to capture the embolic debris released during these treatments is potentially a major advancement, but with an evidence-base that is “evolving”.

• The FDA approval of the first such device, Sentinel, has provided a unique opportunity for TVT Registry to gather clinical use.

Frerker et al. J Am Coll Cardiol Intv 2016;9:171–9.

Cerebral Protection and TVT Registry• Data element added in January 2018 (Version 2). • 3867 cases of TAVR using Sentinel performed at

82 sites have been entered into the TVT Registry.

Version 3 update will have the following data element

Fracturing of sewing rings of surgically implanted prosthetic valves during V-in-V treatment for degenerated bioprosthetic valves

Under-Reporting?Efforts being made to educate site data coordinators to assess whether or not fracturing is being done.

“Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access”

• ClinicalTrials.gov Identifier: NCT02280824

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

• Principal Investigator: Robert J Lederman, M.D. at NHLBI

TVT Registry v3 updates

Updatable procedure list includes:• PCI• LAAO• Permanent Pacer• Mitral Valvuloplasty• Vascular Stent• BASILICA• LAMPOON• Alcohol Septal Ablation

TVT Registry v3 updates• Transcaval access will have its own data element

TVT Registry v3 updates

• Bioprosthetic valve fracture

STS/ACC TVT Registry ResearchOver 30 Manuscripts Published and 30 in preparation

Early pacer implantation is a common complication following TAVR.It is associated with a higher mortality and a composite of mortality or heart failure admission at one year.

Incidence, Predictors, and Outcomes ofProsthesis-Patient Mismatch

in 62,125 TAVR Patients

An STS/ACC TVT Registry Report

Howard C. Herrmann, MD University of Pennsylvania

Philadelphia

Presented 2018 TCT showing worse outcomes with TAVR PPM. Severe PPM

in 12% of all TAVR

The Process of Updating TVT Registry Sites of These Changes in Data Collection

• Identify changes on Data Collection Form• Announce on TVT website• Review at every monthly webinar. • Place a tag line on the signature for all questions coming into TVT• Remind valve coordinators at industry meetings• Reinforce at National NCDR and STS AQO Meetings

TAVR – C (What does C stand for?)

As of March 1, 2019 There is Only One TAVR – C Site in US

First Canine TAVR Performed in the World at Colorado State Ft. Collins CO with UC Health

Interventional Cardiologists Drs. Justin Stroke and Brad Oldemeyer assisting Dr. Brian Scansen, a

Veterinarian Interventional Cardiologist

Data not entered into TVT Registry

because case lacked KCCQ results

“Science tells us what we can do;

Guidelines what we should do; &

Registries what we are actually doing.”Lukas Kappenberger MDHeart Rhythm Society Policy ConferenceWashing ton DC 2005

Conclusions1. The National STS/ACC TVT Registry is the largest source of TAVR (and TMV

repair) information in the world. … (FDA = “A National Treasure”)

2. The data from the TVT is used by multiple Stakeholders throughout the country

3. The TVT Registry continues to inform the world of “Real World” TAVR outcomes, not just trial data.1. Getting better in some areas2. Static in other areas

4. The TVT is now using the data to develop TAVR and TMVR risk models and Composite Outcome measures. These will be the basis for CMS suggested Public Reporting of Outcomes by institution and transparency.

5. The STS/ACC TVT is REALLY Big Data…. Mandated data entry by Law in the U.S. (100% participation)

89

Questions?

Mitral Repair Module of TVT Registry

MitraClip Currently Only Technology

TVT National Volumes Data: Snapshot of U.S. Leaflet Clip

Practice Patterns

STS/ACC TVT Registry

Leaflet Clip Sites and Records Submitted

99 180 227 275 355 3551159

2633

4337

5876

7230

5084

0

1000

2000

3000

4000

5000

6000

7000

8000

2014 2015 2016 2017 2018 2019 YTDSites Records

Significant continued growth in Clip procedures 25-30% annually

Sites are static but 355 is a lot!

Leaflet ClipMedian LOS in Days

(25th and 75th percentiles)

13

17

1412

10

5 53

2 2

7 8 75

4

0

2

4

6

8

10

12

14

16

18

2014 2015 2016 2017 2018

Steady Improvement

Leaflet Clip Age (25th and 75th percentiles)

8786 86 86

85

74 7473 73 73

8281 81 81

80

65

70

75

80

85

90

2014 2015 2016 2017 2018

Elderly, Don’t anticipate much difference with FMR approval??

Leaflet Clip Demographics

90.5% 90.9% 88.0% 87.8% 87.5%

6.3% 5.2% 7.3% 7.3% 7.4%4.0% 4.9% 5.2% 5.9% 5.9%2.2% 2.5% 2.2% 2.4% 2.5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2014 2015 2016 2017 2018White Black Hispanic Asian

Very steady and slightly improving each year: Actually a

reasonable percentage of 80 year olds in America

Leaflet Clip Procedure IndicationsReasons for Determination of Prohibitive Risk

49.8% 51.0%53.1% 55.5%

59.0%

7.6% 8.1% 8.0% 8.4% 8.0%

2.0% 1.3% 1.4% 1.2% 1.4%2.5% 1.0% 1.2% 1.0% 1.0%

27.7%30.3% 28.0% 26.0%

22.3%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

2014 2015 2016 2017 2018Fraility Hostile Chest SLD Porcelain Aorta Unusual Circumstances

Leaflet ClipSTS Operative Mortality Risk

47% 45% 41% 39% 38%47% 49% 46% 43% 42%

0%10%20%30%40%50%60%70%80%90%

100%

2014 2015 2016 2017 2018STS MV Repair >=6% STS MV Replacement >= 8%

Fairly High Risk for open Mitral Surgery

Leaflet ClipMitral Valve Disease Etiology

79% 76% 76% 75% 74%

10% 8% 8% 9% 9%6% 10%11% 11% 12%

5% 6% 5% 5% 6%

0%10%20%30%40%50%60%70%80%90%

2014 2015 2016 2017 2018dMR fMR Mixed Neither

“Mixed” Lesions growing: … Changes with FMR in future

Real World Leaflet-Clip Repair Clinical Outcomes

STS/ACC TVT Registry

Leaflet Clip MortalityIn Hospital 30 Day and One Year

2.9% 2.1% 2.5% 2.2% 2.1%

5.6% 4.4% 4.8% 4.4% 4.8%

25.9%23.7% 22.6% 23.0%

0%

5%

10%

15%

20%

25%

30%

2014 2015 2016 2017 2018In Hospital 30 Day 1 Yr (CMS Linked Data)

Interesting: No change or improvement in 30-day mortality in 5 years …… but

quite low

Leaflet Clip Stroke

0.7%0.4%

0.7%0.9% 0.9%

1.2%0.8%

1.2%1.5% 1.6%

2.9%

2.0%

2.8%3.1%

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

2014 2015 2016 2017 2018

In Hospital 30 Day One Year CMS Linked

In-Hospital 30 Day and One Year Stroke Interesting: No change or improvement in 30-day stroke in 5 years …… maybe even worsening …. But still quite low

Leaflet Clip 2018 NYHA Data

0.8% 2.3%14.5%

60.4%

22.0%33.1% 24.2%

29.9%

11.0%

1.8%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Missing Class I Class II Class III Class IV

Baseline 30 Day

Good Clinical result nationally

Leaflet Clip In Hospital Transfusions

11.4%

9.6%8.9%

8.0% 7.6%

0%

2%

4%

6%

8%

10%

12%

2014 2015 2016 2017 2018

Steady Improvement

Leaflet Clip Morbidity : 30 Day Outcomes

1.4%2.0%

1.3% 1.2% 1.2%

1.9% 1.7% 1.9% 1.6% 1.7%

0.3% 0.3%0.0%

0.5%0.9%

5.0%

3.6%4.1% 4.1%

4.5%

0%

1%

2%

3%

4%

5%

6%

2014 2015 2016 2017 2018

SLDA ASD Closure Major Vasc Comp Major or Disabling Bleed

* Among non-missing follow-up

Very Steady rates of Morbidity. No improvement. But again, fairly low rates.

Leaflet Clip – Alive and Well* (among 1-year survivors with complete KCCQ)

70% 70% 69% 69%

0%10%20%30%40%50%60%70%80%90%

100%

2014 2015 2016 2017

*Among 2,368 pts

*1-Yr KCCQ >= 60 and no more than a 10 unit decrease in KCCQ score from baseline to 1 year

Leaflet ClipBaseline KCCQ Completed

71%

83% 82% 85% 85%

0%10%20%30%40%50%60%70%80%90%

100%

2014 2015 2016 2017 2018

108

Questions?

New Techniques, Not Investigative Devices, in Transcatheter Valve Treatment

• Physicians see first-hand problems-adverse events that arise in their patients in the trenches of clinical care.

• The spirit of innovation is alive to come-up with solutions.• New techniques often use existing technologies on the shelves of cath labs.• “Beneath” the radar screen of FDA approval.• Surgeons for years have developed new surgical techniques in such a fashion.• These new techniques have been studied using formal research proposals, listing

in ClinicalTrials.gov, and with NIH funding.• When to add them as data elements in the TVT Registry is an important issue.• How to add them as data elements is an additional issue.

0ther TVT Registry V3 updates

TAVR Update: New Insights and Perspectives from the U.S. National STS/ACC TVT RegistryDisclosuresDisclosuresHistory of the TVT Registry Value of TVT: The Key to SustainabilitySlide Number 6An Update of the Data Collected in the Three ModulesSlide Number 8An Update of the Data Collected in the Three ModulesSlide Number 11TVT Registry Sites since new NCDSites Enrolled in the TVT Registry as of� October 16, 2019 TVT National Volumes Data: Snapshot of U.S. TAVR Practice Patterns Commercial TAVR Submitted to the TVT RegistrySlide Number 17Slide Number 18TAVR Age�(25th and 75th percentiles)TAVR Age�(25th and 75th percentiles)TVT Registry�TAVR and TAVR ViV ProceduresTAVR Records �Heart Team Reason for ProcedureTAVR� Median LOS in Days�(25th and 75th percentiles)TAVR In-Hospital Mortality Risk Score* �(Median, 25th and 75th %) STS SAVR Risk Score Patients Undergoing TAVR�(Median, 25th and 75th %)�TAVR Access SiteConcurrent and 30-Day PCI with TAVR ProcedureReal World TAVR Clinical Outcomes TAVR: In Hospital�Major and Life-Threatening Bleed TAVR Stroke�In-Hospital, 30 Day, and One Year Stroke TAVR Stroke: In-Hospital, 30 Day, and One Year Stroke TAVR - 30 Day Dialysis TAVR Mortality�In-Hospital, 30 Day, and One Year Mortality TAVR -All Cause Readmission �(Readmitted for any reason, valve or not valve related)�Alive and Well At One Year After TAVR �(among 1-year survivors with complete KCCQ*)TAVR DispositionTAVR Disasters:�Three Major Procedure Events Location of TAVI Procedures: where are they being performed?�TAVR�New Pacemaker after TAVR (Excludes PPM pre TAVR)��New (excludes PPM pre TAVR)�In Hospital and 30-Day Pacemaker Other Clinical Events Intermediate Risk�At 30 Days (As Treated Patients)TAVR: 2018 NYHA Data The Big Question in the U.S. Regarding TAVR: Is There a Significant Volume – Outcome Relationship?? Post-MEDCAC Meeting: �Analyses on Volume-Outcome Relationship in TAVRSlide Number 5030 Day Composite Major Outcomes Related to Site Annual Volume� 2016-2017 Complete One-Year Data from STS-ACC TVT RegistryIs the Data any Good? �Is it Reliable?Is the Data any Good? �Is it Reliable?National Audit ProgramTAVR Module Data CompletenessDQR Submission StatusTVT Registry Base Submissions �Green Yellow Red Status�2014-2018TVT Registry Follow Up Submissions �Green Yellow Red Status�2014-2018TAVR - 30 Day Follow Up Completed �Some follow up assessment 21-75 days after TAVR TAVR�Baseline KCCQ Completed Baseline and One Year KCCQ CompleteData Completeness Becomes Essential if Institutional and Operator Volume Requirements are Replaced with Quality MetricsSTS/ACC TVT Registry �Mortality and Morbidity Composite Risk Model for TAVRTVT Risk Model: Global Rank MethodologySTS/ACC TVT Registry “New Stuff”Slide Number 68Collecting Data on New Techniques is Becoming �Very Important for the TVT RegistryTVT Registry Updates Cerebral ProtectionCerebral Protection and TVT RegistrySlide Number 73Fracturing of sewing rings of surgically implanted prosthetic valves during V-in-V treatment for degenerated bioprosthetic valves�“Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access”TVT Registry v3 updatesTVT Registry v3 updatesTVT Registry v3 updatesSTS/ACC TVT Registry ResearchSlide Number 82Incidence, Predictors, and Outcomes of�Prosthesis-Patient Mismatch�in 62,125 TAVR Patients��An STS/ACC TVT Registry Report����Howard C. Herrmann, MD �University of Pennsylvania�Philadelphia�The Process of Updating TVT Registry Sites of These Changes in Data CollectionSlide Number 85Slide Number 86Slide Number 87ConclusionsSlide Number 89Mitral Repair Module of TVT RegistryTVT National Volumes Data: Snapshot of U.S. Leaflet Clip Practice Patterns Leaflet Clip �Sites and Records Submitted Leaflet Clip� Median LOS in Days�(25th and 75th percentiles)Leaflet Clip Age �(25th and 75th percentiles)Leaflet Clip �DemographicsLeaflet Clip Procedure Indications� Reasons for Determination of Prohibitive Risk�Leaflet Clip�STS Operative Mortality RiskLeaflet Clip�Mitral Valve Disease Etiology Real World Leaflet-Clip Repair Clinical Outcomes Leaflet Clip Mortality�In Hospital 30 Day and One YearLeaflet Clip StrokeLeaflet Clip �2018 NYHA Data Leaflet Clip �In Hospital TransfusionsLeaflet Clip Morbidity : 30 Day OutcomesLeaflet Clip – Alive and Well* �(among 1-year survivors with complete KCCQ)Leaflet Clip�Baseline KCCQ Completed Slide Number 108New Techniques, Not Investigative Devices, in Transcatheter Valve Treatment0ther TVT Registry V3 updates