Results from 2 300 patients in the source tavi registry changes in patient populations with time
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Results from >2,300 Patients in The SOURCE TAVI Registry: Changes in Patient Populations with time. Dr Martyn Thomas on behalf of the SOURCE investigators. Clinical Director, Cardiovascular Services St Thomas’ Hospital Kings Health Partner’s London. Grant/Research Support

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Results from 2 300 patients in the source tavi registry changes in patient populations with time

Results from >2,300 Patients in The SOURCE TAVI Registry: Changes in Patient Populations with time.

Dr Martyn Thomas on behalf of the SOURCE investigators.

Clinical Director, Cardiovascular Services

St Thomas’ Hospital

Kings Health Partner’s

London


Disclosure statement of financial interest

Grant/Research Support Changes in Patient Populations with time.

Consulting Fees/Honoraria

Edwards Lifesciences

Boston Scientific

Cordis

Disclosure Statement of Financial Interest

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship

Company


Background Changes in Patient Populations with time. :THE SOURCE Registry describes the outcomes in the first group of TAVI patients treated with the Edwards SAPIEN Valve in Europe.

COHORT 2: Feb 09 to Dec 09

40 Centres with 1306 patients

TOTAL:

38 Centres with 2344 patients

COHORT 1:Nov 07 to Jan 09

34 Centres with 1123 patients

32 Centres with 1038 patients

  • 2 Centres

  • Elected not to participate.

  • Excluded: 2 Centres / 85 patients

  • Unable to obtain Ethic Cte approval or administrative issues.

=

+

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The SOURCE Registry has:

100% procedure data

30D Data: COH1 – 99.9% | COH2 – 98%

1Yr Data: COH1 – 98% | COH2 – Avail 2011

All consecutively enrolled

Data Extract – 17MAY2010, 30JUL2010

3


Methods consecutive patients
Methods: Changes in Patient Populations with time. Consecutive Patients

  • The current data is from centres who could provide data on 100% of their consecutively treated patients during this time.

  • Centres that could not provide this were excluded.

  • Transfemoral, Transapical, and [(trans-axillary & trans-aortic)=5] cases are included in this consecutive series.

  • The SOURCE Registry used the 23mm and 26mm Edwards SAPIEN THV requiring 22/24F Transfemoralsheaths and 26F Transapicalsheaths.

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Methods
Methods Changes in Patient Populations with time.

This is a clinical registry. All events and values are site reported and there are no core labs.

The SOURCE Registry Principal Investigators reviewed and adjudicated all clinical and adverse events reported into the Medidata Rave Database.

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The SOURCE Registry – Changes in Patient Populations with time. Total Enrollment

Data Extract – 17MAY2010, 30JUL2010

6


The logistic euroscore overestimates but does categorise risk
The Logistic Changes in Patient Populations with time. EuroSCORE overestimates but does categorise risk

Don’t dismiss the value of EuroSCORE to categorise risk


Patient groupings of interest in the source registry
Patient Groupings of Interest in the Changes in Patient Populations with time. SOURCE Registry

Hypothesis: Patient indication may have changed over the time course of the SOURCE registry.

  • Log EuroSCORE >20 (“standard risk”)

  • Log EuroSCORE <20 (usually patients with risk factors not captured by Log EuroSCORE – potentially “lower risk”……..but unclear)

  • Other patients including “Valve in Valve” to treat degenerative aortic bioprosthesis.

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Changes in patient groups with time numbers of patients per category
Changes in patient groups with time Changes in Patient Populations with time. (Numbers of patients per category)

This was not anticipated!!

(4 patients included in database outside Cohort 1 and Cohort 2 have been excluded)

Data Extract – 17MAY2010, 30JUL2010

9


Has the different patient population resulted in a change in 30 day survival
Has the different patient population resulted in a change in 30 day survival?

Data Extract – 17MAY2010, 30JUL2010

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30 day survival standard risk cohort 1 vs cohort 2 with es 20
30 Day Survival: “standard risk” 30 day survival?Cohort 1 vs. Cohort 2 with ES>20

Data Extract – 17MAY2010, 30JUL2010

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30 day survival cohort 1 vs cohort 2 with es 20
30 Day Survival: 30 day survival?Cohort 1 vs. Cohort 2 with ES<20

Data Extract – 17MAY2010, 30JUL2010

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Demographics and risk factors overall group 20 20 why tavi for 20
Demographics and Risk Factors – Overall Group <20 & >20 30 day survival?Why TAVI for <20?

“Frailty” not measured

in the SOURCE database

Data Extract – 17MAY2010, 30JUL2010

13


Comparison of <20 patient demographics and risk factors in Cohort 1 and 2: Has the pattern of risk changed?

“True risk” in Cohort 2 may have gone “up”.

Data Extract – 17MAY2010, 30JUL2010

14


1 year kaplan meier survival when is euroscore reflected in survival benefit cohort 1 es 20 vs 20
1 Year Kaplan Meier Survival: when is Cohort 1 and 2: Euroscore reflected in survival benefit?Cohort 1 – ES <20 vs. >20

P=0.0529

Data Extract – 17MAY2010, 30JUL2010

15


Valve in valve an indication for tavi
“Valve in valve”: an indication for TAVI? Cohort 1 and 2:

  • In The SOURCE Registry trans-catheter valve therapy appears to be an emerging indication for the treatment of a failing surgical aortic bioprosthesis.

  • Can we categorise these patients?

  • Is there “gold standard” surgical data for redo surgery?


Valve in valve patient demographics the source registry
“Valve In Valve” Patient Demographics Cohort 1 and 2: THE SOURCE Registry

VERY HIGH RISK GROUP OF PATIENTS

26/28 TA

approach

Data Extract – 17MAY2010, 30JUL2010

17


Surgical redo avr patient demographics contemporary surgical literature is limited
Surgical redo AVR Cohort 1 and 2: Patient DemographicsContemporary Surgical literature is limited

Perioperative Risk of Redo Aortic Valve Replacement

Ann ThoracCardiovascSurg 2009

Christiansen et al

Operative risk of reoperative aortic valve replacement

J ThoracCardiovascSurg 2005

Potter et al

Reoperative surgery for degenerated aortic bioprostheses: predictors for emergency

Surgery and reoperative mortality: Vogt et al

Eur J CardiothoaracSurg 2000

Appears “low risk” patient population


Risk factors for operative mortality of repeat heart surgery
Risk factors for operative mortality of repeat heart surgery.

Mean age 54.7yrs

  • Factors associated with operative mortality

    - age

    - associated coronary bypass grafting

    - valve thrombosis or endocarditis

    - replacement of mechanical heart valve

Repeat heart valve surgery: Risk factors for operative mortality.

J ThoracCardiovascSurg 2001

Jones et al


Risk factors for operative mortality of repeat heart surgery1
Risk factors for operative mortality of repeat heart surgery.

Predictive risk factors of re-operative AVR mortality

Re-operation for bioprosthetic aortic structural failure – risk assessment.

Jamieson et al. Eur J Cardiothorac Surgery 2003


The source registry valve in valve what valves have been treated where next
The SOURCE Registry: “Valve in Valve” surgery.What valves have been treated? Where next?

  • Previous bioprostheses include Carpentier Edwards, Hancock, Mitraflow and Mosaic (21-25mm valves).

  • This patient population was not anticipated at the outset of the SOURCE registry.

  • Careful data collection planned for this group in the SOURCE XT registry.

  • Because the patient populations undergoing surgical redo AVR and trans-catheter treatment appear so different it will be difficult to compare outcomes. Ideally a randomised trial would resolve this but patient numbers are now relatively small.


Changes in patient populations with time conclusions 1
Changes in Patient Populations with time: surgery.CONCLUSIONS 1

  • There has been a change in the patient population of TAVI patients between Cohort 1 and Cohort 2 of the SOURCE Registry.

  • This is reflected by an increased number of patients with a Log EuroSCORE of <20 in Cohort 2. However the true “risk” of Cohort 2 may well have gone up, reflected by increased patients with heart failure and mitral regurgitation. 30 day outcomes for Cohort 1 and 2 are the same.

  • Urgent need for the development of “TAVI risk score” to include other factors ie. Frailty; as EuroSCORE may not be truly assessing “risk”.

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Changes in patient populations with time conclusions 2
Changes in Patient Populations with time: surgery.CONCLUSIONS 2

  • “Valve in valve” appears an emerging indication for TAVI.

  • The “valve in valve” patients in SOURCE are very high risk.

  • The contemporary data for redo surgical AVR as a comparator is limited but does suggest a completely different patient population.

  • Comparison of these two treatment options will be difficult in the absence of randomised data.


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