Mechanischer Herzklappenersatz - noch zeitgemäß oder ... · Eight papers were included, all of which used the Short-Form 36 Health Survey (SF-36). Postoperatively, most people had

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Mechanischer Herzklappenersatz -noch zeitgem äß oder Implantat der Vergangenheit

Jürgen Ennker

Mediclin Herzzentrum Lahr / Baden

www.ennker.de

www.herzzentrum-lahr.de

KliniknamePräsentationstitel am tt.mm.jjjj 2


� Ideale Klappe

� Kein Klappenversagen / dauerhafte Haltbarkeit

� Keine Thrombogenität

� Kein Widerstand gegen den Blutfluss

� Leichte Implantierbarkeit

�Gibt es derzeit nicht


Aspekte der Klappenauswahl

� Patientenfaktoren

� Alter Größe

� Lebenserwartung´ Begleiterkrankungen

� Schwangerschaftswunsch? Lifest yle

� Operationsspezifische Faktoren

� Einfachheit des chirurgischen Vorgehen

� Risiko einer möglichen Reoperation

� Operative Sterblichkeit


5 Heart Institute Lahr/Baden

Aortic Valve Surgery

Aortic ValveReplacement (AVR)

Transcatheter AorticValve Implantation

(TAVI)

Aortic Valve Repair

Biological

Stentless

Homograft(Ross)

Stented

Mechanical

TransfemoralXenograftSutureless Conventional

Transapical


Aortic Valve Bypass (AVB)

� Minimally invasive alternative to Aortic Valve Replacement (conventional/percutaneous)

� Target market:

- Aortic stenosis patients

- Early market: elderly, high risk

� >30-year track record of favorable clinical outcomes:

- 1,500 AVB Cases Performed

- 193 AVB Cases in Literature

Why has AVB not attracted interest?

� Low surgical adoption due to the lack of delivery instrumentation and therefore high-risk nature of the procedure

Source: Gammie et al., Circulation ePub Sept 15, 2008


An algorithm for choice of prosthetic heart valveAn algorithm for choice of prosthetic heart valve

Rahimtoola SH, JACC 2003;41(6):893-904


AHA Guidelines 2014, Circulation



GuidelinesGuidelines areare notnot alwaysalways helpfulhelpful




Grunkemeier, Rahimtoola, Starr, 1997

Mechanical valve usage


Outlet strut fracture of Björk-Shiley convexoconcave valve



Mechanische Herzklappen

Caged Ball Doppelflügel Klappe

Mono-/Kipp-scheibenklappe

Advantage Med Hall Easy FitStarr-Edwards

Vorteile mechanischer Klappen

�Lebensdauer “100 Jahre”

�Einfach zu implantieren

�Geringes ReOperations Risiko

�Gute Hämodynamik

�Mittlerweile ist das Selbst-management der Antikoagulation möglich

Nachteile mechanischer Klappen

� Antikoagulation (Marcumar) erforderlich, INR 2,5 bis 3,5

� Lebenslange, sehr gute und gewissenhafte Medikamentenkontrolle unabdingbar

� Bereits eine kurze Unterbrechung kann schlimmste Folgen haben (z.B. durch Zahnarztbehandlung)!

� Erhöhtes Blutungsrisiko

� Klappengeräusch

� Vitamin K reiche Ernährung hat Einfluss auf die Antikoagulation z.B. Grünkohl

Ursprung biologischer Herzklappen

Xenograft

� Aortenklappe vom Schwein (porcine Klappen)

� Hancock II, Mosaic, Freestyle

� Klappe aus Rinder Perikard (bovine Klappen)

� Von Medtronic nicht vertrieben

Allograft / Homograft

� Leichenklappe

� Von Medtronic nicht vertrieben

Vorteile biologischer Klappen

� Keine Antikoagulation oder Medikation notwendig

� Jährliche Kontrolle ausreichend

� Kein störendes Klappengeräusch

� Haltbarkeit 6 bis 20 Jahre, abhängig von:

� Alter des Patienten: ab 65 Jahre sehr gut

� Position: Aortenklappen zeigen höhere Haltbarkeit

� Klappen Modell

� Langsame Klappendegeneration, planbare ReOP

� Auch für Frauen im gebärfähigen Alter

Nachteile biologischer Klappen

� Begrenzte Haltbarkeit in Patienten unter 65 Jahren

� Grenzwertige Hämodynamik bei gestenteten, kleinen Klappen (19 und 21 mm)

� Allgemein schwieriger zu implantieren


Zwei Typen von porcinen Klappen

Stented (mit Gerüst)

� Klappe in ein Kunst-stoff Gerüst genäht

Unstented (gerüstlos)

� Klappe weitgehend unverändert

Freestyle™Mosaic™

KliniknamePräsentationstitel am tt.mm.jjjj 22SBAUER 22Klinikname

Kontraindikation for orale Antikoagulation

Patienten ComplianceGastrointestinale BlutungenLebercirrhoseZerebrale BlutungenIntraokulare BlutungenSchwangerschaft(Medikamenteninteraktion(Antidrepressiva,

Antimetabolite, Eisen, Antiarrhythmika(amiodarone), NRSA))


Butchart et al. J Thorac Cardiovasc Surg. 2002; 123: 715-23

Late survival after aortic valve replacement(>30 days ) by anticoagulation variability

low anticoagulation variability

intermediate anticoagulationvariability

0

20

40

60

80

100

0 2 4 6 8 10 12 14 16

Sur

viva

l(%

)

Years aftersurgery

high anticoagulationvariability

P < 0.001

UK Population




Mechanischer Herzklappenersatz -noch zeitgemäß oder Implantat der Vergangenheit

�


Mechanischer Herzklappenersatz -noch zeitgemäß oder Implantat der Vergangenheit

� Eur J Cardiovasc Nurs. 2014 Mar 15. [Epub ahead of print]

� Health-related quality of life of patients after mechanical valve replacement surgery: An integrative review. Thomson Mangnall LJ1, Gallagher RD, Sibbritt DW, Fry MM.

� peer-reviewed studies published between 2000-2013, which focused on patients who had mechanical valve replacement, aged <65 years, and used a valid measure of HRQoL.

� Eight papers were included, all of which used the Short-Form 36 Health Survey(SF-36).

� Postoperatively, most people had positive and sustained HRQoL improvement.

� In the early postoperative period all data showed significant improvement in at least four of eight health domains (physical function, role-physical, vitality, social function). Two-thirds of people also had significant improvement in an additional two health domains (general and mental-health).

� Conclusions:

� Mechanical valve replacement surgery results in importan t and sustainedimprovements in HRQoL .


� Eur J Cardiothorac Surg. 2009 Jul;36(1):84-90; discussion 90. doi: 10.1016/j.ejcts.2009.02.048. Epub 2009 Apr 14.

� Aortic and mitral valve replacement in children: is there any role for biologic an d bioprosthetic substitutes?

� Alsoufi B1, Manlhiot C, McCrindle BW, Canver CC, Sallehuddin A, Al-Oufi S, Joufan M, Al-Halees Z.

� OBJECTIVE: The ideal valve substitute in children does not exist.

� METHODS: Medical records of children who underwent AVR orMVR from 1986 to 2006 were reviewed. Median follow-up durationwas 10.5 years.

� .RESULTS: 110 children (age 15.6+/-2.6 years, 80% females) underwent 123 valve replacements with biologic and bioprostheticsubstitutes including 87 MVR and 36 AVR (13 had both).

� 15 years after valve replacement, 16% of patients had diedwithout subsequent reoperation, 66% underwent valvereoperations, and only 18% remained alive without furtherreoperation.

� CONCLUSION: favorable results such as low valve-relatedmorbidity rate, good long-term survival and functional statusencourage their consideration as valid replacementalternatives in selected children especially females.


� J Heart Valve Dis. 2013 Nov;22(6):810-6.

� Risk-adjusted survival after tissue versus mechanical aortic valve replacement: a 23-year assessment.

� Gaca JG1, Clare RM2, Rankin JS3, Daneshmand MA2, Milano CA2, Hughes GC2, Wolfe WG2, Glower DD2, Smith PK2.

� Between 1986 and 2009, primary isolated AVR, was performed withcurrently available valve types in 2148 patients (1108 tissue valves, 1040 mechanical).

� The average time to death or follow up was seven years, and followup for survival was 96.2% complete.

� RESULTS: Differences (tissue versus mechanical): median age 73 versus 61 years; non-elective surgery 32% versus 28%; CABG 45% versus 35%; renal failure 6% versus 1%; diabetes 18% versus 7% (p<0.01).

� Unadjusted Kaplan-Meier survival was significantly lower with tissuethan mechanical valves; however, after risk adjustment for theadverse profiles of tissue valve patients, no significant difference was observed in survival after tissue or mechanical AVR.

� CONCLUSION: Tissue and mechanical valves achieved simil arsurvival characteristics across the spectrum of patient r isk.


� Int Cardiovasc Res J. 2013 Jun;7(2):71-4. Epub 2013 Jun 1.

� Tricuspid Valve Replacement, Mechnical vs. Biological Valve, Which Is Better?

� Altaani HA, Jaber S.

� The initial trial in tricuspid surgery is repair; however, replacement is done whenever the valve is badlydiseased. Tricuspid valve replacement comprises 1.7% of all tricuspid valve surgeries.

� MATERIALS AND METHODS:

� The present retrospective study was performed using the medical records of 21 cases who underwenttricuspid valve replacement from January 2002 until the end of December 2010. The mean age of theparticipants was 52.3±8.8 years and 66.7% were females. In addition, tricuspid valve replacement was associated with mitral valve surgery, aortic valve surgery, and both in 14.3%, 4.8%, and 33.3% of thecases, respectively. Yet, isolated tricuspid valve replacement and redo surgery were performed in 10 cases (47.6%) and 8 cases (38.1%), respectively. Besides, trial of repair was done in 14 cases (66.7%). Moreover, biological and mechanical valves were used in 76.2% and 23.8% of the patients, respectively.

� RESULTS:

� 57.1% of the deaths had occurred in the cases where the biological valve was used, while

� 42.9% of the deaths had taken place where the mechanical one was utilized.

� CONCLUSIONS:

� The findings of the current study showed no significanthemodynamic difference between mechanical and biologica lvalves.





ESC-guideline Pregnancy


MV vs BV


Trend in the US – towards BV


MV vs. BV




Altersverteilung und Typ von Herzklappenerkrankungen

In Schwellen- und Entwicklungsländern treten Herzklappenerkrankungen früher

auf und/oder ist die Ursache von Herzklappenerkrankungen eher rheumatischer

als degenerativer Natur

Quelle: nach Soler-Soler, J.; Worldwide perspective of valve disease; Heart, 2000


Beispiel: Künstliche Herzklappen in Indien 2012

Anzahl:

MHV: 24.000 (80%)

THV: 6.000

Summe: 30.000

Quelle: Dolcera Market Research Services: “Strategic Insights:Heart Valve Replacement Market – India”, 2012

Zum Vergleich: Künstliche Herzklappen in China (2012)

- insgesamt 115.000 Herzklappen implantiert

- 77.000 mechanische (65%), 38.000 biologische Herzklappen

Künstliche Herzklappen in Deutschland (2011)

- insgesamt 30.000 Herzklappen implantiert

- 4.000 mechanische (14%), 26.000 biologische Herzklappen

Quelle: Medtronic,

Funkat, A. Cardiac Surgery in Germany 2011, ThoracCardiovascSurg, 2012


Ein Blick in die Zukunft….

Quelle: Millenium Research Group: “Heart Valve Replacement Device Market Asia-Pacific”, 2014

Die Prognose zeigt einen deutlich wachsenden Markt, aber bei fast gleichbleibender

prozentualer Verteilung zwischen mechanischen und biologischen Herzklappen


� Zusammenfassung

� Mechanischer Herzklappenersatz:

� Indikation – multifaktoriell - Patientenwunsch

� Einsatz zurückgegangen - verbesserte Antikoagulation

� - geringeres Reoperationsrisiko

� Subgruppen, wie jüngere Pat. - in der wiss Diskussion

� Schwangerschaft und mechanische Klappe möglich

�Aktueller Teil der herzchirurgischen Implantate



Vielen Dank für Ihre Aufmerksamkeit

Jürgen Ennker

Mediclin Herzzentrum Lahr/ Baden

E-Mail [email protected]

www.ennker.de


Documents

Mechanischer Herzklappenersatz - noch zeitgemäß oder ... · Eight papers were included, all of which used the Short-Form 36 Health Survey (SF-36). Postoperatively, most people had