Innehållet i denna fil får endast användas för privat bruk. Kopiering eller annan användning kräver tillstånd från Svein Faerestrand, Haukeland

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1 Innehållet i denna fil får endast användas för privat bruk. Kopiering eller annan användning kräver tillstånd från Svein Faerestrand, Haukeland Universitetssjukhus, Bergen, Norge

2 Financial Disclosure: Professor dr. med. Svein Færestrand Seksjonsleder for Pacing, ICD og Hjertesviktbehandling Hjerteavdelingen, Haukeland Universitetssykehus og Universitetet i Bergen, Norge Served as investigator for: Medtronic Inc., St Jude Medical, Boston Scientific and Biotronic Lectures for: Medtronic Inc. and St Jude Medical Research Grants from: Medtronic Inc. and St Jude Medical Stock Options/Salary Support: none CRT Session. Januarimøtet. Stockholm 24. Januar 2013 Rundt 1/3 av pasientene har ikke god effekt av behandlingen ICD EHRA/HRS Expert Consensus Statement..Europace (2012) 14, n=75 non-responders CRT> 6 months 1. Abraham WT et al. N Engl J Med 2002;346: Young JB et al. JAMA 2003;289: Abraham WT et al. Circulation 2004;110: Abraham WT et al. Heart Rhythm 2005;2:S Chung ES et al. Circulation 2008;117: Abraham WT HRS 73% av pasientene Mullens et al. J Am Coll Cardiol 2009;53: Mullens W et al. J Am Coll Cardiol 2009;53:

3 Inntil nylig var det ingen prospektive randomiserte studier Motstridende resultat i retrospektive studier RV septum plassering ga større revers remodelering enn RV apex (1) Lik LV revers remodelering ved alternative apex eller septum RV ledning posisjoner (2,3) 1. Riedlbauchova L et al. Eu J Heart Fail 2006;8: Bulava A et al. Pacing Clin Electrophysiology 2009;32(suppl 1):S Khan FZ et al.. Pacing Clin Electrophysiology 2011;34: (A) Coronary sinus venogram in left anterior oblique 30 (LAO) view demonstrating anterior, anterolateral, lateral, posterolateral, and posterior left ventricular (LV) segments. LAO Aortaklaffelukning Posteriøre segment forsinket 315 ms B.2010 B

4 Specke Tracking Radial Strain korrelerer med «delayed enhansed CMR» for påvisning av transmurale arr (1, 2) Hos CRT pasienter har Radial strain amplitude <10% på stedet for LV ledningen en høy negativ prediktiv verdi (91%) for response [LV revers remodelering (3)] Bau Becker et al. J Am Coll Cardiol 2008;51(15): Delgado et al. Circulation 2011;123(1): Khan et al. J Am Soc Echocardiogr. 2010;23(11): Hos 85 konsekutive pasienter (alder 66±11 years) ble RV ledningen plassering ble randomisert til: RV-A(n=43) og RV-HS(n=42) LV ledningen ble plassert i det seneste mekanisk aktiverte LV segmentet (konkordant LV ledning) med strain rate >10%, påvist med 2-dimensjonal speckle tracking radial strain (ST-RS) ekkokardiografi. Konkordante LV ledninger oppnådde en hos 72%, likt for RV-A og RV-HS (79% versus 64%; P=0.13). Ingen forskjell på responder rate for LV revers remodelering (reduksjon av LV end-systolisk volume 15%) mellom: RV-A ledninger (26 pasienter [65%]) og RV-HS ledninger (25 pasienter [64%]; P= 0.93). Ingen forskjell på responder rate for LV reverse dyssynkroni (reduksjon av anteroseptal til posterior forsinkelse 50%) ved ST-RS måling: RV-A ledninger (25 pasienter [63%] og RV-HS ledninger (24 pasienter [62%]; P= 0.93). RV-A og RV-HS ved CRT fører til: Samme % LV revers remodelering respondere Samme % LV revers dyssynkroni respondere 3

5 Kristiansen et al. showed similar effects in both RV outflow tract and apical lead positions. Even though this is a small study, the books on RV lead position can hopefully now be closed and we can focus our emphasis on LV lead location Eur J Heart Fail (2012) 14(5): The echocardiographic response from baseline to 6 months after CRT in patients with concordant and discordant LV lead positions. LV ledningen ble prospektivt plassert i det senest aktiverte LV segmentet bedømt ved 2D speckle tracking radial strain ekkokardiografi hos 103 pasienter Mekanisk dyssynkroni målt ved: Anteroseptal til posterior (AS-P) forsinkelse (Speckle tracking radial strain) Interventrikulær mekanisk forsinkelse (IVMD; Pulset Doppler av aorta blodstrøm og pulmonal blodstrøm) Echocardiographic intraventricular dyssynchrony at baseline and 6-month follow-up evaluated by ST-RS echocardiography. Oppnådde konkordant LV lednings plassering hos 70% av pasientene LV revers remodelering respondere (LV-RR; 15% LV end-systolisk volum reduksjon) var: Konkordant LV ledning [51 pasienter (76%)] versus Diskordant LV ledning [13 pasienter (45%); P = 0.003] 4

6 Mekanisk resynkroniserings respondere ( 50% AS-P forsinkelses reduksjon) var: Konkordant LV ledning [44 pasienter (66%)] versus Diskordant LV ledning [10 pasienter (34%); P = 0.005]. Konkordant LV ledningsplassering var den eneste uavhengige prediktor for LV revers remodelerings respondere (odds ratio, 4.177; P= 0.004). Konkordant LV ledningsplassering var uavhengig prediktor for mekanisk resynkronisering respondere (odds ratio, 4.691; P = 0.004) Perhaps, the new finding of the study provides, for the first time, a direct relationship between dyssynchrony-targeted LV lead placement and the beneficial result of mechanical resynchronization... Mechanical resynchronization was observed in 66% of patients with concordance between LV lead location and dyssynchrony, 48% with the adjacent (one segment) relationship, and 0% with the discordant relationship.... Therefore the message is that if one can place the LV lead in the free wall region that has the most severe contractile delay, a maximal reduction in dyssynchrony could be achieved that will be translated to the greatest amount of LV reverse remodelling and best long-term clinical outcome.. Prospektivt randomisert studie av: Målrettet plassering av LV ledningen i segmentet for seneste mekaniske aktivering (Speckle Tracking ekko) og med strain rate > 10% (ikke i arrområder) Effekten på klinisk utkomme av målrettet LV ledningsplassering versus vanlig klinisk praksis for LV ledningsplasseringen Khan et al. J Am Coll Cardiol 2012;59: ) 5

7 Responder Rate: Target vs. Control (70% vs. 55%;p=0.031) Absolutt forskjell på primære endepunkt var 15% [95% CI (2%, 28%)]. J Am Coll Cardiol. 2012;59(17): doi: /j.jacc J Am Coll Cardiol. 2012;59(17): doi: /j.jacc Target gruppen (n=103) vs Kontroll gruppen (n=104) hadde signifikant bedre: NYHA funksjonsklasse 6 minutters gangtest QOL (MLHFQ) LVED reduksjon LVES reduksjon LVEF forbedring J Am Coll Cardiol. 2012;59(17): doi: /j.jacc En oppnår konkordant plassering med akseptabel strain rate (>10%) hos vel 70% av pasientene Programmere så kort AV intervall at en oppnår >92% biventrikulær pacing (1) Konkordant ledningsplassering fører til Ikke evidens for at AV (og VV) delay optimalisering ved bruk av ekkokardiografi eller IEGM-baserte teknikker forbedrer utkomme i den generelle CRT populasjonen Flere respondere med LV revers remodelering Flere respondere med LV revers dyssynkroni Redusert total mortalitet Redusert kombinert innleggelse i sykehus + død Bedring av NYHA funksjonsklasse, 6 minutter gangdistanse og QOL, Ikke adekvate metoder? (optimalisering ved kontroller hver 3. måned, Quick-opt, Smart AV) Behov for kontinuerlig automatisk AV og VV optimalisering hos ambulatoriske pasienter (hvile og anstrengelse). 1. Koplan et al. J Am Coll Cardiol 2009;53:

8 LBBB and intact RV conduction Professor Svein Faerestrand Director of Pacing, ICD and Heart Failure Therapy AV block Department of Heart Disease Haukeland University Hospital and University of Bergen Bergen, Norway LV pacing ESC Congress, Munich August BiV pacing Martin DO et al. Heart Rhythm Nov;9(11): doi: /j.hrthm Epub 2012 Jul 14. Synchronized LV Pacing: LV pacing synchronized with spontaneous conduction could lead to: Paces the LV in coordination with intrinsic RV activation, when present Better LV function than BiV pacing1-3 Better RV function than BiV pacing4,5 + Echo-optimal AV delays during BiV pacing : Continuous optimization: Optimizes AV and VV delays based on periodic, automatic measurement of cardiac conduction Correlate with Inter-Atrial Conduction Time6-8 Correlate with P-wave duration Van Gelder et al., JACC 2005; 46: Verbeek et al., Am. J. Physiol. 2006:H Kurzidim et al., PACE 2005; 28: Lee et al., JCE 2007; 18: Varma et al., JACC: Cardiov. Imag. 2010; 3: Strohmer et al., PACE 2004; 27: Levin et al., JCE 2007; 18: Jones et al., JCE 2010; 21: Comparison between acrt and Echo optimization 94 centers: US, Europe, Canada, Australia, Central Asia, Hong Kong and Japan Enrolment Randomization n=522 Double-blinded Adaptive CRT (n=318) NYHA Class III/IV QRS 120 ms LVEF 35% Follow-up No significant differences between adaptive CRT group and Echo optimized group of patients Age: years NYHA Functional Class III: 94%-96% Ischemic origin: 45%-51% Left Ventricular Ejection Fraction: 25%-25% 2:1 ON vs OFF QRS Duration: 154 ms-156ms Echo optimization (n=160) 6 m. LBBB: 75%- 80% 12 m. Krum H et al. Am Heart J 2012 ; 163:

9 Clinical Composite Score(CCS) developed by Packer Concordance correlation coefficient (CCC) between the AoVTI values under echo-optimized programming under algorithm-recommended programming CCC should exceed 0.82 both at randomization and 6- month post-randomization visits To demonstrate that the ambulatory adjustments of the CRT settings provided by the algorithm are safe acrt arm: 95.5± 5.7% (range: %) ventricular pacing BiV pacing accounted for a median of 50.9% of all ventricular pacing, the rest being LV only pacing Echo arm: 95.1±10.5% (range: %) ventricular pacing Virtually all ventricular pacing was BiV AdaptivCRT is non-inferior to echo optimization performed at 1 and 6 months Non-inferiority P < Results at 6 months for Clinical Composite Score Concordance correlation coefficient (CCC) between the AoVTI values AdaptivCRT algorithm resulted in a 44% reduction in RV pacing In patients with no AV block, LBBB and normal sinus rhythm, AdaptivCRT: Produced mostly synchronised LV pacing (64% + 33%) Resulted in better clinical response at 6 months (81% vs. 68%) n=219 8

10 At the mean follow-up of 9.7 months, the mortality rate was 7.5% in the acrt arm and 8.8% in the Echo arm The rate of first HF hospitalization was 18.6% in the acrt arm and 16.1% in the Echo arm. Neither mortality (log-rank p=0.47) nor first HF hospitalization (log-rank p=0.61) rates were significantly different between the arms. There was no difference in time to first occurrence of VT/VF between the acrt and Echo arms (log-rank p=0.87). The rate of VT/VF per patient-year was 1.68 in the acrt arm and 0.88 in the Echo arm and were not significantly different (GEE p=0.46). A 12% Absolute Higher Response Rate Achieved with AdaptivCRT compared to Historical CRT Trials 1 Over 1,300 Patients Studied Historical Cohort: MIRACLE, MIRACLE ICD, InSync III Marquis *, PROSPECT AdaptivCRT Cohort: Based on Adaptive CRT trial therapy arm * AV optimised only. 1 Singh JP, et al. Clinical Response with Adaptive CRT Algorithm Compared with Echo Guided AV Optimization: A Propensity Score Analysis of Multi- Center Trials. Presentation at European Society or Cardiology Congress % Response Improved as compared to Historical trials 15 % 10 % 5 % 0 % 12 % [95% CI: 2.7% to 19.2%] As expected, acrt patients with a normal AV interval (n=150) received higher % LV pacing (73±25% vs. 18±28%, p<0.001) through 6 months than those with a prolonged AV interval (n=168). David Birnie et al. Abstract at AHA

11 In the subgroup with normal AV, a greater proportion of acrt patients were improved in CCS at 6 months (81% vs. 69%, p=0.04) than Controls. There was also a trend towards lower death and HF hospitalization (HR=0.59, 95% CI: , log-rank p=0.10) with acrt compared to Control in this subgroup. In the acrt arm, % LV pacing 50% was associated with decreased risk of death or HF hospitalization (HR=0.49, 95% CI: , p=0.012). The AdaptivCRT algorithm optimizes AV and VV interval continuously and paces the LV only in pts. with normal AV conduction The acrt algorithm is non-inferior to echo optimization of AV and VV intervals The acrt algorithm reduces RV pacing significantly In patients with normal AV conduction: The acrt algorithm provided mostly synchronized LV pacing The acrt resulted in 12 % better clinical response compared to BiV pacing with echocardiographic optimization In the acrt arm, % LV pacing 50% was associated with decreased risk of death or HF hospitalization Compared to historical CRT data the acrt algorithm improves the the clinical response rate by 12% 10