Εκτίµηση ποιότητας ζωής µετά από διαδερµικές βαλβιδικές παρεµβάσεις Παναγιώτα Γεωργιάδου

Εκτίµηση ποιότητας ζωής µετά από διαδερµικές βαλβιδικές παρεµβάσεις Παναγιώτα Γεωργιάδου Β Τµήµα Αιµοδυναµικών Μελετών και Επεµβατικής Καρδιολογίας Ωνάσειο Καρδιοχειρουργικό Κέντρο Αθήνα

Στένωση Αορτής η πιο συχνή βαλβιδική πάθηση στην Ευρώπη, µε αυξηµένη επίπτωση στις µεγαλύτερες ηλικίες 2.5% ποσοστό εµφάνισης της νόσου στα 75 έτη κ 8.1% στα 85 έτη ταχεία εξέλιξη και υψηλά ποσοστά θνητότητας µετά την εµφάνιση συµπτωµάτων (40% στα πρώτα 2 έτη, εάν δεν θεραπευθεί) 1η θεραπευτική επιλογή- χειρουργική αντικατάσταση 30% των ασθενών µε σοβαρή συµπτωµατική αορτική στένωση κρίνονται ανεγχείρητοι Iung et al. European Heart Journal 2003; 24: 1231 1243 Varadarajan et al. European Journal of Cardio-thoracic Surgery 2006;30: 722 727

Διαδερµική εµφύτευση αορτικής βαλβίδας TAVI-Transcatheter Aortic Valve Implantation Cribier A et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002; 106: 3006-3008 CoreValve 2 διαθέσιµοι τύποι βαλβιδικών αορτικών προθέσεων: Medtronic CoreValve κ Edwards Sapien Edwards Sapien τεχνική δυνατότητα πραγµατοποίησης της TAVI κ η ασφάλεια της µεθόδου έχει αποδειχθεί Leon et al. N Engl J Med 2010;363:1597-1607 Smith et al. N Engl J Med 2011;364:2187-2198 Tamburino et al. Circulation 2011;123:299-308

PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 699 Cohort A: High-Risk Total = 1,057 patients 2 Parallel Trials: Individually Powered Cohort B: Inoperable N = 358 Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR VS AVR TA TAVR VS AVR TF TAVR VS Standard Therapy Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

PARTNER Cohort A: Results Mortality: Numerically but not statistically lower in the TAVI group at 30 days Major strokes: Higher in TAVI-treated patients at 30 days and one year All stroke or TIA: Statistically greater with TAVI at 30 days and one year Outcomes Outcome TAVI (%) Surgery (%) p Mortality, 30 d 3.4 6.5 NS Mortality, 1 y 24.2 26.8 NS Major stroke, 30 d 3.8 2.1 0.20 Major stroke, 1 y 5.1 2.4 0.07 All stroke or TIA, 30 d 5.5 2.4 0.04 All stroke or TIA, 1 y 8.3 4.3 0.04 Smith C et al. NEJM 2011: 364;2187-98

PARTNER Cohort B: Results @ 1-y, rates of all-cause death and the composite of death or repeat hospitalization were dramatically lower in the TAVI group Primary end point and secondary end points End point TAVI (%) Standard (%) Hazard ratio (95% CI) p Primary end points 1-y all-cause death 30.7 50.7 0.55 (0.40 0.74) <0.001 1-y all-cause death or repeat hospitalization 42.5 71.6 0.46 (0.35 0.59) <0.001 Secondary end points 30-d major stroke 5.0 1.1 0.06 30-d vascular complications 16.2 1.1 <0.001 1-y cardiac death 19.6 41.9 <0.001 1-y major bleeding 22.3 11.2 0.007 Survivors: Cardiac symptoms a at 1 y 25.2 58.0 <0.001 a. NYHA class 3 or 4 heart failure Leon M et al. NEJM 2011: 363;1597-607

Valve Durability and Haemodynamic Performance THV have greater valve areas and lower gradients than surgical bioprostheses There was no evidence of structural or non-structural valvular deterioration, stent fracture, deformation, or valve migration Kodali SK et al. N Engl J Med 2012;366:1686 95

5-Year Outcome After TAVI This study demonstrated favorable long-term outcomes after successful TAVI with a 5-y survival rate of 35% Mean AVA decreased on average by 0.06 cm2/ year, and mean TVG increased by 0.27 mm Hg/year throughout the 5-y period Toggweiler S et al. JACC 2012. pii: S0735-1097(12)05533-7

5-Year Outcome After TAVI Moderate prosthetic THV failure was observed in 3 patients at 5 y, but no pt developed severe transvalvular regurgitation or restenosis Concomitant MR improved in the majority of pts and remained improved at the 5-y fu More than 90% of pts were in NYHA class 1 or 2 during the whole observation period Toggweiler S et al. JACC 2012. pii: S0735-1097(12)05533-7

Recent recommendations for the use of TAVI Vahanian A et al. European Heart Journal 2012: 33;2451 96

Εκτίµηση της Ποιότητας Ζωής HRQoL -Health-Related Quality of Life Η εκτίµηση της ποιότητας ζωής είναι πολύ σηµαντική σε υπερήλικες ασθενείς αλλά και πολύ περίπλοκη: 1) η µεγάλη ηλικία είναι ανεξάρτητος προγνωστικός δείκτης θνητότητας κ νοσηρότητας 2) µεγάλη συν-νοσηρότητα 3) αποκλεισµός αυτής της οµάδας από τις κλινικές µελέτες Σηµαντική µείωση των συµπτωµάτων, βελτίωση του λειτουργικού σταδίου και της ποιότητας ζωής µετεγχειρητικά σε ηλικιωµένους ασθενείς µετά από χειρουργική αντικατάσταση αορτικής βαλβίδας κ επαναφορά σε επίπεδα παρόµοια µε αυτά του γενικού πληθυσµού Sedrakyan et al. J Am Coll Cardiol 2003;42:1208 14 Lam et al. Age Ageing 2004;33:307 309 Sundt et al. Circulation 2000; 102: III 70-4

Studies assessing HRQoL in pts undergoing TAVI Gotzmann n=44 Krane n=99 Age Female LES/STS 79.1±7 22(50) 18.3±12.4 81±6 58(58.6) 20 Ussia 81.7±4.7 17(57) 25.3±8.1 n=30 Bekeredjian 86±2.9 47(59) 24±15.1 n=80 Gonçalves 82±8 40(54.1) 19.3±9.9 n=74 Georgiadou n=36 80.5±5.9 15(42) 29.7±13.7 Gotzmann 78±6.6 26(51) 19.6±11.3 n=51 Ussia n=143 81±4.6 85(59) 23.4±14.7 Reynolds n=179 Cohen n=348 Fairbairn n=99 Krane n=186 Kala n=45 Grimaldi n=144 Age Female LES/STS 83±9 97(54) 11.2±5.8 * 84±7 139(42.4) 11.8±3.4 * 80±6 51(51) 20±13 80.8±6.8 118(63) 19.7±12 82±4.5 31(68.9) 22.3±7.6 84.7±3.4 74(51.7) 26.1±16.7 9.2±7.7 Georgiadou P et al. Age Ageing 2013;42:21-6

Methods: Quality of Life Instrument Short Form-36 (SF-36) Description/Role generic health survey of 36 questions each dimension is scored on a 0 100 scale with higher scores reflecting better HRQoL no disease-specific SF-12 12-item questionnaire brief, high feasible cost of losing detailed information

Methods: Quality of Life Instrument Kansas City Cardiomyopathy Questionnaire (KCCQ) Minnesota Living with Heart Failure questionnaire (MLHFQ) EQ-5D (EuroQOL) Description/Role 23-item measuring 5 domains: symptoms, physical limitations, quality of life, social limitations, self-efficacy Heart failure-specific QOL, scores: 0-100 (higher = better) Correlation with NYHA class, independent predictor of mortality (decline of 10 or more is significant) 21-item self administered questionnaire Evaluates heart failure s effects on the pt s physical, emotional, social and mental dimensions The higher the score, the worse (change>5 points is clinical significant) Generic assessment of 5 dimensions: mobility, self care, usual activities, pain-discomfort, and anxiety-depression 3 levels: no problems, some problems, extreme problems Complementary due to low sensitivity- for multi-national use

Baseline HRQoL assessment All studies have unanimously reported TAVI pts to be a full two standard deviations below the average of the general population regarding HRQoL assessment at baseline Baseline summary scores correlated with NYHA class III-IV The co-existence of a chronic disease along with multiple other morbidities is mainly responsible for this enormous decline in pre-procedural HRQoL levels similar to those following a major stroke High prevalence of concomitant CAD with a history of percutaneous or surgical revascularization, renal insufficiency, chronic lung disease and cerebrovascular disease The physical component was severely limited compared with age-matched healthy population before TAVI but there are contradictory results regarding the mental component Georgiadou P et al. Age Ageing 2013;42:21-6

Short-term HRQoL after TAVI Gotzmann Krane Ussia Bekeredjian Gonçalves T r a n s a r t e r i a l corevalve 18 F 7 3 t r a n s a r t e r i a l CoreValve 18 F and 26 transapical Edwards Sapien T r a n s a r t e r i a l CoreValve 18 F Transfemoral CoreValve 18 F 2 1 t r a n s f e m o r a l C o r e V a l v e, 2 8 transfemoral and 25 transapical Edwards Sapien 1 MLHFQ a substantial enhancement in the overall MLHFQ score 3 SF-36 A significant improvement in physical functioning, bodily pain, general health, vitality- No changes in role-physical, social functioning, and mental health- A marked impairment in role emotional A high degree of independence 5 SF-12v2 A marked increase in the 8 health subscales - A severe impairment of pre-procedural summary scores compared with general population, which were restored after the procedure 6 SF-36 A significant increase in all 8 health components, with the greatest gain in physical functioning and the lowest in bodily pain, along with a significant improvement in neurohormonal activation 6.5 MLHFQ A striking improvement in global MLHFQ scores as well as in physical and emotional dimensions- A large majority of patients living independently and reaffirming their decision to have TAVI Georgiadou P et al. Age Ageing 2013;42:21-6

Mid-term HRQoL after TAVI Georgiadou Transarterial CoreValve 18 F 11.3±4.9 SF-36 and SF-12v2 A significant improvement in all domains and the summary scale scores, which were higher than those of general population norms Gotzmann Transarterial CoreValve 18 F 12±1 MLHFQ Persistent beneficial effects on MLHFQ score, exercise capacity and neurohormonal activation Ussia Transarterial CoreValve 18 F or Edwards Sapien 12 SF-12v2 A remarkable improvement in post-procedural summary scores, which were similar to general population norms Reynolds Transarterial Edwards Sapien 12 KCCQ and SF-12 A larger benefit of KCCQ and SF-12 summary scores were observed at 12 months Fairbairn Transarterial CoreValve 18 F 12 SF-2v2 and EQ-5D A sustained marked increase in physical health score compared to baseline with no change in mental health score Krane Transarterial or transapical CoreValve or Edwards Sapien 12 SF-36 A significant increase in physical scores with a minor change in mental scores but both comparable to age-matched population post TAVI

1-Y Results of TAVI in Severe Symptomatic Aortic Valve Stenosis 51 pts underwent transarterial 18F CoreValve mean age 78 ± 6.6 years, 26 (51%) female, mean LVEF: 58.4 ± 12.2% LES 19.6±11.3%, STS 9.3± 4.8% baseline, 30-d and 1-y fu Before TAVI 30 days after TAVI 1 y after TAVI NYHA III/IV 48(94%) 9(18%) 13(26%) <0.001 <0.001 BNP 642±634 340±253 323±266 <0.001 <0.001 Gotzmann et al. AJC 2011; 107:1687-92 Gotzmann et al. Heart 2010; 96:1102-6

1-Y Results of TAVI in Severe Symptomatic Aortic Valve Stenosis MLHFQ 39.6 ± 19 vs 25.1 ± 17.7 vs 26.1 ± 18, p <0.001 6-min WD 185 ± 106 vs 248 ± 119 vs 266 ± 118 m, p<0.001 TAVI revealed sustained symptomatic benefits, lasting improvements in HRQoL reduced neurohormonal activation and enhancement in exercise capacity Gotzmann et al. AJC 2011; 107:1687-92 Gotzmann et al. Heart 2010; 96:1102-6

1-y Results of HRQoL Among Pts undergoing TAVI 186 pts underwent CoreValve or Edwards Sapien, transarterial (n=133) or TA (n=53) mean age 80.8 ± 6.8 years, 118 (63%) female, LVEF>50%-116 (62%) LES 19.7±12.1%, STS 6.5± 6.5% baseline, 3m and 1y follow-up 106 pts completed FU (37 pts died) Krane et al. AJC 2012; 109:1774-81 Krane et al. AHJ 2010; 160:451-7

Krane et al. AJC 2012; 109:1774-81 Krane et al. AHJ 2010; 160:451-7 1-y Results of HRQoL Among Pts undergoing TAVI NYHA shows a clear shift from class III-IV to class I-II @ 3m and 1-y after TAVI @3m, 85% lived independently or with minor help and 86.2% reaffirmed their decision to undergo TAVI (@1-y, 73% and 88.6%, respectively)

Mid-term quality of life improvement after TAVI 42 pts underwent TAVI mean age 80.5 ± 5.9 years, 15 (37.5%) female LES 29.7±13.7% baseline and 11.3 ±4.9 (4-20)m fu CoreValve, 26 mm (50%) and 29 mm(50%), TF n=31 (86.1%) or SUB n=5 (13.8%) Clinical outcomes of study patients Death All 8 (19) Cardiac 1(2.7) Myocardial infarction 0 (0) Stroke 0 (0) New permanent pacemaker implantation 1 (2.7) Georgiadou et al. Am Heart J 2011; 162:232-7

Mid-term quality of life improvement after TAVI Pre Post p value NYHA class (III and IV) 28 (77.7) 0(0) LVEF (%) 48±12.8 56.2±8.4 0.088 AVA (cm 2 ) 0.7±0.1 2.6±2.7 0.001 AVG mean (mm Hg) 47.2±15.5 9.6±5.0 <0.001 AVG peak (mm Hg) 76.2±26.1 15.4±7.8 <0.001 AV regurgitation (moderate to severe) MV regurgitation (moderate to severe) 6 (16.7) 0 (0) 9 (25) 8 (23.5) 0.441 Georgiadou et al. Am Heart J 2011; 162:232-7

Mid-term quality of life improvement after TAVI Mean PSS and MSS of SF-36 21.6 vs. 46.7, p<0.001 and 42.9 vs. 55.2, p<0.001 Mean PCS and MCS of SF-12v12 22 vs 48.9, p<0.001 and 43.3 vs. 52.2, p<0.001 Georgiadou et al. Am Heart J 2011; 162:232-7

Comparisons with general population norms -------- 45.8 -------- 39.9 -------- 46 -------- 40.3

Comparisons with general population norms Ussia et al. EHJ 2009:30;1790-96 Krane et al. AJC 2012; 109:1774-81

Mid-term HRQoL after TAVI PARTNER Cohort B A persistent beneficial effects on global KCCQ summary score by 20 25 points @ 1-y~ 2x NYHA levels SF-12 PCS and MCS were favorable with mean differences of 5.7 and 6.4 points (P <0.001) compared with the standard care @ 6 and 12 m The physical health scores declined insignificantly between 6 m and 1-y in all surveys Reynolds MR et al. Circulation 2011; 124: 1964 72

PARTNER Cohort B: Subgroup Analyses Estimated effect of TAVI vs standard therapy on KCCQ overall summary score A) 6 months B) 12 months Reynolds MR et al. Circulation 2011; 124: 1964 72

Fairbairn TA et al. JACC 2012; 59: 1672 80 Mid- term follow-up results Subgroup Analyses No baseline sex difference, but @ 1-y 1 year, males had significantly higher HRQoL compared with females Younger pts gained equally as those 80 or older Increased operator experience were independent predictors of a greater improvement in HRQOL

Mid- term follow-up results Subgroup Analyses Gonçalves et al. also suggested the presence of significant PVD as a significant determinant of lower improvement in HRQoL due to lower enhancement in physical dimension MLHFQ score Gonçalves A et al. Int J Cardiol 2013;162:117-22

HRQoL assessment after TAVI vs. Symptomatic surgical Severe Aortic AVR Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 699 Cohort A: High-Risk Total = 1,057 patients 2 Parallel Trials: Individually Powered Cohort B: Inoperable N = 358 Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR VS AVR TA TAVR VS AVR TF TAVR VS Standard Therapy Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

PARTNER Cohort A- Within group comparisons KCCQ-Summary- TF Subgroup

PARTNER Cohort A- Between group comparisons KCCQ-Summary- TF Subgroup 30 Treatment Difference (TAVR - AVR) 20 10 0-10 -20 Δ = 9.9 P < 0.001 Δ = -0.5 P = NS Δ = -1.2 P = NS -30 1 month 6 months 12 months Reynolds MR et al. JACC 2012;60:548-58

PARTNER Cohort A- Between group comparisons SF 12-Summary- TF Subgroup 10.0 SF-12 Physical 10.0 SF-12 Mental Treatment Difference (TAVR - AVR) 7.5 5.0 2.5 0.0-2.5-5.0-7.5 Δ = 2.0 P = 0.04 Δ = -0.9 P = NS Δ = -0.4 P = NS Treatment Difference (TAVR - AVR) 7.5 5.0 2.5 0.0-2.5-5.0-7.5 Δ = 5.4 P < 0.001 Δ = 1.2 P = NS Δ = 0.4 P = NS -10.0 1 month 6 months 12 months -10.0 1 month 6 months 12 months Reynolds MR et al. JACC 2012;60:548-58

PARTNER Cohort A- Within group comparisons KCCQ-Summary- TA Subgroup

PARTNER Cohort A- Between group comparisons KCCQ-Summary- TA Subgroup 30 Treatment Difference (TAVR -AVR) 20 10 0-10 -20-30 Δ = -5.8 P = NS Δ = -7.9 P = 0.04 Δ = 0.8 P = NS 1 month 6 months 12 months Reynolds MR et al. JACC 2012;60:548-58

PARTNER Cohort A- Between group comparisons SF 12-Summary- TA Subgroup 10.0 SF-12 Physical 10.0 SF-12 Mental 7.5 7.5 Treatment Difference (TAVR -AVR) 5.0 2.5 0.0-2.5-5.0-7.5 Δ = 0.3 P = NS Δ = -3.3 P = 0.05 Δ = 0.2 P = NS Treatment Difference (TAVR -AVR) 5.0 2.5 0.0-2.5-5.0-7.5 Δ = -4.3 P = 0.02 Δ = -2.5 P = NS Δ = -2.5 P = NS -10.0 1 month 6 months 12 months -10.0 1 month 6 months 12 months Reynolds MR et al. JACC 2012;60:548-58

PARTNER Cohort A: Summary Results Among patients with severe AS who were at high risk for standard valve replacement, both surgical and transcatheter AVR resulted in substantial improvement in disease-specific and generic HRQOL over 1-year fu KCCQ Summary Scale ~ 25-30 points SF-12 Physical ~ 6 points SF-12 Mental ~ 5 points

PARTNER Cohort A: Summary Results Although the extent of improvement at 1-y was similar with TAVI and AVR, there were important differences in the rate and extent of recovery at the earlier time points For pts eligible for the TF approach, TAVI resulted in substantial QOL benefits compared with AVR at 1 m with similar QOL at later time points For pts eligible only for the TA approach, there was no benefit of TAVI over AVR at any time point, and QOL tended to be better with AVR both at 1 and 6 m

HRQoL assessment after TAVI vs. surgical AVR The STACCATO trial Operable patients with isolated AS and an age 75 years The primary endpoint was the composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 days. The study was prematurely terminated after the inclusion of 70 pts The primary endpoint was met in five a- TAVI patients (two deaths, two strokes, and one case of renal failure requiring dialysis) vs. one stroke in the SAVR group (p=0.07) Nielsen HH et al. EuroIntervention 2012;8:383-9

Conclusions TAVI leads to very great improvement in patient-reported symptoms, functional status, and HRQoL over the first year of follow-up, even in a population selected for high surgical risk These advantages of TAVI but only via a transfemoral approach occur at 1 m compared with conventional surgery and are diminished at later time points The development of an optimal set of HRQoL measures, the identification of specific predictors of future HRQoL, a longer-term follow-up would provide more comprehensive understanding of TAVI patient s journey Whether clinical outcomes and durability will be adequate to compete with surgery in younger and healthier patients is unknown

PARTNER-Randomized Controlled Trial PARTNER Trial Design

Patient work-up Lung/renal function tests Carotid Dopplers CT aorta without contrast Trans-thoracic echo Morphology of AV peak/mean grad + AVA Dimensions of AV annulus Morphology of septum Presence/mechanism of MR LV systolic function PAP if possible TOE if annulus 24mm or greater

Σκοπός της µελέτης Η εκτίµηση των αλλαγών στην ποιότητα ζωής, του λειτουργικού σταδίου και της επιβίωση ασθενών µε σοβαρή αορτική στένωση 1 χρόνο µετά από διαδερµική εµφύτευση βιοπροσθετικής αορτικής βαλβίδας

Επιλογή ασθενών Μελετήσαµε διαδοχικά 40 ασθενείς µε γνωστή σοβαρή συµπτωµατική αορτική στένωση, οι οποίοι παραπέµφθηκαν για έλεγχο για πιθανή TAVI Ο έλεγχος για TAVI περιλαµβάνει: - ιατρικό ιστορικό κ κλινική εξέταση - διοισοφάγειο υπερηχογράφηµα - αξονική αγγειογραφία θωρακικής κ κοιλιακής αορτής - δεξιός και αριστερός καρδιακός καθετηριασµός - αορτογραφία κ αγγειογραφία λαγόνιων και µηριαίων αγγείων - Κ/χη, πνευµονολογική κ αναισθησιολογική εκτίµηση!!

ΕΝΔΕΙΞΕΙΣ Σοβαρή Αορτική Στένωση AVA δείκτης 0.6 cm 2 /m 2 27mm AV δακτύλιος 20mm Σηµείο επαφής αορτής µε κόλπους του Valsava 43mm Ηλικία 75 y Logistic EuroSCORE 15% Ηλικία 65 y +1 or more ΚΡΙΤΗΡΙΑ ΑΠΟΚΛΕΙΣΜΟΥ Σήψη ή ενεργός ενδοκαρδίτιδα Υπερευαισθησία ή αντενδείξεις στο ακετυλοσαλικυλικό οξύ ή την κλοπιδογρέλη Αιµορραγική προδιάθεση ή διαταραχές της πήξης Πρόσφατο έµφραγµα του µυοκαρδίου ή εγκεφαλικό επεισόδιο Παρουσία θρόµβου στην αριστερή κοιλία ή κόλπο Προηγούµενη αντικατάσταση αορτικής βαλβίδας Συνυπάρχουσα πάθηση µε προσδόκιµο ζωής <1 έτους Κίρρωση ήπατος Αναπνευστική ανεπάρκεια: FEV1<1L Ιστορικό κ/χη επέµβασης Πνευµονική υπέρταση (PAP>60mmHg) Δεξιά καρδιακή ανεπάρκεια Δυσµορφίες θώρακα Σοβαρή πάθηση συνδετικού ιστού Πορσελανοειδής αορτή Καχεξία

Περιγραφή της συσκευής και της επέµβασης 18 F Medtronic CoreValve βιοπρόθεση Ανάδροµη προσπέλαση διαµέσου της µηριαίας ή της υποκλείδιας αρτηρίας Μέτρια καταστολή κ τοπική αναισθησία Αγγειακή πρόσβαση µέσω αιµοστατικής συσκευής (Prostar TM XL 10-F system) Βαλβιδοπλαστική µε µπαλόνι της αορτικής βαλβίδας Προφυλακτική αντιβιοτική αγωγή 1 ώρα προ της επέµβασης Ακετυσαλικυλικό οξύ 80 mg κ κλοπιδογρέλη 75 mg µία φορά την ηµέρα, πριν κ 6 µήνες µετά την επέµβαση

Εκτίµηση της ποιότητας της ζωής Επισκόπηση Υγείας SF-36 α) Σωµατική Λειτουργικότητα (PF, Physical Functioning) β) Ρόλος-Σωµατικός (RP, Role Physical) γ) Σωµατικός Πόνος (BP, Bodily Pain)) δ) Γενική Υγεία (GH, General Health) ε) Ζωτικότητα (VT, Vitality) στ) Κοινωνική Λειτουργικότητα (SF, Social Functioning) ζ) Ρόλος-Συναισθηµατικός (RE, Role Emotional) η) Ψυχική Υγεία (ME, Mental Health) Γενική κλίµακα της Σωµατικής Υγείας (PSS, Physical Summary Score) Γενική κλίµακα της Ψυχικής Υγείας (MSS, Mental Summary Score) Επισκόπηση Υγείας SF-12v2 Σωµατική Συνιστώσα Υγείας (PCS, Physical Component Summary) Ψυχική Συνιστώσα Υγείας (MCS, Mental Component Summary)

Βασικά χαρακτηριστικά του πληθυσµού της µελέτης Ηλικία 80.5 ± 5.9 Άνδρες 21 (41.6) Διαβήτης 18 (50) Υπέρταση 34 (94.4) Δυσλιπιδαιµία 29 (80.6) Log Euroscore, % 29.7±13.7 Συν-νοσηρότητες Νεφρική ανεπάρκεια 6 (17.1) ΧΑΠ 15 (41.7) Κολπική µαρµαρυγή 10 (27.8) Περιφερική αγγειοπάθεια 9 (25) Ιστορικό ΑΕΕ 7 (19.4) Ιστορικό ΕΜ 8 (23.5) Ιστορικό PTCA/CABG 25 (69.4) Συµπτώµατα NYHA I 0(0) NYHA II 8 (22.2) NYHA III 19(52.7) NYHA IV 9 (25) Στηθάγχη 19 (52.8) Συγκοπή 6 (16.7)

Χαρακτηριστικά της επέµβασης Όλες οι επεµβάσεις πραγµατοποιήθηκαν εκλεκτικά κ επιτυχώς Τοποθέτηση IABP σε 1 περίπτωση Τοποθέτηση κ 2 ης βαλβίδας σε 1 περίπτωση Μηριαία προσπέλαση=31 (86.1%) Υποκλείδια προσπέλαση=5 (13.8%) 26-mm CoreValve βιοπρόθεση= 18 (50%) 29-mm βιοπρόθεση=18 (50%)

Κλινικά χαρακτηριστικά κ υπερηχογραφικά ευρήµατα των ασθενών πριν την επέµβαση κ 1 χρόνο µετά Πριν Μετά p value NYHA λειτουργικό στάδιο (III and IV) 28 (77.7) 0(0) Κλάσµα εξώθησης (%) 48±12.8 56.2±8.4 0.088 Στόµιο αορτικής βαλβίδας (cm 2 ) 0.7±0.1 2.6±2.7 0.001 Αορτική κλίση πίεσης, µέση (mm Hg) 47.2±15.5 9.6±5.0 <0.001 Αορτική κλίση πίεσης, µέγιστη (mm Hg) 76.2±26.1 15.4±7.8 <0.001 Ανεπάρκεια αορτικής βαλβίδας (µέτρια-σοβαρή) 6 (16.7) 0 (0)

Αποτελέσµατα ενδονοσοκοµειακής παρακολούθησης Χρόνος νοσηλείας, (ηµέρες±sd) 9.8±4.8 Θάνατος, n (%) 2 (5.5) Έµφραγµα µυοκαρδίου, n (%) 0 (0) Εγκεφαλικό επεισόδιο, n (%) 1 (2.7) Εµφύτευση βηµατοδότη, n (%) 8 (22.2) Αγγειακές επιπλοκές Μείζονες, n(%) 2 (5.5) Ελάσσονες, n(%) 3 (8.3) Αποτελέσµατα 1-έτους κλινικής παρακολούθησης Θάνατος Ολική 6 (16.6) Καρδιακή 1 (2.7) Έµφραγµα µυοκαρδίου 0 (0) Εγκεφαλικό επεισόδιο 0 (0) Εµφύτευση βηµατοδότη 1 (2.7)

!!Ανάλυση επιβίωσης για τον χρόνο παρακολούθησης (Kaplan Meier)

Αποτελέσµατα επισκόπησης υγείας SF-36 πριν την επέµβαση και 1 χρόνο µετά 92 71 73 83 71 73 82 79 55 40 42 24 28 32 17

Συµπέρασµα Παρατηρήθηκε σηµαντική βελτίωση στα συµπτώµατα, το λειτουργικό στάδιο και στις παραµέτρους της ποιότητας ζωής 1 χρόνο µετά την TAVI Η εφαρµογή των ερωτηµατολογίων επισκόπησης υγείας, αναγνωρίζοντας ατοµικές προτιµήσεις κ προτεραιότητες, µπορεί να αποτελέσει ένα χρήσιµο εργαλείο στην καλύτερη επιλογή των ασθενών πριν την TAVI

Short-term HRQoL after TAVI A significant improvement in HRQoL was reported even in 1 month after the procedure PARTNER- Cohort B: The largest effect sizes were observed in the KCCQ social limitation and QoL components not only within the TAVI group compared with baseline (mean difference, 26 points, 95% CI: 18.6 33.5, P < 0.001 and 31.4, 95% CI: 26.5 36.4, P < 0.001, respectively), but also between the two study arms at 1 month (mean difference, 16.1 points, 95% CI: 8.1 24.1, P < 0.001 and 14.8, 95% CI: 8.6 21, P < 0.001, respectively) PARTNER- Cohort B: The SF-12 physical health was substantially enhanced between and within-groups at 1 month but with a marked change in mental health seen only within the TAVI group at 1 month and between groups at 6 months

Short-term HRQoL after TAVI The benefits of physical functioning are not only sustained but further improved at 6 months after TAVI. 2 studies showed the greatest gain observed in physical functioning 6 months after the procedure. Fairbairn et al. observed the greatest change in physical component to be obtained at 30 days but with further significant improvement to 6 months. Reynolds et al. showed a higher positive impact on SF-12 physical summary scores at 6 months within the TAVI group. Regarding KCCQ, the extent of improvement was greater after TAVI compared with controls at 6 months than that at 1 month (mean between-group difference 21 vs. 13 points), with the KCCQ social limitation and QoL components being the major contributors to these changes

The German Aortic Valve Registry (GARY) 415 pts who survived 12 ms after TAVI (average age 81.9 ± 5.9 years; men 37.3%) HRQoL was assessed with the EQ-5D Neumann T. www.escardio.org 28/8/2012

Summary of SF-12 scores in patients after TAVI Reports suggesting mental health improvement but with the lowest benefit in this domain

PARTNER Cohort A KCCQ-Summary: Substantial Improvement* TF Subgroup P = 0.008 P = NS P = NS * Improvement 20 points vs. baseline among patients with available QOL data Reynolds MR et al. JACC 2012;60:548-58

PARTNER Cohort A KCCQ-Summary: Substantial Improvement* TA Subgroup P = NS at all timepoints * Improvement 20 points vs. baseline among patients with available QOL data