TAVI: I risultati In Europa ed in Italia Nicolino

Una storia Europea… Dieci anni di successi in continua evoluzione

I Registri UE 20-24% 13-16% 11-17% 7-11.5% 5-7% 3-5% 3-5% FRANCE 2  3195 Pts ( 34 centri) Età 82,7±7,2 aa. Euro Score 21%; Edwards SAPIEN 66,9% e CoreValve 33,1% U.K. TAVI  870 Pts (25 centri). Età 81,9 ± 7,1. EuroScore 18.5%; Edwards SAPIEN 47,2% e CoreValve 51,2% BELGIAN 328 Pts (15 centri) Età 82,7±7,2 aa. Euro Score 28%; Edwards SAPIEN 53% e CoreValve 473% GARY  3875 Pts (110 centri) Euro Score 20; Edwards SAPIEN 66,9% e CoreValve 33,1% Successo d’impianto 97% 20-24% 13-16% 11-17% 7-11.5% In our study, one of the most common complications was the need for a permanent pacemaker (in 15.6% of patients). In the other registries, the rates were similar, with 13% in Belgium,17 16.3% in the United Kingdom,16 16.6% in Italy,11 and 6.7% in SOURCE.13 In the PARTNER trial, the reported rates were 3.4% for cohort B18 and 3.8% for cohort A.1 SOURCE (SAPIEN Aortic Bioprosthesis European Outcome) registry, 8.5% (15); FRANCE (French Aortic National CoreValve and Edwards) registry, 12.7% (11); German registry, 8.2% (16); and Italian registry, 5.4% (13). In the PARTNER B cohort, 30-day mortality was 5%, and it was 5.2% in the PARTNER A cohort (as treated analysis) (18,19). This (7.1%) mortality allied to a significant reduction in 30-day mortality that occurred with time (30-day mortality for the 2009 cohort was 4.3%) is an encouraging statistic in relation to the further dissemination of TAVI. The majority (85%) of nontransfemoral approach cases 5-7% 3-5% 3-5% ♥ N Engl J Med. 2012 May 3;366(18):1705-15; ♥ J Am Coll Cardiol. 2011 Nov 8;58(20):2130-8 ♥ Thorac Cardiovasc Surg. 2012 Jul;60(5):319-325; ♥ Interact Cardiovasc Thorac Surg. 2011 May;12(5):762-7

Transcatheter Valve Pilot Sentinel Registry 4571 Pts da 11 Paesi nel 2011-2012  Edwards 42.6% Core Valve 57.4% Logistic EuroScore 20.2% ± 13 (15% G 25% Be ) Sito di accesso 74.2% 16.4% 9% Successo Impianto 96.8% 95.1% 97% Anestesia locale 0-> 100%

PAD  Alto Rischio Transcatheter Valve Pilot Sentinel Registry Caratteristiche Basali p DM 26.8% 29.9% 30.9% 0.07 COPD 25.3% 22.3% 31.7% <0.01 Dialisi 6.1% 7.5% 12.6% Pregresso IMA 15.4% 22.1% 19.9% Precedente intervento 16.2% 30.2% 14.2% Precedente AVR 1.7% 1.02% 1.6% ns FE <30% 5% 5.6% 15.2% FE 30-50% 27.1% 29.6% 29.1% FE > 50% 67.9% 64.8% 58.7% CAD > 1 vaso 18.8% 23.3% 24.8% Log Euroscore 19.9±12.9 22.2±14.2 21.6±13.9 PAD  Alto Rischio

Transcatheter Valve Pilot Sentinel Registry Risultati p Morte (media 7.4%) 5.9% 12.8% 9.7% <0.01 Stroke (media 1.8%) 1.9% 1.6% 1.4% ns IMA (media 0.9%) 0.9% 0.7% Impianto PM 15.5% 4.5% 10.7% Trasfusioni 15% 20.8% 22.9% Fibrillazione Atriale 5.1% 9% 6.5% OspedalizzazIone >10 g 22% 43.8% 39.5% 23.4% vs 6%

PARTNER EU PARTNER EU: 130 TAVI (61 TF, 69 TA), età medio 82.1+5.5 anni; logistic EuroSCORE (33.8% TA vs. 25.7%, p=0.0005). Follow up: 12 mesi. ♥ European Heart Journal (2011) 32, 148–157

Differenza tra Registri e Trial??

Passate le Alpi....

L’esperienza Italiana da… TAVI: in Italia … successo in espansione ♥ Dati Gise

L’esperienza Italiana da… Studio N° Pt N° C Euro Score Accesso Successo Compl. vasc Stroke (H) PM Morte 1 m 6 m 1 aa D’Onofrio 566 20 26 ± 14.4 TA 100% 99% 0% 4.3% 5.3% 7.8% nd D’Errigo 725 101 15 ±12% TF 82% 98% 4% 1.5% 13% 9.9% Petronio 514 13 20% TF 90% 98,6% 1,8% 16.3% 5,4% (2.7%) 15,2% (6%) Tamburino 663 14 23 ±13% 2% 1,2% 16% 12.2% 15% Ussia 181 12 24.0+13.5 TF 95% 91,7% 3.3% 2.8% 12% 11% (6.7%) 23% (11%) V Subclavian approach was used in 141 patients (61% men; median age 83 years; median logistic European System for Cardiac Operative Risk Evaluation score 23.7%). The femoral group of 141 patients was matched for baseline clinical characteristics, except for peripheral artery disease. The 2 groups showed similar procedural success (97.9% vs. 96.5%; p = 0.47), major vascular complications (5.0% vs. 7.8%; p = 0.33), life-threatening bleeding events (7.8% vs. 5.7%; p = 0.48), and combined safety endpoint (19.9% vs. 25.5%; p = 0.26). The subclavian group showed lower rates of acute kidney injury/stage 3 (4.3% vs. 9.9%; p = 0.02), of minor vascular complications at the 18-F sheath insertion site (2.1% vs. 11.3%; p = 0.003), and of all types of bleeding events related to vascular complications. Survival at 2 years was 74.0 ± 4.0% in the subclavian group compared with 73.7 ± 3.9% in the femoral group (p = 0.78). The 2-year freedom from cardiovascular death was 87.2 ± 3.1% versus 88.7 ± 2.8% in the subclavian versus femoral group, respectively (p = 0.84). CONCLUSIONS: The subclavian approach for TAVI is safe and feasible, with procedural and medium-term results similar to the femoral approach. Subclavian access should be considered a valid option not only when the femoral approach is impossible but also when it is difficult, albeit feasible 3 anni: - mort tot 34%; Mort CV 12% Totale 2650 na 21% TF 96% 2% 2,3% 12,5% 7.9% 13%% 19% ♥ Circ Cardiovasc Interv. 2010;3:359-366; ♥ J Thorac Cardiovasc Surg. 2011; 142(4):768-75; ♥ Int J Cardiol. 2012 May 25; ♥ Circulation. 2011;123:299-308; ♥ J Am Coll Cardiol. 2012 Aug 7;60(6):502-7; ♥ Eur Heart J. 2012; 33(8):969-76

Lo Studio: OBSERVANT rischio intermedio 2108 Pazienti: 1383 SAVR, 602 transarterial-TAVI, 123 transapical-TAVI.  Analisi di sottopopolazione a rischio intermedio (133 vs 133 matched) (mean logistic EuroSCORE 9.4±10.4% vs 8.9±9.5%, SAVR vs TAVI; p=0.650). p = 0.001 p = 0.001 Thirty-day mortality was 3.8% for both SAVR and TAVI (p=1.000). The incidence of stroke (1.5% SAVR and 0.0% TAVI; p=0.156) and myocardial infarction (0.8% SAVR and 0.8% TAVI; p=1.000) was not statistically different between groups, whereas a higher requirement for blood transfusion was reported across the surgical cohort (49.6% vs 36.1%; p=0.026). A higher incidence of major vascular damage (5.3% vs. 0.0%; p=0.007) and pacemaker implantation(0.8% vs 12.0%; p=0.001) were reported in the TAVI group. CONCLUSIONS: Patients undergoing transcatheter and surgical treatment of severe aortic stenosis are still extremely distinct populations. In the relatively low-risk propensity-matched population analyzed, despite similar procedural and 30-day mortality, SAVR was associated with a higher risk for blood transfusion, whereas TAVI showed a significantly increased rate of vascular damage, permanent AV block and residual aortic valve regurgitation. 5.0% to 13.5% ♥ Int J Cardiol. 2012 May 25

Predittori di Morte Logistic EuroSCORE Eta’ NYHA class III o IV Accesso transapicale Insufficienza renale Sanguinamento Insufficienza aortica (> 2) BPCO Insuff mitralica (pre)> 2 Successo di Impianto FE <30% Stroke periprocedurale

Dubbi e/o Problemi “comunitari”…. Scelta/gestione dell’accesso Stroke (device di protezione??) Insufficienza Aortica Quale score ???? Trattare proprio tutte le stenosi aortiche???

Emerge dagli studi Scelta/gestione dell’accesso…. Precisa comprensione anatomica multiplanare della valvola e del “percorso da fare” al fine di scegliere: Valvola (tipo/misura) Accesso Modalità di accesso ♥ Failure Device 19F Artery/sheath Ratio ♥ Tutti gli Autori concordi ♥ Am J Cardiol 2012;110:1361–1367)

Emerge dagli studi Stroke/(device di protezione??)…. Media da meta-analisi di 10037 Pts  Stroke + TIA 3,3% 25% Morte 30 g Pazienti a Rischio: Precedente stroke e/o malattia CV Genere femminile Fibrillazione atriale Obesi >2 tentativi di impianto Aumentano rischio di Stroke fino a 8 volte

A 2 anni  perdita di significativita’. Emerge dagli studi Insufficienza Aortica …. 10-15% PARTNER B Terapia medica Dimensione Espansione Posizione 50% Postdilatazione A 2 anni  perdita di significativita’. ♥ Van Belle PCR 2012 ♥ Am J Cardiol 2012;110:1361–1367)

Ottimi risultati nell’alto rischio …. … for miracle not yet ? Valutazione Globale “Olistica”!!! Un/due score non sufficienti !!! ♥ N Engl J Med 2012;366:1696-704; ♥ N Engl J Med. 2012 May 3;366(18):1705-15

Siamo all’inizio …Continuamo uniti… VARC Linguaggio Comune Trials e Registri permanenti

Grazie per l'attenzione!!!

Accesso sicuro…. 141 TS vs 141 TF (61% maschi; età media 83 anni; Log EuroScore medio 23.7%). The 2 groups showed similar procedural success (97.9% vs. 96.5%; p = 0.47), major vascular complications (5.0% vs. 7.8%; p = 0.33), life-threatening bleeding events (7.8% vs. 5.7%; p = 0.48), and combined safety endpoint (19.9% vs. 25.5%; p = 0.26). The subclavian group showed lower rates of acute kidney injury/stage 3 (4.3% vs. 9.9%; p = 0.02), of minor vascular complications at the 18-F sheath insertion site (2.1% vs. 11.3%; p = 0.003), and of all types of bleeding events related to vascular complications. Survival at 2 years was 74.0 ± 4.0% in the subclavian group compared with 73.7 ± 3.9% in the femoral group (p = 0.78). The 2-year freedom from cardiovascular death was 87.2 ± 3.1% versus 88.7 ± 2.8% in the subclavian versus femoral group, respectively (p = 0.84). Arterial sheath size and female gender are important determinants of major vascular complications and life-threatening/disabling ♥ J Am Coll Cardiol. 2012 Aug 7;60(6):502-7. Epub 2012 Jun 20.

TF Morte CV H 3,9% 8.3% nd 0,9%