TAVI NEL PAZIENTE CON STENOSI AORTICA A RISCHIO INTERMEDIO

Lorenzo A. Menicanti IRCCS Policlinico San Donato

G Ital Cardiol 2016;17(12 Suppl 1):22S-30S

G Ital Cardiol 2016;17(12 Suppl 1):22S-30S

G Ital Cardiol 2016;17(12 Suppl 1):15S-21S

Studio osservazionale, multicentrico, prospettico, su pazienticon stenosi aortica severa (area valvolare aortica <1 cm2oppure gradiente transvalvolare medio >40 mmHg oppurevelocità all’efflusso >4 m/s) sottoposti a TAVI (tutti i pazienticonsecutivi, qualsiasi via di accesso e per qualsiasi tipo di protesiimpiantata) o pazienti ad alto rischio chirurgico sottopostiad AVR (criteri: età ≥80 anni o EuroSCORE logistico ≥15%)presso i centri partecipanti durante il periodo di arruolamento

G Ital Cardiol 2016;17(12 Suppl 1):15S-21S

J Am Coll Cardiol 2014;63:2101–10)

25 multicenter registries and 33 single-center studies were included in the analysis.There was no difference in pooled 30-day stroke post-TAVR between the TF and TA approach in multicenter (2.8%[95% confidence interval (CI): 2.4 to 3.4] vs. 2.8% [95% CI: 2.0 to 3.9])and single-center studies (3.8% [95% CI: 3.1 to 4.6] vs. 3.4% [95% CI: 2.5to 4.5]).Similarly, there was no difference in pooled 30-day stroke post TAVR between the CoreValve and EdwardsValve in multicenter (2.4% [95% CI: 1.9 to 3.2] vs. 3.0% [95% CI: 2.4 to 3.7]) and single-center studies (3.8% [95% CI:2.8 to 4.9] vs. 3.2% [95% CI: 2.4 to 4.3]).There was a decline in stroke risk with experience and technological advancement.There was no difference in the outcome of 30-day stroke between TAVR and surgical aortic valve replacement

The analysis first identified 47,297 high-risk patients from 394 sites who had a total of 48,060 admissions between November 2011 and September 2015. The final 2:1 sample included 1495 patients who underwent native TAVR (54% men; mean age 84 years) and 750 patients who underwent valve-in-valve TAVR (61% men; mean age 79 years).

Circulation. 2014;129:504-515

(J Thorac Cardiovasc Surg 2015;149:462-70)

(J Thorac Cardiovasc Surg 2015;149:462-70)

European Heart Journal - Cardiovascular Imaging (2017) 0, 1–8

European Heart Journal - Cardiovascular Imaging (2017) 0, 1–8

SAVR 2000 - 2015

2609 patientsAge Mortality(%) Stroke (%) Euroscore

Logistic

18-60 n. 798 0.9 0.1 5.5

61-79 n. 1442 2.1 0.3 7.9

➢80 n. 369 2.7 0 15.9

Global 1.8 0.2

IRCCS POLICLINICO SAN DONATO

SAVR2000 - 20152609 patients

Mean Age 69 years (20-99)

Transfusions 31%

Redux for bleeding 3.1%

Median

Aortic cross clamp. timeECC TimeStroke

44 ‘56 ‘

0,2%

ICU stay 2 days

LOS 7 days

Sternal revision for instability 0.3%

New Pace maker ~ 3%

IRCCS POLICLINICO SAN DONATO

SVA in pz di età≥80 anni345 pz

Follow upSopravvivenza

97,83%

89,73% 82,74%

79,31%74,97%

68,97%58,47%

47,64%38,11%

34,93%

29,11%

0%

20%

40%

60%

80%

100%

0 1 2 3 4 5 6 7 8 9 10 11 12

sopravvivenza

Ann. Thorac. Surg. 2008;85:1296-302

www.thelancet.com Published online April 3, 2016 http://dx.doi.org/10.1016/S0140-6736(16)30073-3

These methodological flaws invalidate direct comparison between treatments and cannot support authors’ conclusions that TAVI with

SAPIEN 3 in intermediate-risk patients is superior to surgery and might be the preferred treatment alternative to surgery.

RESULTS :

Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation.

TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group.

CONCLUSIONS

TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure.

(Funded by Medtronic; SURTAVI ClinicalTrials.gov number,NCT01586910

This article was published on March 17,2017, at NEJM.org.

This article was published on March 17,2017, at NEJM.org.