**5.1. Mortality**

In the multicenter registries and series, mortality was systematically <10% in patients treated using the transfemoral approach and ranged from 11.3% to 16.9% in patients treated using the transapical approach, probably owing to the higher risk profile of the patients treated via the latter route [73-74].At 1-year follow-up, the survival rates were ~80% (75–85%) for the trans‐ femoral approach and ~70% (63–78%) for the transapical approach.

of surviving patients were in NYHA class I/II at 3-year follow-up. Similarly, the PARTNER trial showed that patients treated with TAVI compared with patients treated with standard medical therapy have better symptom control at 1 year. Indeed, the 1-year rate of NYHA class III or IV was 25.2% for the TAVI group compared with 58.0% for the standard medical therapy

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Stroke: The occurrence of stroke is one of the most –fearing complication of TAVI. The most frequent etiology of procedural stroke is likely to be atheroembolism from the ascending aorta or the aortic arh. Other several factors include manipulation of a wire, positioning of device, performance of the balloon aortic valvuloplasty, air embolism, dissection of the arc vessels and inadequate blood flow to brain during rapid pacing. Reported 30 day stroke rate was 3.5 (ranging from 1.2% to 6.7%) [76]. Additionaly Kahlert et al observed that using diffusionweighed MRI has underlined this issue, demonstrating multiple embolic cerebral lesion in all patients after TAVI. Although most of these lesions were clinically silent, silent cerebral infarcts are associated with subtle cognitive change. Efforts have been directed towards prevention of stroke. Procedural anticoagulation to reach a target activated clotting time over 250 s is suggested. Empiric dual antiplatelet therapy is recommended for 3 to 6 months followed by long-term daily low dose aspirin. Additionally less traumatic valve delivery system and embolic protection devices (Embrella embolic deflector system) currently under devolepment might lower the risk of stroke. However some authors have suggested that stroke risk might

Vascular Complication: Common vascular complication arterial dissection, closure device failure, arterial stenosis, haematoma in the accsess site. Artery avulsion, vessel perforation, annulus rupture represent more severe complications which are fatal if not rapidly treated. In the SOURCE registry, 10.6 % of patients had major vascular complication and major vascular complications were less frequent in the transapical approach (2.4 %) [73-74]. Small vessel diameter, severe atherosclerosis, bulky calcification, and tortusosity are the main determinats of vascular complications. In the future delivery catheter and sheath size will likely decrease which should be associated with reductions in the risk of vascular injury. Additionally, for patients with unsuitable access, alternatives include apical, axillar/subclavian or transaortic

Coronary obstruction and myocardial infarction: Coronary ostia obstruction ( especially of the left main coronary artery ) might occur if an obstructive portion of the valve frame or the sealing cuff is placed directly over a coronary ostium however this is very rare but potentially fatal event [77]. Some cases may require immediate coronary angioplasty or coronary artery bypass graft operation. TAVI has been associated with a variable rate of myocardial infarction, ranging from 0% to 16.3% [73-74] Myocardial infarction could be explained by myocardial tissue compression, hypotension due to rapid pacing, atheroembolism and mechanic complication such as coronary ostia obstruction. Additionally myocardial infarction was associated with an

be lower with transapical access, this has not been a universal finding.

approaches, or treatment of iliofemoral lesion with stents or grafts.

increased cardiac mortality at midterm follow up

group (P, 0.001).

**6. Complications**

As the first of two parallel trials was completed, the results of PARTNER IB showed that TF TAVI was superior to standard therapy in patients not deemed candidates for surgery [73]. The primary endpoint of all-cause mortality was markedly reduced by 46% (P, 0.001). Recently reported 2-year outcomes showed continued encouraging results. At 2 years, the primary endpoint of all-cause mortality was reduced from 67.6% in the standard treatment arm to 43.3% in the TAVI arm (P, 0.001). The PARTNER cohort IA compared TAVI with SAVR and met its non-inferiority endpoint: the all-cause 1-year mortality in the TAVI group was non-inferior to the SAVR group (24.2 vs. 26.8%;P: 0.44; P: 0.001 for non-inferiority) [74]. Some concerns were raised with regard to neurologic events that were somewhat higher with TAVI than SAVR at 30 days (5.5 vs. 2.4%; P: 0.04) and 1 year (8.3 vs. 4.3%; P: 0.04). Although the recently published 2-year results showed that stroke rates were similar for TAVI and SAVR during 1 and 2 years with a hazard ratio of 1.22 (95% CI 0.67–2.23, P: 0.52), the issue of stroke warrants further investigation and should not be underestimated The rate of the composite of all-cause death and stroke was encouragingly nearly identical after TAVI (37.1%) and SAVR (36.4%) at 2 years (P: 0.85)[ 73-74]

Predictors of mortality — Risk factors for early and late mortality were identified in a study of 663 patients undergoing TAVR with CoreValve. Intraprocedural mortality was 0.9 percent. Mortality was 5.4 percent at 30 days and 15 percent at one year. Independent predictors of mortality at 30 days included certain procedural complications (conversion to open heart surgery, cardiac tamponade, major vascular or access site complications) as well as baseline characteristics (left ventricular ejection fraction <40 percent, prior balloon valvuloplasty, and diabetes mellitus). Independent predictors of mortality between 30 days and one year included prior stroke, postprocedural paravalvular leak ≥2+, prior acute pulmonary edema, and chronic kidney disease.

Indeed, in the past few years, 1-year survival rates from some registries have been reported to be ≥80%, and we can expect better survival rates at the 2-year and 3-year follow-ups in the coming years. Importantly, no structural failures of the transcatheter valves have been seen in studies with a follow-up of more than 1 year [73-74].

In addition to baseline and procedural factors, the learning-curve phenomenon and the improvements in valve prosthesis and delivery catheters have also been associated with a substantial improvement in the results obtained with TAVI.

#### **5.2. Symptom improvement**

Three-year follow-up data have been published and are consistent with lasting improvement in cardiac symptoms [72]. While 86% of patients were in NYHA class III or IV at baseline, 93% of surviving patients were in NYHA class I/II at 3-year follow-up. Similarly, the PARTNER trial showed that patients treated with TAVI compared with patients treated with standard medical therapy have better symptom control at 1 year. Indeed, the 1-year rate of NYHA class III or IV was 25.2% for the TAVI group compared with 58.0% for the standard medical therapy group (P, 0.001).
