How accurate are manufacturers' recommendations in determining ineligibility for transfemoral transcatheter aortic valve implantation?

INTRODUCTION: Up to one-third of patients indicated for transcatheter aortic valve implantation (TAVI) may be unsuitable for transfemoral TAVI (TF-TAVI) according to manufacturers' recommendations and numerous professional societies. OBJECTIVE: This study aimed to investigate the predictive value of manufacturers' guidelines for major vascular access site complications using the Perclose ProGlide device. METHODS: Among 208 patients undergoing TF-TAVI, 144 patients (69.2%) were deemed eligible for TF-TAVI according to the manufacturer's instructions. A minimal lumen diameter (MLD) of the femoral artery below the manufacturer's specified limits and/or the presence of circumferential calcification were the reasons for ineligibility. Calcium score (CS), sheath-to-femoral artery ratio (SFAR) and MLD were estimated from computed tomography imaging. Vascular complications (VCs) (defined according to VARC-2 criteria) were retrospectively compared. RESULTS: Patients in the ineligible group had higher SFAR (1.13±0.15 vs. 0.88±0.107, p<0.001) and CS (1.66±0.99 vs. 1.24±0.73; p=0.003), and significantly lower MLD (7.72±1.03 vs. 6.31±0.96 mm; p<0.001) compared to the eligible group. Major (6.3% vs. 12.3%, p=0.13) and minor VCs (10.4% vs. 15.6%, p=0.29) were similar in the eligible and ineligible groups. The ineligible group had higher rates of rupture (0.7% vs. 6.3%; p=0.03). SFAR was the only independent predictor of major VCs (OR 469.1, 95% CI 4.95-44466.57, p=0.008). CONCLUSION: The TAVI team should not decide whether the patient is suitable for a femoral approach based solely on the manufacturer's criteria, and should incorporate additional factors that could be predictive of major VCs.

Balloon aortic valvuloplasty in the transcatheter aortic valve implantation era: A single-center registry.

INTRODUCTION: Percutaneous balloon aortic valvuloplasty (BAV) has been limited by the risk of complications and restenosis. However, growing use of transcatheter aortic valve implantation (TAVI) has revived interest in this technique. We analyzed the current indications for BAV and outcomes in a single center. METHODS: Acute results and long-term outcomes were analyzed in a retrospective single-center registry of patients undergoing BAV between January 2013 and January 2016. RESULTS: Twenty-three patients underwent BAV, 56.5% male, mean age 78±7 years. Indications were severe aortic stenosis and decompensated heart failure (n=5), urgent non-cardiac surgery (n=8), or bridge to definitive treatment (n=10). Peak invasive gradient decreased from a median of 54.0±19.0 mmHg to 28.5±13.8 mmHg (p=0.002). Complications included one ischemic stroke, one lower limb ischemia and one femoral pseudoaneurysm requiring surgery. During a mean follow-up of 11±10 months, eight patients underwent TAVI and two underwent surgical aortic valve replacement. Thirteen patients died, nine of non-cardiovascular causes. On Kaplan-Meier analysis mortality was significantly lower among patients undergoing definitive treatment (20.0% vs. 84.6% at two-year follow-up; p=0.005). CONCLUSION: BAV should be considered for selected patients with temporary contraindications to definitive therapy or as palliative therapy.

Echogenic mobile images in intraprocedural three-dimensional transesophageal echocardiographic monitoring during percutaneous aortic valve implantation: Incidence, characteristics and clinical implications.

INTRODUCTION AND OBJECTIVES: To investigate the incidence and clinical relevance of the presence of mobile echogenic images (MEI) during transesophageal echocardiography (TEE) for monitoring of transcatheter aortic valve implantation (TAVI). METHODS: Consecutive patients referred to our center for transfemoral or transapical TAVI were included. The procedure was monitored by three-dimensional (3D) TEE and images were analyzed by two independent experts. In-hospital follow-up was carried out and correlated with imaging findings. RESULTS: A total of 104 patients were included. MEI were visualized in 11 patients during the procedure (11%) and in over 50% of cases were identified as thrombi, however no differences in periprocedural stroke were found in follow-up. CONCLUSIONS: Visualization of MEI during 3D TEE monitoring of TAVI is relatively common (11%) and in over 50% of cases they are identified as thrombi. The clinical implications of this finding are uncertain, as despite their frequency, the incidence of clinical stroke in this patient population was no higher. 3D TEE is a useful tool for diagnosis of MEI and can alert the operator to their presence.