Transcatheter aortic valve implantation in patients with bicuspid aortic valve: a series of cases.

BACKGROUND: Bicuspid aortic valve (BAV) has been considered a relative contraindication for transcatheter aortic valve implantation (TAVI). Due to more oval shape of the BAV annulus compared to tricuspid aortic valve, the procedure has been discouraged because of an increased risk of stent assembly displacement, uneven expansion, post-procedure paravalvular leakage, stent valve distortion, or other malfunction after implantation. For the same reasons patients with BAV have been excluded from the majority of clinical TAVI trials. AIM: To evaluate the efficacy and safety of TAVI in patients with BAV stenosis. METHODS: We analysed a group of 104 patients admitted to our institution for TAVI between January 2009 and May 2012. During pre-procedure evaluation, transthoracic and transoesophageal (TEE) echocardiography as well as angio-computed tomography (CT) scan were performed to assess aortic valve anatomy and morphology. Appropriate measurements and detailed analyses of imaging data have been accomplished to select optimal access site, prosthesis size as well as to plan the procedure. BAVs were recorded in seven patients (6.7%; mean age 77.7 years). These patients presented with severe symptomatic aortic valve stenosis with a mean aortic valve area of 0.55 cm² (0.46-0.7 cm²) as measured in TEE. All of the patients had been disqualified from surgical valve replacement due to high surgical risk with a mean logistic Euroscore of 19.9%. All of them successfully underwent TAVI using CoreValve (n = 5) or Sapien (n = 2) valves. Follow-up was completed at 30 days, and six and 12 months after the procedure. RESULTS: During follow-up one patient developed an elliptic distortion of the aortic prosthesis in CT, although it did not result in significant malfunctioning of the implant. One patient died of infective endocarditis 30 days after the procedure. Survivors at 30-day follow-up had mild to moderate aortic insufficiency, and it did not deteriorate after six months. At one year follow-up six out of seven patients remained alive. They achieved significant functional improvement by New York Heart Association class compared to baseline. CONCLUSIONS: TAVI may constitute an alternative treatment option for high-risk patients with BAV, resulting in a low periprocedural mortality rate, and good 30-day, six-month, and one-year outcomes.

Vascular complications after transcatheter aortic valve implantation (TAVI): risk and long-term results.

UNLABELLED: Vascular complications are the main safety limitations of transcatheter aortic valve implantation (TAVI). The aim of the study was to assess the incidents, predictors, and the impact of early vascular complications on prognosis after TAVI. This was a single-center analysis of vascular complications related to TAVI. Early vascular complications were defined as incidents within 30 days after TAVI and comprised complications related to transvascular: transfemoral/transsubclavian ,and transapical bioprosthesis implantation. Evaluated risk factors were: (1) clinical characteristics, (2) TAVI route, and (3) center experience. In patients with transvascular TAVI the impact of: (1) diameters of access arteries, vascular sheathes and difference between them, (2) arterial wall calcification, and (3) ProStar devices used for access site closure were assessed. Arterial wall calcification and arteries diameters were measured by 64-slice computer tomography. Arterial wall calcification was graded according to 5° scale. RESULTS: between 2009-2011; follow-up 1-23 months (12 ± 15.55), 83 consecutive patients, and 62-91 (81.10 ± 7.20) years, underwent TAVI: 67 (80.72%) patients had transvascular, and 16 (19.27%) patients had transapical bioprosthesis implantation. We noted 44 (53.01%) early vascular complications: 17 (20.48%) were major and 27 (32.53%) were minor incidents. Independent predictors of early vascular complications were: history of anaemia (OR 3.497: 95% CI [1.276-9.581]; p = 0.014), diabetes (OR 0.323: 95% CI [0.108-0.962]; p = 0.042), percutaneous coronary intervention performed as preparation for TAVI (OR 4.809: 95 % CI [1.172-19.736]; p = 0.029), and arterial wall calcification (OR 1.945: 95% CI [1.063-3.558]; p = 0.03). Of 6 (7.22%) in-hospital and 10 (12.98%) late deaths: 5 (83.33%) patients and 8 (80%) patients respectively had post-procedural vascular complications. Vascular complications, which occurred in 30-days after TAVI, predict late mortality (p = 0.036). Conclusions derived were: (1) TAVI patients with history of anaemia and diabetes required careful monitoring for early vascular complications. (2) If coronary intervention before TAVI is required, it should be performed in the time allowing vascular injuries to heal. (3) Calcification of access arteries is an independent predictor of post-procedural vascular complications; therefore, its estimation should be a regular element of preceding computer tomography. (4) Vascular complications seem to be predictors of late mortality after TAVI.

Antithrombotic therapy - predictor of early and long-term bleeding complications after transcatheter aortic valve implantation.

INTRODUCTION: Dual antiplatelet therapy (DAPT) - aspirin and clopidogrel - is recommended after transcatheter aortic valve implantation (TAVI) without an evidence base. The main aim of the study was to estimate the impact of antithrombotic therapy on early and late bleeding. Moreover, we assessed the impact of patients' characteristics on early bleeding and the influence of bleeding on prognosis. MATERIAL AND METHODS: Between 2009 and 2011, 83 consecutive TAVI patients, age 81.1 ±7.2 years, were included. Bleeding complications were defined by the Valve Academic Research Consortium (VARC) scale. The median follow-up was 12 ±15.5 months (range: 1 to 23) and included 68 (81.9%) patients. RESULTS: Early bleeding occurred in 51 (61.4%) patients. Vitamin K antagonists (VKA) pre-TAVI (p = 0.001) and VKA + clopidogrel early post-TAVI (p = 0.04) were the safest therapies; in comparison to the safest one, peri-procedural DAPT (p = 0.002; p = 0.05) or triple anticoagulant therapy (TAT) (p = 0.003, p = 0.05) increased the risk for early bleeding. Predictors for early bleeding were: clopidogrel pre-TAVI (OR: 4.43, 95% CI: 1.02-19.24, p = 0.04), preceding percutaneous coronary intervention (PCI) (10.08, OR: 95% CI: 1.12-90.56, p = 0.04), anemia (OR: 4.00, 95% CI: 1.32-12.15, p = 0.01), age > 85 years (OR: 5.96, 95% CI: 1.47-24.13, p = 0.01), body mass index (BMI) (OR: 0.86, 95% CI: 0.74-0.99, p = 0.04). Late bleeding occurred in 35 patients (51.4%) on combined therapy, and none on VKA or clopidogrel monotherapy (p = 0.04). Bleeding complications did not worsen the survival. CONCLUSIONS: This study seems to suggest that advanced age, BMI, and a history of anemia increased the risk for early bleeding after TAVI. Clopidogrel pre-TAVI should be avoided; therefore, time of preceding PCI should take into account discontinuation of clopidogrel in the pre-TAVI period. Vitamin K antagonists with clopidogrel seems to be the safest therapy in the early post-TAVI period, similarly as VKA/clopidogrel monotherapy in long-term prophylaxis.

Does contrast agent injection during trans-catheter aortic valve implantation negatively affect kidney function?

BACKGROUND: Trans-catheter aortic valve implantation (TAVI) has recently emerged as an alternative to conventional surgery in high-risk surgical patients with haemodynamically significant aortic valve stenosis. However, patients referred for TAVI are usually elderly individuals (> 80 years) who frequently also suffer from renal impairment. Trans-catheter valve therapies require extensive use of contrast injections with a risk of nephrotoxicity. AIM: To evaluate post-TAVI renal function and to determine whether the exposure to contrast injections might cause reduced kidney function and contrast-induced nephropathy. METHODS: From January 2009 to September 2010, TAVI was performed in 39 patients (26 women and 13 men). The mean age of the patients was 81.43 ± 7.39 years, and the mean volume of contrast material administered was 187.95 ± 91.34 mL. Serum creatinine and glomerular filtration rate (GFR, acc. to the MDRD formula) were estimated in all patients prior to and 1, 2, and 5-8 days after TAVI. RESULTS: Two female patients died on postoperative day 1. Other patients did not show clinically significant reduction in renal function following the procedure (mean creatinine concentration 104.46 vs 99.77 vs 94.56 vs 93.64 mmol/L, NS and mean GFR 52.37 vs 56.63 vs 60.18 vs 61.34 mL/min/1.73 m², NS). CONCLUSIONS: 1. The TAVI procedure, which includes contrast injection does not seem to cause a clinically significant decrease of renal function. 2. None of our elderly patients with severe aortic valve stenosis, multiple co-morbidities, and pre- TAVI renal compromise developed contrast-induced nephropathy.