Cristina Ciuca

Acute kidney injury following transcatheter aortic valve implantation: incidence, predictors and clinical outcome

BACKGROUND Limited data exist on renal complications of transcatheter aortic valve implantation (TAVI) within a comprehensive program using different valves with transfemoral, transapical, and trans-subclavian approach. METHODS Prospective single-center registry of 102 consecutive patients undergoing TAVI using both approved bioprostheses and different access routes. The main objective was to assess the incidence, predictors and the clinical impact of acute kidney injury (AKI). AKI was defined according to the valve academic research consortium (VARC) indications. RESULTS Mean age was 83.7 ± 5.3 years, logistic EuroSCORE 22.6 ± 12.4%, and STS score 8.2 ± 4.1%. Chronic kidney disease at baseline was present in 87.3%. Periprocedural AKI developed in 42 patients (41.7%): 32.4% stage 1, 4.9% stage 2 and 3.9% stage 3. The incidence of AKI was 66.7% in transapical, 30.3% in transfemoral, and 50% in trans-subclavian procedures. The only independent predictor of AKI was transapical access, with a hazard ratio (HR) between 4.57 and 5.18 based on the model used. Cumulative 1-year survival was 88.2%. At Cox regression analysis, the only independent predictor of 30-day mortality was diabetes mellitus (HR 7.05, 95% CI 1.07-46.32; p=0.042), whilst the independent predictors of 1-year death were baseline glomerular filtration rate<30 mL/min (HR 5.74, 95% CI 1.42-23.26; p=0.014) and post-procedural AKI 3 (HR 8.59, 95% CI 1.61-45.86, p=0.012). CONCLUSIONS TAVI is associated with a high incidence of AKI. Although in the majority of the cases AKI is of mild entity and reversible, AKI 3 holds a strong negative impact on 1-year survival. The incidence of AKI is higher with transapical access.

The role of percutaneous balloon aortic valvuloplasty as a bridge for transcatheter aortic valve implantation.

AIMS Many inoperable patients with severe aortic stenosis (AS) are not immediately eligible for transcatheter aortic valve implantation (TAVI). We evaluated the role of percutaneous balloon aortic valvuloplasty (BAV) in this setting. METHODS AND RESULTS Among 210 consecutive patients referred to our institution for BAV, we identified three groups: immediately eligible for TAVI (n=65, 31%), excluded from TAVI (n=67, 32%), BAV as a bridge to TAVI (n=78, 37%). This last group comprised patients with low left ventricular ejection fraction, frailty or enfeebled status, symptoms of uncertain origin, critical conditions, moderate-to-severe mitral valve regurgitation, need of major non-cardiac surgery. Outpatient clinic visit and echocardiography were performed around one month after BAV to decide the final therapeutic strategy. Mean age was 81±8 years and the vast majority of patients had comorbidities and high-risk features. The incidence of periprocedural adverse events was 6.4%: 5.1% death (four patients: one procedural complication, three, natural disease progression), 1.3% minor stroke. After BAV, 46% of these patients were deemed eligible for TAVI, and 28% for cardiac surgery. Patients who underwent TAVI after bridge BAV showed 94% 30-day survival. CONCLUSIONS BAV is a safe and effective tool to bridge selected patients to TAVI when indications are not obvious.

Emerging indications, in-hospital and long-term outcome of balloon aortic valvuloplasty in the transcatheter aortic valve implantation era.

AIMS The introduction of transcatheter aortic valve implantation (TAVI) has generated a renewed interest in the treatment of high-risk patients with severe aortic stenosis. This study describes the indications and long-term outcome of balloon aortic valvuloplasty (BAV) in recent years. METHODS AND RESULTS Between 2000 and 2010, 415 consecutive patients at our institution underwent BAV. The number of BAV per year increased sharply after the introduction of TAVI. Patients were 77.5±10.9 years old and showed important comorbidities (average logistic EuroSCORE=23.9±15.3%). We identified four cohorts according to the indications: 1) bridge for TAVI (B-TAVI; n=162); 2) bridge for aortic valve replacement (B-AVR, n=97); 3) cardiogenic shock (n=23); 4) palliation (n=133). Baseline characteristics were significantly different among groups. In-hospital mortality was 5.1%, and occurred predominantly in patients who underwent BAV in the setting of cardiogenic shock (56.5% vs. around 2% in the other subgroups). Other major events were stroke (0.5%), major vascular complications (2.2%), and life-threatening bleedings (1.5%). The cumulative one-year and two-year mortality rates were 33.2% and 57.4%, respectively, with the highest incidence in the shock group (70.7% and 80.4%) and the lowest in the B-AVR group (21.7% and 38.4%). Rehospitalisation for heart failure was 26.3% at one-year and 47.2% at two-year follow-up. CONCLUSIONS The number of BAV is increasing, mainly due to increased referral of high-risk patients and to the emerging indication of bridge for TAVI. In this complex population, BAV is relatively safe but two-year survival remains poor, and more effective and definitive treatments should be pursued in a timely fashion.

Transcatheter aortic valve implantation with a self-expanding nitinol bioprosthesis: prediction of the need for permanent pacemaker using simple baseline and procedural characteristics.

Objective: To ascertain incidence and predictors of new permanent pacemaker (PPM) following transcatheter aortic valve implantation (TAVI) with the self‐expanding aortic bioprosthesis. Background: TAVI with the Medtronic Corevalve (MCV) Revalving System (Medtronic, Minneapolis, MN) has been associated with important post‐procedural conduction abnormalities and frequent need for PPM. Methods: Overall, 73 consecutive patients with severe symptomatic AS underwent TAVI with the MCV at two institutions; 10 patients with previous pacemaker and 3 patients with previous aortic valve replacement were excluded for this analysis. Clinical, echocardiographic, and procedural data were collected prospectively in a dedicated database. A standard 12‐lead ECG was recorded in all patients at baseline, after the procedure and predischarge. Decision to implant PPM was taken according to current guidelines. Logistic multivariable modeling was applied to identify independent predictors of PPM at discharge. Results: Patients exhibited high‐risk features as evidenced by advanced age (mean = 82.1 ± 6.2 years) and high surgical scores (logistic EuroSCORE 23.0 ± 12.8%, STS score 9.4 ± 6.9%). The incidence of new PPM was 28.3%. Interventricular septum thickness and logistic Euroscore were the baseline independent predictors of PPM. When procedural variables were included, the independent predictors of PPM were interventricular septum thickness (OR 0.52; 95% CI 0.32–0.85) and the distance between noncoronary cusp and the distal edge of the prosthesis (OR 1.37; 95% CI 1.03–1.83). Conclusions: Conduction abnormalities are frequently observed after TAVI with self‐expandable bioprosthesis and definitive pacing is required in about a third of the patients, with a clear association with depth of implant and small interventricular septum thickness.

Causes and timing of death during long-term follow-up after transcatheter aortic valve replacement.

BACKGROUND Transcatheter aortic valve replacement (TAVR) is an effective therapeutic option for patients with severe aortic stenosis at high risk for surgery. Identification of causes of death after TAVR may help improve patient selection and outcome. METHODS We enrolled 874 consecutive patients who underwent TAVR at 3 centers using all approved bioprostheses and different access routes. Clinical outcomes during follow-up were defined according to the Valve Academic Research Consortium 2 definitions. Causes of deaths were carefully investigated. RESULTS Mean logistic European System for Cardiac Operative Risk Evaluation was 23.5% ± 15.3%; Society of Thoracic Surgery score, 9.0% ± 8.2%. The Corevalve (Medtronic, Minneapolis, MN) was used in 41.3%; the Edwards Sapien (Edwards Lifesciences Inc., Irvine, CA) in 57.3%. Vascular access was transfemoral in 75.7%. In-hospital mortality was 5.0%. Cumulative mortality rates at 1 to 3 years were 12.4%, 23.4%, and 31.5%, respectively. Landmark analysis showed a significantly higher incidence of cardiovascular (CV) death in the first 6 months of follow-up and a significantly higher incidence of non-CV death thereafter. At Cox regression analysis, the independent predictors of in-hospital mortality were acute kidney injury grades 2 to 3 (hazard ratio [HR] 3.41) life-threatening bleeding (HR 4.26), major bleeding (HR 4.61), and myocardial infarction (HR 3.89). The independent predictors of postdischarge mortality were chronic obstructive pulmonary disease (HR 1.48), left ventricular ejection fraction at discharge (HR 0.98), and glomerular filtration rate <30 mL/min per 1.73 m(2) (HR 1.64). CONCLUSIONS Around a third of patients treated with TAVR in daily practice die within the first 3 years of follow-up. Early mortality is predominantly CV, whereas late mortality is mainly non-CV, and it is often due to preexisting comorbidity.

Residual aortic regurgitation is a major determinant of late mortality after transcatheter aortic valve implantation.

aortic valve implantation Pedro A. Lemos ⁎, Francesco Saia , Jose Mariani Jr., Cinzia Marrozzini , Antonio Esteves Filho , Luiz J. Kajita , Cristina Ciuca , Nevio Taglieri , Barbara Bordoni , Carolina Moretti , Tullio Palmerini , Marianna D.A. Dracoulakis , Fabio B. Jatene , Roberto Kalil-Filho , Antonio Marzocchi c a Sirio-Libanes Hospital, Sao Paulo, Brazil b Heart Institute, University of Sao Paulo Medical School, Sao Paulo, Brazil c Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy d Irmandade da Santa Casa de Misericordia, Sao Paulo, Brazil

Trans-subclavian versus transapical access for transcatheter aortic valve implantation: A multicenter study

To compare the outcomes of trans‐subclavian (TS) and transapical (TA) access for transcatheter aortic valve implantation (TAVI).

Incidence, prognostic value and management of vascular complications with transfemoral transcatheter aortic valve implantation

Inoperable or high-risk patients with severe aortic stenosis who undergo transcatheter aortic valve implantation (TAVI) have better outcomes compared with those treated with standard medical therapy. As for any other invasive procedure, peri-procedural complications may occur, reducing the procedural success rate and potentially affecting short- and mid-term outcomes. The transfemoral approach prevails over other possible access-site options in most registries. The use of large introducer sheaths and the need for double arterial vascular access can lead to higher rates of vascular complications in this elderly population, with a high prevalence of baseline peripheral artery disease. In this article, we review the results of recent clinical trials and major registries using the two different bioprosthesis currently available for TAVI, focusing on access site-related complications with transfemoral TAVI, their management and relationship with in-hospital and 30-day survival. Awareness of the mechanisms behind these complications might help in their prevention, recognition and management and may ultimately improve the clinical outcome of TAVI procedures.

Incidence, treatment, and outcome of acute aortic valve regurgitation complicating percutaneous balloon aortic valvuloplasty

To evaluate the incidence, treatment, and outcomes of acute aortic regurgitation (ARR) complicating BAV.

Is balloon aortic valvuloplasty safe in patients with significant aortic valve regurgitation

Objectives: To assess safety and effectiveness of balloon aortic valvuloplasty (BAV) in patients with symptomatic severe aortic stenosis (AS) and significant aortic regurgitation.