Novel renal biomarker evaluation for early detection of acute kidney injury after transcatheter aortic valve implantation.

Acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The biomarkers neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), and interleukin-18 (IL-18) are predictive of AKI after cardiac surgery, but there is little data regarding these biomarkers after TAVI. We evaluated the associations between NGAL, KIM-1, and IL-18 levels and the incidence and severity of AKI and changes in serum creatinine after TAVI. This was a prospective pilot study of 66 TAVI cases. Urinary biomarkers were measured at baseline and at 2, 4, and 12 hours after TAVI. Demographics, procedural features, and renal function until discharge were compared between patients with and without subsequent AKI. Seventeen patients (25.8%) developed AKI postoperatively (stage 1, n = 14; stage 2, n = 1; stage 3, n = 2). There were no significant differences in unadjusted mean NGAL, KIM-1, and IL-18 levels between patients with and without AKI at 2, 4, and 12 hours following surgery. After adjusting for the Society of Thoracic Surgeons risk of mortality, this study of three urinary biomarkers showed no association with AKI or creatinine after TAVI. Ongoing efforts to predict and modify the risk of AKI after TAVI remain challenging.

Usefulness of Balloon Aortic Valvuloplasty in the Management of Patients With Aortic Stenosis.

We aim to evaluate the contemporary role and outcomes of balloon aortic valvuloplasty (BAV), based on physician intent, for the management of severe aortic stenosis. This is a prospective, 2-center study of 100 consecutive high-risk patients with severe aortic stenosis who underwent BAV. Before BAV, physicians assigned intent as (1) bridge to decision (BTD); (2) therapeutic bridge to planned therapy; or (3) palliation. Patients in the BTD arm underwent clinical assessment at 30 days to determine eligibility for definitive valve therapy. All patients were followed up to 1 year, with outcomes measured including procedural complications, Kansas City Cardiomyopathy Questionnaires scores, 30-day and 1-year mortality, and definitive valve therapy. Enrolled patients had a mean age of 80.6 (±9.6) years, Society of Thoracic Surgeons predicted risk of mortality of 11.4% (±7.1%), and 91 (91.0%) patients had class III or IV New York Heart Association congestive heart failure. Intent in the 100 study patients was 76 BTD; 20 therapeutic bridge to planned therapy; and 4 palliation. Thirty-day mortality for all patients was 6 of 100 (6.0%), and 1-year mortality for all patients who received definitive valve therapy was 6 of 54 (11.1%). For patients surviving to 30 days, adjusted (by Society of Thoracic Surgeons predicted risk of mortality) Kansas City Cardiomyopathy Questionnaires scores were significantly improved from baseline for all patients and BTD patients. In conclusion, as a bridge to decision and treatment tool, BAV appears to have a valuable role in properly selecting and improving patients to undergo definitive valve replacement.

The outcomes of transcatheter aortic valve replacement in a cohort of patients with end-stage renal disease.

OBJECTIVES: To examine whether transcatheter aortic valve replacement (TAVR) is a safe and effective treatment option for aortic stenosis in patients with end-stage renal disease (ESRD). BACKGROUND: Patients with ESRD undergoing surgical aortic valve replacement have an operative mortality approaching 20% and a 10-year survival of approximately 12%. We investigated whether TAVR is a more reasonable option. METHODS: This is a multicenter, retrospective study of all patients with ESRD who underwent TAVR in 8 institutions between 12/2011 and 02/2013. Demographic characteristics, mortality, major, and minor complications were evaluated. Outcomes were stratified by operative approach. RESULTS: Forty-three patients with a mean age 76.2 ± 11.0 years and a mean STS predicted risk of mortality of 15.53 ± 8.70% underwent TAVR. Mean duration of dialysis was 45.2 ± 52.3 months (median 29.5 months). Transfemoral (TF) TAVR was performed in 31/43 (72.1%), transapical in 11/43 (25.6%), and transaortic in 1/43 (2.3%). Operative mortality was 14.0% (6/43) with TF mortality 6.5% (2/31) and 33.3% (4/12) in non-TF patients. Six-month mortality was 11/43 (25.6%: 16.1% TF, 50.0% non-TF). Complications included stroke in 2.3% (1/43) and life-threatening or major bleeding in 14.0% (6/43). Discharge to another healthcare facility was 27.0% (10/37). Readmission within 30 days of procedure for any cause was 18.9% (7/37). CONCLUSIONS: Patients with ESRD who undergo TAVR are at high risk for mortality and complications. TAVR outcomes are comparable to but not substantially better than those with SAVR. Transfemoral TAVR seems to be at least as safe and effective as the current standard SAVR in patients undergoing aortic valve replacement. © 2016 Wiley Periodicals, Inc.

Relation of frailty to outcomes after transcatheter aortic valve replacement (from the PARTNER trial).

Transcatheter aortic valve replacement (TAVR) is an effective treatment for severe symptomatic aortic stenosis (AS) in patients who are inoperable or at high risk for surgery. However, the intermediate- to long-term mortality is high, emphasizing the importance of patient selection. We, therefore, sought to evaluate the prognostic value of frailty in older recipients of TAVR, hypothesizing that frail patients would experience a higher mortality rate and a higher likelihood of poor outcome 1 year after TAVR. This substudy of the Placement of Aortic Transcatheter Valves trial was conducted at 3 high-enrolling sites where frailty was assessed systematically before TAVR. In total, 244 patients received TAVR at the participating sites. Frailty was assessed using a composite of 4 markers (serum albumin, dominant handgrip strength, gait speed, and Katz activity of daily living survey), which were combined into a frailty score. The cohort was dichotomized at median frailty score. Outcomes measures were the time to death from any cause for >1 year of follow-up and poor outcome at 1 year. Poor outcome was defined as (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score <60, or (3) decrease of ≥10 points in the KCCQ-OS score from baseline to 1 year. At 1 year, the Kaplan-Meier-estimated all-cause mortality rate was 32.7% in the frail group and 15.9% in the nonfrail group (log-rank p = 0.004). At 1 year, poor outcome occurred in 50.0% of the frail group and 31.5% of the nonfrail group (p = 0.02). In conclusion, frailty was associated with increased mortality and a higher rate of poor outcome 1 year after TAVR.

Outcomes of Treatment of Nonagenarians With Severe Aortic Stenosis.

BACKGROUND: Because nonagenarians with aortic stenosis (AS) often present as frail with more comorbid conditions, long-term outcomes and quality of life are important treatment considerations. The aim of this report is to describe survival and functional outcomes of nonagenarians undergoing treatment for AS by surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). METHODS: This is a retrospective analysis of all patients aged 90 years or more undergoing treatment for AS between 2007 and 2013 at two centers. Outcomes were compared between SAVR and TAVR. Long-term survival was compared with an age- and sex-matched population from the Social Security Actuarial Life Table. RESULTS: In all, 110 patients underwent treatment for isolated AS (20 SAVR and 90 TAVR). Mean age was 91.85 ± 1.80 years, and 50.9% were female. The Society of Thoracic Surgeons mean predicted risk of mortality was 11.11% ± 5.74%. Operative mortality was 10.9% (10.0% SAVR; 11.1% TAVR); 2.7% of patients had a stroke. The TAVR patients were more likely to be discharged home (75.9% versus 55.6% for SAVR, p = 0.032). Mean follow-up was 1.8 ± 1.5 years, with a 1-year and 5-year survival of 78.7% and 45.3%, respectively, which approximated the US actuarial survival. There was a significant improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire at 1 year compared with baseline. CONCLUSIONS: Treatment of AS approximates natural life expectancy in select nonagenarians, with no significant difference in long-term survival between SAVR and TAVR. Importantly, patient quality of life improved at 1 year. With appropriate selection, nonagenarians with severe AS can benefit from treatment.

Aortic root rupture after TAVR in two renal transplant patients on chronic immunosuppressant therapy.

Patients on chronic immunosuppressant therapy after renal transplantation have a high rate of in-hospital mortality and approximately 20% mortality rate per year after conventional valve surgery. While transcatheter aortic valve replacement (TAVR) is an appealing option to consider for such patients, there are not significant outcome data for the procedure in this patient population. We report two cases of aortic root rupture after TAVR in renal transplant patients on chronic immunosuppressant therapy.

Left main occlusion secondary to aortic root rupture following transcatheter aortic valve replacement managed by left main stenting.

Acute left main coronary occlusion secondary to a periaortic root hematoma secondary to annular rupture during transcatheter heart valve deployment is reported.

Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR.

OBJECTIVES: To compare iliofemoral arterial complications with transfemoral transcatheter aortic valve replacement (TF-TAVR) utilizing surgical cutdown versus percutaneous access with closure devices in a randomized trial. BACKGROUND: Major vascular complications following TAVR are a significant risk of the procedure. There are no randomized data comparing whether access method in TF-TAVR influences the risk of such complications. METHODS: From June to December 2011, 30 consecutive patients undergoing TF-TAVR were randomized to either surgical cutdown (C) or percutaneous (P) access. Subjects underwent preoperative CT scans, pre- and post-operative bilateral femoral arterial ultrasound and angiography. The primary endpoint was the composite of major and minor vascular complications at 30 days, as defined by the Valve Academic Research Consortium-2. Multivariate predictors of vascular complications were identified. RESULTS: Of the 30 subjects enrolled, 27 were treated with the randomized method of access as randomized. Iliofemoral complications were observed in eight patients (26.7%; C = 4, P = 4), all of which were dissections and/or stenoses that required percutaneous and/or surgical intervention. There were two (13.3%) major and two (13.3%) minor complications in each group. Two covariates that were significantly associated with vascular complications included female sex and baseline femoral arterial velocity on ultrasound. CONCLUSIONS: While surgical cutdown in TF-TAVR is the recommended access for new centers initiating a TAVR program, this small randomized pilot study suggests the lesser invasive percutaneous method in an experienced center is equivalent in safety to the surgical method. Doppler ultrasound may be useful in predicting complications prior to the procedure.