Transcatheter Aortic Valve Replacement After Prior Mitral Valve Surgery: Results From the Transcatheter Valve Therapy Registry.

BACKGROUND: Due to perceived technical challenges, patients with previous surgical mitral valve repair or replacement (SMVR) have been excluded from most transcatheter aortic valve replacement (TAVR) trials. Our objective was to compare the 30-day and 1-year outcomes of TAVR for patients with and without prior SMVR. METHODS: In a retrospective review of The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, we compared 1097 patients with prior SMVR to 46,327 patients without prior SMVR who underwent TAVR between November 2011 and September 2015 at 394 US centers. Preoperative characteristics, procedural details, and clinical outcomes were analyzed. RESULTS: Patients with previous SMVR were younger, more often female, and had higher STS predicted risk of mortality (8.6% vs 6.8%, P < .001). However, there was no difference in 30-day mortality (4.6% vs 5.5%, P = .293), myocardial infarction, stroke, reintervention, new dialysis, or readmission. Moderate/severe paravalvular leak at discharge was also similar (5.8% vs 4.9%, P = .343). At 1 year, morbidity was similar with slightly higher mortality among patients with prior SMVR (20% vs 17.5%, P = .087) that was significant after adjustment (hazard ratio 1.18, P = .043). The type of prior SMVR (repair, bioprosthetic replacement, or mechanical replacement) had no impact on 30-day or 1-year survival. CONCLUSIONS: Patients with prior SMVR undergoing TAVR had similar 30-day outcomes, slightly higher 1-year mortality, and no increase in early paravalvular leak compared with patients who did not have previous SMVR. Prior SMVR should not preclude TAVR for appropriately selected patients.

Clinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Aortic Valves by Four-Dimensional Computed Tomography.

BACKGROUND: The incidence of leaflet thrombosis after transcatheter aortic valve replacement (TAVR) with active surveillance by four-dimensional computed tomography (4DCT) ranges from 7% to 14%. The incidence of leaflet thrombosis when 4DCT is performed for clinical and echocardiographic indications is unknown. METHODS: All patients with prior TAVR or surgical aortic valve replacement (SAVR) who underwent evaluation between October 2015 and January 2017 at our institution and had clinical or echocardiographic indications of leaflet thrombosis were evaluated by 4DCT. Indications for 4DCT by echocardiography included (1) interval increase in mean gradient of 10 mm Hg or more, (2) interval decrease in ejection fraction of 10% or more, (3) thrombus seen on transthoracic echocardiography, (4) persistent or increasing paravalvular leak, or (5) valve dehiscence or thickened leaflets seen on transthoracic echocardiography. Clinical indicators were (1) stroke, (2) transient ischemic attack, or (3) new or worsening heart failure. RESULTS: During the study period, 612 patients underwent TAVR, and 101 patients (55 TAVR; 46 SAVR) met the criteria for 4DCT imaging. Leaflet thrombosis was seen in 17 of 55 TAVR patients (30.9%) and 15 of 46 SAVR patients (32.6%). Follow-up imaging with 4DCT after treatment with anticoagulation showed improvement or resolution in thrombus burden and leaflet excursion in all TAVR patients and in two-thirds of SAVR patients. CONCLUSIONS: One-third of patients with clinical or echocardiographic indications suggestive of leaflet thrombosis were found to have evidence of leaflet thrombosis using 4DCT. This allowed tailored anticoagulation therapy with resolution of the thrombus in most patients and avoiding unnecessary anticoagulation in the remaining two-thirds of patients.

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.

Description of a Method to Obtain Complete One-Year Follow-Up in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

The Centers for Medicare and Medicaid Services National Coverage Determination requires centers performing transcatheter aortic valve implantation (TAVI) to report clinical outcomes up to 1 year. Many sites encounter challenges in obtaining complete 1-year follow-up. We report our process to address this challenge. A multidisciplinary process involving clinical personnel, data and quality managers, and research coordinators was initiated to collect TAVI data at baseline, 30 days, and 1 year. This process included (1) planned clinical follow-up of all patients at 30 days and 1 year; (2) query of health-care system-wide integrated data warehouse (IDW) to ascertain last date of clinical contact within the system for all patients; (3) online obituary search, cross-referencing for unique patient identifiers to determine if mortality occurred in remaining unknown patients; and (4) phone calls to remaining unknown patients or patients' families. Between January 2012 and December 2016, 744 patients underwent TAVI. All 744 patients were eligible for 30-day follow-up and 546 were eligible for 1-year follow-up. At routine clinical follow-up of 22 of 744 (3%) patients at 30 days and 180 of 546 (33%) patients at 1 year had unknown survival status. The integrated data warehouse query confirmed status-alive for an additional 1 of 22 patients at 30 days (55%) and 91 of 180 patients at 1 year (51%). Obituaries were identified for 23 of 180 additional patients at 1 year (13%). Phone contact identified the remaining unknown patients at 30 days and 1 year, resulting in 100% known survival status for patients at 30 days (744 of 744) and at 1 year (546 of 546). In conclusion, using a comprehensive approach, we were able to determine survival status in 100% of patients who underwent TAVI.

Validation of a low-dose contrast 64-slice cardiac computed tomography angiography protocol for aortic valve annulus sizing.

Cardiac computed tomography angiography (CCTA) is the gold standard for accurately sizing the aortic valve annulus prior to aortic valve replacement. A reduction of contrast volume administered for CCTA, without sacrificing image quality, is desirable. Signal-to-noise ratio represents final CCTA image quality. Consecutive patients referred to CCTA for aortic valve annulus sizing were retrospectively analyzed. Patients were grouped into a low-dose contrast (LDCT) group and traditional dose contrast (TDCT) group. In the LDCT group, contrast dose was <50% of the maximal allowable dose (3.7 × estimated glomerular filtration rate). Guided by a time-density curve, the contrast was administered in a two-stage infusion, and retrospectively gated images were acquired with a 64-multidetector computed tomography scanner. Out of 123 patients (age 80 ± 9 years; 46% female), 65 (52.9%) underwent LDCT and 58 (47.2%) underwent TDCT. Contrast volume was significantly lower in the LDCT group (LDCT 41.2 ± 9.8 vs TDCT 76.2 ± 14.2 mL; P < 0.001). The signal-to-noise ratio of the aortic root was 10.4 ± 4.1 for the LDCT group and 8.4 ± 3.3 for the TDCT group (P = 0.004). Aortic root dimensions could be measured in both LDCT and TDCT groups. In conclusion, LDCT with 64-slice CCTA can effectively size the aortic valve annulus to direct aortic valve replacement while offering reduced contrast exposure.

Balloon aortic valvuloplasty to improve candidacy of patients evaluated for transcatheter aortic valve replacement.

OBJECTIVES: Evaluate the role of balloon aortic valvuloplasty (BAV) in improving candidacy of patients for transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients who are not candidates for TAVR may undergo BAV to improve functional and clinical status. METHODS: 117 inoperable or high-risk patients with critical aortic stenosis underwent BAV as a bridge-to-decision for TAVR. Frailty measures including gait speed, serum albumin, hand grip, activities of daily living (ADL); and NYHA functional class before and after BAV were compared. RESULTS: Mean age was 81.6 ± 8.5 years and the mean Society of Thoracic Surgeons predicted risk of mortality was 9.57 ± 5.51, with 19/117 (16.2%) patients non-ambulatory. There was no significant change in mean GS post-BAV, but all non-ambulatory patients completed GS testing at follow-up. Albumin and hand grip did not change after BAV, but there was a significant improvement in mean ADL score (4.85 ± 1.41 baseline to 5.20 ± 1.17, P = 0.021). The number of patients with Class IV congestive heart failure (CHF) was significantly lower post BAV (71/117 [60.7%] baseline versus 18/117 [15.4%], P = 0.008). 78/117 (66.7%) of patients were referred to definitive valve therapy after BAV. CONCLUSIONS: When evaluating frailty measures post BAV, we saw no significant improvement in mean GS, however, we observed a significant improvement in non-ambulatory patients and ADL scores. We also describe improved Class IV CHF symptoms. With this improved health status, the majority of patients underwent subsequent valve therapy, demonstrating that BAV may improve candidacy of patients for TAVR.

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.

Pathologic confirmation of valve thrombosis detected by four-dimensional computed tomography following valve-in-valve transcatheter aortic valve replacement.

A major concern regarding transcatheter aortic valve replacement (TAVR) is leaflet thrombosis. Four-dimensional computed tomography (4D-CT) is the preferred imaging modality to evaluate patients with suspected valve thrombosis. To date, the abnormal findings visualized by 4D-CT suggestive of leaflet thrombosis have lacked pathologic confirmation from a surgically explanted valve in a surviving patient. Herein, we provide pathologic confirmation of thrombus formation following surgical explantation of a thrombosed TAVR prosthesis that was initially identified by 4D-CT.

Should Transcatheter Aortic Valve Replacement Be Performed in Nonagenarians?: Insights From the STS/ACC TVT Registry.

BACKGROUND: Data demonstrating the outcome of transcatheter aortic valve replacement (TAVR) in the very elderly patients are limited, as they often represent only a small proportion of the trial populations. OBJECTIVES: The purpose of this study was to compare the outcomes of nonagenarians to younger patients undergoing TAVR in current practice. METHODS: We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. Outcomes at 30 days and 1 year were compared between patients ≥90 years versus <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire. RESULTS: Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90 years. The 30-day and 1-year mortality rates were significantly higher among nonagenarians (age ≥90 years vs. <90 years: 30-day: 8.8% vs. 5.9%; p < 0.001; 1 year: 24.8% vs. 22.0%; p < 0.001, absolute risk: 2.8%, relative risk: 12.7%). However, nonagenarians had a higher mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score (10.9% vs. 8.1%; p < 0.001) and, therefore, had similar ratios of observed to expected rates of 30-day death (age ≥90 years vs. <90 years: 0.81, 95% confidence interval: 0.70 to 0.92 vs. 0.72, 95% confidence interval: 0.67 to 0.78). There were no differences in the rates of stroke, aortic valve reintervention, or myocardial infarction at 30 days or 1 year. Nonagenarians had lower (worse) median Kansas City Cardiomyopathy Questionnaire scores at 30 days; however, there was no significant difference at 1 year. CONCLUSIONS: In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality rates were statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in nonagenarians as in younger patients. These data support safety and efficacy of TAVR in select very elderly patients.

Prognostic Usefulness of Acute Kidney Injury After Transcatheter Aortic Valve Replacement.

Acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR) has been associated with increased postoperative morbidity and mortality. Long-term outcomes after TAVR with the Edwards SAPIEN valve in patients who develop AKI postoperatively are currently not well described. We retrospectively reviewed 384 consecutive patients undergoing TAVR at 2 institutions from August 2006 to April 2012. AKI was defined and staged according to Valve Academic Research Consortium-2 criteria. The incidence, multivariate predictors, and association of AKI with 3-year mortality were evaluated. Stage 1 AKI occurred in 24.0% of patients (92 of 384), stage 2 in 5.5% (21 of 384), and stage 3 in 8.1% (31 of 384). The overall operative mortality rate was 7.6%, with a mortality of 3.0% in patients with no kidney injury, 7.6% in stage 1, 23.8% in stage 2, and 32.3% in stage 3. The incidence of new postoperative dialysis was 3.1%. Survival at 3 years for no-AKI/stage 1/stage 2/stage 3 was 59.2 ± 3.3%, 43.4 ± 5.2%, 27.8 ± 10.0%, and 25.4 ± 7.9%, respectively. Logistic regression modeling for the combination of stage 2 or 3 AKI after surgery demonstrated that the last preoperative creatinine (for each 1 mg/dl increase, odds ratio = 3.23, 95% CI 1.83 to 5.69; p <0.001) and dye load (for each 10 ml increase, odds ratio = 1.04, 95% CI 1.01 to 1.08; p = 0.006) were significant predictors for AKI. In conclusion, AKI after TAVR is associated with increased postoperative and 3-year mortality. Significant multivariate predictors are potentially modifiable before the procedure.

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.

Sex Differences in Outcomes Following Percutaneous Coronary Intervention According to Age.

BACKGROUND: Women <50 years of age with coronary artery disease may represent a group at higher risk for recurrent ischemic events after percutaneous coronary intervention (PCI); however, no long-term, multicenter outcomes assessment exists in this population. METHODS AND RESULTS: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated the association of sex and age on cardiovascular-related outcomes in 10,963 patients (3797 women, 394 <50 years) undergoing PCI and followed for 5 years. Death, myocardial infarction, coronary artery bypass graft surgery, and repeat PCI were primary outcomes comprising major adverse cardiovascular events. Although procedural success rates were similar by sex, the cumulative rate of major adverse cardiovascular events at 1 year was higher in young women (27.8 versus 19.9%; P=0.003), driven largely by higher rates of repeat revascularizations for target vessel or target lesion failure (coronary artery bypass graft surgery: 8.9% versus 3.9%, P<0.001, adjusted hazard ratio 2.4, 95% confidence interval 1.5-4.0; PCI: 19.0% versus 13.0%, P=0.005, adjusted hazard ratio 1.6, 95% confidence interval 1.2-2.2). At 5 years, young women remained at higher risk for repeat procedures (coronary artery bypass graft surgery: 10.7% versus 6.8%, P=0.04, adjusted hazard ratio 1.71, 95% confidence interval 1.01-2.88; repeat PCI [target vessel]: 19.7% versus 11.8%, P=0.002, adjusted hazard ratio 1.8, 95% confidence interval 1.24-2.82). Compared with older women, younger women remained at increased risk of major adverse cardiovascular events, whereas all outcome rates were similar in older women and men. CONCLUSIONS: Young women, despite having less severe angiographic coronary artery disease, have an increased risk of target vessel and target lesion failure. The causes of this difference deserve further investigation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00005677.

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.

Use of novel antiplatelet agents in acute coronary syndromes.

Acute coronary syndromes (ACS) encompass a broad spectrum of clinical presentations based on underlying pathology that results in myocardial ischemia and/or infarction. Despite advancements in invasive management and secondary preventive therapies, recurrent atherothrombotic coronary events remain a prevalent cause of death and recurrent cardiac events after ACS and, in those who survive, the root of long-standing cardiac comorbidities. Antiplatelet drug therapy has proven beneficial in the reduction of these events, and novel antiplatelet agents have resulted in significant improvement in clinical outcomes over the last decade. However, the balance of optimal platelet inhibition with minimal bleeding complications remains a clinical challenge. This review focuses on more recent advances in antiplatelet therapies used in the treatment of ACS.

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.

Five-year follow-up of patients treated for coronary artery disease in the face of an increasing burden of co-morbidity and disease complexity (from the NHLBI Dynamic Registry).

Management of coronary artery disease (CAD) has evolved over the past decade, but there are few prospective studies evaluating long-term outcomes in a real-world setting of evolving technical approaches and secondary prevention. The aim of this study was to determine how the mortality and morbidity of CAD has changed in patients who have undergone percutaneous coronary intervention (PCI), in the setting of co-morbidities and evolving management. The National Heart, Lung, and Blood Institute Dynamic Registry was a cohort study of patients undergoing PCI at various time points. Cohorts were enrolled in 1999 (cohort 2, n = 2,105), 2004 (cohort 4, n = 2,112), and 2006 (cohort 5, n = 2,176), and each was followed out to 5 years. Primary outcomes were death, myocardial infarction (MI), coronary artery bypass grafting, repeat PCI, and repeat revascularization. Secondary outcomes were PCI for new obstructive lesions at 5 years, 5-year rates of death and MI stratified by the severity of coronary artery and co-morbid disease. Over time, patients were more likely to have multiple co-morbidities and more severe CAD. Despite greater disease severity, there was no significant difference in death (16.5% vs 17.6%, adjusted hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.74 to 1.08), MI (11.0% vs 10.6%, adjusted HR 0.87, 95% CI 0.70 to 1.08), or repeat PCI (20.4% vs 22.2%, adjusted HR 0.98, 95% CI 0.85 to 1.17) at 5-year follow-up, but there was a significant decrease in coronary artery bypass grafting (9.1% vs 4.3%, adjusted HR 0.44, 95% CI 0.32 to 0.59). Patients with 5 co-morbidities had a 40% to 60% death rate at 5 years. There was a modestly high rate of repeat PCI for new lesions, indicating a potential failure of secondary prevention for this population in the face of increasing co-morbidity. Overall 5-year rates of death, MI, repeat PCI, and repeat PCI for new lesions did not change significantly in the context of increased co-morbidities and complex disease.

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.