Hanna A. Jensen

Transapical and Transaortic Transcatheter Aortic Valve Replacement in the United States

BACKGROUND When transcatheter aortic valve replacement (TAVR) cannot be carried out through transfemoral access, alternative access TAVR is indicated. The purpose of this study was to explore inhospital and 1-year outcomes of patients undergoing alternative access TAVR through the transapical (TA) or transaortic (TAo) techniques in the United States. METHODS Clinical records of 4,953 patients undergoing TA (n = 4,085) or TAo (n = 868) TAVR from 2011 to 2014 in The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Centers for Medicare and Medicaid Services hospital claims. Inhospital and 1-year clinical outcomes were stratified by operative risk; and the risk-adjusted association between access route and mortality, stroke, and heart failure repeat hospitalization was explored. RESULTS Mean age for all patients was 82.8 ± 6.8 years. The median STS predicted risk of mortality was significantly higher among patients undergoing TAo (8.8 versus 7.4, p < 0.001). When compared with TA, TAo was associated with an increased risk of unadjusted 30-day mortality (10.3% versus 8.8%) and 1-year mortality (30.3% versus 25.6%, p = 0.006). There were no significant differences between TAo and TA for inhospital stroke rate (2.2%), major vascular complications (0.3%), and 1-year heart failure rehospitalizations (15.7%). Examination of high-risk and inoperable subgroups showed that 1-year mortality was significantly higher for TAo patients classified as inoperable (p = 0.012). CONCLUSIONS Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR.

Outcomes in Nonagenarians Undergoing Transcatheter Aortic Valve Replacement in the PARTNER-I Trial

BACKGROUND This study describes short-term and mid-term outcomes of nonagenarian patients undergoing transfemoral or transapical transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valve (PARTNER)-I trial. METHODS From April 2007 to February 2012, 531 nonagenarians, mean age 93 ± 2.1 years, underwent TAVR with a balloon-expandable prosthesis in the PARTNER-I trial: 329 through transfemoral (TF-TAVR) and 202 transapical (TA-TAVR) access. Clinical events were adjudicated and echocardiographic results analyzed in a core laboratory. Quality of life (QoL) data were obtained up to 1 year post-TAVR. Time-varying all-cause mortality was referenced to that of an age-sex-race-matched US population. RESULTS For TF-TAVR, post-procedure 30-day stroke risk was 3.6%; major adverse events occurred in 35% of patients; 30-day paravalvular leak was greater than moderate in 1.4%; median post-procedure length of stay (LOS) was 5 days. Thirty-day mortality was 4.0% and 3-year mortality 48% (44% for the matched population). By 6 months, most QoL measures had stabilized at a level considerably better than baseline, with Kansas City Cardiomyopathy Questionnaire (KCCQ) 72 ± 21. For TA-TAVR, post-procedure 30-day stroke risk was 2.0%; major adverse events 32%; 30-day paravalvular leak was greater than moderate in 0.61%; and median post-procedure LOS was 8 days. Thirty-day mortality was 12% and 3-year mortality 54% (42% for the matched population); KCCQ was 73 ± 23. CONCLUSIONS A TAVR can be performed in nonagenarians with acceptable short- and mid-term outcomes. Although TF- and TA-TAVR outcomes are not directly comparable, TA-TAVR appears to carry a higher risk of early death without a difference in intermediate-term mortality. Age alone should not preclude referral for TAVR in nonagenarians.

Outcomes for Transcatheter Aortic Valve Replacement in Nonagenarians.

BACKGROUND Transcatheter aortic valve replacement (TAVR) may offer extreme-aged patients a treatment alternative to surgical aortic valve replacement (SAVR). The objective of this study was to describe outcomes of TAVR in nonagenarians using transfemoral and alternative access techniques. METHODS In a retrospective review, we found 95 nonagenarians who underwent TAVR from September 2007 through February 2014 at Emory University using a balloon expandable valve: transfemoral (n = 66), transapical (n = 14), transaortic (n = 14), and transcarotid (n = 1). Morbidity and 30-day and midterm mortality were assessed. Kaplan-Meier plots were used to determine midterm survival rates. RESULTS The mean age of the patients was 91.8 ± 1.8 years, and 49 (52%) were female. Postoperative morbidity included 1 patient (1%) each with stroke, myocardial infarction, pneumonia, and renal failure. The mean postoperative length of stay was 6.8 ± 5.1 days for all patients. Overall 30-day mortality was 3.2%, much less than The Society of Thoracic Surgeons predicted risk of mortality of 14.5% ± 7.3%. There were no deaths in the transfemoral patients, but there were 2 transapical deaths (14.3%) and 1 transaortic death (7.1%). The Kaplan-Meier estimate of median survival was 2.6 years. CONCLUSIONS Extreme-aged nonagenarian patients may have excellent outcomes from TAVR at 30-day and midterm follow-up. Alternative access TAVR is associated with higher morbidity and mortality than transfemoral TAVR. Referral for TAVR of nonagenarians should not be precluded based on age alone.

Transcatheter Aortic Valve Replacement Results in Improvement of Pulmonary Function in Patients With Severe Aortic Stenosis.

BACKGROUND Chronic obstructive pulmonary disease (COPD) has been identified as a risk factor for morbidity and mortality after transcatheter aortic valve replacement (TAVR). We hypothesized that a portion of pulmonary dysfunction in patients with severe aortic stenosis may be of cardiac origin, and has potential to improve after TAVR. METHODS A retrospective analysis was made of consecutive TAVR patients from April 2008 to October 2014. Of patients who had pulmonary function testing and serum B-type natriuretic peptide data available before and after TAVR, 58 were found to have COPD (26 mild, 14 moderate, and 18 severe). Baseline variables and operative outcomes were explored along with changes in pulmonary function. Multiple regression analyses were performed to adjust for preoperative left ventricular ejection fraction and glomerular filtration rate. RESULTS Comparison of pulmonary function testing before and after the procedure among all COPD categories showed a 10% improvement in forced vital capacity (95% confidence interval: 4% to 17%) and a 12% improvement in forced expiratory volume in 1 second (95% confidence interval: 6% to 19%). There was a 29% decrease in B-type natriuretic peptide after TAVR (95% confidence interval: -40% to -16%). An improvement of at least one COPD severity category was observed in 27% of patients with mild COPD, 64% of patients with moderate COPD, and 50% of patients with severe COPD. There was no 30-day mortality in any patient group. CONCLUSIONS In patients with severe aortic stenosis, TAVR is associated with a significant improvement of pulmonary function and B-type natriuretic peptide. After TAVR, the reduction in COPD severity was most evident in patients with moderate and severe pulmonary dysfunction.

Association of Transcatheter Aortic Valve Replacement With 30-Day Renal Function and 1-Year Outcomes Among Patients Presenting With Compromised Baseline Renal Function: Experience From the PARTNER 1 Trial and Registry

Importance The frequency of baseline renal impairment among high-risk and inoperable patients with severe aortic stenosis undergoing a transcatheter aortic valve replacement (TAVR) and the effect of TAVR on subsequent renal function are, to our knowledge, unknown. Objective To determine the effect of TAVR among patients with baseline renal impairment. Design, Setting, and Participants This substudy of patients with baseline renal impairment (estimated glomerular filtration rate [eGFR] ⩽ 60 mL/min) and paired baseline and 30-day measures of renal function undergoing TAVR in the PARTNER 1 trial and continued access registries was conducted in 25 centers in the United States and Canada. Main Outcomes and Measures Patients were categorized with improved eGFR (30-day follow-up eGFR≥10% higher than baseline pre-TAVR), worsened eGFR (≥10% lower), or no change in renal function (neither). Baseline characteristics, 30-day to 1-year all-cause mortality, and repeat hospitalization were compared. Multivariable models were constructed to identify predictors of 1-year mortality and of improvement/worsening in eGFR. Results Of the 821 participants, 401 (48.8%) were women and the mean (SD) age for participants with improved, unchanged, or worsening eGFR was 84.90 (6.91) years, 84.37 (7.13) years, and 85.39 (6.40) years, respectively. The eGFR was 60 mL/min or lower among 821 patients (72%), of whom 345 (42%) improved, 196 (24%) worsened, and 280 (34%) had no change at 30 days. There were no differences in baseline age, body mass index, diabetes, chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, hypertension, pulmonary hypertension, renal or liver disease, New York Heart Association III/IV symptoms, transaortic gradient, left ventricular ejection fraction, or procedural characteristics. The group with improved eGFR had more women, nonsmokers, and a lower cardiac index. Those with worsening eGFR had a higher median Society of Thoracic Surgeons score and left ventricle mass. From 30 days to 1 year, those with improved eGFR had no difference in mortality or repeat hospitalization. Those with worsening eGFR had increased mortality (25.5% vs 19.1%, P = .07) but no significant increases in repeat hospitalization or dialysis. Predictors of improved eGFR were being female (odds ratio [OR], 1.38; 95% CI, 1.03-1.85; P = .03) and nonsmoking status (OR, 1.49; 95% CI, 1.11-1.01; P = .01); predictors of worsening eGFR were baseline left ventricle mass (OR, 1.00; 95% CI, 1.00-1.01; P = .01), smoking (OR, 1.51; 95% CI, 1.06-2.14; P = .02), and age (OR, 1.03; 95% CI, 1.00-1.05; P = .05); and predictors of 1-year mortality were baseline left ventricular ejection fraction (OR, 0.98; 95% CI, 0.97-0.99; P = .003), baseline eGFR (OR, 0.98; 95% CI, 0.96-0.99; P < .001), and worsening eGFR vs no change in eGFR (OR, 1.51; 95% CI, 1.02-2.24; P = .04). Conclusions and Relevance Baseline renal impairment was frequent among patients who underwent TAVR. While improved eGFR did not improve 1-year outcomes, worsening eGFR was associated with increased mortality. Trial Registration clinicaltrials.gov Identifier: NCT00530894

Intensive Glycemic Control in Cardiac Surgery.

Hyperglycemia has been found to be associated with increased morbidity and mortality in surgical patients, yet, the optimal glucose management strategy during the perioperative setting remains undetermined. While much has been published about hyperglycemia and cardiac surgery, most studies have used widely varying definitions of hyperglycemia, methods of insulin administration, and the timing of therapy. This has only allowed investigators to make general conclusions in this challenging clinical scenario. This review will introduce the basic pathophysiology of hyperglycemia in the cardiac surgery setting, describe the main clinical consequences of operative hyperglycemia, and take the reader through the published material of intensive and conservative glucose management. Overall, it seems that intensive control has modest benefits with adverse effects often outweighing these advantages. However, some studies have indicated differing results for certain patient subgroups, such as non-diabetics with acute operative hyperglycemia. Future studies should focus on distinguishing which patient populations, if any, would optimally benefit from intensive insulin therapy.

Nontransfemoral Approaches to Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) is noninferior to surgical aortic valve replacement in patients with high operative risk and superior to medical treatment in patients deemed unsuitable for surgical intervention. However, up to 30% to 50% of patients screened for this intervention are not candidates for TAVR via the preferred transfemoral route because of severe peripheral arterial disease. Alternative access routes must be considered and include the transapical, transaortic, transsubclavian, and transcarotid approaches. The use of alternative access is predicated on appropriate patient selection as determined by a dedicated multispecialty heart valve team and can lead to excellent outcomes.

Two surgical techniques for transaortic transcatheter aortic valve replacement: Is there a preferred technique?

16. Kappetein AP, Head SJ, G en ereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438-54. 17. Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F, et al. Outcomes following transcatheter aortic valve replacement in the United States. J Am Med Assoc. 2013;310:2069-77.

Alternate Vessel Approaches to Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) has been found to be non-inferior to surgical aortic valve replacement (SAVR) in patients with high operative risk and superior to medical treatment in patients who are deemed inoperable. However, about 30 % of patients screened for this intervention are not candidates for TAVR via the preferred transfemoral route due to severe peripheral arterial disease and/or body habitus. In these patients, alternative access routes must be considered. These include the transapical, transaortic, transcarotid, trans-subclavian, and most recently transcaval approaches. The route of alternative access is based on the decision of the dedicated multispecialty heart valve team, upon review of patient variables. This approach leads to optimal outcomes in these challenging, often very comorbid patients. As data emerge about the outcomes of each alternative access route, we foresee more specific patient allocation algorithms to be instituted to guide clinical decision-making. The properties and suitability of different valve and delivery systems for alternative access will also be an intriguing area of research as new valves are continuously developed.

Protecting the aorta during transcatheter aortic valve replacement: Have we found the answer?

Neurologic injury ranging from transient cognitive dysfunction to catastrophic permanent stroke constitutes the single main morbidity of cardiac surgery and largely affects modern transcatheter aortic valve replacement (TAVR). Today, the incidence of cerebrovascular events after TAVR ranges from 3% to 7%. In the current report, Samim and colleagues have explored one of the novel embolic protection devices (EPDs) aimed at reducing these extremely pervasive complications that often carry surmountable challenges to the patient in terms of a reduction in functional status and quality of life, and the healthcare provider in the form of increased hospital stay and need for rehabilitation. In this small series, the authors used an embolic deflection device (Embrella; Edwards Lifesciences Corporation, Irvine, Calif) in the aortic arch to minimize cerebral embolization during transfemoral TAVR. They found that the 15 consecutive patients in the intervention group exhibited a significantly higher number of new ischemic cerebral lesions in postoperative diffusion-weighted magnetic resonance imaging when compared retrospectively with 37 patients who underwent TAVR without any EPD in the same institution (a median of 9.0 lesions [4.0-12.0] in the Embrella group and 5.0 lesions [2.0-7.0] in the TAVRonly group, P 1⁄4 .044). The authors are to be commended for the safe use of the EPD because implementation was successful in all cases, no vascular complications were observed, and the use of EPD did not interfere with the primary TAVR procedure. However, the patient series is small and carries an inherent selection bias because no inclusion/exclusion criteria