End-stage renal disease and severe aortic stenosis: Does valve replacement improve one-year outcomes?

BACKGROUND: Treatment for patients with end-stage renal disease (ESRD) and severe aortic stenosis (AS) includes balloon aortic valvuloplasty (BAV), surgical (SAVR), or transcatheter (TAVR) aortic valve replacement. We compared outcomes among these strategies. METHODS: A retrospective review of patients with ESRD undergoing treatment for severe AS between 07/2007 and 06/2015 was performed at our center. Patients were classified based on treatment: BAV-only, TAVR, or SAVR. Baseline characteristics and 30-day outcomes were compared among groups. A 1-year survival analysis was performed. RESULTS: Of 85 patients, 25 (29.4%) underwent BAV, 30 (35.3%) TAVR, and 30 (35.3%) SAVR. Patients in the SAVR group, compared to the BAV or TAVR patients, were younger (63 vs. 74 vs. 71 years, P = 0.02) and had less prior stroke (3.3% vs. 12.0% vs. 30.0%, P = 0.008). While all BAV patients had NYHA class III/IV, 93.3% and 76.7% of patients had NYHA class III/IV in the TAVR and SAVR group, respectively (P = 0.001). BAV patients were less likely to have atrial fibrillation than TAVR or SAVR patients (16.0% vs. 43.3% vs. 50.0%, P = 0.03). All patients were high risk, but there was a statistical trend to lower STS scores in the SAVR group (8.6% vs. 13.5% vs. 13.5%, P = 0.08). There was no significant difference in 30-day mortality (16.7% vs. 10.0% vs. 10.0%, P = 0.74), but BAV treated patients had an increased 1-year mortality compared to those treated with TAVR or SAVR (87.0% vs. 32.0%, vs. 36.7%, P=<0.001). Independent predictors of 1-year mortality were a higher STS score (HR 1.026, 95%CI 1.002-1.051) and BAV-only strategy (BAV vs. TAVR: HR 3.961, 95%CI 1.595-9.840), but dialysis duration and type, and SAVR versus TAVR were not. CONCLUSIONS: Patients with ESRD and severe AS have a similar and higher survival with TAVR or SAVR when compared to BAV at 1-year. These results may influence patient care decisions favoring valve replacement in AS patients with ESRD. © 2016 Wiley Periodicals, Inc.

Does minimalist transfemoral transcatheter aortic valve replacement produce better survival in patients with severe chronic obstructive pulmonary disease?

OBJECTIVES: To compare outcomes after minimalist and standard transfemoral transcatheter aortic valve replacement (TF-TAVR) in patients with severe chronic obstructive pulmonary disease (COPD). BACKGROUND: TF-TAVR is increasingly performed with conscious sedation and transthoracic echocardiography guidance (minimalist). The safety/efficacy of this technique in patients with severe COPD is unknown. METHODS: We compared demographics, 30-day outcomes and 1-year survival of patients with severe COPD (FEV1% ≤50) who underwent minimalist vs. standard TF-TAVR between 2008 and 2015 at our institution. RESULTS: Of 88 patients with severe COPD, 46 underwent minimalist and 42 underwent standard TF-TAVR. There were no differences on baseline characteristics, except for more history of coronary artery bypass grafting (45.5% vs. 20.6%, P = 0.03) and less history of cerebrovascular disease (16.7% vs. 45.5%, P = 0.03) in the standard TF-TAVR. Seventeen minimalist TF-TAVR patients (41.0%) were transferred directly to the general medical ward with telemetry monitoring (without ICU stay); all standard TF-TAVR patients went to the ICU. Minimalist TF-TAVR patients had shorter procedure time (97 vs. 129 min, P < 0.001), ICU time (21.8 vs. 29.8 hr, P = 0.001) and length of stay (2 vs. 5 days, P = 0.001). There were no differences in procedure complications and 30-day mortality between groups. In our multivariate analysis, minimalist TF-TAVR (HR 0.28, 95%CI 0.08-0.97) and previous coronary revascularization (HR 0.24, 95%CI 0.09-0.65) were associated with increased 1-year survival. In contrast, moderate paravalvular leak (HR 7.73, 95%CI 1.94-30.84) was associated with decreased 1-year survival. CONCLUSION: In patients with severe COPD, Minimalist TF-TAVR results in less resource utilization and improved 1-year survival compared to standard approach. Our findings should be validated in a larger cohort of patients with severe COPD. © 2016 Wiley Periodicals, Inc.

Transcaval Valve-in-Valve-in-Valve Aortic Valve Replacement for Bioprosthetic Valve Degeneration.

A 74-year-old man presented with progressive dyspnea on exertion. History included peripheral arterial disease and coronary artery bypass grafting with aortic valve replacement 12 years ago. Subsequently, the surgical valve developed severe stenosis and moderate insufficiency. He underwent a transapical valve-in-valve transcatheter aortic valve replacement 5 years before presentation. This second valve developed a mean gradient of 66 mm Hg with mild insufficiency. The patient was treated with a third aortic valve using an alternative transcaval approach, significantly alleviating his symptoms.

Predictors and Clinical Outcomes of Next-Day Discharge After Minimalist Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to investigate predictors and safety of next-day discharge (NDD) after transcatheter aortic valve replacement (TAVR). BACKGROUND: Information about predictors and safety of NDD after TAVR is limited. METHODS: The study reviewed 663 consecutive patients who underwent elective balloon-expandable TAVR (from July 2014 to July 2016) at our institution. We first determined predictors of NDD in patients who underwent minimalist transfemoral TAVR. After excluding cases with complications, we compared 30-day and 1-year outcomes between NDD patients and those with longer hospital stay using Cox regression adjusting for the Predicted Risk of Mortality provided by the Society of Thoracic Surgeons. The primary endpoint was the composite of mortality and readmission at 1 year. RESULTS: A total of 150 patients had NDD after TAVR and 210 patients had non-NDD. Mean age and the Society of Thoracic Surgeons Predicted Risk of Mortality were 80.7 ± 8.8 years and 6.6 ± 3.7%, respectively. Predictors of NDD were male sex (odds ratio [OR]: 2.02; 95% confidence interval [CI]: 1.28 to 3.18), absence of atrial fibrillation (OR: 1.62; 95% CI: 1.02 to 2.57), serum creatinine (OR: 0.71; 95% CI: 0.55 to 0.92), and age (OR: 0.95; 95% CI: 0.93 to 0.98). As expected, 84% of patients with complications had non-NDD. After excluding cases with complications, there was no difference in hazard rates of the 30-day composite outcome between NDD and non-NDD (hazard ratio: 0.62; 95% CI: 0.20 to 1.91), but the hazard of the composite outcome at 1 year was significantly lower in the NDD group (hazard ratio: 0.47; 95% CI: 0.27 to 0.81). This difference in the composite outcome can be explained by the lower hazard of noncardiovascular related readmission in the NDD group. CONCLUSIONS: Factors predicting NDD include male sex, absence of atrial fibrillation, lower serum creatinine, and younger age. When compared with patients without complications with a longer hospital stay, NDD appears to be safe, achieving similar 30-day and superior 1-year clinical outcomes.

Readmission rates after transcatheter aortic valve replacement in high- and extreme-risk patients with severe aortic stenosis.

OBJECTIVE: In high- or extreme-risk patients undergoing transcatheter aortic valve replacement, readmissions have not been adequately studied and are the subject of increased scrutiny by healthcare systems. The objectives of this study were to determine the incidence of 30-day and 1-year cardiac and noncardiac readmissions, identify predictors of readmission, and assess the association between readmission and 1-year mortality. METHODS: A retrospective review was performed on 714 patients who underwent transcatheter aortic valve replacement from September 2007 to January 2015 at Emory University. RESULTS: Patients' median age was 83 years, and 46.6% were female. Early all-cause readmission for the cohort was 10.5%, and late readmission was 18.8%. Anemia was related to both early all-cause (hazard ratio [HR], 0.74) and cardiovascular-related readmission (HR, 0.60). A 23-mm valve implanted was associated with early all-cause readmission (HR, 1.73). Length of hospital stay was related to late all-cause (HR, 1.14) and cardiovascular-related readmission (HR, 1.21). Postoperative permanent stroke had an impact on late cardiovascular-related readmission (HR, 3.60; 95% confidence interval, 1.13-11.49). Multivariable analysis identified anemia as being associated with 30-day all-cause readmission, and anemia and postoperative stroke were associated with 30-day cardiovascular-related readmission. Readmissions seemed to be related to 1-year mortality (HR, 2.04; 95% confidence interval, 1.33-3.12). CONCLUSIONS: We show some baseline comorbidities and procedural complications that are directly associated with early and late readmissions, and anemia and postoperative stroke were associated with an increase in mortality. Moreover, we found that readmission was associated with double the hazard of death within 1 year. Whether treatment of identified risk factors could decrease readmission rates and mortality warrants further investigation.

Should We Perform Carotid Doppler Screening Before Surgical or Transcatheter Aortic Valve Replacement?

BACKGROUND: Screening for internal carotid artery stenosis (ICAS) with Doppler ultrasound is commonly used before cardiovascular surgery. Nevertheless, the relationship between ICAS and procedure-related stroke in isolated aortic valve replacement is unclear. METHODS: We retrospectively reviewed patients with artery stenosis who underwent ICAS screening before surgical (SAVR) or transcatheter aortic valve replacement (TAVR) between January 2007 and August 2014. Logistic regression models were used to determine the relation between post-procedure stroke and total (sum of left and right ICAS) and maximal unilateral ICAS. Age, sex, history of atrial fibrillation, cerebrovascular disease and diabetes, left ventricular ejection fraction, and procedure type were considered as covariates. Two-subgroup analyses were performed in patients who underwent TAVR and SAVR, adjusting for procedure specific details. RESULTS: A total of 996 patients underwent ICAS screening before TAVR (n = 467) or SAVR (n = 529). The prevalence of at least ≥70% ICAS was 5.2% (n = 52) and incidence of 30-day stroke was 3.4% (n = 34). Eight patients who underwent carotid intervention before valve replacement and 6 patients with poor Doppler images were excluded from the final analysis. We found no statistically significant association between stroke and either the total or maximal unilateral ICAS for all patients (p = 0.13 and p = 0.39, respectively) or those undergoing TAVR (p = 0.27 and p = 0.63, respectively) or SAVR (p = 0.21 and p = 0.36, respectively). CONCLUSIONS: We found no statistically significant association between ICAS severity procedure-related stroke after aortic valve replacement. This suggests that universal carotid Doppler screening before isolated TAVR or SAVR is unnecessary.

Does a Higher Society of Thoracic Surgeons Score Predict Outcomes in Transfemoral and Alternative Access Transcatheter Aortic Valve Replacement?

BACKGROUND: Nontransfemoral (non-TF) transcatheter aortic valve replacement (TAVR) is often associated with worse outcomes than TF TAVR. We investigated the relationship between increasing Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score and observed mortality and morbidity in TF and non-TF TAVR groups. METHODS: We reviewed 595 patients undergoing TAVR at Emory Healthcare between 2007 and 2014. Clinical outcomes were reported for 337 TF patients (57%) and 258 non-TF patients (43%). We created 3 STS PROM score subgroups: <8%, 8%-15%, and >15%. A composite outcome of postoperative events was defined as death, stroke, renal failure, vascular complications, or new pacemaker implantation. RESULTS: TF patients were older (82.4 ± 8.0 vs 80.8 ± 8.7 years, p = 0.02), whereas the STS PROM was higher in non-TF patients (10.5% ± 5.3% vs 11.7% ± 5.7%, p = 0.01). Observed/expected mortality was less than 1.0 in all groups. The rate of the composite outcome did not differ between STS PROM subgroups in TF (p = 0.68) or non-TF TAVR (p = 0.27). One-year mortality was higher for patients with STS PROM >8% in the non-TF group; however, this difference was not observed in TF patients (p = 0.40). CONCLUSIONS: As expected, non-TF patients were at a higher risk than TF patients for procedural morbidity and death. Although no differences were observed in 30-day deaths or morbidity in different STS PROM subgroups, those undergoing non-TF TAVR at a higher STS PROM (>8%) had higher 1-year mortality. When applicable, TF TAVR remains the procedure of choice in high- or extreme-risk patients undergoing TAVR.

Identification of two novel DQA1 alleles, DQA1*0107 and DQA1*0602, by sequence-based typing in the GoKinD population.

Two novel DQA1 alleles, DQA1*0107 and DQA1*0602, were discovered using DQA1 sequence-based typing (SBT) in participants in the Genetics of Kidneys in Diabetes (GoKinD) Study. The DQA1*0107 allele, found in three unrelated Caucasian participants, contains a novel polymorphism at codon 79 of exon 2 (CGC-->TGC), which results in an amino acid change from an arginine to a cysteine. The participants containing this novel polymorphism also had a 1-bp insertion in intron 2 that is common to the *01 alleles. The DQA1*0602 allele, found in one Caucasian participant, contains a novel polymorphism at codon 139 of exon 3 (AGC-->CGC), which results in an amino acid change from a serine to an arginine. Additionally, the *0602 allele has a base change in intron 1 that is common to the *06 alleles. Both new alleles were isolated using single-allele amplification SBT and confirmed using sequence-specific primer amplification.

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.

Minimalist transcatheter aortic valve replacement: The new standard for surgeons and cardiologists using transfemoral access?

BACKGROUND: A minimalist approach for transcatheter aortic valve replacement (MA-TAVR) utilizing transfemoral access under conscious sedation and transthoracic echocardiography is increasing in popularity. This relatively novel technique may necessitate a learning period to achieve proficiency in performing a successful and safe procedure. This report evaluates our MA-TAVR cohort with specific characterization between our early, midterm, and recent experience. METHODS: We retrospectively reviewed 151 consecutive patients who underwent MA-TAVR with surgeons and interventionists equally as primary operator at Emory University between May 2012 and July 2014. Our institution had performed 300 TAVR procedures before implementation of MA-TAVR. Patient characteristics and early outcomes were compared using Valve Academic Research Consortium 2 definitions among 3 groups: group 1 included the first 50 patients, group 2 included patients 51 to 100, and group 3 included patients 101 to 151. RESULTS: Median age for all patients was 84 years and similar among groups. The majority of patients were men (56%) and the median ejection fraction for all patients was 55% (interquartile range, 38.0%-60.0%). The majority of patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality of 10.0% and similar among groups. The overall major stroke rate was 3.3%, major vascular complications occurred in 3% of patients, and greater-than-mild paravalvular leak rate was 7%. In-hospital mortality and morbidity were similar among all 3 groups. CONCLUSIONS: In a high-volume TAVR center, transition to MA-TAVR is feasible with acceptable outcomes and a diminutive procedural learning curve. We advocate for TAVR centers to actively pursue the minimalist technique with equal representation by cardiologists and surgeons.

High-risk patients with inoperative aortic stenosis: use of transapical, transaortic, and transcarotid techniques.

BACKGROUND: Patient characteristics and procedural outcomes from nontransfemoral (non-TF) transcatheter aortic valve replacement (TAVR) in high-risk or inoperable patients with aortic stenosis have been incompletely reported. The purpose of this study was to compare outcomes with non-TF TAVR access techniques including transapical (TA), transaortic (TAo), and transcarotid (TC) TAVR with a balloon-expandable valve. METHODS: A retrospective review was performed of all patients undergoing TA, TAo, and TC TAVR from 2007 to 2013 at Emory University. Preoperative risk factors and postoperative outcomes were evaluated using Valve Academic Research Consortium-2 definitions. RESULTS: Of 469 patients undergoing TAVR during that period at our institution, 139 underwent TA TAVR, 35 had Tao TAVR, and 11 had TC TAVR. Patients undergoing TC TAVR were younger than those undergoing TA TAVR and TAo TAVR (mean ages: TC, 68.9 ± 23.6 years; TA, 81.3 ± 7.7 years; Tao, 83.8 ± 8.3 years; p = 0.017). Most patients undergoing TAo TAVR were women (82.9%), whereas patients undergoing TA TAVR were more likely to be men (62.6%). Slightly more than half of patients undergoing TA TAVR (54.7%) and TC (54.6%) TAVR had undergone previous coronary artery bypass grafting (CABG), whereas no patients underwent TAo TAVR (0%). There was no preoperative difference in ejection fraction, New York Heart Association classification, significant chronic obstructive pulmonary disease, and The Society of Thoracic Surgeons predicted risk of mortality between TA TAVR, Tao TAVR, and TC TAVR, respectively. Average postoperative length of stay was 9 to 11 days and was similar among groups (p = 0.22). There were 13 (9.4%) TA TAVR operative deaths and 4 (11.4%) operative deaths in the TAo TAVR group. There were no deaths in the TC TAVR group. CONCLUSIONS: In high-risk and inoperable patients who are not candidates for TF TAVR, careful selection of alternative access options can lead to excellent and comparable postoperative outcomes.

Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis.

OBJECTIVES: The aim of this study was to compare transfemoral transcatheter aortic valve replacement (TF TAVR) performed in a catheterization laboratory (minimalist approach [MA]) with TF TAVR performed in a hybrid operating room (standard approach [SA]). BACKGROUND: A MA-TF TAVR can be performed without general anesthesia, transesophageal echocardiography, or a surgical hybrid room. The outcomes and cost of MA-TF TAVR compared with those of the SA have not been described. METHODS: Patients who underwent elective, percutaneous TF TAVR using the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) were studied. Baseline characteristics, outcomes, and hospital costs of MA-TF TAVR and SA-TF TAVR were compared. RESULTS: A total of 142 patients were studied (MA-TF TAVR, n = 70 and SA-TF TAVR, n = 72). There were no differences in baseline comorbidities (Society of Thoracic Surgeons score, 10.6 ± 4.3 vs. 11.4 ± 5.8; p = 0.35). All procedures in the MA-TF TAVR group were successful; 1 patient was intubated. Three patients in the SA-TF TAVR group had procedure-related death. Procedure room time (150 ± 48 min vs. 218 ± 56 min, p < 0.001), total intensive care unit time (22 h vs. 28 h, p < 0.001), length of stay from procedure to discharge (3 days vs. 5 days, p < 0.001), and cost ($45,485 ± 14,397 vs. $55,377 ± 22,587, p < 0.001) were significantly less in the MA-TF TAVR group. Mortality at 30 days was not significantly different in the MA-TF TAVR group (0 vs. 6%, p = 0.12) and 30-day stroke/transient ischemic attack was similar (4.3% vs. 1.4%, p = 0.35). Moderate or severe paravalvular leak and device success were similar in the MA-TF TAVR and SA-TF TAVR groups (3% vs. 5.8%, p = 0.4 and 90% vs. 88%, p = 0.79, respectively) at 30 days. At a median follow-up of 435 days, there was no significant difference in survival (MA-TF TAVR, 83% vs. SA-TF TAVR, 82%; p = 0.639). CONCLUSIONS: MA-TF TAVR can be performed with minimal morbidity and mortality and equivalent effectiveness compared with SA-TF TAVR. The shorter length of stay and lower resource use with MA-TF TAVR significantly lowers hospital costs.

Use of transaortic, transapical, and transcarotid transcatheter aortic valve replacement in inoperable patients.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an effective treatment in patients with severe aortic stenosis unsuitable for surgical aortic valve replacement (SAVR). This study evaluated the early experience with the posttrial application of TAVR, with specific focus on non-transfemoral (TF) access. METHODS: All patients who underwent posttrial TAVR at Emory University from November 2011 to April 2012 were reviewed. During this time, 44 posttrial TAVRs were performed: TF in 18, transapical in 11, transaortic in 12, and transcarotid in 3. RESULTS: A total of 40.9% of all patients were candidates for TF implantation. Mean age was 78.2 ± 11.3 years, and 34.1% were women. Mean ejection fraction was 0.463 ± 0.164, and 90.2% had New York Heart Association class III to IV heart failure. Fifty percent were diabetic, 27.3% had moderate to severe chronic obstructive pulmonary disease, and 20.5% had a prior stroke. The mean creatinine was 1.63 ± 1.74 mg/dL, 9.1% required preoperative dialysis, and 61.4% had undergone prior cardiac operations. No patients had postoperative myocardial infarction, stroke, or required new dialysis. Intraoperative vascular complications occurred in 11.4%. No patient had more than mild perivalvular leak by transthoracic echocardiography at discharge. Mean postoperative ventilator time was 17.8 ± 40.1 hours. Intensive care unit length of stay was 58.0 ± 67.0 hours. Postoperative hospital length of stay was 6.1 ± 4.7 days. The 30-day mortality was 6.8% (3 of 44) for all patients, despite a mean The Society of Thoracic Surgeons Predicted Risk of Mortality score of 12.6. CONCLUSIONS: Less than half of patients deemed appropriate for posttrial TAVR were candidates for TF implantation. The use of all available access routes leads to excellent outcomes in patients deemed inoperable.