Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.

BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

BACKGROUND: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

Coronary circulatory function with increasing obesity: A complex U-turn.

AIMS: The aim of this investigation was to explore and characterize alterations in coronary circulatory function in function of increasing body weight with medically controlled cardiovascular risk factors and, thus, "metabolically" unhealthy obesity. MATERIALS AND METHODS: We prospectively enrolled 106 patients with suspected CAD but with normal stress-rest myocardial perfusion on 13 N-ammonia PET/CT and with medically controlled or no cardiovascular risk factors. 13 N-ammonia PET/CT concurrently determined myocardial blood flow (MBF) during pharmacologically induced hyperaemia and at rest. Based on body mass index (BMI), patients were grouped into normal weight (BMI: 20.0-24.9 kg/m2 , n = 22), overweight (BMI: 25.0-29.9 kg/m2 , n = 27), obese (BMI: 30.0-39.9 kg/m2 , n = 31), and morbidly obese (BMI ≥ 40kg/m2 , n = 26). RESULTS: Resting MBF was comparable among groups (1.09 ± 0.18 vs. 1.00 ± 0.15 vs. 0.96 ± 0.18 vs.. 1.06 ± 0.31 ml/g/min; p = .279 by ANOVA). Compared to normal weight individuals, the hyperaemic MBF progressively decreased in in overweight and obese groups, respectively (2.54 ± 0.48 vs. 2.02 ± 0.27 and 1.75 ± 0.39 ml/g/min; p < .0001), while it increased again in the group of morbidly obese individuals comparable to normal weight (2.44 ± 0.41 vs. 2.54 ± 0.48 ml/g/min, p = .192). The BMI of the study population correlated with the hyperaemic MBF in a quadratic or U-turn fashion (r = .34, SEE = 0.46; p ≤ .002). CONCLUSIONS: The U-turn of hyperaemic MBF from obesity to morbid obesity is likely to reflect contrasting effects of abdominal versus subcutaneous adipose tissue on coronary circulatory function indicative of two different disease entities, but needing further investigations.

Optimal Medical Therapy as First-Line Therapy for Chronic Coronary Syndromes: Lessons from COURAGE, BARI 2D, FAME 2, and ISCHEMIA.

The chronic coronary syndromes (CCS) include patients with a classic history of angina pectoris in the presence of either risk factors for or known atherosclerotic coronary artery disease. Randomized, controlled trials conducted in the optimal medical therapy (OMT) era have convincingly demonstrated that adherence to the outdated paradigm focused on treatment of obstructive coronary disease with initial revascularization fails to reduce death or myocardial infarction and inconsistently reduces angina symptoms. Rather, OMT reduces events and improves symptoms and should be considered first-line treatment for patients with CCS.

Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial.

BACKGROUND: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). METHODS: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. RESULTS: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm2; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. CONCLUSIONS: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

Synthesis of systematic reviews of percutaneous device closure of patent foramen ovale (PFO) for prevention of recurrent cryptogenic stroke: Redundant publications and methodological deficiencies.

Critical assessments of systemic reviews and meta-analyses have found them to often be redundant, lacking in novel perspectives, of poor methodological quality, and written by authors with potential conflicts of interest. We sought to investigate these issues as they relate to systemic reviews and meta-analyses of percutaneous patent foramen ovale closure for the prevention of recurrent cryptogenic stroke.

Design of Clinical Trials Evaluating Sedation in Critically Ill Adults Undergoing Mechanical Ventilation: Recommendations From Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) Recommendation III.

OBJECTIVES: Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators. DESIGN: A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process. PARTICIPANTS: Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process. MEASUREMENTS AND MAIN RESULTS: The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization. CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.

Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk.

BACKGROUND: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar rates of death or stroke at 2 years. Whether TAVR is cost-effective compared with SAVR for intermediate-risk patients remains uncertain. METHODS: Between 2011 and 2014, 3110 intermediate-risk AS patients were treated with TAVR or SAVR in the PARTNER 2 trial (Placement of Aortic Transcatheter Valves 2). A total of 2032 patients were randomized to receive TAVR using the SAPIEN XT valve (XT-TAVR) or SAVR in the PARTNER 2A trial, whereas the PARTNER S3i registry included an additional 1078 patients treated with TAVR using the SAPIEN 3 valve (S3-TAVR), which offers a lower delivery profile and sealing skirt designed to reduce paravalvular regurgitation compared with XT-TAVR. Procedural costs were estimated using measured resource utilization. Other in-trial costs were assessed by linkage of trial data with Medicare claims (n=2333) or by linear regression models for unlinked patients (n=682). Health utilities were estimated using the EQ-5D at baseline and 1, 12, and 24 months. Using a Markov model informed by in-trial costs, utilities, and survival data, lifetime cost-effectiveness from the perspective of the US healthcare system was estimated in terms of cost per quality-adjusted life-year gained. RESULTS: Although procedural costs were ≈$20 000 higher with TAVR than SAVR, total cost differences for the index hospitalization were only $2888 higher with XT-TAVR ( P=0.014) and were $4155 lower with S3-TAVR ( P<0.001) owing to reductions in length of stay with TAVR. Follow-up costs were significantly lower with XT-TAVR (Δ=-$9304; P<0.001) and S3-TAVR (Δ=-$11 377; P<0.001) than with SAVR. Over a lifetime horizon, TAVR was projected to lower total costs by $8000 to $10 000 and to increase quality-adjusted survival by 0.15 to 0.27 years. XT-TAVR and S3-TAVR were found to be economically dominant compared with SAVR in 84% and 97% of bootstrap replicates, respectively. CONCLUSIONS: Among intermediate-risk AS patients, TAVR is projected to be economically dominant from the perspective of the US healthcare system by providing both greater quality-adjusted life expectancy and lower long-term costs than SAVR. If long-term data demonstrate comparable late mortality with TAVR and SAVR, these findings suggest that TAVR might be the preferred treatment strategy for intermediate-risk AS patients based on both clinical and economic considerations. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01314313.

Assessing the risk of an anomalous circumflex artery using balloon aortic valvuloplasty prior to transcatheter aortic valve replacement.

Anomalous origin of the left circumflex coronary artery from the right sinus of Valsalva or proximal right coronary artery (RCA) is a well-known anatomic variation. Although the condition is usually benign, there is risk for compression of the anomalous artery by a prosthetic valve in patients undergoing aortic valve replacement (AVR). In more recent years, balloon aortic valvuloplasty (BAV) has been performed prior to transcatheter aortic valve replacement (TAVR) to serve as a diagnostic tool in the evaluation of symptom relief and procedural risks prior to definitive therapy with TAVR. However, the literature regarding BAV utilization in the assessment of coronary artery anomalies prior to TAVR is scarce. Our case illustrates the importance of performing preoperative BAV to assess the safety of a TAVR procedure in patients with coronary anomalies. Herein, we present a case of a patient who underwent BAV with selective angiography of her anomalous circumflex artery. During balloon inflation, the anomalous circumflex artery was transiently occluded, with complete resolution with balloon deflation. Given these findings, the patient was deemed to be unsuitable for TAVR and offered surgical AVR. This case demonstrates that patients with anomalous coronary circulation may require BAV with selective angiography to fully evaluate risk of coronary occlusion with TAVR.

New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial.

AIMS: Transcatheter aortic valve replacement (TAVR) is now an established therapy for intermediate-risk surgical candidates with symptomatic, severe aortic stenosis. The clinical impact of new-onset left bundle branch block (LBBB) after TAVR remains controversial and has not been studied in intermediate-risk patients. We therefore sought to analyse outcomes associated with new LBBB in a large cohort of intermediate-risk patients treated with TAVR. METHODS AND RESULTS: A total of 2043 patients underwent TAVR in the PARTNER II trial and S3 intermediate-risk registry and survived to hospital discharge. Patients were excluded from the current analysis due to baseline conduction disturbances, pre-existing permanent pacemaker (PPM), and new PPM during the index hospitalization. Clinical outcomes at 2 years were compared between patients with and without persistent, new-onset LBBB at hospital discharge, and multivariable analysis was performed to identify predictors of mortality. Among 1179 intermediate-risk patients, new-onset LBBB at discharge occurred in 179 patients (15.2%). Patients with new LBBB were similar to those without except for more frequent diabetes and more frequent treatment with SAPIEN 3 vs. SAPIEN XT. At 2 years, new LBBB was associated with increased rates of all-cause mortality (19.3% vs. 10.8%, P = 0.002), cardiovascular mortality (16.2% vs. 6.5%, P < 0.001), rehospitalization, and new PPM implantation. By multivariable analysis, new LBBB remained an independent predictor of 2-year all-cause [hazard ratio (HR) 1.98, 95% confidence interval (95% CI) 1.33, 2.96; P < 0.001] and cardiovascular (HR 2.66 95% CI 1.67, 4.24; P < 0.001) mortality. New LBBB was also associated with worse left ventricular systolic function at 1 and 2-year follow-up. CONCLUSIONS: In a large cohort of intermediate-risk patients from the PARTNER II trial and registry, persistent, new-onset LBBB occurred in 15.2% of patients without baseline conduction disturbances or pacemaker. New LBBB was associated with adverse clinical outcomes at 2 years, including all-cause and cardiovascular mortality, rehospitalization, new pacemaker implantation, and worsened left ventricular systolic function. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov #NCT01314313 and NCT03222128.

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.

BACKGROUND: Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODS: We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTS: The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONS: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Autologous fat grafting to lumpectomy defects: complications, imaging, and biopsy rates.

BACKGROUND: Autologous fat grafting is emerging as a promising reconstructive technique after breast conservation therapy (BCT). Recent evidence suggests that autologous fat grafting does not increase the risk of cancer recurrence; however, women may still be subject to unnecessary biopsies secondary to suspicious radiologic findings. The purpose of this study was to assess surgical complications and biopsy rates in these patients. METHODS: We retrospectively reviewed the records of women who underwent autologous fat grafting after BCT at a single institution over a 6-y period. Independent variables included demographic and operative details. Outcome variables included complications, and incidence of palpable masses and/or suspicious breast imaging findings requiring biopsy. Descriptive statistics were generated. RESULTS: Between June 2008 and February 2015, 37 women aged 41 to 74 y (mean 54.4 y) underwent a total of 56 fat grafting sessions for correction of contour deformities after BCT. The mean number of fat grafting procedures was 1.5 (range 1-4) per breast. Follow-up ranged from 1 to 99 mo (mean 29.5 mo). Imaging data were available for 31 (83.7%) breasts after autologous fat grafting. Biopsy was recommended in four cases after suspicious imaging findings or palpable masses (10.8%), with benign pathology in all cases. There was one incidence of a local wound infection. No other local or systemic complications were noted. CONCLUSIONS: Our study demonstrated a risk of unnecessary biopsies after autologous fat grafting. Complication rates were low, and it appears to be a safe reconstructive option for the correction of contour deformities after BCT.

Effect of Race on Outcomes Following Early Coronary Computed Tomographic Angiography or Standard Emergency Department Evaluation for Acute Chest Pain.

Objective: To examine racial differences in outcomes with coronary computed tomographic angiography (CCTA) vs standard emergency department (ED) evaluation for chest pain. Design: Retrospective analysis of the prospective, randomized, multicenter Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography (ROMICAT-II) trial. Setting: ED at nine hospitals in the United States. Participants: 940 patients who were Caucasian or African American (AA) presenting to the ED with chest pain. Interventions: CCTA or standard ED evaluation. Main Outcome Measures: Length of stay, hospital admission, direct ED discharge, downstream testing and repeat ED visit or hospitalization for recurrent chest pain at 28 days. Safety end points: missed acute coronary syndrome (ACS) and cumulative radiation exposure during the index visit and follow-up period. Results: 659 (66%) patients self-identified as Caucasian and 281 (28%) self-identified as AA. AA were younger and more often female compared with Caucasians, had a higher prevalence of hypertension (64% vs 49%, P<.001) and diabetes (23% vs 14%, P<.001) and a lower prevalence of hyperlipidemia (28% vs 51%, P<.001). ACS was more frequent among Caucasians (10% vs 2%, P<.001). Randomization to CCTA resulted in a reduction in median LOS for Caucasians (7.4 vs 24.7 hours, P<.001) and AA (8.9 vs. 26.3, P<.001; P-interaction=.88). Both AA and Caucasian patients experienced greater radiation exposure and more downstream testing with CCTA compared with standard evaluation. Conclusions: Early CCTA reduced median LOS for both AA and Caucasian patients presenting to the ED with chest pain by approximately 17 hours compared with standard evaluation.

Treatment of Keloids With Excision and Adjuvant Radiation: A Single Center Experience and Review of the Literature.

BACKGROUND: Management of keloids has remained a conundrum, because an optimum treatment regimen has yet to be elucidated. Currently, treatment varies widely between more conservative measures, such as steroid injections, topical medications, and silicone sheeting, to more aggressive options, such as surgery and postoperative radiation. The latter combination has been touted to have superior results, with the lowest rates of pathologic scar recurrence. METHODS: We performed a retrospective review to critically evaluate the effectiveness of surgical excision and radiation treatment in patients with keloids. Surgical resection of surgeon-selected keloids, combined with state-of-the-art postoperative cutaneous radiation therapy, was used at a major tertiary referral center. For patients with poor follow-up, phone calls were made to determine recurrence. In addition, we present a review of the current literature to provide a comprehensive synopsis of current keloid treatment. RESULTS: A total of 69 patients' records were reviewed. There were a total of 84 keloids upon pathology review. The overall recurrence rate for all keloids was 27%, and in those followed greater than 1 year, recurrence for keloids was 74%. About half the patients with more than 1 year of follow-up experienced recurrence more than 1 year after treatment. CONCLUSIONS: At this time, the evidence supporting surgery and radiation for the treatment of keloids remains equivocal, and randomized controlled studies are needed to determine the efficacy of this treatment protocol. Most importantly, our data reinforce the need for long-term follow-up in this patient population.

5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.

BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. METHODS: We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894. FINDINGS: We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86-1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003). INTERPRETATION: Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes. FUNDING: Edwards Lifesciences.

Lack of Association between Blood Pressure Management by Anesthesia Residents and Competence Committee Evaluations or In-training Exam Performance: A Cohort Analysis.

BACKGROUND: Prompt treatment of severe blood pressure instability requires both cognitive and technical skill. The ability to anticipate and respond to episodes of hemodynamic instability should improve with training. The authors tested the hypothesis that the duration of severe hypotension during anesthesia administered by residents correlates with concurrent adjusted overall performance evaluations by the Clinical Competence Committee and subsequent in-training exam scores. METHODS: The authors obtained data on 70 first- and second-year anesthesia residents at the Cleveland Clinic. Analysis was restricted to adults having noncardiac surgery with general anesthesia. Outcome variables were in-training exam scores and subjective evaluations of resident performance ranked in quintiles. The primary predictor was cumulative systolic arterial pressure less than 70 mmHg. Secondary predictors were administration of vasopressors, frequency of hypotension, average duration of hypotensive episodes, and blood pressure variability. RESULTS: The primary statistical approach was mixed-effects modeling, adjusted for potential confounders. The authors considered 15,216 anesthesia care episodes. A total of 1,807 hypotensive episodes were observed, lasting an average of 32 ± 20 min (SD) per 100 h of anesthesia, with 68% being followed by vasopressor administration. The duration of severe hypotension (systolic pressure less than 70 mmHg) was associated with neither Competence Committee evaluations nor in-training exam scores. There was also no association between secondary blood pressure predictors and either Competence Committee evaluations or in-training exam results. CONCLUSIONS: There was no association between any of the five blood pressure management characteristics and either in-training exam scores or clinical competence evaluations. However, it remains possible that the measures of physiologic control, as assessed from electronic anesthesia records, evaluate useful but different aspects of anesthesiologist performance.

Autologous Fat Grafting After Breast Reconstruction in Postmastectomy Patients: Complications, Biopsy Rates, and Locoregional Cancer Recurrence Rates.

BACKGROUND: Autologous fat grafting is widely used for refinements in postmastectomy breast reconstruction. However, there are few studies evaluating outcomes in this patient population. The purpose of this study was to assess outcomes of autologous fat grafting after breast reconstruction in postmastectomy patients. METHODS: We retrospectively reviewed the records of consecutive postmastectomy patients who underwent autologous fat grafting after breast reconstruction at a university center over a 5-year period. Patients with at least 6 months of follow-up were included. Medical records were reviewed for demographics, operative details, complications, incidence of palpable masses, and/or suspicious breast imaging findings requiring biopsy, and locoregional cancer recurrence. Descriptive statistics were generated. RESULTS: Between January 2008 and July 2013, 108 women and a total of 167 breast reconstructions underwent autologous fat grafting for revision of postmastectomy breast reconstruction. Their ages ranged from 22 to 71 years (mean, 48 years). Fat grafts were harvested, processed, and injected using the Coleman technique. The mean number of fat grafting procedures was 1.3 (range, 1-4) per breast. Follow-up ranged from 6 to 57 months (mean, 20.2 months). Fifty-three (31.7%) breasts underwent imaging after autologous fat grafting. Suspicious imaging findings requiring biopsy were discovered in 4 (2.4%) breasts, and clinically palpable lesions combined with suspicious imaging findings requiring biopsy were present in another 4 (2.4%) breasts. All 8 biopsies showed fat necrosis, scar, or oil cysts without evidence of malignancy. One (0.6%) local complication (a wound infection at the recipient site requiring oral antibiotics) after autologous fat grafting was reported. During the limited follow-up period, there were no locoregional cancer recurrences. CONCLUSIONS: Autologous fat grafting in conjunction with breast reconstruction resulted in a biopsy rate of 4.8%, and no cases of locoregional cancer recurrence were observed. Based on these preliminary findings, autologous fat grafting appears to be a relatively safe procedure for refinement of the reconstructed breast in postmastectomy patients.