Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years.

BACKGROUND: A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. METHODS: We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. RESULTS: A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. CONCLUSIONS: Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

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.).

Ambulatory Electrocardiography Monitoring for Early Discharge After Minimally Invasive Valve Surgery.

INTRODUCTION: We sought to compare outcomes after early discharge in patients with and without predischarge diagnosis of arrhythmia following minimally invasive valve surgery (MIVS). MATERIALS AND METHODS: We retrospectively reviewed ambulatory electrocardiography (AECG) datasheets and medical records of patients discharged with 14-d AECG monitoring from our facility between October 2019 and March 2022 ≤ 3 d after MIVS. Baseline and clinical characteristics, arrhythmias during AECG monitoring, and 30-d adverse outcomes were reported for the population and stratified by presence or absence of predischarge arrhythmia. RESULTS: Of 41 patients discharged ≤3 d postoperatively of MIVS, 17 (41.5%) experienced predischarge arrhythmias and 24 (58.5%) did not. The population was predominantly male and White with a median age of 62 y [57, 70]. Baseline and clinical characteristics did not differ between subgroups. Most patients (92.7% [n = 38]) experienced one or more tachyarrhythmias during the AECG monitoring period. There were similar proportions of patients experiencing atrial fibrillation in both groups, but patients with predischarge arrhythmias had higher burden of atrial fibrillation on AECG monitoring (27.60% [6.57%, 100%] versus 1.65% [0.76%, 4.32%]; P = 0.004). The predischarge arrhythmia subgroup had higher proportions of patients experiencing nonsustained ventricular tachycardia but lower proportions experiencing supraventricular tachycardia. There were no mortalities within 30 d of surgery. Six (14.6%) patients were readmitted within 30 d with equal proportions of readmissions between subgroups (P = 0.662). CONCLUSIONS: Early discharge timelines and noninvasive monitoring techniques can allow patients to return to their normal activities quicker in the comfort of their own home with no increased risk of morbidity or mortality.

Utilizing ambulatory electrocardiogram monitoring to reduce conduction related death after transcatheter aortic valve replacement.

OBJECTIVE: The purpose of this study is to assess the utility of ambulatory cardiac monitoring (ACM) in detecting delayed advanced conduction abnormalities (DACA) and associated 30-day mortality. BACKGROUND: DACA are well-known complications of TAVR and may be associated with post-discharge mortality within 30-days. METHODS: Between October 2019 and October 2020, TAVR patients who were discharged home without a permanent pacemaker (PPM) were monitored with an ACM device for 14-days. The incidence of DACA at follow up, mortality and readmission within 30-days were investigated. The risk of DACA was assessed in three patient categories based on a composite of their 12-lead electrocardiogram (ECG) data. Group I: Normal pre-TAVR, periprocedural, and discharge ECGs. Group II: Normal pre-TAVR and abnormal subsequent ECGs. Group III. Abnormal baseline and abnormal subsequent ECGs. RESULTS: Among 340 TAVR patients, 248 were discharged home with an ACM device. The overall incidence of DACA was 7% (n = 17), of whom 4% (n = 10) required a PPM. Mortality and readmission between discharge and 30 days was 0% and 8.3%, respectively. Stratification of patients identified 96 (38.7%) patients in Group I: 50 (20%) in Group II, and 102 (41%) in Group III. The incidence of DACA requiring a PPM was 0% in Group I, 4% (n = 2) in Group II, and 8.5% (n = 8) in Group III (p < 0.004). CONCLUSIONS: In TAVR patients who were discharged home with ACM, none died between discharge and 30-days. For those with normal baseline, perioperative and discharge ECG, there were no events of DACA at 14-days.

Sex Disparities in the Treatment of Aortic Stenosis and Related Outcomes: An Analysis of the National Inpatient Sample.

INTRODUCTION: The impact of transcatheter aortic valve replacement (TAVR) on sex disparities has not been well established. This study sought to examine the impact of sex on outcomes following aortic valve replacement (AVR) for aortic stenosis (AS) in the era of routine TAVR. METHODS: We performed a cross-sectional analysis of the National Inpatient Sample (2009-18) to study AS visits for all AVR and in-hospital outcomes as a function of sex. Survey estimation commands were used to provide national estimates. RESULTS: There were an estimated 431,344 surgical AVR (SAVR) and 189,137 TAVR inpatient visits. Mortality was higher in women after SAVR (3.8% ± 0.1 vs. 2.7% ± 0.07, p < 0.001) and TAVR (2.4% ± 0.1 vs. 1.7% ± 0.1, p < 0.001) compared to men. Female patients undergoing SAVR had higher rates of permanent pacemaker (PPM) implantation, stroke, and bleeding (5.9% ± 0.1 vs. 5% ± 0.1, 2.8% ± 0.1 vs. 2.3% ± 0.07, and 37.8% ± 0.8 vs. 29.8% ± 0.6; p < 0.001, respectively) but lower rates of acute kidney injury (AKI) (16.4% ± 0.3 vs. 20.3% ± 0.3, p < 0.001). Women undergoing TAVR had higher rates of stroke and bleeding (2.4% ± 0.1 vs. 1.6% ± 0.09 and 28.7% ± 0.6 vs. 22% ± 0.5; p < 0.001, respectively) but lower rates of PPM and AKI (9.5% ± 0.3 vs. 10.7% ± 0.2 and 11.3% ± 0.3 vs. 13.4% ± 0.3; p < 0.001, respectively). Compared with isolated SAVR, isolated TAVR was associated with lower mortality in women during 2016-18, both after multivariable adjustment (OR = 0.40; 95% CI, 0.27-0.60) and propensity matching (mean difference 0.66% ± 0.2); however, there was no difference in men. CONCLUSION: Although women continue to have higher in-hospital mortality following both TAVR and SAVR as compared to men, TAVR is associated with a lower in-hospital mortality in women compared to SAVR. Thus, TAVR may represent a potential intervention to narrow the sex-based disparities in the management of AS.

Outcomes of minimally invasive aortic valve replacement in patients with obese body mass indices.

BACKGROUND: Minimally invasive heart valve surgery has previously been shown to be safe and feasible in obese patients. Within this population, we investigated the effect of obesity class on the patient outcomes of minimally invasive aortic valve replacement (mini-AVR). METHODS: A single-center retrospective cohort study of consecutive patients with obese body mass indices (BMIs) who underwent mini-AVR between 2012 and 2020. Patients were stratified into three groups according to Centers for Disease Control and Prevention adult obesity classifications: Class I (BMI: 30.0-<35.0), Class II (BMI: 35.0-<40.0), and Class III (BMI ≥ 40.0). The primary outcomes were postoperative length of stay (LOS), 30-day mortality, and direct cost. RESULTS: Among 206 obese patients who underwent mini-AVR, LOS (Class I 5 [3-7] vs. Class II 6 [5-7] vs. Class III 6 [5-7] days; p = .056), postoperative 30-day mortality (Class I 2.44% [n = 3] vs. Class II 4.44% [n = 2] vs. Class III 7.89% [n = 3]; p = .200), and costs (Class I $24,118 [$20,237-$29.591] vs. Class II $22,215 [$18,492-$28,975] vs. Class III $24,810 [$20,245-$32,942] USD; p = .683) did not differ between obesity class cohorts. CONCLUSIONS: Mini-AVR is safe and feasible to perform for obese patients regardless of their obesity class. Patients with obesity should be afforded the option of minimally invasive aortic valve surgery regardless of their obesity class.

Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.

BACKGROUND: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs. METHODS: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing. FINDINGS: Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; pnon-inferiority=0·034, psuperiority=0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; pnon-inferiority=0·0058, psuperiority=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups. INTERPRETATION: The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves. FUNDING: Abbott.

Impact of risk factors on in-hospital mortality for octogenarians undergoing cardiac surgery.

BACKGROUND: Octogenarians undergoing cardiac surgery have higher mortality than their younger counterparts. OBJECTIVES: To determine if various risk factors have the same effect on mortality in octogenarians as in younger patients. METHODS: The National Inpatient Sample data set from 2004 to 2014 was queried to select patients aged 65 years and older who underwent either coronary artery bypass grafting (CABG), valvular heart surgery (VHS), or both (CABG + VHS) within 10 days of hospital admission. The patients were divided into two groups 65-79 years and 80 years and greater. Hospital mortality, patient demographics, comorbidities, and type of hospital admission was evaluated and compared using χ2 and multivariable logistic regressions. RESULTS: About 397,713 patients were identified including 86,345 (21.7%) aged 80 and above. Octogenarians had higher in-hospital mortality for all procedures: CABG (4.94% vs. 2.39%, p < .001), VHS (5.49% vs. 4.08%, p < .001), and CABG + VHS (7.59% vs. 5.95%, p < .001), and this relationship persisted when gender, race, comorbidities, and type of hospital admission were controlled for: CABG (odds ratio [OR] = 1.71; 95% confidence interval [CI] 1.62-1.81); VHS (OR = 1.18; 95% CI 1.11-1.27); and CABH + VHS (OR = 1.17; 95%CI 1.10-1.26). Female gender, renal, or heart failure, nonelective admission, and CABG + VHS were associated with increased risk of in-hospital mortality. Octogenarians had higher rates of these factors (p < .001). The effect size of renal and heart failure and type of surgery was smaller for octogenarians. CONCLUSIONS: Octogenarians undergoing cardiac surgery have higher rates of nonelective admissions, renal and heart failure, and female gender, which are most strongly associated with in-hospital mortality. Differing effect sizes suggest that certain risk factors, such as renal and heart failure, contribute more to mortality in younger patients.

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.

Association between increased-risk donor social behaviors and recipient outcomes after heart transplantation.

BACKGROUND: This study aims to investigate the association between social behaviors of increased-risk donors (IRD) and recipient outcomes after heart transplantation. METHODS: The United Network for Organ Sharing (UNOS) database was queried to identify patients who received a heart transplant between 2004 and 2015. Patients were grouped based on donor's risk status (IRD vs standard risk donor [SRD]). Recipients of IRD were categorized based on donor social behaviors (SB), and recipient survival was assessed. Cox regression analysis was used to identify associations between SB of donors and recipient survival. RESULTS: Out of 22 333 heart transplantations performed during the study period, 2769 (12%) received an IRD graft with the following SB: Unprofessional tattoos or piercings (n = 1722) (63%), cocaine use (n = 916) (33%), heavy smoking (n = 437) (16%), and heavy alcohol abuse (n = 610) (22%). Viral screens detected 72(3%) hepatitis B virus (HBV) positive and 12 (0.4%) hepatitis C virus (HCV) positive at donation. There was no difference in recipient survival based on both donor risk and their social behaviors. Cox regression analysis found only donor HCV infection and non-identical ABO mismatch to be associated with poor recipient survival among recipients of IR grafts. CONCLUSION: Cardiac allografts from IRD, serologically negative for viruses, can safely be used. There is no association between social behaviors of IRD and recipient survival.

Trends in complete heart block after transcatheter aortic valve replacement: A population based analysis.

OBJECTIVES: To define the national rate of complete heart block (CHB) after transcatheter aortic valve replacement (TAVR) and its impact on procedural mortality, overall cost, and length of hospital stay. BACKGROUND: CHB leading to permanent pacemaker (PPM) implantation is one of the most common complications post TAVR. National data on the temporal trend of CHB post TAVR are lacking. METHODS: We queried the 2012-2014 National Inpatient Sample databases to identify all patients who underwent TAVR. Patients with preoperative pacemakers or implantable cardioverter-defibrillators were excluded. Association between CHB and outcomes, and overall trends in rate of CHB, PPM implantation, and inpatient mortality were examined. RESULTS: Of 35,500 TAVR procedures, 3,675 (10.4%) had CHB. Overall, occurrence of CHB significantly increased from 8.4% in 2012 to 11.8% in 2014 (adjusted OR per year: 1.23; 95% confidence interval [CI]: 1.17-1.29, P trend <0.001). During the same period, PPM implantation increased from 9.5 to 13.7% (adjusted OR per year: 1.22; 95% CI: 1.16-1.28, P trend <0.001). Patients with CHB had higher odds of in-hospital mortality when compared to patients without CHB (5.9% vs. 4.2%, adjusted OR: 1.32; 95% CI: 1.12-1.56; p = 0.001). Moreover, CHB was also associated with longer length of stay (LOS) and higher hospitalization cost. CONCLUSIONS: There was a significant increase in rates of CHB and PPM implantation over the study period. Development of CHB was associated with increased in-hospital mortality, LOS, and hospitalization cost.

Discharge disposition of older patients undergoing trans-catheter aortic valve replacement and its impact on survival.

BACKGROUND: Patients undergoing transcatheter aortic valve replacement (TAVR) are likely to be discharged to a location other than home. We aimed to assess the association between discharge disposition after TAVR and patient survival at 1 year. METHODS: Patients admitted from home and survived till discharge after TAVR were divided into two groups based on discharge disposition (home discharge vs. non-home discharge). Pre-operative factors predicting the odds of not being discharged home were identified by using multivariable logistic regression analysis. Study patients were matched one-to-one via a propensity scoring method. Differences in procedural outcomes were compared. Survival of both unmatched and matched pairs was evaluated by using the Kaplan-Meier method with the Kleine-Moesch-Berger stratified log-rank test. RESULTS: Out of 1,160 TAVR patients, 851 were admitted from home and survived till discharge. The incidence non-home discharge was 19% (n = 159). Factors that were significantly associated with non-home discharge were older age, non-transfemoral approach, female sex, frailty status, history of chronic lung disease, pacemaker placement and insulin-dependent diabetes mellitus. One-to-one propensity score matching resulted in 141 patient pairs with similar age, operative risk, frailty and functional status. At 1-year follow-up, all-cause mortality rates were significantly higher in the non-home group than their home counterparts (18% vs. 3%, P = 0.006; stratified log rank test: P = 0.006). CONCLUSIONS: A considerable number of TAVR patients are discharged to a location other than home after the procedure. Not being discharged home after TAVR is associated with a high mortality risk at 1 year.

The impact of frailty status on clinical and functional outcomes after transcatheter aortic valve replacement in nonagenarians with severe aortic stenosis.

BACKGROUND: The impact of frailty status on TAVR outcomes in nonagenarians is unknown. The present study aims to investigate the impact of frailty status on procedural outcomes and overall survival in nonagenarians after TAVR. METHODS: A frailty score (FS) was derived by using preoperative grip strength, gait speed, serum albumin, and daily activities. Patients were divided into two groups: Frail (FS ≥ 3/4) and Non-Frail (FS <3/4). Health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline demographic and clinical characteristics were compared in both groups. The effect of frailty status on outcomes was investigated. Cox regression analyses were performed to determine predictors of overall all-cause mortality. Kaplan-Meier survival curves were used to estimate survival. RESULTS: Seventy-five patients >90 years underwent full assessment for frailty status. There was a significant improvement in overall health status of non-frail patients (mean difference: 11.03, P = 0.032). Unadjusted 30-day and 2-year mortality rates were higher in the frail group than the non-frail group. (14% vs. 2% P = 0.059; 31% vs. 9% P = 0.018). Kaplan-Meier estimated all-cause mortality to be significantly higher in the frail group (log-rank test; P = 0.042). Frailty status was independently associated with increased mortality (hazard ratio: 1.84, 95% C.I: 1.06-3.17; P = 0.028) after TAVR. CONCLUSION: Among nonagenarians selected to undergo TAVR for severe aortic stenosis, a considerable number are frail. Nonfrail patients report a significant improvement in overall health status in the short term. Worse frailty is strongly associated with diminished long-term survival. © 2017 Wiley Periodicals, Inc.

Association of Change in Patient-Reported Health Status after Transcatheter Aortic Valve Replacement, and Postoperative Outcomes.

BACKGROUND: The study aim was to investigate the relationship between postoperative morbidity after transcatheter aortic valve replacement (TAVR) and short-term patient-reported health status, using the Kansas City Cardiomyopathy Questionnaire (KCCQ). METHODS: The association between 30-day post-procedure changes in patient-reported heath status and post-TAVR outcomes was examined. Patients were stratified into three groups based on observed changes in KCCQ-Overall scores (OS): Group A, increase in KCCQ-OS ≥10 points; Group B, KCCQ-OS scores <10 points; and Group C, decline in KCCQ-OS ≥10 points. Variation components of KCCQ scores were determined using paired t-tests. Postoperative morbidity was investigated. Multivariable logistic regression was used to identify pre-procedural factors associated with an increase or decline in KCCQ-OS at 30 days. RESULTS: A total of 223 patients with complete baseline and postoperative 30-day KCCQ responses was studied. At the 30-day follow up there was a significant change in baseline mean KCCQ-OS for all patients (mean difference 14.1; p <0.0001). Improvement in KCCQ-OS ≥10 was observed in 130 patients (58%), 64 patients (29%) had no change, and 29 patients (13%) had a decline in KCCQ-OS ≥10. The incidence of acute kidney injury (AKI), permanent pacemaker (PPM) placement and new-onset arrhythmia (NOA) was higher in group C than in groups A and B: AKI, 11%, 0%, 0%; p <0.001; PPM, 21%, 4%, 6%; p = 0.004; and NOA, 21%, 5%, 8%, p = 0.026. Independent predictors of decline in KCCQ scores after TAVR were PPM requirement (estimate: 0.76 CI 0.22, 1.29; p = 0.005) and NYHA functional class (III/IV) (estimate: -0.41 CI -0.71, 0.10; p = 0.009). CONCLUSIONS: TAVR patients experienced an improvement in health status after the procedure, but for a smaller proportion their health status worsened. Patients who experience perioperative complications may have a decline in their health status after the procedure in the short term.

Predictors of survival following trans-catheter aortic valve closure for left ventricular assist device associated aortic insufficiency.

OBJECTIVE: This study sought to assess the long-term clinical benefits and predictors of survival of trans-catheter aortic valve closure in left ventricular assist device (LVAD) patients. BACKGROUND: LVADs have been shown to increase survival and quality of life in patients with end-stage heart failure. However, severe aortic insufficiency (AI) can develop in up to 50% of patients at 12 months resulting in significant morbidity and mortality. Trans-catheter treatment of LVAD associated AI has emerged as a potential alternative to surgical treatment. METHODS: We conducted a retrospective analysis of all patients undergoing trans-catheter aortic valve closure using an Amplatzer Multi-Fenestrated Septal Occluder "Cribriform" device to assess potential clinical and procedural factors associated with survival. Student's t-tests were used to compare baseline patient demographics and procedural characteristics, as well as patient outcomes immediately post procedure and at 6 months. A P-value of less than 0.05 was considered statistically significant. RESULTS: A total of 10 patients (70% male, median age 59 years) were included. Technical success was accomplished in 100% of patients with a 6 month survival rate of 30% (3/10). Compared with survivors, non-survivors had a higher rate of pre-procedural clinical co-morbidities, an increased likelihood of right ventricular failure, and received larger occluder devices. CONCLUSIONS: Trans-catheter aortic valve closure successfully treats late severe AI in LVAD patients, however, the presence or development of right heart failure portends a worse prognosis. Further studies are needed to investigate the factors involved in the development of right ventricular failure, and potential treatment, in patients undergoing trans-catheter aortic valve closure.

Distribution of donor lungs in the United States: a case for broader geographic sharing.

OBJECTIVES: To evaluate the association between allocation of donor lungs by geographic sharing type (GST) and lung allocation score (LAS). METHODS: UNOS data included lung transplant recipients between 5/4/05 and 09/30/15 (n = 17 416) grouped by GST of donor lungs: local, regional, or national. Recipients were stratified by LAS <50, 50-75, and >75. Kaplan-Meier analysis was used to assess five-yr survival. RESULTS: The majority of lungs were shared locally (n = 9200; 52.8%) followed by nationally (n = 5356; 30.8%) and regionally (n = 2860; 16.4%). There was a significant difference in the mean LAS at transplant (local: 43.7 ± 15; regional: 49.5 ± 18.8; national 51 ± 19.4; p < 0.001). There was a significant association between GST and LAS (p < 0.001). The majority (n = 7431; 58.2%) of recipients with LAS <50 received local lungs. Recipients with LAS >75 received a majority of their organs from national (n = 881; 45.4%) and regional (n = 414; 21.6%) donors. Although statistically significant (p = 0.024), absolute decline in five-yr survival by GST in the national GST was only 1.1% compared to the local GST. CONCLUSIONS: Nearly half of all lungs in the United States are allocated locally to recipients with an LAS <50. Additional studies should determine if organ sharing over broader geographies would improve waitlist outcomes.

Outcomes following emergent open repair for thoracic aortic dissection are improved at higher volume centers.

BACKGROUND: Previous studies have demonstrated that patients undergoing complex surgical procedures at high-volume centers have improved outcomes. The goal of this study was to determine if this volume-outcomes relationship persists at a national level among patients undergoing emergent open repair for thoracic aortic dissection. METHODS: De-identified patient-level data were obtained from the Nationwide Inpatient Sample (2005 to 2008). Patients undergoing emergent aortic surgery for thoracic aortic dissection (n = 1230) were identified by ICD-9 codes and stratified by annual center volume into low volume (≤5 cases/year), intermediate volume (6 to 10 cases/year), and high volume (≥11 cases/year). The Deyo-Charlson co-morbidity score was used to adjust for differences in comorbidity between groups. Major outcomes of interest included: in-hospital morbidity and mortality, length of hospitalization, total hospital costs, and discharge disposition. RESULTS: There was a significant association between in-hospital mortality and center volume (p = 0.014), with low, intermediate, and high-volume centers having mortality rates of 23.4% (n = 187), 20.1% (n = 62), and 12.1% (n = 15), respectively. This relationship persisted when controlling for severity of co-morbid illness (p = 0.007). The number of complications per patient varied significantly by center volume (p = 0.044), with a higher proportion of patients at high-volume centers having no complications. Also, the highest proportion of home discharges was observed among patients at high-volume centers (p = 0.011). CONCLUSIONS: Survival following emergent open repair for thoracic aortic dissection was significantly greater at high-volume centers. These findings suggest that understanding the processes at high-volume centers that underlie this volume-outcomes relationship may improve in-hospital survival and postoperative complications.

Outcomes of patients presenting with acute type A aortic dissection in the setting of prior cardiac surgery: an analysis from the International Registry of Acute Aortic Dissection.

BACKGROUND: Prior cardiac surgery (PCS) can complicate the presentation and management of patients with type A acute aortic dissection (TAAAD). This report from the International Registry of Acute Aortic Dissection examines this hypothesis. METHODS AND RESULTS: A total of 352 of 2196 patients with TAAAD (16%) enrolled in the International Registry of Acute Aortic Dissection had cardiac surgery before dissection, including coronary artery bypass grafting (34%), aortic or mitral valve surgery (36%), aortic surgery (42%), and other cardiac surgery (16%). Those with PCS were older, had a higher frequency of diabetes mellitus, hypertension, and atherosclerosis, and presented later from symptom onset to hospital presentation and diagnosis (all P<0.05). In-hospital mortality was significantly higher for PCS patients (34% versus 23%; P<0.001). Five-year mortality was independently predicted by PCS (hazard ratio [HR], 2.04; 95% confidence interval [CI], 1.05-3.95), age >70 years (HR, 2.65; 95% CI, 1.40-5.05), medical management (HR, 5.10; 95% CI, 2.43-10.71), distal communication (HR, 2.64; 95% CI, 1.35-5.14), and coma (HR, 9.50; 95% CI, 2.05-44.05). Among patients with PCS, in-hospital (43% medical versus 30% surgical; P=0.033) and intermediate-term mortality was higher in patients with medical versus surgical management. Propensity-matched analysis revealed significant increase in mortality with medical management, but not with PCS. CONCLUSIONS: PCS delays presentation, diagnosis, and treatment of TAAAD and is an important adverse risk factor for early and intermediate-term mortality. This effect may be because of increased medical management in this patient population.

Successful Management of Thrombosis of the Proximal Aorta after Implantation with a Biventricular Assist Device.

Continuous-flow ventricular assist devices (CVADs) are associated with a significant complication profile that includes thrombosis of the ascending aorta and aortic valve, thromboembolism, and stroke. Despite an increasing number of reports of thromboembolic complications related to CVADs, there is little in the literature to guide their management. This report describes successful management strategies used during two cases of thrombosis of the ascending aorta during biventricular CentriMag (Levitronix LLC, Waltham, MA) support, including using pre-existing cannulas to initiate cardiopulmonary bypass.