Transcatheter tricuspid valve replacement in dehisced flexible ring.

Transcatheter tricuspid valve-in-surgical annuloplasty ring is an appealing concept in light of the high mortality associated with reoperation on the tricuspid valve. The clinical necessity of this procedure is derived from a considerable failure rate of tricuspid repairs over time. The presented case demonstrates that transcatheter valve-in-ring is a feasible option for patients with flexible tricuspid ring even in the context of significant ring dehiscence. Meticulous procedural planning, preemptively addressing a potential paravalvular leak, and clear understanding of the intricate three-dimensional anatomy are imperative for procedural success.

The impact of surgeon and hospital procedural volume on outcomes after aortic root replacement in the United States.

OBJECTIVE: Surgeon procedural volume for complex cardiac procedures have become important quality metrics. The objective is to determine the association of surgeon and hospital case volume on patient outcomes after an aortic root replacement for aortic root aneurysms. METHODS: From 2009 to 2014, 4629 Medicare patients underwent an aortic root replacement for a root aneurysm. Procedures were performed by 1276 surgeons at 718 hospitals. Patients with endocarditis, aortic rupture, or Type-A dissection were excluded. Procedural volume was defined as mean number of cases performed each year during the study period. The impact of hospital and surgeon volume on adjusted 30-day mortality was analyzed as a continuous variable using adjusted logistic regression with cubic splines. RESULTS: After an aortic root replacement, we observed a nonlinear reduction in the adjusted odds ratio for 30-day mortality as surgeon and hospital volume increased. Surgeons that performed approximately five cases/year and hospitals that completed approximately five cases/year had the greatest reduction in the odds of perioperative death. Patients treated at high-volume hospitals (≥4.5 cases/year) had a lower risk for 30-day postoperative stroke (hazard ratio [HR] = 0.51, p = .008), myocardial infarction (HR = 0.49, p = .016), hemodialysis (HR = 0.44, p = .005), and reoperation (HR = 0.48, p = .003). Additionally, patients treated with high-volume surgeons (≥9 cases/year) had lower risk for stroke (HR = 0.65, p = .005), hemodialysis (HR = 0.65, p = .03), sepsis (HR = 0.62, p = .03), and reoperation (HR = 0.67, p = .004). CONCLUSION: Among Medicare patients undergoing an aortic root replacement, there is a strong inverse relationship between annualized surgeon and hospital case volume and postoperative outcomes. Procedural volume is an important quality metric for this high-risk procedure.

Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement: Insights from the National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Conscious sedation is used during transcatheter aortic valve replacement (TAVR) with limited evidence as to the safety and efficacy of this practice. METHODS: The National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to characterize the anesthesia choice and clinical outcomes of all US patients undergoing elective percutaneous transfemoral TAVR between April 1, 2014, and June 30, 2015. Raw and inverse probability of treatment-weighted analyses were performed to compare patients undergoing TAVR with general anesthesia with patients undergoing TAVR with conscious sedation on an intention-to-treat basis for the primary outcome of in-hospital mortality, and secondary outcomes including 30-day mortality, in-hospital and 30-day death/stroke, procedural success, intensive care unit and hospital length-of-stay, and rates of discharge to home. Post hoc falsification end point analyses were performed to evaluate for residual confounding. RESULTS: Conscious sedation was used in 1737/10 997 (15.8%) cases with a significant trend of increasing usage over the time period studied (P for trend<0.001). In raw analyses, intraprocedural success with conscious sedation and general anesthesia was similar (98.2% versus 98.5%, P=0.31). The conscious sedation group was less likely to experience in-hospital (1.6% versus 2.5%, P=0.03) and 30-day death (2.9% versus 4.1%, P=0.03). Conversion from conscious sedation to general anesthesia was noted in 102 of 1737 (5.9%) of conscious sedation cases. After inverse probability of treatment-weighted adjustment for 51 covariates, conscious sedation was associated with lower procedural success (97.9% versus 98.6%, P<0.001) and a reduced rate of mortality at the in-hospital (1.5% versus 2.4%, P<0.001) and 30-day (2.3% versus 4.0%, P<0.001) time points. Conscious sedation was associated with reductions in procedural inotrope requirement, intensive care unit and hospital length of stay (6.0 versus 6.5 days, P<0.001), and combined 30-day death/stroke rates (4.8% versus 6.4%, P<0.001). Falsification end point analyses of vascular complications, bleeding, and new pacemaker/defibrillator implantation demonstrated no significant differences between groups after adjustment. CONCLUSIONS: In US practice, conscious sedation is associated with briefer length of stay and lower in-hospital and 30-day mortality in comparison with TAVR with general anesthesia in both unadjusted and adjusted analyses. These results suggest the safety of conscious sedation in this population, although comparative effectiveness analyses using observational data cannot definitively establish the superiority of one technique over another.

Veno-Venous Extracorporeal Life Support in Hemodynamically Unstable Patients With ARDS.

When clinicians consider extracorporeal life support (ECLS) for acute respiratory distress syndrome (ARDS) patients with hemodynamic instability, both veno-arterial (VA) and veno-venous (VV) ECLS are therapeutic possibilities. We analyzed 17 patients with ARDS on inotropic or vasopressor support requiring ECLS for refractory hypoxemia. After implementing VV ECLS, pressor requirements (based on norepinephrine equivalents) were significantly lower in all patients (P = .0001 for overall comparison across time points). None of the 17 patients required conversion from VV ECLS to VA ECLS (95% confidence interval 0%-20.0%). In this sample of 17 patients with substantial baseline vasopressor support and hypoxemic respiratory failure, initiation of VV ECLS was associated with reduced pressor requirements. Such a strategy may help avoid complications of VA ECLS in patients with both respiratory and hemodynamic failure.

Variation in use of echocardiography among veterans who use the Veterans Health Administration vs Medicare.

BACKGROUND: Rapid growth in the provision of cardiac imaging tests has led to concerns about overuse. Little is known about the degree to which health care delivery system characteristics influence use and variation in echocardiography. METHODS: We analyzed administrative claims of veterans with heart failure older than 65 years from 2007 to 2010 across 34 metropolitan service areas (MSAs). We compared overall rates and geographic variation in use of transthoracic echocardiography (TTE) between veterans who used the Veterans Health Administration (VA) and propensity-matched veterans who used Medicare. "Dual users" were excluded. RESULTS: There were no significant differences in clinical characteristics or mortality between the propensity-matched cohorts (overall n = 30,404 veterans, mean age 76 years, mortality rate 52%). The Medicare cohort had a significantly higher overall rate of TTE use compared with the VA cohort (1.25 vs 0.38 TTEs per person-year, incidence rate ratio 2.89 [95% CI 2.80-3.00], both P < .001), but a similar coefficient of variation across MSAs (0.36 [95% CI 0.27-0.45] vs 0.48 [95% CI 0.37-0.59]). There was a moderate to strong correlation in variation at the MSA level between cohorts (Spearman r = 0.58, P < .001). CONCLUSION: Overall rates of TTE use were significantly higher in a Medicare cohort compared with a propensity score-matched VA cohort of veterans with heart failure living in urban areas, with similar relative degrees of geographic variation and moderate to strong regional correlation. Rates of TTE use may be strongly influenced by health care system characteristics, but local practice styles influence echocardiography rates irrespective of health system.

Valve-sparing root reimplantation with a Valsalva graft for a trileaflet aortic valve.

Valve-sparing root reimplantation has become an attractive alternative to conventional aortic root replacement in young patients as a means to avoid the anticoagulation required for mechanical roots while improving the durability compared to bioprosthetic valved conduits. In this video tutorial, we present our step-by-step process for performing a valve-sparing root reimplantation with a Valsalva graft for a patient with an aortic root aneurysm and a trileaflet aortic valve.

Neighborhood socioeconomic status is associated with differences in operative management and long-term survival after coronary artery bypass grafting.

OBJECTIVE: We sought to characterize differences in operative management and surgical outcomes after coronary artery bypass grafting associated with the socioeconomic context in which a patient lives. METHODS: We used a validated index of 17 variables derived from the US Census Bureau to assign socioeconomic status at the block group level to patients who underwent isolated coronary artery bypass grafting at a single institution over a 16-year period. Operative mortality, stroke, renal failure, prolonged ventilation, sternal wound infection, reoperation, composite morbidity or mortality, long-term survival, and use of arterial conduits were the outcomes assessed. RESULTS: This study was composed of 6751 patients. Lower socioeconomic status was significantly associated with increased rates of stroke, renal failure, prolonged ventilation, and composite morbidity or mortality in a multivariable analysis. Low socioeconomic status was significantly associated with poorer long-term adjusted survival (hazard ratio, 1.26; 95% confidence interval, 1.03-1.55). Finally, lower socioeconomic status was significantly associated with decreased use of more than 1 arterial conduits in a multivariable analysis. CONCLUSIONS: The socioeconomic context in which a patient lives is significantly associated with short- and long-term outcomes after coronary artery bypass grafting. There may also be variation in operative management, demonstrated by decreased use of arterial conduits. Lower rates of arterial revascularization among socioeconomically disadvantaged patients who undergo coronary artery revascularization may provide a target for intervention.

Thoracic Endovascular Aneurysm Repair Trends and Outcomes in Over 27,000 Medicare Patients for Descending Thoracic Aneurysms.

BACKGROUND: Since United States Food and Drug Administration approval in 2005, thoracic endovascular aneurysm repair (TEVAR) has replaced open surgery to become the preferred treatment for descending thoracic aneurysms (DTAs). This study investigated TEVAR trends during the previous 15 years regarding patient and hospital characteristics and their effect on survival. METHODS: Between 2000 and 2014, 27,079 Medicare patients underwent TEVAR for DTA. We analyzed TEVAR trends during this period and stratified hospitals based on the number of cases completed during the previous 5 years: low (0-19 cases), medium (20-99 cases), and high (≥100 cases) volume. Trends over time were calculated using Poisson regression to determine the average annual percentage changes (aAPC). Survival was calculated using a multivariate Cox regression and adjusted logistic regression with a restricted cubic spline. RESULTS: TEVAR volume significantly increased from 81 cases in 2000 to 3478 cases in 2014 (aAPC, 16.2%; P < .001). During the study period, the proportion of cases performed at medium-volume centers increased (aAPC, 5.2%; P < .001). Thirty-day mortality after TEVAR increased in the recent period (2013-2014) to 8.8% as compared with 6.6% in the early years (2004-2006) of TEVAR (P < .001), and a significant contribution was due to increased patient comorbidity score (aAPC, 1.6%; P < .001). Lastly, TEVAR center volume was significantly associated with 30-day survival when fewer than 33 cases were done in the prior 5 years. CONCLUSIONS: From 2000 to 2014, TEVAR volume accelerated, and centers are gaining more experience. TEVAR patients have become more acute, and mortality has increased over this period. Patient selection and procedural experience are critical to improving outcomes.

Contained rupture of arch aneurysm managed with total arch, frozen elephant trunk and endograft.

We here describe a complex case of a 75-year-old man presenting with contained rupture of an aortic arch aneurysm in the presence of a second thoracic aortic aneurysm. He was managed with emergent total arch replacement with frozen elephant trunk. Another stent-graft was used to achieve hemostasis at the distal anastomosis. He later underwent TEVAR extension to manage his second aneurysm in a staged fashion. This case demonstrates a number of important concepts in the evolving interaction between open and endovascular therapies of the aortic arch, particularly in the emergent setting.

Contained rupture of arch aneurysm managed with total arch, frozen elephant trunk and endograft.

We here describe a complex case of a 75-year-old man presenting with contained rupture of an aortic arch aneurysm in the presence of a second thoracic aortic aneurysm. He was managed with emergent total arch replacement with frozen elephant trunk. Another stent-graft was used to achieve hemostasis at the distal anastomosis. He later underwent TEVAR extension to manage his second aneurysm in a staged fashion. This case demonstrates a number of important concepts in the evolving interaction between open and endovascular therapies of the aortic arch, particularly in the emergent setting.

Optimal timing for heart transplantation in patients bridged with left ventricular assist devices: Is timing of the essence?

OBJECTIVES: Due to the scarcity of donor hearts to meet recipient demands, more than 40% of heart transplants are performed in patients bridged to transplant (BTT) with a left ventricular assist device (LVAD). The objective of this study was to determine the effect of BTT duration with an LVAD on posttransplant outcomes. METHODS: From 2009 to 2014, we identified 2639 fee-for-service Medicare patients who underwent a primary heart transplants with 1186 (45%) patients BTT with an LVAD. The LVAD patients were stratified as BTT ≤31 days (n = 28 [2.4%]), BTT 31-365 days (n = 748 [63.1%]), and BTT >365 days (n = 409 [34.5%]). Patients went directly to heart transplantation and were not bridged in 1453 cases (55%). LVAD duration was analyzed dichotomously and as a continuous variable with adjusted overall survival as the primary end point. RESULTS: All-cause mortality was significantly worse in patients who were BTT <31 days. Survival at 30 days was 81.5% for BTT <31 days, 94% for BTT 31 to 365 days, 95% for BTT >365 days, and 94% for no BTT. At 1 year, survival was 74% for BTT <31 days, 85% for BTT 31 to 365 days, 88% for BTT >365 days, and 89% for no BTT (P = .018). When LVAD duration was analyzed as a continuous variable, patients BTT with an LVAD <34 days had significantly increased mortality. CONCLUSIONS: Patients who underwent heart transplantation within the first month of BTT with an LVAD had significantly increased mortality. However, there was no survival difference among patients who were BTT with an LVAD longer than 31 days.

Geographically Derived Socioeconomic Factors to Improve Risk Prediction in Patients Having Aortic Valve Replacement.

Socioeconomic status (SES) has been associated with adverse outcomes after cardiac surgery, but is not included in commonly applied risk adjustment models. This study evaluates whether inclusion of SES improves aortic valve replacement (AVR) risk prediction models, as this is the most common elective operation performed at our institution during the study period. All patients who underwent AVR at a single institution from 2005 to 2015 were evaluated. SES measures included unemployment, poverty, household income, home value, educational attainment, housing density, and a validated SES index score. The risk scores for mortality, complications, and increased length of stay were generated using models published by the Society for Thoracic Surgeons. Univariate models were fitted for each SES covariate and multivariable models for mortality, any complication, and prolonged length of stay (PLOS). A total of 1,386 patients underwent AVR with a 2.7% mortality, 15.1% complication rate, and 9.7% PLOS. In univariate models, higher education was associated with decreased mortality (odds ratio [OR] 0.96, p = 0.04) and complications (OR 0.97, p <0.01). Poverty was associated with increased length of stay (OR 1.02, p = 0.02). In the multivariable models, the inclusion of SES covariates increased the area under the curve for mortality (0.735 to 0.750, p = 0.14), for any complications (0.663 to 0.680, p <0.01), and for PLOS (0.749 to 0.751, p = 0.12). The inclusion of census-tract-level socioeconomic factors into the the Society of Thoracic Surgeons risk predication models is new and shows potential to improve risk prediction for outcomes after cardiac surgery. With the possibility of reimbursement and institutional ranking based on these outcomes, this study represents an improvement in risk prediction model.

Self-Expanding Valve System for Treatment of Native Aortic Regurgitation by Transcatheter Aortic Valve Implantation (from the STS/ACC TVT Registry).

Transcatheter aortic valve implantation (TAVI) is approved for treatment of symptomatic aortic stenosis in patients at increased risk for surgical valve replacement, but outcomes data in patients with severe native aortic regurgitation (AR) treated with TAVI remain limited. The objective of this analysis was to evaluate outcomes among patients identified in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent TAVI for native AR with a commercially available self-expanding valve system. From January 2014 to December 2017, 230 patients in the TVT Registry underwent TAVI for primary severe native AR using a commercially available self-expanding valve (n = 81, CoreValve; n = 149, Evolut R). For inclusion, AR was either pure or mixed with predominantly moderate/severe AR and mean aortic valve gradient ≤20 mm Hg. Thirty-day outcomes were evaluated using time-to-event methods. Device success was reported in 81.7% of patients (CoreValve, 72.2%; Evolut R, 86.9%; p = 0.0.01). Thirty-day all-cause mortality was 13.3%. All patients presented with moderate/severe AR at baseline; at 30 days, 9.1% of implanted patients with data continued to have moderate and 1.4% severe AR. There was a significant reduction in residual moderate/severe AR from the CoreValve to Evolut R device (19.1% vs 6.3%, p = 0.02). Multivariable analysis revealed factors associated with 30-day all-cause mortality include number of valves used (hazard ratio [HR] 2.361, 1.643 to 3.391, p <0.001), albumin < 3.3 mg/dL (HR 3.358, 1.551 to 7.273, p=0.002), and left ventricular ejection fraction (HR 0.978, 0.957 to 1.000, p = 0.047). Despite higher 30-day all-cause mortality, self-expanding TAVI may be an option in selected patients with AR who have no surgical options.

Association of Tricuspid Regurgitation With Transcatheter Aortic Valve Replacement Outcomes: A Report From The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: The purpose of this study is to evaluate the association of tricuspid regurgitation (TR) severity with outcomes after transcatheter aortic valve replacement (TAVR). METHODS: We analyzed data from 34,576 patients who underwent TAVR at 365 US hospitals from November 2011 through March 2015 submitted to The Society of Thoracic Surgeon/American College of Cardiology Transcatheter Valve Therapy Registry. We examined unadjusted mortality and heart failure readmission stratified by degree of preoperative TR and used multivariable models for 1-year mortality and heart failure readmission. RESULTS: Tricuspid regurgitation was present in 80% (n = 27,804) of TAVR patients, with mild TR in 56% (n = 19,393), moderate TR in 19% (n = 6687), and severe TR in 5% (n = 1,724). Increasing TR severity was associated with a number of comorbidities and The Society of Thoracic Surgeons predicted risk of mortality increased (p < 0.001): no TR (7.3 ± 5.4); mild TR (8.0 ± 5.7); moderate TR (9.6 ± 6.8); and severe TR (10.7 ± 7.4). In unadjusted analysis, moderate and severe TR were associated with increased use of cardiopulmonary bypass, longer intensive care unit and hospital stays, new dialysis, inhospital major adverse cardiac event, inhospital mortality, observed-to-expected inhospital mortality ratio, long-term heart failure readmission, and mortality (p < 0.001). Adjusted mortality at 1 year was significantly worse for patients with severe TR when left ventricular ejection fraction greater than 30% (hazard ratio 1.29, 95% confidence interval: 1.11 to 1.50) as was heart failure readmission (hazard ratio 1.27, 95% confidence interval: 1.04 to 1.54). CONCLUSIONS: Tricuspid regurgitation was common among patients undergoing TAVR. Increasing TR severity was associated with higher risk patients and increased mortality and readmission-particularly for patients with severe TR and left ventricular ejection fraction greater than 30%. The effectiveness of TAVR alone in patients with aortic stenosis and concomitant severe TR may warrant further consideration, particularly for lower risk patients.

Outcomes, readmissions, and costs in transfemoral and alterative access transcatheter aortic valve replacement in the US Medicare population.

OBJECTIVE: To comprehensively evaluate and compare utilization, outcomes, and especially costs of transfemoral (TF), transapical (TA), and transaortic (TAO) transcatheter aortic valve replacement (TAVR). METHODS: All Medicare fee-for-service patients undergoing TF (n = 4065), TA (n = 691), or TAO (n = 274) TAVR between January 1, 2011, and November 30, 2012, were identified using Health Care Procedure Classification Codes present on Medicare claims. Hospital charges from Medicare claims were converted to costs using hospital-specific Medicare cost-to-charge ratios. RESULTS: TA and TAO patients were similar in age, race, and common comorbidities. Compared with TF patients, TA and TAO patients were more likely to be female and to have peripheral vascular disease, chronic lung disease, and renal failure. Thirty-day mortality rates were higher among TA and TAO patients than among TF patients (TA, 9.6%; TAO, 8.0%; TF, 5.0%; P < .001). Adjusted mortality beyond 1 year did not differ by access. TA patients were more likely to require cardiopulmonary bypass (CPB). Increased adjusted mortality was associated with CPB (hazard ratio, 2.13; P < .01) and increased 30-day cost ($62,000 [interquartile range (IQR)], $45,100-$86,400 versus $48,800 [IQR, $38,100-$62,900]; P < .01). Cost at 30 days was lowest for TF ($48,600) compared with TA ($49,800; P < .01) and TAO ($53,200; P = .03). CONCLUSIONS: For patients ineligible to receive TF TAVR, TAO and TA approaches offer similar clinical outcomes at similar cost with acceptable operative and 1-year survival, except for higher rates of CPB use in TA patients. CPB was associated with worse survival and increased costs.

Cost and contribution margin of transcatheter versus surgical aortic valve replacement.

OBJECTIVE: To compare the cost of and payments for transcatheter aortic valve replacement (TAVR), a novel and expensive technology, and surgical aortic valve replacement (SAVR). METHODS: Medicare claims provided hospital charges, payments, and outcomes between January and December 2012. Hospital costs and charges were estimated using hospital-specific cost-to-charge ratios. Costs and payments were examined in propensity score- matched TAVR and SAVR patients. RESULTS: Medicare spent $215,770,200 nationally on 4083 patients who underwent TAVR in 2012. Hospital costs were higher for TAVR patients (median, $50,200; interquartile range [IQR], $39,800-$64,300) than for propensity-matched SAVR patients ($45,500; IQR, $34,500-$63,300; P < .01), owing largely to higher estimated medical supply costs, including the implanted valve prosthesis. Postprocedure hospital length of stay (LOS) length was shorter for TAVR patients (median, 5 days [IQR, 4-8 days] vs 7 days [IQR, 5-9 days]; P < .01), as was total intensive care unit (ICU) LOS (median, 2 days [IQR, 0-5 days] vs 3 days [IQR, 1-6 days]; P < .01). Medicare payments were lower for TAVR hospitalizations (median, $49,500; IQR, $36,900-$64,600) than for SAVR (median, $50,400; IQR, $37,400-$65,800; P < .01). The median of the differences between payments and costs (contribution margin) was -$3380 for TAVR hospitalizations and $2390 for SAVR hospitalizations (P < .01). CONCLUSIONS: TAVR accounted for $215 million in Medicare payments in its first year of clinical use. Among SAVR Medicare patients at a similar risk level, TAVR was associated with higher hospital costs despite shorter ICU LOS and hospital LOS. Overall and/or medical device cost reductions are needed for TAVR to have a net neutral financial impact on hospitals.

Association of Liability Concerns with Decisions to Order Echocardiography and Cardiac Stress Tests with Imaging.

BACKGROUND: Professional societies have made efforts to curb overuse of cardiac imaging and decrease practice variation by publishing appropriate use criteria. However, little is known about the impact of physician-level determinants such as liability concerns and risk aversion on decisions to order testing. METHODS: A web-based survey was administered to cardiologists and general practice physicians affiliated with two academic institutions. The survey consisted of four clinical scenarios in which appropriate use criteria rated echocardiography or stress testing as "may be appropriate." Respondents' degree of liability concerns and risk aversion were measured using validated tools. The primary outcome variable was tendency to order imaging, calculated as the average likelihood to order an imaging test across the clinical scenarios (1 = very unlikely, 6 = very likely). Linear regression models were used to evaluate the association between tendency to order imaging and physician characteristics. RESULTS: From 420 physicians invited to participate, 108 complete responses were obtained (26% response rate, 54% cardiologists). There was no difference in tendency to order imaging between cardiologists and general practice physicians (3.46 [95% CI, 3.12-3.81] vs 3.15 [95% CI, 2.79-3.51], P = .22). On multivariate analysis, a higher degree of liability concerns was the only significant predictor of decisions to order imaging (mean difference in tendency to order imaging, 0.36; 95% CI, 0.09-0.62; P = .01). CONCLUSION: In clinical situations in which performance of cardiac imaging is rated as "may be appropriate" by appropriate use criteria, physicians with higher liability concerns ordered significantly more testing than physicians with lower concerns.