Outcomes Of Aortic Valve Replacement Research Articles

Trends and Outcomes of Aortic Valve Replacement in Patients With Diabetes in the US.

AimsWe aimed to assess the trend and outcome of aortic valve replacement in patients with diabetes.BackgroundDiabetes is associated with higher cardiovascular events.MethodsData from the National Inpatient Sample was analyzed between 2012 and 2017. We compared hospitalizations and in-hospital cardiovascular outcomes in patients with diabetes to those without diabetes, hospitalized for aortic valve replacement.ResultsIn diabetes patients undergoing TAVR, the mean age of participants decreased from 79.6 ± 8 to 67.8 ± 8, hospitalizations increased from 0.97 to 7.68/100,000 US adults (p < 0.002 for both). There was a significant temporal decrease in mortality, acute renal failure (ARF), and stroke. Compared to non-diabetic patients, those with diabetes had a higher risk of stroke, ARF, and pacemaker requirement [adjusted OR = 1.174 (1.03–1.34), 1.294 (1.24–1.35), 1.153 (1.11–1.20), respectively], but a similar adjusted mortality risk. In diabetes patients undergoing sAVR, the mean age of participants decreased from 70.4 ± 10 to 68 ± 9 (p < 0.001), hospitalizations dropped from 7.72 to 6.63/100,000 US adults (p = 0.025), so did mortality, bleeding, and ARF. When compared to non-diabetes patients, those with diabetes were older and had a higher adjusted risk of mortality, stroke, and ARF [adjusted OR= 1.115 (1.06–1.17), 1.140 (1.05–1.23), 1.217 (1.18–1.26); respectively].ConclusionThe recent temporal trend of aortic valve replacement in patients with diabetes shows a significant increase in TAVR coupled with a decrease in sAVR. Mortality and other cardiovascular outcomes decreased in both techniques. sAVR, but not TAVR, was associated with higher in-hospital mortality risk.

Abstract EP11: Long-term Outcomes Of Transcatheter Aortic Valve Replacement Compared With Surgical Aortic Valve Replacement: A Retrospective Cohort Study With Overlap Propensity Score Weighting

Objectives: This longitudinal observational study utilized surgical procedure data from Ontario, Canada to compare mid- and long-term clinical outcomes in a representative real-world cohort of patients (2007-2019) after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Methods: A novel overlap weighting propensity score method was used to match patients on the date of TAVR or SAVR, conditional on baseline patient characteristics. Primary outcomes were all-cause and cardiovascular mortality either in-hospital or at 1, 3 and 5 years post-discharge. Secondary outcomes included ischemic stroke, hemorrhagic stroke, myocardial infarction, acute kidney injury, vascular complications, atrial fibrillation, endocarditis, permanent pacemaker implantation, defibrillator, reintervention, and cause-specific readmission at 1, 3 and 5 years post-discharge. In-hospital outcomes were compared using multivariable logistic regression. Long-term primary and secondary outcomes for patients undergoing TAVR vs. SAVR were compared using an overlap propensity score-weighted competing risks sub-distribution proportional hazards model. Results: The study included 9,355 SAVR and 2,641 TAVR patients. Hazards of all-cause mortality at 1 year (Hazard Ratio [HR], 1.25; 95% CI, 1.06-1.48), 3 years (HR, 1.48; 95% CI, 1.31-1.68) and 5 years (HR, 1.51; 95% CI, 1.36-1.69) were significantly higher in the TAVR compared to SAVR group. Cardiovascular mortality was significantly higher in the TAVR group at 3 (HR, 1.40; 95% CI, 1.08-1.80) and 5 years (HR, 1.41; 95% CI, 1.13-1.77). Non-cardiovascular mortality was also significantly higher in the TAVR group at 1 year (HR, 1.46; 95% CI, 1.03-2.06), 3 years (HR, 1.48; 95% CI, 1.17-1.88), and 5 years (HR, 1.41; 95% CI, 1.16-1.72). Hazards of myocardial infarction were significantly greater in the TAVR at 1 year (HR, 1.72; 95% CI, 1.08-2.74), 3 years (HR, 1.86; 95% CI, 1.35-2.57), and 5 years (HR, 1.82; 95% CI, 1.37-2.42). Hazards of angina readmission were significantly greater in the TAVR at 3 years (HR, 1.94; 95% CI, 1.26-3.00) and 5 years (HR, 1.87; 95% CI, 1.26-2.78). Conclusions: In real-life patients who underwent a TAVR experienced an excess cardiac and non-cardiac mortality compared to SAVR. More studies with long-term follow-up are needed to confirm the long-term clinical benefits of TAVR and effort to improve patient selection are warranted.

Outcomes, Cost, and Readmission After Surgical Aortic or Mitral Valve Replacement at Safety-Net and Non–Safety-Net Hospitals

BackgroundSafety-net hospitals provide essential services to vulnerable patients with complex medical and socioeconomic circumstances. We hypothesized that matched patients at safety-net hospitals and non–safety-net hospitals would have comparable outcomes, costs, and readmission rates after isolated surgical aortic valve replacement (AVR) or mitral valve replacement (MVR). MethodsThe National Readmissions Database was queried to identify patients who underwent isolated AVR (n = 109 744) or MVR (n = 31 475) from 2016 to 2018. Safety-net burden was defined as the percentage of patients who were uninsured or insured with Medicaid, with hospitals in the top quartile designated as safety-net hospitals. After propensity score matching, outcomes for AVR and MVR at safety-net hospitals vs non–safety-net hospitals were compared. ResultsOverall, 17 925 AVRs (16%) and 5516 MVRs (18%) were performed at safety-net hospitals, and these patients had higher comorbidity rates, had lower socioeconomic status, and more frequently required urgent surgery. Observed inhospital mortality was similar between safety-net hospitals and non–safety-net hospitals (AVR 2.2% vs 2.1%, P = .4; MVR 4.8% vs 4.3%, P = .1). After matching, rates of inhospital mortality, major morbidity, and readmission were similar; however, safety-net hospitals had longer length of stay after AVR (7 vs 6 days, P = .001) and higher total cost after AVR ($49 015 vs $42 473, P < .001) and MVR ($59 253 vs $52 392, P < .001). ConclusionsIsolated surgical AVR and MVR are both performed at safety-net hospitals with outcomes comparable to those at non–safety-net hospitals, supporting efforts to expand access to these procedures for underserved populations. Investment in care coordination resources to reduce length of stay and curtail cost at safety-net hospitals is warranted.

Stentless Versus Stented Aortic Valve Replacement for Aortic Stenosis

BackgroundThe differences in long-term outcomes of aortic valve replacement for aortic stenosis between stentless and stented bioprostheses are controversial. MethodsBetween 2007 and 2018, 1173 patients underwent aortic valve replacement for aortic stenosis, including 559 treated with a stentless valve and 614 with a stented valve. A propensity score matched cohort with 348 pairs was generated by matching for age, sex, body surface area, bicuspid aortic valve, chronic lung disease, previous cardiac surgery, coronary artery disease, renal failure on dialysis, valve size, concomitant procedures, and surgeon. The primary endpoints of the study were long-term survival and incidence of reoperation. ResultsImmediate postoperative outcomes were similar between the stentless and stented groups with an overall operative mortality of 2.9% (P = .19). Kaplan-Meier estimation for long-term survival was comparable between the stentless and stented valves in both the whole cohort and the propensity score matched cohort (10-year survival 59% vs 55%, P = .20). The hazard ratio of stentless vs stented valve for risk of long-term mortality was 1.12 (P = .33). The 10-year cumulative incidence of reoperation due to valve degeneration was 5.5% in the stentless group and 4.7% in the stented group (P = .25). The transvalvular pressure gradient at 5-year follow-up was significantly lower in the stentless group (7 vs 11 mm Hg, P < .001). ConclusionsBoth stented and stentless valves could be used in aortic valve replacement for aortic stenosis. We recommend stented valves for aortic valve replacement in patients with aortic stenosis for their simplicity of implantation.

Early outcomes of aortic valve repair versus replacement for aortic regurgitation: a single-center experience

BackgroundAortic valve repair in rheumatic patients is not well-studied. We aimed to present our initial Egyptian experience in the aortic valve repair and compare it with the aortic valve replacement. The study included 85 patients who had an aortic valve surgery for aortic regurgitation (AR) in a single center from 2018 to 2020. We assigned the patients to either aortic valve repair (n= 39) or aortic valve replacement (n= 46). Fifty-nine patients (69.4%) had rheumatic heart disease. Study outcomes were hospital complications and the degree of aortic regurgitation after 6 months in patients who had aortic valve repair.ResultsPatients who had replacement were significantly older (49.6± 7.2 vs. 43.8± 8.6 years: P= 0.002) and had more advanced New York Heart Association (P<0.001) and Canadian Cardiovascular Scoring (P= 0.03) classes. Hypertension (31 (67.4%) vs. 17 (43.6%); P= 0.03) and hypercholesteremia (18 (40%) vs. 17 (18.9%); P= 0.04) were more common in the replacement group. Patients who had replacement had a significantly higher percentage of valve retraction (P<0.001). Cardiopulmonary bypass (54.5 (49.5–60) vs. 45 (41–49) min; P<0.001) and ischemic times (36.5 (31–40) vs. 30 (28–33) min; P<0.001) were longer in patients who had an aortic valve replacement. Blood transfusion (28 (60.9%) vs. 11 (282%); P= 0.003) and ICU stay (24.5 (24–48) vs 23 (20–31) h; P= 0.01) were higher in the replacement group. Hospital mortality was non-significantly different between groups. Four patients had trivial AR (10.3%), and six had mild AR (15.4%) in the repair group. There was no difference in valve pathology or outcomes in aortic valve repair patients for degenerative versus rheumatic pathologies. After a 6-month follow-up, four patients had trivial AR (10.3%), and six patients had mild AR (15.4%) in the repair group.ConclusionsAortic valve repair could be an alternative to replacement in selected patients with rheumatic heart disease. Shorter cardiopulmonary bypass and ischemic times may improve repair outcomes compared to replacement.

СРАВНЕНИЕ ГЕМОДИНАМИЧЕСКИХ ПАРАМЕТРОВ И ОТДАЛЕННОГО ПРОГНОЗА У ПАЦИЕНТОВ ПОСЛЕ АОРТАЛЬНОГО ПРОТЕЗИРОВАНИЯ ИСКУССТВЕННЫМИ КЛАПАНАМИ СЕРДЦА «ПЛАНИКС-Э» И ЗАРУБЕЖНЫМИ АНАЛОГАМИ

The article presents the results of aortic valve replacement with artificial prosthetic heart valves. The study comprised 422 patients after aortic valve replacement with mechanical bicuspid valve prostheses of 19, 21, and 23 mm. The valves used were «Planiks-E», MedIng-2, Carbomedics, ATS Medtronic, St. Jude Medical. Hospital and long-term results are analyzed directly depending on the type-size of the AMHV used. There was a significant decrease in the peak and average transvalvular gradient on the all aortic valves (p &lt; 0.0015), as well as an increase in the effective orifice area (EOA) of the aortic valve. EOA of the prosthesis “Planiks E” was not significantly different from that of its foreign equivalents. The EOA of St.Jude Medical prostheses was significantly larger compared to the Sorin Carbomedics prostheses (p &gt; 0.005). The peak and mean gradients were different significantly (p = 0.007 and p &lt; 0.05). The highest maximum systolic gradient was observed with Sorin Carbomedics prostheses. The phenomenon of prosthesis-patient mismatch of moderate degree in the early postoperative period was observed in 30.3% of patients, and in 4.1% it was severe. For “Planiks-E” prostheses, severe PPM was observed in 3.2% of patients. “Planiks-E” and ATS Medtronic prostheses were less common related to moderate PPM, in 27.80% and 28.60% correspondently. Overall hospital mortality was 3.4%. The risk of developing moderate PPN was 1.66 (95% CI 1.087 – 2.539, p = 0.19). The follow-up period mediana was 3.4 (2.12÷5.93) years. There were no significant differences in survival between patients without or with different PPM degrees (log-rank test, p = 0.539). Among “Planiks-E” the five-year survival rate was 87%.The PPN phenomenon did not significantly affect long-term survival. The heart valve prosthesis “Planiks-E” is comparable in its hemodynamic parameters to similar imported prostheses, the risk of moderate PPN being significantly lower.

Evaluating Differences in Aortic Valve Replacement Outcomes Between Migrants and Non-Migrant Patients in New South Wales

Health care outcomes can vary between Australian-born and migrants (non-Australian born). While survival following aortic valve replacement (AVR) is generally good, outcome differences between Australia-born and migrants is unclear.

Pericardial Versus Porcine Valves for Surgical Aortic Valve Replacement.

There still are controversies on which type between bovine pericardial and porcine valves is superior in the setting of aortic valve replacement (AVR). This study aims to compare clinical outcomes of AVR using between pericardial or porcine valves. The study involved consecutive 636 patients underwent isolated AVR using stented bioprosthetic valves between January 2000 and May 2016. Of these, pericardial and porcine valves were implanted in 410 (pericardial group) and 226 patients (porcine group), respectively. Clinical outcomes including survival, structural valve deterioration (SVD) and trans-valvular pressure gradient were compared between the groups. To adjust for potential selection bias, inverse probability treatment weighting (IPTW) was conducted. The mean follow-up duration was 60.1±50.2 months. There were no significant differences in the rates of early mortality (3.1% vs. 3.1%; p=0.81) and SVD (0.3%/patient-year [PY] vs. 0.5%/PY; p=0.33) between groups. After adjustment using IPTW, however, landmark mortality analyses showed a significantly lower late (>8 years) mortality risk in pericardial group over porcine group (hazard ratio [HR], 0.61; 95% confidence interval, [CI] 0.41-0.90; p=0.01) while the risks of SVD were not significantly difference between groups (HR, 0.45; 95% CI, 0.12-1.70; p=0.24). Mean pressure gradient across prosthetic AV was lower in the Pericardial group than the Porcine group at both immediate postoperative point and latest follow-up (p values <0.001). In patients undergoing bioprosthetic surgical AVR, bovine pericardial valves showed superior results in terms of postoperative hemodynamic profiles and late survival rates over porcine valves.

Atrial fibrillation in severe aortic stenosis: Prognostic value and results of aortic valve replacement

ObjectivesAlthough atrial fibrillation (AF) is common, its impact on long-term mortality has not been reliably determined in patients with aortic stenosis (AS). We aimed to assess whether AF is associated with survival in patients with severe AS and to determine the impact of AF on the results of aortic valve replacement (AVR). MethodsThe study included 1838 consecutive patients with severe AS (77 ± 11 years, male 47%). Upon AS diagnosis, patients were screened for AF using a 12-lead electrocardiogram. The treatment strategy (conservative management or AVR) was selected by the heart team in accordance with current guidelines. The effect of AVR on survival was analyzed as a time-dependent covariate using the entire follow-up period. ResultsAF, diagnosed in 593 (32%) patients was associated with poor survival at 5 years (55 ± 2% vs 74 ± 1% for patients in sinus rhythm, P < .001), even after adjustment for established outcome predictors (hazard ratio [HR], 1.56; 95% confidence interval [CI], 1.33-1.84; P < .001). In patients with AF, AVR was associated with lower mortality (HR, 0.16; 95% CI, 0.12-0.22; P < .001) even in those with no or minimal symptoms (HR, 0.12; 95% CI, 0.08-0.20; P < .001). However, among patients who underwent AVR, those in AF had an excess mortality (HR, 1.59; 95% CI, 1.22-2.08; P < .001). ConclusionsIn severe AS, AF is a strong predictor of mortality even in asymptomatic or minimally symptomatic patients. After AVR, AF remains associated with poorer survival than sinus rhythm. In patients in AF, AVR is associated with lower mortality compared with conservative treatment. Further studies are needed to confirm the benefits of AVR in asymptomatic patients in AF with severe AS.

Abstract 9296: Impact of the Covid Pandemic on Aortic Valve Replacement and Coronary Artery Bypass Graft Surgical Outcomes

Introduction: Patients with coronary artery disease or cardiac valvular disease in need of cardiac surgery are typically high-risk, and may have been impacted either by delays in seeking care for their underlying cardiac condition, or by disruptions in hospital care itself. Hypothesis: we examined changes in volume, complexity, and outcomes for aortic valve replacement (AVR) and coronary artery bypass graft (CABG) patients at a large midwestern teaching hospital during the COVID pandemic. Methods: We used diagnosis and procedure codes to identify all patients undergoing AVR or CABG, without a documented COVID19 diagnosis, at Barnes-Jewish Hospital between 1/2018 and 9/2020. We used multivariable regression models to examine the association between the COVID time period and outcomes, controlling for age, sex, and medical comorbidities. Results: For the AVR and CABG cohort, we saw no statistically significant differences in weekly volume, age, gender, payor, or race (Table 1).In the AVR cohort, patients were more complex during COVID, and risk-adjusted in-hospital mortality was higher during COVID compared to pre-COVID. For the CABG cohort, we found numeric increases but no statistically significant differences in patient complexity, nor in risk-adjusted mortality (Figure 1). Conclusions: We found higher in-hospital mortality among patients undergoing AVR during COVID, a pattern that was not statistically significant in CABG. These findings suggest that outreach to patients is critical to ascertain which patients require necessary surgical care during future pandemic waves or other disruptions to usual care.

Abstract 11419: Outcomes of Transcatheter Aortic Valve Replacement in Patients with High Comorbidity versus Low Comorbidity Burden

Introduction: Transcatheter aortic valve replacement (TAVR)’s on-par performance with surgical aortic valve replacement in clinical trials has led to its successful adoption in patients with high and low mortality risk. Here we evaluate if a correlation exists between comorbidity burden and in-hospital mortality (IHM) in TAVR patients and examine the factors associated with increased IHM. Methods: Using the National Inpatient Sample database, 148,315 adult patients who underwent TAVR from 2016 through 2018 were included in the study. The Elixhauser Comorbidity Index 2020 was used to identify comorbidities. All comorbidities were weighted equally. Patients with &lt;3 comorbidities were assigned to the low comorbidity group (LCG) and those with ≥3 comorbidities to the high comorbidity group (HCG). The primary outcome of interest was IHM in the HCG versus the LCG. Secondary outcomes were average length of stay (LOS) and average hospital charges. Results: The overall IHM rate in our sample was 1.52%. Unadjusted and adjusted IHM odds were not different between groups (unadjusted odds ratio=1.024, P=0.7994; adjusted odds ratio=1.022, P=0.8225). Female sex, non-elective admission for TAVR, and transapical access were found to be independent predictors of IHM when adjusted for other factors (Table). The adjusted average LOS was significantly higher in the HCG than the LCG (3.07 vs. 2.7 days, P&lt;0.0001). The adjusted average total hospital charges billed and average actual cost of hospital services were significantly higher in the HCG than the LCG (213,507 vs 208,019 USD, P=0.0032 and 55,284 vs 54,278 USD, P=0.0078; respectively). Conclusion: In-hospital mortality in TAVR patients is not significantly correlated with comorbidity burden. Female sex and procedural characteristics like transapical access and non-electiveness are more important in determining IHM. Resource utilization is higher in the HCG than the LCG.

Abstract 12911: Outcomes of Transcatheter Aortic Valve Replacement at Teaching versus Non Teaching Hospitals in the United States

Introduction: Transcatheter aortic valve replacement (TAVR) has become widely available across the United States; however, national trends have not been evaluated by hospital teaching status. Hypothesis: There will be no differences in outcomes between teaching hospitals (TH) versus non teaching hospitals. Methods: This was an observational study of patients undergoing TAVR from 2012-2017, utilizing the Nationwide Readmissions Database with appropriate trend weights to generate national estimates. Codes from the International Classification of Diseases were used to identify patients with a primary procedure code for TAVR. TAVRs were stratified by hospital teaching status, while in-hospital mortality, complications, costs, and 30- and 90-day readmissions were compared between the groups. Results: During the study’s timeframe, 123,557 patients underwent TAVR, of which 90% occurred at a TH. The number of TAVRs increased by 744% from 2012 to 2017 (Cochrane-Armitage test, p&lt;0.001), with a larger increase for non-TH. Median age [IQR] was 82.0 [76.0-87.0] and 46.2% were women. Patients undergoing TAVR at a teaching hospital were more likely to have diabetes, dyslipidemia, hypertension, coronary artery disease, congestive heart failure, peripheral vascular disease, and cerebrovascular disease. In-hospital mortality was higher for patients undergoing TAVR at a TH (2.6% vs. 2.2%, p&lt;0.001). After TAVR, there was more stroke (1.5% vs. 0.9%), acute kidney injury (14.6% vs. 11.3%), and myocardial infarction (4.2% vs. 2.8%) in the TH group. TAVR at a TH was associated with higher total cost of care during their index admission (47.9 [37.5-61.9] vs. 44.3 [34.7-58.7] x $1000) and longer length of hospital stay (4.0 [2.0-7.0] vs. 3.0 [2.0-6.0] days). Moreover, patients undergoing TAVR at a TH were more likely to have been discharged to an intermediate care facility or home health care (50.0% vs. 40.9%). 30-day readmissions were higher for the TH group (18.7% vs. 18.0%), while 90-day readmissions were similar across each group (28.4% for the entire cohort). Conclusions: While patients undergoing TAVR at a teaching hospital had more comorbidities, they also had higher in-hospital mortality, more postoperative complications, and greater healthcare costs.

Abstract 10831: Comparison of Clinical Outcomes in Transcatheter Aortic Valve Replacement with Edwards Sapien 3 versus Evolut Series: A Systematic Review and Meta-Analysis

Introduction: The third generation transcatheter heart valve system aimed to improve the safety of transcatheter aortic valve replacement (TAVR). We performed systematic review and meta-analysis to compare clinical outcomes after TAVR with Edwards Sapien 3 (ES3) and Evolut series (MER). Methods: A systematic search was conducted by 2 independent researchers in MEDLINE and EMBASE for studies comparing clinical outcomes after TAVR with ES3 and MER. 1 randomized controlled trial and 11 observational studies met the inclusion criteria. Mantel-Haenszel odds ratios were calculated, and for heterogeneity I 2 statistics were reported. Results: 12 studies with total 7,749 patients were included for final analysis. ES3 and MER were implanted in 4,333 and 3,416 patients respectively. ES3 showed statistically significant decrease in permanent pacemaker implantation at 30-days (OR: 0.60; 95% CI: 0.52-0.70; p&lt; 0.05). Furthermore, TAVR with ES3 showed non-statistically significant trend towards decreased all-cause mortality at 30 days (OR: 0.73; 95% CI: 0.51-1.02; p=0.07), and stroke at 30 days (OR: 0.55; 95% CI: 0.27-1.10; p=0.09). Cardiovascular mortality (OR: 1.03; 95% CI: 0.50-2.15; p=0.93), and acute kidney injury (OR: 1.08; 95% CI: 0.83-1.41; p=0.56) did not show statistically significant difference. Conclusions: While ES3 and MER had similar clinical outcomes, patients undergoing TAVR with ES3 had statistically significant decrease in permanent pacemaker implantation and hence may be favored in patients with pre-existing conduction system disease.

Abstract 10390: Transcatheter and Surgical Aortic Valve Replacement in Children with Congenital Heart Disease: An Institutional Experience

Introduction: Surgical approaches have historically been the mainstay for aortic valve replacement in children and adults, while transcatheter approaches have been increasingly utilized in adults with rare use in children. We hypothesized that short-term outcomes for native aortic valve replacement are comparable between the surgical (SAVR) or transcatheter (TAVR) approach in children. Methods: Patients &lt; 21 years who had native SAVR or TAVR between January 2010 to April 2020 at our institution were included. Analysis focused on short-term outcomes for ages 10-21. SAVR and TAVR were compared using a composite outcome score (stroke within 6 months, readmission within 30 days, death). Pre- and post-procedural characteristics were compared using chi-squared test or Wilcox rank sum test as appropriate. Results: Of 77 patients included, 46 were 10-21 yrs (30 SAVR, 16 TAVR). Mean follow-up was 3.7 yrs for the SAVR group and 1.7 yrs for the TAVR group. There was no significant difference in the composite score between groups (3 SAVR, 2 TAVR; p = 1). Patients in the SAVR group were more likely to have undergone concomitant surgical intervention (e.g., Konno procedure, mitral valve repair/replacement, etc.) and have longer hospital stays (Table 1). Death in the SAVR group was secondary to patient non-compliance with recommended medications and follow-up, resulting in severe aortic stenosis with cardiogenic shock and respiratory failure. Death in the TAVR group was secondary to endocarditis of the valve and associated stroke, which converted from ischemic to hemorrhagic following surgical intervention. Conclusion: Our study suggests similar short-term outcomes for TAVR and SAVR in children and young adults &gt; 10 years of age. Long-term studies are essential in the pediatric population to fully explore the option of transcatheter aortic valve replacement as an alternative to surgical aortic valve replacement.

Trends in Transcatheter and Surgical Aortic Valve Replacement Among Older Adults in the United States

BackgroundRecent trends, including survival beyond 30 days, in aortic valve replacement (AVR) following the expansion of indications for transcatheter aortic valve replacement (TAVR) are not well-understood. ObjectivesThe authors sought to characterize the trends in characteristics and outcomes of patients undergoing AVR. MethodsThe authors analyzed Medicare beneficiaries who underwent TAVR and SAVR in 2012 to 2019. They evaluated case volume, demographics, comorbidities, 1-year mortality, and discharge disposition. Cox proportional hazard models were used to assess the annual change in outcomes. ResultsPer 100,000 beneficiary-years, AVR increased from 107 to 156, TAVR increased from 19 to 101, whereas SAVR declined from 88 to 54. The median [interquartile range] age remained similar from 77 [71-83] years to 78 [72-84] years for overall AVR, decreased from 84 [79-88] years to 81 [75-86] years for TAVR, and decreased from 76 [71-81] years to 72 [68-77] years for SAVR. For all AVR patients, the prevalence of comorbidities remained relatively stable. The 1-year mortality for all AVR decreased from 11.9% to 9.4%. Annual change in the adjusted odds of 1-year mortality was 0.93 (95% CI: 0.92-0.94) for TAVR and 0.98 (95% CI: 0.97-0.99) for SAVR, and 0.94 (95% CI: 0.93-0.95) for all AVR. Patients discharged to home after AVR increased from 24.2% to 54.7%, primarily driven by increasing home discharge after TAVR. ConclusionsThe advent of TAVR has led to about a 60% increase in overall AVR in older adults. Improving outcomes in AVR as a whole following the advent of TAVR with increased access is a reassuring trend.

Reemplazo valvular aórtico a través de esternotomía parcial superior vs. esternotomía convencional media: análisis mediante índice de propensión

ObjectiveTo analyse the results of aortic valve replacement (AVR) through partial upper sternotomy (PUS). MethodologyBetween January 2011 and December 2016, 507 patients underwent simple AVR: 306 through conventional median sternotomy (CMS) and 201 through PUS. The propensity score was used to compare the results of both techniques in 201 patient pairs. ResultsThe average age was 70±11.5 years. Sixty percent were men and 58% had aortic stenosis. The median EuroSCORE II was 1.58% (.99-2.46). The median time of ischaemia and extracorporeal circulation for PUS and CMS was 82 minutes (72-92) and 102 minutes (90-114), vs 66 minutes (55-75) and 87 minutes (75-101), respectively (P<.05). Patients with CMS presented with greater postoperative bleeding and need for blood product transfusion than patients with PUS (P<.05). There were no significant differences between the two groups in the incidence of major adverse cardiovascular and cerebrovascular events in the postoperative period. Hospital mortality rate was 3.7% (P>.05). Five-year survival rate was 83%. After surgery, 96% of the patients were in NYHA functional class I or II and had a mean EQ-5D® health index of .81, regardless of group. ConclusionsAVR by PUS is a safe technique with short-, medium- and long-term results comparable to CMS. It is associated with less postoperative bleeding and need for blood product transfusion, but with a longer duration of ischaemia and extracorporeal circulation.

Outcomes of trans-catheter versus surgical aortic valve replacement for patients with classic low-flow low-gradient aortic stenosis

Abstract Background Classical low-flow low-gradient aortic stenosis (cLFLG-AS) is frequently encountered within clinical practice [1], and is often associated with high mortality [2]. Whilst aortic valve replacement can improve outcomes, there is a lack of real-world data guiding the decision between trans-catheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) in this specific patient cohort. Purpose To compare outcomes between TAVI and SAVR in patients with cLFLG-AS. Methods cLFLG-AS was defined by an aortic valve area &amp;lt;1cm2, mean gradient &amp;lt;40mmHg or peak velocity &amp;lt;4m/s and left ventricular ejection fraction &amp;lt;50%. All patients who met cLFLG-AS criteria who underwent TAVI or SAVR at our tertiary referral centre between 2015 and 2020 were included. Inverse probability weighting was used to adjust for differences in baseline characteristics and the non-random assignment of treatment modalities. The primary end-point was all-cause mortality. Secondary end-points were procedure-related permanent pacemaker implantation, renal replacement therapy (RRT) and stroke. Results 322 patients were included (220 TAVI and 102 SAVR). Baseline characteristics were: male sex 70%, mean gradient 30mmHg (23–35), aortic valve area 0.8cm2 (0.6–0.9). Patients undergoing TAVI were older than the SAVR group (81.3±8.5 vs 70.6±11.1 years, p&amp;lt;0.0001) with higher Logistic Euroscore (19.3 (11.8–32.3) vs 7.1 (3.7–14.1), p&amp;lt;0.0001) (figure 1). At median follow-up of 2.7 years (1.5–4.1), 99 patients had died; 70 (31.8%) had TAVI and 29 (28.4%) had SAVR. Both unweighted and weighted Kaplan-Meier curve analysis was performed; there was similar survival between SAVR and TAVI (log rank test 0=0.27 and p=0.4 respectively) (figure 2). Adjusted hazard ratio (HR) for mortality with SAVR was 0.78 unweighted (95% CI 0.5–1.21; p=0.27) and 0.66 weighted (95% CI 0.26–1.64; p=0.37). In terms of contributory procedural factors, concomitant multiple valve intervention in the SAVR group independently affected mortality (HR 5.47, 95% CI 2.52–11.51, p&amp;lt;0.001). There was no difference in permanent pacemaker insertion or stroke across the two groups, but rates of RRT were higher in SAVR cohort (13.7% vs 0%, p&amp;lt;0.001). Conclusions Despite the TAVI cohort being both older and at higher risk, there was no observed difference in mortality between TAVI and SAVR in the mid-term. Deciding upon intervention choice can therefore be based upon criteria other than the specific presence of a classic low-flow low-gradient state. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Clinical training research fellowship from the British Heart Foundation Baseline characteristics by treatmentKaplan-Meier curves for TAVI vs SAVR

Comparing outcomes of transcatheter versus surgical aortic valve replacement in patients with atrial arrythmias

Abstract Introduction In patients with severe aortic valve stenosis, clinical trials have demonstrated a similar mortality risk with transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) in low to intermediate-risk patients. However, data comparing these procedures in patients with atrial arrhythmias is lacking. Purpose This study aimed to evaluate and compare the in-hospital mortality and outcomes of TAVR and SAVR for severe aortic stenosis in patients with atrial fibrillation or atrial flutter. Methods We performed a retrospective cross-sectional analysis using the 2018 National Inpatient Sample. Patients aged 50 years and older with TAVR or SAVR related hospitalizations were identified. Patients with endocarditis and those undergoing coronary artery bypass grafting or other valvular procedures were excluded. Propensity score matching was utilized to mitigate selection bias. The scoring was based on a multivariate logistic regression model accounting for age, gender, race, hospital type, hospital region, hospital teaching status, median household income, and medical comorbidities. Using 8-to-1-digit match, we paired each admission in TAVR group with one admission in SAVR group. Results In 2018, a total of 3487 TAVRs and 1466 SAVRs were performed in patients who had atrial fibrillation or atrial flutter. TAVR and SAVR had no statistically significant difference in inpatient mortality (0.9% vs 0.8%, p=0.79). However, SAVR was associated with higher odds of cardiogenic shock (OR 1.82; 95% CI 1.41–2.35, p&amp;lt;0.0001), acute kidney injury (OR 2.29; 95% CI 1.77–2.97, p&amp;lt;0.0001), mechanical ventilation (OR 2.06; 95% CI 1.75–2.43, p&amp;lt;0.0001), pneumonia (OR 1.76; 95% CI 1.37–2.28, p&amp;lt;0.0001), pneumothorax (OR 6.38; 95% CI 4.17–9.76, p&amp;lt;0.0001) and postoperative hemorrhage (OR 3.21; 95% CI 2.13–4.85, p&amp;lt;0.0001). On the contrary, SAVR was associated with decreased likelihood of subsequent cardiac conduction disorders (OR 0.63; 95% CI 0.51–0.79, p&amp;lt;0.0001) and pacemaker implantation (OR 0.69; 95% CI 0.49–0.98, p=0.037). SAVR was associated with an increased length of hospitalization (3.9 vs. 8.4 days, p&amp;lt;0.0001), with no difference in medical costs. Conclusion Inpatient mortality for TAVR and SAVR was similar in patients with atrial fibrillation and atrial flutter. TAVR was associated with a lower risk of inpatient complications, indicating greater suitability for high-risk patients. However, clinicians should be cognizant of the increased risk for cardiac conduction disorders after TAVR, necessitating pacemaker implantation. Funding Acknowledgement Type of funding sources: None. Characteristics of the matched cohortForest plot comparing outcomes

Twelve-months safety of valvosoft non-invasive ultrasound therapy (NIUT) in patients with severe symptomatic aortic valve stenosis: a first-in-human study

Abstract Background Despite overall favourable outcome of surgical and transcatheter aortic valve replacement (SAVR/TAVR) in patients with severe calcific aortic stenosis (CAS), not all patients are eligible for an invasive treatment1 because of too high predicted mortality and complications. Cardiawave© has developed a novel non-invasive ultrasound therapy (NIUT) device called Valvosoft to treat calcific aortic stenosis (CAS). Based on preclinical results2,3, a prospective first-in-human study was conducted in two centres in 10 patients in 2019 and a second one in 4 patients in 2020. All patients had symptomatic severe CAS and were not eligible for aortic valve replacement according to local heart teams. Methods Fourteen patients with severe symptomatic CAS not eligible for valve replacement were enrolled. Transthoracic therapeutic ultrasound was delivered by the Valvosoft transducer coupled with an echocardiographic phased-array probe for real-time monitoring. Clinical and echocardiographic evaluation were performed at baseline, discharge, 1-, 3-, 6- and 12-months follow-up. Additionally, the 4 patients of the second study had a brain-MRI performed before and after treatment to rule out silent cerebrovascular events. Results Patients were advanced in age (82.4±5.3 years) with severe comorbidities (57% with heart failure and 50% with coronary heart disease) and severe CAS. No adverse events occurred during the procedure other than isolated ventricular extrasystoles. No device- or procedure-related SAEs were reported at 1-month follow-up as adjudicated by the Clinical Event Committee (CEC). No death, stroke or TIAs or deterioration of neurological status were observed at 1-month follow-up for all 14 patients. During 12-months follow-up, 5 out of the 14 patients died (from 2 to 7 months after the procedure). All deaths were adjudicated as non-procedure related. The survival rate was higher (100%, 93%, 79%, 64% at 1-, 3-, 6- and 12-months) comparing to the natural evolution of the disease on an equivalent studied population4 (94%, 73%, 73%, 54% at 1, 3, 6 and 12-months). No abnormality was detected in any of the 4 patients who had a brain-MRI before and after treatment. Conclusions NIUT seemed feasible and safe and in a small first cohort of very frail patients with severe comorbidities suffering from severe symptomatic CAS. Brain-MRIs performed before and after treatment ruled out silent cerebrovascular events. The survival comparison of the studied population contrasted to the natural evolution of the disease suggests that NIUT is beneficial for these patients with no other medical option. Funding Acknowledgement Type of funding sources: Public grant(s) – EU funding. Main funding source(s): This study has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement 829492 and is supported by the French Government, managed by the National Research Agency (ANR) under the program “Investissements d'avenir” with the reference ANR-16-RHUS-0003 and ANR VALVOSOFT-17-CE19-0019-02.

Outcomes of transfemoral-transcatheter aortic valve replacement with Sapien-3 valve in liver cirrhosis patients

Abstract Background Little is known about the outcomes of liver cirrhosis patients with severe aortic stenosis (AS) who undergo transcatheter aortic valve replacement (TAVR). Methods We undertook a retrospective analysis of consecutive patients with severe symptomatic AS who underwent transfemoral-TAVR with Sapien-3 valve at our Clinic between April 2015 and December 2018, yielding 32 patients with liver cirrhosis on imaging including ultrasound and/or computed tomography. Their baseline characteristics, procedural and long-term outcomes after TAVR with the non-cirrhotic group were compared, along with their management strategies as per the hepatology team. Results Among 1028 patients, 32 were assigned to the cirrhosis, and 996 were assigned to the non-cirrhosis (control) group. Compared with the control group cirrhotic patients were slightly younger in age (74.5 vs 81.2 years), had a slightly higher BMI (31.3 vs 29.3), and had a higher incidence of prior history of myocardial infarction (38% vs 33%). Baseline variables including the history of smoking, hypertension, diabetes, and atrial fibrillation were comparable in both groups. Among cirrhotic patients (n=32), the most common etiologies were non-alcoholic steatohepatitis (NASH) (37.5%), Alcoholism (18.75%), and Hepatitis C (12.5%). The mean MELD-NA score was 11.8 and 67% of patients were Child PUGH Class A and 33% were Child PUGH Class B and all patients had a Child PUGH score of ≥5. 53% of patients (n=17) in the cirrhosis group were evaluated by Hepatology and 12.5% (n=4) were evaluated for a liver transplant but only 1 patient had a liver transplant post-TAVR. Compared with the control group cirrhotic patients had similar 1-year mortality (12% vs 12%, p=1), had a lower rate of 30-day new pacemaker post tavr (6% vs 9% p=0.85), had a higher rate of 1-year readmission for heart failure (12% vs 5% p=0.12) and similar 1-year major adverse cardiac and cerebrovascular event (MACCE) rate (15% vs 14% p=0.98) Conclusion Patients with severe AS undergoing TAVR with concomitant liver cirrhosis demonstrate comparable outcomes compared with their non- cirrhotic counterparts. NASH followed by alcoholic cirrhosis was found to be most common etiology. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2