Mortality In Aortic Valve Replacement Research Articles

Impact of aortic root surgery during transcatheter aortic valve explant

BackgroundTranscatheter aortic valve replacement (TAVR) explantation is currently the fastest-growing cardiac surgery procedure. Issues surrounding TAVR explantation and subsequent surgical aortic valve replacement (SAVR), specifically aortic root surgery, merit further investigation. MethodsA retrospective review of an institutional database identified cases of SAVR after TAVR, with or without concomitant aortic root operations, performed between January 1, 2014, and July 1, 2023, identifying 26 patients. Conventional statistical methods were used to compare groups. ResultsThe mean Society of Thoracic Surgeons predicted risk of mortality for aortic valve replacement was 11.1 ± 6.0% in our cohort. Eight of 26 patients (30.8%) had undergone prior cardiac surgery. Concomitant aortic root enlargement or replacement was required in 12 of the 26 patients (46.2%). The time from TAVR to removal was longer for those requiring root operations compared to those who did not (mean, 783 ± 908 days vs 492 ± 486 days; P = .046). There was a trend toward more frequent infective endocarditis in patients requiring root operations (46.2% [n = 5/12] vs 21.4% [n = 3/14]; P = .155). The 30-day mortality was 19.2% (n = 5/26), with an observed-to-expected ratio of 1.72. Mortality was not significantly different between the 2 groups. ConclusionsTAVR explant remains a high-risk procedure, although adding aortic root enlargement/replacement does not appear to amplify the short-term mortality risk when performed at an experienced institution. These results are important when considering lifetime management of aortic stenosis, particularly in low-risk patients likely to require multiple interventions.

Female underrepresentation and higher mortality in AVR remains: Part 2 - TAVR

Background: Aortic stenosis is a progressive and degenerative disease, which at some stage needs an aortic valve replacement (AVR). Despite an almost equal prevalence of aortic stenosis, female referral to AVR is lower and unexplained, although partly explained in the differences in risk and outcome. The introduction of transcatheter aortic valve replacement (TAVR) increased the treatment palette of especially of older and high-risk patients. It was suggested that lower female referral would likely change as primary result of TAVR showed survival in women than men.

Developing Hemodynamic Valve Deterioration and Mortality in Aortic Valve Replacement

BackgroundAs life span increases, in patients having a bioprosthetic valve, the development of hemodynamic valve deterioration (HVD) is an important concern. We evaluated the association of developing HVD to survival in patients undergoing surgical aortic valve replacement (SAVR). MethodsThe individuals undergoing isolated SAVR and serial echocardiography exams (interval >30 d) were included in this study. HVD was defined as mean pressure gradient ≥ 20 mmHg, mean pressure gradient ≥10 mmHg higher than in the baseline exam, or more than moderate regurgitation on Doppler echocardiography (moderate and severe grade). A time-dependent Cox proportional hazard model was used for this study. ResultsA total of 631 patients were included. The mean age was 71.8 ± 6.1 y old (female: 53.6%). HVD was found in 259 patients (41%) during echocardiographic follow-up (mean 3.3 ± 3.0 y). Patient-prosthetic mismatch was found in 174 patients. One hundred and twenty-six patients died during follow-up (median 62.1 mo, interquartile range 31.1-96.8). The development of HVD was an independent risk factor for death during follow-up (P = 0.038, hazard ratio 1.46, 95% confidential interval: 1.02-2.08). ConclusionsHVD was common after bioprosthetic SAVR during mid-term follow-up. Developing HVD, including moderate and severe grades, was associated with a poor survival rate compared with patients without HVD.

Left Ventricular Hypertrophy and Biomarkers of Cardiac Damage and Stress in Aortic Stenosis.

BackgroundLeft ventricular hypertrophy (LVH) is associated with increased mortality risk and rehospitalization after transcatheter aortic valve replacement among those with severe aortic stenosis. Whether cardiac troponin (cTnT) and NT‐proBNP (N‐terminal pro‐B‐type natriuretic peptide) risk stratify patients with aortic stenosis and without LVH is unknown.Methods and ResultsIn a multicenter prospective registry of 923 patients with severe aortic stenosis undergoing transcatheter aortic valve replacement, we included 674 with core‐laboratory‐measured LV mass index, cTnT, and NT‐proBNP. LVH was defined by sex‐specific guideline cut‐offs and elevated biomarker levels were based on age and sex cut‐offs. Adjusted Cox proportional hazards models evaluated associations between LVH and biomarkers and all‐cause death out to 5 years. Elevated cTnT and NT‐proBNP were present in 82% and 86% of patients with moderate/severe LVH, respectively, as compared with 66% and 69% of patients with no/mild LVH, respectively (P<0.001 for each). After adjustment, compared with no/mild LVH, moderate/severe LVH was associated with an increased hazard of mortality (adjusted hazard ratio [aHR], 1.34; 95% CI 1.01–1.77, P=0.043). cTnT and NT‐proBNP each risk stratified patients with moderate/severe LVH (P<0.05). In a model with both biomarkers and LVH included, elevated cTnT (aHR, 2.08; 95% CI 1.45–3.00, P<0.001) and elevated NT‐proBNP (aHR, 1.46; 95% CI 1.00–2.11, P=0.049) were each associated with increased mortality risk, whereas moderate/severe LVH was not (P=0.15).ConclusionsElevations in circulating cTnT and NT‐proBNP are more common as LVH becomes more pronounced but are also observed in those with no/minimal LVH. As measures of maladaptive remodeling and cardiac injury, cTnT and NT‐proBNP predict post‐transcatheter aortic valve replacement mortality better than LV mass index. These findings may have important implications for risk stratification and treatment of patients with aortic stenosis.

Mitral Valve Plasty During Correction of Combined Mitral-Aortic Valve Diseases

The aim. To study reconstructive operations on the mitral valve (MV) combined with aortic valve replacement (AVR) for combined mitral-aortic valve defects (CMAVD).&#x0D; Materials and methods. The study included 1690 patients with CMAVD who underwent surgical treatment at the National Amosov Institute of Cardiovascular Surgery of the National Academy of Medical Sciences of Ukraine for the period from 01/01/2006 to 01/01/2020. Of these, 429 (23.4%) patients underwent MV reconstruction with AVR.&#x0D; The following valve-sparing procedures were performed: – application of annuloplasty ring: 123 (28.7%); – MV suture annuloplasty: 137 (31.9%); – open mitral commissurotomy: 47 (11.0%); – open mitral commissurotomy + leaflet plication: 4 (0.9%); – application of autopericardial patch on the MV leaflet: 7 (1.6%); – alfieri procedure (MV bicuspidalization): 34 (7.9%); – mitral valve debridgment 12: (2.8%); – plasty with autopericardial patch: 18 (4.2%); – removal of vegetation from MV structures : 7 (1.6%); – resection of MV leaflets with addition of suture annuloplasty: 19 (4.4%); – resection of MV leaflets with addition of an annuloplasty ring: 21 (4.9%).&#x0D; Results. Fatal complications occurred in 4 cases due to heart failure (n = 2) and multiple organ failure (n = 2). Hospital mortality in AVR with MK plasticity MV plasty was 0.9%, which once again emphasizes the importance of traumatic intervention compared with combined mitral-aortic prosthetics, where mortality is 3 times higher. It decreased from 2.9% (2006–2012, n = 128) to 0.3% (2013–2019, n = 301), which indicates the effectiveness of the method with a significant increase in the number of operated patients.&#x0D; After correction, MV regurgitation decreased from +2.4 ± 0.3 to +0.4 ± 0.03. Coaptation of the sash Mk MV leaflets after correction was 7.4 ± 0.6 mm.&#x0D; At the hospital stage there was a decrease in the diastolic peak gradient on the MV from 19.4 ± 4.8 mm Hg to 6.4 ± 0.8 mm Hg. In the remote period, 82.6% of the discharged patients (n = 351) in the period of were followed for 9.3 ± 2.4 years. Better indicators were noted in group of patients with functional class III than those with functional class IV (p &lt;0.05). Fatal outcomes due to thromboembolic complications (n = 29) were caused by the presence of a mechanical aortic prosthesis and partial non-compliance with the protocol of anticoagulant therapy. Unsatisfactory result in the group with changes in the MV was due to the activity of the rheumatic process and progressive heart failure with prolonged atrial fibrillation (n = 37).&#x0D; The etiology of the defect affected the long-term outcome. The activity of the rheumatic process in patients with functional class IV determined changes in the MV leaflets in the long term and worsened the result.&#x0D; MV regurgitation increased from +0.08 ± 0.03 (5 years after surgery) to +1.2 ± 0.3 (10 years after surgery). In the long term there was an increase in the diastolic peak gradient on the MV from 9.4 ± 0.4 mm Hg (5 years after surgery) to 13.4 ± 3.2 mm Hg (10 years after surgery). MV replacement was performed in 4 patients 6, 9, 10, 11 years after surgery.&#x0D; Conclusions. Given the available clinical experience, it is advisable to recommend reconstructive interventions on the MV to correct CMAVD and improve the level of survival and stability of good results.

Aortic valve replacement in elderly and advanced age patients: analysis of preoperative risk factors

Background.Despite an increase in the number of surgeries performed in elderly patients, conventional aortic valve replacement is associated with high postoperative mortality in comparison to young adults. The risk of surgical intervention in elderly patients is associated not only with the age, but also with the presence of a large number of concomitant diseases.Aim.To evaluate the immediate results of conventional aortic valve replacement and assess the impact of preoperative risk factors on surgical treatment.Methods.A retrospective analysis of the results of aortic valve replacement was performed in patients older than 65 years operated in the period from 2011 to 2015 (a total of 253 cases). The mean age of the patients was 70.4±4.14 years. The mean EuroSCORE was 6.09±4.45%. The impact of more than 30 preoperative risk factors on the in-hospital mortality and development of postoperative complications has been analyzed.Results.The overall in-hospital mortality was 10.3%. In-hospital mortality of isolated aortic valve replacement was 4.8%. In-hospital mortality of aortic valve replacement combined with coronary artery bypass grafting was 8.8%. High postoperative mortality rate was reliably associated with the urgency of surgery, a positive history of stroke, obesity, chronic renal failure, chronic obstructive pulmonary disease, pulmonary hypertension, a positive history of malignant neoplasms, polyvascular disease, pre-operative atrial fibrillation, IV class NYHA, post-stenotic aortic dilation, severe calcification, small aortic root.Conclusion.Aortic valve replacement in elderly and advanced age patients have relatively similar results to those of the younger patients. High risk of surgery in advanced age patients is mainly associated with the presence of concomitant extracardiac pathology and preoperative risk factors.

Previous Cardiac Surgery: a Predictor of Mortality in Aortic Valve Replacement?

IntroductionPrevious cardiac surgery (PCS) is a risk factor for operative mortality in pa-tients undergoing reoperative aortic valve replacement (AVR) and may be influenced by the volume of patients in each center. The aim of this study was to evaluate the results of AVR in patients with previous cardiac surgery in a low volume cardiac center (400 cases per year).MethodsBetween January 2006 and December 2016, 854 patients underwent isolated AVR surgery at our institution. Of these, 70 had PCS. Propensity match (PM) was per-formed to balance basal covariates. Operative mortality and survival were the primary outcomes.ResultsThe PCS and first-time surgery (FTS) groups had significant differences in base-line characteristics (PCS group were older, higher incidence of hypertension, endocarditis, NYHA III/IV, lower LVEF, higher creatinine and higher EuroSCORE). In the unmatched population, patients with PCS had higher operative mortality (17.1% vs. 4.6%, P=0.001). In the PM groups, this difference was not significant (12.5% and 3.6%, P=0.08). The only independent predictors for operative mortality found in the PCS group were age and fe-male gender. Age and diabetes were identified as the only independent predictors of sur-vival.ConclusionPCS was not a predictor for operative mortality nor long-term survival in pa-tients undergoing isolated aortic valve replacement.

THE DIFFERENTIAL IMPACT AND LONG-TERM EFFECTS OF MECHANICAL OR BIOLOGICAL VALVE REPLACEMENTS IN MEDICARE PATIENTS ON HEMODIALYSIS

Hemodialysis patients have increased risk for valve replacement and have decreased long-term survival. Debate is ongoing regarding biologic versus mechanical valve replacements in hemodialysis patients. This study sought to investigate the differential impact of biological and mechanical valves on aortic valve replacement (AVR) and mitral valve replacement (MVR) Medicare patients on hemodialysis. Medicare Provider Analysis and Review (MEDPAR) Files were used to identify all hemodialysis patients undergoing aortic valve replacement (AVR) and mitral valve replacement (MVR) between January 2008 and December 2013. Patients were separated based on the use of either bioprosthetic or mechanical valves. Comorbidities present on implantation were assigned using ICD-9 codes and a modified Elixhauser comorbidity index. Propensity matching was used to analyze bioprosthetic and mechanical valves in AVR and MVR patients. Univariate and multivariate models were used to examine survival; all other analyses were conducted using pearson’s chi-square or independent-sample t tests. A total of 11,850 patients were initially included in the study (8775 AVR and 4298 MVR). In propensity matched samples, Kaplan Meier survival analysis indicates that survival was significantly higher in mechanical AVR patients compared to prosthetic AVR patients, although similar between mechanical and prosthetic MVR patients (Figure 1). Overall AVR mortality was significantly lower than MVR mortality (58% vs. 66%, p < 0.01). Bioprosthetic AVR patients were more likely to require redo operations compared to mechanical AVR (2% vs. 1%, p < 0.01). Multivariate logistic regression models indicate that mechanical valves do not provide a protective effect for 30 day mortality in either AVR or MVR patients. Cox proportional models indicate that mechanical valves may provide some protective effect in long-term mortality for AVR patients (HR 0.94 CI 0.88 - 1.02, p=0.05). These results indicate that there is no significant difference in survival or redo operation between bioprosthetic and mechanical valves in MVR patients. However, bioprosthetic AVR patients are significantly more at risk for death or redo operations. It is possible that mechanical AVR offers a long-term survival benefit to older patients on hemodialysis undergoing valve replacement surgery.

Trends and Outcomes of Aortic Valve Replacement in Patients With End-Stage Renal Disease on Hemodialysis

Hemodialysis (HD) patients with aortic stenosis are less likely to undergo aortic valve replacement (AVR) due to their excess perioperative mortality. We aimed to evaluate contemporary utilization and outcomes of combined and isolated AVR in HD patients. The Nationwide Inpatient Sample was used to identify 142,046 patients who underwent AVR in 2005 to 2014, of whom 2,264 (1.6%) were on HD. Crude and adjusted in-hospital outcomes and costs were assessed in unmatched and propensity-matched cohorts of HD and non-HD patients, respectively. The utilization of AVR in HD patients increased significantly (p = 0.047), with a significant decrease in mortality (p = 0.013). Compared with patients not on HD, crude in-hospital mortality in HD patients was twice higher (11.8% vs 6.2%, p <0.0001). HD patients had more blood transfusion and a trend toward more strokes. Lengths of stay and hospital charges, and rates of nonhome discharges were also higher in the HD group. In the propensity-matched cohorts of HD versus non-HD patients, in-hospital mortality rates after AVR remained twofold higher in the HD group (8.1% vs 3.9%, p <0.001). Rates of blood transfusion, cardiac tamponade, length of stay, hospital charges, and nonhome discharges were also higher in HD patients. In conclusion, AVR utilization in HD patients increased and its associated mortality decreased over the last decade. However, AVR mortality in HD patients remained twofold higher compared with non-HD patients. Also, AVR in HD patients was associated with higher cost, longer hospitalizations, and more frequent nonhome discharges.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

Temporal trends in the incidence and prognosis of aortic stenosis: a nationwide study of the Swedish population.

The aging of Western populations is expected to result in increasing occurrence of aortic stenosis (AS), but data are limited. Recent studies have reported declining incidence and mortality for other major heart diseases. We aimed to study temporal trends in the incidence and prognosis for AS in Sweden. With the use of nationwide registers, all adult patients in the Swedish population with a first diagnosis of AS, heart failure, acute myocardial infarction, and aortic valve replacement for AS between 1989 and 2009 were identified and followed up until the end of 2010 for all-cause and cardiovascular-related mortality. The age-adjusted incidence of AS in Sweden declined from 15.0 to 11.4 in men and 9.8 to 7.1 in women per 100 000 between 1989 to 1991 and 2007 to 2009, and the median age at diagnosis increased by 4 years for both men and women. The age- and sex-adjusted relative risk of 1- and 3-year mortality in 2007 to 2009 was 0.58 (95% confidence interval, 0.53-0.63) and 0.60 (95% confidence interval, 0.56-0.65), respectively, compared with 1989 to 1991. Similar improvements were observed for heart failure and acute myocardial infarction. Findings were broadly consistent across subgroups. Postoperative mortality at 30 days declined despite increased median age at diagnosis. Incidence and mortality rates in AS in Sweden declined between 1989 and 2009 to an extent similar to that observed for heart failure and acute myocardial infarction. These findings could suggest that improved risk factor control and cardiovascular therapy, combined with increased use of aortic valve replacement in the elderly and reduced perioperative mortality in aortic valve replacement, have translated into favorable effects for AS.

Predictors of the Size of Prosthetic Aortic Valve and In-Hospital Mortality in Aortic Valve Replacement

Purpose:We hypothesized that gender, age, aortic root dimension, blood group and Left Ventricular End Diastolic and Systolic Diameters may have a significant correlation with the size of mechanical valve used.Methods:We included 48 patients retrospectively who had been operated at a single tertiary hospital. All patients with aortic stenosis or regurgitation were included in the study. Patients who had undergone previous cardiac surgery or concomitant surgical procedures, such as coronary artery bypass grafting, were excluded from the study.Results:The median size of the valves used in males (23mm) and females (21mm) were significantly different (P = 0.001). Size of the valve used was significantly associated with Left Ventricular End Systolic Diameter (LVESD) (r = 0.327, P = 0.007) and aortic root dimension (r = 0.526, P < 0.001). Moreover, significantly higher values of LVESD were observed in the expired patients (P = 0.023).Conclusion:This study shows that aortic root dimension and gender may be important predictors for the size of the prosthetic aortic valve used in aortic valve replacement. Our study also concludes that LVESD has significant relationship with in-hospital mortality. However, more long term clinical trials should be conducted to confirm these relationships.

EComment. Role of global longitudinal strain for evaluation of asymptomatic severe aortic stenosis

Wang et al. [1] elegantly summarise the value of strain imaging in patients with aortic stenosis. The management of patients with asymptomatic severe aortic stenosis (AS) also represents an important clinical dilemma. The reported risk of sudden death whilst adopting a 'watch and wait' policy for symptoms is relatively low (<1% per annum); however in real world clinical practice the close follow-up of patients in published series is often not adhered to [2]. Aortic valve replacement has been advocated as an intervention in these patients which may reduce long-term mortality. Interpretation of these studies requires caution as mortality for aortic valve replacement reported in this series is far lower than the overall 3-4% risk reported from the Society of Thoracic Surgeons (STS) database [2]. It is clear that a better means of risk stratification of patients with asymptomatic severe AS is required. In patients with asymptomatic severe AS a reduction in left ventricular ejection fraction <50% is associated with a poor prognosis. Indeed the European Society of Cardiology and European Association for Cardio-Thoracic Surgery guidelines grade this as a Class I indication for aortic valve replacement [3]. Left ventricular ejection fraction is an imperfect marker of left ventricular systolic function. Myocardial deformation (strain) is a more sensitive marker of contractile function. In a study of 79 patients with asymptomatic severe AS and preserved ejection fraction, a global longitudinal strain of <15% was an independent predictor of mortality adding incremental prognostic value to other markers of risk i.e aortic valve calcification, valvulo-arterial impedance and STS risk score [4]. Furthermore, reduced preoperative global longitudinal strain in patients with preserved ejection fraction has been shown to predict cardiac mortality and morbidity post aortic valve replacement [5]. In summary, myocardial deformation imaging is able to add incremental prognostic data for evaluation of patients with asymptomatic severe AS and preserved ejection fraction. Conflict of interest: none declared.

Aortic Valve Replacement with and without Coronary Artery Bypass Graft Surgery in Octogenarians: Is It Safe and Feasible?

Introduction: Octogenarians are often denied complex surgical intervention. We evaluated the rationality of this bias by comparing the outcomes of octogenarians undergoing aortic valve replacement (AVR) with or without coronary artery bypass grafting (CABG), to those of younger patients. Methods: Data on 476 patients (≥80 years) who underwent AVR or AVR/CABG were compared to the Society of Thoracic Surgeons (STS) database. Results: One hundred and seventeen octogenarians underwent AVR and 263 underwent AVR/CABG. Preoperative comorbidity rates were similar between these 2 respective groups, except for diabetes mellitus (18.8 vs. 30.4%, p = 0.02), previous cardiac stent placement (5.1 vs. 17.9%, p = 0.0006) and prior CABG (8.5 vs. 0.8%, p = 0.0002) and mortality did not differ significantly (5.1 vs. 7.6%, p = 0.51). Multivariate analysis identified preoperative chronic renal failure [odds ratio (OR) = 0.09, p < 0.048], postoperative arrhythmia (OR = 0.29, p < 0.022), sepsis (OR = 37.38, p < 0.000), pneumonia (OR = 8.29, p < 0.038) and renal failure (OR = 10.16, p < 0.000) with increased rates of inhospital mortality in AVR alone and AVR/CABG. Conclusion: AVR alone or AVR/CABG can be safely performed in patients ≥80 years with acceptable morbidity/mortality rates. An age of ≥80 years is not an independent risk factor predictive of increased inhospital mortality.

Comparison of Risk Scores to Estimate Early Mortality in Aortic Valve Replacement for Aortic Stenosis

Comparison of Risk Scores to Estimate Early Mortality in Aortic Valve Replacement for Aortic Stenosis

Optimal pain management after aortic valve implantation: an opportunity to improve outcomes after transapical access in the future?

Ten years after transcatheter aortic valve implantation (TAVI) was pioneered by Alain Cribier in 2002, it has been accepted as an alternative treatment for aortic stenosis. The PARTNER–US trial, in...

Coronary Artery Disease and Aortic Stenosis in the Transcatheter Aortic Valve Replacement Era

Significant coronary artery disease (CAD) is present in up to 50% of patients with symptomatic aortic stenosis (AS). Although numerous databases have shown that the addition of bypass grafting to an aortic valve replacement (AVR) nearly doubles the mortality, surgical series have shown that leaving significant coronary stenosis untreated increases AVR mortality.1–4 Thus, the standard of care for this population has been concomitant coronary artery bypass grafting along with surgical aortic valve replacement. Article see p 1005 Historically, the role of percutaneous coronary intervention (PCI) in the setting of severe AS has been limited and mainly directed to patients with acute coronary syndrome. However, PCI has been occasionally used in treating those patients in whom the risk of surgical AVR is prohibitive in attempts to palliate symptoms or to differentiate coronary from valvular syndromes. Recently, several new indications for PCI in the setting of AS have been proposed: in the context of hybrid procedures using PCI with AVR and in patients undergoing transcatheter aortic valve replacement (TAVR). Several groups have been investigating the role of hybrid procedures for the treatment of concomitant CAD and AS. Percutaneous coronary intervention either immediately preceding or simultaneously with surgery has been shown in limited series to be safe.5 Admittedly, there may be a strong publication bias favoring studies with superior outcomes, and larger studies are underway. The goal of hybrid procedures is to reduce a higher-risk coronary artery bypass grafting (CABG)/AVR to 2 potentially lower-risk and less morbid procedures. There are at least 2 important considerations raised by this concept. First, can PCI be performed safely in the setting of AS, and if so what is the best timing for it? Second, what is the impact of the necessary dual antiplatelet therapy on bleeding with surgery? There are …

Markov Model for Selection of Aortic Valve Replacement Versus Transcatheter Aortic Valve Implantation (Without Replacement) in High-Risk Patients

Comparisons between transcatheter aortic valve implantation without replacement (TAVI) and tissue aortic valve replacement (AVR) in clinical trials might not reflect the outcomes in standard clinical practice. This could have important implications for the relative cost-effectiveness of these alternatives for management of severe aortic stenosis in high-risk patients for whom surgery is an option. The mean and variance of risks, transition probabilities, utilities, and cost of TAVI, AVR, and medical management derived from observational studies were entered into a Markov model that examined the progression of patients between relevant health states. The outcomes and cost were derived from 10,000 simulations. Sensitivity analyses were based on variations in the likelihood of mortality, stroke, and other commonly observed outcomes. Both TAVI and AVR were cost-effective compared to medical management. In the reference case (age 80 years, the perioperative TAVI and AVR mortality was 6.9% vs 9.8%, and annual mortality was 21% vs 24%), the utility of TAVI was greater than that of AVR (1.78 vs 1.72 quality-adjusted life years) and the lifetime cost of TAVI exceeded that of AVR ($59,503 vs $56,339). The incremental cost-effectiveness ratio was $52,773/quality-adjusted life years. Threshold analyses showed that variation in the probabilities of perioperative and annual mortality after AVR and after TAVI and annual stroke after TAVI were important determinants of the favored strategy. Sensitivity analyses defined the thresholds at which TAVI or AVR was the preferred strategy with regard to health outcomes and cost. In conclusion, TAVI satisfies current metrics of cost-effectiveness relative to AVR and might provide net health benefits at acceptable cost for selected high-risk patients among whom AVR is the current procedure of choice.

Abstract 9757: Transcatheter Valve Replacement is a Cost-Effective Alternative to Conventional Surgery in Selected High-Risk Patients

Background: Transfemoral transcatheter aortic valve replacement (TAVR) is cost-effective for management of severe aortic stenosis (AS) in patients with unacceptable risk for aortic valve replacement (AVR). However, the relative cost-effectiveness of TAVR and tissue AVR is ill-defined in high-risk patients where surgery is an option. We developed a Markov model to inform the choice between transfemoral TAVR and AVR in high-risk patients. Methods: A Markov model was developed to examine the progression of patients between health states, defined as peri- and post-procedural, post-complication, and death. The mean and variance of risks, transition probabilities, utilities and cost of TAVR and AVR were derived from meta-analysis of relevant registries, studies and trials. Outcome and cost were derived from 10,000 simulations. Sensitivity analyses were based on the likelihood of mortality, stroke, and other commonly observed outcomes. Further analyses evaluated situations thought to favor tissue AVR or TAVR. Results: In the reference case (age 80, peri-operative mortality of transfemoral TAVR and AVR 5.8 vs 9.1%, annual mortality 22.2 vs 22.5%), the utility of TAVR was greater than AVR (1.71 vs 1.64 QALY). As the cost of TAVR was greater than AVR ($26,176 vs $19,361), the incremental cost-effectiveness ratio (ICER) was $97,357/QALY. In sensitivity analyses, variations in stroke, peri-operative and annual mortality are the main drivers of variation in health outcomes. The current risk profile of transfemoral TAVR offered net health benefits when peri-operative AVR mortality was &gt;5.2%, or stroke post-TAVR was &lt;11.3% (Figure). In a scenario analysis based only on operable PARTNER patients (Cohort A), QALYs for TAVR and AVR were 1.69 and 1.63, with an ICER of $70,633/QALY. Conclusion: TAVR may provide net health benefits at acceptable cost in selected high-risk patients among whom AVR is the current procedure of choice.

Minimally Invasive Valve Surgery With Antegrade Perfusion Strategy Is Not Associated With Increased Neurologic Complications

A Society of Thoracic Surgeons' publication recently associated "minimally invasive" approaches with increased neurologic complications; this proposed association was questionable due to imprecise definitions. To critically reevaluate this issue, we reviewed a large minimally invasive valve experience with robust definitions. From November 1995 to January 2007, 3,180 isolated, non-reoperative valve operations were performed; 1,452 (45.7%) were aortic replacements and 1,728 (54.3%) were mitral valve procedures. Surgical approach was standard sternotomy (28%) or minimally invasive technique (72%). Antegrade arterial perfusion was used in 2,646 (83.2%) patients and retrograde perfusion in 534 (16.8%). Aortic clamping was direct in 83.4%, with endoclamp in 16.4% and no clamp in 0.2%. Patients were prospectively followed in a proprietary database and the New York State Cardiac Surgery Reporting System (mandatory, government audited). A neurologic event was defined as a permanent deficit, a transient deficit greater than 24 hours, or a new lesion on cerebral imaging. Hospital mortality for aortic valve replacement was 4.0% (sternotomy [5.1%] versus minimally invasive [3.4%] p = 0.13); for mitral procedures it was 2.4% (sternotomy [4.8%] versus minimally invasive [1.8%] p = 0.001). Multivariate analysis revealed that age, female gender, renal disease, ejection fraction less than 0.30, chronic obstructive pulmonary disease, and emergent operation were risk factors for mortality. Stroke occurred in 71 patients (2.2%) (sternotomy [2.1%] versus minimally invasive [2.3%] p = 0.82). Multivariate analysis of neurologic events revealed that cerebrovascular disease, emergency procedure, no-clamp, and retrograde perfusion were risk factors. In patients 50 years old or younger (n = 662), retrograde perfusion had no significant impact on neurologic events (1.6% vs 1.1%, p = 0.57). A minimally invasive approach with antegrade perfusion does not result in increased neurologic complications. Retrograde perfusion, however, is associated with increased neurologic risk in older patients.