TAVR Patients Research Articles

Predictors and Risk Calculator of Early Unplanned Hospital Readmission Following Contemporary Self-Expanding Transcatheter Aortic Valve Replacement from the STS/ACC TVT Registry

BackgroundPredictors of hospital readmissions and tools to predict readmissions after TAVR are scarce. Our objective was to identify predictors of early hospital readmission following TAVR in contemporary clinical practice and develop a risk calculator. MethodsPatients with a contemporary self-expanding TAVR between 2015 and 2017 in the STS/ACC/TVT Registry™ database were included. Patients were divided into a derivation and validation cohort (2:1). A risk score was calculated using the derivation cohort based on multivariable predictors of 30-day unplanned readmissions and applied to the validation cohort. ResultsA total of 10,345 TAVR patients at 350 centers were included. Unplanned 30-day hospital readmission was 9.2%. Patients with an early readmission had higher 30-day rates for mortality (2.3% vs. 0.8%, p ≪ 0.001), stroke (4.1% vs. 2.7% p = 0.009), major vascular complications (2.0% vs. 1.0%, p = 0.003) and new pacemaker implantation (25.7% vs. 18.6%, p ≪ 0.001). Multivariable predictors of 30-day readmission included diabetes, atrial fibrillation, advanced heart failure symptoms, home oxygen, decreased 5-m gait speed or the inability to walk, serum creatinine ≫1.6 mg/dL, index hospitalization length of stay ≫5 days, major vascular complication and ≥ moderate post-procedure aortic or mitral valve regurgitation. Based on these predictors, we stratified 30-day readmission risk into low-, moderate- and high-risk subsets. There was a 2.5× difference in readmission rates between the low- (5.8%) and high-risk subsets (14.6%). ConclusionWe stratified the risk of early hospital readmission after TAVR based on a simple scoring system. This score may improve discharge planning centered on the individual's readmission risk. SummaryUnplanned readmissions in the United States are prevalent and costly accounting for $41.3 billion in annual hospital payments and are associated with adverse clinical outcomes. We found that diabetes, atrial fibrillation, advanced heart failure symptoms, home oxygen, frailty, acute kidney injury, prolonged hospitalization, major vascular complications, and moderate or worse post-procedure aortic or mitral valve regurgitation predicted of 30-day readmission following self-expanding TAVR. This information may improve discharge planning centered on each patient's readmission risk.

Ten-year experience with transcatheter and surgical aortic valve replacement in Finland

Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade.Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017.Results: The annual number of treated patients increased three-fold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR (p = .011) and from 4.1% to 1.8% for SAVR (p = .048). Two-year survival improved from 71.4% to 83.9% for TAVR (p < .001) and from 87.2% to 91.6% for SAVR (p = .006). During the study period, a significant reduction in moderate-to-severe paravalvular regurgitation was observed among TAVR patients and a reduction of the rate of acute kidney injury was observed among both SAVR and TAVR patients. Similarly, the rate of red blood cell transfusion and severe bleeding decreased significantly among SAVR and TAVR patients. Hospital stay declined from 10.4 ± 8.4 to 3.7 ± 3.4 days after TAVR (p < .001) and from 9.0 ± 5.9 to 7.8 ± 5.1 days after SAVR (p < .001).Conclusions: In Finland, the introduction of TAVR has led to an increase in the invasive treatment of severe aortic stenosis, which was accompanied by improved early outcomes after both SAVR and TAVR.Trial registration: ClinicalTrials.gov identifier: NCT03385915.Key MessagesThis study demonstrated that the introduction of transcatheter aortic valve replacement has led to its widespread use as an invasive treatment for severe aortic stenosis.Early and 2-year survival after transcatheter and surgical aortic valve replacement has improved during past decade.Transcatheter aortic valve replacement has fulfilled its previously unmet clinical needs and has surpassed surgical aortic valve replacement as the most common invasive treatment for aortic stenosis.

Aortic Valve Replacement is Superior to Conservative Management in Low-Flow, Low-Gradient Aortic Stenosis independently of the presence of true severe stenosis

The survival benefit of surgical (SAVR) or transcatheter (TAVR) aortic valve replacement over conservative management (ConsRx) remains unclear in patients with low-flow, low-gradient (LFLG) aortic stenosis (AS). 476 LFLG AS patients (mean age 75 ± 10 yo, 71% males, 71% classical and 29% paradoxical LFLG, aortic valve area = 0.79 ± 0.15 cm 2 and mean gradient = 26 ± 7 mmHg) were prospectively recruited. Survival was studied using Kaplan-Meier curves. Inverse probability-of-treatment-weighting (IPW) was used to balance patients’ characteristics between AVR and ConsRx groups. Cox proportional hazards regression was used to corroborate the findings and study the benefit associated with of SAVR, TAVR (including transfemoral and transapical accesses). During a median follow up of 32 months, 220 patients died and less than 5% were lost to follow up. AVR markedly reduced the risk of death ( Fig. 1 , Panel A). Interestingly, the benefit extended also to patients with pseudosevere AS ( Fig. 1 , Panel B). These results were consistent with non-weighted univariate and multivariate analyses. TAVR patients had significantly more comorbidities compared to ConsRx or SAVR patients, including older age, previous myocardial infarction, diabetes, renal failure, and more depressed left ventricular function as assessed by NT-proBNP (all with P < 0.05); all of these factors independently associated with increased mortality. After adjustment for these comorbidities and AS severity, TAVR was associated with a lower risk of mortality compared to ConsRx (HR = 0.40; 95%CI [0.22–0.71], P = 0.002), and a similar risk compared to SAVR (HR = 0.83, 95%CI [0.46–1.51], P = 0.52). There was no interaction ( P = 0.93) between treatment and the pattern of LFLG (paradoxical vs classical) with mortality. SAVR and TAVR were associated with better survival compared to ConsRx in both classical and paradoxical LFLG AS patients. The benefit extended to those with pseudosevere AS.

Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk

BackgroundTranscatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk. ObjectivesThe aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria. MethodsIn the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD. ResultsAt 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89). ConclusionsIn the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173)

Insulin Requirements and Management in Trans-Catheter vs. Surgical Aortic Valve Replacement

Objective: Trans-catheter Aortic Valve Replacement/Aortic Valve Implantation (TAVR) are increasingly performed today. We compared insulin requirements between TAVR and Surgical Aortic Valve Replacement (SAVR) patients with and without diabetes mellitus (DM) to determine optimal glucose management strategies during the perioperative period (POP). Methods: Charts of consecutive patients undergoing aortic procedures were retrospectively reviewed for glucose ranges, insulin requirements and routes of insulin administration (subcutaneous vs. intravenous) for patients with and without DM to maintain BG < 180 mg/dl and compared between the surgical and trans-catheter groups. Results: Patients with SAVRs without DM and A1C < 6.5%, needed low dose insulin infusions and could be transitioned to subcutaneous insulin by 1.5 postoperative days. Patients with SAVR and DM had higher insulin requirements and were transitioned by 2.5 postoperative days. Patients with TAVR with no known DM did not need an insulin infusion in the perioperative period. Patients with TAVR with DM and an HbA1C < 6.5% did not require insulin infusions during the procedure but only postoperatively for short periods. Patients with DM and A1C ≥ 6.5%, required higher doses of insulin infusion and transitioned to subcutaneous insulin by postoperative day 1. Conclusions: TAVR patients have different insulin requirements compared to SAVRs (p < 0.05). This information helps build a glucose management algorithm for a procedure which is increasingly performed.

Oxidation-Reduction Potential in Patients undergoing Transcatheter or Surgical Aortic Valve Replacement.

Background Aortic valve stenosis has gained increasingly more importance due to its high prevalence in elderly people. More than two decades ago, transcatheter aortic valve replacement emerged for patients who were denied surgery, and its noninferiority has been demonstrated in numerous studies. Oxidative stress has generated great interest because of its sensitivity to cell damage and the possibility of offering early hints of clinical outcomes. The aim of the present study was to investigate whether there is a significant difference between transcatheter (TAVR) or surgical aortic valve replacement (SAVR) in terms of the changes in oxidation-reduction potential (ORP) and antioxidant capacity. Therefore, we investigated perioperative oxidative stress levels and their influence on clinical outcomes. Methods A total of 72 patients (50% TAVR versus 50% SAVR) were included in the present study. Static oxidation-reduction potential (sORP) and antioxidant capacity were measured using the RedoxSys™ Diagnostic System (Luoxis Diagnostics, USA) in serum samples drawn before and after surgery, as well as on the first postoperative day. In addition, clinical data were obtained to evaluate the clinical outcome of each case. Results TAVR patients had higher preoperative sORP levels compared to the SAVR patients and more severe comorbidities. Unlike the TAVR cohort, patients in the SAVR group showed a significant difference in sORP from the pre- to postoperative levels. Capacity demonstrated higher preoperative levels in the SAVR cohort and also a greater difference postoperatively compared to the TAVR cohort. Regression analysis revealed a significant correlation between pre- and postoperative capacity levels (r = -0.9931, p < 0.0001), providing a method of predicting postoperative capacity levels by knowing the preoperative levels. According to the multivariable analysis, both sORP and antioxidant capacity are dependent on time point, baseline value, and type of surgery, with the largest variations observed for time effect and surgery method. Conclusion A high preoperative sORP level correlated to more severe illness in the TAVR patients. As the TAVR patients did not show significant differences in their preoperative levels, we assume that there was a smaller production of oxidative agents during TAVR due to the less invasive nature of the procedure. Baseline values and development of antioxidant capacity values strengthen this hypothesis. The significant correlation of pre- and postoperative capacity levels might allow high risk patients to be detected more easily and might provide more adequate and individualized therapy preoperatively. This trial is registered with clinicaltrials.gov, identifier: NCT 02488876.

Anomalous Coronary Arteries in TAVR Patients: Anatomic Considerations for Pre-Procedural Planning

Anomalous coronary arteries are reported to occur in 0.2–2.3% of patients undergoing imaging or pathology studies 1 The condition is usually benign and mostly encountered incidentally during corona...

TAVR in Patients with a Low STS Score: A Cohort Study with a Mean Follow Up of 2 Years.

Partner 2 and SURTAVI trials (mean STS score of 5.8 and 4.5) support extending TAVR into the intermediate risk group. We present our results of TAVR in a group with mean STS score of 2.9 and 2 year follow up. This is a prospective cohort study of 46 consecutive patients undergoing TAVR between 2011 and 2016. All patients had severe symptomatic AS. Age, functional status, coronary disease, co-morbidity and imaging parameters were assessed. Patients were followed up for 12-60 months. 46 patients with a mean age of 75 years were enrolled. Mean EF 56%, mean MG 52 mm Hg and mean PG 87 mm Hg. The mean STS score was 2.9. Forty-two underwent transfemoral and 4 transaortic TAVR. Forty-five of 46 valves were implanted successfully. One patient had moderate perivalvular regurgitation (PVR). Post-procedure mean MG was 11 mm Hg. There was one procedure related stroke and one intraprocedural death. Five patients (10.8%) required a permanent pacemaker. 30-day mortality was 2 of 46 (4.3%). Mean follow up was 28 months. Mean MG at 2 years was 12 mm Hg. Late cardiac mortality occurred in 1 patient. TAVR in this group with a low STS score was successful with excellent valve performance. Although the STS score identifies intermediate and high risk patients, it does not account for the overall frailty and limited mobility of many elderly patients placing them at a higher surgical risk despite their low STS scores. A scoring system that captures all such factors is required. Finally, a large scale randomized trial with long term follow up determining the validity of TAVR in truly low risk individuals is necessary.

Caution: Predictors ahead

Radiation dose data can be used as a starting point to establish local TAVR reference levels. Cancer risk is of concern but is very low in the context of TAVR patients. Improvements in clinical radiation management will reduce both patient and staff risk for all procedures.

TCT-396 Association of Peripheral Artery Disease with In-hospital Outcomes after Endovascular Transcatheter Aortic Valve Replacement

Peripheral artery disease (PAD) has been associated with adverse outcomes in patients undergoing TAVR. The procedural (in-hospital) risk of adverse events has not been studied. We aimed to study the in-hospital outcomes of TAVR in patients with and without PAD using the National Inpatient Sample (

TCT-515 SAVR vs TAVR in Patients with Previous Myocardial Infarction: A Nationwide Propensity-Matched Analysis

TCT-515 SAVR vs TAVR in Patients with Previous Myocardial Infarction: A Nationwide Propensity-Matched Analysis

TCT-456 Association of Immediate Improvement in Renal function after Transcatheter Aortic Valve Replacement and Post-operative Outcomes in Patients with Renal Dysfunction

When untreated, Aortic stenosis (AS) patients with renal dysfunction report dismal prognosis. The study aims to investigate operative outcomes in renal dysfunction patients who had transcatheter aortic valve replacement. (TAVR) TAVR patients with ≥ moderately reduced renal function [estimated

TCT-714 Association of Statin and Mortality after Transcatheter Aortic Valve Replacement

Statins may reduce mortality after TAVR through prevention of atherosclerotic events or pleiotropic effects. However, the competing mortality risks in TAVR patients may dilute any positive effect of statins. We sought to understand the association of statin use with post-TAVR mortality. We included

TCT-514 Balloon-expandable Sapien 3 29mm versus self-expandable Evolut R 34mm in TAVR patients with a large annulus: Is there a difference in performance and risk of cerebral embolization?

TCT-514 Balloon-expandable Sapien 3 29mm versus self-expandable Evolut R 34mm in TAVR patients with a large annulus: Is there a difference in performance and risk of cerebral embolization?

Propensity-matched comparison of clinical outcomes after transaortic versus transfemoral aortic valve replacement

We aimed to compare the long-term outcomes of transaortic (TAo-AVR) and transfemoral (TF-AVR) transcatheter aortic valve replacement. Between January 2012 and December 2015, consecutive TAo-AVR and TF-AVR cases were compared using a propensity score-matching analysis. Primary endpoints were 30-day and one-year mortality; 644 TAVR patients were included (163 TAo-AVR and 481 TF-AVR). Peripheral artery disease (31.9% vs. 5%, p<0.001) and coronary artery disease (50.0% vs. 39.3%, p=0.009) were more frequent in TAo-AVR patients. The Society of Thoracic Surgeons scores were not different (6.9% vs. 6.5%, p=0.243). Propensity matching identified 124 well-matched patient pairs. Thirty-day and one-year mortality rates were similar in the overall population of TAo-AVR and TF-AVR patients (7.3% vs 7.6%, p=0.8 and 18.4% vs. 15.8%, p=0.6, respectively), and in the matched cohort (7.3% vs. 6.5%, p=0.8 and 15.3% vs. 16.1%, p=0.8, respectively). Transaortic access was associated with higher risk of new onset of atrial fibrillation (NOAF) (24.4% vs. 9.6%, p=0.012), life-threatening bleedings (6.5% vs. 0.8%, p=0.036) and transfusion (41% vs. 16.7%, p<0.001). No significant differences were observed between the respective 30-day and one-year mortality rates of TAo-AVR and TF-AVR patients. The transaortic approach thus constitutes a valid alternative to TF-AVR, but is associated with higher rates of NOAF, bleedings, and transfusion.

TCT-183 TAVR patients consenting to study participation are healthier than those who do not.

TCT-183 TAVR patients consenting to study participation are healthier than those who do not.

Ninety-Day Readmissions of Bundled Valve Patients: Implications for Healthcare Policy

Medicare's Bundle Payment for Care Improvement (BPCI) Model 2 groups reimbursement for valve surgery into 90-day episodes of care, which include operative costs, inpatient stay, physician fees, postacute care, and readmissions up to 90 days postprocedure. We analyzed our BPCI patients' 90-day outcomes to understand the late financial risks and implications of the bundle payment system for valve patients. All BPCI valve patients from October 2013 (start of risk-sharing phase) to December 2015 were included. Readmissions were categorized as early (≤30 days) or late (31-90 days). Data were collected from institutional databases as well as Medicare claims. Analysis included 376 BPCI valve patients: 202 open and 174 transcatheter aortic valves (TAVR). TAVR patients were older (83.6 vs 73.8 years; P = 0.001) and had higher Society of Thoracic Surgery predicted risk (7.1% vs 2.8%; P = 0.001). Overall, 18.6% of patients (70/376) had one-or-more 90-day readmission, and total claim was on average 51% greater for these patients. Overall readmissions were more common among TAVR patients (22.4% (39/174) vs 15.3% (31/202), P = 0.052) as was late readmission. TAVR patients had significantly higher late readmission claims, and early readmission was predictive of late readmission for TAVR patients only (P = 0.04). Bundled claims for a 90-day episode of care are significantly increased in patients with readmissions. TAVR patients represent a high-risk group for late readmission, possibly a reflection of their chronic disease processes. Being able to identify patients at highest risk for 90-day readmission and the associated claims will be valuable as we enter into risk-bearing episodes of care agreements with Medicare.

Transcatheter valvular interventions in 2017: some things old, some things new!

Transcatheter valvular interventions have changed the landscape of valvular therapies. We examine some studies on transcatheter valvular interventions published in the year 2017 to better understand their implications on clinical practice and future research. Findings from the SURTAVI study suggest TAVR to be a reasonable option in intermediate risk patients with aortic stenosis. Recent studies indicate that valve leaflet thrombosis is associated with poor outcomes. Data from the TVT registry on current transcatheter mitral valve repair are encouraging; alternative repair systems have been subjected to feasibility trials. TAVR for patients with bicuspid aortic valve stenosis appears to be improving. Cerebral embolic protection devices have shown promise but the population in whom they are most likely to provide benefit needs to be better defined. The year 2017 has seen significant advances in the field of transcatheter valvular interventions. Strong foundations have been laid for future studies that are likely to significantly impact clinical practice.

Cardiorespiratory Stability of Patients Undergoing Transcatheter Aortic Valve Replacement Is Not Improved During General Anesthesia Compared to Sedation: A Retrospective, Observational Study

ABSTRACTPurpose: To evaluate whether general anesthesia (GA) provides improved cardiorespiratory stability compared to sedation during TAVR.Methods: A retrospective analysis at a single center, university hospital. Patients undergoing TAVR were given either routine GA or deep sedation with dexmedetomidine for TAVR.Results: The superiority of GA versus deep sedation was evaluated statistically by testing if any of the following were lower in the GA patient group; the incidence of cardiorespiratory perturbations (hypotension, bradycardia, or hypoxemia), the amount of volume resuscitation (crystalloid, colloid, or allogeneic blood administration), or the doses of drugs needed to control blood pressure (epinephrine, norepinephrine, calcium, and nitroglycerine). A total of 206 TAVR patients were studied. Of these, 150 patients underwent TAVR via the transfemoral approach and were included for comparative analysis. In total 58 (39%) received sedation. Sedation patients were older than those who received GA. There were not less cardiorespiratory perturbations in the GA group. No less vasocactive agents were administered in the GA patients. Volume resuscitation was also not less in the patients receiving GA. All broad indices of stability were not lower in GA patients. Patients in the GA group were also more likely to receive a packed red blood cell transfusion. In all, 8 (13.8%) of the patients required conversion of sedation to GA. Patients who received GA were almost twice as likely to be transferred to the ICU intubated.Conclusion: Transfemoral TAVR patients who received GA did not have more cardiorespiratory stability compared to those receiving sedation.

RATES OF ANTICOAGULATION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH ATRIAL FIBRILLATION

Late strokes have been observed to occur in high rates post-transcatheter aortic valve replacement (TAVR). Atrial fibrillation (AF) is a common co-morbidity in TAVR patients, but anticoagulation is problematic due to age or frailty in this population. Our aim was to assess the quality of