Repeat Transcatheter Aortic Valve Replacement Research Articles

TRANSCATHETER AORTIC VALVE REPLACEMENT: FROM IDEA TO IMPLEMENTATION

HighlightsTranscatheter aortic valve replacement is an innovative trend in modern cardiovascular surgery. This minimally invasive image-guided endovascular technology is becoming more and more safe, nowadays it can involve a minimalistic approach in which the aortic valve replacement is performed without incisions, anesthesia and cardiopulmonary bypass - patients are conscious and spontaneously breathing. The article describes a paradigm shift in modern cardiology, in which the concept of treating patients with degenerative aortic valve stenosis has changed over the 20 years of existence of the transcatheter replacement, starting as a method used only in small number of extremely high-risk patients unsuitable for cardiac surgery and now being the most prevalent treatment modality in patients at intermediate and even low surgical risk. The main clinical and technical principles of transcatheter aortic valve replacement, as well as the prospects for the development of this technique, are highlighted. Abstract Transcatheter aortic valve replacement technique was first implemented about 20 years ago, in April 2002. A quarter of a century ago, specialists involved in image-guided surgery would have never believed that they would perform transcatheter interventions on heart valves. Transcatheter interventions are an alternative to open-heart surgery for acquired heart disease. Transcatheter heart valve replacement or repeat transcatheter aortic valve replacement, which do not require incisions, cardiopulmonary bypass, and in some cases general anesthesia, to this day continue to be perceived as revolutionary and breakthrough, saving the lives of many patients. The article presents the main milestones in the development of image-guided endovascular surgery and transcatheter aortic valve replacement technique, the number of which in the United States and several European countries increases by 10–15% annually, reaching hundreds of thousands per year. The etiology and pathophysiology of aortic stenosis, the technique of transcatheter aortic valve replacement and the outcome of this promising minimally invasive procedure are presented.

Feasibility of Redo-Transcatheter Aortic Valve Replacement in Sapien Valves Based on In Vivo Computed Tomography Assessment.

Our aim was to assess the feasibility of repeat transcatheter aortic valve (TAV) replacement for degenerated Sapien3 (S3) prostheses by simulating subsequent implantation of S3 or Evolut, using in vivo computed tomography-based sizing and the impact on coronary and patient-prosthesis mismatch risks. Computed tomography scans from 356 patients with prior S3 TAV replacement implantation were analyzed. The in vivo sizing for second TAV based on averaged area of 3 levels of outflow, mid (narrowest) and inflow, was compared with in vitro recommendations, that is, same size as index S3 for second S3 and 1 size larger for Evolut. Risks of coronary obstruction and patient-prosthesis mismatch were determined by valve-to-aorta distance and estimated effective orifice area, respectively. Overall, the majority of patients (n=328; 92.1%) had underexpanded index S3 with an expansion area of 94% (91%-97%), leading to significant differences in size selection of the second TAV between in vivo and in vitro sizing strategies. Expansion area <89% served as a threshold, resulting in 1 size smaller than the in vitro recommendations were selected in 45 patients (13%) for S3-in-S3 and 13 (4%) for Evolut-in-S3, while the remaining patients followed in vitro recommendations (P<0.01, in vivo versus in vitro sizing). Overall, 57% of total patients for S3-in-S3 simulation and 60% for Evolut-in-S3 were considered low risk for coronary complications. Deep index S3 implantation (odds ratio, 0.76 [interquartile range, 0.67-0.87]; P<0.001) and selecting Evolut as the second TAV (11% risk reduction in intermediate- or high-risk patients) reduced coronary risk. Estimated moderate or severe patient-prosthesis mismatch risk was 21% for S3-in-S3 and 1% for Evolut-in-S3, assuming optimal expansion of the second TAV. Redo-TAV replacement with S3-in-S3 and Evolut-in-S3 could be feasible with low risk to coronaries in ≈60% of patients, while the remaining 40% will be at intermediate or high risk. The feasibility of redo-TAV replacement is influenced by sizing strategy, type of second TAV, native annular anatomy, and implant depth.

Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study

With increasing numbers of patients undergoing transcatheter aortic valve replacement (TAVR), data on management of failed TAVR, including repeat TAVR procedure, are needed. The aim of this study was to assess the safety and efficacy of redo-TAVR in a national registry. This study included all consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from Nov 9, 2011, to Dec 30, 2022 who underwent TAVR with balloon-expandable valves in failed transcatheter heart valves (redo-TAVR) or native aortic valves (native-TAVR). Procedural, echocardiographic, and clinical outcomes were compared between redo-TAVR and native-TAVR cohorts using propensity score matching. Among 350 591 patients (1320 redo-TAVR; 349 271 native-TAVR), 1320 propensity-matched pairs of patients undergoing redo-TAVR and native-TAVR were analysed (redo-TAVR cohort: mean age 78 years [SD 9]; 559 [42·3%] of 1320 female, 761 [57·7%] male; mean predicted surgical risk of 30-day mortality 8·1%). The rates of procedural complications of redo-TAVR were low (coronary compression or obstruction: four [0·3%] of 1320; intraprocedural death: eight [0·6%] of 1320; conversion to open heart surgery: six [0·5%] of 1319) and similar to native-TAVR. There was no significant difference between redo-TAVR and native-TAVR populations in death at 30 days (4·7% vs 4·0%, p=0·36) or 1 year (17·5% vs 19·0%, p=0·57), and stroke at 30 days (2·0% vs 1·9%, p=0·84) or 1 year (3·2% vs 3·5%, p=0·80). Redo-TAVR reduced aortic valve gradients at 1 year, although they were higher in the redo-TAVR group compared with the native-TAVR group (15 mm Hg vs 12 mm Hg; p<0·0001). Moderate or severe aortic regurgitation rates were similar between redo-TAVR and native-TAVR groups at 1 year (1·8% vs 3·3%, p=0·18). Death or stroke after redo-TAVR were not significantly affected by the timing of redo-TAVR (before or after 1 year of index TAVR), or by index transcatheter valve type (balloon-expandable or non-balloon-expandable). Redo-TAVR with balloon-expandable valves effectively treated dysfunction of the index TAVR procedure with low procedural complication rates, and death and stroke rates similar to those in patients with a similar clinical profile and predicted risk undergoing TAVR for native aortic valve stenosis. Redo-TAVR with balloon-expandable valves might be a reasonable treatment for failed TAVR in selected patients. Edwards Lifesciences.

311 Mental Illness and the Development of Postoperative Atrial Fibrillation in Transcatheter Aortic Valve Replacement Patients: Trends over Time

OBJECTIVES/GOALS: The purpose of this retrospective cohort study was to evaluate the impact of mental illness on first-time transcatheter aortic valve replacement (TAVR) and repeat TAVR (viv-AVR) outcomes including postoperative atrial fibrillation (POAF/AFL), as well as trends over time. METHODS/STUDY POPULATION: Using de-identified data reports from the New York Statewide Planning and Research Cooperative System (SPARCS) database from 2005-2018, multivariate logistics models were used to predict endpoints including POAF, the Society of Cardiothoracic surgeon (STS) endpoint (MM), and 30-day readmission (READMIT) in patients with and without mental illness. The TAVR procedure was approved for high-risk patients after 2012, and intermediate-risk patients after 2016, indicting a need to analyze the two populations separately. Multivariate analysis was only conducted on the first-time TAVR patients because of the small n in the viv-TAVR population. RESULTS/ANTICIPATED RESULTS: After 2012, 13.05% (1,810/13,870) of patients undergoing TAVR and 20.83% (15/72) undergoing viv-TAVR were diagnosed with a mental illness before the procedure. After 2016, 15.59% (1,485/9,524) TAVR patients and 20.00% (11/55) viv-TAVR patients had a preoperative diagnosis of mental illness. Multivariate analysis showed that mentally ill patients did not have significant differences in rates of POAF, 30-day readmission, and 30-day composite outcomes when compared to patients without mental illnesses following TAVR procedures after 2012 and 2016. Patients with POAF after both 2012 and 2016 were significantly less likely to be mentally ill, Black, and Hispanic. DISCUSSION/SIGNIFICANCE: Of the mentally ill patients who underwent TAVR, there was no significant difference in short-term outcomes after 2012 vs. 2016, compared to patients without mental illnesses. The small number of mentally ill patients undergoing TAVR may point to provider bias as a contributor to this high selectivity, and further evaluation would be of clinical use.

Coronary access after repeat transcatheter aortic valve replacement in patients of small body size: A simulation study

BackgroundCoronary artery access after repeat transcatheter aortic valve replacement (TAV-in-TAV) is reportedly more difficult because leaflet displacement of the first transcatheter heart valve (THV) impairs coronary cannulation; however, its effects in small patients are unknown. This study aimed to simulate coronary accessibility after TAV-in-TAV in patients of small body size. MethodsWe retrospectively analyzed computed tomography scans after initial THV implantation and classified patients by THV and coronary artery location, valve-to-aorta distance, and valve-to-coronary distance. Risks were compared between the SAPIEN and CoreValve/Evolut series, among THV generations, and between bicuspid and tricuspid aortic valves in the CoreValve/Evolut series. ResultsA total of 254 patients (SAPIEN series, n = 164; CoreValve/Evolut series, n = 90) were enrolled. The average body surface area of the patients was 1.44 m2. Patients were classified as “feasible” (26%), “theoretically feasible with low risk” (19.7%), “theoretically feasible with high risk” (8.7%), or “unfeasible” (45.8%). The “unfeasible” rate was significantly higher in the CoreValve/Evolut series than in the SAPIEN series (78.9% vs 26.2%; P < .001). A significantly higher “unfeasible” rate was identified in the current model of SAPIEN (SAPIEN, 8.3%; SAPIENXT, 1.8%; SAPIEN3, 48.2%; P < .001), but not in the CoreValve/Evolut series (CoreValve, 83.3%; Evolut R, 80.0%; Evolut PRO, 71.4%; P = .587). Patients with a bicuspid aortic valve had a lower “unfeasible” rate compared to those with a tricuspid aortic valve (60.0% vs 86.2%; P = .014). ConclusionsPatients of small body size may have a high probability of “unfeasible” coronary access after TAV-in-TAV, especially when treated with current high-frame devices, suggesting the need for careful strategic planning for initial THV implantation.

Cardiac Reoperations in Patients With Transcatheter Aortic Bioprosthesis

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement (TAVR), the frequency and clinical outcomes of reoperation after TAVR are not well-described. MethodsBetween 2011 and 2020, 1719 patients underwent a TAVR at our institution. Among these, 32 patients (2%) required a reoperation. Additionally, 16 patients who received a TAVR at another institution received a reoperation at our institution. We retrospectively reviewed these 48 patients. The median interval from TAVR to reoperation was 2.3 years. ResultsPrimary reoperations included 37 TAVR valve explants (TAVR-explant; 77%) with surgical aortic valve replacement (SAVR), 8 mitral repairs/replacements (17%), 2 coronary artery bypass grafting procedures (4%), and 1 tricuspid valve replacement (2%). Forty-nine percent of nonaortic valve cardiac lesions were present at the time of TAVR. Furthermore, 18 TAVR-explant patients (49%) were deemed anatomically unsuitable for repeat TAVR based on the index TAVR imaging. During TAVR-explant, 6 patients (13%) with native TAVR sustained various degrees of aortic trauma. Patients with unplanned aortic repair demonstrated a smaller sinotubular junction diameter than those without unplanned repair. In contrast, no unplanned aortic repair was needed in the 14 patients with previous SAVR or the latest 20 consecutive patients. The overall in-hospital mortality was 15%, with an observed-to-expected morality ratio of 1.8. ConclusionsThe clinical impact of post-TAVR reoperation remains substantial despite the lower frequency of unplanned aortic repair over time. The necessity of reoperations or unfavorable repeat TAVR anatomy appears predictable at the time of the index TAVR, and implanters must be mindful of “lifetime management” strategy during candidate selection.

Intravascular Ultrasound for Valve-in-Valve Guidance During Repeat Transcatheter Aortic Valve Replacement.

Intravascular Ultrasound for Valve-in-Valve Guidance During Repeat Transcatheter Aortic Valve Replacement.

Aortic valve reintervention in patients with failing transcatheter aortic bioprostheses: A statewide experience

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement since its approval, the frequency and outcomes of aortic valve reintervention after transcatheter aortic valve replacement are poorly understood. MethodsValve reinterventions, either surgical transcatheter aortic valve explantation or repeat transcatheter aortic valve replacement, between 2012 and 2019 were queried using the Society of Thoracic Surgeons Database and the Transcatheter Valve Therapy Registry through the Michigan Statewide quality collaborative. The reintervention frequency and clinical outcomes including observed-to-expected mortality ratio using Society of Thoracic Surgeons Predicted Risk of Mortality were reviewed. ResultsAmong 9694 transcatheter aortic valve replacement recipients, a total of 87 patients (0.90%) received a reintervention, consisting of 34 transcatheter aortic valve explants and 53 repeat transcatheter aortic valve replacement procedures. The transcatheter aortic valve explant group demonstrated a higher Society of Thoracic Surgeons Predicted Risk of Mortality. Reintervention cases increased from 0 in 2012 and 2013 to 26 in 2019. The proportion of transcatheter aortic valve explants among all reinterventions increased and was 65% in 2019. Self-expandable devices had a higher reintervention rate than balloon-expandable devices secondary to a higher transcatheter aortic valve explant frequency (0.58% [23/3957] vs 0.19% [11/5737]; P = .001), whereas repeat transcatheter aortic valve replacement rates were similar (0.61% [24/3957] vs 0.51% [29/5737]; P = .51). Among patients with transcatheter aortic valve explants, contraindications to repeat transcatheter aortic valve replacement included unfavorable anatomy (75%), need for other cardiac surgery (29%), other structural issues by transcatheter aortic valve device (18%), and endocarditis (12%). For transcatheter aortic valve explant and repeat transcatheter aortic valve replacement, the 30-day mortality was 15% and 2% (P = .032) and the observed-to-expected mortality ratio was 1.8 and 0.3 (P = .018), respectively. ConclusionsAortic valve reintervention remains rare but is increasing. The clinical impact of surgical device explantation was substantial, and the proportion of transcatheter aortic valve explants was significantly higher in patients with a self-expandable device.

Nationally Representative Repeat Transcatheter Aortic Valve ReplacementOutcomes: Report From the Centers for Medicare and Medicaid Services.

The aim of this study was to examine real-world experience with repeat transcatheter aortic valve replacement (TAVR) in a population-based national database. Repeat TAVR is a growing option in patients requiring reintervention for TAVR. However, large-scale studies with longitudinal follow-up are limited. All Medicare beneficiaries who underwent TAVR from 2012 to 2017 were included. Outcomes included 30-day and longitudinal mortality and major adverse cardiovascular events, defined as death, stroke, pacemaker insertion, major bleeding, acute kidney injury, or cardiac arrest. Outcomes of repeat TAVR were compared with surgical explantation after TAVR (TAVR explantation) in a matched analysis. Of 133,250 patients who underwent TAVR, 617 (0.46%) underwent subsequent repeat TAVR at a median interval of 154days (interquartile range: 58-537days). Mortality at 30days and 1 year was 6.0% and 22.0%, respectively. Rates of 30-day stroke and pacemaker insertion were 1.8% and 4.2%. Mortality at 30days was lower in those who underwent their first TAVR during the later era (2015-2017) compared with earlier years (2012-2014) (4.6% vs 8.7%; P=0.049). Repeat TAVR was associated with lower 30-day mortality compared with a matched group undergoing TAVR explantation (6.2% vs 12.3%; P=0.05), although 1-year mortality was similar (21.0% vs 20.8%; P=1.000). The incidence of 30-day major adverse cardiovascular events was higher with TAVR explantation compared with repeat TAVR (risk ratio: 2.92; 95%CI: 1.88-4.99; P≤ 0.001). Repeat TAVR was performed with acceptable30-day mortality in this high-risk population. Short-term outcomes were superior to surgical explantation, but 1-year outcomes were similar. Repeat TAVR will likely be an important option for aortic valve reintervention after TAVR.

Aortic valve reintervention after transcatheter aortic valve replacement

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement (TAVR), there are scant data regarding aortic valve reintervention after initial TAVR. MethodsBetween 2011 and 2019, 1487 patients underwent a TAVR at the University of Michigan. Among these, 24 (1.6%) patients required an aortic valve reintervention. Additionally, 4 patients who received a TAVR at another institution underwent a valve reintervention at our institution. We retrospectively reviewed these 28 patients. ResultsThe median age was 72 years, 36% were female and 86% of implanted TAVR devices were self-expandable. The leading indications for reintervention were structural valve degeneration (39%) and paravalvular leak (36%). The cumulative incidence of aortic valve reintervention was 4.6% at 8 years. Most (71%) were deemed unsuitable for repeat TAVR because of the need for concurrent cardiac procedures (50%), unfavorable anatomy (45%), or endocarditis (10%). TAVR valve explant was associated with frequent concurrent procedures, consisting of aortic repair (35%), mitral repair/replacement (35%), tricuspid repair (25%), and coronary artery bypass graft (20%). Seventy-one percent of aortic procedures were unplanned but proved necessary because of severe adhesion of the devices to the contacting tissue. There were 3 (15%) in-hospital mortalities in the TAVR valve explant group, whereas there was no mortality in the repeat TAVR group. ConclusionsRepeat TAVR procedure was frequently not feasible because of unfavorable anatomy and/or the need for concurrent cardiac procedures. Careful assessment of TAVR procedure repeatability should be weighed at the initial TAVR workup especially in younger patients who are expected to require a valve reintervention.

Advances in Transcatheter Electrosurgery for Treating Valvular Heart Disease

Delivery of electrosurgery energy through catheters and guidewires enables interventionists to ‘cut’ through obstructive intravascular lesions or across cardiac chambers. A novel application of transcatheter electrosurgery is to make controlled lacerations in heart valve leaflets. This review describes three applications of transcatheter electrosurgery of aortic and mitral valve leaflets to enable transcatheter heart valve implantation. Intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow obstruction splits and splays the anterior mitral valve and enables transcatheter mitral valve replacement without left ventricular outflow tract obstruction. Technique modifications and novel applications are described. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction enables transcatheter aortic valve replacement without coronary artery obstruction. The technique is described and novel uses, especially in the setting of repeat transcatheter aortic valve replacement, are discussed. Finally, electrosurgical laceration and stabilization of mitral valve clip devices (ELASTA-Clip) enables transcatheter mitral valve replacement after MitraClip implantation. In conclusion, transcatheter electrosurgery is an important and versatile new tool in structural heart intervention.

Repeat Transcatheter Aortic Valve Replacement and Follow-Up of Embolized Transcatheter Heart Valve After 13 Years

A 79-year-old woman was treated with a 23-mm balloon-expandable transcatheter heart valve (THV) that was initially complicated by an embolized THV requiring deployment in the descending aorta. She presented 13-years later with a degenerated bioprosthesis requiring redo THV. Pre-procedural computed tomography was important in highlighting underexpansion of the initial THV and open leaflets in the embolized valve. (Level of Difficulty: Advanced.)

Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study.

The supra-annular leaflet position and tall stent frame of the self-expanding Evolut PRO or Evolut PRO+ transcatheter heart valves (THVs) may cause coronary occlusion during transcatheter aortic valve replacement (TAVR)-in-TAVR and present challenges for future coronary access. We sought to evaluate the risk of TAVR-in-TAVR with Evolut PRO or Evolut PRO+ THVs and the feasibility of future coronary access. The CoreValve Evolut PRO Prospective Registry (EPROMPT; NCT03423459) prospectively enrolled patients with symptomatic severe aortic stenosis to undergo TAVR using a commercially available latest generation self-expanding THV at 2 centers in the United States. Computed tomography was performed 30 days after TAVR, which we used to simulate TAVR-in-TAVR with a second Evolut PRO or Evolut PRO+ THV and evaluate for risk of coronary obstruction and feasibility of future coronary access. Eighty-one patients enrolled with interpretable computed tomography are reported herein. Computed tomography simulation predicted sinus of Valsalva sequestration and resultant coronary obstruction during future TAVR-in-TAVR in up to 23% of patients. Computed tomography simulation predicted that the position of the pinned THV leaflets would hinder future coronary access in up to 78% of patients after TAVR-in-TAVR. Further THV design improvements and leaflet modification strategies are needed to mitigate the risk of coronary obstruction during TAVR-in-TAVR with self-expanding THVs and to facilitate future coronary access. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03423459.

TCT CONNECT-453 Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With Self-Expanding Prostheses

The supra-annular leaflet position and tall stent frame of the self-expanding Evolut PRO or Evolut PRO+ THV transcatheter heart valves (THVs) may cause coronary occlusion during transcatheter aortic valve replacement (TAVR)-in-TAVR and present challenges for future coronary access. We sought to

TCT CONNECT-464 Risk of Coronary Obstruction Due to Sinus Sequestration in Repeat Transcatheter Aortic Valve Replacement

TCT CONNECT-464 Risk of Coronary Obstruction Due to Sinus Sequestration in Repeat Transcatheter Aortic Valve Replacement

Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States

ObjectivesThis study sought to evaluate the incidence and outcomes of endocarditis after transcatheter aortic valve replacement (TAVR). BackgroundData about endocarditis after TAVR are limited. MethodsThe study investigated Medicare patients who underwent TAVR from 2012 to 2017 and identified patients admitted with endocarditis during follow-up using a validated algorithm. The main study outcome was all-cause mortality. ResultsOf 134,717 patients who underwent TAVR, 1868 patients developed endocarditis during follow-up (incidence 0.87%/year), with majority of infections (65.0%) occurring within 1 year. Incidence of endocarditis declined in recent years. The most common organisms were Staphylococcus (22.0%), Streptococcus (20.0%), and Enterococcus (15.5%). Important predictors for endocarditis were younger age at TAVR, male sex, prior endocarditis, end-stage renal disease, repeat TAVR procedures, liver and lung disease, and post-TAVR acute kidney injury. Thirty-day and 1-year mortality were 18.5% and 45.6%, respectively. After adjusting for comorbidities and procedural complications, endocarditis after TAVR was associated with 3-fold higher risk of mortality (44.9 vs. 16.2 deaths per 100 person-years; adjusted hazard ratio [aHR]: 2.94; 95% confidence interval [CI]: 2.77 to 3.12; p < 0.0001). End-stage renal disease (aHR: 2.12; 95% CI: 1.72 to 2.60), endocarditis complicated by cardiogenic shock (aHR: 2.50, 95% CI: 1.56 to 4.02), ischemic stroke (aHR: 1.56; 95% CI: 1.07 to 2.28), intracerebral hemorrhage (aHR: 1.67; 95% CI: 1.01 to 2.76), acute kidney injury (aHR: 1.44; 95% CI: 1.27 to 1.63), blood transfusion (aHR: 1.28; 95% CI: 1.09 to 1.50), staphylococcal (aHR: 1.71; 95% CI: 1.49 to 1.97), and fungal endocarditis (aHR: 1.72; 95% CI: 1.23 to 2.39) (p < 0.05 for all) portended higher mortality following endocarditis. ConclusionsThe incidence of endocarditis after TAVR is low and declining. However, it is associated with poor prognosis with one-half the patients dying within 1 year.

Repeat Transcatheter Aortic-Valve Replacement: A Viable Treatment Option?

When transcatheter aortic-valve replacement (TAVR) was first approved, treatment was confined to patients at high surgical risk, and late valve failure

A man with end-stage renal failure and uncontrolled hyperparathyroidism with repeat transcatheter aortic valve replacement in a surgical bioprosthetic aortic valve while avoiding patient-prosthesis mismatch.

A man with end-stage renal failure and uncontrolled hyperparathyroidism with repeat transcatheter aortic valve replacement in a surgical bioprosthetic aortic valve while avoiding patient-prosthesis mismatch.

CV3 MECHANICALLY EXPANDED VERSUS SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT IN HIGH-RISK PATIENTS WITH AORTIC STENOSIS: A BUDGET IMPACT ANALYSIS

Each transcatheter aortic valve replacement (TAVR) technology is associated with device-specific benefits and risks. This study evaluated Medicare costs of TAVR with a mechanically expanded valve (MEV) versus a self-expanding valve (SEV) in high-risk patients with severe aortic stenosis. A 1-year budget impact model was developed from a Medicare perspective. MEV and SEV clinical event rates were obtained from the REPRISE III randomized controlled trial at 12 months of follow-up. The model included all relevant procedural complications, including non-disabling and disabling stroke, repeat TAVR procedure, pacemaker implant, surgical aortic valve replacement, hospitalizations for worsening heart failure (HF), major vascular complications, life-threatening bleeds and acute kidney injury. Patient-level costs were assessed for the index TAVR admission (days 0-7) and post-TAVR short- (days 8-30) and long-term (days 31-365) complications. Acute care costs were obtained from 2019 Medicare MS-DRG rates. Long-term care costs for disabling stroke and worsening HF were derived from REPRISE III and published Medicare analyses. One-way sensitivity analysis (OWSA) was performed. At 1 year, disabling stroke, repeat procedure and HF hospitalization rates were lower for MEV compared to SEV; pacemaker rates were higher for MEV. Other complication rates in the model were similar. Total Medicare costs for MEV were lower than SEV ($45,030 versus $47,006). This difference was attributable to the lower costs of disabling stroke (-$1,370), repeat procedure (-$574) and worsening HF (-$314). Pacemaker costs were higher for MEV ($774) than SEV ($477). OWSA showed TAVR procedure costs and the occurrence rates of disabling stroke, repeat procedures and hospitalizations for worsening HF had the greatest influence on model results. MEV is a less costly alternative to SEV at 1 year from a Medicare perspective. Continued technological innovation in TAVR aimed at reducing complications may result in greater savings for payers.

P913What can we expect after valve-in-valve procedures in failed transcatheter aortic valves?

Abstract Background/Purpose With the growing use of transcatheter aortic valve replacement (TAVR), we need to determine if repeat TAVR (TAV-in-TAV) is comparable or even superior to surgical aortic valve replacement followed by TAVR (TAV-in-SAV). Although TAV-in-SAV procedures were shown to provide an almost complete sealing of paravalvular leakage at the expense of elevated gradients, data for TAV-in-TAV are lacking. Hence, we compared echocardiographic and clinical outcome in all TAV-in-TAV and TAV-in-SAV procedures in our institution between Oct. 2007 and July 2017. Methods 130 consecutive valve-in-valve patients out of 2351 TAVR-patients were identified. 24 patients were excluded. Patient data were analysed from our prospectively collected, institutional database. 93% underwent routine out-patient follow-up at 12 months. Results 75 TAV-in-SAV (75±8 years, male 60%; STS score 5.2±4.0%) and 31 TAV-in-TAV patients (78±8 years, male 65%; STS score 4.6±2.8%) formed the final study population. The type of TAV was similarly distributed in both groups (self-/balloon-expandable valves [%] 57/43 vs. 61/39) with transfemoral being the most frequent access site (68% vs. 87%). The mode of prosthesis failure was mainly stenosis in the TAV-in-SAV group (77%), whereas it was mainly intraoperative paravalvular regurgitation (90%) in the TAV-in-TAV group. 10% TAV-in-TAV patients (78±10 years, 33% male, STS score 5.1±1.5%) underwent redo-TAVR for prosthesis-degeneration after a mean time of 2614±862 days. The TAV-in-TAV group (90% single session vs. 10% staged: mean gradient 10±4 mmHg vs. 15±3 mmHg, p=0.096; aortic valve area 1.62±0.36 cm2 vs. 1.45±0.18 cm2, p=0.240) showed lower gradients and larger aortic valve areas (Table 1). No major intraprocedural complications occurred in either group. 30-day mortality was 0%. Table 1 75 TAV-in-SAV discharge 31 TAV-in-TAV discharge p-value 69 TAV-in-SAV 12mFU 30 TAV-in-TAV 12mFU p-value AVA (cm2) * 1.18±0.32 1.61±0.35 &lt;0.001† 1.21±0.36 1.63±0.43 &lt;0.001† Peak Gradient (mmHg) 33±14 23±8 &lt;0.001† 31±14 21±8 &lt;0.001† Mean Gradient (mmHg) 19±8 12±5 &lt;0.001† 18±9 11±4 &lt;0.001† AR (0–3)** 0.4±0.5 0.8±0.7 0.003† 0.4±0.5 0.8±0.6 0.001† LV ejection fraction (%) 49±12 49±16 0.970 54±12 50±10 0.081 *AVA = Aortic valve area; **AR = Aortic regurgitation. 0 = none, 1 = mild, 2 = moderate, 3 = severe. †p&lt;0,05 significant. Conclusion Indications for TAV-in-TAV differ from those for TAV-in-SAV. TAV-in-TAV results in significantly lower gradients and larger aortic valve areas with no relevant aortic regurgitation. Accordingly, failed TAV valves may be treated with TAV-in-TAV in the future.