TAVR Procedures Research Articles

360-Degree Virtual Reality Consultation for the Structural Heart Disease Patient

ABSTRACT Background : Given the need to improve upon physician-patient communication, we employed a 360-degree Virtual Reality (360°VR) visualization platform for face-to-face consultations for TAVR and LAAO procedures. The platform creates patient-specific 360°VR models from volumetric scans (e.g., CT, MRI) that can be manipulated and viewed from any angle. Methods : Forty-six patients were prospectively surveyed regarding their 360°VR consultation experience for aortic valve stenosis and atrial fibrillation. For each patient, a custom 360°VR model was created from their high-resolution CT scans using Precision VR® by Surgical Theater and utilized during the 360°VR consultation. The proposed procedure was simulated in VR to show the interaction of the specific implant with the patient’s anatomy. Patient conversion rate was also evaluated. Results : Compared to prior standard (non-VR) consultations for the same medical condition, patients reported significantly higher satisfaction with the 360°VR consultation and increased understanding of their pathology and proposed procedure. Additionally, 98% of patients agreed the physician communicated well using Surgical Theater. Patients also reported that experiencing 360°VR helped improve their understanding (98%) and comfort level (93%) with the proposed procedure. Importantly, 91% of patients agreed they felt included in decisions about their treatment. Additionally, 76% rated the hospital a 9 or 10 and 81% said they would recommend this hospital. Conversion rates after 360°VR consultations were higher than those for pre-360°VR consultations (100% vs 86%, TAVR; 92% vs 68%, Watchman). Conclusion : These findings support the 360°VR technology as a powerful tool to enhance patient education, engagement and satisfaction for structural heart disease patients. Abbreviations 360°VR: 360-degree Virtual Reality; TAVR: transcatheter aortic valve replacement; LAAO: left atrial appendage occlusion; HCAHPS: Hospital Consumer Assessment of Healthcare Providers and Systems; CMS: Centers for Medicare and Medicaid Services

Contrast-Sparing Imaging Utilizing Spectral Detector CT for Transcatheter Aortic Valve Replacement Procedure Planning

ABSTRACT Background : Cardiac CTA is an indispensable imaging tool for TAVR procedure planning. Post-processing of the dual-energy CT utilizing dual-source and kV-switching approach enables an increase in the density of iodine and allows the reduction of iodine dose. We hypothesized that the use of a dual-layer Spectral Detector CT (SDCT) can enhance the signal of intravascular iodine contrast material, reduce iodine contrast material volume, and facilitate pre-TAVR planning. Methods : We tested this in a preclinical porcine animal model, with results suggesting that spectral imaging may be superior to conventional imaging even at 21-35% of the full contrast medium dose with regard to reader confidence, higher SNR and CNR at the level of the aortic annulus and root. We subsequently followed this up by a prospective human validation study of 24 patients undergoing TAVR. Results : We demonstrate that SNR and CNR with SDCT were significantly higher (highest in lower energy virtual mono-energetic images (VMI) (monoE 40 keV) compared to conventional images, with the spectral images preferred for procedure planning by an experienced TAVR operator and imaging specialist. This was associated with a reduction in inter-observer variability in TAVR sizing measurements in low dose contrast studies (33% of the full contrast dose) resulting in a higher rate of agreement on the choice of valve prosthesis size. Conclusion : Low contrast dose spectral images achieved similar SNR and CNR compared to full contrast dose conventional images. Taken together, our results suggest that the use of SDCT imaging may facilitate the routine use of low contrast dose as part of pre-TAVR imaging.

Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis.

The 3rd generations of transcatheter heart valve system, including Edwards SAPIEN S3 (ES3) and Medtronic's Evolut R, has been developed to specifically improve the safety of transcatheter aortic valve implantation (TAVI). The aim of this work was to provide a summary effect estimate of the peri-procedural characteristics and clinical outcome of patients treated with ES3 versus the Evolut R. We conducted a literature search of PubMed, Ovid and EMBASE (2002 to 2018). Two authors extracted the data independently. The safety and feasibility of Sapien 3 and Evolut R were compared by odds ratios (ORs) with 95% confidence intervals (CIs) in inverse variance method. After a multi-step assessment, a total 6 studies were finally included, yielding 1,664 patients, of which, 768 (46%) used ES3 and 896 (54%) used Evolut R. There was no statistical difference with device success rate (OR 1.15, 95% CI: 0.70-1.91, I2 =0%), 30-day mortality [OR: 0.72 (0.33-1.57), I2 =0%], pre-dilation rate, 30-day stroke, bleeding complication (BC) (major and life-threating), major vascular complication (VC), and paravalvular leakage between the two groups. However, the ES3 group was associated with a higher risk of acute kidney injury (AKI), higher mean aortic valve gradient and better mean left ventricular ejection fraction (LVEF) after TAVR procedure. Moreover, the Evolut R group had a higher rate of post-dilation and new permanent pacemaker implantation (PPMI). Both devices had demonstrated excellent procedural success rate and short-term safety. At 30-day follow-up, both devices shared similar rates of mortality, BC, VC, stroke, and paravalvular leakage (PVL). However, the rate of AKI was higher in the ES3 group, and the rate of PPM was higher in the Evolut R group.

Abstract 373: Meta-analysis of Clinical Outcomes Comparing Use of Transesophageal Echocardiography versus No Transesophageal Echocardiogram During Transcatheter Aortic Valve Replacement

Background: Transesophageal echocardiography (TEE) is routinely used for intraoperative guidance for TAVR procedures. TAVR is also done with minimal imaging or no TEE guidance (minimal imaging approach). The clinical benefits of intraprocedure TEE during TAVR compared to minimal imaging approach has not been well established. Aim: To perform a meta-analysis of available trials comparing effectiveness of intraprocedural TEE versus minimal imaging approach during TAVR procedure. Hypothesis: TAVR with intraprocedural TEE is associated with better clinical outcomes compared with minimalist imaging approach. Methods: 8 retrospective observational studies were identified via a comprehensive literature search that incorporated Embase, MEDLINE, and CENTRAL. Each selected study reported on the comparison between TAVR performed with TEE guidance or with no TEE (minimalist strategy) during the procedure. Studies were screened for risk of bias using a quality assessment tool. Outcomes studied included all-cause mortality, cardiovascular mortality, paravalvular leak as defined by the original trial, readmission within 30 days, stroke, myocardial infarction (MI) , and acute kidney injury (AKI). For each outcome, estimates were pooled and reported as a risk ratio with 95% confidence interval (CI). Results: A total of 2057 patients were divided into TEE (n=1115) vs. non-TEE (n=942) cohorts. No significant difference was seen between TEE vs non-TEE groups in reducing cardiovascular mortality (RR=2.06 [95%CI: 0.91- 4.67], p=0.08 ), all cause mortality (RR= 0.63 [95% CI: 0.21- 1.90], p=0.41), readmission within 30 days (RR=0.49 [95% CI: 0.06-4.41], p=0.53), stroke (RR=0.97 [95% CI: 0.27- 3.47], p=0.96), MI (RR=0.92 [95%CI: 0.26- 3.29], p=0.90), and AKI (RR=1.24 [95% CI: 0.16-9.35], p=0.83). A significant increase in paravalvular leak was observed within the non-TEE group (RR=1.19 [95% CI: 1.01-1.39], p=0.04) in comparison to the TEE group. Conclusion: TEE guidance during TAVR is associated with reduced paravalvular leak when compared with minimal imaging approach. No other clinical difference was observed between the two approaches. Further studies are needed to validate these findings.

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction

BackgroundTranscatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. ObjectivesThe authors sought to examine outcomes following redo-TAVR. MethodsThe Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. ResultsAmong 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. ConclusionsRedo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

The ethics of waiting lists for TAVR procedures.

The ethics of waiting lists for TAVR procedures.

Comparison of 1-Year Pre- and Post-Transcatheter Aortic Valve Replacement Hospitalization Rates: A Population-Based Cohort Study

BackgroundRehospitalization rates post-transcatheter aortic valve replacement (TAVR) are high; however, it is not known how these compare with pre-TAVR hospitalization rates. Our objective was to determine the association between the index TAVR and hospitalization rates pre- and postprocedure. MethodsA retrospective observational study was performed including all TAVR procedures performed in Ontario, Canada, between 2013 and 2017. Patients who died during the index hospitalization were excluded. The primary outcome was all-cause hospitalization within 1 year of TAVR discharge. Hospitalization rates per person-year were calculated and compared for each of the following analogous time periods pre- and post-index TAVR: 1 to 30, 31 to 90, 91 to 365, and 1 to 365 days. Poisson regression models were used to generate rate ratios to compare hospitalization rates. ResultsThe final study cohort included 2547 patients. In the year before TAVR, 60.2% of patients were hospitalized, compared with 45.9% in the year following the procedure. The rate ratio (RR) for the year post-TAVR compared with pre-TAVR was 0.82 (95% confidence interval [CI], 0.77- 0.88). When comparing each parallel time period post- vs pre-TAVR, all intervals were associated with significant reductions in hospitalization after TAVR, except the 30-day periprocedural period. The largest change in hospitalization rates occurred in the 31 to 90 days post- vs the corresponding period pre-TAVR (RR: 0.57; 95% CI, 0.50-0.64) ConclusionTAVR is associated with a significant and sustained reduction in all-cause hospitalization in the year following the procedure compared with the preprocedural period.

CT is the main component of the global exposure to ionizing radiation for patients benefiting from a trans-femoral TAVR

X-rays are widely used for the TAVR realization, for the pre-TAVR assessment (coronary angiography ± PCI and computed tomography), and sometimes in the aftermath of the intervention (electrophysiology study, pacemaker implantation). TAVR currently becomes an alternative to surgical valve replacement for patients at intermediate risk, a population that is likely to experience an increase of the radiation-induced cancer risk following TAVR. The main objective of our study was therefore to evaluate the overall exposure to ionizing radiation for patients benefiting from a trans-femoral TAVR. All patients who underwent trans-femoral TAVR for a symptomatic aortic stenosis in our centre over a 26 months period were included. Dosimetric indicators (i.e. dose area product or dose length product) of pre-procedural coronary angiography and computed tomography, TAVR procedure, and any post-procedural interventions (electrophysiology study and/or pacemaker implantation) were collected and converted into an effective dose. The primary endpoint was the cumulative effective dose, calculated by summing effective doses received during the TAVR procedure and during pre- and post-procedural irradiating exams. One hundred and ninteen trans-femoral TAVR procedures were included, and the mean cumulative effective dose was 37.3 mSv. When only three procedures were necessary (71% of the population), 75% of the overall effective dose was from the computed tomography, while only 11% of this dose came from the TAVR procedure itself and 14% came from the coronary angiogram ( Table 1 , Fig. 1 ). Overall exposure to ionizing radiation for patients benefiting from a trans-femoral TAVR seemed acceptable, and the majority of the overall effective dose was from the computed tomography.

P112 Early respiratory changes after transcatheter aortic valve replacement

Abstract Funding Acknowledgements Sakakibara heart Institute Introduction Transcatheter aortic valve replacement (TAVR) is an alternative treatment for inoperative or high-risk patients requiring surgical aortic valve replacement (SAVR). In previous studies, the vital capacity falls to about 50% immediately after SAVR. Although the vital capacity recovers to about 60-70% in one week, it does not recover to preoperative levels at 3 months following SAVR 1)2). TAVR is expected to preserve respiratory function because TAVR does not require a sternotomy. Purpose The purpose of this study was to investigate early stage respiratory function after a TAVR. We assumed that respiratory function is not reduced after a TAVR. Methods This prospective study was approved by the local ethics committee of our Institute. Written informed consent was obtained from all patients. The subjects were patients who underwent TAVI at our Institute from July 2017 to March 2019. Exclusion criteria included patients who refused to provide informed consent, emergent cases, NYHA (New York Heart Association) Class IV patients, patients receiving inotropes, patients under mechanical ventilation, patients enrolled in other studies, or patients for whom conducting pulmonary function tests were judged to be difficult. The pulmonary function test was conducted once a day until one week after the TAVR procedure. Results The target number was 100, and we ceased registration when informed consent was obtained from 100 patients. TAVR was conducted for 142 cases in this period and 42 cases were excluded. After informed consent was obtained, 17 cases were excluded because they met the exclusion criteria, and the analysis was conducted with 83 cases. The vital capacity and % of vital capacity were significantly reduced from the first day to the sixth day and recovered to preoperative levels at the seventh day after TAVR. The forced expiratory volume was significantly reduced from the first day to the fifth day, and recovered to preoperative levels at the sixth day after TAVR. The percentage of forced expiratory volume at one second was not significantly reduced. Conclusions The respiratory function was reduced in the early stages after TAVR. The respiratory function was reduced mostly on the first day after TAVR and recovered to preoperative levels on the seventh day after TAVR. After TAVR, the respiratory function recovered earlier than after SAVR. We believe that TAVR is more suitable for patients with reduced respiratory function. Abstract P112 Figure. respiratory function after TAVR

The “Chaperone Technique”: Valve-in-Valve TAVR Procedure With a Self-Expandable Valve Inside a Degenerated Sutureless Prosthesis

The “Chaperone Technique”: Valve-in-Valve TAVR Procedure With a Self-Expandable Valve Inside a Degenerated Sutureless Prosthesis

Adjunctive Antithrombotic Therapy for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

ImportanceTranscatheter aortic valve replacement (TAVR) is an established alternative to surgery for patients with severe symptomatic aortic stenosis. Adjunctive antithrombotic therapy used to mitigate thrombotic risks in patients undergoing TAVR must be balanced against bleeding complications, since both are associated with increased mortality.ObservationStroke risk associated with TAVR is lower than that associated with surgical aortic valve replacement in recent trials including patients at intermediate or low risk, but it is constant beginning at the time of implant and accrues over time based on patient risk factors. Patients with aortic stenosis undergoing TAVR also have a sizable risk of life-threatening or major bleeding. Although dual antiplatelet therapy for 3 to 6 months after TAVR is the guideline-recommended regimen, this practice is not well supported by current evidence. In patients with no indication for oral anticoagulation, current registry-based evidence suggests that single antiplatelet therapy may be safer than dual antiplatelet therapy. Similarly, oral anticoagulation monotherapy appears superior to anticoagulation plus antiplatelet therapy in those where oral anticoagulant use is indicated. To date, no risk prediction models have been established to guide antithrombotic therapy.Conclusions and RelevanceDespite the growing volume of TAVR procedures to treat patients with severe aortic stenosis, evidence for adjunctive antithrombotic therapy remains rather scarce. Ongoing clinical trials will provide better understanding to guide antithrombotic therapy.

90Risk-adjusted comparison of in-hospital outcomes of transcatheter and surgical aortic valve replacement

Abstract Background Transcatheter aortic valve replacement (TAVR) is recommended for patients suffering from aortic valve stenosis at increased operative risk or age over 75 years. Beyond that patients with different co-morbidities could profit from TAVR. Purpose The present study analyzes in-hospital outcomes of aortic valve replacement procedures in order to identify subgroups of patients in which TAVR might be preferable. Methods For all 33,789 isolated transfemoral TAVR and SAVR procedures performed in Germany in 2014 and 2015, co-morbidities and in-hospital outcomes were identified by ICD- and OPS-codes. Results Patients undergoing TAVR were older with more co-morbidities and at increased estimated risk (logistic EuroSCORE TAVR: 13.9±10.3%; SAVR: 5.3±4.7%; p<0.001). In order to allow comparison of outcomes after TAVR and SAVR, a covariate and propensity-adjusted analysis was performed in different subgroups. The risk of mortality is significantly lower in patients undergoing TAVR with an age over 80 years (TAVR vs. SAVR 80–84: OR 0.55; p=0.002; ≥85 OR 0.42, p=0.006) and at high operative risk (patients with EuroSCORE >9: OR 0.62, p=0.001). No significant difference in in-hospital mortality occurs between TAVR and SAVR in patients under 80 and intermediate or low risk (<75: OR 0.85; p=0.404; 75–79 OR 0.82, p=0.219; EuroSCORE <4: OR 1.44, p=0.308; EuroSCORE 4–9: OR 0.81, p=0.156). In contrast, patients with advanced renal failure and patients in NYHA-class III/IV had better outcomes after TAVR (GFR<30: OR 0.45, p=0.005; NYHA III/IV: OR 0.72, p=0.015). Female sex, previous CABG, peripheral arterial disease, COPD, pulmonary hypertension, and diabetes were not found to be factors which favor a treatment strategy. Patients undergoing TAVR suffered more often from strokes and acute kidney failure. After risk-adjustment TAVR was associated with a lower risk for acute kidney injuries (OR 0.62, p<0.001). Risk for stroke was similar (OR 1.07, p=0.558). Risk of bleeding (OR 0.17, p<0.001) and requiring prolonged mechanical ventilation (>48h, OR 0.21, p<0.001) was decreased in patients undergoing TAVR. As expected, the TAVR procedure is associated with an increased risk for pacemaker implantations (OR 4.61, p<0.001). Conclusions The present study analyzing over 33.000 real-world procedures confirms that TAVR is the safer procedure in clinical practice for patients with severe aortic valve stenosis at increased operative risk, over 80 years, in NYHA-class III/IV, and with renal failure.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

BackgroundTranscatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients.MethodsWe performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods.ResultsOf the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients’ mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, −1.4 percentage points; 95% Bayesian credible interval for difference, −4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2).ConclusionsIn patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.)

HEART TEAM STRUCTURED TO MAXIMIZE TRANSCATHETER AORTIC VALVE REPLACEMENT OUTCOMES: FIRST 200 IMPLANTS WITH ZERO 30-DAY MORTALITY IN 220 BED HOSPITAL

We initiated a TAVR program at a 220 bed community hospital focusing on interactive decision making by a stable multidisciplinary team. Two weekly meetings were sacrosanct: patient candidate selection, and pre-implant/day of TAVR procedure planning. Our program started October 2013. Patients were

Estimating the additional costs per life saved due to transcatheter aortic valve replacement: a secondary data analysis of electronic health records in Germany.

Aortic stenosis (AS) is the most common valvular heart disease, with a dismal prognosis when untreated. Recommended therapy is surgical (SAVR) or transcatheter (TAVR) aortic valve replacement. Based on a retrospective cohort of isolated SAVR and TAVR procedures performed in Germany in 2015 (N = 17,826), we examine the impact of treatment selection on in-hospital mortality and total in-hospital costs for a variety of at-risk populations. Since patients were not randomized to the two treatment options, the two endpoints in-hospital mortality and reimbursement are analyzed using logistic and linear regression models with 20 predefined patient characteristics as potential confounders. Incremental cost-effectiveness ratios were calculated as a ratio of the risk-adjusted reimbursement and mortality differences with 95% confidence intervals obtained by Fieller's theorem. Our study shows that TF-TAVR is more costly that SAVR and that cost differences between the procedures vary little between patient groups. Results regarding in-hospital mortality are mixed. SAVR is the predominant procedure among younger patients. For patients older than 85years or at intermediate and higher pre-operative risk TF-TAVR seems to be the treatment of choice. Incremental cost-effectiveness ratios (ICER) are most favorable for patients older than 85years (ICER €154,839, 95% CI €89,163-€302,862), followed by patients at higher pre-operative risk (ICER €413,745, 95% CI €258,027-€952,273). A hypothetical shift from SAVR towards TF-TAVR among patients at intermediate pre-operative risk is associated with a less favorable ICER (€1,486,118, 95% CI €764,732-€23,692,323), as the risk-adjusted mortality benefit is relatively small (-0.97% point), while the additional reimbursement is still eminent (+€14,464). From a German healthcare system payer's perspective, the additional costs per life saved due to TAVR are most favorable for patients older than 85 and/or at higher pre-operative risk.

Chronic postthoracotomy pain in transapical transcatheter aortic valve replacement.

Objective:Chronic postthoracotomy pain (CPTP) is a persistent, occasionally debilitating pain lasting >2 months following thoracic surgery. This study investigates for the first time the prevalence and clinical impact of CPTP in patients who have undergone a transapical transcatheter aortic valve replacement (TA-TAVR).Design:This was a single-institution, prospective observational survey and a retrospective chart review.Setting:The study was conducted in the University Hospital.Participants:Patients.Materials and Methods:A survey of 131 participants with either a previous TA TAVR or transfemoral (TF) TAVR procedure was completed. A telephone interview was conducted at least 2 months following TAVR; participants were asked to describe their pain using the Short-Form McGill Pain Questionnaire.Measurements and Main Results:Odds ratio (OR) was calculated using the proportions of questionnaire responders reporting “sensory” descriptors in the TA-TAVR versus the TF-TAVR groups. Results were then compared to individual Kansas City Cardiomyopathy Questionnaire (KCCQ12) scores and 5-min walk test (5MWT) distances. A total of 119 participants were reviewed (63 TF, 56 TA). Among TA-TAVR questionnaire responders (n = 16), CPTP was found in 64.3% of participants for an average duration of 20.5-month postprocedure (OR = 10, [confidence interval (CI) 95% 1.91–52.5]; P = 0.003). TA-TAVR patients identified with CPTP had significant reductions in 5MWT distances (−2.22 m vs. 0.92 m [P = 0.04]) as well as trend toward significance in negative change of KCCQ12 scores OR = 18.82 (CI 95% 0.85–414.99; P = 0.06) compared to those without CPTP.Conclusions:CPTP occurs in patients undergoing TA-TAVR and is possibly associated with a decline quality of life and overall function.

Successful use of percutaneous ECMO and intra-aortic balloon support for a rescue valve in valve TAVR procedure in a patient in cardiogenic shock

Successful use of percutaneous ECMO and intra-aortic balloon support for a rescue valve in valve TAVR procedure in a patient in cardiogenic shock

Abstract 17362: A Multidisciplinary Heart Team Approach to High Risk Transvenous Pacemaker and Defibrillator Lead Extraction Improves Mortality

Introduction: There is a risk of serious complications with high-risk lead extraction (LE) that may increase mortality. Current guidelines do not provide definitive guidance on collaborative involvement of cardiac surgery as compared to other procedures such as TAVR procedures. We report a single center experience of the benefits of a collaborative approach between cardiac surgery and cardiac electrophysiology (EP). Hypothesis: MDHT will improve outcomes in LE Methods: High risk lead extractions had dwell times of at least 4 years for pacemaker leads and 2 years for ICD leads. A multidisciplinary heart team (MDHT) was created based on the TAVR model that includes a combined lead management clinic and a monthly multidisciplinary conference. Prior to MDHT creation, high risk lead extractions were performed either in the hybrid operating room (OR) and cardiology procedure lab with a surgeon on call as needed. After the MDHT creation all cases were performed in the hybrid operating room by a cardiac surgeon, cardiac anesthesiologist and EP together with an interventional radiologist readily available. Results: Prior to MDHT, 169 patients underwent 344 leads extractions. There were six major procedural complications (3.6%) that included 2 procedural deaths (1.2%) during that period (SVC tear, Tricuspid valve avulsion). Following the creation of MDHT, there have been 47 cases performed with 85 leads extracted. There have been two complications requiring surgical repair (one SVC laceration, one RV laceration), which were surgically repaired. With the creation of a MDHT, the rate of major complications was unchanged (Pre vs. Post MDHT 3.6% vs. 4.3%) but there was a lower mortality rate (Pre vs. Post MDHT 1.2% vs. 0%). Conclusions: High risk lead extraction had a fixed complication rate at our institution however a MDHT decreased mortality. A structured multidisciplinary approach, involving EP and cardiac surgery, decreased mortality in a medium sized lead extraction center and should be considered at all centers.

Abstract 17215: Pacing Burden in Those Undergoing Permanent Pacemaker Implantation After TAVR With Latest Generation Valves

Background: Risk factors leading to heart block (HB) and need for permanent pacemaker (PPM) implantation post-TAVR using latest generation heart valves have been described. Yet, little is known regarding pacing burden following PPM implantation among such patients. Objective: We sought to determine follow-up RV pacing burden among those undergoing PPM for HB following TAVR. Methods: From July 2016 to July 2017, we reviewed procedural and 3-month follow-up data (including PPM interrogation data) from all patients undergoing implantation of Edwards Sapien 3® and Medtronic Evolut-R® valves at our institution and requiring implantation of a PPM due to HB secondary to the TAVR procedure. Results: Of 132 included patients who underwent TAVR with new generation valves, 25 (19%) required post-TAVR PPM implantation. Of 25 patients, 18 had available follow-up pacemaker data [Table]. Pacing burden post-PPM implantation of 29mm valves was significantly greater compared to non-29mm valves (40.2% vs. 5.4%, p = 0.02). Those with baseline conduction system disease (RBBB or LBBB) had greater pacing burdens, in particular when 29mm Evolut-R® self-expanding valves were deployed (n=3, RV pacing burden 63.3%). Extension of programmed AV delays produced significant reduction in RV pacing burden. Conclusion: In those undergoing TAVR with latest generation valves complicated by HB requiring PPM use, implantation of larger-sized valves (29 mm Evolut-R® in the present series), as well as baseline RBBB or LBBB results in increased follow-up RV pacing burden. This may be mitigated by adjustment of pacing parameters. Further work investigating long-term pacing burden and its consequences is needed to provide additional insight. Table: Demographics, baseline ECG characteristics, procedural characteristics, pacing mode, pacing parameters and follow-up RV pacing burden.

Complementary Role of the Computed Biomodelling through Finite Element Analysis and Computed Tomography for Diagnosis of Transcatheter Heart Valve Thrombosis.

Introduction The TAVR procedure is associated with a substantial risk of thrombosis. Current guidelines recommend catheter-based aortic valve implantation for prohibitive-high-risk patients with severe aortic valve stenosis but acknowledge that the aetiology and mechanism of thrombosis are unclear. Methods From 2015 to 2018, 607 patients with severe aortic valve stenosis underwent either self-expandable or balloon-expandable catheter-based aortic valve implantation at our institute. A complementary study was designed to support computed tomography as a predictor of complications using an advanced biomodelling process through finite element analysis (FEA). The primary evaluation of study was the thrombosis of the valve at 12 months. Results At 12 months, 546 patients had normal valvular function. 61 patients had THVT while 6 showed thrombosis and dislodgement with deterioration to NYHA Class IV requiring rehospitalization. The FEA biomodelling revealed a strong link between solid uncrushed calcifications, delayed dislodgement of TAVR and late thrombosis. We observed an interesting phenomenon of fibrosis/calcification originating at the level of the misplaced valve, which was the primary cause of coronary obstruction. Conclusion The use of cardiac CT and predictive biomodelling should be integrated into routine practice for the selection of TAVR candidates and as a predictor of negative outcomes given the lack of accurate investigations available. This would assist in effective decision-making and diagnosis especially in a high-risk cohort of patients.