Generation Of Prostheses Research Articles

Impact of Pacemaker Implantation After Transcatheter Aortic Valve Replacement on Long-Term Survival in Patients With Bicuspid Aortic Valve

Limited data are available about the impact of permanent pacemaker (PPM) implantation on long-term survival in patients with a bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR). We aimed to evaluate the long-term clinical outcomes of patients with BAV with AS who underwent periprocedural PPM implantation after TAVR with a self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService-CoreValve Project were collected. Patients were categorized in 2 groups according to PPM implantation after TAVR ("PPM" group) or not ("no PPM" group). The coprimary end points were all-cause death and a composite of cardiac mortality, rehospitalization because of cardiac causes, stroke, and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between the groups in terms of follow-up and baseline characteristics. Patients in the PPM group were more likely to show baseline conduction abnormalities (p=0.023). Patients in the PPM group were more often treated with older generation prosthesis than those in the no PPM group (28.1% vs 5.4%, respectively, p=0.013). At 2years of follow-up, all-cause death in the no PPM and PPM groups occurred in 20.0% and 10.0% of patients, respectively (hazard ratio 0.37, 95% confidence interval 0.08 to 1.67). Similarly, no difference was evident for the composite end point between the 2 groups (no PPM vs PPM: 8 [14.6%] vs 6 [19.3%], hazard ratio 1.67, 95% CI 0.58 to 4.81). In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at 2years of follow-up.

Intermediate Term Clinical Outcomes in Total Ankle Arthroplasty: The CU Total Ankle Registry

Category: Ankle Arthritis; Ankle Introduction/Purpose: Total ankle arthroplasty (TAA) is a common procedure to treat end stage ankle osteoarthritis. Despite recent increase in popularity, there is limited literature assessing clinical and patient-reported outcomes (PROs) in TAA procedures using 5 current generation implants. These measures are an important tool for physicians to better assess patient performance in daily activities. The purpose of this study is to characterize both PROs and clinical outcomes in primary and revision TAA surgeries using current generation prostheses performed by non-design surgeons at a single institution. Methods: Our institution maintains a prospective outcomes registry for patients undergoing TAA at our institution. Patient demographics, relevant case information, PROs and complications are collected. Collected PROs include PROMIS Physical Function (PF), Pain Interference (PI), Depression, Global Physical Health (GPH), Global Mental Health (GMH), and Foot and Ankle SANE. Records are categorized as a primary TAA, or revision involving either a polyethylene only exchange or complete hardware removal and replacement. Differences between groups were determined non-parametrically using Mann-Whitney U tests. In all statistical tests, a p value of less than 0.05 was considered significant. Results: A total of 259 patients were included for analysis; 223 primary and 36 partial or full revision. Average length of stay was 1.6 ± 1 days. There were 18 reoperations (6.95%), with no implant failures within 1 year. Five patients underwent implant revision at an average of 2.5 years. Of these, one was related to delayed infection at year 3, two due to hardware failure in year 2, and 2 polyethylene exchanges in years 2 and 5. All physical health PRO measures showed significant improvements post-operatively (p < 0.0001). Patients reported significant reductions in pain following TAA at 3-months (Figure 1a), and significant improvement of physical function after 6-months (Figure 1b). There were no significant changes in Depression or GMH (Figure 1d). Conclusion: Total ankle arthroplasty is a safe and effective procedure for end-stage ankle arthritis. Patients experience improvement in all physical health PRO metrics at all post-operative time points after 3 months. Complication and early failure rates are lower than that reported in the literature. Long term outcomes and implant longevity will be tracked using the CU Total Ankle Registry. Total ankle arthroplasty improves quality of life in patients suffering from ankle osteoarthritis. Further follow-up and patient enrollment in the CU Total Ankle Registry will help us to identify risk factors for complications and define implant lifespan.

Comparison of Paravalvular Leak in SAPIEN 3 and EVOLUT PRO Valves in Transcatheter Aortic Valve Replacement: A Multicenter Registry

Paravalvular leak (PVL), conduction disturbances, and vascular complications remain the most common complications after TAVR. To address these adverse outcomes, the third generation of transcatheter heart valves has been developed. The last generation prosthesis provides an outer pericardial wrap for enhanced sealing and PVL prevention. This study aimed to compare the incidence and severity of PVL and 1-year survival after TAVR using SAPIEN 3 with those using EVOLUT PRO. An observational retrospective analysis was conducted in 1,481 patients who underwent TAVR for symptomatic severe aortic stenosis in 6 different European centers. The primary end point was to assess the frequency and severity of PVL at 30 days after TAVR. The secondary end point was to compare 1-year survival using EVOLUT PRO with that using SAPIEN 3. SAPIEN 3 transcatheter heart valve was implanted in 78.3% of study participants (n=1,160) whereas EVOLUT PRO was implanted in 21.7% (n=321). PVL is more commonly observed in patients treated with EVOLUT PRO at prehospital discharge (55.1% vs 37.3%) and at 1-month (51% vs 41.4%) and 1-year (51.3% vs 39.3%) follow-up. This difference mainly concerns low-grade (mild/trace) PVL. The frequency of high-degree (moderate/severe) PVL was almost similar in both groups throughout the study period (5.3% vs 5.8% before hospital discharge, 4% vs 3.1% at 1 month, and 3.2% vs 4.9% at 1 year). No significant difference in survival over 1 year has been observed (hazard ratio 0.73 [0.33 to 1.63], p=0.442) (Graphical abstract). In conclusion, the detection rate of PVL after TAVR with third-generation heart valves remains high, and there are no major differences between the devices regarding the frequency of significant (moderate/severe) PVL and survival.

Impact of Indexed Effective Orifice Area on the Quality of Life of Patients after Aortic Valve Replacement.

Improving health related quality of life is an important goal of aortic valve replacement. Inadequate effective orifice area of prosthesis according to the patient's body surface area may be associated with poor outcomes. In this study, we aimed to analyze impact of indexed effective orifice area (iEOA) on patients' quality of life after aortic valve replacement. A total of 138 patients who underwent isolated aortic valve replacement were included to the study. Quality of life assessment was performed with EuroQol Group EQ-5D-5L questionnaire. Patients were divided into three groups based on iEOA (Group 1 had an iEOA of <0.65 cm2/m2 (19 patients), Group 2 had an iEOA between 0.65-0.85 cm2/m2 (71 patients), and Group 3 had an iEOA of >0.85 cm2/m2). Mean EQ-5D-5L scores were compared among the groups statistically. Mean EQ-5D-5L scores were lower in Group 1 than in Groups 2 and 3 (Group 1: 0.72 ± 0.18, Group 2: 0.83 ± 0.20, and Group 3: 0.86 ± 0.9, p = 0.044 and p = 0.014). The EQ-5D-5L score was significantly lower in patients with a ≥20 mmHg transvalvular gradient than those with a <20 mmHg (0.74 ± 0.25 vs. 0.84 ± 0.18, p = 0.014). Our results show that an iEOA <0.65 cm2/m2 is significantly associated with impaired postoperative health-related quality of life. Newer generation prostheses, transcatheter valve implantation, and root enlargement techniques should be kept in mind in preoperative planning.

Aortic valve calcium score: does it correlate with mean transaortic gradient?

Abstract Introduction Aortic valvular calcium score (AVCS) is useful in patients with aortic stenosis for whom echocardiography was not conclusive in grading its severity. Transcatheter aortic valve implantation (TAVI) is an established procedure of treatment in symptomatic severe AS. The burden of aortic valve calcification has been associated with some TAVI related complications (as perivalvular leaks), but at the same time it is well accepted that some degree of calcification is needed to ensure stable anchoring of the prosthesis to the aortic annulus. Purpose To assess if there is a correlation between aortic valve calcium score and mean transvalvular gradient 6 months after TAVI – is a higher AVCS correlated with lower mean transaortic gradient after TAVI? Methods We performed a single-center, retrospective cohort study including patients who underwent TAVI with a preoperative standardized contrast enhanced MSCT with AVCS available. Clinical and echocardiographic data were collected previously to TAVI (pre-TAVI) and at 6 months follow up (6M-FUP). Results A total of 187 patients were included, with 54% female and a mean age of 79.4±9.0 years old. Most patients had tricuspid aortic valve (95.7%); 5 patients had aortic bicuspidy and 3 had aortic valve bioprothesis. Concerning the valve type, 73.3% had new generation prosthesis and the main valve used was the CoreValve Evolut Pro (33.7%). Also, 38,5% needed balloon pre-dilation before TAVI. The mean pre-TAVI aortic transvalvular maximum and mean gradients were 76.5±23.2 mmHg and 48.3±15.5 mmHg, respectively; mean aortic valve area was 0.75±0.16 cm2. The mean AVCS was 2851±1524 AU (Agaston Units); 81.2% of women had AVCS&amp;gt;1300 AU and 74.4% men had AVCS &amp;gt;2000 AU. Comparing transvalvular aortic gradients previously and 6M-FUP after TAVI, there was an average differential of maximum gradient of 61±22 mmHg and of mean gradient of 40±15 mmHg. A negative and weak correlation was found between the AVCS and the maximum gradient (pearson coefficient of −0.181, p=0.02) and between mean gradient at 6M-FUP (pearson coefficient of −0.191, p=0.014). Discussion and conclusion AVCS is a significant predictor for death, stroke and perivalvular leaks after TAVI. On the other hand, high AVCS is associated with better seating in the native annulus during deployment. Nevertheless, high AVCS did not strongly correlated with mean transaortic gradient 6 months after TAVI. Funding Acknowledgement Type of funding sources: None.

Trends and Utilization of Ankle Arthroplasty vs Arthrodesis in the State of New York, 2009-2018

Category: Ankle Arthritis; Ankle Introduction/Purpose: The two most common surgical procedures for end stage ankle arthritis patients who fail conservative management are arthrodesis and arthroplasty. The appropriateness of total ankle arthroplasty versus arthrodesis remains controversial. The long-term outcomes of current generation prostheses are not yet available and there is continued debate regarding the cost-benefit and risk-benefit analysis of each procedure. This study seeks to document rates of arthroplasty and arthrodesis for ankle osteoarthritis in New York in order to ascertain utilization of each procedure over time and stratification by patient demographics. Methods: Patients from 2009-2018 were identified using International Classification of Disease (ICD)-9 and 10 Clinical Modification (CM) codes for ankle osteoarthritis and Current Procedural Terminology or ICD-9 CM and ICD-10 Procedural Classification System procedural codes for ankle arthrodesis or ankle arthroplasty in the New York Statewide Planning and Research Cooperative System (SPARCS) database. SPARCS is an all-payer database collecting outpatient (emergency department, ambulatory surgery, and hospital-based clinic visits) and all inpatient claims in New York. A trend analysis was performed to determine if there was a shift towards either ankle arthrodesis or ankle arthroplasty over time. A multivariable logistic regression was performed to assess the impact of patient demographic factors on the likelihood of receiving arthrodesis versus arthroplasty. The variables included in the analysis were age, sex, race, ethnicity, Social Deprivation Index (linked by ZIP code), Charlson Comorbidity Index, and primary insurance type. Results: 3,735 cases were included in the trend analysis in years 2009-2018. In 2009, 220 (84%) procedures were ankle arthrodesis and 42 (16%) were ankle arthroplasty. By 2018, 274 (43.2%) were ankle arthrodesis and 360 (56.8%) were ankle arthroplasty (p&lt;.0001). Ankle arthrodesis increased 25% over the study period while ankle arthroplasty increased 757%. The multivariable logistic regression showed older age (OR: 0.95, p&lt;.0001) and females (OR: 0.71, p=.0003) had decreased odds of arthrodesis. African American race (OR: 1.63, p=.0459), federal insurance (OR: 1.72, p&lt;.0001), worker's compensation (OR: 1.75, p=.0072), being from an area with higher social deprivation (OR: 1.01, p=.0004) or having &gt;=1 Charlson comorbidities (OR: 1.4, p=.0007) was associated with increased odds of arthrodesis compared to arthroplasty. Conclusion: The present study demonstrates a substantial rise in ankle arthroplasty volume without a matching decrease in ankle arthrodesis volume over ten years. Patients who are wary of the motion limitation of arthrodesis and would previously have gravitated towards nonoperative management may now be finding a commonly performed, motion sparing alternative in arthroplasty. Ankle arthrodesis volume slightly increased, suggestive of nonequivalent patient populations undergoing these two procedures. There are apparent socioeconomic disparities in the utilization of these procedures, likely stemming from numerous nuanced factors but nevertheless also likely reflective of disparities in foot and ankle healthcare access.

Aortic valve calcium score and peri-prothesis leaks after transcatheter aortic valve implantation: a hint?

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The first-line evaluation of aortic stenosis (AS) severity is Doppler echocardiography. Aortic valvular calcium score (AVCS) measured by tomography scans (TS) is useful in patients for whom echocardiography is not conclusive. For high-risk patients with symptomatic severe AS, transcatheter aortic valve implantation (TAVI) is an established procedure of treatment. The burden of aortic valve calcification has been associated with some TAVI related complications. Peri-prothesis leaks (PPL) are an important complication that may compromise TAVI net results and further refinements are required to predict high-risk patients. Purpose: To access if there is an association between aortic valve calcium score and moderate to severe (mod-sev) peri-prothesis leaks immediately and 6 month after TAVI. Methods: We performed a single-center, retrospective cohort study including patients who underwent TAVI with a preoperative standardised TS with AVCS available. Clinical and echocardiographic data were collected previously to TAVI (pre-TAVI) and at 6 months follow up (6M-FUP). Results: A total of 187 patients were included, with 54% female and a mean age of 79.37± 9.029 year-old. Most patients had tricuspid aortic valve (95.7%); 5 patients had aortic bicuspidy and 3 had aortic valve bioprothesis. Considering left ventricular systolic function, the majority had conserved function (73.0%), the remaining had mild (9.7%), moderate (11.4%) or severe (5.9%) dysfunction. Concerning the valve type, 73.3% had new generation prosthesis and the main valve used was the CoreValve Evolut Pro (33.7%). Also, 38.5% patients underwent balloon valve pre-dilation before implantation. In-hospital mortality was 2.7%. At 6M-FUP, 8 of 182 patients had dead. The mean AVCS was 2851 ± 1524 AU (Agaston Units); 81.2% of women had AVCS &amp;gt; 1300 AU and 74.4% men had AVCS &amp;gt;2000 AU. Comparing AVCS with the presence or absence of moderate to severe peri-prothesis leaks, no statistically significant difference was found immediately (no vs mod-sev leak, AS: 2758 ± 2308 vs 3621 ± 1376, p= 0,13) and 6 months after the procedure (no vs mod-sev leak, AS: 2892 ± 2366 vs 3621 ± 1424, p = 0.15). Considering earlier (Portico, CoreValve Evolut R) vs newer valves (CoreValve Evolut Pro; Edward Sapiens 3; Accurate Neo), there was no statistically significant difference relating AVCS and PPL; however, in patients who had newer valves there was a trend to higher AVCS and moderate to severe leaks, both on the immediate (no vs mod-sev leak, AS: 2777 ± 2507 vs 3601 ± 1385, p = 0.07) and at 6 months (no vs mod-sev leak, AS: 2782 ± 2506 vs 3984 ± 1138, p = 0.06). No statistically significant difference was found when comparing pre-ballooning dilatation. Conclusion: Aortic calcium measured by Agatston score did not show an association with new moderate to severe peri-valvular leaks after TAVI. Nevertheless, it seems to be a trend for higher AS and moderate to severe peri-prothesis leaks when newer valves are implanted.

Heterotopic Ossification Following Total Ankle Arthroplasty with Fourth- Generation Prostheses

Category:Arthroscopy; HindfootIntroduction/Purpose:The purpose of the present study was to assess the radiographic incidence, location, and classification of heterotopic ossification (HO) in patients who underwent total ankle arthroplasty (TAA) with a 4th generation prostheses at a minimum of 1-year follow up. Baseline demographic, radiographic, and operative factors between patents with and without HO were compared.Methods:Ninety ankles that underwent TAA with a 4th generation protheses, INFINITY (n = 62) or CADENCE (n = 28) were followed for an average of 23.7 (range, 12-49) months. Incidence and location of HO was assessed on weight bearing radiographs, and severity graded according to the modified Brooker classification. Data was compared between patents with and without HO to identity any predisposing factors.Results:In 90 ankles that underwent 4th generation TAA, HO incidence was 55.6% (n = 50); 56.5% (n = 35) for INFINITY, and 53.6% (n = 15) for CADENCE. Twenty-five cases of HO were observed posteriorly, 16 anteriorly, and 9 combined. Severity was as follows; class I in 19 cases (38%), class II in 20 (40%), class III in 9 (18%) and class IV in 2 (4%). A single ankle required a non- revisional reoperation for HO debridement; reoperation rate of 2%.Conclusion:The present study suggests a similarly high incidence of HO after TAA with two different 4th generation prostheses (INFINITY 56.5%, CADENCE 53.6%). A trend for differences in location and severity between the prostheses may also be present. Given the paucity of literature, additional studies with longer follow-up are warranted to discern the significance of HO following TAA with 4th generation prostheses.

Total Ankle Arthroplasty with Anatomic Lateral Ankle Stabilization (ATLAS) using Synthetic Graft for Instability in Moderate and Severe Pre-Operative Varus Alignment

Category:Ankle; OtherIntroduction/Purpose:More than 50% of patients undergoing Total Ankle Arthroplasty (TAA) have some degree of coronal deformity, which is the most common reason for additional procedures. The purpose of the present study was to assess the early clinical and radiographic outcomes for patients who underwent TAA and Anatomic Lateral Ankle Stabilization (ATLAS) using synthetic graft for instability in moderate and severe preoperative varus alignment.Methods:Seven ankles with moderate or severe varus alignment underwent TAA with a 3rd generation prosthesis (INBONE-2) and ATLAS using synthetic graft between September 2018 and February 2019 at a single institution, and were at least 1 year postoperative (mean 13.3 months, range 12-15). Medical records and charts were reviewed for any revisions, reoperations, or complications. Weight bearing radiographs were assessed using coronal and sagittal alignment parameters preoperatively, and during the latest follow-up.Results:Survivorship for INBONE-2 with ATLAS was 100%; recurrent instability was not observed. Symptomatic talonavicular joint arthritis was recorded for a single patient 12 months postoperatively; there were no revisions, or reoperations. Tibiotalar coronal alignment improved significantly from 17.7 +- 9.3 (range, 10.1-33.6) to 2.3 +- 1.2 (range, 0.9-4.4) degrees (p<0.006), and all ankles achieved neutral alignment in single stage. Regarding sagittal tibiotalar alignment, preoperatively 2 ankles (28.5%) were translated anteriorly and the rest were neutral (71.5%). Significant posterior translation was observed and during the latest follow- up, 4 ankles were neutral (57.1%) and 3 posterior (42.9%) (p<0.009).Conclusion:Satisfactory outcomes were observed at a minimum of 1-year follow-up for patients with moderate or severe varus alignment who underwent TAA with INBONE-2 and ATLAS. ATLAS using synthetic graft may afford advantages over previously described repair techniques. Comparative studies between the Brostrum-Gould and ATLAS are warranted in the TAA population.

426 Percutaneous or surgical access for transfemoral transcatheter aortic valve implantation: a propensity matched analysis of a multicentre registry

Abstract Aims The transfemoral (TF) approach appeared to be the safest and the broadest used approach in TAVI, characterized by a lower rate of periprocedural bleedings and vascular complications and is currently recommended by the guidelines as a first line approach when feasible. If in the early experience TF access was achieved using a surgical cutdown approach, through the last years, there has been increasing evidence of the safety and efficacy of a fully percutaneous approach over a surgical access, albeit available evidences are controverting and mostly including first generation prostheses and high risk patients. The aim of the study is to compare percutaneous and surgical access in a large, real-word, multicentre of TF TAVI. Methods and results Consecutive patients undergoing successful TF TAVI were prospectively enrolled in local clinical registries of five high volume centres in Italy: IRCCS Ospedale Policlinico San Martino (Genoa), IRCCS Policlinico San Donato (Milan), Città Della Salute e della Scienza, (Turin), Ospedale Niguarda Ca’ Granda (Milan), Magna Graecia University, (Catanzaro), between January 2014 to December 2019. Univariate and multivariate analysis using IPTW were performed. A total of 1946 TF TAVI patients (female 42.8%) were prospectively included. Patients underwent surgical access had a significantly higher surgical risk (STS score of 8.9 vs. 6.4, P &amp;lt; 0.001, and EuroSCORE of 15.1 vs. 8.7, P &amp;lt; 0.001, respectively). Overall survival was comparable between the two groups (HR: 1.14, 95% CI: 0.76–1.71). Patients who underwent surgical access experienced more VARC-2 major and VARC-2 minor vascular complications (13% vs. 7%, P = 0.003 and 11% vs. 6.1%, P = 0.007, respectively) and more VARC-2 major/life threatening and minor bleeding (27.4% vs. 17.8, P = 0.001, and 9.6% vs. 2.1%, P &amp;lt; 0.001, respectively). After IPTW adjustment, surgical access was associated with an increased risk of major vascular complications (HR: 3.32, 95% CI: 1.84–5.97), minor bleeding (HR: 4.24, 95% CI: 1.16–15.54) and stage 2–3 AKI (HR: 2.60, 95% CI: 1.07–6.33). Conclusions The performance of the percutaneous transfemoral TAVI approach was safe and feasible and resulted in fewer major vascular complications, bleedings and AKI than the surgical femoral isolation. Procedural time and hospital length were also lower in the percutaneous group. Routine application of the percutaneous approach might reduce acute complications in patients undergoing transfemoral TAVI and reduce procedural time and hospital length.

Long-term outcomes in patients undergoing transcatheter aortic valve implantation: insights on clinical outcomes and prognostic markers from a large cohort of patients

Abstract Transcatheter Aortic valve Replacement (TAVR) has emerged as paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Clinical and performance data on long-term TAVR are still limited. The aim of this study was to determine the survival and the factors predicting mortality after TAVR with the first and second generation of prostheses. Methods From April 2008 to December 2019, the auto-expandible prostheses were implanted in 765 patients with symptomatic severe aortic stenosis with deemed high risk. The first generation prostheses included CoreValve and Accutrak System and the second prostheses included Evolut R and Pro. Results The mean age was 79.4±6.6 years. The logistic EuroSCORE and STS score were 17.1±11% and 5.7±3.9%, respectively. The implantation success rate was 98.87%. In-hospital mortality was 3.7%, and the combined endpoint of death, vascular complications, myocardial infarction or stroke had a rate of 15.1%. The clinical outcomes in according to prosthesis generation were, for pacemaker requirement (CoreValve vs. Accutrak system vs. Evolut R vs. and Evolut pro) 35.3% vs. 26.1% vs. 14.3% vs. 14%, p=0.001; and the paravalvular aortic regurgitation, were: none 28% vs. 44.8% vs. 43.3% vs. 58; mild 40% vs. 32.3% vs. 30.8% vs. 35.2%; moderate 32% vs. 20.3 vs. 23.9% vs. 5.7%; severe 0% vs. 2.6% vs. 0% vs. 1.1, p 0.001 The late mortality (beyond 30 days) was 35.9%. Survival at 1, 3, 5, 7 and 9 years were 88.9%, 76.1%, 61.1%, 44% and 32.6% respectively, after a mean follow-up of 42.3±27 months. The NYHA functional class improved from 3.1±0.6 to 1.77±0.7 in the follow-up. At 5 years, 5 patients had severe prosthetic valve dysfunction (severe stenosis and moderate transvalvular regurgitation The predictors of cumulative mortality were: Charlson index [HR 1.25 (95% CI 1.077–1.461), p=0.004], Readmision Heart Failure [HR 3.02 (95% CI 1.554–5.879), p=0.001], stroke post-TAVR [HR 3.472 (95% CI 1.115–10.53), p=0.032], residual aortic regurgitation [HR 1.45 (95% CI 1.093–1.934), p=0,010], and severe pulmonary hypertension [HR −0.983 (95% CI 0.645–0.423) p=0.032]. Conclusions TAVR is associated with significant survival benefit throughout 3.09 years of follow-up. Survival during follow-up depends particularly among patients with associated comorbidities and cardiac markers such as aortic regurgitation or pulmonary hypertension Funding Acknowledgement Type of funding sources: None.

New applications of ultrasound-based muscle activity sensing for rehabilitation engineering

Traditionally, electromyography using surface electrodes has been the dominant method for sensing muscle activity. Major challenges with surface electromyography include the difficulty in resolving signals from overlying muscles and low signal to noise ratio. In recent years, ultrasound has been investigated as an alternative and complementary modality for sensing functional muscle activity that overcomes several limitations of surface electromyography. Ultrasound imaging can non-invasively resolve individual muscles, including deep and overlying muscles, and detect dynamic activity within different functional compartments in real-time. While the use of ultrasound in the biomechanics community has a long history, the continuing miniaturization of ultrasound instrumentation has opened up new opportunities for using ultrasound in rehabilitation engineering as a biosignal sensing modality for assistive devices. This talk will describe results from our current work on developing miniaturized low-power ultrasound instrumentation for wearable systems, including next generation prostheses and exoskeletons. I will also describe opportunities and limitations for applications of ultrasound in rehabilitation engineering.

Transcatheter aortic valve implantation for pure aortic regurgitation

Transcatheter aortic valve implantation (TAVI) has become an established alternative to surgery in patients with calcific aortic stenosis. Broad implementation of devices and increased experience have led operators to explore the feasibility of TAVI in off-label indication such as pure native aortic valve regurgitation. Given the technical issues related to the absence of leaflet calcification and aortic root or ascending aorta dilation, this procedure is typically performed in patients in whom surgical risk is deemed prohibitive. Although recently published data have shown encouraging results in patients treated with new generation prostheses, new iteration of transcatheter valves, specifically designed for the treatment of aortic regurgitation, is needed. Nowadays, with no dedicated system on the horizon and in order to guarantee the best results, efforts should be made to improve patient selection.

Comparison of postoperative knee flexion and patient satisfaction between newly and conventionally designed medial pivot total knee arthroplasty: a 5-year follow-up matched cohort study.

The medial pivot total knee arthroplasty (TKA) has good patients' satisfaction; however, there is likely the restriction of postoperative knee flexion. The 2nd generation medial pivot TKA prosthesis was designed to improve postoperative knee flexion. This study aimed to compare the clinical outcomes and patient satisfaction between the 2nd generation and 1st generation medial pivot TKA prostheses. We conducted a retrospective study of 472 consecutive TKAs, performed using either the 2nd generation (EVOLUTION™), having smaller posterior femoral condyle and asymmetrical tibial tray, or 1st generation (ADVANCE™) prosthesis. The use of each system was historically determined. Patient age, sex and body mass index were matched between the two groups, with 157 cases ultimately included in each group. Measured clinical outcomes included: knee range of motion, the Knee Society Score, the rate of re-operation, and radiological parameters. Patient satisfaction was evaluated using the 12-item Forgotten Joint Score (FJS-12). The average follow-up period was 5.0 (3.7-6.3) years for the 2nd generation group and 8.7 (6.1-12.8) years for the 1st generation group (p < 0.01). The postoperative knee flexion range was 127° (80°-140°) for the 2nd generation and 118° (90°-135°) for the 1st generation at final follow-up (p < 0.01). On multivariate regression analysis, use of the 2nd generation prosthesis predicted greater postoperative knee flexion. The average FJS-12 score was 64 (0-100) for the 2nd generation and mean 57 (0-100) for the 1st generation (p < 0.01). Other clinical outcomes were similar between the two groups. Compared to the 1st generation, the 2nd generation medial pivot prosthesis provides greater postoperative knee flexion and patient satisfaction.

Long-Term Outcome with New Generation Prostheses in Patients Undergoing Transcatheter Aortic Valve Replacement.

The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014–2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p < 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications.

Five-Year Survival of Transcatheter Aortic Valve Implantation in High-Risk Patients

Although transcatheter aortic valve implantation (TAVI) has become the standard treatment for severe aortic stenosis in high-risk patients in Australia, there is still limited data on long term survival. All patients undergoing TAVI at a single tertiary institution between September 2009 and December 2015 were included. The primary outcome was survival, by linkage of patients with the National Death Index of the Australian Institute of Health and Welfare. Post-procedure data and echocardiographic measurements were retrospectively analysed for all patients. A total of 186 patients were included. It was a high-risk patient population (mean EuroSCORE 31.5±20.5, mean age 83.0±8.2 years). Valve prostheses used were Edwards SAPIEN (ES) (Edwards, Irvine, CA, USA) in 16.1%, Edwards SAPIEN XT (ESXT) in 74.2%, and Medtronic CoreValve (MCV) (Medtronic, Minneapolis, MN, USA) in 9.7%. Median survival time for the entire cohort was 68.2 months (95% Confidence Interval [CI]; Lower Limit [LL] 58.0 months, Upper Limit [UL] not defined). The 2- and 5-year estimates of survival were 85% (LL 80%, UL 90%) and 56% (LL 48%, UL 66%), respectively. There was no statistically significant difference in median survival between the ES and ESXT valves, or implantation approach. Survival was greater in patients with creatinine <200 μmol/L compared to >200 μmol/L (68.8 months [LL 61.4, UL n/a] vs 48.0 months [LL 25.5, UL n/a]). Over the study period, there was a statistically significant trend in increasing mean transvalvular gradient (ES: 1.66 mmHg/yr, p=0.0058; ESXT: 2.50 mmHg/yr, p≤0.001) and maximum velocity (ESXT: 0.16 m/s/yr, p=0.004) and decreasing valve area (ESXT: -0.07 cm2/yr, p<0.001). There was substantial attrition of patient echocardiographic follow-up (number of echocardiograms followed up at 5 years=6, number at risk=41). This study has demonstrated acceptable survival in a high-risk cohort of patients undergoing TAVI, with comparable results to larger international experiences. There was a trend for worsening haemodynamics that needs to be monitored. Future studies need to examine patient quality of life and the performance of newer generation prostheses.

Patients younger than 70 undergoing transcatheter aortic valve implantation: Procedural outcomes and mid-term survival

IntroductionBased on recent data, the indication for transcatheter aortic valve implantation (TAVI) is expanding to individuals at lower surgical risk, who are generally younger than subjects historically treated for severe aortic stenosis. Indeed, younger patients have traditionally been under-represented in current TAVI literature. The aim of the present study is to report about clinical features, procedural outcomes and mid-term outcomes of patients younger than 70 who underwent TAVI in a single high-volume center.Materials and methodsConsecutive patients younger than 70 years of age who underwent TAVI for severe, symptomatic aortic stenosis between 2007 and 2019 at a single, tertiary referral center have been included in this retrospective study. Procedural and mid-term outcomes were analyzed, comparing 1st generation with 2nd generation devices.ResultsBetween 2007 and 2019, 1740 TAVI procedures were performed in our center. Among these, one hundred twenty-nine (7.4%) patients were younger than 70 years at the time of the intervention and were included in the present analysis. Fifty-eight patients (45%) were implanted with a 1st generation prosthesis while seventy-one patients (55%) were implanted with a 2nd generation device. Reasons which lead to a transcatheter approach in this population were: previous CABG (27.9%); porcelain aorta (24%); severe left ventricular systolic dysfunction (21.7%); prior chest radiation (19.4%); severe lung disease (8.5%); hemodynamic instability (7.0%); advanced liver disease (4.6%) and active cancer (3.9%). Overall device success rate was 89%, with no differences among 1st and 2nd generation devices. Threeyears all-cause mortality was 34%, with no difference among the two groups. Low incidence of aortic-valve re-intervention was observed at mid-term follow-up (late valve re-intervention = 2.3%).ConclusionsTAVI in young patient with appropriate indication for intervention is a safe procedure, associated with low rate of in hospital mortality and low rate of severe complications both with 1st and with 2nd generation devices. When considering long term durability, more data are needed; in our case series long-term follow up shows a good survival and also an extremely low rate of valve re-intervention.

Transcatheter Aortic Valve Replacement in Young Low-Risk Patients With Severe Aortic Stenosis: A Review.

In the last decades, transcatheter aortic valve replacement (TAVR) revolutionized the treatment of symptomatic severe aortic stenosis. The efficacy and safety of TAVR were first proven in inoperable and high-risk patients. Then, subsequent randomized clinical trials showed non-inferiority of TAVR as compared to surgical aortic valve replacement also in intermediate- and low-risk populations. As TAVR was progressively studied and clinically used in lower-risk patients, issues were raised questioning its opportunity in a younger population with a longer life-expectancy. As long-term follow-up data mainly derive from old studies with early generation devices on high or intermediate surgical risk patients, results can hardly be extended to most of currently treated patients who often show a low surgical risk and are treated with newer generation prostheses. Thus, in this low-risk younger population, decision making is difficult due to the lack of supporting data. The aim of the present review is to revise current literature regarding TAVR in younger patients.

Heterotopic Ossification Following Total Ankle Arthroplasty With Fourth-Generation Prostheses.

The purpose of the present study was to assess the radiographic incidence, location, and classification of heterotopic ossification (HO) in patients who underwent total ankle arthroplasty (TAA) with a 4th generation prostheses at a minimum of 1-year follow up. Baseline demographic, radiographic, and operative factors between patents with and without HO were compared. Ninety ankles that underwent TAA with a 4th generation protheses, INFINITY (n = 62) or CADENCE (n = 28) were followed for an average of 23.7 (range, 12-49) months. Incidence and location of HO was assessed on weightbearing radiographs, and severity graded according to the modified Brooker classification. Data was compared between patents with and without HO to identity any predisposing factors. In 90 ankles that underwent 4th generation TAA, HO incidence was 55.6% (n = 50); 56.5% (n = 35) for INFINITY, and 53.6% (n = 15) for CADENCE. Twenty-five cases of HO were observed posteriorly, 16 anteriorly, and 9 combined. Severity was as follows; class I in 19 cases (38%), class II in 20 (40%), class III in 9 (18%) and class IV in 2 (4%). A single ankle required a non-revisional reoperation for HO debridement; reoperation rate of 2%. The present study suggests a similarly high incidence of HO after TAA with two different 4th generation protheses (INFINITY 56.5%, CADENCE 53.6%). A trend for differences in location and severity between the protheses may also be present. Given the paucity of literature, additional studies with longer follow-up are warranted to discern the significance of HO following TAA with 4th generation protheses. Level III: Retrospective cohort study.

Long-term outcomes with new generation prostheses in patients undergoing transcatheter aortic valve implantation

Abstract Background Transcatheter Aortic Valve Implantation (TAVI) is today the first option for older patients with aortic valve stenosis (AS) at intermediate or high risk for surgery. Constant development of bioprosthetic valves and delivery systems have reduced complications and improved outcomes over the years. The 3rd generation Edwards Sapien 3 Valve (S3) and the 2nd generation Medtronic Evolut R Valve (ER) are currently the most frequently used worldwide. There is a paucity of published data regarding long term outcomes in these new generation TAVI patients. Methods and results In our retrospective, single-center analysis we included patients with severe Aortic Stenosis who underwent transfemoral TAVI with a new generation prosthesis between 2014 and 2016. Peri- and postprocedural outcomes of these patients were analyzed according to the VARC-2 criteria. The study population consisted of 359 patients (mean patient age 82±7 years, 47% male, mean EuroSCORE II 8.0±8). The S3 group included 215 patients, the ER group 144 patients. Median follow-up period was 3.8 years (IQR 3.3 to 4.4 years, maximum follow-up in living patients 5.1 years). Device Success rates where equal in both groups (93.0% vs. 92.4%, p=0.812). We report a 30-day mortality of 2.8% in the S3 group, 2.1% in the ER group, respectively (p=0.674). There was no difference in stroke rate, conversion to open heart surgery, major vascular complications, life-threatening or disabling bleeding or myocardial infarction. Implantation of a new permanent pacemaker was lower in the S3 group (S3: 27.4% vs. ER: 44.5%, p=0.002). While prosthesis mean gradients where higher in the S3 group (12.0 mmHg vs. 8.2 mmHg, p&amp;lt;0.001), there was a tendency to less paravalvular leaks (PVL ≥2: 1% vs. 3.6%, p=0.088). All-Cause Mortality up to 5 years did not show a difference between both patient groups (mean survival S3 3.5 years, ER 3.3 years, p=0.895). Independent predictors of death where impaired left ventricular function (HR 1.61, p=0.007), chronic kidney injury (HR 1.55, p=0.032), peripheral artery disease (HR 2.10, p=0.003), malignant tumor (HR 2.40, p&amp;lt;0.001) and periprocedural stroke (HR 3.95, p=0.007). Discussion We present a comparison of the new-generation aortic valve prostheses Edwards Sapien 3 and Medtronic Evolut R concerning long-term as well as periprocedural outcomes. The analyzed cohort consisted of patients at intermediate to high surgical risk. Yet, 30-day mortality was very low both in S3 and ER patients. Device success and periprocedural outcomes in both groups were comparable and are in line with previous studies using VARC-2 definitions. Conclusion New generation TAVI valves offer an excellent implant and outcome success rate compared to early transcatheter Aortic valve replacement. Long-term survival was independent of prostheses choice and mainly attributed to pre- and intraprocedural comorbidities and complications. All-Cause Mortality (Kaplan-Meier) Funding Acknowledgement Type of funding source: None