Femoral vessel complications after transfemoral TAVR-A contemporary sonography-based assessment of 480 patients with third-generation transcatheter valves.

BACKGROUND: Postinterventional sonographic assessment of the femoral artery after transfemoral transcatheter aortic valve replacement (TF-TAVR) has the potential to identify several pathologies. We investigated the incidence and risk factors of femoral vessel complications in a modern TAVR collective using postinterventional sonography. METHODS: Between September 2017 and March 2022, 480 patients underwent TF-TAVR with postinterventional femoral sonography at a single center. Clinical outcomes and adverse events were analyzed after the Valve Academic Research Consortium 3 (VARC-3) criteria. RESULTS: In this cohort (51.2% male; age 80 ± 7.5 years, median EuroSCORE II 3.7) 74.8% (n = 359) were implanted with a self-expandable and 25.2% (n = 121) with a balloon-expandable valve. The main access (valve-delivery) was located right in 91.4% (n = 438), and the primary closure system was Proglide in 95% (n = 456). Vascular complications (VC) were observed in 29.16% (n = 140) of patients; 23.3% (n = 112) presented with minor- and 5.8% (n = 28) with major VC. Postinterventional femoral artery stenosis on the main access was observed in 9.8% (n = 47). Multivariable logistic regression analysis revealed female sex (p = .03, odds ratio [OR] 2.32, 95% confidence interval [CI] 1.09-4.89) and the number of used endovascular closure devices (p = .014, OR 0.11, 95%CI 0.02-0.64) as predictive factors for femoral artery stenosis. CONCLUSIONS: The incidence of postinterventional femoral artery stenosis following TF-TAVR was higher than expected with a number of used closure devices and female sex being independent risk factors. Considering the continuous advance of TAVR in low-risk patients with preserved physical activity, emphasis should be directed at the correct diagnosis and follow-up of these complications.

Aortic Valve Replacement in Adult Patients with Decellularized Homografts: A Single-Center Experience.

BACKGROUND: decellularized aortic homografts (DAH) represent a promising alternative for aortic valve replacement in young adults due to their low immunogenicity and thrombogenicity. Herein, we report our midterm, single-center experience in adult patients with non-frozen DAH from corlife. METHODS: safety, durability, and hemodynamic performance were evaluated according to current guidelines in all consecutive patients who had received a DAH at our center since 03/2016. RESULTS: seventy-three (mean age 47 ± 11 years, 68.4% (n = 50) male) patients were enrolled. The mean diameter of the implanted DAH was 24 ± 2 mm. Mean follow-up was 36 ± 27 months, with a maximum follow-up of 85 months and cumulative follow-up of 215 years. No cases of stenosis were observed, in four (5.5%) cases moderate aortic regurgitation occurred, but no reintervention was required. No cases of early mortality, non-structural dysfunction, reoperation, valve endocarditis, or thrombosis were observed. Freedom from bleeding and thromboembolic events was 100%; freedom from re-intervention was 100%; survival was 98.6% (n = 72). CONCLUSIONS: early and mid-term results showed low mortality and 100% freedom from reoperation, thromboembolic events, and bleeding at our center. However, in order for this novel approach to be established as a valid alternative to aortic valve replacement in young patients, long-term data are required.

Structural valve deterioration after aortic valve replacement with the Trifecta valve.

OBJECTIVES: Despite promising short- and mid-term results for durability of the Trifecta valve, contradictory reports of early structural valve deterioration (SVD) do exist. We investigated the incidence of SVD after surgical aortic valve replacement (SAVR) with the Trifecta in our single-centre experience. METHODS: Data of 347 consecutive patients (mean age 71.6 ± 9.5 years, 63.4% male) undergoing SAVR with the Trifecta between 2011 and 2017 were analysed. Clinical and echocardiographic reports were obtained with a median follow-up of 41 months (1114 patient years). RESULTS: Isolated SAVR was performed in 122 patients (35.2%), whereas 225 patients (64.8%) underwent concomitant procedures. The median EuroSCORE II was 4.0 (0.9; 7.1) and 30-day mortality was 3.7% (n = 13). Kaplan-Meier estimates for the freedom of overall mortality at 1, 5 and 7 years were 88.7 ± 1.7%, 73.7 ± 2.6% and 64.7 ± 4.2%, respectively. SVD was observed in 25 patients (7.2%) with a median time to first diagnosis of 73 months. Freedom of SVD was 92.5 ± 0.9% at 5 years and 65.5 ± 7.1% at 7 years. Thirteen patients underwent reintervention for SVD (6 re-SAVR, 7 valve-in-valve), resulting in a freedom of reintervention for the SVD of 98.5 ± 1.1% at 5 years and 76.9 ± 6.9% at 7 years. CONCLUSIONS: We herein report one of the highest rates of SVD after SAVR with the Trifecta. These data indicate that the durability of the prosthesis decreases at intermediate to long-term follow-up, leading to considerable rates of reintervention due to SVD.

Anterior Right Thoracotomy for Rapid-Deployment Aortic Valve Replacement.

BACKGROUND: Minimally invasive aortic valve replacement through anterior right thoracotomy (ART) has shown to be safe and feasible. However, acceptance within the surgical community is low. Rapid-deployment aortic valves may be a game changer due to simplified surgical technique and shorter operative times. Therefore, the combination of advanced surgical techniques like the ART access with rapid-deployment aortic valves was assessed in this study. METHODS: We retrospectively analyzed all patients undergoing ART with the Edwards Intuity Elite (Edwards Lifesciences, Irvine, CA) valve system between 2011 and 2018. Patient data were collected prospectively in an ongoing, single-center registry. Data analysis regarding valve outcome was performed according to current guidelines. RESULTS: In all, 165 patients underwent aortic valve replacement through ART access with the Edwards Intuity valve system (age 73 ± 9 years, 49% female, median European System for Cardiac Operative Risk Evaluation II score 1.6 [range, 0.6 to 10.6]). Median cardiopulmonary bypass time was 114 minutes (range, 61 to 310) and median aortic cross-clamp time was 80 minutes (range, 45 to 230). Thirty-day as well as inhospital mortality was 0.6% (n = 1). Postoperative neurologic events occurred in 3%, resulting in major neurologic deficit in 1 patient. Intermediate and long-term survival was 99%, 98%, and 93% after 6 months, 1 year, and 3 years, respectively. CONCLUSIONS: Implantation of the Edwards Intuity valve system through ART is safe, feasible, and reproducible. The overall results of this single center experience are excellent compared with contemporary series of both surgical and transcatheter aortic valve replacements.

Outcome of rapid deployment aortic valves: long-term experience after 700 implants.

BACKGROUND: The Edwards Intuity Valve System is a bioprosthesis with a balloon-expandable stent frame which enables rapid-deployment (RD). We aimed to analyze our single-center long-term experience with a follow-up until 9 years after aortic valve replacement (AVR) with this bioprosthesis. METHODS: Between May 2010 and May 2019, 700 consecutive patients with severe aortic stenosis or combined aortic valve disease, implanted with a RD valve at our institution, were included in a prospective database. Median follow-up was 19 months and the total accumulated follow-up was 2,140 patient-years. Pre-operative characteristics, operative parameters, survival rates, valve-related adverse events and valve hemodynamics were assessed. RESULTS: Mean age was 74±8 years, 45% female. Concomitant procedures were performed in 339 (48.4%) patients. In case of isolated AVR (361/700), a minimally invasive surgical (MIS) approach was conducted in 283 patients (78.4%). Cardio-pulmonary bypass (CPB) and cross-clamp times for isolated AVR were 107.7±28.2 and 73.8±21.3 minutes for MIS approaches and 92.8±28.8 and 57.5±20.6 minutes for full sternotomy (P<0.001), respectively. Mean gradients at discharge, 1, 3 and 5 years were 13±5, 11±4, 12±5 and 13±8 mmHg. New early pacemaker implantation was required in 8.9% of patients. Re-intervention or re-operation with valve explantation for structural degeneration, non-structural dysfunction or endocarditis, occurred in 21 cases (3%). Thirty-day mortality was 0.7% (5/700) and overall survival at 1, 3 and 5 years was 98%, 91% and 76%. CONCLUSIONS: We report excellent long-term results in this updated single center experience for RD aortic valves regarding durability, safety and hemodynamic performance.

Transcatheter edge-to-edge tricuspid repair for recurrence of valvular regurgitation after left ventricular assist device and tricuspid ring implantation.

Tricuspid regurgitation in patients with left ventricular assist device (LVAD) has a significant impact on prognosis and quality of life, and its effects on liver and renal function could negatively impact planned heart transplantation. The aim of the present case is to report the feasibility and the clinical impact of tricuspid transcatheter edge-to-edge repair in LVAD patients as adjunctive bridge to transplantation strategy. A 59-year-old female patient previously treated with LVAD implantation (HeartMate III) and tricuspid valve repair with 32 mm rigid ring (Medtronic Contour 3D) as bridge to transplantation developed recurrence of significant tricuspid regurgitation with right ventricular decompensation needing inotropic support. Preoperative echo showed torrential tricuspid valve regurgitation Effective regurgitant orifice area(EROA 1.4 cm2 ) with suspicious of partial detachment of the prosthetic ring. The patient was successfully treated with transcatheter edge-to-edge repair with the MitraClip XTR device. Tricuspid regurgitation was reduced by 50% (postoperative EROA 0.7 cm2 ). She remained stable under continuous inotropic support with no other episodes of right ventricular decompensation and was successfully transplanted 30 days after the clipping procedure. Transcatheter treatment of tricuspid regurgitation in a patient with LVAD was an effective strategy to gain time and bridge the patient to heart transplantation.

Rapid-Deployment Aortic Valves for Patients With a Small Aortic Root: A Single-Center Experience.

BACKGROUND: Aortic valve replacement in patients with a small aortic root is a matter of concern in terms of prosthesis-patient mismatch. We evaluated the survival and hemodynamic performance after implantation of a small rapid-deployment aortic valve (EDWARDS INTUITY valve system sizes 19 and 21 mm). METHODS: Between May 2010 and November 2018, 659 consecutive patients with severe aortic stenosis who received a rapid-deployment valve were included in a prospective and ongoing database. A small aortic bioprosthesis (sizes 19 mm and 21 mm) was implanted in 217 (32.9%) patients (mean age 74.9 ± 7.9 years, 85.3% women). Preoperative characteristics, operative parameters, and postoperative outcomes were assessed. RESULTS: Mean gradients at discharge and 1 year were 14.8 ± 5.6 mm Hg and 13.6 ± 4.9 mm Hg, respectively. Mean effective orifice area and the indexed effective orifice area at discharge were 1.55 ± 0.36 cm2 and 0.87 ± 0.22 cm2/m2, respectively, and prosthesis-patient mismatch occurred in 77 (35.5%) patients (25.8% moderate and 9.7% severe). Perioperative mortality was 1.8% (n = 4 of 217) and overall survival at 1 year and 5 years was 91% and 79%, respectively. The presence of any prosthesis-patient mismatch degree did not have a significant influence on overall survival (hazard ratio, 0.95; 95% confidence interval, 0.75-1.19; P = .638). At the last follow-up, mean New York Heart Association functional class was 1.5 ± 0.7 vs 2.8 ± 0.6 at baseline (P < .001). CONCLUSIONS: Surgical aortic valve replacement with rapid-deployment valves has shown improved results concerning hemodynamic performance, with decreased rates of prosthesis-patient mismatch. We observed excellent early-term and midterm survival and a significant improvement in functional class in this subgroup of patients with a small annulus.

Transcatheter Caval Valve Implantation of the Tricento Valve for Tricuspid Regurgitation Using Advanced Intraprocedural Imaging.

A 75-year-old patient with previous mitral and tricuspid reconstruction experienced severe tricuspid regurgitation. On the basis of a prohibitive surgical risk, an interventional heterotopic tricuspid valve implantation was planned. Implantation was performed using fusion-imaging, which facilitated intraprocedural navigation. At 6-month follow-up, the patient presented in improved condition with reduced symptoms. (Level of Difficulty: Advanced.).

Mechanical properties of the everolimus-eluting bioresorbable vascular scaffold compared to the metallic everolimus-eluting stent.

BACKGROUND: Everolimus-eluting bioresorbable vascular scaffolds (BVS) represent an innovative treatment option for coronary artery disease. Clinical and angiographic results seem promising, however, data on its immediate procedural performance are still scarce. The aim of our study was to assess the mechanical properties of BVS by Optical Coherence Tomography (OCT) in clinical routine. METHODS: Post-implantation OCT images of 40 BVS were retrospectively compared to those of 40 metallic everolimus-eluting stents (EES). Post-procedural device related morphological features were assessed. This included incidences of gross underexpansion and the stent eccentricity index (SEI, minimum/maximum diameter) as a measure for focal radial strength. RESULTS: Patients receiving BVS were younger than those with EES (54.0 ± 11.2 years versus 61.7 ± 11.4 years, p = 0.012), the remaining baseline, vessel and lesion characteristics were comparable between groups. Lesion pre-dilatation was more frequently performed and inflation time was longer in the BVS than in the EES group (n = 34 versus n = 23, p = 0.006 and 44.2 ± 12.8 versus 25.6 ± 8.4 seconds, p < 0.001, respectively). There were no significant differences in maximal inflation pressures and post-dilatation frequencies with non-compliant balloons between groups. Whereas gross device underexpansion was not significantly different, SEI was significantly lower in the BVS group (n = 12 (30 %) versus n = 14 (35 %), p = 0.812 and 0.69 ± 0.08 versus 0.76 ± 0.09, p < 0.001, respectively). There was no difference in major adverse cardiac event-rate at six months. CONCLUSION: Our data show that focal radial expansion was significantly reduced in BVS compared to EES in a clinical routine setting using no routine post-dilatation protocol. Whether these findings have impact on scaffold mid-term results as well as on clinical outcome has to be investigated in larger, randomized trials.

Outcome after Elective Percutaneous Coronary Intervention Depends on Age in Patients with Stable Coronary Artery Disease - An Analysis of Relative Survival in a Multicenter Cohort and an OCT Substudy.

BACKGROUND: Age is a strong predictor of survival in patients with coronary artery disease. In elder patients with increasing co-morbidities percutaneous coronary intervention (PCI) is associated with more complications and worse outcome. The calculation of relative survival rates adjusts for the "background" mortality in the general population by correcting for age and gender. We analyzed if elder patients after elective PCI have a worse relative survival compared to younger patient groups. METHODS: A total of 8,342 patients who underwent elective PCI at two high volume centers between 1998 and 2009 were analyzed. RESULTS: The survival of our patients after PCI (observed survival) was slightly lower compared to the general population (expected survival) resulting in a slightly decreasing relative survival curve. In a multivariate Cox regression model age amongst others was a strong predictor of survival. Stratifying patients according to their age the relative survival curves of younger patients (Quartile 1: <58 years; 2,046 patients), elder patients (Quartile 3: 66-73 years; 2,090 patients) and very old patients (Quartile 4: >73 years; 2,307 patients) were similar. The relative survival of mid-aged patients (Quartile 2: 58-65 years; 1,899 patients) was better than that of all other patient groups. The profile of cardiovascular risk factors differs between the various groups resulting in different composition and burden of coronary plaques in an optical coherence tomography sub-study. CONCLUSION: Patients after elective PCI have a slightly worse long-term survival compared to the age- and sex-matched general population. This is also true for different groups of age except for mid-aged patients between 58 and 63 years. Elder patients between 66 and 73 years and above 73 years have a similar relative survival compared to younger patients below 58 years, and might therefore have similar benefit from elective PCI.

Comparison of magnetic wire navigation with the conventional wire technique for percutaneous coronary intervention of chronic total occlusions: a randomised, controlled study.

Wire crossing of a chronic total coronary occlusion (CTO) is time consuming and limited by the amount of contrast agent and time of radiation exposure. Magnetic wire navigation (MWN) might accelerate wire crossing by maintaining a coaxial vessel orientation. This study compares MWN with the conventional approach for recanalization of CTOs. Forty symptomatic patients with CTO were randomised to MWN (n = 20) or conventional approach (n = 20) for antegrade crossing of the occlusion. In the intention-to-treat analysis, MWN showed a shorter crossing time (412 versus 1131 s; p = 0.001), and, consequently, lower usage of contrast agent (primary endpoint 42 versus 116 ml; p = 0.01), and lower radiation exposure (dose-area product: 29 versus 80 Gy*cm(2); p = 0.002) during wire crossing compared to the conventional approach. Accordingly, in the per-protocol analysis, the wire-crossing rate was, in trend, higher using the conventional approach (17 of 31) compared to MWN (9 of 28; p = 0.08). The use of MWN for revascularisation of CTOs is feasible and reduces crossing time, use of contrast agent, and radiation exposure. However, due to a broader selection of wires, the conventional approach enables wire crossing in cases failed by MWN and seems to be the more successful choice.

Evaluation of a canine cranial cruciate ligament repair system for use in equine laryngoplasty.

OBJECTIVE: To report the use of a nylon suture system (Canine Cranial Cruciate Ligament Repair System; Securos Inc Veterinary Orthopedics) as a prosthesis for equine laryngoplasty. STUDY DESIGN: Experimental and prospective clinical study. ANIMALS: Cadaver specimens (n = 5) and 7 horses with left laryngeal hemiplegia. METHODS: A commercially available monofilament nylon suture system was implanted as a laryngeal prosthesis. Arytenoid cartilage abduction was achieved with a tensioning device applied to the suture prosthesis during transnasal endoscopic observation. Suture fixation was achieved with crimping clamps and a crimping device. RESULTS: The nylon suture system was suitable as a laryngeal prosthesis for arytenoid cartilage abduction. The ratchet mechanism of the tensioning device facilitated abduction of the arytenoid cartilage and suture fixation was achieved by the crimped clamp without any loss of tension. Postoperatively, there was a slight loss of tension in 4 horses and complete loss of tension in 1 horse because of cartilage failure. After convalescence, none of the horses had abnormal respiratory noise, exercise intolerance or cough. CONCLUSIONS: A nylon suture system designed for canine cranial cruciate ligament repair was used successfully as a laryngeal prosthesis and facilitated control of the degree of arytenoid cartilage abduction during laryngoplasty. CLINICAL RELEVANCE: For improved control of the degree of arytenoid cartilage abduction during laryngoplasty, use of a nylon suture system with metal crimps should be considered.