Utility of cerebral embolic protection in non-TAVR transcatheter procedures

BACKGROUND: Cerebrovascular events that occur during structural and interventional procedures are a well known risk which is associated with increased mortality. The FDA has approved the use of the Sentinel device in TAVR. Hereby we report on our experience on the safety and efficacy of using Sentinel in a patient population undergoing non-TAVR transcatheter procedures. METHODS: Retrospective analysis of a single center experience with using the Sentinel device for non-TAVR transcatheter procedures. RESULTS: We identified 33 patients (average age was 73.8 years, 36.7% females, and 30% with history of a prior stroke) felt to be at high risk for cerebroembolic events that underwent Sentinel device placement. Sentinel placement was successful in all patients. Examples of high risk features included high atheroma burden in the aortic arch, left sided valve vegetations, intra-cardiac thrombi and severe left sided valve calcifications/thrombi. No patients developed periprocedural stroke or vascular complications. CONCLUSION: Overall, the use of Sentinel for non-TAVR indications appears feasible and safe. The use of cerebral protection devices should be studied further in non-TAVR patients to establish its role and its benefits, especially with expanding the number of non-TAVR transcatheter interventions

A Composite Metric for Benchmarking Site Performance in TAVR: Results from the STS/ACC TVT Registry

Background: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine if there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. Methods: We performed a retrospective cohort study using data from the STS/ACC TVT Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites whose risk-adjusted outcomes were significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. Results: The development cohort consisted of 52,561 patients who underwent TAVR between January 1, 2015 and December 31, 2017. Based on the associations with 1-year risk-adjusted mortality and health status, we identified four periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe peri-valvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) of sites; performance as expected was observed in 242/301 sites (80%); and worse than expected performance was observed in 34/301 (11%) of sites. Thirty-day mortality, stroke, major, life-threatening or disabling bleeding, and moderate or severe peri-valvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. Conclusions: There are substantial variations in the quality of TAVR care received in the United States, and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead

Preclosure of large bore venous access sites in patients undergoing transcatheter mitral replacement and repair

OBJECTIVE: We aim to report on the efficacy and safety of large bore venous access (LBVA) preclosure with Perclose™ (Abbott Vascular Devices) suture-mediated device use following transcatheter edge-to-edge (TEER) and replacement (TMVR). BACKGROUND: Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited. METHODS: Between 2012 and 2019, 354 consecutive high-risk patients with mitral valvular heart disease underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All patients underwent preclosure of LBVA except for one that underwent manual hemostasis. RESULTS: There were no closure device failures. None of the cases required surgical repair of the access site following venous preclosure. Two cases had large hematomas (\u3e6 cm) following Perclose in each group. Six cases had small hematomas (2 cm) with three in each group. There was one major bleeding using Mitral Valve Academic Research Consortium 2 definition (retroperitoneal bleed from arterial puncture) unrelated to the venous closure. Transfusion related to vascular access complication was required in five cases. There were two immediate acute deep venous thromboses postprocedure; one of which occurred after preclosure. There were no arteriovenous malformations, pseudoaneurysms, or access site infections reported following Perclose. CONCLUSION: In this large sample size analysis, Proglide preclosure technique is a feasible and safe alternative approach to achieving hemostasis after removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized trials are needed to compare the different modalities of hemostasis

Biomechanical Effects of Facet Joint Violation after Single-level Lumbar Fusion with Transpedicular Screw and Rod Instrumentation

STUDY DESIGN: In vitro biomechanical study. OBJECTIVE: This study aimed to investigate the biomechanical effects of facet joint violation (FV) on mobility and optically tracked intervertebral disc (IVD) surface strains at the upper level adjacent to L4-5 pedicle screw-rod fixation. SUMMARY OF BACKGROUND DATA: FV is a complication that can occur when placing lumbar pedicle screws; the reported incidence is as high as 50%. However, little is known about how FV affects superior adjacent-level spinal stability, and especially IVD strain, after lumbar fusion. METHODS: Fourteen cadaveric L3-S1 specimens underwent L4-5 pedicle-rod fixation, 7 in the facet joint preservation (FP) group and 7 in the FV group. Specimens were tested multidirectionally under pure moment loading (7.5 Nm). Colored maps of maximum (ε1) and minimum (ε2) principal surface strain changes on the lateral L3-4 disc were generated with the surface divided into 4 quarters anterior to posterior (Q1, Q2, Q3, and Q4, respectively) for subregional analyses. Range of motion (ROM) and IVD strain were normalized to intact upper adjacent-level and compared between the groups using analysis of variance. Statistical significance was set at P \u3c0.05. RESULTS: Normalized ROM was significantly greater with FV versus FP in flexion (11% greater; P =0.04), right lateral bending (16% greater; P =0.03), and right axial rotation (23% greater; P =0.04). Normalized L3-4 IVD ε1 during right lateral bending was greater on average for the FV group than the FP group: Q1, 18% greater; Q2, 12% greater; Q3, 40% greater ( P \u3c0.001); Q4, 9% greater. Normalized ε2 values during left axial rotation were greater in the FV group, the highest increase being 25% in Q3 ( P =0.02). CONCLUSIONS: Facet joint violation during single-level pedicle screw-rod fixation was associated with increased superior adjacent level mobility and alteration of disc surface strains, with significant increases in selected regions and directions of loading

Adjacent-segment effects of lumbar cortical screw-rod fixation versus pedicle screw-rod fixation with and without interbody support

OBJECTIVE: Cortical screw-rod (CSR) fixation has emerged as an alternative to the traditional pedicle screw-rod (PSR) fixation for posterior lumbar fixation. Previous studies have concluded that CSR provides the same stability in cadaveric specimens as PSR and is comparable in clinical outcomes. However, recent clinical studies reported a lower incidence of radiographic and symptomatic adjacent-segment degeneration with CSR. No biomechanical study to date has focused on how the adjacent-segment mobility of these two constructs compares. This study aimed to investigate adjacent-segment mobility of CSR and PSR fixation, with and without interbody support (lateral lumbar interbody fusion [LLIF] or transforaminal lumbar interbody fusion [TLIF]). METHODS: A retroactive analysis was done using normalized range of motion (ROM) data at levels adjacent to single-level (L3-4) bilateral screw-rod fixation using pedicle or cortical screws, with and without LLIF or TLIF. Intact and instrumented specimens (n = 28, all L2-5) were tested using pure moment loads (7.5 Nm) in flexion, extension, lateral bending, and axial rotation. Adjacent-segment ROM data were normalized to intact ROM data. Statistical comparisons of adjacent-segment normalized ROM between two of the groups (PSR followed by PSR+TLIF [n = 7] and CSR followed by CSR+TLIF [n = 7]) were performed using 2-way ANOVA with replication. Statistical comparisons among four of the groups (PSR+TLIF [n = 7], PSR+LLIF [n = 7], CSR+TLIF [n = 7], and CSR+LLIF [n = 7]) were made using 2-way ANOVA without replication. Statistical significance was set at p \u3c 0.05. RESULTS: Proximal adjacent-segment normalized ROM was significantly larger with PSR than CSR during flexion-extension regardless of TLIF (p = 0.02), or with either TLIF or LLIF (p = 0.04). During lateral bending with TLIF, the distal adjacent-segment normalized ROM was significantly larger with PSR than CSR (p \u3c 0.001). Moreover, regardless of the types of screw-rod fixations (CSR or PSR), TLIF had a significantly larger normalized ROM than LLIF in all directions at both proximal and distal adjacent segments (p ≤ 0.04). CONCLUSIONS: The use of PSR versus CSR during single-level lumbar fusion can significantly affect mobility at the adjacent segment, regardless of the presence of TLIF or with either TLIF or LLIF. Moreover, the type of interbody support also had a significant effect on adjacent-segment mobility

Utilization of coronary interventions and outcomes in weekend versus weekday admissions for stemi complicated by cardiogenic shock

Background ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) is associated with high mortality. We evaluated if there was a difference in the utilization of coronary interventions in patients who present with STEMI associated with CS. Methods The National Inpatient Sample, a publicly available database intended to represent 20% of all annual United States hospital admissions was searched for consecutive admission in patients \u3e18 years old from 2006 to 2015 who presented with STEMI and CS. A comparison of procedural interventions, use of hemodynamic monitoring, implementation of mechanical support and outcomes for weekday versus weekend admissions was recorded. Results 186,316 admissions for STEMI with CS were identified. There was no significant difference in adjusted mortality (OR 1.01, 95% CI: 0.96-1.06, p=0.72). The utilization of PCI was higher in weekend admissions (OR 1.10, 95% CI: 1.04-1.16, p=0.001) but the use of CABG (OR 0.94, 95% CI: 0.87-1.01, p=0.09), right heart catheterization (OR 0.96, 95% CI: 0.89-1.02, p=0.19), ECMO (OR 0.91, 95% CI: 0.71-1.18, p=0.48), percutaneous ventricular assist device (OR.91, 95% CI: 0.79-1.05, p=0.19) and IABP (OR 1.03, 95% CI 0.98-1.08, p=0.27) was similar in weekend versus weekday admissions. Conclusion There was no observed difference in the utilization of invasive procedures or outcomes in patients who are admitted with STEMI complicated by CS based on weekday and weekend admission

Subtle segmental angle changes of single-level lumbar fusions and adjacent-level biomechanics: cadaveric study of optically measured disc strain

OBJECTIVE: Changes to segmental lordosis at a single level may affect adjacent-level biomechanics and overall spinal alignment with an iatrogenic domino effect commonly seen in adult spinal deformity. This study investigated the effects of different segmental angles of single-level lumbar fixation on stability and principal strain across the surface of the adjacent-level disc. METHODS: Seven human cadaveric L3-S1 specimens were instrumented at L4-5 and tested in 3 conditions: 1) neutral native angle ( neutral ), 2) increasing angle by 5° of lordosis ( lordosis ), and 3) decreasing angle by 5° of kyphosis ( kyphosis ). Pure moment loads (7.5 Nm) were applied in flexion, extension, lateral bending, and axial rotation, followed by 400 N of axial compression alone and together with pure moments. Range of motion (ROM), principal maximum strain (E1), and principal minimum strain (E2) across different surface subregions of the upper adjacent-level disc (L3-4) were optically assessed. Larger magnitudes of either E1 or E2 indicate larger tissue deformations and represent indirect measures of increased stress. RESULTS: At the superior adjacent level, a significant increase in ROM was observed in kyphosis and lordosis versus neutral in flexion (p ≤ 0.001) and extension (p ≤ 0.02). ROM was increased in lordosis versus neutral (p = 0.03) and kyphosis (p = 0.004) during compression. ROM increased in kyphosis versus neutral and lordosis (both p = 0.03) in compression plus extension. Lordosis resulted in increased E1 across the midposterior subregion of the disc (Q3) versus neutral during right lateral bending (p = 0.04); lordosis and kyphosis resulted in decreased E1 in Q3 versus neutral with compression (p ≤ 0.03). Lordosis decreased E1 in Q3 versus neutral during compression plus flexion (p = 0.01), whereas kyphosis increased E1 in all quartiles and increased E2 in the midanterior subregion versus lordosis in compression plus flexion (p ≤ 0.047). Kyphosis decreased E1 in Q3 (p = 0.02) and E2 in the anterior-most subregion of the disc (Q1) (p = 0.006) versus neutral, whereas lordosis decreased E1 in Q3 (p = 0.008) versus neutral in compression plus extension. CONCLUSIONS: Lumbar spine monosegmental fixation with 5° offset from the neutral individual segmental angle altered the motion and principal strain magnitudes at the upper adjacent disc, with induced kyphosis resulting in larger principal strains compared with lordosis. Segmental alignment of single-level fusion influences adjacent-segment biomechanics, and suboptimal alignment may play a role in the clinical development of adjacent-segment disease

Low-dose carotid computed tomography angiography using pure iterative reconstruction

The aim of this study was to assess if a low-dose carotid computed tomography angiography (CTA) performed with pure iterative reconstruction (IR) is comparable to a conventional dose CTA protocol. Methods: Twenty patients were included. Radiation dose was divided into a low-dose acquisition reconstructed with pure IR and a conventional dose acquisition reconstructed with 40% hybrid IR. Dose, image noise, contrast resolution, spatial resolution, and carotid artery stenosis were measured. Results: Mean effective dose was significantly lower for low-dose than conventional dose studies (1.84 versus 3.71 mSv; P < 0.001). Subjective image noise, contrast resolution, and spatial resolution were significantly higher for the low-dose studies. There was excellent agreement for stenosis grading accuracy between low- and conventional dose studies (Cohen κ = 0.806). Conclusions: A low-dose carotid CTA protocol reconstructed with pure IR is comparable to a conventional dose CTA protocol in terms of image quality and diagnostic accuracy while enabling a dose reduction of 49.6%

The curative management of synchronous rectal and prostate cancer

Objective: Neoadjuvant &amp;quot;long-course&amp;quot; chemoradiation is considered a standard of care in locally advanced rectal cancer. In addition to prostatectomy, external beam radiotherapy and brachytherapy with or without androgen suppression (AS) are well established in prostate cancer management. A retrospective review of ten cases was completed to explore the feasibility and safety of applying these standards in patients with dual pathology. To our knowledge, this is the largest case series of synchronous rectal and prostate cancers treated with curative intent. Methods: Eligible patients had synchronous histologically proven locally advanced rectal cancer (defined as cT3-4Nx; cTxN1-2) and non-metastatic prostate cancer (pelvic nodal disease permissible). Curative treatment was delivered to both sites simultaneously. Follow-up was as per institutional guidelines. Acute and late toxicities were reviewed, and a literature search performed. Results: Pelvic external beam radiotherapy (RT) 45-50.4 Gy was delivered concurrent with 5-fluorouracil (5FU). Prostate total dose ranged from 70.0 to 79.2Gy. No acute toxicities occurred, excluding AS-induced erectile dysfunction. Nine patients proceeded to surgery, and one was managed expectantly. Three relapsed with metastatic colorectal cancer, two with metastatic prostate cancer. Five patients have no evidence of recurrence, and four remain alive with metastatic disease. With a median follow-up of 2.2 years (range 1.2-6.3 years), two significant late toxicities occurred; G3 proctitis in a patient receiving palliative bevacizumab and a G3 anastomotic stricture precluding stoma reversal. Conclusion: Patients proceeding to synchronous radical treatment of both primary sites should receive 45-50.4Gy pelvic RT with infusional 5FU. Prostate dose escalation should be given with due consideration to the potential impact of prostate cancer on patient survival, as increasing dose may result in significant late morbidity. Review of published series explores the possibility of prostate brachytherapy as an alternative method of boost delivery. Frequent use of bevacizumab in metastatic rectal cancer may compound late rectal morbidity in this cohort. Advances in knowledge: To our knowledge, this is the largest case series of synchronous rectal and prostate cancers treated with curative intent. This article contributes to the understanding of how best to approach definitive treatment in these patients