Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.

INTRODUCTION: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. METHODS: We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. RESULTS: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001). CONCLUSIONS: The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.

Management of Failed Bioprosthetic Aortic Valves: Mitigating Complications and Optimizing Outcomes.

The use of bioprosthetic prostheses during surgical aortic valve replacements has increased dramatically over the last two decades, accounting for over 85% of surgical implantations. Given limited long-term durability, there has been an increase in aortic valve reoperations and reinterventions. With the advent of new technologies, multiple treatment strategies are available to treat bioprosthetic valve failure, including valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR). However, ViV TAVR has an increased risk of higher gradients and patient prosthesis mismatch (PPM) secondary to placing the new valve within the rigid frame of the prior valve, especially in patients with a small surgical bioprosthesis in situ. Bioprosthetic valve fracture allows for placement of a larger transcatheter valve, as well as a fully expanded transcatheter valve, decreasing postoperative gradients and the risk of PPM.

Transcaval access for the emergency delivery of 5.0 liters per minute mechanical circulatory support in cardiogenic shock.

OBJECTIVES: The purpose of this study was to describe the feasibility and early outcomes of transcaval access for delivery of emergency mechanical circulatory support (MCS) in cardiogenic shock. BACKGROUND: Vascular access for implantation of MCS in patients with cardiogenic shock is often challenging due to peripheral arterial disease and vasoconstriction. Transcaval delivery of MCS may be an alternative. We describe a series of patients we implanted an Impella 5.0 device, on-table without CT planning, through a percutaneous transcaval access route. METHODS: Ten patients with progressive or refractory cardiogenic shock underwent Impella 5.0 implantation via transcaval access. Demographic, clinical and procedural variables and in-hospital outcomes were collected. RESULTS: All ten underwent emergency implantation of the 7 mm diameter Impella 5.0 device via transcaval access. Six were women, with median age of 55.5 years (range, 29-69). Cardiogenic shock was attributed to idiopathic nonischemic cardiomyopathy (n = 4), myocarditis (n = 2), ischemic cardiomyopathy (n = 2), heart transplant rejection (n = 1), and unknown etiology (n = 1). Median duration of support was 92.1 hr (range, 21.2-165.4). Seven (70%) survived to device explant, with six (60%) surviving to access port closure and discharge. Among survivors, five recovered heart function and one received destination therapy left ventricular assist device. CONCLUSIONS: Transcaval access is feasible for emergency nonsurgical implantation of the Impella 5.0 device in cardiogenic shock with small or diseased iliofemoral arteries. This allows early institution of higher-flow MCS than conventional femoral artery implantation of the 3.5 L Impella CP device, and enables a bridge-to-recovery or bridge-to-destination strategy.

First-in-human transcatheter pledget-assisted suture tricuspid annuloplasty for severe tricuspid insufficiency.

OBJECTIVES: We report the first pledget-assisted suture tricuspid annuloplasty (PASTA) in a patient with torrential tricuspid regurgitation (TR). BACKGROUND: Tricuspid valve regurgitation is a common malignant disease with no commercially available transcatheter therapy. PASTA is a "percutaneous surgical" procedure using pledgeted sutures to create a double-orifice tricuspid valve. METHODS: An 83-year-old man had end-stage TR caused by a defibrillator lead. He consented to undergo PASTA on a compassionate basis. A double-orifice valve was created with pledgeted sutures from percutaneous right ventricular apical access. RESULTS: TR was reduced from torrential to trace. The vena contracta reduced to from 23 to 1 mm and annular area reduced from 1817 to 782 mm2 . However, the annulus dehisced and required closure with a percutaneous nitinol plug. The patient was discharged home and was alive 6 months later but with persistent symptoms. CONCLUSIONS: The anatomy of a double-orifice valve can eliminate TR but a better solution is required to avoid excessive suture tension on annular tissue.

Short- and mid-term outcomes in percutaneous mitral valve replacement using balloon expandable valves.

BACKGROUND: Due to elevated surgical risk, transcatheter mitral valve replacement (TMVR) is used as an alternative for treating failed bioprosthetic valves, annuloplasty repairs and mitral annular calcification (MAC). We report the procedural and longitudinal outcomes for each subtype: Mitral valve-in-valve (MVIV), mitral valve-in-ring (MViR), and valve-in-MAC (ViMAC). METHODS: Consecutive patients undergoing TMVR from October 2013 to December 2019 were assessed. Patients at high risk for left ventricular outflow tract obstruction had either alcohol septal ablation or intentional laceration of the anterior leaflet (LAMPOON). RESULTS: Eight-eight patients underwent TMVR; 38 MViV, 31 MViR, and 19 ViMAC procedures were performed. The median Society of Thoracic Surgery 30-day predicted risk of mortality was 8.2% (IQR 5.2, 19.9) for all. Sapien 3 (78%) and transseptal access (98%) were utilized in most cases. All-cause in-hospital mortality, technical, and procedural success were 8%, 83%, and 66% respectively. Median follow up was 1.4 years (IQR 0.5-2.9 years) and overall survival was 40% at 4 years. Differential survival rates were observed with MViV doing the best, followed by MViR and ViMAC having a <20% survival at 4 years. After adjusting for co-variates, MViV procedure was the strongest predictor of survival (HR 0.24 [95% CI 0.079-0.7]). CONCLUSION: TMVR is performed in at high-risk patients with attenuated long-term survival. MViV has the best success and survival rate, but long-term survival in MViR and ViMAC is guarded.

Safety of same-day discharge after uncomplicated, minimalist transcatheter aortic valve replacement in the COVID-19 era.

OBJECTIVES: We sought to evaluate the safety, efficacy and feasibility of same-day discharge after uncomplicated, minimalist TAVR. BACKGROUND: At the start of the COVID-19 pandemic, we created a same-day discharge (SDD) pathway after conscious sedation, transfemoral (minimalist) TAVR to help minimize risk of viral transmission and conserve hospital resources. Studies support that next-day discharge (NDD) for carefully selected patients following minimalist TAVR is safe and feasible. There is a paucity of data regarding the safety of SDD after TAVR. METHODS: In-hospital and 30 day outcomes of consecutive patients meeting pre-specified criteria for SDD after minimalist TAVR at our institution between March and July of 2020 were reviewed. Outcomes were compared to a NDD cohort from July 2018 through July 2020 that would have met SDD criteria. Primary endpoints were mortality, delayed pacemaker placement, stroke and cardiovascular readmission at 30 days. RESULTS: Twenty nine patients were discharged via the SDD pathway after TAVR. 128 prior NDD patients were identified who met all criteria for SDD. The STS scores were similar between the two groups (SDD 2.6% ±1.5 vs. NDD 2.3% ± 1.2). There were no deaths at 30 days in either group. There was no significant difference in delayed pacemaker placement (SDD 0% vs. NDD 0.8%, p > .99) or cardiovascular readmission (SDD 0% vs. NDD 5.5%, p = .35) at 30 days. CONCLUSIONS: Same day discharge following uncomplicated, minimalist TAVR in selected patients appears to be safe, achieving similar 30 day outcomes as a cohort of next day discharge patients.

Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.

OBJECTIVES: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001). CONCLUSIONS: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.

Complete percutaneous apical access and closure: Short and intermediate term outcomes.

OBJECTIVES: To examine the safety of utilizing transapical access during structural interventions. BACKGROUND: Complex interventions of the mitral or aortic region sometimes require coaxial forces to orient and deliver devices. Apical access can provide coaxial countertraction for either transseptal or retrograde aortic access. This manuscript describes the single center experience of small bore transapical access. METHODS: Retrospective review of cases from 2013 to 2018 at Henry Ford Hospital was performed. Patient demographics and procedure characteristics were abstracted to describe the safety of transapical access using small bore sheaths. RESULTS: A total 21 cases were performed at Henry Ford, most of them for transcatheter mitral valve replacement (81%). The mean sheath size used was 4.7 ± 0.9 Fr and protamine was used at the end of 57% of cases. All patients received nitinol-based plugs, 80.1% were from the Amplatz Duct Occluder II type. Four major complications related apical puncture occurred, two pericardial effusions, two hemothorax. Over a median follow time of 430 days (IQR 50-652) a total of five deaths occurred, two related to the procedure and three late deaths with a median time of 362 days (range 205-628 days). No deaths were associated with transapical access. Echocardiographic follow up did not detect any late structural complications from occluder devices. CONCLUSIONS: Transapical access and closure with nitinol-based devices is feasible and facilitates complex interventions where coaxial forces are need for device delivery and alignment. The most common complication is bleeding and this should be kept in perspective when treating high-risk patients.

Biventricular Impella placement via complete venous access.

Impella (Abiomed, Danvers, MA) is an effective option for emergent treatment of critical refractory cardiogenic shock. However, in patients who have inadequate peripheral arterial access, Impella for left ventricular support sometimes requires surgical access, leading to disadvantages for emergent procedures or invasiveness for very sick patients. In addition, Impella for right ventricular support was recently reported to contribute to the management of severe biventricular dysfunction. In this report, we describe a case of refractory cardiogenic shock in a patient with inadequate vascular access who was treated with biventricular Impella via venous and caval-aortic access under conscious sedation. This technique can be used as a bridge to surgical ventricular assist device or heart transplantation. © 2017 Wiley Periodicals, Inc.

CXCL12 in early mesenchymal progenitors is required for haematopoietic stem-cell maintenance.

Haematopoietic stem cells (HSCs) primarily reside in the bone marrow where signals generated by stromal cells regulate their self-renewal, proliferation and trafficking. Endosteal osteoblasts and perivascular stromal cells including endothelial cells, CXCL12-abundant reticular cells, leptin-receptor-positive stromal cells, and nestin-green fluorescent protein (GFP)-positive mesenchymal progenitors have all been implicated in HSC maintenance. However, it is unclear whether specific haematopoietic progenitor cell (HPC) subsets reside in distinct niches defined by the surrounding stromal cells and the regulatory molecules they produce. CXCL12 (chemokine (C-X-C motif) ligand 12) regulates both HSCs and lymphoid progenitors and is expressed by all of these stromal cell populations. Here we selectively deleted Cxcl12 from candidate niche stromal cell populations and characterized the effect on HPCs. Deletion of Cxcl12 from mineralizing osteoblasts has no effect on HSCs or lymphoid progenitors. Deletion of Cxcl12 from osterix-expressing stromal cells, which include CXCL12-abundant reticular cells and osteoblasts, results in constitutive HPC mobilization and a loss of B-lymphoid progenitors, but HSC function is normal. Cxcl12 deletion from endothelial cells results in a modest loss of long-term repopulating activity. Strikingly, deletion of Cxcl12 from nestin-negative mesenchymal progenitors using Prx1-cre (Prx1 also known as Prrx1) is associated with a marked loss of HSCs, long-term repopulating activity, HSC quiescence and common lymphoid progenitors. These data suggest that osterix-expressing stromal cells comprise a distinct niche that supports B-lymphoid progenitors and retains HPCs in the bone marrow, and that expression of CXCL12 from stromal cells in the perivascular region, including endothelial cells and mesenchymal progenitors, supports HSCs.

Transcaval Access for Large Bore Devices.

PURPOSE OF REVIEW: Examine the latest data and techniques regarding transcaval access and closure. RECENT FINDINGS: Transcaval access was proven to be a feasible and a translatable skill in a 100 patient open-label prospective study. No late complications from fistulas occurred and of all patients alive at 1 year, one fistula remained open. Transcaval is a viable access route for large bore devices. With adequate planning, bleeding and vascular complications are minimal. It should be integrated into the rubric of transcatheter large bore access.

Guidewire electrosurgery-assisted trans-septal puncture.

OBJECTIVES: Electrifying a coronary guidewire may be a simple escalation strategy when trans-septal needle puncture is unsuccessful. BACKGROUND: Radiofrequency energy to facilitate trans-septal puncture through a dedicated device is costly and directly through a trans-septal needle may be less safe. Our technique overcomes these limitations. METHODS: The technique was used in patients when trans-septal needle penetration failed despite excessive force or tenting of the atrial septum. A coronary guidewire, connected to an electrosurgery pencil, was advanced through the trans-septal needle, dilator, and sheath to perforate the interatrial septum during a short burst of radiofrequency energy. With the guidewire tip no longer "active," the dilator and sheath were advanced safely over the wire into the left atrium. In posthoc validation, radiofrequency assisted Brockenbrough needle and coronary guidewire punctures were made in freshly explanted pig hearts and compared under microscopy. RESULTS: Eight patients who required trans-septal access for structural intervention were escalated to a guidewire electrosurgery strategy. Six patients had thickened fibrotic septum and two had prior surgical patch repair. Crossing was successful in all patients with no procedure related complications. The size of punctures (1.11 ± 0.40 mm vs 0.37 ± 0.08 mm, P = .009) and blanched penumbra (3.62 ± 1.23 mm vs 0.72 ± 0.29 mm, P = .003) in pig atrial septum were larger with an electrified needle than electrified guidewire. The hole generated by the electrified guidewire was smaller than by the nonelectrified needle. CONCLUSIONS: When conventional trans-septal puncture fails, a coronary guidewire can be used to deliver brief radiofrequency energy safely and effectively. This technique is inexpensive and accessible to operators.

Validating a prediction modeling tool for left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR).

OBJECTIVE: Demonstrate proof-of-concept validation of a computed tomography (CT) computer-aided design prediction modeling tool to identify patients at risk for left ventricular outflow tract (LVOT) obstruction in transcatheter mitral valve replacement (TMVR). BACKGROUND: LVOT obstruction is a significant and even fatal consequence of TMVR. METHODS: From August 2013 to August 2017, 38 patients in 5 centers underwent TMVR with compassionate use of balloon-expandable valves for severe mitral valve dysfunction because of degenerative surgical mitral ring, bioprosthesis, or severe native mitral stenosis from to severe mitral annular calcification. All patients had preprocedural CT scans performed for anatomic screening, intraprocedural TEE and invasive hemodynamics performed. Preprocedural prediction modeling was performed utilizing computer-aided design (CAD) of the neo-LVOT post-TMVR. Post-TMVR CT scans were obtained and compared to pre-TMVR LVOT modeling datasets for validation. RESULTS: All patients underwent successful TMVR without device embolization. Seven of the 38 patients experienced LVOT obstruction, defined as an increase of ≥10 mmHg LVOT peak gradient post-TMVR. Anatomic screening using CT was validated in 20/38 patients as preprocedural predicted neo-LVOT surface area correlated well with post-TMVR measurements (R2 = 0.8169, P < 0.0001). A receiver operating curve curve found a predicted neo-LVOT surface area of ≤ 189.4 mm2 to have 100% sensitivity and 96.8% specificity for predicting TMVR-induced LVOT obstruction. CONCLUSION: CAD design and CT postprocessing are indispensable tools in predicting LVOT obstruction and necessary for anatomic screening in percutaneous TMVR.

Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve.

OBJECTIVES: Pledget-assisted suture tricuspid valve annuloplasty (PASTA) is a novel technique using marketed equipment to deliver percutaneous trans-annular sutures to create a double-orifice tricuspid valve. BACKGROUND: Tricuspid regurgitation is a malignant disease with high surgical mortality and no commercially available transcatheter solution in the US. METHODS: Two iterations of PASTA were tested using trans-apical or trans-jugular access in swine. Catheters directed paired coronary guidewires to septal and lateral targets on the tricuspid annulus under fluoroscopic and echocardiographic guidance. Guidewires were electrified to traverse the annular targets and exchanged for pledgeted sutures. The sutures were drawn together and knotted, apposing septal and lateral targets, creating a double orifice tricuspid valve. RESULTS: Twenty-two pigs underwent PASTA. Annular and chamber dimensions were reduced (annular area, 10.1 ± 0.8 cm2 to 3.8 ± 1.5 cm2 (naïve) and 13.1 ± 1.5 cm2 to 6.2 ± 1.0 cm2 (diseased); septal-lateral diameter, 3.9 ± 0.3 mm to 1.4 ± 0.6 mm (naïve) and 4.4 ± 0.4 mm to 1.7 ± 1.0 mm (diseased); and right ventricular end-diastolic volume, 94 ± 13 ml to 85 ± 14 ml (naïve) and 157 ± 25 ml to 143 ± 20 ml (diseased)). MRI derived tricuspid regurgitation fraction fell from 32 ± 12% to 4 ± 5%. Results were sustained at 30 days. Pledget pull-through force was five-fold higher (40.6 ± 11.7N vs 8.0 ± 2.6N, P < .01) using this strategy compared to single puncture techniques used to anchor current investigational devices. Serious complications were related to apical access. CONCLUSIONS: PASTA reduces annular dimensions and tricuspid regurgitation in pigs. It may be cautiously applied to selected patients with severe tricuspid regurgitation and no options. This is the first transcatheter procedure, to our knowledge, to deliver standard pledgeted sutures to repair cardiac pathology.

Prospective, randomized comparison of 3-dimensional computed tomography guidance versus TEE data for left atrial appendage occlusion (PRO3DLAAO).

BACKGROUND: Preliminary data comparing 3-dimensional computed tomography (3D-CT) to transesophageal echocardiography (TEE) for left atrial appendage occlusion (LAAO) indicates that 3D-CT provides more accurate measurements and improves case planning. Therefore, we conducted a pilot study comparing 3D-CT to TEE in occluder selection accuracy and procedural efficiency. METHODS: From May 2016 to February 2017, 24 patients were prospectively randomized to undergo LAAO using either TEE or 3D-CT. The primary endpoint was device accuracy while the secondary endpoints included # devices per case, # guide catheters used per case, # fluoroscopy angles used, procedure time, fluoroscopy time, radiation dose, and major adverse events (stroke, MI, device embolization, perforation, death). RESULTS: Procedure success was 100% and 92% for the 3D-CT and 2D-TEE cohorts respectively. Accuracy for 1st device selection 92% and 27% (P = .01) for 3D-CT and 2D-TEE respectively but with intra-procedural upsizing in the 2D-TEE cohort, the 2D-TEE cohort accuracy increased to 64% while the 3D-CT groups 92% was accurate (P = .33). Case planning using 3D-CT was significantly more efficient with respect to device utilization (CT 1.33 ± 0.7 vs. 2D-TEE 2.5 ± 1.2 P = .01), guide catheters (CT 1 vs. 2D-TEE 1.7 ± 0.8 P = .01) and procedure time (3D-CT 55 ± 17 min vs. 2D-TEE 73 ± 24 min P < .05). One major adverse event, a stroke occurred in the 2D-TEE group. CONCLUSION: In this single-center pilot study, CT guided LAAO case planning was associated with improved device selection accuracy and procedural efficiency. This study data supports the notion that comprehensive 3D assessment significantly simplifies LAAO, minimizing the time and number of steps needed.

Long or redundant leaflet complicating transcatheter mitral valve replacement: Case vignettes that advocate for removal or reduction of the anterior mitral leaflet.

Transcatheter mitral valve replacement (TMVR) procedures can be an alternative to surgical valve replacement for high surgical risk patients with bioprosthetic mitral valves, annuloplasty rings, or severe mitral annular calcification (MAC). TMVR can trigger acute left ventricular outflow tract (LVOT) obstruction from permanent displacement of the native anterior mitral leaflet toward the left ventricular septum, more often among patients undergoing valve-in-ring and valve-in-MAC procedures. Although acute LVOT obstruction is well described in the literature, there are important additional complications of TMVR related to the length and/or redundancy of the anterior mitral valve that have been recognized after mitral valve surgery and have not been previously reported in the setting of TMVR. These additional complications include acute mitral regurgitation secondary to prolapsing native leaflet through the TMVR, frozen TMVR leaflet secondary to overhanging native leaflet and late LVOT obstruction in the neo-LVOT secondary to long native leaflet. Preprocedural planning with imaging (echocardiography and computed tomography) and measurement of anterior mitral leaflet length is critical important in understanding the risk for these complications. As transcatheter mitral valve technology proliferates, interactions with the anterior mitral leaflet after TMVR may be more frequent than initially anticipated. We believe that there is no advantage to an intact anterior leaflet and advocate removal or reduction of the leaflet prior to TMVR. © 2017 Wiley Periodicals, Inc.

Thrombotic valvular dysfunction with transcatheter mitral interventions for postsurgical failures.

BACKGROUND: Degenerated surgical mitral valve repairs or surgical prostheses are currently being treated with transcatheter mitral valve replacement (TMVR). We report the procedural and mid-term assessment of thirteen cases. METHODS: From 12/2013 to 12/2015, 13 consecutive patients with degenerated mitral valve repair or valve replacement were treated. Patients were assessed for mitral valve academic valve consortium (MVARC) defined outcomes. RESULTS: Immediate procedural MVARC defined technical success was 92%. At 30 days MVARC device and procedure success were 61% and 84%, respectively. Mean follow-up was 150 days [IQR 40-123 days]. There were 2 late major adverse outcomes, a noncardiac related death (628 days) and a stroke (382 days). The mean mitral gradient decreased from 9.5 ± 3.4 to 5.5 ± 2.6 mm Hg (P < 0.01). Three patients were found to have high gradients, two presented with heart failure while another patient was found to have reduced leaflet motion and abnormal thickening postprocedure. The two patients with heart failure were treated with enoxaparin, which caused subsequent resolution of increased valve gradients in one patient. The other patient could not tolerate prolonged treatment from anticoagulation due to gastrointestinal bleeding. Three of 13 patients were treated with dual-antiplatelet therapy and were suspected to have valve thrombosis. CONCLUSION: Thrombotic related dysfunction post-TMVR occurred in 15% (2/13) of patients and one patient had abnormal leaflet thickening that may have been thrombus related. Dual-antiplatelet therapy was used in all 3 cases suggesting the possible need for oral anticoagulation postmitral valve-in-valve therapy. © 2017 Wiley Periodicals, Inc.

Short-term results of alcohol septal ablation as a bail-out strategy to treat severe left ventricular outflow tract obstruction after transcatheter mitral valve replacement in patients with severe mitral annular calcification.

OBJECTIVES: To evaluate the outcomes of the early experience of percutaneous alcohol septal ablation in patients with severe left ventricular outflow tract (LVOT) obstruction post transcatheter mitral valve replacement (TMVR). BACKGROUND: Severe LVOT obstruction with hemodynamic compromise is a complication of TMVR associated with high mortality. Percutaneous alcohol septal ablation has recently been described as a therapeutic option in this setting. METHODS: Multicenter retrospective review of clinical outcomes of patients undergoing alcohol septal ablation to treat LVOT obstruction after TMVR for severe mitral stenosis with severe mitral annular calcification. RESULTS: Six patients underwent percutaneous alcohol septal ablation to treat LVOT obstruction post-TMVR at six different centers. Five patients had immediate significant reduction in LVOT obstruction with improvement in hemodynamic status while one had persistent LVOT gradient but hemodynamic instability improved. The first patient died on postoperative day 4 due to complete heart block. One patient had initial improvement in LVOT gradient with recurrence on postoperative day 1 thought to be secondary to septal edema, was treated with surgical removal of the transcatheter valve and resection of the anterior mitral leaflet followed by transatrial TMVR and died 3 weeks later due to multi-organ failure. The remaining four patients improved clinically after alcohol septal ablation, were discharged from the hospital and were clinically stable at 30-day follow-up. CONCLUSIONS: Percutaneous alcohol ablation provides acute relief of TMVR-induced LVOT obstruction when septal hypertrophy is a contributing factor. This may be a safer alternative to bail-out surgery in this extremely high-risk patient population. © 2017 Wiley Periodicals, Inc.

Cutaneous phaeohyphomycosis in a hematopoietic stem cell transplant patient caused by Alternaria rosae: First case report.

Alternaria species have been reported as a rare cause of fungal infection in organ and stem cell transplant recipients, but to date, no reports have been published of infection in humans caused by Alternaria rosae. Here, we report cutaneous A. rosae infection in a 66-year-old farmer with a history of primary myelofibrosis who had undergone allogeneic unrelated donor hematopoietic stem cell transplantation. Forty-nine days post transplant, he presented with a nodule on the thumb with no findings suggestive of disseminated infection. Pathology, culture, and molecular speciation showed the nodule was caused by cutaneous A. rosae. He had been on voriconazole as antifungal prophylaxis, but was found to have a subtherapeutic voriconazole level. He was switched to posaconazole based on published in vitro data showing its superior efficacy in Alternaria treatment. Susceptibility testing showed that the A. rosae isolate was indeed susceptible to posaconazole. His cutaneous lesion remained stable, but he died from respiratory failure secondary to lobar pneumonia. At lung autopsy, A. rosae was not identified in the lungs. We believe this to be the first published report, to our knowledge, of A. rosae infection in humans.

Using simulation for teaching femoral arterial access: A multicentric collaboration.

OBJECTIVE: To assess the impact of simulation training on complications associated with femoral arterial access obtained by first year cardiology fellows. BACKGROUND: Prior studies demonstrate a higher incidence of arterial access related complications among patients undergoing invasive cardiac procedures. METHODS: First year cardiology fellows at four teaching hospitals in Michigan tracked their femoral access experience and any associated complications between July 2011 and June 2013. Fellows starting their academic training in July 2012 were first trained on a specially developed simulator before starting their rotation in the catheterization laboratory. The primary outcome was access proficiency, defined as five successful femoral access attempts without any complication or need to seek help from a more experienced team member. RESULTS: A total of 1,278 femoral access attempts were made by 21 fellows in 2011-2012 compared with 869 femoral access attempts made by 21 fellows in 2012-2013. There was a lower rate of access related complications in patients undergoing access attempts by first year fellows in year 2 compared with year 1 (2.1% versus 4.5%, P = 0.003). The number of procedures to achieve procedural proficiency was significantly higher in year 1 compared with year 2 (median 20 versus 10, P = 0.007). CONCLUSIONS: Incorporation of simulation in the training of first year fellows was associated with an improvement in proficiency and a clinically meaningful reduction in vascular complications.