ARISE: First-In-Human Evaluation of a Novel Stent Graft to Treat Ascending Aortic Dissection.

BACKGROUND: Operative mortality for type A aortic dissection is still 10-20% at centers of excellence. Additionally, 10-20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ). OBJECTIVE: The purpose of this study is to assess early feasibility of using these investigational devices to treat ascending aortic dissection. METHODS: This a prospective, multicenter, non-randomized, single-arm study that enrolls patients at high surgical risk with appropriate anatomical requirements based on computed tomography imaging at 7 of 9 US sites. Devices are delivered transfemorally under fluoroscopic guidance. Primary endpoint is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, and 12 months. RESULTS: Nineteen patients were enrolled with a mean age of 75.7 years (range 47-91) and 11 (57.9%) were female. Ten (52.6%) had DeBakey type I disease, and the rest were type II. Sixteen (84.2%) of the patients were acute. Patients were treated with safe access, (7/19 (36.8%) percutaneous, 10/19 (52.6%) transfemoral, 2/19 (10.5%) iliac conduit), delivery, and deployment completed in all cases. Median procedure time was 154 mins (range 52-392) and median contrast used was 111 mL (range 75-200). MACCE at 30 days occurred in 5 patients including mortality 3/19 (15.8%), disabling stroke in 1/19 (5.3%), and myocardial infarction in 1/19 (5.3%). CONCLUSION: Results from the ARISE early feasibility study of a specific ascending stent graft device to treat ascending aortic dissection are promising.

Emergency and Compassionate Use of a Novel Ascending Endograft for Ascending and Arch Aortic Pathology.

PURPOSE: Patients with complicated ascending aortic pathology, including patients with acute type A aortic dissection may be at extreme risk for open repair. Thoracic endovascular aortic repair (TEVAR), infrequently used for the ascending aorta, may be considered an alternative in this setting. We describe early results for emergency and compassionate (E&C) use of a novel endograft, specifically designed for use to treat pathology of the ascending aorta. MATERIALS AND METHODS: This case series evaluated 19 patients (mean age, 68.84±13.12 years; 57.9% female) treated with ascending TEVAR for acute and chronic acute (4), subacute (1), or chronic (1) aortic dissection or pseudoaneurysm (13). Six of the 19 patients (31.5%) were treated under compassionate use and 13 patients (68.4%) were treated under the emergency use exemption. Ten patients (52.6%) received additional devices to extend treatment into the arch and descending aorta. RESULTS: Device delivery was achieved in all patients (100%). Thirty-day mortality and stroke occurred in 3 patients (15.8%) and in 1 patient (5.3%), respectively. In 1 patient (5.3%), with an Unanticipated Adverse Device Event, the aorta ruptured when the endograft eroded into the adventitial portion of dissection site at the posterior aspect of the ascending wall. Devices were explanted in 2 patients (10.5%), 353 and 610 days after the index procedure, respectively. Six patients had endoleaks (31.6%), including type I (n=2, 10.5%), type II endoleaks (n=3, 15.8%), and indeterminate endoleak (n=1, 5.3%). CONCLUSIONS: Delivery and deployment of a novel ascending thoracic stent graft with or without an additional branched arch extension is feasible in patients with complex anatomy and pathology, including acute aortic dissection and pseudoaneurysm. Additional experience with this novel device will further refine the patient population most suitable for endovascular ascending aortic repair for these pathologies. CLINICAL IMPACT: This study describes a novel stent graft specifically designed for treatment of ascending aortic pathology, including acute type A dissection. The patients described in this series constituted a group outside the formal US FDA sponsored clinical trial, and were those accepted as part of an emergency and compassionate use basis.

Factors associated with saphenous vein recanalization after endothermal ablation.

BACKGROUND: Endovenous thermal ablation has emerged as an alternative therapy for the treatment of chronic superficial venous insufficiency (CVI) of the lower extremities. Recanalization, or anatomic failure, of a vein after endovenous radiofrequency ablation (RFA) has been described, albeit an infrequent occurrence. This study was performed to demonstrate risk factors associated with the efficacy of RFA and recanalization in the treatment of CVI. METHODS: Data were collected in an ongoing multicenter registry, which was retrospectively reviewed. This study reviewed 249 limbs that underwent RFA of either the great saphenous vein (GSV) or the small saphenous vein (SSV) over a three-year period, including only patients for whom an intermediate (6 month) follow-up venous duplex ultrasound was available. Patients in whom recanalization was demonstrated via duplex (n = 17, 6.8%) were analyzed for patient-level characteristics. Logistic regression analysis was performed to determine the existence of any significant clinical risk factors associated with anatomic failure. The need for secondary interventions because of clinical symptoms associated with recanalization was analyzed as well. RESULTS: In this cohort, the initial vein occlusion rate was 93.1%. Segmental (n = 9, 53%) or complete (n = 8, 47%) recanalization was seen in 17 limbs (6.8%) after initial successful GSV ablation. All SSV remained persistently ablated. Anatomic failure was associated with higher rate of clinical symptom recurrence (41% vs. 21%; relative risk (RR), 2.75; 95% confidence interval [CI], 0.99-7.6; P < 0.05) and an increased need for secondary vein procedures in the affected limbs (35% vs. 12%; RR, 3.96; 95% CI, 1.3-11.7; P < 0.05). Two recanalized GSVs required repeated endothermal ablation, in efforts to aid in the healing of ulcerations. Patient factors including diabetes, hypertension, hyperlipidemia, anticoagulation or antiplatelet agent usage, presence of deep venous reflux, or tobacco use did not increase the risk of RFA failure. Comparatively, patients with GSV recanalization had a longer mean follow-up time (63.3 vs. 41.6 weeks) but no difference in disease severity (C4, 35% vs. 17%; C5, 18% vs. 15%; C6, 6% vs. 8%; not significant). CONCLUSIONS: Endothermal ablation is an efficacious treatment for CVI with most patients remaining reflux free. Recanalization of an isolated vein segment after RFA, although shown in recent literature to be effected by anatomic risk factors, appears to be a sporadic phenomenon with respect to clinical risk factors. Nevertheless, in our cohort, anatomic failure was associated with a 2-fold increase in symptom recurrence and the need for interval secondary vein procedures. Ultrasound interrogation is recommended especially in patients with persistent or recurrent symptoms or nonhealing ulcerations.

Effect of increasing heart rate and tidal volume on stroke volume variability in vascular surgery patients.

OBJECTIVE: Because heart rate affects ventricular filling, the aim of the present study was to assess the effects of increasing heart rate and tidal volume on stroke volume variability to determine whether this dynamic index is heart-rate dependent. DESIGN: Prospective, randomized study. SETTING: Single university hospital. PARTICIPANTS: Eighteen vascular surgery patients having general anesthesia and endotracheal intubation with an arterial catheter connected to the Vigileo FloTrac system (Edwards Lifesciences, Irvine, CA) and a transesophageal atrial pacemaker (CardioComman Inc, Tampa, FL). INTERVENTION: A 2 × 2 factorial study of changes in heart rate (80 bpm and 110 bpm) and tidal volume (6 mL/kg and 10 mL/kg). MEASUREMENTS AND MAIN RESULTS: With tidal volume at 6 mL/kg, increasing heart rate from 80 mL/kg to 110 bpm caused stroke volume variability to increase from 12.2% ± 5.7% to 13.2% ± 5.3% (p<0.05), and with tidal volume at 10 mL/kg, increasing heart rate from 80 mL/kg to 110 bpm caused stroke volume variability to increase from 19.7% ± 7.9% to 22.0% ± 8.6% (p<0.05). In comparison, increasing tidal volume from 6 mL/kg to 10 mL/kg produced a significantly greater effect on stroke volume variability than increasing heart rate. CONCLUSIONS: Stroke volume variability is sensitive to increases in heart rate in addition to tidal volume. Increasing heart rate caused stroke volume variability to increase significantly, although not to the same magnitude as increasing tidal volume. When using dynamic volume indices, clinicians should be aware of increases in heart rate, although its clinical impact may be relatively minor compared with changes in tidal volume.

What did the transcatheter aortic valve replacement-surgical aortic valve replacement (TAVR-SAVR) trials tell us?

Two families of randomized trials comparing transcatheter aortic valve replacement (TAVR) to surgery for both the Balloon Expandable Valve and the Supra Annular Self-Expanding Valve have been completed to include all surgical risk levels. The result of these trials has led to the approval of TAVR for symptomatic severe aortic stenosis without using risk level as the sole criterion. We have seen an explosion of TAVR in the US to over 98,000 commercial cases in 2022. We have also seen a rapid increase in the use of TAVR in patients less than 65 years of age. With these increases, it is important to ask if they are being driven largely by the data or just the desire for TAVR by both patients and their physicians. Heart team input is a class I indication when deciding between TAVR and surgery. For surgical members of the heart team to appropriately counsel patients, a full understanding of what the TAVR surgery trials tell us as well as what they do not is essential. In this article we will explore those questions.

Open repair of a proximal left subclavian artery mycotic aneurysm with median claviculectomy.

Surgical repair of a subclavian artery mycotic aneurysm is dependent on aneurysm-specific characteristics and anatomic exposures could require sternotomy, thoracotomy, or supraclavicular incisions. Alternatively, a median claviculectomy can be used. We successfully performed a subclavian artery to axillary artery bypass with median claviculectomy in a 23-year-old man with multiple comorbidities. Postoperative Doppler ultrasound showed a patent left axillary artery with a palpable left radial artery, and the patient demonstrated full left shoulder range of motion without any significant deformities. This case suggests that a median claviculectomy can produce satisfactory outcomes in patients with subclavian artery mycotic aneurysms.

Echocardiographic Profiling Predicts Clinical Outcomes After Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Prior studies investigating the impact of residual mitral regurgitation (MR), tricuspid regurgitation (TR), and elevated predischarge transmitral mean pressure gradient (TMPG) on outcomes after mitral transcatheter edge-to-edge repair (TEER) have assessed each parameter in isolation. We sought to examine the prognostic value of combining predischarge MR, TR, and TMPG to study long-term outcomes after TEER. METHODS AND RESULTS: We reviewed the records of 291 patients who underwent successful mitral TEER at our institution between March 2014 and June 2022. Using well-established outcomes-related cutoffs for predischarge MR (≥moderate), TR (≥moderate), and TMPG (≥5 mm Hg), 3 echo profiles were developed based on the number of risk factors present (optimal: 0 risk factors, mixed: 1 risk factor, poor: ≥2 risk factors). Discrimination of the profiles for predicting the primary composite end point of all-cause mortality and heart failure hospitalization at 2 years was examined using Cox regression. Overall, mean age was 76.7±10.6 years, 43.3% were women, and 53% had primary MR. Two-year event-free survival was 61%. Predischarge TR≥moderate, MR≥moderate, and TMPG≥5 mm Hg were risk factors associated with the primary end point. Compared with the optimal profile, there was an incremental risk in 2-year event-rate with each worsening profile (optimal as reference; mixed profile: hazard ratio (HR), 2.87 [95% CI, 1.71-5.17], P<0.001; poor profile: HR, 3.76 [95% CI, 1.84-6.53], P<0.001). Echocardiographic profile was statistically associated with the 2-year mortality end point (optimal as reference; mixed profile: HR, 3.55 [95% CI, 1.81-5.96], P<0.001; poor profile: HR, 3.39 [95% CI, 2.56-7.33], P=0.02). CONCLUSIONS: The echocardiographic profile integrating predischarge TR, MR, and TMPG presents a novel prognostic stratification tool for patients undergoing mitral TEER.

Prognostic Value of Right Ventricular Afterload in Patients Undergoing Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Pulmonary hypertension (PH) and secondary mitral regurgitation (MR) are associated with adverse outcomes after mitral transcatheter edge-to-edge repair. We aim to study the prognostic value of invasively measured right ventricular afterload in patients undergoing mitral transcatheter edge-to-edge repair. METHODS AND RESULTS: We identified patients who underwent right heart catheterization ≤1 month before transcatheter edge-to-edge repair. The end points were all-cause mortality and a composite of mortality and heart failure hospitalization at 2 years. Using the receiver operating characteristic curve-derived threshold of 0.6 for pulmonary effective arterial elastance ([Ea], pulmonary artery systolic pressure/stroke volume), patients were stratified into 3 profiles based on PH severity (low elastance [HE]: Ea <0.6/mean pulmonary artery pressure (mPAP)) <35; High Elastance with No/Mild PH (HE-): Ea ≥0.6/mPAP <35; and HE with Moderate/Severe PH (HE+): Ea ≥0.6/mPAP ≥35) and MR pathogenesis (Primary MR [PMR])/low elastance, PMR/HE, and secondary MR). The association between this classification and clinical outcomes was examined using Cox regression. Among 114 patients included, 50.9% had PMR. Mean±SD age was 74.7±10.6 years. Patients with Ea ≥0.6 were more likely to have diabetes, atrial fibrillation, New York Heart Association III/IV status, and secondary MR (all P<0.05). Overall, 2-year cumulative survival was 71.1% and was lower in patients with secondary MR and mPAP ≥35. Compared with patients with low elastance, cumulative 2-year event-free survival was significantly lower in HE- and HE+ patients (85.5% versus 50.4% versus 41.0%, respectively, P=0.001). Also, cumulative 2-year event-free survival was significantly higher in patients with PMR/low elastance when compared with PMR/HE and patients with secondary mitral regurgitation (85.5% versus 55.5% versus 46.1%, respectively, P=0.005). CONCLUSIONS: Assessment of the preprocedural cardiopulmonary profile based on mPAP, MR pathogenesis, and Ea guides patient selection by identifying hemodynamic features that indicate likely benefit from mitral-transcatheter edge-to-edge repair in PH or lack thereof.

Impact of Left Atrial Pressure on Outcomes After Mitral Transcatheter Edge-to-Edge Repair.

Background: Increased left atrial pressure (LAP) has been associated with adverse outcomes after mitral transcatheter edge-to-edge repair (M-TEER). We sought to evaluate outcomes based on differences in post-procedural LAP measured after final clip deployment. Methods: We included consecutive patients who underwent M-TEER at our institution between 2014-2022 with LAP monitoring. Patients were stratified into 3 groups according to tertiles of post-TEER mean LAP. Outcomes were assessed using Kaplan-Meier analysis and Cox proportional hazard models. Results: We included 273 patients (mean age 76.8±10.8 years, 42.5% women, 78.4% Caucasian). The mean post-TEER LAP was 8.7±1.7 mmHg in tertile 1 (N=85), 14.4±1.6 mmHg in tertile 2 (N=95), and 21.9±3.8 mmHg in tertile 3 (N=93). In comparison with tertile 1, both tertiles 2 and 3 were associated with increased risk of all-cause mortality or heart failure hospitalization at 2 years (adjHR 2.27, 95% CI 1.25-4.12; and adjHR 3.00, 95% CI 1.59-5.64 respectively). Among patients with primary MR, higher LAP was associated with increased risk of 2-year all-cause mortality or heart failure hospitalization [tertile 2 vs. 1: adjHR 3.00, 95% CI 1.37-6.56; and tertile 3 vs. 1: adjHR 5.52, 95% CI 2.04-14.95). However, in patients with secondary MR, neither being in tertile 2 (adjHR 1.53; 95% CI 0.55-4.24), nor tertile 3 (adjHR 2.18; 95% CI 0.82-5.77) were associated with the composite outcome compared with tertile 1. Any degree of LAP reduction following M-TEER was associated with lower mortality or heart failure hospitalization compared with no LAP reduction (adjHR 0.59; 95% CI 0.39-0.88). Conclusions: Elevated LAP after M-TEER was associated with increased 2-year risk of mortality or heart failure hospitalization. Exploration of reasons for elevated LAP after M-TEER, and ways to lower it warrant further investigation.

The management of chronic venous insufficiency with ulceration: the role of minimally invasive perforator interruption.

BACKGROUND: The purpose of this study was to analyze the long-term outcomes associated with interruption of incompetent perforator veins (IPV) using minimally invasive techniques as adjunctive therapies in the management of patients with chronic venous insufficiency (CVI). METHODS: This is a retrospective review of a prospectively maintained venous database collected over 6 years (2005-2011). The study cohort included 64 patients with CVI stage C5 or C6 who underwent minimally invasive perforator interruption with subfascial endoscopic perforator surgery (SEPS) or radiofrequency ablation of IPV (RFA-IPV) as part of the management of their CVI. All patients were referred for evaluation after having failed conservative treatment with compression dressings. Relevant patient characteristics and comorbidities were recorded along with symptom resolution, venous ulcer healing, recurrence, and surgical complications. In addition to clinic follow-up examination by a surgical provider, chart notes from other subspecialties were also reviewed. We also conducted telephone assessments in patients who had been lost to clinic follow-up in order to provide complete outcome data. RESULTS: In this subset (n = 64) of patients with CVI who had adjunctive IPV treatment, 41 (64%) underwent SEPS and 23 (36%) patients underwent RFA-IPV along with ablation of the greater saphenous vein for C5 or C6 disease. The mean patient follow-up was 37 months. There were no differences in patient demographics or risk factors. Twenty-three (88%) SEPS and 12 (100%) RFA-IPV patients (P = NS) with C6 disease went on to completely heal their venous ulcers after the procedure with an average healing time of 5.2 (SEPS) and 4.4 (RFA-IPV) months (P = NS). Overall, 7 (17%) SEPS and 6 (23%) RFA-IPV patients (P = NS) developed a recurrent ulcer after surgical treatment. Procedural complications were seen in 14 (34%) SEPS and 2 (9%) RFA-IPV patients (P = NS), mostly minor. Major complications only occurred in the SEPS group consisting of 2 major amputations caused by pain from nonhealing ulcers and 1 deep venous thrombosis. CONCLUSIONS: This study supports the premise that in patients with advanced venous disease, there may be a demonstrable benefit directly attributable to perforator interruption. Our recurrent ulceration rates are acceptable, with low complication rates in patients undergoing RFA-IPV, thereby making this procedure more attractive in patients with multiple comorbidities. We support an aggressive approach to patients with C5/C6 disease that includes perforator elimination when appropriate.

Branched and Fenestrated Aortic Endovascular Grafts.

Endovascular repair of abdominal and descending thoracic aortic aneurysms has become the standard of care due to improvements in morbidity and mortality compared to open surgical repair. Late durability, however, remains an issue because persistent endoleaks can lead to continued aneurysm expansion and eventual rupture, sometimes years following the original repair. Branched, fenestrated, and physician-modified endografts in the thoracic arch and thoracoabdominal aorta have extended the seal zone in order to mitigate the risks of proximal and distal endoleaks. This review summarizes the current state of branched, fenestrated, and physician-modified endografts used in complex aortic pathologies.

Endovascular Management of the Ascending Aorta: State of the Art.

Endovascular stent graft repair (EVAR) has revolutionized the management of aneurysms and dissections of the thoracic and abdominal aorta and is considered the first-line treatment in such pathologies. Initially designed for patients unfit for open repair, EVAR and thoracic endovascular aortic stent graft repair are associated with improved morbidity and mortality and a faster recovery process. The endovascular revolution of the aorta continues moving proximally, with fenestrated and branch stent grafts currently in clinical trials for the management of thoracoabdominal aortic aneurysms, and several branched thoracic devices are either approved or in trial for management of aortic arch pathologies. The final frontier in the endovascular management of the aorta is the aortic root and ascending aorta. The first early feasibility trial for management of type A aortic dissection has recently concluded with a multicenter phase 2 study slated for the spring of 2023. The following article updates the reader on the unique challenges of endovascular management of the ascending aorta and a look at the future technologies that will define this space.

Cardiovascular collapse during mechanical thrombectomy for acute pulmonary embolism and the role of extracorporeal membrane oxygenation in patient rescue.

BACKGROUND: Driven by the ability to avoid thrombolytics and provide a one stop procedure with immediate hemodynamic improvement, there has been a dramatic increase in the use of mechanical thrombectomy (MT) devices for the treatment of intermediate-to-high risk pulmonary embolism (PE). This study investigated the incidence and outcomes of cardiovascular collapse during MT procedures and demonstrates the role of extracorporeal membrane oxygenation (ECMO) in salvaging patients. METHODS: This single-center retrospective review included patients with PE undergoing MT with the FlowTriever device between 2017 and 2022. Patients presenting periprocedural cardiac arrest were identified and their perioperative characteristics and postoperative outcomes were evaluated. RESULTS: A total of 151 patients with a mean age of 64 ± 14 years who presented with intermediate-to-high risk PE received LBAT procedures during the study period. The simplified PE severity score was ≥1 in 83% of cases and the average RV/LV ratio was 1.6 ± 0.5, with and elevated troponin in 84%. Technical success was achieved in 98.7% and a significant decrease in pulmonary artery systolic pressure (PASP) was observed (37 mm Hg vs 56 mm Hg; P < .0001). Intraoperative cardiac arrest occurred in nine patients (6%). These patients were more likely to present PASP of ≥70 mm Hg (84% vs 14%; P < .001), were more hypotensive upon admission (systolic of 94 ± 14 mm Hg vs 119 ± 23 mm Hg; P = .004), presented lower oxygen saturation levels (87 ± 6% vs 92 ± 6%; P = .023) and were more likely to present with a history of recent surgery (67% vs 18%; P = .004). Four patients were rescued successfully with ECMO and their residual PE was subsequently removed before discharge by surgical embolectomy in two of the four cases and repeat MT in the other two. All five patients (3%) who did not receive ECMO support expired intraoperatively. The overall 30-day mortality was 8% with no death occurring in patients who were salvaged with ECMO. CONCLUSIONS: Large-bore aspiration thrombectomy for acute PE is associated with favorable technical outcomes, but the concern for acute cardiac decompensation is non-negligible in patients presenting with high-risk features and a PASP of ≥70 mm Hg. ECMO can help to salvage some of these patients and should be considered in the treatment algorithms of patients deemed at high risk.

What's New with TAVR? An Update on Device Technology.

Over the last 20 years, transcatheter aortic valve replacement (TAVR) has revolutionized the management of aortic stenosis and has become the standard of care across the entire spectrum of surgical risk. Expansion of TAVR in treating younger, lower-risk patients with longer life expectancies, and treating earlier in the disease process, has seen a continuous evolution in device technology, with several next-generation transcatheter heart valves developed to minimize procedural complications and improve patient outcomes. This review provides an update on the latest advances in transcatheter delivery systems, devices, and leaflet technology.

TAV-in-TAV in Failed Homograft: Redo TAVI in a Patient With 3 Previous Sternotomies.

A 59-year-old male patient with history of rheumatic heart disease with 3 previous surgical aortic valve replacements with the last one being homograft followed by transcatheter aortic valve implantation in failed homograft presented with severe aortic regurgitation and cardiogenic shock requiring urgent TAV-in-TAV-in homograft. (Level of Difficulty: Advanced.).

Feasibility and Outcomes of Mitral Transcatheter Edge-To-Edge Repair in Patients With Variable Degrees of Mitral Annular Calcification.

Background The clinical significance of mitral annular calcification (MAC) in patients undergoing mitral transcatheter edge-to-edge repair is not well understood. There is limited evidence regarding the feasibility, durability of repair, and the prognostic value of MAC in this population. We sought to examine the prognostic value of MAC, its severity, and its impact on procedural success and durability of mitral transcatheter edge-to-edge repair. Methods and Results We reviewed the records of 280 patients with moderate-severe or severe mitral regurgitation who underwent mitral transcatheter edge-to-edge repair with MitraClip from March 2014 to March 2022. The primary end point was cumulative survival at 1 year. Independent factors associated with the primary end point were identified using multivariable Cox regression. Among 280 patients included in the final analysis, 249 had none/mild MAC, and 31 had moderate/severe MAC. Median follow-up was 23.1 months (interquartile range: 11.1-40.4). Procedural success was comparable in the MAC and non-MAC groups (92.6% versus 91.4%, P=0.79) with similar rates of residual mitral regurgitation ≤2 at 1 year (86.7% versus 93.2%, P=0.55). Moderate/severe MAC was associated with less improvement in New York Heart Association III/IV at 30 days when compared with none/mild MAC (45.8% versus 14.3%, P=0.001). The moderate/severe MAC group had lower cumulative 1-year survival (56.8% versus 80.0%, hazard ratio [HR], 1.98 [95% CI, 1.27-3.10], P=0.002). Moderate/severe MAC and Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair were independently associated with the primary end point (HR, 2.20 [1.10-4.41], P=0.02; and HR, 1.014 [1.006-1.078], P=0.02, respectively). Conclusions Mitral TEER is a safe and feasible intervention in selected patients with significant MAC and associated with similar mitral regurgitation reduction at 1 year compared with patients with none/mild MAC. Patients with moderate/severe MAC had a high 1-year mortality and less improvement in their symptoms after TEER.

First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System.

BACKGROUND: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited. OBJECTIVES: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience. METHODS: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported. RESULTS: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001). CONCLUSIONS: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.

Parallel grafts and physician modified endografts for endovascular repair of the aortic arch.

Aortic arch aneurysms are a challenging clinical problem especially in high-risk patients. Open aortic arch replacement, even in the best of centers, carries significant risk of stroke or death in this high-risk population. Many high-risk patients are deemed inoperable and not offered repair. Branched and fenestrated thoracic endografts are currently undergoing clinical trials in the United States but are not yet commercially available. Many elderly and frail patients have significant brachiocephalic occlusive disease or anatomy excluding them for consideration for such clinical trials. These patients also present with acute aortic syndromes requiring urgent or emergent repair and are unable to participate in clinical trials due to the time required to have such devices available. Alternative endovascular therapies, including parallel stent grafts (including Chimneys, Snorkels and Periscopes) and physician modified thoracic endografts, have been used to treat such high-risk patients combined with commercially available thoracic endovascular aneurysm repair (TEVAR) devices. This paper aims to review the techniques and current reported outcomes from parallel stent grafts and physician modified devices used to treat high risk patients undergoing repair for aortic arch pathologies.

An Undiagnosed Ventricular Septal Rupture Presenting as New Onset Heart Failure: A Rare Complication of an Anterior Myocardial Infarction.

Ventricular septal ruptures (VSR) are a rare but fatal complication of acute myocardial infarctions. We present a patient complaining of new onset heart failure symptoms that were found to be secondary to a new ventricular septal rupture from a recently undiagnosed anterior myocardial infarction. The patient underwent successful VSR patch repair with eventual recovery. This case highlights the importance of early diagnosis of VSR and reviews management options and appropriate timing for intervention.