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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.