MANTA versus Perclose for large-bore vessel closure: The evidence continues to grow.

The MANTA is a new, easy-to-use, collagen plug-based vascular closure device specifically designed for large-bore arteriotomy closure. The authors report on their experience comparing the MANTA device with the Perclose ProGlide technique in patients undergoing transcatheter aortic valve replacement. They found similar rates of success and vascular complications with both devices, suggesting that MANTA is a suitable option for these patients. It remains to be determined whether one device will emerge as the ideal choice for most patients. Device cost is a significant barrier to widespread adoption, but price has decreased recently.

Clinical impact of calcified nodules in patients with heavily calcified lesions requiring rotational atherectomy.

Coronary atherectomy has been around for many years, and the body of evidence for its use in complex calcified lesions has grown. Calcific coronary disease presents a particularly challenging clinical scenario in PCI, having poorer outcomes than noncalcified lesions. This study is the first to identify calcified nodules as an independent predictor of worse outcomes after atherectomy and PCI. Continued study of lesion characteristics will improve our understanding of PCI outcomes and help manage patients in the long-term after PCI and stenting.

Preventing tricuspid valve injury during transcatheter pulmonary valve replacement.

The transcatheter pulmonary valve replacement technique has evolved over the past decade. There is risk of injuring the tricuspid valve if the transcatheter device is advanced uncovered across the right heart. Advancing a long sheath past the landing zone and uncovering the device can help mitigate this risk, at the expense of requiring larger-caliber sheaths. Additional refinements of the technique such as the one reported here, along with improvements in device design, are likely to further reduce complications.

Effect of concomitant aortic regurgitation on early hypoattenuated leaflet thickening after transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis.

Identification of hypoattenuated leaflet thickening (HALT) and subacute leaflet thrombosis has become widely recognized. Patients with anatomical changes associated with moderate or greater aortic regurgitation (larger sinus of Valsalva and eccentric left ventricular remodeling) appear to have less HALT early postprocedure compared with those without. Further research on the risk factors including anatomical and hemodynamic variables should further our knowledge of these entities so we can better manage patient both pre and post TAVR.

Thoracic aortic disease: Can we safely cover the branches?

Thoracic aortic disease has usually been treated with surgery. Thoracic endovascular aortic repair is challenging if supra-aortic vessels are involved. In situ fenestration of the main graft from a retrograde approach while using bare-metal stents as bridge stents appears to be a safe and practical technique.

Peripheral arterial disease and transcatheter valve replacement outcomes.

Patients with PAD have worse outcomes after TAVR. The extent and distribution of PAD are important considerations in determining TAVR feasibility and choosing an access site. Further research is needed to establish the best approaches to treating patients with aortic and iliofemoral disease severe enough to limit device delivery.

Assessing atherothrombotic burden with optical coherence tomography analysis may facilitate post-PCI prognostication and antiplatelet therapy.

Atherothrombotic burden (ATB) correlates with myocardial blush grade (MBG), a known predictor of mortality and outcome after ST-elevation myocardial infarction. Quantitative or semiquantitative analysis of ATB with optical coherence tomography may assist interventional cardiologists in post-PCI prognostication and, perhaps, in rendering more aggressive antiplatelet therapy. Future studies comparing treatment strategies for post-PCI patients with elevated ATB or depressed MBG may identify best practices after acute coronary syndromes.

Editorial for: Outcomes after endovascular mechanical thrombectomy in occluded vascular access used for dialysis purposes.

Multimodality interventions, including both percutaneous and surgical approaches, are paramount in maintaining vascular fistula and graft patency in hemodialysis patients. Mechanical thrombectomy with Angiojet AVX or Solent Proxi of AVFs and AVGs achieved acceptable technical and clinical success rates (>90%) in combination with adjuvant percutaneous transluminal angioplasty and stenting. Future prospective studies using intravascular imaging before therapy may be useful when deciding which treatment modalities to use for AVFs and AVGs.

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures.

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study (ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

Branch pulmonary artery stenting in children by using premounted stents: Can we benefit from slenderization?

Children with branch pulmonary artery stenosis represent a challenging cohort for stenting Premounted stent implantation provides immediate obstruction relief and hemodynamic improvement in infants Planned stent intervention is required to account for somatic growth and next stage palliation in children Continued slenderization of adult coronary and peripheral interventions, stent technology, and delivery systems may allow for more durable solutions in light of patient size.

Percutaneous pulmonary valve implantation: It's not like the aortic valve.

The Edwards Sapien S3 demonstrated clinical and technical feasibility in this cohort undergoing percutaneous pulmonary valve implantation. Traversing the tricuspid apparatus with an unsheathed delivery system continues to pose a risk for tricuspid valve injury. Future design innovations need to accommodate for large outflow tracts without adjacent aortic or coronary compression and allow for safe device delivery with minimal trauma to the tricuspid apparatus.

Percutaneous atrial septal occluders: Are we there yet?

In a randomized, controlled trial, the Occlutech Figulla Flex II occluder was shown to be noninferior to the Amplatzer Septal Occluder. Both devices provided greater than 90% efficacy, with limited residual shunting and major complications. Although the risk of overall device erosions was low, larger and longer-term studies are needed to distinguish the differences between devices.

Does single-valve surgery cause ischemia?

Isolated valve surgery is associated with a small incidence of postoperative PCI. PCI after single-valve surgery is associated with elevated mortality and morbidity risk. Possible mechanisms for cardiac ischemia include iatrogenic causes (such as suture-related or air embolism), intimal hyperplasia, and immunologic reaction to the valve prosthesis.

TAVI: How to best predict postprocedural outcomes?

Baseline risk scores for TAVI patients, including STS and EuroSCORE, might not predict long-term outcomes. Including postprocedural data might improve risk stratification. The ACEF-7 risk score includes the lowest creatinine clearance in the first 7 postprocedural days and appears to be a good predictor of worse long-term outcomes.

Myocardial fibrosis and MitraClip: Does it even matter?

Preprocedural myocardial fibrosis as identified by magnetic resonance imaging correlates with worse outcomes after MitraClip placement. Post-MitraClip mitral regurgitation gradient >2 or ischemic cardiomyopathy also correlates with worse outcomes. In the literature, other variables are mentioned (e.g., severe tricuspid regurgitation, atrial fibrillation, postoperative mitral valve area and/or gradient) that correlate with worse post-MitraClip outcomes.

Delivery catheters: Do they truly make a difference in transcatheter pulmonary valve replacement?

Transcatheter pulmonary valve replacement (TPVR) is a safe and feasible procedure for treating pulmonary stenosis, failed right ventricular conduits, or failed bioprosthetic valves. The medtronic melody valve and the Edwards Sapien XT and S3 valves have been the main prosthetic valves used in TPVR. Using the GORE DrySeal sheath helps valve delivery and facilitates TPVR.

Aortic dissection: Is the false lumen really important?

Aortic dissection is associated with a high mortality rate and has been increasingly treated with endovascular therapy. False lumen (FL) patency has been shown to be associated with worse outcomes. FL interventions that incorporate the FLIRT (FL intervention to promote remodeling and thrombosis) concept have been associated with improved aortic remodeling that may confer favorable long-term outcomes.

Use of an AFX aortic cuff in the endovascular treatment of aortocaval fistula secondary to abdominal aortic pseudoaneurysm.

Aortocaval fistula (ACF) is rare and lethal and can be either primary (due to an enlarged abdominal aortic aneurysm) or secondary (iatrogenic or secondary to abdominal surgery) in origin. We describe a case of an ACF secondary to a ruptured abdominal aortic pseudoaneurysm that we successfully treated with a planned endovascular approach using an AFX aortic cuff on both the arterial and venous sides.

Peripheral artery disease: How do genes and pharmacology interplay?

In patients with peripheral artery disease, high on-treatment platelet reactivity (HoTPR) might be associated with worse outcomes for those taking clopidogrel, but not for those taking aspirin. Certain genetic polymorphisms might account for HoTPR. Current literature supports the importance of antiplatelet therapy in treating patients with PAD with clopidogrel, aspirin, or both.

Plug vs. suture: Who wins in large bore access closure?

Large Bore Access in increasingly common and surgical closure used to be the gold standard for closure. Novel less invasive closure devices such as the suture based vascular devices offer a safe alternative to surgery. Recent developments provide us with MANTA (Essential Medical Inc., Malvern, Pennsylvania) a vascular closure device that seems to be as safe and associated with less bleeding. Certain genetic polymorphisms might account for HoTPR.