Project description:BACKGROUND:Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. OBJECTIVES:The authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access. METHODS:A total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%. RESULTS:Transcaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge. CONCLUSIONS:Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).
Project description:An 82-year-old patient presented with severe symptomatic aortic stenosis, a high surgical risk profile, and a history of abdominal aortic replacement. Arterial access vessel conditions precluded transarterial transcatheter aortic valve implantation (TAVI). Transcaval access through the aortic graft was achieved; however, tortuosity and resistance at the graft entry site hampered insertion of the introducer sheath and delivery system. Transcaval TAVI without a sheath was contemplated with the expectation of aortocaval fistulous decompression of blood around the TAVI catheter. Hemodynamic measures remained stable, and the valve was successfully implanted. This case illustrates the feasibility of sheathless transcaval TAVI without relevant hemodynamic compromise.
Project description:ObjectivesThe authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label.BackgroundTranscaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known.MethodsThe authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT).Results100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury.ConclusionsResults are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).
Project description:Transcaval, or caval-aortic, access is a promising approach for fully percutaneous transcatheter aortic valve implantation in patients without good conventional access options. This tutorial review provides step-by-step guidance to planning and executing the procedure, along with approaches to remedy complications.
Project description:Background: A small proportion of patients in need of transcatheter aortic valve replacement (TAVR) are not suitable for the transfemoral approach due to peripheral artery disease. Alternative TAVR approaches are associated with short- and long-term hazards. A novel technique of caval-aortic (transcaval) access for TAVR has been utilized as an alternative access technique. Aim: To compare safety and efficacy of transcaval access as compared to other alternative access (axillary or apical) for TAVR. Methods: A single-center, retrospective analysis of consecutive patients undergoing alternative access for TAVR. Events were adjudicated according to VARC-2 criteria. Results: A total of 185 patients were included in the present analysis. Mean age was 81 years with a small majority for male gender (54%). Of the entire cohort, 20 patients (12%) underwent transcaval TAVR, and 165 patients (82%) underwent TAVR using alternative access. Overall, baseline characteristics were comparable between the two groups. General anesthesia was not utilized in transcaval patients; however, it was routinely used in nearly all alternative access patients. TAVR device success was comparable between the two groups (95%). Acute kidney injury occurred significantly less frequently among transcaval patients as compared to alternative access patients (5 vs. 12%, p = 0.05). Hospital stay was shorter for transcaval patients (6.3 days vs. 14.4; p < 0.001). No difference in early or 30-day mortality (10 vs. 7.9%, p = 0.74) was noted between groups. Conclusions: In patients who cannot undergo TAVR via the trans-femoral approach due to peripheral vascular disease, transcaval access is a safe approach as compared to other alternative access techniques, with lower risk of kidney injury and shorter hospital stay.
Project description:Novel dedicated devices allow transcatheter treatment of pure aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System was introduced as the first dedicated and on-label AR transcatheter aortic valve replacement system, implementing a locator-based and calcium-independent anchoring mechanism. Here, we present the first-in-human transcatheter aortic valve replacement for pure AR via a transcaval access in a patient with prohibitive alternative arterial accesses.
Project description:Transcatheter aortic valve replacement (TAVR) has surpassed surgical aortic valve replacement (SAVR) as the most common treatment strategy for severe symptomatic aortic stenosis over the past decade. As TAVR technology has continued to advance, it has been expanded from being an option only for extreme risk patients to now being the preferred option for the majority of patients with severe aortic stenosis. Recent trials have shown that TAVR is superior or non-inferior to SAVR even in patients at low surgical risk. One limitation of TAVR is the need for large bore vascular access. This has improved over time with smaller sheath sizes and improved delivery systems, but is still a significant issue in a patient population that often has many comorbidities including peripheral arterial disease. Early in the TAVR experience the only option for alternative access was transapical access, which has consistently been linked to increased procedural complications and worsened clinical outcomes. However, in recent years several centers have demonstrated the safety and efficacy of several alternative access strategies including transaxillary, transcarotid, transcaval, and direct aortic. There are no randomized data comparing these strategies, so access site approach is chosen by the multidisciplinary heart team based on patient anatomy and site expertise. We will review the current data in alternative access that in our view supports prioritizing a transaxillary or transcarotid strategy. In addition, we will describe our center's pre-procedural planning, peri-procedural approach, and propose an algorithm for alternative access.
Project description:ObjectivesTo compare the outcomes after transcatheter aortic valve replacement (TAVR) through a transfemoral (TF) and transcarotid (TC) access at our institution.MethodsFrom January 2014 to January 2020, 62 TC-TAVR and 449 TF-TAVR were performed using 2 prosthesis devices (Edwards SAPIEN 3, n = 369; Medtronic Evolut R, n = 142). Propensity score matching was used to adjust for imbalance in the baseline characteristics of the study groups.ResultsPropensity score matching provided 62 matched pairs with comparable operative risk (mean European System for Cardiac Operative Risk Evaluation II, TC-TAVR 7.6% vs TF-TAVR 6.6%, P = .17). Thirty-day mortality (4.8% vs 3.2%, P = 1.00) and 2-year mortality (11.3% vs 12.9%, P = .64) after TC-TAVR were comparable with TF-TAVR. Strokes were numerically more frequent after TC-TAVR compared with TF-TAVR (3.2% vs 0%, P = .23), but the difference did not reach statistical significance. TF-TAVR was associated with a significantly greater risk of permanent pacemaker implantation (29.0% vs 12.9%, P = .04) compared with TC-TAVR. Other complications were not frequent and were similarly distributed between the matched groups.ConclusionsTC access for TAVR was associated with satisfactory results compared to the femoral access. TC-TAVR could be considered a valid and safe alternative to TF-TAVR when femoral access is contraindicated.
Project description:Background Peripheral vascular intervention (PVI) is occasionally required to facilitate delivery system insertion or to treat vascular complications during transfemoral transcatheter aortic valve replacement (TF-TAVR). However, the impact of PVI on outcomes is not well understood. Therefore, we aimed to compare outcomes between TF-TAVR with versus without PVI and between TF-TAVR with PVI versus non-TF-TAVR. Methods and Results We retrospectively reviewed 2386 patients who underwent TAVR with a balloon-expandable valve at a single institution from 2016 to 2020. The primary outcomes were death and major adverse cardiac/cerebrovascular event (MACCE), defined as death, myocardial infarction, or stroke. Of 2246 TF-TAVR recipients, 136 (6.1%) required PVI (89% bailout treatment). During follow-up (median 23.0 months), there were no significant differences between TF-TAVR with and without PVI in death (15.4% versus 20.7%; adjusted HR [aHR], 0.96 [95% CI, 0.58-1.58]) or MACCE (16.9% versus 23.0%; aHR, 0.84 [95% CI, 0.52-1.36]). However, compared with non-TF-TAVR (n=140), TF-TAVR with PVI carried significantly lower rates of death (15.4% versus 40.7%; aHR, 0.42 [95% CI, 0.24-0.75]) and MACCE (16.9% versus 45.0%; aHR, 0.40 [95% CI, 0.23-0.68]). Landmark analyses demonstrated lower outcome rates following TF-TAVR with PVI than non-TF-TAVR both within 60 days (death 0.7% versus 5.7%, P=0.019; MACCE 0.7% versus 9.3%; P=0.001) and thereafter (death 15.0% versus 38.9%, P=0.014; MACCE 16.5% versus 41.3%, P=0.013). Conclusions The need for PVI during TF-TAVR is not uncommon, mainly due to the bailout treatment for vascular complications. PVI is not associated with worse outcomes in TF-TAVR recipients. Even when PVI is required, TF-TAVR is associated with better short- and intermediate-term outcomes than non-TF-TAVR.