Vascular Complications in TAVR: Incidence, Clinical Impact, and Management.
ABSTRACT: Transcatheter aortic valve replacement (TAVR) has replaced surgical aortic valve replacement as the new gold standard in elderly patients with severe aortic valve stenosis. However, alongside this novel approach, new complications emerged that require swift diagnosis and adequate management. Vascular access marks the first step in a TAVR procedure. There are several possible access sites available for TAVR, including the transfemoral approach as well as transaxillary/subclavian, transcarotid, transapical, and transcaval. Most cases are primarily performed through a transfemoral approach, while other access routes are mainly conducted in patients not suitable for transfemoral TAVR. As vascular access is achieved primarily by large bore sheaths, vascular complications are one of the major concerns during TAVR. With rising numbers of TAVR being performed, the focus on prevention and successful management of vascular complications will be of paramount importance to lower morbidity and mortality of the procedures. Herein, we aimed to review the most common vascular complications associated with TAVR and summarize their diagnosis, management, and prevention of vascular complications in TAVR.
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:<h4>Background</h4>Transcarotid transcatheter aortic valve implantation (TAVI) is a worthwhile substitute in patients who might otherwise be inoperable; however, it is applied in <10% of TAVI cases. In patients with established carotid artery stenosis, the risk of complications is increased with the transcarotid access route.<h4>Case summary</h4>We report a case of concomitant transcarotid TAVI and carotid endarterectomy (CEA) in a patient with bovine aortic arch and previous complex infrarenal EndoVascular Aortic Repair (EVAR). The integrity and positioning of the previous EVAR endograft was risked by transfemoral access. The right subclavian artery was only 4.5?mm and the left subclavian was totally occluded so transcarotid access was chosen. The patient recovered well, with no neurological deficit and was discharged home after 72?h. He was last seen and was doing well 6?months post-procedure.<h4>Discussion</h4>In patients with severe aortoiliac disease, or previous aortic endografting, transfemoral access for TAVI can be challenging or even prohibitive. Alternative access sites such as transapical or transaortic are associated with added risk because they carry increased risk of major adverse cardiovascular events, longer intensive care unit and hospital stay, and increased cost. A transcaval approach for TAVI has also been reported but was not suitable for our patient due to prior EVAR. Concomitant TAVI via transcarotid access and CEA can be successful in experienced hands. This case highlights the importance of a team-based approach to complex TAVI cases in high-risk patients with complex vascular access.
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:OBJECTIVES:The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label. BACKGROUND:Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known. METHODS:The 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). RESULTS:100 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. CONCLUSIONS:Results 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:OBJECTIVES:This study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD). BACKGROUND:Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study. METHODS:Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration-approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up. RESULTS:Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD. CONCLUSIONS:The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494).
Project description:<b>Background:</b> 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. <b>Aim:</b> To compare safety and efficacy of transcaval access as compared to other alternative access (axillary or apical) for TAVR. <b>Methods:</b> A single-center, retrospective analysis of consecutive patients undergoing alternative access for TAVR. Events were adjudicated according to VARC-2 criteria. <b>Results:</b> 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%, <i>p</i> = 0.05). Hospital stay was shorter for transcaval patients (6.3 days vs. 14.4; <i>p</i> < 0.001). No difference in early or 30-day mortality (10 vs. 7.9%, <i>p</i> = 0.74) was noted between groups. <b>Conclusions:</b> In patients who cannot undergo TAVR <i>via</i> 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:Background Some concerns remain regarding the safety of transcarotid and transsubclavian approaches for transcatheter aortic valve replacement. We aimed to compare the risk of 30-day complications and death in transcarotid/transsubclavian versus transfemoral transcatheter aortic valve replacement recipients. Methods and Results Data from 20 studies, including 79 426 patients (16 studies) and 3992 patients (4 studies) for the evaluation of the unadjusted and adjusted impact of the arterial approach were sourced, respectively. The use of a transcarotid/transsubclavian approach was associated with an increased risk of stroke when using unadjusted data (risk ratio [RR], 2.28; 95% CI, 1.90-2.72) as well as adjusted data (odds ratio [OR], 1.53; 95% CI, 1.05-2.22). The pooled results deriving from unadjusted data showed an increased risk of 30-day death (RR, 1.46; 95% CI, 1.22-1.74) and bleeding (RR, 1.53; 95% CI, 1.18-1.97) in patients receiving transcatheter aortic valve replacement through a transcarotid/transsubclavian access (compared with the transfemoral group), but the associations between the arterial access and death (OR, 1.22; 95% CI, 0.89-1.69), bleeding (OR, 1.05; 95% CI, 0.68-1.61) were no longer significant when using adjusted data. No significant effect of the arterial access on vascular complication was observed in unadjusted (RR, 0.84; 95% CI, 0.66-1.06) and adjusted (OR, 0.79; 95% CI, 0.53-1.17) analyses. Conclusions Transcarotid and transsubclavian approaches for transcatheter aortic valve replacement were associated with an increased risk of stroke compared with the transfemoral approach. However, these nonfemoral arterial alternative accesses were not associated with an increased risk of 30-day death, bleeding, or vascular complication when taking into account the confounding factors.
Project description:OBJECTIVES:This study describes the first use of caval-aortic access and closure to enable transcatheter aortic valve replacement (TAVR) in patients who lacked other access options. Caval-aortic access refers to percutaneous entry into the abdominal aorta from the femoral vein through the adjoining inferior vena cava. BACKGROUND:TAVR is attractive in high-risk or inoperable patients with severe aortic stenosis. Available transcatheter valves require large introducer sheaths, which are a risk for major vascular complications or preclude TAVR altogether. Caval-aortic access has been successful in animals. METHODS:We performed a single-center retrospective review of procedural and 30-day outcomes of prohibitive-risk patients who underwent TAVR via caval-aortic access. RESULTS:Between July 2013 and January 2014, 19 patients underwent TAVR via caval-aortic access; 79% were women. Caval-aortic access and tract closure were successful in all 19 patients; TAVR was successful in 17 patients. Six patients experienced modified VARC-2 major vascular complications, 2 (11%) of whom required intervention. Most (79%) required blood transfusion. There were no deaths attributable to caval-aortic access. Throughout the 111 (range 39 to 229) days of follow up, there were no post-discharge complications related to tract creation or closure. All patients had persistent aorto-caval flow immediately post-procedure. Of the 16 patients who underwent repeat imaging after the first week, 15 (94%) had complete closure of the residual aorto-caval tract. CONCLUSIONS:Percutaneous transcaval venous access to the aorta allows TAVR in otherwise ineligible patients, and may offer a new access strategy for other applications requiring large transcatheter implants.
Project description:Background:Transcatheter aortic valve replacement (TAVR) is a viable treatment option for managing aortic prosthetic valve dysfunction. Although the transfemoral approach is the most commonly used and preferred treatment strategy for TAVR, complex vascular access, such as aortic aneurysm, severe tortuosity, and shaggy aorta, is challenging. Case summary:An 87-year-old man, who underwent surgical aortic valve replacement for aortic stenosis using a 21-mm Carpentier-Edwards Perimount Valve, presented with New York Heart Association functional Class III dyspnoea. He was diagnosed as having severe symptomatic structural valve deterioration of a bioprosthetic aortic valve. Computed tomography revealed a tortuous and shaggy descending aorta with a saccular aneurysm in the aortic arch. Simultaneous transfemoral valve-in-valve TAVR and Zone 2 thoracic endovascular aortic repair (TEVAR) with debranching were successfully performed using a 22-Fr 65-cm sheath. Although the patient developed paraplegia due to transient spinal cord ischaemia associated with TEVAR, he fully recovered with vasopressor therapy. Discussion:To the best of our knowledge, this is the first report on simultaneous successful 'valve-in-valve' TAVR and debranching TEVAR using the transfemoral approach. This case demonstrated the feasibility of single-stage transfemoral TAVR and TEVAR in a high-risk patient with multicomponent disease.
Project description:<b>Background:</b> The transfemoral (TF) route is the gold-standard access for transcatheter aortic valve replacement (TAVR). In 10-15% of patients, alternative accesses are needed, such as the transcarotid (TC) access. We performed a meta-analysis to compare 30-day mortality and complications between TC-TAVR and TF-TAVR. <b>Methods:</b> We searched PubMed/MEDLINE and EMBASE from inception to January 2021 to identify articles comparing TC-TAVR and TF-TAVR. Patients' baseline characteristics, procedural outcomes, and clinical 30-day outcomes were extracted. <b>Results:</b> We identified 9 studies, among which 2 used propensity-score matching, including 1,374 TC patients and 3,706 TF patients. TC-TAVR was associated with significantly higher EuroSCORE II and Logistic EuroSCORE values (respectively 8.0 ± 6.7 vs. 6.3 ± 5.4, <i>p</i> = 0.002 and 20.8 ± 14.2% vs. 20.0 ± 13.4%, <i>p</i> = 0.04), a higher prevalence of peripheral artery disease (52.6 vs. 32.8%, <i>p</i> = 0.001), previous cardiac surgery (26.3 vs. 22.4%, <i>p</i> = 0.008) and coronary artery disease (64.6 vs. 60.5%, <i>p</i> = 0.020). The pooled results found TC-TAVR to be associated with a significantly higher 30-day mortality risk (RR, 1.41, 95% CI, 1.02-1.96, <i>p</i> = 0.040), and a lower rate of 30-day major vascular complications (RR, 0.48, 95% CI, 0.25-0.92, <i>p</i> = 0.030). No significant difference was found regarding permanent pacemaker implantation, major bleeding and acute kidney injury. A subgroup analysis of the two propensity-score matched studies found a statistically increased risk of 30-day neurovascular complications (RR, 1.61, 95% CI, 1.02-2.55, <i>p</i> = 0.040). <b>Conclusion:</b> Compared with TF-TAVR, TC-TAVR was associated with an increased risk of 30-day mortality, likely related to a higher surgical risk and comorbidity burden, and with an increased risk of 30-day neurovascular complications. Careful preprocedural patient selection and close periprocedural neurological monitoring are paramount.