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The progression of severe TR devolves into right heart failure, liver dysfunction, and renal failure. It is unclear how to manage these patients when end organ dysfunction precludes surgical intervention.
Novel therapies have emerged to treat patients with passive congestion whose TR is too severe for other transcatheter valve therapies. Adaptation of transcatheter aortic valve technology has been used to treat the upstream effects of severe TR by placing a transcatheter valve into the inferior vena cava (IVC) alone
This technique involves implanting a one-way valve at the right atrial–IVC junction, preventing regurgitation of blood into the caval veins. We discuss the first surgically assisted transcatheter implantation of the SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA) into a markedly dilated IVC. In this approach, the IVC diameter is reduced by an external ring.
effective regurgitant orifice areas of 2.12 and 3.1 cm2, respectively, and reduced right ventricular function were referred for a percutaneous approach for the treatment of TR because of multisystem organ disease. Patient A was a 64-year-old man with rheumatic heart disease and a history of mechanical aortic and mitral valve replacements 22 years before presentation. His history was also notable for pulmonary hypertension and hepatic encephalopathy. Patient B was an 85-year-old man with severe aortic stenosis treated with surgical aortic valve replacement, pulmonary hypertension, and myelodysplastic syndrome. Preoperative computed tomographic angiography in both cases revealed large IVC diameters, and the patients were scheduled for surgically assisted percutaneous caval valve implantation (CAVI).
Intraoperative transesophageal echocardiography was used to quantify the torrential TR, as demonstrated in Figure 1. We also illustrated the coaptation defect from a deep transgastric view (Figure 2), with en face three-dimensional imaging (Video 1, Figure 3), and confirmed the size of the IVC, measuring 40.5 and 48.0 mm, respectively (Figure 4). Most CAVIs use an IVC stent that serves as a landing zone for the SAPIEN 3 valve. A caval diameter of <30 mm is desired to correctly accommodate the largest available SAPIEN 3 valve, but diameters of up to 35 mm may be downsized by implanting multiple intravascular stents. In our case, the IVC was too large for a stent-based approach.
Bilateral femoral venous and arterial access was obtained by the surgeons. Right lateral thoracotomy was performed to access the right atrial–IVC junction. In patient A, minor IVC injury with bleeding precluded surgical visualization, and elective cardiopulmonary bypass was initiated via femoral cannulation. Patient B's anatomy did not allow adequate dissection via right thoracotomy, and a mini lower median sternotomy was performed to aid surgical exposure. In both patients, the IVC was encircled with a #34 Simulus semirigid mitral annuloplasty ring (Medtronic, Minneapolis, MN). The ring was cut in the middle, and after encircling the IVC, the two ends were sutured together, and the ring was fixed to the diaphragm with three sutures to prevent movement. A #29 SAPIEN 3 valve was percutaneously advanced along the guidewire and deployed under fluoroscopic and transesophageal echocardiographic guidance, positioned across the ring, which served as a landing zone at the right atrial–IVC junction (Figure 5, Figure 6, Figure 7, Video 2). Valve positioning was at the level of the diaphragm, superior to the convergence of the IVC with the hepatic veins (Figure 8). The valve was oriented approximately 5 mm into the IVC and best visualized with the modified bicaval view (Figure 9, Video 3). Patient A had a slight reduction in effective regurgitant orifice area by proximal isovelocity surface area, and patient B developed a 21% decrease in TR (Figure 10, Figure 11).
Postoperatively, both patients were transferred to the cardiothoracic intensive care unit intubated, on vasopressor and inotropic support. Patient A gained full recovery and was discharged home on postoperative day 14 with improvement in ascites and lower extremity edema. Three-month surveillance transthoracic echocardiography revealed diminished TR. Patient B developed recurrent bleeding of the right hemithorax compromising respiratory status and renal failure requiring renal replacement therapy. The patient was placed on comfort measures and died on postoperative day 21.
The unique geometry of the tricuspid valve makes transcatheter therapies challenging. The annulus is large, elliptical, and nonplanar in shape, with the absence of calcification in secondary TR to anchor the valve (Video 1). In addition, the coronary sinus, right coronary artery, atrioventricular node, and bundle of His are in close proximity to the annulus. In the United States, the only transcatheter option outside of a trial would be off-label use of the MitraClip (Table 1). In early feasibility trials, patients with end-stage right heart failure are typically excluded. Moderate to severe pulmonary hypertension is also an exclusion criteria, because when present it may precipitate right ventricular failure if the tricuspid valve was competent.
This is a palliative procedure designed to alleviate signs and symptoms of right heart failure in patients who are not surgical candidates. The procedure decreases the backflow of blood into the vena cava but does not address the tricuspid valve itself. Regurgitation of blood from the superior vena cava still occurs, though mean IVC pressures have been shown to decrease postprocedurally, and this is the likely mechanism for symptom relief.
Short- and long-term outcome data are limited because of the compassionate use of the device and small sample size. Of 10 patients who underwent CAVI using the stent-based approach, nine had improvement by at least one New York Heart Association functional class. The exception was a patient in cardiogenic shock at baseline. Right ventricular function assessed by tricuspid annular plane systolic excursion improved in nine patients. Thirty-day mortality was 20%, and during the 913-day follow-up, no device malfunction was detected.
Transesophageal echocardiography is an integral part of the procedure. Echocardiography is the ideal method to identify structural abnormalities of the tricuspid valve and to quantify annular dimensions and the effective regurgitant orifice area. Transesophageal echocardiography can assess the size of the vena cava, assist in the placement of a caval stent or ring, guide transcatheter valve deployment, assess for device migration, and evaluate the presence of paravalvular leak. Visualization of the hepatic veins and caval flow into the right atrium is also useful in quantifying hepatic flow reversal or its resolution postprocedurally (Figure 12, Figure 13).
We recognize that this procedure has limitations. As evidenced by our experience, surgical intervention of any type in this patient population carries substantial risk. A thoracotomy or sternotomy is invasive and, some argue, equivalent to open heart surgery, especially if emergent cardiopulmonary bypass is initiated. In addition, collateral blood flow through the azygous, left-sided thoracic veins and esophageal varices may limit the intermediate and long-term efficacy of the procedure.
CAVI is a novel, palliative, transcatheter technique for the treatment of severe TR that avoids the anatomic challenges of the tricuspid valve by placing the valve in a heterotopic position. These cases illustrate the feasibility of surgically assisted CAVI in patients with large IVC diameters. Such cases require a multidisciplinary approach as well as close postoperative surveillance while we continue to learn about the long-term effects of this intervention on patient outcomes.
We thank Aleena Zaidi for her medical illustration.
Fluoroscopic deployment of the SAPIEN 3 valve above the level of the diaphragm at the right atrial–IVC junction. Thin arrow, Edwards delivery sheath; bold arrow, venous extracorporeal membrane oxygenation cannula; dotted arrow, deployed SAPIEN 3 within ring encircling the IVC; interrupted arrow, field suction.
X-plane bicaval view of deployed SAPIEN 3: modified bicaval view in x-plane with focus on IVC showing correct heterotopic deployment of SAPIEN 3 valve (arrow) at the IVC/ RA junction. Star, right atrium; triangle, left atrium.
Isolated tricuspid regurgitation: outcomes and therapeutic interventions.