Originally published December 7, 2018 as an update to Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine, 11th edition
Debra L. Beck and Eugene Braunwald, MD
Increased left atrial pressure leading to pulmonary congestion is common in acute decompensated heart failure. The creation of an interatrial shunt for left atrial decompression has been successfully applied in selected patients, including in those with chronic HF, and has shown early promise. Rodes-Cabau et al reported first-in-human data on the V-Wave Interatrial Shunt, an hourglass-shaped implant containing a 1-way bioprosthetic valve that is implanted by transseptal catheterization.
In this single-arm, open-label study, 38 heart failure patients (mean age, 66 years; 30 with reduced ejection fraction and 8 with preserved ejection fraction) were implanted with the shunt device. Thirty-seven patients had NYHA class III symptoms and one patient had class IV symptoms.
The shunt was successfully implanted in all patients with transesophageal echocardiography-confirmation of correct positioning and unidirectional left-to-right flow through the shunt. There was no periprocedural mortality and 1 patient (2.6%) had a cardiac tamponade within hours of the procedure that was successfully treated. There were no other major device- or procedure-related complications within the first 12 months.
At 3 months, 78% of patients had improved from NYHA class III or IV at enrollment to NYHA class I or II. At 12 months, this figure was 60% (p<0.02). Quality of life improvement of >5 points improvement on one of two scales was seen in 74% at 3 months and 73% at 12 months (p<0.02). Six-minute walk distance showed a mean increase of 41 meters at 3 months and 28 meters at 12 months (p<0.02). However, no improvements were seen in objective measures of left- or right-sided function.
At 3 months, all shunts were patent. But by 12 months, 14% (5 of 36) had occluded and another 36% (13 of 36) were stenotic at the valve. Stenosis severity was assessed as subtotal in 7 cases.
Patients with widely patent shunts had better long-term outcomes than those with stenotic/occluded shunts: a lower rate of the composite of death, left ventricular assist device placement or heart transplantation (p = 0.001), and HF hospitalization (p = 0.008). They also had a significant reduction in pulmonary capillary wedge pressure from baseline to 12 months (p=0.011) compared to those with stenotic or occluded shunts.
Throughout a median follow-up of 28 months there were 10 deaths (8 cardiovascular) and two heart transplantations or LVAD implantations. Beyond 12 months, 10 patients with patent shunts survived to their 24-month anniversary. Of note, in this small feasibility study, these clinical outcomes should be considered only exploratory.
The investigators concluded that interatrial shunting with the novel V-Wave system was feasible and safe in patients with HF with reduced and preserved ejection fraction. Early improvements in clinical functioning were maintained at 12 months despite attenuation of shunt patency in one-half of the patients. “Implementing modifications that likely improve device patency duration while maintaining hemodynamic and functional benefits are worthwhile before launching a randomized trial to confirm these findings in a larger population,” wrote the authors.
Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine features a unique update program by Dr. Braunwald, creating a “living textbook” by featuring twice monthly updates including “Hot off the Press” and Late-Breaking Clinical Trials (links to authors’ presentation slides are also included).
Learn more about Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine, 11th Edition. Download a free chapter here.
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