There are few options when it comes to right ventricular support for patients who are in right heart failure from a multitude of etiologies. At the time of this writing, we are limited to two temporary percutaneous right ventricular assist devices (RVAD) to assist our patients with this problem: the Impella RP and the Protek Duo/ProtekDuo
What is a Protek Duo/ProtekDuo?
The ProtekDuo, made my TandemLife/LivaNova, is a temporary percutaneous right ventricular assist device (RVAD). There are specialists who put this in place: Interventional Cardiologists, Advanced Heart Failure Cardiologists, Intensivists, or other well trained medical specialist.
One could introduce this device via the right internal jugular vein. The specialist uses the assistance of transesophageal echocardiogram and fluoroscopy. One needs to visualize the guidewire and then the cannula transverse the pulmonic valve into the pulmonary artery. This helps confirm proper placement. It is essentially a right atrium to pulmonary artery bypass device.
If you’ve heard the term “mechanical circulatory support”, this is one of those devices. This is FDA for up to 6 days.
I personally went down the rabbit hole of right ventricular assist devices while writing my lecture on Mechanical Circulatory Support titled “Cardiogenic Shock: Rise of the Machines“.
TandemLife could do better at explaining their device on their website.
How Does the ProtekDuo/Protek Duo Right Ventricular Assist Device Work?
Like Extracorporeal Membranous Oxygenation (ECMO), the ProtekDuo is an extracorporeal continuous flow pump. It works along the lines of centrifugal flow. This differs from the Impella devices which are axial-flow. The flow provided by the Protek Duo is up to 4.5L/min.
As it is introduced in the internal jugular vein, the cannula has a proximal inflow cannula which sits in the right atrium. The cannula is fed into the main pulmonary artery which is where the distal outflow lumen is positioned. This creates the right atrium pulmonary artery bypass.
What are the Indications for Protek Duo Cannula Placement
- right ventricular failure s/p left ventricular assist device placement (LVAD)
- s/p cardiotomy with right ventricular failure
- s/p acute myocardial infarction, inferior/right ventricle
- heart transplant patients
The data suggests that approximately 20% of LVAD placements are complicated by RV failure. This device can help mitigate this. Other methodologies can be pulmonary vasodilators, inotropes, vasopressors. Diuretics can also be helpful to offload the RV.
Case reports also describe it in cases of severe pulmonary hypertension, and acute myocarditis.
Deciding whether a patients needs a Protek Duo
Placing a Protek Duo or any RVAD is worth serious consideration. It is not without risk. Also, the earlier its insertion, the better the outcomes. Using the Pulmonary Artery Pulsatility Index (CLICK HERE TO LEARN MORE) is helpful to determine the state. The caveat to this measurement is that right heart pressures need to be measured. A pulmonary artery catheter will need to be placed. The calculation goes as follows:
PAPI=(systolic pulmonary artery pressure-diastolic pulmonary artery pressure)/CVP
PAPI<0.9 indicates possible RV failure and that the clinician should consider RV support. Like everything in medicine, this is NOT an absolute.
PAPI>0.9 indicates that the RV is likely normal. Some literature uses PAPI>1.0.
29 french or 31 french lumen.
A Substitute for VV-ECMO
One of the additional benefits of this device is it’s TandemLung function. To make it simple, that means you can essentially turn this device into VV-ECMO. This is done by placing the same ProtekDuo 29 or 31 french cannula in the right internal jugular vein, and adding an oxygenator. Additional equipment required includes the TandemHeart controller and pump.
Patients need to be anti-coagulated. The brochures recommend an ACT of 180-220 or a PTT of 65-80. Bleeding can occur. The complications seen with central line placement in the internal jugular can be seen here.
What are the outcomes using the Protek Duo?
At of the time of this writing, there are no clinical trials utilizing this technology in patients with right ventricular failure. There are various case studies with links below in the citations where they analyze fewer than 20 patients.
Market competitors to the Protek Duo, to my knowledge, include only the Impella RP by Abiomed. Some key differences between the two include that the Impella RP, at the time of this writing, is inserted only in the femoral vein. This mean the patient cannot ambulate while the device is in place. As mentioned, the Protek Duo is goes in the right internal jugular vein. That allows the patient to ambulate.
In addition, as mentioned above, the Impella RP and Protek Duo/ProtekDuo also differ in their types of flow. The Impella RP provides axial flow while the Protek Duo provides centrifugal flow.
Future Studies on ClinicalTrials.gov
I checked clinicaltrials.gov under “protek”, “protekduo” and “protek duo” on 6/1/2020 and did not find anything. There are no clinical trials at the moment regarding this device.
Citations for Protek Duo and Impella RP
Protek Duo Citations
Aggarwal V, Einhorn BN, Cohen HA. Current status of percutaneous right ventricular assist devices: First-in-man use of a novel dual lumen cannula. Catheter Cardiovasc Interv. 2016 Sep;88(3):390-6. doi: 10.1002/ccd.26348. Epub 2016 Feb 20. PMID: 26895620.
Link to Article
Schmack B, Weymann A, Popov AF, Patil NP, Sabashnikov A, Kremer J, Farag M, Brcic A, Lichtenstern C, Karck M, Ruhparwar A. Concurrent Left Ventricular Assist Device (LVAD) Implantation and Percutaneous Temporary RVAD Support via CardiacAssist Protek-Duo TandemHeart to Preempt Right Heart Failure. Med Sci Monit Basic Res. 2016 May 5;22:53-7. doi: 10.12659/MSMBR.898897. PMID: 27145697; PMCID: PMC4913730.
Link to Article
Link to FULL FREE PDF
Ravichandran AK, Baran DA, Stelling K, Cowger JA, Salerno CT. Outcomes with the Tandem Protek Duo Dual-Lumen Percutaneous Right Ventricular Assist Device. ASAIO J. 2018 Jul/Aug;64(4):570-572. doi: 10.1097/MAT.0000000000000709. PMID: 29095736.
Link to Article
Nicolais, C. D., Suryapalam, M., O’Murchu, B., Bashir, R., O’Neill, B. P., Alvarez, R., … Aggarwal, V. (2018). USE OF PROTEK DUO TANDEM HEART FOR PERCUTANEOUS RIGHT VENTRICULAR SUPPORT IN VARIOUS CLINICAL SETTINGS: A CASE SERIES. Journal of the American College of Cardiology, 71(11), A1314.doi:10.1016/s0735-1097(18)31855-2
Link to FULL FREE Article
Impella RP Citations
Anderson M, Morris DL, Tang D, et al. Outcomes of patients with right ventricular failure requiring short-term hemodynamic support with the Impella RP device. J Heart Lung Transplant. 2018;37(12):1448‐1458. doi:10.1016/j.healun.2018.08.001
Link to Article
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