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 by TandemLife/LivaNova, is a temporary percutaneous right ventricular assist device (RVAD). Specialists who install it are Interventional Cardiologists, Advanced Heart Failure Cardiologists, Intensive Care Physicians, or other well-trained medical specialists.

One could introduce this device via the right internal jugular vein. The specialist uses a transesophageal echocardiogram and fluoroscopy to assist. 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. It is FDA-approved 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, “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 Membrane Oxygenation (ECMO), the ProtekDuo is an extracorporeal continuous flow pump. It works in centrifugal flow, which differs from the Impella devices, which are axial flow. The flow provided by the Protek Duo is up to 4.5L/min.

When introduced in the internal jugular vein, the cannula has a proximal inflow cannula that sits in the right atrium. The cannula is fed into the main pulmonary artery, where the distal outflow lumen is positioned. This creates the right atrium pulmonary artery bypass.

What are the Indications for Protek Duo Cannula Placement

1. right ventricular failure s/p left ventricular assist device placement (LVAD)
2. s/p cardiotomy with right ventricular failure
3. s/p acute myocardial infarction, inferior/right ventricle
4. 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, and vasopressors. Diuretics can also help 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. The Pulmonary Artery Pulsatility Index (CLICK HERE TO LEARN MORE) helps 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 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.

Cannula/Catheter Sizes

29 french or 31 french lumen.

A Substitute for VV-ECMO

One of the additional benefits of this device is its 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 is required, including the TandemHeart controller and pump.

Complications

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 the time of this writing, there are no clinical trials utilizing this technology in patients with right ventricular failure. However, various case studies, with links in the citations below, analyze fewer than 20 patients.

The Competition

To my knowledge, the only market competitor to the Protek Duo is 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 means the patient cannot ambulate while the device is in place. As mentioned, the Protek Duo goes in the right internal jugular vein, which 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 regarding this device at the moment.

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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