First PROTECT IV Patient Case in California

Aditya Bharadwaj, MD, FACC, FSCAI, shares the first PROTECT IV case enrolled in California at Loma Linda University Health Care. He gave this presentation at the 2022 SCAI Scientific Sessions.

The patient was a 64-year-old male with a history of hypertension, diabetes, and peripheral artery disease with prior stents in his left superficial femoral artery (SFA). He presented to an outside hospital with acute limb ischemia of his left lower extremity and was treated for a thrombotic occlusion of his left SFA stent. He developed compartment syndrome requiring fasciotomy and wound vac insertion. Two days later he was transferred to Loma Linda with an NSTEMI with chest pain and elevated cardiac enzymes.

ECG revealed ischemic changes in the anterior leads and coronary angiogram showed significant disease in the distal left main, ostial circumflex, and proximal LAD with a high diagonal with significant stenosis. There was also severe diffuse disease with chronic total occlusion (CTO) in the RCA.

Dr. Bharadwaj reviews right heart cath (RHC) results, noting that the patient was not in shock. After consultation with the heart team and family, the patient consented for potential enrollment in PROTECT IV. Dr. Bharadwaj reviews the screening process, explaining that the patient met the 3-vessel/left main disease criteria and had an LV ejection fraction less than 40% with mild RV dysfunction. The patient was approved for enrollment in PROTECT IV.

Dr. Bharadwaj discusses the revascularization plan for the patient, explaining the PCI strategy challenges. With the revascularization plan in place, the patient was randomized and assigned to the control arm. Dr. Bharadwaj describes how he executed the multi-step revascularization plan without Impella® support. Unable to utilize single-access Impella, Dr. Bharadwaj explains, “with the left groin being involved with acute limb ischemia, I decided to go 7 Fr right radial for PCI.”

The team executed the revascularization plan starting with stent deployment in the diagonal, then proceeding with placing a stent from the left main to the left circumflex and delivering stents to the mid and distal left anterior descending artery. At his 30-day follow-up visit, the patient was “doing very well from a cardiac standpoint.”

Dr. Bharadwaj concludes by explaining that the reason he showed this case was not only because it was a complex case and the first PROTECT IV case at his institution, but “a lot of operators, including me, who trained in the Impella era, have to get ourselves to be comfortable doing these kind of cases and being ready to randomize them, and to do them without an Impella if they get randomized to the control arm.”