Cardiovascular Outcomes Report


2018 Outcomes & Quality Report in Cardiovascular Services

Vascular Disease


Research Advances

Atherosclerosis of the Lower Extremities

Endovascular therapy and minimally invasive treatments are an important modality in the treatment of peripheral vascular disease. At Columbia and Weill Cornell, the large volume of high-risk patients with complex multilevel peripheral arterial disease allows researchers to participate in a number of trials for new endovascular devices. Femoropopliteal lesions pose a difficult challenge because the disease is often diffuse, heavily calcified, and located in an area of the body subject to significant mobility stresses, such as extension, contraction, compression, elongation, flexion and torsion. In the global IMPERIAL trial, Columbia investigators are evaluating the Eluvia drug-eluting vascular stent system for treating superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) lesions up to 140 mm in length. The IMPERIAL trial includes a long-lesion substudy to evaluate the Eluvia stent for treating SFA and/or PPA lesions >140mm and ≤190 mm in length.

Additionally, Columbia and Weill Cornell investigators participate in a number of research trials evaluating newer drug-eluting balloons, lithotripsy balloons, and endovascular bypass procedures. Tibial arteries pose an even greater challenge in management given the small vessel sizes, multi-vessel involvement, and extensive calcification. Columbia and Weill Cornell investigators will soon be participating in trials for new generation devices designed specifically to treat patients with these complex lesions.

Transcarotid Artery Revascularization

Columbia and Weill Cornell researchers are participating in the ROADSTER 2 trial, a multicenter post-approval study to assess the real world treatment of patients at risk for stroke due to carotid artery disease. The study is evaluating the FDA-approved ENROUTE Transcarotid Neuroprotection and Stent System, the first devices designed specifically for TransCarotid Artery Revascularization (TCAR). The ENROUTE stent is indicated for use in high surgical risk patients and is intended to be used in conjunction with the ENROUTE transcarotid neuroprotection system during the TCAR procedure. This first in class device is used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE transcarotid stent.

Program for Advanced Limb Preservation (PALP)

The Program for Advanced Limb Preservation (PALP) at Weill Cornell specializes in the treatment of patients with lower extremity wounds caused by vascular disease and diabetes who are at high risk for foot and leg amputation. PALP is New York City’s only tertiary, multidisciplinary limb preservation service that offers patients — in a single location — comprehensive diagnostic evaluation, advanced wound care treatments, including hyperbaric oxygen therapy, surgical and minimally invasive vascular procedures, reconstructive foot surgery, and investigational treatments such as stem cell therapy.

As one case study, a patient with type 1 diabetes with associated vascular and kidney failure problems, who had a kidney transplant a decade earlier, presented with a right heel ulcer and severe right foot pain that developed while recovering from knee surgery. He had severely compromised circulation due to extensive peripheral artery disease (PAD) and was diagnosed with critical limb-threatening ischemia. Urgent intervention was essential in addition to careful wound care to prevent major limb amputation.

Due to the extent of atherosclerotic vascular disease, minimally invasive treatment was not possible. In January 2018, Weill Cornell vascular surgeons performed a surgical endarterectomy of the patient’s right common femoral artery and a bypass from his right popliteal artery to his anterior tibial artery, which was successful in restoring blood flow to his foot. He also underwent several subsequent surgical procedures to facilitate healing of his foot wound. The patient then went on to have several applications of a human cell-derived substitute in the PALP clinic to further boost wound healing. Nine months later his wound was completely healed. He continues to do well and has resumed his normal activities, including playing golf.