June 01, 2016
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Percutaneous LVAD-assisted PCI viable option in cardiogenic shock, complex anatomy

In cases of extreme cardiogenic shock or very high intervention risk owing to anatomical complexity, PCI with support from a percutaneous left ventricular assist device is a viable revascularization option.

For a retrospective study, researchers evaluated data from 74 patients who underwent PCI with assistance from a percutaneous LVAD (TandemHeart, CardiacAssist Inc.) at Baylor St. Luke’s Medical Center/Texas Heart Institute between 2005 and 2011. Patients were stratified by presentation status as follows: elective (n = 16), urgent (n = 17), emergent (n = 19) or emergent salvage (n = 22). The elective and urgent groups comprised patients with advanced coronary disease who were deemed ineligible for surgical treatment due to complex vascular anatomical features or multiple comorbid conditions; the emergent group comprised patients with cardiogenic shock; and the emergent salvage group comprised patients with recalcitrant cardiogenic shock and/or preprocedural cardiopulmonary arrest.

The researchers calculated estimated procedural risk in these patients using median STS operative mortality and major morbidity scores for aortocoronary bypass procedures. Mortality and morbidity were assessed in association with patient presentation status. After PCI, the percutaneous LVAD was left in place, and patients were progressively weaned from the device as permitted by their hemodynamic condition.

Outcomes and survival rates were documented in-hospital and during 6-year follow-up.
Survival rates by presentation status 30 days after PCI were 94% in the elective group, 88% in the urgent group, 79% in the emergent group and 55% in the emergent salvage group.

All patients in the elective group were successfully weaned from percutaneous LVAD assistance. In this group, 26% required prolonged hospitalization (> 14 days), and mechanical ventilation exceeding 24 hours was needed in one of 16 patients.

Successful weaning from percutaneous LVAD support also was achieved in the urgent group. Prolonged hospital stay was needed in 40% of these patients. Two patients required more than 24 hours of mechanical ventilation after PCI.

The emergent group had an 84% success rate of weaning from percutaneous LVAD support. Cases in which weaning were not successful were due to ventricular tachycardia secondary to arterial cannula thrombosis in one patient and a need to convert to a different LVAD (HeartMate II, Thoratec) in two patients. Hospitalization exceeding 14 days was required for 58% of patients, as was required mechanical ventilation for more than 24 hours.

The emergent salvage group achieved successful weaning from percutaneous LVAD in only 54% of the cohort. Although one patient was successfully bridged to HeartMate II, the remaining 10 patients died as a result of failure to wean. In this group, prolonged hospitalization was needed in 92% of patients who survived the initial hospitalization. Ventilation support exceeding 24 hours was needed in 90% of this group.
At 1-year follow up, the survival rate was 75% in the elective group, 64.7% in the urgent group, 52.6% in the emergent group and 45.5% in the emergent salvage group. At 6 years, the rates were 68.6%, 52.9%, 31.6% and 40.6%, respectively.

A total of 39 deaths were documented; 44% occurred within 30 days after intervention, 36% occurred between 31 days and 1 year after intervention, and 20% occurred during the next 5 years.

“This case series of TandemHeart-supported PCIs from a single center provides real-world data needed to evaluate the long-term survival impact of hemodynamic support for percutaneous revascularization in patients who present in profound cardiogenic shock or elect to undergo extremely risky interventions,” the researchers wrote. – by Jennifer Byrne

Disclosure: The researchers report no relevant financial disclosures.