Repositioning the Medtronic Evolut R and Evolut PRO valves can be done with “acceptable” safety outcomes and low complication rates in intermediate- to low-risk patients, according to a retrospective analysis of data from two clinical trials.
In a comparison of patients with and without repositioning, there were no differences at 30 days in mortality, stroke, vascular complications, or permanent pacemaker implantation among patients who underwent transcatheter aortic valve replacement (TAVR) at high-volume centers.
The findings were published online August 3 in JACC: Cardiovascular Interventions.
They are based on 946 patients implanted with an Evolut R or PRO valve between June 2016 and November 2018 as part of the SURTAVI CAS and Evolut Low Risk trials; repositioning was performed in 318 (33.6%) patients.
By design, the Evolut R and Evolut PRO valves can be resheathed or recaptured during deployment in case of an initial suboptimal position. Early stroke and mortality rates were similar for patients who had valve repositioning in the Evolut R FORWARD study, yet longer-term data and the effect of repositioning in lower-risk patients remains unknown.
“We wanted to understand if the utilization of this mechanism, which requires additional instrumentation in the aortic valve, would pose risks to patients. Our findings reassure that, when needed, the recapture mechanism can be safely used without increasing the risk of adverse events,” first author Guilherme Attizzani, MD, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, told theheart.org | Medscape Cardiology.
SURTAVI CAS evaluated patients at intermediate risk (3% to 15%) and the Evolut Low Risk Trial evaluated patients at low risk (<3%) of early surgical mortality. The primary outcomes were all-cause death and disabling stroke at 30 days.
Patients in the repositioned (RP) group were significantly younger than patients in the nonrepositioned (NRP) group (74.6 vs 75.8 years), had a lower mean Society of Thoracic Surgeons score (2.3% vs 2.6%), and had fewer prior percutaneous coronary interventions (11.9% vs 19.7%). There were no between-group differences in baseline multidetector CT parameters.
The rate of all-cause mortality was similar in the RP and NRP groups at 30 days (0.3% vs 0.3%; P = .99) and at 1 year (1.9% vs 2.9%; P = .44). Rates of disabling stroke were also similar at 30 days (0.3% vs 0.5%; P = 0.71) and 1 year (0.8% vs 0.9%; P = .79), although nondisabling strokes were higher in the RP group at 1 year (5.9% vs 2.6%; P = .02).
Repositioning was associated with higher rates of stage 2 or 3 acute kidney injury at 30 days (2.2% vs 0.5%; P = .01), possibly due to greater use of contrast to redeploy the valve and longer periods of hypotension because of repeated left ventricular outflow tract obstruction, the researchers say.
Five patients in the RP group (1.6%) had coronary obstruction at 30 days, compared with one patient (0.2%) in the NRP group (P = .01). Two senior authors who reviewed the procedural angiograms determined that these events were not related to the resheath or recapture maneuver.
Two patients (0.6%) required reintervention in the subsequent 30 days — both in the RP group (P = .05).
Attizzani and colleagues caution that this was a post hoc retrospective data analysis of subgroups of patients from two different trials conducted at high-volume and experienced centers. The reasons for the resheaths or recaptures were available for only 20% of patients. Because only Evolut R and Evolut PRO valves were used and most patients had normal LV function, the results might not be generalizable to other self-expandable valves or to patients with reduced LV function.
“Prospective studies to evaluate patient characteristics before and after the use of the resheathing and recapturing mechanism could provide insight on the optimal utilization of this feature,” the authors conclude.
“Get it Right” the First Time
Commenting on the study for theheart.org | Medscape Cardiology, Philippe Genereux, MD, interventional cardiologist and codirector of the structural heart program at Atlantic Health System’s Morristown Medical Center, New Jersey, said this study probably represents the “best” available data on this subject.
Genereux said he’s “very concerned” about the almost fourfold increase in coronary occlusion in the RP group compared with the NRP group and the increase in acute kidney injury.
“Obviously, it’s great to have the capacity to recapture and reposition the value to optimize the results. But obviously, it’s always better to get it right the first time and minimize the manipulation. The ideal is to avoid spending more time in the patient during a procedure or decrease the amount of manipulation,” said Genereux.
In a linked editorial, Olivier Barthélémy, MD, and Jean-Phillippe Collet, MD, PhD, from Pitié-Salpêtrière University Hospital, Paris, say it remains to be seen whether the findings in this select population apply to an unselected TAVR population with a broader risk range and with more complex anatomy.
“It is likely that the expected benefit of proper positioning outweighs the hypothetical increased risk of cerebrovascular event. However, although the safety of repositioning appears reassuring, biases cannot be excluded due to the retrospective and observational nature of this study,” they point out.
This “valuable” study paves the way for future research, Barthélémy and Collet write.
“Going further would require the same high-quality standard of data collection including systematic brain magnetic resonance imaging and/or histopathological assessment of emboli protection device-captured debris to more finely assess the safety of repositioning feature of SE-TAVR,” they say.
“Meanwhile, whether anyone would dare abandon repositioning self-expanding TAVR is unlikely,” they conclude.
Medtronic funded both trials. Attizzani has served as a consultant for Edwards Lifesciences, Medtronic, and Abbott Vascular; and served as a proctor for Edwards Lifesciences and Medtronic. A complete list of author disclosures is listed with the original article. Barthélémy has received travel and meeting support from Amgen, Bayer Healthcare, Boston Scientific, and Cardinal Health. Collet has no relevant disclosures. Genereux is a consultant for Medtronic and Edwards Lifesciences and serves as the principal investigator on the EARLY TAVR trial sponsored by Edwards Lifesciences.