Insight From an Italian Delphi Consensus on EVAR Feasibility Outside the Instruction for Use—The SAFE EVAR Study (SAfety and FEasibility of standard EVAR outside the instruction for use)

The SAfety and FEasibility of standard endovascular repair (EVAR) outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons toward the use of standard EVAR for an infrarenal abdominal aortic aneurysm outside the instruction for use through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare—SICVE). A questionnaire consisting of 26 statements was developed, validated by an 18-member advisory board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds, which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: (1) strongly agree, (2) partially agree, (3) neither agree nor disagree, (4) partially disagree, and (5) strongly disagree, whereas in the third round, only three different choices were proposed: (1) agree, (2) neither agree nor disagree, and (3) disagree. We considered the consensus reached when ≥70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. Two-hundred forty-four (40.6%) Italian Vascular Surgeons agreed to participate in the first round of the Delphi consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first-round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, 7 more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). Details about proposed statements and answers provided in the three rounds are reported in the Table. The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available.TableStatements and answers provided in the three roundsStatementRound I, %Round II, %Round III, %Strongly agreePartially AgreeNeither agree nor disagreePartially disagreeStrongly disagreeStrongly agreePartially agreeNeither agree nor disagreePartially disagreeStrongly disagreeAgreeNeither agree nor disagreeDisagree1Performing an EVAR outside the IFU affects short-term outcome85414213557122332548272Performing an EVAR outside the IFU affects mid/long-term outcome36506714049731712543Performing an EVAR outside the IFU results in a worse outcome in terms of AAA-related reintervention37524614344841742334Performing an EVAR outside the IFU results in a worse outcome in terms of AAA-related mortality1051161941350151933744195EVAR outside the IFU is a procedure that should always be avoided in elective settings143510338936836111734496EVAR outside the IFU as an elective procedure should be avoided even in subjects not eligible for open surgery920103823521842241422647EVAR outside the IFU should be avoided regardless of the patient's age522133921324123922630648The proximal aortic neck is an important criterion for evaluating the feasibility of an EVAR procedure outside the IFU7919110––––––––9The aortic bifurcation is an important criterion for evaluating the feasibility of an EVAR procedure outside the IFU3444911228421413358261610The iliac landing zone is an important criterion for evaluating the feasibility of an EVAR procedure outside the IFU3244101133539816263241311The presence of adequate access vessels is an important criterion for evaluating the feasibility of an EVAR procedure outside the IFU403591334339610261241512An EVAR procedure can be performed in the presence of a proximal aortic neck <15 mm in length57352515838220927113An EVAR procedure can be performed in the presence of a proximal aortic neck <10 mm in length184692162045720855232214An EVAR procedure can be performed in the presence of a proximal aortic neck <5 mm in length316622534166195513177015An EVAR procedure can be performed in the presence of a proximal aortic <15 mm in length and an angulation >60°1943141771650720760231716An EVAR procedure can be performed in the presence of a proximal aortic neck diameter >30 mm1345628812439261035353017An EVAR procedure can be performed in the presence of an aortic bifurcation diameter <18 mm2853414112439261060291118Proposing to a patient an EVAR procedure outside the IFU makes the informed consent process more complex (eg, the need to spend more time informing the patient and/or providing him/her with more details regarding risks and benefits)502681334433101127021919Given the inconsistency between what is stated in the guidelines and the results of clinical practice, performing an EVAR procedure outside the IFU requires the physician to give the patient only the information that he or she believes the subject can understand161992927162310262537243920Given the inconsistency between what is stated in the guidelines and the results of clinical practice, performing an EVAR procedure outside the IFU requires the physician to give the patient the information about the procedure relevant to the patient in order to decide592845460255738215321Given the inconsistency between what is stated in the guidelines and the results of clinical practice, performing an EVAR procedure outside the IFU requires the physician to give the patient all available information regarding the procedure and its risks/benefits7914331––––––––22Performing an EVAR procedure outside the IFU also requires a preliminary assessment of preferences and clinical and nonclinical outcomes relevant to the patient (eg, postoperative discomfort, time needed to return to daily activities, and need of support after discharge)503011634831107466221223An EVAR procedure outside the IFU can only be considered after the physician has presented the patient with the best treatment option7022521––––––––24An EVAR procedure outside the IFU can only be considered after the physician has presented the patient with the intervention options that he or she considers to be the safest and most effective62256617019731–––25An EVAR procedure outside the IFU can only be considered after the physician has presented the patient with all available intervention (and nonintervention) options7916221––––––––26Even if the physician thinks that performing an EVAR outside the IFU is the most appropriate procedure for a particular patient, he or she must directly and actively involve the patient in the clinical decision-making process6923242642725275187AAA, Abdominal aortic aneurysm; EVAR, endovascular repair; IFU, instruction for use. 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