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• W2956838365 abstract "ObjectivesVascular complications (VCs) remain a significant cause of morbidity in transcatheter aortic valve implantation (TAVI) patients and are associated with worse outcomes. This research analysed the incidence, impact, and predictors of VCs in transfemoral cases.MethodsA retrospective chart review was performed of 388 consecutive TAVI patients between January 2007 and April 2015, which included 237 transfemoral cases. Major and minor VCs were characterised according to the Valve Academic Research Consortium (VARC) guidelines. Logistic regression was completed to identify predictors of VCs.ResultsWhile VCs occurred in 68 (28.7%) cases, only seven (3.38%) were classified as major complications. Twenty-six (10.9%) of these complications occurred intra-operatively, with four being major (1.6%) and 22 minor (9.3%). Post-operative VCs occurred in 42 cases (17.2%), with three (1.3%) being major. Procedures to correct VCs occurred in 10 (4.2%) cases, with the majority (90%) being surgical and the remainder being treated by endovascular techniques. Nine surgical procedures, predominantly embolectomy, were performed to correct post-operative complications. Female gender was a predictor of all major VCs (B = −2.1, p < .006). Further, a logistic regression analysis found that when the largest sheath was located on the left side, there were increased minor post-operative complications (B = −0.99, p = .007). Dissections and haematomas made up the majority of VCs. Thirty day mortality was six patients (n = 2.5%), and peri-operative VCs were significantly correlated with 30 day mortality (p = .001, R = 0.21). The 30 day readmission rate comprised nine patients (3.8%), with three (1.3%) due to VCs, including haematomas and groin infections.Conclusions: VCs contribute to operative morbidity in TAVI patients. This study demonstrated low major VC rates over an eight year period. Left sided location of largest sheath size and female gender were predictors of VC. Vascular complications (VCs) remain a significant cause of morbidity in transcatheter aortic valve implantation (TAVI) patients and are associated with worse outcomes. This research analysed the incidence, impact, and predictors of VCs in transfemoral cases. A retrospective chart review was performed of 388 consecutive TAVI patients between January 2007 and April 2015, which included 237 transfemoral cases. Major and minor VCs were characterised according to the Valve Academic Research Consortium (VARC) guidelines. Logistic regression was completed to identify predictors of VCs. While VCs occurred in 68 (28.7%) cases, only seven (3.38%) were classified as major complications. Twenty-six (10.9%) of these complications occurred intra-operatively, with four being major (1.6%) and 22 minor (9.3%). Post-operative VCs occurred in 42 cases (17.2%), with three (1.3%) being major. Procedures to correct VCs occurred in 10 (4.2%) cases, with the majority (90%) being surgical and the remainder being treated by endovascular techniques. Nine surgical procedures, predominantly embolectomy, were performed to correct post-operative complications. Female gender was a predictor of all major VCs (B = −2.1, p < .006). Further, a logistic regression analysis found that when the largest sheath was located on the left side, there were increased minor post-operative complications (B = −0.99, p = .007). Dissections and haematomas made up the majority of VCs. Thirty day mortality was six patients (n = 2.5%), and peri-operative VCs were significantly correlated with 30 day mortality (p = .001, R = 0.21). The 30 day readmission rate comprised nine patients (3.8%), with three (1.3%) due to VCs, including haematomas and groin infections. Conclusions: VCs contribute to operative morbidity in TAVI patients. This study demonstrated low major VC rates over an eight year period. Left sided location of largest sheath size and female gender were predictors of VC. What this study addsTranscatheter Aortic Valve Implantation (TAVI) is an excellent option for patients with aortic valve insufficiency. However, the rate of vascular complications is relatively high and should be a consideration in decision making. Involvement of vascular surgery early for recommendations regarding access site, side preference, and anatomical considerations may be beneficial in these patients. Transcatheter Aortic Valve Implantation (TAVI) is an excellent option for patients with aortic valve insufficiency. However, the rate of vascular complications is relatively high and should be a consideration in decision making. Involvement of vascular surgery early for recommendations regarding access site, side preference, and anatomical considerations may be beneficial in these patients. Symptomatic severe aortic stenosis has a 50% two year mortality rate if left untreated.1Ambler G. Omar R.Z. Royston P. Kinsman R. Keogh B.E. Taylor K.M. Generic, simple risk stratification model for heart valve surgery.Circulation. 2005; 112: 224-231Crossref PubMed Scopus (214) Google Scholar, 2Ross J. Braunwald E. Aortic stenosis.Circulation. 1968; 38: 61-67Crossref PubMed Google Scholar Until recently, open surgical valve replacement has been the only effective treatment; however, up to one third of patients are considered ineligible for this procedure.3Leon M.B. Smith C.R. Mack M.J. Miller C. Moses J.W. Svensson L.G. et al.Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010; 363: 1597-1607Crossref PubMed Scopus (5420) Google Scholar Transcatheter aortic valve implantation (TAVI) is an emerging treatment option for these patients.3Leon M.B. Smith C.R. Mack M.J. Miller C. Moses J.W. Svensson L.G. et al.Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010; 363: 1597-1607Crossref PubMed Scopus (5420) Google Scholar, 4Leon M.B. Smith C.R. Mack M.J. Makkar R.R. Svensson L.G. Kodali S.K. et al.Transcatheter or surgical aortic-valve replacement in intermediate-risj patients.N Engl J Med. 2016; 374: 1609-1620Crossref PubMed Scopus (3203) Google Scholar Between 2007 and 2011, there were 17 712 new TAVI candidates in Europe and 9 189 in the United States.5Osnabrugge R.L.J. Mylotte A. Head S.J. Mieghem N.M.V. Nkomo V.T. LeReun C.M. et al.Disease prevalence and number of candidates for transcatheter aortic valve replacement.J Am Coll Cardiol. 2013; 62: 1002-1012Crossref PubMed Scopus (697) Google Scholar Different access routes have been suggested for TAVI, with percutaneous transfemoral access being preferred. VCs as a result of large bore delivery catheters remain a significant clinical issue, particularly with respect to the elderly patient population. Complications reported include arterial dissection, perforation, pseudoaneurysm, rupture, and haematoma, among others.5Osnabrugge R.L.J. Mylotte A. Head S.J. Mieghem N.M.V. Nkomo V.T. LeReun C.M. et al.Disease prevalence and number of candidates for transcatheter aortic valve replacement.J Am Coll Cardiol. 2013; 62: 1002-1012Crossref PubMed Scopus (697) Google Scholar, 6Kahlert P. Al-Rashid F. Weber M. Wendt D. Heine T. Kottenberg E. et al.Vascular access site complications after percutaneous transfemoral aortic valve implantation.Herz. 2009; 34: 398-408Crossref PubMed Scopus (87) Google Scholar, 7Toggweiler S. Gurvitch R. Leipsic J. Wood D.A. Willson A.B. Binder R.K. et al.Percutaneous aortic valve replacement vascular outcomes with a fully percutaneous procedure.J Am Coll Cardiol. 2012; 59: 113-118Crossref PubMed Scopus (244) Google Scholar, 8Genereux P. Head S.J. Van Mieghem N.M. Kodali S. Kirtane A.J. Xu K. et al.Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions.J Am Coll Cardiol. 2012; 59: 2317-2326Crossref PubMed Scopus (455) Google Scholar, 9Van Mieghem N.M. Nuis R.J. Piazza N. Apostolos T. Ligthart J. Schultz C. et al.Vascular complications with Transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience.EuroIntervention. 2010; 5: 673-679Crossref PubMed Scopus (141) Google Scholar, 10Moat N.E. Ludman P. de Belder M.A. Bridgewater B. Cunningham A.D. Young C.P. et al.Long-term outcomes after Transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry.J Am Coll Cardiol. 2011; 58: 2130-2138Crossref PubMed Scopus (770) Google Scholar, 11Gilard M. Eltchaninoff H. Lung B. Donzeau-Gouge P. Chevreul K. Fajadet J. et al.Registry of Transcatheter aortic-valve implantation in high-risk patients.N Engl J Med. 2012; 366: 1705-1715Crossref PubMed Scopus (1042) Google Scholar, 12Hayashida K. Lefevre T. Chevalier B. Hovasse T. Romano M. Garot P. et al.Transfemoral aortic valve implantation: new criteria to predict vascular complications.J Am Coll Cardiol Intv. 2011; 4: 851-858Crossref Scopus (413) Google Scholar, 13Lange R. Bleiziffer S. Piazza N. Mazzitelli D. Hutter A. Tassani-Prell P. et al.Incidence and treatment of procedural cardiovascular complications associated with transarterial and transapical interventional aortic valve implantation in 412 consecutive patients.Eur J Cardiothorac Surg. 2011; 40: 1105-1113PubMed Google Scholar The incidence of major VCs in previous studies ranges from 10% to 17%.5Osnabrugge R.L.J. Mylotte A. Head S.J. Mieghem N.M.V. Nkomo V.T. LeReun C.M. et al.Disease prevalence and number of candidates for transcatheter aortic valve replacement.J Am Coll Cardiol. 2013; 62: 1002-1012Crossref PubMed Scopus (697) Google Scholar, 6Kahlert P. Al-Rashid F. Weber M. Wendt D. Heine T. Kottenberg E. et al.Vascular access site complications after percutaneous transfemoral aortic valve implantation.Herz. 2009; 34: 398-408Crossref PubMed Scopus (87) Google Scholar, 7Toggweiler S. Gurvitch R. Leipsic J. Wood D.A. Willson A.B. Binder R.K. et al.Percutaneous aortic valve replacement vascular outcomes with a fully percutaneous procedure.J Am Coll Cardiol. 2012; 59: 113-118Crossref PubMed Scopus (244) Google Scholar, 8Genereux P. Head S.J. Van Mieghem N.M. Kodali S. Kirtane A.J. Xu K. et al.Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions.J Am Coll Cardiol. 2012; 59: 2317-2326Crossref PubMed Scopus (455) Google Scholar, 9Van Mieghem N.M. Nuis R.J. Piazza N. Apostolos T. Ligthart J. Schultz C. et al.Vascular complications with Transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience.EuroIntervention. 2010; 5: 673-679Crossref PubMed Scopus (141) Google Scholar, 10Moat N.E. Ludman P. de Belder M.A. Bridgewater B. Cunningham A.D. Young C.P. et al.Long-term outcomes after Transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry.J Am Coll Cardiol. 2011; 58: 2130-2138Crossref PubMed Scopus (770) Google Scholar, 11Gilard M. Eltchaninoff H. Lung B. Donzeau-Gouge P. Chevreul K. Fajadet J. et al.Registry of Transcatheter aortic-valve implantation in high-risk patients.N Engl J Med. 2012; 366: 1705-1715Crossref PubMed Scopus (1042) Google Scholar, 12Hayashida K. Lefevre T. Chevalier B. Hovasse T. Romano M. Garot P. et al.Transfemoral aortic valve implantation: new criteria to predict vascular complications.J Am Coll Cardiol Intv. 2011; 4: 851-858Crossref Scopus (413) Google Scholar, 13Lange R. Bleiziffer S. Piazza N. Mazzitelli D. Hutter A. Tassani-Prell P. et al.Incidence and treatment of procedural cardiovascular complications associated with transarterial and transapical interventional aortic valve implantation in 412 consecutive patients.Eur J Cardiothorac Surg. 2011; 40: 1105-1113PubMed Google Scholar VCs, along with annular rupture, coronary occlusion, heart block, and renal failure are the leading causes of adverse events in TAVI patients.14Coeytaux R.R. Williams J.W. Gray R.N. Wang A. Percutaneous heart valve replacement for aortic stenosis: state of the evidence.Ann Intern Med. 2010; 2: 314-324Google Scholar Major VCs are associated with poor clinical outcomes, including a higher incidence of major haemorrhage, cardiac and all cause mortality.15Généreux P. Webb J.G. Svensson L.G. Kodali S.K. Satler L.F. Fearon W.F. et al.Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial.J Am Coll Cardiol. 2012; 60: 1043-1052Crossref PubMed Scopus (398) Google Scholar, 16Steinvil A. Leshem-Rubinow E. Halkin A. Abramowitz Y. Ben-Assa E. Shacham Y. et al.Vascular complications after transcatheter aortic valve implantation and their association with mortality reevaluated by the valve academic research consortium definitions.Am J Cardiol. 2015; 115: 100-106Abstract Full Text Full Text PDF PubMed Scopus (52) Google Scholar, 17Van Mieghem N.M. Tchetche D. Chieffo A. Dumonteil N. Messika- Zeitoun D. van der Boon R.M. et al.Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation.Am J Cardiol. 2012; 110: 1361-1367Abstract Full Text Full Text PDF PubMed Scopus (186) Google Scholar VCs may require urgent surgical or endovascular repair, resulting in greater length of stay in the hospital.18Mwipatayi B.P. Picardo A. Masilonyane-Jones T.V. Larbalestier R. Thomas S. Turner J. et al.Incidence and prognosis of vascular complications after transcatheter aortic valve implantation.J Vasc Surg. 2013; 58: 1028-1036Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar In Toronto General Hospital, a multidisciplinary model is used, with cardiologists and cardiac surgeons working side by side to implant TAVI, with the additional involvement of vascular surgery, most commonly for assessment in high risk vascular access patients and management of post-operative complications. There is a need to adequately characterise VCs in order to mitigate adverse outcomes. While it is a rapidly emerging technology with promise, there is limited literature exploring vascular related adverse events and their effect on mortality and procedural morbidity. The present study analyses a single centre TAVI experience with respect to complications, as defined by the Valve Academic Research Consortium (VARC) 2 guidelines (Table 1),19Leon M.B. Piazza N. Nikolsky E. Blackstone E.H. Cutlip D.E. Kappetein A.P. et al.Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.J Am Coll Cardiol. 2011; 57: 253-269Crossref PubMed Scopus (693) Google Scholar as well as their predictors, management, and 30 day outcomes in patients undergoing transfemoral TAVI procedures.Table 1Alternative clinical conditions for major and minor vascular complications based on Valve Academic Research Consortium (VARC) criteria and VARC 2 consensus on vascular complications19Leon M.B. Piazza N. Nikolsky E. Blackstone E.H. Cutlip D.E. Kappetein A.P. et al.Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.J Am Coll Cardiol. 2011; 57: 253-269Crossref PubMed Scopus (693) Google ScholarMajor vascular complications Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, haematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment Any new ipsilateral lower extremity ischaemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram Surgery for access site-related nerve injury Permanent access site-related nerve injuryMinor vascular complications Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneuysms, haematomas, percutaneous closure device failure) not leading to death, life-threatening or major bleeding, visceral ischaemia, or neurological impairment Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft) Open table in a new tab A retrospective cohort study was conducted at the institution, which included 388 consecutive patients undergoing TAVI between January 2007 and April 2015. Devices implanted included CoreValve (Metronic CV, Irvine, CA, USA), and Edwards Sapien (Edwards Life sciences, Irvine, CA, USA). The delivery sheath diameters for CoreValve and Edwards were 18 F and 22/24 F, respectively. The patient cohort comprised patients who received TAVI via the transfemoral approach. All patients had severe symptomatic aortic stenosis as confirmed by transthoracic echocardiography (mean gradient > 40 mmHg or aortic valve area <1.0 cm2). Of these patients, those who were deemed unsuitable for open valve replacement were considered for TAVI. A multidisciplinary team with interventional cardiologists, cardiac anaesthetists, cardiac surgeons, radiologists, and vascular surgeons (for those high risk vascular access cases identified at TAVI rounds) were involved in patient selection and treatment. Vascular access vessels were evaluated by multislice computed tomography (CT) and arterial duplex studies. It is important to note that during the study period, not all TAVI patients received a pre-operative vascular surgery consultation. All transfemoral cases were completed by interventional cardiology or cardiac surgery and any vascular concerns were discussed with one of six vascular surgeons. Institutional ethics board approval for the study was received (13–6384). After patient selection by the TAVI team, the procedural approach was determined to be transapical, transfemoral, or direct aortic. The access route was selected based on a consensus opinion during a weekly multidisciplinary meeting. CT angiography (CTA) and ultrasound were evaluated before deciding on an optimal approach. Factors such as tortuosity, calcification, diameter, plaque, and aneurysms were considered. Cardiologists evaluated CTA scans by measuring the narrowest common femoral artery (CFA) diameter on axial slices along with patient comorbidities to decide whether a referral to vascular surgery was needed. Patients who were referred to vascular surgeons were further evaluated with CTA via axial and coronal slices to make recommendations. The transfemoral (TF-TAVI) approach was considered the default option unless contraindicated. TAVI was performed based on standard instructions for use that have been outlined previously.20Kodali S.K. Williams M.R. Smith C.R. Svensson L.G. Webb J.G. Makkar R.R. et al.Two-year outcomes after transcatheter or surgical aortic-valve replacement.N Engl J Med. 2012; 366: 1686-1695Crossref PubMed Scopus (1900) Google Scholar, 21Makkar R.R. Fontana G.P. Jilaihawi H. Kapadia S. Pichard A.D. Douglas P.S. et al.Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.N Engl J Med. 2012; 366: 1696-1704Crossref PubMed Scopus (1061) Google Scholar Sheath sizes varied between an outer diameter of 18 F and 24 F depending on the system used to deliver the valve. TF-TAVI was performed initially in the cardiac catheterisation laboratory but latterly in a hybrid operating room under fluoroscopic guidance with percutaneous closure. There were no image fusion techniques or specific guidance software used by the operators. Cases that necessitated open cut down or closure of the groins were performed by vascular surgeons. Percutaneous closure was performed using the Perclose ProGlide Suture Mediated Closure System (Abbott Vascular, Santa Clara, CA, USA).22Solomon L.W. Fusman B. Jolly N. Kim A. Feldman T. Percutaneous suture closure for management of large French size arterial puncture in aortic valvuloplasty.J Invasive Cardiol. 2001; 13: 592-596PubMed Google Scholar Data collection included patient demographics and comorbidities, peri- and post-operative use of vascular consultations, 30 day mortality, procedures, length of hospital admission, and 30 day readmissions. The primary endpoint of the study was the presence of VCs, divided into peri-operative and post-operative and then further into major and minor complications as defined by the VARC 2 criteria (Table 1). Peri-operative VCs were defined as those that occurred in the operating room and within 24 h of surgery, consistent with VARC 2 guidelines.19Leon M.B. Piazza N. Nikolsky E. Blackstone E.H. Cutlip D.E. Kappetein A.P. et al.Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.J Am Coll Cardiol. 2011; 57: 253-269Crossref PubMed Scopus (693) Google Scholar The secondary endpoints included length of stay, procedural and 30 day mortality. A multidisciplinary team composed of cardiologists, vascular surgeons, and allied healthcare professionals were involved in patient selection and treatment. VCs were stratified into major vs. minor, according to the VARC 2 guidelines (Table 1). Vascular surgeons and cardiologists carried out the surgical and interventional management of all VCs. Bleeding secondary to incomplete arteriotomy closure was managed by manual compression, protamine administration, balloon occlusion, and/or stent deployment variably, as dictated by severity and response. Occlusive dissections were treated by angioplasty and/or nitinol stents. Pseudoaneurysms were initially managed by compression, and depending on location and size, treated by thrombin injections. Haematomas resolved with expectant and supportive management. Lacerations and vessel ruptures were treated surgically. Categorical data were expressed as number of patients and frequencies (%), and were compared using Pearson correlations, chi-square analyses, or Fisher exact test. Continuous variables were expressed as mean ± standard deviation (95% CI) and compared using Mann–Whitney U tests (MWU). Demographics, comorbidities, intra-operative, and post-operative characteristics were compared between patients who sustained a VC against those who were complication free. All comparisons were two sided, and p < .05 was considered significant. Logistic regression analyses identified factors associated with peri-operative and post-operative VCs. Multivariable analysis of factors associated with VCs in univariable analysis was undertaken to identify independent predictors of VCs using hierarchical logistic regression with bootstrapping. Variables found to be significantly related to complications in univariable analysis (p < .05) were included in the final regression model. With regard to VCs over time, curve estimation was used to conduct a simple time series analysis. Normal assumptions for this analysis were met. All statistical analyses were performed using SPSS V. 23 (IBM Corporation, Armonk, NY, USA). Mortality analysis between the two groups was performed using Spearman correlation and Kaplan–Meier with events compared using the log rank test (p < .05). Three hundred and eighty eight patients received TAVI between 2007 and 2015 and a total of 237 (61%) patients were treated via the transfemoral approach (Fig. 1). The remainder of the patients received TAVI by way of the transapical (n = 146) or direct aortic (n = 5) method. Baseline characteristics and comorbidities of the transfemoral patients are presented in Table 2.Table 2Baseline characteristics of patients receiving transcatheter aortic valve implantation (TAVI) through transfemoral approachCharacteristicPatients (n = 237)Age – y81.0 ± 8.6Male147 (62.0)Body mass index27.85 ± 6.3Aortic valve area0.76 ± 0.30LVEF – %55.7 (13.7)NYHA Class III208 (87.8) Class IV11 (4.64)Logistic EuroScore12.9 (9.3)Past smoker97 (41)Current smoker14 (6)Hypertension187 (79)Diabetes79 (33.3)Coronary artery disease165 (70)Dyslipidaemia170 (72)Previous aneurysm7 (3)Previous PCI77 (32)Previous CABG63 (27)Past myocardial infarction41 (17)Cerebrovascular disease stroke34 (14.3)Stroke14 (5.9)COPD41 (17.3)Pulmonary hypertension91 (38.3)Renal Creatinine120.5 ± 105 MDRD GFR57.4 ± 20Data are given as n (%) or mean ± standard deviation (SD). Logistic EuroScore is the risk stratification score including age, gender, COPD, extracardiac arteriopathy, neurological dysfunction, creatinine, previous cardiac surgery, critical state, active pericarditis, LV function, unstable angina, recent myocardial infarction, pulmonary hypertension. CABG = coronary artery bypass graft; COPD = chronic obstructive pulmonary disease; GFR = glomerular filtration rate; LVEF = left ventricular ejection fraction; MDRD = modification of diet in renal disease; NYHA = New York Heart Association; PCI = percutaneous coronary intervention. Open table in a new tab Data are given as n (%) or mean ± standard deviation (SD). Logistic EuroScore is the risk stratification score including age, gender, COPD, extracardiac arteriopathy, neurological dysfunction, creatinine, previous cardiac surgery, critical state, active pericarditis, LV function, unstable angina, recent myocardial infarction, pulmonary hypertension. CABG = coronary artery bypass graft; COPD = chronic obstructive pulmonary disease; GFR = glomerular filtration rate; LVEF = left ventricular ejection fraction; MDRD = modification of diet in renal disease; NYHA = New York Heart Association; PCI = percutaneous coronary intervention. Time series analysis failed to show a significant relationship between the proportion of complications and time from 2007 to 2015. This included both cut down (2007–2009) and percutaneous (2010 onwards) cases. In order to better examine change in complications over time using percutaneous access, VCs from 2010 onwards were explored too. There was neither a significant linear nor a quadratic relationship between the proportion of VCs and year (2010–2015, p = .24 (linear) and .26 (quadratic); Fig. 2). In 2010 there were few cases, and no cases with complications. Thus, a relationship was sought between the years 2011 and 2015, excluding the year 2010 as a potential outlier. Both linear and quadratic relationships continued to fail to meet significance in this model (p = .08). There was a total of 68 VCs (28.7%), with 42 (17.9%) occurring during the post-operative period and the remainder (n = 26, 11.4%) during the peri-operative period (Fig. 1). These included haematomas (22), arterial dissections (20), pseudoaneurysms (14), common femoral artery laceration (1), rupture (5), thrombus (4), and fistula (2). Dissections mainly occurred in the femoral system, with 60% (12) being at the level of the common femoral artery and the remainder in the superficial femoral and iliac systems. TAVI patients sustained a total of seven major VCs (3%; Table 3), with all requiring endovascular or open repair. Perforations and lacerations were managed by arterial cut down and primary repair. In certain cases, occlusion balloons were advanced to control bleeding prior to gaining proximal and distal control. It is important to note that ventricular perforations can be treated by both endovascular and open methods, and it is important to maintain a high index of suspicion in patients who are haemodynamically unstable. Lastly, arterial embolisation was treated by cut down and balloon embolectomy.Table 3Treatment of major vascular complications in patients receiving transcatheter aortic valve implantation (TAVI) through transfemoral approacha3% of all transcatheter aortic valve implantation patients sustained a major vascular complication. All patients needed >2 units of blood and operative management.Vascular complication (major)TreatmentVentricular perforationEndovascular vascular plug and pericardiocentesisIliac and femoral dissectionHybrid repairFemoral and cardiac lacerationSurgical repairFemoral perforationSurgical repairIliac perforation (n = 2)Surgical repairDistal embolisationEmbolectomya 3% of all transcatheter aortic valve implantation patients sustained a major vascular complication. All patients needed >2 units of blood and operative management. Open table in a new tab Most minor VCs occurred post-operatively (16.5% vs. 9.3%; Fig. 3). In the peri-operative period, the majority of complications were the result of dissections while post-operatively haematomas and pseudoaneurysms were the main causes. VCs resulted in 17 procedures, with surgical repair being the most common peri-operatively, and thrombin injections post-operatively (Table 4). Vascular surgeons performed all procedures. This constituted 7% of the TAVI population and 25% of patients who sustained a VC.Table 4Peri- and post-operative procedures to treat vascular complications (VCs) (n = 68) of 237 patients receiving transcatheter aortic valve implantation (TAVI) through transfemoral" @default.
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• W2956838365 title "Vascular Complications and Procedures Following Transcatheter Aortic Valve Implantation" @default.
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• W2956838365 doi "https://doi.org/10.1016/j.ejvs.2019.03.014" @default.
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