Iliofemoral artery predilation prior to transfemoral transcatheter aortic valve implantation in patients with aortic valve stenosis and advanced peripheral artery disease.

OBJECTIVES: To investigate the feasibility and safety of percutaneous transluminal angioplasty (PTA) of the iliofemoral arteries (IFA) before transfemoral transcatheter aortic valve implantation (Tf-TAVI) in patients with advanced peripheral artery disease (PAD). BACKGROUND: Although Tf-TAVI represents the access of choice, alternative vascular access routes are preferred for patients displaying advanced PAD. PTA of the IFA represents a less invasive option, broadening the spectrum of patients eligible for Tf-TAVI. METHODS: All patients requiring PTA of the IFA before Tf-TAVI, between 2012 and 2021, were included. Primary efficacy endpoint was the rate of successful transcatheter heart valve (THV) delivery and implantation. Primary safety endpoint was the rate of PTA and access-site-related vascular complications, procedural- and in-hospital complications. RESULTS: Among 2726 Tf-TAVI procedures, 59 patients required IFA predilation. Successful THV delivery and implantation was achieved in 57 (96.6%) patients, respectively. Sheath placement was achieved in 59 (100%) patients with only one minor dissection and no major vascular complications following iliofemoral PTA. Regarding access site complications, two (3.4%) vessel perforations and one (1.7%) vessel rupture were observed, with eight (13.5%) patients requiring unplanned endovascular interventions. There was one intraprocedural death due to THV-induced vessel laceration, while in-hospital all-cause mortality was 8.5% in the present high-risk patient cohort. CONCLUSIONS: Predilation of IFA is safe and effective in patients with advanced PAD. Careful preprocedural planning is paramount in improving procedural safety and efficacy. This strategy has the potential to broaden the spectrum of patients eligible for Tf-TAVI.

Target and non-target vessel related events at 10 years post percutaneous coronary intervention.

AIMS: To define the incidence of events related to the stented vessel (target vessel related events: TVRE) and events related to non-stented vessels (non-target vessel related events: NTVRE) through to 10-year follow-up in patients post-PCI with newer generation drug eluting stents (DES). METHODS AND RESULTS: The current study is a post-hoc analysis of patient level data from two randomised controlled trials in Germany. Patients older than 18 years with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in the native coronary vessels were considered eligible. The endpoints of interest were TVRE (a composite of first target vessel myocardial infarction or target vessel revascularization) and NTVRE (a composite of first non-target vessel MI or non-target vessel revascularization) through to 10 years post PCI. We included 4953 patients in this analysis. Through to 10-years post-PCI, TVRE occurred in 1238 of 4953 patients (cumulative incidence: 25.8%) and NTVRE occurred in 1442 of 4953 patients (cumulative incidence: 30.3%). The majority of TVRE and NTVRE were revascularization events. From 0 to 1 years, the cumulative incidence of TVRE was 15.9% and of NTVRE was 12.3%. From 1 to 10 years, the cumulative incidences of TVRE and NTVRE were 11.2% and 22.4%, respectively. CONCLUSION: At 10-year post-PCI with new generation drug eluting stents, events related to remote vessel disease progression account for a higher proportion of events than events related to the stented vessel. TRIAL REGISTRATION: ISAR TEST 4 ClinicalTrials.gov Identifier: NCT00598676. ISAR TEST 5 ClinicalTrials.gov Identifier: NCT00598533.

Critical adverse events during transfemoral TAVR in conscious sedation. Is an anesthesiologic support mandatory?

BACKGROUND: Transfemoral TAVR (tf-TAVR) under conscious sedation (CS) has become popular. The need of anesthesiologic support during tf-TAVR has been questioned. Critical events during the procedure might require immediate action. We analyzed the frequency of periprocedural critical adverse events (CAE) during tf-TAVR with CS in our institution. METHODS: Tf-TAVR has been performed at our institution since 2007. We excluded patients from the first four years to minimize the influence of any learning curve. CAE were defined as occurrence of 1.) "CPR", 2.) "defibrillation", 3.) "emergency extracorporeal circulation (ECC)" and 4.) "conversion to general anesthesia (GA) not related to 1.)-3.)". Data was prospectively collected in our AVIATOR TAVR registry. RESULTS: 601 patients were analyzed retrospectively. Overall, CAE were recorded in 54 patients (9%). CPR was necessary in 12 patients (2%) and defibrillation in 10 patients (1.6%). ECC was rarely needed (n = 2, 0.3%). Conversion to GA was necessary in 34 patients (5.65%). Procedure-related conversion was necessary in 10 patients. With 24 patients, sedation-related conversion occurred more frequently. Unrest and pain were the most common reasons for conversion (n = 13, 2%) and respiratory distress in 11 patients (2%). Catecholaminergic support was needed in 269 (45%) patients. Vasopressors were more often applied (n = 249, 41%) than inotropes (n = 59, 10%). CONCLUSION: Even in a high-volume center, CAE may occur in nearly every tenth patient. Conversion to GA was the most common CAE. Catecholaminergic support (primary vasopressor support) was needed in nearly every second patient. These points underline the necessity of a cardiac anaesthesiologist to be in the room during the procedure. SUMMARY: Despite experience, critical adverse events (CAE) still occur in TAVR patients. We analyzed the occurrence of CAE and the need for catecholaminergic support in sedated TAVR patients.

Parallel suture technique with ProGlide: a novel method for management of vascular access during transcatheter aortic valve implantation (TAVI).

AIMS: The aim of this study was to evaluate vascular complications using the "parallel suture technique" in patients receiving an Edwards SAPIEN XT (SXT) or SAPIEN S3 (S3) transcatheter heart valve (THV). METHODS AND RESULTS: Two hundred consecutive patients with symptomatic severe aortic stenosis treated with TF-TAVI were included in this study where the "parallel suture technique" was applied for vascular access-site closure. This was achieved by placing the sutures medial and lateral to the puncture site. Vascular access-site complications were defined as vascular dissection, perforation, obstruction, arteriovenous fistula or pseudoaneurysms, and classified according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Duplex sonography was performed routinely in every patient. In patients receiving the S3, the sheath to femoral and iliac artery ratio was significantly lower than in the SXT group, reflecting reduction in sheath sizes for S3. More endovascular interventions were required after SXT implantation as compared to S3 (4% versus 1%, p=0.02). This was due to vascular obstruction or device failure. Moreover, increased life-threatening, major bleedings, and pseudoaneurysms were found in the SXT group (6% versus 1%, p=0.06, 13% versus 3%, p=0.009, 7% versus 1%, p=0.03, respectively). CONCLUSIONS: The "parallel suture technique" using the ProGlide is associated with a low number of vascular complications, even when using larger sheath sizes.