Access For Implantation Research Articles

Left femoral venous access for leadless pacemaker implantation: patient characteristics and outcomes

Abstract Funding Acknowledgements Type of funding sources: None. Background Leadless pacing has become an alternative approach for patients requiring a single-chamber pacemaker. Conventionally, Leadless Micra Transcatheter Pacing System (TPS) pacemakers are implanted via a right femoral venous access. However, due to various reasons, a left sided femoral venous approach may benecessary. We hypothesized that a left sided femoral venous approach is as safe and effective as compared to a right sided approach. Objective We assessed indications, procedural characteristics, safety and mid-term outcomes of Micra TPS implantation via a left femoral venous approach as compared to the conventional right sided approach. Methods and Results: In this retrospective single-center analysis, 143 consecutive patients undergoing Micra TPS implantation were included. 87% (125/143) underwent Micra TPS implantation via a right, and 13% (18/143) via a left femoral venous access. The mean age at implantation was 79.8 ± 7.5 years. Acute procedural success, mean procedure and fluoroscopy times as well as device parameters at implantation and follow-up (mean 15 ± 11.5 months) were similar between the two groups. Five major complications (3.5%) were encountered, all using a right-sided approach. After a transfemoral TAVI procedure, left femoral venous access was used in 42% of cases as compared to 8% in the remaining population (p = 0.003). Final leadless pacemaker position within the right ventricle was mid-septal in 82% (102/125) for right femoral access vs 72% (13/18) for left femoral access (p = 0.16). In the remaining cases (28 %, 5/18), the device was placed infero-septal following a left femoral venous access, as compared to 14% (18/125) for a right sided approach (p = 0.19). No repositioning was needed in 68% (85/125) using a right femoral access vs 72% (13/ 18) patients with a left femoral access (p = 0.84). Conclusions A left femoral venous access for Micra TPS implantation is safe and effective with an excellent implantation success rate similar to a conventional right femoral venous access without longer implantation and fluoroscopy times. The most frequent reason for choosing left- vs. right femoral venous access was a previous transfemoral TAVI procedure.

Left femoral venous access for leadless pacemaker implantation: patient characteristics and outcomes.

Leadless pacing has become an alternative approach for patients requiring a single-chamber pacemaker. Conventionally, leadless Micra Transcatheter Pacing System (TPS) pacemakers are implanted via a right femoral venous access. However, due to various reasons, a left-sided femoral venous approach may be necessary. We hypothesized that a left-sided femoral venous approach is as safe and effective when compared with a right-sided approach. We assessed indications, procedural characteristics, safety and mid-term outcomes of Micra TPS implantation via a left femoral venous approach when compared with the conventional right-sided approach. In this retrospective single-centre analysis, 143 consecutive patients undergoing Micra TPS implantation were included. 87% (125/143) underwent Micra TPS implantation via a right, and 13% (18/143) via a left femoral venous access. The mean age at implantation was 79.8 ± 7.5 years. Acute procedural success, mean procedure and fluoroscopy times as well as device parameters at implantation and follow-up (mean 15 ± 11.5 months) were similar between the two groups. Five major complications (3.5%) were encountered, all using a right-sided approach. After a transfemoral TAVI procedure, left femoral venous access was used in 42% of cases when compared with 8% in the remaining population (P = 0.003). A left femoral venous access for Micra TPS implantation is safe and effective with an excellent implantation success rate similar to a conventional right femoral venous access without longer implantation and fluoroscopy times. The most frequent reason for choosing left vs. right femoral venous access was a previous transfemoral TAVI procedure.

Ultrasound guided axillary vein access: An alternative approach to venous access for cardiac device implantation.

Ultrasound guided axillary vein access (UGAVA) is an emerging approach for cardiac implantable electronic device (CIED) implantation not widely utilized. This is a retrospective, age and sex-matched cohort study of CIED implantation from January 2017 to July 2019 comparing UGAVA before incision to venous access obtained after incision without ultrasound (conventional). The study population included 561 patients (187 with attempted UGAVA, 68 ± 13 years old, 43% women, body mass index (BMI) 30 ± 8 kg/m2 , 15% right-sided, 43% implantable cardioverter-defibrillator, 15% upgrades). UGAVA was successful in 178/187 patients (95%). In nine patients where UGAVA was abandoned, the vein was too deep for access before incision. BMI was higher in abandoned patients than successful UGAVA (38 ± 6 vs. 28 ± 6 kg/m2 , p < .0001). Median time from local anesthetic to completion of UGAVA was 7 min (interquartile range [IQR]: 4-10) and median procedure time 61 min (IQR: 50-92). UGAVA changed implant laterality in two patients (avoiding an extra incision in both) and could have prevented unnecessary incision in four conventional patients. Excluding device upgrades, there was reduced fluoroscopy time in UGAVA versus conventional (4 vs. 6 min; IQR: 2-5 vs. 4-9; p < .001). Thirty-day complications were similar in UGAVA versus conventional (n = 7 vs. 26, 4 vs. 7%; p = .13, p = .41 adjusting for upgrades), partly driven by a trend towards reduced pneumothorax (n = 0 vs. 3, 0 vs. 1%; p = .22). UGAVA is a safe approach for CIED implantation and helps prevent an extra incision if a barrier is identified changing laterality preincision.

Short-term safety and efficacy of transcarotid transcatheter aortic valve implantation with balloon-expandable vs. self-expandable valves.

IntroductionTransfemoral access (TF) is the preferred access for transcatheter aortic valve implantation (TAVI). Transcarotid TAVI (TC-TAVI) is an alternative for patients in whom TF-TAVI is impossible. Two types of valves – balloon-expandable (BE) and self-expandable (SE) – can be used in TC-TAVI procedures.AimComparison of the short-term results of patients treated with TC-TAVI using BE and SE valves.Material and methodsThe retrospective registry included 39 patients in whom the TC-TAVI procedure was performed between 2017 and 2020 (BE-TAVI; n = 10, SE-TAVI; n = 29). Preoperative characteristics, operative and postoperative results, and 30-days mortality were compared.ResultsPatients from the BE-TAVI group had higher surgical risk (EuroSCORE) (10.8% (6.2–14.0) vs. 5.5% (4.3–8.7); p = 0.027). The incidence of chronic obstructive pulmonary disease (COPD) was higher in the SE-TAVI group (34.5% vs. 0%; p = 0.040). In terms of other comorbidities, demographics, preprocedural laboratory results, transthoracic echocardiography (TTE), and multislice computed tomography (MSCT), the two groups were comparable. In both groups, we observed 100% procedural success. The median valve size was larger in the SE-TAVI group (29.0 (26.0–29.0) vs. 26.0 (23.0–26.0); p < 0.001). The hospitalization time was shorter in the BE-TAVI group vs. SE-TAVI (5.8 ±0.6 vs. 6.4 ±0.9; p = 0.043). We did not observe statistically significant differences between BE-TAVI and SE-TAVI in periprocedural and 30-day mortality, or the number of strokes/TIA. Also TTE parameters and NYHA class showed similar improvement at 30 days in both groups.ConclusionsTC-TAVI using balloon-expandable and self-expandable valves showed similar safety and efficacy in 30 days follow-up.

Shockwave Intravascular Lithotripsy in Preference to Alternate Vascular Access to Facilitate Transfemoral Vascular Access for Transcatheter Aortic Valve Implantation

Transfemoral access for transcatheter aortic valve implantation (TAVI) is not always feasible owing to hostile peripheral anatomy. In the early era of TAVI, direct aortic/transapical approaches were used as alternative access techniques; however, these approaches have been largely abandoned owing to inferior patient outcomes [1]. Subsequently, a number of novel alternate-access techniques have emerged, including subclavian, axillary, carotid, and transcaval approaches. More recently, shockwave intravascular lithotripsy (IVL) has offered a novel approach to facilitate the preferred transfemoral approach to TAVI procedures.

Left atrial appendage closure device implantation via transhepatic vascular access: a case report

BackgroundIn patients with non-valvular atrial fibrillation, an estimated 90% of thrombi are located in the left atrial appendage. The WATCHMAN device is a left atrial appendage closure device that is an alternative therapeutic option to reduce the risk of systemic embolization in patients who are intolerant of long-term oral anticoagulation. It can be deployed in the left atrial appendage using a transseptal approach via the femoral vein. Transhepatic venous access is an alternative route for the delivery of the device in a patient with difficult vascular access.Case summaryAn 81-year-old man with persistent non-valvular atrial fibrillation, heart failure with reduced ejection fraction (HFrEF), and diabetes mellitus was deemed a poor candidate for anticoagulation due to recurrent falls and gastrointestinal bleeding. He was selected for a left atrial appendage closure. The initial procedure was aborted after significant resistance to device advancement was encountered in the right femoral vein. Lower extremity venography demonstrated totally occluded femoral and iliac veins bilaterally. The decision was made to implant the device via a transhepatic approach. The procedure had no complications and the patient was discharged on rivaroxaban and aspirin after 3 days.DiscussionTranshepatic venous access is a viable option in patients with poor femoral access for implantation of the WATCHMAN device. It can be done safely. Knowledge of this procedural alternative can greatly enhance patient care.

Transcarotid trancatheter aortic valve implantation under local anesthesia in real life, a retrospective observational comparison with femoral access

Abstract Background Trans-femoral approach is the most commonly used access for trans-catheter aortic valve implantation (TAVI). However, in case of unsuitability, several alterative access routes have been described, namely trans-axillary, trans-aortic and trans-apical. The trans-carotid approach, rarely used, can be of particular help. Purpose To compare trans-carotid with trans-femoral access for TAVI, regarding epidemiological, clinical, procedural features and in hospital prognosis. Methods We retrospectively analyzed the data of 1272 patients treated with TAVI between January 2013 and December 2019. Patients were divided into 2 groups and compared according to the vascular approach: trans-carotid group (n=84) and trans-femoral group (n=1188). Results The trans-carotid group, representing 6.6% of all patients undergoing TAVI, had significantly more hypertension (89.9% vs 75.8%; p=0.002), history of coronary artery disease (78.6% vs 50.5%; p&amp;lt;0.001), peripheral arteriopathy (58.7% vs 9.3%; p&amp;lt;0.0001), ischemic stroke (24% vs 10.5%; p=0.03), chronic obstructive pulmonary disease (30.8% vs 18.4%; p=0.004), surgical aortic valve replacement (12% vs 4.3%; p=0.008) and contralateral carotid endarterectomy (4% vs 0.4%; p=0.012). Average scores of LOGISTIC EUROSCORE and EUROSCORE II were significantly higher in this group (respectively 22.4 vs 15.2 and 8.3 vs 5.56; p&amp;lt;0.0001) and patients were more frequently considered by the Heart Team as at high surgical risk (91.3% vs 68.2%; p&amp;lt;0.0001). When performing TAVI, balloon predilatation and postdilatation were significantly less frequent in the trans-carotid group (respectively 13.3% vs 26.4%; p=0.03 and 21.7% vs 37.6%; p=0.006). However, there was no significant difference between the 2 groups concerning neither the implantation of self-expanding/balloon-expandable valves nor in the fluoroscopy time and dose-area product averages. On post-procedural echocardiographic findings, transaortic mean gradient average and the incidence of significant paravalvular leak were similar. During intra-hospital follow-up, patients in the trans-carotid group had significantly less vascular complications (9.3% vs 23%; p=0.02) and less urgent need of endovascular repair (0% vs 15.8%; p=0.013) without any impact on the need for transfusion. However, the incidence of atrial fibrillation was significantly higher (17.4% vs 9.4%; p=0.036). There was no significant difference between the two groups for the incidence of haemodynamic and neurological complications, high-degree atrioventricular block and in-hospital mortality. Conclusion According to our study, trans-carotid TAVI under local anesthesia can be feasible and safe, especially in more friable patients at higher risk. It was associated with lower incidence of vascular complications but a higher incidence of atrial fibrillation, without impact on in-hospital mortality. Randomized controlled trials are needed to establish a firm conclusion about this novel approach. Funding Acknowledgement Type of funding source: None

Subclavian-Axillary Access for Transcatheter Aortic Valve Implantation with SAPIEN 3: Results from the ACCESS Study

ABSTRACT Background The ACCESS Study is a prospective, multicenter registry to evaluate the efficacy and safety of trans-subclavian and axillary transcatheter aortic valve replacement (TAx-TAVR) with the latest-generation balloon-expandable transcatheter valve (THV). The secondary goal of this study was to determine whether the type of TAx access (left versus right, supraclavicular-subclavian versus infraclavicular-axillary, cutdown versus percutaneous) made a difference in procedural and 30-day outcomes. Methods 75 consecutive patients from March 2016 to June 2018 with hostile femoral anatomy and favorable subclavian or axillary anatomy underwent TAx-TAVR using the SAPIEN 3 THV (Edwards Lifesciences, Irvine, CA) at six experienced centers. Demographics, procedural characteristics, in-hospital, and 30-day outcomes were recorded. Results Successful TAx access was obtained in 73 (97.3%) patients. Left subclavian 32 (42.7%) and left axillary 26 (34.6%) were the most common access sites followed by right subclavian 9 (12.0%) and right axillary 6 (8.0%). Nineteen (25.3%) of the patients underwent TAx-TAVR using a complete percutaneous technique. Vascular access complications requiring intervention during hospitalization occurred in 5 (6.7%). The in-hospital total stroke rate was 5.3% with debilitating stroke occurring in 2.7% of patients and did not appear to differ based on the type of TAx access. Thirty-day mortality was 4.0%. Conclusions TAx-TAVR with the SAPIEN 3 THV is an effective and safe alternative showing high procedural success and low rates of vascular injury. The type of TAx access (left versus right, subclavian versus axillary, cutdown versus percutaneous) does not appear to make a significant difference in procedural and 30-day outcomes. Abbreviations TAVR: transcatheter aortic valve replacement; TAx: trans-subclavian-axillary; THV: transcatheter valve; TA: transapical; TC: transcarotid; TF: transfemoral; LIMA: left internal mammary artery; SEM: standard error of the mean; SD: standard deviation; STS: Society of Thoracic Surgeons; BMI: body mass index; CABG: Coronary artery bypass graft; ICU: Intensive care unit; LOS: length of stay; MI: myocardial infarction; PCI: percutaneous coronary intervention; ESRD: end-stage renal disease; TAo: trans-aortic; TIA: transient ischemic attack.

Transcaval access for the emergency delivery of 5.0 liters per minute mechanical circulatory support in cardiogenic shock.

The purpose of this study was to describe the feasibility and early outcomes of transcaval access for delivery of emergency mechanical circulatory support (MCS) in cardiogenic shock. Vascular access for implantation of MCS in patients with cardiogenic shock is often challenging due to peripheral arterial disease and vasoconstriction. Transcaval delivery of MCS may be an alternative. We describe a series of patients we implanted an Impella 5.0 device, on-table without CT planning, through a percutaneous transcaval access route. Ten patients with progressive or refractory cardiogenic shock underwent Impella 5.0 implantation via transcaval access. Demographic, clinical and procedural variables and in-hospital outcomes were collected. All ten underwent emergency implantation of the 7 mm diameter Impella 5.0 device via transcaval access. Six were women, with median age of 55.5 years (range, 29-69). Cardiogenic shock was attributed to idiopathic nonischemic cardiomyopathy (n = 4), myocarditis (n = 2), ischemic cardiomyopathy (n = 2), heart transplant rejection (n = 1), and unknown etiology (n = 1). Median duration of support was 92.1 hr (range, 21.2-165.4). Seven (70%) survived to device explant, with six (60%) surviving to access port closure and discharge. Among survivors, five recovered heart function and one received destination therapy left ventricular assist device. Transcaval access is feasible for emergency nonsurgical implantation of the Impella 5.0 device in cardiogenic shock with small or diseased iliofemoral arteries. This allows early institution of higher-flow MCS than conventional femoral artery implantation of the 3.5 L Impella CP device, and enables a bridge-to-recovery or bridge-to-destination strategy.

Axillary vein access for antiarrhythmic cardiac device implantation: a literature review.

The current narrative review provides an update of available knowledge on venous access techniques for cardiac implantable electronic device implantation, with a focus on axillary vein puncture. Lower procedure-related and lead-related complications have been reported with extrathoracic vein puncture techniques compared with intrathoracic accesses. In particular, extrathoracic lead access through the axillary vein seems to be associated with lower complication incidence than subclavian vein puncture and higher success rate than cephalic vein cutdown. In literature, many techniques have been described for axillary vein access. The use of contrast venography-guided puncture has facilitated the diffusion of the axillary vein approach for device implantation. Venography may be particularly useful in specific demographic and clinical device implantation contexts. Ultrasound-guided or microwire-guided vascular access for lead positioning can be considered a valid alternative to venography, although current applications for axillary vein puncture need further evaluations.

Influence of implantation access on complication rates in pacemaker implantation: An analysis of quality insurance data

Influence of implantation access on complication rates in pacemaker implantation: An analysis of quality insurance data

ULTRASOUND GUIDED AXILLARY VEIN ACCESS: AN ALTERNATIVE APPROACH FOR VENOUS ACCESS FOR CARDIAC DEVICE IMPLANTATION

Ultrasound (US) guided axillary vein access (UGAVA) is an emerging approach to venous access for cardiac device implantation. Although US guidance is commonly utilized for central venous catheter placement, it is utilized less frequently for the implantation of cardiac devices. There is limited

Short term Outcomes of Transcarotid vs Transaxillary Artery TAVR Procedures: A Single Center Experience

Objective: Patients with prohibitive iliofemoral disease undergoing transcatheter aortic valve replacement (TAVR) often require alternative, nonfemoral access for valve delivery and implantation. To date, there is a paucity of data directly comparing the transcarotid and trans-subclavian access routes. We thus sought to evaluate the short-term outcomes of both approaches. Methods: All TAVR procedures performed via a transcarotid or trans-subclavian approach between June 2015 and May 2019 were included. Data were retrospectively collected from The Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. Outcomes are reported in accordance with the Valve Academic Research Consortium definitions. Results: A total of 131 patients were treated with either transcarotid or trans-subclavian TAVR during the study period (transcarotid=57 vs. trans-subclavian=74). Transcarotid patients had higher Society of Thoracic Surgeons risk scores (14.87±7.58 vs. 11.42±7.52; p=0.018) and prevalence of hypertension (100% vs. 89%; p=0.010). Trans-subclavian patients had higher rates of prior coronary interventions (43% vs. 26%; p=0.045). The transcarotid approach exhibited shorter fluoroscopy time (minutes, 22.55±8.12 vs. 33.62±13.94; p<0.001) and lower contrast volume (milliliter, 92.95±46.15 vs. 113.28±55.00; p=0.026). ICU stay and overall hospital stay were shorter with the transcarotid approach, (hours, 24.9 vs. 72.7; p=0.03) and (days, 5.86±5.56 vs. 8.95±8.23; p=0.016). There were no differences between the groups with respect to 30-day mortality (0% vs. 5.4%; p=0.132), stroke (7% vs. 8%; p=0.816), need for permanent pace-maker or vascular complication. Conclusions: The transcarotid approach yields lesser fluoroscopy time, contrast volume, ICU and overall hospital stay compared to the trans-subclavian approach. Short-term mortality and stroke rates are similar between the two approaches. KEYWORD: e-P-22 The authors do not declare any conflict of interest.

Early outcomes of transcarotid access for transcatheter aortic valve implantation

To evaluate a single-center experience with the transcarotid access for TAVI based on VARC-2 definitions. Fifty successive patients undergoing transcarotid TAVI were included. Locoregional anesthesia was used in 64% of cases. There was no early mortality and one case of stroke (2%). Vascular access-related (all minor) complications occurred in 4% of patients; average hospital stay was 4.6 ± 3.2 days. Device success was adjudicated in 92% of cases, early safety in 96%, and clinical success in 92%. The transcarotid route for TAVI is reproducible and associated with low rates of adverse neurological events, access-related complications and bleeding complications. Routine use of locoregional anesthesia is feasible. Careful surgical management of the common carotid artery is pivotal.

855 Methods of Vascular Access for Transcatheter Aortic Valve Implantation (TAVI) at an Australian Centre

While the majority of TAVI is performed trans-femorally, this method of access is not attainable in all cases. Initially transthoracic, typically transapical, approaches were utilised with cardiothoracic support for these cases, however these techniques have subsequently been demonstrated to produce inferior patient outcomes [[1]Makkar R.R. Thourani V.H. Mack M.J. Kodali S.K. Kapadia S. Webb J.G. et al.Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.New England Journal of Medicine. 2020; 382: 799-809Crossref PubMed Scopus (329) Google Scholar]. All patients who underwent TAVI at a single centre from 2008 to 2019 were reviewed in a retrospective registry analysis. Demographics, point of vascular access and procedural outcomes were collected. A total 522 TAVIs were performed. There were 498 trans-femoral, 16 transapical, 2 direct aortic, 2 subclavian, 1 carotid and 3 trans-caval cases, one of which was abandoned due to inability to access the aorta and then completed trans-femorally with vascular surgical support. Of the 16 trans-apical cases, 8 were in 2009, and the last trans-apical case was performed at our centre in 2017, after which this approach has been abandoned due to increasing evidence, although not at our centre, of poorer operative outcomes in this cohort. All other cases where methods of alternate vascular access were used proceeded without vascular injury, stroke or major bleeding complications. While transfemoral access is the established point of vascular access for TAVI, in some cases, mainly owing to individual vascular anatomy, alternate methods must be pursued. While the transapical approach has fallen out of favour, several other routes, including trans-caval, direct aortic, subclavian and carotid have proceeded without significant complication at our centre.

056 ProGlide Mediated Closure of Transcatheter Aortic Valve Implantation access site is Associated With Lower Vascular Complications Compared to Prostar

056 ProGlide Mediated Closure of Transcatheter Aortic Valve Implantation access site is Associated With Lower Vascular Complications Compared to Prostar

2406Role of implantation access on complication rates in pacemaker implantation

Abstract Introduction The implantation access (IA) either via vena cephalica (VC) or vena subclavia (VS) is the usual procedure in pacemaker implantation (PI). Valid data on head-to head comparisons between access via CV and VS regarding serious complications are missing. Purpose We analyzed potential associations between the type of implantation access and complication rates in a real world data set with 69.957 cases. Methods The 2013 dataset of the German Federal Council, containing information about all 1st pacemaker implantations for Germanywas analyzed. First two cohorts of patients treated via CV or CS access were compared for all relevant variables through descriptive statistics. Secondly all patient-clusters with exactly the same risk-/condition-vector were identified based on the following variables: age, sex, ASA classification (ASA 1–ASA 5), leading symptom, indication for implantation, etiology, ejection fraction (EF), estimated need of stimulation, and all possible 1:1 exact matchings were compared. Results Out of the total cohort of 69,957 patients (mean age 76.2 years, 43.3% females, VC access 36%, VS access 64%) 19,643 pairs with identical profile of all factors contained in the database could be identified. These pairs of all 1:1 matchings had following profile: age 77.07 years, ASA 1 to 4 6.3%, 2 45.0%, 46.9%, 4 1.7%, leading symptoms (dizziness 51.9%, singular cardiac syncope 10.3%, recurring syncope 28,7%), pacemaker indication (AV-Block II/III 11.6%/26.3%, sick sinus syndrome 39,8%, bradycardia in atrial fibrillation 20.0%), unknown etiology 90.3%, estimated need of stimulation (permanent (&gt;90%) 20.9%, frequent (5–90%) 70.2%, rare (&lt;5%) 8.9%), EF (≤35%: 0.4%: 35, 50%: 9.1%, &gt;50%: 79.9%, unknown: 10.5%). Intra- and post-procedural complication [C] rates different between VC and VS are: at least one C: 2.6% (VC), 3.0% (VS) p=0.018; surgical C with need for intervention (haematothorax, pericardial effusion, pouch hematoma): 0.5% (VC), 1.0% (VS) p=0.005; asystole: 0.1% (VC), 0.2% (VS) p=0.047; pneumothorax: 0.1% (VC), 0.7% (VC) p&lt;0.001; dislocated atrial lead: 0.8% (VC), 0.6% (VS) p=0.027. Intra-hospital mortality was 1.0% (VC), 1.1% (VS) p=0.521. Conclusion Our analysis of a large-scale database shows that in patients with first pacemaker implantation the overall rate of complications is relatively low. But even after adjustment for available risk factors there are differences between the access routes: whereas VS access route is associated with statistically significant higher risk of overall complications, i.e. surgical complications, asystole, pneumothorax the VC access has a greater risk of dislocated atrial lead. In view of the two times higher rate of implantations via VS (64 vs. 36%) the clinical implications should be considered when choosing the access route and the VC access should be preferred. Acknowledgement/Funding None

Meta-analysis Evaluating the Safety and Efficacy of Transcarotid Transcatheter Aortic Valve Implantation

We performed a systemic review and meta-analysis of studies evaluating transcarotid vascular access for transcatheter aortic valve implantation (TAVI). Published studies evaluating transcarotid vascular access for TAVI were included in this analysis. Outcomes of interest included 30-day mortality, stroke/transient ischemic attack (TIA), new pacemaker implantation, acute kidney injury (AKI), major vascular complication, major bleeding, and myocardial infarction. Pooled estimate for 30-day mortality was 5.3% (95% confidence interval [CI] 4.0% to 6.8%; I2 = 4%), stroke/TIA was 3.4% (95% CI 2.4% to 4.6%; I2 = 0%), new pacemaker implantation was 15.3% (95% CI 10.8% to 19.7%; I2 = 72%), AKI was 3.4% (95% CI 1.3% to 6.5%; I2 = 58%), major vascular complication was 2.4% (95% CI 1.1% to 3.7%; I2 = 46%), major bleeding was 4.3% (95% CI 2.8% to 6.1%; I2 = 11%), and myocardial infarction was 1.1% (95% CI 0.4% to 2.0%; I2 = 0%). Metaregression was carried out to study the association of effect size with the continuous study-level covariates that included average age, proportion of males, and mean STS score. In this regard, mean STS score showed association with major vascular complications (coefficient: 0.008; p = 0.049). Cumulative meta-analysis carried out showed that there was temporal trend of decreasing incidence of stroke/TIA, major vascular complications, and AKI for transcarotid TAVI. In conclusion, transcarotid access for TAVI is a reasonable choice in patients requiring alternate access to transfemoral route.

Robotic middle ear access for cochlear implantation: First in man.

To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of the drilling trajectory to relevant anatomy. Robotic drilling continued toward the round window. The cochlear access was manually created by the surgeon. Electrode arrays were inserted through the keyhole tunnel under microscopic supervision via a tympanomeatal flap. All patients were successfully implanted with a cochlear implant. In 9 of 9 patients the robotic drilling was planned and performed to the level of the facial recess. In 3 patients, the procedure was reverted to a conventional approach for safety reasons. No change in facial nerve function compared to baseline measurements was observed. Robotic keyhole access for cochlear implantation is feasible. Further improvements to workflow complexity, duration of surgery, and usability including safety assessments are required to enable wider adoption of the procedure.

Internal Jugular Vein as Alternative Access for Implantation of a Wireless Pulmonary Artery Pressure Sensor.

A wireless pulmonary artery pressure sensor (CardioMEMS) is approved for implantation via the femoral vein. The internal jugular vein (IJ) is an attractive alternative access route commonly used in pulmonary artery catheterization. Retrospective chart review was performed for all sensor implants from 10 providers at 4 centers from September 2016 to June 2018. To compare procedural outcomes and discharge efficiency between groups, multivariate analyses incorporating potential confounders were performed. Seventy-three (28%) patients had femoral access, and 189 (72%) had IJ access; demographics were similar between the groups. Complications, including one case of hematoma and 4 cases of mild hemoptysis, and 30-day mortality (2%-3%) did not differ between groups. Provider preference for IJ access substantially increased over time, with IJ accounting for 90% of cases in 2018. After risk-adjustment, IJ cases had 20% (5%-33%) shorter fluoroscopy time (P=0.01) and 24% (7%-38%) lower contrast volume (P=0.008). Compared with outpatient femoral cases, outpatient IJ cases had 62% (52%-69%) faster needle-to-door time and were 34 times (6-235) more likely to have same-day discharge (P<0.001 for both). IJ access for CardioMEMS implant is a safe alternative associated with superior procedural and discharge outcomes. Implanters at 4 high-volume centers adopted IJ access as the preferred implant approach.