Percutaneous decannulation of extracorporeal membrane oxygenation using a plug-based closure device.

BACKGROUND: There is limited experience of using the MANTA plug-based vascular closure device for percutaneous arterial closure of the femoral artery after venoarterial extracorporeal membrane oxygenation. OBJECTIVES: To study femoral artery complications and need for subsequent vascular interventions after percutaneous decannulation of venoarterial extracorporeal membrane oxygenation (VA ECMO) using the MANTA plug-based vascular closure device. METHODS: We studied 34 consecutive patients who underwent percutaneous decannulation of VA ECMO using the MANTA device. Primary outcomes were conversion to surgical cutdown of the groin at decannulation (immediate) or later. Secondary outcomes were type of vascular complication necessitating conversion to surgical cutdown of the groin. RESULTS: Six (17.7%) patients had to undergo immediate (n = 3) or late (n = 3) conversion to surgical cutdown of the groin. Of these, three were owing to occlusion of the common femoral artery resulting in insufficient distal perfusion and three owing to bleeding or pseudoaneurysm. The mechanism of failure was complete intravascular deployment of the MANTA device in three patients, incomplete MANTA sealing of the arteriotomy in one patient, MANTA-unrelated thrombotic occlusion in one patient, and unknown in one patient. Surgical cut-down was typically performed with concomitant catheter thrombectomy with or without patch reconstruction of the artery. CONCLUSION: Percutaneous decannulation of VA ECMO using the MANTA VCD was feasible but a substantial number of patients needed to be converted to unplanned surgical repair, owing to either closure site-located stenosis/occlusion or bleeding. If suboptimal MANTA positioning is suspected, a low threshold for conversion to surgical cutdown of the groin is recommended.

Leaflet thickening and stent geometry in sutureless bioprosthetic aortic valves.

Underexpansion of transcatheter heart valves and the surgically implanted Perceval sutureless aortic valve bioprosthesis has been suggested as an underlying mechanism for hypo-attenuated leaflet thickening (HALT). This was a single-center prospective observational study that included 47 patients who underwent surgical aortic valve replacement with the Perceval sutureless bioprosthesis (LivaNova, London, United Kingdom) from 2012 to 2016 and were studied by four-dimensional cardiac computed tomography (CT). The association between overall and regional expansion and the prevalence of HALT was analyzed. In total 46 patients were included in the analysis. HALT was found in 39.1% of patients and the mean overall prosthesis expansion was 75.5 ± 5.2% (range 64.6-84.8%). Overall expansion did not differ between patients with HALT compared with patients without HALT (mean overall expansion 74.0 ± 5.2% vs. 76.5 ± 5.0%, P = 0.11). The prevalence of HALT was lower in patients with overall expansion > 80% compared to patients with expansion < 80% expansion though not significantly (20% vs. 44.4%, P = 0.16). None or trivial regional underexpansion was found in 94.7% of coronary cusps. There was no significant association between regional underexpansion and the prevalence of HALT (mean coronary cusp angle 120 ± 8° vs. 119 ± 10°, P = 0.53). The prevalence of HALT and overall underexpansion was high in the Perceval sutureless bioprosthetic valve. Overall underexpansion was not associated with HALT. Whether severe overall underexpansion increases the risk for HALT requires further study. Regional underexpansion was uncommon in the Perceval sutureless bioprosthetic valve and not associated with HALT.Clinical trial registration Unique identifier: NCT03753126 (http://www.clinicaltrials.gov).

Implementation of Sweden's first digi-physical hospital-at-home care model for high-acuity patients.

AIM: To evaluate Sweden's first implementation of a 24/7 high-acuity virtual in-patient ward through a digi-physical in-patient care (DPIPC) program, a hospital-at-home care model combining a virtual hospital-based medical command centre and in-person ambulating medical services functioning as an extension of the Department of Medicine at a secondary-level hospital in Stockholm. METHODS: A single-centre descriptive study where adult patients with acute medical illness requiring inpatient-level care were assessed for voluntary treatment in the DPIPC program as a substitute for traditional in-patient care. The primary outcome was patient satisfaction with care. Secondary outcomes included health care use, safety, and quality during the care episode. RESULTS: From October 2022 to June 2023 a total of 200 patients were treated within the DPIPC program. The program covered 63 unique medical conditions, with infectious disease (44%) and pulmonary disease (17%) being the most common. The median length of stay (LOS) in the DPIPC program was 3 days (IQR 3) with a median LOS of 2 days (IQR 3) in the physical hospital prior to inclusion. There were no incidents of patient mortality or hospital-related complications during the DPIPC period. A total of 11 (5.5%) patients were escalated to the traditional hospital, 4 (36.4%) of which required ambulance. The median DPIPC patient satisfaction was 10 (IQR 0) and Net Promotor Score was 88. CONCLUSIONS: Implementing a 24/7 high-acuity virtual in-patient ward is feasible and safe for selected patients with acute medical illnesses. Patient satisfaction and care quality within the program is high.

Bleeding in minimally invasive versus conventional aortic valve replacement.

BACKGROUND: Observational studies have shown reduced perioperative bleeding in patients undergoing minimally invasive, compared with full sternotomy, aortic valve replacement. Data from randomized trials are conflicting. METHODS: This was a Swedish single center study where adult patients with aortic stenosis, 100 patients were randomly assigned in a 1:1 ratio to undergo either minimally invasive (ministernotomy) or full sternotomy aortic valve replacement. The primary outcome was severe or massive bleeding defined by the Universal Definition of Perioperative Bleeding in adult cardiac surgery (UDPB). Secondary outcomes included blood product transfusions, chest tube output, re-exploration for bleeding, and several other clinically relevant events. RESULTS: Out of 100 patients, three patients randomized to ministernotomy were intraoperatively converted to full sternotomy (none was bleeding-related). Three patients (6%) in the full sternotomy group and 3 patients (6%) in the ministernotomy group suffered severe or massive postoperative bleeding according to the UDPB definition (p = 1.00). Mean chest tube output during the first 12 postoperative hours was 350 (standard deviation (SD) 220) ml in the full sternotomy group and 270 (SD 190) ml in the ministernotomy group (p = 0.08). 28% of patients in the full sternotomy group and 36% of patients in the ministernotomy group received at least one packed red blood cells transfusion (p = 0.39). Two patients in each group (4%) underwent re-exploration for bleeding. CONCLUSIONS: Minimally invasive aortic valve replacement did not result in less bleeding-related outcomes compared to full sternotomy. CLINICAL TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov . Unique identifier: NCT02272621.

Routine use of percutaneous femoral cannulation in minimally invasive cardiac surgery.

OBJECTIVES: Large series of percutaneous femoral access for extracorporeal circulation in minimally invasive cardiac surgery (MICS) are scarcely reported. METHODS: This is a single-centre study describing the use of percutaneous femoral access in patients undergoing MICS via minithoracotomy. Femoral artery closure was performed with a plug-based closure device. To reduce the risk for vascular complications, intraoperative ultrasound assessment of correct deployment of the arterial closure device was done during the later period of the study. RESULTS: During a 5-year period, 650 patients underwent percutaneous femoral cannulation and decannulation with device closure of the femoral artery puncture. Two hundred and seven patients (31.8%) were operated in the early phase of the experience (August 2017-August 2019), without the use of intraoperative ultrasound assessment of closure device deployment. During the later period of our experience (August 2019-September 2022), 443 patients (68.2%) were operated, of whom all underwent intraoperative ultrasound assessment of closure device deployment. Of the patients operated without intraoperative ultrasound assessment, 6 patients (2.9%) experienced vascular complications compared with none of the patients in whom intraoperative ultrasound-assessment was used (P < 0.001). In total, 15 patients (2.3%) underwent conversion to surgical cutdown owing to incomplete haemostasis or femoral artery stenosis/occlusion and the mechanism was intravascular deployment of the closure device in all 15 cases. CONCLUSIONS: Percutaneous femoral access in MICS is safe and the need for surgical cutdown was infrequent. The risk for vascular complications is minimized with the use of intraoperative ultrasound assessment of the correct positioning of the vascular closure device. CLINICAL TRIAL REGISTRATION NUMBER: http://www.clinicaltrials.gov; Unique identifier: NCT05462769.

Reducing cardiac tamponade caused by temporary pacemaker perforation in transcatheter aortic valve replacement.

BACKGROUND: Cardiac tamponade caused by temporary right ventricular (RV) pacemaker perforation is a rare but serious complication in transcatheter aortic valve replacement (TAVR). AIMS: To study the incidence of temporary pacemaker related cardiac tamponade in TAVR, and the relation to the type of pacemaker lead used in periprocedural temporary transvenous pacing. METHODS: A single center registry of transfemoral TAVRs in 2014-2020. Main inclusion criterion was peri-operative use of a temporary RV pacing lead. Main exclusion criteria were a preoperatively implanted permanent pacemaker or the exclusive use of left ventricular guidewire pacing. Incident cardiac tamponade was classified as pacemaker lead related, or other. Patients were grouped according to type of temporary RV pacing wire. RESULTS: 810 patients were included (age 80.5 ± 7.3 [mean ± standard deviation], female 319, 39.4%). Of these, 566 (69.9%) received a standard RV temporary pacing wire (RV-TPW), and 244 (30.1%) received temporary RV pacing through a permanent, passive pacemaker lead (RV-TPPL). In total, 18 (2.2%) events of cardiac tamponade occurred, 12 (67%) were pacemaker lead related. All pacemaker lead-related cardiac tamponades occurred in the group who received a standard RV-TPW and none in the group who received RV-TPPL (n = 12 [2.1%] vs. n = 0 [0%], p = 0.022). No difference in cardiac tamponade due to other causes was seen between the groups (p = 0.82). CONCLUSIONS: The use of soft-tip RV-TPPL was associated with a lower risk of pacemaker related cardiac tamponade in TAVR. When perioperative pacing is indicated, temporary RV-TPPL may contribute to a significant reduction of cardiac tamponade in TAVR.

Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations.

BACKGROUND: Arterial access-site related complications constitute a large proportion of adverse events related to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality and hospital cost. AIMS: To evaluate the safety and effectiveness of a novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). METHODS: A single-center observational study evaluating a plug-based VCD (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA) in patients undergoing TAVI at the Karolinska University Hospital, Stockholm, Sweden. The primary outcome was VCD-related major vascular complication according to the criteria of the Valve Academic Research Consortium (VARC)-2. RESULTS: From May 2017 to September 2020 a total of 1000 consecutive patients underwent transfemoral TAVI with arterial access-site management using the MANTA VCD. VARC-2 major vascular complications occurred in 42 (4.2%) patients: 17 (1.7%) patients intraoperatively received a covered stent, 17 (1.7%) patients underwent surgical repair during hospital stay, 3 (0.3%) patients underwent vascular surgery after discharge, 3 (0.3%) patients had major bleeding and 2 (0.2%) patients had symptoms of claudication with conservative treatment. No significant differences in major complications were seen between individual interventionists irrespective of experience with the device. A larger sheath outer diameter to femoral artery inner diameter ratio was the only factor associated with a significant increase of VCD-related major vascular complications. CONCLUSION: This largest ever real-world evaluation of MANTA for large-bore arteriotomy closure in transfemoral TAVI patients indicates effective and safe arterial access-site management with low complication rates and short learning curve. CLINICAL TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov. Unique identifier: NCT04392492.

Percutaneous femoral cannulation and decannulation using a plug-based vascular closure device in minimally invasive cardiac surgery.

Minimally invasive cardiac surgery such as a mitral valve procedure requires femoral arterial cannulation for extracorporeal circulation. To avoid complications associated with surgical groin incisions, such as seromas and infections, percutaneous cannulation techniques can be used. This video tutorial illustrates percutaneous femoral cannulation and decannulation using a plug-based vascular closure device.

Percutaneous Vascular Closure Device in Minimally Invasive Mitral Valve Surgery.

BACKGROUND: Minimally invasive mitral valve surgery requires femoral artery cannulation for extracorporeal circulation, predominantly performed through surgical cutdown. Surgical groin incision is frequently associated with complications such as seroma and infection. We evaluated the safety and efficacy of a percutaneous plug-based large-bore vascular closure device (VCD) for femoral artery closure in minimally invasive mitral valve surgery. METHODS: This was a single-center prospective study comparing patients undergoing minimally invasive mitral valve surgery with femoral cannulation performed either through surgical cutdown or percutaneously with access site closure using a plug-based VCD (MANTA; Teleflex/Essential Medical, Malvern, PA). RESULTS: From 2016 to 2018, a total of 268 (147 surgical cutdown, 121 VCD) patients underwent minimally invasive mitral valve surgery with femoral arterial cannulation of catheters sized 19-F or 21-F. Propensity score matching resulted in 109 matched pairs. In both the overall series and the propensity-matched cohort, VCD patients had a significantly higher incidence of Valve Academic Research Consortium-2 major access site vascular complications (overall cohort: 0% vs 4.1%; P = .013; propensity score-matched cohort: 0% vs 4.6%; P = .024). Bleeding did not occur in any group. In the overall series, surgical cutdown patients had a higher incidence of seroma (10.9% vs 0%; P < .001). Infection and seroma did not occur in the VCD group. CONCLUSIONS: Percutaneous femoral artery cannulation using a novel plug-based VCD in minimally invasive mitral valve surgery eliminates traditional complications frequently seen with surgical cutdown with no femoral access site seroma and infection though at the expense of an increased risk for vascular complications.

Minimally invasive versus sternotomy mitral valve surgery when initiating a minimally invasive programme.

OBJECTIVES: An increasing number of mitral valve operations are performed using minimally invasive procedures. The initiation of a minimally invasive mitral valve surgery programme constitutes a unique opportunity to study outcome differences in patients with similar characteristics operated on through a sternotomy versus a minimally invasive procedure. The goal of this study was to compare short-term outcomes of patients undergoing mitral valve surgery before versus those having surgery after the introduction of a minimally invasive programme. METHODS: The single-centre study included mitral valve procedures performed through a sternotomy or with a minimally invasive approach between January 2012 and May 2019. Propensity score matching was performed to reduce selection bias. RESULTS: A total of 605 patients (294 sternotomy, 311 minimally invasive) who underwent mitral valve surgery were included in the analysis. Propensity score matching resulted in 251 matched pairs. In the propensity score-matched analysis, minimally invasive procedures had longer extracorporeal circulation duration (149 ± 52 vs 133 ± 57 min; P = 0.001) but shorter aortic occlusion duration (97 ± 36 vs 105 ± 40 min, P = 0.03). Minimally invasive procedures were associated with a lower incidence of reoperation for bleeding (2.4% vs 7.2%; P = 0.012), lower need for transfusion (19.1% vs 30.7%; P = 0.003) and shorter in-hospital stay (5.0 ± 2.7 vs 7.2 ± 4.6 days; P < 0.001). The 30-day mortality was low in both groups (0.4% vs 0.8%; P = 0.56). CONCLUSIONS: Minimally invasive mitral valve surgery was associated with short-term outcomes comparable to those with procedures performed through a sternotomy. Initiating a minimally invasive mitral valve programme with a limited number of surgeons and a well-executed institutional selection strategy did not confer an increased risk for adverse events.

[Minimally invasive mitral valve surgery]. / Minimalinvasiv mitraliskirurgi bra alternativ till konventionell kirurgi - Mindre kirurgiskt trauma kan ge färre komplikationer och snabbare återhämtning.

Minimally invasive mitral valve surgery Conventional mitral valve surgery is performed through a full median sternotomy. Minimal invasive mitral valve surgery was introduced in the mid 1990s and is performed through a right mini-thoracotomy. Minimal access mitral valve surgery has grown in popularity and by reducing surgical trauma potential benefits include decreased postoperative bleeding and pain, reduced incidence of sternal wound infections and shortened recovery period after surgery. We report our experience in 97 patients operated during one year where mitral valve surgery was performed through a minimally invasive technique.