Low Complication Rate Research Articles

Safety and effectiveness of pulsed field ablation for pulmonary vein isolation in atrial fibrillation patients: a single centre experience

Abstract Introduction Atrial Fibrillation (AF) is the most frequent arrhythmia in the world with an exponentially increasing prevalence. Pulmonary veins (PV) are the primary triggering sites for AF and pulmonary veins isolation (PVI) is currently the standard therapy alongside pharmacological treatment and should be considered as first-line treatment. Pulsed-fieldablation (PFA) is a novel ablation modality that involves the application of electrical pulses causing cellular death, with preferential tissue specificity. Aim In this study, we evaluated the safety and efficacy of single-shot PFA in AF patients. Methods Single-center registry of consecutive patients undergoing PVI using the pentaspline PFA catheter (all with CARTO3D system v.7 and high-density mapping), between June 2022 and November 2023. Data on demographics, procedural characteristics, and electrocardiographic recurrence (assessed after a 3-month blanking period) were analyzed. Results 152 consecutive patients were included (63 ± 10 years, 57% male), with a mean CHA2DS2-VASc score of 2±1 points, median LVEF of 60% (IQR 59-65%), and a median CT-scan derived left atrial volume index of 56 mL/m2(IQR 44-69 mL/m2). A total of 40% had non-paroxysmal AF and a redo procedure was performed in 17% of patients. The median procedure time was 78 min (IQR 58-111 min) and fluoroscopy time was 11.6 min (IQR 8.2-15.6 min). Additionally, posterior wall isolation (PWI) was performed in 63 patients (41%). There were no esophageal complications, phrenic nerve injuries, cerebrovascular events, or procedure-related deaths. Two patients (1.3%) experienced acute cardiac tamponade, immediately treated with pericardiocentesis. Other complications were primarily vascular, in 5% of cases (4 femoral hematomas, 3 femoral pseudoaneurysms, 1 arteriovenous fistula). Over 293 (IQR 170 - 394) days of follow-up, considering electrocardiographic recurrence, 12% of patients had AF recurrence (5 with paroxysmal AF and 10 with persistent AF). These patients were older (69 ± 7y vs. 62 ± 11y, p=0.016), were more likely to undergo a redo procedure (33 vs. 8%, p=0.004), and had a higher percentage of posterior wall isolation (21 vs. 8%, p=0.038). Conclusions PFA for PVI wall ablation is safe and effective, with 100% intraprocedural technical success, a low rate of complications, and a high percentage of patients free from AF in the short-term.

Intra, short and long-term results of mitral VIV for the degenerated surgical mitral prosthesis from italian VIV registry (MIVIV registry)

Abstract Background/Introduction Reoperation of failed bioprosthetic mitral valves is associated with significant morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) replacement was explored early in the development of THVs with transseptal/transfemoral (TS/TF) and transapical (TA) approaches. Purpose This is the first Italian Registry on mitral VIV and it was designed to explore contemporary MViV outcomes with all types of balloon expandable valves. The present study out of the registry aims to asses the >10 years follow-up outcomes in terms of mortality, gender diversity, and perioperative result. Methods Participating centers used standardized definitions to collect clinical information, including patient demographic characteristics, comorbidities, functional status, quality of life indexes, procedural details, and patient outcomes from consecutive MViV cases. Cohort of 265 patients was available for the primary analysis and follow-up too.The patients were grouped by 11 hospitals in Italy performing VIV for degenerated biological mitral prostheses. Results A total of 265 pts underwent mitral VIV due to bioprosthesis degeneration between January 2010 and January 2023. They have been subdivided by transfemoral (TF) with 117 (44%) pts and transapical (TA) with 148 (55,8%) pts. Most of the patients were of female sex (59,2%) and EuroScore II for surgical re-operation was 16.1%. Mixed disease (48%) was more common than mitral regurgitation (29%) and stenosis (22%). 69,8% of the total cohort was in class NYHA III and the mean LVEF was 54%.Otherwise, there were no significant demographic differences between patients undergoing TS and TA. In TF there was more severe PVL (5%)(p-value: 0,001) and much more cases of severe grade of stenosis (54,7%) and regurgitation (57%)(p-value< 0,0001). Considering intraoperative outcomes, technical success has been established in around 97,7% of the total cohort without difference btw groups. Only 3,3% died during hospitalization without difference between groups (P-value=0,735). LVOT obstruction has been seen in 3,4% in the case of TA and 0 for TF. Only 1,5% of the total cohort underwent surgical conversion as well as embolization in only 1,1%. Overall survival from the total cohort was 91,3% at >10 years, Figure 1. Concerning the freedom from cardiac death (CV death) was 96,6% in the total cohort at 13 years. Concerning the difference between access, the general survival is established at 97,4% in TF while 86,3% in TA (p-value =0,050)(Figure 2). Freedom from CV death was 99,1% in TF and 94,5 in TA (p-value=0,209). In gender analysis differentiation, the general survival in females was 98,5% in TF and 85,6% in TA at 13 years (p-value=0,056). Conclusion(s) Transcatheter MViV using a balloon-expandable valve is associated with high technical success, a low complication rate, and a solid long-term benefit in terms of survival. Transseptal access was associated with lower mortality compared with TA access.Figure 1Figure 2

Current application and results of the combined use of intravascular lithotripsy and rotational atherectomy for the treatment of calcified coronary lesions

Abstract Background Intravascular lithotripsy (IVL) and rotational atherectomy (RA) might be used simultaneously (Rotatripsy) to treat calcified lesions during percutaneous coronary intervention (PCI), though data on the effectiveness and sequence of their use is limited. Purpose To identify indicators for the use of Rotatripsy and to assess its safety and success rates, both acutely as at one-year follow-up. Methods Patients undergoing PCI with IVL and RA across six centers in two European countries from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Angiographic and intracoronary imaging (ICI) data were analyzed centrally. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success (composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised rotatripsy-related complications and MACE at one-year follow-up. Results A total of 114 patients (75±9 years, 78% male) underwent rotatripsy for 120 lesions. Patients presented with an ACS in 58(51%) cases and chronic coronary syndrome in 56(49%). The left anterior descending artery(n=66, 55%) was the most frequently treated target vessel, with diverse lesions being addressed, including bifurcations(30%), ostial(18%), CTO(7%) and in-stent(12%) lesions. The mean burr size was 1.5±0.2mm with a maximum rotational speed of 171±15k rpm and burr/vessel ratio of 0.46±0.2. IVL involved an average of 68±25 pulses and a balloon size of 3.5±0.5mm. The predominant used sequence of rotatripsy was RA followed by IVL(n=106, 88%). Among these cases, IVL was electively combined with RA in 68(57%) lesions, and used for balloon underexpansion(n=37, 31%) and stent crossing failure after RA(n=1, 1%). Additionally, IVL served as bail-out strategy after RA and stenting in 10(8%) and preceded RA in 4(3%) lesions, particularly when balloon/stent delivery failed after IVL. After rotatripsy, stents were implanted in 116(97%) lesions and drug-eluting balloon used in 3(3%). ICI was utilized in 69(58%) target lesions. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications occurred in 4 patients(4%), and included two(2%) coronary perforations, one(1%) dissection and one(1%) burr entrapment. At one-year follow-up (present in 77(67%)), MACE was observed in 7(6%). Conclusions Rotatripsy demonstrated efficacy across diverse clinical and anatomical settings, with the majority of procedures electively employing RA before IVL. High success rates and low complication rates were observed, with few patients experiencing MACE at one-year follow-up.

Collision mapping enables accurate localization of the slow pathway in atrioventricular nodal reentrant tachycardia

Abstract Introduction Atrioventricular Node Reentry Tachycardia (AVNRT) is commonly treated with catheter ablation, with high success and low complication rates. However a small risk of complete AV block still remains. Recent studies could show that using collision map is a feasible approach in mapping the slow pathway. The aim of the current study is to show a reduction of the total ablation points needed to modify/ablate the slow pathway using the collision mapping compared to conventional 3D mapping guided slow pathway modulation/ablation and therefore minimize the risk of a complete heart block. Methods Patients diagnosed with AVNRT (n = 24) underwent collision mapping for slow pathway identification, compared to a historical cohort (n=76) using conventional mapping. For collision mapping a dynamic visualization of atrial propagation during sinus rhythm was condcted. Two propagation fronts were observed to collide at the triangle of Koch, one propagation through the slow and one through the fast pathway. The designated collision zone was considered ideal for catheter ablation (Figure 1). The endpoint after ablation in both groups was non-inducibility of AVNRTs. Results After propensity score matching the collision mapping group needed significantly fewer ablation impulses (2 (IQR 1 - 5) vs. 6 (IQR 2,5 - 11,5) p = 0.002) and shorter ablation time (p < 0.001) compared to the conventional group (Table 1). No significant differences were observed in procedure time (p = 0.209), fluoroscopy time (p = 0.296), or dose area product (p = 0.391). Conclusion Collision Mapping in AVNRT ablation showed a notable reduction in ablation points, suggesting enhanced procedural efficiency and safety.Figure 1Table1

Routine use of ultrasound-assisted catheter-directed thrombolysis for the management of intermediate-high risk pulmonary embolism: a service evaluation project

Abstract Background Intermediate-high risk Pulmonary Embolism (PE) has considerable morbidity. Conservative management could be sub-optimal. Ultrasound-Assisted Catheter-Directed Thrombolysis (UACDT) is used in our centre for the routine management of this presentation. Purpose We assessed the procedure safety and short-term outcomes by reviewing locally performed procedures. Methods This is an observational retrospective cohort study, with a historic control group. Our centre is a District General Hospital (DGH) in the United Kingdom, and we receive referrals from local acute hospitals. Since the introduction of this service in June 2018 until November 2023, 129 patients (2 patients/month) received routine management with UACDT for intermediate-high risk PE. The controls are 75 acute PE patients of comparable risk classes, managed from January to December 2016. We assessed procedural and in-hospital outcomes including minor, major bleeding/complications and death. We also assessed Length of Stay (LoS) in hospital, recurrent Venous Thrombo-Embolism (VTE) and re-admission rates for recurrent PE at 30 days. Reduction of oxygen requirements and improved estimated systolic Pulmonary Artery Pressure (sPAP) post-procedure were assessed as surrogate measures. Continuous variables were analysed with a Mann-Whitney U test, and categorical variables with a Chi-square Test. Results Baseline demographics are listed in Table 1. Mean duration between CT Pulmonary Angiography (CTPA) and the UACDT procedure was 1.6 (±SD 1.4) days, including inter-hospital transfer. Only 6% (8/129) of UACDT cohort received ≤12 mg standard alteplase dose. In the control group, 4% (3/75) of patients received standard 100mg systemic thrombolysis. There was no significant difference in the rates of minor (p= 0.9), major bleeding/complications (p= 0.8), or death (p= 1.0) between both groups. There was also no significant difference in rates of recurrent VTE (p= 1.0) or re-admission within 30 days for PE (p=0.1) (Table 2). LoS in hospital data were ratified, to exclude inappropriate delays (e.g. physiotherapy requirements, etc). We used the date when the patient was declared medically fit for discharge, and no significant difference was noted (p= 0.2). This was confirmed with a regression analysis of UACDT treatment effect (p= 0.9, CI= -3.5 to 3.1). Nonetheless, there was a 25% reduction of median LoS in hospital from 8 days in the controls to 6 days with UACDT. The proportion of patients requiring O2 was also reduced from 69% (89/129) to 41% (54/129) on day 1 post-procedure. A significant reduction of the estimated sPAP by TTE post-procedure was detected by a mean of 10.4 (±SD 13.9) mmHg (p= <0.01). Conclusion UACDT is generally safe with low complications rate. Compared to the control group, there was a reduction in absolute deaths and median LoS in hospital. This can be secondary to the significant acute reduction of systolic pulmonary artery pressure identified.

Independent association between radial secondary access and stroke in patients undergoing transcatheter aortic valve implantation

Abstract Background Radial access has become the primary approach for invasive coronary angiography due to its lower complication rate than femoral access. Transcatheter aortic valve implantation (TAVI) frequently requires a secondary access, which has traditionally been femoral access. However, radial access for TAVI is feasible and gaining popularity, but data on its safety and complication rates is still limited. Purpose To evaluate the occurrence of stroke rate in patients undergoing a TAVI procedure with femoral or radial secondary access. Methods A prospective single-center TAVI registry of 2327 patients who received a TAVI procedure between 2019 and 2022 was conducted. All procedures had the primary access over the femoral route. 337 (14.5%) patients had a secondary access over the radial route, whereas 1990 (85.5%) received a femoral secondary access. The primary endpoint was the occurrence of stroke within the hospital stay. Both groups were compared using the t-test or the Mann-Whitney U test according to the distribution of the data. In a second step, a multivariable model was created in which parameters were included that were associated with the endpoint in the previous analysis, as well as parameters that are known to be associated with stroke. Results: Patients were 81.1 ± 6.3 years old, with a Euroscore II of 5.3 ± 6. A total of 610 (26.2%) patients received a balloon-expandable valve. The primary endpoint (stroke within 30 days of the TAVI procedure) was met by 94 (4%) of all patients. Stroke occurred more often in the group with radial secondary access (6.6% (22) vs. 3.6%(72), p = 0.012). Other significant differences between the two groups included (radial vs. femoral access): burden of atrial fibrillation (36.8% vs. 44.6%, p = 0.007), arterial hypertension (87.4% vs. 92%, p = 0.007), Euroscore II (4.6 vs. 5.5, p = 0.006), and frailty (25.2% vs. 40%, p < 0.001). There were no significant differences between the two groups in terms of secondary diagnosis of diabetes or coronary artery disease, age, occurrence of NYHA class III/IV, gender, or cerebral artery disease. In the multivariate analysis including Age, Euroscore II, NYHA class, gender, secondary diagnosis of arterial Hypertension, diabetes or cerebral artery disease, arterial fibrillation, Frailty and radial secondary access, only radial secondary access was independently associated with in-hospital stroke (p = 0.01). Conclusion Radial secondary access was significantly associated with an increased risk of in-hospital stroke following transcatheter aortic valve implantation (TAVI) in our study population. Intense manipulation of the guidewire and catheter to reach the ascending aorta at the beginning of the procedure and to reach the descending aorta for the final angiogram of the primary access vessel may be causative and should be minimized.

Comparison of Short-Term Outcomes of DSA and ALMIS Approach for Bipolar Cemented Hemiarthroplasty in Patients with Neck of Femur Fracture

Background/Objectives: A neck of femur (NOF) fracture is one of the most common fractures, and its treatment in the geriatric population using cemented bipolar hemiarthroplasty (HA) is a standard procedure worldwide. Various surgical approaches have been described for this operation, aiming to reduce complications and improve early mobilization. The present study compares two minimally invasive approaches, the anterolateral minimally invasive approach (ALMIS) and the direct superior approach (DSA), with respect to their intraoperative and early postoperative complications in cemented bipolar HA. Methods: The medical records of all patients undergoing cemented bipolar HA for a NOF fracture between January 2017 and December 2023 were analyzed. The aim of the study was to compare the two surgical approaches. The evaluation focused on intraoperative parameters and early complications. Results: A total of 226 patients were included in the analysis, with 62 undergoing DSA and 164 ALMIS, with an average age of 83.5 years. The two approaches did not differ significantly in terms of stem implantation quality, length of hospital or intensive care unit stay, postoperative mobilization, or the need for transfusions. However, the ALMIS was associated with a significantly shorter operative time (DSA: 89.7 min vs. ALMIS: 77.2 min; p < 0.01). On the other hand, the DSA had a significantly lower complication rate (DSA: 0/61 vs. ALMIS: 11/163; p = 0.04). Conclusions: In a comparison of the two minimally invasive approaches, DSA and ALMIS, for treating a NOF fracture with cemented bipolar HA, the DSA demonstrated a lower complication rate, though it had a slightly longer operating time.

Feasibility and early outcomes of atrial septal defect prostheses use for percutaneous closure of widely open patent foramen ovale

Abstract Background The efficient closure of patent foramen ovale (PFO) with short canal length and large width, usually associated with atrial septal aneurysm (ASA), remains challenging. These cases frequently require the use of larger PFO devices to avoid the risk of device embolism at the cost of a higher rate of residual shunting, mostly due to interdisk spacing. The use of atrial septal defect (ASD) prosthesis could be useful in these patients. Purpose To describe feasibility and early outcomes of the use of ASD device for percutaneous closure of widely open PFO representing an "ASD-like anatomy". Methods Since January 2022 in a high volume French university center, we started to use ASD device for percutaneous closure of selected cases of PFO with complex anatomy as mainly defined by a sheathed width of PFO ≥ 5 mm and sheathed canal length ≤ 10 mm (Figure 1) facing major per-operative residual shunt with PFO prostheses in some patients. In addition to the descriptive results, we compared this ASD device subgroup with a cohort of patients with similar anatomy but previously treated in our center with PFO device. All available transesophageal echocardiography (TEE) examinations were reviewed. The main objective was to describe the feasibility of the procedure (success and safety), the secondary endpoint was immediate post-procedural moderate to severe residual right-to-left shunt (RLS), defined as ≥ 10 bubbles in the left atrium within 3 cardiac cycles after transfemoral agitated saline injection. Results A total of 65 patients was treated with ASD devices, procedural success was achieved in all patients with a low rate (4,2%) of intrahospital complications (two supraventricular arrythmia, one anaphylactic shock and one minor laryngeal injury) and without device embolism. As compared with a cohort of 127 patients of similar anatomy treated with PFO device, patients in the ASD device group had more complex characteristics especially higher mean sheathed PFO width and shorter mean sheathed PFO canal length. Immediate post-procedural residual moderate to severe RLS did not differ significatively between groups (Table 1). No or minimal shunting was observed in 91% and 92% of cases (p=NS) but the three patients with severe RLS were all in the PFO device group. Conclusion Percutaneous closure of "ASD-like" PFO with ASD prostheses is feasible and safe. Larger studies and longer follow-ups are now required to confirm the expected improved sealing effect with this strategy.

Intravascular lithotripsy in the management of underexpanded stents

Abstract Introduction Stent underexpansion significantly heightens the risk of major adverse cardiac events (MACE), and available treatment options for this condition remain limited. Intravascular Lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, emerges as a promising tool for underexpanded stents. Methods Following PRISMA guidelines, we systematically explored PubMed, SCOPUS, and Cochrane databases up to September 3, 2023, for studies evaluating IVL's safety and efficacy in treating underexpanded stents. We gathered angiographic (QCA) and intracoronary imaging (OCT or IVUS) data, examining the stent's minimal diameter stenosis (MDS), minimal lumen diameter (MLD), minimal stent area (MSA), and minimal lumen area (MLA) pre- and post-IVL application. Procedural success constituted the efficacy endpoint, while peri-procedural complications, in-hospital-30-days and long-term mortality, and MACE were safety endpoints Results This meta-analysis comprised 21 studies including 669 patients and 673 treated lesions in underexpanded stent. The mean age was 73.2 ± 2.1 years, with an overall IVL procedural success rate of 93% [(95% Confidence Interval (CI): 88%-96%, I2=29%), while the in-hospital-30-days and long-term mortality incidence were 1% (95% CI: 1%-3%, I2=0%) and 3% (95% CI: 2%-6%, I2=0), respectively. The 30-days target lesion revascularization (TLR) was approximately 6% (95% CI: 3%-12%, I2=50%). There was a significant increase in the MDS [Standardized Mean Difference (SMD): +50.52%, 95% CI: 39.4-61.6, I2=94%)] and in MSA (SMD: +3.52, 95% CI: 2.47 to -4.58, I2=83%) immediately after IVL application. It was observed a significant increase in MLD (SMD: +1.54, 95% CI: 1.09 to 1.98, I2=95%) and in the MLA (SMD: +3.64, 95% CI: 2.62-4.66, I2=5%). Major procedural and device related complications were 3% (95% CI: 1%-6%, I2=0%) and 1% (95% CI: 0%-2%, I2=85%) respectively. Notably low rates were observed for stent thrombosis (0%, 95% CI: 0%-2%, I2=0%), dissections (1%, 95% CI: 1%-4%, I2=0%), perforations (1%, 95% CI: 1%-3%, I2=0%) and no-reflow (0%, 95% CI: 0%-1%, I2=0%). Conclusions IVL demonstrates promise as a safe and effective strategy for underexpanded stent treatment, characterized by low rates of periprocedural complications. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.30day All-Cause Mortality after IVL use.Minimum Stent Diameter after IVL use.

Single arterial access versus standard access in TAVI: results from a large multicenter registry

Abstract Background The transfemoral approach has become the gold standard primary access for transcatheter aortic valve implantation (TAVI) due to low complication rates. An additional secondary access (ScA) is used for angiographic guidance of the procedure. Recently, small, single-center studies demonstrated feasibility of single-access for transfemoral TAVI without a secondary access. However, comparative and large-scale data are missing. Purpose We assessed vascular and bleeding complications of ScA and Single access (SA) approaches in a large multicenter registry to evaluate both strategies. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 10,120 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. In 9,457 patients who qualified for analysis ScA (80.7% femoral, 19.3% radial) were performed in 8709 (92%) and SA in 748 (8%). Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Median age was 81.9[IQR 78.2, 85.1] years and 48.9% of patients were female (median logistic EuroSCORE II: 3.3% [IQR 2.1, 5.6]). Peripheral artery disease was comparable between groups (13.5 vs. 14.0%, p=0.73). While overall major access-related vascular complications did not differ significantly (6.1% vs. 4.8%, p=0.20), there was a higher incidence of minor complications for ScA compared to SA (9.0% vs. 2.8%, p<0.001). Secondary access complications amounted to 2.7% in the ScA group and were mainly characterized as bleeding (1.2%) and pseudoaneurysms (1.2%) mostly treated conservatively (1.2%), yet in some cases surgical repair was needed (0.8%). No significant difference was observed regarding type III/IV bleeding (4.1% vs. 4.3%, p=0.91), stroke rate (2.4% vs. 3.6%, p=0.05), stage III/IV acute kidney injury (2.4% vs. 2.4%, p=1.00) or all-cause 30-day mortality (5.8% and 5.7%, p=0.99) for ScA compared to SA groups. Conclusion In patients treated with transfemoral TAVI, a single access approach was associated with lower rates of minor access-related vascular complications without compromising overall outcomes, suggesting potential benefits of a minimally-invasive TAVI approach with the omission of additional vascular access.

Procedural and clinical outcomes according to ultrasound-guided access in TAVI: a propensity-matched comparative sub-analysis from the PULSE registry

Abstract Background Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce the incidence of these events, particularly in large-bore arterial access. However, large-scale data on this approach are limited and it has not yet fully been implemented into standard clinical practice during TAVI. Purpose We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided (FG) access from a large multicenter TAVI registry. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 9,295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. USG and FG access were performed in 1,992 (21.4%) and 7,303 (78.6%) patients, respectively. A propensity score was used to match 1,023 FG with 1,023 USG access patients in a 1:1 fashion. The primary endpoint was a composite of minor and major vascular complications at the TAVI-access site or bleeding type II-IV. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Mean age was 81.9±6.25 years and 48.0% of patients were female. Comorbidities and clinical variables were well-balanced in matched groups. The overall risk profile was comparable in USG vs. FG (mean EuroSCORE II: 3.4 [2.1, 6.4] vs. 3.6 [2.2, 5.7], p=0.54). The primary end point occurred in 12.0% in the USG and 17.7% in the FG group, p<0.001. While major large bore access-related vascular complications did not differ significantly (3.5% vs. 4.2%, p=0.49), there was a trend towards lower minor complications for USG compared to FG (5.9% vs. 7.8%, p=0.096). Large bore access-related bleeding occurred in 5.5% versus 7.8% (p=0.04) of patients. Endovascular balloon inflation was required in 0.6% and 3.3% (p<0.001) of all large-bore access vascular complications. Stroke (1.7% vs. 1.5%, p=0.86) and stage III/IV acute kidney injury (3.0% vs. 2.2%, p=0.42) were similar in both groups. Conclusion In patients treated with transfemoral TAVI, ultrasound-guidance for gaining access was associated with lower rates of access-related vascular complications or type II-IV bleeding. Endovascular treatment was required more frequently in case of a fluoroscopy-guided approach. These findings challenge the fact that most TAVI procedures were performed with fluoroscopy-guidance.

Transcatheter vs. surgical aortic valve replacement in patients with aortic stenosis and cardiogenic shock.

Patients with aortic stenosis (AS) and cardiogenic shock (CS) are an extremely high-risk population with a poor prognosis in the absence of definitive therapy. We aimed to compare the outcomes of transcatheter aortic valve replacement (TAVR) with those of surgical aortic valve replacement (SAVR) in patients with AS-CS. We queried the Nationwide Readmission Database (2016-21) to identify patients hospitalized for AS-CS who underwent isolated TAVR or SAVR. In-hospital outcomes of TAVR vs. SAVR were compared using multivariable regression and propensity-matching analyses. Ninety-day readmissions were compared using a Cox proportional hazards regression model. A total of 16 161 patients were hospitalized for AS-CS, of whom 6470 (40.0%) underwent isolated TAVR and 9691 (60.0%) underwent isolated SAVR. From 2016 through 2021, the proportion of TAVR increased from 29.5 to 46.5% and the proportion of SAVR correspondingly decreased in AS-CS (Ptrend < 0.01). After adjustment for baseline characteristics, TAVR was associated with lower odds of stroke [adjusted odds ratio (aOR) 0.63, 95% confidence interval (CI) 0.47-0.84], acute kidney injury (aOR 0.80, 95% CI 0.69-0.93), and major bleeding (aOR 0.54, 95% CI 0.40-0.71) and higher odds of vascular complications (aOR 1.56, 95% CI 1.23-1.97) compared with SAVR. In-hospital mortality, myocardial infarction, permanent pacemaker placement, and 90-day all-cause and heart failure readmissions showed similar rates between TAVR and SAVR. However, hospital length of stay was shorter and total costs and non-home discharges were lower with TAVR than with SAVR. This nationwide observational analysis showed that TAVR is increasingly performed in patients with AS-CS and is associated with similar rates of in-hospital mortality and 90-day readmissions but lower rates of in-hospital complications and resource utilization compared with SAVR.

Comparative safety outcomes of leadless versus transvenous cardiac pacemaker: a systematic review and meta-analysis

Abstract Introduction Leadless Cardiac Pacemakers (LCP) have emerged as a promising alternative to Transvenous Pacemakers (TVP) for managing bradyarrhythmias, especially in cases where TVP options are limited, such as venous access issues in haemodialysis patients or high infection risk individuals. However, long-term safety data, including mortality and hospitalisation rates, are lacking, hindering informed clinical adoption decisions. Purpose This systematic review and meta-analysis compares safety endpoints of LCP with TVP. Methods A systematic search of PubMed, Medline, Embase, Scopus, Web of Sciences, and gray literature was conducted following PRISMA guidelines from release of the Micra LCP to market until May 15, 2023. Meta-analysis was performed using RevMan 5.4. Results Twenty-four studies including data from 33,450 patients (12,802 LCP, 20,648 TVP) were evaluated. The mean age of the population was 77.5 ± 10.6 years, with a mean left ventricular ejection fraction (LVEF) of 58.6 % ± 6.7. Follow-up durations ranged from 6 to 36 months. Compared to TVP, the LCP was associated with significantly fewer overall complications, major complications, acute, mid-term complications, hospitalisations, re-interventions, and device dislodgements (p&amp;lt;0.05). Mortality, tricuspid regurgitation, pacemaker-induced cardiomyopathy, and heart failure hospitalisation rates did not significantly differ. Although LCP showed higher cardiac injury risk, no significant difference in cardiac tamponade rates was observed (Figure 2). LCP exhibited increased vascular-related complications but decreased lung injury, endocarditis, device, and pocket-related issues. Conclusion In the largest review of LCPs, we report that LCP is associated with significantly lower rates of overall complications compared to conventional TVP. This knowledge is critically important as more LCPs enter clinical practice and serves as a baseline against which future data can be evaluated. Nevertheless, proper skill training may help to mitigate the risk of vascular and cardiac injury. These findings underscore the importance of conducting randomized controlled trials to comprehensively evaluate the safety of LCP compared to TVP.Cardiac complication

Real-world evidence of implanting leadless pacemakers after transcatheter aortic valve implantation procedures

Abstract Background Conduction disturbances can be a complication of Transcatheter Aortic Valve Implantation (TAVI) procedures, for which transvenous pacemakers (TVPs) are recommended. Leadless pacemakers (LPs) are a safe alternative to TVPs in a pacemaker-indicated population, but little is known about their use for TAVI-related conduction disturbances. Purpose To examine rates of pacemaker implantation post-TAVI, compare complications, all-cause mortality, and ventricular pacing rates in LP vs. TVP patients, and assess pacemaker deactivations/upgrades in LP patients. Methods Data from Optum’s de-identified Clinformatics Data Mart Database linked to a device registry between 2016 and 2021 were used to identify patients with TAVI procedures that are subsequently implanted with an LP or a TVP. Claims data were used to assess complications and all-cause mortality; device-reported parameters were used to calculate VP rates and deactivations. Complication rates, all-cause mortality, ventricular pacing rates, and device deactivations were calculated for patients with a pacemaker implant between 7 days before and 90 days after TAVI. Chronic complication rates, defined as complications with the potential to occur outside the acute peri- or post-procedural period, were assessed at 1 year. Regressions were used to compare complications and all-cause mortality, adjusting for patient characteristics. Results In a cohort of 18,073 patients with a TAVI procedure, 11.7% were implanted with a pacemaker at 1 year post-TAVI; 76.7% of implants occurred within 7 days. LPs comprised 7.2% of the total pacemaker implants observed. Of those LPs in the registry, around 25% have VDD capability. LP patients were older (avg. 84 LP, 82 TVP, p=0.02) and were more likely to have atrial fibrillation, end-stage or chronic kidney disease, and ventricular arrhythmias. Of patients implanted with a pacemaker within 90 days post-TAVI (LP N=122, TVP N=1,779), there were no differences in 30-day complication rates (12.3% LP, 15.6% TVP, unadj. p=0.33, adj. p=0.27). LP had fewer chronic complications than TVP (0.8% LP, 9.4% TVP, unadj. p=0.02, adj p=0.02) though the sample size was small. LP patients had higher unadjusted 30-day all-cause mortality (4.1% LP, 1.0% TVP, unadj. p=0.01, adj. p=0.06), reflecting the higher acuity of LP patients. At both 30 days and 1 year post-implant, most patients (85.3% LP, 72.7% TVP) continued to receive pacing support (ventricular pacing &amp;gt;10%). TVP patients were more likely than LP patients to be pacing dependent (ventricular pacing ≥90%) at both 30 days (53.8% vs. 29.4%) and 1 year (44.7% vs. 35.7%) post-implant. There were no observed deactivations/upgrades in LP patients at 1 year. Conclusion LPs, when used concomitantly with TAVI procedures, show similar acute and lower chronic complication rates compared to patients treated with TVPs implanted with TAVI. Most patients who received a pacemaker post-TAVI continue to receive pacing support.Acute and Chronic complicationsVentricular pacing

Late outcomes of Fontan operation from the EUROFONTAN experience

Abstract Background Fifty years after the first Fontan operation, the persisting challenges and evolving landscape of post-Fontan complications are explored in the EUROFONTAN experience. Aim of the study is the evaluation of long term outcomes of a large cohort of Fontan patients, focusing on age at Fontan and onset of Fontan-associated liver disease (FALD). Methods A retrospective clinical study across 21 european congenital cardiac centers across Europe. Clinical and operative data of patients who underwent Fontan operation between January 1990 and December 2022 were gathered through a RedCap online database. Results 2606 patients were included in this analysis (M/F: 59%/41%, median age and median weight at Fontan of 4.3 y.o (IQR 3.3-6.4), and 16kg (IQR 14-20), respectively. Most frequent cardiac anomaly were tricuspid atresia and pulmonary atresia with intact ventricular septum (781, 30%). Ventricular morphology was left in 1379 patients (53%), and right in 1029 patients (40%). Extra cardiac conduit (ECC) was performed in the majority of patients (2335, 90%), with a median conduit size of 20mm (IQR 18-20). Early post-operative complications were present in 52% (1340), with an early reintervention in 349 patients (249 surgical , 99 catheter driven) At a median follow-up median of 10 years (IQR 4-15), there were 79 late deaths (3%). Adverse events occurred in 49% (1288 , non-surgical in 962 , surgical in 249). The clinical status was stage A in 60% (1288 patients), while only a minority (1.3%) was in status D. Systemic Ventricular function was normal in 1898 patients (73%), while absent or mild Atrioventricular Valve regurgitation was presnet in 86% (1816). Of note, FALD was detected in 388 (15 %) , and sinus rhythm was present in 99%. Statistical analysis shows that late death and adverse events are significantly associated right ventricular morphology of the systemic ventricle (p-value 0.019). Of note, when compared to lateral tunnel, TCPC extracardiac conduit demonstrated lower late mortality (2.3% vs 8.2%, p-value &amp;lt;0.001) and complication rates (60% vs 48%, p-value 0.001). Analyzing age at Fontan, a linear relationship exists between age and late mortality, whereby mortality increases with advancing age (graph 1). However, concerning the development of late adverse events, the risk decreases with age at Fontan up to 7 years; beyond 7 years, the risk increases with advancing age (graph 2). The analysis demonstrated growing FALD-prevalence with increasing time from Fontan completion (significant especially after 10 years). Conclusion current long term outcomes of Fontan operation are highly satisfactory. However, the longer survival is associated to an increasing incidence of late term extracardiac complications (namely FALD) which are more evident if Fontan is performed at older age.Data of Fontan PatientsCorrelation between age at Fontan and AE

Comparative effectiveness of pulsed field ablation and cryoballoon ablation for atrial fibrillation: a systematic review and meta-analysis

Abstract Background Cryoballoon ablation (CBA) is a well-established technique for treating atrial fibrillation (AF), with a low complication rate related to cryoenergy-induced lesions. Pulsed Field Ablation (PFA) has emerged as a non-thermal alternative, with promising potential to further reduce complications. Purpose We aim to conduct a systematic review and meta-analysis comparing the efficacy and safety of PFA versus CBA in patients with AF. Methods We conducted a systematic search across PubMed, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials (RCTs) or observational studies published between 2013 and 2024 that compared PFA and CBA ablation techniques in patients with AF. Statistical analysis was carried out utilizing RevMan 5.1.7. Heterogeneity was assessed with I² statistics; p-values inferior to 0.05 and I²&amp;gt;25% were considered as significant heterogeneity. Results A total of 840 studies were screened in the initial search, and 26 studies were selected for full-text review based on inclusion criteria. Out of these, 8 observational studies involving 3,113 patients were included. Among these, 1,088 (34.9%) underwent PFA, while 2,025 (65.0%) underwent CBA. Periprocedural complications were significantly lower in patients who underwent PFA compared with the CBA group (RR 0.46; 95% CI 0.29 to 0.74; p=0.001; I²=1%; Fig. 1A). Furthermore, there was a significant reduction in procedure time in the PFA group (MD -8.21 min; 95% CI -13.74 to -2.69; p=0.004; I²=96%; Fig. 1B). However, no statistically significant difference was observed among groups regarding fluoroscopy time (MD 1.63 min; 95% CI -0.22 to 3.48; p=0.08; I²=92%; Fig. 2A), or recurrence of atrial arrhythmias after the blanking period (RR 0.84; 95% CI 0.68 to 1.04; p=0.12; I²=6%; Fig. 2B). Additionally, a subgroup analysis involving only propensity score-matched cohorts was conducted but didn’t show any statistical difference for any outcomes evaluated. Conclusion In this systematic review and meta-analysis, PFA was associated with a lower risk of periprocedural complications and a shorter procedure duration, compared to CBA in patients with AF. Additionally, it didn’t show a potential for reducing the recurrence of atrial arrhythmias, and the data regarding fluoroscopy time were inconclusive.Primary outcomesSecondary outcomes

Treatment Analysis of Limb Fractures Combined with Traumatic Shock

Objective: To evaluate the treatment regimen and efficacy for limb fractures combined with traumatic shock (TS). Methods: A total of 88 patients with limb fractures combined with TS, admitted between January 2021 and December 2023, were selected. Patients were divided randomly using a numerical grouping method. The observation group underwent restricted fluid resuscitation combined with comprehensive treatment, while the reference group received conventional fluid resuscitation combined with comprehensive treatment. Recovery time, fracture prognosis, complications, severity of the condition, and post-fracture joint function were compared between the two groups. Results: The observation group showed shorter symptom recovery times, a higher rate of anatomical fracture reduction, and a lower complication rate compared to the reference group (P &lt; 0.05). After one week of treatment, the severity score of the condition in the observation group was lower than that of the reference group, and all joint function scores were higher in the observation group (P &lt; 0.05). Conclusion: Restricted fluid resuscitation combined with comprehensive treatment for limb fractures with TS can alleviate symptoms, improve fracture prognosis, reduce related complications, decrease the severity of trauma, and enhance joint function. The therapeutic effect is excellent.

Nationwide trends in utilization and safety of ventricular arrythmia ablation in patients with hypertrophic cardiomyopathy

Abstract Background Catheter ablation for ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVC) is increasingly utilized across the nation, while data on its safety in Hypertrophic Cardiomyopathy (HCM) patients is sparse. Purpose To analyze the nationwide trends in utilization and complications of inpatient ventricular arrhythmia ablations in patients with HCM. Methods This study is a retrospective analysis of hospitalizations, in HCM patients 18 years of age and older, who underwent an inpatient VA ablation in the U.S., between 2016 and 2020. We drew data from the National Inpatient Sample (NIS) database. Patients without HCM undergoing the CA for VA were used as controls. Baseline sociodemographic and clinical data, procedural complications, mortality and length of stay were analyzed. Multivariable analysis was performed to identify independent predictors of procedural complications. Results Among a weighted total of 2880 patients hospitalized between 2016 and 2020, who underwent VA ablations, the median age was 67 years (IQR 56-74), 60% were male, and 73% were white. The HCM group had similar age distribution but more women (64.5% vs 33.6%, p&amp;lt;0.001) and more African Americans (13.2% vs. 7.3%, p=0.03). The non-HCM cohort had significantly higher rates of prior myocardial infarction (22% vs 12.4%, p=0.026), ischemic cardiomyopathy (30.1% vs 0.8%, p&amp;lt;0.001), heart failure (70.5% vs 39.7%, p&amp;lt;0.001), and peripheral vascular disease (PVD, 42.9% vs 18.2%, p&amp;lt;0.001). This was reflected in higher Deyo Comorbidity Index in the non-HCM cohort (score of ≥ 2 in 66.6% vs 43%, p&amp;lt;0.001). Overall, the real-world peri-procedural complication rate in the entire cohort was 15.3%, including 6.4% hemorrhagic, 4.5% pericardial, and 2.3% vascular complications. There was a trend for lower complication rate in the HCM group (9.9% vs. 16.7%, p = 0.08). The in-hospital mortality didn’t defer (1.7% vs. 4.2%, p=0.28) and the length of stay was shorter in the HCM group (3.5 vs. 6.4 days, p &amp;lt; 0.001). Multivariable logistic regression analysis showed obesity (OR 2.06; 95%CI: 1.59 - 2.67; p&amp;lt;0.001) and PVD (OR 2.19; 95%CI: 1.34-3.53; p=0.001) to be independent predictors of complications while HCM was not (OR 0.76, 95% CI 0.51-1.14, p = 0.195). Conclusion Real-world data from a nationwide inpatient database shows comparable safety for VA ablation in HCM patients with similar mortality and lower length of stay, compared to non-HCM patients.

Influence of Femoral Stem Geometry on Total Hip Replacement: A Comparison of Clinical Outcomes of a Straight and an Anatomical Uncemented Stem

Background/Objectives: There are many aspects that may influence clinical outcomes in a total hip arthroplasty (THA). The influence of femoral stem on the clinical outcome of THA is probably underestimated in the literature. Our work aims to analyze how uncemented stem geometry (straight or anatomical) in THA might affect outcomes in clinical and radiographic terms. Methods: Over a period of 36 months, in a prospective-observational manner, we collected the results of THA secondary to osteoarthritis (OA) that met the inclusion criteria with the only variable being the straight or anatomical stem design in a single manufacturer. A total of 84 patients were selected and divided into two groups: group A, treated with straight stem (44 patients), and group B, treated with anatomical stem (40 patients). The assessment clinical tools were Harris Hip Score (HHS), Visual Analogue Scale (VAS), and Short Form Health Survey-36 (SF-36). Follow-up controls were at 6 months (T0), 12 months (T1), 24 months (T2), and 36 months (T3). Results: No statistically significant differences emerged between the two groups under analysis with VAS, SF-36, and HHS. At follow-up controls, eight patients (group A) and four patients (group B) showed anterior thigh pain. At T1, there were radiographic signs of aseptic loosening in two cases (group A) and one case (group B). In group A there were two cases of iatrogenic fracture, two cases of dislocation, one case of infection, and two cases of heterotopic ossification. Conclusions: The anatomical stem compared to the straight stem showed lower complication rates outcomes; the anatomical uncemented stem could be considered as a preferred first choice in THA compared to the straight stem.

Patient characteristics and clinical outcome in acute myocardial infarction related cardiogenic shock according to vascular access site for PCI

Abstract Background / Introduction The optimal vascular access site for percutaneous coronary interventions (PCI) in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains uncertain. While observational data favor trans-radial access (TRA) due to lower complication rates and mortality, trans-femoral (TFA) PCI offers advantages such as shorter access and procedure times, along with quicker escalation to mechanical circulatory support (MCS). Purpose In this study, we aimed to investigate factors associated with a transfemoral approach and compare mortality rates between TRA and TFA in AMI-CS patients undergoing PCI. Methods Data from a nationwide registry of AMI-CS patients undergoing PCI (2017-2021) were analyzed. We compared patient demographics, procedural details, and outcomes between TRA and TFA groups. Logistic regression identified access site factors and radial-to-femoral cross-over predictors. Propensity score matched (PSM) analysis examined the impact of access site on mortality. Results Of 1562 patients, 45% underwent TRA PCI, with an increasing trend over time. TFA patients were more often female, had a history of coronary artery bypass grafting (CABG), lower blood pressure, higher resuscitation and intubation rates, and elevated lactate levels. After PSM, 30-day mortality was lower in TRA (33% vs. 46%, p &amp;lt;0.001). Predictors for cross-over included left coronary artery interventions, multivessel PCI, and MCS initiation. Conclusion Significant differences exist between TRA and TFA PCI in AMI-CS. TFA was more common in patients with worse hemodynamics and was associated with higher 30-day mortality compared to TRA. TRA should be the default access, given its feasibility and favorable outcomes in many patients.Baseline characteristicsPredictors for femoral access