Outcomes following duodenectomy in patients with familial adenomatous polyposis.

Background and study aims Some patients with familial adenomatous polyposis (FAP) and extensive duodenal polyposis or cancer require total duodenectomy. Regular postoperative endoscopic surveillance of the remaining jejunum and stomach is recommended, but little is known about the outcomes after this surgery. Patients and methods Patients with FAP who underwent either pancreatoduodenectomy (PD) or pancreas-preserving total duodenectomy (PPTD) were identified at two expert centers. Data about postoperative endoscopic surveillance outcomes were collected, as well as survival outcomes. Results Overall, 119 patients (50% female) underwent duodenectomy (86 PD and 33 PPTD); 100 for benign duodenal polyposis and 19 for duodenal or ampullary cancer. Details of postoperative endoscopic surveillance were available for 88 patients (74%). During a median follow-up of 106 months, 36 patients (41%) were diagnosed with jejunal adenomas after duodenectomy, with a significantly higher proportion in patients who underwent PPTD compared with patients who underwent PD (log-rank, P < 0.01). Two patients developed jejunal cancer (2%). Twenty-six patients (30%) were diagnosed with a total of 66 gastric adenomas, of which 61% were located in the fundus/body and 39% in the antrum. Five patients (6%) developed gastric cancer after a median of 15 years (range 6-23 years), all but one within carpeting fundic gland polyposis. Patients who underwent surgery for cancer had worse survival than patients with benign disease and all but one patient with postoperative gastric/jejunal cancer died. Conclusions After duodenectomy in FAP, a considerable risk of developing adenomas and cancer in the stomach and jejunum exists with poor cancer prognosis, highlighting the need for close postoperative endoscopic surveillance.

Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial.

BACKGROUND: The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in non-left main true bifurcations. AIMS: This study aimed to investigate the 5-year clinical results of the EBC TWO Trial. METHODS: A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. Inclusion criteria required a side branch diameter ≥2.5 mm and side branch lesion length >5 mm. Five-year follow-up was completed for 197 patients. The primary endpoint was the composite of all-cause mortality, myocardial infarction, or target vessel revascularisation. RESULTS: The mean side branch stent diameter was 2.7±0.3 mm and mean side branch lesion length was 10.3±7.2 mm. At 5-year follow-up, the primary endpoint occurred in 18.4% of provisional and 23.7% of systematic culotte patients (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.41-1.38). No significant differences were identified individually for all-cause mortality (7.8% vs 7.2%, HR 1.11, 95% CI: 0.40-3.05), myocardial infarction (8.7% vs 13.4%, HR 0.64, 95% CI: 0.27-1.50) or target vessel revascularisation (6.8% vs 9.3%, HR 1.12, 95% CI: 0.37-3.34). Stent thrombosis rates were also similar (1.9% vs 3.1%, HR 0.63, 95% CI: 0.11-3.75). There was no significant interaction between the extent of side branch disease and the primary outcome (p=0.34). CONCLUSIONS: In large non-left main true bifurcation lesions, the use of a systematic culotte strategy showed no benefit over provisional stenting for the composite outcome of all-cause mortality, myocardial infarction, or target vessel revascularisation at 5 years. The stepwise provisional approach may be considered preferable for the majority of true coronary bifurcation lesions. CLINICALTRIALS: gov: NCT01560455.

Novel adaptations in percutaneous right transaxillary access for transcatheter aortic valve implantation using the sapien ultra valve.

BACKGROUND: Percutaneous transaxillary access is used as an alternative to the transfemoral approach for transcatheter aortic valve implantation in patients with severe peripheral vascular disease. The left transaxillary approach is usually preferred due to ease of valve alignment with the aortic annulus. Some patients have anatomical and physiological factors which preclude this approach. Moreover, most catheterization lab layouts make left-sided approaches to the heart awkward for imaging, visualization, procedural ease, and radiation protection. AIMS: The authors describe novel adaptations to allow successful right transaxillary access for implantation of the transcatheter heart valve using the Edwards Sapien 3 system (Edwards Lifesciences). METHODS: We searched our local structural heart database for all patients who underwent transcatheter aortic valve implantation via axillary access, from January 2021 to January 2022. Patients with left axillary access were excluded. RESULTS: We report 6 percutaneous right transaxillary cases performed in the last year using steps which allow smooth delivery of the SAPIEN 3 Ultra valve down the greater curvature of the aorta and providing co-axial alignment of the valve. Only one patient had a vascular complication with arterial dissection at the closure point managed with 8 mm x 37 mm Bentley uncovered stent at the access site. CONCLUSION: With the modifications described in our article, the right transaxillary approach has now become our preferred secondary access route for TAVI.

OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.

BACKGROUND: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. METHODS: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. RESULTS: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. CONCLUSIONS: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).

Bifurcation left main stenting with or without intracoronary imaging: Outcomes from the EBC MAIN trial.

BACKGROUND: The impact of intracoronary imaging on outcomes, after provisional versus dual-stenting for bifurcation left main (LM) lesions, is unknown. OBJECTIVES: We investigated the effect of intracoronary imaging in the EBC MAIN trial (European Bifurcation Club LM Coronary Stent study). METHODS: Four hundred and sixty-seven patients were randomized to dual-stenting or a stepwise provisional strategy. Four hundred and fifty-five patients were included. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was undertaken at the operator's discretion. The primary endpoint was death, myocardial infarction or target vessel revascularization at 1-year. RESULTS: Intracoronary imaging was undertaken in 179 patients (39%; IVUS = 151, OCT = 28). As a result of IVUS findings, operators reintervened in 42 procedures. The primary outcome did not differ with intracoronary imaging versus angiographic-guidance (17% vs. 16%; odds ratio [OR]: 0.92 (95% confidence interval [CI]: 0.51-1.63) p = 0.767), nor for reintervention based on IVUS versus none (14% vs. 16%; OR: 0.88 [95% CI: 0.32-2.43] p = 0.803), adjusted for syntax score, lesion calcification and ischemic symptoms. With angiographic-guidance, primary outcome events were more frequent with dual versus provisional stenting (21% vs. 10%; adjusted OR: 2.11 [95% CI: 1.04-4.30] p = 0.039). With intracoronary imaging, there were numerically fewer primary outcome events with dual versus provisional stenting (13% vs. 21%; adjusted OR: 0.56 [95% CI: 0.22-1.46] p = 0.220). CONCLUSIONS: In EBC MAIN, the primary outcome did not differ with intracoronary imaging versus none. However, in patients with angiographic-guidance, outcomes were worse with a dual-stent than provisional strategy When intracoronary imaging was used, there was a trend toward better outcomes with the dual-stent than provisional strategy.

Changes in absolute flow, myocardial resistance and FFR after chronic total occlusion percutaneous coronary intervention.

BACKGROUND: Randomised studies of percutaneous coronary intervention (PCI) in patients with chronic total occlusion (CTO) have shown inconsistent outcomes, suggesting incomplete understanding of this cohort and their coronary physiology. To address this shortcoming, we designed a prospective observational study to measure the recovery of absolute coronary blood flow following successful CTO PCI Aims: We sought to identify patient and procedural characteristics associated with a favourable physiological outcome after CTO PCI. METHODS: Consecutive patients with a CTO subtending viable myocardium underwent PCI utilising contemporary techniques and the hybrid algorithm. Immediately after PCI, and at 3-month follow-up, physiological measurements were performed utilising continuous thermodilution. RESULTS: A total of 81 patients were included with a mean age of 63.6±8.9 years, and 66 (81.5%) were male. Physiological measurements of absolute coronary blood flow in the CTO vessel increased by 30% (p<0.001) and microvascular resistance reduced by 16% (p<0.001) from immediately post-CTO PCI to follow-up assessment. Fractional flow reserve increased by 0.02 (p=0.015) in the same period. Prior coronary artery bypass graft (CABG) and a higher estimated glomerular filtration rate (eGFR) were associated with a larger change in absolute flow. An extraplaque strategy was associated with a smaller change in absolute flow. CONCLUSIONS: Post-CTO PCI, there is a continued augmentation in absolute coronary blood flow and reduction in microvascular resistance from baseline to follow-up at 3 months. Prior CABG and a higher baseline eGFR were predictors of a larger change in absolute coronary flow, whilst an extraplaque final wire path strategy predicted a smaller change. Lastly, the patient characteristics and comorbidities had a larger influence than procedural factors on the observed change in absolute flow.

Impact of technique on bifurcation stent outcomes in the European Bifurcation Club Left Main Coronary Trial.

BACKGROUND: Techniques for provisional and dual-stent left main bifurcation stenting require optimization. AIM: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention. METHODS: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte). RESULTS: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020). CONCLUSION: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02497014.

Sex Differences in Clinical Profile and Outcome After Percutaneous Coronary Intervention for Chronic Total Occlusion.

BACKGROUND: There are limited data around sex differences in the risk profile, treatments and outcomes of percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) lesions in contemporary interventional practice. We investigated the impact of sex on clinical and procedural characteristics, complications and clinical outcomes in a national cohort. METHODS & RESULTS: We created a longitudinal cohort (2006-2018, n = 30,605) of patients with stable angina who underwent CTO PCI in the British Cardiovascular Intervention Society (BCIS) database. Clinical, demographic, procedural and outcome data were analysed in two groups stratified by sex: male (n = 24,651), female (n = 5954). Female patients were older (68 vs 64 years, P < 0.001), had higher prevalence of diabetes mellitus (DM), hypertension (HTN) and prior stroke. Utilization of intravascular ultrasound (IVUS), drug eluting stents (DES), radial or dual access and enabling strategies during CTO PCI were higher in male compared to female patients. Following multivariable analysis, there was no significant difference in in-patient mortality (adjusted odds ratio (OR):1.40, 95 % CI: 0.75-2.61, P = 0.29) and major cardiovascular and cerebrovascular events (MACCE) (adjusted OR: 1.01, 95 % CI: 0.78-1.29, P = 0.96). The crude and adjusted rates of procedural complications (adjusted OR: 1.37, 95 % CI: 1.23-1.52, P < 0.001), coronary artery perforation (adjusted OR: 1.60, 95 % CI: 1.26-2.04, P < 0.001) and major bleeding (adjusted OR: 2.06, 95 % CI: 1.62-2.61, P < 0.001) were higher in women compared with men. CONCLUSION: Female patients treated by CTO PCI were older, underwent lesser complex procedures, but had higher adjusted risk of procedural complications with a similar adjusted risk of mortality and MACCE compared with male patients.

Transcatheter Aortic Valve Implantation in Patients With Right Bundle-Branch Block: Should Prophylactic Pacing Be Undertaken?

INTRODUCTION: Right bundle-branch block (RBBB) is a strong predictor of the development of high-grade AV block (AVB) after TAVI. AIMS: To assess mortality, length-of-hospital stay, and cost in patients with RBBB undergoing TAVI according to whether or not they had preprocedural permanent pacemaker (PPM) implantation. METHODS AND RESULTS: A total of 121 patients with RBBB who underwent TAVI between 2009-2021 were included. A total of 41 patients (33.9%) received a prophylactic PPM by clinical preference and 45/80 patients (56%) received PPM after TAVI. Baseline characteristics were balanced. Mortality was similar at 5 years, with death in 17 patients (41.4%) in the prophylactic PPM group vs 27 (33.8%) in the no prophylactic PPM group (adjusted hazard ratio [HR], 1.27; 95% confidence interval [CI], 0.69-2.33; P=.44). Median survival for the prophylactic PPM (4.2 years), post TAVI PPM (4.5 years) and no pacemaker (4.7 years) groups was similar. Sixteen deaths (35.6%) occurred in those receiving PPM after TAVI and 11 deaths (31.4%) occurred in those not receiving PPM (HR, 0.95; 95% CI, 0.43-2.09; P=.90). Thirty-day all-cause mortality was similar. Compared with post-TAVI PPM, prophylactic PPM reduced hospital length of stay (4.3 ± 4.5 days vs 2.5 ± 1.6 days, respectively; P=.02). For the highest and lowest complication and comorbidity scores, prophylactic PPM resulted in cost savings of £297.32 (-2.9%) and excess cost of £423.89 (+5.6%), respectively. There were no major pacing-related complications. CONCLUSIONS: More than half of patients with RBBB undergoing TAVI require PPM shortly after their valve implant. A prophylactic pacing strategy is safe, reduces length of hospital stay, and is cost effective in the United Kingdom.

Single arterial access closure of post-infarction ventricular septal defect: A case series.

BACKGROUND: Post-infarction ventricular septal defect (PIVSD) carries a very poor prognosis. Surgical repair offers reasonable outcomes in patients who survive the initial healing period. Percutaneous device implantation remains a potentially effective earlier alternative. METHODS AND RESULTS: From March 2018 to May 2022, 11 trans-arterial PIVSD closures were attempted in 9 patients from two centers (aged 67.2 ± 11.1 years; 77.8% male). Two patients had a second procedure. Myocardial infarction was anterior in four patients (44.5%) and inferior in five cases (55.5%). Devices were successfully implanted in all patients. There were no major immediate procedural complications. Immediate shunt grade postprocedure was significant (11.1%), minimal (77.8%), or none (11.1%). Median length of stay after the procedure was 14.8 days. Five patients (55%) survived to discharge and were followed up for a median of 605 days, during which time no additional patients died. CONCLUSION: Single arterial access for percutaneous closure of PIVSD is a good option for these extremely high-risk patients, in the era of effective large-bore arterial access closure. Mortality remains high, but patients who survive to discharge do well in the longer term.

Permanent pacemaker implantation and left bundle branch block with self-expanding valves - a SCOPE 2 subanalysis.

BACKGROUND: No detailed data on left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) exist from randomised clinical trials comparing the ACURATE neo and CoreValve Evolut devices. AIMS: Our aim was to assess the incidence and impact of new LBBB and PPI with self-expanding prostheses from a powered randomised comparison. METHODS: From the SCOPE 2 trial, 648 patients with no previous pacemaker were analysed for PPI at 30 days, and 426 patients without previous LBBB were adopted for analysis of LBBB at 30 days.  Results: At 30 days, 16.5% of patients required PPI; rates were higher in CoreValve Evolut compared to ACURATE neo recipients (21.0% vs 12.3%; p=0.004). Previous right bundle branch block (odds ratio [OR] 6.11, 95% confidence interval [CI]: 3.19-11.73; p<0.001) was associated with an increased risk of PPI at 30 days, whereas the use of the ACURATE neo (OR 0.50, 95% CI: 0.31-0.81; p=0.005) was associated with a decreased risk. One-year mortality was similar in patients with and without new PPI. A total of 9.4% of patients developed persistent LBBB at 30 days, with higher incidences in CoreValve Evolut recipients (13.4% vs 5.5%; p=0.007). New LBBB at 30 days was associated with lower ejection fraction at 1 year (65.7%±11.0 vs 69.1%±7.6; p=0.041). CONCLUSIONS: New LBBB and PPI rates were lower in ACURATE neo compared to CoreValve Evolut recipients. The ACURATE neo valve was associated with a lower risk of PPI at 30 days. No effect on 1-year mortality was determined for PPI at 30 days, while LBBB at 30 days was associated with reduced ejection fraction at 1 year.

Feasibility of transcaval access TAVI in morbidly obese patients: A single-center experience.

OBJECTIVES: We report a single-center experience in utilizing the transcaval-access transcatheter aortic valve implantation (TAVI) as an alternative approach in morbidly obese patients. BACKGROUND: Morbidly obese patients present frequently for TAVI. Transfemoral arterial access TAVI in these patients is technically challenging due to deep arterial access, resulting in a higher risk of vascular complications. Transcaval access TAVI is increasingly used in patients with prohibitive iliofemoral arterial access. METHODS: We used the transcaval approach for eight morbidly obese patients who had otherwise technically feasible femoral arterial access. This technique provides an alternative arterial access point that potentially circumvents some of the challenges relating to femoral arterial access. RESULTS: We report eight morbidly obese patients with a mean body mass index of 42.3 ± 6.2 kg/m2 who underwent transcaval access TAVI at our center (mean EuroScore II 2.47 ± 1.83%). The patient mean age was 70.3 ± 9.8 years; six were female. All eight patients underwent a successful and uncomplicated procedure. The median time to discharge was 2 days and all patients were alive at 30 days. CONCLUSIONS: Transcaval access TAVI is a feasible alternative for morbidly obese patients and may reduce vascular complications. Further data are required to evaluate the safety of this approach.

Management and Outcome of Acute Ischemic Stroke Complicating Transcatheter Aortic Valve Replacement.

BACKGROUND: Despite advances in transcatheter aortic valve replacement (TAVR), periprocedural acute ischemic stroke remains a concern. OBJECTIVES: The aims of this study were to investigate acute ischemic stroke complicating TAVR (AISCT) and to describe the indications and outcomes of interventions to treat AISCT. METHODS: An international multicenter registry was established focusing on AISCT within 30 days of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale. Primary outcomes were 1-year all-cause death and neurologic disability status at 90 days according to modified Rankin scale score. RESULTS: Of 16,615 TAVR procedures, 387 patients with AISCT were included (2.3%). Rates of 1-year death were 28.9%, 35.9%, and 77.5% in patients with mild, moderate, and severe stroke, respectively (P < 0.001). Although 348 patients were managed conservatively, 39 patients (10.1%) underwent neurointervention (NI) with either mechanical thrombectomy (n = 26) or thrombolytic therapy (n = 13). In a subanalysis excluding patients with mild stroke, there was no clear 1-year survival benefit for NI compared with conservative management (47.6% vs 41.1%, respectively; P = 0.78). In a logistic regression model controlling for stroke severity, NI was associated with 2.9-fold odds (95% CI: 1.2-7.0; P = 0.016) of independent survival at 90 days. CONCLUSIONS: AISCT carries significant morbidity and mortality, which is correlated with stroke severity. The present findings suggest that neurologic disability for patients with moderate or worse stroke could potentially be improved by timely intervention and highlight the importance of collaboration between cardiologists and neurologists to optimize AISCT outcomes.

Changes in coronary collateral function after successful chronic total occlusion percutaneous coronary intervention.

BACKGROUND: Contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) incorporates wire escalation and dissection/re-entry recanalisation strategies. AIMS: The purpose of the study was to investigate changes in collateral function after CTO PCI and to identify whether the mode of successful recanalisation influences collateral function regression. METHODS: Patients scheduled for elective CTO PCI with evidence of viability in the CTO territory by noninvasive imaging were included in this study. After successful CTO PCI, the aortic pressure (Pa) and distal coronary artery wedge pressure (Pw) during balloon occlusion were measured, both in a resting state and during infusion of intravenous adenosine, allowing the calculation of the pressure-derived collateral pressure index at rest and hyperaemia (CPIrest and the collateral fractional flow reserve [FFRcoll], respectively). Measurements were repeated 3 months later during angiographic follow-up. RESULTS: Eighty-one patients had physiological measurements at baseline and follow-up. In the final cohort the mean age was 64 years and 82% were male. The mean maximal stent diameter and total stent length were 3.2±0.5 mm and 68±31 mm, respectively. Successful strategies were antegrade wiring (64.2%), antegrade dissection re-entry (8.6%), and retrograde dissection re-entry (27.1%). Between the index procedure and follow-up, wedge pressure decreased from 34±11 mmHg to 21±8.5 mmHg (p<0.01), respectively. FFRcoll changed from 0.34±0.11 to 0.19±0.09 (p<0.01) at follow-up and CPIrest from 0.40±0.14 to 0.17±0.09 (p<0.01). Absolute maximum collateral flow decreased from 55±32 ml/min directly after PCI to 38±24 ml/min (p<0.01). There was no relation between the recanalisation technique and changes in FFRcoll. CONCLUSIONS: There was a significant reduction in collateral flow over time, independent of the recanalisation technique.

Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2.

BACKGROUND: The Academic Research Consortium - High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding. AIMS: We sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR). METHODS: Patients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients. RESULTS: Of 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: -2.72 to 6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications. CONCLUSIONS: The ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.

Balloon Seal Separation Leading to SAPIEN 3 Transcatheter Heart Valve Deployment Failure: Complications and Management.

We present two cases of failure of balloon inflation secondary to balloon separation from the delivery catheter when implanting the SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA). Although very uncommon, this is a potentially disastrous complication of transcatheter intervention. Case 1 highlights the complexity of the problem when it occurs and subsequent complications. Case 2 highlights how to manage this issue successfully.

Mobility aids predict mortality after transcatheter aortic valve implantation.

BACKGROUND: Selection of appropriate patients for transcatheter aortic valve implantation (TAVI) can be challenging. Many factors can influence post-procedure outcomes. Traditional surgical scoring systems do not discriminate effectively. Medical parameters and functional indices can characterize mortality risk. Mobility is an important predictive functional index but is largely defined using subjective criteria. AIM: To describe the relationship between mobility, objectively defined by the requirement for gait aids to ambulate, and all-cause 30-day and long-term mortality in patients undergoing TAVI. METHODS: Mobility aid use was assessed in 1444 consecutive patients undergoing TAVI in a single center. Patients were categorized into "unaided," "1-stick," and "higher aid" groups based on the Brighton Mobility Index. Mortality tracking was obtained via the NHS Spine Portal in February 2021. RESULTS: Patients were aged 82 (IQR 78-86). 66% of patients walked unaided, 26% walked with 1 stick, and 8% required more assistance (e.g., 2 sticks, a Rollator, a Zimmer frame, or a wheelchair). Overall 30-day mortality for the whole cohort was 3.5%; 1-year mortality was 12.2%. Mobility was a significant predictor of 30-day mortality (p = 0.025). Use of a higher aid was associated with a mortality odds ratio of 2.83 (95% CI: 1.39-5.74). Mobility was also a significant predictor of long-term mortality (p < 0.001). Odds ratios for 1-stick and higher aid groups were 1.45 (95% CI: 1.21-1.72) and 2.01 (95% CI: 1.55-2.60), respectively. CONCLUSION: Objective assessment of mobility by gait aid use predicts both short and long-term survival in patients undergoing TAVI. Increased dependence on mobility aids is associated with a worse prognosis.

Valve-in-Valve Transcatheter Aortic Valve Implantation for the Failing Surgical Perceval Bioprosthesis.

INTRODUCTION: The Perceval Valve has been increasingly used in Surgical Aortic Valve Replacement (SAVR) recently due to ease of implantation. However, we have seen some cases of relatively early haemodynamic failure of the Perceval valve and these patients may then present for valve-in-valve transcatheter aortic valve implantation (ViV-TAVI). Experience of ViV-TAVI in the Perceval valve is limited. METHODS: We report our experience of VIV-TAVI in four cases of early-failing Perceval valves, two with stenosis and two with regurgitation. We also review the literature with regard to ViV-TAVI for this indication. RESULTS: Four patients aged between 66 and 78 years presented with Perceval valve dysfunction an average of 4.6 years following SAVR. All cases underwent Heart Team discussion and a ViV-TAVI procedure was planned thereafter. Strategies to ensure crossing through the centre of the valve and not outside any portion of the frame were found to be essential. Three patients had self-expanding valves implanted and one had a balloon-expandable prosthesis. The average aortic valve area (AVA) improved from 0.8 cm2 pre-procedure to 1.5 cm2 post-procedure*. The mean gradient (MG) improved from 35.5 mmHg (range 19.7-53 mmHg) pre-procedure to 14.8 mmHg (range 7-30 mmHg) post-procedure. In one patient a MG of 30 mmHg persisted following valve deployment. There were no significant peri-procedural complications. CONCLUSIONS: ViV-TAVI is a useful option for failed Perceval prostheses and appears safe and effective in this small series. Crossing inside the whole frame of the Perceval valve is essential.

Procedural Mortality With Transcatheter Aortic Valve Replacement - Balloon Inflation is Associated With Increased Risk.

OBJECTIVES: To assess the impact of balloon use for predilation, valve implantation, or postdilation on in-hospital mortality among patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR utilizes self-expanding, mechanically expanding, or balloon-expandable valves. Balloon inflation is inherent to deployment of balloon-expandable valves. Balloons may additionally be used with all valve types for pre- and postdilation. The relationships between valve mechanism, balloon use, and in-hospital mortality are not fully characterized. METHODS: Prospective data were collected on 4063 patients undergoing TAVR for aortic stenosis at 4 high-volume centers in the United Kingdom. In-hospital mortality was analyzed according to valve expansion mechanism, use of balloons for pre- and postdilation, and specific cause of death. RESULTS: Mean patient age was 83 ± 8 years. Implanted valves were self expanding (n = 2241; 55%), mechanically expanding (n = 1092; 27%), or balloon expandable (n = 727; 18%). In-hospital death occurred in 66 cases (1.6%). Thirty-six deaths (54.5%) were classified as implantation-related mortalities, with rates of 0.8%, 0.5%, and 1.7% (P=.04) among self-expanding, mechanically expanding, and balloon-expandable technologies, respectively. Patients who underwent balloon inflation at any stage of their procedure (n = 2556; 63%) had significantly higher implantation-related mortality than those who did not (1.3% vs 0.3%, respectively; P<.01). Balloon-expandable valve procedures were associated with significantly higher all-cause mortality (2.6% vs 1.4%; P=.02) and implantation-related mortality (1.7% vs 0.7%; P=.02) than non-balloon-expandable valve procedures. Balloon-related complications accounted for 18 cases (26%) of total in-hospital mortality, including all 12 cases (17.4%) of annular rupture and 5 cases (7.2%) of coronary occlusion. CONCLUSIONS: Balloon use for predilation, valve implantation, or postdilation was associated with an increased mortality risk. Balloon-related complications were the largest contributor to in-hospital mortality, comprising all cases of annular rupture and the majority of coronary occlusion cases.