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Transcatheter edge-to-edge repair (TEER) with MitraClip improves outcomes among select patients with moderate-to-severe and severe mitral regurgitation; however, data regarding sex-specific differences in the outcomes among patients undergoing TEER are limited.An electronic search of the PubMed, Embase, Central, and Web of Science databases for studies comparing sex differences in outcomes among patients undergoing TEER was performed. Summary estimates were primarily conducted using a random-effects model.Eleven studies with a total of 24,905 patients (45.6% women) were included. Women were older and had a lower prevalence of comorbidities, including diabetes, chronic kidney disease, and coronary artery disease. There was no difference in procedural success (odds ratio [OR]: 0.75, 95% confidence interval [CI]: 0.55-1.05) and short-term mortality (i.e., up to 30 days) between women and men (OR: 1.16, 95% CI: 0.97-1.39). Women had a higher incidence of periprocedural bleeding and stroke (OR: 1.34, 95% CI: 1.15-1.56) and (OR: 1.57, 95% CI: 1.10-2.25), respectively. At a median follow-up of 12 months, there was no difference in mortality (OR: 0.98, 95% CI: 0.89-1.09) and heart failure hospitalizations (OR: 1.07, 95% CI: 0.68-1.67). An analysis of adjusted long-term mortality showed a lower incidence of mortality among women (hazards ratio: 0.77, 95% CI: 0.67-0.88).Despite a lower prevalence of baseline comorbidities, women undergoing TEER with MitraClip had higher unadjusted rates of periprocedural stroke and bleeding as compared with men. There was no difference in unadjusted procedural success, short-term or long-term mortality. However, women had lower adjusted mortality on long-term follow-up. Future high-quality studies assessing sex differences in outcomes after TEER are needed to confirm these findings.

We aim to report on the efficacy and safety of large bore venous access (LBVA) preclosure with Perclose™ (Abbott Vascular Devices) suture-mediated device use following transcatheter edge-to-edge (TEER) and replacement (TMVR).Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited.Between 2012 and 2019, 354 consecutive high-risk patients with mitral valvular heart disease underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All patients underwent preclosure of LBVA except for one that underwent manual hemostasis.There were no closure device failures. None of the cases required surgical repair of the access site following venous preclosure. Two cases had large hematomas (6 cm) following Perclose in each group. Six cases had small hematomas (6 cm and2 cm) with three in each group. There was one major bleeding using Mitral Valve Academic Research Consortium 2 definition (retroperitoneal bleed from arterial puncture) unrelated to the venous closure. Transfusion related to vascular access complication was required in five cases. There were two immediate acute deep venous thromboses postprocedure; one of which occurred after preclosure. There were no arteriovenous malformations, pseudoaneurysms, or access site infections reported following Perclose.In this large sample size analysis, Proglide preclosure technique is a feasible and safe alternative approach to achieving hemostasis after removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized trials are needed to compare the different modalities of hemostasis.

To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR).PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown.Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed.Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups.This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients.

Several studies have pair-wise compared access sites for transcatheter aortic valve replacement (TAVR) but pooled estimate of overall comparative efficacy and safety outcomes are not well known. We sought to compare short- and long-term outcomes following various alternative access routes for TAVR.Thirty-four studies with a pooled sample size of 32,756 patients were selected by searching PubMed and Cochrane library databases from inception through 11th June 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data were extracted to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group.Compared with TF, both TAO [RR 1.91, 95% CI (1.46-2.50)] and TA access [RR 2.12, 95% CI (1.84-2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events at 30 days between different accesses. Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28-0.67)] and TC [RR 0.51, 95% CI (0.35-0.73)] access compared to TF. The 1-year mortality was higher in TAO [RR of 1.35, (95% CI, 1.01-1.81)] and TA [RR 1.44, (95% CI, 1.14-1.81)] groups.Non-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with outcomes similar to conventional TF access. Thoracic TAVR access (TAO and TA) translates into increased short and long-term mortality.

Acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR) is a known complication. The prospective validation of various AKI definitions and estimated baseline renal function equations in the context of TAVR remains an ongoing area of research. This study examined the Valve Academic Research Consortium (VARC) 1 and 2 criteria for AKI, and impact of three estimated glomerular filtration rate (eGFR) equations (CKD-EPI, MDRD, and Cockcroft-Gault) on AKI incidence in TAVR patients.Retrospective review of 120 consecutive TAVR procedures over a 4-year period was performed. AKI, including stage, was defined using the VARC 1 and VARC 2 criteria. Univariate and multivariate analyses were performed for association between AKI and known patient, hemodynamic, and procedural variables. Further logistic regression, stepwise logistic regression, and association plots were performed for the three different eGFR calculations.AKI occurred in 22% of VARC 1 patients and 23% of VARC 2 patients. On multivariate analysis, baseline eGFR was predictive of stage 1 AKI by CKD-EPI classification (VARC 1: odds ratio [OR], 0.93; 95% confidence interval [CI], 0.88-0.99; P=.02; VARC 2: OR, 0.93; 95% CI, 0.87-0.99; P=.03) and MDRD (OR, 0.93; 95% CI, 0.88-0.99; P=.03). Non-transfemoral approach was predictive of stage 1 AKI by VARC 2 (OR, 33.33; 95% CI, 1.6-696.41; P=.02).The risk factor associations for AKI post TAVR vary by definitions used. Decreased GFR at baseline by both MDRD and CKD-EPI and non-transfemoral approach were associated with an increased risk of AKI post TAVR.

Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).This study evaluated the safety and efficacy of TCEP during TAVR.Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed.The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, pTCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277).

Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device.A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%).In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices.URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Introduction: Transcatheter mitral valve replacement (TMVR) using aortic transcatheter heart valves (THV) is developing as an alternative to surgery for patients with severely degenerated mitral valve (MV) bioprostheses. Retrospective self-reported registries have collected outcomes on these TMVR procedures in the STS/ACC Transcatheter Valve Therapy Registry and in the Valve-in-Valve International Database. Most reported TMVR procedures for failed surgical bioprostheses have been performed using a transapical access approach. A prospective comprehensive evaluation of mitral Valve-in-Valve (VIV) outcomes, including transseptal access has not previously been conducted. Objectives: To evaluate in-hospital and 30-day clinical outcomes of transseptal mitral VIV with SAPIEN 3 THV in patients with very high surgical risk. Methods: Prospective enrollment of very high surgical risk patients with symptomatic severely degenerated MV surgical bioprostheses in 30 patients at 15 sites in the U.S. Candidates were assessed by a case review committee prior to approval. Baseline qualifying echocardiograms and cardiac CT studies were analyzed by independent core labs. Echocardiograms, cardiac CT studies and neurology evaluations were also performed after mitral VIV procedures. Clinical events were adjudicated by a clinical events committee and safety was monitored by a data safety monitoring board. Results: 26 patients have been enrolled between July 2016 and June 2017. Mean age was 83 years, 62% female, mean STS score was 10% and 62% were in New York Heart Association class III or IV. Transseptal access was used in all procedures. Technical success was achieved in all patients and there was no in-hospital mortality. There was no 30-day cardiovascular mortality and 4% (1 patient) 30-day all-cause mortality (1 patient died of asphyxia on day 29 after choking on pills at home), which was lower than the 30-day mortality in the TVT registry (9%). Detailed procedural, in-hospital and 30-day outcomes will be presented on the complete cohort of 30 patients. Conclusions: In patients without surgical alternatives, transseptal mitral ViV procedures in failed surgical bioprostheses are associated with high technical and procedural success and low 30-day mortality.

The aim of this study was to examine the impact of 3-dimensional (3D) computed tomographic (CT) guided procedural planning for left atrial appendage (LAA) occlusion on the early operator WATCHMAN learning curve.Traditional WATCHMAN implantation is dependent on 2-dimensional transesophageal echocardiographic (TEE) sizing and intraprocedural guidance.LAA occlusion with the WATCHMAN device was performed in 53 patients. Pre-procedural case plans were generated from CT studies with recommended device size, catheter selection, and C-arm angle for deployment.All 53 patients underwent successful LAA occlusion with the WATCHMAN. Three-dimensional CT LAA maximal-width sizing was 2.7 ± 2.2 mm and 2.3 ± 3.0 mm larger than 2-dimensional and 3D TEE measurements, respectively (p ≤ 0.0001). By CT imaging, device selection was 100% accurate. There were 4 peri-WATCHMAN leaks (4.5 mm) secondary to accessory LAA pedunculations. By 2-dimensional TEE maximal-width measurements alone, 62.3% (33 of 53) would have required larger devices. Using 3D TEE maximal-width measurements, 52.8% of cases (28 of 53) would have required larger devices. Three-dimensional TEE length would have inappropriately excluded 10 patients from WATCHMAN implantation. Compared with the average of 1.8 devices used per implantation attempt in PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (82% success rate), the present site averaged 1.245 devices per implantation attempt (100% success rate). There were no intraprocedural screen failures and no major adverse cardiac events.Three-dimensional CT image case planning provides a comprehensive and customized patient-specific LAA assessment that appears to be accurate and may possibly facilitate reducing the early WATCHMAN implantation learning curve.

The AVERT(TM) Contrast Modulation System (AVERT) (Osprey Medical, MN) is designed to reduce contrast volume administration during angiography. The AVERT provides an adjustable resistance circuit which decreases the pressure head delivering contrast towards the patient. The AVERT has not been previously studied in patients undergoing peripheral digital subtraction angiography (DSA). The purpose of this study was (1) to evaluate contrast savings with the AVERT and (2) to evaluate the ability to generate clinically acceptable DSA images in the process. To better define the mechanism of action in the peripheral circulation, we also developed a bench model to study the effects of the AVERT on the hydrodynamics of contrast delivery.Patients undergoing lower extremity DSA (diagnostic or intervention, sheath or catheter) were studied. The following variables were recorded for each injection: starting control syringe contrast volume, contrast volume injected towards patient, contrast volume returned to AVERT reservoir, net contrast administered to the patient and % savings. The AVERT resistance was adjusted manually based on operator's discretion--balancing image quality and contrast savings.About 408 DSA angiographic sequences were obtained in 22 patients undergoing 29 procedures. Almost 68% of the patients had chronic kidney disease. An 82% presented with critical limb ischemia, 18% had claudication. There was an overall 37% ± 14% savings of contrast (31% for diagnostic DSA, 40% for interventional procedures). Overall 91% of all images were acceptable for clinical decision making. Specifically, 94% of diagnostic and 87% of interventional images were acceptable. Injection through a 4 Fr catheter (77% acceptable) resulted in poorer image quality as compared to a 5 Fr catheter (96% acceptable). Image quality for 5, 6, and 7 Fr sheath injections was 86%, 91%, 98%, respectively. The bench model of peripheral angiography demonstrated a significant reduction in reflux of contrast proximal to the end of the catheter without loss of antegrade image quality - confirming the in vivo findings.We demonstrate that the use of the AVERT device during peripheral angiography results in significant contrast savings without compromising image quality.

Designing policies for long-term forest management is difficult, in part because ecological processes that drive forest structure and composition interact strongly, both spatially and temporally, with the many values we want to obtain from the forest. Using the Robson Valley in east-central British Columbia as a study area, we developed a spatio-temporal landscape model to assess the effects of uncertainties about stand-replacing natural disturbance regimes on indicators related to the sustainability of forest harvesting and biodiversity. Results show that key timber policy indicators were relatively less sensitive to natural disturbance regime parameters than were the biodiversity indicators of seral stage distribution and tree species composition. The other biodiversity indicator we examined, structural connectivity among old-forest patches, was among those indicators least sensitive to any of the parameters we varied. Other timber supply indicators— including non-recoverable losses, and volumes and areas disturbed—were the most sensitive to both the particular natural disturbance agent chosen and to the parameters describing its behaviour. Projections of a range of scenarios for present and alternative natural disturbance and management regimes for the study area show that most indicators varied from less than 1% up to 93% from the value of the present management/disturbance regime. Generally, three alternative management policies had weak-to-moderate capabilities of reducing effects of natural disturbances. Despite the range of uncertainties explored, the results provided little indication that, at the scale of the whole study area, current timber-harvesting targets are not sustainable over the long term. However, our findings highlight the lack of knowledge about the future, particularly about changes in climate, resulting in significant uncertainty about the future condition of the forest and about future forest-management opportunities.