Real-world experience with concomitant or staged transcatheter aortic and mitral valve replacements using balloon-expandable valves.

OBJECTIVE: To describe outcomes of patients who underwent transcatheter aortic valve replacement (TAVR) in a native valve or failed bioprosthetic valve or transcatheter heart valve (THV) and a transcatheter mitral valve replacement procedure (TMVR; valve-in-valve [mViV], valve-in-ring [mViR], and valve in mitral annulus calcification [ViMAC]) either concomitantly (same procedure) or staged (different procedures). BACKGROUND: Patient characteristics, procedural details, and outcomes of concomitant or staged TAVR and TMVR procedures are largely unknown. METHODS: Data were extracted from the STS/ACC TVT Registry™ for patients undergoing concomitant or staged TAVR and TMVR with SAPIEN XT, SAPIEN 3, or SAPIEN 3 Ultra (Edwards Lifesciences) THVs. Descriptive results were reported for procedural, index hospitalization, 30-day, and 1-year outcomes. RESULTS: A total of 257 patients underwent TAVR and TMVR in concomitant (n = 135) or staged (n = 122) procedures. Device success was 82.9% and 83.9% for concomitant TAVR and TMVR procedures and 83.8% and 82.5% for staged TAVR and TMVR procedures. Significant improvements in aortic and mitral valve function remained stable through 1 year. All-cause mortality for concomitant and staged groups was 14.7% and 10.5% at 30 days, and 32.8% and 24.6% at 1 year, respectively. Stroke rate for concomitant and staged groups was 0.8% and 3.6% at 30 days and 3.9% and 5.6% at 1 year, respectively. Improvements from baseline to 1 year in NYHA class and KCCQ overall summary scores were observed for all patients. CONCLUSIONS: Concomitant or staged transcatheter treatment of patients with aortic and mitral valve disease can be performed in select high-risk patients in experienced centers.

Transcatheter vacuum-assisted left-sided mass extraction with the AngioVac system.

OBJECTIVES: To study the safety and efficacy of AngioVac for left-sided transcatheter vacuum-assisted mass extraction (TVME). BACKGROUND: The AngioVac system is approved for right-sided TVME and has emerged as an effective and safe alternative for open surgical treatment. The use of the AngioVac device for aspiration of left-sided TVME has been limited. METHODS: Consecutive patients from two Michigan centers who underwent left-sided TVME were included. Data on patient demographics, procedural information, in-hospital and follow-up events were collected through electronic medical records review. Technical success was defined as aspirating of 70%-100% of the material. RESULTS: Ten patients (mean age 58.3 [±17.3] years, 50% male) were included. Indications for TMVE were in large for recurrent embolic events. All patients underwent bilateral cerebro-embolic protection using the Sentinel device. The total mean procedure time was 192.5 (±47.5) min of which the meantime for active aspiration (bypass time) was 9.3 (±4.2) min. The circuit configuration was: arteriovenous (AV) in four cases and arterioarterial (AA) in six cases. Successful aspiration was achieved in 80% of cases. No complications were reported (range follow-up 1-16 months). CONCLUSIONS: Our small case series demonstrates the feasibility and safety of the AngioVac system in left-sided mass extraction. Larger trials are needed to further demonstrate its effectiveness and safety and potentially apply for on-label use.

Preclosure of large bore venous access sites in patients undergoing transcatheter mitral replacement and repair.

OBJECTIVE: 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). BACKGROUND: Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited. METHODS: 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. RESULTS: 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 and >2 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. CONCLUSION: 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.

Sex differences in outcomes of transcatheter edge-to-edge repair with MitraClip: A meta-analysis.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

The impact of pulmonary hypertension on outcomes of transcatheter mitral valve replacement in mitral annular calcification.

OBJECTIVES: To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR). BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Transcatheter Mitral Valve Replacement in Failed Bioprosthetic Surgical Valves and Surgical Annuloplasty Rings.

PURPOSE OF REVIEW: Repeat surgery for failed mitral valve prostheses and repairs are fraught with high rates of morbidity and mortality. Therefore, clinicians have evolved transcatheter technology as an alternative therapy. This review serves as an update as the field has moved out of the early learning curve of treating postsurgical mitral valve failures. RECENT FINDINGS: Mitral valve-in-valve procedures have higher rates of technical success and better in-hospital and 1-year mortality rates than mitral valve-in-ring cases. The higher rates of complications, including left ventricular outflow tract obstruction, paravalvular leak, valve embolization, and need for a 2nd valve, may explain these outcomes. Mitral valve-in-ring procedures have attenuated outcomes as compared to valve-in-valve. Clinicians should be cognizant of the nuanced complexities and the potential for suboptimal outcomes in using balloon-expandable valves for mitral valve-in-ring procedures.

Pacemaker following transcatheter aortic valve replacement and tricuspid regurgitation: A single-center experience.

BACKGROUND: As transcatheter aortic valve replacement (TAVR) procedures increase, more data is available on the development of conduction abnormalities requiring permanent pacemaker (PPM) implantation post-TAVR. Mechanistically, new pacemaker implantation and incidence of associated tricuspid regurgitation (TR) post-TAVR is not well understood. Studies have evaluated the predictability of patient anatomy towards risk for needing permanent pacemaker (PPM) post-TAVR; however, little has been reported on new PPM and TR in patients post-TAVR. METHODS: This retrospective study identified patients at our health system who underwent PPM following TAVR from January 2014 to June 2018. Data from both TAVR and PPM procedures as well as patient demographics were collected. Echocardiographic data before TAVR, between TAVR and PPM placement, and the most recent echocardiogram at the time of chart review were analyzed. RESULTS: Of 796 patients who underwent TAVR between January 2014 and June 2018, 89 patients (11%) subsequently required PPM. Out of the 89 patients who required PPM implantation, 82 patients had pre-TAVR and 2-year post-TAVR echocardiographic imaging data. At baseline, 22% (18/82) of patients had at least moderate TR. At 2-year post-TAVR echocardiographic imaging follow-up; 27% (22/82) of patients had at least moderate TR. Subgroup analysis was performed according to the TAVR valve size implanted. In patients who received a TAVR device < 29 mm in diameter in size, 25% (11/44) had worsening TR. In patients who received a TAVR device ≥ 29 mm in diameter, 37% (14/38) had worsening TR. CONCLUSION: We have demonstrated a patient population that may be predisposed to developing worsening TR and right heart function after TAVR and Pacemaker implantation.

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

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

Real world outcomes using 20 mm balloon expandable SAPIEN 3/ultra valves compared to larger valves (23, 26, and 29 mm)-a propensity matched analysis.

OBJECTIVE/BACKGROUND: Small balloon expandable valves have higher echocardiographic transvalvular gradients and rates of prosthesis-patient mismatch (PPM) compared to larger valves. However, the impact of these echocardiographic findings on clinical outcomes is unknown. We sought to determine the clinical outcomes of 20 mm SAPIEN 3 (S3 BEV) compared to larger S3 BEV in relation to echocardiographic hemodynamics. METHODS: Using the STS/ACC transcatheter valve registry, we performed a propensity-matched comparison of patients undergoing treatment of native aortic valve stenosis using transfemoral, balloon-expandable implantation of 20 mm and ≥ 23 mm S3 BEVs. Baseline and procedure characteristics, echocardiographic variables and survival were analyzed. Multivariable logistic regression was used to identify predictors of 1-year mortality. RESULTS: After propensity matching of the 20 mm and ≥ 23 mm SAPIEN 3 valves, 3,931 pairs with comparable baseline characteristics were identified. Small valves were associated with significantly higher echocardiographic gradients at discharge (15.7 ± 7.1 mmHg vs. 11.7 ± 5.5 mmHg, p < 0.0001) and severe PPM rates (21.5% vs. 9.7%, p < 0.0001). There was no significant difference in 1-year all-cause mortality (20 mm: 13.0% vs. ≥23 mm: 12.7%, p = 0.72) or other major adverse event rates and outcomes between the two cohorts. Based on a multivariable analysis, elevated discharge mean gradient (>20 mmHg), severe PPM and the use of 20 mm versus ≥23 mm were not independent predictors of 1-year mortality. CONCLUSION: SAPIEN 3 20 mm valves were associated with higher echocardiographic gradients, and severe PPM rates compared to larger valves but these factors were not associated with significant differences in 1-year all-cause mortality or rehospitalization.

First-in-human transcatheter pledget-assisted suture tricuspid annuloplasty for severe tricuspid insufficiency.

OBJECTIVES: We report the first pledget-assisted suture tricuspid annuloplasty (PASTA) in a patient with torrential tricuspid regurgitation (TR). BACKGROUND: Tricuspid valve regurgitation is a common malignant disease with no commercially available transcatheter therapy. PASTA is a "percutaneous surgical" procedure using pledgeted sutures to create a double-orifice tricuspid valve. METHODS: An 83-year-old man had end-stage TR caused by a defibrillator lead. He consented to undergo PASTA on a compassionate basis. A double-orifice valve was created with pledgeted sutures from percutaneous right ventricular apical access. RESULTS: TR was reduced from torrential to trace. The vena contracta reduced to from 23 to 1 mm and annular area reduced from 1817 to 782 mm2 . However, the annulus dehisced and required closure with a percutaneous nitinol plug. The patient was discharged home and was alive 6 months later but with persistent symptoms. CONCLUSIONS: The anatomy of a double-orifice valve can eliminate TR but a better solution is required to avoid excessive suture tension on annular tissue.

Incidence of acquired ventricular septal defect after transcatheter aortic valve replacement: A large single center experience.

OBJECTIVE: To determine the rate and clinical outcomes of post-TAVR VSD. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a safe and established procedure for patients with severe symptomatic aortic stenosis. Ventricular septal defect (VSD) is a rare complication of TAVR. The rate of post-TAVR VSD and patient outcomes are not well known. METHODS: A retrospective record review of VSD cases occurring after all TAVRs performed between January 2012 and September 2020 at one urban US tertiary hospital. VSD rate and early- and long-term outcomes were analyzed. Computed tomography images taken before TAVR and transthoracic echocardiograms done before and after each procedure were analyzed. RESULTS: Of the 1908 patients who underwent TAVR in the study period, 7 patients (0.37%) had post-procedure VSD. The average patient age was 77 ± 11 years with average society of thoracic surgeons short-term risk score of 6%. All 7 implanted valves were balloon-expandable. Of the 7 TAVR procedures, 5 were performed on a native tricuspid valve, 1 was performed on a native bicuspid valve, and 1 was done as a "valve-in-valve" procedure on a prior surgical bioprosthetic valve. All VSDs were small and restrictive in nature. Right heart failure in a patient with preexisting right ventricular dysfunction occurred in 1 (13%) patient who died. The remaining 6 patients (86%) were discharged. All 6 patients (86%) were alive and stable at 1 year follow-up, reporting improvement in symptoms (NYHA class I-II), with no evidence of right ventricular dysfunction. CONCLUSION: VSD is a rare complication of TAVR. Hemodynamic and clinical sequelae in majority of the patients in this study did not result in mortality. Proper imaging techniques and appropriate pre-procedure planning are needed to decrease the incidence of VSD formation post-TAVR.

Short- and mid-term outcomes in percutaneous mitral valve replacement using balloon expandable valves.

BACKGROUND: Due to elevated surgical risk, transcatheter mitral valve replacement (TMVR) is used as an alternative for treating failed bioprosthetic valves, annuloplasty repairs and mitral annular calcification (MAC). We report the procedural and longitudinal outcomes for each subtype: Mitral valve-in-valve (MVIV), mitral valve-in-ring (MViR), and valve-in-MAC (ViMAC). METHODS: Consecutive patients undergoing TMVR from October 2013 to December 2019 were assessed. Patients at high risk for left ventricular outflow tract obstruction had either alcohol septal ablation or intentional laceration of the anterior leaflet (LAMPOON). RESULTS: Eight-eight patients underwent TMVR; 38 MViV, 31 MViR, and 19 ViMAC procedures were performed. The median Society of Thoracic Surgery 30-day predicted risk of mortality was 8.2% (IQR 5.2, 19.9) for all. Sapien 3 (78%) and transseptal access (98%) were utilized in most cases. All-cause in-hospital mortality, technical, and procedural success were 8%, 83%, and 66% respectively. Median follow up was 1.4 years (IQR 0.5-2.9 years) and overall survival was 40% at 4 years. Differential survival rates were observed with MViV doing the best, followed by MViR and ViMAC having a <20% survival at 4 years. After adjusting for co-variates, MViV procedure was the strongest predictor of survival (HR 0.24 [95% CI 0.079-0.7]). CONCLUSION: TMVR is performed in at high-risk patients with attenuated long-term survival. MViV has the best success and survival rate, but long-term survival in MViR and ViMAC is guarded.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 think tank.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

Complete percutaneous apical access and closure: Short and intermediate term outcomes.

OBJECTIVES: To examine the safety of utilizing transapical access during structural interventions. BACKGROUND: Complex interventions of the mitral or aortic region sometimes require coaxial forces to orient and deliver devices. Apical access can provide coaxial countertraction for either transseptal or retrograde aortic access. This manuscript describes the single center experience of small bore transapical access. METHODS: Retrospective review of cases from 2013 to 2018 at Henry Ford Hospital was performed. Patient demographics and procedure characteristics were abstracted to describe the safety of transapical access using small bore sheaths. RESULTS: A total 21 cases were performed at Henry Ford, most of them for transcatheter mitral valve replacement (81%). The mean sheath size used was 4.7 ± 0.9 Fr and protamine was used at the end of 57% of cases. All patients received nitinol-based plugs, 80.1% were from the Amplatz Duct Occluder II type. Four major complications related apical puncture occurred, two pericardial effusions, two hemothorax. Over a median follow time of 430 days (IQR 50-652) a total of five deaths occurred, two related to the procedure and three late deaths with a median time of 362 days (range 205-628 days). No deaths were associated with transapical access. Echocardiographic follow up did not detect any late structural complications from occluder devices. CONCLUSIONS: Transapical access and closure with nitinol-based devices is feasible and facilitates complex interventions where coaxial forces are need for device delivery and alignment. The most common complication is bleeding and this should be kept in perspective when treating high-risk patients.

Increased Risk of Perioperative Ischemic Stroke in Patients Who Undergo Noncardiac Surgery with Preexisting Atrial Septal Defect or Patent Foramen Ovale.

OBJECTIVES: To evaluate whether a preoperative diagnosis of atrial septal defect (ASD) or patent foramen ovale (PFO) is associated with perioperative stroke in noncardiac surgery and their outcomes. DESIGN: Retrospective cohort analysis. SETTING: United States hospitals. PARTICIPANTS: Adults patients (≥18 years old) who underwent major noncardiac surgery from 2010 to 2015 were identified using the Healthcare Cost and Utilization Project's National Readmission Database. INTERVENTIONS: Preoperative diagnosis of ASD or patent foramen ovale. MEASUREMENTS AND MAIN RESULTS: Among the 19,659,161 hospitalizations for major noncardiac surgery analyzed, 12,248 (0.06%) had a preoperative diagnosis of ASD/PFO. Perioperative ischemic stroke occurred in 723 (5.9%) of patients with ASD/PFO and 373,291 (0.02%) of those without ASD/PFO (adjusted odds ratio [aOR], 16.7; 95% confidence interval [CI]: 13.9-20.0). Amongst the different types of noncardiac surgeries, obstetric, endocrine, and skin and burn surgery were associated with higher risk of stroke in patients with pre-existing ASD/PFO. Moreover, patients with ASD/PFO also had an increased in-hospital mortality (aOR, 4.6, 95% CI: 3.6-6.0), 30-day readmission (aOR, 1.2, 95% CI: 1.04-1.38), and 30-day stroke (aOR, 7.2, 95% CI: 3.1-16.6). After adjusting for atrial fibrillation, ischemic stroke remained significantly high in the ASD/PFO group (aOR: 23.7, 95%CI 19.4-28.9), as well as in-hospital mortality (aOR: 5.6, 95% CI 4.1-7.7), 30-day readmission (aOR: 1.19, 95%CI 1.0-1.4), and 30-day stroke (aOR: 9.3, 95% CI 3.7-23.6). CONCLUSIONS: Among adult patients undergoing major noncardiac surgery, pre-existing ASD/PFO is associated with increased risk of perioperative ischemic stroke, in-hospital mortality, 30-day stroke, and 30-day readmission after surgery.

Association of peripheral artery disease with in-hospital outcomes after endovascular transcatheter aortic valve replacement.

OBJECTIVES: The aim of this study was to determine the prevalence of peripheral artery disease (PAD) and its association with in-hospital outcomes after endovascular transcatheter aortic valve replacement (EV-TAVR). BACKGROUND: TAVR is an established treatment for patients at prohibitive, high, or intermediate surgical risk. PAD is a significant comorbidity in the determination of surgical risk. However, data on association of PAD with outcomes after EV-TAVR are limited. METHODS: Patients in the National Inpatient Sample who underwent EV-TAVR between January 1, 2012 and September 30, 2015 were evaluated. The primary outcome was in-hospital mortality. RESULTS: A total of 51,685 patients underwent EV-TAVR during the study period. Of these, 12,740 (24.6%) had a coexisting diagnosis of PAD. The adjusted odds for in-hospital mortality [OR 1.08 (95% CI 0.83-1.41)], permanent pacemaker implantation [OR 0.98 (0.85-1.14)], conversion to open aortic valve replacement [OR 1.05 (0.49-2.26)], or acute myocardial infarction [OR 1.31(0.99-1.71)] were not different in patients with versus without PAD. However, patients with PAD had greater adjusted odds of vascular complications [OR 1.80 (1.50-2.16)], major bleeding [OR 1.20 (1.09-1.34)], acute kidney injury (AKI) [OR 1.19 (1.05-1.36)], cardiac complications [aOR 1.21 (1.01-1.44)], and stroke [OR 1.39(1.10-1.75)] compared with patients without PAD. Length of stay (LOS) was significantly longer for patients with PAD [7.23 (0.14) days vs. 7.11 (0.1) days, p < 0.001]. CONCLUSION: Of patients undergoing EV-TAVR, ~25% have coexisting PAD. PAD was not associated with increased risk of in-hospital mortality but was associated with higher risk of vascular complications, major bleeding, AKI, stroke, cardiac complications, and longer LOS.

Transcaval Access for Large Bore Devices.

PURPOSE OF REVIEW: Examine the latest data and techniques regarding transcaval access and closure. RECENT FINDINGS: Transcaval access was proven to be a feasible and a translatable skill in a 100 patient open-label prospective study. No late complications from fistulas occurred and of all patients alive at 1 year, one fistula remained open. Transcaval is a viable access route for large bore devices. With adequate planning, bleeding and vascular complications are minimal. It should be integrated into the rubric of transcatheter large bore access.

Watchman in ascending aorta for systemic protection (WAASP): Novel use of Watchman in ascending aorta for embolic protection-first in man.

We report two cases where left atrial appendage closure (LAA) with Watchman was successfully performed despite presence of definite LAA thrombus. Because there was the risk of thrombus dislodgement, we transiently placed an additional Watchman device in the ascending aorta for embolic protection. © 2017 Wiley Periodicals, Inc.

Guidewire electrosurgery-assisted trans-septal puncture.

OBJECTIVES: Electrifying a coronary guidewire may be a simple escalation strategy when trans-septal needle puncture is unsuccessful. BACKGROUND: Radiofrequency energy to facilitate trans-septal puncture through a dedicated device is costly and directly through a trans-septal needle may be less safe. Our technique overcomes these limitations. METHODS: The technique was used in patients when trans-septal needle penetration failed despite excessive force or tenting of the atrial septum. A coronary guidewire, connected to an electrosurgery pencil, was advanced through the trans-septal needle, dilator, and sheath to perforate the interatrial septum during a short burst of radiofrequency energy. With the guidewire tip no longer "active," the dilator and sheath were advanced safely over the wire into the left atrium. In posthoc validation, radiofrequency assisted Brockenbrough needle and coronary guidewire punctures were made in freshly explanted pig hearts and compared under microscopy. RESULTS: Eight patients who required trans-septal access for structural intervention were escalated to a guidewire electrosurgery strategy. Six patients had thickened fibrotic septum and two had prior surgical patch repair. Crossing was successful in all patients with no procedure related complications. The size of punctures (1.11 ± 0.40 mm vs 0.37 ± 0.08 mm, P = .009) and blanched penumbra (3.62 ± 1.23 mm vs 0.72 ± 0.29 mm, P = .003) in pig atrial septum were larger with an electrified needle than electrified guidewire. The hole generated by the electrified guidewire was smaller than by the nonelectrified needle. CONCLUSIONS: When conventional trans-septal puncture fails, a coronary guidewire can be used to deliver brief radiofrequency energy safely and effectively. This technique is inexpensive and accessible to operators.