Objectives The purpose of this study was to investigate the 5-year outcome following transcatheter aortic valve implantation (TAVI). Background Little is known about long-term outcomes following ...TAVI. Methods The 5-year outcomes following successful TAVI with a balloon-expandable valve were evaluated in 88 patients. Patients who died within 30 days after TAVI were excluded. Results Mean aortic valve gradient decreased from 46 ± 18 mm Hg to 10 ± 4.5 mm Hg after TAVI and 11.8 ± 5.7 mm Hg at 5 years (p for post-TAVI trend = 0.06). Mean aortic valve area increased from 0.62 ± 0.17 cm2 to 1.67 ± 0.41 cm2 after TAVI and 1.40 ± 0.25 cm2 at 5 years (p for post-TAVI trend <0.01). At 5 years, 3 patients (3.4%) had moderate prosthetic valve dysfunction (moderate transvalvular regurgitation in 1, moderate stenosis in 1, and moderate mixed disease in 1). Survival rates at 1 to 5 years were 83%, 74%, 53%, 42%, and 35%, respectively. Median survival time after TAVI was 3.4 years (95% confidence interval CI: 2.6 to 4.3), and the risk of death was significantly increased in patients with chronic obstructive pulmonary disease (adjusted hazard ratio HR: 2.17; 95% CI: 1.28 to 3.70) and at least moderate paravalvular regurgitation (adjusted HR: 2.98; 95% CI: 1.44 to 6.17). Conclusions Our study demonstrated favorable long-term outcomes after TAVI. Signs of moderate prosthetic valve failure were observed in 3.4% of patients. No patients developed severe prosthetic regurgitation or stenosis. Comorbidities, notably chronic lung disease and at least moderate paravalvular regurgitation, were associated with reduced long-term survival.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
The aim of this paper is to report insights from the first 100 consecutive cardiovascular procedures with MANTA closure.
The collagen-based MANTA vascular closure device (Teleflex, Wayne, ...Pennsylvania) has recently been approved for the closure of large-bore femoral access.
Procedural and access site–related complications were analyzed according to Valve Academic Research Consortium–2 criteria. Duration of bleeding after device closure was recorded.
Patients underwent transcatheter aortic valve replacement (n = 75), endovascular aortic replacement (n = 21), or Impella left ventricular support (n = 4). In these 100 patients, a total of 122 MANTA devices were used (22 patients had bilateral large-bore access). None of the patients received protamine. Immediate hemostasis was achieved in 70 patients and hemostasis within 5 min in 87 patients. There were 7 patients with major and 4 patients with minor MANTA-associated vascular complications: femoral artery occlusion in 2, ongoing bleeding in 5, and pseudoaneurysm formation in 4 patients. One patient was treated with covered stent implantation, 7 required surgical revision, and 4 received thrombin injection. Complications occurred significantly more often in patients with peripheral artery disease and a minimal artery diameter <6 mm. Careful review of these complications suggests 3 distinct failure mechanisms. In vessels with narrow femoral artery diameters, elevation of the toggle may lead to occlusion of the artery, incomplete apposition of the plug may lead to perivascular (potentially retroperitoneal) bleeding, or pseudoaneurysm formation may occur.
In this paper, MANTA-associated complications are addressed, 3 distinct failure mechanisms are suggested, and strategies to avoid these complications and improve procedural outcomes are discussed.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
When bioprosthetic cardiac valves fail, reoperative valve replacement carries a higher risk of morbidity and mortality compared with initial valve replacement. Transcatheter heart valve implantation ...may be a viable alternative to surgical aortic valve replacement for high-risk patients with native aortic stenosis, and valve-in-valve (V-in-V) implantation has been successfully performed for failed surgical bioprostheses in the aortic, mitral, pulmonic, and tricuspid positions. Despite some core similarities to transcatheter therapy of native valve disease, V-in-V therapy poses unique clinical and anatomic challenges. In this paper, we review the challenges, selection criteria, techniques, and outcomes of V-in-V implantation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Percutaneous Aortic Valve Replacement Toggweiler, Stefan, MD; Gurvitch, Ronen, MBBS; Leipsic, Jonathon, MD ...
Journal of the American College of Cardiology,
01/2012, Volume:
59, Issue:
2
Journal Article
Peer reviewed
Open access
Objectives The aim of this study was to evaluate vascular complications in a consecutive patient population undergoing transfemoral percutaneous aortic valve replacement (PAVR) applying current Valve ...Academic Research Consortium definitions. Background Vascular complications have been the major cause of mortality and morbidity associated with PAVR. Both open surgical and fully percutaneous access site strategies have been advocated. Methods All patients undergoing transfemoral PAVR during fiscal years 2009 and 2010 were prospectively evaluated at baseline, after the procedure, and at 30 days. Results PAVR was performed in 137 consecutive patients. All but 1 patient underwent planned arteriotomy closure using a percutaneous pre-closure technique. Smaller sheaths, rigorous angiographic and computed tomographic screening and patient selection, and percutaneous vascular repair techniques were increasingly used over this period. From 2009 to 2010, major vascular complications decreased from 8% to 1% (p = 0.06), minor vascular complications decreased from 24% to 8% (p < 0.01), major bleeds fell from 14% to 1% (p < 0.01), and unplanned surgery decreased from 28% to 2% (p < 0.01). A minimal artery diameter smaller than the external sheath diameter, moderate or severe calcification, and peripheral vascular disease were associated with higher vascular complication rates. Conclusions Vascular complications occur more often if the minimal artery diameter is smaller than the external sheath diameter, in the presence of moderate or severe calcification, and in patients with peripheral vascular disease. With careful patient selection, advanced interventional techniques, and a fully percutaneous procedure, marked reductions in vascular and bleeding complications can be achieved.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives The aim of this study was to examine sex differences in outcome after transcatheter aortic valve replacement (TAVR) with real-world data from 2 large centers in Canada. Background ...Transcatheter aortic valve replacement is an effective alternative to surgical valve replacement in symptomatic patients with severe aortic stenosis, but the impact of sex on outcomes remains unclear. The PARTNER (Placement of Aortic Transcatheter Valves) 1A trial demonstrated greater benefit of TAVR over surgery in women, but whether this was due to the poorer surgical outcome of women or better TAVR outcome, compared with men, is unknown. Methods Consecutive patients (n = 641) undergoing TAVR in Vancouver and Quebec City, Canada, were evaluated. Differences in all-cause mortality were examined with Kaplan-Meier estimates, adjusted logistic regression, and proportional hazards models. Results Women comprised 51.3% of the cohort. Balloon-expandable valves were used in 97% of cases, with transapical approach in 51.7 % women and 38.1% men. Women had more major vascular complications (12.4% vs. 5.4%, p = 0.003) and borderline significantly more major/life-threatening bleeds (21.6% vs. 15.8%, p = 0.08). At baseline, women had higher aortic gradients and worse renal function but better ejection fractions. Men had more comorbidities: prior myocardial infarction, prior revascularization, and chronic obstructive pulmonary disease. The adjusted odds ratio for 30-day all-cause mortality favored women, 0.39 (95% confidence interval: 0.19 to 0.80; p = 0.01), and this benefit persisted for 2 years, hazard ratio 0.60 (95% confidence interval: 0.41 to 0.88; p = 0.008). Conclusions Female sex is associated with better short- and long-term survival after TAVR. Added to the PARTNER 1A findings, these results suggest TAVR might be the preferred treatment option for elderly women with symptomatic severe aortic stenosis.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
The objective of this study was to evaluate the timing, predictive factors, and prognostic value of cerebrovascular events (CVEs) after transcatheter aortic valve implantation.
The study included ...1061 consecutive patients who underwent transcatheter aortic valve implantation with a balloon-expandable (64%) or self-expandable (36%) valve. CVEs were classified as acute (≤24 hours), subacute (1-30 days), or late (>30 days). CVEs occurred in 54 patients (5.1%; stroke, 4.2%) within 30 days after transcatheter aortic valve implantation (acute in 54% of cases). The predictors of acute CVEs were balloon postdilation of the valve prosthesis (odds ratio, 2.46; 95% confidence interval,1.07-5.67) and valve dislodgment/embolization (odds ratio, 4.36; 95% CI, 1.21-15.69); new-onset atrial fibrillation (odds ratio, 2.76; 95% CI, 1.11-6.83) was a predictor of subacute CVEs. Late CVEs occurred in 35 patients (3.3%; stroke, 2.1%) at a median follow-up of 12 months (3-23 months). The predictors of late CVEs were chronic atrial fibrillation (2.84; 95% CI, 1.46-5.53), peripheral vascular disease (hazard ratio, 2.02; 95% CI, 1.02-3.97), and prior cerebrovascular disease (hazard ratio, 2.04; 95% CI, 1.01-4.15). Major stroke was associated with 30-day (odds ratio, 7.43; 95% CI, 2.45-22.53) and late (hazard ratio, 1.75; 95% CI, 1.01-3.04) mortality.
In a large cohort of patients undergoing transcatheter aortic valve implantation, the rates of acute and subacute CVEs were 2.7% and 2.4%, respectively. While balloon postdilation and valve dislodgment/embolization were the predictors of acute CVEs, new-onset atrial fibrillation determined a higher risk for subacute events. Late events were determined mainly by a history of chronic atrial fibrillation and peripheral and cerebrovascular disease. The occurrence of major stroke was associated with increased early and late mortality. These results provide important insights for the implementation of preventive measures for CVEs after transcatheter aortic valve implantation.
Objectives This report sought to study the impact of the balloon-expandable SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve (THV) stent frame geometry and position on ...outcomes of transcatheter aortic valve replacement (TAVR). Background Post-implant THV geometry and position might impact atrioventricular conduction, hemodynamic performance, and annular sealing. Methods Eighty-nine consecutive patients who underwent TAVR with a Sapien XT THV had pre- and post-implant multidetector computed tomography, transthoracic echocardiography, and electrocardiograms performed to assess THV stent geometry, atrioventricular conduction, and hemodynamic performance. Results The THV Circularity (THV eccentricity <10% eccentricity = minimum stent diameter/maximum stent diameter) and under-expansion (THV area/nominal THV area <90%) were present in 97.8% (2 of 89) and 0%, respectively. Low THV implantation was associated with new left bundle branch block and complete heart block (3.4 ± 2.0 mm vs. 5.5 ± 2.9 mm, p = 0.01) and with the need for permanent pacemaker implantation (3.5 ± 2.0 mm vs. 7.1 ± 2.5 mm, p = 0.001). In contrast, labeled THV size and THV area oversizing was not associated with atrioventricular conduction disturbances. The relation between inflow stent frame area and annular area was related to paravalvular regurgitation (p = 0.025). Labeled prosthesis size but not prosthesis expansion or eccentricity was related to valve gradient (p = 0.005) and effective orifice area (p < 0.001). Conclusions Low implantation depth of balloon-expandable THVs is associated with clinically significant new conduction disturbances and permanent pacemaker implantation. Importantly, annular area oversizing was not associated with these complications.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
The hypothesis of this study was that local anesthesia with monitored anesthesia care (MAC) is not harmful in comparison to general anesthesia (GA) for patients undergoing Transcatheter Aortic Valve ...Implantation (TAVR).TAVR is a rapidly spreading treatment option for severe aortic valve stenosis. Traditionally, in most centers, this procedure is done under GA, but more recently procedures with MAC have been reported.
This is a systematic review and meta-analysis comparing MAC versus GA in patients undergoing transfemoral TAVR. Trials were identified through a literature search covering publications from 1 January 2005 through 31 January 2013. The main outcomes of interest of this literature meta-analysis were 30-day overall mortality, cardiac-/procedure-related mortality, stroke, myocardial infarction, sepsis, acute kidney injury, procedure time and duration of hospital stay. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.
Seven observational studies and a total of 1,542 patients were included in this analysis. None of the studies were randomized. Compared to GA, MAC was associated with a shorter hospital stay (-3.0 days (-5.0 to -1.0); P = 0.004) and a shorter procedure time (MD -36.3 minutes (-58.0 to -15.0 minutes); P <0.001). Overall 30-day mortality was not significantly different between MAC and GA (RR 0.77 (0.38 to 1.56); P = 0.460), also cardiac- and procedure-related mortality was similar between both groups (RR 0.90 (0.34 to 2.39); P = 0.830).
These data did not show a significant difference in short-term outcomes for MAC or GA in TAVR. MAC may be associated with reduced procedural time and shorter hospital stay. Now randomized trials are needed for further evaluation of MAC in the setting of TAVR.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract Objectives The study sought to identify predictors for delayed high-degree atrioventricular block (AVB) in patients undergoing transcatheter aortic valve replacement (TAVR) and determine the ...need and required duration of telemetry monitoring. Background Little is known about predictors and timing of high-degree AVB. Methods A total of 1,064 patients (52% women) without a permanent pacemaker undergoing TAVR at 3 centers in Switzerland were investigated. Electrocardiograms (ECGs) at baseline and post-TAVR were analyzed to identify atrioventricular and interventricular conduction disorders. Results Periprocedural high-degree AVB occurred in 92 (8.7%), delayed high-degree AVB in 71 (6.7%), up to 8 days post-procedure. In multivariate analysis, delayed high-degree AVB occurred more frequently in men (odds ratio: 2.4, 95% confidence interval: 1.3 to 4.5; p < 0.01), and in patients with conduction disorders post-TAVR (odds ratio: 10.8; 95% confidence interval: 4.6 to 25.5; p < 0.01). Patients in sinus rhythm without conduction disorders post-TAVR did not develop delayed high-degree AVB (0 of 250, 0%). Similarly, the risk in patients with atrial fibrillation but no other conduction disorders was very low (1 of 102, 1%). There was no patient developing delayed high-degree AVB who had a stable ECG for 2 days or more. Conclusion Patients without conduction disorders post-TAVR did not develop delayed high-degree AVB. Such patients may not require telemetry monitoring. All other patients should be monitored until the ECG remains stable for at least 2 days. This algorithm should be validated in a separate patient population.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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