Three-Dimensional Echocardiography Compared With Computed Tomography to Determine Mitral Annulus Size Before Transcatheter Mitral Valve Implantation.

BACKGROUND: Previously, through the use of computed tomography (CT), it has been proposed that D-shaped versus saddle-shaped mitral annulus (MA) segmentation is more biomechanically appropriate to determine transcatheter mitral valve implantation size and eligibility. METHODS AND RESULTS: Forty-one patients with severe mitral regurgitation being considered for transcatheter mitral valve implantation who had undergone cardiac CT and 3-dimensional transesophageal echocardiography (3D-TEE) were retrospectively evaluated. A standardized segmentation protocol for the D-shaped MA was developed using Philips Q-Laboratory mitral valve quantification software. MA dimensions were compared using Spearman's rank correlation and Bland-Altman analysis. Inter- and intraobserver agreement was quantified by intraclass correlation coefficient and Bland-Altman analysis. Mean age was 77±14 years; 71% male (n=29); mitral regurgitation pathogenesis was functional in 54% (n=22) and myxomatous in 46% (n=19). Mean MA area and circumference by 3D-TEE and CT were 11.3±2.7 versus 11.4±3.0 (P=0.67) and 124.1±15.6 versus 123.9±15.5 (P=0.79), respectively, with excellent correlation between modalities (r=0.84 and r=0.86; P<0.0001) and no systematic bias (-0.20±1.8 cm(2) [-3.7 cm(2); 3.3 cm(2)], 0.37±9 mm [-18.0 mm; 17.27 mm]). Mean septal-to-lateral and inter-trigone distances by 3D-TEE and CT were 33.2±4.7 versus 32.5±4.4 (P=0.24) and 31.7±3.5 versus 32.6±3.6 (P=0.06), respectively, with good correlation (r=0.69 and r=0.71; P<0.0001) and no systematic bias (0.77±3.8 mm [-6.7 mm; 8.2 mm], -1.5±3.1 mm [-4.6 mm; 7.6 mm]). There was excellent intra- and interobserver agreement according to intraclass correlation coefficients >0.90 for all parameters. CONCLUSIONS: Similar to cardiac CT, 3D-TEE allows for D-shaped MA segmentation with no systematic difference in MA dimensions between modalities. This study supports the utilization of 3D-TEE as a complementary tool to CT assessment of the D-shaped MA to determine transcatheter mitral valve implantation size.

Transcatheter Aortic and Mitral Valve-in-Valve Implantation for Failed Surgical Bioprosthetic Valves: An 8-Year Single-Center Experience.

OBJECTIVES: We report our 8-year experience in transcatheter aortic and mitral valve-in-valve (VinV) implantation. BACKGROUND: Feasibility and good early outcomes associated with transcatheter aortic and mitral VinV implantation into failed surgical bioprostheses have been confirmed, but the mid-term and long-term outcomes of transcatheter aortic and mitral VinV is unknown. METHODS: A total of 73 patients with aortic (n = 42) and mitral (n = 31) bioprosthetic valve dysfunction underwent transcatheter VinV implantation between April 2007 and December 2013. Edwards balloon-expandable transcatheter valves (Edwards Lifesciences Inc., Irvine, California) were used. Median follow-up was 2.52 years with a maximum of 8 years. RESULTS: Seventy-two patients (mean age 79.7 ± 9.4 years, 32 women) underwent successful VinV implantation (success rate 98.6%). At 30 days, all-cause mortality was 1.4%, disabling stroke 1.4%, life-threatening bleeding 4.1%, acute kidney injury requiring hemodialysis 2.7%, and coronary artery obstruction requiring intervention 1.4%. No patient had greater than mild paravalvular leak. Estimated survival rates were 88.9%, 79.5%, 69.8%, 61.9%, and 40.5% at 1, 2, 3, 4, and 5 years, respectively. The small surgical valve size (19 and 21 mm) was an independent risk factor for reduced survival in aortic VinV patients. At 2-year follow-up, 82.8% of aortic and 100% of mitral VinV patients were in New York Heart Association functional class I or II. CONCLUSIONS: Transcatheter VinV for failed surgical bioprostheses can be performed safely with a high success rate and minimal early mortality and morbidity. Transcatheter VinV provides encouraging mid-term clinical outcomes in this high-risk elderly cohort of patients. Transcatheter VinV is an acceptable alternative therapy for failed aortic or mitral bioprostheses in selected high-risk patients.

A simplified D-shaped model of the mitral annulus to facilitate CT-based sizing before transcatheter mitral valve implantation.

BACKGROUND: The nonplanar, saddle-shaped structure of the mitral annulus has been well established through decades of anatomic and echocardiographic study. Its relevance for mitral annular assessment for transcatheter mitral valve implantation is uncertain. OBJECTIVE: Our objectives are to define the methodology for CT-based simplified "D-shaped" mitral annular assessment for transcatheter mitral valve implantation and compare these measurements to traditional "saddle-shaped" mitral annular assessment. METHODS: The annular contour was manually segmented, and fibrous trigones were identified using electrocardiogram-gated diastolic CT data sets of 28 patients with severe functional mitral regurgitation, yielding annular perimeter, projected area, trigone-to-trigone (TT) distance, and septal-lateral distance. In contrast to the traditional saddle-shaped annulus, the D-shaped annulus was defined as being limited anteriorly by the TT distance, excluding the aortomitral continuity. Hypothetical left ventricular outflow tract (LVOT) clearance was assessed. RESULTS: Projected area, perimeter, and septal-lateral distance were found to be significantly smaller for the D-shaped annulus (11.2 ± 2.7 vs 13.0 ± 3.0 cm(2); 124.1 ± 15.1 vs 136.0 ± 15.5 mm; and 32.1 ± 4.0 vs 40.1 ± 4.9 mm, respectively; P < .001). TT distances were identical (32.7 ± 4.1 mm). Hypothetical LVOT clearance was significantly lower for the saddle-shaped annulus than for the D-shaped annulus (10.7 ± 2.2 vs 17.5 ± 3.0 mm; P < .001). CONCLUSION: By truncating the anterior horn of the saddle-shaped annular contour at the TT distance, the resulting more planar and smaller D-shaped annulus projects less onto the LVOT, yielding a significantly larger hypothetical LVOT clearance than the saddle-shaped approach. CT-based mitral annular assessment may aid preprocedural sizing, ensuring appropriate patient and device selection.

Multidetector CT predictors of prosthesis-patient mismatch in transcatheter aortic valve replacement.

BACKGROUND: Prosthesis-patient mismatch (PPM) is a predictor of mortality after aortic valve replacement (AVR). OBJECTIVE: We examined whether accurate 3-dimensional annular sizing with multidetector CT (MDCT) is predictive of PPM after transcatheter AVR (TAVR). METHODS: One hundred twenty-eight patients underwent MDCT then TAVR. Moderate PPM was defined as an indexed effective orifice area ≤0.85 cm²/m² and severe ≤0.65 cm²/m². MDCT annular measurements (area, short and long axis) were compared with the size of the selected transcatheter heart valve (THV) to obtain (1) the difference between prosthesis size and CT-measured mean annular diameter and (2) the percentage of undersizing or oversizing (calculated as 100 × [MDCT annular area--THV nominal area]/THV nominal area). In addition, the MDCT annular area was indexed to body surface area. These measures were evaluated as potential PPM predictors. RESULTS: We found that 42.2% of patients had moderate PPM and 9.4% had severe PPM. Procedural characteristics and in-hospital outcomes were similar between patients with or without PPM. THV undersizing of the mean aortic annulus diameter was not predictive of PPM (odds ratio [OR], 0.84; 95% CI, 0.65-1.07; P = .16; area under the receiver-operating characteristic curve [AUC], 0.58). THV undersizing of annular area was not predictive of PPM (OR, 0.96; 95% CI, 0.80-1.16; P = .69; AUC, 0.52). Indexed MDCT annular area was, however, predictive of PPM (OR, 0.24; 95% CI, 0.10-0.59; P < .001; AUC, 0.66). CONCLUSIONS: PPM is frequent after TAVR. Appropriate annular oversizing does not reduce the rate or severity of PPM. Patient annulus size mismatch, identified by indexed MDCT annular area, is a significant predictor of PPM.

Transapical transcatheter aortic valve-in-valve implantation: clinical and hemodynamic outcomes beyond 2 years.

OBJECTIVE: The feasibility of transapical valve-in-valve aortic valve implantation into a failed aortic surgical bioprosthesis has been confirmed. The purpose of the present study was to investigate the clinical and hemodynamic outcomes more than 2 years after transapical valve-in-valve aortic valve implantation. METHODS: From April 2007 to May 2010, 8 consecutive patients underwent transapical valve-in-valve aortic valve implantation of either 23- or 26-mm Edwards-SAPIEN balloon-expandable bioprostheses into failed surgical tissue valves (21- to 25-mm valves). Clinical and echocardiographic follow-up was performed in all patients. The mean follow-up duration was 27.8 ± 15.7 months (range, 18-55 months). RESULTS: Transapical valve-in-valve aortic valve implantation was successful in all patients (mean age, 84.1 ± 1.6 years). The predicted operative mortality was 42.1% ± 15.7% by logistic European System for Cardiac Operative Risk Evaluation and 14.4% ± 9.6% using the Society of Thoracic Surgeons risk calculator. The observed 30-day mortality was 12.5%. No strokes or valve embolization/migrations occurred. The mean hospital stay was 9.0 ± 9.1 days. The New York Heart Association class decreased from preoperative class III-IV to postoperative class I in 6 of 7 survivors. The 2-year survival was 87.5%. No late mortality occurred during the follow-up period. The echocardiographic results at 1 to 4 years of follow-up demonstrated stable valve position and function in all patients. The transaortic valve pressure gradients after valve-in-valve aortic valve implantation were greater than 20 mm Hg and less than 15 mm Hg in patients with 21- or 23-mm and 25-mm surgical valves, respectively. CONCLUSIONS: Transapical valve-in-valve aortic valve implantation provides good clinical outcomes and stable valve function beyond 2 years of follow-up. The best hemodynamic and clinical outcomes can be achieved in the patients with a surgical valve size of 25 mm or greater. Valve-in-valve aortic valve implantation could become a viable approach for selected high-risk patients with failed surgical bioprostheses.

Transcatheter aortic valve replacement: outcomes of patients with moderate or severe mitral regurgitation.

OBJECTIVES: The aim of this study was to evaluate the impact of mitral regurgitation (MR) on outcomes after transcatheter aortic valve replacement (TAVR) and the impact of TAVR on MR. BACKGROUND: Little is known of the influence of MR on outcomes after TAVR. METHODS: The outcomes of patients with mild or less (n = 319), moderate (n = 89), and severe (n = 43) MR were evaluated after TAVR at 2 Canadian centers. RESULTS: Patients with moderate or severe MR had a higher mortality rate than those with mild or less MR during the 30 days after TAVR (adjusted hazard ratio: 2.10; 95% confidence interval: 1.12 to 3.94; p = 0.02). However, the mortality rates after 30 days were similar (adjusted hazard ratio: 0.82; 95% confidence interval: 0.50 to 1.34; p = 0.42). One year after TAVR, moderate MR had improved in 58%, remained moderate in 17%, and worsened to severe in 1%, and 24% of patients had died. Severe MR had improved in 49% and remained severe in 16%, and 35% of patients had died. Multivariate predictors of improved MR at 1 year (vs. unchanged MR, worse MR, or death) were a mean transaortic gradient ≥ 40 mm Hg, functional (as opposed to structural) MR, the absence of pulmonary hypertension, and the absence of atrial fibrillation. CONCLUSIONS: Moderate or severe MR in patients undergoing TAVR is associated with a higher early, but not late, mortality rate. At 1-year follow-up, MR was improved in 55% of patients with moderate or severe MR at baseline. Improvement was more likely in patients with high transaortic gradients, with functional MR, without pulmonary hypertension and without atrial fibrillation.

Expanding arch aneurysm causing a "kink" in a Bentall graft and heart failure.

Marfan syndrome is associated with a high incidence of aortic root aneurysm and life-threatening aortic dissection. With the successful use of surgical aortic root replacement, dissection-related mortality has been significantly reduced. We present the case of a patient with Marfan syndrome who presented with heart failure secondary to an unusual graft-related complication 14 years after a Bentall procedure. Investigations revealed a supra-aortic stenosis resulting from a kink in the Bentall graft caused by pressure from an expanding aortic arch aneurysm. The patient underwent surgery with improvement in his ejection fraction and heart failure symptoms.

Transcatheter aortic valve implantation in aortic stenosis: the role of echocardiography.

Aortic stenosis is becoming an increasing health care problem as the population ages. Surgical aortic valve replacement remains the gold standard but is associated with high mortality and morbidity rates in elderly patients and those with multiple comorbidities. The authors explore transcatheter aortic valve implantation as an attractive alternative therapy in this high-risk population and outline its limitations and future directions, with a special emphasis on the role of echocardiography.

Transatrial transcatheter tricuspid valve-in-valve implantation of balloon expandable bioprosthesis.

Transcatheter valve-in-valve implantation into failing mitral and aortic bioprosthetic valves have been reported. This strategy avoids performing high-risk repeat cardiac surgery in elderly patients with multiple comorbidities. Tricuspid valve-in-valve implantation has not been described. We report a case of failing bioprosthetic tricuspid valve in a 48-year-old woman with carcinoid syndrome. We attempted a transatrial transcatheter approach and we successfully deployed a 26-mm Edwards Sapien balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA) into a severely stenotic tricuspid bioprosthesis. This case demonstrates the technical feasibility and safety of this approach. Therefore, tricuspid valve-in-valve implantation may be a viable treatment alternative in carefully selected patients.

Transcatheter valve-in-valve implantation for failed bioprosthetic heart valves.

BACKGROUND: The majority of prosthetic heart valves currently implanted are tissue valves that can be expected to degenerate with time and eventually fail. Repeat cardiac surgery to replace these valves is associated with significant morbidity and mortality. Transcatheter heart valve implantation within a failed bioprosthesis, a "valve-in-valve" procedure, may offer a less invasive alternative. METHODS AND RESULTS: Valve-in-valve implantations were performed in 24 high-risk patients. Failed valves were aortic (n=10), mitral (n=7), pulmonary (n=6), or tricuspid (n=1) bioprostheses. Implantation was successful with immediate restoration of satisfactory valve function in all but 1 patient. No patient had more than mild regurgitation after implantation. No patients died during the procedure. Thirty-day mortality was 4.2%. Mortality was related primarily to learning-curve issues early in this high-risk experience. At baseline, 88% of patients were in New York Heart Association functional class III or IV; at the last follow-up, 88% of patients were in class I or II. At a median follow-up of 135 days (interquartile range, 46 to 254 days) and a maximum follow-up of 1045 days, 91.7% of patients remained alive with satisfactory valve function. CONCLUSIONS: Transcatheter valve-in-valve implantation is a reproducible option for the management of bioprosthetic valve failure. Aortic, pulmonary, mitral, and tricuspid tissue valves were amenable to this approach. This finding may have important implications with regard to valve replacement in high-risk patients.

Transapical transcatheter aortic valve implantation: follow-up to 3 years.

BACKGROUND: We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients. METHODS: Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 +/- 11.5 months with a total of 917.3 months of follow-up. RESULTS: Mean age was 80.0 +/- 8.1 years and predicted operative mortality was 34.5% +/- 20.4% by logistic EuroSCORE and 12.1% +/- 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% +/- 6.4% and 58.0% +/- 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% +/- 6.4% and 69.8% +/- 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 +/- 0.8 to 1.8 +/- 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 +/- 0.3 cm(2) and 10.3 +/- 5.9 mm Hg, respectively). CONCLUSION: Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis.

Transcatheter valve-in-valve aortic valve implantation: 16-month follow-up.

Off-pump transcatheter, transapical valve-in-valve aortic valve implantation into a failed surgically implanted aortic valve was successfully performed in an 85-year-old man. He was discharged on postoperative day 5, and remained well at his 16-month follow-up. Echocardiography at 12 months showed normal prosthetic valve function without displacement, recoil, or regurgitation. Transcatheter transapical valve-in-valve aortic valve implantation is feasible and could be a viable approach for selected patients.

Percutaneous suture edge-to-edge repair of the mitral valve.

AIMS: To describe a new approach to percutaneous mitral valve repair and an illustrative first-in-man experience, we introduce a suture mediated "double orifice", "edge-to-edge" procedure which can be an effective surgical therapy for mitral regurgitation (MR) in selected patient. METHODS AND RESULTS: We describe a novel percutaneous approach to double orifice mitral repair utilising an intra-cardiac suture based system. The procedure was performed in 15 patients in four international centres. Endovascular suture based double orifice mitral repair was feasible with an acute reduction in the severity of MR by > or = 1 grade in nine of 15 patients. At 30 days improvement in MR appeared durable in six patients. Clinical utility was limited by technical difficulties, the inadequacies of current imaging modalities and suture dehiscence. CONCLUSIONS: Percutaneous endovascular suture based cardiac repair is feasible. However, in utilising the current device clinical benefit was limited and the repair not durable. In the future, similar endovascular approaches may enable more complex cardiac repair.

Transcatheter aortic valve implantation: impact on clinical and valve-related outcomes.

BACKGROUND: Transcatheter aortic valve implantation is an alternative to open heart surgery in patients with aortic stenosis. However, long-term data on a programmatic approach to aortic valve implantation remain sparse. METHODS AND RESULTS: Transcatheter aortic valve implantation was performed in 168 patients (median age, 84 years) in the setting of severe aortic stenosis and high surgical risk. Access was transarterial (n=113) or, in the presence of small iliofemoral artery diameter, transapical (n=55). The overall success rate was 94.1% in this early experience. Intraprocedural mortality was 1.2%. Operative (30-day) mortality was 11.3%, lower in the transarterial group than the transapical group (8.0% versus 18.2%; P=0.07). Overall mortality fell from 14.3% in the initial half to 8.3% in the second half of the experience, from 12.3% to 3.6% (P=0.16) in transarterial patients and from 25% to 11.1% (P=0.30) in transapical patients. Functional class improved over the 1-year postprocedure period (P<0.001). Survival at 1 year was 74%. The bulk of late readmission and mortality was not procedure or valve related but rather was due to comorbidities. Paravalvular regurgitation was common but generally mild and remained stable at late follow-up. At a maximum of >3 years and a median of 221 days, structural valve failure was not observed. CONCLUSIONS: Transcatheter aortic valve implantation can result in early and sustained functional improvement in high-risk aortic stenosis patients. Late outcome is determined primarily by comorbidities unrelated to aortic valve disease.

Role of multislice computed tomography in transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) required precise knowledge of the anatomic dimensions and physical characteristics of the aortic valve, annulus, and aortic root. Most groups currently use angiography, transthoracic echocardiography (TTE), or transesophageal echocardiography (TEE) to assess aortic annulus dimensions and anatomy. However, multislice computed tomography (MSCT) may allow more detailed 3-dimensional assessment of the aortic root. Twenty-six patients referred for TAVR underwent MSCT. Scans were also obtained for 18 patients after TAVR. All patients underwent pre- and postprocedural aortic root angiography, TTE, and TEE. Mean differences in measured aortic annular diameters were 1.1 mm (95% confidence interval 0.5, 1.8) for calibrated angiography and TTE, -0.9 mm (95% confidence interval -1.7, -0.1 mm) for TTE and TEE, -0.3 mm (95% confidence interval -1.1, 0.6 mm) for MSCT (sagittal) and TTE, and -1.2 mm (95% confidence interval -2.2, -0.2 mm) for MSCT (sagittal) and TEE. Coronal systolic measurements using MSCT, which corresponded to angiographic orientation, were 3.2 mm (1st and 3rd quartiles 2.6, 3.9) larger than sagittal systolic measurements, which were in the same anatomic plane as standard TTE and TEE views. There was no significant association between either shape of the aortic annulus or amount of aortic valve calcium and development of perivalvular aortic regurgitation. After TAVR, the prosthesis extended to or beyond the inferior border of the left main ostium in 9 of 18 patients (50%), and in 11 patients (61%), valvular calcium was <5 mm from the left main ostium. In conclusion, MSCT identified that the aortic annulus was commonly eccentric and often oval. This may in part explain the small, but clinically insignificant, differences in measured aortic annular diameters with other imaging modalities. MSCT after TAVR showed close proximity of both the prosthesis and displaced valvular calcium to the left main ostium in most patients. Neither eccentricity nor calcific deposits appeared to contribute significantly to severity of paravalvular regurgitation after TAVR.

Transapical transcatheter aortic valve implantation: 1-year outcome in 26 patients.

BACKGROUND: We reported the first case of successful transapical transcatheter aortic valve implantation in a human subject in 2005 and have now completed a 12-month follow-up on our first 26 patients. This is, to date, the longest follow-up of patients undergoing transapical aortic valve implantation. METHODS: Between October 2005 and January 2007, 26 patients (13 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement because of unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-up was performed before discharge and at 1, 6, and 12 months. Data from the 17 patients who survived over 12 months were used for comparisons of the baseline and follow-up results. RESULTS: The mean age was 80 +/- 9 years, and the predicted operative mortality was 37% +/- 20% by using logistic EuroSCORE and 11% +/- 6% by using the Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Six patients died within 30 days (30-day mortality, 23%), and 3 patients died from noncardiovascular causes after 30 days (late mortality, 12%). Among patients who survived at least 30 days, 12-month survival was 85%. There were no late valve-related complications. New York Heart Association functional class improved significantly. The aortic valve area and mean gradient remained stable at 12 months (1.6 +/- 0.3 cm(2) and 9.6 +/- 4.8 mm Hg, respectively). CONCLUSION: Our 1-year clinical and echocardiographic outcomes suggest that transapical transcatheter aortic valve implantation is a viable alternative to conventional aortic valve replacement in selected high-risk patients.

Role of echocardiography in percutaneous aortic valve implantation.

OBJECTIVES: This study was designed to investigate the usefulness and limitations of echocardiography in optimizing the outcome of percutaneous aortic valve implantation. BACKGROUND: Percutaneous aortic valve implantation is an emerging technique that has the potential to revolutionize the treatment of aortic valve disease. To date, however, the technique has been limited by technical constraints. Precise positioning of the valve is essential to minimize the potential for paravalvular regurgitation or device migration. Initial experience with device placement utilized fluoroscopic guidance only. METHODS: Candidates for percutaneous aortic valve implantation were evaluated with transthoracic echocardiography (TTE) to assess aortic annular dimension and aortic valve hemodynamics. Fifty consecutive patients were deemed suitable for percutaneous aortic valve implantation. Seventy-four percent (37 of 50) of patients underwent transesophageal echocardiography (TEE) during the procedure. RESULTS: Eighty-six percent (43 of 50) of patients had successful implantation, of which 77% (33 of 43) had TEE. Transthoracic echocardiography was used to determine annular dimension and was useful in guiding correct device sizing. Transesophageal echocardiography was able to successfully guide device implantation in 97% (33 of 34) of patients in whom the native valve was crossed with the percutaneous heart valve. Transesophageal echocardiography was used for the early detection of paravalvular aortic regurgitation (AR) and complemented fluoroscopy in the detection of complications. Additional balloon dilatation of the percutaneous heart valve was performed in 12 patients because of significant paravalvular AR, with 7 showing improvement in AR grade. After the procedure, early outcomes were evaluated using TTE. All patients in whom the device was successfully placed (43 of 50) had improvement in their aortic stenosis. Paravalvular AR, although present in many patients, is usually mild and has not emerged as a significant problem. CONCLUSIONS: Echocardiography has an important role in case selection, in guiding device placement, and in detecting complications of percutaneous aortic valve implantation.

Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis.

BACKGROUND: Percutaneous aortic valve replacement represents an endovascular alternative to conventional open heart surgery without the need for sternotomy, aortotomy, or cardiopulmonary bypass. METHODS AND RESULTS: Transcatheter implantation of a balloon-expandable stent valve using a femoral arterial approach was attempted in 50 symptomatic patients with severe aortic stenosis in whom there was a consensus that the risks of conventional open heart surgery were very high. Valve implantation was successful in 86% of patients. Intraprocedural mortality was 2%. Discharge home occurred at a median of 5 days (interquartile range, 4 to 13). Mortality at 30 days was 12% in patients in whom the logistic European System for Cardiac Operative Risk Evaluation risk score was 28%. With experience, procedural success increased from 76% in the first 25 patients to 96% in the second 25 (P=0.10), and 30-day mortality fell from 16% to 8% (P=0.67). Successful valve replacement was associated with an increase in echocardiographic valve area from 0.6+/-0.2 to 1.7+/-0.4 cm2. Mild paravalvular regurgitation was common but was well tolerated. After valve insertion, there was a significant improvement in left ventricular ejection fraction (P<0.0001), mitral regurgitation (P=0.01), and functional class (P<0.0001). Improvement was maintained at 1 year. Structural valve deterioration was not observed with a median follow-up of 359 days. CONCLUSIONS: Percutaneous valve replacement may be an alternative to conventional open heart surgery in selected high-risk patients with severe symptomatic aortic stenosis.