Incidence, Predictive Factors, and Prognostic Impact of Right Ventricular Dysfunction Before Transcatheter Aortic Valve Implantation.

Right ventricular dysfunction (RVD) is considered to be a late marker of aortic stenosis. However, there is a lack of consensus regarding the incidence, prognostic impact, and evolution of RVD in patients treated with transcatheter aortic valve implantation (TAVI). All patients treated with TAVI for severe aortic stenosis were included in a prospective single-center database. Patients who had a quantitative assessment of right ventricular (RV) function including tricuspid annular plane systolic excursion (TAPSE) and/or Doppler tissue imaging-derived tricuspid lateral annular systolic velocity (S' wave) measurements were eligible for this study. RVD was defined as TAPSE <17 mm or S' <9.5 cm/s if TAPSE was not available. Between 2014 and 2019, 503 patients with RV function assessment were included. The incidence of RVD before TAVI was 18.7%. Predictors of RVD were diabetes (p = 0.03), atrial fibrillation (p = 0.001), impaired left ventricular ejection fraction (p <0.0001), left ventricular dilatation (p = 0.007), and previous cardiac surgery (p = 0.002). Long-term survival was worse in patients with RVD before TAVI compared with those without RVD (hazard ratio 1.97, 95% confidence interval 1.1 to 3.4, p = 0.01). One year after TAVI, 58.7% of patients with baseline RVD had normal RV function and had similar outcomes as compared with those without RVD at baseline. In contrast, patients with persistent RVD had the worst prognosis. In conclusion, RVD is not rare and has a deleterious prognostic impact in patients treated with TAVI. Recovery of normal RV function is frequent after TAVI, whereas persistence of RVD is associated with poor outcomes.

Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition.

BACKGROUND: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves. METHODS AND RESULTS: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses. CONCLUSIONS: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.

Usefulness of Clopidogrel Loading in Patients Who Underwent Transcatheter Aortic Valve Implantation (from the BRAVO-3 Randomized Trial).

P2Y12-inhibitor initiation with clopidogrel using a loading dose (LD) versus no LD (NLD) provides more rapid inhibition of platelet activation and reduced risk of ischemic events after coronary stenting. Whether a similar beneficial effect is achieved in the setting of transcatheter aortic valve implantation (TAVI) is unknown. We evaluate the effects of preprocedural clopidogrel LD versus no NLD on 48-hour and 30-day clinical outcomes after TAVI. In the BRAVO-3 trial, 802 patients with severe aortic stenosis who underwent transfemoral TAVI were randomized to intraprocedural anticoagulation with bivalirudin or unfractionated heparin. Administration of clopidogrel LD was left to the discretion of the treating physician. For this analysis, patients were stratified according to receiving clopidogrel LD (n = 294, 36.6%) or NLD (n = 508, 63.4%) before TAVI. LD patients more often received a self-expandable prosthesis using larger sheaths. P2Y12-inhibitor maintenance therapy pre-TAVI was similar in patients with LD versus NLD (28.2% vs 33.1%, p = 0.16). LD versus NLD was associated with similar incidences of major adverse cardiovascular events (i e., death, myocardial infarction, or stroke) (4.1% vs 4.1%, p = 0.97) and major bleeding (8.5% vs 7.7%, p = 0.68), but a higher rate of major vascular complications (11.9% vs 7.1%, p = 0.02). Multivariable adjustment showed that clopidogrel LD did not affect any of the studied clinical events, including major vascular complications (odds ratio 0.91, 95% confidence interval 0.60 to 1.39, p = 0.67). Also patients on clopidogrel maintenance therapy and thus considered in steady state were not at reduced risk of major adverse cardiovascular events compared with patients not on clopidogrel (3.7% vs 5.2%, p = 0.36). In conclusion, in patients who underwent TAVI, use of clopidogrel LD was associated with higher vascular complications and otherwise similar clinical events compared to NLD patients.

Incidence, Prognostic Impact, and Predictive Factors of Readmission for Heart Failure After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to assess the incidence, prognostic impact, and predictive factors of readmission for congestive heart failure (CHF) in patients with severe aortic stenosis treated by transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is indicated in patients with severe symptomatic aortic stenosis in whom surgery is considered high risk or is contraindicated. Readmission for CHF after TAVR remains a challenge, and data on prognostic and predictive factors are lacking. METHODS: All patients who underwent TAVR from January 2010 to December 2014 were included. Follow-up was achieved for at least 1 year and included clinical and echocardiographic data. Readmission for CHF was analyzed retrospectively. RESULTS: This study included 546 patients, 534 (97.8%) of whom were implanted with balloon-expandable valves preferentially via the transfemoral approach in 87.8% of cases. After 1 year, 285 patients (52.2%) had been readmitted at least once, 132 (24.1%) for CHF. Patients readmitted for CHF had an increased risk for death (p < 0.0001) and cardiac death (p < 0.0001) compared with those not readmitted for CHF. On multivariate analysis, aortic mean gradient (hazard ratio [HR]: 0.88; 95% confidence interval [CI]: 0.79 to 0.99; p = 0.03), post-procedural blood transfusion (HR: 2.27; 95% CI: 1.13 to 5.56; p = 0.009), severe post-procedural pulmonary hypertension (HR: 1.04; 95% CI: 1.00 to 1.07; p < 0.0001), and left atrial diameter (HR: 1.47; 95% CI: 1.08 to 2.01; p = 0.02) were independently associated with CHF readmission at 1 year. CONCLUSIONS: Readmission for CHF after TAVR was frequent and was strongly associated with 1-year mortality. Low gradient, persistent pulmonary hypertension, left atrial dilatation, and transfusions were predictive of readmission for CHF.

Single-source dual-energy CT angiography with reduced iodine load in patients referred for aortoiliofemoral evaluation before transcatheter aortic valve implantation: impact on image quality and radiation dose.

OBJECTIVES: To compare image quality and radiation dose of pre-transcatheter aortic valve implantation (TAVI) aortoiliofemoral CT angiography (AICTA) provided by standard vs. dual-energy mode with reduced iodine load protocols. METHODS: One hundred and sixty-one patients underwent a two-step CTA protocol before TAVI including cardiac CTA with injection of 65 mL of iodinated contrast agent (ICA), immediately followed by AICTA. From this second acquisition, the following three different patient groups were identified: Group 1: 52 patients with standard AICTA (60 mL ICA, 100 kVp, mA automodulation); Group 2: 48 patients with dual-energy AICTA with 50 % iodine load reduction (30 mL ICA, fast kVp switching, 600 mA); Group 3: 61 patients with an identical protocol to Group 2, but exposed to 375 mA. The qualitative/subjective image quality (13-point score) and quantitative/objective image quality (contrast attenuation and image noise) were evaluated. The radiation dose was recorded. RESULTS: There was no significant difference in non-diagnostic images between the three protocols. Contrast attenuation, signal-to-noise ratio and contrast-to-noise ratio were significantly higher, whereas noise was significantly lower in the standard protocol (all P < 0.05). The radiation dose was lower in the dual-energy protocol at 375 mA (P < 0.05). CONCLUSIONS: Dual-energy AICTA before TAVI results in a reduction of iodine load while maintaining sufficient diagnostic information despite increased noise. KEY POINTS: • Dual-energy AICTA before TAVI results in a 50 % reduction of iodine load. •The reduction of iodine load maintains sufficient image quality despite increased noise. • Using 375 mA in dual-energy mode results in a reduction of radiation dose. • A high tube current setting (600 mA) should be used in overweight patients.

Patients with severe aortic stenosis and reduced ejection fraction: earlier recovery of left ventricular systolic function after transcatheter aortic valve implantation compared with surgical valve replacement.

BACKGROUND: Only 50% of patients with aortic stenosis (AS) and low ejection fraction (EF) improve their contractility after surgical aortic valve replacement (AVR). Long-term prognosis of these patients is strongly correlated to EF recovery after the surgery. The aim of this study was to compare the postoperative left ventricular function recovery in patients with severe AS and reduced EF after AVR and transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Twenty-one patients undergoing AVR for severe AS (<1 cm²) and reduced EF (<45%) were echocardiographically compared with 31 patients treated with TAVI by conventional and two-dimensional (2D) strain method. TAVI patients were older (83 ± 6 vs. 74 ± 13 years, P < 0.001), had more comorbidities (Euroscore 26 ± 15% vs. 16 ± 12%, P < 0.001) and no differences in ischemic heart disease (16.1% vs. 9.5%, P = 0.39). EF was similar in both groups at baseline. Aortic valve area significantly increased (P = 0.01) while pressure gradient decreased (P = 0.009) after both procedures but TAVI was associated with a better EF recovery compared with AVR at day 7. Regional function assessed by radial 2D strain increased in TAVI group but was transiently deteriorated in AVR patients (P < 0.05). Longitudinal as well as circumferential 2D strain progressively increased at follow-up in both groups (P < 0.05). EF was similar in both groups at 3-month follow-up. CONCLUSION: In patients with severe AS and reduced EF, TAVI is associated with faster and better recovery of LV function compared with AVR.

Performance analysis of EuroSCORE II compared to the original logistic EuroSCORE and STS scores for predicting 30-day mortality after transcatheter aortic valve replacement.

The original European System for Cardiac Operative Risk Evaluation (EuroSCORE) has been recently updated as EuroSCORE II to optimize its efficacy in cardiac surgery, but its performance has been poorly evaluated for predicting 30-day mortality in patients who undergo transcatheter aortic valve replacement (TAVR). Consecutive patients (n = 250) treated with TAVR were included in this analysis. Transapical access was used in 60 patients, while 190 procedures were performed using a transfemoral approach. Calibration (risk-adjusted mortality ratio) and discrimination (C-statistic and U-statistic) were calculated for the logistic EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons (STS) scores for predicting 30-day mortality. Observed mortality was 7.6% in the overall population (6.3% and 11.7% for the transfemoral and transapical cohorts, respectively). Predicted mortality was 22.6 ± 12.8% by logistic EuroSCORE, 7.7 ± 5.8% by EuroSCORE II, and 7.3 ± 4.1% by STS score. The risk-adjusted mortality ratio was 0.34 (95% confidence interval [CI] 0.10 to 0.58) for logistic EuroSCORE, 0.99 (95% CI 0.29 to 1.69) for EuroSCORE II, and 1.05 (95% CI 0.30 to 1.79) for STS score. Moderate discrimination was observed with EuroSCORE II (C-index 0.66, 95% CI 0.52 to 0.79, p = 0.02) compared to the logistic EuroSCORE (C-index 0.63, 95% CI 0.51 to 0.76, p = 0.06) and STS (C-index 0.58, 95% CI 0.43 to 0.73, p = 0.23) score, without a significant difference among the 3 risk scores. Discrimination was slightly better in the transfemoral cohort compared to the transapical cohort with the 3 risk scores. In conclusion, EuroSCORE II and the STS score are better calibrated than the logistic EuroSCORE but have moderate discrimination for predicting 30-day mortality after TAVR.

Transapical aortic valve implantation in Rouen: four years' experience with the Edwards transcatheter prosthesis.

BACKGROUND: The first French transapical transcatheter aortic valve implantation (TAVI) was performed in July 2007 in our department. AIMS: To report 4-year outcomes of transapical implantation with the Edwards transcatheter bioprosthesis. METHODS: We prospectively evaluated consecutive patients who underwent transapical implantation with an Edwards transcatheter bioprosthesis between July 2007 and October 2011. Patients were not suitable for conventional surgery (due to severe comorbidities) or transfemoral implantation (due to poor femoral access). RESULTS: Among 61 patients (59.0% men), mean logistic EuroSCORE was 27.5 ± 14.9% and mean age was 81.0 ± 6.8 years. Successful valve implantation was achieved in 59/61 patients (96.7%) of patients. The other two patients required conversion to conventional surgery due to prosthesis embolization and died. Six additional patients died in the postoperative period. Causes of perioperative death were two septic shocks (one of peritonitis), two multi-organ failure, one ventricular fibrillation and one respiratory insufficiency. Intraprocedural stroke was not observed in any patient. The actuarial survival rates at 1, 2 and 4 years were 73.8%, 67.2% and 41.0%. During this 4-year period, four patients died of cardiovascular events, but no impairment of transprosthesis gradient was observed. CONCLUSION: Our series of 61 patients who underwent transapical implantation of the Edwards transcatheter bioprosthesis shows satisfactory results, similar to other reports, considering the high level of severity of patients referred for this method. Transapical access is a reliable alternative method for patients that cannot benefit from a transfemoral approach.

A repetição da valvuloplastia aórtica por balão é uma boa estratégia para alívio dos sintomas e seleção de pacientes para substituição percutânea da valva aórtica / Repeat balloon aortic valvuloplasty is a good strategy for symptom relief and patient selection for percutaneous aortic valve replacement

A valvuloplastia aórtica por balão voltou a ganhar interesse desde o início da era da substituição percutânea da valva aórtica, por ser um procedimento que pode ser repetido como ponte e também por ser boa estratégia para a seleção de pacientes para o novo procedimento. Método: De janeiro de 2001 a janeiro de 2009, 174 pacientes consecutivos com estenose aórtica sintomática grave e alto risco cirúrgico calculado pelo EuroSCORE/STS foram submetidos a valvuloplastia aórtica por balão na França e na Argentina, utilizando-se a mesma técnica. Desse total, 21 (12,1 por cento) precisaram repetir a valvuloplastia aórtica por balão em decorrência de reestenose e os resultados foram comparados aos dos 153 pacientes que realizaram somente o primeiro procedimento. A técnica mais utilizada foi o acesso retrógrado com abordagem femoral utilizando introdutores de 10 F, 12 F ou 14 F, com tamanhos de balão...

Surgical aortic valve replacement after percutaneous aortic valve implantation: what have we learned?

OBJECTIVE: We report the first case description of surgical aortic valve replacement after percutaneous valve implantation. METHODS: An 87-year-old man with severe aortic stenosis who was rejected for surgical intervention underwent percutaneous valve implantation through a retrograde femoral approach. The procedure was complicated by cardiogenic shock caused by severe aortic insufficiency, leading to emergency surgical aortic valve replacement. RESULTS: The operative findings revealed the presence of commissural paravalvular leaks and centrally malapposed leaflets. Surgical replacement was uneventful, and the patient was discharged on day 30, despite a challenging postoperative course. His follow-up at 1 year has been uneventful. This case illustrates that overdilatation of the stent is not recommended because it might worsen central aortic insufficiency. Moreover, the transapical route should be considered when the appropriately sized prosthesis is unable to be inserted because of inappropriate vascular access. However, despite an initial "prohibitive" surgical risk, surgical aortic valvular replacement after percutaneous valve implantation could be easily performed. CONCLUSION: Percutaneous heart valve implantation, which provides a larger surface area than balloon valvotomy, can be offered to patients with cardiogenic shock and severe comorbidities to improve their hemodynamic state and reduce their surgical risk.

Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience.

OBJECTIVES: The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position. BACKGROUND: We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS). METHODS: Thirty-six patients (aortic valve area < or =0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially. RESULTS: Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 +/- 0.11 cm2 to 1.70 +/- 0.10 cm2, p < 0.0001) and transvalvular gradient (37 +/- 13 mm Hg to 9 +/- 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 +/- 18% to 53 +/- 14%, p = 0.02) was most pronounced in patients with ejection fraction <50% (35 +/- 10% to 50 +/- 16%, p < 0.0001). Thirty-day major adverse events after successful implantation were 26% (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related. CONCLUSIONS: Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future.

Acute improvement in global and regional left ventricular systolic function after percutaneous heart valve implantation in patients with symptomatic aortic stenosis.

BACKGROUND: The newly developed percutaneous heart valve (PHV) implantation technique decreases transaortic pressure gradient in patients with aortic stenosis. PHV replacement effects on left ventricular (LV) global and regional systolic function are currently unknown. METHODS AND RESULTS: Eight patients with severe aortic stenosis had 2D echocardiography at baseline and 24 hours after PHV implantation to evaluate changes in LV volume and LV ejection fraction. Regional function, ie, both peak systolic anterior and posterior wall tissue velocity, as well as strain and strain rate imaging, were measured by tissue Doppler imaging from a short-axis view. At 24 hours, a significant reduction in transaortic mean pressure gradient (from 46+/-15 to 8+/-3 mm Hg; P<0.0001) was accompanied by an increase in aortic valve area (from 0.59+/-0.11 to 1.69+/-0.11 cm2; P<0.0001). LV end-diastolic volume remained unchanged (102+/-36 to 101+/-12 mL; P=NS), whereas LV ejection fraction increased (48+/-18% to 57+/-12%; P<0.01). Improvement in posterior wall displacement (posterior wall tissue velocity increased from 2.2+/-0.5 to 4.4+/-1.0 cm/s(-1); P=0.0003) and deformation (strain rate imaging increased from 1.0+/-0.3 to 1.9+/-0.7 s(-1), P=0.009, and strain increased from 11+/-5% to 17+/-9%; P=0.02) were observed. CONCLUSIONS: Immediately after PHV replacement, improvement of LV global and regional systolic function was evidenced by tissue Doppler imaging.

Analysis of nonintervention strategy for in-stent restenosis in Pauci- or asymptomatic patients.

Between January 1996 and May 2000, we retrospectively identified 66 patients (61 +/- 11 years) with in-stent restenosis who did not undergo percutaneous coronary intervention and/or bypass surgery and were maintained on medical treatment alone. In-stent restenosis was diffuse or proliferative in 86% of these patients. At 33 +/- 11 months, 2 patients died, none developed myocardial infarction, and 6 (9%) had target lesion revascularization only (repeat percutaneous transluminal coronary angioplasty). Medical treatment alone was associated with a good long-term clinical follow-up in selected patients with significant documented in-stent restenosis.

Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis.

OBJECTIVES: This study was done to assess the results of percutaneous heart valve (PHV) implantation in non-surgical patients with end-stage calcific aortic stenosis. BACKGROUND: Replacement of PHV has been shown to be feasible in animals and humans. We developed a PHV composed of three pericardial leaflets inserted within a balloon-expandable stainless steel stent. We report the acute and early follow-up results of the initial six PHV implantations. METHODS: An anterograde approach was used in all cases. The PHV, crimped over a 22-mm diameter balloon, was advanced through a 24-F sheath from the femoral vein to the aortic valve and delivered by balloon inflation. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially. RESULTS: All patients were in New York Heart Association functional class IV. The PHV was successfully delivered in five patients. Early migration with subsequent death occurred in one patient who presented with a torn native valve. Acute hemodynamic and angiographic results showed no residual gradient, mild (three patients) or severe (two patients) aortic regurgitation, and patent coronary arteries. On echocardiography, the aortic valve area was increased from 0.5 +/- 0.1 cm(2) to 1.70 +/- 0.03 cm(2) and the aortic regurgitation was paravalvular. Marked and sustained hemodynamic and clinical improvement was observed after successful PHV implants. The first three patients died of a non-cardiac cause at 18, 4, and 2 weeks, respectively, and the other patients are alive at 8 weeks with no signs of heart failure. CONCLUSIONS: Implantation of the PHV can be achieved in patients with end-stage calcific aortic stenosis and might become an important therapeutic option for patients not amenable to surgical valve replacement.

Percutaneous implantation of aortic valve prosthesis in patients with calcific aortic stenosis: technical aspects.

In April 2002, after extensive ex-vivo and animal implantation studies, we performed the first successful implantation of a new percutaneous aortic valve in a patient with endstage aortic stenosis. The purpose of this article is to give a detailed description of the technique of percutaneous implantation of aortic valve bioprosthesis in patients with severe calcific aortic stenosis. Antegrade transeptal approach was used under local anesthesia and mild sedation.

Effectiveness of percutaneous mechanical mitral commissurotomy using the metallic commissurotome in patients with restenosis after balloon or previous surgical commissurotomy.

Balloon mitral valvuloplasty has been reported to give equal or less positive results after previous commissurotomy than after a first procedure. Percutaneous mechanical mitral commissurotomy (PMMC) is a new technique that has not yet been evaluated in this subset of patients. Of 1,175 PMMC procedures (1,175 patients), 173 patients (14.7%) had previous commissurotomy; patients were older (40 vs 35 years of age, p <0.0001) and more often in atrial fibrillation (34% vs 21%, p = 0.0016) than were patients who had not undergone previous commissurotomy. The baseline transmitral gradient was lower (17 +/- 8 vs 19 +/- 8 mm Hg, p <0.002) and the echocardiographic Wilkins score was higher (8.7 +/- 1.9 vs 7.6 +/- 1.8, p <0.0001) for patients who underwent previous commissurotomy. Baseline mitral valve area was comparable between the 2 groups (0.96 +/- 0.21 vs 0.93 +/- 0.24 cm(2)). Immediate results were satisfactory, although slightly less favorable after previous commissurotomy, with a final mitral valve area of 2.01 +/- 0.30 versus 2.12 +/- 0.36 cm(2) (p <0.0001), and a residual transvalvular gradient of 5.0 +/- 3.6 versus 4.2 +/- 4.1 mm Hg (p = 0.003). The rates of procedural success (93%) and severe complications (4.7%) were comparable between the 2 groups. Thus, PMMC is an effective and safe technique for the treatment of mitral restenosis after previous commissurotomy.

Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.

BACKGROUND: The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results. METHODS AND RESULTS: With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation. CONCLUSIONS: Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.