Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Routine HIV testing in acute care hospitals: Changing practice to curb a local HIV epidemic in Vancouver, BC.

Early treatment of HIV infection increases life expectancy and reduces infectivity; however, delayed HIV diagnosis remains common. Implementation and sustainability of hospital-based routine HIV testing in Vancouver, British Columbia, was evaluated to address a local HIV epidemic by facilitating earlier diagnosis and treatment. Public health issued a recommendation in 2011 to offer HIV testing to all patients presenting to three Vancouver hospitals as part of routine care, including all patients admitted to medical/surgical units with expansion to emergency departments (ED). We evaluated acceptability, feasibility, and effectiveness from 2011 to 2014 and continued monitoring through 2016 for sustainability. Between October 2011-December 2016, 114,803 HIV tests were administered at the three hospitals; an 11-fold increase following implementation of routine testing. The rate of testing was sustained and remained high through 2018. Of those tested, 151 patients were diagnosed with HIV for a testing yield of 0.13%. Review of 12,996 charts demonstrated 4935/5876 (96·9%) of admitted patients agreed to have an HIV test when offered. People diagnosed in hospital were significantly more likely to be diagnosed with acute stage (aOR 1·96, 95% CI 1·19, 3·23) infection, particularly those diagnosed in the ED. This study provides practice-based evidence of the feasibility, acceptability, and effectiveness of implementing a recommendation for routine HIV testing among inpatient and emergency department admissions, as well as the ability to normalize and sustain this change. Routine hospital-based HIV testing can increase diagnoses of acute HIV infection and facilitate earlier initiation of antiretroviral treatment.

Early leaflet thrombosis complicating transcatheter implantation of a Sapien 3 valve in a native right ventricular outflow tract.

A 59-year-old female with Tetralogy of Fallot had a previous complete repair with RVOT patch enlargement. She developed subsequent severe symptomatic (NYHA III) pulmonary regurgitation with severe RV dilatation. She had a concomitant interstitial lung disease secondary to hypersensitivity pneumonitis that precluded her from cardiac surgery. After preprocedural assessment using computed tomography, echocardiography and invasive angiography we decided to implant a 29 mm Edwards Sapien 3 valve without pre-stenting. The Sapien 3 valve was implanted in a satisfactory position using rapid RV pacing. The valve appeared well expanded with good circularity on fluoroscopy. A transthoracic echocardiography on the following day showed no pulmonary regurgitation with a peak gradient of 14 mmHg across the prosthesis. At 4 weeks follow-up, the patient felt a marked improvement (NYHA II) but a CT scan showed bileaflet valve thickening with preserved stent expansion. A concomitant echo-doppler showed a significant increase of peak pulmonary gradient to 26 mmHg. After a six weeks course of warfarin therapy, the transpulmonary valve peak gradient came down to 16 mmHg and leaflet thickening resolved on CT. The Sapien 3 system helped achieve a successful transfemoral percutaneous pulmonary valve implantation in a challenging native RVOT anatomy. This case was complicated by early valve thrombosis as documented by CT and was successfully treated with oral anticoagulation.

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.

Red blood cell storage duration and mortality in patients undergoing percutaneous coronary intervention.

BACKGROUND: Blood transfusion has been associated with an increased mortality in patients undergoing percutaneous coronary intervention (PCI). Although the reasons for this remain unclear, it may be related to the structural and functional changes occurring within red blood cells (RBCs) during storage. We investigated whether RBC storage duration was associated with mortality in patients requiring transfusion after PCI. METHODS: We collected data on all RBC transfusions occurring within 10 days of PCI (excluding those related to cardiac surgery) using the British Columbia Cardiac Registry and Central Transfusion Registry. Transfusion details were analyzed according to 30-day survival. RESULTS: From a total of 32,580 patients undergoing PCI, 909 (2.8%) patients received RBCs with a mean storage duration of 25 +/- 10 days. In these 909 patients, mean transfusion volumes were lower in survivors (2.8 +/- 2.1 vs 3.8 +/- 2.9 U, P = .002) than those who died within 30 days. In a multivariate analysis to adjust for baseline risk, mean RBC storage age (HR 1.02 [95% CI 1.01-1.04], P = .002) and transfusion volume (HR 1.26 [95% CI 1.18-1.34], P < .001) both predicted 30-day mortality. Transfused patients who received only older blood (RBC min age >28 days) appeared to be at greater risk of death (HR 2.49 [95% CI 1.45-4.25], P = .001). CONCLUSION: Red blood cell transfusion is associated with increased 30-day mortality in patients undergoing PCI. Although current transfusion practice permits RBC storage for up to 42 days, the use of older red cells may pose an additional hazard to this patient group.

Current balloon-expandable transcatheter heart valve and delivery systems.

OBJECTIVES: Transcatheter valve and valve delivery systems are undergoing rapid evolution. We describe the current generation balloon-expandable valve and delivery systems. BACKGROUND AND METHODS: The SAPIEN XT valve represents the newest generation balloon-expandable aortic bioprosthesis. A cobalt-chromium alloy frame and additional design modifications facilitate a reduction in delivery profile while maintaining structural integrity, hemodynamics, and durability. The RetroFlex 3 delivery system represents the latest clinically available delivery system. It incorporates a fixed, tapered, and deflecting crossing tip to facilitate atraumatic introduction and a rapid inflation lumen to reduce valve motion during deployment. The NovaFlex delivery system represents the next generation delivery catheter. When used in conjunction with the SAPIEN XT valve and a specially constructed introducer sheath the inner and the outer diameters are 18 and 21 F, respectively. RESULTS: The RetroFlex 3 delivery system was utilized in nine patients and the NovaFlex delivery system in four. The valve implanted was the SAPIEN in six and the SAPIEN XT valve in seven. Implantation was successful in all patients. A reduction in device movement during balloon deployment was apparent as compared with earlier delivery systems. Aortic mean gradient fell from 45.6 (+/-15.1) mm Hg to 13.2 (+/-5.1) mm Hg, valve area rose from 0.68 (+/-0.19) to 1.5 (+/-0.28) cm(2). No patient had more than mild paravalvular regurgitation. CONCLUSION: Transcatheter valves and delivery systems continue to improve in terms of profile and ease of use.

First-in-man use of a tapered endovascular stent graft for treatment of aneurysm after coarctation repair.

OBJECTIVES: Endovascular stenting of aneurysms late after surgical repair of coarctation may have to deal with marked changes in aortic diameter proximal and distal to the aneurysm. We report our first-in-man successful use of a custom-made tapered (variable diameter) covered stent. METHODS: The aneurysm was 42 mm in diameter with a length of 40 mm. On MRI, the aorta measured 19.6 mm proximal and 13.3 mm distal to the aneurysm. The aim was to oversize the stent by 10-20%. A covered Cheatham-platinum stent was designed so that cranial portion of the stent would expand to 22 mm and the caudal portion to 15 mm with a length of 8.5 cm when fully inflated. The stent was mounted on a balloon-in-balloon delivery system and was delivered through an 18 F femoral arterial sheath. Rapid-pacing technique was used for deployment. RESULTS: The stent was successfully deployed without complications. After deployment, the stent diameter measured 21.2 mm cranially and 15.6 mm caudally. A mild distal endoleak due to inadequate fixation of the stent graft was resolved by post dilation expanding the stent diameter to 22.1 mm and 15.9 mm, respectively. The femoral access site was closed using two percutaneous closure devices and the patient discharged the day after the procedure. Follow-up CT-angiography showed continued successful exclusion of the aneurysm. CONCLUSIONS: A new custom-made balloon expandable covered stent-design enabled successful treatment of an aortic aneurysm. This design may offer greater potential for more favorable initial angiographic results and potentially long-term outcomes due to superior apposition to the aortic wall.

Percutaneous coronary intervention in the Occluded Artery Trial: procedural success, hazard, and outcomes over 5 years.

BACKGROUND: The Occluded Artery Trial (OAT) was a 2,201-patient randomized clinical trial comparing routine stent-based percutaneous coronary intervention (PCI) versus optimal medical therapy alone in stable myocardial infarction (MI) survivors with persistent infarct-related artery occlusion identified day 3 to 28 post MI. Intent-to-treat analysis showed no difference between strategies with respect to the incidence of new class IV congestive heart failure, MI, or death. The influence of PCI failure, procedural hazard, and crossover on trial results has not been reported. METHODS: Study angiograms were analyzed and adjudicated centrally. Factors associated with PCI failure were examined. Time-to-event analysis using the OAT primary outcome was performed by PCI success status. Landmark analysis (up to and beyond 30 days) partitioned early hazard versus late outcome according to treatment received. RESULTS: Percutaneous coronary intervention was adjudicated successful in >87%. Percutaneous coronary intervention failure rates were similar in US and non-US sites, and did not significantly influence outcome at 60 months (hazard ratio for success vs fail 0.79, 99% CI 0.45-1.40, P = .29). Partitioning of early procedural hazard revealed no late benefit for PCI (hazard ratio for PCI success vs medical therapy alone 1.06, 99% CI 0.75-1.50, P = .66). CONCLUSIONS: Percutaneous coronary intervention failure and complication rates in the OAT were low. Neither PCI failure nor early procedural hazard substantively influenced the primary trial results.

Percutaneous coronary intervention and 30-day mortality: the British Columbia PCI risk score.

OBJECTIVES: To construct a calculator to assess the risk of 30-day mortality following PCI. BACKGROUND: Predictors of 30-day mortality are commonly used to aid management decisions for cardiac surgical patients. There is a need for an equivalent risk-score for 30-day mortality for percutaneous coronary intervention (PCI) as many patients are suitable for both procedures. METHODS: The British Columbia Cardiac Registry (BCCR) is a population-based registry that collects information on all PCI procedures performed in British Columbia (BC). We used data from the BCCR to identify risk factors for mortality in PCI patients and construct a calculator that predicts 30-day mortality. RESULTS: Patients (total n = 32,899) were divided into a training set (n = 26,350, PCI between 2000 and 2004) and validation set (n = 6,549, PCI in 2005). Univariate predictors of mortality were identified. Multivariable logistic regression analysis was performed on the training set to develop a statistical model for prediction of 30-day mortality. This model was tested in the validation set. Variables that were objective and available before PCI were included in the final risk score calculator. The 30-day mortality for the overall population was 1.5% (n = 500). Area under the ROC curve was 90.2% for the training set and 91.1% for the validation set indicating that the model also performed well in this group. CONCLUSIONS: We describe a large, contemporary cohort of patients undergoing PCI with complete follow-up for 30-day mortality. A robust, validated model of 30-day mortality after PCI was used to construct a risk calculator, the BC-PCI risk score, which can be accessed at www.bcpci.org.

Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial.

BACKGROUND: The majority of patients randomized to percutaneous coronary intervention (PCI) in the Occluded Artery Trial (OAT) and its angiographic substudy, the Total Occlusion Study of Canada 2 (TOSCA-2) were treated with bare metal stents (BMS). We aimed to determine if stenting of the target occlusion in OAT with drug-eluting stents (DES) was associated with more favorable angiographic results and clinical outcome when compared with treatment with BMS. METHODS: TOSCA-2 DES was a prospective nonrandomized substudy that provided 1-year angiographic comparison of late loss and reocclusion in 25 patients treated with DES and in 128 treated with BMS. In addition, all PCI-assigned patients enrolled from the time when DES were first utilized were similarly categorized (DES n = 77, and BMS n = 386) and compared using the 3-year cumulative OAT primary combined endpoint of death, myocardial infarction, or Class-IV heart failure, as well as angina. RESULTS: In-segment late loss was 0.14 +/- 0.45 mm for DES and 0.75 +/- 0.86 mm for BMS (P < 0.001). Corresponding binary restenosis rates were 13.0% and 44.3% (P = 0.005). Occlusion at 1 year was observed in 4.0 and 12.1%, respectively (P = 0.23). The 3-year cumulative primary event rate was 13.8% with DES and 12.5% with BMS (hazard ratio 1.08, 99% confidence intervals 0.44, 2.64; P = 0.83). Angina over time occurred less frequently in the DES group (P = 0.01). CONCLUSIONS: Although the reduction of late loss and trend to reduction in reocclusion with the use of DES for PCI of persistently occluded IRA 3-28 days post myocardial infarction did not translate into a signal for reduction in death, reinfarction, or Class IV heart failure, DES use was associated with less angina over time. Further follow-up is warranted.

CT of the ilio-femoral arteries using direct aortic contrast injection: proof of feasibility in patients screened towards percutaneous aortic valve replacement.

PRINCIPLES: Transfemoral aortic valve implantation (TAVI) is a promising treatment modality for selected patients with severe symptomatic aortic stenosis. Peripheral access via the femoral and iliac artery is an important issue, limiting this technique's applicability in patients suffering from peripheral arterial disease. Multislice computed tomography (MSCT) reliably identifies patients with suitable peripheral access. However, MSCT involves an additional contrast dye burden in patients often suffering from renal failure. In this study, the feasibility of direct-aortic-contrast-injection for MSCT was investigated, aiming to reduce total contrast load. METHODS: Patients undergoing evaluation for TAVI underwent an aortogram including iliac and femoral arteries. In 7 selected patients with questionable peripheral access, MSCT was performed by advancing a pigtail catheter to the level of L2, followed by direct injection of 15-20 ml of contrast mixed with an equal volume of saline. This injection was followed by an injection of 40 ml of saline. Scanning was initiated 4 seconds after starting the contrast injection. All MSCT scans were obtained using a 64 slice scanner. RESULTS: In all 7 patients, except one, the distal aorta, iliac and femoral arteries where adequately imaged to allow reliable assessment of peripheral access for TAVI. Of the 7 patients evaluated, 2 were rejected for TAVI based on the information of the MSCT using direct-aortic-contrast-injection. Limitations of the technique may be an underestimation of the arterial diameter due to spasms at the puncture site. CONCLUSION: MSCT using direct-aortic-contrast-injection for assessment of peripheral access for TAVI is feasible and may provide good diagnostic images with a reduced volume of contrast.

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system.

AIMS: Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the RVOT or pulmonary valve. There are no multicentre data on the feasibility and safety of percutaneous pulmonary valve implantation (PPVI) using the SAPIEN 3 (S3) transcatheter heart valve. The aim of this study was to explore the short-term safety, feasibility, and haemodynamic outcomes of PPVI using the S3 transcatheter heart valve. METHODS AND RESULTS: Pulmonic S3 is an observational registry of patients undergoing PPVI with the S3 valve across centres in Europe and Canada. Data for 82 patients (mean age 27.3 years) were obtained. The most common underlying diagnosis was tetralogy of Fallot (ToF) (58.5%), with 16.0% of patients having native RVOT anatomy; 90.2% received pre-stenting. Prosthesis dislodgement occurred in one patient and conduit perforation in another. Both were successfully resolved without the need for open surgery. Peak systolic gradient over the RVOT fell from 46.3 mmHg to 17.2 mmHg, moderate/severe pulmonary regurgitation from 86.3% to 0.0%, and NYHA ≥II from 86.0% to 15.2%. During follow-up, valve thrombosis was observed in two patients which resolved with adequate anticoagulation. No other procedural complications, endocarditis, stent fracture or death were reported within two years. CONCLUSIONS: PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes.

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.

Angina with "normal" coronary arteries: sex differences in outcomes.

BACKGROUND: Several studies have demonstrated that women with nonobstructive coronary disease have a high rate of subsequent investigations, rehospitalizations for recurrent chest pain, and repeat coronary angiography. The sex specificity of this finding is unclear. We therefore undertook an evaluation of sex differences in rehospitalization for acute coronary syndrome (ACS) or chest pain in patients with "angiographically normal" coronaries. METHODS: A retrospective cohort study using prospectively collected angiographic and clinical data on all patients in British Columbia, Canada, presenting for their first cardiac catheterization with suspected ischemic heart disease but angiographically normal coronaries. RESULTS: Among 32,856 patients, 7.1% of men versus 23.3% of women were angiographically normal (P < .001). Among angiographically normal patients, women were older and more likely to present with hypertension, prior stroke, chronic obstructive pulmonary disease, and peripheral vascular disease than men, but Canadian Cardiovascular Society class of angina did not vary by sex. Within 1 year, 1.0% died, (19 women, 18 men, P = .27) and 0.6% had a stroke (13 women, 9 men, P = .91). Readmission to hospital for ACS or chest pain requiring catheterization was significantly higher in women compared to men (adjusted OR 4.06; 95% CI 1.15-14.31). CONCLUSIONS: In a contemporary, population-based cohort presenting for cardiac catheterization for suspected ischemia, women with angiographically normal coronaries were >4 times more likely to be readmitted to hospital for ACS/chest pain within 180 days compared to men. The observed sex difference has important social and economic implications and suggests that traditional diagnostic methods may not be optimal for women.

Prevention and management of transcatheter balloon-expandable aortic valve malposition.

OBJECTIVES: Early clinical outcomes in selected high-risk patients undergoing catheter-based aortic valve replacement (AVR) compare favorably with conventional surgical AVR. Improved understanding of the mechanisms of success and failure of transcatheter AVR will likely improve outcomes further. To this end, we examined our experience during the developmental phases of transcatheter AVR and describe the causes and management of prosthetic valve malposition. METHODS: Transcatheter balloon-expandable AVR was performed in 170 patients at two centers. Malposition was defined as prosthetic valve implantation in a location other than within the native valve. Patients were prospectively identified and followed as part of an ongoing database. RESULTS: Valve malposition occurred in 9 of 170 patients (5.3%). Final position was supravalvular in eight of nine cases. In all cases, embolization to the ascending aorta occurred within a few cardiac cycles following deployment. Importantly, late embolization was not observed. In most cases, the prosthesis was uneventfully repositioned in the more distal aorta. Positioning was subvalvular in one patient (0.6%), resulting in a severe regurgitation with residual native valve stenosis. Implantation of a second transcatheter valve was attempted in six patients and was successful in all. Conventional AVR was performed in two patients, with early mortality in one. At late follow-up (mean 412 days), seven of nine patients remain alive (78%) with a functioning prosthesis and relief of aortic stenosis. CONCLUSIONS: Malposition of current balloon-expandable aortic valves is a largely preventable complication. An improved understanding of the procedure will likely minimize this possibility and mitigate the consequences should malposition occur.

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system.

BACKGROUND: Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking. METHODS AND RESULTS: We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years. CONCLUSIONS: The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS. GOV IDENTIFIER: NCT02302131.

Transapical transcatheter aortic valve implantation in humans: initial clinical experience.

BACKGROUND: Aortic valve replacement with cardiopulmonary bypass is currently the treatment of choice for symptomatic aortic stenosis but carries a significant risk of morbidity and mortality, particularly in patients with comorbidities. Recently, percutaneous transfemoral aortic valve implantation has been proposed as a viable alternative in selected patients. We describe our experience with a new, minimally invasive, catheter-based approach to aortic valve implantation via left ventricular apical puncture without cardiopulmonary bypass or sternotomy. METHODS AND RESULTS: A left anterolateral intercostal incision is used to expose the left ventricular apex. Direct needle puncture of the apex allows introduction of a hemostatic sheath into the left ventricle. The valve prosthesis, constructed from a stainless steel stent with an attached trileaflet equine pericardial valve, is crimped onto a valvuloplasty balloon. The prosthetic valve and balloon catheter are passed over a wire into the left ventricle. Positioning within the aortic annulus is confirmed by fluoroscopy, aortography, and echocardiography. Rapid ventricular pacing is used to reduce cardiac output while the balloon is inflated, deploying the prosthesis within the annulus. Transapical aortic valve implantation was successfully performed in 7 patients in whom surgical risk was deemed excessive because of comorbidities. Echocardiographic median aortic valve area increased from 0.7 +/- 0.1 cm2 (interquartile range) to 1.8 +/- 0.8 cm2 (interquartile range). There were no intraprocedural deaths. At a follow up of 87 +/- 56 days, 6 of 7 patients remain alive and well. CONCLUSIONS: This initial experience suggests that transapical aortic valve implantation without cardiopulmonary bypass is feasible in selected patients with aortic stenosis.

Percutaneous aortic valve implantation retrograde from the femoral artery.

BACKGROUND: Percutaneous aortic valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic aortic valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic aortic valve implantation via the femoral arterial approach is described and the initial experience reported. METHODS AND RESULTS: The valve prosthesis is constructed from a stainless steel stent with an attached trileaflet equine pericardial valve and a fabric cuff. After routine aortic balloon valvuloplasty, a 22F or 24F sheath is advanced from the femoral artery to the aorta. A steerable, deflectable catheter facilitates manipulation of the prosthesis around the aortic arch and through the stenotic valve. Rapid ventricular pacing is used to reduce cardiac output while the delivery balloon is inflated to deploy the prosthesis within the annulus. Percutaneous aortic prosthetic valve implantation was attempted in 18 patients (aged 81+/-6 years) in whom surgical risk was deemed excessive because of comorbidities. Iliac arterial injury, seen in the first 2 patients, did not recur after improvement in screening and access site management. Implantation was successful in 14 patients. After successful implantation, the aortic valve area increased from 0.6+/-0.2 to 1.6+/-0.4 cm2. There were no intraprocedural deaths. At follow-up of 75+/-55 days, 16 patients (89%) remained alive. CONCLUSIONS: This initial experience suggests that percutaneous transarterial aortic valve implantation is feasible in selected high-risk patients with satisfactory short-term outcomes.

Randomized trial of percutaneous coronary intervention for subacute infarct-related coronary artery occlusion to achieve long-term patency and improve ventricular function: the Total Occlusion Study of Canada (TOSCA)-2 trial.

BACKGROUND: In the present study, we sought to determine whether opening a persistently occluded infarct-related artery (IRA) by percutaneous coronary intervention (PCI) in patients beyond the acute phase of myocardial infarction (MI) improves patency and indices of left ventricular (LV) size and function. METHODS AND RESULTS: Between May 2000 and July 2005, 381 patients with an occluded native IRA 3 to 28 days after MI (median 10 days) were randomized to PCI with stenting (PCI) or optimal medical therapy alone. Repeat coronary and LV angiography was performed 1 year after randomization (n=332, 87%). Coprimary end points were IRA patency and change in LV ejection fraction. Secondary end points included change in LV end-systolic and end-diastolic volume indices and wall motion. PCI was successful in 92%. At 1 year, 83% of PCI versus 25% of medical therapy-only patients had a patent IRA (P<0.001). LV ejection fraction increased significantly (P<0.001) in both groups, with no between-group difference: PCI 4.2+/-8.9 (n=150) versus medical therapy 3.5+/-8.2 (n=136; P=0.47). Median change (interquartile range) in LV end-systolic volume index was -0.5 (-9.3 to 5.0) versus 1.0 (-5.7 to 7.3) mL/m2 (P=0.10), whereas median change (interquartile range) in LV end-diastolic volume index was 3.2 (-8.2 to 13.3) versus 5.3 (-4.6 to 23.2) mL/m2 (P=0.07) in the PCI (n=86) and medical therapy-only (n=76) groups, respectively. CONCLUSIONS: PCI with stenting of a persistently occluded IRA in the subacute phase after MI effectively maintains long-term patency but has no effect on LV ejection fraction. On the basis of these findings and the lack of clinical benefit in the main Occluded Artery Trial, routine PCI is not recommended for stable patients with a persistently occluded IRA after MI.

Six-month outcome of transapical transcatheter aortic valve implantation in the initial seven patients.

BACKGROUND: The current treatment of choice for symptomatic aortic stenosis is aortic valve replacement (AVR) with cardiopulmonary bypass (CPB), but AVR is associated with significant operative morbidity and mortality in elderly patients with multiple co-morbid conditions. We recently reported the first successful aortic valve implantation procedure (AVI) via a mini-thoracotomy and left ventricular apical puncture without cardiopulmonary bypass. We now report 6-month follow-up in our initial seven patients. METHODS: Seven patients (77+/-10 years old) with symptomatic aortic stenosis were deemed to be non-surgical candidates for AVR and not suitable for a transfemoral percutaneous heart valve implantation due to aorto-iliac disease. The predicted 30-day operative mortality was 31+/-23% according to logistic Euroscore. Patients underwent minimally invasive transapical AVI. With the guidance of fluoroscopy and transesophageal echocardiography, balloon predilation was followed by deployment of a 26mm Cribier-Edwardstrade mark valve (Edwards Lifesciences Inc., Irvine, CA) during rapid ventricular pacing to reduce forward flow and cardiac motion. RESULTS: Valve implantation was successful in all seven patients. There were no intra-procedural mortalities or complications. Thirty-day operative mortality was 14%. One patient died at day 12 due to pneumonia. Two patients died from non-cardiac diseases at day 51 and 85. The remaining four patients completed 6-month follow-up. The aortic valve area increased from 0.7+/-0.3 to 1.8+/-0.7 and 1.5+/-0.5cm(2) at 1 and 6 months, respectively. The mean transaortic gradient was reduced from 32+/-8 to 10+/-5 and 11+/-8mmHg at 1 and 6 months, respectively. Following AVI, none or trivial, mild, and moderate aortic regurgitation was observed in 4, 2, and 1 patients, respectively. There were no valve-related complications during the follow-up. CONCLUSION: Aortic valve implantation can successfully be performed via a minimally invasive apical approach without the need for cardiopulmonary bypass. The early results in this initial series are encouraging. This initial experience suggests that the minimally invasive transapical approach is a viable alternative for patients in whom open-heart surgery is not feasible or poses unacceptable risks.