Short term-efficacy and tolerability of Rheocarna, a novel direct hemoperfusion adsorptive column, for chronic limb-threatening ischemia in dialysis patients: A single-center case series.

INTRODUCTION: With population aging and lifestyle changes, the number of patients with chronic limb-threatening ischemia (CLTI) is increasing, and refractory or recurrent lesions are more common, especially in chronic dialysis patients. In March 2021, a new type of adsorptive cellulose bead column immobilized with dextran sulfate and L-tryptophan for direct hemoperfusion (DHP) was approved by Japan's medical insurance system as a treatment for CLTI. METHODS: We retrospectively analyzed 17 cases of CLTI in dialysis patients treated with DHP using the novel column (Rheocarna) (DHP-R) at our hospital from May 2021 to October 2022. The short-term of efficacy of DHP-R was judged qualitatively by the foot care team every 2 weeks based on the assessment of skin color, warmth, ulcer epithelialization or shrinkage of the ulcer area, and foot pain. The final judgment of efficacy was made after the final DHP-R session. RESULTS: The median age of patients was 66 years, the median dialysis duration was 10 years, 15 cases (88%) were male, and 15 cases (88%) had diabetes. The median total number of sessions was eight. In comparing the groups in which DHP-R was effective and ineffective, there was no significant difference in any factors including patient background data (i.e., age, diabetes, low-density lipoprotein cholesterol, hemoglobin, dialysis duration, etc.), type of anticoagulants, and presence of episodes of blood pressure drop or circuit clotting during session. Three cases with symptomatic hypotension during the session and two cases with circuit clotting that did not improve with increased heparin dose all resolved immediately after changing the anticoagulant from heparin to nafamostat mesylate (NM). CONCLUSION: Identification of patients' characteristics in which DHP-R is favorable and some reliable index that allow a rapid decision to continue DHP-R are needed. In addition, validating whether the use of NM as anticoagulant affects the efficacy of DHP-R for CTLI treatment remains a challenge to resolve.

Aortic Valve Reconstruction Using Autologous Pericardium for Aortic Stenosis.

BACKGROUND: To determine the feasibility of original aortic valve reconstruction (AVRec) for patients with aortic stenosis (AS), 416 consecutive cases were reviewed. METHODS AND RESULTS: AVRecs for AS were performed for 416 patients from April 2007 through April 2013. All 416 patients were retrospectively reviewed. One hundred and fourteen patients had bicuspid valves and 16 had unicuspid valves. There were 182 men and 234 women. Mean age was 71.2±12.0 years old. On preoperative echocardiography, peak pressure gradient averaged 79.0±33.6 mmHg. Surgical annular diameter was 20.1±2.8 mm. The procedure is based on independent tricuspid replacement by autologous pericardium using original sizing apparatus and template. There was no conversion to prosthetic valve replacement. There were 8 in-hospital mortalities due to non-cardiac cause. On postoperative echocardiography, peak pressure gradient averaged 21.2±10.7 mmHg 1 week after surgery and 14.3±5.0 mmHg 5.5 years after surgery. Four reoperations were done for infective endocarditis. The other 412 patients had less than mild regurgitation. No thrombo-embolic events were recorded. The mean follow-up period was 25.2±17.5 months. Freedom from reoperation was 96.7% with 73-month follow-up. CONCLUSIONS: Medium-term results were excellent. Original AVRec was feasible for the patients with AS. Long-term data will be presented in the future.

Aortic valve reconstruction using autologous pericardium for patients aged less than 60 years.

OBJECTIVE: We have performed an original aortic valve reconstruction using autologous pericardium. The feasibility for patients aged less than 60 years is reviewed. METHODS: From April 2007 to April 2013, aortic valve reconstruction was performed in 108 patients aged less than 60 years. A total of 51 patients had aortic stenosis, 7 patients had annuloaortic ectasia, 7 patients had infective endocarditis, and 43 patients had aortic regurgitation. Fifty-seven patients had bicuspid valves, and 11 patients had unicuspid valves. There were 75 male and 33 female patients, with a mean age of 47.8 ± 11.2 years. Preoperative echocardiography showed an average peak pressure gradient of 86.1 ± 35.1 mm Hg with aortic stenosis. The surgical procedure is based on the independent tricuspid replacement using autologous pericardium. First, the distance between the commissures is measured using an original sizing apparatus, and then the pericardial cusp is trimmed using an original template and sutured to the annulus. RESULTS: There was no conversion to prosthetic valve replacement. There were no in-hospital mortalities. Postoperative echocardiography showed an average peak pressure gradient of 14.8 ± 7.8 mm Hg 1 week after surgery and 12.8 ± 3.1 mm Hg 4 years after surgery. One patient required reoperation because of infective endocarditis. The other 107 patients showed less than mild aortic regurgitation. No thromboembolic events were recorded. The mean follow-up period was 34.2 ± 15.7 months. Freedom from reoperation was 98.9% with 76 months of follow-up. CONCLUSIONS: Original aortic valve reconstruction was feasible for patients aged less than 60 years. Long-term data will be disclosed in the future.

Reconstruction of bicuspid aortic valve with autologous pericardium--usefulness of tricuspidization.

BACKGROUND: This study describes the surgical treatment of bicuspid aortic valve with original aortic valve reconstruction. METHODS AND RESULTS: Aortic valve reconstruction was done in 102 patients with bicuspid aortic valve from April 2007 through September 2011. Thirty-four patients with ascending aortic diameter >45 mm underwent hemi-arch aortic replacement concomitantly. Seventy-seven patients had aortic stenosis, and 25 had aortic regurgitation (AR). Mean age was 63.7±10.0 years old. There were 55 men and 47 women. Harvested pericardium is treated with 0.6% glutaraldehyde solution. The distance between commissures is measured with an original sizing instrument. For bicuspid valve with raphe, the raphe is considered as a commissure in order to measure the distance between each commissure. Without a raphe, we create a new annular margin and commissure using coronary ostium and the sizing instrument as a guide. Then, pericardium is trimmed with original template. Three cusps are sutured independently. The preoperative averaged peak pressure gradient of 71.1±39.0 mmHg was decreased to 16.2±8.8, 13.3±6.0, and 13.9±5.6 mmHg, respectively 1 week, 1 year, and 3 years after operation. AR was trivial. One reoperation was recorded. Mean follow-up was 733 days. There were 5 late mortalities. No thromboembolic event was recorded. CONCLUSIONS: Medium-term results were excellent. Tricuspidization gave good opening and closure of aortic valve with excellent hemodynamics.

Aortic valve reconstruction using autologous pericardium for ages over 80 years.

BACKGROUND: We performed original aortic valve reconstruction using autologous pericardium; the feasibility for elderly patients is reviewed. METHODS: From April 2007 through September 2011, aortic valve reconstruction was carried out in 86 patients over the age of 80 years. Twenty-seven patients were male and 59 were female. Mean age was 82.9 ± 2.5 years. Seventy-two patients had aortic stenosis and 14 had aortic regurgitation. Mean preoperative surgical annular diameter was 19.5 ± 2.5 mm. There were 80 (90.7%) cases of small aortic annulus. Mean preoperative logistic EuroSCORE was 22.9 ± 15.8. RESULTS: Isolated aortic valve reconstructions were performed in 51 patients. Concomitant procedures included coronary artery bypass grafting in 6, hemiarch aortic replacements in 6, 9 maze procedures, and some combinations. No conversion to valve replacement was required. Mean follow-up was 1243 days. There were 3 hospital deaths due to noncardiac causes. No reoperation was needed. Survival at 56 months was 87.0%. No thromboembolic event occurred. Echocardiography 3.5 years after surgery revealed an average peak pressure gradient of 14.6 ± 3.8 mm Hg. No moderate or severe regurgitation was recorded. CONCLUSIONS: Aortic valve reconstruction is feasible for patients older than 80 years, resulting in good hemodynamics and a better quality of life, without anticoagulation.

A total of 404 cases of aortic valve reconstruction with glutaraldehyde-treated autologous pericardium.

OBJECTIVE: To determine the feasibility of original aortic valve reconstruction, 404 consecutive cases were reviewed. The early results are reported here. METHODS: Aortic valve reconstruction was performed for 404 patients from April 2007 through September 2011. The results for all 404 patients were reviewed retrospectively. There were 289 patients with aortic stenosis and 115 patients with aortic regurgitation. One hundred two patients had bicuspid aortic valves, 13 patients had unicuspid valves, and 2 patients had quadricuspid valves. There were 201 males and 203 females. Mean age was 69.0 ± 12.9 years. Preoperative echocardiography revealed an average peak pressure gradient of 79.6 ± 32.5 mm Hg with aortic stenosis. Surgical annular diameter was 20.3 ± 3.2 mm. The surgical procedure is based on the independent tricuspid replacement by autologous pericardium. First, the distance between the commissure is measured with an original sizing apparatus, then the pericardial cusp is trimmed using an original template, and it is sutured to the annulus. RESULTS: There were no conversions to prosthetic valve replacement. There were 7 in-hospital mortalities resulting from a noncardiac cause. Postoperative echocardiography revealed an average peak pressure gradient of 19.8 ± 10.2 mm Hg 1 week after surgery and 13.8 ± 3.7 mm Hg 3.5 years after surgery. Two patients needed reoperation because of infective endocarditis. The other 402 patients showed less than mild aortic regurgitation. No thromboembolic events were recorded. The mean follow-up period was 23.7 ± 13.1 months. Freedom from reoperation was 96.2% at 53 months of follow-up. CONCLUSIONS: Original aortic valve reconstruction was feasible in patients with various aortic valve diseases. Long-term data will be disclosed in the future.

Aortic valve reconstruction with autologous pericardium for dialysis patients.

OBJECTIVES: This study aimed to report on original aortic valve reconstruction for patients on dialysis. METHODS: Aortic valve reconstruction has been performed on 404 cases from April 2007 through September 2011. Among them, 54 cases on haemodialysis were retrospectively studied. Forty-seven patients had aortic stenosis, 5 had aortic regurgitation (AR), and 2 had infective endocarditis. Mean age was 70.2 ± 8.5 years. There were 35 males and 19 females. There were 27 primary aortic valve reconstructions, 11 with CABG, 6 with ascending aortic replacement, 5 with mitral valve repair and 4 with maze. First, in the procedure, harvested pericardium was treated with 0.6% glutaraldehyde solution. After resecting the cusps, we measured the distance between commissures with original sizing instrument. Then, the pericardium was trimmed with the original template. Three cusps were sutured to each annulus. RESULTS: Peak pressure gradient averaged to 66.0 ± 28.2 mmHg preoperatively, and decreased to 23.4 ± 10.7, 13.8 ± 5.5 and 13.3 ± 2.3 mmHg, 1 week, 1 year, and 3 years after the operation, respectively. No calcification was detected with echocardiographic follow-up. Recurrence of AR was not recorded with the mean follow-up of 847 days except for 1 case reoperated on for infective endocarditis 2.5 years after the operation. Three hospital deaths were recorded due to non-cardiac causes. Other patients were in good condition. There was no thromboembolic event. CONCLUSIONS: Medium-term results are excellent. Since warfarin for dialysis patients becomes problematic, a postoperative warfarin-free status is desirable. Aortic valve reconstruction can provide patients with a better quality of life without warfarin.

Aortic valve reconstruction of unicuspid aortic valve by tricuspidization using autologous pericardium.

BACKGROUND: Unicuspid aortic valve is a rare anatomic variant, but patients may require intervention for severe valve dysfunction at a young age. We introduce a new reconstructive technique for diseased unicuspid valve by tricuspidization with glutaraldehyde-treated autologous pericardium. METHODS: From April 2007 through January 2011, we performed 304 cases of aortic valve reconstruction using glutaraldehyde-treated autologous pericardium. During the same period, we encountered 9 patients with unicuspid aortic valve, including 8 male patients and 1 female patient. Mean age was 48.9±19.9 years (14-78 years). Two patients had aortic stenosis (AS), 1 had aortic regurgitation (AR), and 6 patients had both. Our original aortic valve reconstruction technique is characterized by the independent replacement of 3 leaflets with separate measurement of length between each commissure. In the case of a unicuspid aortic valve, we create a new commissure at a higher point along the raphe at the same level with the 1 normally existing commissure. RESULTS: No early mortality or major morbidity was recorded. Postoperative echocardiography showed trivial or no AR, with the peak pressure gradients averaging 10.6±3.3 mm Hg. One-year follow-up echocardiography revealed that the peak pressure gradients averaged 8.6±3.7 mm Hg, with trivial or no AR. The mean follow-up period was 551.1±51.4 days. All 9 patients are in good condition. No reoperation or any additional intervention has been necessary. CONCLUSIONS: Diseased unicuspid aortic valves were treated by our original aortic valve reconstruction technique with excellent early results. We continue to study the long-term results.

Angioplasty with autologous pericardium for bilateral coronary ostial stenosis in Takayasu disease.

Coronary ostial stenosis is usually treated by conventional coronary artery bypass graft surgery. Although patch angioplasty is a widely accepted alternative surgical treatment, it has been reported sporadically. We encountered bilateral ostial stenosis with Takayasu disease. This report describes successful patch angioplasty using glutaraldehyde-treated autologous pericardium of bilateral coronary ostial stenosis owing to Takayasu disease.

Original aortic valve plasty with autologous pericardium for quadricuspid valve.

Quadricuspid aortic valves represent a very rare pathology. Most cases have been discovered incidentally during heart operations or at autopsy. Patients may become symptomatic with aortic regurgitation. We encountered a symptomatic patient with aortic regurgitation and a quadricuspid aortic valve. Successful aortic valve plasty was done with our original technique of tricuspid replacement by glutaraldehyde-treated autologous pericardium.

Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease.

Aortic valve disease is usually treated by prosthetic valve replacement. We have performed aortic valve plasty (AVP) using glutaraldehyde-treated autologous pericardium. AVP was performed for 88 patients from April 2007 through August 2009. Sixty-five patients had aortic stenosis, and 23 patients had aortic regurgitation (AR). Twenty-one patients showed bicuspid aortic valves, and one patient showed quadricuspid valve. There were 43 males and 45 females. Their mean age was 70.6±10.5 years old. First, diseased leaflets excised. Then, the distance between each commissure was measured. The new leaflet were trimmed with an original template from a glutaraldehyde-treated autologous pericardium sample. Finally, the annular margin of the pericardial leaflet was running sutured to each annulus. There was no operative mortality or embolic event. Postoperative echocardiography revealed a mean peak pressure gradient (PG) of 19.0±9.1 mmHg one week after surgery. Thirty-two patients had echocardiography one year after surgery. The peak PG became 12.9±5.8 mmHg. Ten patients showed no AR, 20 patients showed trivial AR, and two patients showed mild AR. Freedom from reoperation is 100% at three years follow-up.