Rami Khouzam, MD. DISCLOSURE The Impossible Dream

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<ul><li> Slide 1 </li> <li> Rami Khouzam, MD </li> <li> Slide 2 </li> <li> DISCLOSURE The Impossible Dream </li> <li> Slide 3 </li> <li> INDEX CASE 64 y/o WM presented with left- sided CP for 3 weeks sharp, continuous, radiating down his left arm, not exacerbated by exertion NTG SL: some relief diaphoresis and palpitations (Similar episode 3 months prior) </li> <li> Slide 4 </li> <li> Past Medical History HTN Diverticulosis, AVMs, Multiple GI bleeds Hyperlipidemia Hypothyroidism Cerebellar stroke1996 Fe. Deficiency anemia Aortic insufficiency Atrial fibrillation </li> <li> Slide 5 </li> <li> Family History CAD, HTN in father Colon cancer in uncle Social History Tobacco &amp; ETOH (+), quit after CVA </li> <li> Slide 6 </li> <li> Medications Aspirin 81 mg Plavix 75 mg Ferrous sulfate 325 mg bid Synthroid 0.05 mg Lisinopril 20 mg Nitroglycerin 0.4 mg SL prn Omeprazole 20 mg </li> <li> Slide 7 </li> <li> PE Gen: Pale Neck: JVD 12 cm CV: S 1 S 2 +S 4 Irregular irregularity 3/6 early diastolic murmur LSB apex Lungs: Fine bilat. basal crackles Abdom: +BS Ext: Trace edema bilat. </li> <li> Slide 8 </li> <li> Labs (pertinent) HGB: 11.8 HCT: 37.2 MCV Ferritin TIBC </li> <li> Slide 9 </li> <li> Slide 10 </li> <li> Dipsesta (3 months earlier): No evidence of ischemia EF: 35%. Cardiomyopathy Cardiac catheterization: Normal coronary arteries Aortic root 3+-4+ AI </li> <li> Slide 11 </li> <li> 2D- Echo: Dilated aortic root with moderate to severe aortic insufficiency LV Diastole: 70 mm TEE: Dilated aortic root at the sinuses of Valsalva maximun diameter 6.3 cm 3-4 + AI Mild global hypokinesis. EF ~ 45-50% </li> <li> Slide 12 </li> <li> CT of Chest/ Abdomen/ Pelvis: Dilated aortic root with ectatic descending thoracic and abdominal aorta No ascending aortic aneurysm identified beyond the root </li> <li> Slide 13 </li> <li> Aortic Aneurysms Incidence: (thoracic) ~ 5.9 per 100,000 person-years Lifetime probability of rupture: 75-80 % 5-year untreated survival rates : 10-20% </li> <li> Slide 14 </li> <li> Size matters risk of rupture within 1 year &lt; 5 cm: 4% 6 cm: 43% 8 cm: 80% </li> <li> Slide 15 </li> <li> PATHOPHYSIOLOGY Aneurysm: localized or diffuse aortic dilatation &gt; 50% normal diameter Weakness or defect in the aortic wall Cystic medial degeneration progressive dilatation Atherosclerosis associated but not enough Other factors: CTD </li> <li> Slide 16 </li> <li> CONDITIONS ASSOCIATED WITH ANEURYSMS ADPKD FMD (Fibromuscular Dysplasia) AVM CTD: Ehlers-Danlos type IV, Marfans syndrome, pseudoxanthoma elasticum Coarctation of the aorta Osler-Weber-Rendu syndrome Bacterial endocarditis </li> <li> Slide 17 </li> <li> SURGICAL TREATMENT Aortic valve or graft replacement or both, depends on patient presentation 1970s and 1980s: No longer was any portion of the aorta beyond reach of the cardiovascular surgeon Cooley, Debakey, and others... </li> <li> Slide 18 </li> <li> Michael E. DeBakey, M.D., is the oldest of five children born to Lebanese immigrants Born in 1908, in Lake Charles, LA While still a medical student, he devised a pump that became one of the essential components of the heart-lung machine, which made open-heart surgery possible Has performed more than 60,000 cardiovascular procedures First to perform successful excision and graft replacement of arterial aneurysms </li> <li> Slide 19 </li> <li> A pioneer in the development of an artificial heart, he was the first to use a heart pump successfully in a patient He also conceived the idea of lining a bypass pump and its connections with Dacron velour DeBakey is currently working with NASA to develop a self-contained, miniaturized artificial heart His DeBakey-Raytheon-ITS telemedicine system uses satellites to electronically link remote sites of the world to the Texas Medical Center for medical training and treatment </li> <li> Slide 20 </li> <li> Aortic insufficiency causes: A) Damage of the aortic valve leaflets: Rheumatic endocarditis Trauma Bicuspid aortic valve Rheumatoid arthritis Myxomatous degeneration Ankylosing spondylitis Marfans syndrome Phenfluramine-phenteramine </li> <li> Slide 21 </li> <li> B) Distortion or dilation of the aortic root and ascending aorta: Aortic root dilatation Systemic hypertension Syphilis Reiters syndrome Ankylosing spondylitis Trauma Dissecting aneurysm Elhers-Danlos syndrome Osteogenesis imperfecta Pseudoxanthoma elasticum Inflammatory bowel disease Annuloaortic ectasia </li> <li> Slide 22 </li> <li> Severe valvular lesions... Until the early 1980s: ONLY surgery 1985: Percutaneous aortic valvuloplasty (PAV) was described by Cribier et al Circulation, April 2004 </li> <li> Slide 23 </li> <li> Results Reduces tight stenosis to moderate: final valve area between 0.7 and 1.1 cm 2 (clearly inferior to a valvular prosthesis usually valve area &gt;1.5 cm 2 ) </li> <li> Slide 24 </li> <li> Risks Hospital mortality from 3.5%-13.5% within 24 hours, 20%-25% of the patients at least 1 serious complication </li> <li> Slide 25 </li> <li> Long-Term Results Benefit decreases and finally disappears after a few months It is now recognized that PAV alone does not change the natural course of the disease </li> <li> Slide 26 </li> <li> Slide 27 </li> <li> New Frontiers Or New Dead-Ends??? </li> <li> Slide 28 </li> <li> Slide 29 </li> <li> Percutaneous Valve Replacement &amp; Repair Mid 1960s: first experiments started 1992: Andersen et al porcine bioprosthetic valve attached to a wire stent in pigs chest Followed by other animal models </li> <li> Slide 30 </li> <li> Slide 31 </li> <li> 2000: percutaneous pulmonary valve replacement started in humans with the report by Bonhoeffer et al (bovine jugular vein sutured into a stent) Lutter et al: similar experiments with a porcine aortic valve mounted into a self- expandable nitinol stent </li> <li> Slide 32 </li> <li> Satisfactory durability of the devices for a period up to 2 years Late 2002: First percutaneous aortic valve implantation in humans, performed by Cribier, in a 57 yo man with severe aortic stenosis, cardiogenic shock and contraindications for surgery </li> <li> Slide 33 </li> <li> Good valve function: AVA 1.6 cm 2 However, the patient died of severe extracardiac complications 4 months later Since then, 6 other such procedures have been performed </li> <li> Slide 34 </li> <li> JACC, March 2004 </li> <li> Slide 35 </li> <li> Prolonged life expectancy, aging population, increased number of patients with degenerative calcific aortic stenosis who NEED Surgical AVR A subset of patients, elderly with declining health status or life-threatening comorbidities AVR too high risk or contraindicated </li> <li> Slide 36 </li> <li> Limited therapeutic options: interest in the development of percutaneously delivered bioprosthetic aortic heart valve </li> <li> Slide 37 </li> <li> Apr. 2002- Aug. 2003: 6 patients; 5 males and 1 female Each patient declined for surgery by cardiac surgeon 3 in cardiogenic shock. All in (NYHA) class IV Balloon valvuloplasty previously attempted in 4 cases </li> <li> Slide 38 </li> <li> Slide 39 </li> <li> Aspirin (160 mg) and Plavix (300 mg): the day before the procedure Trans-septal catheterization from the right femoral vein, heparin 5,000 IV A 7-F flotation balloon catheter for anterograde crossing of the aortic valve </li> <li> Slide 40 </li> <li> Transseptal puncture dilated with a 10- mm balloon catheter, 23 mm balloon catheter advanced from the right femoral vein to predilate the native aortic valve Through a 24-F sheath PHV advanced over the wire, across the interatrial septum within the stenotic native valve </li> <li> Slide 41 </li> <li> Slide 42 </li> <li> In 2 patients, rapid cardiac pacing (200 to 220 beats/min) of the right ventricle during PHV delivery to decrease aortic blood flow and prevent the risk of PHV migration during balloon inflation Post-procedural treatment included aspirin (160 mg), plavix (75 mg) No COUMADIN needed </li> <li> Slide 43 </li> <li> Slide 44 </li> <li> Slide 45 </li> <li> Slide 46 </li> <li> in AVA from 0.49 0.8 cm 2 to 1.66 0.13 cm 2 (p </li> <li> AVA ~ 1.7 cm 2 obtained in all successful cases &gt; 3-fold improvement consistently associated with a striking early improvement of the left ventricular function Results significantly better than those obtained after balloon aortic valvuloplasty which rarely provides in valve area above 0.8 cm 2 </li> <li> Slide 51 </li> <li> Survival &amp; Outcome ?? In this selected population of severe aortic stenosis associated with multiple potentially fatal comorbidities, prolonged survival is unlikely Paravalvular aortic regurgitation noted in all patients post-PHV implantation </li> <li> Slide 52 </li> <li> Advantages: Bioprosthetic valve with stainless steel stent: No NEED for long-term anticoagulation ASA &amp; Plavix: enough I-REVIVE study: Ongoing pilot clinical trial will allow further refinement of the technique and assessment of short and long-term clinical outcomes </li> <li> Slide 53 </li> <li> JACC, March 2004 </li> <li> Slide 54 </li> <li> The technique that will be adopted by the majority of cardiologists has to be: Safe Very low risk of mortality &amp; morbidity Easy to perform The Valve has to be : Ideal Biocompatible with no long-term morbidity Should last preferably for a lifetime but at least 7-10 years Expandable (child) Economical </li> <li> Slide 55 </li> <li> EXCITING new era for percutaneous cardiac intervention If such valves and procedures are proved safe and effective Hundreds of thousands of patients with calcific aortic stenosis &amp; thousands of patients with pulmonic insufficiency may benefit ? Maybe alsoAI </li> <li> Slide 56 </li> <li> Conclusions At the present stage, there are more questions than answers: How can we prevent the obstruction of coronary ostia and paravalvular leaks in asymmetric calcified orifices? What will be the ideal material? Jugular bovine veins are limited in size, their outcome in the systemic circulation is unknown Valves made of polymer or biological material are to be designed and evaluated </li> <li> Slide 57 </li> <li> Lessons from the past suggest that in this field, a close collaboration between interventionists and surgeons is of utmost importance First applications of percutaneous aortic valve replacement in humans opens a new era for research and potential clinical application for the percutaneous treatment of acquired valve disease </li> <li> Slide 58 </li> <li> Zeus made Pandora, the first mortal woman, because he was mad at Prometheus who had had given the mortals special gifts, so he decided to give them one more: Pandora Each god gave her something to make her perfect. Venus gave her beauty, Mercury gave her persuasion, Apollo gave her music, Hephaestus gave her voice, Hermes gave her pettiness in her tiny brain, etc. Finally she was ready for Earth </li> <li> Slide 59 </li> <li> Zeus gave her to Epimetheus (Prometheus' brother) Prometheus had said to Epimetheus not to take anything from the Olympians, especially Zeus Epimetheus was about to decline, but as soon as he looked at her and saw her beauty, he accepted Zeus' gift Epimetheus gave Pandora a box that she was forbidden to open </li> <li> Slide 60 </li> <li> Every day Pandora wondered what was in the box She knew she mustn't open it, but she was extremely curious and could not bear not to know its contents As soon as she pulled the cover off, all of the evil and mistrust flew out into the world When Pandora looked at the bottom of the box, she saw that the only thing left was hope to Comfort mankind </li> <li> Slide 61 </li> <li> From a DREAM.. To a REALITY ?? </li> <li> Slide 62 </li> <li> Slide 63 </li> </ul>